"Do drug firms suppress unfavourable information about new products?"

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Article Source: "Pharmaceuticals: Absence of evidence," The Economist, November 27th 2008.

"In theory, there should be no difference between what the regulators are told about a new drug’s strengths and weaknesses and what doctors and other researchers read in journals." A study published in PLoS Medicine sought to test that hypothesis.

(B)y looking at all the new-drug applications approved by the FDA in 2001 and 2002, the researchers got hold of a comprehensive set of data. They checked whether, five years later, details on all of those trials had made it into print intact.....

Only three-quarters of the original trials were ever published, and it turned out that those with positive outcomes were nearly five times as likely to be published as those that were negative. Earlier investigations have shown that the explanation is not editorial bias: well-designed studies in which drugs fail have as good a chance of being published in leading journals as those in which drugs succeed.

In the years studied by Dr Bero, 155 primary outcomes appeared in both regulatory filings and in the medical literature. However, the FDA knew about 41 others that never made it into a journal. On top of that, 17 outcomes appeared in publications without having first been discussed in regulatory filings. Fifteen of these 17 made the drugs in question look better. And even when published studies had been filed with the FDA, on several occasions the published conclusions differed from those reported to the FDA in ways that favoured the new drugs.

Comment: This is worrisome. While it is good that the scientific panels deciding on whether to license a drug have more or less complete information, it is unfortunate that the physicians prescribing medications don't have access to all the information in their journals, even if they need it.

On the other hand, I don't know how one would go about requiring firms or researchers to seek publication of their results, or to write them up well, or how one would require journals to publish those submissions. (And of course, physicians don't have the time both to read all the literature and to treat patients.)

I suppose metaanalyses such as the Cochrane Collaboration provide an alternative, and better source of information. Still...... JAD