Following reports that a panel of cancer experts recommended that the Food and Drug Administration (FDA) consider revoking approval of the drug Avastin for advanced breast cancer, right-wing blogs have attempted to portray the debate as cost-driven rationing of health care. However, the FDA does not consider cost in its decisions, and studies have shown that Avastin -- which was given “accelerated approval” in 2008 with the requirement that further studies confirm its benefits -- has serious side effects without significantly prolonging life.
Right-wing blogs mislead on Avastin trials to revive rationing myth
Big Government: Avastin issue shows “emerging model for rationing health care at the FDA.” An August 13 Big Government post stated, “Big Government.com alerted it [sic] readers weeks ago about the emerging model for rationing health care at the FDA.” The post falsely claimed: “The FDA is considering 'de-listing' the drug Avastin for use with breast cancer patients -- not because it doesn't work, but because of its cost” and claimed:
With a new government health care regime paradigm being established, cost to insurance companies and government health care services will play a critical role in whether patients will have the option of life extending drugs.
In an earlier post, Big Government stated of the Avastin issue: “Welcome to the future. The government will create subjective standards to determine whether life extending drugs will be covered not based on their safety but based on their cost.”
RedState: "[T]he Avastin example shows how ObamaCare cost-benefit analysis will hurt the sick." An August 3 RedState post, titled, “Rationing at the Food and Drug Administration,” claimed, “The idea that ObamaCare may lead to rationing is close to reality and the Avastin example shows how ObamaCare cost-benefit analysis will hurt the sick.” The post concluded by claiming “the Avastin example is evidence of our future under the ObamaCare regime. A future of arbitrary decisions by federal bureaucrats and health care decisions based on cost.”
Hot Air: “With the new ObamaCare regime in place, the issue of cost has now become openly part of the FDA process.” In an August 16 Hot Air post, blogger Ed Morrissey falsely suggested that the FDA was concerned with the monetary cost of Avastin, asking “Would the FDA even be re-reviewing Avastin for its application to breast cancer without the cost issue? I'm skeptical... With the new ObamaCare regime in place, the issue of cost has now become openly part of the FDA process. This is a perversion of their mission, which is supposed to only involve product safety and effectiveness, not bean-counting. ”
But the FDA did not consider monetary cost, only the drug's health risks and benefits
AP: “FDA and its advisory panels don't consider cost effectiveness when reviewing drugs for approval.” A July 28 Associated Press article reported:
But the FDA and its advisory panels don't consider cost effectiveness when reviewing drugs for approval; the agency is charged only with reviewing a product's health risks and benefits. An independent panel of cancer experts convened by FDA voted 12-1 last week to recommend dropping the agency's endorsement of Avastin's use against breast cancer. The panel cited recent studies finding that the drug did not extend patients' life spans and also increased the incidence of side effects and other complications.
The Wall Street Journal similarly reported, “Advisory panels do not discuss monetary costs of the drugs they consider.”
NY Times: FDA panel found that “the studies did not confirm” the benefit used for initial approval of Avastin. The New York Times reported on July 20 that “use of Avastin did not prolong the women's lives by a statistically significant amount” and the new studies “showed even fewer signs that it could prolong lives.” From the Times:
Avastin was given so-called accelerated approval in early 2008, a way for the FDA to approve drugs for life-threatening diseases based on less than complete evidence of effectiveness. Manufacturers must then do further studies to confirm the benefit of the drug.
The two new trials sponsored by Roche for this purpose showed a much smaller effect of the drug, so small, that the committee voted 13-0 that the studies did not confirm the initial benefit.
In the initial study, use of Avastin delayed the worsening of patients' disease by about 5.5 months. Those who received Avastin plus the chemotherapy drug paclitaxel went a median of 11.3 months before their tumors worsened, or progressed, compared to 5.8 months for those who got paclitaxel alone.
But use of Avastin did not prolong the women's lives by a statistically significant amount, the gold standard for cancer drugs. And the drug had serious side effects for some patients.
The two new studies, in which different chemotherapy drugs were used with Avastin, showed even fewer signs that it could prolong lives. And the delay in a tumor worsening was much smaller. In one trial, it was just under a month and in the other about one to three months.
Wash. Post : Advisory panel found low effectiveness, significant side effects. An August 16 Washington Post article noted:
An FDA advisory committee voted 12 to 1 on July 20 to withdraw Avastin's authorization for advanced breast cancer based on two new studies that the advisers concluded had not shown that the drug extends life. Not only that, the committee concluded that the studies indicated the drug slowed tumor growth for even less time -- perhaps as little as about a month. “The vast majority opinion of the committee was that the drug was not doing very much, and what it was doing was more than offset by the negative,” said Wyndham Wilson of the National Cancer Institute, who chaired the committee. Avastin can cause a variety of potentially serious side effects, including blood clots, bleeding and heart failure. “In our best judgment, we did not feel this drug was safe to give relative to its benefits,” Wilson said.
The recommendation has been praised by many cancer experts and by advocates for breast cancer patients.
“The FDA should never have approved Avastin for breast cancer to begin with,” said Fran Visco of the National Breast Cancer Coalition. “We don't see evidence of benefit, but we do see evidence of harm.”