It begins: FDA may pull Avastin approval over cost concerns

When Barack Obama and the Democrats spent most of a year pushing their deeply unpopular health-care system overhaul, they repeatedly insisted that government intervention in the market would not mean that treatment decisions would come down to cost issues — even while demonizing providers as Tonsil Vultures and amputation-happy predators.  Today, however, the Washington Post reports on an effort at the FDA to decertify Avastin as a treatment for breast cancer and its implications for cost savings at Medicare:

Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.

The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments? …

The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment.

“It’s hard to talk about Avastin without talking about costs,” said Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs.”

Avastin got approved through a fast-track process demanded by Congress several years ago when complaints about the length of getting new treatments approved reached a fever pitch.  Subsequent testing has called into question some of the assumptions made about Avastin, particularly about the effectiveness in delaying advanced tumor generation in breast cancer.  However, others note that the drug works for a large number of women, even if it doesn’t necessarily work for them all:

“I’m very upset,” said Leslie Twohig, 48, of Lothian, Md., who has been taking Avastin for eight months and credits the drug with helping her survive. “How long will I be able to stay on Avastin? Are they going to take it away? I know it’s working for me. Right now I am able to enjoy my life. Every morning I wake up and wonder how long it’s going to go on.”

“I am very concerned about people who are receiving the drug and may feel threatened that they may not be able to receive it,” said the Dana-Farber Cancer Institute’s Winer, who is also chief scientific officer for Susan G. Komen for the Cure, a breast cancer patient advocacy group. “This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit. “

Would the FDA even be re-reviewing Avastin for its application to breast cancer without the cost issue?  I’m skeptical.  As the Post notes, the FDA doesn’t do a lot of follow-up on fast-tracked approvals.  Avastin didn’t just get lucky to get renewed attention from the FDA.

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.  If Medicare doesn’t want to cover Avastin, that should be a separate issue handled by CMS and HHS.  This strongly suggests that the FDA has become politicized to a degree where their recommendations lose credibility — a dangerous situation for consumers and providers alike.