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.