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).

Growth in ER use fueled by insured patients, not uninsured.

The nonprofit, nonpartisan Center for Health System Change reports that most of the increase in ER use in recent years has been the result of increased E use by insured patients:

U.S. hospital emergency department (ED) visits increased to almost 108 million annually in 2000 and 2001, an increase of about 16 percent from 1996-97. Emergency department visits between 1996-97 and 2000-01 increased 24 percent for privately insured people, 10 percent for Medicare beneficiaries, 10 percent for self-pay or no-charge—typically uninsured—patients but were unchanged for Medicaid beneficiaries, according to the study based on data from the Centers for Disease Control and Prevention's (CDC) National Hospital Ambulatory Medical Care Survey.

Together, privately insured and Medicare beneficiaries accounted for almost two-thirds of the overall increase in ED visits. In contrast, self-pay or no-charge patients accounted for about 11 percent of the increase in ED visits. People with other sources of coverage—worker's compensation, for example—or unknown coverage accounted for the remaining increase.

For privately insured people, the 24 percent increase in ED visits paralleled an across-the-board increase in ambulatory care use, including a 29 percent increase in physician office visits between 1996-97 and 2000-01, the study found. In contrast, for uninsured people, the 10 percent increase in ED visits was accompanied by a 37 percent decrease in physician office visits, resulting in uninsured people relying on emergency departments for an even greater part of their medical care. One-fourth of all doctor visits by the uninsured now take place in emergency departments, compared with 17 percent in 1996-97.

"Uninsured people clearly are not a major factor in increased crowding at most hospital emergency departments, but uninsured people's growing reliance on emergency care indicates decreased access to other sources of care, including physician's offices. Getting medical care outside of the emergency department is definitely becoming more difficult for uninsured people," said HSC Senior Health Researcher Peter Cunningham, Ph.D., who co-authored the study with HSC Research Assistant Jessica May.

A news release and a link to the full report are here.

GAO report on specialty hospitals.

The article in this morning's NY Times on the rise of specialty hospitals (see below) mentions a report from the Government Accounting Office on the phenomenon. As today's "Health Law Highlights" from American Health Lawyers Association points out, the report "notes that specialty hospitals are largely for-profit and, in many cases, are owned in part by physicians. Specialty hospitals as a group tended to be less likely to have emergency departments, with 72% of cardiac hospitals, 50% of women's hospitals, 39% of surgical hospitals, and 33% of orthopedic hospitals having emergency departments. In contrast, 92% of general hospitals have emergency departments."

From this morning's NY Times: More on Schiavo, PVS, Medicare.

The NY Times is filled with stuff today:

• Schiavo I: article in "The Week in Review" about brain-damage and family decision making by Dudley Clendinen;
• Schiavo II: good piece by Sheila Dewan on the practical aspects of ethics consultations in cases like the Schiavo imbroglio (warning: this link will only last a few days);
• Schiavo III: an informative article about the American Academy of Neurology's guidelines for diagnosing permanent vegetative state (you can read them for yourself here);
• a front-page piece about the dramatic rise of specialty hospitals and the Medicare reimbursement scheme that has contributed to it.

FDA eases stance on importing medicines

The FDA has softened the official (hard) line against importing drugs from Canada, according to an article in today's Boston Globe: "'We're not considering legal action against cities or states,' said William K. Hubbard, associate commissioner for policy and planning at the FDA." The FDA isn't giving up its suits against the major suppliers to these state and local programs, however:

Hubbard said the FDA would continue its court battles against "businesses that sell commercial quantities of drugs" from overseas. The agency sent a cease-and-desist letter last month to CanaRx, the company that arranges for Canadian drugs to be shipped to Springfield. The Justice Department is awaiting a ruling after suing in Oklahoma to shut down a chain of stores that provide Canadian drugs under the names Rx Depot and Rx of Canada.

Presumably the cities and states are free to negotiate with Canadian pharmacies for discounted prices and employees would then be able to place their orders directly from the Canadian firms.

Slate opinion piece on the Schiavo case

There was a very good column by Dahlia Lithwick over at Slate. It builds on Alta Charo's point that this is case is mostly about who should decide and when should the state overrule that person's choices (and why).

Schiavo case reviewed by Florida's medical ethics community.

