Cool that I just discovered your affiliation with the Star-Ledger. That paper has a great rep for covering pharma. I’m not too far from you, in southern NY.

All the best,
paul

Apparently Russian patients, in consultation with their doctors, will be able to decide whether to try that drug for the indicated condition, whereas in the USA, patients, in consultation with their doctors, have no option to decide whether to take Provenge, which an independent panel of experts found both safe and efficacious for AIPC based on years of clinical trials and which even scientists (Schlom, et al) at our National Cancer Institute wrote in a peer reviewed journal is effective in affording a survival benefit.

At least on that issue, which country’s citizens have greater freedom, Americans or Russians? Sad. Sad not just for the hundreds of thousands of American prostate cancer patients, sad for our democracy, or should I say, autocracy. The Provenge story is a prime example of how we are no longer a democratic republic of, by and for the people. I love my country, but I have a very heavy heart.

For those unaware of the specifics of Dr. Howard Isadore Scher’s alleged Conflicts of Interests, here’s the details.

Scher reported only 3 COI’s to the FDA per his filing in late February available at the FDA website which appears to be composed of ownership of 1 stock and 2 competing industry interest.

Internet research shows the following for Scher thus far and please particularly note #1 and #17:

1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge

2. GPB BIOTECH: financial conflict of interest per Scher in MedPage

3. PHARMION: financial conflict of interest per Scher in MedPage

4. SANOFI-AVENTIS: grants & research support

5. BRISTOL MYERS SQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;

8. INNOVIVE PHARMACEUTICALS: principal investigator

9. INFINITY PHARMACEUTICALS: principal investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)

13. CONFOMA THERAPEUTICS: scientific advisory board

14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2

15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II

16. MEDIVATION, INC: principal investigator MDV3100

17. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest

There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 17 COI’s found so far on the internet.

Even more disturbing is the FDA’s Office of Inspector General and others investigators at the FDA and HHS to whom this information has been supplied and their apparent failure to investigate these charges over the past 10 months.

Yet, last week when several floral bouquets were sent to Dr. von Eschenbach, FDA Commissioner, they sprang into instant action within 1 business day to “investigate” who sent the flowers.

Why did Alison Martin at NIH help Scher with his post-AC letter urging non-approval of Provenge? (per FOIA documents)

One may draw the parallel that allegedly the FDA’s Richard Pazdur is the moral equivalent of Spitzer’s East Side NYC’s madam, Kristin Davis with Pazdur having Scher and Hussain in his stable and doing his bidding.

With approximately 83 men dying daily of AIPC, the total deaths since May 9, 2007 are 27,805.

Approvenge Provenge (at least conditionally) so that prostate cancer patients and their physicians can decide whether or not these TERMINAL cancer patients should have it or not.

Civil disobedience is the only means this corrupt system will be changed. It worked for AIDS and works for breast cancer patients.

Why can’t it work for everyone else?

It is almost unbelievable that while roughly 30,000 men in America die from PCa each year, a vastly safer and superior treatment sits idled for potentially years.

Why hasn’t this story been picked up by a hundred reporters/editors/producers such as yourself across America? Where is the outrage?

The degree of indifference demonstrated by the vast majority of those whose positions grant them the ability to rectify/expose/investigate this travesty is astounding.

The legacy of innocent blood, needless suffering, and stolen hope will stain the reputations and dog the consciences of all those who engineered the denial of Provenge and of those who failed to rectify the injustice.

At the time of their release we did not know that they were sent and received by Pazdur, Woodcock, Goodman and von Eschenbach. We also did not know that they were written on Memorial Sloan Kettering and University of Michigan letterhead. We also did not know that NCI employees helped with the letter campaign. Through FOIA responses we now know that the lobbying by these two doctors absolutely 100% happened.

We still do not have the e-mails that accompanied transmittal of the letters to Richard Pazdur because he refuses to provide them as requested by CareToLive in August 2007, per their Freedom of Information Act request. Dr. Pazdur claims he needs more time to be able to locate them and make a copy of them for us.

That those Doctors, for reasons other than the science, sabotaged Provenge, is a disgrace not only to their role as special governemnt employees, but a disgrace to their respective institutions.

Now, after the FDA has been made fully aware of the lack of due process given Provenge, they continue to do nothing to rectify the mistake. They refuse to put the due process back in. The lack of action on behalf of the FDA, now knowing what occurred is a disgrace that all Americans should be furious over.

The FDA by federal law must properly respond to a Citizen’s Petition, a law they have thus far refused to comply with in this matter.

• What were Dr. Scher’s concerns relative to Provenge becoming the new “standard of care” (if it were to have been approved) in terms of his not being able to fully enroll patients in the ongoing Asentar Phase 3 studies as well as in other chemotherapeutic trials (e.g., involving Taxotere) in which he was engaged at the time? How did this affect his behavior at, and following, the AC meeting?

• Who asked Dr. Scher to write his infamous letter to the FDA disparaging Provenge shortly after the favorable March 29, 2007, AC meeting?

