The FDA Prefers To Have Foxes Guarding The Henhouse

Feel free to discuss any topic of general interest, so long as nothing you post here is likely to be interpreted as insulting, and/or inflammatory, nor clearly designed to provoke any individual or group. Please be considerate of others feelings, and they will be considerate of yours.

Moderators: Rosie, Stanz, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh

Post Reply
User avatar
tex
Site Admin
Site Admin
Posts: 35349
Joined: Tue May 24, 2005 9:00 am
Location: Central Texas

The FDA Prefers To Have Foxes Guarding The Henhouse

Post by tex »

Hi All,

Financial conflicts of interest are a major problem with medical advisory panels, and now the FDA has decided to take a step backward, to allow more "biased advisers" to make those recommendations.
Before it was withdrawn, 9 of 10 FDA advisers with industry links voted for valdecoxib to stay on the market. Valdecoxib was manufactured and marketed by GD Searle and Company – the same company that has been mired in controversy over another of its former products – the artificial sweetener aspartame.

In 2008, the FDA took a bold step of limiting the percentage of a panel’s members with financial conflicts of interested to 13 per cent. Now, though, it turns out that the FDA’s leader, Margaret Hamburg, has hinted she may row back on this decision. There’s talk that conflict of interest restrictions is leading to a dearth of relevant experts which, in turn, is slowing new product approvals.
Is Ms. Hamburg trying to say that there are no medical experts who do not receive financial incentives from the pharmaceutical industry? Based on the following quote, apparently, she's just dead set on destroying fair and honest objectivism among board members.
Some commentators have pointed out the fact that there should be no dearth of independent experts. Back in 2008 the BMJ published a list of about 100 such independent experts [3]. This list was sent to the FDA back in 2008, and several groups have re-submitted the list to the FDA. The FDA, though, has failed to contact individuals on the list and request their services, despite now claiming to have a dearth of such experts.
Talk about stonewalling. :roll: I can't help but wonder how much money she receives from Big Pharma, either openly, or under the table. :monkey:

http://www.drbriffa.com/2011/08/22/cont ... -interest/

While we're dissing the FDA, I found the following information from another of Dr. Briffa's blogs to be extremely interesting. The red emphasis is mine, of course:
Just a day after listening to these radio broadcasts I noticed that the British Medical Journal had recently published a news story concerning whistle-blowing on the other side of the Atlantic [1]. The journal reported on a letter sent by 9 doctors and scientists employed by the FDA (US Food and Drug Administration) to President Barack Obama.

The opening paragraph of the letter reads thus: “The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press, and the American people, have repeatedly expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.”

The letter details several specific instances of alleged ‘systemic corruption and wrongdoing that permeates all levels of the FDA and has [plagued the Agency far too long'. These include approval of medical devices by single individuals despite overwhelming opposition from FDA experts, and delays in the approval of emergency contraception medication without prescription as a result of 'political pressure'. You can read the full letter here.

The idea of FDA officials making decisions in seeming isolation and contrary to expert advice reminded me of the FDA's approval of the artificial sweetener aspartame. The company who originally developed aspartame (the pharmaceutical company G D Searle) had been petitioning the FDA for many years in an effort to get their product licensed. The company didn't have much luck until a new FDA commissioner was appointed after Ronald Reagan came to power. The new commissioner, Dr Arthur Hull Hayes, duly granted aspartame a license, a decision which went against the FDA's own scientific board of inquiry's recommendations. (Hayes subsequently took a position with Burson-Marsteller, the firm in charge of public relations for G D Searle).
http://www.drbriffa.com/2009/04/20/lett ... imidation/

And the tradition continues, to the detriment of the health of U. S. consumers of pharmaceutical products. :roll:

Tex
:cowboy:

It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Post Reply

Return to “Main Message Board”