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\rsid16724824\rsid16729239\rsid16733656}{\*\generator Microsoft Word 10.0.2627;}{\info{\title Research on the Terminally Ill:}{\author Mary M. Flannery}{\operator Mary M. Flannery}{\creatim\yr2003\mo4\dy29\hr21\min57}{\revtim\yr2003\mo4\dy29\hr21\min57}
{\version2}{\edmins1}{\nofpages58}{\nofwords14071}{\nofchars80207}{\*\company Flannery Law}{\nofcharsws94090}{\vern16437}}\margl1440\margr1440 \widowctrl\ftnbj\aenddoc\noxlattoyen\expshrtn\noultrlspc\dntblnsbdb\nospaceforul\formshade\horzdoc\dgmargin
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\par }{\insrsid14420898\charrsid2832199 Research on the Terminally Ill:
\par }{\insrsid10777413\charrsid2832199 A Balancing Act Between Facilitating Access to Innovative Therapies and Protecting Vulnerable Subjec}{\insrsid12728299\charrsid2832199 ts in Search of One Last Hope for}{\insrsid10777413\charrsid2832199  Survival}{
\insrsid13258570\charrsid2832199 
\par }{\insrsid13258570 
\par 
\par 
\par 
\par 
\par 
\par Mary M. Flannery
\par Class of 2003
\par April 29, 2003
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par 
\par }\pard \ql \li0\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin0\itap0\pararsid13258570 {\insrsid13258570 
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\par This paper is submitted in satisfaction of both the course requirement and the third year written work requirement.}{\insrsid13593037 \page }{\insrsid13258570 
\par }\pard \qc \li720\ri720\sa360\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid4871813 {\i\insrsid7481879 Abstract}{\i\insrsid15797060 
\par }\pard \qj \fi720\li720\ri720\sa360\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid7481879 {\insrsid7481879 This paper presents the application of the current federal regulatory }{\insrsid13505936 system}{\insrsid7481879  }{
\insrsid13505936 governing }{\insrsid7481879 clinical research}{\insrsid8549709  in the United States}{\insrsid7481879  to research involving terminally ill subjects, with a special emphasis on those }{\insrsid11942569 patients}{\insrsid7481879 
 battling terminal cancer.  }{\insrsid8549709 To begin, I describe the current regulatory system governing the approval process for new drugs, the guidelines established by the federal regu
lations for the conduct of clinical research involving human subjects, and the federal initiatives t}{\insrsid13505936 hat have been developed}{\insrsid8549709  to increase and expedite access to experimental therapies for }{\insrsid11942569 terminally}{
\insrsid8549709  ill patients.  In addition to tracing the roots of the informed consent paradigm in research with human subjects, I also consider the sufficiency and efficacy of this model as applied to clinical research involving the }{\insrsid11942569 
terminally}{\insrsid8549709  ill.  Addressing in particular the continuing war against cancer, I present some of t
he most notorious controversies and case law that have emerged in the last century with respect to new experimental cancer therapies, as well as the role of Congress in the ongoing debate concerning access to investigational treatments by terminal patient
s.  Finally, I consider the specific vulnerabilities and }{\insrsid11942569 experiences}{\insrsid8549709  of desperately ill individuals fighting to survive, characteristics that make them particularly susceptible to coercion and exploitation}{
\insrsid5920918 , and, therefore, potentially in need of }{\insrsid13505936 additional safeguards to adequately }{\insrsid5920918 protect them in the research endeavor.}{\insrsid11954432\charrsid11954432 
\par }\pard \qj \li0\ri0\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid13593037 \page }{\insrsid16458034 I.  }{\ul\insrsid16458034 Introduction}{\ul\insrsid16458034\charrsid16458034 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12728299 {\insrsid15018181 During }{\insrsid2847248 a congressional hearing }{\insrsid12728299 held }{\insrsid2847248 
last year addressing the current state of cancer prevention and research in the United States, Tommy }{\insrsid8585313 Thompson}{\insrsid2847248 , Secretary of the }{\insrsid8585313 Department}{\insrsid2847248  of Health and Human Services}{
\insrsid12728299 ,}{\insrsid2847248  offered sobering statistic}{\insrsid14499141 s from the war against cancer: }{\insrsid12728299  }{\insrsid14499141 i}{\insrsid2847248 n 2002, 1.2 million new cases of cancer were expected in the United States, }{
\insrsid9723695 and }{\insrsid2847248 approximately 550,000 Americans}{\insrsid14499141  are}{\insrsid9723695  expected to die of cancer}{\insrsid14499141  annually}{\insrsid9723695 , translating into roughly 1,500 deaths per day, and a quarter of all de}
{\insrsid12662146 aths annually, caused by various}{\insrsid13138599  forms of the destructive}{\insrsid9723695  disease.}{\cs16\super\insrsid9723695 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See Cancer Prevention and Research: }{
\i\insrsid1061099\charrsid12728299 Hearing Before the Subcomm. on Labor, Health and Human Services, and Education of the Senate Comm. on Appropriations}{\insrsid1061099 , 107th  Cong. (June 4, 2002) (s
tatement of Sec. Tommy Thompson, Department of Health and Human Services).}}}{\insrsid14499141   }{\insrsid12662146 In addition, }{\insrsid14499141 Senator Tom Harkin aptly noted in his opening statement, \'93
[a]ll of us in this room today have had our lives touched by this killer}{\insrsid14710441 ,\'94 revealing that he had lost his only two sisters and two of his three brothers to cancer.}{\cs16\super\insrsid4546759 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
(statement of Sen. Tom Harkin, Chairman, Senate Subcomm. on Labor, Health and Human Services, and Education).}}}{\insrsid12662146   }{\insrsid14944432 
\par }{\insrsid12662146 Dismal as the numbers are, }{\insrsid14710441 the hearing }{\insrsid12662146 did not focus on the devastating statistics with which we are all undoubtedly aware, but rather }{\insrsid14710441 was devoted to address}{\insrsid14944432 ing
}{\insrsid14710441  the effectiveness and progress of the administration\rquote s \'93three-pronged offensive \endash  research, treatment and prevention.\'94}{\cs16\super\insrsid4546759 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }}}{\insrsid13446702   }{\insrsid8653767 
Of particular relevance to this paper, several witnesses at the hearing stressed the }{\insrsid8585313 importance}{\insrsid8653767  of clinical trials in cance
r research.  Secretary Thompson, for example, posed the crucial question of how to get new and promising cancer drugs to the market as quickly as possible, and noted a positive trend toward increased access to such therapies, stating that one-half of the 
cancer drugs in the last three years have }{\insrsid12728299 made it to the market}{\insrsid8653767  within six months.}{\cs16\super\insrsid15018181 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
(statement of Tommy Thompson).}}}{\insrsid8655050 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid8656953 \tab While effective clinical research }{\insrsid1065011 
has significantly contributed to the advances made thus far in the fight against cancer, and will un}{\insrsid12728299 questionably}{\insrsid1065011  continue to do so in the 
future, several aspects of the current clinical research mechanisms in place have prompted interested parties to enlist in the war }{\insrsid12728299 against cancer, as well as other life-threatening diseases, }{\insrsid1065011 and }{\insrsid12728299 to }
{\insrsid1065011 voice their concerns}{\insrsid9593128  on a }{\insrsid6034019 number of issues, including }{\insrsid9593128 claims that there are insufficient resources to make clinical trials function as effectively as possible and }{\insrsid6034019 
complaints }{\insrsid9593128 that investigators are overly burdened with complex regulatory procedures.  In addition, and more germane to this paper, there is a concern that strikes at the heart of the ethics of clinical trial research: }{
\insrsid14944432  }{\insrsid9593128 the protection of human subjects.  As one witness testifying at the above hearing asserted, while clinical trials involving patients with cancer are \'93the requisite path for our advances\'94 in cancer research, \'93
unfortunately, there are infrequent \endash  but, in some cases, serious \endash  lapses in protection of human subjects.\'94}{\cs16\super\insrsid15018181 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 (statem
ent of Dr. Ronald Herberman, Director, University of Pittsburgh Cancer Institute).}}}{\insrsid5972266   
\par \tab In the pages that follow I will }{\insrsid7221357 focus on}{\insrsid5972266  one group of human subjects in particular, a group of individuals for whom conven
tional therapies are either unavailable or ineffective and for whom experimental therapies and drugs may offer their only hope of survival.  }{\insrsid13708168 Perhaps more so than any other class of research subjects, the plight }{\insrsid8585313 
of terminally}{\insrsid13708168  ill patients exemplifies the balancing act engaged in by the Food and Drug Administration (FDA), }{\insrsid6034019 which has struggled at times to emphasize}{\insrsid13708168  the value of }{\insrsid8585313 promoting}{
\insrsid13708168  access to experim}{\insrsid6034019 ental and unapproved treatments, while at the same time, recognizing }{\insrsid12728299 the importance and }{\insrsid13708168 value of protecting vulnerable research subjects.}{
\cs16\super\insrsid13708168 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Baruch A. Brody, }{\i\insrsid1061099 Research on the Vulnerable Sick}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 Beyond Consent}{\insrsid1061099 
 45 (Jeffrey P. Kahn et al. eds., Oxford University Press, 1998).}}}{\insrsid7221357 
  Specifically, this paper presents the application of the current regulatory framework for clinical research to trials and research involving terminally ill subjects, with a special emphasis on those patients battling termina
l cancer.  Questions posed and considered include whether the informed consent model adequately protects terminally ill subjects who choose to participate in research}{\insrsid6034019 ;}{\insrsid7221357 
 whether the vulnerabilities of this class of subjects warrants their inclusion in the federal regulations that explicitly provide additional safeguards to certain \'93vulnerable\'94 populations, such as pregnant}{\insrsid6034019 
 women, children, and prisoners;}{\insrsid7221357  and whether the FDA and related regulatory powers have struck an appropriate balance between providing expanded and expedited access to potentially life-saving, albeit experimental, therapies and }{
\insrsid4784187 sufficiently protecting those subjects who may be willing to try anything in the hope that they will win the war that has likely already ravaged them both physically as well as psychologically.
\par }{\insrsid8587280 \tab }{\insrsid15208592 With those issues in mind, t}{\insrsid8587280 
his paper first sets out the federal regulatory system governing the approval process for new drugs in the United States, the guidelines established by the federal regulations for the conduct of research }{\insrsid8585313 involving}{\insrsid8587280 
 human subjects, and }{\insrsid16604698 the federal initiatives that have been developed in or}{\insrsid8981642 der to increase and expedite}{\insrsid13780257  access to }{\insrsid16604698 experimental therap}{\insrsid12728299 ies for}{\insrsid8981642  }{
\insrsid8585313 terminally}{\insrsid8981642  ill patients.  }{\insrsid12728299 In addition, }{\insrsid8981642 it }{\insrsid3893597 traces the roots of the informed consent paradigm that has become central to clinical research with human subjects, and }{
\insrsid8981642 considers }{\insrsid3893597 the efficacy and }{\insrsid8585313 sufficiency}{\insrsid3893597  of this model as applied to clinical research involving the }{\insrsid8585313 terminally}{\insrsid3893597  ill.}{\insrsid16660222 
  Delving more specifically into the war on cancer,}{\insrsid1335985  this paper briefly describes some}{\insrsid12728299  of the most}{\insrsid16660222  notorious controversies and case law }{\insrsid1335985 
that have emerged in the last century concerning}{\insrsid16660222  ne}{\insrsid1335985 w experimental cancer therapies and the expe}{\insrsid15208592 riences of desperate patients }{\insrsid12728299 fighting t}{\insrsid15208592 o}{\insrsid1335985 
 gain access to them.  }{\insrsid12728299 Likewise, the}{\insrsid1335985  role of Congress and the efforts of concerned members to }{\insrsid13780257 
increase access to investigational treatments, as well as attempts by other interested parties to ensure the safety and protection of research subjects, will be highlighted.  Finally, this paper will consider }{\insrsid13203042 the specific vulner
abilities of individuals battling terminal illnesses, characteristics that make them particularly susceptible to coercion, undue influence and exploitation in the research endeavor.  After considering such issues, the reader is encouraged to draw his or h
er own conclusion }{\insrsid8585313 concerning}{\insrsid13203042  the appropriate balance to be struck between expanding access to }{\insrsid8585313 experimental}{\insrsid13203042  therapies for the terminally ill and }{\insrsid3542307 
providing adequate safeguards to guarantee the protection of desperately ill subjects who may view investigational and unapproved treatments as their last chance for survival.}{\ul\insrsid8981642 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid16458034 II.  }{\ul\insrsid16458034\charrsid16458034 An Overview of the Drug Approval Process}{
\ul\insrsid11667704\charrsid11667704 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid6294014 In order to }{\insrsid10189978 get }{\insrsid6294014 governmental approval for new drugs, ap}{\insrsid13384500 
plicants must meet the }{\insrsid6294014  safety and effectiveness standards established under the federal Food, Drug }{\insrsid11102593 and Cosmetic Act of 1938 (FDCA}{\insrsid6294014 ), which requires \'93substantial evidence\'94
 of safety and efficacy prior to approval.}{\cs16\super\insrsid6294014 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 U.S.C. \'a7 355(d); }{\i\insrsid1061099 see }{\insrsid1061099 Michael E. Horwin, }{\i\insrsid1061099 \'93War on Cancer\'94: Why Does the FDA Deny Access to Alternative Cancer Treatments?}{
\insrsid1061099 , 38 Cal. W.L. Rev. 189, 197 (2001).}}}{\insrsid6294014   }{\insrsid9057824 Spurred by a national scandal in which nearly one hundred people died after ingesting a drug marketed as \'93Elixir Sulfanilamide,\'94 the 
liquid base of which was }{\insrsid3236562 poisonous}{\insrsid9057824 , the FDCA }{\insrsid7809547 imposed a new and strengthened drug approval process requiring, among other things, drug sponsors to provide evidence of safety before marketing a drug.}{
\cs16\super\insrsid7809547 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Richard J. Nelson, Note & Comment, }{\i\insrsid1061099 Regulation of Investigational New Drugs: \'93Giant Step for the Sick and Dying\'94?}{\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 77 Geo. L
.J. 463, 469 (1988).}}}{\insrsid1523633   However, it did not require evidence that the drug was in fact beneficial for its intended uses.}{\cs16\super\insrsid1523633 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid1523633 
  It was not until another drug-related tragedy in the early 1960s that FDA control over the approval and distribution of new drugs was tightened.  The thalidomide tragedy and the tremendous public reaction to its h
orrific side-effects, including severely deformed and disabled babies, prompted Congress to amend the FDCA in 1962 to provide a more }{\insrsid3236562 aggressive}{\insrsid1523633  system of pre-market }{\insrsid3236562 review}{\insrsid1523633 
 and mandatory approval before bringing new drugs into the market.}{\cs16\super\insrsid1523633 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 
see also FDA Proposals to Ease Restrictions on the Use and Sale of Experimental Drugs, 1987: Hearing Before a Subcomm. of the Comm. on Government Operations}{\insrsid1061099 , 100th Cong., 1st Sess. 15 (1987) (testimony of Richard C
ooper, former Chief Counsel of FDA) (asserting that the thalidomide disaster was the \'93actual triggering point\'94 for the 1962 amendments); }{\i\insrsid1061099 Views of Senators Kefauver, Carroll, Dodd, Hart, and Long}{\insrsid1061099 
, 1962 U.S. Code Cong. & Admin. News 2898, 2905-07 (citing history of thalidomide as reason for strengthening drug approval process, and noting that \'93
[u]nder [the present system] it is the American people who unknowingly serve as guinea pigs for experiments by the drug companies\'94); 108 Cong. Rec. 17,378 (1962) (statement of Sen. Hruska) (citing history of thalidomide \'93
to illustrate the necessity of additional provisions in the law\'94).}}}{\insrsid13843883   In addition to adding the safety and effectiveness }{\insrsid12728299 \'93substantial evidence\'94 standard}{\insrsid13843883 
, the amendments granted the FDA discretionary power over determining necessary clinical testing of proposed drugs and allowed the FDA to revoke authorization for clinical trials if there was any evidence that the drug was unsafe.}{
\cs16\super\insrsid13843883 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified in scattered sections of 21 U.S.C. \'a7\'a7 301-81); }{\i\insrsid1061099 see }{\insrsid1061099 21 U.S.C. \'a7\'a7 321, 355.}}}{\insrsid7231775 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid16458034 A.  }{\ul\insrsid16458034 Investigational New Drugs (INDs) and }{\ul\insrsid15220766 Preclinical Hurdles}{
\ul\insrsid6061098\charrsid6061098 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16406746 {\insrsid10840542 
The preclinical hurdles that must be passed in order to gain FDA approval begin with an initial phase of preclinical inv}{\insrsid219178 estigations and animal studies to
 determine whether the drug is reasonably safe for clinical trials and has potential for treating a specific disease.}{\cs16\super\insrsid219178 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 John Patrick Dillman, Note, }{\i\insrsid1061099 
Prescription Drug Approval and Terminal Diseases: Desperate Times Require Desperate Measures}{\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 44 Vand. L. Rev. 925, 928 (1991).}}}{\insrsid219178   If such a determination is made, }{
\insrsid10183608 the drug\rquote s sponsor }{\insrsid219178 or manufacturer }{\insrsid10183608 may submit an application for an investigational new drug (IND) exemption in order to facilitate further drug research and development.}{
\cs16\super\insrsid10183608 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  FDCA \'a7
 505(i); }{\i\insrsid1061099 see }{\insrsid1061099 21 C.F.R. \'a7 312.40 (2003); }{\i\insrsid1061099 see also }{\insrsid1061099 Patricia C. Kuszler, }{\i\insrsid1061099 Financing Clinical Research and Experimental Therapies: Payment Due, But From Whom?}{
\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 3 DePaul J. Health Care L. 441, 447 (2000); }{\i\insrsid1061099 see also }{\insrsid1061099 Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 199.   }}}{\insrsid10183608   }{
\insrsid10566905 Included in the IND application must be such items as a description of both the drug composition and manufacturing and quality controls methods, all information derived from preclinical testing, statements about the drug\rquote 
s history, an outline of the proposed phases of further testing, a statement identifying an institutional review board with reviewing authority over the investigation, and an agreement by the applicant to report any significant hazards and side effects.}{
\cs16\super\insrsid10566905 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Dillman, }{\i\insrsid1061099 supra }{\insrsid1061099 note 12, at 928.}}}{\insrsid10566905   }{\insrsid10183608 At this stage }{\insrsid10182607 
in the approval process, and thirty days after the FDA receives the IND application,}{\cs16\super\insrsid9647625 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 21 C.F.R. \'a7 312.40(c).}}}{\insrsid10182607  }{\insrsid10183608 the drug\rquote s sponsor }{
\insrsid16406746 may begin}{\insrsid4478629  the three }{\insrsid10182607 required }{\insrsid4478629 phases of human trials, which must satisfy certain human subject prot}{\insrsid4856547 ections and be approved by an In}{\insrsid4478629 vesti}{
\insrsid4856547 gational Review Board (\'93IRB\'94), which is appointed to oversee the trials and ensure that they }{\insrsid4007923 are ethical and the rights of stu}{\insrsid4666219 dy participants are protected.}{\insrsid4856547   }{\insrsid10840542 

\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid4666219 B.  }{\ul\insrsid4666219 The Role of IRBs in Clinical Research}{\ul\insrsid13188373\charrsid6061098 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid4007923 \tab }{\insrsid9647625 Peer review by IRBs characterizes clinical research with human subjects in the United States.  }{
\insrsid4007923 An IRB is an independent committee of physicians, statisticians, community advocates, and others that must initially approve and periodically review every clinical trial in the U.S. to ensure that the risks are as low as possible and are }
{\insrsid15340799 justified by the}{\insrsid4007923  potential}{\insrsid9192659  benefits}{\insrsid15340799  of the research}{\insrsid9192659 .}{\cs16\super\insrsid9192659 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See ClinicalTrial
s.gov: An Introduction to Clinical Trials}{\insrsid1061099 , A Service of the National Institutes of Health,  }{\i\insrsid1061099 at }{\insrsid1061099 http://www.clinicaltrials.gov/ct/gui/info (last visited Mar. 31, 2003).}}}{\insrsid5398288 
  Consisting of at least five individuals with varying backgrounds and diverse training, }{\insrsid9267552 IRB }{\insrsid5398288 membership}{\insrsid9267552  is intended}{\insrsid5398288  to promote objectivity in the r
eview process and to counter any institutional or professional bias that might interfere with the IRB\rquote s critical objective of protecting research subjects.}{\cs16\super\insrsid5398288 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See}{\insrsid1061099  21 C.F.R. \'a7
 56.107(a). }}}{\insrsid9267552   Moreover, membership requirements are designed to ensure the professional competence and expertise of }{\insrsid1575110 an IRB}{\insrsid5398288  }{\insrsid9267552 as well as to foster \'93
sensitivity to such issues as community attitudes\'94 }{\insrsid1575110 and respect for certain \'93vulnerable categor[ies] of subjects.\'94}{\cs16\super\insrsid1575110 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}}}{\insrsid1575110  }{\insrsid9267552  }{
\insrsid15340799 Its primary role is to make sure that each research institution is eth}{\insrsid14893110 ically and scientifically sound,}{\insrsid15340799  as well as to ensure that the human subjects are selected in an equitable manner and }{
\insrsid16406746 have }{\insrsid15340799 given their informed, voluntary consent before participating in any studies.}{\cs16\super\insrsid15340799 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 21 C.F.R. \'a7 56.111 (2003); }{\i\insrsid1061099 see also }{\insrsid1061099 D. Christian Addicott, }{
\i\insrsid1061099 Regulating Research on the Terminally Ill: A Proposal for Heightened Safeguards}{\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 15 J. Contemp. Health L. & Pol\rquote y 479, 482 (1999).}}}{\insrsid14893110 
  In order to protect the rights and welfare of human research subjects, IRBs review the informed consent documents and procedures involved in research projects and require research investigators to address several ethical issues before submitting their }
{\insrsid8615584 protocols}{\insrsid14893110  for review.}{\cs16\super\insrsid14893110 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Charles R. McCarthy, }{\i\insrsid1061099 The Institutional Review Board: Its Origins, Purpose, Function, and Future}{\insrsid1061099 , }{\i\insrsid1061099 in  }
{\ul\insrsid1061099 Research on Human Subjects: Ethics, Law and Social Policy}{\insrsid1061099  316 (David N. Weisstub ed., 1998).}}}{\insrsid2776540   This early pressure imposed by IRBs has led many investigators and IRB 
members to agree that the main effect of an IRB is felt before they even review a protocol.}{\cs16\super\insrsid2776540 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid2776540   
\par }{\insrsid9337933 \tab In evaluating a research protocol, IRB members consider several features outlined in the federal regulations under which IRBs operate.}{\cs16\super\insrsid9337933 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 56.111; }{\i\insrsid1061099 see }{\insrsid1061099 
Dale L. Moore, }{\i\insrsid1061099 An IRB Member\rquote s Perspective on Access to Innovative }{\i\insrsid1061099\charrsid9534082 Therapy}{\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099\charrsid9534082 57 }{\insrsid1061099 
Alb. L. Rev. 559, 562 (1994).}}}{\insrsid9337933   These regulations require, for example, that the risks to subjects are minimized and are reasonable in relation to the }{\insrsid8615584 anticipated}{\insrsid9337933 
 benefits and the importance of the knowledge to be }{\insrsid8615584 gained}{\insrsid9337933  by the research.}{\cs16\super\insrsid9337933 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 56.111(a)(1)-(2).}}}{\insrsid16722733   Additionally, an IRB must find that the selection of subjects is equita
ble; that material facts will be disclosed; that }{\insrsid8615584 research}{\insrsid7411717  investigators and sponsors }{\insrsid16722733 have }{\insrsid7411717 obtain}{\insrsid16722733 ed}{\insrsid7411717  and document}{\insrsid16722733 ed}{
\insrsid7411717  informed consent from each prospective subject or authorized }{\insrsid8615584 representative}{\insrsid6621076 ; and that }{\insrsid16722733 additional }{\insrsid6621076 safeguards are established for \'93vulnerable\'94 subjects}{
\insrsid7411717 .}{\cs16\super\insrsid7411717 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{
\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 56.111(3)-(5).}}}{\insrsid12601057 
  After completing its evaluation, an IRB may approve a research protocol, approve a protocol contingent on certain modifications, or disapprove and reject a protocol.  Perhaps it is because of their broad authority and responsibility for scrutini
zing all research protocols that IRBs are considered by some to be the \'93backbone of the federal regulatory system.\'94}{\cs16\super\insrsid12601057 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 19, at 482.}}}{\insrsid9337933 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid9534082 C.  }{\ul\insrsid16406746 The Phases of Clinical Trial Research}{\ul\insrsid9192659\charrsid12125853 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid6621076 \tab }{\insrsid12125853 Clinical trials on human subjects generally include three phases.  }{\insrsid13775776 Phase I trials, 
}{\insrsid16406746 which typically include}{\insrsid13775776  a small group of healthy human subjects, focus on determining the safety, relative toxicity, and side effects of a drug at various doses.}{\cs16\super\insrsid13775776 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Dillman, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 12, at 928; }{\i\insrsid1061099 see also ClinicalTrials.gov: An Introduction to Clinical Trials}{\insrsid1061099 , }{\i\insrsid1061099 supra }{\insrsid1061099 note 16, }{\i\insrsid1061099 at }{
\insrsid1061099 http://www.clinicaltrials.gov/ct/gui/info.}}}{\insrsid13775776   In addition to its primary goal of }{\insrsid8615584 determining}{\insrsid13057786  a drug\rquote s safety profile, investigators in Phase I trials a
lso work to determine how, and at what rate, the drug is absorbed, metabolized, and eliminated from the body.}{\cs16\super\insrsid13057786 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Dillman, }{\i\insrsid1061099 supra }{\insrsid1061099 note 12, at 928-29.}}}{\insrsid10619232 
  In Phase II testing, investigators first administer the drug to symptomatic patients who actually }{\insrsid8615584 suffer}{\insrsid10619232  from the condition or disease being targeted by the drug.}{\cs16\super\insrsid10619232 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 929.}}
