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a common practice in the U.S., though transcripts of the council's October meeting indicate that proposal has been withdrawn.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.

Withdrawal of "futile" life-sustaining treatment over family objection.

The Baby Miller case discussed here on Sept. 30, involved the resuscitation of a newborn over the objections of parents who wanted no heroic measures. That dispute represents the classic "right to die" scenario. The "reverse right to die" case -- sometimes called the "duty to die" case -- reverses the roles of family and caregiver, with the latter claiming that further aggressive treatment will not benefit the patient. These so-called "futility" disputes can be difficult to resolve. If the patient doesn't die first, and if the family doesn't change its mind about continuing aggressive treatment, the physicians and the hospital staff are in a tough predicament: (a) keep providing therapy they believe to be unethical to continue or (b) unilaterally remove life-support over the objections of family. Texas is one of the few states in the country with a statute that provides legal protection for the health care professionals and institutions that take the latter course. (See Health & Safety Code § 166.046.) A case reported in an article in today's Independent (London) illustrates the problem:

An elderly woman, whose feeding tube was withdrawn by doctors against the wishes of her family, died in hospital yesterday.

Olive Nockels, 91, became the focus of a legal battle about treating the elderly after being admitted to the Norfolk and Norwich Hospital more than two weeks ago. She was unconscious and doctors suspected she had suffered a stroke after an operation to pin a broken hip.

They advised her relatives last week that there was no chance of recovery. They said using drips and tubes to feed and hydrate her would unnecessarily prolong her suffering and the tubes were withdrawn on Friday 3 October.

But Mrs Nockels' family objected and obtained an interim court order on Monday compelling the doctors to restart feeding and hydration until a full hearing could be held. Ivy West, 60, Mrs Nockels' daughter, said: "We think she would still be here now if they had not taken her drip away for three days before they were forced to put it back."

It will, of course, be a very difficult case in which to prove causation. There is no doubt, however, that the peremptory action taken by the hospital exacerbated the family's distrust. The ethics rules that govern these types of disputes appear to be about the same in Great Britain as they are in the States:

The British Medical Association says the "active and intentional" termination of a patient's life is illegal but adds that medical treatment, including artificial feeding and hydration by tube, can be withdrawn when it is "futile, when it would not be in the patient's best interest ... or when the patient has refused further treatment".

Experience with the Texas law since its enactment 4 years ago suggests that having legal authority for withdrawals of futile treatment actually helps families accept the ethical principle that there are limits to the duty to treat.

Where do disagreements over end-of-life care come from? Michael Wilks, chairman of the BMA ethics committee, said it well:

"If doctors decide a treatment is not providing benefit, it is unethical to continue to provide it. The commonest reason for a breakdown between a health team and relatives is a failure of communication."

Med-mal crisis hits Australia.

Just as in a dozen or more states in the U.S., Australian doctors are claiming that skyrocketing med-mal premiums are forcing them out of the practice, according to a story in the Sydney Morning Herald. The story leads with Michael Kaye's claim:

The amount Michael Kaye is paid by Medicare to see a new patient has not quite doubled to $52 since he started working at Mona Vale Hospital in 1982, while the cost of his medical indemnity insurance has gone up from $100 to $50,000.

Dr Kaye has resigned in protest.

"I can't work without insurance and I can't afford the insurance," he said yesterday.

He is one of three obstetricians at the hospital to tender resignations this week, to become effective in three months unless the Government can find a way to stem rocketing insurance costs.

Dr Kaye says the hospital's eight orthopedic surgeons have resigned and about 12 more specialists plan to join them.

As here, the plaintiffs' bar has a different take on the med-mal crisis, but so far the rhetoric seems to be outpacing the analysis of causes and effects. Dr. Kaye is hoping for a no-fault compensation scheme, but meanwhile the bad blood between doctors and lawyers bodes poorly for a reasoned dialogue: "I got into this to help people, not try and defend myself to some smart-arse years after the event. Lawyers and judges can take a year to make a decision, we have to do it in half an hour or less."

Medicine and the practice of capital punishment.

Two articles in today's New York Times discuss two points of intersection between the practice of medicine and the death penalty:

1. Yesterday, the Supreme Court of the United States denied certiorari in an 8th Circuit case -- Singleton v. Norris (U.S., 02-10605) [requires subscription to WestLaw] -- in which the court of appeals, sittin en banc, ruled that medicating a mentally ill death row inmate in order to make him competent to be executed does not constitute cruel and unusual punishment. According to The Times' article, this is the first case in the country, state or federal, to so hold. That may be why the Supremes denied review; normally they like to let a few more courts chew on a problem before they tackle it (called "percolation"). The AMA, by the way, is against physicians participating directly in capital punishment (Opinion E-2.06: "When a condemned prisoner has been declared incompetent to be executed, physicians should not treat the prisoner for the purpose of restoring competence unless a commutation order is issued before treatment begins.")

