Professionalism/Ethics and ADHD Diagnosis

Introduction

Symptoms of ADD were first recognized by Sir George Frederick Still during the Goulstonian Lectures discussing Some Abnormal Physical Conditions in Children.  Still explains “a notable feature in many of these cases of moral defect without general impairment of intellect is a quite abnormal incapacity for sustained attention” . ADD was formally recognized in psychiatry in 1968 with the addition of hyperactivity coming in 1980 .  Since then, explanation of the disease has expanded with increasing specificity and characterization.

In the late 90s and early 00s diagnosis in children for ADHD increased from 7% to 9%. In 2011 diagnoses rose to 11%, and in 2016 the percent of all children taking ADHD medication was 5.2%, of those diagnosed with ADHD 62% were taking medication for it.

To accompany this rise in diagnosis, ADHD medication has become a multi-billion dollar industry. Marketing has sought to expand the scope of the disease characterizing carelessness and impatience as symptoms of ADHD. Companies leave the onus of diagnosis and prescription with doctors but are creating an environment where patients and their relatives are led to believe the solution is a pill. Companies work to downplay the side-effects of these medications, some of these being "sleep problems, decreased appetite, delayed growth, headaches and stomachaches, rebound (irritability when the medication wears off), tics, moodiness and irritability". It should be noted, "The Food and Drug Administration has cited every major A.D.H.D. drug — stimulants like Adderall, Concerta, Focalin and Vyvanse, and nonstimulants like Intuniv and Strattera — for false and misleading advertising since 2000, some multiple times".

History of Adderall

Benzedrine was introduced in 1936. The firm, Smith, Kline and French created and manufactured the drug. Sales went from 500,000 to 2 million dollars from 1941 to 1945. Ritalin was FDA approved in 1952. In the early 60s, Ritalin and other amphetamines were abused so frequently that in 1971 it was ruled a Schedule II narcotic. A Schedule II narcotic means that it has a high potential for abuse and needs a new prescription every time a refill is ordered. Doctors and patients had a harder time justifying the prescription and by the late 70s amphetamines were abused much less.

In 1973, Obetrol, an amphetamine made by Rexar for weight loss, was withdrawn by the FDA. Nothing was done to stop its manufacturing, so it stayed on the market until the 1990s. In 1994, Richard Griggs bought Rexar and Obetrol. Obetrol wasn't selling that well at that time but Griggs noticed that it was doing well in Utah, one doctor using it for ADHD. Griggs bought Rexar in 1994 and rebranded Obetrol as Adderal. He came up with name "Adderall" to sound like "Add for All". Griggs said, "It was meant to be an inclusive thing". The FDA quickly banned Griggs from selling Adderall because it was still banned and there had not been new trails. He submitted a new application that he was unsure would pass. A lobbyist told him he was "golden" because a senator was furious that his son could no longer get Adderall. In 1997, Shire bought Richwood, for 186 million dollars.

Shire began paying for clinical trials of Adderall. In a 2000 interview with Stephan Antosson admitted that "the vast majority" of clinic research was funded by Shire. In 2002, Dr. William W. Dodson received 2,000 dollars from the Shire to talk in front of 70 doctors claiming that the effects of Adderall XR were "generally mild". Dodson diagnoses 300 new patients a year with A.D.H.D and believes these patients should be on medication for life. From 2010 to 2011, he has received 45,500 dollars in speaking fees. In an interview with PBS, Dodson claims that "properly adjusted medication does not change the child's personality any more than eyeglasses."; when he was asked if he thinks money and free samples given to doctors would change prescription habits, he responded: "If it did not change prescriptions habits, most drug companies wouldn't do it." Another doctor, Dr. Joseph Biederman was paid 1.6 million dollars in speaking fees, by companies including the Shire. Biederman was sanctioned after a three-year investigation concluded that he violated conflict of interest rules.

Shire's marketing worked. From 1996 to 1999 prescriptions for amphetamines (mostly Adderall) rose from 1.3 million to 6 million. From 2007 to 2011 amphetamine sales increased by 46 percent.

Increase in Diagnosis

The increased in prevalence of the disease is difficult to pinpoint as University of California, Berkeley, psychologist Stephen Hinshaw notes “ADHD is just like depression, just like autism, just like schizophrenia in that it's a symptom-based mental disorder. We don't have a blood test or a brain scan yet that's definitive. … It's always a bit arbitrary as to who is actually above the cut and who is below because we don't know exactly where the cut is". Working with health economist Richard Scheffler, the two discovered “policy had an indirect influence over these diagnoses. We found that during the late 1980s and throughout the 1990s, several states passed consequential accountability laws … Instead of funding schools based on the number of students in them, funding became based on their students' standardized math and reading test scores. Schools were rewarded for doing better.” Hinshaw and Scheffler conclude, “Basically, you diagnose these kids because improving their performance helps the school's performance”.

Other causes for the rise in diagnosis are related to increased parental pressure for a diagnosis from physicians, increased awareness and acceptance of the disease, or from self-diagnosis through the internet.

