Unanimous Supreme Court victory for the children of Texas.

I can't remember the last time the Supreme Court justices all agreed in an Eleventh Amendment case, but it happened yesterday in Frew v. Hawkins (U.S., No. 02-628, Jan. 14, 2004). Bottom line: Texas officials must abide by a consent decree to which they consented in 1996 to increase spending on the Medicaid program's Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program. Legally, the case involves an interesting question whether federal courts can compel a state to adhere to the terms of such a consent decree consistent with the Eleventh Amendment, which in a number of analgous situations has been held to shield states from federal court actions for money damages. I say it's "interesting" because -- despite the Court's unanimous opinion -- it's an arguable point. In this case, the trial judge rejected Texas' Eleventh Amendment argument. On appeal, however, the conservative Fifth Circuit Court of Appeals bought the state's argument. But politically and morally, it's hard to see how Texas' position was anything but crass, cold-hearted, underhanded, and punitive. Here's the syllabus of the Court's opinion:

As a participant in the Medicaid program, Texas must meet certain federal requirements, including that it have an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program for children. The petitioners, mothers of children eligible for EPSDT services in Texas, sought injunctive relief against state agencies and various state officials, claiming that the Texas program did not meet federal requirements. The claims against the state agencies were dismissed on Eleventh Amendment grounds, but the state officials remained in the suit and entered into a consent decree approved by the Federal District Court. In contrast with the federal statute’s brief and general mandate, the decree required state officials to implement many specific proposals. Two years later, when the petitioners filed an enforcement action, the District Court rejected the state officials’ argument that the Eleventh Amendment rendered the decree unenforce-able, found violations of the decree, and directed the parties to submit proposals outlining possible remedies. On interlocutory appeal, the Fifth Circuit reversed, holding that the Eleventh Amend-ment prevented enforcement of the decree because the violations of the decree did not also constitute violations of the Medicaid Act. Held: Enforcement of the consent decree does not violate the Eleventh Amendment.

(a) This case involves the intersection of two areas of federal law: the Eleventh Amendment and the rules governing consent de-crees. The state officials argue that a federal court should not enforce a consent decree arising under Ex parte Young, 209 U. S. 123, unless it first identifies, at the enforcement stage, a violation of federal law such as the EPSDT statute itself. This Court disagrees. The decree here is a federal court order that springs from a federal dispute and furthers the objectives of federal law. Firefighters v. Cleveland, 478 U. S. 501, 525. The petitioners’ enforcement motion sought a remedy consistent with Ex parte Young and Firefighters and accepted by the state officials when they asked the court to approve the consent decree. Pennhurst State School and Hospital v. Halderman, 465 U. S. 89, in which this Court found Ex parte Young’s rationale inapplicable to suits brought against state officials alleging state-law violations, is distinguishable from this case, which involves a federal decree entered to implement a federal statute. Enforcing the decree vindicates an agreement that the state of-ficials reached to comply with federal law. Federal courts are not reduced to approving consent decrees and hoping for compliance. Once entered, that decree may be enforced. See Hutto v. Finney, 437 U. S. 678.

(b) The state officials and amici state attorneys general express le-gitimate concerns that enforcement of consent decrees can undermine sovereign interests and accountability of state governments. How-ever, when a consent decree is entered under Ex parte Young, the response to their concerns has its source not in the Eleventh Amend-ment but in the court’s equitable powers and in the direction given by Federal Rule of Civil Procedure 60(b)(5), which encompasses an equity court’s traditional power to modify its decree in light of changed circumstances. See, e.g., Rufo v. Inmates of Suffolk County Jail, 502 U. S. 367. If a detailed order is required to ensure compliance with a decree for prospective relief that in effect mandates the State to ad-minister a significant federal program, federalism principles require that state officials with front-line responsibility for the program be given latitude and substantial discretion. The federal court must en-sure that when the decree’s objects have been attained, responsibility for discharging the State’s obligations is returned promptly to the State and its officials. The basic obligations of federal law may re-main the same, but the precise manner of their discharge may not. If the State establishes reason to modify the decree, the court should make the necessary changes; otherwise, the decree should be en-forced according to its terms. 300 F. 3d 530, reversed.

This litigation started in 1993, based upon the plaintiffs' claim that Texas has dealt children in desperately poor families a really lousy hand, in violation of their federal-law obligations. If the plaintiffs were right (and I suppose we won't know, technically, since there was no trial and therefore no findings of fact on the underlying claims), it's been over a decade now that these kids have been denied services required by federal law. Perhaps this disgraceful record on children's health is about to come to an end.

Ambiguous Gifts: When Patients Give and Doctors Take

Good article by Denise Grady on VIP patients, gifts from patients, George Harrison's signed guitar, and the morally ambiguous topic of physicians and hospitals who profit from their association with the rich and famous.

Seniority: Two Holes in the Medicare Drug Law/

Finally, somebody is asking the questions that need to be asked about the Medicare reform law signed by
Dubyah last month. In an article in today's NY Times, Fred Brock asks:

What impact will it have on pharmaceutical companies' programs that offer free drugs to low-income people, including those on Medicare? Why does the law prohibit beneficiaries from buying private insurance to cover the considerable gaps in coverage?

As for the first question:

The drug companies themselves are struggling with the first question, as is their trade group in Washington, the Pharmaceutical Research and Manufacturers of America. But one thing is clear: if the companies do not change their requirements by 2006, thousands of older low-income Americans will lose access to free or nearly free drugs. That's because participants in the programs generally must not have any drug coverage or access to it. Of course, they will have access to drug coverage in 2006 - although with coverage gaps that could cost thousands of dollars a year.

The free-drug programs are crucial for many recipients. The income limits are not that strict: in some cases, people earning up to $50,000 a year can qualify. The drugs are commonly dispensed through doctors or via discount cards; patients usually have to requalify regularly and apply separately to each company that makes the drugs they need.

I am particularly interested in that second question:

The prohibition against buying private insurance, meanwhile, will hit middle-income people the hardest. "Many people will be forced to put out their own money, even if they want to buy insurance," Mr. Hayes [president of the nonprofit Medicare Rights Group] said.

A report accompanying the final Medicare bill when it was passed last year said the insurance prohibition was to keep beneficiaries from becoming "insensitive to costs." Well, if your mother needs a prescription, her "sensitivity" is not going to lessen her need, but the cost may lessen her ability to buy it. And why shouldn't she be allowed to buy private insurance to help if she wants to? By that logic, should we prohibit auto insurance to make people sensitive to high repair costs?

Some administration and Congressional officials argue that older Americans would consume less health care if they had to pay more for it, so the government would save money. Maybe, but what are the health consequences?

Deane Beebe, a spokeswoman for the Medicare Rights Center, said: "The whole concept is based on the idea that people will use too much medication if they have coverage. We're really troubled by that."

Mr. Hayes added, "There is something very unrealistic about politicians who think that people will rush off to take prescription medication they don't need."

Hayes believes that the prohibition might be eliminated before 2006, partly because of pressure from insurance companies that want to sell the coverage. "A lot of people who voted for this bill," he said, "had no clue about this provision."

Dallas Morning News: public health comes first.

Thank God the Dallas Morning News has weighed in on the public-health issues facing Dallas County with an editorial that urges the County Commissioners to split the health department from the county's Department of Health and Human Services. The mid-90's merger of public health and welfare functions, says the editorial, was "to cut overhead costs. The budget concerns back then may have been justified. But they have been overtaken by today's more pressing challenges. For one, the county has had to step up its bioterrorism preparedness in this post-9-11 world. And that duty is certain to grow." More importantly:

many physicians have become concerned about the combined department's apparently poor record of controlling diseases. The Dallas County Medical Society cites the county's alarming rates of sexually transmitted diseases, its high incidence of tuberculosis and its low rate of childhood immunizations. A re-energized Health Department would be better able to identify public health problems early on and map out strategies for solving them.

The medical society -- under the leadership (on this issue, as on so many more) of past president Robert Haley -- also deserves our thanks for jaw-boning the county (and the editorial board of the Dallas Morning News, apparently) for adequate public health resources and controls.

2002 shows higher rate of health-care inflation than 2001.

Is anyone in the health care industry really surprised to learn that, "[f]ueled by rising hospital costs and health insurance premiums, U.S. employers, consumers and the government spent 9.3% more on health care in 2002 than they did in 2001"? (USA Today) Not surprised, perhaps, but that doesn't mean everyone took the news in stride. Forbes, for one, opined that "Health Care Costs Rise Beyond Belief":

U.S. health care costs are rising so fast that not only do they outstrip the prior year, they even exceed forecasters' ability to project them.

In mid-2002, the U.S. Department of Health and Human Services projected that national health expenditures would reach $2.8 trillion in 2011--an estimate based on a mean annual growth rate of 7.3%. Since then, the growth rate has increased significantly to 9.3%--to the point where health spending is already at nearly 15% of GDP, according to Centers for Medicare & Medicaid Services (CMS), a unit of HHS.

This increase--and future projections--don't take into account the potential effects of the prescription drug entitlement in the Medicaid bill passed by Congress last year.

The full report from CMS is available in Health Affairs (for a hefty fee; unhelpful article abstract is here); some of the details are on the CMS website here.