}{\insrsid10619232   At this stage investigators evaluate the drug\rquote s safety in a larger population than Phase I and attempt to establish the optimal }{\insrsid8937483 
dosage, as well as statistical end points that represent the targeted favorable outcome of the study, }{\insrsid10619232 and to prelim}{\insrsid8937483 inarily}{\insrsid10619232  assess the drug\rquote s efficacy.}{\cs16\super\insrsid10619232 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{
\insrsid8937483  }{\insrsid6621076 
\par }{\insrsid8937483 \tab Phase III trials offer the next opportunity for investigators to further refine their research and again to gauge the safety and }{\insrsid8615584 effectiveness}{\insrsid8937483  of their drug.  }{\insrsid2696583 
At this stage the investigators\rquote  objective is to d
etermine the effectiveness of the drug or treatment in the affected population, based on the statistical end points established in Phase II.  By conducting at least two studies within a larger subject population, }{\insrsid9981141 
the investigators strive to confirm the drug\rquote 
s effectiveness, monitor side effects and adverse reactions resulting from long-term use, compare the study drug to more common treatments, and collect and record information that will facilitate the safe use of the drug or treatment by patients.}{
\cs16\super\insrsid9981141 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also ClinicalTrials.gov: An Introduction to Clinical Trials, supra }{\insrsid1061099 note 16, }{\i\insrsid1061099\charrsid9121488 at}{\insrsid1061099 
  http://www.clinicaltrials.gov/ct/gui/info.}}}{\insrsid8937483 
\par }{\insrsid14508462 \tab }{\insrsid8615584 Although the FDA\rquote s assessment of safety and effectiveness, as well as its determination whether to approve or reject a drug\rquote 
s entry into the market, occurs after Phase III, an additional phase resembling post-marketing surveillance, rather than testing, is sometimes added.}{\cs16\super\insrsid8615584 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Dillman, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 12, at 929.}}}{\insrsid8615584   }{\insrsid6906165 Phase IV includes the company\rquote s ongoing evaluation of the drug\rquote s safety during routine use, and }{\insrsid16406746 
allows the FDA to similarly ree}{\insrsid6906165 valuate its approval and, in certain circumstances, to demand either a rec}{\insrsid9133716 all or relabeling of the drug}{\insrsid9534082 .}{\cs16\super\insrsid9133716 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid9133716   Additio
nally, if the drug is being successfully administered for off-label indications, the company will often begin further clinical testing for those uses in an effort to expand the potential market for the drug.}{\insrsid9534082\charrsid9534082 
\par }{\insrsid662492 \tab Upon successful completion of Phase III trials, and where the data indicates that the drug is safe and effective for i}{\insrsid2781734 ts intended purpose, the drug\rquote s }{\insrsid662492 sponsor may file a New Drug }{
\insrsid8615584 Application}{\insrsid662492  (NDA) with the FDA.}{\cs16\super\insrsid662492 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099  at 930.}}}{\insrsid662492 
  Frequently spanning thousands of pages of accumulated data and analyses, the NDA supplies FDA reviewers with information about test results, chemical compositions, proposed labeling, manufacturing methods, and data surrounding safety and effectiveness.}
{\cs16\super\insrsid662492 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See id.}}}{\insrsid662492   }{\insrsid2781734 If the application is deemed complete, the FDA must respond within 180 days with an action letter that either (1) approves the application and grants permission to market the drug,}{
\insrsid6309708  (2) determines that the application is basically approvable, but deficient in some respect, (3}{\insrsid2781734 ) rejects the application for cause}{\insrsid6309708 , indicating the need for substantial amendment to the }{
\insrsid15103107 application,}{\insrsid6309708  or (4}{\insrsid2781734 ) }{\insrsid8615584 requests}{\insrsid2781734  supplemental information from the drug\rquote s sponsor.}{\cs16\super\insrsid2781734 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 930-31.}}}{
\insrsid6309708   }{\insrsid662492 
\par }{\insrsid6309708 \tab At this stage in the drug approval process, an applicant that has been rejected by the FDA can either amend the application or request a notice of opportunity to be heard (NOOH).  Depending on whether th}{\insrsid14564307 
e FDA considers the amendment to be}{\insrsid6309708  a \'93major amendment,\'94 the FDA has certain time limits within which to review the revision and/or to issue a NOOH, and additionally }{\insrsid16406746 exercises }{\insrsid12324062 
further discretionary power in }{\insrsid8615584 granting}{\insrsid12324062 , postponing, or denying the hearing.}{\cs16\super\insrsid12324062 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  at 931.}}}{\insrsid6309708 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid14564307 III.  }{\ul\insrsid14564307 Loosening the Regulations for Desperately Ill Patients}{
\ul\insrsid14564307\charrsid14564307 
\par }\pard \qj \li0\ri0\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid14564307 A.  }{\ul\insrsid14564307 Compassionate Use }{\ul\insrsid6061098 IND}{\ul\insrsid16406746 s}{\ul\insrsid6754763 
 and Other Access Mechanisms}{\ul\insrsid6061098 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid6061098 \tab }{\insrsid13110838 While federal regulations offer a protective framework to ensure the safety and effectiveness 
of drugs that enter the market, critics of the regulatory regime have urged a relaxation of its more stringent requirements, attacking, for instance, the long delays ass}{\insrsid3236562 ociated with compiling}{\insrsid13110838 
 sufficient information to satisfy the \'93substantial evidence\'94 standard for new drugs and the barriers it imposes }{\insrsid6754763 to }{\insrsid13110838 innovative }{\insrsid9730311 drugs and }{\insrsid3236562 therapies}{\insrsid9730311 .}{
\cs16\super\insrsid6912951 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Michael D. Greenberg, }{\i\insrsid1061099 AIDS, Experimental Drug Approval, and the FDA New Drug Screening Process}{\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 3 N.Y.U.J. Legis. & Pub. Pol\rquote 
y 295, 315 (1999/2000) (noting that the \'93downside to the system is the substantial barrier that it imposes to new and innovative forms of treatment\'94).}}}{\insrsid9730311 
  Perhaps, in part, as a response to these calls for a less rigid regime, in 1977 the FDA introduced the \'93compassionate}{\insrsid3156053  use IND}{\insrsid9730311 \'94}{\insrsid3156053  exemption to the regulation\rquote s prohibition ag
ainst the use of unapproved drugs to treat severe forms of illness.}{\cs16\super\insrsid9730311 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 4 [Drugs-Cosmetics] Food Drug Cosm. L. Rep. (CCH) P71,112 (Oct. 5, 1987); }{\i\insrsid1061099 see also 
}{\insrsid1061099 Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 471; Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 315-16.}}}{\insrsid9730311   Often conceived as the forerunner to the new }{\insrsid6754763 \'93T}{
\insrsid9730311 reatment IND,}{\insrsid6754763 \'94}{\insrsid9730311  compassionate }{\insrsid14825728 use }{\insrsid9730311 INDs }{\insrsid15432693 represented one of the FDA\rquote s informal attempts to respond to }{\insrsid6754763 
and satisfy the demands of the desperately ill}{\insrsid15432693  to gain access to experimental treatments}{\insrsid2116597 .}{\cs16\super\insrsid15432693 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Lois K. Perrin, Note, }{
\i\insrsid1061099 The Catch-22 for Persons with AIDS: To Have or Not to Have Easy Access to Experimental Therapies and Early Approval for New Drugs, }{\insrsid1061099 69 S. Cal. L. Rev. 105, 119 (1995).}}}{\insrsid3737343 
  In particular, such exemptions were granted on a case-by-case basis pursuant to the request of the primary care physician of a critically ill patient to prescribe an experimental drug not yet approved by the FDA patient in certain circumstances \'93
even though the primary purpose [was] not investigation but treatment.\'94}{\cs16\super\insrsid3737343 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See}{\insrsid1061099  4 [Drugs-Cosmetics] Food Drug Cosm. L. Rep. (CCH) P71,112; }{\i\insrsid1061099 see also }{
\insrsid1061099 Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 471.}}}{\insrsid16464006   }{\insrsid15423180 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid3236562 Although}{\insrsid16464006  compassionate use INDs offered }{\insrsid15423180 
another potential avenue for severely ill patients to pursue, and \'93were oriented to the end of treatment rather than the end of clinical research,\'94}{\cs16\super\insrsid15423180 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 37, at 316.}}}{\insrsid15423180  critics noted the inadequacies of such exemptions, pointing out that they were not formalized in the federal regulations and their use was largely ad hoc and very poorly publicized.}{\cs16\super\insrsid15423180 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{
\insrsid1061099 Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 471.}}}{\insrsid15423180   }{\insrsid7602418 Specifically, }{\insrsid11612946 critics }{\insrsid7602418 argued that}{\insrsid11612946  }{\insrsid7602418 
access to new drugs via the compassionate use exemption became a function of individual doctors\rquote  willingness and capacity to petition the FDA for its approval, a process typically involving significant paperwork, }{\insrsid3236562 delay}{
\insrsid7602418 , and bureaucracy.}{\cs16\super\insrsid7602418 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 316; }{\i\insrsid1061099 see also }{\insrsid1061099 Peter S. Arno & Karyn L. Feiden, }{\i\insrsid1061099 
Against the Odds: The Story of AIDS Drug Development, Politics and Profits }{\insrsid1061099 34-35 (1992) (noting that, reportedly, the informality of the compassionate use procedure favored well-connected patients over those less fortunate).}}}{
\insrsid7602418   Moreover, such exemptions depended considerably on the willingness of drug companies to supply their experimental new drugs, without charge, based on the prospect of future profit from commercialization.}{\cs16\super\insrsid7602418 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{
\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 316.}}}{\insrsid8813207   Limited or uncertain incentives for these companies, in addition to the }{\insrsid10189639 
ad hoc and potentially very burdensome FDA approval process for individual, patient-by-}{\insrsid3236562 patient}{\insrsid10189639 
  applications, as well as escalating pressure on the FDA to adopt new reforms in the drug approval process in the face of the increasingly formidable AIDS epidemic, prompted the FDA to adopt new regulations designed to increase }{\insrsid3236562 access}{
\insrsid10189639  to, and accelerate the approval process for, new and experimental drugs and therapies}{\insrsid3236562  for seriously or terminally ill patients}{\insrsid10189639 .}{\cs16\super\insrsid3236562 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid6061098 
\par }{\insrsid4271644 Similar to the compassionate use pro
cedure, another early informal access mechanism designed to make experimental treatments more accessible to desperate patients was the personal use import exemption, which permitted individual patients to import limited quantities of unapproved drugs for 
their own personal medical use.}{\cs16\super\insrsid4271644 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also }{\insrsid1061099 Eric Lindemann, Note, }{\i\insrsid1061099\charrsid5921476 Importing AIDS Drugs: Food and Drug Administration Policy and its Limitations
}{\insrsid1061099 , }{\insrsid1061099\charrsid5921476 28 Geo. Wash. J. Int'l L. & Econ. 133, 134 n.8 (1994).}}}{\insrsid4271644   }{\insrsid5921476 
As with the compassionate use procedure, the personal use exemption was never formally enacted into federal regulation and suffered from its own set of }{\insrsid137959 criticisms.}{\cs16\super\insrsid137959 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 316n.125; }{\i\insrsid1061099 see also }{\insrsid1061099 Lindemann, }{\i\insrsid1061099 supra }{\insrsid1061099 note 46, at 134n.8.}}}{\insrsid13965039 
  For example, the personal use exemption provided fertile ground for the growth of buying clubs to facilitate the importation of }{\insrsid4271644 experimental}{\insrsid13965039  drugs from Europe and South America, and }{\insrsid7685213 
posed potentially significant and damaging risks to the }{\insrsid4271644 effectiveness}{\insrsid7685213  and success of American clinical trials, either by leading research subjects to secretly supplement their treatment protocols}{\insrsid6754763 
, perhaps to avoid receiving a}{\insrsid7685213  placebo, or by decreasing the number of voluntary research participants.}{\cs16\super\insrsid7685213 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 317; }{\i\insrsid1061099 see also }{\insrsid1061099 Arno & Feiden, }{\i\insrsid1061099\charrsid7685213 supra }{\insrsid1061099 note 43, at 60-70.}}}{\insrsid137959   }{\insrsid5533977 
Likewise, it was criticized as an additional threat to effective drug development due to the potential financial disincentives to domestic drug development,}{\insrsid11812018  likely motivating patients}{\insrsid5533977 
 to take advantage of cheaper drugs made }{\insrsid4271644 available}{\insrsid5533977  for importation from overseas, even though such drugs may also have been approved }{\insrsid11812018 in the United States}{\insrsid7895313 , albe
it marketed at a higher price}{\insrsid11812018 .}{\cs16\super\insrsid7895313 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 317; }{\i\insrsid1061099 see also}{\insrsid1061099  Lindemann, }{
\i\insrsid1061099\charrsid7895313 supra}{\insrsid1061099  note 46, at 154-56.}}}{\insrsid2828941   Lastly, by allowing those patients \'93desperately in need of treatment\'94
 to opt out of the regulatory regime, the personal use exemption was criticized as skewing consumer choice and leading to }{\insrsid6754763 the commercial exploitation of }{\insrsid2828941 such individuals, who would likely lack the information required}{
\insrsid6754763  to evaluate the utility of many}{\insrsid2828941  experimental therapies.}{\cs16\super\insrsid2828941 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 37, at 317 (offering as an example of this scenario the situation that occurred in the late 1980s with a widely imported, unapproved anti-AIDS drug, dextran sulfate, that was later shown to be ineffective as treatment); }{\i\insrsid1061099 see also }
{\insrsid1061099 Arno & Feiden, }{\i\insrsid1061099 supra }{\insrsid1061099 note 43, at 71-82 (noting that one AIDS activist took the position that it was irrelevant whether the drug "worked," and that 
AIDS patients should be allowed import access regardless).}}}{\insrsid2828941   }{\insrsid3236562 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid7360546 B.  }{\ul\insrsid3679256 Treatment IND}{\ul\insrsid6754763 s}{\ul\insrsid3679256  }{\ul\insrsid16326325 
and Expanded }{\ul\insrsid4271644 Access}{\ul\insrsid7360546  Initiatives }{\insrsid3679256\charrsid5649833 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid11298560 \tab In response to calls }{\insrsid6114641 for more expansive and formalized reforms in the drug appro
val process, including measures that would surpass the informal and frequently inconsistent efforts already attempted,}{\insrsid11298560  the FDA }{\insrsid15737766 instituted significant reforms in the late 1980s}{\insrsid12922401 
, loosening its long-standing policy of requiring extensive testing of new drugs}{\insrsid15737766 .}{\cs16\super\insrsid12922401 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 463.}}}{\insrsid15737766   }{
\insrsid8615584 The first such reform came in 1987, when the FDA changed its approach and policy regarding i}{\insrsid6754763 nvestigational new drugs }{\insrsid8615584 by enacting provisions that specifically authorized the \'93treatment use\'94
 of such agents,}{\cs16\super\insrsid8615584 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{
\insrsid1061099  The \'93treatment use\'94 of a drug includes the use of a drug for diagnostic purposes.  If a protocol for an investigational drug meets the criteria of the applicab
le regulations, the protocol is to be submitted as a treatment protocol under the same provisions.  }{\i\insrsid1061099 See }{\insrsid1061099 21 C.F.R. \'a7 312.34(a) (2003).}}}{\insrsid8615584  allowing patients with \'93serious or immediately 
life-threatening\'94 diseases}{\cs16\super\insrsid8615584 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  The regulations define an \'93immediately life-threatening disease\'94 as \'93a stage of a disease in which there is a reasonable
 likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.\'94  21 C.F.R. \'a7 312.34(b)(3)(ii) (2003).  Although the regulations do not define \'93serious\'94
 disease, the preamble to the regulations offer several illustrations \'93normally [to] be considered serious diseases or stages of diseases,\'94 including Alzheimer\rquote s disease, advanced multiple sclerosis, and advanced Parkinson\rquote 
s disease.  52 Fed. Reg. 19,466, 19,467 (May 22, 1987) (codified at 21 C.F.R. \'a7 312).  By contrast, diseases that are \'93normally [to] be considered to be immediately life-threatening\'94
 include advanced cases of AIDS, advanced congestive heart failure, and most advanced metastatic refractory cancers.  }{\i\insrsid1061099 Id.}{\insrsid1061099  }}}{\insrsid8615584 
 to gain access to some experimental drugs for medical treatment, rather than for the traditional purpose of research, where \'93no comparable or satisfactory alternative drug or other therapy is available.\'94}{\cs16\super\insrsid8615584 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 312.34(a) (2003).  }{
\i\insrsid1061099 See}{\insrsid1061099  Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 463; }{\i\insrsid1061099 see also }{\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 127.}}}{\insrsid8615584   }{
\insrsid3609602 Accordingly, a drug manufacturer may apply for permission to distribute a \'93}{\insrsid8615584 Treatment}{\insrsid3609602  IND\'94 before final approval by the FDA, with the primary objective being \'93
to facilitate the availability of promising new drugs to }{\insrsid8615584 desperately}{\insrsid3609602  ill patients as }{\insrsid8615584 early}{\insrsid3609602  in the drug development as po
ssible, before general marketing begins, and to obtain additional data on the drug\rquote s safety and effectiveness.\'94}{\cs16\super\insrsid3609602 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 312.34(a); }{\i\insrsid1061099 see }{
\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 127.}}}{\insrsid3609602   }{\insrsid7041413 
One observer noted that such an effort to expand access to experimental therapies signaled a shift in the way the FDA, Congress, the pharmaceu
tical industry, health professionals, and health activists view the role of drug development and regulation in the U.S., as it highlighted the use of an investigational agent not primarily to gain information about its safety and effectiveness, as in cont
rolled clinical }{\insrsid8615584 studies}{\insrsid7041413 , but to treat certain seriously ill patients.}{\cs16\super\insrsid7041413 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Ken Flieger, }{\i\insrsid1061099 FDA Finds New Ways to Speed Treatments to Patients}{\insrsid1061099 
, FDA Consumer Special Report (Jan. 1995), }{\i\insrsid1061099 at}{\insrsid1061099  http://www.fda.gov/fdac/special/newdrug/speeding.html. }}}{\insrsid3679256 
\par }{\insrsid8346749 \tab In order to promote the goal of speeding the \'93journey from laboratory to bedside of important new drugs for devastating illness,\'94 while simultaneously safeguarding the public from unsaf
e or ineffective products and ensuring the }{\insrsid8615584 validity}{\insrsid8346749  and integrity of controlled }{\insrsid8615584 clinical}{\insrsid8346749  trials, the Treatment IND regulations set forth certain criteria to be met }{\insrsid15760099 
by any IND treatment or trea}{\insrsid6754763 tment protocol, including: (i) t}{\insrsid15760099 he drug is intended to treat a s
erious or immediately life-threatening disease; (ii) there is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population; (iii) the drug is under investigation in a contr
olled clinical trial, under an IND in effect for the trial, or all clinical trials have been completed; and (iv) the sponsor of the controlled clinical trial is }{\insrsid8615584 actively}{\insrsid15760099 
 pursuing marketing approval of the investigational drug with due diligence.}{\cs16\super\insrsid15760099 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 312.34(b)(1).}}}{\insrsid4793273   Furthermore, treatment protocols and INDs are conditional upon compliance with safeguards }{
\insrsid6754763 in place for }{\insrsid4793273 the IND process, including the regulations governing informed consent of human subjects, institutional review boards, distribution of the drug through qualified e
xperts, adequate production facilities, and submission of IND safety reports.}{\cs16\super\insrsid4793273 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 312.34(c).}}}{\insrsid8346749 
\par }{\insrsid1264293 \tab For a drug intended to }{\insrsid8615584 treat}{\insrsid1264293  a }{\insrsid10251723 \'93}{\insrsid1264293 serious disease,}{\insrsid10251723 \'94}{\insrsid1264293 
 the FDA Commissioner may deny a request for Treatment IND status if there is insufficient evidence of the drug\rquote s safety and effectiveness to support such use.}{\cs16\super\insrsid1264293 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 312.34(b)(2).}}}{
\insrsid10251723   If the Commissioner grants such request, howeve}{\insrsid4403553 r, a drug may be made }{\insrsid8615584 available}{\insrsid4403553  for}{\insrsid10251723  treatment use }{\insrsid4403553 
during of after Phase III clinical trials, or, in appropriate circumstances, as early as Phase II trials.}{\cs16\super\insrsid4403553 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 312.34(a).}}}{\insrsid4403553   For an \'93immediately life-threatening disease,\'94
 the Commissioner may similarly deny a drug\rquote s Treatment IND status}{\insrsid1264293  if the available evidence \'93fails to provide a reasonable basis for }{\insrsid8615584 concluding}{\insrsid1264293 
 that the drug: (A) May be effective for its intended use in its intended patient population; or (B) Would not expose the patients to whom the drug is to be administered to an unreasonable and significant additional risk of illness or injury.}{
\insrsid2697483 \'94}{\cs16\super\insrsid1264293 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{
\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 312.34(b)(3).}}}{\insrsid4265919   However, approval of Treatment IND }{\insrsid4403553 status for drugs targeting such immediately terminal}{\insrsid4265919  diseases }{\insrsid4403553 may }
{\insrsid4265919 be available \'93earlier than Phase III, but ordinarily not earlier than Phase II.\'94}{\cs16\super\insrsid4265919 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 312.34(a).}}}{\insrsid14176633   By allowing early access to }{\insrsid12922401 
new and innovative drugs and therapies, Treatment INDs }{\insrsid2697483 offer some relief from the}{\insrsid13652276  long }{\insrsid8615584 delays}{\insrsid13652276  }{\insrsid2697483 often associated with}{\insrsid13652276  the normal drug appr
oval process, relief that }{\insrsid2697483 is}{\insrsid13652276  obviously welcomed by terminally ill patients with little hope left of }{\insrsid2697483 finding effective alternative therapies.}{\insrsid1264293 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid7551911 C.  }{\ul\insrsid13182584 Expedited Development and Accelerated Approval}{\ul\insrsid7551911  Reforms}{
\ul\insrsid13182584\charrsid13182584 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid13652276 \tab In addition to }{\insrsid5649833 Treatment INDs, expanding access to experimental drugs and therapies }{\insrsid1705094 
was}{\insrsid5649833  a motivating force }{\insrsid1705094 behind}{\insrsid5649833  the FDA\rquote 
s expedited review provisions, which focus on accelerating or short-cutting the ordinary clinical trial process in order to obtain full FDA approval in a shorter period of time.}{\cs16\super\insrsid5649833 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 321.}}}{\insrsid1705094   In August of 1988, Vice President George Bush, Chairman of the Presidential Task Force of Regulatory }{\insrsid8615584 Relief}{\insrsid1705094 
, asked the FDA to design procedures to speed the \'93marketing of new therapies intended to treat AIDS and other life-threatening illness,\'94 urging the FDA to more efficiently facilitate the approval process and to \'93}{\insrsid8615584 transfer}{
\insrsid1705094  \'85 the fruits of biomedical research to the marketplace.\'94}{\cs16\super\insrsid1705094 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 129 (citations omitted).}}}{
\insrsid1705094   Quickly responding to the }{\insrsid2697483 clear }{\insrsid1705094 sense of urgency, the FDA issued a \'93fast-track\'94 regulation in October of 1988, which }{\insrsid2697483 was to}{\insrsid14561061  include procedures \'93
designed to speed the availability of new therapies to }{\insrsid8615584 desperately}{\insrsid14561061  ill patients, while preserving appropriate guarantees for safety and effectiveness.\'94}{\cs16\super\insrsid14561061 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  53 Fed. Reg. 41,516, 41,516 (Oct. 21, 1988); }{\i\insrsid1061099 
see }{\insrsid1061099 Nelson, }{\i\insrsid1061099 supra }{\insrsid1061099 note 8, at 473.}}}{\insrsid13652276 
\par }{\insrsid13182584 \tab }{\insrsid16326325 The expedited development regulations, known as \'93Subpart E\'94 regulations, initially proposed in 1988, were codified in 1992 }{\insrsid2697483 in order}{\insrsid16326325  to }{\insrsid13182584 
expedite the review of new drugs }{\insrsid2697483 by introducing}{\insrsid8994334  }{\insrsid13182584 several reform measures}{\insrsid8994334  and new}{\insrsid13182584  aspects of FDA review}{\insrsid12191879 
 for the approval of new drugs and biologicals that treat \'93life-threatening and severely-debilitating illnesses}{\insrsid8994334 ,}{\insrsid12191879 \'94}{\insrsid8994334  including}{\insrsid12191879 :}{\insrsid8994334 
 early consultation between the FDA }{\insrsid2697483 and }{\insrsid8994334 pharmaceutical developers; FDA monitoring of the clinical trial process;}{\insrsid14896565  }{\insrsid8994334 
abbreviation of clinical trials required in NDA submissions; and FDA authority to require Phase IV post-marketing research as a condition for NDA approval.}{\cs16\super\insrsid8994334 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 21 C.F.R. \'a7\'a7
 312.80-321.88; }{\i\insrsid1061099 see also }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 321-22 (adding that, at a policy level, the Subpart E regulations stressed the importance of flexibility in the FDA\rquote 
s application of the FDCA\rquote s safety and effectiveness standards, especially in recognition f the increased risk-tolerance of seriously ill patients for whom no effective treatment alternatives existed).  }}}{\insrsid12191879   }{\insrsid16210910 

\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid16210910 An additional step in reforming the traditional FDA review process came in }{\insrsid14896565 1993}{\insrsid16210910 
 when}{\insrsid1513666  the FDA\rquote s \'93accelerated approval}{\insrsid14896565 \'94 regulations were codified and included as an essential element a}{\insrsid14165056  provision adopting}{\insrsid12191879  \'93surrogate endpoints\'94 }{
\insrsid14165056 to be used as standards for gauging treatment outcome}{\insrsid2697483 s}{\insrsid14165056  and}{\insrsid12191879  the empirical basis f}{\insrsid14165056 or FDA approval of a new drug.}{\cs16\super\insrsid14165056 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 21 C.F.R. 
