Free Newsletter
Should Kessler return to FDA?
Free newsletter via e-mail
Tools
Another day, another handful of potential healthcare and pharma watchdogs (not to mention a suggested to-do list). Apparently, the rumor that former Sen. Tom Daschle might take over at HHS was misguided; he's now said to be slated as the White House's own healthcare reform czar. Which raises the possibility--some might say fear--that HHS may be led by Rep. Rosa DeLauro of Connecticut. She's been a sometime critic of FDA and pharma, with a stated dislike of DTC ads, according to In Vivo. Plus, she decries shoddy foreign manufacturing and too-friendly relationships among industry and regulators.
As for FDA, here are some other names to put on that list of folks we're sure you're keeping:
- Ezekiel Emanuel, brother to President-elect Obama's newly named chief of staff. He's now NIH's top bioethicist, and In Vivo says his vitae is a heavyweight. Whether he ends up at the FDA or not, he could wield some influence, even if only in an informal advisory role. He's big into conflict-of-interest issues, which of course have been in the news a lot lately.
- Jerry Avorn, a Harvard pharmacoepidemiologist, could add expertise in drug safety and post-marketing surveillance to an agency that's trying to beef up its operations in those areas. Plus, as a Harvard man, he shares one diploma crest with Obama.
- And then there's David Kessler. Yes, he's already done a tour of duty at the FDA, but some say he wants to get back into government. In Vivo likes the idea because it's been predicting a Kessler-like chief for the agency. And Kessler's at a bit of a crossroads; he recently left his post as Dean of the UCSF Medical School.
Meanwhile, Eye on FDA is advancing a top three list of priorities for the incoming FDA leadership: Develop a road map for implementation of FDAAA; spell out just what makes a successful Risk Evaluation and Management Strategy; and come up with guidance on online marketing. What are yours?
- read the In Vivo article
- check out the Eye on FDA to-do list
Related Articles:
Who will take over at the FDA, HHS?
Kindler: Take politics out of the FDA
How will Obama change pharma?
Med school fires ex-FDA commish
Comments
By Anonymous | Posted 2:13pm | November 10, 2008
Is this the same Dr. Ezekiel Emmanuel?
_______________________________________________
LA Times: NIH Dissident Scientists Hire Drug Industry Lawyers--Evidence of Journalistic Shilling
Fri, 22 Apr 2005
Pulitzer Prize winner David Willman of the Los Angeles Times, whose investigative reporting first revealed the major covert conflicts of interest among top scientists and administrators at the National Institutes of Health (NIH), reports that a group of NIH dissidents who oppose the new rules barring financial deals with biotech and pharmaceutical companies, have hired a law firm to provide legal and lobbying services on their behalf.
Willman reports that the firm, Arent Fox, has been lobbying congressional leaders "seeking to dismantle earlier bipartisan support for the tougher NIH ethics rules." The dissidents call themselves "the Assembly of Scientists," their leader is NIH bioethicist, Dr. Ezekiel Emmanuel.
The conflict of interest rules were adopted after the magnitude of those conflicts were laid bare--first by the LA Times, then by Congressional investigations:
"More than 530 NIH scientists took consulting fees, stock or stock options [totaling millions of dollars] as compensation from biomedical companies from 1999 through 2003."
These investigations found that "most of the payments were hidden from public view. The payments raised questions about the scientists' impartiality in overseeing clinical trials or making public recommendations on the use of new drugs or other commercial treatments."
Willman's latest revelations add another layer of evidence and draw the lines that connect the dots of the interlocking directorate that appears to link the ethically challenged, greedy and arrogant NIH scientists and the industry which is the source of their moral lapse, is now revealed as their hired defender.
The LA Times reports that the NIH dissidents have hired a high-powered law firm, Arent Fox, whose lobbying reach is to the congressional leadership. Arent Fox "represents the makers of pharmaceuticals, medical devices, and dietary supplements. One of its longtime clients is the Biotechnology Industry Organization, which last year urged the NIH to allow agency scientists to continue serving as private, paid consultants."
"The chairman of Arent Fox, Marc L. Fleischaker, said in an interview that his firm was providing lobbying and legal services to the dissidents at a discount." Why not, given that the firm's more usual billing is to the war chests of pharmaceutical giants who have an interest in influencing the nation's biomedical researchers who set the agenda for medical research and practice guidelines?
NIH scientists insist on having the best of both worlds-namely, high paid prestigious positions at taxpayers' expense, while they engage in private deals with corporate partners whose interests do not coincide with the public interest. As a congressional committee accused NIH scientists of wanting to have "the option of corruption."
By watchingfromtokyo | Posted 5:18am | November 17, 2008
Song of the rampant techno-warbler
We insist on no interruption
To our research projects' progress;
The option of corruption
Will ensure results to satisfy excess.
RIP
Post new comment
Paid Research Reports
- Stakeholder Opinions: Vaccines in Emerging Markets (Asia) - Opportunities in China, India, South Korea and Taiwan
- Big Pharma Performance Before, During and Beyond the Global Recession
- Optimizing Lifecycle Management: Maximizing commercial lifespan through label expansion and combination products
- The CRO Market Outlook: Emerging markets, leading players and future trends
- Pharmaceutical Sales Force Effectiveness Strategies
- Commercial Insight: Influenza Vaccines and Antivirals - The pandemic's long-term impact
