- Fiona Godlee, editor, BMJ
The US Food and Drug Administration says it may loosen its conflict of interest policies (doi:10.1136/bmj.d5070). A shortage of independent experts means that its current rule—no more than 13% of advisers with industry ties—is delaying the introduction of new drugs, says its commissioner.
This attack of nerves is reminiscent of the New England Journal of Medicine’s U-turn in 2002, which reversed an earlier ban on commissioning editorials and reviews from authors with ties to industry. The journal said it had found that some fields could not be covered (N Engl J Med 2002;346:1901-2). Since then, like the BMJ and other major journals, it has asked authors to declare their financial and other competing interests and decides each case on its merits.
But the NEJM’s failed experiment ended 10 years ago and things have changed. Financial ties between academics and industry are now on the wane. As Jeanne Lenzer reports (doi:10.1136/bmj.d5070), a survey of over 3000 academics in 2009 found that half had no industry ties, and of these a third were full professors (Health Affairs 2009;28:1814-25). Critics of the FDA’s suggestion cite the fact that the proportion of panel members with industry ties is well below 13%. Although the vacancy rate on panels was high in 2009, they say it’s now falling.
So now is not the time for cold feet. If anything it’s time to push even harder. Industry’s influence on regulatory decisions is well documented. Quoted in Lenzer’s report, Curt Furberg cites the FDA’s vote on whether or not to withdraw valdecoxib. BMJ investigations found similar evidence of influence on decisions at the European Medicines Agency over oseltamivir (BMJ 2010;340:c2912) and rosiglitazone (BMJ 2010;341:c4848) And if seeking independent expertise does slow things down a bit, might that not be a good thing? Only last month, an FDA panel voted to withdraw the breast cancer drug bevacizumab, which had been given “accelerated approval” in 2008 (BMJ 2011;343:d4244).
Back tracking now on conflicts of interest would send the wrong message, especially to the EMA, which has some catching up to do. It still has a reputation for being more on the industry’s side than the public’s, not helped by its outgoing executive director Thomas Lönngren’s revolving door appointment as an adviser to industry (www.pharmatimes.com/Article/11-01-18/Ex-EMA_chief_joins_new_market_access_business.aspx).
WHO too is vulnerable to criticism on this score. A recent report on its handling of the A/H1N1 influenza pandemic concluded that it had not followed its own rules on conflict of interest and that these needed strengthening (BMJ 2011;342:d3378). Now it is under fire for proposals that would increase industry’s influence on how it sets its priorities (doi:10.1136/bmj.d5012). A word of warning to its director general: back in the 1990s, among those telling WHO to stick to its knitting and focus on infectious diseases in the third world were experts covertly funded by the tobacco industry (BMJ 2000;321:314, doi:10.1136/bmj.321.7257.314).
The FDA should stand firm. Not only is the tide turning in its favour, but strong policies are helping to turn the tide. So here’s a question: should the BMJ repeat the NEJM’s experiment and ban editorials and clinical reviews from authors with ties to industry? I’d welcome your views in rapid responses.
Cite this as: BMJ 2011;343:d5147