FDA, Big Pharma, & Corruption

More than four out of five Americans think drug companies have too much influence over the Food and Drug Administration, and 84 percent believe that advertisements for prescription drugs with safety concerns should be outlawed, reveals a striking new survey from Consumer Reports.

New rules proposed by the FDA would reduce this level of corruption by allowing doctors to receive a maximum of $50,000 per year from companies impacted by their decisions. (Thereby making the FDA numerically less corrupt than it is now, but still tolerating blatant conflicts of interest. It’s like setting a “bribery ceiling.”)

Dr. Bennett reported that on March 29, 2007 an FDA advisory panel consisting of outside experts reviewed Provenge for the FDA and overwhelmingly recommended approval of Provenge. “What followed appeared to border on the bizarre. Two of the 17 panel members who had been placed on the panel under suspiciously orchestrated circumstances carried out an unheard of public and visceral campaign against Provenge, sometimes with factually incorrect data. These two doctors, it turns out, had conflicts of interest that for some reason they failed to disclose on their conflict of interest waiver application as required by federal law“Provenge is an immunotherapy and not a chemotherapy. This is the first time a treatment for end-stage disease was recommended by an FDA expert advisory committee but rejected by the FDA

April 29, 2009 – A novel, experimental treatment vaccine improved the survival of men with advanced prostate cancer in the largest trial yet of the therapy, researchers reported Tuesday

Mitchell Gold, CEO of the Seattle-based biotech company Dendreon, which makes the vaccine, called the results from the company’s latest trial “unambiguous.”

“Today, Dendreon, our employees, and the scientific community have made a major step forward in demonstrating that the immune system can be harnessed in the fight against cancer,” he said in a presentation Tuesday afternoon. “We hope and sincerely believe that this is just the beginning of a new era in medicine.”

Two years later still not approved, WHY NOT? FDA!




What about ReGen?  Why did this happen?


Here’s some background on what happened. The FDA, apparently correctly, declined to let ReGen’s knee-implant product go in for fast-track approval. After the second time, a bunch of Democrats in Congress from New Jersey, where ReGen is based, went to see the FDA chief. Two days later, the FDA chief handed the request to an underling, who took a shortcut through the normal approval process, let ReGen influence who got on the approval panel, distorted what the panel said, and approved it.

The FDA’s regular committee process was circumvented, says Dr. Mabrey, the Baylor surgeon and committee chair, because members were given only six days to review hundreds of pages of documents instead of the usual several weeks.

When Dr. Schultz summed up the meeting in a letter afterward, he said the committee “clearly and unanimously” found Menaflex to be at least as effective as other surgical meshes on the market.

A majority of the eight committee members, including Dr. Mabrey, said in interviews that Dr. Schultz was wrong in saying the members were unanimous. “I made a point of noting that we were not unanimous,” Dr. Mabrey says. “The important thing is that we didn’t say the device was substantially equivalent to other devices.” In addition to Dr. Mabrey, at least two committee members expressed reservations. Dr. Mabrey says if he had known Dr. Schultz was going to approve the device citing the panel, he would have strongly spoken out against it.

These are just a couple examples there are plenty more   HERE

The FDA is now so clearly the regulatory puppet of Big Pharma that it has proven itself unable to reform from within. It’s time for the U.S. public and its legislative representatives to revoke the power of authority over drug safety that has been granted to the FDA in monopoly fashion. It’s time to put the power of drug safety into the hands of people who actually care about safety, not those who benefit from drug sales. And it’s time to end the oppressive, Dark Ages reign of the U.S. Fraud and Drug Administration which is not only complicit in the deaths of literally hundreds of thousands of Americans, but which seems determined to continue its campaign of power and corruption, no matter what the cost in the American lives.

The FDA has also faced a series of scandals involving its failure to enforce many federal laws because it would negatively affect the profits of the wealthy companies that pay it hundreds of millions of dollars in “fees.” The appalling negligence has even been documented in a scathing congressional report that confirms the FDA allows companies that annually pay it more than $400 million in fees to compromise public safety.

Expert, Dr. Michael Wilkes, the Vice Dean at the University of California, Davis, School of Medicine, stated that FDA has “systematically ignored District Field Officers and regularly overridden their explicit and well documented concerns about drug safety and public health.”24 According to Dr. Wilkes:

What is needed is a complete overhaul of the agency and its approval process they also want President Obama, to sign new legislation that would protect government employees who speak out against corruption.


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