hide that antidepressants are not as effective
By Benedict Carey
From The New York Times
NEW YORK .- The laboratories manufacturers of antidepressants, like Prozac (fluoxetine), never published results of nearly a third of the clinical trials done to obtain approval of these drugs, as well deceived, deliberately, to physicians and consumers about their real effectiveness. This was revealed by a study published yesterday in The New England Journal of Medicine.
In published clinical studies on antidepressants, about 60% of the people who drank reported getting significant relief from depression, compared with about 40% of those taking placebo pills. But if you include the less positive trials, unpublished, the benefits fade: antidepressants are better that placebos only by a modest margin, ending that report.
Previous studies have found a similar tendency to report positive results in a wide variety of medications, and many researchers have questioned the supposed effectiveness of antidepressants. But this new analysis, which reviewed data from 74 trials with 12 different drugs, is the most thorough to date.
And it documents a large difference: while 94% of studies with positive results became public, only 14% of those with disappointing or uncertain results were succeeded.
The findings probably will fuel the continued debate about how information about drug trials is reported. In 2004, after revelations that negative findings from antidepressant clinical studies were not published, a group of leading journals agreed to stop publishing clinical trials that were not registered in a public database.
trade groups representing major global pharmaceutical companies announced that their members would begin to spread more information about their studies faster, on its own database: www.clinicalstudyresults.org . And last year, Congress gave current legislation that expands the types of clinical trials and the depth of information that must be reported to www.clinicaltrials.gov, a public database operated by the National Library of Medicine that country.
The website of the Food and Drug Administration (FDA), United States, provides limited access to recent reviews of clinical trials, but critics say it is mur difficult to "navigate."
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"This is a very important study for two reasons," said Dr. Jeffrey M. Drazen, editor in chief The New England Journal of Medicine -. The first is that when you prescribe a drug, you want to be sure you have the best possible information, one would not do if you only knew a third of the truth about a drug. "
Second, Dr. Drazen continued, is that "we must be respectful of people who participate in a clinical trial.
" They assume some risk when entering the study, "and then the drug company hides the data?" he asked. "This kind of thing do we take issue with passion. "
Alan Goldhammer, vice president of regulatory affairs for Pharmaceutical Research and Manufacturers of America, which represents American drug companies, said the new study does not mention that industry and government have taken steps to ensure that information from clinical trials more transparent.
"All this is based on information prior to 2004, and since then we killed the myth that companies have something to hide," Goldhammer said.
In the study, researchers identified all antidepressant clinical trials submitted to the FDA between 1987 and 2004. The studies involved 12,564 patients for testing drugs like Prozac (fluoxetine), Eli Lilly, Zoloft (sertraline), Pfizer and Effexor (venlafaxine), of Wyeth.
The researchers obtained unpublished data from more recently approved drugs through the FDA website. For older drugs, tracked hard copies of unpublished studies through colleagues, or taking advantage of the law on freedom of information. After all studies contrasted with databases of published studies, and also wrote to ask whether a particular drug study had been published.
found that 37 of 38 studies that the FDA considered positive were published in medical journals. The agency considered other 36 studies, negative or unconvincing, and of those only 14 were published.
But 11 of those 14 articles published "reported positive results" do not coincide with the review of the FDA, said the study's lead author, Dr. Erick H. Turner, a psychiatrist and former FDA reviewer.
Turner said the selective reporting of favorable studies predisposes patients to disappoint. "The conclusion is that people who are considering taking an antidepressant should be more careful when taking them," he said, and do not be surprised if does not work the first time and not think something is wrong with them. "
As doctors, he concluded, "they end up asking" how can it be that these drugs work so well in school, but I'm not getting that answer. "
250 Million dollars a year in Argentina generates sales of antidepressant drugs.
Source:
The Nation printed edition Published in Science / Health
January 18, 2008
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