VOICES for REASON

If you’re interested in issues surrounding health care reform, be sure to check out VfR often. I’ll regularly be linking to interesting and informative articles I’ve come across in following the debate on this topic. Here goes.

• Doctors are struggling to make ends meet.
• A growing number of doctors are choosing “concierge medicine.” What is it and should you sign up?
• ObamaCare turned two last week—here are the brutal facts about what it’s achieved.
• Private insurers will find it increasingly difficult to stay in business if ObamaCare is not overturned or repealed.
• Big drug companies are no longer chasing blockbuster drugs.
• “By 2037, health insurance will swallow your entire paycheck”—read about the possibility here and here.

And be sure to check out the recent commentary on ObamaCare at ARI’s Laissez-Faire blog.

The debate “about the quality of our Iran intelligence is mostly an irrelevance,” Bret Stephens argues:

Iran’s real nuclear-weapons program is hiding in plain sight. The serious question policy makers must answer isn’t whether Iran will go for a bomb once it is within a half-step of getting one. It’s whether Iran should be allowed to get within that half-step. …

You may not be able to divine whether a drinker, holding a bottle of Johnnie Walker in one hand and a glass tinkling with ice in the other, actually intends to pour himself a drink. And perhaps he doesn’t. But the important thing, at least when it comes to intervention, is not to present him with the opportunity in the first place.

I also agree with Stephens that intelligence reports have become politicized.

But I’d identify a further problem that undermines U.S. policymaking:  we pay scant attention to — indeed, we routinely discount — the ideological character and militant goals of a regime like Iran. That’s a factor that must feed into our thinking and assessment of a regime that seemingly avails itself of every opportunity to bring harm or “death to America.”

image: wikimedia commons

Are you tired of watching the government intervene more and more in the economy and in your life? If so, you should check out the blog Laissez-Faire: The Uncompromised Case for Capitalism. ARC’s Don Watkins and Yaron Brook are working to reverse today’s anticapitalist trend by bringing you the gold standard in pro-capitalist thought. Here are just a few highlights from last week:

• Breaking News: Goldman Sachs’ Corporate Culture Encourages Money-Making
• Yaron Answers: Should the U.S. Return to a Gold Standard?
• How Not To Cut Government

While you’re there, be sure to bookmark the blog and register for the Ending Big Government newsletter.

Who owns your cells? The FDA seems to think it does, given its lawsuit against Regenerative Sciences, a company that treats orthopedic injuries by extracting, culturing and reinjecting adult stem cells derived from a patient’s bone marrow.

The case is precedent-setting in that FDA is claiming authority to regulate a patient’s own cells as though they were chemical drugs. As one researcher describes it:

If you start to look at this product as being the patient’s own stem cell, how can the FDA claim Regenerative is manufacturing [cells] – they’re culturing them. . . . They seem to have lost perspective on using autologous stem cells. There’s just no way you could apply manufacturing standards. . . . The FDA does not come into a cardiology practice and tell doctors how to do their surgeries or how to do heart replacements. And yet they feel they can come into a stem cell clinic.

The problem with FDA “coming into a stem cell clinic” is that this could have a significantly chilling effect on this whole field of medical research. Under the burden of FDA’s regulatory intervention, the costs of developing adult stem cell treatments would explode and treatments that might have otherwise been profitable might never even make it to market—as has happened with drug development in the U.S. And while stem cell therapies are under FDA review, patients will be denied government permission to use treatments derived from their own cells.

Christopher Centeno, the director of Regenerative Sciences, described to Forbes his company’s perspective on the case:

We see this lawsuit as a 21st century civil rights issue that will define what control you have about the use of your own cells and tissue. If a loved one is dying in intensive care and a well done study shows that the patient’s own cells can be used to help, does the patient get to decide to use those cells, or is that a decision for the FDA? Will the patient still be alive while we wait on Washington to issue this decision?

The prospect of patients dying waiting for FDA to act is, unfortunately, all-too real.

Because the agency has the power to keep drugs and medical devices off the market while its regulators plod through their labyrinthine review process, doctors and patients are forbidden by law from using treatments that lack the FDA’s stamp of approval, even with informed consent. In cases where the patient has little time left and no other options, this can lead to tragic outcomes.