2. In a second article, Adam Liptak reports that in more than 30 states that allow execution by lethal injection, a three-drug "cocktail" is used. One of the drugs -- pancuronium bromide -- is a paralytic. Increasingly, corrections officials and medical experts are questioning the practice of paralyzing prisoners as part of the execution process, particularly given the chance that the other drugs used may have inadequately anesthetized the patient. The result in such a case -- where a prisoner could be conscious, starved for oxgyen, and unable to move -- would be akin to turning the inmate's body into a living tomb. It probably goes without saying that the AMA's Opinion E-2.06 also forbids physicians from administering the cocktail, which may paradoxically increase the chance that just such an unintended effect will be produced.

Minority children: over- or underrepresented in medical research?

There's an excellent news release from the University of Chicago today about the participation of minority children in research studies. African-American children are overrepresented (in comparison to their percentage of the total population) in clinical trials, while Hispanic and white children are underrepresented. The last four paragraphs of the release are the most provocative:

Both black and Hispanic children were overrepresented in research on topics that were potentially stigmatizing, such as studies of child abuse, high-risk behaviors or HIV. Fifteen percent of the U.S. population is black but 30 percent of the children in potentially stigmatizing research studies were African American. While 17 percent of the U.S. population is Hispanic, only 10 percent of the children in medical research were Hispanic, and 17 percent of those involved in potentially stigmatizing studies.

"There are possibly benign and not so benign explanations for these findings," Ross said. "Our data could not distinguish. Clearly, black and Hispanic children should be overrepresented in AIDS research as they account for 82 percent of all reported pediatric AIDS cases. On the other hand, there are data to suggest that there is racial and ethnic bias in who is questioned about child abuse."

Why black children were more likely to be involved in clinical research is unclear. One possible explanation may simply be that academic medical centers are disproportionately located in urban centers where minorities live. The authors note that the ongoing shift of clinical research from major medical centers to smaller, suburban, private practices, could reverse this trend.

They conclude on a cautionary note. "Despite the participation of minority children in research, there are data that show that these benefits are not being translated into their clinical care. This should be a top priority." (emphasis added)

A heart transplant program too good to be true.

The Albany (N.Y.) Times-Union has an article in today's paper about Albany Med's three-year-old heart-transplant program. Seems it has outcomes far better than many more established transplant centers at more vaunted institutions. That may be because its recipients were healthier than the transplant surgeons were letting on. By exaggerating the acuity of their patients' illness, the surgeons were leapfrogging sick patients on the transplant list and simultaneously skewing their statistics by putting hearts in healthier patients who could be expected to have better recoveries. What they did is, of course, a violation of the rules established by the United Network for Organ Sharing (UNOS), which administers this country's transplant program under contract with the Department of Health and Human Services (DHHS). The Division of Transplantation of DHHS' Health Resources and Services Administration in turn oversees implementation of the National Organ Transplant Act through its organ-transplantation regulation. UNOS' audit of Albany Med's statistics turned up "discrepancies" that led Albany Med to suspend operation of the transplant center and the two surgeons who run it (see Albany Med's press release). Violations of UNOS protocols are enormously unfair to patients who were in line for a new heart but lost out to patients beneath them on the list. Rank manipulation of the rules of the game also undermines the public's confidence in the whole process. Logically, it's not a stretch to imagine that lessening of confidence in the fairness of the system could have an impact on the willingness of families to designate brain-dead loved ones as organ donors. Bad (and sad) news.

The parents vs. physicians trap

The October 13 issue of U.S. News and World Report continues the Baby Miller theme of parents vs. physicians with this report on the conflict between the parents of Parker Jensen and his physicians. Twelve-year-old Parker was diagnosed earlier this year with Ewing's sarcoma, an aggressive cancer. A tumor was removed from his mouth, and four doctors recommended he receive follow-up chemotherapy to reduce the chance of a recurrence. But Parker's parents refused, despite the fact that "With chemo, the survival rate is approximately 70 percent," while without it, "your chance of living is about 20 percent." His parents whisked him from Utah to Idaho, and local prosecutors charged the parents with kidnapping. Despite the return of cancer, the parents are adamantly against chemo for their son ("The state of Utah needs to leave us alone") and a court hearing is schedule for sometime this month.

