More on the ongoing saga of suppressing negative results of drug trials. From the front page of today's New York Times.
When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden, scientists independent of the companies say.
Within the drug industry, companies are sharply divided about how much information to reveal, both about new studies and completed studies for drugs already being sold. The split is unusual in the industry, where companies generally take similar stands on regulatory issues.
Eli Lilly and some other companies have posted hundreds of trial results on the Web and pledged to disclose all results for all drugs they sell. But other drug makers, including Merck and Pfizer, release less information and are reluctant to add more, citing competitive pressures.
As a result, doctors and patients lack critical information about important drugs, academic researchers say, and the companies can hide negative trial results by refusing to publish studies, or by cherry-picking and highlighting the most favorable data from studies they do publish.
But that's not the half of it. In PlosMedicine Richard Smith, former editor of BMJ, cites other way drug companies corrupt the peer-review system for evaluating clinical trials:
Examples of Methods for Pharmaceutical Companies to Get the Results They Want from Clinical Trials
Conduct a trial of your drug against a treatment known to be inferior.
Trial your drugs against too low a dose of a competitor drug.
Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic).
Conduct trials that are too small to show differences from competitor drugs.
Use multiple endpoints in the trial and select for publication those that give favourable results.
Do multicentre trials and select for publication results from centres that are favourable.
Conduct subgroup analyses and select for publication those that are favourable.
Present results that are most likely to impress—for example, reduction in relative rather than absolute risk.
Given his twenty five years of experience what's Smith's cure?
How might we prevent journals from being an extension of the marketing arm of pharmaceutical companies in publishing trials that favour their products? Editors can review protocols, insist on trials being registered, demand that the role of sponsors be made transparent, and decline to publish trials unless researchers control the decision to publish. I doubt, however, that these steps will make much difference. Something more fundamental is needed.
Firstly, we need more public funding of trials, particularly of large head-to-head trials of all the treatments available for treating a condition. Secondly, journals should perhaps stop publishing trials. Instead, the protocols and results should be made available on regulated Web sites. Only such a radical step, I think, will stop journals from being beholden to companies. Instead of publishing trials, journals could concentrate on critically describing them.
I am no fan of bigger government but for information as critical as this we need a truly independent evaluation. If that cannot be done then at least the post-marketing safety analysis should be done and paid for by the government. Letting the pharmaceutical companies do these seems to be cheaper but in the long run the savings are not worth it. The temptation to rig the system is just too great.
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