There's a good article in the Gainesville Sun today that contains the analysis of medical ethicists and legal experts in Florida. The commentary seems focused primarily upon Terry Schiavo's desire to avoid unwanted invasive treatments, but Alta Charo, quoted in an article in the Post-Crescent (Appleton-Neenah-Menasha, Wisc.) makes the more generally useful point that Schiavo is about the ability of a surrogate decision maker to make his or her decision stick in the event of a family dispute. "Once an individual has lost the ability to speak for herself, somebody must speak for her,” and once that happens, legal questions abound: who can speak for her? does the answer to that question change when the family disagrees about the outcome? what are the evidentiary standards and substantive rules that constrain the surrogate's choice? Of course, all those issues have been litigated for the better (or worse) part of 7 years: Terry's husband has been found to be the lawful surrogate and the choice he's made has been found to be consistent with the law of Florida for such choices, which makes the intervention by the legislature and the governor appallingly bad and shockingly opportunistic.

Schiavo redux.

The Times' web article on constitutional issues raised by the Florida legislation (mentioned here late yesterday) appeared in print today. Privacy, of course, is the big issue -- does Terri Schiavo have a right to have her medical decisions made by her husband or can the state override her surrogate's choice (based upon substituted judgment)? Beyond that, does a statute that is addressed to only one person's situation impermissibly blur the line between "legislature" (which typically decides policy issues prospectively and generically) and "court" (which typically decides issues retroactively and in the context of individual cases)? Problem is, those distinctions are frequently blurred by both courts and legislatures. The practice of passing "special legislation" for the benefit of one individual is so well established in the federal system that Congress has a separate calendar just for those measures. Florida's law on special legislation is reportedly quite narrow, and there may be some real question whether the Schiavo law would pass muster in that state.

The New York Times editorialized against the legislature's and governor's overruling of the many court decisions that have quite unremarkably upheld Terry Schiavo's husband's right to make the decision he's made.

Schiavo: reactions the day after.

Some reactions to the Florida legislature's and governor's intervention in the Schiavo case yesterday:

Democratic presidential hopeful Joe Lieberman backed the legislature and governor: "I believe that certainly in cases where there is not a living will ... I feel very strongly that we ought to honor life and we ought not to create a system where people are being deprived of nutrition or hydration in a way that ends their lives."

Harvard Law professor Larry Tribe is critical of the intervention, saying that it "violates the core principles" of the Supreme Court's 1990 decision in the Cruzan case. The New York Times ran a piece on their web page today - presumably intended for print on Thursday - laying out some of the constitutional arguments.

Senate Passes Ban on Abortion Procedure.

The Senate passed the partial-birth abortion bill today, according to a Washington Post report. Here's the text of the bill, S. 3 (when will newspapers start running bill numbers in their stories?)

Schiavo update #3

The Florida Senate jumped on the bill like a june bug on a water lily, Governor Bush signed the law, and pursuant to the law, he ordered Terri Schiavo's feeding tube reinserted. See The Washington Post's summary of the day's events.

There's nothing on the Governor's web site about this yet, but news announcements are posted here, so stay tuned. The bills are S12-E and H35-E. (The "E" is a reference to the fact that the legislature went into its fifth special session of the year on the 20th of this month.) Here are the key documents:

text of H35-E as engrossed and enrolled (PDF) (text);
text of S12-E (PDF) (text);
FindLaw's posting of the House bill as amended by the Senate; and
Senate staff analysis (PDF only).

Schiavo update #2.

A senate committee voted 10-2 this morning to send the House bill to the Senate floor for a vote, tentatively scheduled to occur this evening (according to the AP).

The same story reports that the federal judge who was assigned the case brought by the Advocacy Center for Persons with Disabilities has dismissed the case, writing that "federal courts - other than the U.S. Supreme Court - are forbidden from interjecting themselves into matters already decided by state courts."

The Schiavo case: legal process run amok.

As reported in numerous news outlets this morning, including the Sacramento Bee, the Florida House passed a bill yesterday that would authorize Gov. Jeb Bush to intervene and order a feeding tube for Terri Schiavo, a woman who has been diagnosed as being in a permanent vegetative state for the past 10 years. (You can find a House press release on the bill here. Unfortunately, it doesn't give the bill number, and I've so far been unable to find the bill through a text search of the House web site.) The bill is now before the Senate.

I've laid out the procedural and clinical details of this case in an earlier post. This latest move by parents, at least one sibling, and various right-to-life and disability-rights groups is either "desperately needed . . . to protect the people of this state" (Rep. Sandy Murman) or a bill that "so oversteps our role . . . it turns democracy on its head" (Rep. Dan Gelber). At the risk of repeating myself, this is apparently all about politics as a contact sport, with Terri Schiavo as the football. According to the AP, the attorney for her husband/guardian "said he thinks the legislation would be unconstitutional. He said it is Terri Schiavo's right under the Florida Constitution to not be kept alive artificially."

