Tom Bowden — 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

The latest issue of George Mason Law Review, currently in the mail to subscribers (how quaint that sounds in this digital age), contains my review of an important new book on the landmark Supreme Court case of Lochner v. New York. The book is called Rehabilitating Lochner: Defending Individual Rights Against Progressive Reform, by David E. Bernstein, a professor at George Mason University School of Law.

I welcomed the opportunity to review Bernstein’s book because the Lochner case stands as an enduring symbol of the most important debate in American legal history. Do individuals have natural rights that government must respect, even when political majorities want to infringe upon them? The majority in Lochner said yes—but Justice Oliver Wendell Holmes, Jr., in a famous dissent, said no. In the century since that 1905 case was decided, legal thinkers have returned time and again to Holmes’s dissent, about which I have written at length elsewhere, to support the idea that judges must step aside and allow legislatures to write laws as if individuals have no rights that the majority must recognize.

Bernstein’s book is attracting attention from prominent legal scholars and commentators. Richard Epstein, professor of law at New York University, wrote in the Claremont Review of Books that Bernstein reaffirms a “classical liberal paradigm” that the Supreme Court should employ to “confess, and undo, its prior errors.” In Commentary, Glenn Reynolds—the University of Tennessee law professor and Instapundit guru—wrote: “The false narrative of Lochner has controlled the past for decades, but Bernstein’s clear and incisive work may wrest that control away and move us back to the truth.” And columnist George Will endorsed Bernstein’s argument that “Progressivism . . . is hostile to America’s premise that individuals possess rights that preexist government and are not fully enumerated in the Constitution.”

Rehabilitating Lochner has a limited purpose. It does not set out to resolve the fundamental question whether individuals have natural rights, nor does it even present Bernstein’s view on the matter. It is rather a work of historical revisionism, meant to clear out the nasty underbrush that has grown up around this oft-cited but little understood case. In my review, I summarize Bernstein’s achievement this way:

     Here, then, is the demythologized Lochner. It was a well-reasoned opinion based on strong precedent and time-honored judicial philosophy, not a textually absurd act of judicial malfeasance. It was a sincere attempt to uphold constitutionally protected liberty, not a cynical mask for prejudice. It resulted in the defense of individual liberty against power-wielding political pressure groups, not the surrender of defenseless individuals to callous Social Darwinism. And it was a progenitor of decisions that would recognize constitutionally protected rights in a variety of contexts, not a doctrinal plague-carrier to be exterminated by right-thinking scholars and judges.

It is books like this one that are laying the groundwork for a future in which America’s judiciary—and especially the Supreme Court—can intelligently assess its past conduct and chart a future course that’s consistent with the nation’s founding ideals.

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

In BusinessWeek’s “Debate Room” this week, I take the “pro” position on the topic: “Dear Government, U.S. Business Doesn’t Need You.” Here’s part of what I said:

Jobs are created by private businesses when they expand production, launch new products, and develop new markets. Government’s proper task is to protect the rights of these job creators (and the people who fill the jobs). That means enforcing laws against embezzlement, fraud, breach of contract, and all the other crimes and civil wrongs that violate the right to free, voluntary trade.

After that, government’s No. 1 priority is to butt out. Our lawmakers need to be pondering how to roll back the programs that stifle job creation. From Federal Reserve-driven currency manipulation that fogs up the economic prediction windshield to costly and demoralizing regulations such as Sarbanes-Oxley that treat businesspeople as guilty until certified innocent and on to runaway “stimulus” spending that sucks capital out of the private sector, government “help” actually kills business initiative.

My opponent advocates economic protectionism, even higher spending on education, and other forms of what I call “welfare for business.” Who’s the winner of this debate? You be the judge—and be sure to post your comments on the BusinessWeek.com website.

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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

My colleague Don Watkins just posted an online comment to a recent column by Al Lewis concerning Ayn Rand. Ordinarily Don wouldn’t have bothered, except that Lewis’s diatribe went out under the auspices of the Wall Street Journal, the nation’s largest circulation daily newspaper. I’ve reproduced Don’s comment in its entirety below:

Al Lewis suggests that today’s prominent admirers of Ayn Rand (such as Rep. Paul Ryan, Rush Limbaugh, and Justice Clarence Thomas) “would be crushed to learn that she might never love them back.” Lewis wants us to know how baffled he is at Rand’s refusal, during her lifetime, to forge alliances with everyone who claimed to have something in common with her politics.

Lewis’s column, for all its childish, hit-and-run bluster, invites attention to an important fact about Ayn Rand. As a crusader for laissez-faire capitalism, Rand traced the historical decline of freedom to a series of crucial intellectual errors. Her task, as she saw it, was to advance rigorous arguments demonstrating the system’s virtues, in order to persuade reasonable people to change their minds.

