Understanding Attention Deficit Disorder (ADD/ADHD): To Medicate or not to Medicate?

By Ilse D. Carrizales
2010, Vol. 2 No. 09 | pg. 1/1
ADHD Medication

Introduction to Attention Deficit Disorder (ADD/ADHD)

Attention Deficit Hyperactivity Disorder (ADHD), also known as Attention Deficit Disorder (ADD), has become increasingly prevalent in children and adolescents as the years have passed. Reports show that more than two million school-aged children are diagnosed with this neurobehavioral disorder that may transition with them into their adult lives (“ADHD-A Public”). ADHD is an important public health concern because it causes impairment in school performance as well as in socialization habits (Lesesne, Perou, and Brann). While there are many different ways to treat ADHD, such as counseling, therapy, and prescription medication, which is seemingly effective in helping children improve concentration, the question remains: should very young children, known to be naturally "hyper," be medicated for this condition? Currently, the effects of many drugs have not been studied in young children, which also leads to the question of whether the Food and Drug Administration (FDA) should more stringently regulate the use of stimulant drugs given to children.

Although ADHD does not have an exact definition, a large number of scientists agree that ADHD is a biologically based disorder of the nervous system. People with ADHD show “symptoms of impulsiveness, inattentiveness, and hyperactivity” yet different problems are seen in children than in adults (“Preschool Attention” 1). According to a diagnostic manual that the American Psychiatric Association composed, there are three types of ADHD: inattentive, hyper-impulsive, and combined. A person that is diagnosed with ADHD “has trouble focusing on activities, organizing finishing tasks, and following instructions” (Bren). A child that is diagnosed with ADHD is said to be constantly running around and constantly active. He or she shows excessive emotions and usually speaks out of turn as well as says inappropriate things. Adults tend to multitask, are always restless and always act on impulse (Bren).

People with ADHD tend to have behavioral problems that sometimes lead to serious consequences. Children diagnosed with ADHD tend to visit the emergency room more often than those who do not have ADHD. Adolescents with ADHD are said to engage in risky behavior more often than those without ADHD and are also more likely to drop out of school. Adults with ADHD suffer from depression and anxiety more often than those adults without ADHD (Bren). According to Russell Barkley, director of psychology at the University of Massachusetts Medical Center, “90 percent of ADD children are academic underachievers, 25 percent are held back at least one grade, 36 percent don’t finish high school (compared with 9 percent of the general population) and more than half have no friends during childhood” (qtd. in Koch). Statistics illustrate that 72 percent of boys and 68 percent of girls in juvenile detention centers suffer from ADD or ADHD. Those affected by ADHD are said to have higher auto accident rates and speeding tickets than those without ADHD (Koch).

ADHD and its Challenges: Diagnoses and Misdiagnoses

ADHD is a social problem that leads to many health and safety concerns. There are an estimated 2.5 million children and 1.5 million adults currently taking stimulant drugs to treat ADHD (Ginsberg). According the National Institute of Mental Health (NIMH), it is estimated that 3 to 5 percent of children residing the United States have ADHD. In other words, it is as if 1 out of 25 or 30 children have ADHD. Nora Galil, M.D., a psychiatrist in private practice in Washington, D.C., claims boys are also more commonly diagnosed than girls but this is rapidly changing. The reason boys are three times more likely to be diagnosed than girls is because symptoms are more easily recognized in boys. Boys are more active whereas girls tend to daydream and therefore go unnoticed (Bren).

The over diagnoses of ADHD as well as the over use of stimulant drugs to treat ADHD is a social problem affecting society today. Critics argue that the over diagnosis of ADHD causes the over prescription of stimulants, which pose serious health risks in the long term. On the other hand, ADHD experts and scientists say that while over diagnosing may occur in isolated cases, a greater number actually go undiagnosed and, therefore, go untreated (Koch). Over diagnosing ADHD is a common problem because currently no one test is able to determine if someone has ADHD but rather a specialist has to make the diagnosis. Paul Andreason, M.D., a drug reviewer in the FDA’s Division of Neuropharmacological Drug Products states that since many health professionals believe that ADHD is being over-diagnosed, the history of patients should be considered by doctors before diagnosing them. Diagnosis is usually based on a comparison of “a person’s pattern of behavior against a set of criteria established by the American Psychiatric Association” (qtd. in Bren 3). A specialist can be a number of professionals such as a psychologist, psychiatrist, or even a developmental or behavioral pediatrician. ADHD is the most common diagnosis for children 3-5 years old, but not much is known about effects of medication on this age group (“Preschool Attention” 1).

The overdiagnosis and misdiagnosis of ADHD can cause harm to the child that is being diagnosed. While it is said that some stimulants help children with ADHD function better, the same stimulant might cause a child without ADHD to have negative results. According to Raymond Woosley, M.D., Ph. D., a clinical pharmacologist and vice president for Health Sciences at the University of Arizona, a child that is misdiagnosed may have a negative increase in blood pressure since a regular increase is seen normally in ADHD children that are taking stimulants. Woosley recommends that a child’s blood pressure and heart rate should be monitored closely for safety reasons (Bren 6).

Though there is speculation of overdiagnosis, the American Medical Association’s (AMA) Council on Scientific Affairs noted that there is an insufficient amount of evidence that points to overdiagnosis or misdiagnosis. A reason given for the rise of diagnosis was because the diagnostic criteria have been broadened and therefore more people are being diagnosed (Koch). A great number of times, children are diagnosed with ADHD when in reality they might just have dyslexia or something as simple as vision problems (Koch).

