Darn: More Bumps for Dendreon

Dendreon’s (NASDAQ:DNDN) vaccine for prostate cancer, Provenge has always been dogged with controversy, both before its 2010 U.S. FDA approval, and now with its efficacy and clinical studies being called into question by Marie Huber, a scientist and former hedge fund analyst.

It’s a classic stand-off between medicine and Wall Street. The fortunes of the single-product company and its investors depend upon the acceptance of this vaccine, the same now in serious doubt because of a crusader who has given up her job, salary, and health insurance in her motivation to help “vulnerable and desperate patients.”

Marie Huber published a paper in the Journal of the National Cancer Institute saying she has no conflict of interest in the matter. Thomson Reuters has analyzed securities filings and found no positions in Dendreon held by her former hedge fund employer. And yet accusations abound. An anonymous commentator on InvestorVillage.com remarked in February that Huber’s work was about to be published “a few days before our earnings. Her agenda is obvious.”

Keeping these questions aside, what are Huber’s concerns about Provenge?

She claims that the clinical studies, based on which the FDA released approval, were fundamentally flawed, and may have had a two-fold effect.

One, they made Provenge look better compared to the placebo used in terms of the longevity of life achieved by older victims of prostate cancer after administration of the vaccine. Two, the comparative test, specifically the placebo, may have resulted in the earlier deaths of patients due to a disruption of their immunological systems caused by testing. The net result put Provenge in a better light, and thereby helped secure its approval.

The company has claimed that Huber’s reasoning is flawed, and that Provenge has actually helped thousands of patients. “I’m looking forward to getting this to patients around the world,” said President and Chief Executive John Johnson.

The vaccine costs $93,000 plus doctor’s fees and other charges, and is custom-made for each patient at a Dendreon facility.

Steve Rosenberg of the National Cancer Institute is of the opinion that Provenge does work the way it is meant too n the immune system activation, but there remains a question as to whether the T-cells are killing the tumor. FDA spokeswoman Rita Chapelle said there is a “lack of evidence of anti-tumor activity,” the reason for which “is unclear.”

Several questions have been raised against the analysis by supporters of Provenge, chief among them being that the number of white blood cells that are removed are too small to cause permanent damage to the immune system and cause earlier death.

Be that as it may, Huber is planning to bring her case to European regulators, as they review Dendreon’s application for approval of Provenge.

To contact the reporter on this story: Saul Griffith at staff.writers@wallstcheatsheet.com

To contact the editor responsible for this story: Damien Hoffman at editors@wallstcheatsheet.com