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Submitted in Satisfaction of the Required Course Paper and the Written Work Requirement

Supervisor: Professor Peter Barton Hutt

Harvard Law School

April 2004

Marguerite R. Lombardo

Class of 2004


This paper argues that stimulant drugs, such as Ritalin and Adderall, are overprescribed for the treatment of Attention-Deficit/Hyperactivity Disorder. Overprescription is viewed through a physician -centered lens. That is, physicians overprescribe stimulant drugs to the extent they inadequately evaluate a patient before prescribing. The physician-centered approach contrasts sharply with a patient -centered approach which defines as overprescription the extent to which stimulant drug prescription rates exceed the actual prevalence of ADHD. Overprescription is important to address because it contributes to stimulant drug abuse among young adults. Legitimate patients with valid prescriptions, particularly on college campuses, are giving away or selling their stimulant medication to their peers. Overprescription contributes to this problem by unnecessarily inflating the number of prescriptions available for diversion. In light of such stimulant abuse, this paper considers four potential solutions for reducing overprescription: (1) decreasing stimulant drug production quotas; (2) changing stimulant drug labeling; (3) monitoring physician prescribing via state prescription drug monitoring programs; and (4) restricting the speech of external actors, such as school personnel and pharmaceutical companies, who may pressure parents to seek medication for their children. After evaluating and rejecting each of these approaches, two alternative strategies for reducing overprescription of stimulant drugs are offered: (1) conducting research investigating the practical problems physicians face when evaluating patients for ADHD and, then, incorporating the insights gleaned into educational efforts and (2) promoting more active leadership and oversight by state medical associations and boards. To provide a background for discussing overprescription, stimulant abuse, and possible remedies, the paper begins reviewing Attention Deficit/Hyperactivity Disorder, the practice of treating the disorder with prescription stimulants, and the import of stimulant drugs being Schedule II controlled substances.


The debate regarding Attention-Deficit/Hyperactivity Disorder (“ADHD” or “ADD”) and prescription of stimulant drugs is exhausting to wade through. The dialogue’s emotion is palpable and the issues are many. A mother reports closely guarding the fact that her child took medication for ADD because “[t]oo often [she] got one of those ‘looks’ saved for people who ‘abuse their children with drugs’ or ‘take the easy way out.’”[1] She implored society to be understanding of parents who opt for medication: “Parents need all the support they can get - not additional judgment from people who haven’t walked in their moccasins. There are times when ADD medication is a viable and wise choice, and that choice deserves respect.”[2] Demonstrating a distinctly different perspective, another individual argued that Ritalin is likely “prescribed to any child who shows natural excess energy, and is used to subdue children just to make it easier on the teachers....[D]iscipline is rare because those in authority are afraid of being sued....”[3] One headline admonishes readers “Debate Over ADD Pointless - Kids are Suffering From It”[4] while another asserts “Widespread Misuse of Ritalin is [a] National Disgrace.”[5]

In the New England Journal of Medicine two physicians observe that in their experience, “parents are relieved when their child is given a diagnosis of ADHD, since they have spent years blaming themselves for not being able to control the child’s behavior.”[6] By contrast, controversial psychiatrist Dr. Peter Breggin[7] informed a young patient, “‘they say you’re mentally ill, my friend. But actually you’re a brat.’”[8]

The shrill tenor of the dialogue regarding ADHD and stimulant drugs is likely driven by fear and confusion. A general sense exists among the lay population that prescription of stimulant drugs is entirely out of control; this concern has been exacerbated by vocal critics of stimulant medications who claim ADHD is a fiction and that stimulants are prescribed to drug children into submission.[9] Reading through the voluminous debate, one begins to picture society sitting on the beach helplessly being engulfed by a wave of prescriptions.

The main thesis of this paper is that stimulant drugs are, in fact, overprescribed and that this problem contributes to stimulant drug abuse among young adults. Section I begins with a brief discussion of ADHD, the practice of treating the disorder with prescription stimulants, and the import of stimulant drugs being Schedule II controlled substances. Section II considers the appropriate lens through which to view overprescription of stimulant drugs. Two approaches to overprescription are considered: (1) a patient -centered approach tied to the actual prevalence of ADHD and (2) a physician -centered approach that focuses on the quality of the evaluation a physician conducts before prescribing stimulant drugs. This section concludes that overprescription should be viewed through a physician-centered lens and, from such a perspective, that stimulant drugs are overprescribed. Section III argues that overprescription is important because it contributes to stimulant abuse among young adults. Patients with valid prescriptions are giving away or selling their medication to third-parties. Overprescription contributes to this problem by unnecessarily inflating the number of prescriptions available for diversion.

Next, remedies are considered. Section IV evaluates and rejects four potential strategies for reducing overprescription of stimulant drugs: (1) reducing annual stimulant drug production quotas; (2) changing stimulant drug labeling; (3) supervising physician prescribing via state prescription drug monitoring programs; and (4) restricting the speech of external actors, such as school personnel and pharmaceutical companies, who may pressure parents to medicate their children. Finally, Section V highlights two alternative strategies for reducing overprescription. The first calls for in-depth research regarding the micro-level, practical problems physicians encounter when evaluating and treating ADHD. The insights gleaned from such research can then be incorporated into physician educational efforts. The second strategy, an adjunct to the first, suggests that state medical associations and boards should demonstrate more leadership in the areas of ADHD and prescription of stimulant drugs and, in addition, that state medical boards should more actively oversee physician practices.

Section I. ADHD, Prescription Stimulants, and Schedule II Controlled Substances


ADHD was born over a century ago. In a 1902 address to the Royal College of Physicians of London, Dr. George Still identified a condition in children that he characterized as a “defect in moral control.”[10] Children with the condition were described as having an impaired ability to control their activity for the good of others and the good of themselves.[11] The case descriptions Still provides are reminiscent of today’s notion of hyperactivity and impulsivity. For example, Still described a five-year-old girl as:

[E]xtremely passionate[,] if crossed in any way she will throw herself down on the floor and scream and kick....She is also wantonly mischievous, turns on the water-taps and leaves them running....She is said to have very little sense of obedience and corporal punishment seems to have little or no restraining effect.[12]

Similarly, an eleven-year-old boy is depicted as “extremely excitable and very passionate on slight provocation...he will go up to children who are quite strangers to him...and snatch away their toys, not in order to keep them...but apparently because he enjoys their grief....”[13] To identify a defect in moral control, Still emphasized the necessity of considering the age of the child and the degree of the stimulus being presented.[14]

Thus began the complicated and controversial trajectory of ADHD.[15] Since Dr. Still’s observations in 1902, different labels have been attached to a group of behavioral symptoms that includes hyperactivity, attention difficulties, and impulsivity. During the 1950s, for example, the condition was labeled “minimal brain damage” and then “minimal brain dysfunction.”[16] By the 1960s, labels such as “hyperactive child syndrome,” “hyperkinetic reaction,” and “hyperkinetic impulse disorder” were used.[17] In the 1970s, problems of attention and impulsivity were more heavily emphasized while the previous focus on hyperactivity waned.[18] This shift in perspective culminated in 1980 when the American Psychiatric Association (“APA”) included in the third-edition of the Diagnostic and Statistical Manual of Mental Disorders (“DSM”) a disorder called “Attention Deficit Disorder.”[19] In 1987, in the next version of DSM, hyperactivity remerged as a prominent characteristic and the disorder was renamed “Attention Deficit Hyperactivity Disorder.”[20]

The final twist, at least to date, occurred in 1994 when APA published the fourth edition of the DSM (“DSM-IV”).[21] DSM-IV retains the name “Attention Deficit Hyperactivity Disorder” and defines the “essential feature” of the disorder as a “persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.”[22] In a new development, however, DSM-IV classifies the disorder into three subtypes: Predominately Hyperactive-Impulsive, Predominately Inattentive, and Combined Type.[23]

ADHD’s etiology likely involves the central nervous system, but the disorder’s exact cause is unknown and no discrete diagnostic test exists.[24] Diagnosis is made, therefore, entirely by evaluating the behavior and history of the patient.[25] In brief, the diagnostic criteria outlined in DSM-IV are: (1) six or more of the symptoms of inattention or hyperactivity-impulsivity must have been present for at least six months, (2) some symptoms must have caused impairment before seven years of age, (3) the individual must exhibit impairment in at least two settings such as at school and home, (4) the individual must demonstrate clinically significant impairment in social, academic, or occupational functioning, and (5) the symptoms must not occur exclusively during the course of another disorder or be better accounted for by another disorder.[26]

Symptoms of inattention that DSM-IV lists include: failing to give close attention to details or making careless mistakes in schoolwork or other activities, difficulty organizing tasks and activities, and being easily distracted by extraneous stimuli.[27] Symptoms of hyperactivity or impulsivity include: fidgeting with hands or feet or squirming in seat, running about or climbing in situations in which such behavior is inappropriate, and blurting out answers before questions have been completed.[28]

Treating ADHD with Prescription Stimulants

The practice of treating ADHD with central nervous system stimulants has its origins in Dr. Charles Bradley’s 1937 observations regarding the effect of Benzedrine on the behavior of children at the Emma Pendleton Bradley Home.[29] The thirty children Dr. Bradley studied were of normal intelligence, between 5 and 14-years old, and had a variety of neurological and behavior disorders.[30] During the Benzedrine treatment, many of the children demonstrated an improvement in their schoolwork; indeed, fourteen of the children reportedly responded in a “spectacular fashion.”[31] Their teachers observed an increased interest in school materials, a motivation to accomplish as much work as possible and, in most cases, enhanced speed of comprehension and accuracy.[32]

Notwithstanding Bradley’s striking results, treating children with central nervous stimulants did not become commonplace until the 1960s.[33] Methylphenidate, most commonly known by its brand name Ritalin, was first synthesized in Europe in 1944 and introduced to the United States in 1955.[34] The Food and Drug Administration (“FDA”) first approved methylphenidate for treatment of drug-induced lethargy, mild depression, and narcolepsy.[35] In the early 1960s clinical trials demonstrated Ritalin’s efficacy and in 1961 FDA approved Ritalin for treatment of childhood behavior problems.[36]

Today, the American Academy of Pediatrics (“AAP”) recommends stimulant drugs as the primary treatment for ADHD.[37] Two of the most common prescription stimulant drugs are: (1) methylphenidate the most familiar brand name being, as previously noted, Ritalin and (2) amphetamine the most familiar name being Adderall. A study of elementary public school students in two Virginia cities during 1995, for example, found that 90.0% of medication administered during school hours for ADHD was methylphenidate.[38] Likewise, another study found that in 1998 methylphenidate constituted 84.2% of the medication administered to Maryland public school students for ADHD, while 11.6% received amphetamine.[39] Methylphenidate prescriptions reached a plateau during the mid-1990s, while prescriptions for amphetamine sharply increased during the second half of that decade.[40]

The most common side-effects of stimulant medication, described as “mild, short lived, and responsive to dosing or timing adjustments” include: insomnia, decreased appetite, stomachache, headache, and jitteriness.[41] Concerns have been raised regarding the relationship between stimulant drugs and a number of serious health consequences, but to date none of these concerns has morphed into widespread doubt regarding the safety of stimulant drugs. The following discussion briefly outlines four health concerns that have generated a fair level of discussion in recent years: liver cancer, heart attacks, violence, and substance abuse.

Research reported in the mid-1990s found an association between methylphenidate and liver tumors in mice; a second study of rats found no association.[42] The tumors were mainly non-malignant, although some malignant tumors were found in males.[43] FDA concluded that the study “produced a ‘weak signal’ that the drug may have the potential to cause cancer....”[44] Upon FDA’s request, Ritalin’s manufacturer updated its labeling to include the mouse study findings, and sent physicians an informational letter.[45] In the last five years, the relationship between methylphenidate and liver cancer was only mentioned once in major newspaper articles.[46]

A second health concern came to the fore in 2000, when a fourteen year-old boy, who had been taking Ritalin for ten years, died of a heart attack.[47] The medical examiner concluded that the Ritalin treatment likely caused the heart attack.[48] The examiner’s conclusion, however, was generally assailed by the medical community.[49]

Third, after the Columbine High School shootings in 1999, questions were raised about the relationship between psychotropic drugs and violent behavior.[50] This is so because one of the Columbine shooters had been taking Luvox, a medication for depression, and school shooters in three separate incidents reportedly had been taking Ritalin.[51] This connection between psychotropic drugs and violence has largely been pressed by ardent opponents of such medications including Dr. Peter Breggin and the Citizens Commission on Human Rights, an organization affiliated with the Church of Scientology.[52]

Finally, arguably the most contentious debate has questioned whether stimulant drug treatment in childhood is associated with substance abuse later in life. The latest entry in this discussion, a 2003 meta-analytic study conducted by a host of noted physicians, concluded that stimulant drug treatment for ADHD reduces the risk of later substance abuse.[53] Undoubtedly, this particular debate will continue.

Prescription Stimulants are Schedule II Controlled Substances

Under the Controlled Substances Act[54] (“CSA”), amphetamine and methylphenidate are Schedule II controlled substances.[55] Schedule II substances have an accepted medical use, but a high potential for abuse that, in turn, may lead to severe psychological or physical dependence.[56]

Every person who manufactures, distributes, or dispenses Schedule II controlled substances must register with DEA.[57] Physicians must register since “dispense” is defined to include “deliver[ing] a controlled substance to an ultimate user...by, or pursuant to the lawful order of, a practitioner, including...prescribing....”[58] Reflecting on the purposes of the CSA, the Supreme Court in United States v. Moore [59] examined the Act’s legislative history and explained: “Congress was particularly concerned with the diversion of drugs from legitimate channels to illegitimate channels. It was aware that registrants, who have the greatest access to controlled substances and therefore the greatest opportunity for diversion, were responsible for a large part of the illegal drug traffic.”[60]

In addition to registering, the CSA places two additional requirements on physicians with respect to Schedule II controlled substances: all prescriptions must be in writing and no refills may be issued.[61] Other registrants must also comply with record keeping and reporting requirements.[62] Through this regulatory scheme “Congress created a ‘closed distribution system’ to help DEA identify individuals who divert controlled substances to nonmedical uses.”[63] DEA controls the amount of Schedule II substances within the system by establishing annual production quotas.[64] The quotas must provide for, “the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.”[65] In addition to these regulatory provisions, the CSA also enumerates prohibited acts and defines penalties.[66]

Section II. Overprescription of Stimulant Drugs


There is a general sense that stimulant drugs are overprescribed. Some commentators explicitly assume overprescription: “While it is no secret that Ritalin is often over-prescribed....”[67] Many commentators, however, simply cite the latest stimulant drug statistics, seeming to imply that the sheer magnitude of such figures indicates overprescription. For example, one article stated, “[In 2000] doctors wrote almost 20 million monthly prescriptions for the stimulants....The drugs had sales...of $758 million, 13 percent more than in 1999.”[68]

Rather than resting on assumptions, the following discussion attempts to sort out whether stimulant drugs are in fact overprescribed. This section begins by discussing the descriptive data that has fueled concerns about overprescription. Next, a patient- centered model of overprescription is examined and ultimately rejected.[69] The patient-centered model considers stimulant drugs to be overprescribed to the extent the prevalence of prescriptions exceeds the actual prevalence of ADHD. Following this, a physician- centered model of overprescription is offered. The physician-centered model deems as overprescription the extent to which physicians prescribe stimulant drugs for conditions that resemble ADHD without first conducting a thorough evaluation for ADHD. This section ultimately concludes that from a physician-centered perspective stimulant drugs are overprescribed.

Descriptive Data: Raising Concerns about Overprescription

Production of stimulant drugs has increased dramatically in recent years. Between 1990 and 2003, methylphenidate production increased by a factor of 13.4 and amphetamine production increased by a factor of 26.3.[70] This trend has generated concerns about overprescription because stimulant drugs are mainly used to treat ADHD[71] and because over 90.0% of the methylphenidate produced in the United States is prescribed domestically.[72]

The number of children and adolescents being treated with stimulant drugs also increased substantially during the 1990s. One article reviewed available estimates, and concluded that between 1990 and 1995 there was an approximately 2.5-fold increase in the prevalence of youths with methylphenidate prescriptions.[73] Similarly, among 6 to 14-year old North Carolina Medicaid recipients there was 2.2-fold increase in the stimulant medication prevalence between 1992 and 1998; the medication prevalence was 4.4% in 1992 and 9.5% in 1998.[74] Finally, and undoubtedly the most controversial, one study estimated that between 1991 and 1995 there was a 3.0-fold increase in the rate of stimulant medication among 2 to 4-year olds.[75] Ritalin’s labeling informs physicians that the drug “should not be used in children under six years, since safety and efficacy in this age group have not been established.”[76] Adderall, by contrast, is “[n]ot recommended for children under 3 years of age.”[77]

Geographic data has also raised concerns about overprescription. Methylphenidate and amphetamine use vary considerably from one state to the next, as well as within states.[78] In Hawaii, for example, the average rate of methylphenidate distribution in 1995 was 51g per 10,000 population while Virginia’s average rate was 295g per 10,000 population.[79] These data may raise concerns since the predominant view is that the etiology of ADHD involves the central nervous system[80] and, as such, the actual prevalence of the disorder would not be expected to vary geographically. Areas with high use of stimulant drugs, therefore, may represent overprescription since there is no reason to believe that the prevalence of ADHD is in fact any higher in these areas.[81]

Time trend and geographic data introduce the possibility that stimulant drugs are overprescribed, but provide no conclusive answers. There are valid reasons, for example, as to why production of stimulant drugs, and the number of individuals prescribed such drugs, increased over time including:

[I]ncreased public and physician awareness and acceptance of the condition; acceptance of a broader case definition as appropriate [as demonstrated by DSM-IV]; greater knowledge of the illness course, justifying lengthier treatment (e.g. of adolescents); fewer interruptions in treatment because of diminished concerns about growth retardation; and increased treatment of adults.[82]

Nonetheless, such factors merely raise possible additional explanations for the time trend data, and do not exclude the possibility of overprescription. Determining how to bridge the empirical gap between describing stimulant drug trends and actually quantifying overprescription has been challenging.

