The Other Drug War: The Fight for the Patient’s Voice

There’s a war on drugs being waged in San Diego’s back yard and it’s not the one we’re used to hearing about. Just 35 miles up the freeway in Oceanside sits Genentech’s state-of-the-art biologics manufacturing facility, which is dedicated to producing Avastin, the world’s best-selling and controversial cancer drug pulled by the FDA last month for the treatment of advanced breast cancer.

The decision has divided the breast cancer community and inspired protests from patients and doctors. Even congress is up in arms with conservatives decrying it as proof of the latest health care rationing. As expected, Genentech has appealed the decision and the fight for access to Avastin is front and center of the latest health care debate between the greater good and individual autonomy.

Avastin was granted accelerated approval for breast cancer in 2008 when a clinical trial showed that the drug, when combined with paclitaxel (a standard chemotherapy agent), delayed the progression of tumors by 5.5 months though it only extended lives by a “statistically insignificant” amount. At the time, this was enough for FDA reviewers to give conditional approval provided that additional studies showed that the drug was safe and effective.

Two larger studies unveiled late last year showed that Avastin, when combined with two other chemotherapy agents, stalled tumor growth by a mere one to three months with no prolongation of life at all. Worse yet, researchers discovered some serious and potentially fatal side-effects including severe high blood pressure, stroke, perforation of the gastrointestinal tract and heart conditions. Roughly 1.6 percent of women who took the drug developed heart failure and 1 percent of all study patients died from some Avastin-related cause.

There is no denying that the drug impedes the development of metastatic tumors for some breast cancer patients. Since it is FDA-approved to treat kidney, colon, brain and lung cancer, for now physicians can still prescribe the drug “off label” to patients with breast cancer. However, if Genentech’s appeal is rejected, insurance companies will eliminate coverage of the drug. Some already have including Regence and Excellus, which cover millions of Americans — not to mention Medicare, which is poised to follow suit.

If this happens, “super-responders,” patients who thrive an extra one or two years while on the medication, will be forced to pay for treatment themselves, which critics of the FDA’s decision claim is tantamount to a death sentence. Most patients, like Christi Turnage, can’t afford the $8,000 a month out-of-pocket for treatment.

For the last two years, Turnage’s metastatic cancer has remained unchanged and she and her doctor agree that Avastin is to credit. But since the statistical average disregards her “non-average” response to treatment, the 48-year-old nurse and mother of three could see her life raft ripped away.

“This is not a worthless drug by any means…there is almost certainly a group of women who get a big benefit,” says Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute, in an interview with the Washington Post.

Experts like Winer claim that the 1 percent risk related to taking Avastin is negligible when faced with advanced breast cancer’s ultimate side-effect of death. Ask any late stage cancer patient faced with that choice. Advocates are pushing hard to compel the FDA to give patients a seat at the table in the approval process.

The benefit of allowing this is obvious. Who better to weigh the potential risks and benefit than the very individuals whose lives are at stake? Shouldn’t they at least have a voice in the process? As it stands, members of the NRA have more voice at their respective table than dying cancer patients.

On the other hand, if patients are allowed more input, how will that bode for the future of drug regulation? Some insist it will set a dangerous precedent where science is trumped by emotion. Where dispassionate, evidence-based reason is upstaged and shanghaied by the desperate plea for compassion. Add to that public confusion over evidence-based treatment and anecdotal proof. How much erosion of regulatory control can the system withstand before policy is decided by public opinion?

In light of this, whose responsibility should it be to decide whether a dying patient can take that risk? Whose right is it? If every late stage breast cancer patient is allowed to roll the die, should taxpayers and insurance companies foot the monthly $8,000-plus bill to improve that patient’s quality of life for a short period of time? Should they pay for that expensive treatment for all women if only a few will benefit?

Given the runaway cost of health care and the growing burden of Medicare spending, are we being irresponsible to throw money at a dying cause? What is the dollar value of an extra year, month or week of life anyway? And who has the right to determine that?

For now, Genentech and thousands of patients, doctors and advocates are awaiting the FDA’s decision on whether to grant a hearing. Regardless of the outcome, it is clear that the future of drug regulation — and thousands of women — is at stake.

Kim Faulkner is a SDICCCA teaching intern in the English Department at Grossmont College and writes as a member of the San Diego Center for Ethics in Science and Technology.

The Reuben H. Fleet Science Center and the San Diego Center for Ethics in Science and Technology will be hosting a free public forum to discuss the role of the patient’s voice in the drug approval process. Come join the conversation on February 2 at 5:30 p.m.