FDA Scientists Complain to Obama of 'Corruption'
By Susie Madrak Friday Jan 09, 2009 10:00amI used to work for an consulting firm that specialized in FDA compliance for pharma and medical device companies, and I can tell you the consultants had no faith whatsoever in the FDA approval process during this administration. Looks like their concerns were warranted:
WASHINGTON (AP) — 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 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.
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another casualty of the wrecking crew.
I am shocked!
shocked!
really ?? No surprise here, neither surprised that citizens are surprised at this.
Just look at the leadership at FDA and big Pharma companies. Its just a revolving door between them. Past admin has supported it.
don't expect any change !!
Shocked! Shocked I tell you!
It worked for Claude Rains in Casablanca, but not here, apparently.
This "atmosphere" has been a problem for decades, and we have no reason, yet, to expect better from this administration.
"A spokeswoman said the Obama transition team had no comment."
.
... SO? (/Cheney)
Like we never saw this coming.
Currently, our Government is filled with cowards who fear the incompetent fools and criminals working along side. But really, what does a criminal and incompetent fool need to become successful at their jobs but cowardice from the enabler.
.
that we must become alert and sensitive to those civil servants that still remain who are intent on doing the best job they are able.
I have to believe that there must be a few in spite of thirty years of the Reagan
RevolutionCarnage.To believe otherwise is to think there is no hope.
Policy comes from our laws made by the Congress and enforced by the Executive. They must pay tribute to we the people.
However, it is my previous paragraph wherein is described our greatest challenge.
This is true. And economics should be bottom UP! Trickle down (top down) is Reagan theory and has been proven to be an horrific failure. I would like Paul Krugman to address this sometime in a forum here. But I digress. Sorry, move along.
But how is the top supposed to pay tribute to We the People when We the People can't even get our duly elected Representatives to faithfully represent the People. Hell, half the people I talk to don't even care to communicate to elected officials and think that elected officials can think for themselves...
... Look what kind of tribute these scum pay back for such independence?
A society that fears it's Government is a society run through Tyranny...
But a Government that fears it's people is one that respects the People's demands; A Democracy.
As I said, that is our greatest challenge.
for 40 years, and have never yet received a satisfactory reply to ANY query have lodged.
I have by now learned that I shall NEVER receive any satisfactory responses from anybody in elected office...
Yes, I do ask 'em indelicate questions: I ask 'em why they lie to me, promise me stuff which they have no intention of redeeming, make stupid statements, and suck up to the asshole theo-fascists.
I have no doubt that this has gone on in Democratic administrations as well. It sure would be nice to see the Obama administration do something about this. We will have to wait and see. We do have hope but I regret o say not much history.
Every time I hear a talking head complaining about Obama The Messiah, I think of things like this, and how much corruption we're going to continue to uncover, and how his election alone has given whistleblowers the courage to speak out.
The prostitution of science for political gain is nothing new in 'Murikah. Just any any drug law reformer trying to get the Gub'mint to live up to it's own laws regarding the use of scientific data to guide policy instead of ideology; when it comes to things like cannabis, it hasn't done that for decades.
A perfect case of this has been the Data Quality Act suit filed by Americans for Safe Access. HHS bureaucrats have stonewalled the case for YEARS, using one bureaucratic trick after another, or simply refusing to do what they are mandated to do by law.
Because if they did so, and were forced to examine the information regarding cannabis, they'd see the criteria for drug scheduling under which it was made illegal after 1970 would be false. But Uncle's Fed agencies haven't been doing their jobs lately, and that goes for the previous Administration, as well. And they've never been punished for their failures. Science has taken a back seat to politics for many years in this country, not just under Junior's reign, and what has been happening at FDA is but the thinnest edge of a carpet whose center is humped Everest-high with all the other illegalities swept under it.
The Soviet Union once politicized science, and look at what happened to it. We're following in the same steps, whether we want to admit it or not. Will we wind up the same way?
This story is consistent with the book "The Republican War on Science" by Chris Mooney in that we have yet ANOTHER example of the far right abandoning the process of falsification inherent to science. Can anyone say, "Faith Based Medicine?" As long as someone makes money from it, it must be true, right?
In government? Naw, I don't believe it.
This is all very well and good, a bunch of professionals complaining about unfairness and the incompetence of managers on the job. But it gets ignored because frankly, everybody is pretty much overworked, ruled by incompetent idiots and constrained by bad workplace politics.
What they need to do in order to get Americans interested is to make a movie starring an attractive woman with big breasts. It will win an Oscar and everyone will become informed and horrified by the situation. Unless this happens, it's business as usual.
It is probably next to impossible to root out the 8 years of changes made in order to destroy government agencies from the inside, which the "free market" corporatists have succeeded in doing.
It's going to take some big boobs and a couple of lingering full frontal nudity scenes for this problem to get the attention it truly deserves. Or...maybe an HBO miniseries. With lots of toplessness and simulated oral sex scenes.
'use intimidation to squelch scientific debate,'
If intimidation does not work, then the facts are simply changed. This was common practice with the Bush Administration. Not only in the FDA, but any agency that dealt with anything related to health, science or the environment. They were scared of all that 'sciencey' stuff. Remember the big scandal about the Bush Administration doctoring research and recommendations concerning climate change? I'll never forget that 'interview' a NASA scientist, I believe, did with Sixty Minutes concerning climate change. All during the interview a Bush Administration official chaperoned the whole thing.
Difference in philosophy: Republicans think the gov't works for business, Democrats know it exists to serve the people.
The difference is that the Pukes ARE the elites they serve; the Dims are just wannabees...
The FDA history of abusing and neglecting it's regulatory power in favor of Pharna does not ebb and flow with D/R administrations as you suggest.
signed by every Federal employee over GS-7 or gs-9.
He doesn't have to act an any of them...yet.
But if they're in his pocket, maybe a lot of the Bushevik moles will be less inclined to try to tube the pooch...
But of course no one could have anticipated or imagined that under the Bush administration's leadership the truth would be punished and lies rewarded. And I'm sure no accountability or investigation is warranted. That's why all relevant emails were deleted.
The FDA sends reps to international CODEX Alimentarius meetings. Their job is to defeat grass roots US DHSEA law.
By promoting standards the FDA likes, instead of standards already set by our DSHEA, the FDA can grab more regulatory power.
The mechanism is CODEX. If a country does not "harmonize" their law to CODEX, they can be subjected to trade sanctions.
Nutritional supplements compete with FDA/Pharma interests. Your freedoms established in US DSHEA law interfere with their money-pump dynamics-- Pharming and milking your disease.
LE Magazine April 2002
Does the FDA protect us?
...the FDA warned pharmaceutical-giant Schering-Plough for years that it needed to improve safety and oversight at its manufacturing facilities and for years Schering promised to do so. Among Schering’s problems were making asthma inhalers that did not have any medication inside. Acute asthma attacks suffocate 5,438 Americans every year.[6] With no medication in an inhaler, any asthma attack can be lethal. The FDA repeatedly found the same problem with these asthma inhalers (no medicine inside), but it took Schering years to correct the problem. Schering recently stated that they may be forced to pay a $500 million dollar fine to settle the matter.[7]
It may appear that the FDA is coming down hard on Schering, but the fact is that Schering was given numerous warnings by FDA inspectors and still failed to consistently put medication into their inhaler product
Anyone really surprised . . . The FDA is controlled by big money corporations and is corrupt like all other agencies under the direction of Mr. bUsh. The task that lies ahead for this new president and Congress is beyond belief . . . just wondering where to start drains me!
I wish it were. This has gone on for administrations r and d. No big dif.
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