It is extremely difficult to diagnose children ages 3-5, because children that age group are known to naturally be hyper or inattentive. In order for children to be diagnosed as having ADHD, they must display severe, persistent, and frequent symptoms that are described in the American Psychiatric Association’s diagnostic manual. Symptoms must also demonstrate that behavior children display is “inconsistent with developmental level” (“Preschool Attention” 1). It is recommended by the American Academy of Child and Adolescent Psychiatry that in order for children of all ages to be diagnosed with ADHD, doctors should perform psychiatric evaluations of the child, as well as have interviewed the child’s parents, and have monitored the child in a variety of settings (“Preschool Attention” 1).

Attention Deficit Disorder: Research and Controversy

The controversy of ADHD has been around for many years. Not only is the disorder of ADHD controversial but so are the different forms of treatment. The first report regarding the benefits of stimulant medication in treating ADHD was published by Charles Bradley in 1937, but it actually spoke about the benefits before the definition of ADHD had even been known. Bradley mentioned that the use of amphetamines helped children that had been hospitalized for disturbed behavior (Wolraich, McGuinn, and Doffing 18). In 1947, some researchers at the Wayne County Training School in Northville, Michigan, discovered that some common symptoms in children that were mentally retarded. The symptoms consisted of hyperactivity as well as distractibility. Because of such findings, children that were overactive and were distracted easily were called “minimal brain damage” and even “minimal brain dysfunction” (Koch). By the 1960s those two terms stopped being use, as there was never any evidence that showed brain damage. Ritalin was the first stimulant used to treat those with hyperactivity in 1961(Koch). In the 1970s, 62 double-blind, placebo-controlled studies were being reported. Since then, more and more studies on stimulant medications have been carried out and recent results show that the use of stimulant medications is effective in helping treat children with ADHD (Wolraich, McGuinn, and Doffing 18). Ritalin, otherwise known as methylphenidate hydrochloride, is “a short-acting compound with an onset of action within 30-60 minutes and a peak clinical effect usually seen between 1 and 3 hours after administration” (Schwartz 67). These types of stimulants are said to decrease the overactivity of motor functions as well as impulsive behaviors (Schwartz 67). Also, more research in the 1970s was focusing more on “attention deficits” as being the cause of behavior problems but members of Congress questioned whether scientists were just trying to medicated children with a great amount of energy. Current controversy surrounding treatment of ADHD has to do with stimulants being overprescribed. In February 1998, the International Narcotics Control Board (INCB) reported that the use of stimulants “may often just be the easy way out of a complex problem” (Koch). Although some parents do choose to medicate their children automatically, a great number of parents have sued the school districts for trying to get their ADHD child to take medications. Some school districts told parents that children with ADHD would not be allowed into the classrooms unless they were medicated because if the child was disruptive, they would disrupt the learning of the other children. Debra Jones, president as well as the founder of Parents Against Ritalin (PAR), claims that a reason that school districts are trying to get children medicated is strictly economic. Schools receive extra money for every child that is classified with ADHD (Koch).

The first hearing to try to get sponsorship on research for the use of behavior-modification drugs on elementary school children was held on September 29, 1970. At this hearing, when asked the question why high energy levels in children was considered a “disease,” John Holt, an educator and author, stated, “We consider it a disease because it makes it difficult to run our schools as we do… for the comfort and convenience of the teachers and administrators who work in them” (qtd. in Koch). After hearing such a statement, the subcommittee became concerned that schools were pressuring parents to administer stimulants to their children in order to lower their energy level (Koch).

With the rise in popularity of ADHD, people started to wonder in the 1970s whether or not ADHD, or what was then called Attention Deficit Disorder (ADD), was actually a disorder. Although there were many doubts, more than 2000 scientific articles were published by the end of the decade. That American Psychological Association (APA) first listed ADD in its third revised Diagnostic and Statistical Manual (DSM) in 1980, and that decade soon saw a rise, just like the 1970s, in research pertaining to ADD. Thomas Armstrong, author of The Myth of the A.D.D. Child, noted that in every DSM that was revised after 1980, ADD was being defined more broadly every time especially in the most recent DSM, (DSM-IV), published in 1994 (Koch).

The FDA and Attention Deficit Disorder

The FDA is the gatekeeper of new drugs being accepted into the marketplace therefore the U.S. relies on them to fulfill their responsibilities in helping keep consumers safe (Miller 19). The FDA was first established in 1962, and is currently funded by billions of dollars yearly in order for it, with about ten thousand employees, to carry out research to evaluate new drugs (Miller 4). In the mid-1980s, Vice President George Bush, began a governmental study to speed the process of drug approval. The Bush Administration believed that the best way to speed the process was to have nongovernmental experts evaluate the drugs. A pilot study was put in place to see if the new process would be effective but when the Clinton administration came to office, interest in the FDA declined (Miller xxvi-xx). Currently, the FDA does not test the drugs; it only evaluates and approves them after receiving data about them. The FDA consists of more than 40 advisory committees that are composed of experts outside of the FDA. Committees were created so that they could help the FDA with their product development and evaluation. It must be kept in mind that committees do not have any power and are there just to give the FDA a thorough report of research (Worsnop).

The idea of having a committee regulate the use of drugs began in 1901, when contaminated smallpox vaccines led to an outbreak of tetanus which then resulted in the death of many children. People immediately petitioned for the federal government to pass a law that stated that a drug would not be able to be sold without being pre-approved by two different licenses, this led to the creation of the Biologics Act of 1902. Four years later, Congress decided to enact the Federal Food and Drugs Act of 1906, so that all drugs, not just biological drugs, would be regulated. In 1938, when the FDA began to take shape, a drug on the market killed more than a hundred people which prompted Congress to submit a New Drug Application, which would describe the uses of the drugs as well as its safety. Soon, the FDA was allowing drugs to be marketed based solely on their effectiveness and not the safety (Miller 11-13).

