Source: http://www.investors.com/NewsAndAnalysis/Article.aspx?id=547365
09/15/2010
The cancer drug bevacizumab, or Avastin, is pricey but well worth it to insured patients. ASSOCIATED PRESS View Enlarged Image
Supporters of health reform said it would never happen. Maybe they got caught up in their own rhetoric. Maybe they just didn't want to believe it was possible. But rationing in America has started.
This week, the Food and Drug Administration is expected to revoke approval of the drug Avastin for the treatment of advanced breast cancer. Louisiana Republican Sen. 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."
It seems that even loyal Democrats have noticed the Obama administration's not-so-subtle policy shift toward rationing. According to Politico, many of the 34 House Democrats who voted against the health reform bill are aggressively touting their "no" votes in campaign ads.
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.
Jean Grem of the FDA's Oncology Drug Advisory Committee was cited in the Wall Street Journal explaining why she voted to deprive breast-cancer patients of Avastin: "We aren't supposed to talk about cost, but that's another issue."
Two years ago, the FDA approved Avastin for breast cancer on the condition that further research would show the drug extended life expectancy. Everyone expected the drug to maintain its approval. 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in "overall survivability" was reported this summer, an FDA advisory panel recommended that Avastin's approval be withdrawn. Top FDA officials must decide by Friday whether they will accept or reject the panel's counsel.
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.
Here, Avastin is a miracle drug. In the manufacturer's critical phase III study, tumors shrank in nearly 50% 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 — known as "super-responders" — an Avastin regime translates into years of additional life.
If the FDA strips Avastin of its approval, it's likely that private insurers and Medicare would stop covering the medicine, effectively removing Avastin from the anti-breast cancer arsenal.
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. Created using a patient's own white blood cells, the drug costs $93,000. The FDA has already approved Provenge as safe and effective, yet Medicare officials are currently deciding whether it will pay for the medicine.
If officials decide Provenge isn't worth covering, it will mark the first time Medicare has refused to pay for an FDA-approved anti-cancer drug.
The outrage over the administration's campaign against expensive but effective drugs has not been muted. Major cancer advocacy groups like Susan G. Komen for the Cure and the Ovarian Cancer National Alliance have come out in strong support of both Avastin and Provenge.
It's terrifying to think that distant, faceless bureaucrats are now making Americans' health care decisions. Welcome to Obama-Care.
• Pipes is president and CEO of the Pacific Research Institute. Her new book, "The Truth About Obamacare" (Regnery), was just released.
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