Navigation Links
Cancer Experts Received Threats for Opposing Controversial Drug

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 minori ty. 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.


'"/>




Related medicine news :

1. Fibroids unlikely to Turn Cancerous
2. Virus Level could Predict Cervical Cancer Risk
3. Cancer Doctors Okays Controversial Prostate Therapy
4. Potential New Cancer Gene Identified
5. Consensus on "Combination Therapy" for Breast Cancer
6. Cancers of Colon & Rectum linked to Cigarette Smoking
7. Life Saving Cancer Drugs – From Chicken! Possible Says Dolly’ Creatos
8. The Cancer Rumour mill working over time
9. Cancer drugs in development nearly doubled since 1995
10. Radioactive Seeds used in Prostate Cancer treatment can migrate with the body
11. Cancer patients turning to Internet for information
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced ... attorneys chosen by their peers for this recognition are considered among the top 2 ... received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 ... Market by Type (Standard Pen Needles, Safety Pen Needles), ... (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) ... MarketsandMarkets, This report studies the market for the forecast ... to reach USD 2.81 Billion by 2021 from USD ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
Breaking Medicine Technology: