This column is a collaboration between KHN and The New Republic.
Originally published 1/04/11 on Kaiser Health News
I respect honest disagreements about policy. You think health care reform is a bad idea? That it will run up the deficit or make it harder to find a doctor? I think you’re wrong, but that’s a reasonable debate and I’m happy to have it, just as long as you’re truthful about what you are arguing and make some good faith effort to learn the facts.
Often, though, the noisiest voices in the health care reform debate don’t do those things. They see a headline, figure out its political utility and use it to score cheap points. And they do so without any apparent interest in the nuances of policy or science that might make the issue just a little bit complicated.
Sometimes we see this on the left. But, at least in the last few years, we’ve seen it much more frequently on the right. It happened throughout 2009 and 2010, during the debate over the Affordable Care Act, when conservative critics claimed that the initiative would create “death panels” charged with making decisions to stop treatments for people deemed too old to save. Now it’s happening again in the wake of a controversial regulatory ruling about a cancer drug.
The drug is Avastin, manufactured by Genentech. Last month, the Food and Drug Administration announced that it was withdrawing approval of the drug for treatment of late stage breast cancer. The move was not unexpected or without grounding. In September, an FDA advisory committee that includes not just physicians but also patient advocates had recommended the change by a 12-to-1 vote.
But conservative critics have been pouncing anyway. Sen. David Vitter, R-La., calls the decision “the beginning of a slippery slope leading to more and more rationing under the government takeover of health care.” Breitbart’s “Big Government” deems it “the result of ObamaCare” and its determination “to ration care to the sick and elderly.”
Where to start? Well, how about the actual scientific background. Avastin attacks tumors by, in effect, cutting off their supply of oxygen. Physicians have used it successfully, generally in conjunction with other forms of chemotherapy, to fight other cancers. A few years ago, when one initial trial suggested it also retarded tumor growth in late-stage breast cancer, the FDA gave provisional approval — on the condition that the manufacturer provide follow-up studies confirming that the drug was both safe and effective.
At the time, plenty of oncologists were skeptical about the drug’s promise. And it looks like those skeptics were right. In two subsequent clinical studies, Avastin did not prolong life expectancy for late-stage breast cancer victims. Avastin did stop tumor growth for a few months, thus extending what oncologists call “progression-free survival.” But the delay was shorter than the initial study had suggested and the studies did not show that a higher quality of life followed. On the contrary, patients were more likely to suffer from the drug’s many painful and potentially toxic side effects, which include massive bleeding, gastrointestinal tract perforations, kidney damage and heart failure.
You wouldn’t know it from the commentary, but the FDA has been rejecting drugs without proven benefits and such serious side effects since long before the phrase “Obamacare” was even part of the political lexicon. That’s what drug approval agencies like FDA do, and it helps explain why advocacy organizations like the National Breast Cancer Coalition, who very much want what’s best for cancer patients, endorsed the decision. As journalist Merrill Goozner, who knows the issue as well as anybody, wrote, “science, not politics, prevailed.”
In addition, it’s not as if the FDA is taking the drug off the market completely. The December ruling does not affect FDA approval of the drug for other cancers, where studies have shown clearer benefits. Nor does it prevent a physician from, at his or her own discretion, prescribing the drug to treat a patient with late-stage breast cancer. This sort of off-label use, as it is known, is pretty common.
No, the likely impact will be on insurers, including both Medicare and private carriers, who use FDA approval as guidance in their decisions may decide against paying for it. (Several insurers have reportedly made the decision already.) And that’s what has even some more respectable voices in this debate, like Susan G. Komen for the Cure, worried. The drug is so expensive, at up to $8,000 a month, that few patients could pay for it on their own. And it’s always possible that, notwithstanding the study results, some very narrow class of patients will derive some benefit from the drug.
The FDA acknowledges as much. It has also offered to work with Genentech to design new clinical trials in which the manufacturer would make the drug available at low or no cost in order to pinpoint that sub-population. Among other things, in such trials FDA could be sure that patients taking the drug understand fully the drug’s potentially painful side effects.
Maybe the conservative critics think more clinical trials are not enough — that insurance programs always have an obligation to reimburse treatments of such dubious benefit and high risk, regardless of cost. Fine. That’s a respectable argument. But where was the conservative outrage when the state of Arizona recently declared that its Medicaid program would no longer pay for certain transplants? The state was engaging in precisely the sort of rationing that the FDA supposedly has done with Avastin, but with one key difference. Arizona appears to have made its decision without the extended, rigorous scientific debate that preceded FDA’s ruling. As best as I can determine, via Google, none of the right’s usual suspects uttered a peep.
Of course, that was the sort of rationing that happens all the time in the U.S. already — rationing by income. And it’s the kind of rationing that the new health law would greatly reduce, if not eliminate outright, by making sure more people have insurance and that their insurance comes with more consumer protections. But acknowledging that notion would mean grappling with the complicated realities of medicine and health care policy. And, as we’ve seen so many times, that’s not something many of reform’s critics on the right like to do.
Jonathan Cohn is Senior Editor with the New Republic.