Consider a device designed to replace a brittle aortic valve that was recently approved by the FDA. During a four-year period of FDA’s review, the device was used safely in Europe while being denied to American patients. According to AEI’s Scott Gottlieb:

more than 15,000 patients world-wide will receive the device by the time it’s slated for approval in the U.S. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery, have died during the intervening four years.

How would you feel watching a loved one die, knowing that the only thing standing between him and a possible life-saving treatment is a group of government bureaucrats who think they have the right to deny it to him?

Or consider the beta-blocker class of drugs. In the mid-70’s, these had been shown to reduce the risk of secondary heart attack and some were adopted for this purpose overseas. “But in the U.S.,” writes CEI’s Sam Kazman:

FDA imposed a moratorium on beta-blocker approvals due to the drugs’ carcinogenicity in animals. . . . In effect, FDA was denying needed cardiac drugs to people at high risk of heart attacks because of the unproven possibility that those drugs might cause cancer years in the future. Finally, in 1981 FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant, of course, that as many as 100,000 people may have died waiting for FDA to act.

Kazman calls these many thousands of individuals—in this and other similar cases—the FDA’s “invisible victims.”

The field of adult stem cell therapy has been slow to develop and treatments that show signs of real promise are only just beginning to emerge. It would be tragic if regulatory intervention by FDA were to stifle this field in its infancy.

More reasons to doubt the efficacy of sanctions on Iran: The U.S. has agreed to exempt Japan and ten other countries from sanctions over Iranian oil. All of that sounds eerily familiar. In 1996, the U.S. passed the Iran-Libya Sanctions Act in response to Iran’s initial efforts to become a nuclear state. This report (pdf) from Congressional Research Service describes how that Act was circumvented, in practice, through numerous exemptions.

Are you tired of watching the government intervene more and more in the economy and in your life? If so, you should check out the blog Laissez-Faire: The Uncompromised Case for Capitalism. ARC’s Don Watkins and Yaron Brook are working to reverse today’s anticapitalist trend by bringing you the gold standard in pro-capitalist thought. Here are just a few highlights from last week:

• Capitalist Secrets: Laissez-Faire Enriched Workers
• Everything You Need to Know About the Apple Antitrust Case
• Yaron Answers: Why do we have such a poor choice of political candidates?

While you’re there, be sure to bookmark the blog and register for the Ending Big Government newsletter.

Reading this despatch from Kabul is fascinating: The NYT‘s journalist is clearly disturbed by what he observes, and agonizes over what might explain it. The most salient explanation is just so far beyond what he regards as credible, that he keeps searching. In vain. What comes to the surface is the profound role that Islam has in the life of people of the Muslim world — and how, still today, many in the West struggle to grasp that fact.

The mullah was astounded and a little angered to be asked why the accidental burning of Korans last month could provoke violence nationwide, while an intentional mass murder that included nine children last Sunday did not.

“How can you compare the dishonoring of the Holy Koran with the martyrdom of innocent civilians?” said an incredulous Mullah Khaliq Dad, a member of the council of religious leaders who investigated the Koran burnings. “The whole goal of our life is religion.”
…
“To Muslims, and especially to Afghans, religion is much higher a concern than civilian or human casualties,” said Hafez Abdul Qayoom, a member of Afghanistan’s highest clerical body, the Ulema Council. “When something happens to their religion, they are much more sensitive and have much stronger reaction to it.”
…
Afghans are quick to recall a proverb: “You give your money away for your life, but you give your life away for your religion.”

The entire article is here.

There is currently a debate underway about the FDA’s authority to regulate stem cell therapies. The FDA is suing a Colorado-based company, Regenerative Sciences, which has developed a procedure to treat a person’s damaged joints by extracting and re-injecting his own stem cells. The FDA is arguing that the procedure involves more than “minimal manipulation” of the stem cells and therefore falls under the FDA’s authority, requiring a lengthy review and approval process—as other drugs and devices do—before being made available to patients.

There has been controversy over the idea of the FDA asserting the power to regulate a person’s own stem cells—and for good reason. If the FDA loses this case, says one scientist, it “would not be in a position to regulate the production and delivery of patients’ stem cells into themselves. That would remove massive commercial barriers to the implementation of this science and technology, because it would remove a lot of steps that cost a lot of time and money.”

