LEDA at Harvard Law
School LEDA at Harvard Law
School
THE INVASION OF RITALIN:
A CALL FOR FEDERAL REGULATION AND PUBLIC POLICY REFORM
[REDACTED VERSION]
MARINA BONANNI
CLASS OF 2004
MARCH 2004
SUBMITTED IN SATISFACTION OF THE FOOD AND DRUG LAW COURSE REQUIREMENT
Attention Deficit Hyperactivity Disorder (ADHD), a mental disorder whose symptoms include inattention, impulsivity, and hyperactivity, afflicts a significant percentage of American children. The treatment most often prescribed for ADHD is Ritalin, a stimulant drug produced and marketed by Novartis Pharmaceuticals Corp. While Ritalin is oftentimes effective in the treatment of ADHD, lack of pediatric testing of the drug, reports of abuse of the prescribed drug, and vague ADHD diagnosis and treatment practices indicate gaps in the federal policy relating to the disorder and the drug. The FDA ought to engage in policy reform to limit the accessibility of Ritalin, increase public awareness regarding both the diagnosis and treatment of ADHD and the risks inherent in abuse of Ritalin, and implement more stringent regulations requiring pediatric testing in order to reduce the risks inherent in the treatment of children with Ritalin.
Medications are mysterious potions. We take them when our doctors so prescribe, and we protest when our insurance company refuses to cover the payments for prescription drugs. We trust our doctors to accurately diagnose our ailments, and to prescribe for us the most efficacious treatment, without being influenced by drug companies or sources of bias or other incorrect information. Given the complexity of the medical practice, we defer to our doctor’s expertise and experience, especially when that expertise is used to treat our sick children. While we, as adults, might refuse treatment for ourselves, few parents refuse to give their children the treatments prescribed by their pediatricians. The pediatric pharmaceutical market is large, and many drugs, both prescription and over-the-counter are developed and marketed each year to treat children. This paper is about one such drug, Ritalin. As is described in more detail below, Ritalin is a pharmaceutical drug intended for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD), a psychological ailment that causes, among other symptoms, an inability to focus and to remain calm. While Ritalin can be highly effective in the treatment of ADHD, the FDA’s policies regarding the diagnosis of ADHD and the prescribing of Ritalin are ineffective.
This paper explores the problems inherent in the federal policy regarding Ritalin and proposes policy changes to rectify those problems. In the first section, I define ADHD and explain the forms of treatment generally used with children suffering from its symptoms. In the second section, I identify three important social problems related to Ritalin that relate to areas of weakness in the federal policy regarding Ritalin: (1) the lack of requirements for pediatric testing and labeling of the drug; (2) the misuse and abuse of the drug among teenagers and young adults; and (3) the vagueness of diagnosis and the lack of standards for accurate diagnosis and calculated treatment of child patients suspected of having ADHD. Finally, in the third section, I outline policy proposals geared toward increasing pediatric testing of Ritalin, reducing accessibility of the drug when it might contribute to abuse, and modifying the process of diagnosis in order to reduce the risk of misdiagnosis and unnecessary or ineffective medicating of children suffering from ADHD.
ADHD is a psychological ailment afflicting between four and ten percent of American children[1] resulting from underdevelopment of the parts of the brain that control attention and stop inappropriate behavior.[2] Its usual symptoms include “inattention, distractibility, and impulsiveness, usually associated with excessive motor activity, or hyperactivity.”[3] For children with ADHD, these symptoms are severe, and left untreated, may affect the child’s self-esteem (leading to feelings of inadequacy or inability). Furthermore, ADHD is often associated with the development of other problems and diseases, including developmental disorders such as dyslexia and other language disorders, and has also been associated with juvenile delinquency.[4] While symptoms of ADHD may become evident from a very young age, ADHD usually persists from childhood into adolescence and, oftentimes, adulthood.[5]
Often, the diagnosis of ADHD follows disruption in the classroom, where teachers experience difficulty in controlling these hyperactive and inattentive children. Schoolteachers and administrators therefore respond by communicating with parents and suggesting medical treatment. Medical diagnosis of ADHD is not precise, and is often critiqued as being overly vague. As Therese Powers explains, “[o]ften it is difficult to determine whether a child truly suffers from ADHD or whether teachers and parents are instead dealing with an undisciplined, difficult child.”[6] Diagnosis is founded on behavioral guidelines (Appendix A), but since these symptoms may not be visible to the clinician, he or she often must rely on the reports of parents and teachers about the behavior tendencies of the child being diagnosed.