FDA Corruption Complaint to Obama

FDA scientists complain to Obama of 'corruption'

Associated Press
By RICARDO ALONSO-ZALDIVAR – 3 days ago

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 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.

"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.

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 — which is the agency's reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

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.

A spokeswoman said the Obama transition team had no comment.

What's Worse - The Condition or Side Effect?

We have all seen the pharmaceutical commercials where the list of side effects is 10 times worse than the condition it is "treating". Does anyone have any common sense left or are we all brainwashed to believe everything they are told by TV and doctors (and TV doctors)?

The media couldn't be biased towards their largest revenue source (pharmaceutical advertising) could they? Why are the same pharmaceutical drugs more expensive in the USA than EVERY OTHER COUNTRY? BECAUSE THEY GET IT. Our laws and socialized medicine (Medicare and other welfare programs) allow it. Who's the chump here? We all are.

From Healthmad.com

http://www.healthmad.com/Medicine/Prescription-Drugs.95408

Terrifying Side Effects of Prescription Drugs

Here are 25+ terrifying side effects that can be caused by prescription drugs.

Reading or hearing about side effects of prescription medication can sometimes be horrific. I often wonder if taking the medication to ease a condition is worth the risk of experiencing some of the awful side effects that come with medicine. The following is a list of some of terrifying side effects that come with many prescription drugs currently on the market.

* Drainage, crusting, or oozing of your eyes or eyelids
* Swollen, black, or "hairy" tongue
* Changes in the shape or location of body fat
* Decrease in testicle size
* Sores or swelling in your rectal or genital area
* Blue lips or fingernails
* Purple spots on the skin
* White patches or sores inside your mouth or on your lips
* Irregular back-and- forth movements of the eyes
* Enlarged breasts in males.
* Unusual risk-taking behavior, no fear of danger
* Extreme Fear
* Hallucinations, fainting, coma
* Fussiness, irritability, crying for an hour or longer
* Paralysis
* Thoracic Hematoma (bleeding into the chest)
* A blood clot in the lung
* Liver damage
* Kidney damage
* A lump in your breast.
* Decreased bone marrow function
* Congestive heart failure
* Shingles
* Nerve pain lasting for several weeks or months
* Bleeding that will not stop
* Coughing up blood or vomit that looks like coffee grounds

Finally, there is one drug on the market, EvaMist, which includes all of the following possible side effects:

* Breast cancer
* Cancer of the uterus
* Stroke
* Heart attack
* Blood clots
* Dementia
* Gallbladder disease
* Ovarian cancer
* High blood pressure
* Liver problems
* High blood sugar
* Enlargement of benign tumors of the uterus ("fibroids")

These are only some of the possible side effects of prescription drugs. Unfortunately, there are many more.

What do you think? Want some?

Diseases and Conditions