“Large enough to be meaningful”—who decides?

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


An adventure in historical revisionism

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.


What to expect from the Obamacare litigation

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


Rhetoric vs. Reality: Obama’s response to the Iranian assassination plot

The rhetoric: Following the busting of an Iranian plot to kill a Saudi envoy in Washington, the Obama administration promised to pursue the “toughest sanctions.”

The reality: a New York Times headline sums up: “U.S. talks tough to Iran, but Holds Off on Harsher Moves.” The story goes on: “Despite issuing harsh calls for Tehran to be held to account, the Obama administration does not plan to shift its policy of pressure on the Iranian government.”

What’s fascinating here is twofold: (1) Iran is already enmeshed in an intricate web of “tough” sanctions going back many years, accomplishing little. (2) Even if truly effective sanctions were an appropriate response (it’s not even remotely enough), it’s utterly pathetic that the chances of actually imposing them are next to nil. That’s because Iran’s friends at the United Nations will likely undercut or scuttle a U.S.-led push for sanctions, just as they have done in the past.

Tehran is a regime that has already demonstrated a staggering degree of temerity and militancy: just think of its three-decades-long record of lethal attacks on Americans and U.S. interests. What effect will U.S. rhetoric and non-action have on it? We’ve seen that movie before. That policy of appeasement through inaction has brought us here.

What we should do in response requires a separate discussion, but at minimum, contemplate what a truly resolute, self-assertive U.S. policy would begin with: a frank reckoning of Iran’s militant character and malignant goals. Establishing that kind of moral clarity is a necessary condition for enabling us to confront the threat from the regime.

image: flickr


Don’t be confused by the Occupy Wall Street protesters

Here are my recent comments on the Occupy Wall Street protests:

Some Americans have expressed sympathy with the Occupy Wall Street protesters because they oppose bank bailouts and the incestuous relationship between Washington and Wall Street.

“Americans are understandably upset by what they see as ‘crony capitalism,’” said the Ayn Rand Center’s Don Watkins. “But the real motive of the protesters is not to end ‘crony capitalism’–it’s to attack real capitalism and end whatever is left of it in America.

“For years, Washington has favored certain bankers by intervening in the market. But that has nothing to do with genuine capitalism. Capitalism means that the government does one thing–protects us from force and fraud–leaving us free to conduct our economic affairs as we see fit. A capitalist government doesn’t intervene to pick winners and losers, or to save companies from their mistakes.

“But the Wall Street protests aren’t calling for an end to government intervention in markets–they want to increase it. Most of them, for example, want to increase wealth redistribution in the name of fighting income inequality.

“Contrary to their rhetoric, they do not oppose the banks on the grounds that Wall Street is in bed with Washington. Notice, for instance, the plans to protest outside the home of investor John Paulson, who cannot be accused of getting government favors, and the lack of complaints about taxpayer money being poured into GM, Chrysler, and Solyndra. They chose to protest Wall Street because, whatever its flaws, it symbolizes genuine capitalism.

“What the protesters object to is not government stacking the deck to determine winners and losers. They just want the government to pick different winners and losers. They want to take the ‘capitalism’ out of ‘crony capitalism’–not the other way around.”


Photo: Paul Stein


New Forbes.com Column: What We Owe Steve Jobs

Forbes.com has published the latest column by Yaron Brook and me, “What We Owe Steve Jobs.”

Watching the world mourn Steve Jobs, we are reminded of how massive crowds of Americans used to gather to celebrate the launch of a new bridge or a new railroad. There is a widespread recognition that Jobs was a creative genius who changed our world profoundly and for the better. Even President Obama, not usually given to praising businessmen, said that Jobs “transformed our lives, redefined entire industries, and achieved one of the rarest feats in human history: he changed the way each of us sees the world.”

All of this raises an important and to-date unasked question: what do we owe Jobs and productive geniuses like him?

You can read the entire column here.


9/11–A Decade Later [video]

Last month in Washington D.C., ARC hosted a symposium to explore American foreign policy in the post-9/11 decade. For those who were unable to attend live or to watch the live streamed video, below are the videos of the three panel discussions.

Upheavals in the Middle East: Assessing the political landscape

The Islamist Threat: From AfPak to Jyllands-Posten and Times Square

Iran, Israel and the West


Watch ARC speakers during “Capitalism Awareness Week”

Over the next week, ARI speakers will participate in “Capitalism Awareness Week.” Capitalism Awareness Week is being spearheaded by the student publication The Undercurrent, and will feature a series of events at college campuses addressing what capitalism really is and how our country would be far more prosperous and just if markets were free.

