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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by zazenducke on January 17, 2008, at 12:09:56
http://www.nytimes.com/2008/01/17/health/16cnd-depress.html?pagewanted=print
.... a team of researchers identified all antidepressant trials submitted to the Food and Drug Administration to win agency approval from 1987 to 2004. The studies involved 12,564 adult patients testing drugs like Prozac from Eli Lilly, Zoloft from Pfizer and Effexor from Wyeth.The researchers obtained unpublished data on the more recently approved drugs from the F.D.A.s Web site. For older drugs, they tracked down hard copies of unpublished studies through colleagues, or using the Freedom of Information Act. They checked all of these studies against databases of published research, and also wrote to the companies that conducted the studies to ask if specific trials had been published.
They found that 37 of 38 trials that the F.D.A. viewed as having positive results were published in journals. The agency viewed as failed or unconvincing 36 other trials, of which 14 made it into journals.
But 11 of those 14 journal articles conveyed a positive outcome that was not justified by the underlying F.D.A. review, said the new studys lead author, Dr. Erick H. Turner, a psychiatrist and former F.D.A. reviewer who now works at Oregon Health and Sciences University and the Portland Veterans Affairs Medical Center. His co-authors included researchers at Kent State University and the University of California, Riverside.
Dr. Turner said the selective reporting of favorable studies sets up patients for disappointment. The bottom line for people considering an antidepressant, I think, is that they should be more circumspect about taking it, and not be so shocked if it doesnt work the first time and think somethings wrong with them, he said.
For doctors, he said, They end up asking, How come these drugs seem to work so well in all these studies and Im not getting that response?
Dr. Thomas P. Laughren, director of the division of psychiatry products at the F.D.A., said the agency had long been aware that favorable studies of drugs were more likely to be published in journals.
Its a problem weve been struggling with for years, he said in an interview. I have no problem with full access to all trial data; the question for us is how do you fit it all on a package insert, the condensed prescribing information that accompanies many drugs.
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If it won't fit on the package insert couldn't you get a bigger insert or would that contribute to global warming by using too many trees? Such an ethical dilemna for the FDA.
Posted by Phillipa on January 17, 2008, at 12:19:31
In reply to Bias in reporting antidepressant effectiveness, posted by zazenducke on January 17, 2008, at 12:09:56
Agree isn't this a bit like the Star D study. I really don't know just a guess. Phillipa
Posted by Jamal Spelling on January 17, 2008, at 12:38:03
In reply to Bias in reporting antidepressant effectiveness, posted by zazenducke on January 17, 2008, at 12:09:56
> Dr. Thomas P. Laughren, director of the division of psychiatry products at the F.D.A., said the agency had long been aware that favorable studies of drugs were more likely to be published in journals.
>
> Its a problem weve been struggling with for years, he said in an interview. I have no problem with full access to all trial data; the question for us is how do you fit it all on a package insert, the condensed prescribing information that accompanies many drugs.If you have no problem with full access to trial data, Dr Laughren, then why do researchers have to invoke the Freedom of Information Act in order to access this data?
Posted by linkadge on January 17, 2008, at 23:04:45
In reply to Re: Bias in reporting antidepressant effectiveness, posted by Jamal Spelling on January 17, 2008, at 12:38:03
Yeah, thats the real world. Might as well just tell us outright, then people can move on with their lives as opposed getting hooked on boards like this.
Linkadge
Posted by okydoky on January 19, 2008, at 14:50:21
In reply to Re: Bias in reporting antidepressant effectiveness, posted by linkadge on January 17, 2008, at 23:04:45
At least here I can read about this discussion and hear about other people's experiences in
real life wilth these drugs including ones not approved by the FDA.
By the way that is about the most positive thing I have thought all day in my depressive state!
This is the end of the thread.
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