[7] Also, as Powers indicates, “[i]t may become impossible to differentiate ADHD from symptoms of a child's social environment when a child is subjected to inadequate, disorganized, or chaotic environments.”[8] According to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV), ADHD diagnosis criteria are focused on three areas: inattention, impulsivity and hyperactivity.[9] ADHD is often diagnosed as a result of a child’s consistent pattern of underachievement. But as Farley indicates, not everyone who underachieves has ADHD, and not everyone who experiences difficulty paying attention has ADHD.[10] The correct diagnosis of ADHD is therefore very tricky, and “narrowing a diagnosis to ADHD requires more than a single visit to the doctor.”[11] Rather, as Patricia Quinn, M.D. (a developmental pediatrician) explains, diagnosis must involve conversations between the doctor and the patient, the parents and nurses and teachers.[12] While it may be difficult to diagnose, the diagnosis of ADHD is “recognized by all leading medical authorities in the United States, including the American Medical Association, American Psychiatric Association, American Academy of Pediatrics and the US surgeon general.”[13]
Despite this difficulty in accurate diagnosis, ADHD is the “most commonly diagnosed behavior disorder in North America,”[14] and is the condition most treated with prescription medications in American schools. In most cases, that prescription is dispensed by school officials during the school day.[15] Methylphenadine hydrochloride (commonly known as ‘Ritalin’), is produced and marketed by Novartis Pharmaceuticals Corp. (formerly Ciba-Geigy Corp.) for the treatment of ADHD for adults and children above the age of 6. As early as mid-1995, 1.5 million school-aged children were medicated with Ritalin.[16] While the FDA has also approved other stimulant medicines for the treatment of ADHD, including dextroamphetamine (Dexedrine and its generics) methamphetamine (Desoxyn), and an amphetamine-dextroamphetamine combination (Adderall),[17] Ritalin is the most popularly known and discussed stimulant used to treat ADHD. And although the drugs are known to stimulate the central nervous system, even the FDA admits that “no one knows exactly how they work in treating ADHD.”[18] Similarly, the Novartis product description (Appendix B) states “there is neither specific evidence which clearly establishes the mechanism whereby Ritalin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.”[19] However, stimulants are widely used to treat ADHD. As Nicholas Reuter, FDA associate director for international and domestic drug affairs, has explained, “[s]timulants have been used to treat ADHD for over three decades ... and the amount used has increased steadily during that period.”[20]
Ritalin is a stimulant drug and is not devoid of side effects. These include insomnia and nervousness, as well as loss of appetite, abdominal pain, weight loss and dermatological problems.[21] Ritalin may also present some psychological problems. As Powers explains, “Ritalin has also been characterized as having the "potential for serious psychological dependence." Most minor side effects usually disappear as the child becomes tolerant of the drug. The long term side effects of stimulant drugs on a growing child's brain are still not completely known.”[22] According to Wendy Sharp, a social worker and researcher at the National Institute of Mental Health’s child psychiatry branch, when taken properly, Ritalin is not an addictive drug.[23]
However, Ritalin remains a mysterious medication. Beyond side effects, the risks of taking Ritalin are not all known. FDA announced in 1996 findings reported by the National Toxicology Program and based on studies of rodents that indicated a weak connection between the drug and the development of liver cancer.[24] Furthermore, under the UN Convention on Psychotropic Substances, all international drug control agencies include Ritalin among other stimulants (such as cocaine) in Schedule II, which includes the most addictive and abuse-prone drugs available.[25] The Convention prohibits the direct-to-consumer advertising of such drugs because of their dangerous nature.[26]
Ritalin (and other stimulant drug) treatments usually begin with a trial period, during which diagnosed children and parents are encouraged to discuss with the diagnosing doctor changes in behavior and any experienced side effects. These discussions aid the doctor in determining the most effective dose for the child. Treatment programs differ depending on the child and the severity of his or her symptoms. Research conducted by the National Institute of Mental Health has demonstrated that the most effective treatment involves three doses of Ritalin per day.[27] This generally means that at least one dose must be dispensed by school officials during the school day. Children who need the medication to pay attention may take it during the week and not during weekends or vacations. Others may take the medication every day.[28] Ritalin may not be sufficient in the treatment of ADHD. As Sharp suggests, “[p]robably the most beneficial treatment for ADHD involves the entire family system, and behavior management is usually a part of this treatment.”[29] This underscores the importance of the involvement of a mental health professional in the treatment of children suspected of having, or already diagnosed with, ADHD.