Patient-Centered Model of Overprescription

One method for bridging the empirical gap is to compare the extent to which the prevalence of stimulant drug prescriptions exceeds the actual prevalence of ADHD.[83] This is a patient -centered model because it hinges the propriety of prescription on whether or not a patient has ADHD. The patient-centered model has a clean, bright-line quality and an intuitive appeal, but from the outset is fraught with problems.

The first difficulty is that the actual prevalence of ADHD is not definitively known.[84] The only firm conclusions that existing estimates yield are that the prevalence of ADHD in school age children is not lower than 3.0%, the rate is likely in the vicinity of 7.0%, and that the disorder is more prevalent in males.[85] A second complexity, as the geographic data would predict, is that estimates of stimulant prescription prevalence vary across communities. As such, whether stimulant drugs are overprescribed may depend on the community studied. For example, one study found relatively low prescription rates in the Maryland public schools during 1998.[86] The prescription prevalence rates for ADHD medication were estimated to be 4.5% for elementary school students, 4.3% for middle school students, and 1.3% for high school students.[87] Across all education levels, the medication rate for boys was estimated to be 5.8% as compared to 1.5% for girls.[88]

Another study, however, found ADHD medication rates of 8.0% and 10.0% respectively for elementary school children in two Virginia cities in 1995.[89] Importantly, 17.0% of white male children were taking ADHD medication.[90] Similarly, 9.5% of 6 to 14-year olds enrolled in the North Carolina Medicaid program in 1998 were prescribed stimulant medication; the prescription prevalence for white males was approximately 18.0%.[91] From a patient-centered perspective, these two latter studies suggest that white male children are overprescribed stimulant drugs since none of the ADHD prevalence estimates[92] seem to justify such high prescription rates. [93]

In a final patient-centered study, researchers reviewed the medical and school records of a birth cohort in Minnesota and classified subjects into one of four categories: (1) Definite ADHD, (2) Probable ADHD, (3) Questionable ADHD, and (4) Not ADHD.[94] Then, the percentage of subjects receiving medication in each diagnostic category was examined.[95] Of those with Definite ADHD, 86.5% were prescribed either a stimulant medication alone or in combination with another drug, as compared to 40.0% Probable subjects, 6.6% Questionable subjects, and 0.2% Not ADHD subjects.[96] The extent to which these results represent patient-centered overprescription is difficult to interpret since only records were used to assess ADHD status and, as it has been noted, physicians may assign a patient to the diagnostic category for purposes of attaining insurance or disability benefits.[97]

Beyond the practical, operational difficulties, the patient-centered model of overprescription is conceptually unsound. The model ties overprescription to the actual prevalence of ADHD, thereby assuming that physicians appropriately prescribe stimulant drugs only when a patient’s condition rises to the level of clinical ADHD. As Professor Rachel Klein argues, this assumption conflicts with the routine and accepted practice of medicine:

It is not at all unusual for effective medications to be used clinically beyond the limits of their approved indications....However, in doing so, it is also likely that treatment rates will exceed the rate of the disorder in question, leading to concerns about overtreatment. That is true for all effective treatments, including antibiotics.[98]

Klein’s analysis essentially relies on the practice of “off-label” prescribing of drugs.[99] More specifically, simply because ADHD is an indication for which stimulant drugs are approved, does not mean that physicians may only prescribe when ADHD is present.[100]

Physicians have off-label prescribing freedom for good reason.[101] As Dr. Russell Barkley, a leading expert on ADHD persuasively asserted, “‘We have forgotten what our actual mission is -- the relief of suffering and impairment. If the use of medication helps us do that job, stop hand-wringing about the extent to which we are using medication in this country.’”[102] This observation suggests that if a patient is struggling, but their symptoms do not rise to the level of ADHD, their physician should be empowered to exercise clinical judgment and prescribe a stimulant drug without their actions being labeled overprescription.[103]

Accepting as true that physicians may appropriately prescribe stimulant drugs for patients other than those meeting the diagnostic criteria for ADHD is not equivalent, however, to deciding that stimulant drugs are not overprescribed. Rather, this premise simply shifts the focus of the overprescription inquiry away from the patient and the actual prevalence of ADHD and towards the physician’s conduct.

Physician-Centered Model of Overprescription


The physician -centered model of overprescription focuses on the process a physician uses to evaluate a patient before prescribing stimulant drugs; the model is not concerned with the physician’s ultimate diagnostic conclusion. Under the model, prescription of stimulant drugs does not constitute overprescription to the extent a physician reasonably believes the patient has a problem that will be effectively treated with a stimulant drug.[104] Reasonable belief is acquired through adequate evaluation. A physician that prescribes a drug merely upon the observation that a patient is exhibiting behavior that resembles ADHD, without probing further, overprescribes. Reflecting this view, one article in the scientific literature points out, “under some circumstances physicians’ evaluations and assessments of children with suspected ADHD may be inadequate, leading to inappropriate diagnosis and treatment of presumptive ADHD....”[105]

FDA recently promulgated a regulation regarding the labeling of systemic antibiotics that implicitly supports the physician-centered model of overprescription.[106] This regulation requires systemic antibiotic labeling to state that “the drug product should be used only to treat or prevent infections that are proven orstrongly suspected to be caused by bacteria.”[107] In explaining its choice of words, FDA explained:

The agency disagrees with the opinion that there is no difference between “suspected” and “strongly suspected.” Since many infections could theoretically be either viral or bacterial, the direction to use antibiotics for suspected bacterial infections could be interpreted as approving of antibiotic use whenever there is a possibility of a bacterial infection. Therefore, the final rule retains the word “strongly.”[108]

A cogent interpretation of this reasoning suggests that FDA approves of reasonable use of antibiotics. Such use, presumably, can be achieved only by adequately evaluating patients.

Evaluating a Potential Difficulty with the Physician-Centered Model

Describing the Difficulty

There is one potential difficulty with accepting the physician-centered model of overprescription. The difficulty lies in whether there is a distinction between “inappropriate prescription” and “overprescription” of stimulant drugs. More specifically, what if consensus exists that physicians inadequately evaluate patients for ADHD before prescribing stimulant drugs, thereby inappropriately prescribing, but a portion of patients nonetheless experience some degree of incidental symptomatic relief?[109] Under these circumstances, is it fair to classify a physician’s conduct as overprescription? Would doing so conflict with Dr. Barkley’s aforementioned observation that a physician’s core mission is to treat suffering?[110]

The distinction, if any, between inappropriate prescription and overprescription is particularly relevant in the context of ADHD and stimulant drugs. This is so because it is likely that patients will experience some symptomatic improvement notwithstanding inappropriate prescription. Stimulant drugs tend to improve most individuals’ behavior, even those without ADHD, in the areas of hyperactivity, impulsivity, and attention.[111] This is in sharp contrast to drugs such as antibiotics which, if a bacterial infection is absent, will have no remedial effects. As the FDA states in its antibiotic labeling regulation:

“[H]alf of the 100 million antibiotic prescriptions a year written by office-based physicians in the United States are unnecessary because they are prescribed for the common cold and other viral infections, against which antibiotics are not effective ....Thus, using antibiotics when they are not necessary contributes to the increasing prevalence of antibacterial resistance without providing any benefit to the patient .[112]

The relationship between inappropriate prescription and overprescription of stimulant drugs is also important to sort out for a reason specific to the central argument of this paper: Overprescription contributes to stimulant abuse by unnecessarily inflating the number of individuals with prescriptions available for diversion. If inappropriate prescription and overprescription are not coextensive, it may be unwarranted to deem the number of individuals with stimulant drug prescriptions as unnecessarily inflated. Stimulant prescriptions may be cleansed of their inappropriate taint by virtue of the patient’s symptomatic relief. If so viewed, the physician’s inappropriate prescription is severed from the analysis and, while such conduct remains an independent wrong, cannot contribute to an unnecessary inflation of stimulant prescriptions because, in fact, no unnecessary inflation occurs .

Dismissing the Difficulty

Notwithstanding the incidental symptomatic improvement patients may experience, inappropriate prescription and overprescription of stimulant drugs should be viewed as synonymous. That is, when a physician prescribes a stimulant drug without adequately evaluating a patient, the physician overprescribes. The discussion by Jensen et al., in their study of ADHD and stimulant drugs, supports this conclusion.[113] One of the study’s main findings was that eight of sixteen children prescribed stimulant medication in the study population did not meet the full criteria for ADHD, but nonetheless had high levels of ADHD symptoms;[114] as such these children likely experienced at least a fair degree of symptomatic relief via the drug treatment. While Jensen et al. did point to the high level of symptoms as an indication that medication had been appropriately prescribed,[115] this fact alone did not control their analysis:

It would have been optimal to have better process measures of mental health professionals' treatment practices [rather than only lay interviewer observations], that is, the actual nature and quality of care rendered by providers and the extent to which services used empirically based treatments. Such in-depth measures are required to truly gauge what constitutes appropriate treatment, or to determine "over- versus underprescribing ."[116]

This physician-centered analysis makes eminently good sense. A contrary conclusion would, in effect, sanction a clearly unwise policy outcome: prescribing stimulant drugs based on guesswork as long as some incidental benefit to the patient is, as it almost always will be, expected to occur.

The Physician-Centered Model of Overprescription Suggests Stimulant Drugs are Overprescribed

The following discussion argues that, viewing overprescription through a physician-centered lens, stimulant drugs are overprescribed. First, the steps generally agreed as necessary to accurately diagnosis ADHD are outlined. Then, evidence is presented that suggests there is a considerable failure to employ these methods. Stimulant drugs, therefore, are overprescribed because physicians are prescribing without first conducting the necessary evaluation. To challenge this conclusion, one would need to argue that an informed clinical decision about treatment can be made without conducting the comprehensive ADHD evaluation or, alternatively, that physicians routinely engage in the necessary evaluation. Given the evidence to the contrary, both arguments would appear difficult to convincingly mount.

Steps Necessary to Adequately Evaluate a Patient for ADHD

ADHD is not a simple disorder to evaluate and diagnose. This is so because no discrete test exists for ADHD,[117] most individuals exhibit the behaviors associated with ADHD to some extent,[118] and patients with other psychological or medical conditions may present with similar symptoms.[119] Moreover, primary care clinicians, who likely have not been extensively trained in psychological evaluation,[120] most frequently diagnosis and treat ADHD.[121] While the AMA Council Report observed that “few data exist on...exactly what a minimally satisfactory level of investigation entails,”[122] a core group of elements is repeatedly identified.

For example, the American Academy of Pediatrics recently issued guidelines to assist primary care physicians in evaluating and diagnosing ADHD.[123] The AAP guidelines offer physicians six key recommendations: (1) initiate an evaluation for ADHD when a child 6 to 12 years-old presents with inattention, hyperactivity, impulsivity, academic underachievement, or behavior problems; (2) the diagnosis of ADHD requires that the child meet DSM-IV criteria for the disorder; (3) assessment requires evidence directly obtained from parents or caregivers; (4) assessment requires evidence directly obtained from the child’s classroom teacher or other school professional; (5) evaluation should include assessment for coexisting conditions; and (6) other diagnostic tests may be used to assess coexisting conditions such as learning disabilities, but are not recommended to establish the diagnosis of ADHD.[124]

The AAP also explained: “The diagnosis usually requires several steps. Clinicians will generally need to carry out the evaluation in more than 1 visit, often indeed 2 to 3 visits.”[125] Finally, the AAP stressed that the guidelines were intended to guide primary care physicians in “relatively uncomplicated cases.”[126] By implication, therefore, in more complex cases the ADHD evaluation would require additional assessment.

The AMA Council Report, published before AAP’s guidelines were issued, identified similar steps as necessary to assess ADHD[127] and further elaborated:

To make this diagnosis appropriately, the clinician must be familiar with normal development and behavior, gather information from several sources to evaluate the child’s symptoms in different settings, and construct an appropriate differential diagnosis for the presenting complaints. This helps...to distinguish children with ADHD from unaffected children whose parents or teachers are mislabeling normal behavior as pathological.[128]

The Report went on to note that “[t]aking the necessary multiple histories, performing a careful examination, and obtaining appropriate testing will require several visits and may require a multidisciplinary team approach, specialty consultation, or both in some cases.”[129] Likewise identifying such core evaluation components, an article in the New England Journal of Medicine highlighted: (1) screening for behavioral symptoms, including teacher rating scales, (2) taking a family history, (3) a medical evaluation if one has not recently been completed, (4) assessment of differential diagnoses and coexisting conditions and, (5) if evidence of a learning disorder is present, psychometric testing.[130] Finally, the physician labeling for stimulant drugs tends to reflect the clinical literature. The labeling for Ritalin, for example, contains a “Special Diagnostic Considerations” section stating:

[The] specific etiology of [ADHD] is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources....The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more...[enumerated] characteristics. [131]

Evidence of Inadequate Evaluation

Little is known about the way physicians evaluate ADHD,[132] but evidence suggests that a fair number of physicians do not use the routinely noted core procedures. Accordingly, many patients likely are prescribed stimulant drugs on the basis of less than informed clinical judgment. This constitutes physician-centered overprescription.[133]

The most convincing evidence of inadequate evaluation may be the current realities of primary care medicine. An article in Parenting magazine captures the crux of the problem:

Unfortunately, the careful interview and search for coexisting conditions can be sidetracked by the schedules many doctors follow today. “I was giving a lecture last year to adolescent-medicine practitioners about how to diagnose [ADHD in] children, when someone raised her hand,” says Glen Elliott, Ph.D, M.D., director of child and adolescent psychiatry at the University of California, San Francisco. “She said, ‘We’re scheduling two patients every fifteen minutes. How can we possibly do what you are suggesting in seven-and-a-half minutes?’” You can’t, Dr. Elliott told her. That’s the problem.[134]

Echoing this sentiment, the AMA Council Report noted that evaluation and diagnosis of ADHD cannot be completed in a “typical 15-minute primary care office visit.”[135] While noting “there have been descriptions of such assessments in typical pediatric settings”[136] the Report’s phrasing suggests that such rigorous, time consuming evaluations are exceptional rather than routine.

Observations in the Consensus Statement developed by a panel of ADHD experts attending the 1998 National Institutes of Health, Consensus Development Conference also support that physicians, to some extent, inadequately evaluate ADHD:

There is wide variation among types of practitioners with respect to frequency of diagnosis of ADHD. Data indicate that family practitioners diagnose more quickly and prescribe medication more frequently than psychiatrists or pediatricians. This may be due to the limited time spent making the diagnosis. Some practitioners invalidly use response to medication as a diagnostic criterion, and primary care practitioners are less likely to recognize comorbid...disorders.[137]

Finally, a cross-sectional, national survey of primary care physicians conducted in 1999-2000, suggests that all the core evaluation procedures are not routinely implemented.[138] Among the practices revealed were the following: (1) the majority of physicians spent fifteen to forty-five minutes and at least 2 office visits to confirm a diagnosis of ADHD; (2) 60.0% reported using formal diagnostic criteria, but only 28.0% reported using DSM criteria; (3) 50.0% to 70.0% reported using any teacher or school information; (4) 50.0% of the respondents obtained vision and audiologic tests; and (5) most reported routinely assessing for co-existing conditions, 74.0% for tic disorders and 91.0% for depression and conduct disorder.[139] Interestingly, the response rate to the survey was only 54.0% (N=1076).[140] As such, it could be argued that physicians taking the time to answer the survey are more aware of ADHD, and engage in more extensive evaluations, than non-responding physicians.[141] Put differently, these data may underestimate the extent to which ADHD is inadequately evaluated and, accordingly, do not represent the extent to which stimulant drugs, viewed through a physician-centered lens, are overprescribed.

