What an agonizing few weeks it has been for women with late-stage breast cancer.
First federal officials decided on Dec. 16 that they would revoke approval of Avastin, the blockbuster drug, to treat advanced breast cancer. Then, before the drug maker could even appeal the ruling, some insurance companies seized the chance to deny coverage.
So much for the promise that bureaucrats would never come between patients and their doctors.
Perhaps the most visible of these patients is Christi Turnage, a 48-year-old Mississippi nurse and mother of three. Her doctors agree that Avastin has kept her metastatic breast cancer in check for more than two years, without the ravaging effects of
chemotherapy. Nearly 10,000 Americans have signed her online petition in support of Avastin, and her son, Josh, produced a moving
YouTube video appeal.
"The stress level in my household has been multiplied times 1,000," Turnage said. "My boys are running around saying, 'What are we going to do, what are you going to do, what can we do?'"
If drug maker
Genentech's appeal to the Food and Drug Administration fails, and the FDA "de-lists" Avastin for breast cancer, her insurance company likely would stop coverage. Then she would have to stop treatment, because the Turnage family — like most — can't afford the $8,000-a-month price tag for Avastin.
Already some health insurance companies covering millions of Americans, including Regence and Excellus, have revised their policies to eliminate coverage of Avastin for new breast cancer patients.
Medicare appears poised to follow suit. Palmetto GBA, a company that determines Medicare coverage for different regions, recently gave notice that it would no longer pay for Avastin to treat breast cancer in South Carolina, Ohio, West Virginia, California, Nevada and Hawaii. That contradicted FDA assurances that Medicare reimbursement would remain in place until Genentech had exhausted its appeals.
Elizabeth Thompson, president of the Susan G. Komen for the Cure, responded with outrage, stating it was "the consequence we were concerned about," and urging "third-party payers to fund Avastin for those women who benefit."
Palmetto reversed its decision and will continue coverage — for now.
Many in the medical community are stunned by the FDA's move, convinced that allowing a handful of government officials to dictate medical practice to millions of
cancer sufferers sets a fatally flawed precedent.
Research has not yet demonstrated that, on average, Avastin extends life by more than a few weeks — but it has indicated that the drug impedes cancer from spreading through the body. The drug, which retains FDA endorsement for treating many other cancers, works by shutting off the lifeline that
tumors need to grow: the
blood supply.
And the "average" overlooks the reality that some patients, like Turnage, are super-responders who thrive on Avastin for years.
Ironically, the same data the FDA used to reject Avastin had the opposite persuasive effect on the European Medicines Agency, which just reiterated its approval of Avastin for breast cancer.
Washington's decision is even more outrageous given the fact that Avastin has earned a breast-cancer-treatment recommendation from the influential National Comprehensive Cancer Network, a nonprofit alliance of
oncologists and pathologists from the nation's most respected cancer centers. More than 100 countries follow the network's guidelines for how to treat cancer, as do several U.S. insurance companies, including
Aetna,
Humana and WellPoint Inc.
As the network's chief executive officer, Bill McGivney, recently noted, no other organization in medicine has attained such a level of trust.
"This is not a worthless drug by any means," Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston, told
the Washington Post. "There is almost certainly a group of women who get a big benefit."
Another of those women is retired California art teacher Patricia Howard, who says that infusions of Avastin every three weeks over the past two years have enabled her to have a "beyond fabulous" life by shrinking tumors in the lining of her lung and eliminating fluid that made it difficult to breathe.
Her appeal to the FDA, unfortunately, fell on deaf ears. "One doctor got up during the meeting and said 'This drug gets women only to first base and we want a home run.' Howard recalled. "I felt like jumping up and saying I don't mind just being in the ballgame."
It's time for the FDA to listen to Patricia Howard and Christi Turnage, to activist groups such as Susan G. Komen for the Cure, and to the National Comprehensive Center Network. And somebody should remind the FDA that for patients with advanced breast cancer, the most awful side effect of all is death.