Depending upon a decision to come today, the FDA may begin to implement a form of rationing by preventing a drug to treat late stage breast cancer, Avastin, from reaching the market based primarily upon cost. The drug was shown to prolong life by an average of 3.5 months, though some survived for years. It was set to be finally approved, but a panel struck down this approval with a 12-1 vote. The drug is rather expensive, but was shown to be effective. An editorial from the Washington Examiner states:
Doctors and patients were then stunned last summer when the ODAC ruled, by a vote of 12-1, that the drug did not produce clinically meaningful results. Why did the panel deny the obvious evidence of Avastin's effectiveness? One member of the FDA's panel, Jean Grem of the University of Nebraska, said, "We aren't supposed to talk about cost, but that's another issue." If the FDA follows through on the ODAC's finding and revokes Avastin's approval, both the government and private insurers will quickly cease paying for its use on breast cancer sufferers.Sally Pipes writes in Forbes:
Government bean counters were never supposed to determine what your treatment options are, and patient advocacy groups are justifiably outraged. If Avastin and other expensive wonder drugs are denied approval because of costs, proponents of government-run health care will have to no choice but to admit "death panels" have gone from rhetoric to reality.
Despite all evidence to the contrary, the advisory committee claims its recommendation had nothing to do with Avastin's cost. The FDA's top brass will doubtlessly take the same line and claim that its decision to ratify that recommendation was based solely on the drug's medical efficiency.This pending FDA decision is only further proof of a government panel making decisions that should be made by a doctor and his or her patient. People are beginning to admit the presence of "death panels" in Obama administration policy, but their presence has been seen for quite a while. Funding for "comparative effectiveness" health care research, determining what treatments are most effective for a given malady, was arguably the most under emphasized part of the stimulus bill. The general concept of "comparative effectiveness" appears benign. as most Americans want to make sure that the receive the best treatment for a disease and do not wish to receive unnecessary, ineffective treatment. Comparative effectiveness research is performed and presented in aggregate, but treatment is performed on individuals. When results are applied to decisions made by government panels, it is just another indication that further government intervention results in less freedom and volitional control to the individual. Last year, the U.S Preventative Services Task Force recommended reducing the frequency of mammograms and the age to begin the screening. The Task Force made this recommendation all while not soliciting the opinion of either a radiologist or an oncologist. While the recommendations were not further pushed by the Department of Health and Human Services, it provides an open door for government panels' recommendations to affect coverage and thus, potential early detection.
The truth is that Avastin is expensive. A year-long supply for breast cancer treatment costs upwards of $80,000.
However, many American women are getting something priceless in return for those dollars: life and vitality. In one clinical trial, nearly 50% of patients receiving Avastin witnessed their tumors shrink. Another study found that patients receiving the drug in conjunction with chemotherapy lived "progression-free" twice as long as patients without it.
However, if the FDA revokes Avastin's approval, public insurance programs like Medicaid and Medicare could decide to refuse coverage of the treatment. Many private insurers would likely do the same. Indeed, several major insurance companies--including Regence and HSCS--have already reacted to the FDA Avastin debate by restricting coverage for the drug in the treatment of breast cancer.
Of course, doctors would still be able to prescribe the drug "off label." But because patients wouldn't have coverage, the only ones that could still use Avastin would be the small minority that can afford to pay its full price out-of-pocket.
Once again, Governor Palin's prescient comment is vindicated. You can put lipstick on a death panel by calling it the FDA, comparative effectiveness research, or the U.S. Preventative Services Task Force, but it's still a death panel.
Cross posted here and here.