In case you weren’t paying attention, the FDA revoked its approval of Avastin for the treatment of breast cancer last week:
U.S. regulators revoked approval of Roche AG’s Avastin as a treatment for metastatic breast cancer, a move the drugmaker has said could put as much as 800 million Swiss francs ($873 million) in revenue at risk.
Avastin, with $6.2 billion in 2010 sales, didn’t extend patients’ lives and triggered serious side effects including high blood pressure and bleeding when used to attack the disease, said Commissioner Margaret Hamburg of the Food and Drug Administration in a statement today. The drug remains approved for colon, lung, kidney and brain cancer.
We’ve covered this issue as it’s progressed here on the blog, and I can’t say that I’m surprised by this decision. Nor can I say that I’m dismayed by it. I’ve thought that the FDA handled this decision thoughtfully, and it turns out that other do, too. Avik Roy, with whom I sometimes respectfully disagree, has a nice post up on this issue that hits all the right notes:
The Wall Street Journal, and others, have denounced the FDA’s move as “a chillingly blunt assertion of regulatory power.” But my ManhattanInstitute colleague Paul Howard is the guy who gets it right, in a blog post for Medical Progress Today:
If you think (as I do) that the FDA should be expanding the accelerated approval pathway and allow more drugs to get to market based on promising early studies. rather than waiting for large Phase III clinical trials that can take years to complete, you can argue that this outcome actually strengthens AA. Critics have charged that AA is sop to industry, and that companies never do the follow up studies to support AA. Avastin proves them wrong.
This is exactly the point. If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren’t as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see the FDA handle more cases like this one, not less
There have to be some objective criteria by which we decide what drugs merit approval. When those criteria are agreed upon ahead of time, and then those criteria are not met, we have to follow through. That’s what the FDA did here.
I’d like to make one other point. This decision means that the manufacturer can no longer promote Avastin for breast cancer. It’s still approved for marketing for other cancers. But that’s not all. Patients can still request Avastin for breast cancer. Doctors can still prescribe Avastin for breast cancer. Patients can still get Avastin and take it for breast cancer. And, although insurance doesn’t have to cover Avastin, many plans still will. Including Medicare:
The Medicare federal insurance program for the elderly and disabled will continue paying for Roche Holding’s drug Avastin for breast cancer, despite the health regulator’s decision to revoke approval.
So even though the FDA revoked coverage for Avastin because patients did worse in overall survival than patients in the control arm, where Avastin was replaced with a placebo, the government will continue to pay the $100,000 or so per year the treatment costs.
I’m not opposed to people having the right to get and pay for the treatment they like. In fact, their ability to do so is arguably one of the strengths of the US health care system. But I don’t think there are many who would argue that people have a right to have any therapy they want, no matter how expensive, no matter how ineffective, paid for with tax dollars. We keep talking about how we need to cut spending on Medicare. Perhaps not paying for drugs that have had their FDA approval revoked might be a place we could start.
