A recent British Medical Journal study questioning the efficacy of new generation antidepressants leads to a renewed query on the overall drug review process.
In a special report last week’s BMJ asks do we really know the truth about antidepressants? Or statins? Or any other drug on the market?
Lack of access to data is an ongoing problem in the United States, despite passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which requires clinical trials to be registered in a public database, write journalists Jeanne Lenzer and Shannon Brownlee.
Although it’s a positive step towards greater transparency, the act may not reduce the likelihood of dangerous or ineffective drugs remaining on the market as much as some people might have hoped, they warn. For example, not all trials have to be registered and access to full data is also constrained by trade secrecy laws.
To overcome this, researchers often request data under the Freedom of Information Act, but various rules can still prevent full access to underlying results.
Trade secrecy laws, for example, permit companies to withhold all information about drugs that do not win approval for a new indication, even when the drug is already on the market for other indications.
Such data are protected as trade secrets so that drug companies aren’t put at a “competitive disadvantage” when other companies, learning of the initial studies, aren’t forced to expend the same “wasted efforts.”
This was the case with valdecoxib, a COX 2 inhibitor that failed to gain FDA approval to treat acute pain in 2001. As a result, some of the trial information was withdrawn from the FDA website, leaving researchers and the public in the dark about possible side effects.
But it is precisely these failed trials that should be made public, argue the authors.
One suggestion is to make the FDA database available to researchers. The FDA says that it is far too onerous to put all its material online. But, as a number of experts have pointed out, the burden on the FDA from future Freedom of Information requests would be lessened if it posted all its data.
Ultimately, redacting clinical information from studies, forcing companies to expend “wasted efforts,” and failing to insist that data derived from trial participants be placed in the public domain simply cannot be reconciled with what is in the public interest, write the authors.
Trial participants, as well as patients who take drugs and doctors who prescribe them, deserve nothing less than the assurance that all the news – not just the good news – has been carefully assessed, they conclude.
An editorial, also published in BMJ, suggests that before we embrace any treatment as first line, it is prudent to ask whether its efficacy is beyond question. It also calls for drug regulatory authorities such as the FDA to make their reviews publicly and retrospectively available on the world wide web.
The full paper may be viewed at this site: http://press.psprings.co.uk/bmj/march/feat532.pdf
And, the editorial (p2-3 of pdf): http://press.psprings.co.uk/bmj/march/edit0803
Source: British Medical Journal