A letter to the editor in today's Sarasota Herald Tribune entitled "Some Things Are Worse Than Death" provides some perspective on the struggle of Terri's parents. Still, it's hard to believe that after 10 years and countless expert opinions, the parents insist that a little more rehab will restore their daughter to even a minimum quality of life. With his permission, here is an e-mailed summary of Terri Schiavo's condition from Ron Cranford, a neurologist who has personally examined her:

Terri Schiavo is in a classic permanent vegetative state. I have personally examined her and testified at a 6 day evidentiary hearing in Tampa in October, 2002, where six doctors testified on her neurologic condition, chances of recovery, and any possibility of her responding to treatment. The trial court judge concluded Terri was in a persistent (permanent) vegetative state, there was no possibility of recovery, and no chance of her responding to any treatment, including vasodilator therapy and hyperbaric oxygenation. Terri's most recent CT scans (extensively reviewed during the evidentiary hearing) show massive atrophy of the cerebral hemispheres, and the cerebellar hemispheres and brain stem, findings typical for a patient with severe and irreversible brain damage secondary to hypoxic-ischemic encephalopathy after 13 years in this condition. The trial court judge reviewed the videotaped examinations of the doctors testifying and completely rejected the opinion of the Florida neurologist representing the Schindler family that Terri showed signs of cognitive functioning. The one physician who was most likely persuasive in convincing Judge George Greer of Terri's neurologic condition was the neurologist from Cleveland, Ohio, who was the court appointed medical expert and thus not representing either the Schindler family and Michael Schiavo, the husband. Interestingly, not only did the 3 judge court of appeals agree with the trial court judge, but also reviewed the videotaped examinations of the doctors and agreed that Terri showed no signs of cognition.

If you look closely at the short videotapes released by the Schindler family, and know exactly what you're looking for, you'll see that Terri does not have sustained visual pursuit, the classic finding for someone outside a vegetative state. In the close up views of the mother interacting with Terri, you'll notice that it "appears" at times for a few seconds that Terri is "looking" at her mother, but, if you look closely, her eyes are not really tracking her mother most of the time. And she definitely would be tracking her mother the vast majority of the time were she not in a vegetative state.

According to an attorney who appears to be close to this case, a Florida-based nonprofit organization -- The Advocacy Center for Persons With Disabilities -- has filed an action in federal court to block the state court's dehydration order. He says their action is based upon "29 U.S.C. § 794(E) [sic]" (I assume he means 29 U.S.C. § 794e, which is a funding mechanism à la Baby Doe (42 U.S.C. §§ 5106g, 5106i(b)) but without the substantive treatment standards) and 42 U.S.C. § 15043(a)(2)(b) (which confers no legally enforceable rights as far as I can tell). As of 10am (CDT) this morning, there was nothing on their web site about the action.

To quote Letterman: "Is this something, or is this nothing?"

On Wednesday, Bayer Biological Products announced "the creation of an independent bioethics advisory body, the Bayer International Bioethics Advisory Council (BIBAC). The newly developed council, the first privately-funded international council of its kind, is dedicated to exploring and developing recommendations on ethical issues associated with biological products, such as those produced from blood plasma." Here's the background:

BIBAC is an expanded, international version of the highly successful former Canadian bioethics council, called the Bayer Advisory Council on Bioethics (BACB). Established in 1997 in response to Canadian public concerns about the safety and availability of blood and plasma, the BACB quickly established itself as a credible authority providing valuable counsel in dealing with the complex blood-related issues of the time. In fact, its inaugural paper, "Creutzfeldt-Jakob Disease, Blood and Blood Products: A Bioethical Framework" contributed to significant policy decisions in both Canada and the United States.

BIBAC's first paper can be viewed on the BIBAC Web site at www.BIBAC.org.

Another interesting grant of certiorari.

Congress is fond of using its powers under the Taxing and Spending Clause to enact legislation that might be at least questionable if it was passed as a straight-up regulation. Think, for example of EMTALA (imposing duty to screen and treat on hospitals as a condition of their receipt of federal health care funds) or Baby Doe (imposing enforcement obligations on states to ensure that infants receive "medically indicated treatment" as a condition of the receipt of federal funds for CPS programs). As a general proposition, Congress enjoys roughly the same freedom to legislate to promote the general welfare of the public as is enjoyed by state and local officials who exercise comparably broad broad "police powers" when they legislate.

