health care — VOICES for REASON

As expected (and dreaded, by some), the U.S. Food and Drug Administration has revoked its approval of Avastin for treatment of advanced breast cancer. The Wall Street Journal has reported and editorialized on the event, which came in the form of a 69-page decision by Food and Drug Commissioner Margaret A. Hamburg, M.D.

If you wade through the legalese and medical technicalities all the way to page 38, you will encounter Dr. Hamburg’s crucial conclusion about Avastin’s effects on “PFS.” What’s PFS? It’s an acronym for “progression free survival,” a period of time during which a patient’s disease fails to worsen. In other words, for a patient in a fatal stage of breast cancer, an extra day of PFS = an extra day of no tumor growth.

Back to page 38, where Dr. Hamburg concludes that “the evidence does not show that Avastin has had an effect on PFS large enough to constitute clinical benefit.” The italics are mine—to stress the kind of value judgment Dr. Hamburg is making. What does that mean, “large enough”? According to Dr. Hamburg, it means “large enough to be meaningful to a patient.”

Do you see what’s going on here? Dr. Hamburg, a federal bureaucrat, is claiming a right to decide whether a particular period of delayed tumor growth is “meaningful” to individual patients whom she will never meet, much less examine and treat. In the particular case of Avastin, the latest statistics show that median PFS ranges from 0.8 months to 2.9 months, depending on which study you look at. By putting “median” in italics, I’m stressing that half the women in these studies experienced even longer periods of delayed tumor growth than those deemed not “large enough” to matter. Yet our law permits an FDA bureaucrat to limit these women’s access to medication, simply because an equal number of other women are predicted to benefit less, or not at all.

This is the practical meaning of collectivized medicine, about which I wrote at greater length last year, in a PJMedia op-ed called “The Avastin Travesty”:

But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer — only individuals do. Metaphors aside, a society doesn’t get sick and die — only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.

Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average — or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?

The FDA’s experts take professional pride in refusing to allow such individual considerations to influence their decisions. Instead, they float among the statistical clouds, observing that Avastin delays tumor growth by only 3 to 12 weeks on average and that some patients actually get worse after taking the drug. From behind a veneer of scientific respectability supplied by charts and graphs that ignore the individual patient, these experts then ask a question to which no rational answer can be given: What is the meaning to society of one month in an individual’s life?

In the ongoing debate over American medicine, it is crucial to understand how often we are asked to sacrifice the individual’s welfare for the alleged needs of society.

Image: WikiMedia Commons

Now that the Obama administration has asked the Supreme Court to decide the fate of Obamacare, conservatives are again waxing enthusiastic about the case’s significance. According to Human Events, for example, “The case before the Supreme Court is our last line of legal defense against a fundamental reconstitution of the relationship between American citizens and their government.”

Last month, in a Daily Caller op-ed, I voiced my opinion that this ship has already sailed—in other words, there has already been a “fundamental reconstitution of the relationship between American citizens and their government,” and the pending Obamacare litigation doesn’t really challenge that consensus:

The only argument with any chance of success in today’s Supreme Court starts by admitting that Congress has authority to control every single economic “activity” known to mankind—farming, building, manufacturing, transporting, storing, insuring, selling, buying, leasing, practicing medicine, operating a hospital, you name it—but then denies any authority to invade the sacred right of “inactivity.”

It’s hard to blame the plaintiffs for relying on this cooked-up technicality. Faced with the Supreme Court’s long-standing and intransigent refusal to uphold the American ideal of individual rights, they really had two options: do nothing, and watch while Obamacare completes the ruin of private health insurance—or sue to overturn the statute, but without daring to challenge Congress’s stranglehold over the economy.

Perhaps in the future, a new generation of Supreme Court justices will be open to interpreting the Commerce Clause objectively. In the meantime, sadly, the Obamacare litigation will do nothing to vindicate the founding fathers’ vision of a government whose authority is limited to protecting individual rights.

Even Randy Barnett, the Georgetown law professor who’s been the intellectual architect of the Obamacare challenges, believes it’s important not to overstate the litigation’s importance. In a recent radio interview, Barnett responded to his host’s comment that a Supreme Court decision striking down Obamacare would mean Congress’s power is “significantly limited.” Barnett answered:

I totally disagree that this is going to limit Congress’ power. I wish it would, Hugh. I wish a victory here would roll back Congress’ power, but it won’t. It’ll just basically say that a power that they’ve gone 230 years without ever exercising before, which is the power to make everybody do business with a private company, that power they’ve never exercised before, they’re not going to be able to exercise in the future. That’s all it’s going to say. And so it’s going to be a very important principle to establish that there still are limits. And if we lose this case, it’s going to be really, really bad. But if we win the case, it’s going to basically preserve the status quo, which is not where I think it ought to be. I think we ought to roll back federal power, but this case is not the case to roll back federal power. This is the case to say this far and no farther.

In contrast to some conservatives, then, Barnett is not under a starry-eyed impression that a favorable Supreme Court opinion will “roll back federal power.” This is a good perspective to keep in mind as the case goes forward.

Image: WikiMedia Commons

With Medicare facing unfunded liabilities that top $30 trillion, Washington is scrambling for ways to hold down the program’s soaring costs. And in the usual fashion, the proposals on the table ignore the fact that it is the government that created this problem in the first place.

One of the main ways ObamaCare attempts to address Medicare’s spending spree is by creating the Independent Payment Advisory Board (IPAB), a fifteen-member board empowered to reduce payments to health care providers.

But critics of IPAB have voiced concern that cutting fees for doctors and hospitals will make them less willing to accept Medicare patients and as a result, retirees will find it difficult to find doctors. For the same treatment, doctors today are already paid 20% less by Medicare than they are by private insurers. More than 13% of family physicians don’t accept Medicare patients, and a quarter of doctors limit the number they treat. Under ObamaCare, Medicare’s chief actuary predicts that the program’s payment rates will fall below even Medicaid’s, which infamously underpays doctors by more than 40%, in which case many more doctors will likely stop treating Medicare patients.

Taking a step back, it’s important to recognize that we’ve been debating what to do about skyrocketing Medicare spending since the program was first brought into existence four decades ago. One side argues that Medicare costs are out of control and we need to cut back on spending, and the other side retorts that cutting spending will lead to lower quality care. The usual compromise has been to try to root out “fraud, waste, abuse” through “smart” cuts. But these have proved elusive—Medicare costs continue to rise.

In reality, there are only two basic ways the government can curb its costs—rationing services by shrinking who and what Medicare covers or capping the amount it pays for services, i.e., price controls. Both approaches amount to reducing the amount of care Medicare provides. IPAB is not a novel concept—it is just another price control that will lead to a further shortage of doctors and hospitals, thereby subjecting Medicare patients to longer wait times.

Are we forced then to choose between spending ourselves into bankruptcy and limiting the quality of the elderly population’s medical care? No. This conflict is inherent only in a system where people are forced to subsidize each others’ health care, as we are today.

In a system where you are responsible for your own health care, what your retired neighbor spends on medical services is no one’s business but his own. If he wants to see an expensive specialist or try a costly drug, he is free to do so because the expense will come out of his own pocket (or whatever arrangement he has with a private insurance company). People in such a system pay for the quality of health care they want and can afford.

But in the system we have today, the quality of health care a retiree gets is everybody’s business because it is paid for by our tax dollars. And when taxpayers and their representatives decide that the price of a treatment is more than they are willing to shell out, they cut back by reducing coverage or capping prices. Individual retirees who may have benefited from the treatment then have no choice but to accept poorer quality care. In today’s system, the quality of health care a retiree can get depends not on the kind of care he wants and how much he has saved but on what government bureaucrats have decided they can “afford” to give him.

The solution to Medicare’s problems is not to allow government bureaucrats to dictate how much providers get paid and what level of care is “reasonable.” The solution is to challenge the fundamental idea of the program, which forces all of us to foot the bill for seniors’ health care needs.