• Who helped Dr. Scher write his letter to the FDA? At least one draft of Dr. Scher’s letter (v.3) was found on a PC in NCI, and at least one NCI employee attended a meeting called at the FDA to discuss this letter. (Letter and Information Source: NCI FOIA request and telcon with the NCI FOIA officer)

• Who leaked the letter disparaging Provenge written by Dr. Scher (as well as those letters written by Drs. Hussain and Fleming) to The Cancer Letter? (Letter Source: FDA FOIA requests)

• At the time of the Provenge AC meeting, Dr. Scher was the co-lead on Novacea’s Phase III Asentar drug trials for prostate cancer…a drug that was being developed in direct competition with Provenge. What impact did this have on Dr. Scher’s judgment and activities during and in the months following the AC?

• Dr. Scher is on the Scientific Advisory Board of ProQuest Investments, a healthcare venture capital firm. Internet sources also show him to be an officer and a member of the board of directors of the same firm. At the time of the Provenge AC meeting, ProQuest Investments owned in excess of 8% of Novacea. What impact did this have had on Dr. Scher’s judgment and activities during and in the months following the AC?

• Just 3 weeks after the FDA sent Dendreon a Complete Response (“Approvable”) letter, Novacea signed a $440 million co-development deal for its late stage prostate cancer drug, Asentar, licensing product rights to Schering-Plough Corporation. Deals such as this can take up to a year or more to develop and mature. What did Dr. Scher know, on March 29, 2007, regarding the soon-to-be-announced Novacea/Schering-Plough agreement on Asentar? (As we know, that deal was cancelled today.)

• What would have been the general nature of the financial impact on ProQuest Investments and Novacea as a result of Provenge being approved in May, 2007? It can be concluded, certainly, that the Asentar trials (and, thus, Novacea’s stock price) would have suffered and that the deal with Schering-Plough would not have been concluded on such generous terms, had it been concluded at all.

Calls for an investigation into this matter have come from many quarters, not the least of which was one in December 2007 from Congressmen Michael Michaud, Dan Burton, and Tim Ryan (at 11). On February 13, 2008, however, Congressman Dingell’s House Committee on Energy and Commerce responded to the call for hearings in the matter of conflicts of interest (COIs) regarding how the FDA handled Dendreon’s application for Provenge by rejecting the request on the basis of two arguments:

• “FDA has not yet made a final decision on this product, and it is the practice of this Committee to allow a regulatory agency such as FDA to complete its statutorily-mandated processes and render a final decision before initiating formal investigative action.”

• “A preliminary investigation into the record of the March 29, 2007, Open Session of the Cellular, tissue and Gene Therapies Advisory Committee that reviewed Provenge shows that the two advisory panel members you mentioned in your letter [Dr. Howard Scher and Dr. Maha Hussain] were granted waivers in compliance with the conflict of interest rules in force at that time.”…”Importantly, since the advisory panel that considered Provenge met, a new law strengthening conflict of interest provisions now governs FDA advisory panels.”

Unfortunately, neither statement has anything to do with the original request for hearings!

In their original letter of December 13, 2007, to Mr. Dingell, et al., Hon. Michael Michaud, Dan Burton, and Tim Ryan noted that:

“Prostate cancer activists have raised questions about two of the negative voters [at the March 29, 2007, Provenge AC meeting], academic medical oncologists Maha Hussain and Howard Scher. Dr. Howard Scher is lead investigator for a competing cancer drug made by Novacea and is listed as an adviser to a large venture capital firm that is also a major investor in Novacea. We believe the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto the advisory committee evaluating Provenge nor should the FDA appoint an adviser to a large investor in such a competitive firm as a panel member. It is important that Congress examines possible ethical violations of these panel Members considering the viability of potentially important life-saving drugs.”

Simply put, the three congressmen (and other congressmen who supported them, including Congressman Patrick Murphy of Pennsylvania) were asking the Committee to investigate the COIs of Drs. Scher and Hussain. They were not asking the Committee to force the FDA to approve Provenge; protocols already are in place to address that issue later this year or in 2009.

As to the waivers granted, citing the fact that a new law strengthens COI provisions basically closes the door after the horse has left the barn. The fact is, had the FDA acted in good faith prior to the Provenge AC meeting, it would have rejected Drs. Scher’s and Hussain’s waiver requests. A study published by BioCentury, The Bernstein Report On BioBusiness®, March 26, 2007, noted the following:

“Under the draft guidance, Scher either would be prevented from voting or excluded from the meeting.”

As regards to Dr. Maha Hussain:

“The waiver notes that Hussain is the principal investigator on a research contract awarded by a competing company for a product that is not related to Provenge. Under the draft guidance this probably would not be considered a conflict. However, the fact that her husband owns stock in three competing companies, valued at $15,000-$300,000, would at minimum prevent her from voting. If the total value of the stock exceeds $50,000, Hussain wouldn’t even be at the table if the new policy were in effect.”

Vince Tolino, Director, Ethics and Integrity Staff, FDA, should never have forwarded Scher’s and Hussain’s waiver requests to Randall Lutter, Ph.D., Associate Commissioner for Policy and Planning, FDA, and the latter never should have approved them.

Since May 8, 2007 (the date that Dendreon, the maker of Provenge, received its Complete Response letter from the FDA, requesting additional data that could take 1 to 2 years to acquire), more than 27,000 men have died of prostate cancer (PCa), many of whom could have been helped by Provenge.