Terry Kalley is wearing a Pepto-Bismol pink T-shirt as he intones into a microphone outside the Food and Drug Administration’s office in Silver Spring, Md.: “What right does the FDA have to make a decision that should be left to a woman and her doctor?” he asks. “What will they take away next?”
Kalley’s wife, Arlene, is a breast cancer patient who has been taking the immensely popular cancer drug Avastin. His vociferous campaign exemplifies the pressure on the FDA, which is being pressed to rethink its decision to revoke approval of Avastin for treating breast cancer. It’s also, in its own way, a metaphor for the political debate over what role the government should play in health care.
To the Kalleys, of Troy, Mich., it’s simply a case of bureaucrats taking away options from cancer patients, and they have plenty of platforms to voice their opinions, including his organization, Freedom of Access to Medicines.
Dr. Milton Wolf, a radiologist who writes columns for the conservative Washington Times newspaper, called the FDA committee a “death panel” last week.
Of course, it’s the FDA’s job to do precisely what it is doing--decide which drugs are safe and effective enough to use and which are not. FDA Commissioner Margaret Hamburg will make the decision on Avastin after reviewing the evidence presented at the meeting on Tuesday and Wednesday.
Strong evidence shows that while Avastin can have remarkable effects on some tumors of the colon, brain, and elsewhere, it doesn’t help breast cancer patients live any longer, and it can in fact kill some people. It is the world’s best-selling cancer drug, but it also has side effects ranging from internal bleeding to high blood pressure.
"Patients with late-stage cancer are often desperate for help and grasp at straws," Richard Deyo of the Oregon Health and Science University told The Washington Post last year. "Without this regulatory move, the drug would continue to be used, and would presumably not benefit anyone and add a lot of treatment costs."
Avastin is made by Genentech, a California company that is now a subsidiary of Swiss drug giant Roche. The drug was cleared for use against breast cancer in 2008 under an accelerated approval process that required Roche to do studies to confirm that the drug, which starves tumors by cutting off blood supply, helped breast cancer patients live longer.
The studies did not show any benefits from using the drug, which can cost up to $88,000 a year. In July 2010, expert advisers to the FDA recommended withdrawing approval of Avastin for breast cancer.
Because it’s an approved drug, any doctor can prescribe it for any patient--a practice called off-label prescribing. And so far, most insurers are still paying for it, although Medicare and other federal programs usually do not pay for unapproved uses of a drug.
Nonetheless, some patients were outraged, as was Roche, which stands to lose about $1 billion of its $6 billion-a-year sales of Avastin. Last July, Sen. David Vitter, R-La., wrote to the FDA to accuse the advisers of taking cost into consideration--something the agency denies.
Genentech appealed the decision; on the first day of the two-day hearing at the FDA, Roche officials questioned agency staff about the ruling. "Women with this incurable disease should have the option to choose this medicine,” Genentech said in a statement. The company will present its case on Wednesday.
Some oncologists say that there may be some “super-responders” who benefit from the drug, but the FDA’s Patricia Keegan said at the meeting on Tuesday that she saw no evidence of this in any of the studies.
Besides outspoken patient advocates, a giant drug company, and conservative columnists, Avastin has some other heavy hitters on its side. Billy Tauzin, the former representative from Louisiana who became head of the Pharmaceutical Research and Manufacturers of America, credits Avastin for saving his life when he had a gastrointestinal tumor.
Tauzin, who now walks the Hill as a lobbyist for AT&T, rarely hesitates to tell his story about his battle with cancer, calling Avastin "a miracle drug."