Stem cell research.

If you're not a microbiologist, or if you've just been out of touch with stem-cell issues for the past 6 months, getting back up to speed on the science of stem-cell research and the regulatory issues and ethical debate can be a daunting matter. The August issue of the Mayo Clinic (no relation) Proceedings can get you on top of the issue in an hour.

First, there is "An Overview of Stem Cell Research and Regulatory Issues" by Christopher R. Cogle, MD; Steven M. Guthrie, BS; Ronald C. Sanders, MD; William L. Allen, JD; Edward W. Scott, PhD; and Bryon E. Petersen, PhD. -- a good overview of the science and the public-policy debate.

Second, there's a commentary by Neil D. Teise, MD on "Stem Cell Research: Elephants in the Room," described as an "exceedingly personal" commentary on "issues of scientific methods and sociopolitical situation that impact the science."

Finally -- and likely to generate the most interest in political circles because of the prominence of some of the authors -- there's another commentary by William P. Cheshire, Jr; Edmund D. Pellegrino; Linda K. Bevington; C. Ben Mitchell; Nancy L. Jones; Kevin T. FitzGerald; C. Everett Koop; and John F. Kilner entitled "Stem Cell Research: Why Medicine Should Reject Human Cloning." Although the authors "enthusiastically affirm the importance of medical research and ardently support the goal of healing people," they conclude:

"To rewrite medical ethics to permit human cloning would ensnare physicians in a perilous compromise of professional standards. To acquiesce to human embryonic cloning would be to disregard, to an unprecedented degree, the value of new human life. Human cloning would also represent a decided step toward the devaluing of humanity universally because justifications of human cloning research disturbingly imagine a category of dismissable human
life. Such a designation is utterly foreign to the Hippocratic ethic, which respects human beings at all stages of life."

Arguing for a total and permanent ban on both reproductive and research cloning, the authors go beyond the majority position of the President's Council on Bioethics, whose report last July called for a permanent ban on "cloning-to-produce-children" and offered a split decision on "cloning-for-biomedical-research," with 10 members calling for a 4-year moratorium and 7 members supporting "cloning-for-biomedical-research now, while governing it through a prudent and sensible regulatory regime."

Single-payer national health insurance.

This week's JAMA has published a "Proposal of the Physicians' Working Group for Single-Payer National Health Insurance" (abstract; full article requires paid subscription). The challenge, as they see it, is to get the richest country on earth to finance basic health care for all Americans, including the 41 million without health insurance. Here's how: "We endorse a fundamental change in US health care—the creation of an NHI program. Such a program, which in essence would be an expanded and improved version of traditional Medicare, would cover every American for all necessary medical care. An NHI program would save at least $200 billion annually (more than enough to cover all of the uninsured) by eliminating the high overhead and profits of the private, investor-owned insurance industry and reducing spending for marketing and other satellite services." As reported by Modern Healthcare's "Daily Dose, the AMA itself remains opposed to a single-payer national plan.

"Promotion" of off-label drug use?

Good story from the Associated Press on a whistleblower suit in Boston that accuses Parke-Davis and its parent, Warner Lambert (all part of Pfizer now) of various nefarious and underhanded activities to encourage physicians to prescribe Neurontin "for unapproved uses such as relieving pain, headaches, and psychiatric illnesses." (Additional details about the alleged marketing abuses are described in an article in the Indianapolis Star.) Prescribing for an off-label use is perfectly legal, but manufacturers may not "promote" approved drugs for off-label uses. "Promotion," as the article makes clear, is a vague term, which allows for some leeway. Up to a point, we should welcome off-label uses, which are a cornerstone of medical progress, and who better than the manufacturer to know how the drug might be used in addition to its approved uses? But the law clearly expresses a preference for manufacturers to develop their theories about approved drugs through formal clinical trials and resubmission of data to the FDA to expand the claims for which the drug may be marketed. It will be interesting to see where the district court draws the line between innovation and patient safety.

Medical error and poor penmanship.