Image: dreamstime

Over at The Daily Caller they have my take on the Obamacare litigation. Yes, it would be a good thing to stop Obamacare in the courts. But the victory, if it comes, will stop far short of restoring the Founding Fathers’ vision of political freedom for every American to engage in business and earn a living. In the article, I put it this way:

In desperation, their lawyers tugged on a tiny thread in the vast fabric of Commerce Clause jurisprudence. It turns out that the Court has consistently affirmed Congress’s power to control economic “activity”—but not “inactivity.” Therefore, the plaintiffs argue, Congress surely went too far by enacting the individual mandate, since the decision not to buy insurance is mere “inactivity.”

Let me translate: The only argument with any chance of success in today’s Supreme Court starts by admitting that Congress has authority to control every single economic “activity” known to mankind—farming, building, manufacturing, transporting, storing, insuring, selling, buying, leasing, practicing medicine, operating a hospital, you name it—but then denies any authority to invade the sacred right of “inactivity.”

It’s hard to blame the plaintiffs for relying on this cooked-up technicality. Faced with the Supreme Court’s long-standing and intransigent refusal to uphold the American ideal of individual rights, they really had two options: do nothing, and watch while Obamacare completes the ruin of private health insurance—or sue to overturn the statute, but without daring to challenge Congress’s stranglehold over the economy.

Perhaps in the future, a new generation of Supreme Court justices will be open to interpreting the Commerce Clause objectively. In the meantime, sadly, the Obamacare litigation will do nothing to vindicate the founding fathers’ vision of a government whose authority is limited to protecting individual rights.

If Americans are going to effectively oppose Big Government laws and regulations, they will have to do more than stand up for the right to sit down. They will have to defend the right to engage in economic activity of every kind—without government permission, and without carte blanche regulation by Congress under the Commerce Clause.

Image: Wikimedia Commons

Over at the Wall Street Journal online, Gregory Conko has an interesting article about the Food and Drug Administration’s upcoming hearing on Avastin. That’s the cancer-fighting drug that was recommended for disapproval by the FDA’s oncology committee almost a year ago.

Conko, a senior fellow at the Competitive Enterprise Institute, has focused on the really important theme here. Choices about whether to undertake risky, expensive treatments are properly made by the individual patient, in consultation with her doctor, not by compulsion from a government bureau. He writes:

When well-known scientist Stephen Jay Gould was diagnosed with a rare form of lung cancer in July 1982, he was told the diagnosis meant a median survival time of just eight months. His doctor gave up on him. But he lived another 20 years.

“Means and medians are the abstractions,” he wrote in Discover magazine in 1985. “Therefore, I looked at the mesothelioma statistics quite differently—and not only because I am an optimist . . . but primarily because I know that variation itself is the reality.”

Like Gould’s doctor, the FDA and its technocratic supporters are giving up on breast cancer patients because of their slavish obsession with median response rates. Everyone can agree that, on average, Avastin does not extend most patients’ life expectancy. But some patients have responded incredibly well, living years longer than expected. The medical community calls them “super responders.” Statisticians might describe them as “outliers.” But they’re real people, alive because of Avastin.

I had something similar to say in an op-ed a while back, responding to the oncology committee’s finding that Avastin does not “represent a favorable risk/benefit analysis.”

Does that mean the drug fails to help any woman more than it hurts her? Not at all—many individual women benefit from the drug. But the FDA regards such facts as sentimental distractions, to be deliberately ignored when deciding the fate of a drug like Avastin. The FDA’s idea of a risk/benefit analysis deals with health in the aggregate, as revealed in statistics involving large populations, not with the health of individuals.

But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer—only individuals do. Metaphors aside, a society doesn’t get sick and die—only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.

Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average—or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?

The FDA’s experts take professional pride in refusing to allow such individual considerations to influence their decisions. Instead, they float among the statistical clouds, observing that Avastin delays tumor growth by only 3 to 12 weeks on average and that some patients actually get worse after taking the drug. From behind a veneer of scientific respectability supplied by charts and graphs that ignore the individual patient, these experts then ask a question to which no rational answer can be given: What is the meaning to society of one month in an individual’s life?

I’m glad Gregory Conko and CEI are speaking up on this issue. Everyone interested in making sure pharmaceutical companies have the freedom to sell life-saving drugs should follow this controversy closely.

Image: Wikimedia Commons

Certain portions of the Patient Protection and Affordable Care Act—better known as Obamacare—“may violate the Constitution of Ayn Rand, but they do not violate the Constitution of the United States.” So said Acting Solicitor General Neal K. Katyal on Wednesday, defending Obamacare before a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit.