Section III. Why Overprescription of Stimulant Drugs Matters: Patient Diversion and Third-Party Abuse


Stimulant drug abuse is not a recent phenomenon. In Sweden during the 1960s, for example, intravenous abuse of central nervous system stimulants was described as “the most serious of all drug-abuse problems.” [142] Such abuse was associated with serious health consequences including hepatitis, septicemia, and psychotic reactions.[143] Today, in the United States, while there have been reports of individuals injecting stimulant drugs, oral and intra-nasal abuse (i.e. crushing the pills and snorting the powder) are considerably more common.[144]

As the following discussion reveals, stimulant abuse appears to be particularly common among young adults on college campuses. Individuals without prescriptions obtain stimulant drugs from peers with valid prescriptions and abuse the drugs recreationally or to enhance their concentration and academic productivity. Overprescription of stimulant drugs contributes this problem by unnecessarily inflating the number of individuals with valid prescriptions available for diversion.[145] College campuses are a concentrated source of valid prescriptions largely because students prescribed a stimulant drug as children or adolescents may still be taking the drug when they enter college.[146]

Prescription Stimulants: A Study Drug

Anecdotal reports from around the country suggest that a fair number of college students abuse stimulant drugs for a unique purpose: to enhance their concentration and increase academic productivity. Reflecting this use, Ritalin has been dubbed “Vitamin R” or the “‘cramming drug.’”[147] A University of Miami pre-law student “pops a Ritalin pill” before studying for an important exam.[148] The student noted that he would “‘go for hours studying when [he] took the Ritalin....In college there is so much pressure to succeed, and this is Miami, where people want to go out and have fun, too. Sometimes you have to turn to alternative methods to succeed.’”[149] Echoing this sentiment, a University of Chicago student who had used Adderall twice to facilitate studying reflected, “‘Adderall gave me the ability to actually focus...I know that it’s highly addictive but everything in moderation. If [Adderall] is what I need to get me to focus, that’s what I’ll do.’”[150] Another University of Chicago student reportedly “stayed awake for nearly four days straight in order to study, popping [an Adderall] pill or two every day.”[151]

A University of Colorado, Boulder student described taking her brother’s Ritalin “when she needs to cram for a final exam,” explaining, “‘It’s a wonder drug....It makes you have the energy and motivation to study all day.’”[152] A former Duke University student reported that he knew of ten to twenty Duke students who had used methylphenidate illicitly, explaining “‘It’s like speed. They snort it....I think most people take it not to go out and party but to stay awake and work even if they don’t have ADD.’”[153] Another Duke student emphasized, “‘I definitely know Ritalin and Adderall are abused a lot during finals....I remember last year it was going for five dollars a pill or something ridiculous.’”[154] Finally, a Tufts University student reflected, “‘I would say ‘study drugs’ like Ritalin and Adderall are used fairly frequently, especially around finals time.’”[155]

Prescription Stimulants: A Party Drug

Stimulant drugs are also abused recreationally. In 1995, a 19-year-old died after snorting Ritalin at a party.[156] A 29-year-old woman had “no idea she had a popular party drug on hand” until a friend called and asked if the woman would mail her some of her leftover ADD prescription.[157] A Calgary police detective observed that “users often crush the pills and snort them to get a cocaine-like rush....[And that] he has found young people who frequent the rave dance-party scene ‘stacking’ the drug Ecstasy with Ritalin to try to prolong their high.”[158] At Texas A&M, a student reported that during a two-day chili cook-off at a fraternity, “a handful of students snorted Ritalin to stay up all night and drink more alcohol.”[159] This student elaborated that Ritalin abuse was “‘[P]retty mainstream throughout [his] fraternity....People wanted to be really wired and stay up late...instead of being a dumb drunk you’d be an awake drunk’ on Ritalin.”[160] A Southern Methodist University student reflected back on her high school days where she “watched [her] friends crushing up Ritalin tablets and snorting the powder in order to get a rush.”[161] She added that when she got to college she discovered that “[R]italin was just as popular in college as it was in high school.”[162]

Legitimate Patients: Giving Away and Selling Their Prescriptions

A plethora of anecdotal evidence offers convincing support that a major source of the stimulant drugs being abused are legitimate patients who give away or sell their prescriptions.[163] For example, a Kansas State fraternity member revealed, “‘In my fraternity house, there were seven or eight guys who got pills from two guys who actually had a prescription.’”[164] At the University of California, Berkley, a student said “that for purposes of concentration, ‘friends take Ritalin during midterms and finals if someone has enough to share.’”[165] One of the previously mentioned University of Chicago students, diagnosed with mild ADD but never prescribed a stimulant drug, admitted she “recently started buying Adderall for $2 a pill from a friend with a prescription.”[166] A Harvard University senior described a former classmate who would sell his prescription ADD medication, reporting that he would say, “‘Oh, I'm going to go pick up my prescription, and then that'll be nice, easy...however much money it is....And so then he could make like $600 if he sold each of them for $10.’”[167] Likewise at Texas Christian University, a student reported that he “gets his Ritalin prescription at the Health Center or from his private physician at home....[And] then sells each pill for $2 to $3.”[168] Explaining his actions he stated, “‘I’m willing to do it every so often for a friend....But I don’t want to be known as a supplier.’”[169] At Duke University a student reported being approached by other students who knew he had a prescription for Ritalin, and noted that “‘At first, when it was a friend of mine, I let her have it, and then after that, I didn’t want it to get out of hand so I stopped giving it to people.’”[170] A Tufts University student admitted giving her Ritalin to friends and reasoned, “‘If they think it helps them, I feel like at this point so many people are prescribed it who shouldn’t be.’”[171]

Extent of Stimulant Abuse

While the relative frequency of such anecdotal accounts suggests a sizeable amount of stimulant abuse, the actual extent of the abuse is unclear. Some college students report no knowledge of abuse[172] or estimate that only a small number of people abuse stimulants.[173] Likewise, drug abuse surveys are occasionally pointed to as evidence that, while some abuse may be occurring, the problem is not widespread. For example, one article observed: “Though the problem hasn't reached epidemic proportions - only 5.1 percent of local high-school students and 3.4 percent of middle-school students reported using Ritalin without a prescription in the past 30 days in the 2002 Massachusetts Youth Health Survey - it has caught on significantly among suburban youths.”[174] Likewise, an official at the University of Chicago pointed to a “low prescription drug abuse report rate” in a recent student survey.[175]

The 2002 National Survey on Drug Use and Health measured the extent of non-therapeutic use of prescription stimulant medications via a self-report survey.[176] The study found that in 2002, 4.3% of those 12 to 17-years reported lifetime non-medical use of stimulants, while10.8% of those 18 to 25-years reported such lifetime use.[177] For both age groups, lifetime use increased slightly between 2001 and 2002.[178] A 1998 survey of 44,232 high school students conducted by researchers at Indiana University, found that nearly 7.0% of respondents reported illicitly using methylphenidate at least once, with 2.5% reporting monthly or more frequent use.[179] Finally, a survey of 150 University of California, Berkley students revealed that 44.0% of respondents knew of Ritalin’s use as a study aid and 29.0% knew of its use as a recreational drug.[180] Only 1.0% of respondents reported using Ritalin for study purposes, but 4.0% knew someone who had so used Ritalin.[181]

While there is some consistency across these results, self-report surveys in all probability ineffectively capture the extent to which stimulant drugs are being abused. Survey participants may underreport drug use because they fear being detected.[182] As a letter written to the Hartford Courant , convincingly reasoned: “[Part of] the problem with such surveys stems from the fact that truly endangered young drug users are terrified of the legal consequences. They lie on surveys and say they don’t do drugs out of fear the answers may be traced back to them.”[183]

The extent of drug abuse is also sometimes gauged by considering emergency room visits.[184] From this perspective, stimulant abuse would seem to be a minor problem. For example, data from the Drug Abuse Warning Network (“DAWN”) revealed that in Seattle in 2002, stimulant drugs were not among the top five drugs involved in drug abuse related emergency department visits.[185] The top five drugs being: alcohol in combination with other drugs, cocaine, heroin, narcotic analgesics (pain relievers), and marijuana.[186] The AMA Council Report pointed to such data as evidence that while stimulant drug abuse may be a problem, it is not as extensive as other drug abuse problems:

[DAWN] data on emergency department visit monitoring show a 6-fold increase between 1990 and 1995 in mentions of methylphenidate. A “mention” simply indicates that the patient listed the drug as one taken: it is not necessarily the drug leading to the emergency department visit, nor is there any medical confirmation. The rate of cocaine mentions, by contrast, is 40 to 50 times higher.[187]

As with survey data, however, using emergency department visits as a way to measure the extent of stimulant abuse is problematic. The strategy almost certainly underestimates the extent of abuse since the physical consequences of abuse tend to be relatively mild. Demonstrating this, one study, examining cases reported to poison centers found that, for cases with known outcomes involving exposure only to methylphenidate, the most common effects were tachycardia, agitation/irritability and hypertension.[188] In most cases, therefore, individuals that abuse stimulants probably do not need medical attention. Moreover, college students abusing the drugs to enhance their concentration and academic productivity may be especially vigilant about the amount of drug they take for fear that too high a dose may interfere with their studying.[189]

Health Consequences of Stimulant Abuse


As just noted, the physical consequences of stimulant abuse tend to be relatively minor. Nonetheless, serious physical consequences have been reported. For example, as previously mentioned, a 19-year-old died after snorting Ritalin at a party.[190] As another example, traces of Ritalin were found in the body of a 19-year-old Mississippi teenager who, after drinking a couple of beers, “began talking philosophically, announced Jesus was coming and left [his dorm room].”[191] The individual, who did not have a Ritalin prescription, disrobed and wandered around nude for thirty-minutes until police arrived; the teenager was bleeding from the head when police found him and later died of a fractured skull.[192] In another tragic event, a female Boston University student, who had been taking a diet pill, also took Adderall to study for an exam.[193] The combination of the two pills, reportedly “overwhelmed her heart” and she entered a coma while sleeping.[194]


Prescription stimulants are classified as Schedule II controlled substances because abuse of the drug “may lead to severe psychological or physical dependence.”[195] Notwithstanding this, the psychological consequences of stimulant abuse, and the total effect on the lives of those abusing these drugs, are not frequently mentioned. Four factors may contribute to this lack of discussion.

First, it may be believed that adolescents and college students only fleetingly experiment with stimulant drugs. As the AMA Council Report observed, “[W]hile nonmedical stimulant use may be somewhat more common among adolescents in recent years...the pattern of use for the vast majority appears to be experimental and not of the type (regular, heavy, injecting, etc) likely to lead to serious adverse consequences.”[196] Some anecdotal evidence does support this conclusion. One individual revealed, “Yes, I admit to snorting [Ritalin] once, too. I was a curious high schooler....But I will never forget the terrible headache that it gave me....”[197] Likewise one student reported, “‘I’ve used study drugs before for finals, but it isn’t something that I do often at all....’”[198]

It is questionable to assume, however, that stimulant abuse is generally experimental or infrequent. College students abusing stimulants to enhance their concentration and academic productivity may be particularly prone to regular abuse. This is so because, as a health educator at the University of California, Berkley noted, academic pressure likely fuels the problem:

“‘Berkley has the reputation of being very competitive, and it is; everyone’s bright. Sometimes people are brighter than you and that’s hard for some students to recognize. It’s like ‘Oh my goodness you’re not the only student with straight A’s on the campus’’”....Some students believe that studying with the aid of Ritalin gives them a competitive edge.[199]

Given that academic pressure is unrelenting, it seems plausible that individuals may abuse stimulants relatively frequently and, thus, increase their chances for abuse. As a professor from the psychology department at the University of California, Berkley observed: “‘You might say ‘I need to study for a big test coming up’ so you take [Ritalin] then. But then you decide you liked how it worked and start taking it whenever you study. Once you start taking it more and more, you are more prone to becoming addicted.’”[200]

Second, some may believe that even if individuals routinely abuse stimulant drugs their abuse mimics therapeutic use by those diagnosed with ADHD. That is, those abusing stimulant drugs are thought to take them orally, in amounts resembling therapeutic doses, and are therefore unlikely to experience adverse consequences.[201] Perhaps demonstrating this view, the coordinator of an ADHD support group in Massachusetts hypothesized that some individuals who abuse stimulant drugs may have undiagnosed ADHD and thus be “‘self-medicating.’”[202]

Third, psychological consequences may not be focused on because college students tend not to demonstrate behavior consistent with psychological addiction. The Director of Harvard Medical School’s Division on Addiction, Howard J. Shaffer, laid out a three part model for understanding addiction: “One simple model for understanding addiction is to apply the three Cs: [1] Behavior that is motivated by emotions ranging along the C raving to C ompulsion spectrum; [2] C ontinued use in spite of adverse consequences; and [3] Loss of C ontrol.”[203] One example of behavior likely to fit this model is that of a 33-year-old Wisconsin mother who “[was] suspected of robbing eight pharmacies to obtain [Ritalin]. She described to authorities an addiction so out of control that she fashioned toy weapons and hogtied clerks while apologetically robbing pharmacies.”[204]

As previously discussed, however, it is likely that a college student abusing stimulant drugs need not travel outside their immediate environment to refresh their supply of the drug. As the clinical director of psychiatry at the University of Wisconsin-Madison’s Health Services observed, “‘On most college campuses, you can go to the library and probably walk away with some (Ritalin) easily....”[205] As such, college students do not have to engage in desperate acts to obtain stimulant drugs that would draw attention themselves and signal psychological addiction.[206] A DEA official noted this fact: “Adolescents don’t have to rob a pharmacy, forge a prescription, or visit the local drug dealer to acquire these drugs - they have little difficulty obtaining them from friends or classmates at school.”[207] It is faulty logic to assume, therefore, that simply because we do not see indicia commonly associated with psychological addiction that the mental state is absent.

Finally, the lack of focus on psychological consequences may be due to the socially acceptable, indeed encouraged, behavior some engage in while abusing stimulant drugs: ferocious studying. This activity is likely to engender acclaim rather than concern. The outward manifestation of abuse, however, should not obscure the psychological experience of the individual. Someone with an eating disorder, for example, may be the essence of beauty, but psychologically struggling with a disorder that has taken over her life and controls her every action. Similarly, individuals abusing stimulant drugs may be outwardly accomplished and academically prolific, but simultaneously be experiencing considerable psychological turmoil.

Section IV. Evaluating and Rejecting Four Strategies for Reducing Overprescription of Stimulant Drugs


Overprescription of stimulant drugs contributes to third-party abuse by unnecessarily inflating the number of patients with valid prescriptions available for diversion. Overprescription is the problem. Patient diversion and third-party abuse are the consequences. This section considers and rejects four strategies for reducing overprescription: (1) reducing annual production quotas for stimulant drugs, (2) changing stimulant drug labeling, (3) monitoring physician prescribing via state prescription drug monitoring programs, and (4) restricting the speech of external actors, such as school personnel and pharmaceutical companies, who may pressure parents to medicate their children.

The problem , of course, could be recast as patient diversion and third-party abuse. Accordingly, the focus would be on decreasing these behaviors rather than on attempting to reduce overprescription. This strategy is inadvisable. Given the parameters of patient diversion and third-party abuse, it would be difficult to devise an effective strategy. Warning patients that diversion is illegal[208] is, in all frankness, an empty threat. As the diversion paradigm is from one college student to another, the chance of detection is in the range of miniscule to nonexistent.[209] Moreover, crafting effective educational messages about the health consequences of stimulant abuse would be difficult since the physical consequences typically are minor and, at the present time, the psychological consequences are not well understood.[210]

Strategy One: Annual Production Quotas Cannot be Relied on to Reduce Overprescription

Each year, DEA must set production quotas for Schedule II controlled substances that “provide for the estimated medical, scientific and research needs of the United States.”[211] It could be convincingly argued that to the extent overprescribed stimulant drugs are not required to meet medical needs. That is, pursuant to the physician-centered model of overprescription, medical need would be deemed equivalent to the amount of a drug necessary to fill informed prescriptions. Similarly, by definition, stimulant drugs diverted from patients to third-parties are not used for medical purposes. As such, one heavy-handed approach to curbing overprescription would be to simply reduce the amount of stimulant drugs available to be prescribed. While the solution’s simplicity is appealing, a close examination of FDA and DEA’s roles in setting the production quotas forecloses any possibility of taking into account overprescription, patient diversion, or third party abuse.[212]

FDA’s Role in Setting Annual Production Quotas

FDA assists in setting the annual production quotas by investigating the amount of controlled substances necessary to meet the estimated medical, scientific and research needs and transferring this information to DEA.[213] This statement of responsibility sounds as if it might vest FDA with the authority to take overprescription into account in determining the amount of stimulant drugs needed to satisfy medical needs. Indeed, given the breadth of FDA’s investigation in making scheduling decisions,[214] one might expect FDA to have such authority.

To take overprescription into account, FDA could engage in the following analysis. First, as it currently does, FDA would estimate medical need based on pharmaceutical sales and marketing data.[215] Then, FDA would estimate the extent to which stimulant drugs are overprescribed.[216] Finally, FDA would discount the estimate of medical need based on the pharmaceutical sales and marketing data to reflect the extent of overprescription.

This methodology for estimating medical need, while it may make logical sense, would far exceed FDA’s authority. This is so because FDA is prohibited from interfering in the doctor-patient relationship.[217] Pharmaceutical sales data essentially represent the culmination of clinical judgment. Each prescription a physician issues contributes to the entire amount of the drug sold. Therefore, if FDA made a downward adjustment to the sales data it would be tantamount to second-guessing clinical decision making. The principle that FDA may not interfere in the doctor-patient relationship surely prohibits this result.

DEA’s Role in Setting Annual Production Quotas

Just as FDA does not have the authority to take overprescription into account, DEA does not have the authority to consider either patient diversion or third-party abuse when setting the production quotas. “Regulated persons” under the CSA refers to “a person who manufactures, distributes, imports, or exports a listed chemical....”[218] Patients are not regulated persons under the CSA, but instead constitute “ultimate users” meaning “a person who has lawfully obtained, and who possesses, a controlled substance for his own use....”[219] As one commentator pointed out, “[p]atients, the last link in the distribution chain...are recognized as being lawfully in possession of controlled substances. [Patients] are not regulated parties under the CSA and are not intended to be objects of diversion monitoring systems.”[220]

The First Circuit’s opinion in Western Fher Laboratories implicitly supports that in setting the annual production quotas for controlled substances DEA: (1) may only consider prescription drug diversion with respect to regulated persons and (2) may consider drug abuse only if it constitutes a proxy for such diversion:

Although the evidence of reported thefts and losses involves a very small amount...there was testimony that Preludin was “one of the most popular of the abuse drugs,” that it has been “the principal problem” for retailers in Philadelphia, as well as of special concern in Houston, Kansas City, and Washington, and that illicit sales bring prices of up to $15 per dosage unit...This evidence supports the conclusion that substantial amounts [of the unexplained difference between national sales by the wholesaler and prescriptions dispensed] are being illicitly diverted somewhere along the pipeline .[221]

Since patient to third-party diversion occurs outside the regulatory pipeline, DEA presumably does not have the authority to take such diversion into account in setting the production quotas. Likewise, DEA may not take into account third-party abuse of stimulants, diverted to third-parties by patients, because such abuse is not a proxy for diversion from the pipeline.

