Friday, June 15, 2007

Ellen Goodman on stem cells

Ellen Goodman's column on the stem-cell breakthrough (a "breakthrough" if you're a mouse anyway) today in the Boston Globe hit just the right notes:

  • Congress' bill to increase federal funding for stem-cell research (S. 5) is heading to the President, who -- if he keeps his promise, and who thinks he won't? -- veto the bill in order to protect the embryos that would otherwise be destroyed for their stem cells. The research report on reprogramming mouse skin cells to act like pluripotent stem cells, writes Goodman, will surely be a part of the president's spin ("see, told you so, we don't actually need to use human embryos").

  • That's possibly good politics (unless everyone sees through it) but bad science. First, we don't know how to do this in humans, or even whether we can do this in humans. "Second, this breakthrough actually began with scientists studying the genes in mice embryos. Anybody who wants to repeat the work in humans will have to use human embryos to learn the same mechanics."

So this well-timed announcement about the switchability of skin cells in mice shouldn't for a minute provide cover for a presidential veto of this bill.

Thursday, June 14, 2007

In health care, high cost not necessarily the same as high quality

Just an excellent article in today's NY Times about a study that shows significant disparities between health care charges and health care quality. This is a must read for teachers of health care law survey courses. Here's a bit from the early paragraphs:

Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.

In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.

And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.

Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.

Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care.

Expensive medicine may, in fact, be poor medicine.

“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.

Some Pennsylvania employers said the state’s findings, based on data from 2005, might put more pressure on insurance carriers and hospitals to start demonstrating the value of care. “It now provides us a tool to have a serious dialogue with our carriers,” said Mark Dever, a benefits consultant for Duquesne Light, a regional utility in Pittsburgh.

“We have to question,” he said. “There’s a big difference in price — why?”

The report by the Pennsylvania Health Care Cost Containment Council, a state agency, provides a rare public glimpse of detailed information about hospital payments and patient outcomes. And the seemingly random nature of the payments is striking.

Although federal Medicare payments are largely fixed, they varied somewhat among the Pennsylvania hospitals surveyed. The far greater disparity involved commercial insurers, which must negotiate their rates hospital by hospital.

And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly
$80,000 in average payments received by the other hospitals, with poorer track records.

“It doesn’t make sense,” said Marc P. Volavka, the executive director of the Pennsylvania Health Care Cost Containment Council. “Certain payers are paying an awful lot for poor quality.”

He points to some of the experiments to change how hospitals are paid, like Geisinger Health System in central Pennsylvania, which is trying to demonstrate its commitment to high-quality care by offering a 30-day warranty on its cardiac surgery.

“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive
for a hospital to provide the kind of care that leads to better outcomes and lower payments.

What's up when the rich and well-insured can't get standard-of-care? You could teach an entire health law course on the basis of this one article, if you wanted to explore the in's and out's of this article.

The study is here and the press release about the study is here.

Tuesday, June 12, 2007

SCOTUS: Home health workers not entitled to overtime pay

The Supreme Court has held that home healthcare workers are not entitled to overtime pay (Long Island Care at Home, Ltd. v. Coke).

Here's AHLA's excellent media review of the Court's decision:
  • In a unanimous decision in Long Island Care at Home, Ltd. v. Coke (pdf), the Supreme Court found that home healthcare workers employed by a private company or employer are not covered by laws on overtime pay or the minimum wage because they are "companion workers." ABC World News (6/11, story 9, 0:20, Gibson) noted that the decision "has implications for the nation's one million home healthcare workers and the people for whom they care."

  • The Washington Post (6/12, D2, Barnes) reports that yesterday the Supreme Court ruled "that workers in the fast-growing home-care industry are not entitled to overtime pay." The court's decision upheld "a 1975 Labor Department regulation," which exempts "workers paid by third parties from minimum-wage and maximum-hour rules." The high court said the regulation "was a valid exercise of the power given to the agency by Congress."

