Treatment Online

Some Drug Data Obscured, But Process Moves Toward Transparency
> 1/18/2008 8:53:16 AM

When a pharmaceutical company finds evidence that its new drug is effective, it makes sure that everyone knows about it. And positive findings should be followed with enthusiasm, because they likely herald an improvement in some problematic area of human life. But what happens to all of the negative findings? Many critics of the pharmaceutical industry have warned that by suppressing negative findings and releasing only triumphant studies, companies are distorting the data and fooling the public into having false-confidence in the efficacy of drugs. This accusation has been particularly vehemently aimed at antidepressants, which bring in millions of dollars every year though some researchers have reported that their effect is not much different from that derived from a placebo. A recent study published in the New England Journal of Medicine helps to settle the dispute over whether evidence really is skewed.�

The study, led by Dr. Erick Turner, examined 74 FDA-registered antidepressant studies, 31% of which were never published. There was a clear pattern that determined whether a study was likely to be published: 37 of the 38 studies with positive results were published, while only 14 out of 36 negative studies made it into public scrutiny. Additionally damning is the fact that of the 14 published negative studies, 11 were framed or edited in a way that made them appear to confirm the benefit of the drug in question. Let�s look at this from the perspective of a patient or doctor reading the journals for advice. It would appear to this observer, who only has access to the published studies, that 94% of trials for a drug are positive, when the FDA reports that only 51% of the total are positive. In addition, a separate analysis by Dr. Turner estimates that the effect size of antidepressants is being exaggerated by an average of 32%. Clearly, this is an extreme bias of the pool of evidence, one that significantly impairs the ability of reporters, patients, and doctors to judge the effectiveness of a drug.

To avoid falling into the trap of selective reporting, we must mention the possibility that negative studies are left to gather dust not because they are incriminating, but because they are uninteresting. This is certainly a possibility; even serious scientific journals compete for the most important and sensational studies, and a finding that a drug does does not cure leprosy is just less compelling than the story of a promising drug that ends up doing nothing. While both may equally further science, the positive finding probably has more chance of being published.

The New York Times gave apologist Alan Goldhammer from the Pharmaceutical Research and Manufacturers of America an opportunity to defend drug companies. While he did not deny that evidence suppression happened in the past, he claimed that drug companies have taken big steps to make their studies more transparent. As Dr. Turner limited his examination to studies from 1987 to 2004, it is possible that he missed a recent trend towards objective disclosure. A large evidence suppression scandal in 2004 spurred many journalists to declare that they would not report on studies that are not submitted to a public database as they progress. Since then, many databases have been set up with the stated goal of increasing transparancy, but their inclusiveness and accuracy are still debated. If pharmaceutical companies really are starting to be more forthcoming, that is no reason to let up the pressure for even greater disclosure. The fact is that companies will always have an incentive to play up the good news on their products, and only strong and constant scrutiny from external agents will force them to reveal inconvenient results.

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