\'a7 314.510; }{\i\insrsid1061099 see also }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 322 (asserting that the accelerated approval and Subpart E regulations, together, \'93
reflected a substantial shift in FDA policy to accommodate the reality of the AIDS epidemic and its attendant political pressures\'94).}}}{\insrsid3307707 
  Rather than defining positive outcome in terms of extended patient survival, as was typical in earlier clinical research practice, the accelerated approval }{\insrsid8615584 procedure}{\insrsid3307707  allows \'93surrogate endpoints\'94 to serve as }{
\insrsid15485511 predictive measures of clinical and therapeutic benefit, desp}{\insrsid2697483 ite the fact that they may not }{\insrsid3307707 be direct measures of how a patient}{\insrsid15485511  feels, functions or }{\insrsid8615584 survives}{
\insrsid15485511 .}{\cs16\super\insrsid3161779 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{
\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also}{\insrsid1061099  Flieger, }{\i\insrsid1061099 supra }{\insrsid1061099 note 56, at 4; Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 37, at 323 (using as an example research on AIDS drugs where clinical trial outcome might be measured in terms of CD4 cell counts, an index of human immune function that marks the physiological progression of AIDS).}}}{\insrsid3161779 
  Moreover, the regulations }{\insrsid1143654 suggest that surrogate endpoints may be used in clinical trials even \'93
where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate }{\insrsid8615584 outcome}{\insrsid1143654 ,\'94 provided that additional post-marketing stud
ies are diligently carried out in order to verify the ultimate clinical }{\insrsid8615584 benefit}{\insrsid1143654  of the new drug.}{\cs16\super\insrsid1143654 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 314.510.}}}{\insrsid15870046   }{\insrsid1143654 
Bypassing more conservative empirical methods, such as strict reliance on \'93survival or irreversible morbidity\'94 data, }{\insrsid2697483 and by }{\insrsid8615584 permitting}{\insrsid1143654  the use of }{\insrsid7681124 surrogate endpoints}{
\insrsid2697483 , the FDA demonstrates its}{\insrsid7681124  commitment to making new drug products more widely and rapidly }{\insrsid8615584 available}{\insrsid7681124  to patients }{\insrsid15870046 
who otherwise have little hope to gain access to alternative and innovative drugs and therapies}{\insrsid7681124 .}{\insrsid15870046   
\par While expanded access to new drugs may offer desperate patients some }{\insrsid4089752 comfort when standard treatments have been exhausted and proven futile, some have argued that efforts such as the FDA\rquote s policy for exped}{\insrsid9334755 
ited approval of new drugs lack}{\insrsid4089752  specific prerequisites}{\insrsid9334755  for follow-up studies and fail}{\insrsid4089752  to enumerate FDA enforcement power.}{\cs16\super\insrsid4089752 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Perrin, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 136.}}}{\insrsid4089752  }{\insrsid15870046  }{\insrsid4089752 Moreover, skeptics claim that the accelerated approval process exposes an even larger number of people to }{\insrsid3236562 uncertainty}{
\insrsid4089752  than expanded access protocols, and emphasize the }{\insrsid14103719 inherent uncertainty in relying upon surrogate endpoint data}{\insrsid7431535 , as well as}{\insrsid14103719  the }{\insrsid3236562 possibility}{\insrsid14103719 
 that the clinical benefit }{\insrsid7431535 may never even}{\insrsid14103719  emerge.}{\cs16\super\insrsid14103719 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 136, 144.}}}{\insrsid12411769  }{\insrsid83832  Although o}{\insrsid12411769 
ther federal initiatives have been introduced to }{\insrsid83832 streamline }{\insrsid12411769 the drug approval process and make new drugs more quickly available to }{\insrsid83832 certain desperate populations, s}{\insrsid12411769 uch as }{
\insrsid549080 terminal}{\insrsid12411769  AIDS and cancer patients}{\insrsid15425558 , the FDA procedures designed to expand access }{\insrsid7431535 and}{\insrsid15425558  accele}{\insrsid83832 rate approval}{\insrsid15425558 
 have dominated its efforts at regulatory reform of drug development and }{\insrsid7431535 the }{\insrsid15425558 guidelines concerning research with human subjects.}{\cs16\super\insrsid83832 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  For example, the \'93parallel track\'94
 program, for example, was designed exclusively to target AIDS and HIV-related conditions, and, although very similar to the treatment IND regulations, it took an additional step by providing that \'93
expanding availability protocols might be approved for promising investigational drugs when the evidence for effectiveness is less than that generally required for a treatment IND.\'94
  Expanded Availability of Investigational New Drugs Through a Parallel Track Mechanism for People with AIDS and other HIV-Related Disease, }{\insrsid1061099\charrsid15425558 57}{\insrsid1061099  Fed. Reg. 13,250, 13,256 }{
\insrsid1061099\charrsid15425558 (1992)}{\insrsid1061099 ; }{\i\insrsid1061099 see }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 324-25.  The parallel
 track initiative developed in part based on an earlier joint protocol sponsored by the FDA and National Cancer Institute, referred to as \'93Group C\'94 procedures, which permitted oncologists treatment access to }{\insrsid1061099 
experimental cancer drugs outside of controlled clinical trials.  }{\i\insrsid1061099 See }{\insrsid1061099 Expanded Availability, 57 Fed. Reg. at 13,256; }{\i\insrsid1061099 see also }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{
\insrsid1061099 note 37, at 325 (asserting that the parallel track policy purposely excluded diseases other than AIDS from its reach and was intended as a pilot program to asses
s the incremental benefits and risks of expanded access beyond that provided by other FDA initiatives).}}}{\insrsid15425558   }{\insrsid4793273 \tab }{\insrsid9961593 
\par }{\insrsid14753809 Despite the above reforms initiated during the late 1980s and early 1990s,  concerned consumers, legislators and drug manufacturers continued to criticize the rising costs and }{\insrsid225367 delays}{\insrsid14753809  of FDA review.}{
\cs16\super\insrsid14753809 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 343 (noting that by 1993, the average drug development time for FDA approval was approximately 12 years, at an averag
e cost of 350 million dollars per new drug).}}}{\insrsid14753809   In particular, }{\insrsid27005 critics stressed the inefficiencies in the coordi
nation between the FDA and pharmaceutical manufacturers in the design of clinical trial research, as well as the burdensome delays caused by \'93confusing [FDA] communications\'94 and \'93inadequate [FDA] guidance.\'94}{\cs16\super\insrsid27005 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{
\insrsid1061099 ;}{\i\insrsid1061099  }{\i\insrsid1061099\charrsid7551911 Drugs and}{\i\insrsid1061099  Biologics: Hearings Before the }{\i\insrsid1061099\charrsid7551911 Subcomm. on Oversight and Investigations of the House Comm. on Commerce}{
\insrsid1061099 , 104th Cong. 13-15 (1995) (statement of Christian W. Nolet, National Director, Life Sciences Industry Group).}}}{\insrsid1774601   In response to these and other concerns, the Fo
od and Drug Administration Modernization Act (FDAMA), signed into law in 1997, contained several provisions that addressed the new drug approval process.  One commentator succinctly enumerated these elements of the FDAMA,}{\cs16\super\insrsid15481297 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{
\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 37, at 344-45.  Greenberg also noted other provisions in the FDAMA that bear on the drug approval process, such as the renewal of the Prescription Drug User Fee Act of 1992, which permits the FDA to collec
t user fees from drug companies filing new drug applications, as well as provisions calling for increased FDA accountability.   }{\i\insrsid1061099\charrsid15481297 See}{\insrsid1061099  S. Rep. No. 105-43, at 2, 4-5.}}}{\insrsid1774601  }{
\insrsid7431535 which included, among other provisions, the following:}{\insrsid1774601  }{\insrsid7431535  }{\insrsid1774601 (1) Congress adopted into law a set }{\insrsid8617375 of expanded access provisions intended to supplement the FDA\rquote 
s regulatory reforms and to stress the access of experimental drugs to patients with serious and life-threatening diseases;}{\cs16\super\insrsid13004505 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid13004505 See}{\insrsid1061099 
 Pub. L. No. 105-115 561, 111 Stat. 2296 (1997); }{\i\insrsid1061099 s}{\i\insrsid1061099\charrsid13004505 ee also}{\insrsid1061099  S. Rep. No. 105-43, at 76 (explaining the  preconditions to expanded access under statute).}}}{\insrsid8617375 
 (2) Congress amended the FDCA to formalize the \'93fast track\'94 status for expedited approval of new drugs, including corresponding federal review pr}{\insrsid8325783 ocedures based on surrogate end}{\insrsid7431535 point data, as well as allowed}{
\insrsid8617375  the FDA to begin its review before the completion of an NDA;}{\cs16\super\insrsid13004505 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid13004505 See}{\insrsid1061099  Pub. L. No. 105-115 112, 111 Stat. 2296; }{\i\insrsid1061099 see also}{
\insrsid1061099  S. Rep. No. 105-43, at 88.}}}{\insrsid8617375  }{\insrsid7431535 and }{\insrsid8617375 (3) Congress set out }{\insrsid1777766 for the FDA }{\insrsid8617375 an explicit mission statement}{\insrsid1056278 , }{\insrsid13004505 
which holds the }{\insrsid15481297 agency t}{\insrsid13004505 o protecting the public health through product regulation and to providing prompt review of clinical trials and drug research.}{\cs16\super\insrsid13004505 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid13004505 See}{\insrsid1061099 
 Pub. L. No. 105-115 406, 111 Stat. 2296; }{\i\insrsid1061099 see also}{\insrsid1061099  S. Rep. No. 105-43, at 2.}}}{\insrsid12337341   The balancing act in which t}{\insrsid12547648 he FDA seems to be constantly }{\insrsid12337341 engaged}{
\insrsid12547648  is reflected in these more recent efforts to reform the new drug approval process}{\insrsid7431535 , as the agency}{\insrsid12337341  }{\insrsid12547648 attempts to effectively maneuver itself and its resources }{\insrsid12337341 
between the two primary objectives of expanding access to potentially life-saving drugs for the seriously and terminally ill and protecting those individuals from the risks inherent in clinical }{\insrsid12547648 trial research.  At the core }{
\insrsid7431535 of the debate concerning early}{\insrsid12547648  access to experimental therapies and clinical research for the terminally ill seems to be the issue of the }{\insrsid225367 meaningfulness}{\insrsid12547648  of the patients\rquote 
 informed consent, }{\insrsid225367 particularly}{\insrsid12547648  }{\insrsid225367 where}{\insrsid12547648 
 information available to desperately ill subjects is less than perfect and the potential risks are often not easily quantifiable.  Because of the centrality of informed consent }{\insrsid16724824 
to any discussion of clinical research involving human subjects, it is that topic to which I will now turn.}{\insrsid12547648 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid7551911 IV.  }{\ul\insrsid7551911 The }{\ul\insrsid8616821 Informed}{\ul\insrsid7551911 
 Consent Paradigm in Human Subject Research}{\insrsid6621076 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid9529099 \tab The National Institutes of Health }{\insrsid7431535 (NIH) }{\insrsid9529099 define \'93informed consent\'94 as \'93
the process of learning the key facts about a clinical trial before deciding whether or not to participate,\'94 as well as \'93a continuing process throughout the study to provide information for participants.\'94}{\cs16\super\insrsid9529099 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 
ClinicalTrials.gov: An Introduction to Clinical Trials}{\insrsid1061099 , }{\i\insrsid1061099 supra }{\insrsid1061099 note 16, }{\i\insrsid1061099\charrsid4397857 at}{\insrsid1061099  http://www.clinicaltrials.gov/ct/gui/info.}}}{\insrsid8348650 
  In order to gain approval from an IRB to conduct clinical trials, researchers must give subjects \'93sufficient opportunity to consider whether or not to participate [and] minimize }{\insrsid340970 the possibility of coercion or undue influence.\'94}{
\cs16\super\insrsid340970 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. 
\'a7 50.20.}}}{\insrsid340970   }{\insrsid15734145 As set forth explicitly in the regulations, the \'93basic elements of informed consent\'94 include such items as a statement that the study involves research}{\insrsid7431535 ;}{\insrsid15734145 
 a description of the purposes of the research an}{\insrsid7431535 d the procedures to be followed;}{\insrsid15734145  an explanation of any reasonably }{\insrsid16330442 foreseeable risks}{\insrsid15734145  and discomforts to the subject, a}{
\insrsid7431535 s well as any expected benefits;}{\insrsid15734145  and a disclosure of any alternative courses of treatment that might be beneficial.}{\cs16\super\insrsid15734145 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 50.25(a) (\'93
Basic elements of informed consent\'94).  In addition to the \'93basic elements of informed consent,\'94 the regulations set forth several additional elements of informed consent that are required in special circumstances.  }{\i\insrsid1061099 See id. }{
\insrsid1061099 \'a7\'a7 50.25(a)(5)-(8), 50.25(b)-(d), 50.27 (\'93Documentation of informed consent\'94).}}}{\insrsid340970 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid8348650 While some evidence suggests that }{\insrsid1986216 the informed consent framework was recognized in }{\insrsid8348650 
regulations for clinical research and experiment}{\insrsid1986216 ation }{\insrsid8348650 as early as the nineteenth century,}{\insrsid1986216  }{\insrsid6687329 in general the Nuremberg Code of 1947}{\insrsid2831329  (\'93Code\'94)}{\insrsid6687329 
 is recognized as the first document to set out ethical principles in human subject research based on informed consent.}{\cs16\super\insrsid6687329 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6687329 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 
Debra Johnson & Kathleen E. Squires, }{\i\insrsid1061099 Women and Clinical Trials}{\insrsid1061099 , }{\i\insrsid1061099\charrsid4397857 at}{\insrsid1061099  http://www.natap.org, at 3 (last visited Mar. 31, 2003; }{\i\insrsid1061099 see also}{
\insrsid1061099  David N. Weisstub et al.,}{\i\insrsid1061099  Establishing the Boundaries of Ethically Permissible Research with Vulnerable Populations}{\insrsid1061099 ,}{\i\insrsid1061099  in }{\ul\insrsid1061099 
Research on Human Subjects: Ethics, Law and Social Policy}{\insrsid1061099 , }{\i\insrsid1061099 supra }{\insrsid1061099 note 20, at 355 (asserting that the Nuremberg Code \'93
initiated a process of inquiry on an international scale that has led to the evolution of various general ethical principles intending to guide participants in the research endeavor\'94).}}}{\insrsid10966349 
  Promulgated at the end of the 1946-47 trial of Nazi physician-experimenters, the Nuremberg Code was created by U.S. judges in response to the horrific }{\insrsid3411517 non-therapeutic and nonconsensual }{\insrsid10966349 
Nazi experiments involving the murder and torture of concentration camp prisoners.}{\cs16\super\insrsid10966349 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 George J. Annas, }{\i\insrsid1061099 Questing 
for Grails: Duplicity, Betrayal and Self-Deception in Postmodern Medical Research}{\insrsid1061099 , 12 J. Contemp. Health L. & Pol\rquote y 297, 301 (1996).}}}{\insrsid3411517   Although it was formulated in reaction to s
uch deplorable experiments, it was intended to be, and, indeed, has become, a universal and authoritative legal and ethical document regulating human research standards internationally.}{\cs16\super\insrsid3411517 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
(adding that it remains \'93one of the premier human rights documents in world history\'94).}}}{\insrsid8152160   Declaring that \'93[t]he voluntary }{\insrsid15734145 consent}{\insrsid8152160  of the human subject is absolutely essential,\'94
 and setting out nine other required elements in any research involving human subjects, the Code paved the way for today\rquote s info}{\insrsid7685801 rmed consent guidelines and }{\insrsid8152160 regulation of clinical research.}{
\cs16\super\insrsid8152160 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 Nuremberg Code}{\insrsid1061099 , }{\i\insrsid1061099\charrsid4334099 excerpted from}{\insrsid1061099 :}{\i\insrsid1061099  \'93Permissible Medical Experiments}{\insrsid1061099 ,\'94
 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10: Nuremberg (Oct. 1946-Apr. 
