Avastin: There's the truth and then there's the politics behind the cancer drug [The conversation]
Avastin has been the topic of debate Tuesday, as Genentech, the manufacturer of the cancer drug, defends itself in a two-day trial against the Food and Drug Administration. At issue: The FDA plans to withdraw its approval of Avastin because it doesn't work in curing late-stage breast cancer, nor does it help in improving a patient's quality of life.
Conservative critics fear that this is "ObamaCare" in action. RedState's Brian Darling is one such dissenter:
The FDA is forging forward to de-label the drug Avastin, which means that unless they change their mind in the appeals process, Medicare will soon refuse to pay for the cost of it. Furthermore, since private health insurance takes their cues from the government, most private health insurance plans are likely to stop covering this drug as well. The drug has proven to work, and the FDA is basically saying that cost is a factor in approving the life-extending drug.
This is a preview to the world we shall live in under ObamaCare. If the law is not stricken ... by the U.S. Supreme Court, expect this fact pattern to repeat over and over again. If the FDA stands by this move the drug will still be available to those who can afford it, but for those who can't it's a different, potentially tragic, story.
Jonathan Cohn of the New Republic pushes back on this accusation. From the New Republic, via NPR:
Maybe the conservative critics think more clinical trials are not enough -- that insurance programs always have an obligation to reimburse treatments of such dubious benefit and high risk. Fine. That's a respectable argument, albeit a very expensive one. But where was the conservative outrage when the state of Arizona recently declared that its Medicaid program would no longer pay for certain transplants? The state was engaging in precisely the sort of rationing that the FDA supposedly has done with Avastin, but with one key difference. Arizona appears to have made its decision without the extended, rigorous scientific debate that preceded FDA's ruling. As best as I can determine, via Google, none of the right's usual suspects uttered a peep.
Of course, that was the sort of rationing that happens all the time in the U.S. already -- rationing by income. And it's the kind of rationing that the new health law would greatly reduce, if not eliminate outright, by making sure more people have insurance and that their insurance comes with more consumer protections. But acknowledging that notion would mean grappling with the complicated realities of medicine and health care policy. And, as we've seen so many times, that's not something many of reform's critics on the right like to do.
In a December 2010 editorial, the New York Times defended the FDA but offered a suggestion that splits the difference between the FDA and Genentech:
We believe the F.D.A. has shown courage in following the scientific evidence on this highly emotional issue. Even some advocacy groups for breast cancer patients have applauded the agency’s decision for making clear that the drug does not work very well. […]
Genentech plans to request a hearing with the F.D.A. to argue the case for retaining Avastin's status as an approved breast cancer treatment. It should focus on proposing ways to identify the subset of women who can really benefit from Avastin.
On Tuesday, the NYT’s editorial board praised Avastin -- not for its ability to treat cancer but as an affordable treatment for macular degeneration -- and took Genentech to task:
Until now, however, there was no scientific proof about whether Avastin was as effective as Lucentis. The National Eye Institute sponsored a two-year clinical trial whose first-year results were published in late April. It suggests that the cheaper Avastin is just as effective as Lucentis at preventing vision loss. More people taking Avastin were hospitalized, an adverse effect that needs further exploration, but there were no significant differences in the rate of deaths, heart attacks and strokes.
If these findings and the drug's safety are confirmed in the second year, Medicare could save hundreds of millions of dollars annually if doctors used Avastin. But, as the system now works, Medicare cannot push doctors to switch. That means that taxpayers will likely continue to pay a lot more for a treatment that is no more effective. That makes no sense for anybody, except the drug maker.
If Genentech really cared about the patients benefitting from its drugs, rather than the bottom line, it would follow the NYT's suggestion, and it would also take oncologist Frederick C. Tucker Jr.'s recommendation to heart:
Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech's attempt to have it ignore scientific evidence.
Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech's money and efforts would be better spent on research for more meaningful treatments for breast cancer.
It would be nice to think that the people who're in the business of manufacturing drugs actually care about the people who're taking their drugs.
--Alexandra Le Tellier
Photo: Avastin is produced by California-based Genentech Inc. Credit: Genentech Inc. / Associated Press