Medical error in general -- medication error in particular -- is undoubtedly a complex systemic problem, but one of the more obvious sources of the problem is the bad handwriting of many physicians. They are not alone, of course, with their poor penmanship, but few of us can kill someone with an undecipherable scrawl. The solution? Tens of millions of dollars of computer wiring and hardware installations per hospital to support a Palm-Pilot-based system of medical data entry, starting with the physicians and medical students who write the progress notes and medication orders, according to a story in today's Los Angeles Times (free subscription required). It's too soon for this to be the standard of care, but that time is coming, so hospitals can pay now or they can pay later, but they are going to have to pay.

Medicare reform.

Finally, someone is starting to focus on the inability of private health plans to provide Medicare benefits -- including the drug benefit under consideration by a conference committee in Congress -- at anything remotely resembling lower costs (to beneficiaries or to the Medicare program itself). According to an article in today's New York Times, out-of-pocket expenses for Medicare enrollees in existing private health plans have doubled since 1999. Anyone who thinks privatizing the Medicare program will be a panacea for projected budget increases, especially in light of the-pharmacy-benefit-we-really-can't-afford, needs to take a look at the report that the Times' article was based upon, which was issued today by the Commonwealth Fund.

Doctor listings on the Web.

An article in today's Washington Post makes the point that if health plans (and I assume some hospitals, as well) can't keep their on-line list of physicians cleansed of doctors who are deceased or who have been disciplined for sex-related felonies, what does this tell us about their on-going peer-review?

Living organ donors.

An Associated Press story today (published in The Cleveland Plain Dealer and probably a thousand other places as well) makes the point that (a) more donors come from living donors than from cadavers and (b) the transplant "system" is not doing a very good job of collecting and tracking data or providing meaningful and accurate informed-consent disclosures concerning risk.

Health reform and Harry Truman.

As students in my health law class know, the current health care woes of the U.S. are part of a familiar pattern, dating back to the beginning of the 20th century. By the time Harry Truman became president, he was sufficiently concerned that he included universal health care coverage in his first message to Congress. A story in today's Lawrence (Kan.) Journal-World is a nice reminder of Truman's worries for our system and the similarities between then and now.

Health care coverage for the college-bound.

Excellent discussion in the New York Times today about the ins and outs of health care plans for college students. Even though most college-aged students are fairly young and pretty healthy, it pays to pay attention to the fine print, especially if you plan to rely on one of the parents' employer-provided family coverage, and most especially if that's a managed care plan, which can have some severe limits on non-emergency out-of-network care.

Health care reform.

Scott Burns' nationally syndicated column ran a particularly good story August 7th on health care as a "bet-the-country-sized problem." Here are the numbers:

The unfunded liabilities of Medicare, according to the latest generational accounting figures from economists Jagadeesh Gokhale and Kent Smetters, now amount to $35.5 trillion. That's about five times the $7.2 trillion unfunded liability of Social Security. It's also about 10 times the Treasury debt held by the public.

Worse, the Medicare liability is growing with the speed of a nasty cancer. It will increase by $1 trillion more by next year's presidential election, dwarfing the recognized federal deficit. Then it will grow $5 trillion more by the presidential election of 2008.

There's also so good stuff here from John Wennberg's "Dartmough Atlas of Health Care," showing that "geography is destiny" when it comes to what sorts of health care services you get.

Medical staff issues.

Modern Healthcare's Daily Dose reported last week on a decision that holds that "[t]he medical staff of 222-bed Community Memorial Hospital of San Buenaventura, Ventura, Calif., is a legal entity and may sue the hospital's board over a new code of conduct and control of a $250,000 bank account. . . . The physicians contend the code of conduct and a new conflict-of-interest policy threaten the medical staff's independence and ability to police quality. . . . Hospital attorney Lowell Brown of the Los Angeles office of Foley & Lardner said, 'The question remains: Who gets to run the hospital -- the medical staff or the board?'"

Medical retainer fee (a/k/a "boutique medicine") nixed in Washington.