\par 1949), vol. 2, at 181-81 (setting out 10 principles to aid physicians and researchers in
 human subject research, including providing proper preparations and adequate facilities to protect subjects against injury, disability or death, and permitting subjects to terminate the experiment if desired), }{\i\insrsid1061099 reprinted in }{
\ul\insrsid1061099 Ethics of Research with Human Subjects: Selected Policies and Resources}{\insrsid1061099  12-13 (Jeremy Sugarman et al. eds., 1998).}}}{\insrsid9529099 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4397857 {\insrsid2831329 Despite the }{\insrsid3278887 promotion o}{\insrsid2831329 f the Code as an international ethical guide for resear}{
\insrsid540270 chers, its stringent and }{\insrsid2831329 demanding standards led to the formulation of other codes of ethics and research, regulations, and laws that provided a more balanced approach }{\insrsid5781393 
to research involving human subjects.  }{\insrsid9382017 One such creation, the Helsinki Declaration of 1964 (\'93Declaration\'94), which seemed ostensibly to reaffirm the Code\rquote s dedication to ensuring that research with human subjects \'93
conform[s] to the ethics of the medical profession generally\'94 and that \'93certain basic principles [are] observed in order to satisfy moral, ethical and legal concepts,\'94}{\cs16\super\insrsid9382017 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Introduction to the }{\i\insrsid1061099 Nuremberg Code}{
\insrsid1061099 , }{\i\insrsid1061099 Trial of War Criminal Before the Nuremberg Military Tribunals Under Control Council Law No. 10}{\insrsid1061099  (Oct. 1946-Apr. 1949).}}}{\insrsid9382017 
 offers more flexible guidelines and a broader framework within which physicians and researchers can ethically conduct their trials.}{\cs16\super\insrsid9382017 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Annas, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 83, at 303 (adding that the goal of the Declaration of Helsinki was \'93to replace the human rights-based agenda of the Nuremberg Code with a more lenient medical ethics model that permits paternalism\'94); }
{\i\insrsid1061099 see also }{\insrsid1061099 Richard W. Garnett, }{\i\insrsid1061099 Why Informed Consent?  Human Experimentation and the Ethics of Autonomy}{\insrsid1061099 
, 36 Cath. Law. 455, 472-73 (1996) (noting that the new approaches, such as the Helsinki Declaration, \'93strike a compromise between the Code\rquote s idealism and the perceived need for more flexible, permissive,
 and perhaps realistic guidelines for research\'94); Jay Katz, }{\i\insrsid1061099 The Consent Principles of the Nuremberg Code: Its Significance Then and Now}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 
The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation}{\insrsid1061099  227, 238 (suggesting that modern research regulations are less rigid and demanding than the Code).}}}{\insrsid9382017   }{\insrsid8397380 
In addition to presenting \'93basic principles\'94 applicable to all research involving human subjects, the Declaration further }{\insrsid9382017 divides}{\insrsid8397380  research into therapeutic (\'93}{\insrsid9382017 Medical}{\insrsid8397380 
 Research Combined with Professional Care,\'94 or \'93Clinical Research\'94}{\insrsid2308901 ) and non}{\insrsid9382017 -}{\insrsid2308901 therapeutic (or \'93Non-Clinical Research\'94).}{\cs16\super\insrsid2308901 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 
World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects}{\insrsid1061099 , adopted by the 18th World Medical Assembly in Helsinki in
 1964, as amended by the 29th World Medical Assembly (1975), 35th World Medical Assembly (1983), 41st World Medical Assembly (1989), }{\i\insrsid1061099 reprinted in }{\ul\insrsid1061099 Ethics of Research with Human Subjects}{\insrsid1061099 , }{
\i\insrsid1061099 supra }{\insrsid1061099 note 85, at 14-18.  Garnett noted that a major difference betwee
n the two codes is the Declaration's recognition and regulation of therapeutic research.  While the Declaration recognized that the same ethical principles should govern when conducting research with healthy volunteers as with those in need of care, the C
ode only addressed non-therapeutic experimentation.  }{\i\insrsid1061099 See }{\insrsid1061099 Garnett, }{\i\insrsid1061099 supra }{\insrsid1061099 note 87, at 473n.83 (citations omitted).}}}{\insrsid6032439   As a result, Professor George Annas }{
\insrsid7880071 suggests that the line between treatment and research is blurred, and the distinction between researcher and physician, as well as between subject and patient, is effectively }{\insrsid540270 eliminated}{\insrsid7880071 .}{
\cs16\super\insrsid7880071 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Annas, }{\i\insrsid1061099 supra }{\insrsid1061099 note 83, at 303.}{\i\insrsid1061099  }}}{\insrsid7880071   }{\insrsid9382017 Asserting that \'93research becomes treatment, the researche
r becomes the healer, and the subject becomes the patient,\'94 Annas adds that in this way the current trend in clinical research goes further than the Declaration\rquote s principles, as \'93
language is used to obscure the truth and justify the unjustifiable,\'94 not only in the more primitive cold war radiation experiments conducted in the U.S. in the 1940s through the 1960s, but in today\rquote 
s clinical trials and research performed on terminally ill cancer and AIDS patients as well.}{\cs16\super\insrsid9382017 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099  at 304.}}}{\insrsid13384500 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid15753516 \tab In an effort to further broaden the rea
ch and increase the ease of applicability of ethical principles to guide research involving human subjects, in 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research}{\insrsid12850135  (\'93Commission\'94)}
{\insrsid15753516  published the }{\i\insrsid15753516 Belmont Report}{\insrsid12850135 , }{\insrsid9185216 described by the Commission as }{\insrsid12850135 a statement of }{\insrsid9185216 three }{\insrsid540270 \'93}{\insrsid12850135 
basic ethical principles}{\insrsid9185216 \'94 }{\insrsid12850135 and guidelines that}{\insrsid9185216  should provide an analytical framework to guide the resolution of}{\insrsid12850135  ethical problems }{\insrsid9185216 arising from }{
\insrsid12850135 research }{\insrsid9185216 involving human subjects}{\insrsid12850135 .}{\cs16\super\insrsid9121488 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, }{\i\insrsid1061099 
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research}{\insrsid1061099 , 79 Fed. Reg. 12,065 (Apr. 18, 1979), }{\i\insrsid1061099 reprinted in }{\ul\insrsid1061099 Ethics of Research with Human Subjects}{
\insrsid1061099 , }{\i\insrsid1061099 supra }{\insrsid1061099 note 85, at 19-30.}}}{\insrsid3306244   Stating that the codes and rules developed in the latter half of the twentieth century \'93often are inadequate to cover complex situations,\'94 and \'93
at times they come into conflict, and they are frequently difficult to interpret or apply,\'94 the }{\i\insrsid3306244 Belmont Report }{\insrsid3306244 suggests that \'93[b]roader ethical principles will }{\insrsid16144849 provide}{\insrsid3306244 
 a basis on which specific rules may be formulated, criticized and interpreted.\'94}{\cs16\super\insrsid3306244 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 19.}}}{\insrsid11494393   With that principle in mind, the }{\i\insrsid11494393 Belmont Report }{
\insrsid11494393 sets out }{\insrsid540270 three \'93basic ethical principles}{\insrsid11494393 \'94 to form the basis for the protection of human subjects: respect for persons, beneficence, and justice.}{\cs16\super\insrsid11494393 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 20-24.
}}}{\insrsid7677656   Moreover, it provides a set of requirements }{\insrsid11812414 based on }{\insrsid7677656 
those three comprehensive principles, focusing on (1) informed consent, (2) risk/benefit assessment, and (3) the selection of subjects of research.}{\cs16\super\insrsid7677656 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 24-30; }{
\i\insrsid1061099 see also}{\insrsid1061099\charrsid2128619  }{\insrsid1061099 Nancy M. P. King et al., }{\i\insrsid1061099 Relationships in Research: A New Paradigm}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 
Beyond Regulations: Ethics in Human Subjects Research}{\insrsid1061099  8-10 (Nancy M. P. King et al. eds., 1999) (noting that the current system of federal regulati
on of research with human subjects reflects, and is both grounded in and justified by, the \'93principlist paradigm in the }{\i\insrsid1061099 Belmont Report}{\insrsid1061099 \'94).}}}{\insrsid11812414 
  Likewise, the federal regulations governing research with human subjects, known as the federal \'93Common Rule,\'94}{\insrsid161640  requires the establishment of IRBs to review and approve research, }{\insrsid540270 and sets out }{\insrsid161640 
the conditions of such approval, including extensive informed consent requirements, a mandate that risks to subjects be minimized and }{\insrsid1473041 reasonable}{\insrsid161640 
 in relation to expected benefits, that subjects be selected equitably, and that appropriate protections exist for special populations of subjects.}{\cs16\super\insrsid161640 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 The Common Rule}{\insrsid1061099 
, 56 Fed. Reg. 28012 (June 18, 1991); }{\i\insrsid1061099 see }{\insrsid1061099 King et al., }{\i\insrsid1061099 supra }{\insrsid1061099 note 94, at 10.   Promulgated in 1991, t
he Common Rule applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency.  In addition, IRBs are required under the Common Rule by 16 federal departments and agencies, as w
ell as for research involving drugs, medical devices and biologics, regulated by the FDA.  }{\i\insrsid1061099 See }{\insrsid1061099 McCarthy, }{\i\insrsid1061099 supra }{\insrsid1061099 note 20, at 316. }}}{\insrsid13633380   Before considering these }{
\insrsid1473041 regulations}{\insrsid13633380  as they are applied, and }{\insrsid1473041 perhaps}{\insrsid13633380  should be applied, to one such \'93special population,\'94 namely, terminally ill cancer patients, it may be helpful to firs}{
\insrsid14905577 t consider the }{\insrsid10640332 unique experiences and characteristics of the }{\insrsid14905577 patients themselves and their b
attle against not only the disease, but at times the regulatory powers that deny them access to experimental treatments which, at least in thei}{\insrsid540270 r minds, offer one last hope for a cure}{\insrsid14905577 .}{\insrsid15753516\charrsid15753516 

\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4928036 {\insrsid15487564 V.  }{\ul\insrsid15487564 Cancer Research:  }{\ul\insrsid4928036 Lessons from the Past}{\ul\insrsid2309932 
 and Implications for the Future}{\ul\insrsid15487564  }{\ul\insrsid9993541\charrsid15487564 
\par }\pard \qj \li0\ri0\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid15487564 A.  }{\ul\insrsid15487564 An Introduction to Cancer Research}{\insrsid3812620 \tab }{\insrsid15487564 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540270 {\insrsid3812620 Approaching clinical cancer research as a model for clinical trials overall, it has been argued that the \'93
characteristics that make clinical trials ethically important, and problematic, exist in cancer trials in exaggerated form.\'94}{\cs16\super\insrsid3812620 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Benjamin Freedman, }{\i\insrsid1061099 
The Ethical Analysis of Clinical Trials: New Lessons for and from Cancer Research}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 The Ethics of Research Involving Human Subjects: Facing the 21st Century}{\insrsid1061099 
 320 (Harold Y. Vanderpool ed., 1996).}}}{\insrsid3812620   }{\insrsid924957 In particular, and f}{\insrsid3812620 rom an ethical point of view, \'93cancer research has been the paradigm of trials entailing not simply }{\insrsid11350809 uncertainty}{
\insrsid3812620  but very serious risks on the part of subject participants.\'94}{\cs16\super\insrsid3812620 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  at 321.}}}{\insrsid924957   }{\insrsid5651409 Moreover, a phenomenon }{\insrsid3225406 well known in ca
ncer research is equally applicable to all areas of clinical research:  the misconception on the part of patients participating in a study that they will be receiving effective treatments not otherwise available.}{\cs16\super\insrsid3225406 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{
\insrsid14900546   }{\insrsid4202324 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid924957 As an illustration, in the 1980s and 199
0s, researchers searching for more effective breast cancer treatments began administer}{\insrsid540270 ing}{\insrsid924957 
 higher doses of chemotherapy followed by procedures to curb the severe adverse and toxic side effects by re-infusing harvested bone marrow to rescue the patient from the chemotherapy\rquote s ravishing effects.}{\cs16\super\insrsid924957 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 
Kuszler, }{\i\insrsid1061099 supra }{\insrsid1061099 note 13, at 457.}}}{\insrsid14900546   Despite the treatment\rquote 
s life-threatening side effects, including bleeding disorders, infections, organ dysfunction, severe nausea and gastrointestinal problems, to name just a few, desperate cancer patients }{\insrsid4657870 will}{\insrsid15680593 ing t
o try anything viewed it as their}{\insrsid4657870  final chance for a cure.}{\cs16\super\insrsid4657870 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 458.}}}{\insrsid4657870 
  Although there had been little research showing the safety and efficacy of the treatment, and despite the high mortality rate involved, many women, approximately 12,000 to 30,000 in}{\insrsid12330212  the United States}{\insrsid4657870 , embraced it a}{
\insrsid15680593 s their}{\insrsid4657870  last }{\insrsid540270 chance for survival in}{\insrsid4657870  a devastating struggle }{\insrsid540270 in which no other therapies had proven effective.}{\cs16\super\insrsid12330212 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 459.}}}{
\insrsid3812620 
\par }{\insrsid2517619 Given the often lethal side effects experienced by cancer patients who }{\insrsid11350809 through}{\insrsid2517619  their pain and suffering \'93choose\'94 to go still fu
rther in their search for a cure by participating in experimental drug trials, researchers have begun to question what these increasingly invasive and severe approaches translate into for the quality of life of }{\insrsid4142985 the }{\insrsid2517619 
patients}{\insrsid4142985  involved}{\insrsid2517619 .}{\cs16\super\insrsid2517619 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Freedman, }{\i\insrsid1061099 supra }{\insrsid1061099 note 96, at 323.}}}{\insrsid8604220   As a result, quality
 of life research and evaluation have become an integral part of the efforts to refine the ethics of }{\insrsid11350809 cancer}{\insrsid8604220  clinical trials.}{\cs16\super\insrsid8604220 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid10224220 See id.}}}{\insrsid10640332 
  Below is a brief overview of some of the most widely publicized and influential \'93battles\'94 in the war on cancer, including those that ended in the courtroom}{\insrsid540270 , as well as in the halls of Congress,}{\insrsid10640332 
 before arbiters positioned ultimately to decide the fate of patients ravaged both physically and psychologically by the disease.}{\insrsid5979408\charrsid9772601 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid7874876 B.  }{\ul\insrsid7874876 Cancer \'93Quackery\'94: }{\ul\insrsid3935163  }{\ul\insrsid7874876 The }{
\ul\insrsid12786420 Laetrile }{\ul\insrsid7874876 Experience}{\ul\insrsid13633380 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid275071 \tab }{\insrsid8461076 Throughout the twentieth century desperately ill cancer patients have been promised a variety of \'93
cures\'94 or effective therapies for cancer by anxious researchers and often well-meaning physicians hoping to conquer the deadly disease once and for all.  Harry Hoxsey presented his cancer \'93cure\'94
 before World War II, but was ultimately found guilty of fraud only after many patients had become victims of his scam.}{\cs16\super\insrsid8461076 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Stuart L. Nightingale, }{
\i\insrsid1061099 Second Binational Symposium: United States\emdash Israel \endash  Papers on the Role of Epidemiology and Regulatory Programs}{\insrsid1061099 , Public Health Rep. 1984; 99: 333-338 (1984).}}}{\insrsid5969405 
  Another unproven remedy, Krebiozen, gained popularity in the 1950s after being endorsed by a distinguished investigator, although }{\insrsid2312518 ultimately}{\insrsid5969405  it, too, had vanished by the beginning of the 1970s.}{
\cs16\super\insrsid5969405 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also }{\i\insrsid1061099\charrsid6360091 United States v. Rutherford}{\insrsid1061099 , 442 U.S. 544, 558 (1979) (citing other examples of the \'93
wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and \'93
Fountain of Youth\'94 mixtures of spices, oil, and suet\'94).}}}{\insrsid5969405  }{\insrsid8461076  }{\insrsid5969405 
Not to be outdone by these more primitive therapies, Laetrile entered the scene with little noise in the 1960s and early 1970s, and soon garnered much support and positive pub}{\insrsid3935163 licity as the new miracle \'93cure}{\insrsid5969405 \'94}{
\insrsid3935163  for cancer.}{\cs16\super\insrsid5969405 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Nightingale, }{\i\insrsid1061099 supra }{\insrsid1061099 note 104, at 334.}}}{\insrsid5969405  
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid5969405 The Laetrile experience was }{\insrsid13772346 perhaps }{\insrsid6360091 the most notorious controversy}{\insrsid275071 
 involving the public policy questions and concerns surrounding the access to experimental and highly unconventional treatments by desperately ill patients}{\insrsid8461076 .}{\cs16\super\insrsid5969405 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Greenberg, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 306-07.}}}{\insrsid8461076   Touted by advocates to be an effective therapy for cancer, }{\insrsid13772346 the uncertainties surrounding the \'93remedy\'94
 were profound.  Besides agreement that Laetrile is obtained from apricot kernels, there was much confusion o}{\insrsid3935163 ver what the substance exactly was}{\insrsid13772346  and how it should be promoted to the public.}{\cs16\super\insrsid13772346 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{
\insrsid1061099 Nightingale, }{\i\insrsid1061099 supra }{\insrsid1061099 note 104, at 334 (noting that supporters claimed that Laetrile is 1-mendelonit
rile beta glucuronide, confiscated samples revealed amygdalin, and it was additionally advertised as vitamin B-17, a drug, and a food).}}}{\insrsid15687040   Similarly, confusion also marked the actual proven value in treating patients, }{\insrsid1730481 
as supporters praised its effectiveness in curing, mitigating, and even preventing cancer, as an analgesic, as well as in treating such conditions as sickle cell anemia, hypertension, and parasitic diseases.}{\cs16\super\insrsid1730481 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid3302462 
  Despite their clamorous words of support, the fact remained that there was no controlled trial data upon which to hang their cause}{\insrsid14515632 , and FDA approval, therefore, remained out of reach}{\insrsid3302462 .}{\cs16\super\insrsid3302462 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{
\insrsid1061099 ; }{\i\insrsid1061099 see also }{\insrsid1061099 Greenberg, }{\i\insrsid1061099 supra }{\insrsid1061099 note 37, at 307.  }}}{\insrsid3671613 
  The result was disheartening, as desperate patients were lured into the hands of suspicious black-market practitioners, who successfully peddled the scientifically my}{\insrsid3935163 sterious and unapproved substance}{\insrsid3671613 .}{
\cs16\super\insrsid14035776 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Dale H. Gieringer, }{\i\insrsid1061099 Compassion Vs. Control: FDA Investigational-Drug Regulation}{\insrsid1061099 , Cato Policy Analysis No. 72 (May 20, 1986), at 9-10 (suggesting that, \'93
[g]iven that Laetrile was relatively non-toxic, especially in comparison with other cancer treatments at the time, a rational medical case could have bee
n made for its use, especially in conjunction with other treatment, and it might at least have been beneficial as a placebo\'94); }{\i\insrsid1061099 but see }{\insrsid1061099 Victor Herbert, }{\i\insrsid1061099 
Laetrile: The Cult of Cyanide Promoting Poison for Profit}{\insrsid1061099 , American Journal of Clinical Nutrition 32 (May 1979), at 1121-58 (noting that a couple of accidental poisonings from Laetrile overdoses were reported).}}}{\insrsid3671613 
  At the same time, the FDA\rquote s rejection of Laetrile did not stop several states from passing pro-Laetrile legislation}{\insrsid14035776 
 in the years prior to the release of clinical study results that finally put an end to the lingering uncertainty of the drug\rquote s efficacy.}{\cs16\super\insrsid14035776 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 In 1978, studies conducted by the National Cancer Institute finally began to conclusively dispel the lingering scientific uncertainty over Laetrile\rquote s efficacy.  }{\i\insrsid1061099 See }{\insrsid1061099 Geiringer, }{\i\insrsid1061099 supra }{
\insrsid1061099 note 111, at 10.}}}{\insrsid3671613  }{\insrsid9921631 
\par }{\insrsid14515632 In order to understand the promotional success of Laetrile, one need only consider the desperate position in which cancer }{\insrsid2312518 patients}{\insrsid14515632 
 find themselves, particularly in the terminal stages of the disease.  The psychological distress of these patients would certainly lead them to embrace therapies, no matter how unconve}{\insrsid3935163 ntional, that offer some hope for}{\insrsid14515632 
 }{\insrsid3111026 a \'93cure,\'94}{\insrsid14515632  or at least alleviation of some of their pain and suffering.}{\insrsid5063459   In addition, some claim that the popularized \'93success\'94
 of Laetrile was due in part to the messages relayed to the public by its supporters, who claimed that organized medicine, colluding with the drug industry, the American Cancer }{\insrsid2312518 Society}{\insrsid5063459 
, and the government, was taking part in a conspiracy to prevent Laetrile from entering the market.}{\cs16\super\insrsid5063459 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Nightingale, }{\i\insrsid1061099 supra }{\insrsid1061099 note 104, at 334.}}}{\insrsid5063459   }{
\insrsid1198395 By participating in t}{\insrsid4859925 he campaign supporting }{\insrsid1198395 Laetrile, }{\insrsid4859925 
cancer patients were fighting not only to gain access to the treatment, but were also taking part in an effort to defy the establishment, a prospect that was likely attractive to those patients with little trust in }{\insrsid2312518 government}{
\insrsid4859925  regulations and critical of any motives }{\insrsid3935163 colored by}{\insrsid4859925  paternalism.}{\cs16\super\insrsid4859925 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid4618979 
\par }{\insrsid6238648 Psychological anxieties aside, many cancer patients and La}{\insrsid13313494 etrile advocates pushed to the forefront of the debate }{\insrsid6238648 \'93freedom of choice\'94}{\insrsid13313494 
 arguments, asserting that Laetrile should be accessible to them regardless of whether the FDA had approved it or the scientific community stood behind it.}{\cs16\super\insrsid13313494 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid7098152 
  In other words, patients and advocates argued that when no other therapies had proven effective and nothing else was left to try, they, as informed and }{\insrsid2643356 consenting adults, should be }{\insrsid7098152 
free to use Laetrile without government }{\insrsid5715918 interference.  In time, the \'93freedom of choice\'94 line of argument developed into a more sophisticated claim for a comprehensive \'93right of access\'94
 to experimental therapies such as Laetrile.}{\cs16\super\insrsid5715918 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 123.}}}{\insrsid11413086   }{\insrsid6360091 One c}{\insrsid11413086 ritical issue 
posed by such an expansive right }{\insrsid6360091 is }{\insrsid11413086 whether FDA regulations, in accordance with the FDCA, should apply without modification to the terminally or seriously ill}{\insrsid6360091 
 seeking to gain access to investigational or unapproved treatments.}{\cs16\super\insrsid11413086 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid6360091   In 1979, the }{\insrsid3935163 United States }{\insrsid6360091 
Supreme Court first spoke on this issue}{\insrsid3935163 ,}{\insrsid6360091  and it is its unanimous opinion in }{\i\insrsid6360091 United States v. Rutherford}{\insrsid3935163  to which I will}{\insrsid6360091  now turn.}{\insrsid11413086  }{
\insrsid6905514\charrsid12786420 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid6887681 C.  }{\ul\insrsid6887681 When Courts Intervene: }{\ul\insrsid4871813  }{\i\ul\insrsid6887681 Rutherford }{
\ul\insrsid6887681 and Related Case Law}{\ul\insrsid11667704\charrsid6887681 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid6360091 In}{\i\insrsid13008465\charrsid11667704  Rutherford}{\insrsid13008465 , the }{\insrsid6360091 Supreme Court }{
\insrsid13008465 addressed the issue of }{\insrsid15280935 whether}{\insrsid13008465  the government has the right to prevent terminally ill patients from }{\insrsid15280935 choosing}{\insrsid13008465  a drug treatment that is unapproved by the FDA.}{
\cs16\super\insrsid13008465 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 442 U.S. 544 (1979).  }}}{\insrsid2040394   T}{\insrsid13008465 erminally ill cancer patients brought suit against the U.S. }{\insrsid15280935 Government}{\insrsid13008465  to enjoin the interference with the}{\insrsid2040394  shipment and sale of 
Laetrile}{\insrsid13008465 .}{\cs16\super\insrsid13008465 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 548.}}}{\insrsid13008465   The Tenth Circuit had remanded the case to the FDA to determine whether Laetrile was a }{\insrsid8587199 \'93}{\insrsid13008465 new drug}{\insrsid8587199 
\'94}{\insrsid13008465  under \'a7 201(p)(1) of the Act}{\insrsid8993135  and, therefore, }{\insrsid8587199 was subject to the \'93safety\'94 and \'93effectiveness\'94 standards of the }{\insrsid10027363 FDCA}{\insrsid8587199 
.  The FDA concluded that Laetrile was a \'93new drug\'94 as defined in \'a7 201(p)(1) and fell within neither of the }{\insrsid10027363 FDCA}{\insrsid8587199 \rquote s grandfather provisions.  After rev}{\insrsid7752212 iewing the FDA\rquote 
s decision, the district c}{\insrsid8587199 ourt found that Laetrile was exempt from premarketing approval under the Act\rquote s 1962 grandfather clause, and, alternatively, that the Commission}{\insrsid3935163 er}{\insrsid8587199 
 of the FDA had infringed constitutionally protected privacy interests by denying cancer patients access to Laetrile.  }{\insrsid7752212 Upholding the district court\rquote s injunction, which allowed plaintiffs to }{\insrsid15280935 receive}{
\insrsid7752212  the drug, the Tenth Circuit asserted that \'93as a matter of law \'85 the \lquote safety\rquote  and \lquote effectiveness\rquote  terms used in the statute have no reasonable application to terminally ill cancer patients.\'94}{
\cs16\super\insrsid7752212 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 582 F.2d 1234, 1236 (1978).}}}{\insrsid10427242   In order to address concerns that Laetrile was toxic when orally administered, the court limited relief to intravenous injections for patients under a doctor\rquote 
s supervision and directed the FDA to promulgate regulations \'93as if\'94 the drug had been found \'93safe\'94 and \'93effective\'94 for terminally ill cancer patients.}{\cs16\super\insrsid10427242 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  at 1237.}}}{
\insrsid1014037 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid9198865 \tab In a unanimous opi
nion written by Justice Marshall, the Supreme Court reversed, holding that the FDA had the authority to require safety and effectiveness for all drugs, including }{\insrsid15280935 those}{\insrsid9198865  intended to treat terminally ill patients.}{
\cs16\super\insrsid9198865 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  442 U.S. 
