Thursday, January 9, 2014

The Marketing of ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is, like other psychiatric disorders, diagnosed based on symptoms, not biology. Although the symptoms described by the disorder have been known for centuries, it didn’t take its present name until the DSM III was published in 1980. ADHD had a treatment before it was ever conceptualized as a disorder. In 1937, Charles Bradley made a chance finding that the stimulant Benzedrine improved behavior and school performance in some children. These children had symptoms that we would now associate with ADHD, such as short attention span, hyperactivity, and impulsiveness.

Diagnosis of ADHD and medication treatment of it has skyrocketed in recent years. Last April, I blogged that almost 1 in 5 American high school boys are diagnosed with ADHD. There has been a 41% increase in diagnosis of ADHD in American children in the last decade. The increased diagnosis correlates with increased prescription of stimulant medications like Ritalin and Adderall. The number of children on medication for the disorder had increased from 600,000 in 1990, to 3.5 million today. Sales of stimulant medication in 2012 were nearly $9 billion, more than five times what they were ten years earlier. ADHD is now the second most frequent long-term diagnosis made in children, narrowly trailing asthma.

I blogged last July that stimulant drugs don’t improve long-term academic outcomes in children with ADHD. There may be a short term boost in school performance, but when evaluated years later, children treated with stimulants don’t function better than untreated children. Then why are they being prescribed so widely?

A recent New York Times article talks about how pharmaceutical company marketing is a major culprit behind the explosion in ADHD diagnosis and treatment. It also provides a detailed account of the various marketing tricks used to con doctors, parents, and patients into accepting the story that there are millions of undiagnosed children and adults with ADHD who would benefit from stimulant treatment.

Marketing to Doctors

Marketing to doctors is the original and most effective method for drug companies to promote ADHD drugs. A common technique is the pharma-sponsored doctor meeting, in which a paid physician spokesman presents to other doctors. The New York times article gives an example of William Dodson, a psychiatrist from Denver, who presented to 70 other doctors in Pasadena, California, in April 2002. Dodson encouraged his audience to “educate the patient on the lifelong nature of the disorder and the benefits of lifelong treatment.” This statement contradicts scientific knowledge. Studies have shown that about half of children with ADHD do not have the disorder as adults. Little is known about the risks or efficacy of long-term medication use.

Dodson’s presentation asserted that stimulants aren’t “drugs of abuse” because people who overdose either feel nothing, or feel bad. Then why are these drugs classified among the most likely to be abused? Severe heart problems and psychotic behavior can result from an overdose.

A slide in the presentation also warned that later in life, children with ADHD risked “job failure or underemployment,” “fatal car wrecks,” “criminal involvement,” “unwanted pregnancy”, and STD’s. This may be true, but studies haven’t shown whether stimulant treatment decreased the later risks for these bad outcomes.

Dodson, who received $2000 for this talk from Shire, and earned $45,500 in speaking fees from pharma in 2010-2011, makes a new ADHD diagnosis in about 300 patients a year, and always recommends their taking stimulants for life. “If people want help, my job is to make sure they get it,” Dodson said.

Many scientific studies cited by Dodson and other drug company speakers involve Joseph Biederman, a Harvard child psychiatrist. Biederman’s research has had major pharma funding. Biederman also made $1.6 million in speaking and consulting fees. Findings from Biederman’s studies on ADHD and different brands of stimulants are cited by pharma posters and pamphlets.

We can conclude from Biederman’s research findings the following:
  1. ADHD is underdiagnosed.
  2. Stimulants are effective and safe.
  3. Unmedicated ADHD results in risks of academic failure, drug dependence, auto accidents, and criminal behavior.
In 2006, Biederman said, “If a child is brilliant but is doing just O.K. in school, that child may need treatment, which would result in their performing brilliantly at school.”

According to Richard M. Scheffler, professor of health economics and public policy at University of California, Berkeley, “[Biederman] didn’t have a balance. He became totally convinced that [medicating ADHD is] a good thing and can be more widely used.”

Pharma advertises heavily for ADHD drugs in medical journals, the same journals that published pharma-sponsored research supporting the use of the drugs. The Journal of the American Academy of Child & Adolescent Psychiatry, the most prominent publication in the field, went from no ADHD med ads from 1990-1993 to about 100 pages per year a decade later. Almost every full-page color ad was for an ADHD drug.

Drug sales reps promote ADHD drugs to doctors in person. Brian Lutz, an Oakland, CA-based Shire salesman for Adderall XR from 2004-2009, said he met with 75 psychiatrists in his territory at least every 2 weeks. He showed the doctors posters and pamphlets that emphasized the medicine’s benefits. Side effects or possible abuse were played down. Lutz would refer only to the small print in the package insert or offer Shire’s phone number for additional information about risks.