It was this serious mission that kept Rand on constant watch for advocates who might claim to be her allies, but whose arguments actually undermined the cause of freedom. Consider the examples Lewis mentions. When libertarians argued that capitalism leads to anarchism—or when Reaganite conservatives argued that a woman’s individual right to the pursuit of happiness must be sacrificed to a month-old embryo—or when right-leaning Christians argued that the profit motive, though immoral, is tolerable because it benefits society—Ayn Rand distanced herself and her philosophy from those movements. Why? Because she thought their arguments would hurt, rather than help, the cause of freedom.

In today’s world, to be selective about one’s allies is to invite accusations of dogmatism. But it was precisely Rand’s lack of dogmatism—her conviction that only rational, persuasive arguments can change the world—that made her so careful about avoiding confusion in making the case for capitalism.

From the wild array of accusations, distortions, and half-truths contained in Lewis’s column, I have selected this one issue for a too-brief discussion—the rest don’t merit rebuttal. Rand’s arguments and alliances deserve to be taken seriously, not treated in the cavalier fashion that Lewis adopts.

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

The death of Dr. Jack Kevorkian, who agitated ceaselessly for laws that would allow competent adults to seek medical assistance in ending their own lives, painlessly and with dignity, brought to mind an op-ed I wrote a while back. Here’s an excerpt:

The Declaration of Independence proclaimed, for the first time in the history of nations, that each person exists as an end in himself. This basic truth—which finds political expression in the right to life, liberty, and the pursuit of happiness—means, in practical terms, that you need no one’s permission to live, and that no one may forcibly obstruct your efforts to achieve your own personal happiness.

But what if happiness becomes impossible to attain? What if a dread disease, or some other calamity, drains all joy from life, leaving only misery and suffering? The right to life includes and implies the right to commit suicide. To hold otherwise—to declare that society must give you permission to kill yourself—is to contradict the right to life at its root. If you have a duty to go on living, despite your better judgment, then your life does not belong to you, and you exist by permission, not by right.

For these reasons, each individual has the right to decide the hour of his death and to implement that solemn decision as best he can. The choice is his because the life is his. And if a doctor is willing (not forced) to assist in the suicide, based on an objective assessment of his patient’s mental and physical state, the law should not stand in his way.

While I don’t necessarily endorse all of Dr. Kevorkian’s positions and actions, I do honor his insistence that the legal system should accommodate the right of a competent, terminally ill adult to end his life at the time, and in the manner, of his own choosing.

It is a national disgrace that only two states (Oregon and Washington) make physician-assisted suicide legal under procedures calculated to supply objective evidence of the patient’s choice in the matter, and only one other state (Montana) has opened the door to reform.

Image: Wikimedia Commons

Three years ago, in an op-ed called “Your Child Is Not State Property,” I wrote the following:

Education, like nutrition, should be recognized as the exclusive domain of a child’s parents, within legal limits objectively defining child abuse and neglect. Parents who starve their children may properly be ordered to fulfill their parental obligations, on pain of losing legal custody. But the fact that some parents may serve better food than others does not permit government to seize control of nutrition, outlaw home-cooked meals, and order all children to report for daily force-feeding at government-licensed cafeterias.

Last week, I came across an interesting op-ed in the Wall Street Journal, called “If Supermarkets Were Like Public Schools.” There, Donald J. Boudreaux, a professor of economics at George Mason University, uses a similar analogy at much greater length, to make a point about the economic insanity of our public education regime. An edited excerpt:

Suppose that groceries were supplied in the same way as K-12 education. . . .

Being largely protected from consumer choice, almost all public supermarkets would be worse than private ones. . . .

How could it be otherwise? Public supermarkets would have captive customers and revenues supplied not by customers but by the government. Of course they wouldn’t organize themselves efficiently to meet customers’ demands. . . .

As for the handful of radicals who call for total separation of supermarket and state—well, they would be criticized by almost everyone as antisocial devils indifferent to the starvation that would haunt the land if the provision of groceries were governed exclusively by private market forces.

In the face of calls for supermarket choice, supermarket-workers unions would use their significant resources for lobbying—in favor of public-supermarkets’ monopoly power and against any suggestion that market forces are appropriate for delivering something as essential as groceries. Some indignant public-supermarket defenders would even rail against the insensitivity of referring to grocery shoppers as “customers,” on the grounds that the relationship between the public servants who supply life-giving groceries and the citizens who need those groceries is not so crass as to be discussed in terms of commerce. . . .

In reality, of course, groceries and many other staples of daily life are distributed with extraordinary effectiveness by competitive markets responding to consumer choice. The same could be true of education—the unions’ self-serving protestations notwithstanding.

I urge you to read the whole (short) article. The economic case for total separation of education and state is unanswerable. But the economic case is not enough—I’m convinced that only a moral challenge to public education can achieve fundamental change. Our children are not state property, and we shouldn’t let educational bureaucrats (and the politicians who protect them) get away with acting otherwise.

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