FDA PLAYS GOD

The FDA today allowed a hearing on its approaching decision to ban the sale of Avastin in the US for women with advanced breast cancer. The FDA initially allowed the drug on the market, since it was meant for women with metastatic breast cancer, a deadly cancer leaving women with few options of therapy, but after conducting three trials with no benefit, they are pulling the drug.

You can find the article here http://www.nytimes.com/2011/06/29/business/29drug.html?_r=1

The FDA, its board and its director are making a rational self-preserving decision. The FDA will be held responsible when a drug kills a patient, it will be chastised by the government, and someone will have to take the fall and the blame. When a drug is allowed on the market and saves 1, but accelerates or aggravates the condition of 9 others, despite the desperate need those patients harbor for any means to survive, the FDA will be criticized. A less publicized evil, a less sensational and public death, is the death of the woman with metastatic breast cancer who has no option to turn to, no matter how infinitesimal the chance of recovery that option may provide, it is still an option the FDA has prohibited. That woman's death will go unsung and un-blamed. The FDA will not have to answer to it, and the FDA can hide behind its numbers and studies, telling a woman it is too dangerous for them to have the option to take.

Priscilla Howard, who has survived with advanced breast cancer for 32 months while taking Avastin, rebutted the FDA's studies with the simple truth that "despite the potential side effects from Avastin, metastatic breast cancer has only one — death,” a poor option is better than no option. An arduous recovery better than no recovery, and a risk for life better than a sentence of death.

The FDA serves an important purpose in their testing of drugs. Consumers must be informed when making decisions. Competent understanding of the risks and rewards of different therapies is a fundamental cornerstone of a marketplace which leads to rational risk-managed decisions. The risk averse may avoid Avastin, and others likely would not. The FDA should inform consumers, but should not dictate life and death decisions for them. People should not have to flee the country to save their life. People should not die waiting for a drug to be released which can save their life. The FDA has killed more people waiting for a life saving drug than it has saved from preventing harmful unproven drugs from entering the market. Allow drugs onto the market, and have it clearly stated that they are not FDA approved. If studies are done and they are unsafe, inform consumers they have a FDA warning.

The FDA is not our parent, it is not looking out for our best interest, it is looking out for its own interests, which inadvertently leads it to playing God, which no one should do, especially not the Government.