Baby Miller case decided by Texas Supreme Court

One year, five months, and twenty-seven days after oral argument, the Texas Supreme Court decided the Baby Miller case today. The court, whose ranks were depleted by retirements, voted 7-0 to affirm the Court of Appeals in an opinion written by retiring Justice Craig Enoch. A few quick thoughts:

1. This is a devastating loss for the family, which has a lifetime of expensive nursing and medical care to pay for. With post-judgment interest, the judgment for the family had to have been worth over $100 million by now. The Court of Appeals reversed and rendered a take-nothing judgment, and today the Supreme Court said, "that's right."

2. The major damage done by the Court of Appeals to the Natural Death Act (now the Advance Directives Act) was technically left alone by the Supreme Court. It affirmed on other state-law grounds and said it didn't need to reach the NDA/ADA issue. But the court offered some dicta that ought to make it clear the court thought the Court of Appeals blew it, which it did (big time). So my major hope for the opinion -- that the NDA/ADA would be restored to its natural meaning -- was half-way realized.

3. The court also side-stepped the Baby Doe issue in the case. It describes the Baby Doe rule as an appropriations/funding rule, which is satisfied by the fact that Texas has CPS policies and procedures in place to respond to reports of failure to provide medically indicated treatment to infants. Period. It does not seem interested in reading Baby Doe as establishing a standard of care, at least unless CPS has been called into a case, which it was not in this case, so as far as the court is concerned: no big deal. But in any event, the court said "this is a state-law, not federal-law, case so we won't technically decide the Baby Doe issue." This is okay with me (even though I think Baby Doe does implicate state law and does establish a standard of care as a matter of state law). Anything the court could have said about Baby Doe (other than what it did say) could only have made a bad rule worse.

The really disquieting part of the decision is its reliance on the 1920 Moss case (link requires Westlaw subscription).

First of all, it's an opinion by the Texas Commission of Appeals of the Texas Supreme Court, not the Supreme Court itself; this is an oddity of Texas judicial history that makes the precedent potentially not as strong as it might otherwise be.

Second, and following from the first, the Supreme Court (in 1920) "approved the judgment in the case," which is generally regarded as weakening the precedential value of an opinion. If the court adopted the opinion of the commission, the precedential value would be higher.

Third, the holding of Moss is this: A surgeon was liable for performing surgery on a minor without the consent of the patient's parents because although "there was an absolute necessity for a prompt operation, [surgery was] not emergent in the sense that death would likely result immediately upon failure to perform it. In fact, it is not contended that any real danger would have resulted to the child had time been taken to consult the parent with reference to the operation. Therefore the operation was not justified upon the ground that an emergency existed."

Amazingly (in light of the Miller court's use of Moss), the Moss opinion ends with this: "The law wisely reposes in the parent the care and custody of the minor child, and neither a physician nor those in temporary custody of the child will be permitted, in a case of this character, to determine those matters touching its welfare." So the Miller supreme court is "guide[d]" (the court's term) to affirm the court of appeals decision against the parents on the basis of an opinion from 1920 of dubious precedential value containing a ringing endorsement of parents' prerogatives to give or withhold consent and setting a very high standard for an exception (more than "an absolute necessity for a prompt" intervention, there must be an emergency "in the sense that death would likely result immediately upon failure to perform the [intervention]." Curious.

Fourth, in Moss, the surgeon relied in good faith on the apparently valid consent of the child's aunt. He had no reason to suspect there was a lack of consent. In Miller, there was every reason to know there was no valid consent. Moss looks like a case that stands for the simple proposition that we will presume consent in a true emergency as long as there's no reason to believe consent has not or would not be given. But of what relevance is that rule to the Miller case?

Fifth, assume that Moss is good law. Does it really support this result? After all, the hospital seems to have had just about the entire day either to get the parents' consent or to get a court order to override the parents' refusal, and it did neither. I don't think Moss really says this is alright.

Curiouser and curiouser.

Big Increase Seen in People Lacking Health Insurance

Robert Pear of the New York Times has an article on the Census Bureau's report on health coverage and the uninsured. Texas's percentage of uninsured is the highest in the country (24.1%), more than triple the rate for Minnesota, the lowest (8%). Why? Here are two reasons: "Texas, facing fiscal problems and unwilling to raise taxes, cut back Medicaid and its Children's Health Insurance Program this year." Our state CHIP saga is particularly deplorable. The state left over $600 million in federal matching funds on the table because of its unwillingness to allocate money to the program. No state funds = no federal match. Details here.

New form of defensive medicine.