Clark: No pro-life appointments to the federal bench if he's elected.

According to a story in today's Manchester Union Leader Gen. Wesley Clark "said yesterday he would never appoint a pro-life judge to the federal bench because the judge’s anti-abortion views would render him unable to follow the established judicial precedent of the 1973 Roe v. Wade decision." I am pro-choice, but I wonder how wise it is to establish an abortion-rights litmus test, any more than a pro-life litmus test should be used by Republican presidents. First, we're not talking about Supreme Court appointments only: Clark's announcement included all federal courts. This ignores the fact that we expect lower-court judges to follow Supreme Court precedent, and their freedom to "vote their conscience" is correspondingly constrained. (This is why I was comfortable supporting the nomination of Mike McConnell, a vociferous critic of Roe, to the US Court of Appeals for the Tenth Circuit.) Second, what's sauce for the goose is sauce for the gander. A single issue litmus test on abortion is decried by liberals when the Republicans invoke it to eliminate pro-choice judicial candidates. Unless that's all bluff and bluster, we should be willing to stand behind that position when it cuts the other way. That, or just shut up when the Republicans exercise their constitutional right to stack the judicial deck against abortion rights.

For-profit Medicare HMOs match, exceed nonprofits' care.

As reported lots of places, including the Boston Herald, a report in today's New England Journal of Medicine (abstract only; full text requires expensive subscription): "The rates of carotid endarterectomy, cardiac catheterization, coronary-artery bypass grafting, and percutaneous transluminal coronary angioplasty were higher in for-profit health plans than they were in not-for-profit health plans; the rates of use of other common costly operative procedures were similar in the two types of plan. After adjustment for enrollee case mix and other characteristics of the plans, the for-profit plans had significantly higher rates than the not-for-profit plans for 2 of the 12 procedures we studied and had lower rates for none." This is definitely one of those glass-half-full or half-empty stories. The Herald story included some follow-up with the authors:

The results were unexpected, but not surprising, said Dr. Eric C. Schneider, a Harvard School of Public Health assistant professor.

"It's very difficult among health plans in general to change the decision-making of physicians and patients,'' he said. "And with liability concerns, health plans may feel that it would be too risky to deny a procedure.'' . . .

In some cases, nonprofits provided fewer procedures, but it's not clear why, Schneider said. It's possible that nonprofit administrators have a better sense of how to care for problems without relying on surgery.

The study clearly shows that "fears about for-profits skimping on high-cost procedures might be unfounded,'' Schneider said. But it doesn't show whether they provide the same level of care when it comes to preventive and other services.

I.M.F. Report Says U.S. Deficits Threaten World Economy

Two cheery reports from the NY Times and Washington Post today raise the question whether the US can continue in its fiscally and environmentally profligate ways.

First, an International Monetary Fund report concluded that the United States is running up a foreign debt of such record-breaking proportions that it threatens the financial stability of the global economy, warning that large budget deficits posed "significant risks" not just for the United States but for the rest of the world. Times article. IMF Occasional Paper 227: "U.S. Fiscal Policies and Priorities for Long-Run Sustainability." A small but important part of the planned deficit, of course, is the recently enacted Medicare prescription drug benefit that we cannot afford.

Second, the Post reports that researchers have published a study (abstract) in the science journal, Nature that concludes that "[m]any plant and animal species are unlikely to survive climate change. New analyses suggest that 15-37% of a sample of 1,103 land plants and animals would eventually become extinct as a result of climate changes expected by 2050." They continue:

For some of these species there will no longer be anywhere suitable to live. Others will be unable to reach places where the climate is suitable. A rapid shift to technologies that do not produce greenhouse gases, combined with carbon sequestration, could save 15-20% of species from extinction. The cover shows a species in the firing line. Boyd's forest dragon, Hypsilurus boydii, is found in Queensland, Australia. About 90% of its distribution would become climatically unsuitable by 2050, on maximum climate warming scenarios.

At some point, industrialized societies have to start getting serious about their ethical obligations to the planet's other inhabitants, as well as to the future. My colleague, Jeff Gaba, has amply demonstrated that arguments about "our obligations to future generations" are fraught with ambiguity, hidden assumptions, and various forms of bad logic, but the rhetorical point somehow seems to survive, at least for me: What gives industrialized nations the right to consume not only a disparate share of the world's natural resources to support their economies anlifestyleses, but also up to a third of the world's species (that's 1.25 million species), as well? This is a bioethics question of transcendent importance.

Maine's Prescription Drug Discount Program on Hold -- Again.

Apparently Maine's star-crossed drug discount program, which survived a Supreme Court challenge in 2003, is again on hold as state officials assess the impact of the recently enacted Medicare reform law. You can read about it in the daily Kaiser health policy report.

Ernst & Young faces civil health fraud charges in Philly.

Kaiser's daily web report collects stories today about the civil case filed on Monday against Ernst & Young in connection with advice it allegedly gave to hospitals that in turn overbilled Medicare:

U.S. Attorney's Office in Philadelphia Files Lawsuit Against Ernst & Young for Allegedly Providing Hospitals Advice That Led to Medicare Overpayments
[Jan 06, 2004]
U.S. Attorney Patrick Meehan in Philadelphia on Monday filed a civil complaint against the accounting firm Ernst & Young for allegedly advising hospitals to overcharge Medicare for common blood tests, leading to excess reimbursements of $900,000 between 1991 and 1995, the New York Times reports (Freudenheim, New York Times, 1/6). The lawsuit claims that because of billing advice given by Ernst & Young, nine hospitals in Connecticut, Indiana, Pennsylvania and Virginia submitted more than 200,000 false claims to the government. The suit contends that the nine hospitals' laboratories used equipment that automatically performed a more thorough level of testing than necessary in some cases, which allowed the hospitals to bill for the complete battery of tests, regardless of whether they were requested by physicians, to maximize Medicare reimbursements. According to Ernst & Young attorney Mark Tuohey, the government permitted such billing until 1996, at which time Ernst & Young advised its clients to stop the practice. If found guilty, Ernst & Young could be ordered to pay three times the amount of damages and millions of dollars in fines. Associate U.S. Attorney James Sheehan said some of the hospitals involved in the dispute have already repaid Medicare (Caruso, AP/Long Island Newsday, 1/5).

Fascinating.

Purdue Pharma spanked by judge for Oxycontin patent claim

As reported in USA Today and elsewhere, a federal judge ruled that Purdue Pharma patents protecting its bestselling painkiller Oxycontin are invalid. The court's opinion states that Purdue's patent application was deceptive and that its patents are unenforceable, clearing the way for drug maker Endo Pharmaceuticals Holdings to sell a generic version of the drug. This is the same judge who held in 2000 (require WestLaw subscription) that Purdue had not obtained its patents through inequitable conduct. It will be interesting to see (when yesterday's opinion becomes available) what changed between 2000 and 2004. Meanwhile, there's lots of interesting background in the N.Y. Times' story on this decision.

New Jersey allows stem cell use in research

New Jersey's governor signed a bill (S. 1909 [passed without amendment - now P.L.2003, c.203]) on Sunday that makes the Garden State the second in this country to legalize embryonic stem cell research, while making human reproductive cloning unlawful. (California's the other state: see Health & Safety Code § 125300 (stem cell research) and § 24185 (cloning).) It's a fine line, and one that bedeviled the President's Council on Bioethics in its 2002 report on cloning, but it's an important line for those who believe that stem cells are the most promising source out there of treatments for a wide variety of diseases and conditions, including traumatic spinal cord injuries.

Reimportation of drugs from Canada.

The Kaiser Family Foundation did its usual excellent job in an article today that pulls together reports from disparate sources concerning the FDA's refusal to accept Canadian assurances that reimported drugs are safe:

FDA Pharmacy Affairs Directory Tom McGinnis on Dec. 24, 2003, said that a safe, legal program to reimport lower-cost, U.S.-manufactured prescription drugs from Canada would likely cost hundreds of millions of dollars, the AP/Richmond Times-Dispatch reports. In addition, McGinnis said that the FDA would never rely on Canadian inspections of prescription drugs to determine their safety. McGinnis said that although the FDA inspects pharmaceutical companies worldwide, Health Canada relies on inspections conducted by the home nations of the companies. McGinnis said, "We've never accepted inspection results from another country." He added that a reimportation program is "just not going to work. There would have to be mechanisms set up, and we would have to get permission from the Canadian government to inspect." Health Canada spokesperson Emmanuel Chabot defended the safety of the Canadian inspection system. He said, "We conduct regulatory reviews of drugs to ensure there is sufficient evidence of safety, efficacy and quality before they receive authorization to be sold in Canada." According to the AP/Times-Dispatch, the FDA position on reimportation "sets the tone" for an HHS study on the safety of the practice required under the new Medicare law (Baldor, AP/Richmond Times-Dispatch, 12/25/03). In recent months, a number of state and local governments have asked the federal government to allow them to import prescription drugs from Canada, the Washington Times reports (Fagan, Washington Times, 1/2). More than 12 states -- such as Iowa, Illinois, Minnesota and New Hampshire -- have considered or plan to implement reimportation programs, USA Today reports. Kevin Concannon, director of the Iowa Department of Human Services, said that the statements FDA officials "make about consumer safety or drug safety are the most bogus words I've seen spoken from a government agency. ... There's more protection of pharmaceutical manufacturers than there is of patients" (Welch, USA Today, 12/31/03). However, HHS spokesperson Bill Pierce said that the agency has twice determined that "we could not guarantee the safety" of reimported prescription drugs, adding, "Nothing has changed since that time" (Washington Times, 1/2).

