The U.S. Food and Drug Administration did something highly unusual on Dec. 16: It revoked its previously granted approval for using a drug called Avastin to treat late-stage metastatic breast cancer. The FDA’s decision dimmed the lights on the Christmas trees of some 17,500 breast-cancer patients whose doctors prescribed Avastin for them this year.
Avastin reduces blood flow to tumors. This allows it to halt the spread of breast cancer in some patients. In one clinical trial, 52 percent of Avastin users saw their tumors stop growing or spreading to other parts of their bodies. In most other breast cancer patients, Avastin acts as a pause button, sparing women from deteriorating further – at least temporarily. On average, Avastin can extend patients’ lives by four to five months. However, some “super-responders” react especially well and enjoy unexpected years of additional life.
FDA bureaucrats know this but ignored the evidence. The FDA stated last week that Avastin does not offer “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.”
But a “sufficient” benefit to whom? If Avastin satisfies women with breast cancer, despite the possibility of hypertension, bleeding and other side effects, shouldn’t that suffice? If their doctors believe these patients are getting good treatment with Avastin, why should they be overruled by “experts” in Washington, D.C.?
Adding several months to the life of an average metastatic breast-cancer patient may not be “sufficient” to the FDA. So, FDA commissioners should ask themselves this question: “Is Avastin’s benefit ‘sufficient’ if it lets a breast cancer patient live long enough to celebrate one more holiday season with her family and friends?”
Pharmaceutical executives also closely followed the FDA’s edict. Just two years ago, the FDA endorsed this drug to battle breast cancer. (Avastin remains authorized to combat cancers of the brain, kidney, lung, colon and other tumors.) But what the FDA giveth, the FDA taketh away. Just two years later – poof! – on Dec. 16 the FDA’s approval of Avastin for the treatment of breast cancer vanished.
How are drug-company managers supposed to make business decisions in this environment? According to Tufts University’s Center for the Study of Drug Development, the average new medication costs $1.3 billion to research, test, and bring to market. The cost to develop Avastin was $2.3 billion.
Watching the FDA behave this capriciously will make pharmaceutical CEOs think over and over again before deploying such tremendous resources.
Federal officials can green-light a new therapy and then – mere months later – say, “Nevermind,” even as patients weigh its costs, risks, and benefits and still clamor for it. Such uncertainty will slow, not speed, medical innovation.
The “decision was a difficult one for the agency,” said FDA official Janet Woodcock, who stressed that the decision was made by officials with experience treating cancer patients, including some who had been “personally touched by the disease.”
One of America’s premier breast-cancer advocacy groups spoke out in the wake of the FDA’s ruling.
“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it, and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs,” said Elizabeth Thompson, president of Susan G. Komen for the Cure.
Thompson’s concerns are well-founded. Avastin is not cheap: It can cost as much as $8,000 per month. Absent FDA approval, Medicare and Medicaid, two programs of the government which fall under the Centers for Medicare and Medicaid Services, could refuse to pay for this drug. Regence and HSCS, two private health insurers, already have restricted compensation for supplying Avastin.
Ironically for liberal Democrats fueled by “fairness,” President Barack Obama’s FDA is creating a two-tier system in which only breast cancer patients with deep purses will have access to Avastin. The result? The haves will live, and the have nots will die.