On Dec. 16, the Food and Drug Administration made a decision that could cause thousands of breast cancer patients to lose their last hope. That day, officials voted to revoke approval for Avastin for the treatment of late-stage breast cancer.
This move is 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 they ignored the evidence. Last week, officials said 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 upward of $90,000.
But for many of the 17,500 American women who are prescribed Avastin every year, those dollars translate into a substantial amount of extra life.
Even among patients who do not 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.
The exact same day the FDA revoked Avastin’s approval, its counterpart across the Atlantic Ocean 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 a treatment called paclitaxel, substantially prolonged progression-free survival. They ruled to retain its approval.
Public insurance programs could use the FDA’s 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 without the help of insurance. Effectively, the FDA has decided that many late-stage breast cancer patients can have extra time with their loved ones only if they can afford Avastin themselves.
Worse still, this decision could smother future pharmaceutical development. Genentech, Avastin’s developer, spent some $2.3 billion creating the treatment. In reaction to the FDA decision, other 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 is true that Avastin cannot save most of them. But for a select group, the drug improves life dramatically. It should not be put on the chopping block.
Sally C. Pipes is president and CEO of the Pacific Research Institute. Her latest book, “The Truth About Obamacare” (Regnery 2010), was released recently.