The reason that the use of Ritalin has sparked such vast amounts of national discussion and public outcry (not to mention mass-tort litigation) is that, despite its many side effects and the lack of long-term health and safety information, many children take the medication “for the wrong reasons.”[30] Since, as explained above, the diagnosis of ADHD is founded on such vague guidelines, it is not difficult to diagnose ADHD when in fact, the child is merely acting like a child. As Powers explains,
Some parents may panic if their child is not the perfect student, the best athlete, or the most attractive child. Parents always want their children to do as well as possible and often will purchase whatever "enhancement" they can afford. Parents may have limits as to how far they are willing to go to achieve this perfect life for their child. In a distorted effort to create the perfect child, however, many parents may encourage their healthy child to take "enhancement drugs" such as Ritalin ...[31]
ADHD is a real disorder, and those children who suffer from its symptoms ought to be treated with whichever combination of therapies, both medicinal and behavioral, are most likely to effective. However, the policies governing the diagnosis and treatment of ADHD do not all promote this sort of efficiency. The following section discusses those policies and practices that are especially problematic with respect to ADHD and Ritalin.
The Problems with Ritalin
Lack of Pediatric Testing
Historically, pediatric testing of medications in the United States was conducted without standards and had the unfortunate effect of leading to the medical exploitation of children. With the adoption of strict standards, and the pressures that liability and civil suits could place on such testing, pharmaceutical companies began to phase out this sort of testing. For these, among other reasons, most pharmaceutical companies have decided to avoid pediatric testing of drugs.[32] Only twenty percent of drugs in general, and only six out of the ten drugs most prescribed for children, have undergone pediatric testing.[33]
Because of the lack of pediatric testing, the true safety and effectiveness of drugs used to treat children, not to mention side effects and possible dangers of use by small children, remain unknown. ““The problem,” warns Dr. Glen Elliott, director of the Langley Porter Psychiatric Institute's children's center at the University of California, San Francisco, “is that our usage has outstripped our knowledge base. Let's face it, we're experimenting on these kids without tracking the results.””[34] The current FDA policy allows physicians to prescribe medications for off-label uses so long as the prescription is based on substantial medical evidence, which is defined as “two or more adequate and well-controlled studies performed by experts qualified by scientific training and expertise.”[35] However, considering the vast amount of conflicting scientific studies published in numerous medical journals each year, this condition is not difficult to satisfy. Therefore, physicians may legally prescribe to children drugs that have not been tested on children, and whose safety and effectiveness with regard to children is unknown.
The fact that children are facing serious risks when they receive prescriptions for off-label uses of medications has not gone unnoticed. In January 2002, President Bush signed into action the Best Pharmaceuticals for Children Act, which, among other provisions, provided the incentive of extended exclusivity or patent rights for pharmaceutical companies that conduct additional testing on children.[36] Prior to the passing of this Act, few drugs were tested on or labeled for children, and a 1994 study found that six of the ten most commonly prescribed drugs for children lacked pediatric labeling.[37] However, it should be noted that, while the Act provided incentives for the conducting of pediatric testing and provided assistance with the granting of public and private funds for additional pediatric testing of drugs commonly prescribed for children, the Act did not require pediatric testing of drugs, nor do the incentives it provides place an economic burden, and therefore have the effect of a requirement of such testing, on pharmaceutical companies.
Lack of pediatric testing translates to lack of precise indications for pediatric use. A report released in 1997 and still currently available on the FDA’s website reports the safety and effectiveness of a list of drugs prescribed for the treatment of various children’s illnesses and disorders. This report critiqued the sparse availability of safety and effectiveness information for some pediatric age groups and identified Ritalin among ten drugs that were most widely prescribed for pediatric use “despite inadequate pediatric labeling.” As the report indicated,
The absence of pediatric labeling information may sometimes require the physician caring for children to choose between prescribing drugs without well-founded dosing and safety information or utilizing other, potentially less effective, therapy. Inadequate pediatric labeling thus exposes children to the risk of unexpected adverse reactions or lack of optimal treatment. Even after a drug has been used in pediatric patients for some time, and there has been substantial clinical experience with the drug, directions for safe and effective use in pediatric patients are not provided on the label.[38]