Notwithstanding this relatively straightforward legal explanation, an interesting conceptual reason exists for why DEA may not consider patient diversion. If DEA discounted patient diversion in calculating the production quotas, it would simultaneously and unavoidably be discounting patient prescriptions; the drugs being diverted also constitute valid patient prescriptions. The result of such a discount would be to create a genuine possibility that the production quotas would not meet legitimate medical need for stimulant drugs. This is so because legitimate medical need is satisfied if enough of a controlled substance is produced for patients to fill their prescriptions.[222]

Strategy Two: Stimulant Drug Labeling Cannot be Relied on to Reduce Overprescription

As previously discussed, FDA recently promulgated a regulation to “help educate physicians and the public about the [antibiotic resistant bacteria] problem and to encourage physicians to prescribe systemic antibacterial drugs only when clinically necessary.”[223] This new regulation requires that all systemic antibiotics contain certain “context of product use information.”[224] Directly under the product name the following statement must appear:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of this antibacterial drug product and other antibacterial drugs, the product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.[225]

The regulation also requires: (1) a statement similar to that appearing under the product name in the “Indications and Usage” section; (2) in the “General” subsection of the “Precautions” section a statement indicating “that prescribing the antibacterial drug product in the absence of a proven or strongly suspected bacterial infection of a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria” and (3) in the “Information for patients” subsection of the “Precautions” section a recommendation that clinicians advise patients on the appropriate use of antibiotics.[226]

As a strategy for reducing physician-centered overprescription of stimulant drugs, FDA could promulgate a stimulant drug labeling regulation based on the antibiotic regulation.[227] Similar to the antibiotic regulation, the stimulant drug regulation would educate physicians and the public about the problem of patient diversion and third-party abuse and encourage prescription of drugs only after a complete evaluation. First, directly under the product name, the following statement would be required: “To reduce the public health problem of stimulant drug abuse, this product should be used only after the physician conducts a comprehensive evaluation of the patient.”[228] Second, a similar statement would appear in the “Indications and Usage” section; this section already contains a “Special Diagnostic Considerations” subsection noting that adequate diagnosis of ADHD requires the use of medical, special psychological, educational, and social resources.[229] Third, in the “General” subsection of the “Precautions” section the label would be required to state: “Prescribing the drug without first conducting a comprehensive evaluation may contribute to the stimulant abuse problem in third-parties.” Fourth, an “Information for patients” subsection would be added to the “Precautions” section recommending that physicians explain to patients the importance of taking the stimulant medication exactly as prescribed, and that the patient should not share the medication with any other individual. Finally, a statement would be added to the existing, standard black box warning on stimulant drugs regarding Drug Dependence in patients[230] educating physicians about the risk of stimulant abuse in third-parties. The warning would explain that evidence exists that some patients divert their medications to others and, accordingly, physicians should be cognizant of this risk when prescribing stimulant drugs.[231]

Notwithstanding the prudence of requiring such labeling, the regulation would almost certainly exceed FDA’s authority. This is true for two reasons. First, although FDA does not clearly point to a source of authority for promulgating the antibiotic regulation, [232] it arguably relied on its responsibility to ensure the efficacy of approved drugs.[233] That is, FDA promulgated the regulation in response to a public health problem threatening the efficacy of an entire class of approved drugs. Supporting that this was FDA’s rationale, the “Objective of the Final Rule” explains: “Drug-resistant bacteria pose a public health risk by reducing the effectiveness of prescription antibacterial drug products. Some disease-producing bacteria can adapt and become resistant to newly developed drugs within a couple of years....”[234] While it would have been helpful for FDA to have cited specific statutory authority,[235] this rationale seems ironclad.[236] Importantly, this rationale is clearly inapplicable to the public health problem of stimulant drug abuse. Stimulant drug abuse does not threaten the efficacy of any particular prescription drug, much less an entire class of drugs.

The second reason the proposed stimulant drug regulation would exceed FDA’s authority is that the regulation would be aimed at protecting third-parties rather than towards promoting the safe use of drugs in patients . In promulgating a labeling regulation for a prescription drug it is a fortiori that the objective of the regulation is to ensure the safe or effective use of the drug in patients . Since it would be illegal for a physician to prescribe a stimulant drug to non-patient third-parties,[237] it would be illogical to grant FDA authority to require labeling information to protect the health of such third-parties.[238] While prescription stimulant abuse is a clear public health problem, this alone does not vest FDA with the authority to require an across the board revision of stimulant drug labeling.[239]

Using slightly different reasoning, Judge McGowan of the D.C. Circuit expressed a similar substantive theme in his concurrence in Am. Pharm. Ass’n v. Matthews .[240] In the proceedings below, the D.C. District Court concluded that a FDA regulation restricting the distribution of methadone, a Schedule II controlled substance, exceeded FDA’s authority.[241] The challenged regulation would have restricted the distribution of methadone to direct shipments from manufacturers to approved treatment programs, approved hospital pharmacies, and selected community pharmacies when hospital pharmacies were unavailable.[242] FDA’s rationale for the regulation was that methadone had not been shown to be safe for its approved indications under the conditions of use that existed at the time.[243] FDA argued “that the term ‘safe’ should be interpreted with reference not only to the inherent qualities of the drug...but also in the sense of the drug’s being secure from possible misuse.”[244] The D.C. District Court rejected this rationale.[245]

The D.C. Circuit affirmed, and in his separate concurrence Judge McGowan agreed that methadone was “safe” within the meaning of the FDCA, despite the possibility for misuse.[246] FDA’s disputed regulation would not, he reasoned, impact a physician’s ability to make an “informed and sound medical judgment about medical safety and effectiveness,” but rather was an attempt to “control drug misuse by persons who have no intent to try to use [the drug] for medical purposes.”[247] Similarly, the proposed stimulant labeling regulation would not assist physicians in making informed medical decisions regarding treatment of their patients, but rather its sole purpose would be to control stimulant abuse by third parties.

Strategy Three: Supervising Physician Prescribing via State Prescription Drug Monitoring Programs Should Not be Relied on to Reduce Overprescription

Prescription Drug Monitoring Programs (“PDMPs”) are state surveillance programs “designed to facilitate the collection, analysis, and reporting of information on the prescribing, dispensing, and use of prescription drugs within a state.” [248] Almost all PDMPs monitor prescriptions of Schedule II controlled substances, most use an electronic monitoring system, and the programs are typically lodged in either law enforcement or public health agencies.[249] There is some evidence that PDMPs reduce “unwarranted prescribing,”[250] and that physicians in states with PDMPs are less likely to prescribe frequently diverted drugs.[251] In 2002, fifteen states had PDMPs,[252] and the federal government hopes more states will develop such programs.[253]

Most PDMPs operate retroactively.[254] That is, prescribing, dispensing, and use data are collected and physicians or members of law enforcement request information from the program.[255] A few PDMPs operate proactively, however, by collecting prescribing data and systematically analyzing it to identify, among other types of activities, physicians that have unusual prescribing practices.[256] Proactive PDMPs can be used to “identify medical providers that may be overprescribing and inform them that their patterns are unusual .”[257]

There are three reasons why PDMPs should not be relied on to reduce overprescription of stimulant drugs. First, physician-centered overprescription of stimulant drugs is likely a systemic problem and, therefore, not amenable to a proactive PDMP type approach. A surveillance system is a sensible approach to identifying and remedying a problem only if the target event is rare enough to be detectable.[258] Indeed, as explicitly noted, proactive PDMPs are used to identify physicians with unusual practices.

Second, even if proactive PDMPs were a conceptually appropriate strategy, the reality is that PDMPs are expensive and most states likely do not have the resources to make physician centered overprescription of stimulant drugs a priority.[259] If financial resources were available to fund proactive state PDMPs, the priority would likely be on analyzing prescribing practices for Schedule II pain relievers, such as OxyContin. This is so because abuse of pain relievers is not infrequently associated with devastating health consequences including overdose and death.[260]

Finally, although decreased prescription of controlled substances is touted as a positive consequence of PDMPs, this is not necessarily so. For example, the American Alliance of Cancer Pain Initiatives reasoned that physicians in states with prescription monitoring programs may be reluctant to prescribe pain management drugs because they are fearful of sanctions.[261] As a consequence, such programs may lead to “less than optimal pain management.”[262] Similarly, systematic monitoring could lead to less than optimal use of stimulant drugs. This critique of PDMPs highlights that the success of any strategy designed to decrease overprescription should not be measured solely by the net decrease in the number of prescriptions. Instead, from a physician-centered perspective, success should be measured by the extent to which informed prescribing increases . Confidence in physician prescribing renders the actual number of prescriptions issued relatively meaningless.

Strategy Four: Restricting the Speech of External Actors who may Pressure Parents to Medicate Their Children Should Not be Relied on to Reduce Overprescription


The debate regarding overprescription has recently turned its attention to the pressure school personnel and pharmaceutical companies, through their speech, place on parents to seek stimulant medication for their children.[263] State legislation has been proposed, and in two states passed, prohibiting school personnel from recommending psychotropic drugs for students. Also, there has been vigorous discussion regarding direct-to-consumer advertising of stimulant drugs. The following discussion briefly outlines the state legislative efforts and the direct-to-consumer advertising debate and, then, argues that this shift in focus towards outside actors and away from physicians constitutes unwise policy.

State Legislation

Legislation prohibiting school personnel from recommending stimulant drugs arguably originated in the April, 1999 Columbine High School shootings. In November, 1999 the Colorado Board of Education passed a non-binding resolution that, in summary, “urge[d] teachers and other school personnel to use discipline and instruction to overcome problem behavior in the classroom, rather than to encourage parents to put their children on [stimulant drugs].”[264] Those who supported the resolution “said they were motivated, in part, by evidence that they said suggested that dozens of violent crimes, including the massacre...at Columbine High School...had been committed by young people taking psychotropic drugs.”[265] The impetus for this belief was, almost certainly, ardent opponents of stimulant medication, convinced a link exists between psychotropic drugs and violence, who testified at the informal hearings held on the resolution. [266] At the time the resolution was passed no other states were considering similar measures.[267]

Today, Connecticut[268] and Virginia[269] both have passed legislation requiring their respective school boards to adopt policies prohibiting school personnel from recommending a psychotropic drug for any child. The text of both states’ legislation explicitly allows school personnel to recommend that a child undergo a medical evaluation. Similar bills have been introduced in a number of other states.[270] Reportedly, “[t]he legislative push is a reaction to what its advocates call overprescription of the drugs.”[271] Rep. Lenny T. Winkler, the sponsor of the Connecticut legislation, explained her rationale:

[Rep. Winkler] said she introduced the bill after hearing too many stories about parents feeling pressured by school officials to treat their children’s problems with psychotropic drugs. [She] said...she does not believe that school officials are qualified to make recommendations about such drugs to parents. But since teachers are held in high esteem...parents would listen to their medical recommendations.[272]

Direct-To-Consumer Advertising of Stimulant Drugs

The debate regarding direct-to-consumer advertising of stimulant drugs, and the pressure such advertising may impose on parents to medicate their children, began recently. This is so because the trend of marketing controlled substances directly to consumers is a recent phenomenon. Until 2001, all parties apparently were observing a 1971 international treaty prohibiting the marketing of controlled substances.[273] In 2001, the British company Celltech Pharmaceuticals, the maker of the stimulant drug Metadate CD, “‘stepped up and beyond everyone else’” a DEA official stated, “‘by advertising a drug [to the general public] with a high potential for abuse.’”[274] Despite the bold nature of Celltech’s foray, United States federal law does not prohibit such advertising and FDA seems to have acquiesced to the practice so long as advertisements contain appropriate warnings.[275]

Today, stimulant drug advertising is abundant.[276] The nature of the advertising has made many uneasy: “Ads inevitably raise expectations sky high -- implying that taking a pill will create an obedient pliable child who will regularly do his homework and complete chores around the house.”[277] Direct-to-consumer advertising has also evoked cutting critiques of the pharmaceutical industry:

Even when medications work, they are not substitutes, morally or medically, for more parental involvement, more effective discipline and better teaching. However, this point of view is likely to be overwhelmed by the spate of TV commercials for Strattera or Concerta. Unfortunately, there are no stock dividends or equity for family therapy or special education.[278]

Such concerns have led some to suggest that FDA should ban, or at least restrict, the direct-to-consumer advertising of stimulant drugs.[279]

Policy Concerns Raised by Shifting the Focus Away from Physicians

Certainly, curtailing the speech of school personnel and pharmaceutical companies would decrease overprescription of stimulant drugs. Less information would lead to less demand for stimulant drugs and thereby reduce the opportunities for physicians to overprescribe. Focusing the overprescription debate so heavily on the speech of external actors rather than physicians, however, is unwise for two policy reasons. First, and particularly relevant in the pharmaceutical company advertising context, information about stimulant drugs is indisputably valuable. For example one commentator reasoned, “Advertising to parents has some obvious advantages. It may help them become aware that their child has a treatable problem, or that other or newer treatment options exist. It also helps de-stigmatize the use of psychotropic drugs which have been shown to be helpful to large numbers of children.”[280] Curtailing such informative speech, therefore, out of fear that its contents will be inappropriately dealt with clearly treads on dangerous policy grounds.

A principle expressed in the Supreme Court’s commercial speech jurisprudence is useful in understanding this policy concern: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.”[281] Indeed, in the context of stimulant drugs, this principle applies with special force. Parents are unable to obtain stimulant drugs for their children without a physician’s prescription.[282] Thus, preventing outside actors from relaying information to parents does not, and in fact cannot , operate to protect parents from themselves. Instead, restrictions operate to protect parents and their children from physician overprescription. Concern that physicians will deal inappropriately with informed parents must not be used as a reason to impede parents from receiving potentially vital drug information.

The second reason it is unwise to focus on the pressure outside actors wield through their speech is that this strategy essentially absolves physicians from responsibility. Overprescription becomes the work of zealous teachers and pharmaceutical companies. This subtle shift in attribution is apparent in the following excerpt:

[T]he clear purpose of marketing a drug directly to parents is so they'll ask their physician about it -- or even pressure them to prescribe it. “They're trying to force the gates open by having patients go and tell doctors what they should prescribe to them,” says Dr. Alvin Poussaint, professor of psychiatry at the Harvard Medical School.[283]

Regardless of the extent to which outside forces exacerbate overprescription, however, it is imperative that we continue to tie ultimate responsibility for prescribing stimulant drugs to the physician.

The reasoning of the Supreme Court of Pennsylvania in Incollingo v. Ewing, [284] supports this conclusion. In Incollingo the court held that, notwithstanding a finding of negligence on the part of the pharmaceutical company,[285] the prescribing physician remained liable.[286] As the court stated, “We decline to accept the proposition that a qualified doctor can so easily turn himself into a dupe....The court below was correct in not permitting him to take refuge behind the asserted liability of the manufacturer.”[287] Identifying a persuasive rationale for this result, one commentator argued: “Society has a large investment in each physician and in return expects a certain level of competence.”[288] Indeed, in the context of prescribing Schedule II controlled substances our expectations should be elevated. Through the federal registration and prescription requirements,[289] physicians are undeniably put on notice that special care must be taken in prescribing stimulant drugs.

Section V. Two Alternative Strategies for Combating Overprescription


As alternatives to the four strategies previously discussed -- reducing production quotas, changing stimulant drug labeling, supervising physician prescribing via prescription drug monitoring systems, and restricting the speech of school personnel and pharmaceutical companies -- the following discussion offers two strategies for creating a lasting reduction in physician-centered overprescription of stimulant drugs.[290] First, more research needs to be conducting regarding the extent of physician-centered oveprescription and the practical difficulties primary care physicians experience that underlie the problem. The insights gained through this research can be used to create effective educational efforts. Second, state medical associations and boards should show more leadership in the areas of ADHD evaluation and prescription of stimulant drugs. Likewise, state medical boards should take a more active role in overseeing physician conduct. These suggestions are not particularly sophisticated, but nonetheless are likely to be effective as they directly address the root of physician-centered overprescription: ADHD evaluation practices.

Research and Education

Measuring the Extent of Overprescription

An important first step is to collect more data regarding the extent and character of physician-centered overprescription. Knowing little about the way in which physicians evaluate and treat ADHD, makes crafting remedial efforts difficult. To collect such data, Chan et al.’s cross-sectional survey of primary care physicians should be replicated.[291] Since distribution rates of stimulant drugs vary geographically, however, rather than conducting another national study, state or local surveys should be conducted. National level data will obscure regional variations in evaluation practices.[292]

Further, Chan et al. appear mainly to have collected data regarding physician evaluation practices[293] rather than physicians’ ultimate prescription decisions. It would be useful to know, for example, not only whether or not a physician routinely evaluates patients for coexisting conditions, but also the extent to which physicians that fail to do so prescribe stimulant drugs. To gather this information, an anonymous survey querying physicians on their evaluation techniques, could also ask about the number of patients the physician currently is treating with stimulant drugs. Collecting this type of data would allow a better estimate, from the physician-centered perspective, of the extent to which stimulant drugs are overprescribed.

Understanding Obstacles Physicians Face and Creating Effective Educational Efforts

As many commentators recognize, educated physicians are the key to appropriate stimulant drug prescriptions. The AMA Council Report, for example, “encourages efforts by medical schools, residency programs, medical societies, and continuing medical education programs to increase physician knowledge about ADHD and its treatment.”[294] Creating effective educational efforts, however, hinges upon understanding the practical difficulties primary care physicians encounter in evaluating ADHD and prescribing stimulant drugs.[295]

The practical problems physicians face are distinct from the macro-level forces that fuel overprescription such as the current United States health care system.[296] Instead, practical difficulties are the more tangible, operational difficulties physicians encounter. Consider, as one example, “Recommendation 2” of the American Academy of Pediatrics’s diagnosis and evaluation guidelines: “The diagnosis of ADHD requires that a child meet DSM-IV criteria.”[297] Dr. Diller’s discussion in Running on Ritalin , provides useful insight into how this recommendation could raise a practical dilemma for physicians:

In all the behaviors listed by the DSM under ADD, the word often is used to describe behavior that has become a problem. How useful is this? In thinking about [a particular patient], for example, I wonder how the term applies to his playing with pencils. Does it mean, perhaps, three times in an hour? Or just often enough to be noticed? And is it the frequency that makes it a problem, or something else? What precisely does he do with the pencil - is he tapping it, gnawing on it, rolling it in his fingers. (One of these might suggest overactivity, another might indicate anxiety, yet another just boredom.) A certain kind of absurdity begins to enter the process.[298]

No doubt, Dr. Diller, a pediatrician that specializes in child development and behavior,[299] is not alone in his questions. Research must be conducted to uncover the character and extent to which physicians encounter such difficulties; the insights gleaned from the research will greatly help shaping effective educational efforts.[300] Working towards ameliorating macro-level problems, such as fighting for a wise and just health care system, is essential, but such battles must not obscure efforts to better understand and rectify more readily actionable, practical problems.

