FDA Scientist Complain to Obama about FDA corruption

FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Ricardo Alonso-zaldivar, Associated Press Writer Thu Jan 8, 6:22 pm ET

WASHINGTON – In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.

FDA spokeswoman Judy Leon said in response: "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."

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency's reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along," the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright © 2009 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.

http://news.yahoo.com/s/ap/20090108/ap_on_go_ot/fda_dissidents/print

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Important Supreme Court Pharma Case to be Heard

In damage cases filed against pharma companies, many times the companies claim that they cannot be sued because the FDA approved the drug in question. Soon the Supreme Court will hear a case that wants consumers to be allowed to sue even if the FDA has approved a drug. This could be very interesting.

Not only are six current and formers editors of the New England Journal of Medicine supporting the consumers' right to sue but 47 state attorney generals and two former FDA commissioners are supporting the move as well.

Perhaps as a nation, we will soon formally recognize that the FDA cannot be relied upon to insure a safe pharmaceutical sysem.

Duncan

Here is a excerpt from a news article with link from Pharmagossip:

In a brief filed with the US Supreme Court, six current and former editors of the New England Journal of Medicine stated that consumers should be allowed to sue pharmaceutical firms for failing to warn about a drug's dangers, even if its prescribing information was approved by the FDA. The brief was filed in case being reviewed by the Supreme Court in which a jury awarded $6.8 million to a plaintiff who had her arm amputated after being injected with Wyeth's nausea drug Phenergan (promethazine).

http://pharmagossip.blogspot.com/

http://snipurl.com/3hfou

Why we can't depend on the FDA

Here is a succinct summary by Jim Edwards on why the FDA cannot be relied upon to police big pharma. Be sure to follow the link at the end because it has links to the GAO (Government Accounting Office) detailed reports on each of the points.



FDA's Most Embarrassing Moments
August 1, 2008

You can read them in detail here.

But here's a summary:

1. After rule-change that allowed consumer drug advertising, didn't hire enough staff to police consumer drug advertising.

2. Post-marketing monitoring no good. Why? FDA doesn't know how to do post-market monitoring.

3. Took 11 months to successfully execute an off-label violation warning letter.

4. Supposed to be inspecting foreign drug manufacturers, but, uh, can't speak foreign languages.

5. Decided that emergency contraceptive should not be available to under-age rape victims.

6. Although elderly people take most drugs, forgot to ask companies whether they had tested their drugs on the elderly.

This entry was posted on August 1, 2008 at 3:05 pm and is filed under Uncategorized.

http://jimedwardsnrx.wordpress.com/2008/08/01/fdas-most-embarrassing-moments/

http://snipurl.com/3fctw

Dangerous Prescriptions- Frontline Program

In this Frontline Program, they are investigating our drug safety system. This program is from 2003 and years before the scandals with Vioxx, Celebrex, Avandia, and Paxil; nevertheless, the basic information and analysis of the problems in drug safety are still relevant. -Duncan



In "Dangerous Prescription," FRONTLINE® investigates the integrity of America's drug safety system. Through interviews with current and former FDA officials, critics, a pharmaceutical industry representative, and consumers, the one-hour documentary examines the FDA's handling of several drugs that were approved but later were pulled from the market after causing injuries and even deaths. The program also examines the role that drug companies play in the approval and monitoring of prescription drugs, and questions whether the FDA's current system is adequate for protecting the public.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/synopsis.html

http://snipurl.com/35zh9