Comments on: The Mysterious Provenge Letter To The FDA http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/ News, Comment and Conversation Fri, 10 Feb 2012 21:28:52 +0000 http://wordpress.org/?v=2.6.2 By: Monica http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-23195 Monica Thu, 25 Oct 2007 05:16:17 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-23195 Ed, You are awesome. I'll tell you what keep doing what you are doing because YOU are making a difference. I am proud to be a part of Care to Live which by the way existed before the lawsuit. Each day when I wake up I think about the lives of Prostate Cancer patients, cancer patients who could benefit from Provenge and eventually other therapies in the works... I am very angry. I know this is all about MONEY. My friend and neighbor has decided to stop all chemotherapy because it feels worse than the cancer itself and besides her physician told her she should continue with it to give her an extra 6 months to live...BS! If it was Scher himself or a close family member diagnosed with stage 3-4 cancer what would he do?? Some people will do almost anything for money and power at the expense of others. Provenge if approved will change the lives of cancer patients and their loved ones, and the way we view cancer and medicine as a whole... This whole thing has not been a surprise to me, crime occurs in a variety of ways... Ed,

You are awesome. I’ll tell you what keep doing what you are doing because YOU are making a difference. I am proud to be a part of Care to Live which by the way existed before the lawsuit. Each day when I wake up I think about the lives of Prostate Cancer patients, cancer patients who could benefit from Provenge and eventually other therapies in the works…

I am very angry. I know this is all about MONEY. My friend and neighbor has decided to stop all chemotherapy because it feels worse than the cancer itself and besides her physician told her she should continue with it to give her an extra 6 months to live…BS!

If it was Scher himself or a close family member diagnosed with stage 3-4 cancer what would he do??

Some people will do almost anything for money and power at the expense of others.

Provenge if approved will change the lives of cancer patients and their loved ones, and the way we view cancer and medicine as a whole…

This whole thing has not been a surprise to me, crime occurs in a variety of ways…

]]> By: Kyoto27 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22973 Kyoto27 Tue, 23 Oct 2007 16:16:00 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22973 David Hamilton, If trusting a colleague over at NCI to copy check a letter is not earthshattering...one would assume Dr Scher would also take pains as an honored Special Government Employee of these United States to also have his COI submissions fact checked? Or is that too earthshattering to ask of this very heavily invested special employee of America? David Hamilton,

If trusting a colleague over at NCI to copy check a letter is not earthshattering…one would assume Dr Scher would also take pains as an honored Special Government Employee of these United States to also have his COI submissions fact checked? Or is that too earthshattering to ask of this
very heavily invested special employee of America?

]]> By: Tony F http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22970 Tony F Tue, 23 Oct 2007 16:00:13 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22970 Ed, I'll tell you I've got the biggest grin of incredulity on my face. Will this tragedy ever end? Will prostate cancer victims ever get access to Provenge or will they continue to die at the rate of 83 men per day--each and every day? Thanks for keeping us updated! Ed,

I’ll tell you I’ve got the biggest grin of incredulity on my face.

Will this tragedy ever end?

Will prostate cancer victims ever get access to Provenge or will they continue to die at the rate of 83 men per day–each and every day?

Thanks for keeping us updated!

]]> By: Hard Ball http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22884 Hard Ball Tue, 23 Oct 2007 04:55:42 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22884 Regardless of whether a conspiracy exists or not, the whole developing story of the in house conflicts of interest deserves to be critiqued by the SEC or Justice Dept. This story has long since passed the point of having the fox examine the hen house. Thank you Ed for bringing this story to light. It becomes more interesting each time you fit a new piece into the perplexing puzzle. Regardless of whether a conspiracy exists or not, the whole developing story of the in house conflicts of interest deserves to be critiqued by the SEC or Justice Dept.
This story has long since passed the point of having the fox examine the hen house.

Thank you Ed for bringing this story to light. It becomes more interesting each time you fit a new piece into the perplexing puzzle.