In light of the stimulant abuse problem on college campuses, understanding the practical challenges faced by physicians practicing at college health service centers may be a prudent place to begin research efforts. Ensuring that overprescription is minimized on college campuses, and thus not contributing to stimulant abuse, is a manageable step in the much larger task of decreasing overprescription across the medical profession as a whole. Fortunately, evidence suggests that physicians at some student health service centers are already attuned to these issues. At the University of Colorado, Boulder, for example, “students [are required] to go through a series of tests and a parent interview before doctors will prescribe Ritalin.”[301] Suggesting that there may be room for improvement on some campuses, however, a student at another school, “believes that the [stimulant diversion problem] partially stems from the distribution of prescriptions to students. ‘When I was prescribed it, I went in and they said, ‘Here’s a trial amount; tell me what the effect is....’’”[302]

Fostering Leadership and Accountability in the Medical Community

State medical associations and boards should assume a more active role in overseeing physician evaluation of ADHD and prescription of stimulant drugs. This role is inherent in their organizational purposes. The Massachusetts Medical Society, for example, lists as one of its priorities “standards of high quality.”[303] Similarly, the Massachusetts Board of Registration in Medicine identifies as part of its core mission “to serve the public by striving to ensure...that [licensed] physicians...provide to their patients a high standard of care....”[304]

Demonstrating leadership is one way in which these organizations can help reduce overprescription of stimulant drugs. To accomplish this, these organizations should decide upon and adopt guidelines for the evaluation of ADHD[305] and the prescription of stimulant drugs.[306] While such guidelines would, in all likelihood, resemble the recommendations already in the literature -- i.e. using formal diagnostic criteria, screening for coexisting conditions, etc...-- the act of adopting guidelines would signal to physicians that state medical leaders place importance on proper assessment of ADHD and prescription of stimulant drugs.

State medical boards can also assist in reducing overprescription by holding physicians accountable when their level of care is inadequate. The actions of Connecticut’s medical board exemplify this recommendation. In Isgut v. State of Conn. Med. Examining Bd. ,[307] Dr. Isgut was assessed a $4,500 civil penalty “for failing to meet the standard of care required of physicians in Connecticut with respect to the care and treatment of a patient that he had prescribed [R]italin for and failed to monitor properly.”[308] In 1997, the 21-year-old patient “complained to [Dr. Isgut] that he was having difficulty with reading, studying, organizing and finishing his work.”[309] Dr. Isgut diagnosed the patient with ADD and prescribed a fourteen day trial of Ritalin; the patient came in for a follow-up visit approximately two weeks later and reported improvement.[310] For the next nineteen months Dr. Isgut continued to issue the patient new Ritalin prescriptions after speaking with him on the phone.[311] In March 1999, Dr. Isgut saw the patient in person, “noticed [he] looked tired, but failed to see any signs of drug abuse,” and continued to issue the patient Ritalin prescriptions.[312] On June 8, 1999, the patient committed suicide.[313]

The Board sanctioned Dr. Isgut, not for the patient’s suicide,[314] but for failing to see a patient for which he had prescribed Ritalin at least every six to twelve months and for not conferring with a health care professional at the patient’s college.[315] The Connecticut Superior Court upheld its decision, affirming the Board’s position that, based on its own expertise, it had the authority to decide the standard of care for a licensed physician treating a patient with Ritalin.[316]

The Connecticut Board’s actions are actually quite remarkable. The Board sanctioned a physician for prescribing conduct that, in all probability, did not vary substantially from many physicians in the same community. While Dr. Isgut’s treatment of the patient does not appear blatantly inadequate, the Board stepped in and implicitly asserted that higher quality care is expected of physicians practicing in Connecticut. Medical boards in other states should follow the Connecticut Board’s example and not set their expectations, and degree of oversight, according to the level of care routinely provided in evaluating ADHD and prescribing controlled substances.[317]


The time has come to stop counting Ritalin prescriptions and change the lens through which we view overprescription of stimulant drugs. The correct lens is the physician-centered model of overprescription. Physicians inadequately evaluate patients for ADHD before prescribing stimulant drugs. This is overprescription and the solution is to change physician prescribing practices. Doing so will, of course, be neither easy nor quick as it requires an across the board elevation in the standard of care. The daunting nature of this task, however, must not leave us paralyzed. Physician-centered overprescription is contributing to stimulant drug abuse among young adults. While such abuse may have a different countenance than we typically associate with illicit drug use, we must not be lulled into concluding that stimulant abuse is therefore not a problem. Beyond this, it is undeniably detrimental to the practice of medicine, patients, and society in general, when it begins to feel as if prescription drugs are prescribing themselves.

[1] Katrina Shawver, ADD Medication Deserves Respect , ARIZ. REPUBLIC , Aug. 1, 2001, at 4, available at LEXIS, News Library, Arizrp File.

[2] Id.

[3] Sue Russell, Opinions, Subduing Rowdiness , ARIZ. REPUBLIC , Sept. 12, 1999, at 6B, available at LEXIS, News Library, Arizrp File.

[4] Mary Jo Kochakian, HARTFORD COURANT , Feb. 23, 1999, at F4, available at LEXIS, News Library, Htcour File.

[5] John Breeding, Editorial, AUSTIN AMERICAN-STATESMAN , Jan. 13, 1995, available at LEXIS, News Library, Austin File.

[6] Alan J. Zametkin & Monique Ernst, Review Article, Problems in the Management of Attention-Deficit-Hyperactivity Disorder , 340(1) NEW ENG. J. MED. 40, 40 (1999).

[7] Dr. Breggin does not believe ADD is an actual disorder, stating in one article “there is no medical, neurological or psychiatric justification for the A.D.D. diagnosis,” and is an outspoken opponent of stimulant drugs. Peter R. Breggin, Letter to the Editor, Whose Attention Disorder Does Ritalin Treat? , N.Y. TIMES , May 20, 1996, at A14, available at LEXIS, News Library, Nyt File. The mainstream scientific community vigorously disputes Dr. Breggin’s views and at least two judges have ruled that his credentials were insufficient to be an expert witness, one noting that he showed “‘blinding bias’” and that his testimony was a “‘house of cards.’” Michael Freedman, A Headache for Novartis , FORBES , July 23, 2001, at 60, available at LEXIS, News Library, Mags File.

[8] Arthur Allen, The Trouble with ADHD , WASH. POST , Mar. 18, 2001, (Magazine), at W08, available at LEXIS, News Library, Wpost File.

[9] Beginning in 2000, a spate of class action lawsuits were filed alleging, among other claims, a conspiracy involving Novartis Pharmaceutical Corp. (the successor of Ciba-Geigy Corp. and current manufacturer of Ritalin), the support organization Children and Adults with ADHD (“CHADD”), and the American Psychiatric Association (“APA”) “to create and then promote the ‘disease’ called [ADHD] and Ritalin as the drug of choice to treat it.” Steven Keeva,No Deficit of Attention Here: Ritalin Class Action Suits Are Making Some Drug Companies Hyper , 87 A.B.A.J., June 2001, 28, at 28, available at LEXIS, News Library, Mags File. To date, such conspiracy claims have been unsuccessful. See, e.g. , Vess v. Ciba-Geigy Corp. USA , 317 F.3d 1097, 1106 (9th Cir. 2003) (“Vess alleges a fraudulent conspiracy between the APA and the other defendants, but he does not provide the particulars of when, where, or how the alleged conspiracy occurred.”); see also Susan Feyder, Lawyer Uses Winning Strategy to Defend Novartis in Ritalin Cases , STAR TRIB. (Minneapolis), June 3, 2001, at 1D, available at LEXIS, News Library, Strib File; see generally Larry S. Goldman et al., Report for the Council on Scientific Affairs, American Medical Association, Diagnosis and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents , 279(14) JAMA 1100, 1101 (1998) [hereinafter AMA Council Report]. The Report canvases a number of fears that have arisen regarding ADHD and stimulant drugs.

[10] George F. Still, Some Abnormal Physical Conditions in Children , 1 LANCET 1008, 1008 (1902).

[11] Id.

[12] Id. at 1012.

[13] Id .

[14] Id. at 1008.

[15] See LAWRENCE H. DILLER, RUNNING ON RITALIN 50-55 (1998). Dr. Diller provides an overview of the history and development of the condition now known as ADHD beginning with Dr. George Still’s 1902 observations and continuing through the present day.

[16] Id. at 52.

[17] Id.

[18] Id. at 52-53.

[19] Id. at 53.

[20] Id. at 54. Today, in common parlance, ADHD and ADD are often used interchangeably. Id.


[22] Id. at 78.

[23] Id. at 80.

[24] Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder, 16(2) NIH Consens Statement Online 1, 5 (1998), at http://consensus.nih.gov/cons/110/110_statement.htm [hereinafter Consensus Statement].

[25] Zametkin & Ernst, supra note 6, at 40-42.

[26] DSM-IV, supra note 21, 83-85.

[27] Id. at 83-84.

[28] Id. at 84.

[29] Charles Bradley, The Behavior of Children Receiving Benzedrine , 94(3) AM. J. OF PSYCHIATRY 577 (1937); see also , Diller, supra note 15, at 24-25.

[30] Bradley, supra note 29, at 587-88. The case descriptions range from “specific educational disabilities, with secondarily disturbed school behavior,” to a “retiring schizoid child” and an “aggressive, egocentric epileptic child.” Id. at 588.

[31] Id.

[32] Id.

[33] Diller, supra note 15, at 24.

[34] Id. at 21.

[35] Id.

[36] Id. at 24-25. While stimulant drugs are still used to treat conditions other than ADHD, including narcolepsy and depression, such alternative uses comprise only a small percentage of stimulant use in the United States. AMA Council Report, supra note 9, at 1103.

[37] American Academy of Pediatrics, Clinical Practice Guideline: Treatment of the School-Aged Child with Attention-Deficit/Hyperactivity Disorder , 108(4) PEDIATRICS 1033, 1037 (2001), available at http://www.aap.org/policy/s0120.html . While AAP did recommend behavior therapy to treat ADHD, the strength of evidence for this recommendation was rated only as “fair” as compared to the “good” rating for its recommendation regarding stimulant drug treatment. Id . at 1037; see also The MTA Cooperative Group, A 14-Month Randomized Clinical Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder , 56(12) ARCH. GEN. PSYCHIATRY 1073, 1078 (1999) (finding, among other results, that stimulant medication alone and a combination of medication and behavioral treatment were “clinically and statistically superior” to behavioral treatment alone and community care alone in treating the core symptoms of ADHD). The precise way in which stimulant drugs work remains unclear. See Diller, supra note 15, at 106-7 (outlining the various hypotheses on stimulant drugs’ mode of action).

[38] Gretchen B. LeFever et al., The Extent of Drug Therapy for Attention Deficit-Hyperactivity Disorder Among Children in Public Schools , 89(9) AM. J. PUB. HEALTH 1359, 1361 (1999).

[39] Daniel J. Safer & Michael Malever, Stimulant Treatment in Maryland Public Schools , 106(3) PEDIATRICS 533, 534 (2000).

[40] Terrance Woodworth, Deputy Director, Office of Diversion Control, Drug Enforcement Administration, Statement Before the Committee on Education and the Workforce: Subcommittee on Early Childhood, Youth, and Families , (May 16, 2000) at http://www.usdoj.gov/dea/pubs/cngrtest/ct051600.htm.

[41] AMA Council Report, supra note 9, at 1104. Some patients also exhibit motor tics, a small number experience cognitive impairment “that responds to dosage reduction or drug cessation” and, although rare, psychosis has occurred. Id.

[42] See Study of Ritalin’s Cancer-Causing Potential , Updates, 30(3) FDA CONSUMER 3, 3-4 (1996) available at http://www.fda.gov/fdac/departs/396_upd.html.

[43] Id.

[44] Id. at 3.

[45] Id.

[46] This observation is based on searching LEXIS, News Library, Majpap File, between 1/01/1999 and 4/16/2004, for (methylphenidate or ritalin and "liver cancer"). The one article published during this period reports that Dr. Peter Jensen, senior adviser to the director of the National Institute of Mental Health, “called...claims regarding a cancer risk ‘very irresponsible,’ and said the FDA had carefully considered the safety of Ritalin in animals and people.” Diet-Behavior Link is at Heart of ADHD Debate, ORLANDO SENTINEL TRIB. , Nov. 2, 1999, at E4, available at LEXIS, News Library, Orsent File. Likewise, almost completely dismissing the liver cancer study, Dr. Diller observed, “I mention [the study] only to highlight the possibility, however unlikely, that despite sixty years of stimulant use with children demonstrating remarkable physical safety, some as-yet-undiscovered negative effect of Ritalin still could be found.” Diller, supra note 15, at 264.

[47] See Some Experts Dispute Claim Against Ritalin, HARTFORD COURANT , Apr. 18, 2000, at A6, available at LEXIS, News Library, Htcour File.

[48] Id.

[49] Id. ; see also Sarah A. Webster & Mike Martindale, Doctors Dispute Role of Ritalin in Death, DETROIT NEWS , Apr. 18, 2000, at 1A, available at LEXIS, News Library, Detnws File. Oddly, however, in the middle of a report on abuse of stimulant drugs, the Community Epidemiology Work Group (“CEWG”), of the National Institute on Drug Abuse, states “[Recently] a suburban Detroit boy (14 years old) died of a heart attack caused by chronic, long-term effects of its use.”COMMUNITY EPIDEMIOLOGY WORK GROUP, NATIONAL INSTITUTES OF HEALTH, EPIDEMIOLOGIC TRENDS IN DRUG ABUSE 92 (2000) [hereinafter CEWG Report], at http://www.drugabuse.gov/PDF/CEWG/CEWG600.pdf. As newspaper accounts do not suggest that the fourteen year-old was abusing his Ritalin prescription, it is unclear whether this incident was mistakenly included in CEWG’s report, or whether CEWG was expressing its view that Ritalin had in fact caused the heart attack, thus indicating a conflict of opinion in the medical community.

[50] See Michael Janofsky, Colorado Fuels U.S. Debate Over Use of Behavioral Drugs , N.Y. TIMES , Nov. 25, 1999, at A1, available at LEXIS, News Library, Nyt File.

[51] See Ann Schrader, Drugging Kids: No Easy Fix, DENVER POST , Nov. 22, 1999, at A-01, available at LEXIS, News Library, Dpost File.

[52] See id. ; see also Janofsky, supra note 50.

[53] Timothy E. Wilens et al., Does Stimulant Therapy of Attention-Deficit/Hyperactivity Disorder Beget Later Substance Abuse? A Meta-analytic Review of the Literature , 111(1) PEDIATRICS 179, 182 (2003); see also Marilyn Chase, Ritalin at Center of Addiction Debate , CHI. SUN-TIMES , May 23, 1999, at LI45, available at LEXIS, News Library, Chisun File (discussing previous research on stimulant drugs and subsequent substance abuse including one study indicating that Ritalin treatment increased risk of later abuse).

[54] 21 U.S.C.S. § 801 et seq . (MB 2004). Functions assigned to the Attorney General under the CSA are delegated to the Administrator of the Drug Enforcement Administration (“DEA”). Judicial Administration, Drug Enforcement Administration, 28 C.F.R. § 0.100 (2004). Functions assigned to the Secretary of Health and Human Services under the CSA are delegated to the Commissioner of Food and Drugs. Delegations of Authority and Organization; Reorganization and Republication, 66 Fed. Reg. 30,992, 30,995 (June. 8, 2001) (to be codified at 21 C.F.R. pt. 5.10).

[55] Food and Drugs, Schedules of Controlled Substances, 21 C.F.R. § 1308.12(d) (2004). In 1995, the support organization CHADD, see supra note 9, petitioned DEA to lower Ritalin from Schedule II to III. Diller, supra note 15, at 38-40. DEA considered, and was about to deny, CHADD’s petition when a financial connection between CHADD and Ritalin’s then manufacturer Ciba-Geigy Corp. was revealed. Id. 39-40. CHADD subsequently withdrew its petition. Id. ; see also John Merrow, Reading, Writing and Ritalin , N.Y. TIMES , Oct. 21, 1995, at 21, available at LEXIS, News Library, Nyt File (discussing the financial connection between CHADD and Ciba-Geigy Corp. and CHADD’s petition to decontrol Ritalin).

[56] 21 U.S.C.S. § 812(b)(2). The CSA provides for five schedules of controlled substances: Schedules I through V. § 812. Schedule I drugs have no accepted medical use in the United States and a high potential for abuse. § 812(b)(1). Drugs in Schedules II through V have an accepted medical use and a descending potential for abuse. § 812(b)(2)-(5). In making the decision to schedule a drug, DEA relies on a scientific and medical evaluation provided by FDA. § 811(b). The factors FDA must consider include: scientific evidence of the drug’s pharmacological effect, the state of current scientific knowledge regarding the drug, the risk, if any, to public health, its psychic or physiological dependence liability, and any medical or scientific considerations involved in the drug’s actual or relative potential for abuse, its history and current pattern of abuse, as well as the scope, duration and significance of abuse. § 811(b)-(c). FDA’s recommendations to DEA regarding scientific and medical matters are binding. § 811(b).

[57] 21 U.S.C.S. § 822(a).

[58] 21 U.S.C.S. § 802(10).

[59] 423 U.S. 122 (1975).

[60] Id. at 135 (citations omitted).

[61] 21 U.S.C.S. § 829(a).

[62] 21 U.S.C.S. § 827.

[63] David E. Joranson, Guiding Principles of International and Federal Laws Pertaining to Medical Use and Diversion of Controlled Substances , (1993) at http://www.medsch.wisc.edu/painpolicy/publicat/93nida.htm . Joranson provides a useful and concise overview of laws relating to controlled substances including the CSA.

[64] 21 U.S.C.S. § 826.

[65] 21 U.S.C.S. § 826(a).

[66] 21 U.S.C.S. §§ 841-864.