After many revisions and additions to the FDA’s drug acts, the final outcome in 1962 made it so that all drugs would be disapproved unless FDA showed approval unlike previous times when drugs were automatically marketed unless denied by the FDA (Miller 15). Whenever a new drug is introduced to the FDA, in vitro screening is performed which is then followed by testing the drugs on animals in order to determine “therapeutic activity and possible toxicities” (Miller 84). If animal testing results show positive therapeutic activity it is then clinically tested. Before the drug can be given to any humans, the sponsor first has to apply and be approved by the Investigational New Drug (IND) (Miller 84).

The first scientific papers to investigate the use of selective serotonin reuptake inhibitors (SSRI) in children were not published till the late 1990s. Studies being published stated it was safe for children to be taking SSRIs yet different information was being given to the FDA. In order for a drug to be approved by the FDA, the drug must show evidence of at least two positive outcomes of a study. In other words, researchers needed to present to the FDA information showing that patients that were given drugs were doing significantly better than those who were receiving a placebo. Even if this was only the case in two different studies and all the other showed negative outcomes, the drug would still be approved. The biggest issue with this is that once the FDA approves a drug, even if it is only approved for adults, there is nothing to stop doctors from prescribing those drugs to children. A great example of a drug where this occurred is Prozac. Prozac was not approved for children until 2003, yet many doctors had been prescribing to children legally for many years (Leo 30-31).

A clinical study was administered to see how effective stimulants were for young children with ADHD. The study examined children ages 6 and younger because not much is known about this age group and stimulants. Results showed that stimulants were less effective in this age group while side effects such a less positive social behavior were observed (Lee 301).

There are both proponents and opponents to social problem of whether the FDA should more stringently regulate the use of stimulant drugs in children with ADHD. Those who believe that the FDA should more stringently regulate the use of stimulant drugs in children include some parents of children with ADHD, various psychologists, and even several doctors and pediatricians. Specific parties would include the likes of Grandparents and Parents against Ritalin (GPAR), and advisory panel for the FDA called FDA Safety and Risk Management Committee, as well as the International Center for the Study of Psychiatry and Psychology (ICSPP) (Wechsler 114).

Those who feel the FDA should not more stringently regulate the use of stimulant drugs in children are composed of drug manufacturers and safety experts, and once again numerous parents and doctors. Specific proponents include the National Mental Health Association, a group called Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), as well as the FDA Pediatric Advisory Committee (“Advocates…Committee” 5).

Though there are numerous reasons for arguing that the FDA should more stringently regulate the use of stimulant drugs in children with ADHD, one of the biggest is the health of children. According to the Journal of the American Medical Association, “drugs with the FDA’s imprimatur kill over 100,000 Americans each year an put 1.5 million others into the hospital,” (qtd. in Hawthorne 29). The use of stimulant drugs in young children has not been tested, yet there is an estimated 2.5 million children taking ADHD drugs (Ginsberg). It is also estimated that 1 percent of preschool aged children have been prescribed stimulants like Ritalin, even though those drugs have not been approved by the FDA for those under the age of 6 years old (“Preschool Attention” 1). Stimulant drugs are known to pose health risks for those taking them. Parents Against Ritalin (PAR), a group composed of 2, 600 members, feel that children are being unnecessarily being drugged and that parents should choose to treat children with alternatives to medicine such as therapy (Koch). Sydney Walker III, a neurologist and psychiatrist recommends that children not be prescribed Ritalin because identical symptoms of ADHD can be caused by numerous things. Lead poising, infections, heart problems, and even infections cause children to behave a certain way that will not be fixed by stimulant drugs (Koch).

ADHD medications are said to have many negative side effects such as liver damage or even the onset of Tourette’s syndrome. Tourette’s syndrome is defined as “incurable, involuntary tics” (Koch). Stimulants are also said to cause depression mania, and even death which in turn causes doctors to prescribe more medicine such as antidepressants (Koch). Critics also say that giving stimulants to a child can inhibit their overall growth. Since they would be exposed to very high doses of amphetamines, the human brain is also said to shrink. The shrinking of the brain is called “amphetamine brain syndrome”, a condition that was first predominantly seen in the 1960s and 1970s, when the abuse of amphetamines was at an all time high. Walker states that the use of amphetamines is causing “basal constriction of the blood vessels in the brain” which is in turn causing the shrinkage of the brain (Koch). A study in 1986, by Henry A. Nasrallah showed that brain shrinkage was observed more often in men that were diagnosed as children. In other words, men that were diagnosed with children had been taking stimulants which showed that the shrinkage was caused more likely by the drugs than by the disorder (Koch). Other side effects that have been noticed in children taking stimulant drugs are “appetite loss, weight loss, disturbed sleep”, stunted growth, and there have even been reports of sudden cardiac death (“Preschool Attention” 2).

Because of the many risks that stimulants pose, the FDA’s Pediatric Advisory Committee, proposed that a suicide warning as well as warning of sudden cardiovascular death be included in antidepressant labels. When looking at specific ADHD medication, results indicated that Concerta users report a great number of cardiovascular problems. Those who use methylphenidate reported “hallucinations, suicidal thoughts, psychotic behavior and aggression” (Szabo). A study at Columbia University compared suicidal thoughts in children taking antidepressants such as Prozac and Zoloft with those taking a placebo and found differences. In other words preliminary findings in the investigation of suicidal thoughts concluded that suicidal thoughts, though rare, was seen more often in those children on antidepressants (Elias).

In 2004, the Centers for Disease Control and Prevention reported that more than 2, 500 children who were taking ADHD drugs were treated at emergency rooms for serious heart or blood pressure problems. Not only are side effects dangerous they can also be deadly. From 1993 to 2003, the FDA received reports of 19 deaths of children that were taking drugs for ADHD (Rockoff).

