Health Roundup

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Science  26 May 2006:
Vol. 312, Issue 5777, pp. 1105
DOI: 10.1126/science.1130059

Lots of things are happening all at once in the health sector, so it's a good time for a roundup. Let's saddle up and start with intriguing news from the United Kingdom. As reported in the 3 May issue of the Journal of the American Medical Association by Banks et al., Britons in the 55 to 64 age cohort are significantly healthier than their U.S. counterparts despite much lower per-capita health expenditures. The U.S.-UK difference for several diseases exists at all socioeconomic levels, and it's large: Diabetes prevalence is twice as high in the U.S. sample. The differences are not attributable to behavioral risk factors (drinking, smoking, and obesity), but they do depend on self-reporting, which may explain why they are minimally reflected in mortality differences.

This reminded me that in his splendid 1974 book Who Shall Live? the economist Victor Fuchs compared two neighboring U.S. states that had approximately equal health expenditures and physician coverage. Despite this similarity, he showed that one of them—Utah—had a much healthier population than its neighbor, Nevada. Although Fuchs believes that behavioral factors are important in this comparison but not in the British analysis, the similarity between the two is worth noticing. It made me want to entitle this editorial “Brits Are from Utah, Yanks From Nevada.” But that would have left out other issues, which follow.

Last week saw the looming deadline for U.S. seniors to register for the Medicare prescription drug benefit, which might have made everyone more health policy-conscious. Maybe that's why a campaign is under way to give Americans with life-threatening diseases access to therapies that are untested for efficacy or safety. An organization called the Abigail Alliance, supported by the conservative Washington Legal Foundation, recently appealed an adverse district court decision to the U.S. Court of Appeals for the District of Columbia Circuit. A 2:1 majority there ruled that Food and Drug Administration (FDA) regulations that would withhold drugs from terminally ill patients violated the Due Process clause of the Constitution. The majority decision, as both the dissent and a scathing Washington Post editorial pointed out, invented a new patient right: one asserting that if you're terminally ill and have tried everything else, the government cannot interfere with your right to an unapproved therapy.


Well, this is not exactly a novel claim; it's a hardy perennial. Twenty-five years ago, the unapproved therapy in vogue was Laetrile, a purported cancer remedy made from apricot pits. Some doctors brought suit in district court on behalf of a plaintiff named Rutherford, who had wanted to try those apricot pits, and sued the FDA for getting in his way. The Tenth Circuit Court saw no right of access to Laetrile, whereupon plaintiffs appealed the case to the Supreme Court, which supported the FDA position in a unanimous 9-0 decision. Even if I hadn't been a defendant, I would have applauded it as a powerful statement on behalf of the public health.

The majority in the Abigail Alliance case made an attempt to dismiss the Rutherford precedent by pointing out that Phase I clinical trials had not been done on Laetrile. But Phase I testing simply seeks to determine appropriate dosage ranges; it does not establish safety. And safety is determined not just by toxicity but by a favorable relationship between risk and benefit. The dissent made the point that the majority had missed by quoting from Supreme Court Justice Thurgood Marshall's opinion for the majority in Rutherford: “For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.”

Laetrile Redux is going legislative in a hurry. A pending Senate bill, cosponsored by Senators Brownback and Imhofe, would embed in statute the rights envisioned by the Abigail Alliance and (temporarily, at least) by the DC Circuit majority. Here is what it would mean. Drugs that have passed Phase I testing and some animal studies could be given to terminally ill patients whose doctors certify that they have sought other approved therapies to no avail. Despite some fig-leaf patient protections in this bill, it will do almost exactly what the Alliance would like. The interesting question now is whether this current Supreme Court would endorse Rutherford, support the DC Circuit majority's newly invented right, or take a pass. Place your bets.

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