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.”
An Epidemic of Attention Deficit Disorder
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.
Copyright © Data Based Medicine Americas Ltd.
The NY Times ran a very good article with this editorial on the selling of ADHD. It featured a psychologist who once campaigned for ADHD awareness and now regrets his part in an unfolding “national disaster”:
The most darkly hilarious part of the article was the quote from a brochure for Adderall XR: “Amphetamines have been used medically for nearly 70 years. That’s a legacy of safety you can count on.” They have a legacy, all right … but hardly one of safety.
It bewilders me how so many “experts” seem to have forgotten the last epidemic of amphetamine abuse, in the ‘60’s and ’70’s. Repressed memory, maybe? They were probably well aware of it as teenagers when many of their favorite psychedelic bands were warning that “Speed Kills.” That epidemic, like this one, was fueled by doctors’ careless prescribing and drug company promotion of speed as a weight-loss solution (and earlier, as a remedy for fatigue and depression).
Amphetamines were still a big problem when I worked in the railroad industry in the late 70’s. Anyone who’s worked with, or lived with, a “speed freak” can tell you that these are not benign drugs – and they can be wickedly addictive. I knew several back then who got their start by bumming their girlfriend’s diet pills. (Adderall itself is a re-purposed version of a diet pill called Obetrol, which was Andy Warhol’s drug of choice I believe.) Today they’re likely to get it straight from the doctor for “adult ADHD” – sometimes, after sampling their children’s pills.
Indeed, Alan Schwarz of the New York Times has written a great series of articles on ADHD. His stories, which have appeared on the front-page of the New York Times Sunday edition, have impact what some notable and long-time ADHD insiders have to say about diagnostic abuse and associated drug use. However, the broader public seems to be relatively numb. A decade ago when rates of ADHD diagnosis were at least 50% lower than they are today, the public was vocally concerned. Today, the public has been relatively silent – at least in the community where I conducted ADHD research between 1995 and 2005. In the past, any ADHD news story or commentary resulted in a firestorm of expressed opinion. Last month, an ADHD op-ed that was published in the local paper resulted in zero (0) responses (http://www.dailypress.com/news/opinion/dp-nws-oped-watson-1211-20131217,0,5149623.story). Interesting!
When discussing ADHD, we are talking about a disorder that responds well to stimulants, not their abuse. Ritalin and Adderall have proven to be very safe over time if taken as prescribed.
Aspirin is more dangerous when it is abused.
Nothing taken over time is likely to be safe. All medicines are poisons. So they need to be used judiciously and with recognition that even if helpful on one level they still come with risks
This same multi tiered scam is reported so often, that it begins to read like this:
“And, so another day dawned with the sun appearing in the east…
Blah. blah,blah– big yawn!”
BUT, in reality, this very concise recap:
“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. – See more at: https://davidhealy.org/drug-traffic-accidents-adhd/#sthash.IO1kTz55.dpuf”
should be followed by the sound of a stampeding swat team! or at least police sirens– or fast approaching— Bells? Whistles? A flag on the play?
Fraud for profit that has proven serious health risks, is a crime. Right?
A really fascinating story would explain why the FDA is a crap shoot for this level of crime stopping power– and, for the love of Larry, can we please get the skinny on why there is a rise in the tone of alacrity with each reminder that now– even doctors can view the public as so many suckers born every minute !
I still take issue with the statement “There is no doubt that a small percentage of children, perhaps 5 percent, have the disorder.” The diagnosis is the problem as it is not a scientifically validated diagnosis. Big Pharma has been able to pull this kind of fraud off because we all want to believe that ADD, Depression, Anxiety, etc. are medical diseases. If you can convince the public that there is something wrong with them, you can easily sell them “treatments” for their afflictions. Whether 5% vs. 50% of kids have the disorder doesn’t really matter….. Stealing $5.00 or $5m….both are stealing.
It is a scientifically valid disorder. It is widely acknowledged by the vast majority of Medical Doctors and scientists around the world as a real and easily treated biochemical/electrical/neuronal complex medical dysfunction.
Adult ADHD is not scientifically valid. Until a very few years ago – 10 at most – most doctors didn’t agree it existed. Scientific vlidity doesn’t emerge overnight- other than from marketing departments – who can sell ideas like lowered serotonin in depression
Excellent to-the point paper by Professor David Antonuccio about the “Mythical ADHD and LeFever’s research. I too take issue with the statement that there is no doubt that a small percentage of children have ADHD. That statement, with nothing scientifically to back it up, perpetuate=s the Myth of ADHD In my practice of 40 years, almost all the kids who come in with an ADHD diagnoses are, after a careful evaluation depressed, and always for a very good reason. So be clear, depression is also not a real disease, but a state of mind based upon the realities of our experience. By the way, the percentage of ASDHD diagnosed kids who aren’t depressed usually have some metabolic problem or allergic reaction to various things, a thyroid problem, endocrine problem, etc.