The lack of pediatric testing is especially troubling in light of the practice of diagnosing ADHD and prescribing Ritalin for toddler-aged children. A study published in 2000 by the Journal of the American Medical Association reported that the use of certain psychotropic drugs, including anti-depressants and stimulant drugs like Ritalin, in two to four-year-olds doubled or even tripled between 1991 and 1995.[39] Experts have attributed this increase, at least in part, to “frustrated parents, agitated day-care workers and 10-minute pediatric visits.”[40] The problem with this sort of prescribing is that ADHD is especially difficult to diagnose in children under the age of five. Even to the trained eye, it is not easy to distinguish between a toddler’s normal behavior and symptoms of ADHD. As Kalb noted, child rambunctiousness may be due to the “terrible twos” or “trying threes” or to stressors in the home such as divorce. “Experts worry that some doctors are making diagnoses based on symptom checklists rather than on thorough evaluations of a child's life both in and out of the home.”[41]
Ritalin’s labeling warns against use of the medication by children below the age of six.[42] However, FDA permits off-label uses by prescribing physicians. Therefore, this warning is ineffective at best. Experts worry that, despite the FDA’s granting of permission to physicians to prescribe the drug for off-label uses, that the prescribing of Ritalin for toddlers is especially dangerous. This danger arises not only from the potential side effects of Ritalin use but also the lack of information as to the effect of such psychotropic drugs on brain development.[43] As Joseph Coyle, the Chair of the Harvard Medical School’s department of psychiatry, explains, “the period between birth and 4 is time of tremendous change in the maturation of the brain ... we need to be very cautious.”[44]
Misuse and Abuse of Ritalin
Ritalin and it’s sister medications are stimulant drugs. Because of their chemical similarities to the street drug “speed,” there is a high degree of abuse of these prescription equivalents. The FDA Consumer Magazine reported in the fall of 2001 that there were reports of abuse of Ritalin among middle and high school students. As Meadows reports, “some have used it to suppress their appetite or to stay awake while studying. The DEA lists Ritalin as a "drug of concern" and reports that some abusers have dissolved the tablets in water and injected the mixture, which can block small blood vessels and damage the lungs and retina of the eye.”[45] Despite the potential for such dangers, misuse among teens is rampant. In May 2000, a fourteen-year-old boy was charged and received five years probation for attempting to sell Ritalin to other students, as a total of fifteen boys were implicated for illegally trading Ritalin.[46] “In his testimony, the student described Ritalin as a "poor man's cocaine.”[47]
Similarly, a 1995 article in Newsweek told the story of Lisa (an alias), who testified to having snorted the drug with friends at Colgate University.[48] The students obtained the drug from a younger sibling who was prescribed the medication for ADHD. As Lisa recounted, “ ‘It makes you really hyperactive ... Anything you want to read, you want to read it right then. Anything you want to do, you want to do it right then: organize your room, organize your life.’ She says she has taken the drug occasionally since, and knows a number of students who use it: to study, to write papers or just for the buzz.”[49] This type of abuse is facilitated by the ease of obtaining the drug. As Leland explains, “with so much Ritalin in circulation, it’s easy to get. Drug professionals put the going rate at $3 to $15 a hit.”[50] Such abuse is dangerous. While the drug may be safe when used in accordance with the prescribing physician’s instructions in children accurately diagnosed with ADHD, abuse of Ritalin may lead to addictive use, and places the abusers at risk of strokes, hyperthermia, hypertension, hypertension and seizures.[51]
Because of this abuse potential, “the U.S. Drug Enforcement Administration has placed stringent controls on their manufacture, distribution and prescription. For example, DEA requires special licenses for these activities, and prescription refills aren’t allowed.”[52] States also reserve the right to place greater restrictions on the use of these drugs, including limiting the size or duration of the prescriptions.[53] Despite this regulation, misuse of the drug does take place, and many stories in the press have described unfortunate incidents in which teenagers have taken Ritalin from others with ADHD and have snorted it like cocaine.[54] The problem of abuse does not seem to affect the children diagnosed with ADHD. As Patricia Quinn, M.D., a developmental pediatrician in Washington D.C. explains, “there’s actually less substance abuse in people diagnosed with attention deficit disorder who take medication and do well than in the general population.”[55] However, there is a risk of abuse by those children who surround those diagnosed with ADHD.
It is of particular relevance that those treated by Ritalin are often children. Unlike adults, who are blessed not only with privacy but also the ability to resist peer and other social pressures, children are highly susceptible and vulnerable to the pressures around them. Children diagnosed with a psychological disorder, and who, as a result, struggle in the school setting, are particularly likely to feel pressure from their social environments. It is therefore not at all inconceivable that a child could easily be pressured to hand over his or her Ritalin prescription to a bully, who later intends to abuse the drug for its stimulant effects. It is also not difficult to imagine the ease with which older siblings may steal medications from their younger brothers and sisters. Furthermore, the fact that Ritalin is a prescription drug approved by the FDA may reassure children who abuse the drug that it is safe and that it would not be available if its use was dangerous. The label “prescription” carries with it the connotation of safety, and children and teenagers are especially likely to misunderstand the risks involved with unapproved uses of this drug.