The birth of an idea: iatrogenesis

There's an excellent review in the Sunday N.Y. Times of Sherwin Nuland's "The Doctors' Plague," a history of Ignac Semmelweis' attempt to nail down the etiology of childbed fever. If Semmelweis isn't exactly a household name, it may have to do with the fact that Pasteur, Lister, and Koch would need another 10 years after Semmelweis' research to develop a unified germ theory of disease. Also: Semmelweis' genious as an epidemiologist seems to have been matched by his dismal indifference to bench science --

Semmelweis was a lopsided genius. His singular talent lay in sorting through reams of data and finding subtle patterns squirming beneath -- all the while ignoring the essence of the infection lying within his fingers' reach. In Semmelweis, an insightful epidemiologist seemed to have collided with a blind pathologist. And unfortunately, the more he struggled to make the two prongs of his scientific inquiry meet, the more desperate and unreasonable he seemed to become. His book on childbed fever, written at the end of his life, reads more like a manic manifesto than a treatise. Scientific history never seems to have forgiven him for it.

But what continues to fascinate is Semmelweis' insight -- perhaps a commonplace in this century, but heretical int he 19th -- that puerperile fever was the result of an infection that was passed on from doctor to patient because of a lack of basic sanitation as physicians moved from patient to patient. The review (by Siddartha Mukherjee) concludes:

To the post-Thalidomide generation of doctors -- to doctors inured to the fact that a medicine or procedure can itself be toxic -- Semmelweis's discovery may come as no surprise. But, as Nuland reveals in some of his most reflective paragraphs, for the high-minded physicians of Vienna and Budapest this was a deeply unsettling premise, for it struck directly at the self-image of their profession. Doctoring was supposed to be a do-good business. It wasn't supposed to make young mothers die of preventable illnesses. What Semmelweis had managed to expose was a hidden anxiety within medicine itself, doctors' ''horror at the possibility that they had been killing their patients for years.''

It is this anxiety that still haunts us. In 2003, 150 years after Semmelweis, some of the most disturbing pieces of medical news involved iatrogenic complications -- doctors' plagues, if you will. The first -- SARS -- was an infection that was spread through hospital wards, often carried by doctors, much like the infections that had vexed Semmelweis in the 1850's. The second -- the so-called million-women study, which revealed the toxic side effects of hormone replacement therapy -- marked a moment of deep introspection in women's health, making doctors question their cavalier willingness to push theories and medicines on patients long before the evidence on them had accumulated.

Like Semmelweis himself, Nuland's book is short, intense and single-minded, and these larger themes and implications are left teeming underneath the text, for readers to peer in closely and uncover. ''To receive his due of honor,'' Nuland writes, Semmelweis ''had to be rediscovered.'' ''The Doctors' Plague'' succeeds for exactly that reason: in telling the story of childbed fever, Nuland has managed to rediscover a critical moment in the history of medicine, the anxieties of which, although somewhat attenuated, persist today.

Pharmacy plan in Florida scuttled after one day.

According to the Orlando Sentinel (reported Jan. 3 (requires free registration; AP picked the story up today -- see, e.g., NY Times/AP story),

Amid an outcry from patients and pharmacists, the state of Florida on Friday abruptly pulled the plug on a new system that forces private pharmacists to decide whether to make poor and medically needy patients pay a fee for prescriptions that have been free.

Health advocates and state lawmakers blasted the system, started just two days ago, which they said is illegal and could force thousands of poverty-stricken people to pay fees they can't afford -- or, at worst, deny lifesaving drugs to critically ill patients.

"We've made pharmacists the gatekeepers," said state Rep. Anne Gannon, D-Delray Beach. "They're deciding whether people live or die."

Don't look now, but the same thing is happening in Dallas County's own Parkland Memorial Hospital, where patients who are too poor to afford prescription meds and too "rich" to qualify for Parkland's health plan are being sent home from the ER and from surgery without the drugs they need to stay alive. As the Dallas Morning News editorialized on Saturday, the County Commissioners have a couple of big votes lined up this week, one of them on Parkland's plan to add to its current main hospital/8 clinics. (The other vote concerns a successor to health commissioner Betty Culbreath. What the editorial didn't mention is that Dallas County is currently experiencing a public-health meltdown. We lead the state in any number of infectious diseases and we lack the infrastructure to have a clue -- let alone a plan -- about an outbreak of salmonella that affected more than 650 people in all 50 states until we were warned by the CDC that something fishy was going on in the Anatole's salsa kitchen (story).) Meanwhile, it seems like business as usual on the Commissioner's Court, where public health -- not to mention life-and-death policies affecting Parkland patients -- seems to be a low priority at best. Shame on the Court and (so far) on County Judge Margaret Keliher, whose campaign touted that electing her would be good for Parkland. We're watching . . . .

Medicare and Medicaid - the outlook to 2050

This just in from the AHLA's Health Law Highlights:

CBO Predicts Federal Healthcare Program Spending May Reach Unsustainable Levels Under Current Policies

Total federal spending for Medicare and Medicaid in 2050 could range from 6.4% to more than 21% of gross domestic product (GDP), the Congressional Budget Office (CBO) predicted in its recently released long term budget outlook. In 2003, the programs accounted for 3.9% of GDP. "Unless taxation reaches levels that are unprecedented in the United States, current spending policies will probably be financially unsustainable over the next 50 years," CBO said.

The report is here.

U.S. News: Science calls at the deathbed(1/12/04).

The January 12 issue of U.S. News and World Report has a compelling article about human research conducted on "the nearly dead." The article contrasts research on University of Pittsburgh patients who have already been declared dead according to neurological criteria ("brain dead") but not yet taken off the respirator and research on terminally ill patients at M.D. Anderson who are expected to die soon after life-support is removed. The risk-to-benefit ratio for a dead patient is, of course, extremely low (pretty close to 0/0). The same is almost true of patients as to whom the decision has been made to withdraw life-sustaining treatment and allow the patient to die, but the risk is not zero:

"You can harm living people in ways that you can't harm dead people," says [Pittsburgh ethics panel member Michael] Wicclair. For example, what if the doctors are wrong and the person doesn't die after withdrawal of the machines?

Rebecca Pentz, formerly at M.D. Anderson and now at Emory, is organizing a conference on the topic for Spring 2004. Should be a lively event.

Safire: From politics to books, my 2004 picks

William Safire's New Year's prediction column is always a hoot. This year's outing was no exception. Apart from his prediction of the Academy Award for "Best Picture" ("Mystic River" -- my youngest son concurs), note item 8:

8. The scientific advance of the year will be (a) age retardation enhanced by memory protection; (b) a single pill combining erectile dysfunction treatment with a fast-acting aphrodisiac; (c) neuroscientists' creation of a unified field theory of the brain; (d) the awakening of geneticists to the liberating study of bioethics.

Safire's answer? (d)

British Medical Association's call for review of medical ethics training.

As reported in today's Scotsman, the British Medical Association today (i) published an 800-page 2nd edition of Medical Ethics Today, and (ii) called for a government-funded review of how effectively ethics and basic law are being taught in medical schools and how the system can be improved. A table of contents and a sample chapter are available from the BMA's web site and can be ordered here. It's a pricey paperback (£60) and they charge £18 for shipping to the US - converted to $US the total comes to about $134.42. You can get it for the same £60 but for a lot less in shipping charges through Amazon-UK.

There’s a Blurry Line Between Rx and O.T.C.

Interesting piece by Gina Kolata on the way prescription meds get reclassified for over-the-counter sales. The article accurately states:

At the heart of its decisions, the FDA says, are straightforward scientific and medical questions. Is there a low potential for abuse or misuse? Can consumers use it for self-diagnosed conditions? Can the drug be adequately labeled? Are doctors needed for its safe and effective use?

It also says:

The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.

How can both statements be true? Consider the morning-after pill, which an expert panel has recommended to FDA Commissioner Mark McClellan be made available as an OTC drug, and the competing social agendas at work:

If the morning-after pill were sold over the counter, doctors who opposed the change said at the F.D.A. hearing, teenagers would avoid counseling on responsible sexual behavior. Some also said that making the drug over the counter would interfere with their relationship with their patients. Those favoring the change said that teenagers are going to have unprotected sex in any case and needed a safe way to avoid pregnancy.

And then there's the impact of insurance:

In other cases, straightforward commercial considerations can determine how a company wants a drug classified. For example, drug manufacturers know that patients with drug coverage often prefer prescriptions to paying the full cost of over-the-counter drugs.

Doctors say they see this insurance effect all the time. Dr. James Osborne, an internist in Greensboro, N.C., says when patients with occasional heartburn ask for a prescription for Nexium, he often suggests they buy Pepsid, which costs 24 cents a day for the four pills needed to equal prescription strength, or about 17 times less than Nexium. "They say, 'It doesn't matter, doc. I have a drug card,' " Dr. Osborne said.

