Morning Resumption: The FDA Follies, Continued
Well -- the plot certainly thickens in the FDA antidepressants-and-children story, which seems to be ripening into a genuine scandal.
As I noted in a previous post, the FDA brass already had some serious explaining to do for suppressing the results of a 2003 meta-analysis that showed an increased suicide risk among children prescribed antidepressants. Yesterday's hearings on the topic before the House Energy and Commerce subcommittee on oversight and investigations uncovered an even greater embarrassment: The agency -- at least to hear drug company executives tell it -- actually urged pharmaceutical manufacturers to weaken labeling that raised warnings about the drugs' risks to minors, and to withhold from doctors and the public the fact that in some clinical trials the antidepressants performed no better than placebos. FDA's rather lame excuse for encouraging the withholding of negative information: the agency didn't want to "scare families and physicians away from the drugs" -- and, the agency asserts, "the jury is still out" on them.
Leaving aside for a moment the fact there are other, non-drug treatments for depression that can be quite effective -- and the question of what kind of society throws Paxil, Prozac, and Zoloft at people too young to have any legal or intellectual say in their own care (11 million antidepressant prescriptions for minors were written in 2002 alone) -- FDA's logic here has to be viewed as little short of astonishing. If "the jury is still out," my vote would have gone to more caution in the labeling rather than less. According to the Post article linked above, more than two-thirds of all studies of antidepressant use among children have failed to show that the drugs are effective -- yet the public would have no way of knowing that, as only the positive trials tend to get published. According to testimony by a Pfizer vice president yesterday, Pfizer had planned to add to labels for Zoloft language noting that two studies of Zoloft involving depressed children had revealed that the medication performed no better than placebos. FDA's response was that the agency "[did] not feel it would be useful to describe these negative trials in labeling, since these may be misinterpreted as evidence that Zoloft does not work."
Which is, of course, exactly what the results of the trials were saying. For these children, it did not work.
Of course, fobbing off the responsibility onto FDA is also a self-serving move for the drug companies, which haven't exactly been eager to promote the negative results of clinical trials -- even when the public has paid big money for them. In the current case, as an inducement for the drug companies to conduct further clinical trials on antidepressants, Congress granted extensions of the companies' patents on these drugs that were worth literally billions of dollars in windfall revenues to the pharmaceutical industry. The extension given to Pfizer alone was worth $1 billion.
It's this kind of tomfoolery that drove the editors of twelve medical journals, including heavyweights like the New England Journal of Medicine, JAMA, and The Lancet, to declare this week that henceforth they would publish pharmaceutical company-sponsored drug research only when all studies related to the research were registered in a public database (such as ClinicalTrials.gov) from the get-go. Registration, of course, merely means divulging the existence of a trial; the companies would not be required to actually post the trial's results. And the drug companies may simply decide not to publish -- though publication in a top-tier journal can greatly boost a drug's sales. In any case, it's a step in the right direction.
As I noted in a previous post, the FDA brass already had some serious explaining to do for suppressing the results of a 2003 meta-analysis that showed an increased suicide risk among children prescribed antidepressants. Yesterday's hearings on the topic before the House Energy and Commerce subcommittee on oversight and investigations uncovered an even greater embarrassment: The agency -- at least to hear drug company executives tell it -- actually urged pharmaceutical manufacturers to weaken labeling that raised warnings about the drugs' risks to minors, and to withhold from doctors and the public the fact that in some clinical trials the antidepressants performed no better than placebos. FDA's rather lame excuse for encouraging the withholding of negative information: the agency didn't want to "scare families and physicians away from the drugs" -- and, the agency asserts, "the jury is still out" on them.
Leaving aside for a moment the fact there are other, non-drug treatments for depression that can be quite effective -- and the question of what kind of society throws Paxil, Prozac, and Zoloft at people too young to have any legal or intellectual say in their own care (11 million antidepressant prescriptions for minors were written in 2002 alone) -- FDA's logic here has to be viewed as little short of astonishing. If "the jury is still out," my vote would have gone to more caution in the labeling rather than less. According to the Post article linked above, more than two-thirds of all studies of antidepressant use among children have failed to show that the drugs are effective -- yet the public would have no way of knowing that, as only the positive trials tend to get published. According to testimony by a Pfizer vice president yesterday, Pfizer had planned to add to labels for Zoloft language noting that two studies of Zoloft involving depressed children had revealed that the medication performed no better than placebos. FDA's response was that the agency "[did] not feel it would be useful to describe these negative trials in labeling, since these may be misinterpreted as evidence that Zoloft does not work."
Which is, of course, exactly what the results of the trials were saying. For these children, it did not work.
Of course, fobbing off the responsibility onto FDA is also a self-serving move for the drug companies, which haven't exactly been eager to promote the negative results of clinical trials -- even when the public has paid big money for them. In the current case, as an inducement for the drug companies to conduct further clinical trials on antidepressants, Congress granted extensions of the companies' patents on these drugs that were worth literally billions of dollars in windfall revenues to the pharmaceutical industry. The extension given to Pfizer alone was worth $1 billion.
It's this kind of tomfoolery that drove the editors of twelve medical journals, including heavyweights like the New England Journal of Medicine, JAMA, and The Lancet, to declare this week that henceforth they would publish pharmaceutical company-sponsored drug research only when all studies related to the research were registered in a public database (such as ClinicalTrials.gov) from the get-go. Registration, of course, merely means divulging the existence of a trial; the companies would not be required to actually post the trial's results. And the drug companies may simply decide not to publish -- though publication in a top-tier journal can greatly boost a drug's sales. In any case, it's a step in the right direction.
posted by ahab at 8:23 AM
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