Misunderstandings about the risks involved with Ritalin use may also stem from the exclusive population that abuses the drug. Ritalin is not the poor man’s drug. According to Lisa Herz, a clinical social worker who works with adolescents with drug and alcohol problems, the Ritalin problem is “mostly a white upper-middle-class phenomenon, like anorexia: it’s not widespread, it’s concentrated.”[56] Generally accepted social norms in modern society often wrongly classify drug problems as stemming exclusively from poor neighborhoods with largely minority populations. We may therefore be reluctant to recognize the gravity of the Ritalin abuse problem, preferring to perceive it as off-label uses of prescription medications. However, while the abuse may be taking place among groups that we would not usually expect to abuse drugs seriously, and may be of a drug that has been approved by the FDA, the use of Ritalin by teenagers who do not have ADHD is a dangerous problem that must be addressed.
Accurate diagnosis of ADHD is crucial to our society’s well-being. We do not want a society where doctors prescribe medications to control normal mood changes and differences in attitude. As Kluger states, “the world would be a far less interesting place if all eccentric kids were medicated toward some golden mean.”[57] We also do not want a society where drugs replace parental discipline in the child-rearing process. However, in the case of ADHD, often times diagnosis results from pressure from schools (rather than parents). As Powers explains,
Hyperactivity has become a convenient "wastebasket diagnosis" into which doctors and impatient parents, teachers, and school administrators toss too many hard to handle children .... The ultimate pressure for the use of Ritalin comes from school administrators. Some argue that school administrators have come to regard Ritalin as essential to the education of hyperactive children without giving much weight to the importance of other, equally valid, forms of therapy. As a result, parents feel pressured from the schools' threats that if they do not allow their child to take Ritalin, their child will be placed in an isolated environment or may possibly face expulsion.[58]
Parents defer not only to the suggestions of their doctors but also to school officials. We usually regard school officials as experts in the field of childrearing. Therefore, when a school administrator suggests to a parent that his or her child may be suffering from ADHD, that parent is likely to trust the administrator and take the child to be evaluated by a doctor.
However, as explained above, the guidelines for diagnosing ADHD are vague and the diagnosis process imprecise. Diagnosing difficulties are exacerbated by a feature that is all-too-prevalent in the medical industry: instead of leaving the diagnosis of mental disorders to mental health professionals, as specialization in the medical field would suggest, the diagnosis of ADHD and subsequent prescribing of Ritalin and similar drugs is often conducted by other medical practitioners (namely pediatricians). As Kluger explains, this doctor “isn’t likely to have the time or training necessary for the extensive evaluations needed before drugs can be properly prescribed – much less the required follow-up visits.”[59]
The lack of precise diagnosing guidelines for ADHD, and the subsequent risk of misdiagnosis, is troubling, particularly because of the stigma attached to the diagnosis of ADHD, especially for children. As Garza explains,
The first label which usually attaches before a child is diagnosed stems from a teacher's aversion to having a 'hyperactive child' in her classroom. After the child is diagnosed with ADHD, the 'learning disabled' label attaches. Eventually, an individual with self-esteem and self- concept difficulties may be labeled as a 'loner.' Ultimately, ADHD affects a child's self-esteem by creating feelings of vulnerability, inability, and inadequacy. Consequently, several studies show that "individuals with ADHD are as much as seven times more likely than others to develop an antisocial personality or drug abuse problem in adulthood."[60]
Yet another psychological effect inherent in the prescribing of drugs dispensed several times each day for long term periods is the likelihood that the child will come to perceive pill-popping as a normal and perhaps even favorable practice. There is a danger to teaching our children that medications should be taken without so much as an afterthought. If children become too comfortable with the idea of medications, they might not learn the importance of being cautious before taking medications and the importance of trying to treat psychological problems through non-pharmaceutical means before receiving prescriptions. As Piety wisely asks, “what effect does it have on us to believe that all our troubles can be treated with a pill? It looks uncomfortably like laying the foundation for a junkie mentality.”[61] These lingering psychological effects render the proper diagnosis of ADHD that much more important to the proper development of children. However, reports testifying to the misdiagnosis and the hurried diagnosis of ADHD abound.
In addition to the stigma involved, misdiagnosis of ADHD is particularly troubling because of the potential dangers of Ritalin use by children who do not in fact suffer from ADHD. An important concern is that hurried diagnosis may be a precursor for inadequate follow-up care by a medical practitioner. As Garza indicates, since “not all individuals respond well to drug therapy, ... those taking medications should be carefully monitored.”[62] Therefore, not only could a child be misdiagnosed with ADHD and subsequently mistreated with Ritalin, but his or her doctor might fail to recognize problems with the treatment because of lack of monitoring.
Also problematic is the possibility that drug therapy may take the place of other psychological and psychiatric treatments that might be more effective in the treatment of the child’s condition. In their hurried visits, doctors may be jumping the gun in prescribing drug therapies without considering other options. Child psychologists have noted that therapy and other related treatments can at times replace the need for drug treatments.[63] It is therefore of utmost importance that doctors spend the required time to correctly diagnose ADHD and to carefully select the best treatment option for each individual patient. Just as we are careful not to take medications that may interact with each other, we do not want our physicians to prescribe to our children medications when less invasive and safer methods, such as behavior therapy, might be just as or more efficient in the treatment of ADHD.