It is speculated that one reason that children are becoming hyperactive is due to negligence of their parents, as well as harsh discipline on a child that has poor impulse control. As an alternative to drugs being used to treat ADHD, proponents believe that children should be provided with emotional counseling instead. Not only should the children attend counseling but they should attend behavior management sessions with their parents (Bren). Parent training is said to be especially beneficial for preschool aged children (4-6 years old). Parents that attend parent training sessions are shown how to set limits as well as appropriate forms of punishments. When tested, results revealed that children whose parents had been receiving parent training had better results than those with only general counseling (“Preschool Attention” 3).

Some Doctors and health care administrators believe that the idea of drugs being regulated by the FDA is a good idea. It not only helps take the burden off them of malpractice, but it alleviates their worries about the cost of patient care (Schwartz 217). An FDA advisory committee recommended on February 9, 2006, that due to the possibility of sudden death in children being treated with stimulants, medication guides (Med Guides) should be given to patients. These medications guides would include warnings on possible side effects. The guides would also inform patients that if they develop heart problems, chest pains, or even hallucinations, to report it to their doctor immediately (Rockoff).The statistics that led the committee to make such a recommendation included 25 sudden deaths of stimulant users, most of which were children. Although in the past, warnings were only carried out if risks were clear, statistics made committee to want to include potential risks (“Debate over Warnings”). The FDA advisory committee also recommended for drugs to include information of potential risk of hallucinations for children with ADHD taking stimulants (Rubin).

In order to insure that stimulant ADHD drugs would be more stringently regulated the Drug Safety and Risk Management Advisory Committee is pushing for a black box warning to be included on stimulant medications. Due to lack of evidence showing ADHD medications are actually benefiting children, FDA officials are pushing for more forceful safety warnings (Wechsler 114). Black box warnings are “bold-faced labels that often leads to fewer prescriptions and sales” (Ginsberg). Having a black box warning helps drug makers because if a fatal side effect occurred, they can say that they had put the warning on the box (Ginsberg).

Opponents feel that by regulating the prescription of drugs for ADHD more stringently, it would deprive the patients of the best treatment. This assumption comes from the belief that doctors would now be overly hesitant to prescribe medications to their ADHD patients. Including a warning on drug labels might scare pediatricians and general practitioners to the point where they would rather just not prescribe any drugs though children might need them, predicted Suzanne Vogel-Scibilia, a Beaver, PA., psychiatrist. Also, Robert Laughren, M.D., director of FDA’s Division of Psychiatry Products, thought the use a black box warning would be overstating a drugs problem. This could lead to less patients being able to receive treatment because of raised safety concerns (Wechsler 114). In accordance, Russell Katz of the FDA’s Neuropharmacology committee, does not think that a warning label for should be included on drug labels because it is not yet known whether the drugs are causing the suicides or whether it is just a symptom of the disease (Elias). In fact, Michael Goodman, chief of neurology at the Jefferson/DuPont Children’s Health Program, stated that all the problems that drugs are causing might not even be the drug but rather just improper prescribing, so therefore it would not be right to regulate ADHD drugs more than they are currently being regulated (Ginsberg).

In order to support the assumption that doctors would be too frightened to prescribe drugs, the Competitive Enterprise Institute (CEI) gave a survey to clinical oncologists in 1995. It was discovered that two thirds of oncologists agreed that the FDA “hurt their ability to give the best possible care to a patient on at least one occasion” (Miller 36). Sixty percent of the oncologists felt that restrictions in place by the FDA were making it harder for them to perform their job. A similar survey was given to cardiologists a year later, which showed that 57 percent of the participants felt that due to delays of products being approved, the FDA was actually costing patients their lives (Miller 36). Reasons like these is what makes opponents not want to put more regulations on drugs for it will be an even slower process to get them to their patients. Although oncology might not seem relevant to ADHD, both fields could require a pharmaceutical intervention. By presenting the survey given to oncologists, it is just a way of giving another perspective on the regulations enforced by the FDA.

The bar for approval is constantly being raised by the FDA, which has caused the time for a drug that gets manufactured to reach the consumer to double from 8.1 years in the 1960s, to 15.2 years today. Also, the NDA approval now takes up to 14 years, which causes drug developers to say that drugs are being overregulated (Miller 25). While some critics may say that drugs are not being overregulated, but rather this slow process is necessary to assure safeness, this is not always the case. Comparisons of the U.S. FDA and that of the United Kingdom’s equivalent, the European Agency for the Evaluation of Medical Reports (EMEA), revealed that even though the EMEA had a greater number of drugs (4%) that had been discontinued due to safety reasons than the FDA (3%), the EMEA had a larger number of drugs that had been approved. Percentages show that the differences in drugs being discontinued did not vary too much, which could mean that the FDA takes too long in the process of regulating drugs (Miller 27).

Although proponents who believe that the FDA should more stringently regulate the use of stimulant drugs given to children mention that stimulants might not even be necessary to treat children with ADHD, opponents believe otherwise. According to a study by Galil that was mentioned, children benefit from taking stimulants daily to treat their ADHD (Bren). Studies have shown that children with ADHD who are taking stimulants are less likely to abuse illegal drugs than those who are not medicated (Koch). Also, studies on methylphenidate have shown short-term improvements of ADHD symptoms of inattention as well as in hyperactivity. The use of medication also showed signs of improvement in relationships and a decrease in aggression. Just like any other drug, methylphenidate had side effects but they were said to be mild. Side effects included headaches, stomachaches, and anxieties…all were symptoms that were seen in children that had taken a placebo as well. All side effects are said to decrease just by decreasing the dose of mediation that the patient ingesting (Wolraich, McGuinn, and Doffing 21). The National Mental Health Association (NMHA) is also in accordance that ADHD medications are necessary and they do feel that more scientific research needs to be done before the FDA tries to regulate stimulants (“Advocates…Committee” 5). Another organization that feels that ADHD medications are crucial for treatment is CHADD (Children and Adults with Attention Deficit/Hyperactivity Disorder). CHADD believes that both drugs and therapy are necessary for an improvement in behavior (ADHD Black Box) 6). Research now suggests that the combination of medical and behavioral therapies is extremely effective in treating ADHD (“ADHD- A Public”).