You can stay abreast of developments in the drug field by monitoring the home page of the FDA's Center for Drug Evaluation and Research, which also features a handy daily or weekly e-mail update service. There's also an OTC information page there.

More on medical marijuana.

Angel McClary Raich, one of the successful plaintiffs (on appeal) in yesterday's ruling by the 9th Circuit (see below) has her own website, "Angel's Fight to Stay Alive" with tons of background information.

Medical marijuana use survives US Controlled Substances Act.

The US Court of Appeals for the 9th Circuit yesterday ruled that the federal government lacked the authority under the Commerce Clause of the US Constitution to criminalize the individual use of marijuana for medicinal purposes. The court's opinion is here (FindLaw) and here (court's web site). In most constitutional law cases, the facts are everything. Here is the court's recitation of the facts in this case:

B. Factual Background

Appellants Angel McClary Raich and Diane Monson (the “patient appellants”) are California citizens who currently use marijuana as a medical treatment. Appellant Raich has been diagnosed with more than ten serious medical conditions, including an inoperable brain tumor, life-threatening weight loss, a seizure disorder, nausea, and several chronic pain disorders. Appellant Monson suffers from severe chronic back pain and constant, painful muscle spasms. Her doctor states that these symptoms are caused by a degenerative disease of the spine. Raich has been using marijuana as a medication for over five years, every two waking hours of every day. Her doctor contends that Raich has tried essentially all other legal alternatives and all are either ineffective or result in intolerable side effects; her doctor has provided a list of thirty-five medications that fall into the latter category alone. Raich’s doctor states that foregoing marijuana treatment may be fatal. Monson has been using marijuana as a medication since 1999. Monson’s doctor also contends that alternative medications have been tried and are either ineffective or produce intolerable side effects. As the district court put it: “Traditional medicine has utterly failed these women . . . .”

Appellant Monson cultivates her own marijuana. Raich is unable to cultivate her own. Instead, her two caregivers, appellants John Doe Number One and John Doe Number Two, grow it for her. These caregivers provide Raich with her
marijuana free of charge. They have sued anonymously in order to protect Raich’s supply of medical marijuana. In growing marijuana for Raich, they allegedly use only soil, water, nutrients, growing equipment, supplies and lumber originating from or manufactured within California. Although these caregivers cultivate marijuana for Raich, she processes some of the marijuana into cannabis oils, balm, and foods.

On August 15, 2002, deputies from the Butte County Sheriff’s Department and agents from the Drug Enforcement Agency (“DEA”) came to Monson’s home. The sheriff’s deputies concluded that Monson’s use of marijuana was legal under the Compassionate Use Act. However, after a three-hour standoff involving the Butte County District Attorney and the United States Attorney for the Eastern District of California, the DEA agents seized and destroyed Monson’s six cannabis plants.

The court concluded that this entirely local, entirely intrastate activity of growing and using the pot fell outside the federal government's authority to regulate or criminalize pursuant to its power to regulate interstate commerce. This case will be the talk of Constitutional Law classes all across the country in January. The Commerce Clause has been so expansively interpreted in such a long line of cases over so many decades that any opinion that perceives a limit on Congress' power to regulate commerce will be seen as an outlier, no matter how compelling the facts. Indeed, you can count on the fingers of one hand the number of cases (since 1937) in which the Supreme Court has ruled that Congress exceeded its powers under the Commerce Clause, and all of them have been decided in the last 10 years. The thinking was that a more conservative Supreme Court thought the activist Congress needed to have its wings clipped so that it wouldn't have a blank check to regulate any activity it wanted to touch, no matter how local and no matter how much it was a subject of traditional state concern.

Now the worm has turned, and the liberal 9th Circuit (the most-reversed court of appeals in the federal system) has used this new view of the Commerce Clause to rule against John Ashcroft's Justice Department and uphold individual marijuana use in these cases. Stay tuned . . . I rather suspect the Department of Justice might want to run this one by SCOTUS. Meanwhile, news reports and commentary can be found on Google News.

Not-So-Public Relations - How the drug industry is branding itself with bioethics. By Carl Elliott

Carl Elliott from Univ. of Minnesota's Center for Bioethics - an excellent bioethics think tank - has a great commentary on Eli Lilly's efforts to bolster sales of its new and very expensive antisepsis drug, Xigris, through (among other things) its funding of the "Values, Ethics & Rationing in Critical Care Task Force." The story broke with the Wall Street Journal on September 18 (available here with a subscription). Elliott is predictably and properly critical of the potentially insidious influence of corporate dollars -- especially, it seems, Big Pharm's dollars -- on the research agenda and opinions of bioethicists. He concludes:

Somehow corporate-funded bioethicists have not been touched by the bad publicity. Many bioethicists continue to insist that they are learning from their industry relationships and shaping company policy for the better. A task force commissioned by the two major American professional bioethics bodies—the American Society for Bioethics and Humanities and the American Society of Law, Medicine and Ethics—concluded last year that private corporations should be encouraged to seek out paid bioethics consultants, because "bioethics will have an impact on that (corporate) activity only if bioethicists can be part of the dialogue." The task force went on to endorse the practice of bioethicists advertising their own services as private consultants.

So the next time you meet a bioethicist, pay close attention; he may look like a bioethicist, but when you peel back his mask, you just might see the adman smiling back.

Pattern of Mistakes Found in Zoo Deaths (washingtonpost.com).

HealthLawBlog doesn't often cover developments in the world of veterinary medicine, but a two-part Washington Post series on problems at the National Zoo in Washington, DC, is irresistible. Yesterday's article focused on possible areas of malpractice, as well as shoddy record-keeping and medical records that have been altered after the fact, with many links to the documents themselves on the newspaper's web server. Today's article offers more of the same, with an additional, pointed review of the Zoo's oversight by the Smithsonian. Fascinating reading.

Links to N.Y. Times articles.

Links like the one in the post immediately below are a little iffy. The Times takes articles off its free site after a few days and then limits access based on your ability or willingness to pay. They have relented to some extent, by allowing Dave Winer and USerland to provide stable links to their articles for the benefit of blawgers like me and readers like you. Thus, the Userland link to the article below should be good forever. But I pulled that article up through Google News, and their link, which is the one I used below, uses the same "partner=" format as Userland's link and may be just as stable.

Fortunately, at least with respect to some of their reporting on Medicare, the Times has announced that it will keep their articles in a section of their web site that is free to the public. So -- again, in theory -- the link to the Times' web page for Reed Abelson's piece should be good for a long time, as well. I don't actually believe it and will continue to provide Userland or Google News links until the whole question of stability settles out.

Hospitals Say They’re Penalized by Medicare for Improving Care.

Reed Abelson has an excellent piece in this morning's N.Y. Times about the Medicare prospective payment system (PPS) for reimbursing hospitals for in-patient care. The upshot is that hospitals that creatively and effectively produce the best health outcomes for their patients are often systematically punished by a reimbursement system that pays on the basis of admissions and discharges, rather than outcomes. The lead example in the article is Utah's Intermountain Health Care network, which

says it saves at least 70 lives a year. By giving the right drugs at discharge time to more people with congestive heart failure, Intermountain saves another 300 lives annually and prevents almost 600 additional hospital stays.

But under Medicare, none of these good deeds go unpunished.

Intermountain says its initiatives have cost it millions of dollars in lost hospital admissions and lower Medicare reimbursements. In the mid-90's, for example, it made an average profit of 9 percent treating pneumonia patients; now, delivering better care, it loses an average of several hundred dollars on each case.

"The health care system is perverse," said a frustrated Dr. Brent C. James, who leads Intermountain's efforts to improve quality. "The payments are perverse. It pays us to harm patients, and it punishes us when we don't."

And it's not just the providers who think the system is perverse:

"Right now, Medicare's payment system is at best neutral and, in some cases, negative, in terms of quality — we think that is an untenable situation," said Glenn M. Hackbarth, the chairman of the Medicare Payment Advisory Commission, an independent panel of economists, health care executives and doctors that advises Congress on such issues as access to care, quality and what to pay health care providers.

In a letter published in the current edition of Health Affairs, a scholarly journal, more than a dozen health care experts, including several former top Medicare officials, urged the program to take the lead in overhauling payment systems so that they reward good care.

Even the departing head of the Medicare program agrees with this assessment: "'It's one of the fundamental problems Medicare faces,' said Thomas A. Scully, who as the administrator of the Centers for Medicare and Medicaid Services has encouraged better care by such steps as publicizing data about the quality of nursing home and home-health care and by experimenting with programs to reward hospitals for their efforts."

Children's Hospital Bans Smoking by Staff.

I am no fan of the tobacco industry, but I wonder about today's news story that all employees of a children's hospital in Columbus, Ohio, will be barred from smoking anywhere on the "sprawling hospital grounds" effective May 2004. Is this about the health of employees? The health of patients and families? A public health statement? A form of public education? Aesthetics? (The CEO is quoted as saying patients should not have to contend with the lingering scent of cigarette smoke on staff members returning from breaks.) Ironically, no one quoted in the article, including the spokesperson for a second-hand smoke organization, claimed that this ban was to improve the healthiness or cleanliness of the hospital environment. As long as this is happening in a private hospital, there would appear to be no constitutional issue involved, so the hospital is well within its rights. But does that make the policy right?

