Scientists inform Obama of Corruption at the FDA

[jreelawg]

" Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."...

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."

Among the charges:

• Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

• Devices have not been properly labeled.

• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

• FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."

• Manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, the scientists said, has resulted "in absolutely nothing: No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted.""

http://www.cnn.com/2009/POLITICS/01/09/fda.scientists/index.html

So far Obama and his team have declined to comment. Is it impossible to clean up the Notoriously corrupt FDA?

 

[Alfi]

Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

Arrrrggg - they be more what'cha call guidlines.

 

[fourier jr]

along the same lines, merck started up a phony peer-reviewed journal to promote its products
http://blog.bioethics.net/2009/05/merck-makes-phony-peerreview-journal/

 

[mgb_phys]

"Currently, there is an atmosphere at $AGENCY in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at $AGENCY where honest employees committed to integrity and the $AGENCY mission can act without fear of reprisal."

Among the charges:

• Scientists and doctors have been threatened and told, on occasion, to ignore $AGENCY regulations.

• Devices have not been properly labeled.

• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

• $AGENCY experts have been excluded from product meetings because manufacturers felt that they were "biased."

• Manufacturers have been allowed to market their products without $AGENCY approval.
...
Is it impossible to clean up the Notoriously corrupt $AGENCY?

New forum game - pick a value for $AGENCY where the above wouldn't be true. This isn't limited to federal agencies or the USA.

 

[Vanadium 50]

" Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama

President-elect?

 

[OAQfirst]

In a statement, the Food and Drug Administration told CNN, "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."

In the context of the allegations, this doesn't read very well.

 

[Evo]

The article is from before Obama was inaugurated.

 

[LowlyPion]

He's had 100 days and hasn't cleaned it up yet?

 

[mheslep]

The President, and the Congress, have had years to become familiar with the situation, acknowledge recognition, and at least announce the direction of a correction policy, if not execute one.

 

[edward]

The FDA's image has become a bit tarnished the past few years. To resolve the issue they decided to contract a PR firm. It all went down hill from there.

A competition, as prescribed by government policy, was not held to get the lowest bid for the $300,000 contract. Instead, FDA officials came up with a plan to ensure the work would go to a Washington public relations firm with ties to the FDA official arranging the deal, according to an examination by The Washington Post.

The plan used a circuitous route around the standard government contracting procedures. The contract was awarded in July to Alaska Newspapers Inc., a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides. The idea was for ANI to hand over the work to Qorvis Communications, the Washington firm, documents show.

http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100103061.html

 

[jreelawg]

I think that the main root of the vast corruption within so many government agencies is the revolving door phenomena. There should be better laws against people leaving a sector in industry to work for an agency or organization dealing in their industry. Here is a list detailing some cases of revolving doors.

http://sourcewatch.org/index.php?title=Government-industry_revolving_door

It doesn't look good that Obama's Nomination for FDA commissioner, Margaret Hamburg, entered via revolving door. Margaret has left her position as a member of the board of directors at Henry Schein, Inc. to join the FDA.

http://people.forbes.com/profile/margaret-a-hamburg/40368

"Henry Schein, Inc. is the largest distributor of healthcare products and services to office-based practitioners in the combined North American and European markets. Customers include dental practices and laboratories, physician practices, and animal health clinics, as well as government and other institutions."

http://investor.henryschein.com/pho...i_domain=www.henryschein.com&hsi_locale=us-en

 

[edward]

Margaret Hamburg appears to be a highly qualified person for the job.

http://www.nlm.nih.gov/changingthefaceofmedicine/physicians/biography_136.html

She has probably been a member of a lot of boards.

Here is how she got the job.

Serves on the board of Washington's Sidwell Friends Academy, where Sasha and Malia Obama are students.

http://www.time.com/time/nation/article/0,8599,1884627,00.html