According to a Surgeon General’s report from December 1999, medication is effective in 80 percent of the people with ADHD. The Center for Disease Control (CDC) reported that approximately 2.5 million children ages 4-17 were taking medication for their ADHD. CHADD feels that though ADHD medication is safe, it should not be taken without proper evaluation of ones own doctor (“FDA Warning”).

Concerns have been raised by different organizations pertaining to the issue of where the FDA is receiving research results. The American Academy of Child and Adolescent Psychiatry (AACAP) was concerned about the data that the FDA is obtaining from their MEDWATCH database. FDA committees have been quick to show that negative side effects, such as cardiovascular risks, were seen in studies. Dr. Larry Greenhill, a child and adolescent psychiatrist, testified at a March 22, 2006, hearing that some patients that were said to have acquired cardiovascular problems from taking ADHD medications already had a pre-existing cardiac disease. Also, he stated that a large number of patients were on a variety of medications not just ADHD related. Because of these findings, data that was presented should not determine what ADHD medications cause adverse cardiac events. AACP feel that before the FDA puts warning on cardiovascular risks, additional studies should be conducted (“ADHD Black Box” 6).

Instead of using a “black box” warning, the FDA Pediatric Advisory Committee (PDA) proposed using stronger language in the current warning. After reviewing data on the safety of ADHD medication, PDA did not find it to be necessary for such a strong warning to be added for not much data has been shown stating how prevalent risks actually are and the little evidence that has been presented has been very week (“Advocates…Review” 4-5). Since there is a lack of strong evidence, doctors refuse to stop the prescription of ADHD medication. Lawrence Diller, a doctor specializing in behavioral pediatrics, will not stop giving his patients stimulants to treat their ADHD. He stated that for the past 70 years, ADHD medicine had been around and people have shown improvements. He also noted that perhaps a reason that more negative side effects are being known is because of the increase in their use (Szabo).

Both parties make valid arguments to support their stance on whether or not the FDA should more stringently regulate the use of stimulant drugs given to children. All arguments that were presented have underlying values. When examining the proponent’s arguments, it appears that they value health, honesty, and safety. The opponent’s arguments show that they value capitalism, free choice, and just like the proponents, health.

Should the FDA more Stringently Regulate the use of Stimulant Drugs Given to Children?

Upon the completion of the presentation of the cases for both those who believe the FDA should more stringently regulate the use of stimulate drugs given to children and those who do not agree, each issue side’s argument’s strengths and weaknesses will be analyzed. When examining the health and safety issues, proponents who believe that the FDA should more stringently regulate the use of stimulant drugs given to children argue that stimulant medications pose health risks to children and therefore should not be prescribed. On the other hand, opponents of the social problem believe that there health risks are minimal. This issue is relevant to the argument because the FDA would have to enforce stricter regulations of stimulant prescriptions given to children or leave regulations the way they are currently. In order to support their argument, those in favor of stricter regulations provided a great amount of data from studies accomplished at Columbia University as well as for the Centers for Disease Control and Prevention. The studies provided statistics as to the amount of children that experienced negative side affects from taking ADHD medications. Opponents of stricter regulations referenced numerous statements that were given by specialists of ADHD such as Michael Goodman, chief of neurology at the Jefferson/DuPont Children’s Health Program, a Surgeon General, as well as referenced studies from credible sources such as the National Mental Health Association (NMHA), and CHADD in which they all state that sufficient evidence that shows that health risks are caused by the medication is minimal. Proponents of stricter regulations had a stronger argument with this first issue because they provided more statistics and used credible sources for these statistics such as the Journal of the American Medical Association, instead of using their opinions. Proponents of stricter regulations made their argument even stronger by stating the different negative side effects that occur as well as how many children are affected. Those opposing stricter regulations tended to rely on opinions more often than on valid research. Opponents of stricter regulations arrived at conclusions by an improper appeal to authority when they used CHADD. CHADD is just an organization with opinions and does not carry out research. Another weakness of the argument that was made by those who oppose stricter regulations is that they composed their argument from ignorance. The opponents of stricter regulations mentioned that since there is not enough proof that the ADHD medications are solely causing negative side affects, then ADHD medications are safe to use.

In regards to the necessity of ADHD drugs, those who believe stricter regulations are necessary states that drugs are not necessary to improve a child’s behavioral problems while those not wanting stricter regulations state otherwise. This issue is relevant to the argument because if research proves ADHD drugs to be necessary then it will be easier to prescribe them but on the other hand if they are not necessary then drugs will more stringently regulated and alternatives will need to be examined. Opponents of stricter regulations had stronger arguments because they used reliable sources such as the NMHA and various studies that all show that it is necessary for people with ADHD to be medicated. Concrete evidence was used such as a report given by the Surgeon General in 1999, in which it is stated that medication is in fact effective in 80 percent of the people with ADHD. This writer feels that 80 percent is a great number to present with data when trying to prove something. One weakness that is seen in the argument is that once again, the opponents of stricter regulations relied on heavily on CHADD for information. CHADD did not have any supporting research to support any of their claims so it seems like they are all mere opinions. Those who support stricter regulations lack substance in their arguments. The claim that ADHD medications were not necessary was based on a “speculation” that hyperactivity was due to negligence of parents or harsh discipline. The argument that was made by proponents of stricter regulations was not very convincing and was lacking further evidence.