The critiques of Ritalin presented above have been presented by a number of parents and medical professionals around the country and the world. A number of lawsuits, and a class action suit, have been launched alleging conspiracy on the part of Ritalin’s producer, Novartis, and prescribing physicians. “Although plaintiffs attorneys have declined to provide details, they say a number of psychiatrists have come forward to talk about the pressures exerted on them, as individual practitioners and as APA members, to change from being psychotherapists to being pill-pushers. Since the suits have been filed, whistleblowers from Novartis have allegedly come forward as well.”[64] In addition to consumer suspicions as to the safety Ritalin and the accuracy of ADHD diagnoses, as Leland described as early as 1995, ADHD has become a “fashionable diagnosis.”[65] This is reflected in the rapid increase in number of diagnoses during the past decade. These lawsuits and critiques, and the vast amount of social discourse that has taken place over the past decade regarding the medication of children’s mental disorders, emphasize the importance of the issues outlined in this article. For these reasons, it is especially important for us to take a critical look at the regulation of Ritalin and similar substances.
Self-regulation by medical practitioners represents one portion of the response to this social discourse. In a report by its Council on Scientific Affairs, the American Medical Association (AMA) made a few recommendations related to the diagnosis and treatment of ADHD. These recommendations included encouraging physicians to use standardized diagnostic criteria (including the DSM-IV) in diagnosing ADHD, encouraging the creation of practice guidelines for ADHD by specialty societies, encouraging efforts by educational institutions and programs to increase physician knowledge about ADHD, and encouraging the use of “individualized therapeutic approaches” to treatment, including pharmacotherapy, psychoeducation, behavioral therapy, among others.[66] While the AMA was certainly well-intentioned in issuing this report, mere ‘encouragement’ for change in the medical practice is not a sufficient response to the problems outlined above. Furthermore, while the AMA can no more than ‘encourage’ physicians to change their practice, it is important for a federal agency to step in and actually regulate this area. While the question of who should be responsible for this assessment and reform may spark debate, I propose that the FDA is the most qualified and the best equipped agency for the policy proposals suggested below.
The House of Representatives is currently considering a bill, the Pediatric Research Equity Act (introduced in 2003) that would further strengthen the requirements of pediatric testing for new drugs and biologics.[67] It is important that Congress recognize the need for requiring increased pediatric testing of drugs that are used to treat children. However, it is also important for the FDA to issue regulations requiring a certain degree of such testing, as well as corresponding labeling. While some might argue that the additional testing requirement might prevent drug manufacturers from entering into the pediatric drug production market, for fear of increased liability or in order to avoid the costs of conducting additional testing, the FDA could adopt policies restricting these risks in order to assure continued development and production of pediatric drugs.[68] Such protections are not alien to the FDA, and already exist for vaccine manufacturers.[69] There is no question that pediatric testing is complicated and involves complex consent and ethical questions.[70] However, complication should not preclude such testing. Merely providing incentives for companies to conduct testing is not sufficient, and the risk of harm to children receiving untested medications is great. Rather than providing such incentives to reward those who conduct studies, we must require testing and implement penalty systems for pharmaceutical companies that are non-compliant. If we are to increase the amount of medications used to treat our children, the FDA must respond accordingly by assuring the safety and effectiveness of those medications as used for children, not just adults. For this reason, the FDA must require the submission of clinical pediatric studies from pharmaceuticals who produce drugs that are commonly used in children.
The dangers of prescription drug abuse are self-evident. These dangers and risks are exacerbated by the fact that the abuse is taking place among the population of young adults. Teens who abuse Ritalin are unlikely to end in rehabilitation or treatment in emergency rooms.[71] It is this fact about Ritalin that is particularly troubling. Teenagers hearing this piece of information are likely to underestimate the dangers of using the drug. Furthermore, teenagers and young adults are likely to use Ritalin in combination with other drugs, which may pose additional medical dangers. Federal policies designed to reduce the possibilities of such abuse are therefore necessary. While it may not be possible for the government to eliminate the abuse of prescription drugs, certain FDA actions may contribute to a decrease in this practice. These efforts must focus not only on limiting the availability of the abused drug but also changing social attitudes about the benefits and dangers of using prescription drugs. FDA could achieve limited accessibility of Ritalin and similar drugs by people who lack prescriptions for those drugs by reducing the amount of Ritalin available. This could be done not only by reducing the quantity of Ritalin that may be prescribed at one time, as well as by reducing the amount of unnecessary prescribing of Ritalin that takes place by placing greater pressure on medical professionals to refer ADHD diagnosis and treatment decisions to mental health professionals.
