Drugmakers Nix Long-Term Study On ADHD Meds
30 CommentsBy Ed Silverman // March 8th, 2010 // 8:43 am
A confidential report issued last fall by Novartis on behalf of several drugmakers that sell ADHD meds concludes it isn’t feasible to conduct an observational, comparative long-term study to validate a signal of adverse psychiatric or cognitive outcomes from the long-term use of methylphenidate in children and adolescents with ADHD. Methylphenidate is sold as Ritalin and Concerta, for instance.
The 18-page report, which recently began circulating on the Internet, was compiled in response to a requirement issued last year by the European Commission to conduct such a study after the Committee for Medicinal Products for Human Use expressed concerns about safety issues, including sudden death, cerebrovascular disorders and psychiatric disorders as well as the effects on growth (see here).
However, the manufacturers - which refer to themselves as a consortium and include Johnson & Johnson and Shire - conclude a study isn’t feasible. Why? Comorbidity. “It is well established that ADHD co-occurs with other psychiatric disorders, including disruptive behavioral disorders such as oppositional defiant disorder, conduct disorder; and mood disorders such as depression, bipolar disorder; and anxiety disorders.” In other words, adverse events may be explained by other psychiatric disorders, such as bipolar disorder, for which still other meds may be needed.
“The difficulty (in conducting a feasibility study) stems, in part, from the fact that the endpoints of interest are part of the natural course of the disease, may also be related to the severity of the ADHD symptomatology and the overall psychiatric condition of the patients and the resulting treatment needs, leading to confounding by indication,” according to the report. Interestingly, the report cites various studies by Harvard University’s Joseph Biederman, who is credited with spearheading a big increase in the number of kids diagnosed with bipolar disorder, but was accused by a US Senator of failing to fully disclose payments from drugmakers, including J&J (see here and here).
harpy
bullsh*t
SteveM
I’m not an expert, so can’t make a judgment on this subject.
But Joseph Biederman is the Joseph Mengele of child psychiatry. His validation of the Big Pharma claim is meaningless.
Lisa Van Syckel
Ahhh, excuse me,… no such thing as bipolar disorder in children!!! Wont find it in the psychiatric bible, and you wont find it in the future psyche bible either.
Harpy is correct, this issue is BullShit..
Patient who knows
Well if it has Novartis name on it you can be sure it is BullSh*t.
Remember folks Novartis = no veritas, but they sure are rich…
Dan Vasella spent a few years in Psychotherapy to help re-frame his life. I am sure he wasn’t helped with these drugs, so, why is it OK that we can do this with other people’s children?
M Helm, MD
I agree with harpy.
The person most connfused about bipolar disorder and ADHD is Dr. Biederman. He was paid handsomely to sell-out a generation of children to PhRMA interests and muddy the waters for clnicians (far too many of whom apparently learned in medical school to listen to what the teacher says rather than to critcally evaluate a theory).
There are a number of reasonably good tools to identify ADHD, but like every other “mental health” diagnosis, all other possible causes of the observed behavior must be ruled out. My impression is that most kids get the diagnosis from a teacher or their own parents - whether or not it is accurate. I also have the impression that parents believe that ADHD medicines can make their children smarter or more disciplined without any effort or adverse effect. Lack of initial diagnostic accuracy IS a legitimate problem, but fixing that may decrease the market for ADHD meds.
I’m pretty confident that NIH and some of the European agencies could conduct this study. The problem is that it is an expensive and time consuming proposition. The current patents will have long expired by the time the results are in, and someone (or several) in PhRMA have done the financial calculus that the goodwill for funding/starting the study will do nothing to enhance revenue or profitability.
Any manufacturer of drugs would make the same call. Far better to continue to encourage the use of an imperfect/potentially harmful (but approved and widely used) medication so that some day you may also sell the “antidote” - if it is patentable. Far better also to choose to not know if one of the existing (by that time generic) medications is in fact the ideal treatment with no more than minor risks over a very long-term - this would make the “next-generation” far more difficult to sell.
The response is disappointly predictable and crass if you are an advocate for patients and the progress of science. However, if you are making medicines for profit, the best answer to this challenge is to produce a fig leaf to cover your real interest.
Listening to both sides of the PhRMA mouth, we are left to conclude that inventing a new medicine - never before conceived - is less difficult for PhRMA than studying the actual effects of a medicine they already make. That is a bitter pill of irony too hard to swallow. But it is a good recipe for high profits and little perception of trustworthiness.
Justice in MI
Lord Biederman notwithstanding, aren’t there essentially always “confounding” variables and “comorbidities” in observational studies of psychotropics?