On the final issue of warning labels on prescription boxes, supporters of stricter regulations maintain that it is necessary to put warning labels on prescription boxes but opponents of stricter regulations say that warning labels are not needed. This issue is relevant to the argument because if warning labels get put on prescription boxes more people will be aware of the dangers posed by ADHD medications which is a good thing for the supporters of stricter regulations, but opponents of stricter regulations say it will have a negative outcome because less people will be taking their prescriptions. Proponents of stricter regulations had a stronger argument once again because they gave numerous examples of what the warnings would entail as well as the degree of the problems. Heart problems, hallucinations, and cardiovascular diseases are all side effects that many patients were unaware on how often and to what degree they occur. Those who support stricter regulations mentioned that there were 25 sudden deaths of stimulant users which were predominantly children. A weakness in the argument of those proponents of stricter regulations was that they used false presumption; they assumed that since there was a lack of evidence showing how medications are benefiting children it must automatically mean that there it is more harmful than beneficial since that is the only evidence they have. Opponents of stricter regulations claim that putting warning labels on drug boxes would deprive patients of the best treatments. That argument alone is not only an exaggeration but the opponents of stricter regulations are trying to use a theory as proof without any concrete evidence. Those against stricter regulations also argue that doctors would be overly hesitant to prescribe medications, and patients would be hesitant to take them. In order to support that argument, a survey that was given to clinical oncologists in 1995 was used as data. Although a survey is a good form of evidence it is only a type of supporting evidence and should not be used as the sole evidence. Opponents of stricter regulations failed to give any further reasons to support their assumptions that patients would be deprived of their medications.

In order to adequately evaluate the social issue of ADHD stimulant drug use regulation, the moral reasoning of the proponents of stricter regulations as well as its opponents needs to be assessed. Those in favor of stricter regulations focus on the well being of children with ADHD that are taking stimulant medications, their primary obligation is to children with ADHD. Proponents of stricter regulations value freedom more than order, but not more than equality. They are known to favor government intervention when it comes to economic matters but not for non-economic matters. Supporters of ADHD stimulant drug use regulation strongly value health and safety above all else. The health of children with ADHD is one of the main reasons that they are pushing for stronger regulations of ADHD stimulant drugs. They want to do as much as is possible to protect children from being exposed to what could be unnecessary negative side effects. The concern of the supporters of the social issue for the use of warning labels on drug boxes demonstrates their value of honesty. By using warning labels the supporters of the social issue hope to inform those with ADHD of the negative side effects of the drugs so that they can make their own educated choice of whether or not they want to take the drugs. It is clear that self-reliance and education are both valued.

There are both positive and negative consequences to the solution that was proposed by the proponents of stricter regulations, which is that ADHD drugs should be more stringently regulated. If ADHD drugs become more stringently regulated then more people will become aware of the benefits as well as the dangers of ADHD medications. This is both good and bad because people will be able to make informed decisions about taking the stimulants and therefore become in charger of their health, but at the same time might not listen to their doctors advice and decide not to take medication even thought it could be necessary.

The normative principle used by the proponents of stricter regulations is the Principle ofPaternalism. This principle states that a legitimate goal of public authority is minimizing or lessening needless human suffering. This principle is seen in the proponents of stricter regulations because they favor a person to know the side effects of the medicine and then decide whether they want to experience those side effects or if it is even necessary for their well being.

Opponents of the further regulations, those who do not agree with more stringently regulating ADHD stimulants for children focus more on doctors and drug companies than on the health of children with ADHD. Their main concern is for doctors and drug companies to stay in business with as minimal obstacles in their way to prescribing stimulants. Though their main obligation is to doctors and drug companies, they are also obligated to children with ADHD. Opponents of stricter regulations value social order more than freedom and value both more than equality. This is seen by the proponents of stricter regulations because they mention that regulations should not become more stringent for the process of getting the drugs approved would be even slower and also, it would be harder for drug companies to be successful. They do not feel that it is necessary for patients with ADHD to know all of the dangerous side effects that are involved.

Opponents of stricter regulations value capitalism above all else; their main concern is the prosperity of the drug companies. In addition, since opponents of the social issue do mention that drugs should not be more stringently regulated because it would mean that those with ADHD would not be able to have as easy an access, even if they wanted, to medication though it might be necessary for their health. This clearly shows that free choice is valued, and just like the proponents of the social issue, so is health. Though health is valued on both sides, health is clearly not a main concern of the opponents of the social issue.

There are both negative and positive consequences of not regulating ADHD stimulant medications more stringently. One is that people with ADHD can have easier access to the medication that might be necessary for their health and therefore might be able to improve their behavior. On the other hand, not knowing all of the side effects could actually lead to a decrease in health if medications are actually taken. Both outcomes would have to be investigated by a longitudinal study in order to see which is more accurate.

Overall, the normative principle of the opponents of stricter regulations is the Principle of Autonomy. The Principle of autonomy states that each rational agent has the right to make informed decisions in regards to his or her own well-being. Accordingly, opponents of the social issue do not think that it is necessary for the government to regulate the use of stimulant drugs for stimulants drugs can be regulated by the person receiving the drugs as well as their doctor. By speaking to their doctors, those with ADHD can make their own decision of whether or not they want to take the medication, for the doctor never uses force.

After much consideration of the arguments and moral reasonings made by both sides of the social issue, it would be best to enforce more stringent regulations of ADHD stimulants that are given to children. Proponents who feel that ADHD stimulants should be more stringently regulated made some great arguments such as stating many negative side effects that affect people taking medication and the degree of harshness of the side effects. Most people do not thing twice about taking medication that is given to them by their doctor because it is an automatic assumption that the doctor is giving them something that is necessary to better their health. This writer does agree that it is a good thing for people to be aware of the dangers of the medicine so that they can make an informed decision that will be affecting their health.

For a solution to the social problem, more stringent regulations for ADHD stimulants such as using warning labels on drug boxes as well as giving people medical booklets should be enforced. This solution will address the social problem because it will be helping those that are diagnosed with ADHD remain as healthy as possible. The solution would be successful because people would be more aware of what medicine they are taking and how their health would be affected. By providing warning labels, patients will not be deprived of their medications, but rather would have more of a choice.