People are right to be concerned about this. Typically when the FDA gets involved, it means more expensive treatments that take years longer to hit the market. For a field that is only just beginning to realize some of its promise, FDA regulatory delays could nip it in the bud.

The FDA’s intervention in the field of gene therapy provides a precedent. According to Christopher Scott of Stanford University’s Center for Biomedical Ethics, “there were concerns that the science was moving too quickly, so the FDA stopped all trials and the field was effectively shut down. There was such a severe reaction on the part of regulatory agencies that the science was effectively moribund, and now it is slowly coming back to viability.”

It would be a shame if a burgeoning field such as stem cell therapy was similarly stifled by the FDA’s intrusion.

In my last post, I shared an observation that government regulation always seems to grow in scope and, once established, almost never shrinks. How does that pattern become established? There are many factors that lead to the entrenchment of regulatory power and it’s ever-growing reach.  Over the next few posts, I’ll discuss some of these underlying causes.

Ayn Rand viewed the pattern of increasing regulation as inevitable in the kind of political system that we have, which she described as a “mixed economy.” Because we have a combination of freedoms in the form of individual rights and controls in the form of ad-hoc, piecemeal regulations curtailing those rights, Rand viewed our system as inherently unstable. In her words:

“A mixed economy has no principles to define its policies, its goals, its laws—no principles to limit the power of its government. The only principle of a mixed economy—which, necessarily has to go unnamed and unacknowledged—is that no one’s interests are safe, everyone’s interests are on the public auction block, and anything goes for anyone who can get away with it. Such a system—or, more precisely, anti-system—breaks up a country into an ever-growing  number of enemy camps, into economic groups fighting one another for self preservation in an indeterminate mixture of defense and offense, as the nature of such a jungle demands. While politically a mixed economy preserves the semblance of law and order, economically it is the equivalent of the chaos that had ruled China for centuries: a chaos or robber gangs looting –and draining the productive elements of the country.”

When a question arises about whether stem cell research of the kind that Regenerative Sciences is doing should be regulated, think about all of the lobbying groups with their varying agendas and motivations that claim to have a stake in what the outcome is. Doctors, private corporations, researchers, patients, relatives of patients, insurance companies, pharmaceutical companies, religious opponents of scientific research, universities, political parties, and so on. Each group will immediately feel the urgent need to clamor for regulations and actions that will protect what they claim are the interests of some deserving group. Each group claims to have its own need for protection or concessions–which entail new restrictions or controls on others. No wonder lobbying is a multi-billion dollar industry! No wonder massive institutions like the FDA have expanded, in the face of these alleged high-priority claims! The upshot is a continual erosion of freedom in favor of regulation.

In all of this clamoring, legitimate questions get lost. Questions such as whether there is really a safety threat presented by these particular stem cell technologies (unclear), whether existing laws around fraud and product liability are already sufficient to protect patients’ rights (they are), whether there might be private groups or companies that can offer an independent evaluation of stem cell technology providers (try Googling it).

Instead, in a mixed economy, the pattern is that every problem looks like a nail and the hammer is always to increase regulation.

But surely there’s a limit to all the claims that might be raised and therefore some limit to the growth of regulation? Stay tuned for my next installment.

Think of some of the most tyrannical regimes you’ve heard of–ones that enforce racist policies, deny their subjects basic freedoms, condone slavery. Now suppose that they concoct and push a story ascribing their own crimes to a regime that in fact respects individual rights. Would anyone believe that? Would anyone let the tyrannies downplay their own oppressive record and damn an unjustly accused state?

Sadly, yes, argues this incisive oped by Efraim Karsh, a Middle East scholar. Responding to “Israel Apartheid Week” which is going on at college campuses, Karsh contends that the “apartheid” charge against Israel “is not only completely false but the inverse of the truth.

If apartheid is indeed a crime against humanity, Israel actually is the only apartheid-free state in the Middle East – a state whose Arab population enjoys full equality before the law and more prerogatives than most ethnic minorities in the free world, from the designation of Arabic as an official language to the recognition of non-Jewish religious holidays as legal days of rest.

By contrast, apartheid has been an integral part of the Middle East for over a millennium, and its Arab and Muslim nations continue to legally, politically and socially enforce this discriminatory practice against their hapless minorities.

Well worth reading; the whole thing is here.