Wednesday, October 15, 2008

Let the Sun Shine in on Research Conflicts

The Senate Finance Committee’s probe of physicians with extensive financial conflicts is gathering steam: first, Stanford University removed its psychiatry chief Alan Schatzberg as principal investigator of a federally funded study after Congressional investigators discovered that he owned $6 million of stock in a company whose drug he was studying and touting in medical journals (back story). Then last week, Charles Nemeroff, the dean of American psychiatry, was asked to step down as chief of psychiatry at Emory University after the same investigators found that he failed to fully disclose to Emory much of the thousands of dollars in consulting and speaking fees he was earning each year from companies whose drugs he too was promoting (back story). Most recently, the National Institutes of Health (NIH) has announced that it is freezing a $9.3 million, five-year grant to an Emory University center for research on treatments for depression, according to The Atlanta Journal-Constitution .

But while the NIH has finally been scolded into enforcing its own decades-old conflict of interest policies, legislation that would mandate the public reporting of such financial conflicts remains moribund. The Physician Payment Sunshine Act, introduced last year by Sen. Charles Grassley (R-IA), a ranking member of the Senate Finance Committee, would mandate the public reporting of payments (over $500 in a calendar year) to doctors and other health-care professionals by drug and medical device companies (back story).

Making public such information might make doctors think twice about accepting such large sums of money from the industry. Such disclosures would also make it harder for medical centers and federal agencies to ignore blatant financial conflicts, which, as I point out in my book, Side Effects, can spawn the publication of studies that are flawed and inaccurate. And finally, a payment registry would alert consumers to biases among doctors upon they rely for supposedly objective medical advice. As Grassley has said, “Making information about financial relationships open to scrutiny is the right thing to do.”

This landmark legislation was supposed to have been attached to a Medicare bill that passed this summer. In the process, however, it got watered down and then detached from the Medicare bill, says Dr. Peter Lurie, deputy director of the health research group at Public Citizen in Washington. He says the bill was altered to accommodate the concerns of the pharmaceutical industry and doctors’ groups.

Lurie notes, for example, that there’s a new clause in the bill pre-empting any state law that requires a similar public accounting of payments to doctors, as well as a new provision that delays the reporting of such payments for products under development.

“One could argue that those are precisely the kinds of conflicts we should be most interested in,” Lurie says.

Jill Kozeny, a spokeswoman for Sen. Grassley, said state law was pre-empted to ensure uniform nationwide reporting of financial conflicts. The provision to delay reporting for products under development was added to protect trade secret information. Drug companies had argued for the delay on grounds that they don’t want competitors to know what products they have under development.

Whether in its original or revised form, the bill isn’t going anywhere soon. As Lurie notes, “Congress is dealing with a few other pressing issues right now. Kozeny agrees. She says that "new legislation starting from scratch will be pursued by Sen. Grassley" in January. And it might actually have a chance of passage, Lurie predicts, especially if the country elects a Democratic president in November, along with more Democrats to the House and Senate.

1 comment:

Anonymous said...

There's a problem with you, your book, and your site. All three need more publicity. Thank you for helping in the fight to expose conflicts of interest, issues related to mental health, and "pharmaceutical variations of ethics and morals." I agree with your optimism about a Washington controlled by Democrats. I'm generally opposed to a stranglehold that could diminish the security of checks and balances, but after the Republican domination this country has suffered, I'll confidently accept the "risk" of a Democratic majority for at least a couple of years.

I've ordered Side Effects and am looking forward to turning off my computer and reading it. I heard your book being discussed on Love 105 FM (Mpls,MN) Sunday morning. Silly me, I missed much of it because I was working at my computer, trying too look up some of the items you were talking about. Had I been of a clear head and mind, I would have just stuck a gosh-darned cassette tape in and recorded the show. It's a good thing I have some mental illnesses, because if I was normal, I would have been sleeping at that time of day and completely missed the show.