]]> By: David Hamilton http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22847 David Hamilton Tue, 23 Oct 2007 00:07:06 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22847 Personally, I think this letter draft looks almost exactly like what you'd expect if a leading researcher had sought a colleague's assistance in drafting the strongest and most convincing letter to the FDA possible. For one thing, scientists aren't always the most graceful writers around. For another, it wouldn't exactly be earthshattering if someone like Scher was to have a trusted colleague over at the NCI, either. Finally, there's nothing remotely incriminating in the body of the letter itself that I can see. The author (presumably Scher) and the reviewer (presumably someone at the NCI) both write as FDA outsiders -- for instance, note the section on page one of the letter in which the reviewer suggests quoting FDA's own guidance back at it -- and so there's no evidence to suggest that either one is Pazdur or one of his minions. The corrections and suggestions mostly seem like banal copyediting and there's no chortling or rubbing of hands over how they're going to stick it to Dendreon or Provenge or whoever. As for why the FOIA didn't turn up the emails that were also presumably exchanged -- well, it's not unheard of for people who want to maintain some confidentiality in correspondence to use Web-based email that presumably wouldn't generate agency "records" subject to FOIA, even if doing so might violate some other rule. Then again, I don't think any of the conspiracy theories that so many people find irresistable here actually make much sense in the first place. Personally, I think this letter draft looks almost exactly like what you’d expect if a leading researcher had sought a colleague’s assistance in drafting the strongest and most convincing letter to the FDA possible. For one thing, scientists aren’t always the most graceful writers around. For another, it wouldn’t exactly be earthshattering if someone like Scher was to have a trusted colleague over at the NCI, either.

Finally, there’s nothing remotely incriminating in the body of the letter itself that I can see. The author (presumably Scher) and the reviewer (presumably someone at the NCI) both write as FDA outsiders — for instance, note the section on page one of the letter in which the reviewer suggests quoting FDA’s own guidance back at it — and so there’s no evidence to suggest that either one is Pazdur or one of his minions. The corrections and suggestions mostly seem like banal copyediting and there’s no chortling or rubbing of hands over how they’re going to stick it to Dendreon or Provenge or whoever.

As for why the FOIA didn’t turn up the emails that were also presumably exchanged — well, it’s not unheard of for people who want to maintain some confidentiality in correspondence to use Web-based email that presumably wouldn’t generate agency “records” subject to FOIA, even if doing so might violate some other rule.

Then again, I don’t think any of the conspiracy theories that so many people find irresistable here actually make much sense in the first place.

]]> By: jack http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22845 jack Mon, 22 Oct 2007 23:47:58 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22845 none of this matters. Provenge will only be approved when DNDN gets new management. Pray the SEC cleans this corporate sewer up. this is the way government agencies work,the way they have always worked. Its DNDNs fault,they did not partner up with a company who has these guys greased. Pure idiocy. none of this matters. Provenge will only be approved when DNDN gets new management. Pray the SEC cleans this corporate sewer up.
this is the way government agencies work,the way they have always worked. Its DNDNs fault,they did not partner up with a company who has these guys greased. Pure idiocy.

]]> By: Ian http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22841 Ian Mon, 22 Oct 2007 23:23:13 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22841 I find it interesting that in the draft(v3)page 3, first paragraph, the author uses the word "amongst." ("It is also curious that the reported publication of the study...did not list CVA "amongst" the AE.") Just a hunch, but I'd bet Dr. Scher doesn't normally use the word "amongst" but perhaps Dr. Pazdur does. I think Pazdur wrote the content of the draft version (with some input from Scher), and Scher "cleaned up" the letter to be published in The Cancer Letter. Scher sent the draft along with the final copy (that was published) to denote the co-authorship. Just my theory... I find it interesting that in the draft(v3)page 3, first paragraph, the author uses the word “amongst.” (”It is also curious that the reported publication of the study…did not list CVA “amongst” the AE.”) Just a hunch, but I’d bet Dr. Scher doesn’t normally use the word “amongst” but perhaps Dr. Pazdur does. I think Pazdur wrote the content of the draft version (with some input from Scher), and Scher “cleaned up” the letter to be published in The Cancer Letter. Scher sent the draft along with the final copy (that was published) to denote the co-authorship. Just my theory…