As reported in the Puget Sound Business Journal (Seattle), the Commissioner of Insurance in the state of Washington has determined that the growing practice of physicians charging patients a retainer for premium access (responses on nights and weekends, office appointments on short notice, etc.) violates the state's insurance laws. In two draft technical assistance advisories, the deputy commissioner of insurance ruled that such arrangements are, in effect, insurance, because "[t]he fee is paid by the patient regardless of the amount of services provided [and] even if no services are provided. These arrangements result in a transfer of risk and, in essence, are insurance agreements." Actually, the transfer-of-risk/insurance element of the analysis seems weird to me. In what sense do the doctors take on risk? The care isn't pre-paid with the retainer; only access is pre-paid. The patient's health insurer is going to be tapped for the care, and no part of the insurer's risk is being shifted downstream to the physician. Granted, there is some risk that the demand for services at any given time might outstrip the physician's ability to schedule, but that's not a financial risk, is it? The higher the utilization, the higher the fees for the physician. I'm not sure I see any insurance element in this arrangement at all. On the other hand, I think Troy Brennan's ethical analysis of these arrangements in the New England Journal of Medicine (Volume 346:1165-1168 -- April 11, 2002) (subscription required for full text) is spot on: "[T]he development of luxury primary care might be seen as a crystallizing event. The medical community must be prepared to step forward with ideas and programs that ensure an equitable distribution of health care services. No matter how innovative and attractive luxury primary care is to some patients and physicians, it poses questions about equity. We should identify ways in which luxury primary care can be regulated by the medical profession (perhaps by mandatory cross-subsidies and careful monitoring of the prevalence of such care), while also addressing other threats to access. The questions that luxury primary care poses should remind us that as physicians we have a commitment to the equitable distribution of health care and therefore a duty to address market innovations that could leave some patients without access to care." Thanks to health lawyer Jeff Sconyers for bringing this decision to my attention.

Abortion funding.

According to the San Antonio Express-News, "[s]ix Planned Parenthood affiliates can continue to perform abortions with privately raised funds in Texas without jeopardizing $13 million in annual state funds, under a temporary injunction granted by a federal judge Monday." The court's injunction effectively stays a recent state law that would otherwise have gone into effect on Sept. 1. See also article in Austin American-Statesman. Hate to admit it, but I am coming up dry in my search for a bill number on this budget item . . . .

Stem cell research.

Celgene Cellular Therapeutics broke ground yesterday on a facility that will harvest stem cells from placentas and umbilical cords, thus sidestepping the moral morass produced by harvesting stem cells from embryos or fetal tissue, according to an article in today's Monroe (La.) News Star. NIH has the next move: where do these stem cell lines fit within the President's research-funding policies announced two years ago this month?

Brain surgery.

And while I'm on the subject of technological challenges to "human nature," consider the article in today's L.A. Times entitled "New surgery to control behavior". There are examples -- and this might be one of them -- of technology that makes us more human, not less.

Gene therapy.

A thought-provoking piece on germ-line therapy appeared in today's issue of The (Melbourne) Age. Bill McKibben's article is based upon his forthcoming book, the apocalyptically entitled, Enough: Genetic Engineering and the end of Human Nature, and ends with this paragraph: "Right now our technology is advanced enough to make us comfortable, but not so advanced that it has become us. We have enough insight from Darwin and Freud and Watson and Crick to allow us to understand some of what drives us, but we’re not yet completely reduced to hardware. We have Prozac for the incapacitated and pain-ridden, but it’s not encoded in our genes. We have enough medicine to give most of us a good shot at a long life, but not so much as to turn us into robots. We are suspended somewhere between the prehistoric and the Promethean. Closer to the Promethean. Close enough." McKibben's argument, which relies to a considerable degree on assumptions about our shared understanding of the notion of "human nature," reminds me of the position of Dr. Leon Kass, chairman of the President's Council on Bioethics, whose most recent book, The Beginning of Wisdom: Reading Genesis, was reviewed quite respectfully in yesterday's New York Times (subscription required).

Med mal insurance crisis.

The GAO's new report on the med mal insurance crisis should be required reading for anyone (including me) who has said med mal recoveries aren't the real culprit behind rising premiums - it's the business cycle combined with myopic and greedy insurance companies' business plans. Turns out it is both and a lot more, too.

Medicare drug benefit.