Furthermore, the FDA could use its immense and influential press power to warn against the dangers of prescription drug abuse in order to motivate parents to strictly regulate the dispensing of Ritalin to their children diagnosed with ADHD and preventing others from having access to those drugs, while also preventing their children who have ADHD from sharing their prescriptions with others. While the federal government has engaged in large anti-drug campaigns, the war against the abuse of prescription drugs could better be described as a scrimmage. Perhaps it is time for the FDA and the DEA to increase their efforts against the abuse of prescription drugs. It is important that the public recognize that prescription drug abuse is just as dangerous as abuse of other drugs. The fact that prescription drugs abuse generally takes place among wealthier white Americans, while general drug abuse is focalized in poor minority neighborhoods, is irrelevant in light of the general need to prevent abuse of all drugs in the interest of the public health. It is therefore important for federal agencies to engage in programs to increase public awareness of the problem of prescription drug abuse, especially in situations where parents maintain a great degree of control over the dispensing of the drugs in question.
Conclusion
In his famous novel, Brave New World , Aldous Huxley introduced the concept of soma, a “happy” drug dispensed to all citizens in an imagined future society. While some might deem it a conspiracy theory, soma seems to have invaded modern American society in the form of psychotropic drugs. As a report published by the President’s Council on Bioethics as recently as October 2003 suggests, “Ritalin and similar stimulants can be, and quite possibly are being, used to mollify or improve children who suffer no disorder except childhood and childishness.”[73] Murray identified the cause of this phenomenon as “a combination of anxious parents, overburdened teachers and obliging doctors.”[74] While this may explanation might be an oversimplification, the problems inherent in the diagnosis and treatment of ADHD, and the risks of abuse and misuse of Ritalin and similar treatments are very real problems. No authority is more qualified to assess and rectify these problems than the federal Food and Drug Administration. The FDA can most easily and efficiently implement and enforce a system of rules, regulations and incentive programs that prevent the over-medication of our nation’s children and prevents the interference of child brain development with the overuse of under-tested psychotropic drugs. It is time for the FDA to accept this mandate in the name of protecting the public health.
Appendix A
According to the American Psychiatric Association, a diagnosis of ADHD must meet the following guidelines:
either six of these inattention symptoms:
or six of these hyperactivity or impulsiveness symptoms:
[Redacted]
[1] Therese Powers, Race for Perfection: Children’s Rights and Enhancement Drugs , 13 J.L. & Health 141, 142 (1999). Other sources suggest that ADHD may affect as many as twelve to thirteen percent of American school children and three to five percent of children around the world. See Bertha Nelda Garza, Attention Deficit Hyperactivity Disorder (ADHD): A Childhood Diagnosis or a Criminal’s Defense? 4 Scholar 81, 83 (2001).
[2] Praveen Madhiraju, R.I.P. Ritalin in Proportion! The Eighth Circuit’s Restriction on a Parent’s Right to Have Schools Accommodate the Needs of their Disabled Children: Debord and Davis, 95 Nw. U. L. Rev. 1661, 1664 (2001).
[3] Powers, supra note 1, at 142.
[4] Id. at 144.
[5] Report 5 of the Council on Scientific Affairs, available on the American Medical Association website at http://www.ama-assn.org/ama/pub/article/2036-2423.html.
[6] Powers, supra note 1, at 143.
[7] Id. These guidelines were supplemented in 2001 by the American Academy of Pediatrics (AAP), which established the following additional guidelines: “The new guidelines require doctors to routinely evaluate children ages six to twelve who exhibit signs associated with this disorder. The guidelines also require the doctor's determination that the child display the symptoms in at least two settings, such as the home and school. Finally, to establish a correct diagnosis, the guidelines require that the symptoms interfere with the individual's academic and social environment for at least six months. ” Garza, supra note 1, at 86.
[8] Powers, supra note 1, at 143.
[9] Garza, supra note 1, at 85.
[10] Dixie Farley, Attention Disorder: Overcoming the Deficit; Abuse of Attention Deficit Drug can be Deadly , FDA Consumer Magazine (July-August 1997), available at http://www.fda.gov/fdac/features/1997/597_adhd.html.
[11] Id.
[12] Id.
[13] Steven Keeva, No Deficit of Attention Here: Ritalin Class Action Suits are Making Some Drug Companies Hyper , 87-JUN A.B.A. J. 28, 30 (2001). It should be noted that this report was made by Novartis, the producer and distributor of Ritalin.
