FDA: Quashing Science Through Managerial Reprisals

NYT Gardiner Harris has:

FDA Scientists Accuse FDA of Misconduct

The US House Energy and Commerce Committee News Release of Nov 17.

Serious, and Lawless Misconduct, Coercion and Intimidation from top FDA officials, ..... is under Congressional Investigation.

Eight FDA Scientists in May this year contacted FDA Commissioner Andrew von Eschenbach: voicing their concerns. Frustrated, on Oct 14, 2008, these Eight then contacted Rep. John Dingell of the House Committee on Energy and Commerce to revoice their concerns. Their redacted letter opens with:

"This letter seeks your urgent intervention because serious misconduct by managers of the U.S. Food and Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA's mission to protect and promote the health of all Americans. Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE)."

Congressmen Dingell and Stupak returned This Letter on 17 Nov '08 to FDA Commissioner von Eschenbach. (para. 2)

"These Scientists make well documented allegations that senior managers within CDRH "ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law." The CDRH scientists also state that CDRH managers ordered them "to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements such as obtaining proper informed consent from human beings."

But what do you expect when FDA funds itself, in part, through $500 Million in "User Fees" from the very Drug and Device manufacturers FDA is Supposed to be regulating. Freedom Works tagged This palm greasing scam 11 years ago as the headache it's Continued to prove itself .

Reuters in Feb '08 had FDA looking for even More Industry money in 2009.

"The spending plan includes $628 million in user fees paid by industry in exchange for the agency meeting targets in speeding review of new product proposals."

Do you Really think that even More Industry Money/Incentive to FDA is going to accrue to the patient's benefit over the "User Fee" payers benefit?

"The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science."

FDA Compensation Practices, considering the tug of war between FDA Scientists who are Doing the research, and FDA management who are "speeding review" of the "User Fee" paying manufacturers products, ..... might suggest a solution, ..... in just 2 words. It's under "Employees Exceeding Compensation Threshold in 2007"

The House Energy and Commerce Committee has been investigating FDA for 2 years, and they make available a whole Pile of documents here.

Eye On FDA closes their post hoping that FDA can rehabilitate its image. That is a sentiment we can get on board with. However;

Image over substance is Why FDA Has its Image problem. If the "World's Gold Standard" wants to stand as the 8th Wonder of the World, rather than the shivering, Parkinsonian afflicted Colossus of Rhodes it currently appears to be, it 1st needs to get its Antipsychoticed and Antidepressed head out of its Antipsychoticed and Antidepressed culture of managerial "User Fee" reprisal, butt.

The global spread of those Psychiatric symptom poisoning toxins is a cancer of as yet undreamt, let alone unrecognized, proportions. Left unchecked it Will eat out Western Civilization itself. No branch of medicine is, or ever was, Less deserving of legitimacy than Psychiatry: which derives its Diagnoses of Illness from its own, Money Making, self vested show of hands Opinions.

There are No 'Ill' neurons which can be Poisoned, or Electrocuted, out of Anyone's mind.

Psychiatry cannot cure the Illnesses it claims to Diagnose, and admits it. Psychiatry has devised a Billing Code to Profit from the Illnesses Psychiatry itself creates, and not only Admits it, but charges $85 just to buy its Billing Codes. Psychiatry has Code after Code, to continue Billing with, for the Iatrogenic Illnesses which are its annually compounded bite.

Its current Drug Money Treatment presents only an ever expanding capture net to homogenize humanity through poisoning out as many people as it can Profitably Label. And into that Poisonous, Dope Dealing Mire unwittingly trek, ..... our future Einsteins (backstory), ..... along with all lesser mortals. Psychiatry in its aggregate is the sum total of its Billing codes: a perpetual motion, self deepening pit of FDA approved, Real illness, suffering, death, and debt.

DSM-IV-TR Billing Code: 301.9: Personality Disorder, Not Otherwise Specified