Yesterday, SCOTUS granted certiorari in Sabri v. United States, No. 03-44. In the case, a developer was charged with bribing a city council member in Minneapolis. The federal statute under which he was charged makes it a crime to pay a bribe of at least $5,000 to an official whose agency receives at least $10,000 in federal money. There's no requirement that the bribe be related to the federal program for which federal funds are received by the official's agency. Linda Greenhouse's description of the case in today's N.Y. Times includes the suggestion that this case could signal the Court's interest in cutting back on Congress' powers under the Spending Clause, just as it has been doing in connection with the Commerce Clause over the past 5 years. In his blawg, Prof. Eric Muller (passed along to members of the Con Law Prof listserv by Eugene Volokh) wonders why an exercise of Congress' Spending Clause powers should be suspect when a ban on bribes over $5,000 could have been enacted pursuant to Congress' power to regulate interstate commerce. Fair question. (The district court dismissed the charges but the 8th Cir. reinstated them as a constitutional exercise of Congress' powers under the "necessary and proper" clause. The 8th Cir. case -- U.S. v. Basim Omar Sabri -- is available for free here.)

Terri Schiavo's final days.

The New York Times ran an article by Abby Goodnough on the final legal and medical moves in the case of Terri Schiavo, diagnosed as being in a permanent vegetative state after an anoxic event in 1990. I've previously discussed this case here.

SCOTUS declines review of medical-marijuana gag-rule case.

The Supreme Court denied cert. in a 9th Circuit case (Walters v. Conant, No. 03-40) that ruled doctors couldn't be prohibited by the federal government from discussing the risks and benefits of medical marijuana with patients in states that have legalized medical marijuana, although if they help the patients obtain pot they can be prosecuted as accessories or for conspiracy, at a minimum. The freedom-loving Bush Administration sought review. The 9th Circuit case is Conant v. Walters, 309 F.3d 629 (9th Cir. 2002); you can read it here (requires subscription to Westlaw) or here (free on Findlaw).

Genetic discrimination bill passes Senate, 95-0.

Modern Healthcare's "Daily Dose" reports that S. 1053 passed in the Senate today by a 95-0 vote. (If you're looking for confirmation (and remarks from the floor), today's Congressional Record will publish the proceedings tomorrow.) The bill, sponsored by Sen. Olympia Snowe (R.-Me.) and 10 co-sponsors, would prohibit employers and insurers from making employment and coverage decisions on the basis of genetic information. The provisions seem largely to duplicate similar provisions already enacted by many states, including Texas (Insurance Code; Labor Code). Ted Kennedy praised the measure; the president of the Health Insurance Association of America criticized it as unnecessary in light of the antidiscrimination provisions in HIPAA.

Pregnancy Created Using Infertile Woman's Egg Nucleus.

It's not all that common for a news story to give me an exam question in three of my courses, but this one comes pretty close.

Denise Grady has a piece in today's N.Y. Times that picks up on an AP story that ran on Monday concerning a Chinese procedure for extracting the nucleus of a fertilized egg, inserting the genetic material into a denucleated egg of another woman, and implanting the "new" egg into the uterus of the first woman. The process initiated a pregnancy in a woman who previously could not maintain a pregnancy with a blastocyst beyond the two-cell stage. The new technique resulted in three fetuses, one of which was aborted to give the other two a better chance of survival, and the remaining fetuses died at 24 and 29 weeks. Because this technique involves nuclear transfer, the process has set off alarms among those who are uncomfortable that this is one more step toward human reproductive cloning. It's not exactly cloning, which involves making a genetic copy of oneself, but Jeffrey Kahn of the University of Minnesota worries that it amounts to "'proof of principle' for cloning even if no copying took place."

The technique also adds to biotech's contributions to Family Law exam questions. Consider this headline, from today's Belfast (Ire.) News: "Scientists Create Test Tube Twins with Two 'Mothers'."

It also raises a nice question for a Bioethics exam. As today's Newsday article on the story put it:

But none of her three developing fetuses survived, and some question the ethics of such research.

"The gestational outcome was a disaster," said Dr. James Grifo, director of the division of reproductive endocrinology at New York University. Grifo and his NYU colleague, Dr. John Zhang, are listed on the abstract of a paper on the case to be delivered today at the American Society for Reproductive Medicine meeting in Texas. Grifo said they didn't have anything to do with the clinical research "beyond showing them how to do it."