Torres v. Shire & Other Misconduct

Gerardo Torres was the Vice President and Scientific Lead of the Business unit at Shire. In 2008, Gerardo Torres headed an "ADHD awareness tour." Torres said, "Shire developed this mobile screening initiative as a forum to educate the public about ADHD in adults and provide information and resources to individuals about this disorder. This program demonstrates Shire's on-going commitment to providing information for those who may be struggling with the symptoms of ADHD." In the Shire 2005 annual report Torres is a featured person and has nothing but praise for the company. He says, "Shire’s portfolio of marketed and development drugs make it very well positioned in ADHD. Our vision is to have several unique products serving most if not all types of ADHD patient." He was clearly an important figure and an advocate for the work Shire was doing.

Eventually he started to realize that something was amiss. He thought that too many people were taking these drugs and according to his lawyer, "he couldn't sleep at night." He was worried that families were being pressured to consume ADHD medications. He accused Shire of claiming things about their drugs that simply weren't true. They claimed that it could help prevent sexually transmitted diseases, divorce, and other issues. Gerardo Torres filed a lawsuit against shire while he still worked there. Shire lost this case and was required to pay almost $60 million dollars to the Department of Justice as a result. Torres received a $5.9 million dollar payout as a result.

Another lawsuit was filed by Anita Hsieh, Kara Harris and Ian Clark, who were former Shire sales representatives. Apparently they were told to try and collect patients files from doctors so that they could find patents to target. They would also phone Medicaid for Vyanase approval hiding the fact that they were Shire reps. When they tried to raise an issue, they were fired. These three reps also received $5.9 million each from the government for their whistle blowing. The government wanted to continue to encourage outing bad practices. Shire maintains that they did not do anything wrong.

ADHD Marketing to the General Public

The marketing discussed here will only be related to Shire and pushing their ADHD medication. Shire has very target ad campaign to reach those with ADHD. One poster says, "I'm depressed...Could it be ADHD? ADHD was found in 32% of adults with depressive order." Another add has a strikingly sad children's drawing of a family that is captioned, "The disruption of ADHD affects more than their grades." Finally an ad with a husband and a silhouette of a bride is titled, "Adults with ADHD were about 2 times more likely to be divorced." These ads are targeted at secondary manifestations of the symptoms of ADHD, not the symptoms themselves. In this way, Shire could reach a larger audience with their campaign.

Another, more subtle campaign can be seen targeted at children. Shire helped fund a medical comic for kids that helps explain ADHD. In it, there's a heroic character that proclaims, "Medicines may make it easier to pay attention and control your behavior!" This comic book also suggests other form of treatment such as therapy and counseling. It can be seen however, that this comic book is in Shire's monetary interest. If younger people become dependent on the company's drug then that's a profit into the person's adulthood.

Roger Griggs, the person who purchased Rexar and coined the term Adderall, said he "strongly opposes marketing stimulants to the general public because of their dangers".

Conclusion

The reason ADHD has professional and ethical implications is due to the difficulty in providing an impartial diagnosis. It is unique in that there exists no specific test for ADHD and therefore interpretation of subjective evidence is required in making a diagnosis.  The professional must provide their diagnosis under social pressures from parents or the patient themselves treating a positive diagnosis and subsequent prescription as the only solution to academic, relationship, and lifestyle problems. Pharmaceutical companies only exacerbate these feelings in their crafting of adds exploiting these insecurities. 

Ultimately diagnosis is the responsibility of the professional, their expertise is necessary as they have been entrusted to render diagnosis based on their medical training. Allowing diagnosis to come from an often-untrained source such as the patient’s relatives, the patient themselves, or an outer entity is a failing on the part of the professional to their profession.   

Lapses in professional judgement regarding medical diagnosis merit ethical consideration.  Exploiting one’s position and expertise for monetary or career benefit is ethically wrong.  Colluding with companies in this exploitation doubly so.  Medical professionals take an oath to “Do No Harm” and it must be acknowledged that a diagnosis which has no foreseeable end as well as adherence to a lifetime of medication can be quite impactful on how someone defines their life and how their life is in turn defined by those around them.  For this reason, professionals should treat the lives of their patients as the most important factor in their diagnosis, anything less is professionally irresponsible and ethically questionable.

Suggestions for Future Work

The New York Times article The Selling of Attention Deficit Disorder had a great deal of information that may merit further exploration. ADHD advocacy groups such as CHADD and ADDItude are also worth looking into. Ironically the ADHD Institute (an educational platform funded and developed by Shire) referenced in this page for its description of changes that the DSM-IV and DSM-V brought to ADHD should be addressed for its validity in reporting on those changes.

The page as of now relates only to ADHD diagnosis in the United States but would likely benefit from international information, specifically addressing any similarities or differences between ADHD diagnosis in the United States and other countries.

The page mainly discusses a case involving Shire Pharmaceuticals though it is suspected other such cases exist and exploring them may prove helpful to the chapter. It was difficult to find concrete reasons for an increase in diagnosis due to the subjective nature of ADHD diagnosis, future work may serve to provide more objective reasoning as information becomes available.

There are also other pharmaceutical companies that have misleading advertising campaigns or advertise in a way to reach a broader audience. An example is that erectile dysfunction ads have been viewed several million times by children though they're not supposed to be. Looking more into the ways that companies target their ads could give interesting insight into the diagnosis of other illnesses.