I think you missed the worst drugs of all, Darvon, Darvocet, Distalgesic and Co-Proxamol. See; http://www.youtube.com/watch?v=vw5O4tgErsg

Shame on Von E.
Shame on his minions.
Shame on the FDA.
Shame on Big Pharma.
Shame on Scher et al.

And shame on all those who look the other way while TENS of thousands of men die every year from a common form of cancer.

Regardless, if you think we need to develop and retain people like Richard Pazdur, you are way off base! He is poison for the American people! His track record shows his business relationships are more important than the health of the taxpayers.

Further, he left a six-figure job to work at the FDA. His choice, not ours. You can read that story here:

http://money.cnn.com/magazines/fortune/fortune_archive/2006/02/20/8369155/index.htm

So why do you suppose he left that six-figure job? It wouldn’t have been because he hobnobs with big pharmaceutical lobbyists? Bristol-Myers Squibb wouldn’t have any influence on his decisions would it? Are there financial rewards there that would make it better than a six-figure job? I don’t know, I am just asking? I’ll try not to be too naive, if you promise the same.

Just study the ImClone case. He knew he couldn’t release FDA info but according to some good sources he was able to hand them off a Bristol-Myers Squibb lobbyist so people could find out inside FDA information to the detriment of patients and investors who pay his salary. He was dragged before Congress on this one.

And isn’t that what he did in the Provenge case? Handed off letters that FDA employees signed off on so they could be leaked by The Cancer Letter? No, I ain’t paying for this. They do not deserve bonuses.

Who needs to retain people who flip-flop like this idiot:

The FDA extended Avastin’s use to breast cancer and Pazdur said:

“We wanted to have the regulatory flexibility to approve effective drugs where there isn’t overall survival,” said Dr. Richard Pazdur, who oversees cancer drugs at the F.D.A. He said the agency had sympathy for the view that delaying the progression of life-threatening disease “may be a direct clinical benefit in itself.”

Dr. Pazdur of the F.D.A. and Dr. David Schenkein, a senior vice president of Genentech, both said it was undecided whether a survival benefit would be needed to obtain full approval.

http://www.nytimes.com/2008/02/23/business/23drug.html?_r=2&th&emc=th&oref=slogin&oref=slogin

When it came to Provenge, Pazdur told Businessweek this:

The agency, he says, is routinely made a scapegoat by both patients and company executives who refuse to abandon a drug despite an obvious lack of efficacy. “Believe me, if there were a clear survival effect, the drug would be approved,” says Pazdur.

http://www.businessweek.com/magazine/content/08_22/b4086000467675_page_2.htm

When pushed about Provenge, the FDA says the decision was based on science, a nice vague answer. But for Avastin, Pazdur said the decision was because the agency had sympathy. Why not sympathy for 96,000 American men who have late stage prostate cancer and have no other option?

Avastin didn’t have to show survival but Provenge must? Where is the consistency here? But the reality is, Provenge did show survival and that was the number one reason why they called for an FDA Advisory Committee!!

The Advisory Committee voted Provenge safe 17-0 and that it showed substantial evidence of efficacy, 13-4. That Advisory Committee was called and we paid for it with our tax dollars because Provenge showed survival! Pazdur is a liar and I refuse to pay bonuses to retain evil talent like his and I will stay after this until the FDA throws him out the door!!

But let’s look at the FDA as a whole:

Didn’t Von E cry that they didn’t have enough money to keep up with the science and the inspections? And Congress believed him and sent them $275 million? So they decided to use some of that to reward themselves for doing nothing?

Ok, I can’t accuse them of doing nothing. They did let contaminated pet food make it to the shelf. And toothpaste. And cough syrup. And leaded toy trains. And either tomatoes or peppers with salmonella. And, they let China process tea leaves with a drying process that has trucks sit over the tea leaves because they dry faster under the exhaust and China uses leaded gasoline!

In addition to all of that, they kept worthy, helpful products like Provenge and Junovan off the shelf.

This is truly disgusting.

Last April I was in the FDA lobby in Rockville. Instead of medical journals and food journals, visitors and employees were greeted with a stack of Wall Street Journals. The FDA is too busy with Wall Street, no wonder it can’t get the food and drugs right! And for this, they get a bonus???? I don’t think so. This is my opinion and I am sticking to it!

It’s an old game.

Many of them have failed to perform their duties. They should get a reduction in their pay packages and pass the bonuses to the citizens of the country who have been harmed by their dereliction of duty.

So the image of money being poured into FDA ain’t the way it is. We have a lot of great people working there, and a senior management many of whom engage in varying degrees of CYA’ing, corruption, and similar.

As with a company or industry, it is critical to differentiate separate levels and departments within FDA. The problem is - and has been - almost entirely in the managerial ranks, and at the top.

Somebody needs to do something about this!! Are you listening, McCain, Obama, the tooth fairy, santa clause, somebody, anybody???