Whoa. Let’s slow down.

As everyone knows, there’s only one U.S. Constitution. So Katyal’s reference to “the Constitution of Ayn Rand” is obviously a rhetorical device—but for what end? For the purpose of reviling through mockery a certain view of the Constitution’s nature and purpose, a view championed not only by Ayn Rand but by the Founding Fathers themselves.

Rand held that the Constitution’s purpose was and is the protection of individual rights to life, liberty, property, and the pursuit of happiness. Although she was not a constitutional scholar and never originated a theory of legal interpretation, she knew as a matter of history and political philosophy that the Constitution embodies a certain view of the relationship between the individual and the government. In her article “The Nature of Government,” she wrote:

Today, when a concerted effort is made to obliterate this point, it cannot be repeated too often that the Constitution is a limitation on the government, not on private individuals—that it does not prescribe the conduct of private individuals, only the conduct of the government—that it is not a charter for government power, but a charter of the citizens’ protection against the government.

Elsewhere in the same article, she said:

A complex legal system, based on objectively valid principles, is required to make a society free and to keep it free—a system that does not depend on the motives, the moral character or the intentions of any given official, a system that leaves no opportunity, no legal loophole for the development of tyranny.

The American system of checks and balances was just such an achievement. And although certain contradictions in the Constitution did leave a loophole for the growth of statism, the incomparable achievement was the concept of a constitution as a means of limiting and restricting the power of the government.

Expanding on Rand’s view, I wrote the following in an op-ed for the Christian Science Monitor:

As a matter of historical fact, the Founding Fathers wrote the Constitution for a certain purpose. They wanted a government that would respect and protect the individual’s rights to life, liberty, property, and the pursuit of happiness. Aside from certain contradictions (the worst of which, toleration of slavery, required a bloody civil war to expunge), the Constitution is dedicated to protecting the individual from society by means of a limited government. The Supreme Court cannot objectively interpret the document’s language apart from this essential purpose.

Regrettably, however, too many of today’s judges reject this approach to constitutional interpretation. Instead, they follow the path marked out by Justice Oliver Wendell Holmes, Jr., who sat on the Supreme Court from 1902 to 1932. “All my life I have sneered at the natural rights of man,” Holmes wrote, reflecting his view that the individual rights venerated by the Founders have no objective validity and therefore no role in discerning the Constitution’s meaning.

Judges may harbor personal opinions on man’s rights, Holmes conceded, but such notions have “nothing to do with the right of a majority to embody their opinions in law.” Holmes’s view directly contradicts that of James Madison, the Father of the Constitution, who reviled unlimited democracy as “incompatible with personal security or the rights of property.”

Unfortunately, for more than a century, the Supreme Court has interpreted the Constitution without regard to the principle of individual rights. As a result, a statute like Obamacare—which contains wholesale violations of the rights of doctors, patients, and insurance companies—could sail through Congress without much worry that the courts will bar the way.

We can now see more clearly the purpose behind Katyal’s sarcastic reference to “the Constitution of Ayn Rand.” Even though virtually all the case law is on his side—even though the courts have given Congress carte blanche to rule the economy—Katyal realizes there’s a stubborn individualism in America that refuses to lie down in submission while a juggernaut like Obamacare rolls over them. Because Ayn Rand has actually articulated and defended the moral basis of this American ideal, she stands out as the symbol of what Katyal wants to warn against. By singling her out, Katyal is reminding the judges that the American ideal of individual rights is none of their concern—that the Supreme Court regards the Constitution’s purpose as irrelevant to interpreting its language—that the judges’ job is to rubber-stamp Obamacare and not worry about its victims.

The judges on the Eleventh Circuit, who are duty-bound to follow Supreme Court precedent, will not be breaking new ground in the realm of constitutional interpretation. But if some future Supreme Court were to move the judiciary toward a more objective approach, those justices would not be enforcing some imaginary “Constitution of Ayn Rand.” They would be enforcing the one and only Constitution of the United States, that often misunderstood yet precious gift of our freedom-loving forebears.

image: wikipedia/cc

Forbes.com has just published the latest column by Yaron Brook and me, part 3 on the subject of ObamaCare and the debate over preexisting conditions. In this installment, we describe how a the attempt to stop insurers from taking into account preexisting conditions is paving the way for socialized medicine.

