Dr. Thomas R. Fleming, Ph.D., a prostate cancer survivor and nationally recognized statistician specializing in clinical trials design and analysis, has written a letter urging FDA officials not to approve Dendreon’s application at this time.

Echoing concerns about post-hoc analysis expressed by FDA statistical reviewer Dr. Bo-Guang Zhen, Fleming disagrees with a prostate cancer survivor on the FDA’s March 29 advisory committee who said that Dendreon’s sipuleucel-T (Provenge) vaccine offers "an opportunity to make a choice."

Fleming writes: "As a fellow person living with prostate cancer I strongly disagree with [this] statement that all patients want is a ‘choice.’ Patients want an ‘informed choice.’”

Fleming also singles out remarks by panel member Francesco Marincola, who said, "Even if we make a mistake, even if the [therapy] is not this effective, there is so much to learn by starting to see patients being treated with this and see what else can be added." Fleming says:

"One does not need marketing approval in order to continue clinical research studies evaluating sipuleucel-T Marincola’s position is tantamount to advocating that regulatory approval be provided for interventions that have not been established to provide a favorable benefit-to-risk profile, in order to enable a sponsor to market potentially ineffective and even harmful products to patients, without a requirement for obtaining informed consent, in order to further investigation in the field. Such use of patients for research purposes without obtaining full informed consent is illegal as well as unethical. Such practice would be in direct violation of federal law . . . . ."

Like the lettters to the FDA from oncologists Howard Scher M.D. and Maha Hussain M.D., Fleming’s letter was first published in The Cancer Letter.

Dr. Fleming, who is Professor and Chair of Biostatistics and Statistics at the University of Washington, in 2002 received the FDA Commissioner’s Special Citation Award for Extraordinary Contributions to the Agency.

In 2006, Center for the Public Interest’s Integrity in Science Watch reported that Dr. Fleming was "booted" from an FDA Advisory Committee for conflict of interest after the FDA received a complaint about his conflicts of interest from the company whose drug was about to come before the panel. Other panelists received waivers for their consulting with competitor firms. FDA officials at the time told the Wall Street Journal that their refusal to grant Fleming a waiver was unrelated to a complaint from the sponsor company, Oscient. "Fleming told the Journal that he is concerned that the integrity of the advisory committee process ‘would be significantly compromised if there is a possibility that a company could intervene in the committee-making process.’"

Dr. Fleming is on the Advisory Board of Biovex, Ltd, a company that is developing vaccines for the treatment of cancer (Biovex makes OncoVEX^(GM-CSF) , an oncolytic virus designed to selectively kill tumor cells. OncoVEX is in clinical trials for head and neck cancer, metastatic melanoma, pancreatic cancer and colorectal cancer). Fleming is also on the clinical oncology advisory board of Sunesis and on the Oncology Clinical Advisory Board of Idera Pharmaceuticals.

The text of Fleming’s letter is here.