Publicly available internet information shows these apparent Scher COIs (so far): [Particular attention is directed to items 1, 2 and—especially–15, but ALL—in totality– are important and telling, imo]

1. Novcea: STUDY CHAIR of DN-101; Grants & Research support - Direct competitor to Provenge

2. Medivation, Inc: PRINCIPAL INVESTIGATOR MDV3100;

3. Innovive Pharmaceuticals: PRINCIPAL INVESTIGATOR

4. Infinity Pharmaceuticals: PRINCIPAL INVESTIGATOR

5. Cougar Biotechnology: PRINCIPAL INVESTIGATOR; Advisory Board

6. Department of Defense: PRINCIPAL INVESTIGATOR PC Clinical Trials-P1 and P2

7. Bristol Myers Squibb: Consultant, Grants & Research support

8. Millennium Pharmaceuticals: Grant of Research support

9. sanofi-aventis: Grants & Research support

10. Genta: Scientific Advisory Board (as of March 6, 2007; since removed from web, but cached)

11. Biogen-Idec: Joint stock with spouse

12. Pfizer: Joint stock with spouse

13. Pharmion: Financial Conflict of Interest per Scher quote in MedPage

14. GPB Biotech: Financial Conflict of Interest per Scher quote in MedPage

15. PROQUEST INVESTMENTS: Consultant, Scientific Advisory Board; Limited Partner FINANCIAL interest

Go back and read #15 again…. He’s reported to be a “LIMITED PARTNER” in a Proquest partnership; doesn’t that suggest FINANCIAL investment?????

Here are three of the 1,000 or so patients treated with Provenge:

Edwardo Garcia of California who appeared at the FDA AC meeting speaking in favor of Provenge… alive after 7 years post-treatment

Kenneth Agnor of Chesapeake, VA. Read his story here:
http://content.hamptonroads.com/story.cfm?story=125573&ran=108297

Note his doctor, Paul Schellhammer, a Norfolk urologist, has treated 30+ patients and is active in the current, on-going D9902b Provenge trial.

… and Bruce Tower’s story about his success with Provenge here:

http://www.cedarcreekpilot.com/local/local_story_221172118.html

Unfortunately, imo, this controversy is taking away from the ultimate goal: assisting prostate cancer patients access to life-extending treatments which give the added benefit of a solid Quality of Life.

Those able are invited to attend a rally for Prostate Cancer patients at the FDA in Washington, DC on Sept 18th at 10 am.

Good Luck to all cancer victims!

While I delivered a statement in favor of Provenge at the hearing and marched in this week’s Raise a Voice rally in Washington, I’m sure I am typical of the vast majority of the prostate cancer survivor community in recoiling from the threats made against Drs. Scher and Hussain. I am also disturbed by unsupported allegations against the integrity of these doctors. A smear campaign should be no part of our advocacy effort. While I disagree with the stands taken by these two highly respected physicians and researchers, I fully respect their right to express their views and find nothing wrong with their writing post-hearing letters to the FDA and communicating them to the Cancer Letter, if they were the ones to do that. This is America, and we have a constitutional right to free speech. Moreover, the FDA is not a rubber stamp for its advisory committees and has a right and duty to make judgements on drug approvals.

Dr. Scher made several points, and I have a reasoned disagreement with some of those. However, here is an excerpt that also bothers me, as it did Dr. Scher: “Imbalances in disease aggressiveness and disease extent were noted between the Sipuleucel-T and “control” groups including a higher proportion with Gleason 6 disease or less at diagnosis (26.8% vs. 15.6%), and a lower proportion with both bone and soft tissue disease (52% vs. 69%) at the time therapy was started. Both factors favored the Sipuleucel-T arm, predicting a longer survival for the “treated” patients independent of therapy. The 2:1 randomization increased the power of the experimental arm, but it may have inadvertently made the small 43 patient control group more heterogeneous and less representative of the global population of men for whom the indication was proposed. The potential impact of heterogeneity in small patient cohorts was shown when a post-study change in the progression times of two patients (a change not accepted by the Agency), resulted in a change in the significance estimates.”

In essence, imbalances in the arms of the trial could be behind the apparent benefit in a small trial with a very small control group of 43 patients, some of whose members elected to receive salvage Provenge and/or docetaxel. Drs. Hussain also addressed this point. I have raised a fresh point regarding possible imbalance in my reply yesterday under Dr. Hussain’s letter.

From my School of Hard Knocks perspective as an eighth year survivor of a challenging case of prostate cancer, I would like to see some kind of interim approval that would allow access while not treating Provenge as a standard of care or benchmark, pending conclusive results of the larger trial, hopefully at the time the interim analysis is made in about a year. But I appreciate the reasoned, fact-based, experience and expertise-based positions of both Drs. Scher and Hussain. I thank them for their service on FDA panels and hope they will be willing to continue that service.

The news titled “Novacea and Schering-Plough Enter Into Worldwide Development and Commercialization Agreement for Asentar, a Novel Treatment for Prostate Cancer” was just published at your web site. Howard Scher is the lead investigator of Asentar. Scher claimed that he had no Conflict of Interests after he sent this letter to the FDA. Well, we know he lied now.