Even the conservative Cato Institute hates this Medicare reform law.

Read their critique (largely based on the fiscal irresponsibility of the thing) here.

Clinton-era policy makers analyze Medicare reform law.

As reported by Reuters this afternoon (click here), liberal health care policy experts are blasting the new Medicare reform package.

Medicare chief to resign.

In the past hour everyone's reporting that Tom Scully has submitted his resignation as CMS chief effective Dec. 16th. Here is the CBS Marketwatch story. As reported in today's Washington Post ("Medicare Chief Scully Says He's 'Checking Out of Dodge'") Scully was extensively involved in the Conference Committee negotiations over the Medicare reform legislation passed last week (which the White House says the President will sign next Monday). Indeed, as possessor of the most detailed and encyclopedic knowledge of the massive new law, he is now in a position to provide highly remunerated value to law firms and investment bankers keen to make a buck in health care over the next few years. As reported not only in the Post article, but in more detail in today's New York Times (Google link; should be stable, but if not try this), the bidding war over Scully's services has been going on for about 6 months. His participation in the Medicare reform negotiations was based upon a waiver he received from CMS's ethics office. In light of Scully's pre-CMS salary as president of the Federation of American Hospitals ($675,000), one might well expect to see his compensation top 7 figures, especially if he works out a combination arrangement with a law firm and an investment banking firm. As the papers are quick to concede, no one is alleging that Scully took any position during negotiations over the future of Medicare with an eye toward his future employment options, and Scully is an honorable man. Also, Scully might have been the perfect choice to spearhead the Administration's efforts to get a passable reform bill out of conference. The ethics clearance, however, was handy, n'est-ce pas?

Church May Penalize Politicians

Great article in Monday's L.A. Times about the rustlings within the Catholic Church to discipline Catholic politicians whose public positions contradict Church orthodoxy. The article is here (requires free registration). According to the article, "Punishments could range from bans on speaking appearances at Catholic institutions to excommunication." It's not just a theoretical possibility, either: "A few of America's 195 dioceses, including Dallas and Philadelphia, bar abortion-rights politicians from speaking at Catholic churches and schools. In April, news leaked that Bishop Robert Carlson of Sioux Falls, S.D., had sent a letter asking the state's Democratic Sen. Tom Daschle to stop calling himself a Catholic."

I have no quarrel with the Catholic Church advocating public policy, nor should the Church -- or any church or religious organization -- feel constrained about identifying politicians with whom it agrees and disagrees. And any faith community has the right to define the content of its core beliefs, as well as to identify those whom it regards as "in" and "out" of the faith's traditions and beliefs. But at least since JFK tried to put this issue to rest, I thought American politicians, and the polity to which they appeal, had a pretty clear idea that politicians don't (and shouldn't) take their lead from church leaders. More to the point: Can't a Catholic politician believe privately that abortion or the death penalty is wrong and yet profess publicly that the country's policies should be open to alternative moral views? That a pro-choice law represents an appropriate balance of competing private moralities, even if -- as a practicing Catholic -- that politician might fervently desire that the law was otherwise?

Texas Doctors’ Group Settles FTC Price-Fixing Charges

Another Texas physicians' group came up short in a price-fixing investigation by the FTC. This must be at least the third (possibly fourth) in the last 18 months or so. The FTC's press release gives some details and a link to the file documents.

Do religious groups have to follow laws they don't believe in?

Texas Health Blog provides a link to this AP story about litigation in NY and Calif. concerning whether the Catholic Church's employee health plan has to include contraceptives in employee health plans. The Catholic Church regards contraceptive use as immoral, but in 20 states failure to provide coverage for contraceptives is deemed (by statute) to discriminate against women. "The 20 states that require private-sector insurance coverage for prescription contraceptives include Arizona, California, Connecticut, Delaware, Iowa, Georgia, Hawaii, Maine, Maryland, Massachusetts, Missouri, Nevada, New Hampshire, New Mexico, New York, North Carolina, Rhode Island, Texas, Vermont and Washington." In both NY and Calif., as well as in other states, "churches are exempt from having to provide contraception coverage for employees who work inside parishes and houses of worship. That is known as the 'religious employer exemption' because the parishes generally serve worshippers and employ those with similar religious views. . . . Several states have no such exemptions for religious entities. Other versions exempt church groups and 'qualified church-controlled organizations.'"

20 Questions for Senior Judge Richard Arnold.

Howard Bashman's "20 Questions" session (on his blog, How Appealing) with Senior Judge Richard Arnold should be required reading for all law students, especially students with an interest in appellate practice or in securing a judicial clerkship after graduation. Or, for that matter, with an interest in a life lived greatly in the law.

Keillor on Twain.

He's been called the Mark Twain of our generation, a born story-teller whose tales from the heartland of America have been embraced by sophisticates on both coasts. So there's a special treat in today's "Writer's Almanac" in the form of Keillor's mini-biography of Twain, whose birthday it is today:

It's the birthday of Mark Twain, born Samuel Langhorne Clemens, in Florida, Missouri (1835). He wrote Life on the Mississippi (1883), The Adventures of Huckleberry Finn (1884), and his own favorite, The Personal Recollections of Joan of Arc (1891). He was cynical and irreverent, but he had a tender spot for cats. There were always kittens in the house, and he gave them names like "Sin" and "Sour Mash." "Mamma has morals," said his daughter Suzy, "and Papa has cats." Twain swore constantly and without shame. His streams of profanity alarmed his wife. One day he cut himself shaving, and she heard a string of oaths from the bathroom. She resolved to move him to repentance, and she repeated back to him all the bad words he had just said. He smiled at her and shook his head. "You have the words, Livy," he said, "but you'll never learn the tune."

After Twain published The Adventures of Huckleberry Finn, he had a great deal of cash on his hands, which he invested in a typesetting machine that was very complicated and demanded more and more investment. In the end, it didn't work. He had to declare bankruptcy, and he decided to go on a worldwide lecture tour, the proceeds of which he would use to pay back all of his creditors. His visits to Africa and Asia convinced him that a God who allowed Christians to believe that they were better than savages was a God he wanted no part of.

Mark Twain said, "It is better to keep your mouth shut and appear stupid than to open it and remove all doubt." And he said, "Good friends, good books and a sleepy conscience: this is the ideal life."

Thanksgiving poem, on the rocks, with a twist.

Today's Book Review section of the N.Y. Times includes a poem by Susan Kinsolving -- "Fill the Cavity with Crumbs" about Thanksgiving at her home the year she was divorcing her "almost-ex". The internal rhymes propel this domestic drama across the page, suggesting the kind of hidden logic by which most families (and family get-togethers) proceed. Very nice.

More reactions to the Medicare reform bill.

It's been touted -- by supporters and critics alike -- as the most sweeping set of changes to Medicare since its inception in 1965. It is therefore not surprising, I suppose, that the political reactions to House Bill 4 (at least at this early stage -- months if not years before the full implications of this thing will be known and understood) are confounding the pols and pundits. Two articles in today's N.Y. Times pretty well summarize the situation:

• "But although some economists on the left and right might wring their hands, younger workers don't seem to be complaining. According to polls, members of the post-boomer generation are actually more enthusiastic than their elders about this new legislation. Their feeling is partly due to a desire to see their parents and grandparents save money on drugs, which ultimately redounds to their own benefit. And a lot of these younger adults — like members of Congress who voted for the bill — probably haven't quite focused on who will pay for the program or how." (A $400 Billion Purchase, All on Credit, John Tierney)
• "[Retirees] express disappointment but little surprise because, they say, they never had high hopes. They say they feel they were sold out, by Republicans and AARP, which endorsed a Medicare bill drafted mainly by Republicans. But the Democrats, they say, did not fight hard enough for a better drug benefit." (Florida Elderly Feel Let Down by Drug Benefit, Robert Pear)

US Congress OKs nanotech bill.

According to a report in the on-line version of The Scientist, Congress has passed S. 189, the "21st Century Nanotechnology Research and Development Act." This is a terrific article, with links to a previous piece on the biomedical ethical implications of nanotechnology and various studies and reports on nanotechnology, as well as an easy-to-get overview of the field. For more information, visit the federal government's National Nanotechnology Initiative web site.

Organ retrieval practices tightened up in UK.

As reported in London's Financial Times, "The UK government is to tighten up the rules governing the removal of organs and tissues after death. . . . The legislation, announced in the Queens' speech on Wednesday, will make consent the fundamental principle governing organ removal and set up an an authority with over-arching power to regulate transplantation, anatomical examination, post mortem studies and the use of human tissue in education and research." The article explains that consent has been required since 1994, "but that has not prevented abuses":

As many as 20,000 brains were illegally removed and kept by doctors without the consent of parents in the 1970s 80s and 90s at Alder Hey children's hospital in Liverpool while thymus glands were given to a pharmaceutical company in exchange for cash.

The harrowing events at Alder Hey led to some parents having to conduct up to four funerals as organs from their children were returned at different times.