]]> By: DNDN_Watchdog http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22839 DNDN_Watchdog Mon, 22 Oct 2007 23:18:43 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22839 Ed, Thanks for helping to shed more light on the Provenge/FDA scandal. Tens of thousands of men are going to suffer and die before The Truth is outed and those responsible for unethically and immorally delaying Provenge approval are identified and properly confronted for explanation. Also, we read in your note that "the two cancer docs received threats." This has been posted in other writings many times before BUT there has NEVER been ANY proof of these allegations produced by Scher or Hussain. WHY?? To make it look like they are the "victims?" So...what WERE the threats and let's see the actual proof. Why are there no PUBLIC records to confirm their claims?? Talk is cheap. Thanks again, Ed!! Ed,
Thanks for helping to shed more light on the Provenge/FDA scandal.
Tens of thousands of men are going to suffer and die before The Truth is outed and those responsible for unethically and immorally delaying Provenge approval are identified and
properly confronted for explanation.

Also, we read in your note that “the two cancer docs received threats.” This has been posted in other writings many times before BUT there has NEVER been ANY proof of these allegations produced by Scher or Hussain.
WHY??
To make it look like they are the “victims?”
So…what WERE the threats and let’s see the actual proof.
Why are there no PUBLIC records to confirm their claims??
Talk is cheap.

Thanks again, Ed!!

]]> By: Kyoto27 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22833 Kyoto27 Mon, 22 Oct 2007 22:33:06 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22833 Interesting that the Abstract notes under the topic of DISCUSSION the following tidbit: “Prolongation of life is ultimately the primary objective of therapy directed toward prostate cancers representing any clinical state. It can be achieved by eliminating the disease surgically, with radiation or by medical means, or, in theory by slowing the disease to the point where the patient dies of other, nonprostate cancer–related causes. There are, however, other treatment objectives of importance to patients in addition to prolongation of life, illustrated by the therapies approved for use for patients with castration resistant disease. Among them are mitoxantrone and prednisone, strontium-89 (Metastron), and samarium-153 (Quadramet), all of which were approved to palliate pain (39–43). Zometa was approved on the basis of reducing the risk of skeletal complications (40), whereas mitoxantrone and prednisone were shown to reduce the constitutional symptoms of an increasing disease burden (39). Noteworthy is that none of these therapies were approved on the basis of trials using an end point of tumor regression, and none were approved on the basis of an effect on PSA. In fact, most had no effect on PSA, and the clinical benefits were shown without prolongation of life. Only docetaxel, recently approved by the Food and Drug Administration for the treatment of patients with castration-resistant disease, was shown to prolong life in a randomized prospective clinical trial (15). Interesting that the Abstract notes under the topic of DISCUSSION the following
tidbit:
“Prolongation of life is ultimately the primary objective of therapy directed toward prostate cancers representing any clinical state. It can be achieved by eliminating the disease surgically, with radiation or by medical means, or, in theory by slowing the disease to the point where the patient dies of other, nonprostate cancer–related causes. There are, however, other treatment objectives of importance to patients in addition to prolongation of life, illustrated by the therapies approved for use for patients with castration resistant disease. Among them are mitoxantrone and prednisone, strontium-89 (Metastron), and samarium-153 (Quadramet), all of which were approved to palliate pain (39–43). Zometa was approved on the basis of reducing the risk of skeletal complications (40), whereas mitoxantrone and prednisone were shown to reduce the constitutional symptoms of an increasing disease burden (39). Noteworthy is that none of these therapies were approved on the basis of trials using an end point of tumor regression, and none were approved on the basis of an effect on PSA. In fact, most had no effect on PSA, and the clinical benefits were shown without prolongation of life. Only docetaxel, recently approved by the Food and Drug Administration for the treatment of patients with castration-resistant disease, was shown to prolong life in a randomized prospective clinical trial (15).

]]> By: grr http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22829 grr Mon, 22 Oct 2007 22:04:37 +0000 http://www.pharmalot.com/2007/10/the-mysterious-provenge-letter-to-the-fda/#comment-22829 Wouldn't a lot of NCI researchers be out of a job if Provenge were approved? Wouldn’t a lot of NCI researchers be out of a job if Provenge were approved?

]]>