Antidepressant Use And Conflicts Of Interest
20 CommentsBy Ed Silverman // September 7th, 2007 // 9:42 am
In the explosion of information yesterday surrounding the use of antidepressants, suicides and Black Box warnings, there was a little noticed item. The study in the American Journal of Psychiatry was authored by eight people, two of whom have rather noticeable conflicts of interest.
The study, which received front-page treatment in The Washington Post, was co-authored by Robert Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago, who has served as an expert witness for Wyeth, the company that sells Effexor. And J. John Mann, a psychiatry professor at Columbia University, has received research support from Glaxo, which sells Paxil, and served as an adviser to Eli Lilly, which peddles Prozac and Cymbalta.
How do we know? These competing interests were noted at the bottom of the study, but not in the Washington Post story. Meanwhile, as we pointed out yesterday, the American Psychiatric Association has harshly criticized the FDA for placing the warnings on product labels, saying this scares away some docs and patients. The APA publishes the medical journal, by the way, which to its credit, listed the conflicts.
These conflicts don’t necessarily suggest the data or conclusions are incorrect - that’s worthy of a separate analysis and discussion - but given the drumbeat of info coming from the psychiatric community, these should have been reported by the Post. And the medical journal should have been widely and easily accessible to the media, which it wasn’t. Full understanding requires full disclosure, from everyone.
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Lisa Van Syckel
A.P.A Angry at FDA—Congressional Hearing
Rep Michael Ferguson (R-NJ)
Energy and Commerce
Subcommittees on Health and Oversight & Investigation
In the last week,the FDA has drafted many changes to the Med Guide for antidepressants,and I have a copy of each of the two. Most Strikingly,the title of these med guides was changed.The previous onesaid,”medication guide about using antidepressants in children and adolescents.” That Title was changed,and I have, I’d like to submit both these for the record…it was changed to “medication guide,antidepressant medicines,depression and other serious mental illnesses and suicidal thoughts and actions.”It just seems to me that the old versio of the medication guide was more thorough and sort of concentrated exclusively on the potential adverse reactions that could occur when taking antidepressants.The new version just seems to delve into a whole discussion on depression.Can you tell me why,do you have any idea why these changes were made in that way,
Dr. Steven Galson,Director of the FDA’s Center for Drug Evaluation and Research:
Yes,I have a very good idea. It’s not easy to explain,so if you give me just a few minutes to do it.Um. this has been one of the most contentious and difficult areas of drug regulation over the past few years in FDA,but not atypical,in that new information has been developed about potential risks related to these products since they’ve been on the market and those are the risks that are discussed in the med guides with suicidality…..
THE PSYCHIATRIST COMMUNITY,THE AMERICAN PSYCHIATRIC ASSOCIATION,HAS BEEN VERY VERY ANGRY WITH THE FDA BECAUSE THEY THINK THAT DISSUADING PEOPLE WHO REALLY NEED THESE DRUGS FOR DEPRESSION FROM TAKING THEM and therefore contributing to the number of people that are expressing suicidal activity.And this is of course something that worries us a lot…..
My deepest gratitude to Rep. Mike Ferguson for his continued support and dedication to our Nation’s Children and their Families!!!……
Reality
God help me for entering the morass that this topic typically evolves (devolves) into, but…
1. To paraphrase, conflict of interest is a situation, not a behavior. Top docs do research because they are top docs and are paid for their time and expertise, as would anyone in any other industry. The conflicts were disclosed in the article. Period. By saying, “which to its credit, listed the conflicts,” is a backhanded compliment that just stokes the flames for those who come to bash pharma and research.
2. What do you mean, “the journal the medical journal should have been widely and easily accessible to the media, which it wasn’t.”? Journals have things called subscriptions. If major media outlets don’t already have general subscriptions to journal publishers, I’m sure they can pony up the $25 or so to access the PDF online. Or they could, you know, go to a library. Meanwhile, if they gave reprints away for free of a study that supported their claims or appeared somehow pro-pharma, the pharma bashers would no doubt rail against that.
There are some things wrong with pharma, but when you actively try to create controversy where there is none is rank sensationalism.
Ed Silverman
Hi Reality,
To help you understand my thinking, right or wrong, I wasn’t offering a backhanded compliment. A journal should list conflicts and, to its credit, this journal did so. Listing conflicts uniformly is still a fairly new development and should be encouraged at all turns. So that’s why I wrote what I wrote.
As to whether the journal article was accessible, yes, you’re correct to say one can purchase the article online. It’s also fair to say that free text could have been provided. The New England Journal of Medicine, for instance, will so so with certain articles that it knows will generate a lot of attention. This is a similar circumstance and, in my view, warranted a similar approach.
Any and all are free to consider my view as ‘rank sensationalism,’ but I wrote what I did in hopes of pointing out issues that could stand improvement, whether it was the Post’s failure to note a conflict or the journal’s decision not to disseminate a study about a controversial topic so that a thorough understanding is more easily and quickly gained.
I hope this helps, and I appreciate that you took the time to write.
Regards
ed
Pharmalot
Reality
Ed,
On re-reading it, perhaps I just mentally put the wrong spin on it, as the COI issue is a hotbutton of mine. But combined with the accessibility issue, the “by the way” struck me as somewhat smarmy and disingenuous.
I apologize for the over/misread, and the sensationalist comment.
Reality
I also conflated your criticism of the Post with criticism of the journal. Doubleplus bad on my part.