  • The Chicago Tribune (6/12, Rose) adds, "The decision came in a test case by Evelyn Coke, a 73-year-old Jamaican immigrant who, with union backing, sued a Long Island, N.Y.-based home-care agency."

  • The AP (6/12) writes, "Lawyers for Coke challenged the Labor Department regulation, and the 2nd U.S. Circuit Court of Appeals in New York City ruled in the workers' favor," saying "it was 'implausible' that Congress would have wanted the Labor Department to wipe out protection for an entire category of workers."

  • The Los Angeles Times (6/12, Savage) reports, "With an estimated 1 million workers now assisting the elderly and the injured in their homes, unions and civil rights groups had urged the justices to repeal the rule because it deprives many of the nation's lowest-paid workers of a decent wage. These employees tend to be women and minorities and often work all night, but they do not earn enough to rise above the poverty level, the advocates said."

  • However, UPI (6/12) reports, "The issue is not that home-care agencies do not want to pay better wages, said New York State Association of Health Care Providers President Phyllis Wang, but because Medicare and Medicaid rates are set by the government, home healthcare agencies cannot raise rates like more traditional businesses in order to provide higher wages and benefits."

  • Also, a separate AP (6/12, Yost) story notes that "Coke's former employer, Long Island Care at Home Ltd., says it would experience 'tremendous and unsustainable losses' if it had to comply with federal overtime requirements."

  • Moreover, the New York Times (6/12, B3, Greenhouse) adds, "The Bloomberg administration filed an amicus brief in the case, arguing that a victory for Ms. Coke could force the city, state and federal governments, which finance home care through Medicaid, to pay $250 million more a year to the 60,000 home-care attendants in the city." The Times continues, "The main question in the case was whether several 1974 amendments to the Fair Labor Standards Act (FLSA) exempted home-care aides employed by agencies from minimum-wage and overtime protections. In contrast, all sides agreed that those amendments exempted aides hired directly by the elderly or infirm." Writing for the court, Justice Stephen G. Breyer "acknowledged that the Labor Department had issued conflicting regulations. One says that home-care aides employed through agencies or other third parties are exempt from protections under the Fair Labor Standards Act, and another that aides should not be exempt from minimum-wage and overtime protections unless they work in the home of their employer."

  • USA Today (6/12, Biskupic) reports, "AARP lawyer Sarah Lock said the decision would make it more difficult for families to find attendants to undertake personal care of the ill and elderly, such as bathing and dressing. Lock called the decision a 'great disappointment' for AARP members of the baby-boom generation who are caring for aging parents and also concerned with their own needs." The "Service Employees International Union (SEIU), which backed Coke, and other advocates for home-care aides said they would push for federal legislation to lift the exemption or encourage a new administration to interpret the FLSA to cover the attendants." Ruling won't affect every state.

  • Meanwhile, Bloomberg (6/12, Stohr) reports, "At least 10 states impose their own minimum-wage and overtime requirements on providers that employ home-care workers."

  • For example, the Philadelphia Inquirer (6/12, Von Bergen) notes that "yesterday's decision will have little bearing on two local overtime cases involving home-care workers," because "Pennsylvania wage laws do not have the same ambiguities as the federal law. ... Philadelphia-area home-health employees, working with the Service Employees International Union, have filed lawsuits against two nonunion home-care agencies -- Lee's Industries Inc., of Germantown, and Total Health Home Care Corp., of Upper Darby."

  • The Wall Street Journal (6/12, A12, Bravin, Anderson) also notes the Supreme Court's decision.

Monday, June 11, 2007

"Boarding" in EDs on the rise, according to survey

The number of uninsured (and underinsured) continues to rise. Where do these patients go for their health care? The most obvious answer is emergency departments, which are required by Medicare to screen for emergency conditions and to stabilize any they find, regardless of ability to pay. Even those without an emergency condition may get their sore throat and fever treated, or perhaps they will be triaged to the ambulatory care clinic down that hallway and to your left. Meanwhile, hospitals continue to close their emergency rooms after years of struggling to provide care for those uninsured patients, reducing the emergency-care capacity of one community after another.

