I was sitting in my car committed to coming into work and focusing on the many tasks at hand, when I made the mistake of reading Ezra Klein’s Wonkbook as I left the parking lot. (As a side note, Ezra and his crew deserve huge praise for that, as I’m sure it’s a lot of work). I spent the entire walk to my office muttering curses under my breath and drawing looks from people I passed.
What got me so angry? This (emphasis mine):
Earlier this month, the Food and Drug Administration banned doctors from prescribing Avastin, a potent but costly drug, to patients with advanced-stage breast cancer. According to the FDA, the drug doesn’t offer “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” Yet in some clinical trials Avastin has halted the spread of patients’ cancer for months, providing respite to women and their families wracked by physical and psychological pain.
That’s David Rivkin and Elizabeth Foley in the WSJ. The rest of the piece is on how this was obviously a cost decision, the government is rationing, and DEATH PANELS!
They are both pretty accomplished people. Well educated. Smart, I’d bet. And they’re lawyers! So I think it would be very possible for them to know this simple fact: The FDA’s decision does not tell doctors what to do.
I hate to repeat myself, but there are only so many ways to describe simple facts again and again. Doctors can (and do) prescribe drugs off label (emphasis mine):
The FDA approves a drug for prescription use, and will continue to regulate the pharmaceutical industry through the work of the Division for Drug Marketing, Advertisement and Communication (DDMAC).The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008. Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request. 21 U.S.C. §360aaa-6.
Here is what the decision means. It will now be less likely that insurance will cover Avastin for breast cancer. It also means that the manufacturer can’t promote Avastin for breast cancer. The following are also true, however:
Can patients still request Avastin for breast cancer? Yes.
Can doctors still prescribe Avastin for breast cancer? Yes.
Can patients pay for the Avastin legally and get it for breast cancer? Yes.
Can Avastin still be used (and often be covered for insurance) for other cancers? Yes.
This decision is not pulling Avastin off the shelves. It’s not even prohibiting doctors from prescribing Avastin for breast cancer. How do I know this? One way might be to read the WSJ from two weeks ago:
If breast cancer is removed from the Avastin label, doctors could still prescribe the drug “off label” to women with the disease.
Another way might be to read this from a WSJ blog on that article:
But the FDA says this recommendation only marks the beginning of a process. For the time being, Avastin remains FDA-approved in combination with the chemo agent paclitaxel for the first-line treatment of metastatic, HER-2 negative breast cancer, and should still be available for those patients. Genentech can request a public hearing to contest the proposed withdrawal of the indication, which it says it will do...
The drug is approved in the U.S. for use against colon, kidney, brain and lung cancers, which means physicians might prescribe it off-label even if the breast-cancer indication is eventually removed. Insurers might not cover it for that use, however.
Mr. Rivkin and Ms. Foley are either lying in their editorial, or woefully misinformed. And I’m not talking a little misinformed; I’m talking completely misinformed about the meaning of the FDA’s decision, which was the point of the piece. If they are so misinformed, then why are they permitted to write a piece in one of the largest newspapers in the country?
I get that politicians sometimes say things that aren’t true. Their goal is politics. But newspapers are supposed to be interested in facts, aren’t they?
NOTE: I completely acknowledge that the cost of Avastin means that the vast majority of people in the United States will not be able to afford it out of pocket if insurance does not cover it. I ask you to acknowledge that this same argument can be made for pretty much all the tens of millions of uninsured and many, many more underinsured Americans for almost every significant therapy. I ask you to also acknowledge that a similar decision was made (but that time completely for cost reasons, and with much less evidence of ineffectiveness) in Arizona for transplants with much less opposition and coverage from the media. If you want to discuss a system to fix this for everyone, I’m all ears. But only being upset when people have to pay out of pocket for one drug is cherry picking.