Malcolm Ritter's AP story (from the Ft. Worth Star-Telegram) on the ASRM conference in San Antonio quotes others who aren't so sure about the "roadmap to cloning" argument:

R. Alta Charo, professor of bioethics at the University of Wisconsin at Madison, said the Chinese work is not a direct analogy to cloning. A key difference is that the transferred DNA does not have to be reprogrammed to act properly in an egg as it does in cloning, she said. So the study result doesn't offer a direct indication of the outcome of attempts to clone humans, she said.

[Dr. Joe Massey, a fertility specialist at Reproductive Biology Associates in Atlanta] and [Dr. David Sable, director of the division of reproductive endocrinology at the St. Barnabas Medical Center in Livingston, N.J.,] said the experiment was not cloning, with Massey stressing that it wasn't aimed at copying an individual. "This is not a pathway to cloning. It's not about that," Massey said.

Finally, for the Administrative Law exam, consider this: Dr. Grifo, the NYU researcher who advised the Chinese team, "said the Food and Drug Administration indicated that work he was doing might be subject to government regulation, and he stopped his experiments in 1998 because of the energy and money required to comply." I wonder what the FDA is thinking this morning about his participation in the Chinese experiment.

Stopping a clinical trial before it's complete.

The New York Times editorialized today about a recent decision to end a clinical trial of a breast-cancer treatment because the results were looking so good, the researchers wanted to get the apparently beneficial treatment out to a larger number of women than just those who were enrolled in the research:

The study was testing the value of administering the drug letrozole to older women who had already taken tamoxifen to ward off a recurrence for about five years, the point at which tamoxifen loses its power. The results exceeded expectations. When compared with a placebo, letrozole cut the recurrence rate nearly in half.

As the Times correctly points out, "[t]here seems little doubt that a trial must be terminated if it is harming the participants"; indeed, that is precisely what data safety monitoring boards do. But, as the editorial observes:

By halting the study in midstream, the researchers made the new treatment available to the placebo group and to many thousands of other cancer survivors as well. The downside is that early termination kept them from determining whether the treatment actually saved lives, how long women should keep taking the drug or the likelihood of such adverse effects as osteoporosis and cardiovascular problems.

The National Breast Cancer Coalition has criticized the National Cancer Institute's decision to halt the clinical trial, and their paper makes a lot of sense. The National Cancer Institute's explanation for its decision, with a link to a Q&A page on the letrozole study, is here. The researchers' article, which is scheduled to appear in the New England Journal of Medicine on November 6, was posted to the journal's website on October 9 "[b]ecause of its potential therapeutic implications." [Abstract available here without subscription]

Separation of Egyptian conjoined twins begins in Dallas today.

Excellent article in this morning's Dallas Morning News by Laura Beil about the ethics of performing surgery to separate two Eqyptian brothers who are joined at the tops of their heads. As co-chair of the ethics committee at Children's Medical Center Dallas, where the separation is being performed, I have given lengthy interviews to a lot of reporters about the ethics of separation and the process that we went through at Children's, and Laura's piece is the only one I've seen (so far) that has attempted to lay out the ethical analysis. The article also quotes Prof. Adrienne Asch of Wellesley College, who makes a valid point about society's culturally determined notions of what is "normal":

The surgeons know there are those who will take exception with the decision to operate. One expert who disagrees is Adrienne Asch, a professor of reproduction and bioethics issues at Wellesley College in Massachusetts.

Dr. Asch is disturbed by the drive to separate conjoined twins because it is usually based on the sense that being conjoined is not a "normal" way to live. But what does normal mean? Does it mean average, or outside statistical boundaries, or desirable? Star athletes and Nobel Prize winners have outstanding qualities that are not considered normal, she pointed out. "We think of some non-normal things as desirable," she said.

People live good lives in a variety of circumstances, and it is not for others to decide whether their circumstances are a burden. To ask whether two conjoined brothers should be separate, she said, is almost akin to asking a black person whether they should be white, or a woman whether she would be better off as a man.

"I don't even like the word normal," she said.

If society considered it acceptable to be conjoined, being attached to your brother or sister would be an unusual but perfectly legitimate way to live, she said. The biggest disability facing these twins, is that society considers it strange. "That's the principal impairment of being conjoined," she said.

I am not so sure that stigmatization is the biggest impairment facing a child with a sibling who is his size and weight attached to the top of his head, or that with these brothers we are dealing with a physical condition that would be considered "normal" in other societies but not here. But I do agree that "normal" is a loaded term that is not particularly helpful in resolving the question whether to separate or leave together conjoined twins.