One of the consequences of this pattern is that the remaining emergency rooms operate at or near capacity for far more hours of far more days than ever before -- over capacity, too, forcing emergency room personnel to treat patients in hallways while they wait for an examining room or in-patient room to open up. The practice is called "boarding," and according to a recent survey of doctors in NY, NJ, and CT conducted by the American College of Emergency Physicians, "boarding has increased significantly in recent years." Yesterday's NY Times had the story, which explored the quality-of-care implications of the practice.

Sunday, June 10, 2007

New dispute over frozen embryos

Just in time for Monday's 4th Bioethics class, here's a Dallas Morning News article on the dispute in Austin over the disposition of frozen embryos, involving a divorcing couple and their interrupted plans for an IVF pregnancy. (The article exemplifies one of my pet peeves about journalists' tangential (at best) understanding of legal process. In its last paragraph, the article states, "Arguments before the Texas Supreme Court in the Roman case have not yet been set," but nowhere this statement does the reporter ever say what the outcome was at the trial court level (Family Court? Probate Court? In what county?) or the intermediate appellate level.)

This is a replay of the famous Tennessee Supreme Court case, Junior Davis v. Mary Sue Davis, which was the first case to say that, absent extraordinary circumstances, the ex-spouse who wants to avoid parenthood should ordinarily be allowed to do so:

In summary, we hold that disputes involving the Disposition of preembryos produced by in vitro fertilization should be resolved, first, by looking to the preferences of the progenitors. If their wishes cannot be ascertained, or if there is dispute, then their prior agreement concerning Disposition should be carried out. If no prior agreement exists, then the relative interests of the parties in using or not using the preembryos must be weighed. Ordinarily, the party wishing to avoid procreation should prevail,
assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. However, if the party seeking control of the preembryos intends merely to donate them to another couple, the objecting party obviously has the greater interest and should prevail.
Most courts have followed the Tennessee court's lead in this arena.

As for the Texas case, here is the appellate court' s opinion (the husband won: "We hold that the embryo agreement provides that the frozen embryos are to be discarded in the event of divorce. By awarding the frozen embryos to Augusta, the trial court improperly rewrote the parties’ agreement instead of enforcing what the parties had voluntarily decided in the event of divorce. Accordingly, the trial court abused its discretion in not enforcing the embryo agreement. ") and a link to the Supreme Court's docket sheet in Roman v. Roman. Petitioner's reply brief on the merits is due June 15th, though the parties in this case have received many extensions of time during their year at the Supreme Court; all told, the case has been kicking around for almost 5 years (nearly as long as the Romans' marriage lasted). More to follow . . . .

Saturday, June 09, 2007

Health Lawyers News, June 8

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

Articles & Analyses

Current Topics

Table of Contents © AHLA, 2007. Reprinted by permission.

Thursday, June 07, 2007

On the day before the House passed the stem-cell funding bill (S. 5 passed in the Senate on April 11), which Pres. Bush has promised to veto, there was interesting, potentially revolutionary (but potentially not) news on the stem-cell science front: Skin cells from mice have been reprogrammed to act as stem cells. If that carries over to humans and the results are consistently reproducible, we're looking at a way to avoid using embryonic stem cells, thus mooting the pro-life objection against destroying an embryo (even one you created as a clone of yourself) to obtain a fresh supply of stem cells. Here are some links and summaries from AHLA:
  • NBC Nightly News (6/6, lead story, 3:05, Williams) led its broadcast with "an amazing piece of science" having to do "with medicine," as well as "with a hugely divisive political issue, embryonic stem cells and their potential to cure the sick and disabled." NBC (Bazell) added, "This is indeed an astounding and elegant piece of scientific research. It's not going to end the debate about embryonic stem cells, but it could be a big step in that direction."

  • The CBS Evening News (6/6, story 3, :30, Couric) noted that "researchers say they have found a way to make stem cells out of ordinary skin cells in mice. If the technique works in humans, scientists might using human embryos. Experts believe stem cells could be used to treat diseases ranging from diabetes to Parkinsons."

