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Controversy over FDA’s plans to relax rules on conflicts of interest

Posted Aug 22 2011 8:19am

The Food and Drug Administration (FDA) in the US decides, among other things, which drugs should be licensed for doctors to prescribe and which should retain their license should evidence of harm emerge. In these jobs, the FDA is advised by panels made up of researchers and doctors. It makes sense for not too many panel members to have financial or other ties to the drug industry – that’s because such conflicts of interest have been shown to affects individuals’ opinion on, say, a drug’s risk.

By way of example, a recent news piece in the British Medical Journal [1] cites the example of the painkiller valdecoxib (Bextra) which pulled from the market in 2005 due to evidence that it increased the risk of cardiovascular disease. Before it was withdrawn, 9 of 10 FDA advisers with industry links voted for valdecoxib to stay on the market. Valdecoxib was manufactured and marketed by GD Searle and Company – the same company that has been mired in controversy over another of its former products – the artificial sweetener aspartame.

In 2008, the FDA took a bold step of limiting the percentage of a panel’s members with financial conflicts of interested to 13 per cent. Now, though, it turns out that the FDA’s leader, Margaret Hamburg, has hinted she may row back on this decision. There’s talk that conflict of interest restrictions is leading to a dearth of relevant experts which, in turn, is slowing new product approvals.

There has been strong opposition to the FDA’s mooted relaxing of the rules on conflicts of interests. For example, the BMJ reports [2] that the National Physicians Alliance (NPA) in the US, which represents about 20,000 doctors and medical students, has written to Margaret Hamburg to say it is “dismayed” at the suggestion of a change in rules. The NPA, which accepts no funding from drug or device manufacturers, wrote in its letter to Hamburg that “We place the best interests of our patients above all others and avoid conflicts of interest and financial entanglements. The health of our patients is our first concern.”

Some commentators have pointed out the fact that there should be no dearth of independent experts. Back in 2008 the BMJ published a list of about 100 such independent experts [3]. This list was sent to the FDA back in 2008, and several groups have re-submitted the list to the FDA. The FDA, though, has failed to contact individuals on the list and request their services, despite now claiming to have a dearth of such experts.

There’s no doubt in my mind that if the FDA relaxes its rules on conflicts of interests it will be a major retrograde step. One would expect better from a supposedly independent body. Except that it’s not independent at all: manufacturers pay the FDA to have their products evaluated. This very fact does draw the independence of the FDA into question.

However, there are other concerns too. See here for a blog post from 2009 in which FDA insiders accuse the organisation of corruption, wrongdoing and intimidation.

References:

1. Lenzer J. FDA is criticised for hinting it may loosen conflict of interest rules. 2011;343:d5070

2. Lenzer J. Doctors join protest over change to FDA rules on conflict of interest. 2011;343:d5269

3. Lenzer J, et al. Naming names: is there an (unbiased) doctor in the house? BMJ 2008; 337:a930

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