Modern Healthcare's Daily Dose has a short piece today about a new report from the Center for Studying Health System Change. As DD reports, "Some physicians are reacting to higher malpractice premiums by declining elective referrals, sending patients to emergency rooms and refusing on-call duty."

End-of-life care and the battle over medical proxy's right to decide.

The Boston Globe published a lengthy article in Sunday's edition about an elderly woman in a locked-in state and the attempts by Mass. General to provide palliative care only, over the objections of her daughter/surrogate decision maker.

The Times got it wrong.

An article in today's New York Times follows up on research first published last year in the medical journals Brain (abstract only; full text requires subscription) and Neurology (abstract). The gist of the research is that many "permanently unconscious" patients are in neither a coma nor a permanent vegetative state; instead, they may be experiencing some degree of consciousness:

The implications of this research, both for medical ethics and practical policy, are potentially huge. Traumatic brain injuries are a significant health problem in the United States, but the study and treatment of them are clouded with a sense of hopelessness, a feeling that consciousness is too mysterious to be understood. When faced with patients in a vegetative state, doctors can do little more than wait to see if they wake up. No treatment has ever been definitively shown to help patients recover consciousness, and doctors can't predict which patients will emerge from a vegetative state and which won't. If patients don't show signs of recovery in a few weeks, they usually wind up at home with their families or in nursing homes, and they rarely see a neurologist again. In 1976, in a famous court case, the parents of Karen Ann Quinlan, a woman who had been in a vegetative state for about a year, won the right to take her off a ventilator (after which she lived until 1985). ''There's a point where people give up'' and discontinue aggressive treatment, says Joseph J. Fins, chief of the division of medical ethics at Weill Medical College. ''The question is, Are we giving up too soon on the ones who might become more functional?'' Schiff and his colleagues say that the answer, in too many cases, may be yes.

Indeed, some of the patients may be able to recover, however fleetingly, quite remarkable levels of conscious interaction with others, through deep massage:

Giacino works hard to tease out hints of awareness in a patient. Sometimes he can actually coax patients into consciousness by working his fingers deep into their muscles. Neurologists have found that the stimulation of the nerve endings in the muscles can be powerful enough to arouse activity in networks of neurons in the brain. Giacino has a particular knack for the technique, and after a few seconds of muscle work, he can get some minimally conscious patients to speak. Some tell him their names, others tell him to leave them alone. As soon as he removes his hands, they slip away again.

Marie Conniff has seen Giacino work this transformation many times. On New Year's Day in 1998, her son Scott was on duty as a New York policeman when a drunken driver rammed his car. Today, Scott sits in a wheelchair, his gaze often drifting across the room. Sometimes he laughs, sometimes he growls like a bear. He gives hard kicks to a big orange beach ball hanging from the ceiling. When Giacino begins to work her son's muscles, Conniff finds herself startled at how well Giacino can bring Scott back, in the look on his face, the clarity of his movements. ''I see a lot of what I had before he got hurt,'' she told me.

Until now, I have been very skeptical of claims that patients in a persistent or permanent vegetative state were "disabled" patients in need of protection against discriminatory policies that give up on the disabled as if they were already dead. The accepted paradigm for PVS is that the neocortical hemisphere is, for all intents and purposes, dead. This article -- quite misleadingly -- suggest that it is quite plausible that some number of such patients, diagnosed as PVS in accordance with protocols published by the American Academy of Neurology, experience relatively high levels of functioning, some of which might be recovered through appropriate therapies. Some of researchers whose work is discussed in this article have written to The Times to dispute any such implication. (I'll provide a link when and if The Times publishes their letter.) They want to clarify that PVS is and continues to be a valid diagnosis from which there is no return to sentience.

Medicare reform.

Saul Friedman argues in today's Newsday ("GRAY MATTERS: Ideology and Meanness in Medicare Debate") that "as it now stands, any legislation that is likely to emerge based on the bills passed in June by the House and Senate would be hopelessly inadequate, too costly and too complicated for most Medicare beneficiaries. I doubt that the members of Congress who are writing it could explain it to their aging parents. More important, the legislation is a kind of pact with the devil, for the price of a paltry drug benefit is the eventual privatization and death of Medicare. In addition, the legislation would not only encourage private insurance companies to sell prescription drug coverage, the House version would help beneficiaries pay the premiums to lure them to sign up for a better deal with private insurance and desert Medicare. The intended result is the demise of Medicare, which leaves health care for the nation's elderly in the hands of dozens of private insurance and drug companies." Friedman continues:

While Medicare's opponents may take cover in ideology in the debate over these larger issues, ideology can't explain the myriad outrages buried in the 800 pages of the legislation that would cost the taxpayers unnecessary billions and pick the pockets of the sickest and oldest among us.