  • The Chicago Tribune (6/6, Kaplan) reports, "If the discovery applies to human cells -- and researchers are optimistic that it will -- it would offer a straightforward method for creating a limitless supply of cell lines tailor-made for patients without any ethical strings attached. ... 'This is truly the Holy Grail -- to be able to take a few cells from a patient, say a cheek swab or some skin cells, and turn them into stem cells in the laboratory,' said Dr. Robert Lanza, an embryonic stem-cell researcher and head of scientific development at Advanced Cell Technology Inc. in Worcester, Mass., who was not involved in the research. 'It would be like turning lead into gold.'"

  • In a front-page article, USA Today (6/7, 1A, Vergano) says that "the findings, by three teams publishing in the journals Nature and Cell Stem Cell, mean the reprogrammed cells may offer a non-controversial way...to make rejection-free tissues for transplant patients. But research still hasn't shown that the same cells will work in humans too, the study's authors say."

  • The Wall Street Journal (6/7, Naik) runs a similar report under the headline "Stem-Cell Breakthrough May Ease Ethical Debate." On its front page, the New York Times (6/7, A1, Wade), meanwhile, says that "the technique seems likely to be welcomed by many who have opposed human embryonic stem cell research. It 'raises no serious moral problem, because it creates embryoniclike stem cells without creating, harming or destroying human lives at any stage,' said Richard Doerflinger, the United States Conference of Catholic Bishops' spokesman on stem-cell issues."

  • The Christian Science Monitor (6/6, Spotts) adds, "many researchers say that progress in the U.S. has been hampered by limits...Bush imposed on federally funded human embryonic stem-cell research nearly six years ago." But "the limits also have prompted some labs to hunt for alternate ways to derive cells."

  • In a front-page article, the Washington Post (6/7, A1, Weiss) reports, "Acutely aware that their new work could undermine that key political goal, the scientists cautioned that their success with mouse cells does not guarantee quick success with human cells." They "called for Congress to pass the bill, which would give federally funded researchers access to embryos slated for destruction at fertility clinics. 'A human is not a mouse, so a lot more work has to be done,' said Marius Wernig, who led one team with Rudolf Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Mass."
  • Along those lines, the New York Times (6/7, A32, Pollack) runs another story titled: "A Long, Uncertain Path For New Cell Technique."

Monday, June 04, 2007

TB quarantines are usually a local matter, rarely federal

That's what last night's AP story on Drew Speaker reported. True enough, and this case illustrates that local authority is still pretty much hit-or-miss. Maryland officials claimed not to have the authority to detain or quarantine him, but as the AP reports, many state and local jurisdictions do. Speaker was being kept in quarantine pursuant to a federal order -- the first in 44 years -- but that order lapsed Saturday night, when it was replaced by a local Denver order.

  • CDC's Division of Tuberculosis Elimination has some good information about the case.

  • The ACLU has published some comments on the Speaker case. Although it says there is no indication that federal law has been violated by his quarantine, the group emphasizes the need to get judicial review of Speaker's continued detention. It also has links to its comments on the CDC's proposed rule on quarantining travelers (70 Fed. Reg. 71892-71948 (Nov. 30, 2005)).

Top SSRN downloads in public health law

Here are the top 10 SSRN downloads in public health law as of the end of May:

Sunday, June 03, 2007

Groopman on medical error: it's not all about systems

There's an interesting blog post by Rob Cunningham over at Health Affairs, ostensibly about Jerome Groopman's new book, How Doctors Think. Here's a sample:

[T]he subtlety of the cognitive biases associated with diagnostic error in Groopman’s work and other studies suggests a daunting re-education challenge. Greater reciprocity in doctor-patient relations is a part of the answer that is consistent with many IT champions’ vision of patient-centered care. Other problems are not nearly as well recognized. Mark Graber and colleagues, cited above, found “premature closure,” or the inclination of physicians to settle on a diagnosis before they have gathered enough information or considered all the alternatives, to be the single most common source of cognitive failure. But there are a whole slew of other mental and behavioral weaknesses that may enter into the clinical encounter and drive it into a ditch.

