Thursday, June 09, 2011
"I shudder at the thought of a government panel assigning a value to a day of a person's life." Louisiana Sen. David Vitter said that in response to the Food and Drug Administration's possible removal of the drug Avastin as a treatment for advanced breast cancer. The Republican went on, "It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough."
Okay, senator, would you spend a billion taxpayer dollars to keep a terminal patient going for an extra 24 hours? Don't bother answering, because your dramatics have zero to do with the issues involved. The FDA's job is merely to judge a drug's effectiveness. An FDA advisory committee found that Avastin did not help breast cancer patients live longer, while its toxic side effects made them feel sicker. At a cost of around $90,000 a year, this is an expensive drug, but its price plays no role in these deliberations.
Because of the passions surrounding the debate -- fanned by "anti-government" Republicans and Avastin's maker, Genentech, owned by the Swiss company Roche -- the FDA initially overrode the committee and allowed the continued use of Avastin for breast cancer pending further study.
When hearings on Avastin commence late this month, expect gravely ill women to credit it for their survival. Expect think tanks funded by the pharmaceutical industry to churn out op-eds in its favor. And expect politicians who say they don't want government in health care to nonetheless insist that government pay for a costly breast cancer treatment deemed to do more harm than good.
It happens that the FDA still considers Avastin valuable for treating colorectal, lung, kidney and brain cancers. If it were a "miracle drug" for advanced breast cancer, why would the FDA nix that use and approve the others?
Ideally, only science will influence the FDA's final decision, expected in September. Supporting Roche's position is a recent reversal by European regulators, relaxing their own curbs on treating breast cancer patients with Avastin. (They recommended its possible utility in combination with Xeloda, another drug made by Roche.) That judgment awaits final approval by the European Commission.
We understand the terror felt by women with advanced breast cancer and their understandable wish to try all their options. But an option is meaningless if unbiased research doesn't back it up as potentially helpful. And when our society pays for treatments that don't work, it has less money for those that do.
Even if the FDA vetoes Avastin as a breast-cancer drug, it would still accept it for other diseases. Thus, doctors could continue prescribing Avastin off-label to breast cancer patients. However, FDA disapproval of Avastin as a breast cancer treatment would prompt private insurers to not cover that use -- even though they legally could.
So much for the Republican fairy-tale vision of private insurers giving us whatever we want because they must compete for our business. The realities will also not stop "conservatives" from grandstanding during the Avastin hearings with their worn complaints about government bureaucrats making important health care decisions.
Meanwhile, Rep. Kay Granger, a Texas Republican, makes this interesting argument in bashing the FDA's position on Avastin: "It is troubling that women in Germany and France will soon have access to a life-saving drug, while women in the U.S. will not."
Heavens. Granger couldn't possibly be talking about those socialized health care systems in Europe that she and other Republicans say they are trying to save us from. But she is.
There will be difficult debates ahead on what expensive medical care taxpayers should subsidize. This is not one of them.
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