One extraordinary example is a provision prohibiting the government from saving money by using its buying power to negotiate volume discounts with drug companies to get the best prices on drugs for beneficiaries. Indeed, the legislation would exempt drug companies from the cost controls that govern every other Medicare provider - doctors, hospitals and laboratories.

There's more to read -- and to fume over -- in Friedman's excellent review of all that's wrong with what's going on in the Conference Committee that is trying to harmonize the House and Senate bills. I agree with Friedman: If the price tag for a prescription drug benefit we can't afford includes the ruination of the Medicare program, let's hope the conferees come up empty-handed.

When an untested drug is a patient's last chance.

An article in the Boston Globe this week explored the problems faced vby patients with terminal illnesses who have run out of drugs to help them fight their disease. In the view of some, "the current ways to get experimental drugs -- through clinical trials, 'compassionate-use' or 'expanded-access' programs -- are tragically inadequate." In response, some patients' groups are suing the FDA "to create a new level of review called Tier 1 Initial Approval. Under this plan, patients would be able to get an experimental drug if it has passed Phase I trials, if the patient has been rejected from clinical trials of the drug, and if nothing else has worked. Perhaps most controversially, they also want to allow patients to pay manufacturers for the drugs, an issue that opens a Pandora's box of ethical and liability questions." Opposition to the proposed new classification is mounting. "Nancy Roach, a director of the Marti Nelson Cancer Foundation based in Vacaville, Calif., . . . opposes the Tier 1 idea, saying, 'It would rip the heart out of clinical research.' . . . At the end of a Phase I (safety trial), a drug may have been tested in only a few dozen people. (It is not until Phase II and Phase III trials that a drug is tested in more people and researchers study dosages and efficacy.) 'You don't give drugs to people unless there's a good reason to, you know how to give them, and the person has some chance of benefiting,' she said." The widely respected physician-ethicist, Marcia Angell is also against the idea: "'New drugs are far more likely to fail than to succeed,' she said, 'so the chances are that a patient will be hurt by a drug rather than helped.' . . . She said she also is appalled that patients might end up paying manufacturers for experimental drugs. Drug companies already 'are profitable beyond any industry,' she said. 'They are protected by the government. They have monopoly rights, patents, tremendous tax breaks.' And the opposition doesn't stop there. Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said it would be "potentially reckless" for manufacturers to release drugs after only Phase I trials because at that point there is "no proof of efficacy at all."

Boston Children's Hospital.

More cases, going back three years, not just one (the main focus of the Mass. Department of Public Health's scathing report last week), are starting to emerge. (See story in today's Pembroke Mariner.)

Children's Hospital in Boston.

With The Boston Globe's archive policy, it's hard to find the links to all of its articles about the investigations into deaths there over the past year. Here's everything I can find (with no guarantees that these links will continue to work forever):
September 18 | September 19 | September 20 | September 22 | September 23

There's a bit of a media frenzy going on, but it's a compelling story with the additional lesson that if it could happen at one of the country's best hospitals, it could happen in yours, too.

214th birthday of the Judiciary Act of 1789.

Please allow a former teacher of Civil Procedure and Federal Courts to note the anniversary of the passage of the Judiciary Act of 1789. Building on the sketchiest of language in Article III of the Constitution (which provides for "one supreme Court, and . . . such inferior Courts as the Congress may from time to time ordain and establish"), the Act gave us the District Court/Court of Appeals/Supreme Court structure we have today, though with very different functions for the lower courts. The Act also filled in the details of diversity jurisdiction; created removal jurisdiction, the predecessor of the All Writs Act, and a rule that compels discovery in actions at law to the same extent as proceedings in chancery; codified the "no adequate remedy at law" rule for equitable actions; created rules of procedure for trials and appeals; defined the (nondiscretionary) appellate jurisdiction (as opposed to the discretionary jurisdiction over writs of review) of the Supreme Court; and created the office the the United States Attorney in each federal judicial district. All of this and more can be tracked from 1787 to 1982 through the "Landmark Judicial Legislation" page of the Federal Judicial Center.

Medical error at a children's hospital

The Boston Globe has printed another good article on the recent deaths at the local children's hospital, this time focusing on the systemic, root causes (still a matter of conjecture) and considering whether there's something in the culture of teaching hospitals -- or at least some of them -- that stands in the way of effective communication, accountability, appropriate decision making, and safe system design. Important questions all.

Proposition 12: the dawning of a new day . . . .

Here's a good one from the unbeatable Ben Sargent . . . http://www.ucomics.com/bensargent/2003/09/16/