at 552.}}}{\insrsid10425736   The Court reasoned that \'93[n]othing in the h
istory of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety and effectiveness standards in \'a7 201(p)(1), suggests that Congress }{
\insrsid15280935 intended}{\insrsid10425736  protection only for persons suffering from curable diseases.\'94}{\cs16\super\insrsid10425736 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 552.}}}{\insrsid10425736   In fact, the Court pointed to concerns expressed in congressional del}{
\insrsid13788593 iberations surrounding the 1938 Act and 1962 Amendments that even \'93individuals with fatal illnesses, such as cancer, should be shielded from fraudulent cures,\'94 as well as to Committee Reports noting the \'93}{\insrsid3935163 FDA
\rquote s policy of considering }{\insrsid15280935 effectiveness}{\insrsid13788593  when passing on the safety of drug}{\insrsid3935163 s}{\insrsid13788593  prescribed for \lquote life-threatening disease.\rquote \'94}{\cs16\super\insrsid13788593 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099 
 at 552-53; }{\i\insrsid1061099 see, e.g.}{\insrsid1061099 
, 79 Cong. Rec. 5023 (1935) (remarks of Sen. Copeland, sponsor of the 1938 Act); 83 Cong. Rec. 7786-7787, 7789 (1938) (remarks of Reps. Phillips and Lea); 108 Cong. Rec. 17399 (1962) (remarks of Sen. Kefauver).}}}{\insrsid6761068   }{\insrsid2040394 

\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid6761068 Deferring to the FDA\rquote s determination not to allow the distrib
ution of Laetrile, the Court cautioned that to accept the Court of Appeals\rquote  ruling that the }{\insrsid3935163 FDCA\rquote s}{\insrsid6761068  safety and efficacy standards have no }{\insrsid15280935 relevance}{\insrsid6761068 
 for terminally ill patients \'93is to deny the Commission}{\insrsid15548422 er\rquote s authority over all drugs, however toxic or ineffectual, for such individuals.\'94}{\cs16\super\insrsid15548422 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  442 U.S. at 557-58; }{\i\insrsid1061099 see }{\insrsid1061099 
Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 200 (asserting that the Court in }{\i\insrsid1061099 Rutherford }{\insrsid1061099 was \'93sensitive to the authority of the FDA\'94
 and its position that only FDA approval can ensure that terminal cancer patients are ensured a \'93therapeutic gain\'94).}}}{\insrsid2040394   Furthermore, the Court offered a justification for the uniform application of the FDCA\rquote 
s efficacy standard, stating, \'93if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible.\'94}{\cs16\super\insrsid2040394 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  442 U.S. at 556.}}}{\insrsid2040394 
  Expressing concern over the inherent imprecision in labeling patients as \'93t}{\insrsid3935163 erminally ill,\'94 which it asserted}{\insrsid2040394  is \'93often impossible \'85 except in retrospect,\'94 the Court }{\insrsid1978871 warn}{
\insrsid3935163 ed}{\insrsid1978871  that exempting e}{\insrsid3935163 xperimental drugs with no proven}{\insrsid1978871  effectiveness in the treatment of cancer \'93would lead to needless deaths and suffering among \'85 patients characterized as 
\lquote terminal\rquote  who could actually be helped by legitimate therapy.\'94}{\cs16\super\insrsid1978871 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 556-57 (noting also that \'93
[e]ven critically ill individuals may have unexpected remissions and may respond to conventional treatment\'94) (citations omitted).}}}{\insrsid9198865 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid10027363 \tab Subsequent cases have applied the reasoning presented by the Court in }{\i\insrsid10027363 Rutherford}{\insrsid10027363 
, affirming its conclusion that the FDCA contains no exception for term}{\insrsid14430120 inally ill patients and its caution that finding otherwise would subject these \'93highly vulnerable patients\'94 to the \'93vast range
 of self-styled panaceas that inventive minds can devise.\'94}{\cs16\super\insrsid14430120 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 
{\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid3935163 Cowan v. United States}{\insrsid1061099 , 5 F. Supp. 2d 1235, 1242-43 (N.D. Okla. 1998) (citations omitted ).}}}{\insrsid8412815   In one such case, }{
\i\insrsid8412815 Cowan v. United States}{\insrsid8412815 , the plaintiff, a terminally ill AIDS patient seeking to gain access to an experimental goat neutralizing antibody drug, did not challenge the applicabili
ty of the FDCA, but asserted that he meets an exception to it and asked the Court to prohibit the FDA from interfering with the administration of the unapproved drug.}{\cs16\super\insrsid8412815 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 1239.}}}{
\insrsid8669191   Following }{\i\insrsid8669191 Rutherford}{\insrsid8669191 , the court rejected plaintiff\rquote s claim and reaffirmed the Supreme Court\rquote s statement of the law under the current statutes and regulations, }{\insrsid3935163 
declaring }{\insrsid8669191 that \'93[p]laintiff\rquote s physician may not administer the goat neutralizing antibody absent prior approval of the FDA.\'94}{\cs16\super\insrsid8669191 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 1242 (adding that \'93
to permit terminally ill patients to seek any type of treatment regardless of the effectiveness of such treatment would create a cottage industry existing solely to provide potential panaceas to highly vulnerable patients\'94).}}}{\insrsid8669191   }{
\insrsid3935163 Adding that although it was sy}{\insrsid352925 mpathetic to plaintiff\rquote s situation, }{\insrsid3935163 the }{\insrsid352925 required course of action for plaintiff and his physician}{\insrsid3935163  was}{\insrsid352925  to \'93
pursue approval of his Investigational New Drug application as quickly as possible\'94 and \'93obtain appropriate approval through the proper regulatory authorities.\'94}{\cs16\super\insrsid352925 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  at 1243.}}}{
\insrsid352925   Lastly, the court made clear that the decision whether to grant such exemptions from the IND process for terminally ill patients is one that rests properly with Congress and not with the courts.}{\cs16\super\insrsid352925 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{
\insrsid1061099  }}}{\insrsid10027363\charrsid8669191 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid15544223 Since }{\i\insrsid15544223 Rutherford}{\insrsid15544223 , lower courts have wrestled with claims by terminal patie
nts that they have a right under the Constitution t}{\insrsid7476690 o access unapproved medicines, and have consistently struck down such claims, reasserting the basic principles in }{\i\insrsid7476690 Rutherford}{\insrsid7476690 .  }{\insrsid198554 
While the Supreme Court in }{\i\insrsid198554 Rutherford }{\insrsid198554 did not directly address the claim by plaintiffs that they had a constitutionally protected \'93privacy\'94
 right to use laetrile, on remand the Court of Appeals for the Tenth Circuit rejected that claim, finding that, \'93although a decision by a patient whether to have a treatment or not is a protected right, the \lquote 
selection of a particular treatment, or at least a medication, is within the area of governmental interest in protecting public health.\rquote \'94}{\cs16\super\insrsid198554 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Seeley v. State of Washington}{\insrsid1061099 
, 940 P.2d 604, 612 (Wash. 1997) (quoting }{\i\insrsid1061099 Rutherford v. United States}{\insrsid1061099 , 616 F.2d 455, 457 (10th Cir.), }{\i\insrsid1061099 cert. denied}{\insrsid1061099 , 449 U.S. 937 (1980)).}}}{\insrsid10309694   Likewise, other }{
\insrsid5849598 federal }{\insrsid10309694 courts have followed the Tenth Circuit\rquote s lead in holding that the selection of a particular treatment or }{\insrsid8220240 medicine}{\insrsid10309694  is not a protected right }{\insrsid8220240 under}{
\insrsid10309694  the Constitution.}{\cs16\super\insrsid10309694 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See Seeley}{\insrsid1061099 , 940 P.2d at 613; }{\i\insrsid1061099 See, e.g., Carnohan v. United States}{\insrsid1061099 
, 616 F.2d 1120 (9th Cir. 1980) (finding that constitutional rights of privacy and personal liberty did not give plaintiff the right to get access of laetrile free of lawful exercise of government police power); }{\i\insrsid1061099 Kulsar v. Ambach}{
\insrsid1061099 , 598 F. Supp. 1124 (W.D.N.Y. 1984) (holding that patients had no constitutional right to a drug treatment which the FDA ordered removed from commerce); }{\i\insrsid1061099 United States v. Burzynski}{\insrsid1061099 
, 819 F.2d 1301, 1314-15 (5th Cir. 1987) (finding unsupportable plaintiffs\rquote  claim for injunctive relief against interference with interstate distribution of an unapproved cancer drug, antineoplastons, based on the asserted \'93
constitutional right to obtain medical treatment that is encompassed by their right to privacy\'94).}}}{\insrsid5849598   State courts have similarly }{\insrsid8220240 rejected}{\insrsid5849598  terminally ill patients\rquote 
 claims based on a constitutionally protected right to privacy, concluding that the right to obtain unapproved drugs wh}{\insrsid1777458 ose efficacy has not been proven}{\insrsid5849598  is not a fundamental right.}{\cs16\super\insrsid5849598 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See, e.g.}{
\insrsid1061099 , }{\i\insrsid1061099 People v. Privitera}{\insrsid1061099 , 591 P.2d  919, 925-26 (Cal. 1979), }{\i\insrsid1061099 cert. denied}{\insrsid1061099 
, 444 U.S. 949 (1979) (applying a rational basis analysis where terminally ill cancer patients asserted a right to be treated with an unapproved drug, and finding that 
the state statute met this standard and therefore did not violate the federal constitutional right of privacy); }{\i\insrsid1061099 Seeley}{\insrsid1061099 
, 940 P.2d at 613-14 (applying the rational basis standard of review and upholding the challenged legislation categorizing marijuana as a schedule I controlled substance).}}}{\insrsid14767131   }{\insrsid5849598 
\par }{\insrsid1777458 As a final illustration, i}{\insrsid7476690 n }{\i\insrsid7476690 Garlic v. Food and Drug Administration}{\insrsid7476690 , plaintiffs }{\insrsid8220240 suffering}{\insrsid7476690  from Alzheimer\rquote s disease challenged the FDA
\rquote s failure to approve the drug tetrahydroaminoacrinine (THA) as a treatment for their }{\insrsid1777458 severely}{\insrsid7476690  debilitating disease.}{\cs16\super\insrsid7476690 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  783 F. Supp. 4 (D.D.C. 1992).}}}{\insrsid7103291 
  Asserting that the Ninth and Fourteenth Amendments guarantee them a right to follow a course of medical treatment designed to \'93prolong and improve\'94 one\rquote s life, they }{\insrsid7673504 argued that the FDA wa
s unconstitutionally interfering with the private importation of the drug.}{\cs16\super\insrsid11349487 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 5.}}}{\insrsid9916108 
  While acknowledging that several courts have recognized that decisions concerning medical treatment are \'93essentially personal, and therefore may affect an individual\rquote s right to liberty or privacy,\'94}{\cs16\super\insrsid9916108 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See, e.g.,}{
\insrsid1061099  }{\i\insrsid1061099 Whalen v. Roe}{\insrsid1061099 , 429 U.S. 589 (1976); }{\i\insrsid1061099 New York State Ophthalmological Soc\rquote y v. Bowen}{\insrsid1061099 , 854 F.2d 1379 (D.C. Cir. 1988).}}}{\insrsid9004216 
 the District Court for the District of Columbia }{\insrsid15013974 cited }{\i\insrsid15013974 Rutherford}{\insrsid15013974  and held that plaintiffs had not stated a valid claim under the Constitution.}{\cs16\super\insrsid15013974 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See Garlic}{\insrsid1061099 
, 783 F. Supp. at 5.}}}{\insrsid9004216   Expressing sympathy for plaintiffs\rquote  \'93sense of exigency and frustration,\'94 the court reaffirmed }{\i\insrsid9004216 Rutherford}{\insrsid9004216 \rquote s }{\insrsid3829267 well-established }{
\insrsid1777458 tenet that \'93}{\insrsid9004216 the Federal Food, Drug, and Cosmetic Act makes no special provision for drugs used to treat terminally ill patients.\'94}{\cs16\super\insrsid9004216 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  (quoting }{
\i\insrsid1061099 Rutherford}{\insrsid1061099 , 442 U.S. at 552) (leaving no doubt that \'93
plaintiffs must wait for THA to pass the rigorous statutory and regulatory process designed to ensure that a medication is safe as well as effective before it is marketed to the public\'94).}}}{\insrsid11891238\charrsid9004216 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid7432150 D.  }{\ul\insrsid7432150 The Plight of Dr. Burzynski in the War on Cancer}{\ul\insrsid4653999 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid15420292 \tab The constant interplay between the cou
rts, Congress, the FDA, and the interested public with respect to the issue of access by terminally ill patients to unapproved and experimental drugs and treatments is a testament to the very heated debate that has been kept alive, and, indeed, re-fueled,
 }{\insrsid12137736 for much of the twentieth century and into the twenty-first.  An illustrative example of the powerful interaction among these key players is one that began when Stanislaw Burzynski, a }{\insrsid8220240 Polish}{\insrsid12137736 -born }{
\insrsid8220240 physician}{\insrsid12137736  with a doctorate in biochemistry, }{\insrsid8220240 discovered}{\insrsid12137736  a reportedly non-toxic cancer therapy in 1967.}{\cs16\super\insrsid12137736 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Sue A. Blevins, }{
\i\insrsid1061099 FDA: Keeping Medication from Cancer Patients}{\insrsid1061099 , Regulation, Cato Institute, Vol. 20, No. 1 (1997); }{\i\insrsid1061099 see also }{\insrsid1061099 David Wagner, }{\i\insrsid1061099 Friend or Enemy?}{\insrsid1061099 
, Insight on the News, at 8 (Aug. 17, 1998).}}}{\insrsid6318695   Escaping communist oppression in his home country, Burzynski came to the United States in 1970 and began work on his discovery}{\insrsid272330 
, an alternative cancer drug called antineoplaston, which simply means \'93anticancer}{\insrsid6318695 .}{\insrsid272330 \'94}{\cs16\super\insrsid6318695 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Blevins, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 141.}}}{\insrsid8410050  
 Desperately ill cancer patients flocked to Burzynski and his cancer research institute, seeking to obtain his experimental therapy as a last hope after traditional chemotherapy and radiation had failed or }{\insrsid5332888 only }{\insrsid8410050 
intensified their illnesses.}{\cs16\super\insrsid8410050 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 (noting that since 1977 more than 2,500 Americans have sought out Burzynski\rquote s experimental therapy).}}}{\insrsid5332888   }{\insrsid14493478 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid5332888 Despite the benefits reported by many patients, who claimed}{\insrsid11811773  }{\insrsid1777458 that }{
\insrsid11811773 the}{\insrsid14493478  antineoplaston}{\insrsid11811773 s}{\insrsid14493478  actually reduced their tumors}{\insrsid5332888  and that they had gone into complete remission, without experiencing the dreadful toxic side effects typically }{
\insrsid8220240 associated}{\insrsid14493478  with many anticancer drugs, the American Cancer Society added Burzynski\rquote s treatment to its \'93unproven methods\'94 blacklist in 1983.}{\cs16\super\insrsid14493478 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid14493478 
  The FDA entered the ring several months later when it sought an injunction against Burzynski\rquote s use of the drug to treat patients because it had not been approved in accordance with the agency\rquote s }{\insrsid11811773 new }{\insrsid14493478 
drug approval process}{\insrsid11811773  under the FDCA}{\insrsid14493478 .  Refusing to issue a broad injunction against the drug\rquote s use, which would }{\insrsid8220240 effectively}{\insrsid14493478  shut down Burzynski\rquote 
s clinic, the federal judge allowed the doctor to continue treating patients in Texas, but }{\insrsid8220240 prohibited}{\insrsid14493478  him from shipping the drug across state lines.}{\cs16\super\insrsid14493478 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid11811773 
  As expected, out-of-state patients came to Texas to be treated by Burzynski and shipped the }{\insrsid8220240 drug}{\insrsid11811773  interstate, leading to a fierce battle between the doctor and the federal government that lasted more than a decade.

\par In July of 1985, the government applied for and }{\insrsid8220240 obtained}{\insrsid11811773  a warrant to search Burzynski\rquote s clinic as part of a criminal }{\insrsid8220240 investigation}{\insrsid11811773  based on the FDA\rquote 
s referral to the Department of Justice.}{\cs16\super\insrsid11811773 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See United States v. Burzynski}{\insrsid1061099 , 819 F.2d at 1305.}}}{\insrsid1184585   Patient records and other 
property were seized as evidence to show that antineoplastons had been shipped outside the state and were being distributed in interstate commerce in violation of several federal mandates as well as the district court\rquote s initial }{\insrsid8220240 
injunction}{\insrsid1184585 .}{\cs16\super\insrsid1184585 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid3625694   }{\insrsid5055649 In addition to
 federal raids on his research facilities, Burzynski was subjected to three federal grand jury investigations between 1986 and 1994, although none led to an indictment.}{\cs16\super\insrsid5055649 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Blevins, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 141.}}}{\insrsid5055649   }{\insrsid16412174 
\par }{\insrsid1777458 In 1994, t}{\insrsid5055649 he doctor\rquote s endeavor seemed to be looking up, with the FDA even approving his }{\insrsid8220240 manufacturing}{\insrsid5055649 
 facility and granting him permission to conduct clinical research trials, until }{\insrsid16412174 Burzynski welcomed a chance to }{\insrsid12089425 publicly endorse }{\insrsid16412174 
his treatment by appearing in March of 1995 on the CBS television show \'93This Morning\'94 with three of his patients who had apparently beaten terminal cancer after receiving antineoplastons.}{\cs16\super\insrsid16412174 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid16412174 
  Later that same day federal }{\insrsid8220240 agents}{\insrsid16412174  again raided Burzynski\rquote s clinic, and eight months later a federal grand jury, the fourth to be convened within a span of nine years, handed d
own an indictment against the doctor, }{\insrsid8220240 charging}{\insrsid16412174  him with 40 }{\insrsid8220240 courts}{\insrsid16412174  of distributing an unapproved drug in interstate commerce, 34 }{\insrsid8220240 counts}{\insrsid16412174 
 of mail fraud, and one count of contempt of }{\insrsid8220240 court}{\insrsid16412174 .}{\cs16\super\insrsid16412174 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also }{\insrsid1061099 Wagner, }{\i\insrsid1061099 supra }{
\insrsid1061099 note 141, at 8 (noting that the doctor\rquote s appearance on television is when \'93[t]hings took a turn for the worse for Burzynski, when he seized an opportunity to promote his cause the American way \endash  through the media\'94).}}}{
\insrsid11811773 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid1777458 \tab While the battle}{\insrsid207768  waged }{\insrsid15221787 on in}{\insrsid207768  the }{\insrsid12583328 courtroom}{
\insrsid207768 , Congress entered the scene the same year when Representative Joe Barton}{\insrsid8401439  }{\insrsid12741863 and his Subcommittee on Oversight and }{\insrsid12583328 Investigations}{\insrsid12741863  of the House Commerce Committee}{
\insrsid207768  held hearings during July of 1995}{\insrsid12741863  to probe charges that the U.S. Attorney\rquote s office in Houston and the FDA had acted improperly and harassed Burzynski through investigations that began in 1983}{\insrsid207768 .}{
\cs16\super\insrsid207768 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Wagner, }{\i\insrsid1061099 supra }{\insrsid1061099 note 141, at 8; }{\i\insrsid1061099 see also }{\insrsid1061099 Blevins, }{\i\insrsid1061099 supra }{\insrsid1061099 note 141.}}}{\insrsid1463941   }{
\insrsid3492509 During the hearings, which addressed alleged abusive and retaliatory practices by the FDA, }{\insrsid13252293 one of Burzynski\rquote s patients, who had successfully undergone antineoplaston therapy after bein
g diagnosed with an inoperable brain tumor, offered dramatic testimony in support of the experimental therapy, }{\insrsid8401439 asserting, \'93[i]t\rquote s like I\rquote 
m at war against cancer, and the government keeps trying to take away the only weapon I have.\'94}{\cs16\super\insrsid8401439 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Wagner, }{\i\insrsid1061099 supra }{\insrsid1061099 note 141, at 8.}}}{\insrsid8401439 
  Responding to the allegations of abuse, then-FDA chief David Kessler testified in November of 1995, denying that any pattern of retaliation or abuse existed, and, ironically, the 75-count }{\insrsid12583328 indictment}{\insrsid8401439 
 against Burzynski was handed down just five days later.}{\cs16\super\insrsid8401439 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid1777458   }{\insrsid2241484 As the saga continued }{\insrsid1777458 on multiple fronts}{\insrsid2241484 
, the Burzynski case went to trial in January of 1997, but ended with a hung jury just two months later, with the judge dismissing the mail fraud charges and federal }{\insrsid12583328 prosecutors}{\insrsid2241484 
 dropping the 40 counts of unauthorized distribution.}{\cs16\super\insrsid2241484 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 ; }{\i\insrsid1061099 see also }{\insrsid1061099 Sue A. Blevins, }{\i\insrsid1061099 FDA\rquote 
s War on Dr. Burzynski and His Patients: Physician and Patients Win!}{\insrsid1061099\charrsid4546001 ,}{\i\insrsid1061099  }{\insrsid1061099 Medical Sentinel, Vol. 3, No. 4 (1998), at 135.}}}{\insrsid2241484   In M
ay of 1997, a second federal trial to address Burzynski\rquote s lone remaining contempt charge resulted in an acquittal after just three hours of jury deliberation.}{\cs16\super\insrsid2241484 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}}}{\insrsid4590387   }{
\insrsid12984677 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid4590387 While Burzynski\rquote s 14-year battle with the FDA may have appeared to be over, the \'93miracle\'94 doct
or and his experimental \'93cure\'94 finally victorious, the }{\insrsid1777458 controversy}{\insrsid4590387  }{\insrsid1777458 rages}{\insrsid9836640  on, as Burzynski\rquote s patients, as well as other desperately ill patients in}{\insrsid5269795 
 search of a last chance at life}{\insrsid9836640 , continue to plead with Congress to reign in the FDA\rquote s control over}{\insrsid13729119  terminally ill}{\insrsid9836640  patient}{\insrsid1777458 s\rquote }{\insrsid9836640 
 access to experimental drugs.}{\cs16\super\insrsid9836640 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Blevins, }{\i\insrsid1061099 FDA\rquote s War on Dr. Burzynski and His Patients}{\insrsid1061099 , }{\i\insrsid1061099 supra }{\insrsid1061099 note 154, at 135.}}}{\insrsid13437360 
  For example, in 1998 Representative Barton led a new set of hearings concerning FDA abuses before the House Committee on Government Reform and Oversight.  Addressing the Committee, the father of a 6-year-old patient of Burzynski dramatically asserted, 
\'93[f]rom the time we went to Dr. Burzynski [for antineoplaston treatment], the biggest threat to [my son\rquote s] life was not can}{\insrsid9057653 cer, it was the FDA,\'94 and scolded the FDA\rquote s \'93cold disregard for the life of [his] son and
 Dr. Burzynski\rquote s other terminal cancer patients,\'94 as well as the \'93legal maneuvers\'94 it employed to stop them from receiving the treatment.}{\cs16\super\insrsid9057653 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 
(citing the congressional testimony of Jack Kunnari, the father of 6-year-old Dustin Kunnari).}}}{\insrsid9057653   Such tactics, he claimed, were both \'93un-American and unconstitutional,\'94 and it was Congress\rquote  job to put an end to th
em once and for all.}{\cs16\super\insrsid9057653 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{
\insrsid1061099  }{\i\insrsid1061099 Id.}}}{\insrsid13437360 
\par }{\insrsid213319 Since the unfolding of the case of Dr. Burzynski, similar allegations of abuse and calls for action have been recorded in congressional hearings, and an increasing number of members of Congress have joined the debate, many of whom hav
e expressed concern over the \'93inherent injustice in preventing cancer victims from having the medical freedom to try to save their lives.\'94}{\cs16\super\insrsid213319 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 201.
