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Science, Ethics, and Politics: The Case of Avastin

The recent controversy over the approval of Avastin for metastatic breast cancer reflects the political polarization that characterizes contemporary America. Avastin provides marginal benefit in the aggregate for patients with advanced breast cancer. There is no rigorous evidence from randomized controlled trials that it increases survival; testimonials of breast cancer patients who have survived longer than average while taking Avastin do not amount to evidence of a causal connection between taking the drug and mortality. Additionally, the drug carries substantial risk and costs approximately $88,000 per year to treat one patient.

The FDA initially approved Avastin for advanced breast cancer under its accelerated approval program because the drug prolonged progression-free survival, a surrogate endpoint. But the agency sought to rescind approval based on additional randomized trials that failed to confirm a favorable risk-benefit ratio, and at the end of June an advisory panel convened by the FDA voted unanimously to recommend against approval.

The same day, the Wall Street Journal ran an editorial, under the heading, “Race Against the Cure,” recommending that the FDA maintain approval of Avastin for end-stage breast cancer. Whether or not one finds this clever, the heading (and the editorial as a whole) displays a disregard for the truth that is at once incredible and irresponsible. By rescinding approval of Avastin for breast cancer, the FDA in no way sets back the search for a cure. New drugs that show solid evidence of prolonging survival surely will be approved; furthermore, as some breast cancer advocacy groups pointed out, approving marginally effective treatments sets a low bar and may fail to provide an incentive to develop truly effective agents.

The editorial not only lambasts the FDA for “enforcing a culture of research and development” that impedes innovation, but baldly asserts that “thousands of women may die more quickly and live with more pain because government regulators substitute their own opinions about clinical meaningfulness for those of oncologists and their patients.” However, innovation is valuable only insofar as it is accompanied by evidence of improvement in terms of clinically meaningful outcomes of survival or quality of life – evidence that is lacking in the case of Avastin for advanced[?] breast cancer. Moreover, the editorial suggests that there is no role for the FDA in using scientific evidence to determine whether drugs are licensed and marketed, taking us back to the laissez-fair culture of the early 20th century before the FDA was accorded gatekeeping authority by Congress.

The high cost of Avastin, and of other novel cancer drugs that cost up to $100,000 per treatment regimen to achieve at best modest survival benefits, clearly influences the debate. Is cost relevant to the policy decision regarding licensing Avastin for advanced breast cancer? The FDA has no authority to take cost into consideration in decisions regarding drug licensing; indeed, the agency does not typically know what a drug will cost when it considers approval for the first indication. If drugs lack a favorable risk-benefit ratio, they shouldn’t be licensed and marketed regardless of cost. However, the escalating cost of cancer drugs, which few patients could afford without access to collective resources provided by taxpayer dollars or private health insurance premiums, underscores the public interest in rigorous evaluation of safety and efficacy prior to introducing new drugs into clinical practice.

The Journal’s editorial is right about one thing. The FDA’s position on Avastin for breast cancer is not a matter merely of science. Science informs, but does not dictate, the value judgments that determine health policy concerning the licensing (and coverage) of drugs. Ethics has something to say about how to make these value judgments – what weight to give, on the one hand, to the interests of individual patients and their physicians in access to expensive, marginally effective treatments for cancer, and, on the other hand, to the public interest in responsible policy judgments about licensing and coverage of new drugs in light of scientific evidence about potential benefits and risks.

But these policy judgments ultimately are backed by basic political commitments. In a climate of antipathy to government regulation, the FDA’s scientifically-guided role in protecting and promoting the public health deserves popular support. Exposing the shoddy rhetoric and arguments of opponents of the FDA’s regulatory authority may offer some help in the political struggle over the role of government in the health arena.

Franklin G. Miller, Ph.D., is a member of the senior faculty in the Department of Bioethics, Clinical Center, National Institutes of Health. Steven Joffe, M.D., M.P.H., is a physician in the Department of Pediatric Oncology at Dana-Farber Cancer Institute and in the Department of Medicine at Children’s Hospital Boston. The opinions expressed are those of the author and do not reflect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

Published on: July 8, 2011
Published in: Bioethics, Health and Health Care

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