Editorial Note: In an End of Year post on RxISK, the concept of a Drug Traffic Accident was introduced. This can refer to being run over by a drug, sometimes called side effects, or adverse events, or adverse drug reactions or it can refer to the trafficking of drugs. This post covers both types. The first part is written by David Antonuccio and the second by the Editorial Board of the New York Times.
You are a decorated researcher, with multiple peer reviewed nationally funded research grants on the prevalence and treatment of ADHD. These have shown that the rate of diagnosis of ADHD seems to be rising inexorably. You have developed a model behavioral program that is relatively inexpensive and can be implemented in any classroom in America.
Industry funded critics come out of the woodwork to call you a fringe scientist, an attempt to marginalize that appears to be standard operating procedure when new developments threaten industry profits and firmly entrenched beliefs. You are accused of inflating the prevalence of ADHD in order to further your “anti-medication agenda”, despite the fact that you are open to medication treatment for patients with severe problems who have been properly evaluated.
You decide that you must stand up for the data, no matter whose ox is gored. You warn that there are at least some communities in the United States where the rate of ADHD and related drug treatment exceed all reasonable estimates of the disorder. You gladly participate in public debate with your critics because you see it as a way to advance the science and participate in important academic discourse.
Then, out of nowhere, an anonymous typewritten complaint, that you are not permitted to see, launches a series of investigations into your research. Academics from all over the world rally to your defense by signing a petition supporting you. You are absolved of any wrongdoing in three subsequent investigations, recommended for promotion and granted the honor of a sabbatical. But ultimately your research is suspended and the data buried forever apparently because the university where you work is worried about the political fallout from the controversy. To make matters worse, since your position is not protected by tenure, your contract is not renewed the next year. So much for academic freedom!
About a decade later the data you produced are replicated and your work is essentially vindicated. In fact, new national studies suggest that ADHD is being diagnosed and medicated at rates that are higher than what your research indicated.
This may sound too far fetched to be true but it is what happened to Dr. Gretchen Lefever, a leading epidemiologist and ADHD researcher from Virginia. The details of her story are compelling and can be found in the peer reviewed journal article entitled “Shooting the Messenger”, published in Contemporary Psychotherapy.
Her story is reflected in the famous Arthur Schopenhauer quote, “All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.”
By THE EDITORIAL BOARD, New York Times, Dec 18th
The hard-sell campaign by drug companies to drive up diagnoses of attention deficit hyperactivity disorder, or A.D.H.D., and sales of drugs to treat it is disturbing. The campaign focused initially on children but is now turning toward adults, who provide a potentially larger market.
There is no doubt that a small percentage of children, perhaps 5 percent, have the disorder and that medication can alleviate the symptoms, such as inability to concentrate, that can impede success in school or in life. Some studies have shown that medications helped elementary schoolchildren who had been carefully evaluated for A.D.H.D. improve their concentration and their scores on reading and math tests.
Recent data from the Centers for Disease Control and Prevention showed that 15 percent of high-school-age children had been diagnosed with the disorder and that the number of children taking medication for it had soared to 3.5 million, up from 600,000 in 1990. Many of these children, it appears, had been diagnosed by unskilled doctors based on dubious symptoms.
A two-decade campaign by pharmaceutical companies promoting the pills to doctors, educators and parents was described by Alan Schwarz in The Times on Sunday. The tactics were brazen, often misleading and sometimes deceitful. Shire, an Irish company that makes Adderall and other A.D.H.D. medications, recently subsidized 50,000 copies of a comic book in which superheroes tell children that “Medicines may make it easier to pay attention and control your behavior!” Advertising on television and in popular magazines has sought to persuade mothers that Adderall cannot only unleash a child’s innate intelligence but make the child more amenable to chores like taking out the garbage.
The potential dangers should not be ignored. The drugs can lead to addiction, and, in rare cases, psychosis, suicidal thoughts and hallucinations, as well as anxiety, difficulty sleeping and loss of appetite. On Tuesday, the Food and Drug Administration warned that some A.D.H.D. medications, including Ritalin, Concerta, and Strattera, may, in rare instances, cause prolonged and sometimes painful erections known as priapism in males of any age, including children, teens and adults.
So many medical professionals benefit from overprescribing that it is difficult to find a neutral source of information. Prominent doctors get paid by drug companies to deliver upbeat messages to their colleagues at forums where they typically exaggerate the effectiveness of the drugs and downplay their side effects. Organizations that advocate on behalf of patients often do so with money supplied by drug companies, including the makers of A.D.H.D. stimulants. Medical researchers paid by drug companies have published studies on the benefits of the drugs, and medical journals in a position to question their findings profit greatly from advertising of A.D.H.D. drugs.
The F.D.A. has cited every major A.D.H.D. drug, including the stimulants Adderall, Concerta, Focalin and Vyvanse, for false and misleading advertising since 2000, some of them multiple times. The companies, when challenged, typically stop those misleading claims, but the overall impact appears marginal. The number of prescriptions for A.D.H.D. drugs for adults ages 20 to 39 nearly tripled between 2007 and 2012, and sales of stimulant medications in 2012 were more than five times higher than a decade earlier.
Curbing the upsurge in diagnoses and unwarranted drug treatments will require more aggressive action by the F.D.A. and the Federal Trade Commission, which share duties in this area. It will also require that doctors and patients recognize that the pills have downsides and should not be prescribed or used routinely to alleviate every case of carelessness, poor grades in school or impulsive behavior.
The true rate of hyperactivity in children that could unequivocally benefit from ADHD medication is unlikely to be more than 1%.
Shire is not an Irish company any more than Forest Laboratories is. Both have a base there for tax reasons.