}}}{\insrsid6835572   For example, one Congressman, prompted by the many phone calls and letters his office had received regarding the plight of }{\insrsid1777458 Dr. }{\insrsid6835572 Burzynski, testified that \'93[w]hatever the FDA\rquote 
s concerns are, the problem remains they are denying patients with life-threatening diseases access to this [experimental] therapy,\'94 and \'93fail to recognize that people\rquote s lives and rights are being trampled in this process.\'94}{
\cs16\super\insrsid6835572 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 FDA Does Not Serve Public By Denying Treatment of Last Resort Pursued by Terminally Ill Patients}{\insrsid1061099 , 142 Cong. Rec. H. 4115 (daily ed. Apr. 29, 1996) (statement of Rep. Pallone).}}}{\insrsid6835572 
  In an emotional appeal for change in the face of l}{\insrsid1777458 ife-or-death circumstances, he }{\insrsid6835572 pleaded that \'93as we continue down the path toward FDA reform, let us be mindful of patients with life-}{\insrsid15103107 threatening}
{\insrsid6835572  diseases who are grasping at their last hopes to continue to live.\'94}{\cs16\super\insrsid6835572 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}}}{\insrsid9057653 
\par }{\insrsid16143874 Even after Burzynski had been cleared of all charges his story remained a heated backdrop for continued congressional debate regarding patient access to }{\insrsid15103107 experimental}{\insrsid16143874 
 treatments and legislation to promote }{\insrsid10445909 it}{\insrsid16143874 .}{\cs16\super\insrsid7368498 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See, e.g.}{\insrsid1061099 , }{\i\insrsid1061099 The Plight of Dr. Stanislaw Burzynski}{\insrsid1061099 
, 143 Cong. Rec. H. 5176 (daily ed. July 11, 1997) (statement of Rep. Pallone) (calling the government\rquote s conduct in Burzynski\rquote s case \'93disturbing\'94 and its treatment of Burzynski \'93reprehensible,\'94 adding that the government \'93
placed cancer patients at jeopardy at one point\'94 and \'93badly utilized\'94 taxpayer money and resources).}}}{\insrsid10497649   Accompanying such discussions has been an undying concern for the protection of human subjects in }{\insrsid15103107 
experimental}{\insrsid10497649  }{\insrsid15103107 clinical}{\insrsid10497649  research.  For example, in a 1997 hearing before }{\insrsid1777458 the }{\insrsid10497649 House Subcommittee on Human Resources, the Deputy Commissioner and }{\insrsid15103107 
Senior}{\insrsid10497649  }{\insrsid15103107 Advisor}{\insrsid10497649  to the FDA }{\insrsid15103107 Commissioner}{\insrsid10497649 , Mary Pendergast, }{\insrsid2777676 discussed the FDA\rquote 
s policies concerning the protection of human research subjects and emerging issues involving access to }{\insrsid15103107 experimental}{\insrsid2777676  treatments and}{\insrsid6952375  informed consent}{\insrsid2777676 .}{\cs16\super\insrsid2777676 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 
See Biomedical Ethics: }{\i\insrsid1061099\charrsid14699728 Hearing Before the Subcomm. on Human Resources of the House Comm. on Government Reform and Oversight}{\insrsid1061099 
, 105th Cong. (May 8, 1997) (statement of Mary K. Pendergast, Deputy Commissioner and Senior Advisor to the Commissioner of Food and Drugs, U.S. Food and Drug Administration) (hereinafter \'93Pendergast testimony\'94).  }}}{\insrsid6952375 
  Setting out the basic structure for human research protection in the U.S. and the interco}{\insrsid10445909 nnection between the FDA and}{\insrsid6952375  }{\insrsid15103107 Department}{\insrsid6952375  of Health and Human Services (DHHS) regulations,}{
\cs16\super\insrsid7015518 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 Both the FDA and the Department of Health and Human Services (HHS) have regulations addressing the protection of human research subjects (20 C.F.R. Parts 50 and 56 for FDA; 45 C.F.R. Part 46 f
or HHS).  While the HHS regulations apply to research that is conducted or supported by HHS and are implemented by the National Institutes of Health (NIH), the FDA regulations apply to human subject research involving products regulated by the FDA, whethe
r the research is privately or publicly funded.  Although the FDA and HHS regulations are essentially identical, the two agencies apply them in ways that reflect their distinct missions (}{\i\insrsid1061099 e.g.}{\insrsid1061099 
, NIH implements the HHS regulations through assurances made by th
e institutions where the research is done, while FDA regulates the investigators who conduct the research and the IRBs that review proposed research studies).  Both sets of regulations apply where a research project is conducted or supported by HHS and in
volves a product regulated by FDA.  In sum, they are \'93complementary and together they set forth criteria that are needed to protect research subjects.\'94  Pendergast testimony at 6.}}}{\insrsid6952375  Pendergast highlighted the FDA\rquote 
s vigilance in protecting the rights and welfare of human research subjects, asserting that }{\insrsid4591387 the \'93[FDA] take[s] no human right more seriously than the protection of people enrolled in clinical trials.\'94}{\cs16\super\insrsid4591387 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{
\insrsid1061099 at 4.}}}{\insrsid10704503   
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid2309932 E.  }{\ul\insrsid2309932 Legislative Proposals for Expanded Access: }{\ul\insrsid5510670  }{\i\ul\insrsid2309932 
The Access to Medical Treatment Act}{\ul\insrsid2309932\charrsid2309932 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid10704503 In 1998, a series of hearings were held to address ways to expand acc
ess to investigational and alternative therapies for seriously ill and dying patients, including new \'93legislation that would give all Americans the freedom to choose their own }{\insrsid16656099 medicines}{\insrsid10704503 .\'94}{
\cs16\super\insrsid10704503 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 Clinical Trial Subjects: Adequate FDA Protections: Hearing Before the House Comm.}{\i\insrsid1061099\charrsid610698  on Government Reform and Oversight}{\i\insrsid1061099 , }{\insrsid1061099 
106th Cong. (Apr. 22, 1998) (statement of Dan L. Burton, Chairman, House Comm. on Government Reform and Oversight).}}}{\insrsid6580468   }{\insrsid12411270 One piece of proposed legislation, entitled \'93}{\insrsid12871574 The }{\insrsid12845521 
Access to Medical Treatment Act}{\insrsid12871574 \'94}{\insrsid12845521  (\'93AMTA\'94),}{\insrsid12411270  has been repeatedly in}{\insrsid12845521 troduced in Congress since 1993}{\insrsid2366623 .}{\cs16\super\insrsid2366623 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 
S. 1955, 106 Cong. (1999); H.R. 746, 105 Cong. (1997); S. 578, 105 Cong. (1997); H.R. 2019, 104 Cong. (1995-96); S. 1035, 104 Cong. (1995-96); H.R. 4696, 103 Cong. (1993-94); H.R. 4499, 103 Cong. (1993-94); }{\i\insrsid1061099 see also }{\insrsid1061099 
Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 201 (presenting the comments of Senator Bob Dole, an original co-sponsor of the legislation: \'93
In a free market system, it seems to make sense to make available non-harmful alternative medical treatments to individuals who desire such treatments, without the Federal Government standing in the way.\'94).}}}{\insrsid2366623   Generat}{
\insrsid6580468 ing much debate over the}{\insrsid2366623  years since its first introduction in Congre}{\insrsid10445909 ss, }{\insrsid2366623 AMTA }{\insrsid12845521 provides }{\insrsid16656099 that patients}{\insrsid12845521  may be treated by a}{
\insrsid920834 ny}{\insrsid12845521  licensed healthcare practitioner with any }{\insrsid5930241 method of }{\insrsid12845521 medical treatment }{\insrsid5930241 the patient desires}{\insrsid12845521 
, even if the treatment has not yet been approved by the FDA}{\insrsid5930241 , and provided that a comprehensive list of }{\insrsid16656099 requirements}{\insrsid5930241  are met}{\insrsid12845521 .}{\cs16\super\insrsid12845521 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 \'93
Access to Medical Treatment Act,\'94 2001 H.R. 1964, S. 1378, 107th Cong. (2001); }{\i\insrsid1061099 see also }{\insrsid1061099 Blevins, }{\i\insrsid1061099 FDA: Keeping Medication from Cancer Patients}{\insrsid1061099 , }{\i\insrsid1061099 supra }{
\insrsid1061099 note 141 (maintaining that the Access to Medical Treatment Act addresses the issue which stands at the crux of the problem with most regulations today, namely, that \'93
they restrict the freedom of individuals to engage in voluntary transactions\'94).}}}{\insrsid5930241   For example, }{\insrsid5388868 Section 3 of the }{\insrsid10445909 proposed legislation }{\insrsid5388868 requires the healthcare practitioner to use 
\'93generally accepted principles and current information\'94 to conclude that the unapproved drug, when used as }{\insrsid16656099 directed}{\insrsid5388868 
, will not cause a danger to the patient, to inform the patient that the drug is not approved by the FDA, to allow the patient s
ufficient opportunity to consider whether or not to use the drug and to minimize the possibility of coercion or undue influence when making a recommendation to the patient, to disclose any }{\insrsid16656099 financial}{\insrsid5388868 
 interest that he or she may have in the drug, and }{\insrsid2366623 to adhere to stringent informed consent procedures set forth in the legislation.}{\cs16\super\insrsid2366623 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 \'93
Access to Medical Treatment Act,\'94 107th Cong. \'a7 3; }{\i\insrsid1061099 see also }{\insrsid1061099 Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 201 (outlining the requirements of the legislation).}}}{\insrsid13660323 
\par }{\insrsid4026916 The increased access to experimental treatments available under AMTA has been applauded by groups such as the }{\insrsid801098 American Association for Health Freedom}{\insrsid4026916 , which }{\insrsid3367098 claims that the legislat
ion is necessary \'93to stop the legal harassment many alternative practitioners face from the FDA and state medical boards.\'94}{\cs16\super\insrsid3367098 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Sue A. Blevins, }{\i\insrsid1061099 Legalize Alternative Medicine}{
\insrsid1061099 , Christian Science Monitor (Boston, MA) (Mar. 28, 1996), at 20.}}}{\insrsid3367098   Other advocates assert that AMTA is necessary \'93because of the FDA\rquote s\emdash and the pharmaceutical industry\rquote s\emdash 
entrenched hostility to new treatments.\'94}{\cs16\super\insrsid3367098 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Wagner, }{\i\insrsid1061099 supra }{\insrsid1061099 note 141, at 8.}}}{\insrsid486846   These proponents attack the increasing influence of the drug industry over the FDA, particularly through the }{
\insrsid10445909 use of }{\insrsid486846 user fees that pharmaceutical companies must pay to file new drug applications with the FDA under the Prescription Drug User Fee Act.}{\cs16\super\insrsid486846 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 
  Those opposed to the imposition of user fees claim that industry funding of the FDA through such fees undermines th
e credibility and independence of the FDA.  They argue that the imposition of user fees has made the FDA too close to the pharmaceutical industry, which has pressured the FDA to approve drugs too quickly, and that the industry is essentially \'93buying
\'94 drug approvals, and thus compromising the entire review and approval process.}}}{\insrsid1197433   Other advocates focus on the FDA\rquote s \'93unnecessary and unwanted\'94
 interference in the personal health decisions of Americans.  House Representative Dan Burton voiced this objection succinctly during a congressional hearing on alternative medicines, asserting, \'93Americans do not }{\insrsid10445909 need }{
\insrsid1197433 the government, in this case the FDA, telling them how to treat their illnesses, especially when state-level protections are already in place to safeguard the public from those who might do harm to patients.\'94}{
\cs16\super\insrsid14774197 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 Alternative Medicines: }{\i\insrsid1061099\charrsid223032 Hearing Before the House Comm. on Government Reform and Oversight}{\insrsid1061099 , 105th Cong. (Feb. 12, 1998) (statement of Dan L. Burton, Chairman, House Comm. on Governmen
t Reform and Oversight).}}}{\insrsid12070529   Moreover, Burton characterized the FDA\rquote s process for patient access to unapproved and experimental treatments as \'93
a good example of the nature of the federal government to micromanage the lives of individual Americans, often }{\insrsid549080 unnecessarily}{\insrsid12070529 .\'94}{\cs16\super\insrsid12070529 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099 
  Burton explained that access to unapproved drugs and therapies in the development process generally requires participation in a clinical trial.  However, if a patient does not meet the strict guidelines established for a tri
al, his or her access may be entirely \'93shut off, with no appeal,\'94 with the FDA making the \'93life or death decision as to whether a patient can have the treatment under a special exception.\'94}}}{\insrsid12070529 
\par }\pard \qj \fi720\li0\ri0\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid16462389 On the other side of the debate, }{\insrsid3367098 critics }{\insrsid3301674 respond by arguing}{\insrsid3367098 
 that the AMTA would pose serious risks to consumers who will have access to possibly dangerous treatments and therapies.  Thus, critics remain steadfast in their belief that all drugs should be required to go through the FDA\rquote 
s approval process before consumers can gain access to them.}{\cs16\super\insrsid3367098 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Wagner, }{\i\insrsid1061099 supra }{\insrsid1061099 note 141, at 8. }}}{\insrsid801098   }{\insrsid14553222 
During a series of congressional hearings in 1998 addressing clinical trials and patient safety, one}{\insrsid801098  }{\insrsid14553222 FDA insider}{\insrsid801098  aptly voiced his concerns with AMTA, warning that the proposed legislation \'93w
ould lower the standard for safety, thus putting patients at unnecessary risk,\'94 and would have at least three unintended and severe consequences:}{\insrsid15221787  }{\insrsid801098 
 (1) the bill would reduce, or wholly eliminate, the critical process of scientific data collection necessary 
to establish the safety and effectiveness of a product; (2) the bill would diminish any assurance of appropriate informed consent and human subject protection; and (3) the bill would make it extremely difficult to protect consumers against health fraud.}{
\cs16\super\insrsid801098 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099\charrsid223032 Clin}{\i\insrsid1061099 ical Trials and Patient Safety: }{\i\insrsid1061099\charrsid223032 H}{\i\insrsid1061099 earing Before the House Comm.}{\i\insrsid1061099\charrsid223032  on Government Reform and Oversight}{
\insrsid1061099 , 105 Cong. (Apr. 22, 1998) (testimony of Michael A. Friedman, M.D., Lead Deputy Commissioner, Food and Drug Administration).  }}}{\insrsid14553222   Moreover, this AMTA critic stressed the FDA\rquote 
s efforts to balance two compelling factors:}{\insrsid15221787  }{\insrsid14553222  the controlled study necessary to identify treatments that }{\insrsid10445909 may improve patients\rquote  health,}{\insrsid14553222 
 and the desire of terminally and seriously ill patients, with no }{\insrsid7351365 effective}{\insrsid14553222  options available, to have the earliest access to unapproved and experimental drugs and treatments that could be the best therapy for them.}{
\cs16\super\insrsid14553222 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 Id. }{\insrsid1061099 (adding that the FDA\rquote s primary concern with the AMTA is that it would weaken the protections of the FDCA, and, specifically, that it would limit the FDA\rquote s ability to ensure \'93
reasonable safety, effectiveness, informed consent, and scientific data collection\'94).}}}{\insrsid14096599   Emphasizing the former factor, another critic concerned }{\insrsid6710996 with}{\insrsid14096599  AMTA\rquote 
s potential implications offered this plea}{\insrsid6710996  }{\insrsid8353281 for more rigorous drug testing:}{\insrsid12929413 
\par }\pard \qj \li720\ri720\sa360\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid10445909 {\insrsid6710996 Without extensive drug testing we just can\rquote 
t tell which hand holds a dangerous poison, and which conceals the life saving drug.  }{\insrsid549080 Without}{\insrsid6710996  proper testing even a potentially life saving treatment may be harmful if given in the wrong d
ose, or to the wrong patients.  I want people to have choices too.  But they should have real choices, involving scientific data about how much harm and good various treatment alternatives can be expected to }{\insrsid12929413 
achieve.  We have a [sic] only one proven solution.  We need public policies to promote more drug testing, not still more new loopholes that could endanger the health and safety of millions of peo}{\insrsid10445909 ple.}{\cs16\super\insrsid12929413 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099\charrsid223032 
Clin}{\i\insrsid1061099 ical Trials and Patient Safety}{\i\insrsid1061099\charrsid5987493 : H}{\i\insrsid1061099 earing Before the House Comm.}{\i\insrsid1061099\charrsid5987493  on Government Reform and Oversight}{\insrsid1061099 
, 105 Cong. (Feb. 4, 1998) (statement of Thomas J. Moore, Senior Fellow, Center for Health Policy Research, George Washington University Medical Center). }}}{\insrsid12929413 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid2579958 After several un}{\insrsid10445909 successful attempts to pass }{\insrsid2579958 AMTA in Congress, it seems }{
\insrsid7351365 clear}{\insrsid10445909  thus far that the majority of congressman and s}{\insrsid2579958 enators believe that the risks outweigh the potential benefits in permitting patients the }{\insrsid7351365 freedom}{\insrsid2579958 
 to access the medical treatments of their choice.}{\cs16\super\insrsid2579958 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 201.}}}{\insrsid7625001   But while critics remain staunchly opposed, }{\insrsid10445909 AMTA }{
\insrsid7625001 advocates}{\insrsid10445909  }{\insrsid7625001 will undoubtedly continue to focus their energies on achieving its passage, most likely invoking emotional pleas by }{\insrsid7351365 terminally}{\insrsid7625001  ill patient}{
\insrsid10445909 s and their families who view AMTA}{\insrsid7625001  as a giant step toward increased access to treatments that offer one last hope for survival.}{\cs16\super\insrsid7625001 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See, 
e.g., Legislative Priorities for the 107th Congress: Access to Medical Treatment Act \endash  HR 1964/S1378}{\insrsid1061099 , American Association for Health Freedom, at http://healthfreedom.net (last visited Mar. 31, 2003).}}}{\insrsid8353281   }{
\insrsid655938 For example, 
testifying at yet another congressional hearing addressing access to experimental and alternative treatments, one impassioned supporter of expanded access recounted her battle against a fatal cancer and the successful, yet experimental and unapproved, tre
atment she received from Dr. Burzynski only after several physicians had }{\insrsid10445909 issued her a death sentence and absolutely no hope }{\insrsid6039613 under conventional therapies.  Speaking from personal }{\insrsid549080 experience}{
\insrsid6039613 , she }{\insrsid16340959 poignantly questioned the FDA\rquote s policy toward experimental drug approval for the terminally ill, asking}{\insrsid8675833  the committee convened that day}{\insrsid16340959 , }{\insrsid6039613 \'93
Who gave FDA the right to play God?  Was it the intent of Congress to give FDA the kind of power it exercises over life and death with no accountability?  By denying terminally ill cancer patients access to antineoplastons, this agency literally decides 
\lquote who shall live and who shall die.\rquote \'94}{\cs16\super\insrsid6039613 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Alternative Medicines: }{\i\insrsid1061099\charrsid9515742 Hearing }{\i\insrsid1061099 Before the House Comm.}{\i\insrsid1061099\charrsid9515742  on Government Reform and Oversight}{
\insrsid1061099 , 105th Cong. (Feb. 4, 1998) (statement of Mary Jo Siegel).}}}{\insrsid1197433 
\par }{\insrsid13373527 Whether one is a proponent or a critic of expanding access to experimental drugs and therapies for terminally ill patients, there is one issue of
 concern upon which all participants in the debate can agree: there must be adequate safeguard}{\insrsid13793149 s}{\insrsid13373527  in place for the protection of subjects who take part in clinical research and}{\insrsid13793149 
 trials.  In the next section I will explore the federal regulations governing research involving human subjects, and, specifically, research involving certain \'93vulnerable\'94
 classes, as well as the application of the current regulatory framework to one class in particular:}{\insrsid10445909  }{\insrsid13793149  the terminally ill.}{\fs22\insrsid10956526\charrsid13793149 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid9515742 V}{\insrsid4871813 I}{\insrsid9515742 .  }{\ul\insrsid9515742 The Terminally Ill as a \'93Vulnerable\'94 Po
pulation?}{\ul\insrsid9772601 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid13375346 \tab }{\insrsid10445909 The regulations govern}{\insrsid11554990 ing}{\insrsid7540975  clinical research}{\insrsid13793149 
, in addition to the provisions applicable to all research,}{\insrsid7540975  provide additional safeguards for certain \'93vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disab
led persons, or economically or educationally disadvantaged persons.\'94}{\cs16\super\insrsid7540975 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 56.111(a)(3).}}}{\insrsid7540975   Citing the same \'93special\'94 populations, the regulations additionally provide that \'93
[w]hen some or all of the subjects, \'85, are likely to be vulnerable}{\insrsid1576507  to coercion or undue influence,\'94 the IRB involved must ensure that \'93}{\insrsid7540975 additional s}{\insrsid1576507 
afeguards have been included in the study to protect the rights and welfare of these subjects.\'94}{\cs16\super\insrsid1576507 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 56.111(b).}}}{\insrsid10489173 
  The additional protections available to these subjects can generally be separated into three types: }{\insrsid10445909  }{\insrsid10489173 (1) structural provisions addressing how IRBs will be compri}{\insrsid10445909 sed and who will make decisions;}{
\insrsid10489173  (2) substantive provisions governing the types of research that will be }{\insrsid16330442 allowed}{\insrsid10445909 ;}{\insrsid10489173  and (3) procedural provisions }{\insrsid12537203 
to guarantee that no research is done without the voluntary and informed consent of subjects.}{\cs16\super\insrsid12537203 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 485.}}}{\insrsid13375346 
\par }{\insrsid15816162 \tab In order to ensure that members of the IRBs adequately represent the interests of certain \'93vulnerable\'94 subjects, the regulations provide that \'93
[i]f an IRB regularly reviews research that involves a vulnerable category of sub
jects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are }{\insrsid16330442 knowledgeable}{\insrsid15816162 
 about and experienced in working with those subjects.\'94}{\cs16\super\insrsid15816162 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 56.107(a).}}}{\insrsid5853868   In addi
tion, the types of research that are approved by IRBs will depend on the presence of vulnerable populations.  Similarly, the presence of vulnerable subjects signals a }{\insrsid16330442 requirement}{\insrsid5853868 
 of heightened scrutiny to guarantee the informed consent before research may begin, as well as }{\insrsid1574300 throughout the research process.}{\cs16\super\insrsid1574300 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 \'a7 56.111; }{
\i\insrsid1061099 see also }{\insrsid1061099 Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 486-88 (describing some of the \'93general provisions designed to protect any human subject who may be vulnerable to coercion or undue influence
\'94).}}}{\insrsid5510669 
