The Era of Rationing Begins
September 30, 2010
By December, the Food and Drug Administration (FDA) is expected to revoke approval of the drug Avastin for the treatment of advanced breast cancer. U.S. Senator David Vitter has described the anticipated move as "the beginning of a slippery slope leading to more and more rationing under the government takeover of health care," says Sally C. Pipes, president and CEO of the Pacific Research Institute.
- The FDA claims its decision won't be based on cost, but Avastin isn't cheap -- a full regimen costs about $100,000 a year.
- Avastin has proven to be a wonder drug for countless women with stage IV breast cancer, slowing the disease's progression and dramatically extending life.
- But when no significant increase in "overall survivability" was reported this summer, an FDA advisory panel recommended that Avastin's approval be withdrawn.
No cancer drug has ever been taken off the market based solely on "overall survivability." Traditionally, calculations of a drug's effectiveness have been based on tumor response and progression-free survival rates, says Pipes.
Here, Avastin is a miracle drug.
- In the manufacturer's critical phase III study, tumors shrank in nearly 50 percent of patients receiving the medicine.
- Patients who received Avastin in conjunction with chemotherapy lived nearly twice as long as would otherwise be expected without their disease worsening.
- For some patients an Avastin regime translates into years of additional life.
Government rationing doesn't stop at Avastin.
- Medicare coverage for Provenge, a drug for advanced prostate cancer, is also in jeopardy.
- Like Avastin, Provenge is expensive, costing $93,000 a year.
- The FDA has already approved Provenge as safe and effective, yet Medicare officials are currently deciding whether it will pay for the medicine.
It's terrifying to think that distant, faceless bureaucrats are now making Americans' health care decisions, says Pipes.
Source: Sally C. Pipes, "The Era of Rationing Begins," Pacific Research Institute, September 27, 2010.
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