And wouldn’t a well-designed observational study cover the question?
patrons99
Long term cardiotoxicity is a VERY real concern for most of the ADHD meds. Most of them are stimulants, sympathometic amines, relatives of amphetamine. Adderall is nothing more than mixed amphetamines. Most of them are just me-too agents. They are grossly over-prescribed. They are dangerous drugs in much the same way that “speed” is dangerous. That’s been known for a long time. Why they keep gaining market approvals from FDA is a mystery to me. It’s a public disservice. The cost to society in terms of human suffering (morbidity) has been high, not to mention the completely unnecessary burden on the federal fisc.
pharmavet
The following comments are from a psychiatric resident, excerpted from another website, concerning so-called childhood psychaitric disorders. Interesting food for thought.
“I did a Sub-I as a 4th year on what I thought was an excellent inpatient child psych unit. I went into it think I’d hate it, and only did it in order to get experience with child psych disorders prior to becoming an intern (as I now have to see all psych consults, adult or children, in the ED).
I was alarmed at the degree of social pathology. For the most part, the children on this unit were the “canary in the coal mine” of some extremely, disturbingly, messed up families. These kids needed a life transplant and what child psychiatry had to offer was polypharmacy.
The upside to my month as a Sub-I on inpatient child psych, was that my attending (a wonderful man) made every effort to get these kids whose problems were caused by trouble at home off the long and ludicrous med lists they came in on. We would slowly taper these kids off their meds and basically see what we had, make a clean diagnosis, and then go from there. Also, while on an inpatient unit the kids were able to work daily with the child psychologist - an intervention I thought more appropriate for these socially troubled youths. They needed to learn how to handle their emotions, which isn’t something a pill can teach.”
pharmavet
If this is a big enough public health problem, let the government conduct the studies. Somehow they found the money to conduct landmark studies like the LRCC cholesterol reduction study, which showed the benefits of cholesterol lowering, and the Women’s Health Initiative Study, which showed the dangers of estrogens. Those studies, in fact were much larger than the one under consideration here.
Justice in MI
Great points, here. This a bit tangential, but the rate of Adderall use for academic “performance enhancement” is chilling. A pre-med told me the other day that she’d estimate half the pre-meds use it–beying it from friends or finding a pill factory to rx it. Studies suggest about 25% of college students “pharm,” as they call it.
Of course, none of this is medically supervised, and few students have any idea of risks, dosing, interactions, etc.
One of the more grievous signs of the times….
M Helm, MD
Pharmavet,
My experience has been that most academic units (where the psychiatry resident did his 4th year sub-internship) spend more time removing medications and arranging useful and effective, though time-consuming and poorly reimbursed interventions. Private psychiatric hospitals and out-patient psychiatrists spend more time focused on starting medications and providing medication managment services, while disregarding the social pathology (which they don’t get paid to fix), and minimizing the contribution of outpatient counselling (which many complain that patients and families ‘resist’). The drugging of our children is a direct consequence of a set of ‘perverse incentives.’ Even academicians (such as Biederman) are not immune to this.
If you ever watch ‘Supernanny’ you can see easily how a set of consistently applied behavioral tools can dramatically improve problem behaviors. Immature humans are not born knowing how to behave in society, they learn this from their environment. I’m not disputing that there are some very disturbed children and some real pathology out there - I’ve seen it (and referred to Child and Adolescent Psychiatrist who I know and trust). But mostly those cases are very rare. It is difficult to explain how more than 10% of kids “need” psychotropic medications (including stimulants). In my part of the world, More than 4% of school age children covered by Medicaid (more than half the total population of children) are treated with antipsychotics. While there is wide-spread agreement that this is likely bad for kids and the general public, their has been great reluctance from the entrenched mental health interests on whom our Medicaid program relies for guidance to do anything effective about it.
SteveM
Re: Dr. Helm
Concur completely. The problem is that psycho-pharm has infiltrated psychiatry completely. So even the ethically toxic Big Pharma money is not very important any more because the drugs as primary therapy model has become normative.
The problem with the medical community from this outsider’s point of view is that its members won’t call a spade a spade on account of professional courtesy or something.
Peter Kramer has been espousing his brain drugs as pixie dust gospel since Listening To Prozac. I mean his professional reputation depends upon him sustaining that obsolete viewpoint. Does anybody in psychiatry put the knock on Kramer for being an egotistical nitwit when he spouts for the NY Times or Salon?
And how about this recent report by child psychiatrist Joan Luby:
http://www.health24.com/news/Depression/1-903,51967.asp
Luby claims that half(!) of all kids have significant psychiatric disturbances. Where are the counters from fellow psychiatrists to this obviously flawed piece of tendentious research? Once Pharma gloms onto reports like that, it’s all over for the kids. Luby’s a menace.