Ideology and science (II)

The current issue of the eminent journal Science has an editorial by Alan Leshner entitled, "Don't Let Ideology Trump Science" (I don't know for sure, but you may need to be a subscriber to view this article). Here's the gist of it:

The moralizers are trying to muck with U.S. science again. A flurry of activity over the past few weeks has followed the effort of a right-wing religious group to call into question almost 200 National Institutes of Health (NIH) grants focusing on behavioral and social aspects of issues such as sexuality, HIV/AIDS transmission, and drug abuse . . . This incident could have been written off as noise by a fringe group had it not come almost on the heels of the near-passage in the House of Representatives last July of what came to be known as the "Toomey Amendment," after its author Rep. Patrick Toomey (R-PA). By a vote of 212 to 210, the House just missed defunding four NIH research grants on sexual behavior that had already been through rigorous scientific peer review and approval by NIH Institute National Advisory Councils . . . .

We are not concerned that Congress wishes to exert oversight over the U.S. research agenda and research priorities. That is their job, and we want our representatives to do it well. We also believe that the scientific community should be fully accountable to the public, because much science is publicly funded and the public is the ultimate beneficiary of our work. By nature, science is an open enterprise that invites examination and criticism--and more often than not, it is actually strengthened by public scrutiny. Oversight bolsters public confidence in the scientific enterprise and provides incentives for scientists to interact with the public, explain the importance of their research, and spread an ethic of intellectual curiosity and critical thinking that helps make our society more innovative and dynamic.

On occasions like the present one, however, healthy scrutiny gives way to irresponsible attack. The recent assaults on science were not directed at broad research questions or national research priorities. Instead, they were aimed at imposing ideology and religious doctrine on the awarding of individual research grants, intervening in and thereby subverting the scientific peer review system that has served both science and national needs so well.

The moral judges who are doing this don't like the fact that HIV is spread through sexual contact, and they believe that drug addicts have made bad personal choices that have led to addiction. Is their disapproval of these behaviors a justification for stifling research on the diseases that result? Do they suppose that some form of national denial will make these problems go away? Regardless of personal feelings about the etiology of these illnesses, we need to understand their causes and transmission patterns if we are ever to get a handle on some of society's most pervasive public health problems.

WSJ.com - Remaking Medicare

Not sure whether this requires a subscription or not, but for a pretty good roundup of news and analysis of the Medicare reform law, this Wall Street Journal site is good.

Ideology and science (I)

An editorial in today's Palm Beach Post is a reaction to an article I missed from the Nov. 21 Wall Street Journal. Here's a snippet from the Journal article by Antonio Regaldo:

Advocates for infertile couples have raised alarms over draft documents released by President Bush's Council on Bioethics that recommend sweeping changes in the way assisted reproduction is regulated in the U.S.

The draft recommendations, quietly posted to the council's Web site last month, call on the federal government to track and monitor embryos created for fertility purposes. They call for far-reaching legislation that would curtail embryo research and some common business practices. One proposal called for banning the sale of human eggs and sperm, a common practice in the U.S., though transcripts of the council's October meeting indicate that proposal has been withdrawn.

"The recommendations and legislation could change the face of reproductive medicine in this country," said Pamela Madsen, executive director of the American Infertility Association, an advocacy group in New York.

A final report from the ethics panel, formed by President Bush in 2001 following the divisive stem-cell debate, won't be released until next year. Council staff said the drafts are discussion documents and subject to change.

But critics and even some members of the 17-person council said the drafts signaled an ongoing effort by conservative members of the council to create new protections for human embryos created in fertility laboratories.

Here is the Palm Beach paper's reaction in an editorial entitled, "Find a Cure for Ideology":

President Bush's Council on Bioethics is reviving attempts to ban therapeutic cloning for research -- and this time, patients suffering from debilitating diseases and scientists seeking cures for them wouldn't be the only potential victims. In its latest inappropriate invocation of ideology, the president is using his panel to urge Congress to assign legal rights to human embryos. Not only would such unnecessary legislation disrupt research toward cures for Parkinson's, diabetes and other widespread diseases, the action would make it harder for infertile couples to conceive.

Referring to the embryos as "children-to-be," the panel's draft recommendations -- reported in The Wall Street Journal -- call for the federal government to track the creation, use and disposition of embryos. The panel suggests a ban on using an 11-day-old or older embryo for research, restrictions on surrogate mothers and limits on the reason a woman could get pregnant by in vitro fertilization. Would enforcement require parents to declare that they plan to "produce a live-born child"? How does such a requirement fit the panel's claim that it wants to protect women "against certain exploitative and degrading practices"?

According to a study by the Rand Corp. and the Society of Assisted Reproductive Technology, nearly 90 percent of the 396,526 embryos in storage throughout the United States as of April 2002 were designated for future family-building by the patients who created them. Fewer than 3 percent -- 11,000 -- are available for donation for research. Those that are were designated, correctly, by the parents, not the government.

Two years ago, President Bush approved spending federal money on embryonic stem-cell research but set limits on the study. The cell lines he approved for federally financed research were initially grown on mouse cells -- which, a medical ethics panel formed by Johns Hopkins University said this month, could expose humans to an animal virus their immune systems could not fight. Safer stem-cell lines, the panel said, now exist but aren't eligible for federal financing. The president would rather allow ideological debates to halt progress.

Twenty-five years after the birth of the first "test-tube baby," Congress should not let the president and his advisers distract from the quest for life-saving discoveries.

The draft recommendations come in a staff working paper entitled "Biotechnology and Public Policy: Biotechnologies Touching the Beginnings of Human Life/Defending the Dignity of Human Procreation."

The Seattle Times: Big Pharm Big Winner in Medicare Sweepstakes.

The Seattle Times put their finger on a number of important issues in today's editorial on the new Medicare bill:

With the closely held GOP legislation approaching 1,000 pages, it will take time to fully understand all that was included and what the cost will be.

Amen, brother. Ever read a session law? It's an interesting exercise. This is what got delivered to House members and Senators just before the Thanksgiving recess: (1) text of the legislation (678 pp.), (2) the joint explanatory statement of the Conferees (403 pp.), (3) a summary of the Medicare conference agreement, (4) a summary of the regulatory and contracting reform conference agreement, (5) a table of Congressional Budget Office estimates for major provisions of H.R. 1 and S. 1 (the competing versions of the Medicare reform bill), and (6) the CBO's 68-page analysis of both bills as of June 27 (i.e., before the conference committee started whacking at the bills to forge their compromise). It will take days, if not weeks, to track these changes back through existing provisions to make sense of the whole thing, and just as long, if not longer, to get a solid estimate of costs and savings from the bipartisan CBO.

Still, this much is known, as Washington Sen. Patty Murray put it, "The Senate has passed a bill that fundamentally changes the Medicare program while adding a meager 'drug benefit.' "

A bipartisan desire for a prescription drug benefit for the 40 million people on Medicare morphed into a legislative catch-all that tied enough disparate interests together to pass sweeping changes.

An initial impulse is to say that the bloated Medicare bill is better than nothing. That is not clear at all.

What does seem pretty clear, however, is that, "in the final analysis, U.S. pharmaceutical companies will be better protected than elderly Americans in the overhaul of Medicare passed by Congress." Consider:

• "Private employers will receive $70 billion in tax-free subsidies to encourage continued drug coverage for retirees once the Medicare drug plan begins in 2006."
• "The new drug benefit will be administered by private companies and health plans with $12 billion in subsidies."
• "In the meantime, Medicare is specifically prohibited from using its buying power to negotiate discounts for bulk drug purchases or create any price structures for reimbursement."
• "Also, the government cannot have a preferred list of cost-effective drugs or specify a cheaper generic substitute for a costlier name brand. Medicare sets prices with doctors and hospitals but is prevented by law from doing the same thing with prescription medicine."
• "The final bill did not directly ban reimporting cheaper drugs from Canada, but requires Department of Health and Human Services approval, which has been refused."

So how did Big Pharm come out? "Drug companies have a direct stake in being for expanded coverage, and against formularies, price caps and Canadian imports."

And how did Medicare beneficiaries and rural providers -- the ostensible targets of this reform package -- make out?

• "The bill costs $400 billion over 10 years, and includes $25 billion in higher payments to rural hospitals and doctors. Other hospitals and doctors facing cuts under current law will receive higher payments or avoid future cuts."
• For two years, 2004 and 2005, Medicare beneficiaries can buy a discount card worth a savings of about 15 percent. Starting in 2006, the Medicare plan will collect a monthly $35 premium and charge a $250 deductible. Then insurance would pay 75 percent of drug costs up to $2,250. Then coverage stops until the retiree pays the next $2,850 out of pocket. Both the premium and gap in coverage are forecast to grow 78 percent in the first seven years of the plan. . . . Premiums and deductibles would be waived for seniors with incomes up to $12,123, and $6,000 in assets. Other seniors, especially with incomes over $80,000 a year, will find higher premiums."

The verdict?

Each piece could have been handled separately. A clean prescription bill was possible. So was more money for rural hospitals. But taken together, they provided political cover for a fundamental change in the 38-year-old government-run Medicare plan.

Democrats did not get the drug plan they wanted, and many conservative Republicans are simply appalled at the expense: "We are saddling future generations with enormous liabilities," said Sen. Don Nickles, R-Okla.

Narrow approval in the House and reluctant passage in the Senate are tell-tale signs not of triumphant compromise, but deep misgivings about what was accomplished. Only the nation's drug companies are absolutely sure.

