Oncologists Threatened For Opposing Cancer Drug

Cancer Docs Threatened For Opposing Drug
June 3rd, 2007 10:04 pm By Ed Silverman

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 ASCO, The New York Times reports.

The experts, Howard Scher of Memorial Sloan-Kettering Cancer Center and 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. And as the Times reminds us, some investors stood to profit if the drug was approved and others if it was rejected (there were loads of short sellers).

The FDA 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," Hussain told The Times at the American Society of Clinical Oncology meeting. She said she would continue for now to serve on FDA advisory panels.

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 publiclly rallying to his support. "There's no one else standing up and saying this is ridiculous."

When he gave a talk at the conference on Sunday, 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 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. An FDA advisory panel endorsed the effectiveness of the drug by a 13-4 vote in March. Provenge had extended lives in two small clinical trials, though the results were somewhat weak by various statistical standards. The panel voted that the drug was generally safe, although there were signs it could increase the risk of strokes.

But both Scher and Hussain, who, unlike most of the panel members, actually treat patients with prostate cancer, argued that the evidence fell short of proving the drug worked and that they did not want to give patients false hopes. The two later each wrote a letter to the FDA reiterating their arguments.

About 15 prostate cancer survivors and advocates held a demonstration on Saturday urging the FDA to approve Provenge. A larger rally is planned for Washington, DC on Monday.

Charles Bennett, a Wisconsin physician whose grandfather and an uncle died from prostate cancer, organized the Saturday protest, but insisted it was peaceful. "I absolutely don't condone and would abhor any threatening behavior. That is way over the line. (But) there are a lot of guys with prostate cancer who are very passionate" about Provenge.

Pharmalot