Marketing to Parents, Teachers, and Children

The relaxing of federal regulations in the 1990’s allowed pharma to market controlled substances directly to the public. Drug companies took advantage of this to target ADHD drugs to parents, especially mothers. A magazine ad for Concerta had a mother saying, “Better test scores at school, more chores done at home, an independence I try to encourage, a smile I can always count on.” A 2009 ad for Intuniv had a child in a monster suit take off his hairy mask to reveal his wonderful smiling self. The text read, “There’s a great kid in there.”

The Food and Drug Administration (FDA) has repeatedly instructed drug companies to withdraw these types of ads, and has sent many warning letters. The FDA claims that the ads are false and misleading, or exaggerate the effects of the medication. Last February, Shire agreed to pay $57.5 million in fines for improper advertising and sales of several ADHD drugs, including Vyvanse, Adderall XR, and Daytrana.

Susan Parry of Mercer Island (outside Seattle) said that in the 1990’s, teachers pushed her into having her son Andy evaluated for ADHD. One teacher said that her own twins were doing great on Ritalin. A school psychologist gave her a pamphlet, which said that “parents should be aware that these medicines do not ‘drug’ or ‘alter’ the brain of the child. They make the child ‘normal.’” A pharma sales rep provided the pamphlet, which had a Ciba-Geigy logo, to the school district. Parry put her son on Ritalin for 3 years, but took him off when he had sleep problems and heart palpitations. Parry’s husband said that he “definitely felt seduced and enticed [by the Ciba-Geigy pamphlet]. I’d say baited.”

If we believe that pharma has any scruples, this is belied by their direct marketing to children. Pharma is not above marketing a controlled, highly addictive drug to children. Shire, manufacturer of Adderall and the longtime ADHD drug market leader, recently paid for 50,000 copies of a comic book. In this book, superheroes tell children, “Medicines may make it easier to pay attention and control your behavior!”

Marketing to Potential Adult Patients

Estimates of the prevalence of adult ADHD in the U.S. have typically ranged from 3 to 5 percent. Since adults outnumber children, the adult market could be potentially twice as large as the child market. Pharma has taken note of this and ramped up marketing to adults. Nearly 16 million prescriptions for ADHD meds were written for people ages 20 to 39 in 2012, almost triple the 5.6 million just 5 years before. This corresponds to an estimated 2 million patients.

William Dodson, the paid pharma psychiatrist spokesman mentioned above, in 2004 authored a booklet marketed to doctors. Sponsored by Shire, the booklet said that, “about 10 percent of adults have ADHD, which means you’re probably already treating patients with ADHD even though you don’t know it.” The 10% adult prevalence figure doesn’t reflect research findings. The booklet contains a quote from Dodson’s patient named Scarlett. “If you give me a drink or a drug, I’ll abuse it, but not this medication. I don’t consider it a drug. Drugs get abused. Medication helps people have satisfying lives.”

A Shire print ad for adult ADHD showed a happy couple’s wedding photo with “DIVORCED” stamped on it. The intention was to suggest that untreated ADHD leads to divorce. It cites a Biederman study which showed higher rates of divorce for adults with ADHD. This ad was misleading, because the study didn’t evaluate whether stimulant treatment had any effect on divorce rates.

Web searches for ADHD bring up short quizzes that can encourage normal people to think they might have the disorder. I tried the quiz on, and got a “ADHD Possible” result. I have some inattention symptoms, but don’t fit the (DSM-V) diagnostic criteria because they weren’t present before age 12. It’s easy for someone who doesn’t have the disorder to answer the 6 questions and get an “ADHD Possible” or “ADHD May Be Likely” result. In fact, in a NY Times-sponsored nationwide telephone poll, almost half of over 1100 adults in the poll scored in the possible or likely ADHD range (remember that true ADHD adult prevalence, as measured by scientific studies, is in the range of 3 to 5 percent). These tests influence many patients and doctors to see the disorder when it doesn’t in fact exist.

Tyrone Williams, a psychiatrist in Cambridge, Mass, thinks that these tests are misleading. “I do think that there are some people out there who are really suffering and find out that maybe it’s treatable. But these symptoms can be a bazillion things. Sometimes the answers are so simple and they don’t require prescriptions – like ‘How about eight hours of sleep, Mom, because four hours doesn’t cut it?’ And then all their ADHD symptoms magically disappear.”