The conference committee proceeding to hammer out a prescription drug benefit for Medicare keeps getting messier and messier. Forget for a moment that the price tag -- conservatively estimated at $400 billion a year -- is a budget buster. And put aside the notion that the drug benefit will go to the 90% of seniors above the federal poverty line as well as the 10% below. (I don't know where it makes sense to draw the line on this entitlement -- 10% above the poverty line? 25% above? -- but at this price, and in these economic times, you'd think Congress would show a little more interest in targeting this benefit to help those who most need it, not to senior whose incomes can cover drug costs, or whose retirement health plans already include a drug benefit.) Now the plot thickens as conferees deal with the impasse over prescription-drug reimportation. As reported in The Washington Post, the House bill would allow reimportation from Canada and two dozen other countries, while the Senate version would allow reimportation only from Canada. The Boston Globe and others report that 53 senators have signed a letter that says the House version is a deal-breaker for them, and the drug industry trade organization PhRMA supports the senators' position. PhRMA says it's a safety issue: we don't know how those drugs have been stored and transported, and substandard handling practices can reduce the potency of the drugs. The FDA and its parent agency, DHHS, also have historically opposed reimportation on safety grounds. (A nice review of reimportation is in the Sept./Oct. 2002 issue of FDA Consumer magazine.) In addition to the safety issues, PhRMA has another concern that the senators aren't talking about: the impact of "importing foreign government's price controls" on the pharmaceutical industry's bottom line and ultimately on its R&D budgets. Thus, PhRMA "urge[s] Congress and the Administration to . . . overturn foreign governments' price controls on prescription medicines. Foreign governments' policies . . . lead to free-riding on American consumers and reduce the pace of development of new medicines." Using Rep. Bernie Sanders' analysis of drug company profitability (as reported by Forbes), the concern about slashing R&D budgets does seem a bit overdrawn. Reliance on Forbes' numbers has been challenged by the conservative Buckeye Institute, but even by their reckoning, industry profits were at 18.3%. Buckeye was taking aim at a Public Citizen report that pegged industry profitability at a rollicking 33%; Sanders' numbers reflected a more conservative calculation of 18.6%. Even at 18%, industry profits are robust. The policy question for Congress is how much of a hit the industry can take and still produce new drugs that benefit us all.

Duke's transplant woes.

The Raleigh News & Observer reports in an article today that Duke's transplant program was given a clean bill of health by the regional CMS office in Atlanta. At issue were a lack of coordination between the transplant center and the regional organ procurement organization, as well as problems with dialysis equipment that were discovered after the death of Jesica Santillan last summer. The story is an interesting representation of today's health care system in a microcosm: Duke states that its goal "is to maintain the highest safety standards for the benefit of our patients and staff," while the paper notes that "[a]t risk were the hospital's Medicare and Medicaid reimbursements, which make up 40 percent of its revenues." Duke's chances of losing Medicare/Medicaid certification are about equal to my chances of setting the Major League Baseball home run record, but the publicity alone, let alone the theoretical possibility, tends to focus the institution wonderfully.

Dumb and DOMA.

President Bush, in his news conference on Wednesday, July 30, put his "compassionate conservative" principles out in full view by stating that we should be tolerant of gays and lesbians (despite his reference to them as "sinners" -- that must be the compassionate side of Dubya), while at the same time stating that administration lawyers are looking into the legal steps necessary to make sure that "marriage" is a status that will be reserved to opposite-sex couples as a matter of federal law. Putting aside the most likely explanation for this comment -- that he was appealing (or pandering, as you like it) to his conservative base -- and taking his words at face value, exactly what the lawyers are looking into is a bit of a mystery. Maybe a constitutional amendment, though clean-up hitter and press secretary Scott McClellan did not take the bait on that one at his daily press briefing on Thursday. (By the way, kudos to the White House press office for a fully functional search engine and an indexed press briefing feature on their web page. In terms of functionality, the Bush crew got off to a slow start, but the availability and functionality of retrievable White House comments is now excellent.) As many have noted, the 1996 Defense of Marriage Act ("DOMA") already establishes (i) that "marriage" means opposite-sex unions for purposes of federal statutes, rules, benefits, and programs and (ii) that states do not have to give full faith and credit to any other state's legal decrees to the contrary. It's hard to see how all this would have come up, at least at this time, if it weren't for the Supreme Court's decision in Lawrence v. Texas, which not only struck down Texas' Penal Code provision on homosexual sodomy but also ruled that the states' police powers need more than a purely moral basis to pass even rational-basis review by the federal courts.