Dendreon Disapproval: FDA Builds a Bridge to Afterlife

May.29.07 | About: Dendreon Corporation (DNDN)

Last week in, “Dendreon: I Want the Truth”, I stated that in "my next article, I will share my discoveries of certain panel members, their highly irregular posture of writing to tabloid newsletters, and their conflict of interests.”

My initial article was going to focus on Dr.s Scher, Hussain and Fleming (a bio-statistician) who felt compelled to publish articles against the approval of Dendreon's (NASDAQ:DNDN) Provenge. Much has been written about their conflicts of interest as well as their involvement with Taxotere (the only drug currently available for prostate cancer patients), and their unorthodox steps of “leaking” their letters against the approval of Provenge to a fine publication, “the Cancer (ous) Letter”.

As I started digging into the story, little did I know that I would find such manure, politics, and corruption. I found an insidious Cancer within the FDA that is multiplying itself, driving promising treatments to extinction. This Cancer is life-threatening to not only to Dendreon, but to many other enterprises with promising new treatment options.

Until this malady is remedied investing in small Bio-tech firms is hazardous to your wealth. This malady seems to stem from one man's ego and his vengeful behavior.

As for the patients, Dr. Andrew von Eschenbach’s much ballyhooed, “a bridge rather than a barrier”, seems to lead to an afterlife much sooner than necessary.

FDA needs treatment to fight its own cancer. It is going to take drastic surgery, chemotherapy, and the introduction of “fresh” ideas and thought processes to cure this disease. Dr. Andrew von Eschenbach is a cancer survivor. Is he up to the task of fighting this insidious cancer or has he been afflicted by this malady too?

The “fresh” ideas and thought processes introduced by Dr. Andrew von Eschenbach can be found in my article, “A Lost Hope? Dendreon Derailed While Archaic FDA Promises 'New Era'". In order for those fresh ideas to take root, the cancer must be dealt with drastic steps.

This cancerous condition was identified by a series of articles and commentaries in the Wall Street Journal dating back to 2004.

In Pazdur's Revenge (Wall Street Journal, 12-20-04), the Wall Street Journal notes that recent revelations about Vioxx and Celebrex had created a perfect storm where avaricious trial lawyers “have launched a campaign of unprecedented size and scope that threatens the R&D budgets not just of Merck but of the entire pharmaceutical industry.” Says one trial lawyer: “It’s not as big as asbestos and it’s not as big as tobacco but its number three.”

Meanwhile, “Congressional opportunists” and some bureaucrats at the FDA used the controversy to “make it even harder for innovative therapies to get to market.” One of those bureaucrats was Richard Pazdur, “the FDA’s oncology (cancer) drugs chief,” who wanted to slow down the fast-track approval process for new cancer drugs. “The faster approval concept was a response to protests from AIDS activists in the 1980s and was later extended to cover therapies for other terminal diseases.” The Journal says that the “Pazdur interpretation of the rule would effectively kill the accelerated approval process, since there are off-label therapies for just about everything.”

A series of articles followed in July 2005, starting with: Pazdur’s Cancer Rules --The FDA's oncology chief gets his revenge.

It said:

…The Iressa move is Dr. Pazdur's way of sending another "message" about the necessity of doing things his way. It isn't so much a withdrawal as a relabeling of the product. Patients currently on the drug will be able to continue with it. But come September no new patients will be able to start on it outside FDA-approved clinical trials. In other words, the option to use Iressa freely as a front-line cancer treatment will disappear.

Isn’t it interesting that AIDS, which is a new disease compared to prostate cancer has many drugs and treatment options, while prostate cancer victims have only one drug…Taxotere.

Can you say monopoly?

Additional Resources can be found here, here and here.