Dendreon's Provenge: The Latest Twist Comes From Washington
The biotech momentum players and the Dendreonites--or Dendreonians--are buzzing about the story we broke on "Power Lunch" Thursday that three members of Congress are asking the House Energy and Commerce Committee to hold a hearing about the Dendreon/Provenge saga.Dendreon shares spiked on very heavy volume.
The trio want an investigation into alleged conflicts of interest by two of the outspoken doctors who sat on the FDA panel that reviewed the prostate cancer drug and who voted against recommending approval of it. The targets are Drs. Howard Scher and Maha Hussein. The letter doesn’t detail any specific allegations against Dr. Hussein, but it does point out that Dr. Scher was the lead clinical trial investigator for a prostate cancer drug from the biotech Novacea and that he has a relationship with an investment fund that owns or owned NOVC shares. That stock tanked last month on negative news about that drug.
A spokesperson for the committee told me late yesterday that they hadn't even received the letter yet. I got it in an email from a source in the "Dendreon/Provenge army". The spokesperson said when the committee gets the letter that it'll be reviewed and then a decision will be made whether to launch an investigation and/or hold a hearing. She added that the Committee has a lot on its plate right now and, of course, we're heading into the holidays.
So, while it's anyone's guess when a move might be made, I suspect that especially in this election year the Democrats will not turn down a golden opportunity to probe allegations about a lightning-rod agency (the FDA) headed by a Bush appointee (Dr. Andrew von Eschenbach).
Here's the emailed statement I received from the University of Michigan's Comprehensive Cancer Center on behalf of Dr. Hussein:
"Dr. Maha Hussain, a leader expert on prostate cancer, was asked by the FDA to be part of its Advisory Committee. She completed the FDA's detailed paperwork disclosing potential conflicts of interest, and a recent review by the University of Michigan Medical School's Conflict of Interest Board found that Dr. Hussain complied with all University and Medical School conflict of interest policies. It is the culture of academia and the demonstration of academic freedom that expects, and indeed, requires, faculty to express professional opinion within their area of expertise. Dr. Hussain has provided expertise to an important public body using the highest scientific and ethical standards."
A spokesperson for Memorial Sloan-Kettering, Dr. Scher's home base, wasn't as expansive. She only said that it's premature to comment right now. You may recall that Dr. Scher hired private security to protect him at an oncology conference earlier this year because he'd reportedly received threats over his position on Provenge. I also called Dendreon CEO Dr. Mitchell Gold for reaction, but through a spokesperson I was told he'd have no comment.
What impact, if any, this will have on Provenge is unclear. The FDA says it makes decisions about drugs based solely on the science, not politics. Dendreon is currently testing Provenge in a 500-patient study. Preliminary results are expected around the middle of next year. And if the men on Provenge live significantly longer, then Dendreon says the FDA has indicated it might approve the drug. Otherwise the agency will wait another year or two for the final test results to come in.
Whether the drug actually works and whether the preliminary test results will show that it works is arguably the hottest push-and-pull biotech investor battles ever. And it's about to get even hotter.
Questions? Comments? Pharma@cnbc.com