Those that oppose more stringent regulations of ADHD stimulants argue that it will not be beneficial to drug companies or doctors since they will not be able to sell or prescribe as many stimulants. This writer is not disputing that the information that was given to show how it will negatively affect drug companies and doctors but their prosperity is not nearly as important as a person’s health. Opponents of stringent regulations argue that ADHD stimulants should still be prescribed because even though it is known that patients develop side effects, there is not enough evidence that shows that the negative side effects are caused by the drugs alone. This writer believes that if there is a known chance that the drugs are causing negative side effects, putting people’s life in danger is unethical. This opinion was formed based on the Principle of Paternalism. The Principle of Paternalism states that a legitimate goal of public authority is minimizing or lessening needless human suffering. A human being’s health should be prioritized over capitalism of pharmaceuticals.

After having researched the topic of whether or not stimulant drugs for children with ADHD should be more stringently regulated, two experts in ADHD were interviewed. The reason for the interviews was to assist in making a final conclusion after having reached a tentative one in support of more stringent regulations. Both interviewees were asked a total of 8 questions that included probes, which addressed different issues and moral reasonings that were involved in the controversy of regulating stimulant drugs. The first person to be interviewed was Dr. Whitney Hall, PhD. Dr. Hall is a staff psychologist at ADD Health and Wellness Center which provides individualized treatment plans specifically for people with ADD/ADHD or related symptoms. Dr. John Breeding, the second interviewee, is a psychologist with a private practice in Austin. Dr. Breeding is the director of Wildest Colts Recourses (a non- profit organization), and counsels both parents and children and leads workshops on how to handle children with ADHD.

Both interviewees were asked the same questions with the first one being, “Should the FDA more stringently regulate the use of stimulant drugs to treat children with ADHD?” and they both had very different answers. Hall responded by saying that she believes that stimulant drugs are already being regulated to a degree and feels that it is an adequate degree. She went on to explain how they are already being regulated such as people cannot call a prescription in, it has to be done in person, she explained that no more than thirty days worth of medication is given to a patient, and that in order to get a refill the patient or their parent must go personally to pick up a written prescription. Breeding on the other hand stated that more stringent regulations should be enforced. He believes that stimulant drugs should only be offered when there is evidence of a disease and there is no evidence indicating that ADHD is a disease.

They were both also asked if they felt that ADHD is being over diagnosed in children, and once again both had different perspectives. Hall clarified that ADHD is not necessarily being over-diagnosed but rather improperly diagnosed. Some reasons that she presented for the improper diagnosis is because there are times when a child can simply have a learning disorder or other numerous problems. When the same question was asked of Breeding, he was quick to mention that he could not answer my question because of the way it was asked. He explained that it was an invalid question from his perspective because he did not see ADHD as a valid condition. He sees ADHD as being a completely invalid concept, and as he pointed out earlier, there is not any evidence that showed that ADHD is not a disease so therefore it can not be overly diagnosed.

The next question that was asked was whether they thought that it was necessary for children diagnosed with ADHD to be given psychoactive drugs to treat the disorder. Hall explained that it varied by individuals. She felt that some people might need medications more than others but by no means does it mean that treatment must start with medications. When asked what age it is appropriate to give stimulants to children, Hall stated that she was not comfortable answering such a question because she herself does not prescribe medication. She did not want to give any false information. Breeding felt that just like he had mentioned before, there was absolutely nothing to be treated. He thought it was more of an ethical question that was asking whether it was appropriate to treat children to help improve their behavior. After restating the question he said that he was protectionist to children and did not feel that it was appropriate to give children medications. He mentioned that there were many negative side effects such as stunted growth, cardiovascular problems, and many more negative side effects. He felt that adults should be able to make their own decisions regarding what drugs are being put in their bodies but children do not yet understand and therefore cannot make these informed choices that negatively affect their body. Breeding strongly felt that it is never appropriate to give stimulants to children for it was like the equivalent of giving them cocaine.

Keeping on the same topic, both were asked what alternatives they would recommend for treating ADHD. This was the first question that both Hall and Breeding agreed on. They both mentioned nutritional because nutrition might be a reason children have behavioral problems. Hall further explained how while there is no solid science that says there is one specific diet, food additives should be avoided and sugar intake should be decreased. She mentioned that supplements can be helpful such as Omega 3, which helps produce cell membrane which in turn helps the brain function. Coaching a child was also recommended by Hall. Coaching a child, she explained, would provide the child with structure in their life. When being coached, children are helped with their homework and mnemonics. Both experts believed that working with parents is beneficial to the child. Breeding mentioned that he usually helps parents because children are too young to understand what is occurring. By explaining to the parents things like how to provide structure in their children’s life, like having the same morning routine, the child would be receiving help. Counseling said to be effective in children if they were having behavioral issues because of emotional problems. Breeding elaborated by saying that there are numerous reasons why some label children with having ADHD even though there is no such thing. He mentioned that people make the assumption that our current school system works for everyone when it does not. Sometimes children develop behavior problems that become alleviated once they transfer schools or even something just as simple as a change in teacher.

When asked if it is possible for the FDA to regulate stimulant drugs both interviewees answered yes. Hall declared that while she does think it is possible to regulate stimulant drugs, she feels that they are being regulated adequately and there is no need for more stringent regulations. She added that medication is not always the right path for everyone and that medicines do have negative side effect but that there are currently many ways to test for ADHD in a manner that is very reliable. She mentioned that a provisional diagnosis has to occur, the child’s background and history must be examined, and that neuropsychological testing should be administered. On the other hand, Breeding said that it is possible to regulate stimulants but in principle only. He mentioned that the government could do whatever they want and that while the FDA is supposed to be and independent agency it is not because they rely to heavily on drug companies for money. He mentioned that the best way to regulate the stimulant drugs is to actually ban the drugs and make them illegal altogether, only for children though.

