Comments on: Friend Or Foe? The FDA’s Controversial Cancer Doc http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/ News, Comment and Conversation Sun, 21 Mar 2010 16:11:29 +0000 http://wordpress.org/?v=2.6.2 By: Steven Walker http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-214136 Steven Walker Mon, 17 Mar 2008 22:27:56 +0000 http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-214136 The media debate regarding what FDA should and should not do in approving cancer drugs generally takes place from 40,000 feet at the sound bite level. This blog is an exception. Even Anna Mathews story in the WSJ, which looked at the man and the views of several observers of Dr. Pazdur, did not reach the level of an analysis of his decisions. The reader is left with a sense that approval of cancer drugs is based on the height of a "bar." This analogy, taken from track and field high-jump competitions, is simply not applicable to standards for approving new cancer medications. The concept that there can be an effective one-size-fits-all approach (the height of a bar set to a tiny fraction of an inch above the ground) to developing and approving cancer drugs is ludicrous. The drugs are different and do different things, the cancers are different (even at different stages of the same disease in the virtually the same patient), and the risk/benefit calculus for patients for whom approval is being sought is infinitely different - in fact the statistical approach preferred by Pazdur to the exclusion of all else can't come close to handling the reality that is cancer. The reason Dr. Pazdur has been such a lethal disaster for cancer patients (my quote in the WSJ article) is that he thinks there is a one-size-fits-all approach that should be applied in every case to every drug, no matter the differences. The result has been an alarming failure on his part to regulate effectively for people who have cancer. Viewed from their perspective, it is difficult to imagine Dr, Pazdur is aware that seriously- and terminally-ill patients exist beyond those few he uses up in his incrediubly unethical mandated, randomized, double-blind, placebo-only controlled clinical trials in his endless pursuit of p-values based on body-count statistics. Instead, he mindlessly pursues staistical metrics, delaying and denying approvals (thus coercing the few patients he needs into his unethical trials because they have no place else to go) to ensure those metrics are produced by the drug companies, no matter how compelling and irrefutable the data in hand already are, or how dire the need for many thousands of patients - who instead die waiting. For Dr. Pazdur, it is not about medical progress, sound science or good judgment, it is about the mindless pursuit of a "policy" we call Decelerated Approval that he unilaterally created in 2003 at an ODAC meeting. In a time of exploding knowledge regarding the causes of cancer, and the cause and effect of drugs being developed to treat it, Dr. Pazdur has remained locked into an archaic, ignorance-based, alrmingly crude, statistical approach to evaluating virtually every drug that comes before him. Fortunately, the support for his approaches is eroding both inside and outside the FDA, and the recent Avastin decision is a result of that erosion. But we have to look back only months to see the effects of his mistakes. Tens of thousands of Americans are still waiting for drugs like Genasense and Provenge. His bosses appear to have finally awakened to what he has been doing, thanks to the informed and persistent efforts of real patients, but they are moving very slowly - too slowly - for many who will still die waiting. The devil really is in the details, and fully understanding what is wrong with Dr. Pazdur's office of oncology drug products can't be seen from 40,000 feet or described with sound bites. Understanding how he has applied his narrow-mindedness to each of the many, many drugs he has needlessly delayed over the past several years requires an examination of each drug's development track. A careful examination of each drug, many of them now approved, reveals a pattern of mistakes and delay that have directly caused the premature deaths of more than a million Americans with cancer over the last 6 years. We think it is time for new leadership in FDA's cancer drug division, and we hope FDA's senior leadership will arrive at the same conclusion soon. A lot of lives depend on it. In the interview excerpts published along with the WSJ story, Dr. Pazdur referred to his critics (certain cancer patients and their advocates) as "bullies." I think those now dying (and calling for his dismissal) as they wait for drugs like Provenge and Genasense that have already shown substantial evidence that they imnprove and extend life, might think he is the bully - after all, dying is considered by most rational persons as being quite a serious event. A few weeks ago the WSJ editorial page pointed out that in addition to the scientific weaknesses of Dr. Pazdur's decisions, there is a moral component to all of this. They were right, and the FDA's cancer drug division is on the wrong side of the argument. Steve Walker The media debate regarding what FDA should and should not do in approving cancer drugs generally takes place from 40,000 feet at the sound bite level. This blog is an exception. Even Anna Mathews story in the WSJ, which looked at the man and the views of several observers of Dr. Pazdur, did not reach the level of an analysis of his decisions. The reader is left with a sense that approval of cancer drugs is based on the height of a “bar.” This analogy, taken from track and field high-jump competitions, is simply not applicable to standards for approving new cancer medications. The concept that there can be an effective one-size-fits-all approach (the height of a bar set to a tiny fraction of an inch above the ground) to developing and approving cancer drugs is ludicrous. The drugs are different and do different things, the cancers are different (even at different stages of the same disease in the virtually the same patient), and the risk/benefit calculus for patients for whom approval is being sought is infinitely different - in fact the statistical approach preferred by Pazdur to the exclusion of all else can’t come close to handling the reality that is cancer. The reason Dr. Pazdur has been such a lethal disaster for cancer patients (my quote in the WSJ article) is that he thinks there is a one-size-fits-all approach that should be applied in every case to every drug, no matter the differences. The result has been an alarming failure on his part to regulate effectively for people who have cancer. Viewed from their perspective, it is difficult to imagine Dr, Pazdur is aware that seriously- and terminally-ill patients exist beyond those few he uses up in his incrediubly unethical mandated, randomized, double-blind, placebo-only controlled clinical trials in his endless pursuit of p-values based on body-count statistics. Instead, he mindlessly pursues staistical metrics, delaying and denying approvals (thus coercing the few patients he needs into his unethical trials because they have no place else to go) to ensure those metrics are produced by the drug companies, no matter how compelling and irrefutable the data in hand already are, or how dire the need for many thousands of patients - who instead die waiting. For Dr. Pazdur, it is not about medical progress, sound science or good judgment, it is about the mindless pursuit of a “policy” we call Decelerated Approval that he unilaterally created in 2003 at an ODAC meeting. In a time of exploding knowledge regarding the causes of cancer, and the cause and effect of drugs being developed to treat it, Dr. Pazdur has remained locked into an archaic, ignorance-based, alrmingly crude, statistical approach to evaluating virtually every drug that comes before him. Fortunately, the support for his approaches is eroding both inside and outside the FDA, and the recent Avastin decision is a result of that erosion. But we have to look back only months to see the effects of his mistakes. Tens of thousands of Americans are still waiting for drugs like Genasense and Provenge. His bosses appear to have finally awakened to what he has been doing, thanks to the informed and persistent efforts of real patients, but they are moving very slowly - too slowly - for many who will still die waiting. The devil really is in the details, and fully understanding what is wrong with Dr. Pazdur’s office of oncology drug products can’t be seen from 40,000 feet or described with sound bites. Understanding how he has applied his narrow-mindedness to each of the many, many drugs he has needlessly delayed over the past several years requires an examination of each drug’s development track. A careful examination of each drug, many of them now approved, reveals a pattern of mistakes and delay that have directly caused the premature deaths of more than a million Americans with cancer over the last 6 years. We think it is time for new leadership in FDA’s cancer drug division, and we hope FDA’s senior leadership will arrive at the same conclusion soon. A lot of lives depend on it. In the interview excerpts published along with the WSJ story, Dr. Pazdur referred to his critics (certain cancer patients and their advocates) as “bullies.” I think those now dying (and calling for his dismissal) as they wait for drugs like Provenge and Genasense that have already shown substantial evidence that they imnprove and extend life, might think he is the bully - after all, dying is considered by most rational persons as being quite a serious event. A few weeks ago the WSJ editorial page pointed out that in addition to the scientific weaknesses of Dr. Pazdur’s decisions, there is a moral component to all of this. They were right, and the FDA’s cancer drug division is on the wrong side of the argument.