Where are you guys?
Stephanie
It is tougher and tougher for parents to advocate for the kids and keep them off the meds. The schools are supposed to provide services as dictated in their IEP’s but since the therapists are over loaded they skip on some of the more “mild” cases and when you call out the school on no improvement, the very first words out of their mouths are “He has an attention problem”! I continually get subtle and sometime not so subtle hints from the school to look into medication. I am holding firm, but I am sure they wear down quite a few parents.
I know many children and some adults on these meds and I don’t think they really realize the dangers that could be ahead for them.
David, Health Blogger
I have written extensively about ADHD medications and the very first thing that needs to be noted about them is this:
For those with ADHD, treatments like Ritalin and Adderall can be life changing in an extremely positive way.
That said, we need to know what long term effects of these medications are.
They are being used for long, long periods of time. I am positive that their incidence of psychiatric effects is much higher than is commonly believed, with one number I looked at as high as 1/400.
I wrote an analysis of the long term effects of Adderall where I was able to find some physiological effects of long term use. I was not able to find any data on psychiatric effects.
http://healthlifeandstuff.com/2010/01/long-term-effects-of-adderall/
We have a right to know.
JaT
When did behavior become a medical condition treatable by toxic substances?
“It is well established that ADHD co-occurs with other psychiatric disorders, including disruptive behavioral disorders such as oppositional defiant disorder, conduct disorder; and mood disorders such as depression, bipolar disorder; and anxiety disorders.”
You can be:
Disruptive
Oppositional
Moody
Depressed
Manic
Anxious
It means that you are feeling and thinking.
Heaven forbid.
vince
A recent piece in the NYT notes that the work of ” Joey {the patron saint of anti- psychotics for 2 year olds} Biederman” is about to be rewritten
“Revising Book on Disorders of the Mind” Benedict Carey NYT 2/10/10
“…. One significant change ……. that grew out of recent findings that many wildly aggressive, irritable children who have been given a diagnosis of bipolar disorder do not have it.
The misdiagnosis led many children to be given powerful antipsychotic drugs, which have serious side effects, ….
….“The treatment of bipolar disorder is meds first, meds second and meds third,” said Dr. Jack McClellan, a psychiatrist at the University of Washington who is not working on the manual. “Whereas if these kids have a behavior disorder, then behavioral treatment should be considered the primary treatment.”
Some diagnoses of bipolar disorder have been in children as young as 2, and there have been widespread reports that doctors promoting the diagnosis received consulting and speaking fees from the makers of the drugs…..
Any report that cites Joe is suspect on it’s face.
Justice in MI
Thanks for the link, David. I have some students to whom I’ll pass this on.
Vic
All,
Being the parent of a child who is “diagnosed” as ADD (NOTE NOT ADHD), my wife was asked by a TEACHER in the school if we had plans to medicate our child. When I heard this from my wife, my answer was essentially simple: “I’m interested to know what medical school the TEACHER graduated from and what specialty her license was?” When my wife (also a teacher) gave me a look of “how dare you ask such a question”, my next response was even more simple: “I think I need to call the District Attorney and inform them that they have someone practicing medicine without a license here”.
I’m sorry but nowadays, it is FAR too common even in the schools for the kids to be “diagnosed” with these so-called mental disorders and many parents believe the school because “they are the ‘professionals’”. My answer to that: figure out what it means to be a professional and what your limitations are. Then work to reform the educational system to lessen the INSANE pressures on our children academically (read as “REVOKE NO CHILD LEFT BEHIND” which simply leaves 50% of children behind) and all the insane levels of testing (started where I live in Grade 2 with “practice English and Math tests” and continuing through Grade 12).
We also might consider the impact of many of these drug companies on local educational ideas. At the doctor with my son today while I was sitting in the exam room awaiting the doctor, I noticed a very impressive wall of pamphlets which undoubtedly was produced and sent to the office by pharma companies. Among the drugs listed was Concerta….NEXT!
Maybe if we allow the kids to actually BE KIDS and have a life outside of the school and doctor’s offices….we might not need NEARLY as many (over-)medicated children. But god help the Big Pharma CEO who suggests such things.
Oh, and by the way, before anyone gets the wrong idea here…I actually currently WORK in the industry and have these feelings…imagine those who don’t who have no “insider’s insight” into the GOOD that some drugs can do.