ADHD is real, disabling, humiliating, crippling and endlessly criticized. I have it. It devastated me. No one knew what was wrong with me. but I was condemned by my Harvard/Radcliffe educated parents, my teachers, my peers and me, non-stop. It was hell. At 40, I was dx’d, treated and given a new life. Why doesn’t ANYONE ask us for our accounts? We are human. ADHD hurts, bad, deeply. Why make fun of us through condemning all doctors and an industry that saved our lives? Doesn’t anyone want to hear from us? How cruel you are. Vicious, mocking, tormenting–just like the people from our past.
ADHD is real for sure – it is rare and affects children but they grow out of it and temporarily while it is a problem stimulants can make a difference. The problem is once a set of loose criteria are drawn up – like a hororscope lots of people can figure they have the condition in this case of their future is mapped out in the other. All of that is fine but what you are not taking into account is marketing and how pharmaceutical company marketing can take vague criteria and use them to suck people into taking meds – none of which are safe.
Stimulants can help people, whether you have a diagnosis or not. One of the other options is that we differ – which we do – and that the kinds of difference that lead to ADHD diagnosis might be better viewed as a different set of skills with the best option being finding where these skills fit in and not turning to a drug to help you fit in.
I guess you don’t see the people I sse who have been badly damaged by taking a pill to change themselves in order to fit in
“ADHD is real for sure – it is rare and affects children but they grow out of it and temporarily while it is a problem stimulants can make a difference…” Dr David
Often, children do not grow out of it. But, stimulants do make a difference–often, a profound, life-saving change. However, since you shut me out, as I said you would and as almost everyone does, you know nothing about the suffering I endured until I was 40. Dr. David, as a doctor, don’t you have some empathy for someone who describes living in hell for decades? Isn’t there the slightest concern about someone/anyone who has been brutalized for years? When it was unnecessary?
This is what I am trying to tell people. Why doesn’t Anyone ask us what it was like, during the time we were left on our own, without proper medical care? Why isn’t someone curious enough to inquire? If I claimed a drug a lifted me out of the depths of autism or mental retardation or schizophrenia, and my new life clearly reflected such a dramatic recovery, people would be astounded and would clamor to talk to me personally (not me personally but anyone having gone through this) to try to understand what had happened. That is the natural response to a life changing event one has had. Not with ADHD. Why? Why won’t someone Listen? Why are we discounted, ignored, dismissed without the slightest twinge of conscience? I feel I am shouting through a megaphone to a deaf world, “Hear us”. We have insights into this disorder. It practically killed us. It was torture for me to attend school every day unable to learn. To sit in my chair and to try to find something to do or think about as time passed crushingly slowly, was excruciating. Not knowing what was wrong with me and being condemned constantly was worse than death. There are kids and adults today who are not diagnosed. We adapt. We compensate. We specialize in fooling people. I knew when to nod my head, smile, look sympathetic or interested, through the tone of a voice or facial expressions or body language, and it worked for a while and depending on the situation. I never knew I did that until meds gave me the ability for the first time in my life at age 40, to hear, to see, to focus without even trying. Take us into account as real human beings when you offer your opinions about it. Why doesn’t it make sense to find out what we have to say? How does it hurt to give us a voice?
I think you are badly misreading things. I wrote the first guidelines for the use of stimulants for children in the UK so to accuse me of neglecting a problem or not working to make treatments available just doesn’t stack up. I still use them.
Similar I was among the first to use SSRIs in the UK having done a PhD on the serotonin system. I still use them. But the situation has gone mad – there are likely at least 99 being harmed by the indiscriminate use of these drugs for every one who benefits.
I have no doubt that people can benefit from a stimulant but the mass marketing of Adult ADHD which has no basis in reality is harming people. Many doctors give people an ADHD diagnosis in order to give them a stimulant – this is crazy. Giving a stimulant may be helpful but someone needs to monitor whether in fact it is helpful rathe than say you have ADHD and therefore need to continue having them.
ADHD has become a gateway diagnosis to getting multiple diagnoses and ending up on polypharmacy. I’m glad you are benefitting but what do you say to the many who have been harmed by this industry? I’m not calling for a ban just for some realism and the ability to both use and stop these medicines
Dr. David, I appreciate your interest in having a discussion on this topic. I cannot solve the “mass marketing” problem nor forbid doctors from violating their oaths or don’t do proper follow up. My goal at the moment has nothing to do with those issues. You would not tell a cancer patient who was rejoicing in the healing treatment she received, settle the problems of misdiagnosis, the money wasted on research or how greedy medical doctors only seek to make big bucks for trying to treat cancer, or the drug companies peddling drugs that allegedly reduce the size tumors or kill cancer cells. You wouldn’t expect a patient to attempt to resolve those matters when having an open dialogue about her cancer, would you?
Many drugs have serious side-effects. Warning labels advise against prescribing/using them when certain conditions exist. But, again, not my point.
I made another comment that is gone. I don’t want to repeat the same things. At the risk of doing so, I will make this brief.
Why, WHY, Dr. David, is no one seeking to find out what happened to us? Why is no one thrilled for the “breakthrough” modern medicine has made in and for us? Why isn’t anyone really and truly and honestly, eager to explore what our transformation has been like? That is a fair question.
The marketing is your problem. There is no incentive for drug companies to investigatte what might be wrong with you when they can make so much money out of not investigating it. Are horoscope designers going to sit down and work out which forecasts are accurate and why?