\par \tab }{\insrsid3495985 Although the regulations use the term \'93vulnerable\'94 to identify subjects who may need additional protections, they do not }{\insrsid10445909 explicitly }{\insrsid3495985 
define the term.  Rather than providing specific criteria with which to define \'93vulnerable\'94 populations, the regulations instead offer examples}{\insrsid4730832  of the types of subjects who may be considered}{\insrsid3495985  vulnerable.}{
\cs16\super\insrsid3495985 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 486-87 (noting that even when the current regulations were first propo
sed after an extensive review of the then-existing regulatory scheme, neither the Department of Health and Human Services nor the President\rquote 
s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research provided any specific guidance or criteria with which to define vulnerable populations).}}}{\insrsid14967466 
  However, it is possible to divide into two groups the types of \'93vulnerability\'94 to which the regulations seem to apply: }{\insrsid16330442 vulnerability}{\insrsid14967466  due to }{\i\insrsid14967466 circumstances}{\insrsid14967466 
 and vulnerability due to }{\i\insrsid14967466 cognitive defects}{\insrsid14967466 .}{\cs16\super\insrsid14967466 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Jessica W. Berg et al., }{\ul\insrsid1061099 Informed Consent: Legal Theory and Clinical Practice}{
\insrsid1061099  266-67 (2d ed., Oxford University Press, 2001).}}}{\insrsid7491410 
  For example, the former category includes prisoners, pregnant women, and economically disadvantaged persons, while the latter category encompasses children and mentally disadvantaged persons.}{\cs16\super\insrsid7491410 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 266.}}}{
\insrsid7491410   While such classifications may }{\insrsid4730832 plausibly }{\insrsid7491410 be made, the categories may frequently overlap and any lines drawn undoubtedly will become blurred.}{\cs16\super\insrsid7491410 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
at 266-67 (citing as an example of overlapping categories a 1999 case that involved psychiatric research on teenage prison inmates).}}}{\insrsid12484370   
\par \tab }{\insrsid16330442 While}{\insrsid12925134  the regulations provide explicit protections for certain \'93vulnerable\'94 }{\insrsid16330442 populations}{\insrsid12925134 , termin
ally ill subjects must seek any additional safeguards in the general provisions applicable to all \'93vulnerable\'94 populations}{\insrsid82633 , and whether and to what extent these rules apply is }{\insrsid1981570 open to question}{\insrsid12925134 .}{
\cs16\super\insrsid82633 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 492 (asserting that the terminally ill, unlike children, pregnant women, fetuses, and prisoners, have no dedicated 
regulations to guarantee that they are not victimized in unethical research).}}}{\insrsid1981570   Those who oppose the inclusion of terminally ill subjects as a \'93vulnerable\'94 population emphasize the fact that the relevant regulatory framework }{
\insrsid16330442 and}{\insrsid1981570  the official government }{\insrsid16330442 documents}{\insrsid1981570  neither list nor discuss the }{\insrsid16330442 terminally}{\insrsid1981570  ill in such terms.  Moreover, they }{\insrsid16330442 claim}{
\insrsid1981570  that characterizing the }{\insrsid16330442 terminally}{\insrsid1981570  ill as vulnerable would }{\insrsid480680 further stigmatize those already }{\insrsid16330442 suffering}{\insrsid480680  from loss of personal dignity and }{
\insrsid16330442 autonomy}{\insrsid480680 .}{\cs16\super\insrsid480680 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099  at 492-93 (noting, however, that to conclude that their judgment is impaired by these factors would demean them as well as discredit reality).}}}{
\insrsid480680  
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid4014013 Responding to the above arguments against the inclusion of the terminally ill as}{\insrsid4730832  a \'93vulnerable\'94
 population}{\insrsid4014013  in the }{\insrsid16330442 regulations}{\insrsid4014013 , one IRB member notes that \'93[m]any research subjects are vulnerable simply because they are ill,\'94 and adds that the vulnerability of ill patients \'93
depends on the gravity of their illness and their level of desperation.\'94}{\cs16\super\insrsid4014013 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Moore, }{\i\insrsid1061099 supra }{\insrsid1061099 note 22, at 565-66.}}}{\insrsid4014013   }{
\insrsid5535081 Similarly, }{\insrsid4014013 advocates for this position}{\insrsid5535081  have continued to point to characteristics shared by the }{\insrsid16330442 terminally}{\insrsid5535081  ill and \'93vulnerable\'94 }{\insrsid16330442 populations}{
\insrsid5535081  such as prisoners and children.  For instance, Jay Katz asserts, \'93[l]ike children, }{\insrsid4730832 [terminally ill patients\rquote ]}{\insrsid5535081  ability to make informed }{\insrsid16330442 decisions}{\insrsid5535081 
 is often either impaired or disregarded, and, like soldiers and prisoners, they are \'85 \lquote captives\rquote  of their disease, their physicians and hospital, and their }{\insrsid16330442 enforced}{\insrsid5535081  isolation.\'94}{
\cs16\super\insrsid5535081 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Jay Katz, 
}{\ul\insrsid1061099 Experimentation with Human Beings}{\insrsid1061099  1053 (1972); }{\i\insrsid1061099 see}{\insrsid1061099  Joni N. Gray et al., }{\ul\insrsid1061099 Ethical and Legal Issues in AIDS Research}{\insrsid1061099  52 (1995) (stating that 
\'93[t]o be sure, research participants with fatal illnesses are vulnerable in many ways\'94).}}}{\insrsid5535081   }{\insrsid4014013  }{\insrsid9649702 Likewise, a former editor of the New England Journal of Medicine expressed well the source of the }{
\insrsid16330442 vulnerability}{\insrsid9649702  of terminally ill subjects when he noted that \'93[t]he thumb screws of coercion are most relentlessly applied \'85 [to] the most used and useful of all experimental subjects, the }{\insrsid16330442 patient
}{\insrsid9649702  with disease.\'94}{\cs16\super\insrsid9649702 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Franz J. Ingelfinger, }{\i\insrsid1061099 Informed (but Uneducated) Consent}{\insrsid1061099 , 287 New Eng. J. Med. 465, 466 (1972).}}}{\insrsid3164529 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4730832 {\insrsid3164529 While the regulation}{\insrsid4730832 s}{\insrsid3164529  fail to define the term \'93vulnerable,\'94 l
eaving the category open-ended allows IRBs }{\insrsid16330442 to assess}{\insrsid3164529  the vulnerability of the subjects involved and to determine whether or not the regulations are applicable.  One commentator notes that the fact that the example}{
\insrsid4730832 s}{\insrsid3164529  of vulnerable populations provided in the regulations vary from provision to provision suggests that the types of subjects }{\insrsid16330442 listed}{\insrsid3164529  were \'93
meant to be illustrative, rather than denominative.\'94}{\cs16\super\insrsid3164529 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 493.}}}{\insrsid11080483   Indeed, the }{\insrsid4808301 regulations}{\insrsid11080483 
 refer to vulnerable subjects in several provisions and offer a slightly different image of who these subjects are in each provision.}{\cs16\super\insrsid10241181 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Moore, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 22, at 568 (adding that the sources of these groups\rquote  vulnerabilities, including institutionalization and diminished decision-making capacity, vary).}}}{\insrsid11080483   For }{\insrsid4730832 example}
{\insrsid11080483 , the section addressing the rules of IRB membership lists as vulnerable categories of subjects \'93children, prisoners, pregnant women, or handicapped or mentally disabled persons.\'94}{\cs16\super\insrsid9516929 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  21 C.F.R. \'a7 56.107(a).}}}{\insrsid11080483   }{
\insrsid4808301 Meanwhile}{\insrsid11080483 , the section setting forth the criteria for IRB approval of research lists as vulnerable populations \'93children, prisoners, pregnant women, handicapped, or mentally disabled persons, or }{\insrsid4808301 
economically}{\insrsid11080483  or  educationally disadvantaged }{\insrsid4808301 persons}{\insrsid11080483 .\'94}{\cs16\super\insrsid9516929 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 \'a7 56.111(a)(3).}}}{\insrsid3497524   Lastly, the re
gulations provide explicit guidelines and additional safeguards for research with three specific categories of subjec}{\insrsid4730832 ts:  pregnant women and fetuses, prisoners,}{\insrsid3497524  and children.}{\cs16\super\insrsid9516929 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  45 C.F.R. \'a7\'a7
 46.201-46.211, 46.301-46.306, 46.401-46.409. }}}{\insrsid3497524   }{\insrsid4730832 
\par }{\insrsid3497524 In addition}{\insrsid3164529 , while formal government publications lack explicit references to additional protections for terminally ill subjects,}{\cs16\super\insrsid2774096 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 492-93; }{\i\insrsid1061099 see generally, e.g.}{\insrsid1061099 , President\rquote s Commission for the Study of Ethical Problems in Medicine and Biomedical Research, }{
\i\insrsid1061099\charrsid2774096 Implementing Human Research Regulations: The Adequacy and Uniformity of Federal Rules and of Their Implementation}{\insrsid1061099  (1983); Food and Drug Administration, }{\i\insrsid1061099\charrsid2774096 Current Issues 
}{\i\insrsid1061099 in }{\i\insrsid1061099\charrsid2774096 Human Subject Protection}{\insrsid1061099  (1996).}}}{\insrsid3164529  }{\insrsid2774096 there are indications }{\insrsid13057546 in early publications that regulators}{\insrsid2774096 
 were cognizant of the special concerns related to research with this population.}{\insrsid3164529   }{\insrsid82633 The }{\i\insrsid82633 Belmont Report}{\insrsid82633 , for example, specifically mentioned the terminally ill as a potentially \'93
incompetent\'94 group, providing that \'93[e]ach class of subjects that one might consider as }{\insrsid16330442 incompetent}{\insrsid82633  (}{\i\insrsid82633 e.g.}{\insrsid82633 , infants and young children, mentally disabled patients, the }{
\i\insrsid16330442 terminally}{\i\insrsid82633  ill }{\insrsid82633 and the comatose) should be considered on its own terms.\'94}{\cs16\super\insrsid82633 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Belmont Report}{\insrsid1061099 
 at 13 (emphasis added).}}}{\insrsid13057546   
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid13057546 As a result, many commentators }{\insrsid15034427 claim}{\insrsid13057546  that the }{\insrsid11615621 terminally}{
\insrsid13057546  ill do in fact fall into the \'93vulnerable\'94 population category under the regulations, and point to a number of features shared by the terminally ill with the vulnerable populations explicitly mentioned in the provisions.}{
\insrsid400403   }{\insrsid15034427 Such characteristics, in turn, make }{\insrsid11615621 terminally}{\insrsid15034427  ill patients who may be considering whether to take part in clinical research extremely vulnerable to coercion}{\insrsid15343787 
, exploitation,}{\insrsid15034427  and undue influence.}{\cs16\super\insrsid15034427 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 496.}}}{\insrsid15034427   As one commentator noted in his discussion on patients\rquote 
 perceptions of illness and }{\insrsid11615621 suffering}{\insrsid15034427 , \'93[i]t is natural for a sick person to perceive that he or she has become isolated from the rest of the community, to feel vulnerable and mortal.\'94}{
\cs16\super\insrsid15034427 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099 
 Robert M. Timko, }{\ul\insrsid1061099 Clinical Ethics: Due Care and the Principle of Nonmaleficence}{\insrsid1061099  85 (University Press of America, Inc., 2001).}}}{\insrsid7936679   This feeling of isolation and est
rangement from relationships with others leads the terminal patient to question his or her own capacity to act autonomously with regard to others.  In this way, recognizing that illness is a source of diminished autonomy, terminal patients may be more wil
ling to entrust their }{\insrsid7816902 doctors}{\insrsid7936679  with significant decision-making authority, believing that they themselves are incapable of rational, independent decision-making.}{\cs16\super\insrsid7936679 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
at 86 (emphasizing the \'93anomie, depression, and sense of estrangement from one\rquote s life-plan that occur with the onset and development of illness,\'94 and which lead to a loss of autonomy); }{\i\insrsid1061099 see also }{\insrsid1061099 Addicott, 
}{\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 496 (noting that the psychological response of terminal patients after 
diagnosis may be exacerbated by the physiological symptoms of the illness, and patients may be reluctant to question the authority of their doctors).}}}{\insrsid7816902   
\par   }{\insrsid13979862 While the regulations provide specific guidelines for certain \'93special\'94 populations, includ
ing pregnant women and fetuses, prisoners, and children, the common thread that seems to run through these groups is the concern that their vulnerability to coercive pressures and undue influence l}{\insrsid14961223 imits, if not}{\insrsid13979862 
 wholly eradicates, their ability }{\insrsid14961223 to give truly voluntary consent.  The terminally ill share characteristics with these groups that render them more susceptible to coercion }{\insrsid12810479 
and outside influence, which should call into serious question the sufficiency of the informed consent model as applied to research}{\insrsid16149212  with terminally ill subjects.  }{\insrsid4730832 Given these concerns, t}{\insrsid16149212 
wo elements of informed consent must be considered in order to understand the protections accorded to vulnerable populations: }{\insrsid4730832  }{\insrsid16149212 information and voluntariness.}{\cs16\super\insrsid14099102 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Addicott, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 485.}}}{\insrsid16149212   As applied to children}{\insrsid8075894  or the mentally handicapped}{\insrsid16149212 , for example, the issue is }{\insrsid4808301 whether}{\insrsid16149212 
 they can adequately understand the information provided in order to }{\insrsid4808301 rationally}{\insrsid16149212  decide whether to participate in the research.  As applied}{\insrsid14099102  to prisoners, on the other hand, the question is }{
\insrsid4808301 whether}{\insrsid14099102  their consent can in fact be given voluntarily due to the inherently confining and coercive nature of prison.}{\cs16\super\insrsid14099102 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 485-86.}}}{
\insrsid16149212   }{\insrsid12351446 These two concerns, in turn, may both be present in the case of research with }{\insrsid4808301 terminally}{\insrsid8075894  ill subjects.  Like children or the }{\insrsid4725417 mentally}{\insrsid8075894 
 handicapped, terminally ill patients are often considered incapable of making rational, informed decisions; and like prisoners, they are often seen as not \'93really\'94}{\insrsid938258  free, but instead }{\insrsid8075894 as \'93captive\'94
 to their illness and the coercive circumstances in which they }{\insrsid4730832 find themselves}{\insrsid8075894 .}{\cs16\super\insrsid8075894 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Garnett, }{\i\insrsid1061099 supra }{\insrsid1061099 note 87, at 482 (expressi
ng concerns that terminally ill patients \'93might submit to quackery in a hopeless and desperate attempt to beat the inevitable,\'94 or \'93out of misplaced or entirely genuine altruism,\'94 and the fear that the \'93ritual of informed consent\'94
 is often viewed as a mere formality rather than \'93an opportunity for choice or a vehicle for empowerment\'94).}}}{\insrsid938258   Viewed in these terms, such analogies suggest}{\insrsid12351446 
 that similar procedural protections as those provided to children and prisoners should also be available to the terminally ill.}{\insrsid13057546 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid16729239 \tab In order to fully explore the vulnerabilities shared by terminally ill patients and the \'93vulnerable\'94
 populations explicitly mentioned in the regulations, it may be useful to consider more closely t}{\insrsid6234810 he reality experienced by termina}{\insrsid16729239 lly ill individuals.}{\insrsid6234810   }{\insrsid1539021 
One writer has suggested that cancer and AIDS have perhaps become linked as the two most feared ways to die, and notes that cancer, like AIDS, \'93leads to a hard death,\'94 adding that \'93
[t]he most terrifying illnesses are those perceived not just as lethal but as dehumanizing, literally so.\'94}{\cs16\super\insrsid1539021 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Susan Sontag, }{\ul\insrsid1061099 Illness as Metaphor and AIDS and its Metaphors}{\insrsid1061099  126 (1990).}}}{\insrsid1539021   }{
\insrsid1015302 The \'93universal fears\'94 of}{\insrsid1539021  cancer patients h}{\insrsid4730832 ave been termed \'93the six Ds:  }{\insrsid1015302 
death, dependency, disfigurement, disability interfering with normal life functions, disruption of relationships, and discomfort or pain resulting from the disease itself.}{\insrsid4730832 \'94}{\cs16\super\insrsid1015302 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 19, at 499.}}}{\insrsid1015302   }{\insrsid4730832 Moreover, t}{\insrsid1015302 he prevalence of psychiatric disorders in }{\insrsid1729381 terminal}{\insrsid1015302  cancer patients has been well documented.  }{\insrsid3303092 
In one study in which 215 cancer patients were selected at random, forty-seven percent of the patients suffered from psychiatric disorders.}{\cs16\super\insrsid3303092 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id.}{\insrsid1061099 
 at 499-500 (noting that of the patients with disorders, sixty-eight percent had \'93
adjustment disorder with depressed, anxious, or mixed mood; 13% had major depression; 8% had an organic mental disorder; 7% had a personality disorder; and 4% had anxiety disorder\'94) (footnotes omitted).}}}{\insrsid14550445 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid8140550 In addition to the psychological symptoms of illness, the physiological symptoms may further impair the cognitive }{
\insrsid1729381 function}{\insrsid8140550  and mental status of the terminal patient.  For instance, with cancer patients, \'93fatigue, recovery from surgery and radiation, [and] toxicity from drugs (including antibiotics and pain medicine) may all alte
r thinking ability, dampening the sharpness, rapidity, and productivity of the [patient\rquote s] thought processes.\'94}{\cs16\super\insrsid8140550 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 500 (quoting 
Stephen P. Hersh, }{\i\insrsid1061099 Death From The Cancers}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 Living With Grief When Illness is Prolonged}{\insrsid1061099  100 (Kenneth J. Doka & Joyce Davidson eds., 1998)).}}}{
\insrsid15298865   Frequent hospitalization, not uncommon for terminally ill patients, may also contribute to their diminishing sense of control over their environment and decision-making ability.  Similar to prisoners, a \'93vulnerable\'94
 population under the regulations, hospitalized }{\insrsid1729381 patients}{\insrsid15298865  become entirely dependent on the institution\rquote s staff and undoubtedly develop a sense of helplessness and apathy }{\insrsid11413828 with respect to}{
\insrsid15298865  their situation and any treatment decisions that must be made.}{\cs16\super\insrsid15298865 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 501.}}}{\insrsid3750831   T}{\insrsid13455497 he hopelessness that often blurs}{\insrsid3750831 
 the }{\insrsid1729381 terminal}{\insrsid3750831  cancer patient\rquote s cognitive abilities }{\insrsid11413828 likely strikes}{\insrsid3750831  at the heart of the informed consent model.  As one commentator notes, terminally ill patie
nts who become depressed may be more likely to consent to take part in research because the concept of risk is meaningless to them.  In particular, \'93
they become malleable and vulnerable to coercion precisely because they do not care whether they live or die.\'94}{\cs16\super\insrsid3750831 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 502-03 (asserting that terminally ill patients may, in their desperation, fail to even a
ttempt to evaluate the risks and benefits of experimental research, \'93having already made up their minds to try any available treatment).}}}{\insrsid8594756   }{\insrsid946920 
\par As this}{\insrsid13455497  utter h}{\insrsid946920 opelessness leads many terminally ill patients to latch on to the mantra that they have \'93nothing to lose,\'94}{\insrsid13455497  }{\insrsid946920 it is not surprising that they}{\insrsid10514821  }{
\insrsid946920 frequently }{\insrsid10514821 ignore the potential risks and blindly consent to participate in research due to a phenomenon known as \'93therapeutic misconception.\'94
  In particular, desperate patients often fail to understand that they are taking part in research that may not be intended primarily for their benefit, perhaps completely unaware that the research is meant to study toxicity levels of drugs and dose }{
\insrsid12520777 schedules}{\insrsid10514821 , not to cure their illnesses.}{\cs16\super\insrsid10514821 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 
at 503-04.  Addicott describes one study in which investigators examined the motivation and understanding of 
patients participating in Phase I cancer trials.  The results of the study showed that patients were motivated to take part in the research almost exclusively because of a belief that it would make them better.  }{\i\insrsid1061099 See generally}{
\insrsid1061099  Christopher K. Daugherty et al., }{\i\insrsid1061099 Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials}{\insrsid1061099 , 13 J. Clin. Oncol. 1062-72 (1995).}}}{\insrsid10307399 
  One commentator focuses on the \'93self-deception inherent in seeing experimentation as treatment, }{\insrsid12520777 especially}{\insrsid10307399  in terminally ill cancer patients\'94 who participate in Phase I drug }{\insrsid12520777 studies}{
\insrsid10307399  with anticancer agents.}{\cs16\super\insrsid10307399 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Annas, }{\i\insrsid1061099 supra }{\insrsid1061099 note 83, at 310.}}}{\insrsid10307399   While researchers at the National Cancer Institute refer to such studies as \'93potentially therapeutic,\'94
 FDA regulations }{\insrsid13129192 provide that Phase I studies are }{\insrsid12520777 intended}{\insrsid13129192  to have no therapeutic content, but rather are to determine \'93
toxicity, metabolism, absorption, elimination, and other pharmacological action, preferred route of administration, and safe dosage range.\'94}{\cs16\super\insrsid12877484 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 310-311 (quoting }{
\i\insrsid1061099 The}{\insrsid1061099  }{\i\insrsid1061099\charrsid12877484 President\rquote s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research}{\insrsid1061099 , Protecting Human Subjects 65 (1981)).}}}{
\insrsid12877484   As a result, Phase I trials are transformed into \'93experimental therapy,\'94 eradicating altogether the distinction between experimentation and therapy.}{\cs16\super\insrsid12877484 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 
at 311 (adding that roughly 94% of researchers admit that adult patients enroll in Phase I studies largely for the possible medical benefit); }{\i\insrsid1061099 see }{\insrsid1061099 Eric Kodish et al., }{\i\insrsid1061099 Ethical Issue
s in Phase I Oncology Research: A Comparison of Investigators and Institutional Review Board Chairpersons}{\insrsid1061099 , 10 J. Clinical Oncology 1810, 1812 (1992); Mortimer B. Lipsett, }{\i\insrsid1061099 
On the Nature and Ethics of Phase I Clinical Trials of Cancer Chemotherapies}{\insrsid1061099 , 248 JAMA 941, 941-42 (1982).}}}{\insrsid1975920   Not surprisingly, }{\insrsid1249515 
