(from The Wall Street Journal, December 30, 2010)
The FDA’s restrictions on the drug Avastin are the beginning of a long slide toward health-care rationing
By DAVID B. RIVKIN JR. AND ELIZABETH PRICE FOLEY
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.
Ponder the FDA’s justification—there wasn’t “sufficient” benefit in relation to Avastin’s risks. Sufficient according to whom? For your wife, mother or daughter with terminal breast cancer, how much is an additional month of good-quality life worth? And what costs should be weighed? Like all drugs, Avastin has side effects including bleeding and high blood pressure. But isn’t the real cost to these women a swifter, less dignified death? The FDA made a crude cost calculation; as everyone in Washington knows, it wouldn’t have banned Avastin if the drug cost only $1,000 a year, instead of $90,000.
The Avastin story is emblematic of the government’s broader agenda to ration care based on cost and politics. Once ObamaCare comes into full force, such rationing will be pervasive. When the government sees insufficient benefit, all but the wealthiest and most politically connected will have to go without.
Think it can’t happen here? Think again. The 2009 stimulus bill spent $1.1 billion to research “comparative effectiveness.” That’s the same approach used by Britain’s National Health Service to ration care, weighing cost against factors such as the ever-elusive concept of quality of life. And in an interview that year, President Obama confessed that “the tougher issue . . . is what do you do around things like end-of-life care.” Pushed to articulate a solution, he replied, “It is very difficult to imagine the country making those decisions just through the normal political channels.” He asserted that we needed “some independent group” to “give [us] some guidance.”
He got that wish. ObamaCare created a commission—the Independent Payment Advisory Board—tasked with limiting spending on Medicare. Its recommendations will be binding, unless Congress can come up with equivalent cost-savings of its own. For the first time, an unelected group will be empowered to limit health spending for the vulnerable elderly.
ObamaCare proponents derided fears of “death panels” as a product of tea partiers’ fevered imagination, and they lamented when Congress removed the provision that would have provided for end-of-life counseling that might coax the elderly away from life-sustaining but expensive treatments. Not to fear: The administration has resurrected that provision through regulations, and Medicare will now pay for such counseling as part of elderly “wellness assessments.” Yes, the “death panels” charge is somewhat crude, but combine cost-based rationing with end-of-life counseling and, well, here we are.
There’s an enormous difference between government-imposed rationing and treatment decisions in the private sector. When insurance companies deny coverage—for example, on grounds that treatment is “experimental” or not “medically necessary”—they do so based on contract language agreed to in advance by subscribers. If you don’t like what a particular insurer offers, you’re free to shop around. Moreover, you and your doctor have extensive rights to appeal the insurer’s denial, and wealthy patients can pay for the care out of their own pockets.
But when the government denies approval of a medication, there will often be no appeal and no escape. For example, while doctors can still prescribe Avastin for other kinds of cancer—allowing them to prescribe it “off-label” to breast-cancer patients—this is merely fortuitous, something that’s not the case with many other drugs. The next time the FDA bans a drug because its benefits are not “sufficient,” patients may not be so lucky. FDA disapproval will be the equivalent of the emperor’s thumbs-down.
This whole scheme doesn’t stand up to legal scrutiny. Government-imposed cost-benefit rationing raises serious constitutional concerns. Individual bodily autonomy is one of the oldest recognized rights. Its constitutional significance is reflected in Supreme Court decisions acknowledging the rights to refuse unwanted treatment and to access treatments such as contraception and abortion. Freedom to make medical decisions is central to the autonomy and dignity encapsulated by the majestic word “liberty” in the Constitution’s due process clauses.This isn’t to say that government can never interfere with bodily autonomy. State governments can, for example, force citizens to submit to certain treatments (like vaccinations) because of their unique “police power” to protect citizens’ health and safety. And the federal government can ban trade in snake oil treatments through its power to regulate commerce.
But even when Congress uses its enumerated powers, it cannot do so in ways that violate individual rights. It cannot, for example, decide to pay for the health care only of a certain racial group, or only of citizens who agree not to criticize the government. Such laws would violate equal protection and freedom of speech. Congress’s spending power is limited by other important constitutional provisions. One of those is the right to bodily autonomy.
When it comes to that right, courts have held that laws cannot impose an “undue burden” on access to life-preserving treatment. And there’s no greater burden than blocking access to such medical treatments on the grounds that the average person, according to a government agency’s reckoning, won’t benefit sufficiently.
If the government wants to reduce health-care spending, it can impose higher beneficiary cost-sharing, means-testing or other limits on eligibility that would be perfectly constitutional. But it can’t restrict every American’s access to proven treatments. With regard to medical care, the government must weigh delicate considerations of cost, quality of life and other factors individually—not collectively—in order to preserve citizens’ rights and dignity.
If government can limit Americans’ choice of effective medical treatments, there’s no limit to its control over our bodies, and the right to bodily autonomy is an illusion. In the context of the new health law, the FDA’s Avastin decision is the tip of a looming iceberg of government rationing. It must be challenged.
Mr. Rivkin, an attorney in Washington, served in the Justice Department under President George H.W. Bush. Ms. Price Foley is professor of law at Florida International University College of Law and the author of “Liberty for All: Reclaiming Individual Privacy in a New Era of Public Morality” (Yale, 2006).