The six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal.

“The scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the letter states. Because of the corrupt conditions, the scientists say that the agency is “fundamentally broken” and as such is “failing to fulfill its mission.”

The scientists who penned the letter all work in the Center for Devices and Radiological Health,” a division of the FDA that “regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines,” according to a report by CNN.

“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” according to the letter, which was addressed to President-elect Obama’s transition team leader, John Podesta.

The complaints of the scientists in the Devices and Radiological division iterate many of the same grievances raised by scientists from the FDA’s drug review division when Merck’s painkiller Vioxx came under fire in 2004.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the letter states. “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.”

Occasionally, scientists and doctors examining medical devices and equipment have been told during the approval process to ignore FDA regulations. The letter also charges that managers lacking the right level of knowledge and experience are authorized to push products through the approval process while ignoring concerns about safety and efficacy.

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.

The letter also charges that devices entering the market have been improperly labeled, and that manufacturers have been allowed to market their products without the FDA’s approval.

Internal investigations of these charges has amounted to “absolutely nothing,” according to the scientists. “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.”

In response to the accusations, FDA spokeswoman Judy Leon said “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.”

SOURCE: Chantix Recall › FDA scientists say their agency is corrupt and broken

Yesterday, Senators John Cornyn (R-TX) and Barack Obama (D-IL) rebuked the VA and demanded an investigation. Both the White House and VA officials dismissed the criticism, with White House deputy press secretary Tony Fratto calling the story an example of “irresponsible reporting.”

Today, however, more congressman are voicing their anger over the study, demanding answers, and calling for action.

Congressmen Bob Filner (D-CA), who is Chairman of the House Committee on Veteran Affairs, together with Rep. Ed Markey (D-MA), and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veteran’s Affairs. In it, they voiced their alarm over the reported allegations and demanded copies of paperwork involved in the studies.

“Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans,” said Rep. Markey today.

The Congressmen sate in their letter, “When you’re taking advantage of a very vulnerable population, people who have served the country, and the agency that’s responsible for their welfare isn’t putting their welfare first, that’s a pretty serious breach of ethics.”

SOURCE: Chantix Recall › Outcry grows over VA Chantix tests

Today ABC reports that Senators Barack Obama (D-IL) and John Cornyn (R-TX) are demanding an investigation.

In the study, the VA gave 140 US soldiers with PTSD Chantix, not revealing to them that the drug had been linked to a number of physical and psychological side effects, including anxiety, nervousness, tension, depression, suicidal thoughts, attempted suicide, and actualized suicide. The Food and Drug Administration issued Chantix warnings months before the VA was compelled to notify the participating veterans.

Senator Cornyn told the VA Secretary to start asking questions and to take whatever measures are necessary to “identify the responsible parties, provide appropriate care to any veterans who have undergone this testing, and ensure that any unethical practices are immediately brought to a halt.”

Barack Obama made a public statement on the issue, saying “It is outrageous and unacceptable that our government would irresponsibly endanger veterans who have already sacrificed so much for our country.”

Despite the outcry, the White House wasn’t compelled to take action, finding apparently no fault in enlisting veterans with PTSD in a smoking cessation study and giving them a drug known for its potential to create a range of emotional and psychological havoc.

Deputy Press Secretary Tony Fratto dismissed the story as “irresponsible reporting,” claiming that the behavior of one soldier with PTSD taking Chantix was not concern enough to halt the entire study.

Barack Obama issued a statement on the matter today on his web site.

“Our veterans – particularly those suffering from mental health injuries – should have the very best health care and support in the world, they should never be needlessly exposed to drugs without proper notification of the dangers involved or effective monitoring of the side effects. I will immediately be asking for a full and thorough investigation of how our government could yet again let down our veterans and their families who have given so much to their country, and who have paid so much for the failures of civilian leadership in Washington,” said Senator Obama.

“It is time to demand accountability and to ensure that this kind of breach of trust never takes place again,” Obama said.

SOURCE: Chantix Recall › Senators Obama and Cornyn question VA over Chantix tests