a number of commentators have criticized the conflation of research and treatment, the doubling of researchers and physicians, subjects and patients, and have little, if any, regard for the distinction, }{\insrsid3691396 
exemplified in the Helsinki Declaration,}{\insrsid1975920  between therapeutic and non}{\insrsid3691396 -therapeutic}{\insrsid1975920  research}{\insrsid3691396 .}{\cs16\super\insrsid3691396 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Annas, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 83, at 310-312; }{\i\insrsid1061099 see also }{\insrsid1061099 Robert J. Levine, }{\ul\insrsid1061099 Ethics and Regulation of Clinical Research}{\insrsid1061099  8-10 (2d ed., Urban & Schwarzenberg, 1986).}}
}{\insrsid10514821 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid8535180 VI}{\insrsid4871813 I}{\insrsid8535180 .  }{\ul\insrsid8535180 Terminal Patients Speak for Themselves: }{
\ul\insrsid11413828  }{\ul\insrsid8535180 Advocates for a \'93Right of Access\'94}{\ul\insrsid12809747\charrsid12809747 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid8586974 Although}{\insrsid12520777  the vulnerabilities}{\insrsid11413828  shared by}{\insrsid12520777  the terminally ill }{
\insrsid11413828 and}{\insrsid12520777  certain groups explicitly mentioned in the regulations may support}{\insrsid8586974  the }{\insrsid12520777 calls for }{\insrsid8586974 additional safeguards for t}{\insrsid6702736 erminall}{\insrsid8586974 
y ill subjects who choose to participate in research trials, perhaps one of the groups that most vigorously opposes regulatory restrictions}{\insrsid6702736  is the }{\insrsid5181069 one they are intended to protect:}{\insrsid11413828  }{\insrsid5181069 
 the }{\insrsid6702736 terminally ill}{\insrsid5181069 .  Not only are }{\insrsid11547164 terminally}{\insrsid5181069  ill }{\insrsid11413828 patients}{\insrsid5181069 , who often view experimental therapies as their last}{\insrsid11413828 
 chance to beat the inevitable}{\insrsid5181069 , generally willing to take part in research, but they often compete for the chance to do so.}{\cs16\super\insrsid5181069 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See}{\insrsid1061099  Addicott, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 19, at 493-94.}}}{\insrsid2691814   Desperately ill cancer patients, for example, may believe that it is in their interest to gain access to }{\insrsid11547164 experimental}{\insrsid2691814 
 treatments, and, indeed, in some cases it is rational to want to try an unapproved drug when, compared with the alternative, the }{\insrsid11547164 potential}{\insrsid2691814  benefits justify the risks involved.}{\cs16\super\insrsid2691814 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 
Robert M. Veatch, }{\i\insrsid1061099 From Nuremberg Through the 1990s: The Priority of Autonomy}{\insrsid1061099 , }{\i\insrsid1061099 in }{\ul\insrsid1061099 The Ethics of Research Involving Human Subjects:  Facing the 21st Century}{\insrsid1061099 
 55-56 (Harold Y. Vanderpool ed., 1996) (posing the question whether a priority for autonomy gives terminally ill individuals a right 
of access to experimental agents, not only over-the-counter agents such as aspirin, but also restricted drugs controlled by investigational new drug research).}}}{\insrsid11624491 
\par Advocates for expanded access to experimental treatments for the terminally ill claim that the freedom of each patient to choose his or her weapons of cho}{\insrsid10770320 i}{\insrsid11624491 ce is }{\insrsid10770320 critical }{\insrsid11624491 
to each patient\rquote s personal dignity, autonomy, and control ove}{\insrsid10770320 r his or her body.}{\cs16\super\insrsid10770320 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See, e.g., }{\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 39, at 121 (noting that when the desperately ill patient exhausts all available conventional therapies cannot gain access to an experimental or investigational therapy, his or her plight is clear: the \'93patient is destined to suffer or die\'94).}}}
{\insrsid8019433   }{\insrsid11547164 The calls for a comprehensive \'93right of access\'94 to experimental therapies}{\insrsid11413828  raise two distinct issues:  }{\insrsid5849823 (1) }{\insrsid1729381 whether}{\insrsid5849823 
 the current FDCA regulations should apply without modification to the terminally or seriously ill, and (2) whether constitutionally protected liberty or privacy interests exist to protect the right to choose unapproved or experimental treatments.}{
\cs16\super\insrsid5849823 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{
\i\insrsid1061099 See id.}{\insrsid1061099  at 123.}}}{\insrsid5849823   As Marshall\rquote s opinion in }{\i\insrsid5849823 Rutherford }{\insrsid11413828 illustrates}{\insrsid5849823 , the FDCA makes no exception for }{\insrsid14307134 
experimental or unapproved }{\insrsid5849823 drugs used to treat the terminally ill, and thus the safety and efficacy }{\insrsid1729381 requirements}{\insrsid5849823  are applicable}{\insrsid14307134  to such patients without }{\insrsid1729381 exemption}{
\insrsid14307134  or modification.}{\cs16\super\insrsid14307134 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 442 U.S. 544.}}}{\insrsid14307134   
\par With respect to the second issue,}{\insrsid11547164  }{\insrsid14307134 whether a constitutionally protected privacy interest encompasses the right of access to unapproved or experimental treatments, some advocates have }{\insrsid11547164 
embraced the claim that the right to privacy is fundamental and \'93protects the individual from unwarranted governmental intrusions into certain personal decisions \'85 that have som
e relation to child rearing and education, contraception, marriage, family relationships and procreation.\'94}{\cs16\super\insrsid11547164 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Scott H. Power, }{\i\insrsid1061099\charrsid8019433 The Right of Privacy i
n Choosing Medical Treatment: Should Terminally Ill Persons Have Access to Drugs Not Yet Approved by the Food and Drug Administration?}{\insrsid1061099 , }{\insrsid1061099\charrsid8019433 20 J. Marshall L. Rev. 693}{\insrsid1061099 , 703-04}{
\insrsid1061099\charrsid8019433  (1990)}{\insrsid1061099  (footnotes omitted)}{\insrsid1061099\charrsid8019433 .}}}{\insrsid11547164   }{\insrsid3691493 
Specifically, advocates for this reading to support a right to experimental therapies assert that the right to privacy should include the personal therapeutic choices of the seriously or }{\insrsid11547164 terminally}{\insrsid3691493 
 ill for three reasons:}{\insrsid4871813  }{\insrsid3691493  (1) the freedom to care for one\rquote s health is of a highly personal nature that should ultimately rest with the individual; (2) a regulation denying access to unapproved drugs severely
 interferes with the lifestyle of the }{\insrsid11547164 terminally}{\insrsid3691493  ill patient; and (3) only the terminally ill person is affected by the decision to choose experimental and unapproved drugs.}{\cs16\super\insrsid3691493 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 
at 705.}}}{\insrsid12351446 
\par }{\insrsid14307134 In addition to ex}{\insrsid1918755 panding the privacy argument to }{\insrsid12202522 encompass the right of access}{\insrsid11413828 , }{\insrsid12202522 some }{\insrsid6832729 
commentators have pointed to the Fifth and Fourteenth Amendments to the Constitution to support their claim that the freedom of each citizen to choose a treatment of choice in fighting a terminal illness is a basic liberty to which they cannot be depr}{
\insrsid11413828 ived.  In the words of one }{\insrsid6832729 commentator, the U.S. }{\insrsid12084448 government}{\insrsid11413828 ,}{\insrsid6832729  \'93}{\insrsid12084448 through}{\insrsid6832729 
 the FDA, deprives [terminally ill patients] of their interests in life and liberty by precluding them from obtaining life-extending drugs or by coercing them to participate in placebo studies.\'94}{\cs16\super\insrsid16401376 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Bret L. Lansdale, }{\i\insrsid1061099\charrsid16401376 
A Procedural Due Process Attack on FDA Regulations: Getting New Drugs to People With AIDS}{\insrsid1061099 , }{\insrsid1061099\charrsid16401376 18 Hastings Const. L.Q. 417}{\insrsid1061099 , 419}{\insrsid1061099\charrsid16401376  (1991)}{\insrsid1061099 
; }{\i\insrsid1061099 see }{\insrsid1061099 Perrin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 39, at 151 (citing as support for advocate\rquote s calls for a \'93right to access\'94 the Fifth Amendment\rquote s guarantee that no person sh
all be deprived of life, liberty, or property without due process of law).}}}{\insrsid16587496   Embracing the Fifth and Fourteenth Amendments\rquote  due process guarantees, courts should }{\insrsid11413828 therefore }{\insrsid16587496 
acknowledge a terminally ill patient\rquote s \'93due process right of access to new, potentially life-extending drugs.\'94}{\cs16\super\insrsid16587496 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Lansdale, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 227, at 419. }}}{\insrsid5055379   Following that line of reasoning, another }{\insrsid12084448 proponent}{\insrsid11413828  of the \'93right of}{\insrsid5055379  access\'94 asserts that \'93
[i]t would be illogical in the extreme to hold, on the one hand, that a person has a constitutional right to refuse treatment needed to sustain life (}{\i\insrsid5055379 Cruzan}{\i\insrsid9582333  v. Director, Missouri Dep\rquote t}{\i\insrsid5055379 
 of Health}{\insrsid5055379 , 497 U.S. 261 (1990)) and, on the other, that a person has no constitutional right to receive a treatment that may sustain life.\'94}{\cs16\super\insrsid5055379 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Government v. The Terminally Ill}{
\insrsid1061099 ,}{\i\insrsid1061099  }{\insrsid1061099 Letter from Jonathan W. Emord, Attorney, Emord & Associates, P.C., Counsel to the Burzynski Patient Organization,}{\i\insrsid1061099  in}{\insrsid1061099 
 Regulation, The Cato Review of Business and Government, Vol. 20, No. 2 (1997), }{\i\insrsid1061099 available }{\i\insrsid1061099\charrsid15671383 at}{\insrsid1061099  http://www.cato.org/pubs/regulation/reg20n2-let.html (hereinafter \'93
Letter from Jonathan W. Emord\'94) (asserting that \'93[w]hen the state denies a terminally il
l patient freedom to elect a course of treatment, deprives that patient of bodily integrity, robs that patient of control over his or her person, and effectively dictates one therapy, there is little left of liberty\'94).}}}{\insrsid15533311 
  Seizing upon language from Justice O\rquote Connor\rquote s concurring opinion in }{\i\insrsid15533311 Cruzan}{\insrsid15533311 , where the Court held }{\insrsid8669564 that the Due Process Clause does not }{\insrsid12084448 require}{\insrsid8669564 
 the state to repose judgment on matters concerning the right to refuse treatment with anyone but the patient herself}{\insrsid15533311 ,}{\cs16\super\insrsid4464872 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See Cruzan v. Director, Missouri Dep\rquote 
t of Health}{\insrsid1061099 , 497 U.S. 261 (1990).}}}{\insrsid15533311  one commentator finds }{\insrsid4464872 support}{\insrsid15533311  in the analogy between the terminally ill patient who chooses to }{\i\insrsid15533311 refuse }{\insrsid1799648 
life-saving treatment and the }{\insrsid12084448 terminally}{\insrsid1799648  ill patient who wishes to }{\i\insrsid1799648 receive }{\insrsid1799648 a treatment that may sustain life, offering }{\insrsid11413828 as support }{\insrsid1799648 O\rquote 
Connor\rquote s powerful words in that opinion: }{\insrsid11413828  }{\insrsid1799648 \'93A seriously ill or dying patient whose wishes are not honored may feel a captive of the machinery required 
for life-sustaining measures or other medical interventions.  Such forced treatment may burden that individual\rquote s liberty interests as much as any state coercion.\'94}{\cs16\super\insrsid1799648 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 
Letter from Jonathan W. Emord, }{\i\insrsid1061099 supra }{\insrsid1061099 note 229}{\i\insrsid1061099  }{\insrsid1061099 (quoting O\rquote Connor\rquote s concurring opinion in }{\i\insrsid1061099 Cruzan}{\insrsid1061099 , 497 U.S. at 288).}}}{
\insrsid5849823 
\par }{\insrsid13506701 Finally, the calls for a}{\insrsid11413828  comprehensive \'93right of}{\insrsid13506701  access\'94 }{\insrsid6363742 have embraced autonomy as an \'93absolute priority,\'94 }{\insrsid11413828 a liberty right}{\insrsid6363742 
 enjoyed both by researchers }{\insrsid11413828 and }{\insrsid4725417 patients, which}{\insrsid6363742  must be respected.}{\cs16\super\insrsid6363742 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 See }{\insrsid1061099 Veatch, }{
\i\insrsid1061099 supra }{\insrsid1061099 note 221, at 56-57.}}}{\insrsid12990158   Speaking to this proposition, one commentator asserts, \'93[i]f investigators were willing to cooperate with subjects who had rational, subjective preferences 
for [investigational new drug] agents, then their autonomy as well as that of the subjects would support their providing the agents to them.\'94}{\cs16\super\insrsid12990158 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  at 56.}}}{
\insrsid1854725   Moreover, labeling certain patients, including metastatic cancer patients, as \'93among the worst-off members of society,\'94 this }{\insrsid11413828 advocate for access }{\insrsid1854725 declares that \'93these patients have an }{
\insrsid4725417 entitlement}{\insrsid1854725 -right claim to access to }{\insrsid4725417 experimental}{\insrsid1854725  agents,\'94 and, furthermore, \'93
[i]f they are plausible among the least well-off, they have claims of justice that may override the autonomy of the investigators.\'94}{\cs16\super\insrsid1854725 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 56-57.}}}{
\insrsid4683797   Thus, in such circumstances, the principle of autonomy effectively disappears and the investigators\rquote  \'93moral duty to help the least well-off gain access to experimental treatments\'94 takes center stage in the patient\rquote 
s fight }{\insrsid8857960 to live}{\insrsid4683797 .}{\cs16\super\insrsid4683797 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 57.}}}{\insrsid8857960   It is }{\i\insrsid8857960 justice}{\insrsid8857960 , and not mere }{\i\insrsid8857960 social beneficence}{\insrsid8857960 
, that guides this view; in sum, \'93[i]t is what we }{\i\insrsid8857960\charrsid8857960 owe}{\insrsid8857960  to the least well-off among us.\'94}{\cs16\super\insrsid8857960 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 (emphasis added).}}}{
\insrsid7816902 
\par }\pard \qj \li0\ri0\sb120\sa120\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309932 {\insrsid4871813 VIII}{\insrsid8616821 .  }{\ul\insrsid8616821 Conclusion}{\ul\insrsid8616821\charrsid8616821 
\par }\pard \qj \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13593037 {\insrsid12343216 \tab }{\insrsid6958470 The FDA}{\insrsid7280316 , through the development of the current regulatory regime}{\insrsid6958470 
 and ethical guidelines}{\insrsid7280316 , has }{\insrsid10879317 attempted to }{\insrsid7280316 strike an appropriate balance between }{\insrsid10879317 two compelling values: }{\insrsid6958470  }{\insrsid10879317 promoting access to new, }{
\insrsid7280316 experimental and potentially life-saving therapies for the terminally ill}{\insrsid10879317 ,}{\insrsid7280316  and protecting this unique class of subjects from research abuse and coercion}{\insrsid10879317 .  Advoca
tes for increased access may ask, \'93}{\insrsid6958470 [w]}{\insrsid7675742 hy should terminal patients, who according to orthodox me}{\insrsid8133879 dicine will die, be prevented f}{\insrsid7675742 r}{\insrsid8133879 o}{\insrsid7675742 
m accessing non-orthodox therapies through their medical doctors?\'94}{\cs16\super\insrsid5201658 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Horwin, }{\i\insrsid1061099 supra }{\insrsid1061099 note 7, at 222.}}}{\insrsid10879317   }{\insrsid11561713 
In particular, if a patient understands that the treatment has not been approved by the FDA and that the risks and benefits cannot be full}{\insrsid14429038 y identified or quantified, and nonetheless }{\insrsid11561713 
gives his or her informed consent to participate in the research, why should he or she be prevented from making that choice?}{\cs16\super\insrsid11561713 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id. }{\insrsid1061099 at 222-23.}}}{
\insrsid11561713   }{\insrsid7955398 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7955398 {\insrsid11561713 On the other side of the spectrum, }{\insrsid10879317 
those concerned with the particular vulnerabilities that often characterize }{\insrsid12997367 the }{\insrsid10879317 terminally ill}{\insrsid12997367  urge that more stringent regulatory protections should be in place for such patients, }{
\insrsid6958470 who frequently are i}{\insrsid12997367 ndividuals \'93desperate for a cure and }{\insrsid4871813 [who] }{\insrsid12997367 
often suffer from depression, anxiety, or other psychological disorders that may be exacerbated by the physiological symptoms of their illness}{\insrsid5201658 es}{\insrsid12997367 .\'94}{\cs16\super\insrsid5201658 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Addicott, }{\i\insrsid1061099 supra }{\insrsid1061099 
note 19, at 524.}}}{\insrsid14429038   }{\insrsid6958470 As a result}{\insrsid14429038 , proponents of heightened standards for research involving the terminally ill
 have proposed a number of additional safeguards and regulatory reforms to better ensure the safety and protection of terminally ill subjects, including an explicit recognition in the regulations of the terminally ill as }{\insrsid6958470 a \'93vulnerable
}{\insrsid14429038 \'94}{\insrsid6958470  population,}{\insrsid14429038  which at a minimum would alert researchers and IRBs \'93to familiarize themselves with the unique difficulties their subjects face,\'94
 as well as a requirement in the regulations that }{\insrsid7955398 psychological }{\insrsid15674695 evaluations}{\insrsid7955398  and subject advocates are}{\insrsid6958470  employed}{\insrsid7955398  to protect the integrity
 of the informed consent process.}{\cs16\super\insrsid7955398 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 
\chftn }{\insrsid1061099  }{\i\insrsid1061099 See id. }{\insrsid1061099 at 524 (adding to the list of proposed regulatory reforms a requirement that IRBs that work with the terminally ill have at least one member who is a repres
entative of the terminally ill, a requirement that researchers who work with terminally ill patients undergo psychological training, and a mandate providing that research generally should involve the terminally ill only if it is intended to benefit them).
 }}}{\insrsid7955398 
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6503396 {\insrsid8133879 While rational individuals}{\insrsid3288992  will come to different conclusions as to ho}{\insrsid8157648 w the bal}{
\insrsid6958470 ance should be struck, perhaps one}{\insrsid8157648  primary benefit to be gained from engaging in the debate is that }{\insrsid6958470 through such discussions }{\insrsid8157648 we will undoubtedly }{\insrsid15674695 become}{
\insrsid8157648  more aware of the diverse interests and values at stake}{\insrsid9248169 ,}{\insrsid8157648  and }{\insrsid9248169 therefore }{\insrsid8157648 better able to design research programs to accommodate these interests.  }{\insrsid14308481 
The current regulatory regime, including recent federal initiatives and proposed reforms, seems to emphasize three essential values: }{\insrsid6958470  }{\insrsid14308481 
protecting vulnerable research subjects, promoting access to new and much-needed therapies, and satisfying the \'93social need for research to validate new needed therapies.\'94}{\cs16\super\insrsid6958470 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Brody, }{\i\insrsid1061099 supra }{\insrsid1061099 note 6, at 45.}}
}{\insrsid14308481   However, with the ebb and flow of }{\insrsid9248169 scientific and medical }{\insrsid14308481 advances, as well as }{\insrsid9248169 the inevitable }{\insrsid14308481 
setbacks, history has demonstrated that policy shifts and regulatory reforms must adapt to the changing times.  For example, citing the \'93proliferation of new and deadly diseases,\'94 one commentator notes}{\insrsid6958470  that}{\insrsid14308481  \'93}
{\i\insrsid6958470\charrsid13724354 [}{\i\insrsid6958470 r}{\i\insrsid6958470\charrsid13724354 ]}{\i\insrsid14308481 esearch}{\insrsid14308481  over the past decade has shifted in the public\rquote 
s mind from an enterprise in which subjects need protection to one in }{\insrsid6503396 which subjects demand access.\'94}{\cs16\super\insrsid6503396 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  Berg et al., }{\i\insrsid1061099 supra }{\insrsid1061099 
note 188, at 273. }}}{\insrsid6503396   }{\insrsid6378635 
\par }{\insrsid6503396 Nevertheless, it seems clear from the constant back and forth wrangling over }{\insrsid6958470 the potential benefits and risks of }{\insrsid6503396 clinical research and access to experimental therapies that \'93
there are [still] serious deficiencies in the current system for the protection of the rights and interests of human subjects.\'94}{\cs16\super\insrsid6503396 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid1061099 \chftn }{\insrsid1061099  }{\i\insrsid1061099 Id.}{\insrsid1061099  (citation omitted).}}}{
\insrsid8601815   As depicted in the preceding pages, the interplay between Congress, the courts, the medical and scientific communities, }{\insrsid6958470 as well as}{\insrsid8601815  }{\insrsid15674695 terminally}{\insrsid8601815  i}{\insrsid12933823 
ll patients }{\insrsid6958470 themselves}{\insrsid12933823 , }{\insrsid8601815 has continued to play an essential role in the debates surroundin}{\insrsid6686216 g clinical research}{\insrsid6958470  involving human subjects}{\insrsid6686216 .}{
\insrsid9642248   Perhaps only by maintaining a constant dialogue between these key participants will terminally ill patients get the benefits they deserve from clinical research, enjoying the protections provided under the regulations }{\insrsid12872061 
while at the same time}{\insrsid9642248  gaining access to potentially life-saving new therapies}{\insrsid14112158  \endash  both goals, although seemingly irreconcilable at times, tailored to respect the dignity and autonomy of those individuals who st}{
\insrsid11537423 and at the heart of the debate, }{\insrsid14112158 battling their}{\insrsid6378635  illnesses armed with}{\insrsid14112158  }{\insrsid6378635 promising }{\insrsid11537423 new }{\insrsid6378635 weapons}{\insrsid11537423 
 as well as appropriate shields of protection.}{\insrsid5920918 
\par }\pard \qc \li720\ri720\sa240\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid9248169 {\insrsid5920918 \page }{\insrsid9248169 
\par }\pard \qc \li720\ri720\sa360\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid9248169 {\i\insrsid15737983 Epilogue and }{\i\insrsid5920918 Dedication}{\i\insrsid5920918\charrsid13258570 
\par }\pard \qj \fi720\li720\ri720\sa360\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid11942569 {\insrsid5920918 
This paper is dedicated to a very dear friend of mine who is currently battling ovarian cancer and who recently began a twelve-week Phase II clinical trial at a major medical institution.  When I first began
 researching the topic for this paper, my friend had just enrolled in the trial and was filled with extreme hope that the experimental treatment would be successful in beating the insidious disease.  Sadly, painfully aware that her cancer was not respondi
ng to the treatment, my friend dropped out of the trial after just six weeks and returned once }{\insrsid9248169 again to try more conventional }{\insrsid5920918 
chemotherapy treatments instead.  As I researched the federal regulations and policies governing clinical research involving termin
ally ill patients, and as I explored the emotionally-charged and dire circumstances in which many such individuals find themselves, I remained constantly mindful of the experience of my friend, as she continues to search for an effective treatment to beat
 the disease \endash  a final hope in her painful battle against cancer.    
\par }\pard \qj \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6503396 {\insrsid7360546\charrsid6503396 
\par }}