  • Tonight Yaron Brook will debate Dane Smith, the president of Growth and Justice, on whether regulating capitalism is a moral necessity or moral treason.
  • On Thursday, Sept. 29, Don Watkins will tackle America’s entitlement crisis and answer whether the entitlement state and its leading programs—Medicare, Medicaid, and Social Security—can and should survive.
  • On Tuesday, Oct. 4, John Allison, an ARI board member and retired chairman and CEO of BB&T Corporation, will discuss the causes, consequences, and cures of the recent financial crisis.

The best part is: all of these events will be streamed live over the web. So be sure to check them out!

More information can be found at capitalismweek.org (which is also where the events can be streamed live).


Elizabeth Warren’s Social Shakedown

If intellectual obscenities could be ranked, it would be hard to outdo Elizabeth Warren’s recent tirade against America’s wealth creators:

There is nobody in this country who got rich on his own. Nobody.

You built a factory out there? Good for you. But I want to be clear: you moved your goods to market on the roads the rest of us paid for; you hired workers the rest of us paid to educate; you were safe in your factory because of police forces and fire forces that the rest of us paid for. You didn’t have to worry that marauding bands would come and seize everything at your factory, and hire someone to protect against this, because of the work the rest of us did.

Now look, you built a factory and it turned into something terrific, or a great idea? God bless. Keep a big hunk of it. But part of the underlying social contract is you take a hunk of that and pay forward for the next kid who comes along.

There is a lot one could say about this quote–notice, for instance, that it totally ignores the benefits made possible by the factory–but I’ll confine myself to this: underlying Warren’s rant is a disastrous view of the proper relationship between the individual and society.

On Warren’s view, society is some collective entity with its own interests and prerogatives, and if you want to be a part of society, you have to surrender some of your interests and prerogatives–above all, some of your freedom. Warren calls it a “social contract.” I call it a “social shakedown.”

The Founding Fathers, in a view they inherited from Locke and which was elaborated by Ayn Rand, had a radically different view of the relationship between the individual and society. They held that society is not some collective entity. It is only a collection of individuals–each with his own aims and interests. The basic problem of politics, they held, was how sovereign individuals could gain the benefits of living in society without surrendering their ability to pursue their own interests.

The solution was to base society on the principle of individual rights: each individual has an inalienable right to life, liberty, property, and the pursuit of happiness. You were free to live your life for your own sake and according to your own independent judgment. The government’s job was simple: to make sure no one interfered in that pursuit by violating your rights. Not to build roads or schools or to confiscate what you earn when you build a factory. To protect your freedom.

The result was the first voluntary society in history–a society where people dealt with one another only by mutual consent to mutual advantage. In such a society, if no voluntary cooperation is possible, individuals are free to go their own way.

In a voluntary society there is no such thing as some undefined, unlimited debt to “society.” Those who educate workers, pave roads, or put out fires are fully remunerated for their work by their customers. They have no further claim on anyone’s wealth–to say nothing of the bizarre idea that their services give Elizabeth Warren or Barack Obama a claim on anyone’s wealth. As for the government itself, that’s more complicated. A limited government is indispensible for individuals to flourish and we certainly have a moral obligation to pay for it. But in today’s context, when most of what government does is violate rights, interfere with wealth creators, and tax away their profits, it takes no small amount of chutzpah to talk about the debt they owe to government.

Individuals do create wealth, and morally they have a right to the wealth they create. But to appreciate that, you have to reject Warren’s collectivist social shakedown in favor of the individualist tradition of the Founding Fathers.


A Palestinian state?

At the United Nations this week, the Palestinians will ask for — and possibly get — endorsement for their own independent state. But first, a quick reality check on what a Palestinian state means. This seven-part report from the Middle East Media Research Institute documents the rule of Hamas since it took over Gaza — in a bloody civil war — four years ago. To draw a brief sketch: Hamas has arbitrarily seized private land and bulldozed homes; censored the press; mocked freedom of assembly; killed political opponents (including those accused of “collaboration” with Israel); exploited civilians and private homes as human shields for armaments; imposed sharia law; and colluded in and carried out rocket attacks on Israel. And so the Islamists of Hamas have followed in the footsteps of the rival faction, the Fatah/PLO, which under Yasser Arafat had built up a horrifically repressive dictatorial regime. Arafat’s successor, Mahmoud Abbas, whose faction nominally has authority over parts of the West Bank, is known to celebrate suicide bombers, even honoring terrorists by naming streets after them.

For Palestinian leaders to demand a state of their own in order to sanctify their tyrannical rule is perverse.