Death Panels Begin: Reaction to FDA’s Decision to Begin Rationingby Capitol Confidential
The Food and Drug Administration’s (FDA) announced yesterday that it would ration the late-stage cancer drug Avastin for breast cancer patients. (Ironically, the same day, the EU announced it would not ration access to Avastin.) The reaction to the FDA’s decision has been fierce:
Rep. Kay Granger: “For the 17,500 women across the country who rely on Avastin to survive, I am extremely disappointed the FDA has chosen to take away one of the very few options for the treatment of late-stage breast cancer. To make matters worse, this announcement comes on the same day that European drug regulators approved the continued use of Avastin for women with late-stage breast cancer. 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. I will continue to work in the 112th Congress to ensure doctors and patients continue to have access to every available treatment option.”
Rep. Rodney Alexander: “As expected, the Obama administration has begun its process of rationing health care with its announcement to remove Avastin from the market for women suffering from metastatic breast cancer. Today’s decision to limit women’s access to a lifesaving treatment is amiss, and indicative of the frightful direction our health care system is headed. For the government to deny access to such a viable treatment is a severe intrusion into personal health care decisions that should be left between the patient and the doctor. Given that this drug helps over 17,000 patients manage their disease, it appears this move is merely based on cost cutting and rationing rather than on any real medical grounds. Avastin has extended the lives of thousands of individuals suffering from this devastating disease. Going forward, they will no longer be afforded that opportunity. This decision represents the first major example of things to come if components of the recent health care overhaul are allowed to continue. I will work with others in the incoming majority to restore the fundamentals of the U.S. health care system.”
Susan B. Komen Foundation for a Cure: Komen for the Cure’s president, Elizabeth Thompson said that the organization is concerned about the potential impact on women who are benefitting from Avastin if the FDA ultimately removes its approval for the drug for breast cancer treatment. “We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program.”
Sally Pipes, Pacific Research Institute: “The FDA claims its decision had nothing to do with Avastin’s cost and was based solely on the drug’s medical effectiveness. This isn’t believable. Every year about 40,000 American women die from breast cancer. Avastin is the last hope for many not to meet that fate. While the drug is costly, it often provides immense benefits to patients.”
Sen. David Vitter: “With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. We can’t allow this government takeover of health care to continue any further. I urge the FDA to consider any forthcoming appeals of this decision and immediately reverse course.”
Reps. Fred Upton, Sue Myrick, Joe Pitts and Phil Gingrey: “Metastatic breast cancer patients often have limited options for treatment due to the aggressive nature of the disease. Patients in Europe will continue to have access to Avastin, one of the only drugs that treat women with stage IV breast cancers. Today, the European Medicines Agency issued a statement that it has confirmed that the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.’ However, in this country the Food and Drug Administration (FDA) is withdrawing approval for Avastin to treat late-stage breast cancer. Many in Congress have expressed concerns that the FDA’s review of Avastin would be predicated on its price – not in its effectiveness in treating patients. Allowing the FDA to factor in the cost of a drug when determining whether that drug should be approved is the first big step towards government rationing. The FDA should only look at the safety and efficacy of a drug. Allowing the FDA to inject cost into the approval process jeopardizes the care of those nearly 18,000 women who rely on this drug. At a time when Europe is moving away from restricting access to life-saving medications, the FDA appears to be moving in the opposite direction. Last year, the United States Preventive Services Task Force recommended that women under 50 forgo routine mammography screenings. Today, the FDA is withdrawing its approval of a drug that helps prolong the lives of thousands of women living with aggressive breast cancer. Unfortunately, this is only just the beginning. The new health reform law – the so-called Patient Protection and Affordable Care Act – creates 159 new boards, commissions, and agencies that will destroy the doctor-patient relationship and replace it with federal bureaucrats deciding who gets care and what treatments they can receive. A doctor making medical decisions with informed patients has been the foundation of our medical system. The Energy and Commerce Committee is committed to repealing the new health care law and we will hold hearings to hold the FDA accountable for its decision and protect access to treatment for the thousands of women who rely on this drug.”
Jim Martin, 60Plus: The Food and Drug Administration’s decision to “de-label” the drug Avastin will ration the drug from breast cancer patients and create a two-tiered system where the wealthy will have access to the life-extending drug and everyone else will be denied access. This is wrong and must be repealed. The FDA’s decision is based on cost, pure and simple, and when you deny treatment based on cost it’s called rationing. Do not be fooled by the rhetoric — this is a direct consequence of passage of President Obama’s health care reform bill. Denying treatment based upon the cost of the drug opens the door to rationing of other drugs. 60Plus urges the United States Congress to immediately overturn this decision and allow breast cancer patients access to the treatments they need.
Wall Street Journal: Yesterday the Food and Drug Administration moved to revoke its regulatory approval of Avastin for metastatic breast cancer. Withdrawing a cancer treatment is almost never done, and though the decision was expected, that does not make it any less reprehensible.
The FDA said in a statement that it is removing Avastin’s breast cancer indication because the biologic does not provide “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” Ponder that “sufficient.” The agency is substituting its own judgments about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren’t any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency – the FDA’s counterpart in the European Union – decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network – a consortium of 21 leading cancer centers that issues evidence-based medical guidelines – reaffirmed its position that Avastin is valuable in some cases.
But such finely graded distinctions are not part of the FDA’s bureaucratic culture. The FDA provisionally (and reluctantly) approved Avastin for breast cancer in 2008 under an accelerated process for serious diseases. But the cancer drugs division believes that such flexibility is too friendly to industry and took extraordinary measures to rig the review process against Avastin’s maker, Genentech, as we reported on August 18 in “The Avastin Mugging.”
Genentech is contesting the ruling through a formal FDA appeals mechanism, and Avastin will remain available on an “off label” basis, because it is still approved for other cancers such as those of the lung, kidney and brain. However, private insurers are generally reluctant to reimburse for therapies that are not FDA-approved. .
One depressing implication is what the decision says about health-care financing as government entitlements expand. Avastin is a political target because of its high cost – a typical course runs as high as $88,000 – and after ObamaCare all medical questions are inevitably political questions too. In September, the FDA and Medicare proposed a “parallel review” process that will allow the two agencies to coordinate market and reimbursement approval. Medicare is also increasingly opening “national coverage determination” reviews that allow a government board to decide if a therapy is “reasonable and necessary.”
Another danger is to the future of medical innovation. Cancer treatment advances incrementally. Every year doctors are better able to pair medicines with the biomarkers pointing to the individuals who are most likely to respond and learn more about tumor angiogenesis, which is the process of cancer growth that Avastin helps to choke off. The FDA’s assault will make it harder to conduct and enroll patients in further clinical studies, to say nothing of its message about the regulatory risk for drugs still in development.
The greatest tragedy will fall on the women who are suffering from an incurable disease and whose caregivers are trying to improve their quality of life in the months they have left. The FDA is taking away one of their only options.
No comments:
Post a Comment