The NY Times just released an article showing what a great guy Richard Pazdur is. This caused me to revisit journalistic integrity. The reason I did that is because I am going to present some rather harsh information about Richard Pazdur that this NY Times reporter, Gardiner Harris, refused to address. It appears to me that this reporter is a friend of Pazdur and this precludes him from maintaining journalistic integrity. This NY Times reporter will insult patient advocates while standing up for a guy who is supposed to be the ultimate patient advocate, a doctor.

http://www.nytimes.com/2009/09/16/health/policy/16cancer.html?_r=1

The preamble for The Society of Professional Journalists states:

Members of the Society of Professional Journalists believe that public enlightenment is the forerunner of justice and the foundation of democracy. The duty of the journalist is to further those ends by seeking truth and providing a fair and comprehensive account of events and issues. Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty.

Please note: Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty. It does not say to serve government employees and, in particular, doctors who work for the FDA, a government agency.

On its website, the New York Time states:

For more than a century The New York Times Company has stood for quality, integrity and distinguished journalism.

Will it remain standing for quality, integrity and distinguished journalism? The NY Times says readers dissatisfied with a response or concerned about the paper’s journalistic integrity may reach the public editor at public@nytimes.com or (212) 556-7652.

As you read the article penned in favor of Richard Pazdur, while denouncing those who protested against him, notice what is left out rather than what is puffed in. Why didn’t Gardiner mention Provenge or ImClone, two big blemishes on Richard Pazdur’s resume? Richard Pazdur is a conflicted liar. We the people should not have to see our tax dollars go to such a manipulator who pretends to be a doctor. He wouldn’t know the Hippocratic Oath if you smacked him over the head with it.

A good way to test the character of a doctor is to watch how he or she reacts in an emergency room. People are rushed to emergency room for many life threatening problems. The good doctors and nurses spring into action trying everything they can to save a life. Richard Pazdur does not react that way. In 2002, he leaked inside FDA information, which Gardiner is correct to point out is against the law, to a powerful Bristol-Myers Squibb lobbyist so he could get it into the hands of Paul Goldberg, who just happens to share tables at conferences with Richard Pazdur and this NY Times reporter, Gardiner Harris. This kept an effective treatment from reaching dying patients.

In 2007, Richard Pazdur raised his ugly head again and stopped a safe and effective, non-evasive, non-toxic prostate cancer treatment called Provenge from reaching 96,000 eligible men. The men had no other option. They had a quick destiny with death. Paul Goldberg assisted Pazdur with his non-peer reviewed medical publication called the Cancer Letter. Together, they leaked three letters that were supposed to be confidential. Why didn’t Gardiner Harris include this in his article?

Richard Pazdur took a lot of heat for this and rightly so. It doesn’t take a brain surgeon to connect the dots and see it was for political reasons that he let men die needlessly. Even one-sided reporter Matthew Herper of Forbes Magazine penned it like this:

“But right now, its stock is dangerous to buy, because its fate will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

http://www.forbes.com/2007/04/20/prostate-dendreon-stock-biz-cx_mh_0420dendreon.html

Herper also mentioned, and as far as I am concerned helped leak, the confidential letters.

Protests were held outside the FDA Headquarters in Rockville, MD, at the ASCO Convention in Chicago, and by way of a march in Washington, D.C. Ads were placed in newspapers and on buses - see http://caretolive.com/wp-content/uploads/2007/11/bustailphoto72.jpg ). A protest was held outside the Marriott Hotel in Philadelphia because the FDA was there and Janet Woodcock was there sharing the dais with a pharmaceutical firm that had a deal with the competitor of the treatment Pazdur stopped. A gentleman came outside the Marriott and asked what was being said about Ms. Woodcock because it mattered. It mattered to the FDA that the public not see her image was tainted.

