FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR
updated 5:10 p.m. CT, Thurs., Jan. 8, 2009 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, on the letterhead of the agency's Center for Devices and Radiological Health.
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.
A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.
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 within the agency.
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FDA Scientists Complain About Corruption Inside The Agency
By Anna Boyd 13:39, January 11th 2009
A group of nine scientists at the Food and Drug Administration sent a letter to President-elect Barack Obama and his transition team, asking for immediate intervention as the agency is “fundamentally broken” and fails to fulfill its mission.
“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,” read the six-page letter, written on the agency’s Center for Devices and radiological letterhead.
The scientists went even further and said there is an atmosphere at FDA in which the honest employee fears the dishonest one, when it should be the other way around. Moreover, the FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
Responding to the accusations, agency spokeswoman Judy Leon said the FDA has been working “very closely” with Mr. Obama’s transition team and will address any issues or concerns the team presents. She added the agency is “actively engaged in a process to explore the staff members' concerns and take appropriate action.”
Members of the transition team weren't available to discuss over the issues in the letter or whether they intend to address it publicly.
FDA Scientists Ask For Obama’s Help To Fight Corruption Inside The Agency
By Irene Collins 18:43, January 10th 2009
It appears that some scientists at the FDA wrote to President-Elect Barack Obama’s transition team, basically begging for help and outlining a number of problems with an agency they describe as “fundamentally broken.” Nine scientists who claim the FDA is a “fundamentally broken” agency authored the letter, sent Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.
The letter, addressed to John Podesta, says the atmosphere at the agency is one where “the honest employee fears the dishonest employee.”
Podesta is head of the Obama transition team but others receiving copies include Tom Daschle, Obama’s pick to lead the Department of Health and Human Services; Joshua Sharfstein, the physician leading the transition team’s assessment of FDA activities; and Senator Edward Kennedy, chairman of the health committee.
The scientists wrote that they have raised their concerns with FDA Commissioner Andrew von Eschenbach and Bill McConagha, an attorney and the assistant commissioner for accountability and integrity at the agency, but added that the agency has taken no action to address the issues.
In addition, they wrote that FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
The Obama transition team has not issued a statement about the scientists’ complaint of corruption among FDA managers.
For whatever it's worth, myself and others have been asking for an investigation into the FDA and the USDA et al for a decade or more. ...TSS
Friday, June 13, 2008
Federal Oversight of Food Safety: FDA Has Provided Few Details GAO-08-909T June 12, 2008
Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK
FDA SCIENCE AND MISSION AT RISK
UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL WASHINGTON D.C. 20250
DEC 28, 2007
Mr. Terry S. Singeltary, Sr. P.O. Box 42 Bacliff, Texas 77518
Subject: FOIA Appeal-Log No. 08-00034 (No. 07-00060)
Dear Mr. Singeltary:
This is in response to your December 3, 2007, Freedom of Information Act (FOIA), 5 U.S.C. & 552, appeal of the November 20, 2007, decision of Ms. Deirdre MacNeil, FOIA/Privacy Act (PA) Attorney, Office of Inspector General (OIG), Department of Agriculture (USDA). As explained below, your FOIA appeal is denied.
As background, on March 1, 2007, you requested the "final results of the TSE Mouse-bioassays of those Atypical TSE in the Vermont Sheep." FOIA requires the release of agency records except where one or more of the nine enumerated exceptions apply. On November 20, 2007, Ms. MacNeil responded to your request by sending you seven pages from Hotline files PS-3340-0024, which was responsive to your request. Ms. MacNeil withheld identifying information pursuant to Exceptions 6 and 7(C) of the FOIA. See 5. U.S.C.& 552(b)(6) and (7)(C). On December 3, 2007, you appealed Ms. MacNeils decision.
To The Honorable Inspector General USDA,
see full history of this saga here ;
Tuesday, April 29, 2008 Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency ----- Original Message -----
From: "Terry S. Singeltary Sr." firstname.lastname@example.org To: "Bovine Spongiform Encephalopathy" BSE-L@aegee.org Cc: email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.
Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.
Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations. ...
snip...please see full text ;
Interference at the EPA Science
Sunday, December 28, 2008
MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy
I thought a quick review of the Bush's terribly flawed and failed mad cow disease policy, from the illegal feeding of literally millions and millions of pounds of highly suspect, and banned mad feed, to the failed BSE surveillance program, all of which exposed, needlessly, millions of people to the mad cow agent i.e. Transmissible Spongiform Encephalopathy. ...
Parentage-based DNA traceback in beef and dairy cattle 2008
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
snip...full text ;
USDA CERTIFIED DEADSTOCK DOWNER COW SCHOOL LUNCH PROGRAM
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518