[67] Bret Robinson, Letters to the Editor, Ritalin -- Drug Helps Son Think, Make Good Grades, Control Behavior , SEATTLE TIMES , Mar. 11, 2000, at A13, available at LEXIS, News Library, Seattm File.

[68] Kate Zernike & Melody Petersen, Schools’ Backing of Behavior Drugs Comes Under Fire , N.Y. TIMES, Aug. 19, 2001, at 1, available at LEXIS, News Library, Nyt File. These statistics follow a brief discussion of overprescription. Thus, the adjacent placement of the statistics makes it appear as if the authors are implying, or at least raising the possibility of, overprescription based on the magnitude of the figures. See also 227(9) JAMA 1029, 1029 (1974) (mentioning a similar tendency to extrapolate overprescription of antibiotics from the mere volume of prescriptions).

[69] The literature does not actually refer to “patient-centered” or “physician-centered” models of overprescription. These terms are simply a useful method for organizing the analysis.

[70] The factor increase in production = 2003 Quota/1990 Quota. See James M. Swanson et al., Correspondence, More Frequent Diagnosis of Attention-Deficit-Hyperactivity Disorder , 333(14) NEW ENG. J. MED. 944, 944 (1995) (using this method to analyze production quota data). The production quota figures were obtained from the Federal Register. Quotas for Controlled Substances in Schedules I and II, 55 Fed. Reg. 33,182 (Aug. 14, 1990) (1990 methylphenidate quota 1,768 kg; amphetamine quota 417 kg); Controlled Substances: Final Revised Aggregate Production Quotas for 2003, 68 Fed. Reg. 56,322 (Sept. 30, 2003) (2003 methylphenidate quota 23,726 kg; amphetamine quota 10,987 kg).

[71] See supra note 36.

[72] AMA Council Report, supra note 9, at 1104.

[73] Daniel J. Safer et al., Increased Methylphenidate Usage for Attention Deficit Disorder in the 1990s , 98(6) PEDIATRICS 1084, 1085 (1996).

[74] Jerry L. Rushton & Timothy J. Whitmire, Pediatric Stimulant and Selective Serotonin Reuptake Inhibitor Prescription Trends: 1992 to 1998 , 155(5) ARCH. OF PEDIATRICS & ADOLES. MED. 560, 562 (2001).

[75] Julie Magno Zito et al., Trends in the Prescribing of Psychotropic Medications to Preschoolers , 283(8) JAMA 1025 , 1026-27 (2000). This finding was the impetus for a White House initiative, announced in March 2000 and spearheaded by Hilary Rodham Clinton, to investigate the use of psychotropic medications in preschool children. Robert Pear, White House Seeks to Curb Pills Used to Calm the Young , N.Y. TIMES , Mar. 20, 2000, at A1, available at LEXIS, News Library, Nyt File.

[76] PHYSICIAN’S DESK REFERENCE 2,297 (58th ed. 2004) [hereinafter PDR].

[77] Id. at 3,143.

[78] Woodworth, supra note 40. This conclusion is based on examining data from DEA’s Automation of Reports and Consolidated Orders System (“ARCOS”).

[79] Robert C. Morrow et al., Research Letter, Methylphenidate in the United States, 1990 Through 1995 , 88(7) AM. J. PUB. HEALTH 1121, 1121 (1998).

[80] See Consensus Statement, supra note 24. It has been argued, however, that the geographic variations in distribution of stimulant drugs suggest that ADHD is not solely a neurological phenomenon. See, e.g., Lawrence H. Diller, Correspondence, 340(22) NEW ENG. J. MED. 1766, 1766 (1999) (“The wide variation may be accounted for by social, cultural, and economic influences, which include the readiness to accept a biologic explanation and medical intervention for behavioral problems, fears of educational failure, access to medical systems, and parenting styles.”); but see Alan J. Zametkin & Monique Ernst, Correspondence, 340(22) 1767, 1767 (1999) (“[T]he logic [Dr.] Diller uses to make his point is not valid. He implies that parenting style and fears of lack of achievement by children motivate parents to medicate a social and cultural problem. The immense literature on the genetics of the disorder, the sequelae, and 50 years of biologically based research argue against Dr. Diller’s interpretation.”).

[81] Researchers in Tennessee used similar logic when evaluating the high per capita consumption of several controlled substances within that state: “In the absence of any data suggesting that Tennesseans are more needful than persons in other states, such drugs are likely being overprescribed.” Anderson Spickard, Jr. et al., Prescribing Controlled Substances in Tennessee: Progress, Not Perfection , 92(1) S. MED. J. 51, 51 (1999) available at http://www.sma.org/smj1999/jansmj99/spickard.pdf.

[82] AMA Council Report, supra note 9, at 1105.

[83] Esther H. Wender, Editorial, Attention-Deficit/Hyperactivity Disorder: Is It Common? Is It Overtreated? , 156(3) ARCH. PED. & ADOLES. MED. 209, 209 (2002) (“The question of overtreatment is closely related to prevalence because treatment rates in a population should not exceed the expected prevalence of the disorder.”).

[84] Diller, supra note 15, at 70-72.

[85] See, e.g., American Academy of Pediatrics, Clinical Practice Guideline: Diagnosis and Evaluation of the Child With Attention-Deficit/Hyperactivity Disorder , 105(5) PEDIATRICS 1158, 1159 (2000) [hereinafter AAP Evaluation Guidelines] (pointing to research suggesting the prevalence in school age children is approximately 8.0%-10.0% and that an estimated 9.2% of males and 2.9% of females may have ADHD); AMERICAN PSYCHIATRIC ASSOCIATION , DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS , FOURTH EDITION, TEXT REVISION 90 (4th ed. Text Revision 2000) (estimating the prevalence in school-age children to be between 3.0%-7.0%); William J. Barbaresi et al., How Common is Attention-Deficit/Hyperactivity Disorder? Incidence in a Population-Based Birth Cohort in Rochester, Minn , 156(3) ARCH. PEDIATRICS & ADOLES. MED . 217, 218 (2002) (reviewing medical and school records, and using the study’s most stringent criteria -- i.e. records included both a clinical diagnosis of ADHD and at least one form of supporting documentation -- the cumulative incidence for a Minnesota birth cohort by 19-years of age was 7.5%; as the stringency of the criteria for identifying ADHD decreased the cumulative incidence increased to a high of 16.0%); PATRICIA N. PASTOR & CYNTHIA A. RUEBEN, NATIONAL CENTER FOR HEALTH STATISTICS, CENTERS FOR DISEASE CONTROL, ATTENTION DEFICIT DISORDER AND LEARNING DISABILITY: UNITED STATES, 1997-98 3 (2002) (finding nearly 7.0% of parents with children 6 to 11-years old reported ever being told that their child had ADD; boys were more likely to have received a diagnosis); Zametkin & Ernst, supra note 6, at 40 (noting that ADHD affects approximately 4.0% of all children, but that estimates vary considerably, from 3.0%-11.0% or higher).

[86] Safer & Malever, supra note 39.

[87] Id. at 534.

[88] Id.

[89] See LeFever et al., supra note 38, at 1361.

[90] Id.

[91] See Rushton & Whitmire, supra note 73, at 562-63.

[92] See supra note 85.

[93] Both LeFever et al., supra note 38, at 1363, and Rushton & Whitmire, supra note 74, at 563, make this observation. Nonetheless, Professor Rachel Klein of New York University’s Child Study Center has argued that such findings should be accorded limited weight because many children with ADHD go untreated. Rachael Klein, Are We Overdiagnosing ADHD in our Kids? at http://www.aboutourkids.org/aboutour/articles/overdiagnose.html. This argument, however, merely demonstrates that more than one problem exists with the evaluation of ADHD and prescription of stimulant drugs. Individuals are no less over-treated with stimulant drugs simply because others are under-treated.

[94] Barbaresi et al., supra note 85, at 218-19.

[95] Id.

[96] Id. at 219. The investigators present disaggregated results, i.e. the percentage of subjects prescribed stimulant medication alone is presented, as is the percentage receiving stimulant medication in combination with another drug. The figures cited here simply combine these results.

[97] See Diller, supra note 15, at 72. Those with Probable ADHD, for example, had in their records either a clinical diagnosis without any supporting documentation or no clinical diagnosis and both forms of supporting documentation. Barbaresi et al., supra note 85, at 219. That a subject had a “Clinical Diagnosis” of ADHD appears simply to mean that “ADHD” or “ADD” or some relative thereof, was included in the subject’s records. Id. at 218.

[98] Klein, supra note 93.

[99] See generally William L. Christopher, Off-Label Drug Prescription: Filling the Regulatory Vacuum , 48 FOOD & DRUG L. J. 247 (describing the contours of off-label use). In a decision involving methylphenidate production quotas, DEA’s Administrator appears to explicitly acknowledge that physicians may prescribe controlled substances off-label without restriction. See Ciba-Geigy Corp. and MD Pharmaceutical, Inc., 53 Fed. Reg. 50,591, (pinpoint cite unavailable) (Dec. 16, 1988) (“Methylphenidate...is approved by FDA for the treatment of [ADD] and narcolepsy. FDA does not, however, ‘regulate the practice of medicine.’ Physicians can and do legally and appropriately prescribe a drug for conditions other than those for which it is approved by FDA.”); compare Lars Noah, Challenges in the Federal Regulation of Pain Management Technologies , 31 J. L. MED. & ETHICS 55, 61 (2003). Noah infers from the oversight DEA exercises over physicians, via the registration requirement for example, that physicians’ authority to prescribe controlled substances off-label may be curtailed.

[100] See Christopher, supra note 99, at 248. Christopher identifies as off-label use prescription for a condition not listed on the drug’s label.

[101] See id . at 248-49 (pointing to, for example, effective treatment of cancer patients and “serendipitous drug discovery” as benefits of off-label prescription).

[102] Eileen M. O’Connor, Medicating ADHD: Too much? Too soon?, 11(32) MONITOR ON PSYCHOLOGY (2001) at http://www.apa.org/monitor/dec01/medicating.html ; see, e.g. , Diller, supra note 15, at 337 (“In my role as a doctor, my mandate and instinct are to help individual patients and their families as best as I can. In my practice, that very often means prescribing Ritalin....”).

[103] While this rationale appears facially unimpeachable, careful consideration reveals an interesting question. Patients whose symptoms do not rise to the level of ADHD are non-disordered individuals. It is worth considering whether, philosophically, off-label rationales should apply when treatment has been extended beyond a clinical population to a so-called normal population. Klein may be alluding to this point when she states: “The issue then becomes whether it is justified to use stimulants in children other than in those with frank ADHD .” Klein, supra note 93 (emphasis added). However, this statement is followed by Klein’s comment: “There is no clear answer to this question since there have been no systematic studies.” Id. As philosophical quandaries are not typically amenable to systematic study, it is unclear exactly what Klein means by “justified.” See generally Diller, supra note 15, at 312-41 (providing a fascinating analysis of the philosophical issues raised by stimulant drugs; indeed, a meta-theme of Running on Ritalin is whether treatment of patients without clear ADHD is philosophically justified).

[104] “Overprescription” as used in this paper is distinct from prescribing that violates the CSA. A registered physician is authorized to prescribe controlled substances to the extent authorized by their registration and in conformity with the provisions of the CSA. 21 U.S.C.S. § 822(b). To be a valid exercise of their prescription authorization, a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a) (2004). A physician that knowingly or intentionally issues a prescription other than in such circumstances violates the CSA. 21 U.S.C.S. 841(a); 21 C.F.R. § 1306.04(a). The facts of cases in which physicians violate the CSA are clearly distinct from overprescription. See, e.g., United States v. Varma, 691 F.2d 460 (10th Cir. 1982) (upholding a physician’s conviction under the CSA where the patient told the doctor he wanted Ritalin so he could stay awake while gambling in Las Vegas and, while the doctor refused to prescribe Ritalin for this purpose, he did agree to prescribe the drug so the patient could stay awake while driving to Las Vegas; a number of other factors, including an entirely superficial evaluation, supported sustaining the physician’s conviction); see also David Kessler, Regulating the Prescribing of Human Drugs For Nonapproved Uses Under the Food, Drug, and Cosmetic Act , 15(4) HARV. J. ON LEGIS. 693, 697 (“Short of...extreme conduct it is unlikely that the well-intentioned physician who prescribes improperly would ever be prosecuted under the [CSA].”); Spickard et al., supra note 81, at 51 (distinguishing “criminally motivated” misprescribing from “non-criminally motivated” misprescribing).

[105] Jensen et al., Are Stimulants Overprescribed? Treatment of ADHD in Four U.S. Communities , 38(7) J. AM. ACAD. CHILD ADOLES. PSYCHIATRY 797, 798 (1999). The title of one chapter in Running on Ritalin , is “Attention Deficit Disorder: In the Eye of the Beholder;” under the title Dr. Diller quotes Supreme Court Justice Stewart’s oft cited observation regarding pornography: “I know it when I see it.” Diller, supra note 15, at 47. The fundamental tenet of the physician-centered model of overprescription is that this type of reasoning alone should not supplant thorough evaluation of the patient.

[106] Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. 6,062 (Feb. 6, 2003) (codified at 21 C.F.R. pt. 201).

[107] Id. at 6,063 (emphasis added).

[108] Id. at 6,068; see also Kessler, supra note 104, at 701-03. Also supporting a physician-centered model of overprescription, Kessler discusses a 1968 Department of Health, Education, and Welfare Task Force on Prescription Drug report that enumerated a number of types of improper prescription; each type of improper prescription focused on the conduct of the physician, for example “use of drugs with an inherent hazard not justified by the seriousness of the illness.” Id. at 701.

[109] The precise contours of this query must be distinguished from another deceptively similar inquiry. That is, the query assumes that inappropriate prescription of stimulant drugs yields only incidental benefit to the patient. Incidental benefit is distinct from effective treatment of a patient’s underlying condition. It would be different, and perhaps much more difficult, to argue that inappropriate prescription also constitutes overprescription if, despite inappropriate prescription, the treatment the patient received via a stimulant drug was equally as effective as any treatment the patient would have received had the physician reasonably evaluated the patient. See Benzodiazepines: Use, Overuse, Misuse, Abuse? 1 LANCET 1101, 1102 (1973) (appearing implicitly to make a version of this more difficult argument, in a different context, by stating: “The possibility that benzodiazepines are as effective as other drugs (and probably safer than most) for many mood states in medical practice does not mean that their extent of use is appropriate.”) (emphasis added). Importantly, given the variety of conditions that ADHD symptoms may mimic, see infra note 119, conditions that probably can be more effectively treated via regimes other than stimulant drugs, it is likely that patients who are inappropriately prescribed stimulant drugs experience incidental symptomatic relief rather than effective treatment.

[110] See supra text accompanying note 102.

[111] See Diller, supra note 15, at 73-74 (“Perhaps the most significant observation to make is that all the behaviors that have been embraced by the ADD diagnosis...respond to some extent to stimulants. Furthermore, we know that such response is not restricted to children diagnosed with ADD; [stimulant drugs act] on ‘normals’ as well.”).

[112] Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. at 6,062 (emphasis added). The point is, that in the case of drugs for which incidental patient benefit does not routinely occur in the face of inappropriate prescription, there likely is no particular reason to ponder whether, from a policy perspective, drugs should always be deemed overprescribed to the extent inappropriately prescribed. Although distinctions may well exist in the antibiotic context between inappropriate prescription and overprescription, the line would not appear to be drawn on the basis of routine incidental patient benefit. For example, the choice of language in a discussion by the American Medical Association’s Department of Drugs during the 1970s regarding misuse of antibiotics suggests that the two terms represent distinct concepts: “[I]t is true...that there appears to be ‘an inappropriate use of antibiotics and a massive overuse’....” Response to Commentary, 227(9) JAMA 1029, 1029 (1974) (emphasis added). If the two terms were viewed as coextensive, then the use of both would be superfluous. Of note, routine, incidental patient benefit is not discussed. See id. 1029-30; see also 68 Fed. Reg. at 6,067-68 (debating the contours of “inappropriate use” of antibiotics).

[113] Jensen et al., supra note 105.

[114] Id. at 800-01. This finding may have been accounted for by the fact that the children were evaluated for ADHD symptoms by lay interviewers after they already were taking medication. Id. at 802. As the finding is being cited for its conceptual relevance rather than its empirical validity, however, unraveling why the children did not meet the criteria for ADHD at the time of the evaluation is of little importance.

[115] Id. at 797, 802.

[116] Id. at 803 (emphasis added); see also Kessler, supra note 104, at 702-03. Kessler provides examples of drugs that are frequently improperly prescribed including amphetamine ; there is no mention of incidental benefit to the patient. See also Spickard et al., supra note 81, at 51-52. In their article describing efforts in Tennessee to reduce “misprescribing” of controlled substances, the authors implicitly accept that inappropriate prescription is equivalent to overprescription by exclusively focusing on the physician’s conduct.

[117] See supra text accompanying note 24.

[118] Indeed, DSM-IV includes as a differential diagnosis “Age-Appropriate Behaviors in Active Children.” APA, DSM-IV, supra note 21, at 82.

[119] See Zametkin & Ernst, supra note 6, at 42 (“Because attentional difficulties are common in most psychiatric conditions, as well as in a wide variety of diffuse brain diseases, the clinician must consider alternative diagnoses....The history taking, with use of brief screening questions, should cover depression, anxiety, substance abuse, sources of psychosocial stress, and in particular, Tourette’s disorder or chronic motor tics.”).

[120] Observing this, one psychiatrist noted, “I believe it is a mistake to take the responsibility of making a diagnosis in an area of specialty different from the one that we practice. Psychiatrists do not deliver babies, repair hernias or diagnose skin conditions. The same should apply in the case of the psychiatric diagnosis of ADHD.” Manuel Mota-Castillo, Letters to the Editor, Psychiatrists -- Not Primary Care Physicians -- Should Diagnosis ADHD, AM. MED. NEWS , Jan. 8, 2001, at http://www.ama-assn.org/amednews/2001/01/01/edlt0101.htm.

