stltoday.com - a great editorial on Avastin

Two things about the cancer-fighting drug Avastin stood out when it entered the market in 2004.

The first was its promise. Avastin is part of a new generation of drugs that block the formation of blood vessels needed to nourish tumors. It was given "accelerated approval" for breast cancer treatment by the U.S. Food and Drug Administration.

The second was its staggeringly high price. A full year's treatment could cost $100,000 or more. Genentech, the firm that developed the drug, capped Avastin's cost at $57,000 a year - but only for patients taking it to treat cancers for which it is approved by the FDA. For other, so-called "off-label," uses each dose of Avastin costs about $13,700.

That's a lot of money, but it could be a bargain for someone who's dying of cancer - a person with little time and no other good treatment options.

But the evidence for Avastin's effectiveness always was mixed. In early testing on breast cancer, it was shown to prevent tumors from growing, but not to extend the lives of patients who took it. Two newer studies have shown even less benefit.

Last week, an advisory panel recommended that the FDA withdraw its approval of Avastin as a treatment for breast cancer.

It's not clear when the FDA might act on its advisory panel's recommendation. If the agency does withdraw its approval, it would have big financial implications for women with advanced breast cancer.

Insurance companies immediately would stop covering the drug. Doctors could continue to use it to treat breast cancer, but patients would have to pay for it themselves. Most would be unable to afford it.

That raises some tough questions: Should the FDA continue its approval of Avastin for breast cancer so that insurance companies would continue to pay for it?

Would that be a good thing for patients or simply a waste of money for the rest of us? Or, if the FDA does pull its approval, should patients even try to come up with money to pay for it on their own?

Studies convinced 12 of 13 experts on the advisory panel that Avastin simply is not effective against breast cancer.

But some doctors disagree. They say that because it slows the growth of cancerous tumors, the drug can dramatically improve the quality of life for people with serious cancer. How much is quality of life worth?

In 1998, The New York Times reported on the work of Dr. Judah Folkman, the brilliant researcher who first envisioned killing cancer by starving tumors of blood.

One quote in the article really created a splash: "Judah is going to cure cancer in two years," predicted Dr. James Watson, a Nobel Prize winner.

The new drugs helped, but they haven't cured cancer. They have further complicated the fundamental conundrum of U.S. health care: How to find the proper balance between the costs and benefits of new treatments and technology.

The FDA deserves credit for reviewing the evidence on Avastin. Some other drugs that were granted accelerated approval have not received such scrutiny.

The agency should follow its experts' recommendations and withdraw approval of the drug for breast cancer.

That will be unpopular with cancer patients and their families. The FDA should make drug-approval decisions based on science, not on hopes and promises.

via stltoday.com

Posted via email from Jack's posterous