My comments:
Pharmaceutiful companies are buying out and corrupting the most important regulation agencies in the world. Even the Hong Kong government follows FDA guidelines. What has this world come to? Money is blinding the eyes of pharmaceutical executives. I wonder when their consciences will start acting up on them. By the time they realize that their decisions to manipulate, corrupt government agencies have resulted in deaths and excruciating pain and suffering of so many fellow Americans, fellow human beings, it will probably be too late to reverse the damage done.
Big respect to those scientists that spoke out despite the risk of losing their jobs and having their reputations smeared by the powerful drug companies.
A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law. The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.
"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.
The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.
The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."
They sent a similar letter in October to the powerful House Energy and Commerce Committee, but the latest one provides more detailed allegations about problems at the agency, such as the threat of disciplinary action against scientists who dissent from management.
Source:
http://online.wsj.com/article/SB123142562104564381.html
The letter made headlines when it was sent last year to John Podesta of Obama's transition team. Written by a group of scientists on FDA letter head -- but with their names blacked out for fear of retaliation -- the letter describes a nightmare of bungling and self-dealing among higher-ups at the drug safety agency. It begs Obama to step in and reform the shop: ... 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 cites three dark chapters in FDA history:
More evidence of the insane lengths the federal government will go to against whistleblowers has been revealed in the form of a lawsuit from a group of FDA scientists and doctors. The group had been trying to blow the whistle on fraud and abuse in the FDA, in the form of approvals for medical devices that didn't actually meet health and safety standards. The scientists reached out to Congress to blow the whistle... and in response, the FDA started spying on their personal emails. Yes, it does appear that these scientists were accessing their personal Gmail accounts from work computers, and using them to work with Congressional staffers to craft their whistleblowing complaint, but does that give the FDA the right to spy on their personal communications? The doctors, via their lawsuit, believe the answer is no.
The FDA is defending its actions by claiming that this whistleblowing involved "improperly disclosed confidential business information about the devices," and it wanted an investigation of the doctors involved. That sounds ridiculous. Or, perhaps, all too typical. It seems clear that the FDA bosses just didn't like the fact that some folks there blew the whistle on what they were doing and took vindictive actions. This is exactly the kind of thing that a Whistle Blower Actshould protect. That it doesn't do so already is really a shame.
http://www.techdirt.com/articles/20120201/01043517616/whistle-blowing-scientists-trying-to-prevent-dangerous-products-reaching-market-sue-fda-snooping-their-personal-email-accounts.shtml
Pharmaceutiful companies are buying out and corrupting the most important regulation agencies in the world. Even the Hong Kong government follows FDA guidelines. What has this world come to? Money is blinding the eyes of pharmaceutical executives. I wonder when their consciences will start acting up on them. By the time they realize that their decisions to manipulate, corrupt government agencies have resulted in deaths and excruciating pain and suffering of so many fellow Americans, fellow human beings, it will probably be too late to reverse the damage done.
Big respect to those scientists that spoke out despite the risk of losing their jobs and having their reputations smeared by the powerful drug companies.
A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law. The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.
"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.
The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.
The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."
They sent a similar letter in October to the powerful House Energy and Commerce Committee, but the latest one provides more detailed allegations about problems at the agency, such as the threat of disciplinary action against scientists who dissent from management.
Source:
http://online.wsj.com/article/SB123142562104564381.html
The letter made headlines when it was sent last year to John Podesta of Obama's transition team. Written by a group of scientists on FDA letter head -- but with their names blacked out for fear of retaliation -- the letter describes a nightmare of bungling and self-dealing among higher-ups at the drug safety agency. It begs Obama to step in and reform the shop: ... 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 cites three dark chapters in FDA history:
- Former chief Andrew von Eschenbach's interference with the approval of a knee device.
- The approval of a breast cancer detection device by director of the Office of Device Evaluation Donna-Bea Tillman even though all FDA experts voted against it, following a phone call from Connecticut congressman Christopher Shays.
- And the approval by Daniel Schultz of a medical device that prevents tissue scarring against the unanimous opinion of his scientific staff.
More evidence of the insane lengths the federal government will go to against whistleblowers has been revealed in the form of a lawsuit from a group of FDA scientists and doctors. The group had been trying to blow the whistle on fraud and abuse in the FDA, in the form of approvals for medical devices that didn't actually meet health and safety standards. The scientists reached out to Congress to blow the whistle... and in response, the FDA started spying on their personal emails. Yes, it does appear that these scientists were accessing their personal Gmail accounts from work computers, and using them to work with Congressional staffers to craft their whistleblowing complaint, but does that give the FDA the right to spy on their personal communications? The doctors, via their lawsuit, believe the answer is no.
The FDA is defending its actions by claiming that this whistleblowing involved "improperly disclosed confidential business information about the devices," and it wanted an investigation of the doctors involved. That sounds ridiculous. Or, perhaps, all too typical. It seems clear that the FDA bosses just didn't like the fact that some folks there blew the whistle on what they were doing and took vindictive actions. This is exactly the kind of thing that a Whistle Blower Actshould protect. That it doesn't do so already is really a shame.
http://www.techdirt.com/articles/20120201/01043517616/whistle-blowing-scientists-trying-to-prevent-dangerous-products-reaching-market-sue-fda-snooping-their-personal-email-accounts.shtml