[14] Richters, J. et al. MTA Background and Rationale . J. Am Acad. Child and Adolesc. Psych. 1995; 34: 987-1000, at http://www.adhdinfo.com/info/start/about/start_info_for_parents.jsp.
[15] Rex R. Schultze, Reading, Writing and Ritalin: the Responsibility of Public School Districts to Administer Medications to Students , 32 Creighton L. Rev. 793, 794 (1999).
[16] Farley, supra note 10.
[17] Id .
[18] Id.
[19] Available at http://www.fda.gov/cder/foi/label/2002/18029slr032lbl.pdf.
[20] Farley, supra note 10.
[21] Powers, supra note 1, at 144. Less common but more severe side effects include allergic reactions, bruising, and abnormally low red and white blood cell counts.
[22] Id.
[23] Farley, supra note 10.
[24] Don McLearn, Ritalin Studies, available at http://www.fda.gov/bbs/topics/ANSWERS/ANS00705.html.
[25] Keeva, supra note 13, at 30.
[26] Id.
[27] Schultze, supra note 15, at 796.
[28] Farley, supra note 10.
[29] Id.
[30] Powers, supra note 1, at 146.
[31] Id.
[32] Lauren Hammer Breslow, the Best Pharmaceuticals for Children Act of 2002: the Rise of the Voluntary Incentive Structure and Congressional Refusal to Require Pediatric Testing , 40 Harv. J. on Legis. 133, 139-140 (2003).
[33] Id. at 148.
[34] Jeffrey Kluger et al., Medicating Young Minds: Drugs Have Become Increasingly Popular for Treating Kids with Mood and Behavior Problems. But How Will that Affect them in the Long Run? 11/3/03 Time Mag. 48, 2003 WL 58582889 (2003).
[35] Breslow, supra note 32, at 145.
[36] Id. at 133.
[37] Id.
[38] Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients , available at http://www.fda.gov/cder/guidance/pedrule.htm.
[39] Claudia Kalb, Drugged-Out Toddlers: A New Study Documents an Alarming Increase in Behavior-Altering Medication for Pre-Schoolers , 3/6/00 Newsweek 53 (2000).
[40] Id.
[41] Id.
[42] Id.
[43] Id.
[44] Id.
[45] Michelle Meadows, Prescription Drug Use and Abuse , FDA Consumer Magazine (Sept. – Oct. 2001), available at http://www.fda.gov/fdac/features/2001/501_drug.html.
[46] Garza, supra note 1, at 90-91.
[47] Id. at 91.
[48] John Leland, A Risky Rx for Fun (Abuse of Drug Ritalin) , 10/30/95 Newsweek 74 (1995).
[49] Id.
[50] Id.
[51] Id.
[52] Farley, supra note 10.
[53] Id.
[54] Id.
[55] Id.
[56] Leland, supra note 48.
[57] Kluger, supra note 34.
[58] Powers, supra note 1, at 148.
[59] Kluger, supra ntoe 34.
[60] Garza, supra note 1, at 89-90.
[61] Tamar R. Piety, “Merchants of Discontent”: an Exploration of the Psychology of Advertising, Addiction, and the Implications for Commercial Speech , 25 Seattle U. L. Rev. 377, 438 (2001).
[62] Id. at 93.
[63] Kluger, supra note 34.
[64] Keeva, supra note 13, at 30.
[65] Leland, supra note 48.
[66] Report 5 of the Council on Scientific Affairs, available on the American Medical Association website at http://www.ama-assn.org/ama/pub/article/2036-2423.html.
[67] Pediatric Research Equity Act of 2003, H.R. 2857, 108th Cong. (2003).
[68] As Breslow proposes, “[a] mere four million dollar study is not the crux of the problem--liability is. Perhaps the new ethics regulations will help to set up guidelines that can serve as defenses in the courtroom. Congress might also consider creating an arm of the FDA that oversees pediatric studies. Such oversight could then serve as a form of an "FDA defense" to a lawsuit. That is, drug companies could have an affirmative defense to a lawsuit for a failed pediatric test or adverse side effect if they followed the FDA's procedures.” Breslow, supra note 32, at 190.
[69] In 1986, Congress passed the National Childhood Vaccine Injury Act, which, among other provisions, provided to vaccine manufacturers protection from liability in order to assure the continued production and supply of vaccines. See Id. at 141.
[70] See Id. for a more comprehensive discussion of the difficulties inherent in pediatric testing of pharmaceutical drugs.
[71] Leland, supra note 48.
[72] Breslow, supra note 32, at 145.
[73] Alan Murray, Brave New Irony: Bioethics Issue Needs State’s Watchful Eye , 10/21/03 Wall St. J. A4, 2003 WL-WSJ 3983224 (2003).
[74] Id.
[75] Farley, supra note 10.