The bottom line, according to Groopman, is that doctors often don’t ask the right questions and don’t listen carefully enough when the patient answers. . . .

It's an interesting problem, and not just for medical schools and training programs. Earlier in the blog post, Cunningham referred to "rushed patient encounters and imperious, overconfident practitioners [as] merely the most obvious symptoms of what can go wrong." I don't know what legislators and regulators can do about imperious and overconfident practitioners, but it's certainly worth asking what systemic conditions have contributed to the rushed patient encounters, as well as other health-care ills -- e.g., "an apparent decline in physicians’ clinical skills, driven at least in part by increasing dependency on high-tech diagnostic tools and financial incentives to see more and more patients."

When we get the health care system we deserve, we also get the practitioners (and practices) we deserve, as well.

Meanwhile, Groopman made an appearance on the Colbert Report recently. Here are the (somewhat predictable) results:

Shouldn't someone at his publisher's have told Dr. Groopman he was going onto a comedy show?

Art Caplan on Dr. Death's release and legacy

I'm glad Art sees this guy the same way I do. Here are some nuggets:
  • I believed Kevorkian was a very dangerous killer [in 1994], and I still believe it now. He helped dozens of depressed and disabled people die without trying very hard to convince them to live.

  • Kevorkian believes in suicide on demand. He thinks that doctors have an obligation to help anyone who decides that their life is not worth living, whatever their reason. Some of the 130 people he helped die had no terminal illnesses. Some were clearly depressed. Others had histories of mental illness. Only a few got any counseling. Kevorkian helped them all to die.

  • Kevorkian’s problem was and is that he likes death way too much. The enthusiasm he brought to his cause was always deeply troubling. No doubts, no ambivalence, ever seemed to cross his mind as he dispatched his victims. The fact that he helped some to die within hours of meeting them, the fact that he would turn a disabled man’s death into a national spectacle by giving a tape of his murder to "60 Minutes" — never mind that they used it! — and the fact that he never seemed to try particularly hard to talk those who came to him out of their decision to die made him morally suspect then and hardly worth hearing from now.

As Caplan points out, the carefully crafted Oregon Death with Dignity Act has resulted in relatively few actual suicides, while at the same time providing the encouragement to develop more effective (and available) palliative care programs. On balance, I am still against legalizing physician-assisted-suicide, but public opinion is slowly swinging in favor of legalization and Oregon has demonstrated that, at least in a state like Oregon, it's possible to avoid the abuses that people like me have worried about.

SSRN: Top health law downloads

End-of-month (or beginning-of-month) recap of the top 10 SSRN downloads in health law (look for public health law rankings tomorrow):

Saturday, June 02, 2007

Tubercular lawyer's world-wide travel raises public health questions

"Drew" Speaker, and every public-health office and official he encountered in the past couple of weeks, are now at the center of a serious controversy. The best single story that summarizes what we know so far appeared in this morning's New York Times. In addition to a full account of Speaker's travels and discussions with public-health officers, John Schwartz asks all the right questions:

  1. "Why would a well-informed person aware of medical concerns get on an airplane after receiving a diagnosis of a disease that could be fatal to others?"
  2. "Why would he flee from health authorities once the diagnosis became even more grave?"

  3. "How could the man’s father-in-law, an expert in tuberculosis at the C.D.C., accede to the trip?"

  4. What does this saga tell us about the legal and practical gaps in our ability to limit the public's exposure to an infected individual, especially one with a motive -- whether benign or malicious -- to be evasive?

