“Provenge, FDA Panels And Conflicts Of Interest”
from http://www.pharmalot.com/2007/07/provenge-fda-panels-and-conflicts
The steaming controversy over Provenge - whether the prostate-cancer vaccine should be approved; the two FDA advisory panelists who went out of their way to delay agency approval; threats made to the two docs; and outrage among cancer patients and biotech investors - isn’t going away anytime soon. In fact, it resurfaced this morning on the front page of The Washington Post.
For those following this mess, the story didn’t really add much. For those who were unaware, though, the Post provided a good round-up, complete with significance and the bitter remarks of Maha Hussain, one of the FDA panelists, who fears for her safety. Both she and the other dissenting doc, Howard Scher, required private security at a recent meeting of cancer docs, for instance.
Here’s the quickie backdrop: the FDA panel this spring voted that Dendreon’s Provenge was safe and effective. The two docs weren’t convinced, though, and wrote the agency about concerns they had with Provenge trials, triggering the FDA delay. The stock, meanwhile, was gyrating. And cancer patients and their families were outraged, prompting protests and Internet missives.
Their fury was stoked, in part, by disclosures that Scher and Hussain had conflicts of interest. Scher (pictured to the left) has ties to other drugmakers - such as AstraZeneca and Sanofi-Aventis - with cancer meds. He’s also lead investigator for Novacea’s prostate cancer drug. And a patient group, ProvengeNow, cites info that Hussain was on Novacea’s advisory board. However, Novacea spokesman Paul Leland says the only tie to Hussain was a one-time fee she was paid for reviewing trial data two years ago.
continued …
Responses:
Paul Haider
Dr. Howard Scher was not only a dissenting voter against the approval of Provenge, but his over the top crusade against Provenge approval was inappropriate and, I believe, due to his huge conflicts of interest that were not adequately disclosed or considered by the FDA.
Dr. Howard Scher is the lead investigator of their phase III clinical trial for Asentar, an oral treatment for prostate cancer and a direct competitor of Provenge for AIPC patients. Additionally, Dr. Scher is a Novacea advisory board member. As per Novacea’s form 10-K filed with the SEC in April 2007, Novacea’s ability to commercialize Asentar would suffer if marketing approval of Provenge for AIPC were granted. On May 30th, less than 3 weeks after Dendreon was denied immediate marketing approval for Provenge by the FDA, Schering-Plough and Novacea entered into a worldwide development and commercialization agreement for Asentar worth over $450 million plus royalties if all milestones are met as anticipated. Novacea will receive an upfront payment of $60 million, including $35 million as reimbursement for past research and development expenses, a license fee of $25 million, as well as a commitment by Schering-Plough to purchase $12 million of Novacea common stock at a predetermined price within ten days of the closing. Additionally, the agreement provides Novacea with potential pre-commercial milestone payments of up to $380 million, and tiered royalties on worldwide sales of Asentar.
Proquest Investments (and its principals) are major shareholders of Novacea. Dr. Howard Scher is a scientific advisor for and has been granted an ownership interest in Proquest Investments. There are roughly 23 million shares outstanding in Novacea. According to SEC documents filed May 15, 2006, Proquest Investments (or it’s principals) own 1/3 of all the outstanding stock issued in Novacea, a company with a $220 million market capitalization. Below is a table that details ownership in Novacea by Proquest Investments (or it’s principals).
As of May 15th, 2006
Owner
Shares
PercentageProQuest Investments II, L.P.
1,779,767
8.0%ProQuest Investments II Advisors Fund, L.P
75,508
0.3%ProQuest Associates II LLC
1,855,275
8.3%Jay Moorin
1,910,988
8.5%Alain Schreiber
1,855,275
8.3%Total
7,476,813
33.4%larry larsen
I was diagnosed with prostate cancer in July, 2004. My PSA indicates the cancer may again be rearing its ugly head. I understand from your article that there is a new therapy that was voted safe(17/17) and efficacious(13/17) by an expert advisory panel and that possibly has extended the lives of several patients by years. I also understand there is a chemotherapeutic toxin available that essentially may add a few days or weeks of life to advanced prostate cancer patients, and is guaranteed to make them wish they were dead. Evidently, the earlier a patient with recurrent cancer takes a promising new immunotherapy, the more benefit they might obtain from the therapy.
I find this all so confusing. What to do!? I assume the new therapy is or will be available soon. Certainly nobody would deny dying cancer patients the opportunity to make their own informed decision with their personal physician in a case of life or death. After all, we aren’t talking about mild diabetes or hypertension or a cold. It sounds so promising, but then it isn’t absolutey, definitely, most assuredly, 100% statistically safe.
On the other hand, a chemotoxin sounds so reassuring. I’m sure the toxin must kill the tumor cells quite dead. Yes, that’s probably 100% statistically sure. But can they give me a high enough dose to kill all the cancer cells without killing me? Oh my! Oh bother! What to do!?Is there a wizard kind of doctor I can go to that will guide me in my decision? One that will be unbiased? One that has my life more at interest than his/her wallet? You mentioned some physicians in your article. Would they be such a physician?
Maybe I should go to a famous medical university or school or cancer center for advice. But their names seem to be so different nowadays. So do their faculty and curricula. Can you recommend one of the following that I have found. They seem to be pretty representative:
1. Hippocritic Loath School of Medicine
2. Venture Capital University School of Medicine
3. HedgeFund Medical School and Cancer Institute
4. Medical Investing and Science Advisory University
5. Big Pharma Chemotoxin Research Center
6. Making Money Speaking and Advising Medical Hospital
7. Memorial Cancer PseudoEthics Cener
8. Professional Medical Conflicts of Interest University
9. SuperSuccessful Medical Conflicts of Interest UniversityThank you for any help you can give me. Patients rely on their doctors for guidance, but often the docs are busy with finance institutions or sponsoring this or that…I feel so sorry them…always on call for their brokers 24/7. Anyway, let me know which of the above facilities will have a kind, helpful wizard that will be more than an illusion behind a curtain found along the yellow brick road to Wall Street. Maybe you can do even more in-depth articles on this. Every other media has just given me a quarter and told me to call someone who cares.
Thank you so kindly
larry larsen
Another bizarre aspect is this:
Scher is on record with a claim that he has no involvement with any competitor of Provenge. He’s many things, and among them is being a TWO-FACED MANIPULATOR.
A disgrace to the noble science of medicine.
Comment by moiliiliquarry — July 7, 2007 @ 10:13 pm