For its part, Big Pharm's trade association, PhRMA, posted an announcement on its president, Alan Holmer's web page that was emphatically jubilant about the historic victory for seniors and disabled persons," not to mention Big Pharm, eh, Brother Holmer? Amen.

AHLA's Health Law Highlights: House Clears Bill Allowing FDA To Require Pediatric Drug Testing.

On November 19, the House passed by voice vote a bill that would give the Food and Drug Administration (FDA) clear statutory authority to require drug companies to conduct appropriate pediatric clinical trials on medicines taken by children. The measure (S. 650) cleared the Senate by a unanimous vote in July. The bill would restore the FDA's so-called pediatric rule, which was invalidated by the U.S. District Court for the District of Columbia in October 2002. The court found that the FDA had exceeded its authority in imposing certain pediatric testing requirements on drug manufacturers. (Association of Am. Physicians & Surgeons v. Food and Drug Admin., No. 00-02898 (D.D.C. Oct. 17, 2002)). To read the "Pediatric Research Equity Act of 2003," search for S. 650 here.

House tentatively passes Medicare drug bill after lengthy vote.

It took a 3-hour roll call that ended at 3 a.m. Saturday morning, and the GOP leadership had to quell a rebellion among their more conservative members, but the House passed the Medicare reform bill in the wee hours of the morning today, 220-215, with nearly all Democrats voting against. Here's the AP wrap-up story. The bill goes to the Senate now, where Sen. Ted Kennedy (D-Mass.) is threatening to filibuster, over the objections of his own party leader, Tom Daschle (D-S.D.).

Motorized wheelchairs: Medicare billing probe widens.

An article in the San Jose Mercury News reports that the Medicare fraud investigation into the motorized wheelchair scam is widening . . . plenty of details here if you're just getting up to speed on this issue.

Medication errors almost doubled over the past year.

According to its fourth annual report on medication errors, released today by U.S. Pharmacopeia, the number of medication errors in U.S. hospitals increased by 82% last year. A news release is available, including an e-mail address to obtain a copy of the report. Here's an excerpt of findings from the press release

"The report data revealed that more than one-third of the medication errors reaching the patient involved a patient aged 65 or older," said Diane Cousins, R.Ph., vice president of the Center for the Advancement of Patient Safety (CAPS) at USP. "As the senior population continues to increase, USP is calling for hospitals to focus on reducing medication errors among seniors. Seniors and their families need to become more involved in their care."

Specifically with reference to the senior population, the 2002 MEDMARX data report revealed a number of significant findings, including:

• A majority (55 percent) of fatal hospital medication errors reported involved seniors.
• When medication errors caused harm to seniors 9.6 percent were prescribing errors.
  When harm occurred, wrong route (7 percent), such as a tube feeding given intravenously, and wrong administration technique (6.5 percent), such as not diluting concentrated medications, were the second and third most common errors among those aged 65 and over.
• Omission errors (43 percent), improper dose/quantity errors (18 percent), and unauthorized drug errors (11 percent) were the most common types of medication errors among seniors.

"We are seeing a strong upsurge in the number of medication errors in the database," Cousins said. "This increase is a positive step toward identifying and eliminating medication errors and ensuring the safety and well-being of all hospital patients. By identifying medication error trends and problem areas, hospitals will be able to prevent future errors and reduce patient harm and injuries."

Of the 192,477 medication errors documented by MEDMARX, the vast majority were corrected before causing harm to the patient. However, 3,213 errors, or 1.7 percent of the total, resulted in patient injury. Of this number, 514 errors required initial or prolonged hospitalization, 47 required interventions to sustain life, and 20 resulted in a patient's death. Compared with 2001 data, a smaller percentage of reported errors resulted in harm to the patient (1.7 percent in 2002 versus 2.4 percent in 2001).

The 2002 MEDMARX data report also found that incorrect administration technique continues to be responsible for the largest number of harmful medication errors (6.2 percent). This occurs when medications are either incorrectly prepared or administered, or both. Examples include not diluting concentrated medications, crushing sustained-released medications, wrong eye application of eye drops, and using incorrect IV tubes for medicine administration.

Health care facilities attributed medication errors to many reasons and often cited workplace distractions (43 percent), staffing issues such as shift changes and floating staff (36 percent), and workload increases (22 percent), as contributing factors. Although workplace distraction remains the leading factor contributing to medication errors, the data revealed a drop from 47 percent in 2001.

A limited number of high-alert medications continue to cause the most severe injury to patients when an error is committed. For example, three of the top medications frequently involved in harmful errors were insulin, heparin, and morphine. . . .

More details on Medicare compromise in The Washington Post.

Here's a good summary from the Post's Amy Goldstein.

Maureen Dowd on organ donation.

Maureen Dowd wrote an excellent op-ed piece today on organ donation. Hope it makes a difference. For a bird's-eye view of the dire situation we're in, check out the data summary on the web site of the United Network for Organ Sharing (UNOS), which runs the Organ Procurement and Transplantation Netword (OPTN) under contract with DHHS.

"For Middle Class, Health Insurance Becomes a Luxury"

That's the title of a good article, dateline Dallas, by Stephanie Strom in today's New York Times. The article reports that the folks without health insurance are, increasingly, folks like you and me -- middle class, often with decent jobs, but priced out of the market. Without meaning to sound too unfeeling, this is precisely the development that is needed for there to be any lift under the wings of health care reform. Remember the old saying that a recession is when your neighbors lose their jobs and a depression is when you lose yours? The same principle seems to apply to health care: a health care problem is when 43 million neighbors lack health insurance, and a health care crisis is when you lack it, too. I've yet to read anything about the massive Medicare reform package that includes the new prescription drug benefit (see below) that will do anything to make health care benefits more available to these 43 million Americans.

Medicare prescription drug benefit deal approved in principle by conferees.

The deal was struck between "top Republicans in Congress and two Democratic senators" and was announced on Saturday. See article in today's New York Times.) I guess it remains to be seen whether other top Democrats can be persuaded to go along. This has become one of the all-time "Christmas tree" bills, with a little light or gew-gaw for everyone:

Besides adding drug benefits to Medicare, the bill would inject competition and market forces into Medicare and establish a new mechanism to help hold down Medicare costs. It would also offer tens of billions of dollars in subsidies and other aid to employers to encourage them to continue providing health benefits, including drug coverage, to retirees.

So scuttling this bill would require members to explain to the folks back home not just why the drug benefit got killed (and apparently "because we can't afford it" just isn't a good answer these days), but also why this or that favorite provision also had to be killed. Will this make the bill bulletproof? We'll see . . . .

Schiavo case is prompting experts to ask: Could it happen in my state?

The Stamford (Ct.) Advocate reports today that an expert on living wills believes Connecticut's living will law is too narrow and wouldn't necessarily protect against the nightmare scenario that is presently playing itself out in Florida. Offhand, Connecticut's doesn't sound that different than Texas' law, except that the expert believes a patient is not in a terminal condition if there's even a 0.1% chance of survival. That's a pretty useless standard, if true, but it's not how Ct. Stat. § 19a-570 (requires WestLaw subscription) defines "terminal condition." Our own law in Texas clearly gives the spouse of an incompetent patient with no advance directive the authority to consent to the withholding or withdrawal of life-sustaining treatment, including artificial nutrition and hydration, once the patient is diagnosed as having a terminal or irreversible condition. Permanent unconsciousness clearly qualifies as the latter.

New play based on the trial of Carrie Buck.

According to an article in the Sioux City Journal, Northwestern College's Jeff Barker, a professor of theater and speech, has written a play, "Kin," based on the trial of Carrie Buck, the central figure in the famouse Supreme Court case of Buck v. Bell. This was the case in which the Court, in an opinion written by Oliver Wendell Holmes, Jr., upheld the Commonwealth of Virginia's decision to sterilize Carrie Buck. As the opinion states: "Carrie Buck is a feeble minded white woman who was committed to the State Colony above mentioned in due form. She is the daughter of a feeble minded mother in the same institution, and the mother of an illegitimate feeble minded child." The court's rationale was simple enough: "[t]hree generations of imbeciles are enough." Research in the late 20th century discovered the extent of Virginia's eugenics program: 8,300 persons sterilized, 4,000 at the Lynchburg facility where Carrie and her sister were sterilized. The research was summarized in an essay by Stephen Jay Gould ("Carrie Buck's Daughter") in The Flamingo's Smile. An excerpt appears here.

False Claims Act recoveries at all-time record level.

As reported by Modern Healthcare, the Justice Department says it has collected $2.1 billion under the False Claims Act for the fiscal year that ended September 30, $1.7 billion of which came from health-care fraud settlements. This includes "$641 million by HCA, $382 million by Abbott Laboratories, $280 million by AstraZeneca and $51 million by Tenet Healthcare Corp." Relevant sources on the federal government's fraud-fighting efforts include:

• press release: "JUSTICE DEPT. CIVIL FRAUD RECOVERIES TOTAL $2.1 BILLION FOR FY 2003; FALSE CLAIMS ACT RECOVERIES EXCEED $12 BILLION SINCE 1986";
• The Department of Health and Human Services And The Department of Justice Health Care Fraud and Abuse Control Program Annual Report For FY 2002.