My Own Experience With Stimulant Drugs

I have some of the symptoms of the inattention subtype of ADHD, such as difficulty holding attention on tasks, disliking sustained mental effort, being easily distracted, and forgetful. I have little problem with hyperactivity or impulsivity. I don’t fit the ADHD diagnostic criteria because these symptoms started after age 18. Nevertheless, at age 34, while struggling to keep up with schoolwork in biology, I talked my psychiatrist into prescribing me Ritalin. I was thus an example of an adult who was prescribed stimulants off-label for inattention symptoms. Pharma marketing wasn’t a major factor in influencing my decision to experiment with Ritalin. Being knowledgeable about neuroscience and psychopharmacology, I thought that Ritalin might be useful in my struggle to keep up with undergraduate science classes.

I found that Ritalin helped me somewhat with academics. It wasn’t a large boost, but it did help me concentrate and focus. The reason why I had to quit taking it after about 6 months, however, was that I felt it increased emotional suppression and decreased desire for socialization. Emotional suppression and social difficulties had been problems for me for many years, and I didn’t like the fact that Ritalin made it worse. I also felt addicted to Ritalin, getting a minor “high” every time I took a pill. I didn’t want to sell my soul to the pharma devil, to become a Ritalin addict, to sacrifice what little emotions and social life I had, to get slightly better grades.

Other people with normal emotions and social skills, but with inattention and hyperactivity symptoms, may not be as sensitive as I was to these side effects. But I think these effects are important and should not be overlooked, especially for children. As children grow, not only their academic skills, but social and moral skills need to be developed. Ritalin and other stimulants may help with academic performance over the short term, but “growing up” isn’t only about doing well in school. Children need to acquire habits of self-discipline, social skills, control over emotion, and responsibility. These habits cannot be found in a pill. This is probably the reason for the lack of long-term improvement in functioning of children with ADHD who are on stimulants, as compared to not taking stimulants. Parents sell their child’s soul to the pharma devil in order to placate teachers and make the child fit in the classroom environment, but the child is stunted in his long-term development.

Comparison With Autism

It’s interesting to compare ADHD with autism. The prevalence of both ADHD and autism has skyrocketed in recent decades. Autism spectrum prevalence is now approximately 1%, a 20-fold increase over the last 3 decades, and 78% increase between 2002 and 2008. Compared to 15% of school-age boys diagnosed with ADHD, the 2% of boys diagnosed with autism spectrum is tiny, but the point here is that prevalence in both ADHD and autism spectrum has greatly increased in the last few decades. One major difference between the two is that although ADHD has a (short-term) effective pharmacological treatment, there is no medication to treat the core symptoms of autism. While many children with autism are prescribed antidepressants, stimulants, and antipsychotics, these medications don’t treat the symptoms of social and communication impairments that define autism. So we can’t blame pharma marketing for the increase in autism prevalence.

It’s likely that the increase in autism prevalence is due to a combination of changes in diagnostic practices, increased public awareness, and actual increase in true frequency of autism. The increase in ADHD prevalence is probably caused by the same factors as with autism, except that pharma marketing must also be added in.

Environmental Risk Factors For ADHD and Disruptive Behavior

ADHD, like most behavioral disorders, is caused by a combination of genes and environment. The rapid increase in ADHD prevalence in recent decades is likely not a result of a major population genetic change, since these changes occur over much longer periods of time. Environmental factors (in addition to the ones mentioned in the previous paragraph) are involved in this prevalence increase. To explain this, any proposed environmental factors must have increased in intensity the past several decades. This excludes some common proposed environmental factors such as lead contamination, cigarette and alcohol use during pregnancy, and low birth weight. Lead paint has been outlawed, cigarette use among adults has declined in half from 1965 until 2011, alcohol use has declined slightly over the past 25 years, and many more women abstain from drinking when pregnant than before. Birth weights in the U.S. increased during the second half of the 20th century, but have declined in the last several decades. The decline is under 2%.

The American diet has changed significantly in the past 50 years, mostly in negative ways. The contribution of diet to obesity is well known and has an obvious causal connection. The connection of diet to ADHD is less obvious, but has been proposed and extensively researched. The idea that refined sugar may make children hyperactive makes some sense, but research doesn’t support it. A trendy theory is that food additives is a contributing factor for ADHD. There is little research support for this, although it’s possible that some artificial food colorings may increase hyperactivity in some children.

I’ll propose a different hypothesis about environmental risk factors for ADHD. I’ll begin by combining the so-called “disruptive behavioral disorders” (ADHD, Oppositional Defiant Disorder, and Conduct Disorder) into one entity. Not including predominantly inattentive ADHD, I’ll call this entity “disruptive behavior”. The DSM separates out the components of this psychiatric triad on the basis of symptoms and treatments, with the idea that ADHD is a biological-based disorder that can be treated by stimulants, and Oppositional Defiant Disorder (defying authority, noncompliance, tantrums) and Conduct Disorder (delinquent and criminal behavior) are separate entities, with different causes and treatments. They frequently co-occur, however, and this separation is unwarranted. It’s like separating depression and anxiety. Although depression and anxiety have different symptoms and treatments, they frequently co-occur, and this separation can hinder the search for causes.

