Wednesday, November 18, 2009
Ghostwriting haunts Congress' hallowed halls
The U.S. Chamber of Commerce and other business groups are shopping around for an economist to study the impact of current health care legislation and then distribute results that health care reform is a job killer, reports the Washington Post. Joining the U.S. Chamber are some other mighty big names, such as the National Association of Manufacturers.
The U.S. Chamber wanted to hire an economist to study the issue, then get other economists to sign onto the results, and then attack health care legislation in an ad campaign. (Oops, they assumed the economist's results would be unfavorable.) Isn't this like a drugmaker drafting a medical study and then shopping around for a doctor to put his or her name on it?
Ghostwriting is a huge problem for the credibility of peer reviewed studies, so why would this be any different? Should we hold economic research to the same standards as other scientific research?
No, because this isn't peer-reviewed. This is politics.
Medical research authors are required to disclose funding for their research. In this case, any economist who might sign onto to the project would have to disclose conflicts of interest with not only the U.S. Chamber, but from the other lobbying groups who contributed to the study (in this case, $5,000 apiece).
Medical researchers are required to report their outcomes, good or bad. But positive publication bias is a known factor in medical research. In the case of the U.S. Chamber, it was questioned whether a positive outcome would be reported. After some hemming and hawing, a spokesman later said it would educate the organization's position.
Any economist who'd sign on with the U.S. Chamber's project would skip the peer review process and enter straight into the hardscrabble world of politics and lobbying. Yes, these lobbyists are entering into the public discourse and trying to influence the outcomes of legislation that impacts every person. But there are different standards for political lobbying groups like the U.S. Chamber than for medical researchers, so it's a bit Pollyanna-ish to expect them to be above board.
Besides, the Chamber's own message boards are clobbering the organization's opposition to health care reform. Check out the responses to a recent Chamber post that chastised the House vote on its legislation. Start here and keep scrolling down as members and small businesses speak their mind.
Labels: conflict-of-interest, health care reform
posted by Ryan DuBosar at
8:00 AM
0 Comments
Wednesday, October 21, 2009
So that's what that slide does.
The disclosure slide has become a standard feature of medical lectures. A good percentage of the time speakers disclose nothing, or something silly like their love of the Yankees.
But yesterday, at the ACR meeting, I saw a disclosure slide that even the speaker himself described as "very conflicted." This doctor was there to offer his expertise on osteoporosis drugs so it's not exactly shocking that's he worked with a long list of pharma companies.
Even so, his potential conflicts stuck in my mind, popping up when he expressed suspicion about the effectiveness of generics or pooh-poohed concerns about side effects. For example, "there have been more papers written about osteonecrosis of the jaw associated with bisphosphonates than there have been cases."
Of course, there's no way to know if an interested expert is actually conflicted, but I do now have the anecdotal proof that those disclosure slides serve as more than just an opening for the speaker's warm-up joke.
Labels: conflict-of-interest, rheumatology
posted by Stacey Butterfield at
2:21 PM
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Wednesday, July 8, 2009
Good news for complainers.
We reported a few months ago about the brouhaha that erupted when a JAMA reader went public about his concerns with a study author's potential conflict of interest and attracted the journal's wrath in response. At the time, journal officials said that they would require anyone with a beef to keep their complaints confidential.
According to the Wall St. Journal, they've now changed their minds. Now, the editors suggest that the complaint investigation process would be "enhanced" by keeping your mouth shut. In case you were wondering, you can feel free to go to the media with your complaints about the ACP Internist blog. We'd appreciate the publicity.
Labels: conflict-of-interest, research
posted by Stacey Butterfield at
3:54 PM
0 Comments
Monday, May 4, 2009
Researcher's disclosures plant seed of doubt
With conflict of interest issues so much in the news, one can't help but wonder about the integrity of certian studies. When researchers disclose ties to companies that stand to benefit from a study's conclusions, how can the results--however valid--not be tainted?
A case in point: An article in MedPage Today reports that research presented recently at the American Urological Association meeting in Chicago concluded that switching patients from brand-name to generic urologic drugs resulted in lower efficacy and more side effects.
The article dutifully points out that while generic drugs must be FDA approved as bioequivalent to the branded versions, the U.S. definition of bioequivalence encompasses a fairly wide range, from 80% to 125% of the active compound, thus opening the door to differences in efficacy.
The two small observational studies showed that control of lower urinary tract symptoms decreased by as much as 42.5% when patients were switched to a generic alpha-blocker or 5 alpha-reductase inhibitor (5ARI) from a brand-name drug.
Cause for concern? Maybe, but one can't help but wonder when the researcher, Steven A. Kaplan, M.D., of Weill Cornell Medical College, discloses relationships with several makers of the branded drugs used in the study (Detrol by Pfizer, Uroxatral by Sanofi, Vesicare by Astellas Pharma and Avodart by GSK). "Patients and their physicians need to be aware of the implications of switching to generic medications," Dr. Kaplan told MedPage.
We might add that it also pays to read the fine print.
Labels: conflict-of-interest, urology
posted by Janet Colwell at
3:22 PM
0 Comments
Monday, August 4, 2008
FDA's new conflict-of-interest guidelines
Seems like everyone is getting on the conflict-of-interest bandwagon when it comes to drug companies.
New FDA guidelines prohibit the experts who advise during committee meetings to participate if they, their spouse or minor child have more than $50K financial interest in the companies that will be affected by their actions at the meeting.
Below $50K, the expert may get a waiver by the FDA to participate, but only if his or her input is deemed essential. The number of waivers given will be limited, and FDA will post on its Web site, in advance of the meeting, the reasons for each waiver.
Other changes:
-Advisory committee members must now vote all at once, insted of one-at-a-time. the aim is to avoid "momentum" that could sway people to vote in line with those who preceded them.
-Votes will be immediately announced at the meeting.
-Committee member votes will be posted on the FDA Web site.
-FDA will post the background materials it gives to committee members on its Web site at least 48 hours before the meeting starts.
What do you think of these guidelines? Is $50K a reasonable cutoff? How difficult is it to find experts who have little or no financial interest-- as from consulting or speaking fees-- in these companies? Do the voting and waiver rules go far enough to ensure transparency?
Labels: conflict-of-interest, drug companies, FDA
posted by Jessica Berthold at
5:00 PM
0 Comments
ACP Internist hosted Grand Rounds on June 16, wrapping up the best of the medical blogosphere. Click here for the complete wrap-up.
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