Do we know this? HH, it seems to me that you (and many on investors’ message boards) misinterpret the FDA’s waiver system, or else distort it. Conflict of interest is a serious problem if it is hidden or concealed. (All too often it is concealed from patients participating in clinical trials, by failure to inform these patients that some of the clinical investigators stand to gain financially. See e.g. in last week’s New York Times, …. a Downside to Full Disclosure. One of the worst cases of this in recent US history was exposed by the Seattle Times in their series March 11-15, 2001 Uninformed Consent).

Let’s get one thing clear. Dr. Scher did not claim that he had no conflicts of interest, neither before nor “after he sent his letter.” On the contrary, before he participated on the Advisory Committee, he DECLARED 3 potential conflicts of interest, and received a waiver for them from the FDA. His declaration is in the public record and on the FDA website. Regrettably, the FDA blacks out words that identify the specifics, but this applies to all the waivers. Several members of the committee that was convened March 29-30 received conflict of interest waivers: Glenn Dranoff, M.D.; Mary M. Horowitz, M.D.; Maha Hussian, M.D., FACP; Mary J. Laughlin, M.; James J. Mule, Ph.D.; Derek Raghavan, M.D., Ph.D. (Dr. Raghavan was unable to attend this meeting); Howard I. Scher, M.D.; Savio L. C. Woo, Ph.D.

OK. So, Dr. Scher is lead investigator in Novacea’s Asentar Phase III clinical trial. The public has known this for more than a year, at least since April 2006. Did Scher conceal it from the FDA Advisory Committee? Not likely. Here’s what he declared (regrettably, FDA hides specific identities of competing firms):

I acknowledge that contigent upon public disclosure of the following financial interest listed below …. I am eligible to receive waivers ….
Grant (related) Competing Firm $100,000-$300.000
Grant (related) Competing Firm $100,000-$300.000
Stock Competing Firm $5.000-$100,000
I hereby request that FDA make this information publicly available on my behaIf. I understand that without public disclosure of the interests the waiver is not valid.

That’s his summary declaration. And here’s the FDA’s understanding (page 2) of what Scher declared:

Dr. Scher advised the FDA that he has a financial interest related to the above topic that could potentially be affected by his participation in the matter at issue. Dr. Scher reported that he has joint stock in … at a current value of …. Additionally he reported that his institution has a grant from (competing firm) . The grant is current and his institution receives … per year from 2006-2007. Dr. Scher receives no salary from the grant. The grant is to study a licensed, approved drug (…) in prostate cancer trials. … is a licensed drug currently used in other cancer therapies. Dr. Scher also reported that his institution has a grant from (competing firm). The grant is current and his institution receives … per year from 2006-2008. Dr. Scher receives no salary from the grant. The grant is to study an investigational drug (…) that is also being studied in several types of cancer. It is unlikely that Dr. Scher’s participation in the discussions on March 29 of a cellular therapy for prostate cancer will have a direct and predictable effect on his financial interest.

What are the competing firms? Novacea’s Asentar is an investigational drug and could be the one “that is also being studied in several types of cancer” for which Scher’s institution receives the second mentioned grant (Novacea says “we are developing Asentar as a novel, oral anti-cancer agent which we expect will have applicability to multiple tumor types … including prostate, breast and colon”). If so, Dr. Scher did not lie about this at all. He told the FDA the facts, they considered the matter, and for reasons they state they issued a waiver.

In any case, how much of a conflict actually exists between Provenge and Asentar? I for one don’t believe Provenge is being suppressed by a conspiracy by the chemotherapy cartel. Dr. Petrylak’s re-analysis of Dendreon’s data indicates that Provenge has more impact on survival when used with Taxotere than when used alone. Asentar (a patented concentrated form of a high-dose vitamin D3) is being tested with Taxotere versus Taxotere alone. If both Provenge and Asentar are approved, Some AIPC patients probably will use both.

So far I haven’t seen anything that convinces me that Scher’s, Hussain’s and Fleming’s letters to the FDA were motivated by financial interests.

Nonetheless, more needs to be brought out about a range of conflicts of interest that come into play during clinical trials and during the rest of the approval process. And more needs to be done to speed up delivery of safe and effective drugs to cancer patients in the clinic. Thank for your interest and your input. Please believe that I care about men with AIPC.

I am curious as to whether or not this drug has been researched in conjunction with standard slash, poison, burn cancer treatments or the more advanced radiated seed therapies that my 2 friends, both elderly men, are currently receiving. Due to the fact that the drug in question (Provenge) very simply put “excites” the body’s own immune system as a line of defense against the cancer cells, it is really no wonder that the drug does not arrest the growth of cancer. If the body’s immune system were capable of eradicating the cancer cells, no treatment would be necessary. I would like to know exactly what positive things for the immune system the drug shows. Information is sketchy.

My questions are two-fold in subject matter: FIRST… has any research been done in control groups to test the validity of using this drug in combination with the standard prostate cancer treatments in use today? I am just a lay person in this area, but wondered if this drug might not be the extra ‘push’ that would help standard treatment be:

1. more effective in arresting cancer cell growth

2. of assistance in helping the body recover from the harmful side effects that current
standard treatments can cause

SECOND… are more studies planned regarding the possiblity of drug related CVA’s? Was the CVA connection definite?

Thank anyone who can help me to better understand.

Emma