And so it is with Gardiner Harris reporting for the NY Times. He wants you, the reader, to think and be convinced Richard Pazdur is a nice guy. Well I am here to tell you Richard Pazdur is not a nice guy at all. Gardiner, and any good journalist, needs to show the business relationships of Pazdur. As the old saying goes, just follow the money.

On May 30th, 2008, there was a ten city protest held by CareToLive. Why all the protests? Because Richard Pazdur stopped Provenge from reaching men who were dying from prostate cancer. Pazdur tried to get out in front of the protests by talking to Katie Couric a couple days before the ten city rally. He told Katie, all Provenge had to do was show survival. Well folks, Provenge did show survival. That was the number one reason the FDA called for an Advisory Committee. That committee, paid with our tax dollars, looked at Provenge with all of its warts and blemishes, and it voted. That panel voted Provenge safe, 17-0, and said it showed SUBSTANTIAL EVIDENCE OF EFFICACY, by a vote of 13-4. That is why Pazdur had to team up with Paul Goldberg, just like he did in 2002, to stop Provenge.

CareToLive, a not for profit corporation, sued Richard Pazdur, among others (see http://www.caretolive.com/CTLfinalvsPazScher.pdf ). While the courts blocked all discovery, Pazdur was busy deleting his e-mails and shredding his documents. He didn’t want anyone to know he stopped a safe and effective treatment from reaching dying patients. That is why folks rose up to protest. Where is the outrage NY Times? This would-be doctor let the patients die.

After he stopped Provenge from reaching the patients, Dendreon, the manufacturer of Provenge, continued with a Phase III study. The FDA allowed an interim look. In October 2008, an Independent Data Monitoring Committee stated Provenge showed a safe profile and a 20% survival advantage over placebo. 30,000 men die every year in the U.S. of prostate cancer. 20% would mean 6,000 would survive. You would think Pazdur, and his FDA colleagues, would hustle like an emergency room doctor or nurse, and give this treatment to the men ASAP. The data supported the Phase III trials the FDA looked at back in 2007 which the Advisory Committee highly recommended with the 17-0 safe vote and 13-4 efficacy vote. Still, Pazdur sits on his cold-hearted duff while men die in large numbers.

This past April the final data were reported. Provenge continued to show a safe profile and the survival advantage was now up to a 22.5% advantage over placebo. Still, Pazdur exhibits his stone cold manner. Recently, he spoke to a USA Today reporter and told her the FDA approves treatments using interim data. Folks, from everything I am showing here, why doesn’t Pazdur get Provenge to the men right now? It was safe and effective in March 2007, October 2008, and April 2009. What is wrong with this picture?

Last week, I lost a good friend, Bruce Tower. Bruce could have been on Provenge for over two full years now. 96,000 men could have been on it in 2007, or in 2008, or in 2009. Instead, 22.5% of over 71,000 men have died at the hands of Richard Pazdur who Paul Goldberg helps and Gardiner Harris touts. I just wanted you folks to have the real story. Ask your government to toss Richard Pazdur out of the FDA.

Richard Pazdur testified under oath saying he had nothing to do with the Provenge decision. How can that be? Gardiner Harris is showing you in his article, Pazdur controls the cancer approvals. “No cancer medicines can be sold to or even tested on people without the imprimatur of Dr. Pazdur and his staff of about 150 oncologists, toxicologists and other specialists,” Gardiner wrote. To me, it appears Pazdur committed perjury.

Richard Pazdur also hurt the war on cancer. By stopping Provenge, he delayed advances in immunotherapy. Instead of putting chemo in the body which kills good cells along with the bad cells, people could be rebuilding their immune system to fight off the bad cells while leaving the good cells alone. This is what Pazdur sabotaged. This is quite the travesty. We don’t need doctors like Richard Pazdur.

