Two prominent cancer experts receive e-mail and other forms of threats for opposing the drug Provenge meant for treating prostate cancer. Cancer survivors and advocates however, hold a demonstration on Saturday to urge the FDA to approve the drug. Controversy surrounding GlaxoSmithKline's diabetes drug Avandia also intensifies.
The persons responsible for sending the threats are yet to be identified. However, it is clear that the doctors' public opposition to the drug, Provenge, has angered some patients with prostate cancer and their advocates, who insist the drug would provide relief to desperate patients with scarcely any alternatives. Approval of drugs,
Last May, the Food and Drug Administration said that it would not approve Provenge without foolproof evidence that it was safe and effective.
Patients with incurable diseases, desperate for treatment, often advocate for approval new drugs, even if the research data supporting them are not fully encouraging. But it is the threats received by people with opposing views that makes the situation alarming.
Drs. Scher and Hussain first publicly voiced dissenting views. But threats can discourage rational discussion of drugs and deter experts from serving on government advisory committees.
Provenge is now the latest focal point of a long-running and acrimonious debate about the quantum of evidence required for approval of drugs meant terminable diseases. Provenge was found to prolong lives in two small clinical trials, though the results were not sound by various statistical standards.
An F.D.A. advisory panel endorsed the effectiveness of the drug by a 13-4 vote during last March. The panel voted 17-0 that the drug was generally safe, although there were some signs it could increase the risk of strokes. Unlike most of the panel members, both Dr. Scher and Dr. Hussain, are actually the ones who treat patients with prostate cancer and they voted in the minority. They argued that the evidence fell short of proving that the drug was effective. They did not want to give patients false hope and wrote a letter to the F.D.A. reiterating their arguments.
About 15 prostate cancer survivors and advocates held a demonstration on Saturday to urge the agency to approve Provenge. Meantime, the controversy surrounding GlaxoSmithKline's diabetes drug Avandia intensified on Wednesday as a medical expert told Congress that executives threatened to sue him when he raised questions in 1999 about the treatment's safety.
"Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough post-market study of its heart risks," stated Rep. Henry Waxman, D-Calif, who chairs the House Committee on Oversight and Government Reform.
GlaxoSmithKline acknowledged the need for more studies, but described Avandia as safe. FDA Commissioner Andrew von Eschenbach said that FDA is ordering Glaxo and rival Eli Lilly to add black box warnings, about heart failure, to their diabetes drugs Avandia and Actos.