They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.
Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.
Significantly, the head of Roche/Genentech’s research arm vowed to pursue a new clinical trial that would look for biomarkers that might indicate which women might benefit from the drug. “We are disappointed with the outcome,” said chief medical officer Hal Barron. “We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States.”
Here’s how to interpret today’s decision. Anecdotes are not science. And those breast cancer patients who insist that Avastin is the reason why they are remaining alive longer than average will still have access to the drug. Why? If any insurance companies stop paying for Avastin’s use in breast cancer, the company is promising to make it available to anyone “who may be facing obstacles.” That won’t be many. Most insurance companies and Medicare will continue to follow the National Comprehensive Cancer Network guidelines. NCCN’s guideline writing committee, a third of whom have financial ties to Roche/Genentech, has said it will not withdraw Avastin’s use in metastatic patients. A few years ago, CMS passed a rule that said it would reimburse any use of a cancer drug, even if the FDA had not approved it for that use, if it was included in the NCCN guidelines and accompanying formulary.
That’s why we need guideline-writing committees without conflicts of interest.
The author, Merrill Goozner, is an award-winning journalist and author of ’The $800 Million Pill: The Truth Behind the Cost of New Drugs’ who writes regularly at Gooznews.com.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
