paidher

Cougar Biotechnology: Stalking Prostate Cancer

<<Provenge seems to work well only in a subset of the HRPC patients.>>

Bryan,
I don't know which subset of HRPC patients are you referring to?

Critics of Provenge who contend the survival benefits of Provenge aren’t robust enough to warrant FDA marketing approval demean the human reality.

We know that patients who received Provenge had a 4.5 month median survival advantage than that reported for the placebo arm. Nearly twice as effective as Taxotere’s 2.3 month survival benefit. Even more impressive, patients that received Provenge followed by Taxotere where shown to increase their median survival to 35 months.

Yet, the survival advantages for Taxotere are enough to garner FDA marketing approval but not for Provenge? Taxotere showed a lower survival advantage and significantly adverse side effects when compared Provenge.

Without question, there is a large unmet medical need. Each year approximately 50,000 men die from prostate cancer. Yet, the only FDA approved treatment for end stage prostate cancer in 45 years has been Taxotere.

These barriers to reason must not stand. We must bring truth and reason to power in the public arena. I pray for change at the highest levels of the FDA.

Dendreon: The FDA's Commissioner Doth Protest Too Much!

March 29th marked the 1 year anniversary where an overwhelming majority of FDA experts convened and confirmed that Provenge met the safety and efficacy criteria for marketing approval. Yet, the science and normal process at the FDA was overturned by a small group of people with inordinate influence. After the overwhelming panel vote, Dr. Scher even lobbied the FDA Commissioner himself to withhold Provenge. Dr. Francesco Marincola, who himself participated in the Provenge AC, stated that his role as a member of the advisory board was “to express his opinion during the meeting but it would be ill advised to influence the FDA decision beyond that point.”

A fiduciary duty is the highest standard of care imposed by law. As an employee of the FDA, Dr. Scher has a fiduciary duty up hold to all Americans and is expected to be loyal to and act in the best interests of all Americans. As such, Dr. Scher must put aside his own personal interests and must not profit from his position. The foundation of Dr. Scher’s position is based upon good faith, loyalty, and trust. A fiduciary must not put themselves in a position where their interest and duty conflict.

As a Board Member to ProQuest Investments, a $1 billion venture capital fund, whose largest single investment was in Novacea, and whose lead product, Asentar, is in direct competition with Provenge, Dr Scher’s fiduciary duty at the FDA conflicted with his fiduciary duty to promote the interests of ProQuest and its investment in Novacea. This is like a lawyer representing both the plaintiff and the defendant in the same legal matter. The lawyer cannot make either the plaintiff or the defendant’s interes ts a top priority if both the plaintiff and the defendant’s interests are diametrically opposed. Dr. Scher should have recused himself from the Provenge Advisory Committee.

I am unaware of any action by the FDA to investigate and correct the obvious conflicts of interest that surround Dr. Scher's participation. Justice delayed is justice denied. This principle is the basis of the right to a speedy trial. The FDA has acted too slowly in investigating this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!

Dr. Scher should have recused himself from the Provenge advisory committee. He had a fiduciary duty to do so. Furthermore, it was inappropriate for Dr. Scher to lobby Dr. von Eschenbach personally to delay Provenge after the advisory committee meeting. And the leaking of letters from Dr. Scher, Dr. Maha Hussain and Dr. Thomas Fleming to the public was inappropriate, inimical to Provenge approval and dastardly. What is going on at the FDA to ignore these obvious attempts to sabotage a non-toxic treatment for terminal cancer?