The black box warning was mentioned earlier in the paper, but just to reiterate it is an intense warning that goes on prescription drug boxes. Hall felt that the FDA should not enforce black box warnings for there is not sufficient evidence that says the medications alone are causing negative side effects. She stated that the risk of stimulants for people with ADHD is not higher than those people that take stimulants and do not have ADHD, the risk are unclear. Breeding, on the other hand, thought that the black box warning was a step in the right direction. He stated that the use of the black box warning was an acknowledgment that the drugs can cause suicide.

Both interviewees were asked to give their expert opinion on a tentative solution to the problem. The solution that was presented to them was that the black box warning should be used more and that a medical pamphlet should accompany the drugs that are being prescribed. Hall disagreed with this solution by saying that the black box should not be used for there is not enough evidence that says the side effects are being caused by the stimulants. Instead she proposed regulating the media. She said that the media’s treatment of ADHD blows everything out of proportion which in turn scares parents away from medication that may be needed. By mentioning how the media’s role affects how ADHD is viewed by the public, Hall introduced a new perspective to this paper. Hall was enthusiastic while answering the questions and was careful not to give me any false information so she did not speak on topics she was unsure of. Although she was very knowledgeable about ADHD itself, she did not feel too certain about giving me information pertaining to the medications. She made it clear that since she did not prescribe medicine, she was not the person to be answering some of the questions. Hall was very professional in answering all the questions and always gave a great amount of information in support of her answers.

Unlike Hall, Breeding did agree with the solution but to a certain extent. While he thought the use of the black box warning and the medical pamphlets were a great idea, he did have concerns that the pamphlets may be biased depending on where the information was from. He did state though that drug makers are usually very good about putting accurate information on medicine labels. Breeding was extremely knowledgeable about the topic of ADHD as well as the controversy over stimulant drugs use in children. He referred to some of his own books that he has written as well as some pamphlets that he made. The interview with Breeding reaffirmed this writer’s tentative solution.

After having completed extensive research, interviewing experts in ADHD, and having analyzed and contemplated all of the information, this writer supports the enforcement of more stringent regulations on stimulants for children with ADHD. Although Hall mentioned that a black box warning was unnecessary and that some parents do get scared off from using stimulants Dr. Breeding made a good point by saying that parents should be aware of any risks that are even slightly possible. Both interviewees thought that parents should be informed about the stimulants which is why this writer feels that enforcing black box warnings and giving medical pamphlets to parents might help with better regulating stimulant drugs because parents will be able to make a more informed decision and will not just rely on their doctor’s opinion.

Conclusion and Author's Remarks

This author’s arguments are supported by obligations, values, consequences, and normative principles that are significant in my life. As a psychology major, and someone who is pursuing a doctorate in counseling psychology, this writer feels that they are obligated to help keep children safe and healthy. Children cannot speak for themselves so this writer feels that they obligated to be their voice. This writer’s values further strengthen this writer’s opinions because they value health, safety, self-reliance and education. Analyzing different consequences also helped this writer make a decision. By not regulating stimulant drugs more stringently, people who need medicine will be able to have access to it easier. However, if stimulants do become more stringently regulated, people will be more aware of what is being put in their bodies and of the negative side effects involved. Finally, normative principles were also considered when thinking of a solution. This opinion was formed based on the Principle of Paternalism. The Principle of Paternalism states that a legitimate goal of public authority is minimizing or lessening needless human suffering. A human being’s health should be prioritized over capitalism of pharmaceuticals. Even if there is not sufficient evidence that points directly to stimulant drugs saying that they are the sole cause of negative side effects, there is enough evidence that say that they can be the cause of some negative side effects. This is the main reason that thought of including medical pamphlets occurred because if people do become scared of the black box warning, they can read for themselves what each side effect is and how prevalent the side effects are.

For the purpose of civic engagement, the author presented this research to numerous Child Development classes that were studying ADHD. It was beneficial for students to hear both sides of an issue instead of just learning about the one side that is presented to them or forming their opinions based on the media.


“ADHD- A Public Health Perspective.” Centers for Disease Control and Prevention Website. 15 Sep. 2007 .

“ADHD Black Box Warning Update.” The Brown University Child & Adolescent Psychopharmacology Update 8.5 (2006), 6. Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

“Advocates Pleased with FDA Committee Review of ADHD Medications.” The BrownUniversity Child & Adolescent Psychopharmacology Update 10.6 (2006),1- 5.Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

“Advocates Pleased with FDA Review of ADHD Medications.” Mental Health Weekly 3 Apr. 2006: 4-5. Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

Bren, Linda. “ADHD: Not Just for Kids Anymore.” FDA Consumer Magazine Nov.-Dec. 2007. U.S. Food and Drug Administration Website. 16 Sep. 2007 .

“Debate Over Warnings for ADHD Stimulants.” Pediatric Alert 23 Feb. 2006. Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

Elias, Marilyn. “ADD Suicide Warnings to Antidepressant Labels, FDA Asks.” USA Today 23 Mar. 2004. Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

“FDA Warning on ADHD Medications ‘Premature’: National ADHD Advocacy Group Urges Further Research.” Ascribe Newswire: Health 15 Feb. 2006. Health Source. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

Ginsberg, Thomas. “ADHD Drugs Don’t Need ‘Black Box’ Warning, Advisory Panel Says.” The Philadelphia Inquirer 22 Mar. 2006. Academic Search Complete. EBSCO. Scarborough-Phillips Lib., Austin. 16 Sep. 2007.

Hawthorne, Fran. Inside the FDA. Hoboken: Wiley, 2005.

Koch, Kathy. “Rethinking Ritalin."

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