Publish drug data or be damned(Image: Lubitz + Dorner/Plainpicture)
TAKE a prescription drug, and you also take a leap of faith: faith that your doctor has made the right diagnosis, that you won’t suffer an adverse reaction, and that the company that developed the drug didn’t conceal anything about it from the authorities.
The last of these ought to be the least of a patient’s worries. Sadly, the pharmaceutical industry has a shameful track record on this front. Time and again, companies have been caught pulling the wool over regulators’ eyes in a bid to get their products on the market.
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One of the most egregious cases was that of the painkiller rofecoxib, or Vioxx. Launched in 1999, it was used by about 80 million people before its maker, Merck, pulled it in the face of compelling evidence that it increased heart attack risk – a fact the company knew but kept secret for five years.
Sharp practice of this kind is still widespread. Drug trials are not always registered. The results of around half never see the light of day, and positive results are more likely to be published than negative ones. As a result, the evidence on which regulators and doctors make life-and-death decisions is fragmentary and biased in the interests of the drug companies.
“The evidence on which regulators and doctors make crucial decisions is fragmentary and biased”
That needs to change, and it is changing. From next year, all clinical trials in the European Union will have to be registered in a publicly accessible database, and all results published within a year of the trial ending.
This is welcome, but it is not enough. It will only apply to future trials, even though most medicines were approved based on trials done long ago. There are also fears that the new regime will not prevent the industry hiding negative results. In fact, it could make matters worse by creating the impression that the problem has been solved.
The new system does not, in fact, demand full disclosure. Companies will merely be compelled to release documents known as clinical study reports. These are more detailed than journal articles but do not contain full information, down to the level of individual participants.
Releasing such fine-grained data is problematic as it can reveal the identity of anonymous volunteers, which is why companies will not be made to do so. That may seem an acceptable compromise, but some critics say it fails to eliminate the temptation for companies to bury bad news.
The no-compromise position has now been vindicated by a fresh analysis of the data from a notorious clinical trial called Study 329. Carried out in the 1990s, it was the first to find a link between the antidepressant paroxetine (sold as Paxil or Seroxat) and suicidal behaviour. The drug’s manufacturer, GlaxoSmithKline, did not disclose this information until compelled to do so by a court ruling. GSK did not, however, have to release full patient data.
Now those results have been analysed by independent researchers, who say the suicide link was stronger than previously revealed (see “New look at antidepressant suicide risks from infamous trial“). This, they say, shows that total transparency is the only way to stop drug companies from cheating us.
Further progress is possible. Researchers are developing ways to release full data without compromising anonymity. And GSK deserves belated credit for finally releasing all the data from this particular trial: other companies take note. But it is clear that if the case for full disclosure was already strong, it is now overwhelming.
This article appeared in print under the headline “Publish, or be damned”