SCOTUS' take on the Supreme Court's grant of certiorari in the Texas ERISA/HMO case.

SCOTUS is a terrific blog run out of the Goldstein Howe law firm that tracks the US Supreme Court's docket and various related comings and goings. Here's SCOTUS' post on the Court's recent grant of cert in the HMO case out of the 5th Circuit. And here's SCOTUS' link to the NY Times' coverage of the case.

HealthSouth's CEO Scrushy indicted on 85 counts this morning.

Federal prosecutors in Alabama claim he masterminded the plot, to which several executives have already pleaded guilty, to cook HealthSouth's books to the tune of $2.5 billion.

A Catholic priest and bioethicist takes on the Governor and legislature of Florida.

There's a good article in this morning's Miami Herald in which Fr. Kevin O'Rourke disputes the ethics of keeping Terri Schiavo alive.

''For Christians, it is a blasphemy to keep people alive as if you were doing them a favor, to keep people alive in that condition as if it benefits them. It doesn't benefit them,'' O'Rourke argues. ``I know it is wrapped up in the pro-life, antiabortion activity, and while I am antiabortion, I also know there is eternal life and that we should not confuse or equate the antiabortion effort with the notion of withdrawing life support from dying people.

``They act as though the most important thing is to lead a long life and Christians who read the Gospel seriously believe that it is a good life you are pursuing, not a long life. But this notion of having a long life has become the watchword for these groups. Life is terminal. Life by definition is going to have an end.''

Human research then and now.

Interesting article in the Th Daily Pennsylvanian - UPenn's campus paper, about the University's decision to give a lifetime achievement award to dermatologist and professor emeritus Albert Kligman. In addition to his pioneering work on Retin-A, Dr. Kligman entered into numerous contracts with pharmaceutical companies to test their drugs, which he often did on the inmates of Holmesburg Prison and the elderly residents of the Riverview Home. An article in the same paper last Friday quotes Art Caplan, the head of the bioethics program at Penn, as saying:

Our attitude is that in some ways his experiments from current standards... don't pass muster. . . But according to the standards of the day, doing experiments on prisoners was common. . . . There's no doubt that scientifically and medically he did pioneering and important work . . . At the same time, I think it's appropriate in acknowledging him to comment that some of the things that happened in the time were immoral. . . . Science has advanced and, in fact, ethics have advanced. . . . You have this problem that comes up all the time of holding people [to today's standards when evaluating their past actions] . . . There's been a shift in attitudes from the '50s to today in terms of research on prisoners and the rights of people to be informed . . . I think it's fine and appropriate to say to people [that] what we did then we've learned is wrong, and we are committed to doing better . . . I think that's owed the people. I think that's appropriate for the University to say.

U.N. to Consider Whether to Ban Cloning of Human Embryos

As reported in an article in today's N.Y. Times, the UN is considering whether to approve a ban on all human cloning or to limit it to reproductive cloning only. This is the same issue reported on by the President's Council on Bioethics in the summer of 2002 (report here).

Supreme Court to Rule on ERISA Preemption Question in Suits Over Patients Denied Treatment.

As reported by the AP earlier today (here's the Chicago Tribune link to the story, but there are millions of others out there), the Supreme Court of the United States ("SCOTUS") granted review this morning in an HMO-reform/ERISA case out of Texas. Two cert. petitions were granted in the case: Aetna Health Inc. v. Davila, No. 02-1845, and Cigna Healthcare of Texas Inc. v. Calad, No. 03-83. In the U.S. Court of Appeals for the Fifth Circuit, the case was styled as Roark v. Humana, 307 F.3d 298 (5th Cir. 2002) (here are links to the Westlaw version of the case [requires subscription] and the FindLaw version [free PDF]). In the interest of time, I will post the first two paragraphs of the Fifth Circuit's opinion and add my own commentary later:

This suit consolidates multiple district court actions and appeals for consideration of common issues. Ruby Calad, Walter Thorn, Juan Davila, and Gwen Roark sued their respective health maintenance organizations ("HMO's") for negligence under Texas state law: They alleged that although their doctors recommended treatment, the HMO's negligently refused to cover it. The HMO's removed to federal court, arguing that because each plaintiff received HMO coverage through his employer's ERISA plan, the claims arose under ERISA. The plaintiffs moved to remand.

The respective district courts denied Calad, Davila, and Roark's remand motions and dismissed their claims under Fed.R.Civ.P. 12(b)(6), citing ERISA preemption. The district court granted Thorn's remand motion. Roark, Calad, and Davila appeal the refusal to remand and, in the alternative, the dismissal. Thorn's HMO appeals the remand. We affirm the judgments in Roark's and Thorn's cases and reverse with respect to Calad and Davila.

The Roarks' claims are the only ones held by the court to have been partially preempted under section 502 of ERISA (the complete preemption provision); thus the district court properly denied their motion to remand. After that, the district court ruled the remaining claims were preempted by section 514 of ERISA (the ordinary preemption provision of the federal law), which the Fifth Circuit affirmed on the bas sis of its earlier Corcoran case, which it found to be indistinguishable. More later . . .

Palm Beach editorialist weighs in on the Schiavo case.

Randy Schultz, editor of the editorial page of the Palm Beach Post has a great editorial in today's paper. Schultz carefully reviews the judicial history of the case and the opinions filed by judges, observing along the way:

"It is likely that no guardianship court," the judges said, "has ever received as much high-quality medical evidence in such a proceeding." The appeals court looked at the full-length videotapes of Ms. Schiavo, not the excerpts on TV news programs. The judges examined brain scans. The conclusion: Terri Schiavo is in a permanent vegetative state.

But as Judge Altenbernd noted in June: "Each of us, however, has our own family, our own loved ones, our own children... we understand why a parent who had raised and nurtured a child from conception would hold out hope that some level of cognitive function remained. If Mrs. Schiavo were our own daughter, we could not but hold to such a faith."

So the court sees Terri Schiavo as a person. The court knows the tragedy, of her condition, the family fight, the unpleasant decision. "It is a thankless task," Judge Altenbernd wrote, "and one to be taken with care, objectivity and a cautious legal standard designed to promote the value of life.

"But it is also a necessary function if all people are to be entitled to a personalized decision about life-prolonging procedures independent of the subjective and conflicting assessments of their friends and relatives... the law currently provides no better solution that adequately protects the interests of promoting the value of life."

Saving the best for last, Schultz concludes: "It should have ended there. The courts have spent years on Terri Schiavo's case and acknowledged the difficulty. The governor and Legislature spent two hours and proclaimed themselves saviors. So who's being reckless and uncaring?"

Stem cells and President Bush.

There is a nice 1-2-3 sequence of articles in The Washington Post over the past week concerning stem-cell research and President Bush.

(1) The series started with a column by syndicated Post columnist Michaeld Kinsley that appeared on October 24 (One Reason Not to Like Bush (washingtonpost.com)). In this piece, Kinsley argued that Bush's policy on federal funding was "unexpectedly restrictive" and was based upon two factual assumptions that turn out not to be true: (1) there are 60 viable stem cell lines available for stem cell research (turns out it's more like 10) and (2) there is hope for the process by which adult stem cells could be switched on to behave like pluripotential embryonic stem cells, a claim that has been authoritatively debunked by an article in the scientific journal Nature.


(2) The Bush administration replied with an Op-Ed in the Washington Post on October 30 by Jay Lefkowitz, who was chair of the White House Domestic Policy Council until last month. Lefkowitz asserted that the president "made the first-ever offer of federal aid to support the research" and responds to Kinsley's attack on the two bedrock assumptions that underlay the president's policies.

(3) Kinsley's reply ("Kabuki and Stem Cells") appeared on October 31. He yields no points to Lefkowitz, and his arguments on the merits of the stem-cell debate are worth reading. Of greater interest to some will be Kinsely's critique of Lefkowitz' response "as an illustration of modern Washington dishonesty":

I do not assert that Republicans are more dishonest than Democrats -- only that this document is a choice example of the state of the art.

The distinguishing feature of modern Washington dishonesty is that it is almost transparent, barely intended to deceive. It uses true-ish factoids to construct an implied assertion about reality that is not just false but preposterous. Modern Washington dishonesty is more like a kabuki ritual than a realistic, Western-style performance. The goal is not to persuade but merely to create an impression that there are two sides to the question without actually having to supply one of them.

Kinsley then nicely skewers Lefkowitz' points, 1 by 1, 1-2-3.

Schiavo developments.

1. The ACLU's brief on behalf of Michael Schiavo "as guardian of Terry Schiavo" against the Florida legislation can be found here (52 pp., PDF).


2. Newsday, the L.A. Times, and others are reporting that Jay Wolfson, a University of South Florida professor and "expert on health care financing, has been appointed to independently investigate the case . . . . A judge on Friday named [him] as Terry Schiavo's guardian." Prof. Wolfson's web site is here.
3. Today's Pittsburgh Post-Gazette has an excellent piece on the case, with useful observations from Alan Meisel, whom I think of as the Magister Ludi of "the right to die," and neurologist Ron Cranford.

The New York Times will be publishing a profile of Michael Schiavo in tomorrow's (Nov. 2) paper. Here's the link to it on today's web site (if that link doesn't work, try this; I'm experimenting with Google links to see if they are stable as the Userland feeds).