The preexisting condition rule places crippling limits on the ability of insurers to create policies based on their best assessment of risk. It will turn them into essentially passive middlemen, who no longer appraise and control risk, but who merely perform the administrative function of doling out health care benefits. It’s only a matter of time before people start to ask: Why not save money by cutting out the middleman? (That, indeed, is what happened with student loans. After decades of subsidies and regulations, the government shoved the banks aside and took over the student loan market.)

You can read the whole column here.

Forbes.com has just published the latest column by Yaron Brook and me, part 2 on the subject of ObamaCare and the debate over preexisting conditions. In this installment, we describe how a free market in health insurance might deal with preexisting conditions.

Imagine a world without health insurance. You’re a young entrepreneur and you notice that a perennial problem people face is how to protect themselves against the risk of incurring costly and unexpected medical expenses. For most, the apparent option–save enough money to cover any medical bill–is impractical: what if they get sick before they save enough? Or what if the cost of treatment exceeds a person’s capacity to save?

You realize that wherever there’s a problem, there’s an opportunity. You could convince some of the people in your town to purchase from you insurance that pays out in the event of accident or serious illness. But starting such a company would require a lot of work, a lot of financial capital, and complex actuarial and business skills that take a long time to acquire. You would need to set  rates to make sure more money is coming in than is going out; process claims to separate the legitimate from the illegitimate ones; and grow your client base. The challenges are enormous, but if you succeed, the value you provide clients would be huge and the profit potential should be as well.

After some careful deliberation, you decide to launch the business. You launch the first health insurance company. Your idea quickly catches on, and soon other health insurance companies spring up in your town and beyond.

You can read the whole column here.

Forbes.com has just published the latest column by Yaron Brook and me, on the subject of ObamaCare and the debate over preexisting conditions.

In his recent State of the Union, Obama named as the not-to-be-compromised central achievement of his health care bill that it put an end “to the days when insurance companies could deny someone coverage because of a preexisting condition.” ObamaCare does indeed make it illegal for insurance companies to refuse to cover people with preexisting medical conditions or to charge them higher prices.

Far from justifying an expansion of the state’s role in medicine, however, the issue of preexisting conditions illustrates how badly we need to disentangle government from American medicine.

You can read the whole column, the first in a series, here.

(Related discussion here.)

Richard Pazdur, the FDA’s top regulator of cancer drugs, is busy defending his agency’s decision to rescind approval of Avastin for treating breast cancer. In this Wall Street Journal article, he’s quoted as saying “the drug has a marginal effect on tumor growth.” As I indicate in my Pajamas Media article, he’s talking about the drug’s effect on average.

But as we know, averages are drawn from the experiences of actual individuals, some of whom have a better experience than the average. (And even the average experience, he admits, is positive.) Yet the FDA regards it as its professional duty to ignore every particular individual’s benefit, in favor of a collective decision. (The image accompanying this post is an actual slide from an FDA PowerPoint presentation, showing graphically how the agency conceives its risk-benefit analysis as collective rather than individual.)

Wait, did I say the FDA ignores the patients who benefit? That’s not quite true. Toward the end of the article, Pazdur makes a startling admission. “There may be a subset of women who could be helped by Avastin, but Genentech [Avastin’s manufacturer] needs to figure out who they are,” the article says.

Although the phrasing is cagey, Pazdur clearly knows what the rest of the world is shouting—that some women with breast cancer are benefiting from the drug. Nevertheless, he is perfectly comfortable with the FDA’s decision to withdraw approval of the drug. Why? Because some other women don’t benefit, and Genentech cannot yet scientifically separate the two groups.

It never occurs to Pazdur to question whether one individual woman’s right to undergo a successful treatment should hinge on whether some other women can’t share that benefit. To him and his FDA cohorts, sick people are dots on a statistical curve, and it’s only the curve that matters.

Image: Food and Drug Administration, “Overview and Introduction to Drug Regulation,” Slide No. 5