conflict of interest
What governments can learn from scientific enquiry
The last couple of weeks has been an depressing time for those of us who believe in freedom of information (FOI). As Wikileaks founder, Julian Assange, awaits his fate in Dickensian conditions for publishing secret memos which various governments believe should not have been in the public domain, I have been thinking about FOI, conflict of interest (COI) and the parallels with the world of research evidence.
In the UK, under the Freedom of Information Act, any individual, anywhere in the world, is able to make a request to a public authority for information. The information may be withheld only if the public authority considers that the public interest in withholding the information is greater than the public interest in disclosing it. The objection of the US government and others to Wikileaks has largely been that sensitive information may “threaten national or even global security”, and so should have been withheld. To a doctor without diplomatic training, this seems like a knee-jerk response to any disclosure of information which could be of interest to the public and is an insult to our intelligence as well as an overused excuse for preventing FOI. The problem is that the powers that be in global politics often have COI, which is really the reason for stopping FOI, rather than any threat to security.
FOI and COI are not new concepts in scientific research or indeed, medical care of patients. There have been several welcome moves in recent months to make research data and the research process more transparent. Undoubtedly, the age of blogs and Twitter have pressured debate and change in a way we could not have imagined. The British Medical Journal has been encouraging online rapid responses for some years, but is largely alone in inviting immediate comment and debate regarding its articles. A recent Science publication regarding “A Bacterium That Can Grow by Using Arsenic Instead of Phosphorus” led to such a fervent online debate that even Nature, one of the most respected scientific journals, has had to admit that “Bloggers and online commentators have an important part to play in the assessment of research findings, and many researchers' blogs, in particular, contain better analyses of the true significance of a scientific finding or debate than is seen in much of the mainstream media”.
Although peer review has many strengths as a process, it has too often been the veil behind which other scientific journals hide information and COI, and it has its flaws. A Pubmed search with the terms “conflict of interest” leads to 8249 hits and “freedom of information” leads to 2583 hits, so these are clearly issues that occupy the minds of scientists. “Peer review” as a term reminds me of “national security”........In research, just as in government, COI is not just financial, although money does usually talk loudest.
Rather than resisting public pressure for greater freedom of information regarding political processes and imprisoning citizens without charge, perhaps governments would do well to invite debate and comment in the way that the scientific journals are now being forced to.
Serious conflicts of interest of Avandia panel member
If you weren’t aware last week, Rosglitazone or Avandia as it is known in the trade, was in front of the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee at the FDA to see if it should remain on the market.
Overall the panel voted 20-12 to keep it on the market. That means 1/3rd of the panel wanted the drug removed from sale as they considered the harms so bad they outweigh any potential benefits. 17 of the panellists in favour wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Based on the evidence I'd have voted for its removal.
This is where it gets bad. Endocrinologist David Capuzzi, who was on the panel confirmed he has been a Glaxo's speakers for several years. Get this ‘he doesn't see the relationship as a conflict,’ of course not. Capuzzi defended the drug during the meeting. Oh, by the way he was one of three members who wanted the drug to remain on the market with no additional earnings or restrictions.
Dr Capuzzi received $3,750 from GSK between April 2009 and March 2010. He has also received $8,000 in speaking fees form GSK before that period and $3,000 in the 2nd quarter of this year, total $14,750.
One member who voted to keep Avandia on the market, Arthur Moss , said "I'm surprised we weren't told.” Do you know what, I’m not surprised, are you? It seems the information was never given to the committee or to the public, and the FDA is investigating.
Because they didn’t get 32 individuals without conflicts they should hold the panel meeting and vote again. Outrageous!