Pazdur went so far as to string along DOJ attorneys and the courts for two years while hiding documents requested under the FOIA, only to reveal that he supposedly deleted them and shredded them two years prior. It is quite telling that Richard Pazdur can produce for the NY Times reporter an old e-mail sent from someone in Arizona who was angry and critical of him but yet if he receives letters from a doctor at Memorial Sloan-Kettering or the University of Michigan, he promptly destroys them as unimportant. 

Pazdur and his staff, Maha Hussain and Howard Scher, have worked for and may still work for Bristol-Myers Squibb, the largest chemo manufacturer in the country. Since we know Pazdur has a good friend who is a powerful lobbyist for Bristol-Myers and Pazdur shares the same lawyer as Paul Goldberg of the Cancer Letter, these connections are just too strong to ignore. They stopped Provenge for a reason and it was not because of the science and Pazdur doing his job. Go speak to the families who lost their special man while Pazdur acted like a control freak on a mission for his business associates. Follow the money, not the story Gardiner Harris conjured up. You can always follow the real story on www.CareToLive.com

And wait until you read this:

http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon/

Now here is a quick recap of what we do know about Richard Pazdur:

* He was invited by CBER to participate in the Provenge Advisory Committee hearing (for some dumb reason).

* He invited Maha Hussain and Howie Scher to the party.

* He attended the AC and his presence was used as supportive arguments (by Maha).

* He actively spoke to and passed notes back and forth (per several sources at AC) in an effort to coach Maha at the hearing.

* He destroyed documents and deleted e-mails that might provide more insight into what role he took.

* He took an anti-Provenge stance in media articles, post decision.

* He proclaimed a reason for non-approval was that IMPACT might show it did not work and the FDA would be made to look foolish.

* He was upset that by the time the Provenge BLA consideration came up that it was not assigned to CDER rather to CBER.

* With the help of Janet Woodcock, he wanted and tried to have a new division set up (for which he would be in charge) that would rule over the future of immunotherapies.

* The letters quickly ended up in the hands of his buddy, Paul Goldberg.

* He is in charge of coordinating with our friends at NCI. Whatever happened to Alison Martin? Where is she today?

Also, it is clear that he used his influence to affect the decision. If it is in any way wrong, remember it is the agency’s lack of transparency on the process that would cause any perception that mistakes were made. Andrew von Eschenbach, the former FDA Commissioner, was not involved except to the extent that he could have overruled the decision or could have granted the CareToLive Petition (even after interim at the very least). It is true that we think that Andy was influenced by others outside the FDA, not Pazdur.

What is clear is that the egotistical maniac wants all decisions to be his, and his alone. Real Due Process will in many cases continue to be an after thought as long as he is there.

Pazdur clearly does not want publicity to his Provenge debacle as he knows that it’s the best example of the FDA’s seeming willingness to let him run loose and if he keeps at it (”I am the FDA”), a successful suit against the FDA on denial of due process grounds will eventually be waged by a license applicant. It is bad form for the FDA to allow him to run around and play his power games as he wants. The writer of the New York Times article, Gardiner Harris, went out of his way not to mention the Provenge matter, which may well have been at Pazdur’s request.

I would fathom that Pazdur desperately does not want his career defined by Provenge, yet he keeps talking.

And one final note:

At a June18, 2008 meeting, Pazdur delivered the 10 minute speech “Past Experiences in Drug Development”. Maybe that’s why he didn’t get Provenge, he’s living in the past.

But notice who was there on the 7:15 Dinner Panel:

7:15 p.m.
Salon E Dinner Panel: “Major Oncology Topics in the Press”
Panelists
Moderator:  Richard Pazdur, MD
Paul Goldberg (The Cancer Letter)
Gardiner Harris (New York Times)

http://www.acceleratingworkshop.org/modules/aaa0/index.php?id=24

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Tags: Dendreon, DNDN, FDA, Howard Scher, Michael Milken, New York Times, Prostate Cancer, provenge, Richard Pazdur

This entry was posted on Wednesday, September 16th, 2009 at 4:21 pm and is filed under The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.