[121] One study found that in 1995, 75.4% of office visits for ADHD by those 14-years and younger were made to primary care physicians, 12.4% of the visits to psychiatrists, and 12.2% of the visits to other specialties. Deborah A. Zarin et al., Datapoints: Treatment of Attention-Deficit Hyperactivity Disorder by Different Physician Specialties , 49 PSYCHIATRIC SERVICES 171 (1998) at http://ps.psychiatryonline.org/cgi/content/full/49/2/171.

[122] AMA Council Report, supra note 9, at 1105.

[123] See generally AAP Evaluation Guidelines, supra note 85.

[124] Id.

[125] Id. at 1159.

[126] Id.

[127] AMA Council Report, supra note 9, at 1102.

[128] Id. at 1101.

[129] Id. at 1105.

[130] Zametkin & Ernst, supra note 6, at 40-42.

[131] PDR, supra note 76, at 2,297.

[132] AMA Council Report, supra note 9, at 1105.

[133] Of course, on the first page of its guidelines, AAP explicitly states, “The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.” AAP Evaluation Guidelines, supra note 85, at 1158; see also AMA Council Report, supra note 9, at 1100 (including a similar statement). Nonetheless, such admonishments do not invalidate considering the extent to which physicians follow the core procedures as a measure of stimulant overprescription. That a physician retains the freedom to exercise their clinical judgment in a particular case does not preclude considering the extent to which physicians in general fail to implement the core evaluation procedures as a measure of overprescription. Essentially, the exceptional patient does not swallow up the general rule that in most cases the core procedures should be followed.

[134] Gurney Williams III, Hyperactive Hype? , PARENTING , Sept. 2000, at 120, available at LEXIS, News Library, Mags File.

[135] AMA Council Report, supra note 9, at 1105 (emphasis added).

[136] Id. (emphasis added).

[137] Consensus Statement, supra note 24, at 10. Indeed, it is not surprising that primary care physicians may be less likely to recognize comorbid disorders because they are not extensively trained in such disorders. See Mota-Castillo,supra note 120.

[138] Eugenia Chan et al., Variations in Treatment Practices For Attention Deficit Hyperactivity Disorder: A National Survey of Primary Care Physicians , PEDIATRIC ACAD. SOCIETIES ABSTRACT (2002) at http://www.aap.org/research/abstracts/02abstract14.htm. Only the abstract for this study could be located. It is unclear whether an expanded description of the study is published elsewhere.

[139] Id.

[140] Id. Further, only 84.0% (N=905) of the surveys returned met “data quality criteria.” Id.

[141] The Abstract did not discuss Chan et al.’s analysis of their results. As such, it is unclear whether the researchers discussed this methodological issue elsewhere.

[142] Einar S. Perman, Speed in Sweden , 283(14) NEW ENG. J. MED. 760, 760 (1970).

[143] Id.

[144] See CEWG Report, supra note 49, at 92.

[145] This argument is more specific than merely arguing that increased availability of a controlled substance, in general, contributes to diversion and abuse. See, e.g., GOVERNMENT ACCOUNTING OFFICE, GAO-04-110, PRESCRIPTION DRUGS: OXYCONTIN ABUSE AND DIVERSION AND EFFORTS TO ADDRESS THE PROBLEM (2003) 5 [hereinafter GAO OxyContin Report] (struggling to thoroughly embrace such a general argument: “The rapid growth in OxyContin sales, which increased the drug’s availability in the marketplace, may have made it easier for abusers to obtain the drug for illicit purposes....However, we could not assess the relationship between the increased availability of OxyContin and locations where it is being abused and diverted because the data on abuse and diversion are not reliable, comprehensive, or timely.”). The key to the instant argument is that the mechanism through which valid stimulant drug prescriptions are being diverted and abused is clear: legitimate patients with prescriptions. By comparison, with other prescription drugs such as OxyContin, where patient diversion may not typically act as such a facilitating mechanism, it may be harder to accept that increased availability substantially contributes to abuse and diversion.

[146] See, e.g., Zito et al., supra note 75, at 1027 (finding that between 1991 and 1995 the prevalence of methylphenidate prescriptions among 15 to 19-year olds in the study population increased by 311%); see also Jayne Suhler, Ritalin Called Prescription for Trouble on Campus , DALLAS MORN. NEWS , Apr. 18, 1999, at 1A, available at LEXIS, News Library, Dalnws File (noting the head of psychiatry at the University of Wisconsin’s Health Services observation that “students who grew up on Ritalin go to college bearing their own prescriptions and sell pills to friends for a few dollars....”).

[147] Johnny Diaz, Ritalin Becoming Recreational Drug of Choice for College Kids , MIAMI HERALD , Oct. 23, 2001, available at LEXIS, News Library, Allnws File.

[148] Id.

[149] Id.

[150] Saleet Wolf, Adderall Pervades University , CHICAGO MAROON , Nov. 3, 2003, at http://maroon.uchicago.edu/news/articles/2003/11/03/adderall_pervades_un.php.

[151] Id.

[152] Amy Reinink, Colleges Eye Ways to Curb Ritalin Abuse , DENVER POST , Dec. 13, 2001, at A29, available at LEXIS, News Library, Dpost File.

[153] Molly Nicholson, Some Duke Students Abuse Ritalin to Study , UNIVERSITY WIRE, THE CHRONICLE , Sept. 18, 2002, available at LEXIS, News Library, Allnws File.

[154] Id.

[155] Julia Lifschultz, Recreational Use of Prescription Drugs Widespread at Tufts U , UNIVERSITY WIRE, TUFTS DAILY , Oct. 20, 2003, available at LEXIS, News Library, Allnws File.

[156] Diane Struzzi, Teens Learn Dangers of Ritalin Use, ROANOKE TIMES & WORLD NEWS , Apr. 24, 1995, at C1, available at LEXIS, News Library, Roanok File.

[157] Martha Irvine, Kids With Attention Disorder Pressed to Sell Their Drugs , SEATTLE TIMES , Nov. 19, 2001, at A6, available at LEXIS, News Library, Seattm File.

[158] Id.

[159] Suhler, supra note 146.

[160] Id.

[161] Nell Blewett, Ritalin Available, Abused at College , DALLAS MORN. NEWS , May 4, 1999, at 21A, available at LEXIS, News Library, Dalnws File.

[162] Id.

[163] Stimulant drugs also may be stolen from individuals with legitimate prescriptions. For example, a Central Connecticut State University student was arrested on charges of stealing Ritalin from his roommate and selling it on campus; he also, reportedly, was observed abusing the stolen medication. Court News , HARTFORD COURANT , May 18, 2000, at B2, available at LEXIS, News Library, Htcour File. A doctor at the University of Miami, reported that one of his patients hides his Ritalin prescription at night out of fear that other students may steal the pills. Diaz, supra note 147. Likewise, a college student reported that her brother, a Vanderbilt University student, was forced to hide his Adderall in his sock drawer because other students were stealing the prescription from his room. Nicholson, supra note 153.

[164] Oksana Boyko, Prescription Drugs Abused , KAN. ST. COLLEGIAN , Nov. 12, 2003,at http://www.spub.ksu.edu/stories/111203/new_drugs.shtml .

[165] Allison Cho, Making the Grade, BERKLEY MED. J. ISSUES (Fall 2000)at http://www.ocf.berkeley.edu/~issues/fall00/Allison.html .

[166] Wolf, supra note 150.

[167] ABC News, Wonder Drugs Misused , Feb. 25 (appears to be a 2003 posting)at http://abcnews.go.com/sections/GMA/Living/GMA030225Ritalin_abuse.html .

[168] Chrissy Braden, Active Abuse , TCU DAILY SKIFF , Apr. 6, 2001, at http://www.skiff.tcu.edu/SkiffWeb040601/active.html .

[169] Id.

[170] Nicholson, supra note 153.

[171] Lifschultz, supra note 155.

[172] See Nicholson, supra note 153.

[173] See Wolf, supra note 150.

[174] Cara Nissman, Your S.T.U.F.F. , BOSTON HERALD , Oct. 27, 2003, at 030, available at LEXIS, News Library, Bherld File.

[175] Wolf, supra note 150.

[176] OFFICE OF APPLIED STATISTICS, SAMHSA, 2002 NATIONAL SURVEY ON DRUG USE AND HEALTH [hereinafter SAMHSA Survey], at http://www.oas.samhsa.gov/nhsda.htm#NHSDAinfo. The information cited is drawn fromResults, Section 5. Trends in Lifetime Prevalence of Substance Use .

[177] Id.

[178] Id.

[179] DIVERSION CONTROL PROGRAM, DRUG ENFORCEMENT ADMINISTRATION, STIMULANT ABUSE BY SCHOOL AGE CHILDREN: A GUIDE FOR SCHOOL OFFICIALS , [hereinafter DEA School Guide] at http://www.deadiversion.usdoj.gov/pubs/brochures/stimulant/stimulant_abuse.htm.

[180] Cho, supra note 165.

[181] Id.

[182] See SAMHSA Survey, supra note 176 (identifying possible sources of bias in the introduction to Results, Section 5. Trends in Lifetime Prevalence of Substance Use ).

[183] Mark J. Skarzynski, Teen Drug Surveys Unreliable , HARTFORD COURANT , Sept. 29, 2000, at A14, available at LEXIS, News Library, Htcour File. The other part of the problem this correspondent identified was over-reporting of drug use: “I may be 24 years old, but, not too long ago, I was the wise guy in middle school and high school who received those surveys and put down that I used crack twice a day, heroin once a week, PCP once an hour and so on. I was lying because I thought it was funny. I had never seen these drugs or known anyone who had used them. I had many friends who would also laugh about lying on the surveys.” Id.

[184] Reports to poison centers are also sometimes considered as a measure of drug abuse. See, e.g., Wendy Klein-Schwartz & Jean McGrath, Poison Centers’ Experience with Methylphenidate Abuse in Pre-Teens and Adolescents , 42(3) J. AM. ACAD. CHILD & ADOLES. PSYCHITARY 288 (2003). This study evaluated data collected by the American Association of Poison Control Centers Toxic Exposure Surveillance System between 1993 and 1999 and found that 11,149 methylphenidate exposures were reported for those 10 through 19-years of age; 11.2% of the exposures involved intentional abuse. Id. at 290; see also CEWG Report, supra note 49, at 92 (reporting the number of stimulant drug poison center reports for a few locations).

[185] SAMHSA, HIGHLIGHTS FROM DAWN: SEATTLE, 2002, THE DAWN REPORT (2004), at http://dawninfo.samhsa.gov/pubs_94_02/shortreports/metro/files/Seattle_ADA.pdf.

[186] Id.

[187] AMA Council Report, supra note 9, at 1104.

[188] Klein-Schwartz & McGrath, supra note 184, at 291.

[189] Although, as one physician noted, it is difficult for those abusing the drug as a “test-taking strategy” to know the correct dose, the consequences of guessing wrong this physician listed were mild: headache, stomachache, or becoming overfocused or too vigilant. Julie Deardorff, Revving Up The Brain , CHI. TRIB. , Mar. 7, 2004, at Q1, available at LEXIS, News Library, Chtrib File.

[190] See Struzzi, supra note 156.

[191] Bob Ross, Ritalin Found in Body of Teen, TIMES-PICAYUNE (NEW ORLEANS, LA) , Mar. 30, 1995, at B1, available at LEXIS, News Library, Notpic File.

[192] Id.

[193] See Lifschultz, supra note 155.

[194] Id.

[195] 21 U.S.C.S. § 812(b)(2)(c). Psychological addiction and physical dependence, as the terms suggest, are not the same. See Michelle Meadows, Prescription Drug Use and Abuse , 35(5) FDA CONSUMER 19, 20, 22 (2001); see also infra text accompanying note 203 (describing a model of psychological addiction). This section’s discussion is mainly concerned with psychological addiction, but does not draw the distinctions between addiction and dependence that would be necessary in a more in-depth analysis.

[196] AMA Council Report, supra note 9, at 1104; see also Nissman, supra note 174 (“[A leading physician] said long-term abuse remains fairly rare. ‘Misuse is often taking a pill a single time just to try it’....”).

[197] Blewett, supra note 161.

[198] Lifschultz, supra note 155.

[199] Cho, supra note 165.

[200] Id.

[201] See Zametkin & Ernst, supra note 6, at 44 (“Parents of school-age and teenage children must be reassured that, when used orally and in commonly prescribed dosages, stimulants do not lead to drug abuse or dependence.”); Diller, supra note 15, at 264 (“In the typical dosage range...Ritalin does not produce either tolerance or addiction.”).

[202] Nissman, supra note 174; see also supra text accompanying note 166.

[203] Howard J. Shaffer, What is Addiction? A Perspective , at http://www.hms.harvard.edu/doa/html/whatisaddiction.htm.

[204] Peter Maller & Lauria Lynch-German, Ritalin High Attracts Adults in Wisconsin , MILWAUKEE J. SENTINEL , Feb. 8, 2001, at 01A, available at LEXIS, News Library, Miljnl File.

[205] Diaz, supra note 147.

[206] Although evidence suggests that some students on college campuses are stealing stimulant drugs from their peers, it is unclear whether the individuals that do so are personally abusing the drugs, and therefore the theft may be a signal of addiction or, instead, stealing prescriptions to sell to others. See supra note 163.

[207] See DEA School Guide, supra note 179 (introductory remarks by Laura M. Nagel, Deputy Assistant Administrator, Office of Diversion Control).

[208] Patient diversion and third-party possession of prescription stimulants are illegal under the federal CSA. 21 U.S.C.S. § 841(a)(1): “Except as authorized by this title it is unlawful for any person knowingly or intentionally...to distribute...a controlled substance....” (emphasis added); 21 U.S.C.S. § 844 (prohibiting possession). Diversion and possession also likely violate state law. See, e.g., MASS. GEN. LAWS ch. 94C, § 32A (MB 2004) (prohibiting distribution); MASS. GEN. LAWS ch. 94C, § 34 (MB 2004) (prohibiting possession).

[209] See Reinink, supra note 152 (“[C]olorado State University...would like to start a prevention program, but an absence of police records makes it a thorny task. Students are using unprescribed Ritalin said [a psychiatrist at the school] but they’re not getting caught.”).

[210] This is not to say that educational efforts should not be attempted. See, e.g., Diaz, supra note 147 (referencing an educational campaign at the University of Miami in which school officials, around the time of final exams, “posted fliers and posters around the...campus warning students of the negative effects of using unprescribed Ritalin as a late-night study aid[;]” the precise content of these flyers is not discussed).

[211] 21 U.S.C.S. § 826.

[212] Even if DEA and FDA did have the authority to take these problems into account when setting the quotas, doing so would raise serious policy concerns. See Noah, supra note 99, at 63 (rejecting the idea that reduction of production quotas is a wise way to deal with diversion and abuse of pain relievers such as OxyContin: “[Responses such as reducing quotas] to widespread misuse may undermine recent efforts to provide patients with better pain management. It makes little sense to protect irresponsible physicians and illegitimate users from their own bad judgment if it means sacrificing the welfare of those in genuine need.”). Moreover, any effort to reduce stimulant drug quotas would surely face strong opposition from the medical community. See American Medical Association, Policy H-100.975 Schedule II Drug Supply (“The AMA will...(2) work with the DEA and FDA to improve the process involved in determining the manufacturers’ quotas of Schedule II drugs so that adequate supplies of such drugs are maintained in order not to compromise patient care.”).

[213] 42 U.S.C.S. § 242(a) (MB 2004). Interestingly, unlike FDA’s binding recommendation to DEA regarding scheduling decisions, see supra note 56, FDA’s determination of the necessary amount of Schedule II substances is only a discretionary recommendation. § 242(a).

[214] See supra note 56.

[215] CENTER FOR DRUG EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION, MANUAL OF POLICIES AND PROCEDURES 4200.2, FORECASTING SCHEDULE I AND II SUBSTANCE AND DRUG NEEDS 3 (2003) ; see also Western Fher Laboratories v. Levi , 529 F.2d 325, 328-29 (1st Cir. 1976) (using sales data to estimate medical need).

[216] Although this task obviously would be difficult to accomplish, indeed its recalcitrant nature is a major theme of this paper, an estimate could be made. Using the physician-centered model, FDA could review the available information regarding the extent to which physicians are making uninformed treatment decisions and arrive at an estimate of overprescription. If FDA did have the authority to take overprescription into account when estimating medical need, a considerably more extensive body of research regarding physician prescribing practices would almost certainly exist.

[217] See United States v. Evers, 643 F.2d 1043, 1048 (5th Cir. 1981)(“‘Throughout the debate leading to the enactment [of the FDCA], there were repeated statements that Congress did not intend the [FDA] to interfere with medical practice and references to the understanding that bill did not purport to regulate the practice of medicine as between the physician and the patient. Congress recognized a patient’s right to seek civil damages in the courts if there should be evidence of malpractice, and declined to provide any legislative restrictions upon the medical profession.’” (quoting FDA policy expressed in 37 Fed. Reg. 16,503 (1972)); see also Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. at 6,071 (also quoting and discussing 37 Fed. Reg. 16,503).

[218] 21 U.S.C.S. § 802(38).

[219] 21 U.S.C.S. § 802(27).

[220] Joranson, supra note 63.

[221] 529 F.2d at 330 (emphasis added).

[222] See Ciba-Geigy Corp. and MD Pharmaceutical, Inc., 53 Fed. Reg. at 50,591 (pinpoint cite unavailable) (“The CSA requirement for a determination of legitimate medical need is based on the undisputed proposition that patients and pharmacies should be able to obtain sufficient quantities of methylphenidate...to fill prescriptions. A therapeutic drug should be available to patients when they need it.”).

[223] Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. 6,062, 6,062.

[224] Id . at 6,071.

[225] Id. at 6,063.

[226] Id.

[227] In his article regarding federal regulation of pain management technologies, Noah points to the proposed, at that time, antibiotic labeling regulation as an example of how “public health agencies have responded [to overprescription of antibiotics] by pleading with physicians to exercise restraint in prescribing....” Noah, supra note 99, at 63, n.169.