Steve Walker

]]> By: Tony F http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-205739 Tony F Wed, 12 Mar 2008 17:20:13 +0000 http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-205739 It appears to me from what I read in the media that Pazdur creates his own controversy and engenders the distain of his critics. What Pazdur seems to work hard to do is to cover up and down right violate the Federal Government's own rules and regulations regarding FOIA requirements. His actions speak loudly that he is above the law which applies to all. Shame on Dick Pazdur! Comply with the law or suffer the consequences of your own making. It appears to me from what I read in the media that Pazdur creates his own controversy and engenders the distain of his critics.

What Pazdur seems to work hard to do is to cover up and down right violate the Federal Government’s own rules and regulations regarding FOIA requirements. His actions speak loudly that he is above the law which applies to all.

Shame on Dick Pazdur!

Comply with the law or suffer the consequences of your own making.

]]> By: Dick and Jane http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-205582 Dick and Jane Wed, 12 Mar 2008 13:16:55 +0000 http://www.pharmalot.com/2008/03/friend-or-foe-the-fdas-controversial-cancer-doc/#comment-205582 See Dick. See Dick Pazdur. See Dick Pazdur try to avoid FOIA requests from CareToLive. Why, Dick, why?? Hear the cries of thousands upon thousands of Pca victims. Hear them begging for Provenge. Hear them asking the FDA why? See the AC vote on Provenge. See the vote 17-0 for SAFETY and 13-4 for SUBSTANTIAL EFFICACY. See the FDA turn Provenge down. Why FDA, why?? See Dick The Decider See Dick and Scher and Fleming having insomnia. Why, Dick, why?? Look, Dick, look. See the chemo-cartel. See the chemo-cartel sleeping like babies. Why Dick, why?? See Dick.
See Dick Pazdur.
See Dick Pazdur try to avoid FOIA requests from CareToLive.
Why, Dick, why??

Hear the cries of thousands upon thousands of Pca victims.
Hear them begging for Provenge.
Hear them asking the FDA why?

See the AC vote on Provenge.
See the vote 17-0 for SAFETY and 13-4 for SUBSTANTIAL EFFICACY.
See the FDA turn Provenge down.
Why FDA, why??

See Dick The Decider
See Dick and Scher and Fleming having insomnia.
Why, Dick, why??

Look, Dick, look.
See the chemo-cartel.
See the chemo-cartel sleeping like babies.
Why Dick, why??

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