FDA Delays Decision on Use of Breast Cancer Drug

Published May 31, 2016

Members of President Barack Obama’s administration almost uniformly support a woman’s “right to choose” an abortion. We’ll soon know whether the administration also supports a woman’s right to choose Avastin, an anti-breast-cancer drug.

On September 17 the U.S. Food and Drug Administration postponed its decision on an advisory panel’s recommendation to revoke Avastin’s approval as a breast-cancer treatment. It is now expected to issue a ruling in mid-December.

Avastin restricts blood flow to tumors, which can decelerate their growth. In one clinical trial, about 50 percent of women saw their tumors stop expanding or spreading.

So, what’s the FDA’s problem?

What Price a Few Months?

The FDA panel argues Avastin extends the lives of breast-cancer patients, on average, by just five months—sometimes more, sometimes less. But this is no argument for rejecting the drug. If Avastin really is as ho-hum as skeptics claim, women and their doctors will abandon it.

Avastin is expensive. Treatments can hit $8,000 per month, in part to recover high research and development costs and fund the search for future drugs.

But the FDA shouldn’t disapprove drugs for this reason. It normally approves drugs for safety and effectiveness, not cost. Patients and doctors should decide whether Avastin makes economic sense.

Cost Clearly a Factor

Although the agency officially claims cost has nothing to do with the panel’s decision, Jean Grem of the FDA’s Oncology Drug Advisory Committee was cited in the The Wall Street Journal explaining why she voted to deprive breast-cancer patients of Avastin: “We aren’t supposed to talk about cost, but that’s another issue.”

In an August 12 letter to the FDA, Susan G. Komen for the Cure identified another potential problem with pulling Avastin from the market: “We are particularly concerned about … the message that this decision sends about drug development for women with advanced breast cancer.”

When the CEOs of Lilly, Merck, and Pfizer watch FDA advisers bashing Avastin, it makes them less, not more, likely to devote precious research dollars to discover breakthroughs for breast cancer and other diseases. If the FDA decertifies Avastin for breast-cancer patients, it will chill America’s laboratories.

Leave It Alone, Patients Urge

For actual breast-cancer survivors and current patients, this controversy ignores a fundamental point: Avastin keeps them alive—although not as long as we’d like, at least it works for a while. Such real people and their loved ones have started a petition to urge the FDA to leave Avastin alone. Josh Turnage is a young Mississippian whose mother fights breast cancer with Avastin. He recently produced a moving video about her fight, and it features testimonials by several women on what Avastin means to them.

“A day in the life of a cancer patient is a gift,” writes one Virginian with breast cancer. “The panel who advises the FDA cannot assess or appreciate the value of an extra day, week, or month for a person who is facing mortality.”

“My life depends on this drug, and my quality of life also depends on it,” one Californian with breast cancer notes. “Without Avastin, I have no hope. I deserve the right to choose. I deserve the right to live as long as I can.”

If Washington wants to stand up to cancer in a truly meaningful way, our leaders should insist that these women have a right to choose their form of treatment.

Sally C. Pipes ([email protected]) is president and CEO of the Pacific Research Institute and author of “The Truth About ObamaCare.” A different form of this article originally appeared at AOL News. Reprinted with permission.


Internet Resources:

Petition: Stop the FDA From De-Certifying Avastin: http://www.thepetitionsite.com/3/stop-the-fda-from-disproving-avastin-to-treat-metastatic-breast-cancer/

Video: Stories From Avastin Users: http://www.youtube.com/watch?v=PkSZ__SvxGQ