NYT on conflicts of interest at the FDA

At some point I am going to have to split up my blog into several other blogs, maybe one on Korea, one on Hawaii and US issues, maybe an entire one on US politics, one on my lame photos, and especially one on medical sociology and public health. 

Until then, I'll just do short blurbs on things like this: two stories adding up to concern over how well the FDA is doing its job and protecting the public. 

The first is about a report from none other than the inspector general of  the Department of Health & Human Services warning that the FDA has been rather lax on the issue of oversight during its trials. From the article:

The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.

Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.

In 42 percent of clinical trials, the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem...

Lovely, just lovely. The second story describes a rush to approve devices despite a lack of scientific consensus about their efficacy and appropriateness. From the article:

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one.

The FDA is supposed to be protecting the public, but a popular complaint among itchy-finger deregulationists is that the FDA takes too danged long to approve things they seem to know (before the FDA has done its work) should be approved. (I joked about that here.)

What those folks don't seem to understand (or just don't care about) is that the FDA is tasked with watching out for the health interests of the people, not the financial interests of the constituents of powerful people. Political influence should not play a role in whether or not something gets approved. (I still wonder sometimes if Donald Rumsfeld's connections with government led to an allegedly inappropriate approval of aspartame—that's NutraSweet for those of you in Rio Linda.)

I don't know if the FDA has become lax and overly business-friendly as a direct result of policies set up by the Bush administration or if this problem was a longer time in coming. The second story may indicate the former, but the first story is about HHS's own investigation; in other words, a Bush administration department checking up on another Bush administration agency. 

Finally, this story is not directly Korea-related, but I can't help imagining that if these same news items had been about the Republic of Korea instead of the United States, there would be oh-so-many in the Marmot's Hole whine cellar moaning how this was yet another sign of how backward and messed up Korea compared with, say, the rest of the first world.