Disruptive behavior occurs much more frequently among boys than girls. Difficulty paying attention, hyperactivity, impulsivity, defying authority, and noncompliance are defining characteristics. Untreated, this condition can turn into more serious delinquent and criminal behavior. There are sociological factors that have radically increased in the U.S. in the past half century, and that can logically be connected to disruptive behavior. The defining characteristics of these factors are:
  • Instability
  • Lack of structure
  • Lack of discipline
  • Lack of positive role models
In an unstable environment, one which lacks structure and discipline, one in which authority figures are weak or nonexistent, it’s reasonable to expect disruptive behavior. Specific factors include single parent families, permissive parents, lack of discipline in the home and school, unstable, dangerous neighborhoods, lack of male role models, delinquent peers, and a permissive, nonjudgmental wider society. Single parent families are archetypes of problem environments associated with disruptive behavior. Single parents families are unstable, a result of unmarried or divorced parents having split up. They don’t have the structure of a two-parent family. They are usually headed by females, who aren’t effective in disciplining male children. The absentee father puts a void in what should be a male role model. The number of children living in single parent households has nearly doubled in 50 years, with one in three children raised without a father.

Most of these environmental risk factors have become much worse in the U.S. in the last 50 years, at the same time of skyrocketing ADHD diagnoses. There is correlational evidence tying them to disruptive behavior, along with a logical connection. We’ve been in effect undergoing a real-life experiment. The research question is whether it’s possible to socialize children in the absence of stability, structure, discipline, and positive role models. Some children do OK in this environment: most girls and some boys. The boys who don’t do well have a certain genetic predisposition, one that can lead to problems, but that can also lead to creative achievement and leadership. The experiment has failed for these boys. This was obvious 30 years ago, and more obvious now. Every new boy diagnosed with ADHD and prescribed stimulant drugs is evidence of this failure.

None of these sociological factors are easy to change, certainly not for an individual therapist or doctor. The problem is so widespread it’s impossible to hold anyone accountable. It’s easy to blame the single moms, but they are single for a reason, and many times the reason has to do with problems with the father: he abandons the family, he abuses substances, he’s unemployed, he’s abusive, or he’s in jail. People from just about every walk of life have been responsible for the social changes that have led to the current predicament: parents, educators, lawyers, politicians, intellectuals, businessmen, artists, musicians, etc.

The psychiatric-pharma alliance has come to the rescue, offering drugs to control these boys’ behavior. The drugs will help boys do better in school, stay out of trouble, accomplish more. That was the marketing slogan. But the reality is that children with ADHD who take medication don’t do any better in the long term than children with ADHD who don’t take medication. Another reality is that boys are not accomplishing as much as girls. They perform worse at school, drop out of school more, and attend college at a lower rate (42 men versus 58 women). While it’s wonderful that girls are doing so well, it would be even more wonderful if boys kept up.

Example scenario

Let’s take an example of Laura, a stressed-out single mom with a boy named Mark who’s misbehaving and not paying attention in elementary school. Laura yells and screams a lot at Mark, but otherwise has no concept of proper discipline or authoritative parenting skills. She sees TV commercials for stimulant drugs showing smiling medicated boys with ADHD. She hears from Mark’s teacher that she should consider medicating Mark. In the old days, Mark would have gotten disciplined in school for his behavior, but in our brave new world of education that’s no longer allowed. Pharma sends pamphlets to schools promoting ADHD drugs, and the teacher gives Laura a pamphlet. It’s hard to find an available child psychiatrist, so Laura brings Mark to his pediatrician. After a 10 minute examination of Mark, the doctor prescribes a stimulant med. Mark’s pediatrician has been visited by pharma reps selling ADHD drugs, and has been to a pharma-sponsored seminar promoting stimulant drugs. It’s difficult to blame Laura for making the decision to fill the prescription and drug Mark for his ADHD.

Policy Recommendations and Conclusions

Stimulants are already controlled substances, so we need to tighten the controls. One policy change would be to not allow primary care doctors to prescribe stimulants for ADHD. They don’t have the training or time to make a proper psychiatric diagnosis. We can outlaw direct pharma marketing of stimulants to the public. Even better would be to require proof of long-term efficacy before allowing stimulants to be prescribed for ADHD in children.

We need to address the environmental risk factors for ADHD. Discouraging single parenting, training parents in authoritative parenting skills, restoring discipline to schools, improving neighborhoods, having positive role models for boys, and promoting positive, ethical behavior in the media can help reduce the prevalence of ADHD and juvenile delinquency.