Atlex
Ed,
I appreciate your points in this entry; however, it is worth noting that many of those blogging against these studies also have conflicts of interest including expert witnesses on behalf of those suing the pharma industry, Scientologists who have religious reasons for bashing mental health professionals, and parents, while regretably having experienced a tragedy, put blame for all of the ills of the world on the pharma industry. In addition, in contrast to the impression created by the vocal bloggers on your site, it is worth pointing out that the vast majority of experts in mental health side with the APA. Finally, note that only one SSRI remains with patent exclusivity. Thus, as far as antidepressants go, there is limited financial motivation for big pharma to generate these new studies. The majority of future sales will be going to generic manufacturers and strengthen their ability to compete against brand manufacturers.
Atlex
Lisa Van Syckel
When “Pharma” and their “Apologists” cant defend the safety and efficacy of their “ANTIDEPRESSANTS” they blame the child……Parents…………Members of Congress……..Plaintiffs Attorneys….Reporters…..Whistleblowers……Religion…. yada,yada,yada…
APA is made up of a bunch of jokers…..
Maybe,just maybe,if they acted like a group of professionals they wouldnt be bashed so much….
Lisa Van Syckel
Atlex,
I take it,that,that is not your real name…
You hide behind a curtain,and bash parents and their children…..Please…..
Cowards like you, should “PRACTICE WHAT THEY PREACH”…….
Atlex
Lisa,
Nice name calling! So if someone says something you disagree with, rather than having a rational discourse, you call him/her a coward. I notice that you had nothing to say about the points I made.
By the way, what do you think I am preaching beyond belief in science and data? Also, where did I bash parents and children? If you read what I wrote, you will note that I stated that they have conflicts of interest as much as the authors of the study.
Atlex
jason
Atlex,
Just when I was done going to this site…….. another actual voice of reason. Thanks for reminding me I am on the majority, not the vocal minority side of things.
Lisa Van Syckel
Parents have “CONFLICT OF INTERESTS”..
Please Explain..
My name is Lisa Van Syckel,and I am a Houswife and Mother.
What’s you name,and what do you do for a living…
Lisa Van Syckel
Hi Jason,
How are you?…Hope all is well with the Family…
James
Atlex,
It isn’t worth engaging with Lisa. She substitutes shrill invective for reason. Your time will be better served doing nearly anything else.
Lisa Van Syckel
“SHE SUBSTITUTES SHRILL INVECTIVE FOR REASON”
OOOH…. PLEASE!!!!
Attacking Mommies dont do you justice!!!……
I suggest you stick to Marketing!!!!….
jason
Your time will be better served by doing nearly anything else –
James, I will admit, that comment made me laugh out loud. Great thing to read before heading to bed.
Lisa - thanks for asking my family is doing great, hope yours is as well. You do have to admit it was kind of funny :)
Have a great weekend everyone - going to be beautiful here.
Gareth Ellzey
For decades there has been a revolving door between the FDA and pharmaceutical companies. Ralph Nadar documented it nearly 30 years ago. To say this is not a conflict of interest, or to excuse the financining of pharma aplogists by stating that of course the companies hire the doctors, is disingeneous at best, and wilfully ignorant at worst. The roster of psychiatrists who are shilling for the same drug companies who financed their ‘research’ is lengthy and ignoble.
The branching out of the psychoceutical industry into the field of infants and toddlers is a testimonial to greed and profit-taking over real concern for ‘mental health.’ I’d feel a lot more sympathetic if most of the so-called mental disorders for which pharmaceuticals are prescribed weren’t just voted into being at psych conventions.
If the pharmaceutical companies would concentrate on real, scientifically proven diseases, like hypothyroidism, pheumonia, even cancer, that can be objectively tested, there would be much less controversy.
José Luis Meléndez
Atlex,
It would be wise you define what is meant by confict of interest. That way you won’t confuse dishonesty an betrayal from the psychiatric comminuy and pharma dollars weighing more than life with conviction and integrity of those who will defend their love ones until the end. Suicidality has no organic etiology as no mentall illness does. It’s a personal and social tragedy. One that antidepessants can provoke. And you have to admit what psychiatrist have already admiitted: they have no cures. So they shoul close their shop and that way do humanity a great favor. Hope they pay you well.
José Luis
Yolande lucire
Some suicides might tbe atributed to cackhanded warnings which did not contain information about how to taper slowly from antidepressants and the dangers of the withdrawal period. Some parents and doctors might have panicked and stopped meds suddenly, Most of the new suicides would be attributable to Zyprexa and Risperdal, now that 7 out of every 1000 kids are being medicated by antipsychotics, Zyprexa and risperidone two of the most suicidogenic drugs in clinical trial history and the fact that the (mis) diagnosis of bipolar in kids for which these two which they are licensed (but not in kids) has gone up forty fold, Research and references can be found if you see my submission to the Productivity Commission in Australia.
http://www.pc.gov.au/study/medicaltechnology/subs/subpr047.pdf.
paula
There’s certainly worrying food for thought in Yolande Lucire’s article above, http://www.pc.gov.au/study/medicaltechnology/subs/subpr047.pdf , where it says “…These newer antipsychotics are now subject to a FDA advisory in the elderly as they have a relative risk of death of 1.7 to sugar pills. The magnitude, indeed enormity of this problem can be seen when you review that Vioxx had a risk of something like 1.3 of inducing a heart attack, not a death…”
hiutopor
Hi all!
Very interesting information! Thanks!
Bye