[228] The labeling for Adderall already contains a black-box warning directly under the product name stating: “Amphetamines have a high potential for abuse....[P]articular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly .” PDR, supra note 76, at 3,143 (emphasis added). The strategy discussed in this section, however, questions whether FDA has the authority to promulgate a regulation requiring all stimulant drugs to include similar information on their labels.

[229] See supra text accompanying note 131.

[230] For example, the Ritalin warning states: “Ritalin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior....” PDR, supra note 76, at 2,297-98.

[231] See supra note 228.

[232] The actual explanation FDA gives in response to comments that the regulation exceeds it labeling authority is quite muddled. Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, 68 Fed. Reg. at 6,071. After disavowing any attempt to regulate the practice of medicine, FDA states that it is “appropriate to include in labeling information necessary for the safe and effective use of the drug, including information about the context of product use.” Id . FDA then analogizes to the labeling of anesthetic agents which often, presumably voluntarily, includes similar context of use information. Id. The authoritative force of voluntary labeling for a mandatory regulation is obviously weak.

[233] 21 U.S.C.S. § 355(b)(1)(A) (MB 2004).

[234] Id. at 6,073.

[235] Indeed, FDA may only promulgate regulations pursuant to 21 U.S.C. 371(a) that “‘effectuate a congressional objective expressed elsewhere in the [FDCA].’” Ass’n of Am., Physicians and Surgeons v. FDA, 226 F. Supp.2d 204, 213 (D.D.C. 2002) (quoting Pharm. Mfrs. Ass’n v. FDA, 484 F. Supp. 1179, 1183 (D. Del. 1980)).

[236] A persuasive argument can be made that 21 U.S.C. 352(f), requiring that all labeling bears adequate directions for use, implicitly authorizes the antibiotic regulation. Once an antibiotic-resistant bacteria strain develops for a particular drug, the labeling for that drug would no longer contain information for safe and effective use; the drug, in effect, would be misbranded. 21 U.S.C.S. § 352(f). Since FDA has the power to stop misbranding once it occurs, it is eminently sensible to empower FDA to stop inevitable misbranding before it occurs by requiring context of product use information.

[237] See supra note 104.

[238] In March, 2004, the Bush Administration unveiled a strategy to attack prescription drug abuse. See DRUG ENFORCEMENT ADMINISTRATION, REDUCING PRESCRIPTION DRUG ABUSE at http://www.whitehousedrugpolicy.gov/news/press04/prescrip_fs.pdf (summarizing highlights of the plan). Pursuant to the new initiative “FDA will work to ensure that product labeling clearly articulates conditions for the safe and effective use of controlled substances....Specific examples include identifying patients for whom these products are appropriate and that recommends a ‘stepped care’ approach to the treatment of chronic pain....” Id . Of note, the labeling examples offered focus solely on patients. This is so despite the existence of a clear public health problem with respect to non-patients abusing pain medications. See GAO OxyContin Report, supra note 145, at 10. Thus, the labeling examples’ exclusive focus on patients may further support that FDA does not have the authority to promulgate a labeling regulation for an entire class of controlled substances to protect the health of third-parties.

[239] See Ass’n of Am., Physicians and Surgeons, 226 F. Supp. at 213 (noting that FDA’s power to promulgate regulations pursuant to 21 U.S.C. 371(a) “does not constitute an independent grant of authority that permits FDA to issue any regulation the agency determines would advance the public health.”).

[240] 530 F.2d 1054 (D.C. Cir. 1976) (per curium) (McGowan J., concurring) aff’g Am. Pharm. Ass’n v. Weinberger , 377 F. Supp. 824 (D.D.C. 1974).

[241] Weinberger, 377 F. Supp. at 825.

[242] Id. at 826.

[243] Id. at 827.

[244] Id. at 828.

[245] Id. at 829.

[246] Matthews , 530 F.2d at 1055.

[247] Id. at 1056.


[249] Id. at 11 (outlining characteristics of existing PDMPs).

[250] Id. at 15.

[251] Id. at 16.

[252] Id. at 7.

[253] See Press Release, Office of National Drug Control Policy, U.S. Drug Prevention, Treatment, Enforcement Agencies, Take on “Doctor Shoppers” and “Pill Mills” (March 1, 2004) at http://www.whitehousedrugpolicy.gov/news/press04/030104.html .

[254] PDMP Report, supra note 248, at 13.

[255] Id.

[256] Id. Proactive PDMP data are also analyzed to “identify individuals...or pharmacies that have unusual use...or dispensing patterns that may suggest potential drug diversion, abuse, or doctor shopping.” Id.

[257] Id. at 9-10 (emphasis added).

[258] While Noah lists “enhanced tracking of prescriptions” via prescription monitoring programs as one option for dealing with the “overuse of narcotic analgesics” he neither identifies this operational difficulty nor elaborates upon how such a system would achieve its goal. Noah, supra note 99, at 64. Of course, it may be that overprescription of narcotic analgesics is not a systemic problem, thus making identification of physicians that overprescribe more feasible and, accordingly, the PDMP approach to reducing overprescription more logical.

[259] PDMP Report, supra note 248, at 19 (“Given a state’s particular funding availability and priorities, PDMP costs can involve a major hurdle.”).

[260] The 2004 GAO OxyContin Report demonstrates this fact: “Pain patients, teens, and recreational drug users who had abused OxyContin reportedly entered drug treatment centers sweating and vomiting from withdrawal. In West Virginia, as many as one-half of the approximately 300 patients admitted to a drug treatment clinic in 2000 were treated for OxyContin addiction....[A] newspaper’s investigation of autopsy reports...found that OxyContin had been involved in over 200 overdose deaths in Florida since 2000. In addition, a forensic toxicologist commented that he had reviewed a number of fatal overdose cases in which individuals took a large dose of OxyContin in combination with alcohol or other drugs.” See GAO OxyContin Report, supra note 145, at 10.

[261] THE AMERICAN ALLIANCE OF CANCER PAIN INITIATIVES, STATEMENT ON STATE PRESCRIPTION MONITORING PROGRAMS (2002) [hereinafter AACPI Statement] at http://www.aacpi.org/../regulatory/PMP.pdf; see also Spickard et al., supra note 81, at 53 (“Nor do we know that changes in the [DEA rankings indicating less of a controlled substance is being prescribed after implementing strategies to reduce misprescribing] are necessarily ‘good’....Prescribing fewer pain killers than appropriate is not likely to attract the attention of the [medical board] but it is misprescribing nonetheless.”).

[262] AACPI Statement, supra note 261.

[263] See generally Matthew N. Strawn, Comment, Recent Developments in Direct Consumer Advertising of Attention Disorder Stimulants and Creating Limits to Withstand Constitutional Scrutiny , 19 J. CONTEMP. HEALTH L. & POL'Y 495 (2003) (providing an overview of the recent state legislative activity and the debate regarding direct-to-consumer advertising of stimulant drugs).

[264] Janofsky, supra note 50; see also Eagle Forum, Colorado School Board Passes Resolution Warning About Ritalin , 167 EDUCATION REPORTER (1999) at http://www.eagleforum.org/educate/1999/dec99/ritalin.html#resolution

(providing the actual text of the resolution).

[265] Janofsky, supra note 50.

[266] In early summer 1999, a mere step in time after the Columbine shootings, the Citizens Commission on Human Rights, an organization affiliated with the Church of Scientology, sent Colorado state legislators, “a slick magazine....[That] raised the question about a possible link between psychiatry and school violence.” Schrader, supra note 51. The president of CCHR’s American branch testified at the informal hearings regarding the school board resolution as did Dr. Peter Breggin who shares CCHR’s belief concerning a link between school violence and psychotropic drugs. See Janofsky, supra note 50.

[267] See Janofsky, supra note 50.

[268] CONN. GEN. STAT. § 10-212( b) ( LEXISNEXIS 2003).

[269] VA. CODE ANN. § 22.1-274.3 (MB 2004).

[270] See, e.g., A.B. 2286, 2003-2004 Leg., Reg. Sess. (California); H.B. 343, 2003 Leg; 105th Reg. Sess. (Florida); H.B. 2227, 183rd Gen. Crt., 2003 Reg. Sess. (Massachusetts); H.B. 4025, 92nd Leg., 1st Reg. Sess. (Michigan); A.B. 5760, 226th Leg., Reg. Sess. (New York); H.B. 2272, 49th Leg., 2nd Sess. (Oklahoma); H.B. 1016, 187th Gen. Assem., 2003-2004 Reg. Sess. (Pennsylvania); H.B. 6023, Gen. Assem., 2003 Jan. Sess. (Rhode Island); H.B. 706, Gen. Assem., Adjourned Sess. 2003-2004 Biennum (Vermont); H.B. 2571, 58th Leg., 2004 Reg. Sess. (Washington).

[271] Zernike & Petersen, supra note 68.

[272] Oshrat Carmiel, Board Weighs Drug Policy , HARTFORD COURANT , Oct. 12, 2001, at B3, available at LEXIS, News Library, Htcour File.

[273] Convention on Psychotropic Substances, Feb. 21, 1971, 32 U.S.T. 543, Article 10 (“Each Party shall, with due regard to its constitutional provisions, prohibit the advertisement of [controlled substances in Schedules I through IV] to the general public.”); see Strawn, supra note 263, at 502; see also Zernike and Petersen, supra note 68.

[274] Zernike & Petersen, supra note 68.

[275] Id.

[276] See Strawn, supra note 263, at 506; see also Editorial, Pharmaceutical Companies Find New Ways to Reach Anxious Parents -- Go Direct , SAN FRAN. CHRON. , Dec. 29, 2003, at A14, available at LEXIS, News Library, Sfchrn File [hereinafter Go Direct Editorial].

[277] Go Direct Editorial, supra note 276; see also Zernike & Petersen, supra note 68 (“The ads evoke a sense of Rockwellian calm. Children chat happily next to a school bus. A child’s hand gently touches the hand of an adult. In one...an approving mother embraces her beaming son as the drug itself is named and promoted.”).

[278] Lawrence H. Diller, Letters to the Editor, Readers Weigh in On the Direct Marketing of ADD Drugs , SAN FRAN. CHRON. , Jan. 5, 2004, at B6, available at LEXIS, News Library, Sfchrn File.

[279] See Strawn, supra note 263, at 506-20 (describing calls for restriction and providing a constitutional analysis); see also Go Direct Editorial, supra note 276 (“The [FDA], which approves these drugs, should consider implementing additional controls on how they're marketed. The so-called ‘brief summaries’ that appear in tiny type alongside print ads must be more complete and user friendly.”); Noah, supra note 99, at 64 (noting that to deal with overuse of narcotic analgesics: “The federal government could...try to limit promotional efforts.”).

[280] Go Direct Editorial, supra note 276.

[281] 44 Liquormart, Inc. v. Rhode Island , 517 U.S. 484, 503 (1996).

[282] The Connecticut Board of Education reportedly viewed the legislation forbidding teachers from recommending psychotropic drugs as “redundant, because an outside professional would be needed to prescribe medication in any case.” Ami Albernaz, Debate on Ritalin Use Continues , 12(3) MA. PSYCHOLOGIST (2003) at http://www.masspsy.com/leading/0310_ritalin.html.

[283] Go Direct Editorial, supra note 276.

[284] 444 Pa. 263 (Pa. 1971), reh’g on damages, 444 Pa. 299 (Pa. 1971).

[285] 444 Pa. at 291-93.

[286] Id. at 284.

[287] Id .

[288] John W. Hust, Recent Case, Stevens v. Parke, Davis & Co., 507 P.2d. 653 (Cal. 1973) , 43 Cincinnati L. Rev. 224, 230-31 (1974).

[289] See supra text accompanying notes 57-58, 61.

[290] See generally Diller, supra note 15, at 332-337. Dr. Diller offers a number of recommendations and solutions to the “ADD/Ritalin Dilemma,” id. at 332; a few are similar in tenor and content to those discussed in this section.

[291] See Chan et al., supra note 138.

[292] For example, assume that 80% of physicians in region X use the DSM-IV criteria while only 20% of physicians use the criteria in region Y. Combining the data from region X and Y will show that, on average 50% of physicians use the DSM-IV criteria. Clearly, this figure inaccurately represents physician practices in both X and Y.

[293] This is surmised based on the results reported in the Pediatric Academy Societies Abstract. See Chan et al., supra note 138. As previously noted, neither the actual survey, nor a more detailed discussion of the study, could be located.

[294] AMA Council Report, supra note 9, at 1106; see also Noah, supra note 99, at 64 (suggesting that: “[E]nhanced [federal] agency efforts to educate health care professionals [may] offer the best mechanism for achieving the ideal balance between promoting appropriate use [of narcotic analgesics] in patients and discouraging excessive or otherwise inappropriate prescribing.”).

[295] While Noah does not discuss the issues involved in creating effective physician educational efforts, see supra note 294, his choice of citations implies that taking into account the barriers physicians encounter is critical. For example, Noah cites a Journal of the American Medical Association article entitled “Why Don’t Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement.” Noah, supra note 99, at n.176. The cited source is a review article of studies that examined barriers to physician adherence to guidelines in a variety of medical areas, from asthma to measles immunization. See generally Michael D. Cabana et al., 282(15) JAMA 1458 (1999).

[296] See Consensus Statement, supra note 24 (“[L]ack of insurance coverage for psychiatric or psychological evaluations...presents a major barrier to accurate classification, diagnosis and management of ADHD....Mental health benefits are carved out of many policies offered to families, and thus access to treatment other than medication might be severely limited. Parity for mental health conditions in insurance plans is essential.”); see also Cabana et al., supra note 295 (classifying barriers that may undercut physician adherence to guidelines into a number of different categories; what are referred to in this paper as macro-level obstacles, Cabana et al. would likely refer to as “environmental-related barriers,” or “external barriers” while practical problems might be placed in, among other categories, “lack of self-efficacy,” “guideline related barriers,” or “patient-related barriers” ).

[297] AAP Evaluation Guidelines, supra note 85, at 1160.

[298] Diller, supra note 15, at 61.

[299] Id. at 5.

[300] Of course, there are likely no definitive answers to physicians’ practical questions. Indeed, this appears to be Dr. Diller’s main point in discussing the pencil example. Id. at 61-62. In its guidelines, the AAP itself points out, “[T]he behavioral characteristics specified in the DSM-IV, despite efforts to standardize them, remain subjective and may be interpreted differently by different observers....These complexities in the diagnosis mean that clinicians using DSM-IV criteria must apply them in the context of their clinical judgment.” AAP Evaluation Guidelines, supra note 85, at 1163. The point of the suggested research and education is not to definitively answer practical questions -- for example, using Dr. Diller’s scenario, deciding that playing with pencils five times an hour equals “often” -- but instead to uncover the questions physicians have and, based on this information, develop education programs to help physicians better exercise their clinical judgment.

[301] Reinink, supra note 152; see also Suhler, supra note 146 (The head of psychiatry at the University of Wisconsin Health Services reports that he “writes Ritalin prescriptions for about 60 students per year, but only after a rigorous evaluation.”).

[302] Lifschultz, supra note 155.

[303] MASSACHUSETTS MEDICAL SOCIETY ONLINE, MISSION AND STRATEGIC GOALS , at http://www.massmed.org/about/mission.asp.

[304] COMMONWEALTH OF MASSACHUSETTS BOARD OF REGISTRATION IN MEDICINE ONLINE SERVICES , MISSION STATEMENT , at http://www.massmedboard.org; see also , Joranson, supra note 63 (“State licensing and disciplinary boards administer the medical practice laws and have the principal governmental responsibility to protect [the] public health from improper, incompetent, and unlawful practices.”).

[305] See AMA Council Report, supra note 9, at 1106 (making the same recommendation); see also Bonna M. De La Cruz, Legislators Not Ready to Regulated Ritalin , THE TENNESSEEAN , May 18, 2000, at 6B, available at LEXIS, News Library, Tnsean File. The executive director of Tennessee’s Select Committee on Children and Youth offered such a recommendation.

[306] In 1995, the Tennessee Board of Medical Examiners adopted such a set of prescribing guidelines for controlled substances. See Spickard, et al. supra note 81, at 52.

[307] 2003 Conn. Super. LEXIS 385 (Conn. Super. Ct. 2003).

[308] Id. at *2. The analysis in this section is not necessarily asserting that a monetary fine is the appropriate sanction. Mandatory continuing medical education regarding evaluation of ADHD and prescription of stimulant drugs may indeed be a more appropriate remedy. In Tennessee, for example, the Board of Medical Examiners, in conjunction with the Physician Health Program of the Tennessee Medical Foundation, refers physicians identified as “non-criminally motivated misprescribers” of controlled substances to a continuing medical education course designed to help improve their prescribing practices. See generally Spickard, supra note 81 (describing the education course).

[309] 2003 Conn. Super. LEXIS 385 at *3-4.

[310] Id. at *4.

[311] Id. at *4-5.

[312] Id.

[313] Id. at *5.

[314] Id. at n.1. Of course, the suicide likely brought the physician’s conduct to the Board’s attention and undoubtedly influenced its decision.

[315] Id.

[316] Id. at *6-8.

[317] This principle resembles the Pennsylvania Supreme Court’s reasoning in Incollingo where the court rejected that the standard of care routinely being provided in the community was determinative in a malpractice action. 444 Pa. at 282-83. A contrary conclusion, the court reasoned, “would be to say that as long as a course of conduct, however unreasonable by ordinary standards, is the norm for the group, all members of the group are thereby insulated from liability so long as they do not deviate therefrom.” Id. at 282. The court further went on to quote Justice Holmes “‘What usually is done may be evidence of what ought to be done, but what ought to be done is fixed by a standard of reasonable prudence, whether it is usually complied with or not.’” Id. at 282-83 (quoting Texas & Pacific Railway Co. v. Behymer, 189 U.S. 468, 470 (1903) (Holmes, J.)).