[gdpawel]

Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration's decision giving accelerated approval to biotech company Genentech's application to market its drug Avastin as a treatment for metastatic breast cancer at this time.

"The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, the decision is a victory for drug companies, but not for patients," BCA Executive Director Barbara A. Brenner said.

BCA has long opposed Genentech's application, arguing that no evidence has been presented that shows Avastin improves overall survival or quality of life.

In its application to the FDA, Genentech said that a clinical trial indicated that Avastin prolongs progression-free survival. However, BCA argued that that endpoint is meaningless because it does not address the patient's quality of life during those additional months, a very real question because of some of the serious side effects a number of the women experienced, and it has not been shown to correlate with overall survival.

Breast Cancer Action is a national watchdog and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic.

Since 1998, BCA has refused to accept funds from corporations that may create a real or apparent conflict of interest for BCA. Corporations covered by this policy include pharmaceutical companies.

I think the Breast Cancer Action's comment about the FDA lowering the bar on the approval of breast cancer therapies is very valid.

The FDA rejected the recommendation of its advisory panel because the benefit in slowing tumor growth wasn't believed to be worth the added risk of serious side effects, including high blood pressure and death. Avastin killed more patients than the control arm.

This mirrors the statin debacle. Drug companies didn't have to prove that lowering cholesterol did anything positive for patients, just that it lowered cholesterol.

So we're back to square one again. Instead of showing a drug can increase survial, all they have to do is show that it can shrink a tumor. Didn't we just come from that neanderthal moment?

Avastin is already approved for advanced colon and lung cancer and was already Genentech's best-selling drug last year. However, an additional indication of Avastin for advanced breast cancer would drive new revenue for the company.

The introduction of targeted drugs has not been accompanied by specific predictive tests allowing for a rational and economical use of these drugs. There should be an immediate recognition that matchmaking between cancer and cancer treatment is one area in cancer research and treatment which is deserving of much greater attention and utilization.

There should be an inclusive effort to study and utilize technologies which are based on both the sub-cellular (molecular) level and at the cellular (cell function/cell culture) level. Because what may benefit one individual cancer patient may not benefit another.