BY SALLY C. PIPES – In December, the Food and Drug Administration (FDA) made a decision that could cause thousands of breast cancer patients to lose their last hope. That day, FDA officials voted to revoke approval for Avastin for the treatment of late-stage breast cancer.
This move was a disgrace.
Avastin reduces blood flow to tumors, allowing 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, temporarily sparing women from deteriorating further. On average, Avastin extends life by a few months. However, some “super responders” react especially well and enjoy additional years.
FDA bureaucrats know this but ignored the evidence. The FDA stated last month that Avastin does not offer “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.”
How could the FDA come to such a conclusion? The agency was likely influenced by Avastin’s cost. Medicare, Medicaid, and private insurers typically pick up a substantial slice of the tab for Avastin, and an annual regimen costs upwards of $90,000.
But for many of the 17,500 American women prescribed Avastin every year, those dollars translate into a substantial amount of extra life – days and months they wouldn’t have had to spend with their friends and families.
Even among patients that don’t experience a substantial increase in lifespan, Avastin can still significantly improve their quality of life, enabling them to better enjoy the time they have left and meet death with grace and dignity.
Ironically, the exact same day the FDA revoked Avastin’s approval, its counterpart across the Atlantic did the opposite. The European Union’s Committee for Medicinal Products for Human Use had conducted a similar investigation into Avastin in breast cancer treatment. Officials found that the drug, when used in combination with another treatment called paclitaxel, substantially prolonged progression-free survival, and they ruled to retain its approval.
There was a time when U.S. regulators appreciated these miracles. Back in 2008, the FDA granted the drug temporary approval for breast cancer treatment after considering research showing that women on a pharmaceutical cocktail including Avastin lived a median of two to three months longer than patients on a regimen without it.
Last summer, however, the FDA’s Oncologic Drugs Advisory Committee revisited that decision and recommend it be reversed. On Dec. 16, the general body made that recommendation official.
Public insurance programs could use the decision as justification to stop covering Avastin for breast cancer. Private insurers are likely to follow suit. In fact, several national insurers – including Regence and HSCS – have already started restricting reimbursements for Avastin for breast cancer.
So most women are going to be stuck trying to pay for Avastin out-of-pocket. Effectively, the FDA has decided that many late-stage breast cancer patients can get extra time with their loved ones only if they have enough zeros on their bank statement.
Worse still, this decision could smother future pharmaceutical development. Genentech, Avastin’s developer, spent some $2.3 billion creating this treatment. In reaction to this decision, other drug firms will be less likely to make the investments required for research into advanced drugs.
Every year, 40,000 American women die of breast cancer. It’s true that Avastin can’t save most of them. But for a select group, the drug improves life dramatically. It shouldn’t be put on the chopping block.
Sally C. Pipes is President, CEO and Taube Fellow in Health Care Studies at the Pacific Research Institute. Her latest book, The Truth About Obamacare (Regnery 2010), was just released.