The FDA takes a few steps forward on reforming how the AC panel votes –and which members are allowed to vote. Good. But what happens next? The FDA moves into closed session…with no record, no transparency and makes a ‘yeh/nay’ decision without a summary finding of the arguments (or an accounting of who voted ‘nay’ and ‘yeh’ in the closed session). Is this reform???? The FDA has no less an impact on American lives than does the Supreme Court –and if the Supremes are made to publish a record of their findings, why shouldn’t the FDA? Is the FDA afraid to be on record?
Is it afraid its ‘nay/yeh’ votes will be noted by Big Pharma? Or the media? Or American citizens? Or Congress? Unless the FDA is mandated to also cast its votes in an open hearing, this reform is as suspect as the Complete Response Letter that Dendreon received after an overwhelming nod for approval from the AC panel.

I hope Ed that you will push for transparency in the FDA’s final decision making process.
Americans are owed no less.

1. I read the report. Maha Hussain, one of the alleged “conflicted” doctors who sat on the Provenge AC meeting March 29th is included in the study… see page 12-1 of the report.

Interestingly, Howard Isadore Scher, the other apparent “conflicted” doctor wasn’t on their list… could it be because his data would have skewed their report???

2. About a week ago, Ed, you suggested you will look into the alleged “death threats” against Hussain and Scher regarding their participation in the Provege AC because many, including myself, contend there were no credible “death threats” made to the and because no media person has seen either these allegations or, what any ordinary US citizen would do in their shoes, file a police report of the incidents.

Just holding your feet to the fire a bit so as not to let it out of your memory bank that you are going to look into this and report back your finding… hopefully, of FACTS and not just rumors or 3rd party comments.

3. Let your readers also know that Scher COI allegations of having way more than he reported to the FDA have been made to:

HHS, Office of Investigative Services
FDA
DoJ
FBI
SEC
… and numerous Congress-people and Senators…..

… yet no one person or agency has taken in interest in the alleged law violation be Scher and his COI.

4. Don’t want to let yet another opportunity escape to keep Scher’s alleged COI and what he reported to the FDA in order to acquire a seat and vote in judgment of Provenge March 29th in front of your audience.

Those familiar with this part of the Provenge tale recall that Scher certified to the FDA that he had 3 conflict of interests–2 competing company associations and 1 personal stock holding.

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.

…. 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.

Lastly, let’s not forget the 83 men who die EACH DAY from prostate cancer and their families. God Bless them and their loved ones!

Since May 9th FDA adverse decision on Provenge, over 15,000 men have died….. in just 6 months.

Where’s the public outcry against this travesty?

It’s about time that the FDA got it’s priorities straight. This has been (and continues to be) one of the most corrupt agencies in Washington.

New proposed FDA rules on COIs…tests show that neither Hussain nor Scher would have been allowed on the Provenge AC…
Look at this review of the proposed new FDA rules that was published earlier this year; under the new rules, neither Dr. Scher nor Dr. Hussain would have been permitted to participate in the Provenge AC!

BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS MARCH 26, 2007
By Steve Usdin
Washington Editor

When FDA’s Cellular, Tissue and Gene Therapies Advisory Committee meets this week to discuss whether the agency should approve the first cancer vaccine, a product that could establish proof of principle for an important new therapeutic class, several of the votes will be cast by internationally respected experts who were invited to join the committee on an ad hoc basis because of their specific expertise.

The picture might look quite different if FDA’s new draft guidance for determining conflict of interest and eligibility for participation on its advisory committees were in force. Under the proposed policies, three of the invited experts probably would be ineligible to vote on Provenge sipuleucel-T from Dendreon Corp. (DNDN, Seattle, Wash.).

And two might be completely barred from participating in the discussions.

The new, more stringent criteria for participating in advisory committee meetings will limit or preclude the participation of “a significant fraction” of serving committee members, Associate Commissioner for Policy and Planning Randall Lutter told reporters last week.

The policies are needed “so that the public has confidence in the integrity of the recommendations” made by the committees, Lutter said. They are intended to strike a balance between “having the best possible access to scientific experts who may by the nature of their work have had ties to private industry that is driving biomedical innovation in this country, and at the same time seeking to ensure we have the fullest public confidence in our advisory committee process.”

