Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon’s Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.

The background to these threats goes back to March 29, when both doctors voted No on an Advisory Committee appointed to decide whether Provenge has substantial efficacy as an immunotherapy for late-stage, androgen independent prostate cancer (AIPC). Twom other panel members voted No while 13 voted Yes. Rather than accept the majority decision, Scher and Hussain wrote letters to the FDA reiterating their objections to immediate approval. Their letters were obtained and published by The Cancer Letter, which went on to publish a third letter to the FDA opposing Provenge approval, from biostatistician Thomas Fleming Ph.D. The Cancer Letter also received a letter in favor of Provenge approval, signed by doctors who are Dendreon investors and a by a researcher at Sanofi-Aventis. Scher’s, Hussain’s and Fleming’s letters are reprinted on this website. These letters have been subjected to heated analysis investors’ message boards.

During and after the Committee meeting, Dr. Hussain expressed willingness to support compassionate use or expanded access to Provenge whilst the trial went on. Dendreon CEO Mitch Gold said last week, “We have given thought to that and we believe that the best way to bring Provenge to market and to help patients is through the approval regulatory process we are pursuing currently. The company doesn’t have the resources to participate in an expanded access or compassionate use [program].”

New York Times health writer Andrew Pollack, in a report from Chicago today, raised the possibility that the death threat and other threats came from prostate cancer patients. Pollack offered no evidence for this:

Two prominent prostate cancer experts have been threatened for opposing approval of a controversial new drug and are being protected by bodyguards as they attend the nation´s largest cancer conference here.

The experts, Dr. Howard Scher of Memorial Sloan-Kettering Cancer Center and Dr. Maha Hussain of the University of Michigan, received email and other threats, according to spokeswomen for Sloan-Kettering and for the cancer conference.

It is not known who sent the threats. However, it is clear that the doctors´ public stance against the drug, Provenge, has inflamed the passions of some men with prostate cancer and patient advocates, who say the drug would offer hope to desperate patients with few or no alternatives.

Many investors also have made big bets on the stock of the drug’s developer, Dendreon, a Seattle biotechnology company, whose stock has fluctuated wildly based on prospects for the drug. Some investors stood to profit if the drug was approved and others if it was rejected.

The F.D.A. said in May that it would not approve Provenge without more evidence that it was safe and effective.

Patients with incurable diseases often advocate for approval of new drugs even if the data supporting them are not perfect. But threats to those who take an opposing position on a drug appear to take such advocacy to a new level. That could discourage rational discussion of drugs or deter experts from serving on advisory committees to the Food and Drug Administration, where Drs. Scher and Hussain first publicly voiced their opinions.

“Intimidation or harassment is going to make qualified people think twice about serving in national positions,” Dr. Hussain said in a brief conversation here at the annual meeting of the American Society of Clinical Oncology. She said she would continue for now to serve on F.D.A. advisory panels.

Dr. Scher also was reluctant to comment, saying, “This is a situation I’ve never been in before.”

But he seemed distressed that other doctors were not publicly rallying to his support. “There´s no one else standing up and saying this is ridiculous,” he said.

When he gave a talk at the conference on Sunday, Dr. Scher was accompanied by three men wearing suits and earphones but without mandatory conference name badges.

A spokeswoman for the oncology association said it had been working with the two doctors and was increasing security at the conference

Christine Hickey, a spokeswoman for Sloan-Kettering, said Dr. Scher had received e-mails and phone calls, including one e-mail entitled “your murder.” A copy of his biographical page on the Sloan-Kettering website was defaced.

Provenge has become the latest focal point of a long-running and sometimes bitter debate about the degree of evidence needed for approval of drugs for life-threatening diseases.

Cancer Experts Threatened After Opposing Drug (login-in required; the version now online is much shorter than the above, and Pollack’s byline has been removed).

We first heard of a death threat against Dr. Scher from a reliable source in late April after his letter to the FDA. No indication suggested that this threat came from any patient or advocacy group. All along, invective and “rants” against Scher and Hussain have been high on investor message boards, with no such feelings expressed on a leading prostate cancer mailing, PPML at acor.org.

By last week, investors were circulating Dr. Scher’s email address and phone number, urging that his office be bombarded with FAXes, and analysing an EDGAR record of his investments. Based on Scher and Hussain’s declarations to the FDA and receipt of COI waivers, Dendreon investors who allege that the two oncologists are motivated by financial interests seems to see nothing wrong with the fact that one of the clinical investigators for Provenge, Dr. Paul Schellhammer, who edited a report on the Phase III trials for publication, benefits financially from the company.

Yesterday a group of Dendreon investors, including some who are medics and some who are prostate cancer patients, staged a protest outside the Chicago meeting, ASCO, where Scher needed bodyguards inside. The protesters dressed in blue jeans and blue T-shirts, copy-catting a style pre-arranged by prostate cancer patients and advocates for the Raise a Voice Assembly and assembly in Washington DC (June 4). Jim Kiefert of US Too! dropped by at the Chicago event. The protesters received media coverage, but had not applied for a license to assemble and leaflet. After about an hour police asked them to move on.

Folks, this is not grassroots cancer patient activity, it’s astroturf advocacy — or naked grassroots investor activity. Ironically, some investors have whined that prostate cancer patients are not helping THEM on behalf of Dendreon.

To follow their opinions visit: investorvillage.com