I have received several comments on my Aug 10 post about the recent court decision to deny terminally ill patients the right to potentially effective treatment–on the grounds that they are “experimental.” You know, the drug might turn out to cause impotence in male patients 20 years after taking it, so that is a major concern for a dying patient.

I have decided that this is a subject worth more than a passing mention, and will be revisiting it regularly. Who knows, I should start a whole new blog on it. That is something worth considering.

Please go and read the comments that people have posted. They are well thought out, poignant, and filled with very intriguing information. Especially about Provenge. It seems that the article I took the information from said that Provenge extended life 4.5 months. As a commenter posted, some patients have now survived 15 months longer than they should have. A drug that adds over a year of life of a dying patient should not be ignored or dismissed. But there may be some sinister underlying reasons.

This is a comment I received, and I think the information is worth reading. It is so typical of the FDA, and may explain the heart of the Provenge controversy. It is also frightening, to see just how much conflict of interest the FDA is steeped in.

Roxanne,

I am writing to you in response to your article, Dying? Tough Luck, dated August 10th, 2007. Dr. Howard Scher, as an employee of the FDA, has been granted a level of public trust and the stewardship of such a position demands the highest levels of ethical and moral conduct. Voting on and participating in an FDA advisory meeting in order to determine which drugs receive FDA marketing approval in which you play a decisive role in and in which you have a financial interest in (or counter interest in), is contrary to unbiased public concern and counter to the fiduciary duty Dr. Scher accepted as a special government employee and FDA panel advisor. Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant’s own sibling participating on a jury resulting in a hung jury decision. Knowing of Dr. Scher’s close professional relationship to ProQuest Investments, how is the public to believe that the FDA made the correct decision? Surely you can see the travesty of his participation in this matter. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests.

The fact that Dr. Howard Scher sits on an advisory board to ProQuest Investments and has been granted an ownership position in ProQuest Investments, a $1 billion venture capital fund which has a major financial ownership stake in Novacea, a direct competitor to Provenge, and is allowed to participate in and vote on marketing approval of Provenge is unacceptable ethically. Furthermore, Dr. Scher’s apparent over the top crusade to deny this choice to terminally ill patients for what appears to be financial gain is immoral in light of the lack of treatment options available to terminally ill androgen-independent prostate cancer (AIPC) patients and when considering the undeniable survival benefit demonstrated in combination with Taxotere, the only FDA approved treatment for AIPC.

The survival data shows that the patients that received Provenge had longer median survival (4.5 months) than that reported for Taxotere therapy, without having to endure 7 months of infusion therapy and coping with the poisonous toxic side effects related to Taxotere infusion. In support of its efficacy, a direct correlation between Provenge induction of immune response and survival benefit was also demonstrated in these patients. Most impressively, the data analysis also shows that when Provenge treated patients were subsequently treated with Taxotere, their median survival almost doubled (from 20 months to 35 months). This is compelling survival data further supporting the efficacy of Provenge for hormone refractory prostate cancer. In comparison, Taxotere increases median survival by only 2-3 months. This increase in survival is so dramatic and remarkable, it could not have been due to a random chance. This clearly shows that Provenge is effective at extending overall survival from AIPC beyond any reasonable doubt. This is amazing data.

Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. Both Dr. Howard Scher and Dr. Maha Hussain, each of whom voted in the minority and are very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from Provenge may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report by Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute).

A request for a Conflict of Interest Waiver was requested by Dr. William Freas, Director of Scientific Advisors and Consultants for CBER, on February 5, 2007. The request was concurred by Vince Tolino, Director of Ethics and Integrity, on February 26, 2007. On March 8, 2007, Dr. Howard Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon’s FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. I don’t understand how the need for Dr. Howard Scher’s individual services could outweigh the above demonstrated conflict of interest created by the financial interest attributable to Dr. Scher. I can’t imagine an individual participant with more financial conflicts of interests sitting on the FDA advisory panel for Provenge. It is my fear that Dr. Scher’s financial interests have come before the best interests of terminal AIPC patients.

There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.

Provenge should be approved now! Cancer patients and advocates will be holding an FDA rally September 18th raise awareness of the current situation and elicit change at the FDA. You can find out more at: http://www.arighttolive.com Please come support cancer patients September 18th. Every voice counts.