FDA critics praised the announcement as vindication of their claims that the advisory process has been corrupted, while some former senior agency officials warned it will harm public health by preventing or deterring highly qualified scientists from participating on committees.

New filters

The draft guidance replaces previous policies, which did not spell out criteria for granting waivers from government COI regulations, with an algorithm for determining eligibility to participate (see “Conflict-of-Interest Algorithm,” A18). Generally, the decision tree would exclude individuals who have financial interests of $50,000 or more that might be directly affected by a meeting’s outcome — or have had such interests in the previous 12 months.

In addition to the potential advisor’s financial interests, the criteria apply to spouses; minor children; current or prospective employers; general partners; and organizations for which the individual serves as an officer, director, trustee, or general partner. The draft guidance defines a prospective employer as “anyone with whom the employee has any arrangement concerning future employment or with whom he/she is seeking or negotiating for employment.”

Under the new policies, individuals with a relevant direct financial interest in a meeting’s outcome of less than $50,000 could be permitted to participate on a non-voting basis if they have unique qualifications and relevant expertise, and it is difficult to find someone with similar qualifications without a disqualifying financial interest.
Although FDA has left itself flexibility to waive these criteria in exceptional circumstances, the agency has stated it generally will apply its guidelines more stringently than required.

For example, the guidelines state that the calculation of potential COI should exclude ownership of up to $15,000 of stock in a company with a product under discussion, or in a company with a competing product. Nonetheless, according to the guidance, because “the public may perceive some financial interests involving securities in organizations potentially affected by advisory committee recommendations as problematic,” FDA intends to “implement a policy of generally limiting participation to non voting in such circumstances even where full participation would be permitted.”

Test case

The COI waivers for the Provenge meeting posted on FDA’s website on March 13 — eight days before the draft guidance was released — illustrate the potential impact of the new policies.

The Cellular, Tissue and Gene Therapies Advisory Committee is oriented toward specific technologies, not a specific therapeutic field. No one on the committee specializes in prostate cancer.

FDA has granted a waiver to Maha Hussain, a professor at the University of Michigan Health System, who will participate as a voting consultant to the committee.
The waiver document notes that Hussain “has a national reputation in the fields of cancer research and clinical care for advanced genitourinary cancers” and is a member of FDA’s Oncology Drugs Advisory Committee (ODAC).

“There is a critical need on the Committee for clinical care expertise in the treatment of advanced, metastatic prostate cancer patients who don’t respond to standard treatment,” according to the waiver. It also asserts that her “clinical trial expertise will contribute to the Committee’s discussion of appropriate patient populations and study end points.”

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.

Another oncologist with extensive experience in prostate cancer clinical trials, Howard Scher, received a waiver for the Provenge meeting. He is chief of genitourinary oncology services at the Sidney Kimmel Center for Prostate Cancer, Memorial Sloan-Kettering Cancer Center. Scher has served as a consultant to ODAC, so he “understands the FDA mission to move new therapies forward at the same time protecting the welfare of patients,” the waiver form states.

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

He owns stock in a firm that competes with DNDN valued at $5,000-$100,000. In addition, Memorial Sloan-Kettering has a grant from a competing company valued at $100,000-$300,000 to study a licensed, approved drug in prostate cancer trials.

——————————————————-

Note that this article was dated prior to the March 29, 2007, Provenge AC meeting. It’s clear that the FDA knew then that it had a serious problem. In fact, the agency had the responsibility then, regardless of whether or not the new rules were in effect, to screen AC members carefully for conflicts of interest. Dr. Scher, in particular significantly underreported his COIs, which could be - and were - easily uncovered through searches on the Internet. That CBER was lax in vetting the members of the Provenge AC can’t be argued? Why the Office of the Inspector General, HHS, is not investigating this matter continues to puzzle the patient and investor communities alike. Even stranger is the fact that DOJ is representing the very people in the CTL lawsuit that it should be investigating, proving once again that life within the Beltway is the closest thing to living with Alice in Wonderland.