  5. How much freedom -- of movement, from surveillance -- will Americans tolerate in order to limit their exposure to infectious disease?
One of the more interesting lessons of this story revolves around Speaker's decision -- which he admits, "In hindsight, maybe it wasn't the best decision" -- to ignore the CDC's instruction not to fly home from Rome on a commerical airliner:
He said that when he was contacted by a representative of the Centers for Disease Control in Rome, he was told that he could not fly home unless he chartered a plane — at a cost of $100,000 — and that he should check into a local hospital. “I felt very abandoned,” he said, emphasizing that he firmly believed he could not infect others. He said he feared he might end up “stuck in an Italian hospital indefinitely, where I could die.”
As Michael Osterholm, an epidemiologist who directs the Center for Infectious Disease Research and Policy at the University of Minnesota, observed:

“Short of a military state where you have 24/7 surveillance on someone, you have to count on the good will of the individual.

He called this a fact of life in an open society, one that could lead to major problems in an outbreak of pandemic influenza, in which many people would probably be boarding planes knowing they were sick to get away from an epidemic. “They would say, ‘I want to make sure I get out,’ ” whatever the risk to others. In that kind of situation, he said, the public health system would inevitably be unable to keep up.


There are a couple of AP stories today that add to what we know about Speaker:

  • TB Lawyer Called 'Pillar' of Community photo
    ATLANTA (AP) - The story of how Andrew Speaker met his future bride still draws laughs from his friends. The young attorney met Sarah Spence Cooksey, an aspiring lawyer, at an Atlanta pub and handed her his fancy business card. When she called, she asked for "Mr. Speaker." But the man she ended up...

  • TB Patient Faces 2 Months in Hospital photo
    DENVER (AP) - The man quarantined with a dangerous strain of tuberculosis will likely spend up to two months in a hospital while he receives a battery of antibiotics and is evaluated for possible surgery, his doctors said. Andrew Speaker is the first infected person quarantined by the U.S....
The most comprehensive coverage of this story seems to be over at the Harvard Public Health School's World Health News site. Here are the stories they've featured:
  • Man With TB Apologizes for Putting Others at Risk
    Lawrence K. Altman and John Holusha (The New York Times, June 1, 2007)
    "The Atlanta lawyer who flew on crowded airplanes while infected with a dangerous form of tuberculosis said today he did not think he presented a danger when he flew and he apologized to his fellow passengers." See also: TB Treatment a 'Challenge,' Doctor Says (The Atlanta Journal-Constitution, June 1, 2007)

  • Agent at Border, Aware, Let In Man With TB
    Lawrence K. Altman (The New York Times, June 1, 2007)
    "The man with a dangerous form of tuberculosis who flew to Europe for his wedding and honeymoon was identified yesterday as a 31-year-old Atlanta lawyer. Department of Homeland Security officials said he re-entered the country from Canada when a customs agent let him pass despite knowing that the man was being sought by health authorities." Free registration required.
  • Case of TB Traveler Reveals Holes in Global Disease Control
    Elisabeth Rosenthal (International Herald Tribune, May 31, 2007)
    "The U.S. health authorities failed to notify their Italian counterparts that an American tourist with an extremely dangerous form of tuberculosis was staying in a Rome hotel this month until he was leaving the country, Italian officials said Thursday. That time lapse allowed him to leave Rome and fly to Prague and Montreal, potentially exposing dozens of people to an often lethal germ."

  • TB Patient's Father-in-Law a CDC Microbiologist
    (Associated Press, May 31, 2007)
    "The honeymooner quarantined with a dangerous strain of tuberculosis was identified Thursday as a 31-year-old Atlanta personal injury lawyer whose new father-in-law is a CDC microbiologist specializing in the spread of TB and other bacteria."

  • Near Misses Allowed Man With Tuberculosis to Fly
    Lawrence K. Altman and John Schwartz (The New York Times, May 31, 2007)
    "A series of 'understandable' near misses accounted for a Georgia man’s odyssey to Europe in which he might have exposed fellow passengers on a series of commercial flights to an exceptionally dangerous form of tuberculosis, federal officials said [Wednesday]." Free registration required.

  • Isolating an Evasive TB Patient
    Editorial (The New York Times, May 31, 2007)
    "Congressional oversight committees ought to examine whether health officials dropped the ball -- and what steps can be taken to ensure that patients infected with deadly contagious diseases protect others from infection." Free registration required.

