Drug AVASTIN/the truth behind it part 2

Misleading Media             http://www.cancerdecisions.com:80/021708.html
                                        Dr Ralph MOSS PhD



Articles in the media have on the whole given the impression that Genentech has clinched the case for Avastin's efficacy, and that approval would seem to be just a matter of time. The New York Times, which often is skeptical of drug company claims, threw caution to the wind in this instance with its headline: "In Second Trial, Avastin Is Found Effective in Treating Breast Cancer" (New York Times, 2/13/08). This implies that drug company claims in press releases are the same as facts established by independent scientists in peer-reviewed studies.

Many other news sources made the same error. Reuters, for example, led with "Genentech's Avastin Meets Breast Cancer Study Goal," and the Wall St. Journal proclaimed: "Avastin With Chemotherapy Is Effective in Cancer Trial."

Huge amounts of money hang in the balance. Avastin, which costs patients and their insurers $4,400 per month, last year generated $2.3 billion in the US alone. Sales are projected to rise to $2.7 billion by 2009. The breast cancer market might be worth an equal or even greater amount, since there are more new cases of breast cancer in the US each year (181,000) than of colorectal cancer (154,000).

When ODAC recommended against extending the indication for Avastin last December, Genentech's stock fell about $10 per share. This meant an instant loss of around $10 billion for the company. It has recovered a bit since then, and on the announcement of the AVADO study, its shares rose 2.4 percent, to $71.60. According to J.P. Morgan analyst Geoffrey Meacham, there is now a 50-50 chance that FDA will approve Avastin for breast cancer. "The key question," said Meacham, "is whether the FDA will want better results on the drug's ability to improve the overall survival rate of patients. That data will be more difficult and time-consuming to produce than data on how long patients survive without the condition progressing" (AP, 2/13/08).

On the other hand, according to Michael Aberman, an analyst with Credit Suisse, without survival data the new trial would not increase the chance for Avastin's approval this month (Pollack 2/13/08). As Andrew Pollack wrote in the Times, "The decision is being closely watched as a barometer of the agency's standards toward approving new cancer drugs or expanding uses of current medications. It is possible the F.D.A. will delay the decision past February so it can consider the new data."

I once again urge readers to email FDA Commissioner Andrew von Eschenbach, MD, and Richard Pazdur, MD, director of FDA's office of oncology drug products, with their opinions on this matter. Consumer input could be crucial, especially at this critical juncture.

What I will convey to them, in my own letter, is that FDA should NOT approve Avastin for breast cancer until and unless there is impartial scientific proof that the drug actually extends women's overall survival.

Their email addresses are as follows:

andrew.***@****

richard.***@****

Letters by concerned citizens are, in my opinion, the main thing that is preventing FDA from yielding to drug industry pressure. They could influence FDA to put the needs of cancer patients above those of the drug companies, and only approve drugs that actually prolong lives.





--Ralph W. Moss, Ph.D

[Sunes]

PLEASE check who Ralpf Moss  just google his name...but anyway