US News

Rage at FDA’s bid to nix breast-cancer Rx

Health-care reform may have suffered its first casualty yesterday after the Food and Drug Administration moved to revoke its approval of an expensive drug to battle breast cancer, prompting cries of government rationing.

But agency officials insisted that an advisory committee decision to withdraw authorization of the blockbuster drug Avastin — which could cost its manufacturer, Roche, $1 billion in annual sales — had nothing to do with its price.

They said the cancer-fighting benefits associated with the popular drug do not outweigh the risks.

“None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects,” said FDA’s Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“The limited effects of Avastin combined with the significant risks led us to this difficult decision.”

Health officials said side effects include holes in the stomach and intestines, bleeding and blood clots.

Avastin, the world’s best-selling cancer drug, with global sales of $5.8 billion, is the top-selling product for Roche, whose Genentech unit makes the drug. The company said the FDA decision is “potentially taking a choice away from the thousands of women facing the disease.”

“Our goal is to cure cancer,” said Sandra Horning, a cancer survivor and Genentech’s global head of oncology. “The reality is many people in the United States are diagnosed each year with an advanced cancer that is not curable. For these individuals, there is clearly a need for multiple treatment choices.”

The drug, which is prescribed to about 17,500 breast-cancer patients each year, remains approved to treat several other types of cancer, including colon, lung, kidney and brain cancer.

The FDA said the company had 15 days to request a hearing to review the decision. Medicare, the US health insurance for the elderly and disabled, will continue covering Avastin for breast cancer while Roche’s appeal continues, officials said.

Critics denounced the FDA move as a rationing tactic to lower the cost of health care.

“With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug,” said Sen. David Vita (R-La.). “We can’t allow this government takeover of health care to continue any further.”

Avastin costs about $8,000 a month in the United States, although Roche caps the annual price at $57,000 per patient.

The FDA decision was also criticized for limiting treatment options for desperately ill women.

Breast-cancer advocacy groups, including the Susan G. Komen Foundation, said revoking Avastin for breast cancer use would be a mistake.

“We want to be sure that women who are using Avastin and for whom it is working can continue to have access to it,” said Komen Foundation President Elizabeth Thompson.

Republicans, whose ranks were strengthened during the midterm election, have vowed to repeal the health-care reform law pushed by President Obama.

A federal judge on Monday declared a provision of the new law requiring Americans to purchase medical insurance unconstitutional. Judge Henry Hudson said the government cannot force people to buy health coverage, though the Obama administration is appealing the ruling.

leonard.greene@nypost.com