Former Pharma Marketing Director
A little bit dated, but a link to a Canadian story about how a child has been suspended from school because he isn’t taking his ritalin….
http://www.canada.com/montrealgazette/story.html?id=65bee20c-b7b9-46ca-87c7-7477cec32bdb&k=89866
patrons99
I’m not sure where the saying “speed kills”, but I personally believe that it applies to the ADHD medications as a class. At some point your body will pay a price for long term stimulation of the nervous system. If you withdraw too fast from them, a “crash” should be expected. If you stay on them too long, one should perhaps ask whether there has been up- or down-regulation of receptors, e.g. beta adrenergic receptors in the heart, and what effect this might have on your cardiopulmonary “reserve” capacity. Addiction, dependence, withdrawal, overdosing and drug-drug interactions are additional concerns.
http://en.wikipedia.org/wiki/Amphetamine
patrons99
FPMD - very interesting article, thanks. I noticed that the boy was on ritalin and paxil at one point. That’s an interesting cocktail, or “gemisch” for the chemists amongst us. It is no real surprise that the boy became agitated, lost his appetite, and couldn’t sleep. I wonder if their might be a pharmacogenetic explanation?
Public schools shouldn’t be allowed to use coercion to force ANY medications upon their students. On the other hand, if the boy was seriously disruptive in class, I might understand why he was suspended indefinitely. Home schooling or private schools would still be an option for the family.
The family should be free to choose not to medicate their child. It is distressing to hear the public school had an “intervention plan” that not only identified a student as “at risk”, but then mandated the drugging their student…that is outrageous. Kind of puts a different spin on “no child left behind”, doesn’t it.
patrons99
Long term studies of cardiac safety and putative cardiotoxicity are needed. Hard clinical endpoints (e.g., hospitalizations, all-cause mortality, survival) are needed, not surrogate endpoints.
“Cardiac safety of central nervous system stimulants in children and adolescents with attention-deficit/hyperactivity disorder” by Winterstein AG, et al, in Pediatrics, 2007 Dec; 120(6):e1494-501
http://www.ncbi.nlm.nih.gov/pubmed/18055666?dopt=Abstract
Former Pharma Marketing Director
Patrons99,
I was shocked when I came across that article a few years ago, and remembered it in light of what Ed has posted here.
The point is that you also have to understand the mechanism behind the “intervention plan”. DO you think the school came up with this independently? I don’t think so. I think this was the result of some educational, read marketing plan, that the school was educated on and was probably sponsored by a drug company. I cannot see anyone initiating this independently. Do we all just reach the conclusion that there is some drug out there that we need ot be taking to correct some sort of ailment, perceived or not. No, rather we are marketed to think that the pharma business has our backs covered.
A pill for every ailment, an ailment for every pill…..
patrons99
It’s brilliant!
“A pill for every ailment, an ailment for every pill…”
What a perfect one-liner for the times in which we live!
Well done, FPMD.
patrons99
FPMD - “DO you think the school came up with this independently?”
No, I don’t. It doesn’t pass the “smell test” or the “appearance of impropriety test”.
It would be particularly alarming if their “intervention plan” included a specific marketed drug, e.g. Ritalin.
pharmavet
As one of the ’60’s gurus said: “Reality is for people who have difficulty dealing with drugs”.
pharmavet
As one of the ’60’s gurus said: “Reality is for people who have difficulty dealing with drugs”.
Seth
A couple of things. The majority of ADHD meds written have pretty much gone generic. Concerta on the verge of it.
I’m 43 years old and society doesn’t want to deal with me without my meds. I’d love to not take my generic Adderall, but then you’ll call me a fag for my gay-like behavior and arrogant for my god like behavior.
Former Pharma Marketing Director
Oh Thanks Patrons99, after all I come from marketing, I am used to coming up with these things…
Pharmavet, I agree with you on this one, reality IS for people who have difficulty dealing with drugs…
Former Pharm Rep
Thanks for the link David. That was a great article. I have a 6 year old boy diagnosed with ADHD since he was 5. Suspected by ped neuro at age 3, but they can not make a diagnosis that young. I have also been a pharmaceutical rep for one of the pharma giants for 9 years. I did try Ritalin for a short time and it made my son angry and he could not stop crying. We stopped that in a matter of days. Many have posted and are right the specialist only want to keep writing scrips for more meds. The last visit to our neurologist we left with a script for Straterra which is not a stimulant but still has a black box warning for liver damage. Being I was in the industry you would think I would not have a problem trying every different med to find the one that “works”. But, like your post and link shows I could not find any long term data on the effects if taken for many years. I looked for alternative treatments and have been very blessed to have found for my son intensive occupational therapy with listening therapy works. His teacher and school psych both said if they did not know he had ADHD they would never know he had it. The OT works on the sensory system. We go to a well known center in Colorado for his treatments. We also give him pharmaceutical grade Omega 3’s. I wanted to share for any desperate parents looking for alternatives. Remember I am a drug rep too!