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).