Post by unlawflcombatnt on Jul 16, 2007 15:51:04 GMT -6
In one of the most disgusting, slimy, greed-motivated moves I've ever seen, a group of investors have published an ad in the Washington Post urging Congress to override an FDA decision to not approve a drug. Of course, the drug is one that these dirtballs have invested in heavily.
The drug is called "Provenge," or generically as Dendreon. It's an immunomodulator designed to fight prostate cancer. The FDA refused to approve the drug, due to insufficient studies showing that it prolonged survival.
The Dendreon saga is somewhat murky, though this is largely due to lies and distortions published by it's greedy shareholders. Their latest ad in the Washington Post is exemplary of how wealthy stockholders try to misinform and deceive the public. In this case, they're trying to get public opinion and Congress to override the legitimate health concerns of the FDA.
In general, Dendreon has not been conclusively proven to extend the life of Prostate Cancer victims. There is a rigid, completely justifiable protocol that the FDA requires for drug approval. Dendreon (Provenge) has not passed that protocol.
In March, a panel of FDA advisors voted 13-4 that there was evidence that Dendreon was effective, potentially paving the way for approval. However, in order to get this 13-4 vote, the criteria for efficacy had to be changed. The initial trial included an extremely small number of patients, only 225 total. Some of the panelists were not convinced of its efficacy initially. It was only after taking a 2nd look, after changing the criteria, that the panel was able to state that the evidence showed Dendreon to be "effective."
However, 3 top cancer researchers wrote to the FDA, saying Dendreon (Provenge) should not be approved. Two of these researchers had served on the FDA panel, and had already voiced their concerns.
The 3rd letter, from statistician Thomas Fleming, one of the world's leading experts on clinical trial assessment, was the most convincing. From Forbes
" Five years ago, he (Fleming) warned against approving AstraZeneca's lung cancer pill Iressa because clinical data were not convincing. He was right--Iressa failed in a big clinical trial, and its use was severely restricted.
Fleming wrote that he was invited to participate in the March 29 panel that voted to approve Provenge, but declined because he had done some consulting for Dendreon. He wrote that he was kept awake the night the panel voted. The survival data might look compelling, he wrote, but because the trial had not been designed to prove Provenge extended lives, there was a big risk that the results were a fluke....
Approving Provenge might make it difficult to find out whether Provenge's benefits are real. Patients might drop out of the ongoing clinical trial in order to get the drug, not placebo. How, he asked, would that be good for prostate cancer patients?
In an e-mail, Fleming confirmed the accuracy of the letter and said he had only rarely written such letters as part of his work for the FDA.
If Provenge had been approved, the decision would have overturned the rigid policies the FDA has put in place for data about medicines. That could have resulted in a free-for-all as biotechs presented lots of re-analyzed studies in long-shot attempts at getting past regulators. Because of the decision today, that's not going to happen...."
Dendreon/Provenge has not be "approved" by the FDA. Ever. It has been recommended as "potentially approveable" by the FDA.
The FDA has cut Dendreon tremendous slack even here. They've stated that they will accept "interim" results as proof of its efficacy. Those will be available in 2008, which is much sooner that the normally required 2-3 year time period.
But this still isn't good enough for the greedy slimeball investors. Their profits concerns outweigh their concern for the health and wellbeing of their fellow Americans.
What a surprise.
The drug is called "Provenge," or generically as Dendreon. It's an immunomodulator designed to fight prostate cancer. The FDA refused to approve the drug, due to insufficient studies showing that it prolonged survival.
The Dendreon saga is somewhat murky, though this is largely due to lies and distortions published by it's greedy shareholders. Their latest ad in the Washington Post is exemplary of how wealthy stockholders try to misinform and deceive the public. In this case, they're trying to get public opinion and Congress to override the legitimate health concerns of the FDA.
In general, Dendreon has not been conclusively proven to extend the life of Prostate Cancer victims. There is a rigid, completely justifiable protocol that the FDA requires for drug approval. Dendreon (Provenge) has not passed that protocol.
In March, a panel of FDA advisors voted 13-4 that there was evidence that Dendreon was effective, potentially paving the way for approval. However, in order to get this 13-4 vote, the criteria for efficacy had to be changed. The initial trial included an extremely small number of patients, only 225 total. Some of the panelists were not convinced of its efficacy initially. It was only after taking a 2nd look, after changing the criteria, that the panel was able to state that the evidence showed Dendreon to be "effective."
However, 3 top cancer researchers wrote to the FDA, saying Dendreon (Provenge) should not be approved. Two of these researchers had served on the FDA panel, and had already voiced their concerns.
The 3rd letter, from statistician Thomas Fleming, one of the world's leading experts on clinical trial assessment, was the most convincing. From Forbes
" Five years ago, he (Fleming) warned against approving AstraZeneca's lung cancer pill Iressa because clinical data were not convincing. He was right--Iressa failed in a big clinical trial, and its use was severely restricted.
Fleming wrote that he was invited to participate in the March 29 panel that voted to approve Provenge, but declined because he had done some consulting for Dendreon. He wrote that he was kept awake the night the panel voted. The survival data might look compelling, he wrote, but because the trial had not been designed to prove Provenge extended lives, there was a big risk that the results were a fluke....
Approving Provenge might make it difficult to find out whether Provenge's benefits are real. Patients might drop out of the ongoing clinical trial in order to get the drug, not placebo. How, he asked, would that be good for prostate cancer patients?
In an e-mail, Fleming confirmed the accuracy of the letter and said he had only rarely written such letters as part of his work for the FDA.
If Provenge had been approved, the decision would have overturned the rigid policies the FDA has put in place for data about medicines. That could have resulted in a free-for-all as biotechs presented lots of re-analyzed studies in long-shot attempts at getting past regulators. Because of the decision today, that's not going to happen...."
Dendreon/Provenge has not be "approved" by the FDA. Ever. It has been recommended as "potentially approveable" by the FDA.
The FDA has cut Dendreon tremendous slack even here. They've stated that they will accept "interim" results as proof of its efficacy. Those will be available in 2008, which is much sooner that the normally required 2-3 year time period.
But this still isn't good enough for the greedy slimeball investors. Their profits concerns outweigh their concern for the health and wellbeing of their fellow Americans.
What a surprise.