  • Earlier:
    CDC May 29 Media Relations Telebriefing Transcript
    Atlantan Quarantined with Deadly TB Strain (The Atlanta Journal-Constitution, May 30, 2007) Free registration required.
    CDC Warns of Possible TB Exposure on Atlanta-Paris Flight (The Atlanta Journal-Constitution, May 29, 2007) Free registration required.

Dr. Death out of prison

I can't let the moment pass without acknowledging the release -- after 8 years in the Michigan prison system -- of Jack Kevorkian, a former pathologist who performed active euthanasia (a/k/a "murder") on a patient, filmed it, and allowed "60 Minutes" to air the event (AP, courtesy of Forbes). ("60 Minutes" will broadcast an interview with Mike Wallace this Sunday.)

He's a ding-bat, to be sure. Even many proponents of physician-assisted suicide cringe at the mention of his name. In the name of physician-assisted suicide ("PAS"), he helped strangers, not patients, kill themselves without ensuring that they were terminally ill, without assessing their mental state, and without seriously exploring less drastic means of addressing the concerns that led these citizens to seek out Kevorkian's services. Most, if not all, of the safeguards built into the Oregon Death With Dignity Act were routinely ignored in his quest for publicity for his cause. He shone a spotlight on an issue that needed to be examined and debated, but the way he did it might well have set the PAS movement back years, if not more. The New York Times has a good article on Kevorkian and the status of PAS around the country.

Dutch reality tv program -- "Big Donor Show" -- a hoax

Wouldn't you know: One of the stories that lured me out of semi-retirement and back to HealthLawBlog -- the one about the Dutch tv network that was about to air a show featuring a terminally-ill patient interviewing three candidates in kidney failure to decide which one would get her kidney -- turns out to be a hoax by the network, designed to pressure government officials to reform organ-transplantation laws in the Netherlands. According to the AP (courtesy of The Washington Post), the terminally-ill patient was simply a role played by a Dutch actress (Leonie Gebbink, looking none-too-ill in her publicity shot).

It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:
  • there are currently 96,047 registered patients on various waiting lists

  • over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:

[click to enlarge]







Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.

Friday, June 01, 2007

Health Lawyers News, June 1

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

  • CMS Implements New Marketing, Education Requirements For PFFS Plans
    Abby L. Block Director of the Centers for Medicare and Medicaid Services’ (CMS’) Center for Beneficiary Choices sent a memo May 29 to Medicare Advantage (MA) Private fee-for-service (PFFS) plans reminding them that CMS is requiring new outreach processes to ensure beneficiaries and providers are informed about the distinctive features of Medicare PFFS plans. Full Story
  • Baucus, Grassley Urge IRS To Update Reporting Forms For Nonprofits
    Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) sent a letter May 25 to Treasury Secretary Henry Paulson urging him to update Form 990 and Form 990 PF that nonprofits file with the Internal Revenue Service (IRS) in order to gain greater transparency into the workings of tax-exempt organizations including charities. Full Story

Articles & Analyses

Current Topics


Table of Contents © AHLA, 2007. Reprinted by permission.

Thursday, May 31, 2007

NIH creates and confers new AID research awards

This is a little late in hitting the usually up-to-the-moment HealthLawBlog (!), but it's still worth noting. NIH has created the NIH World AIDS Day Awards to recognize truly brilliant, trail-blazing work by researchers and program managers whose contributions to AIDS research have probably saved the lives of millions. One of the recipients this past year was Bob Yarchoan (who, I am proud to say, was a college classmate of mine). Here's what the award citation said about Bob:

A joint award to Robert Yarchoan, M.D. and Hiroaki Mitsuya, M.D., Ph.D. of the National Cancer Institute — for their individual and combined achievements, groundbreaking discoveries and innovative and original scientific contributions that have significantly advanced HIV treatment research. Their landmark clinical studies, demonstrating that AZT could result in partial restoration of the immune response and temporary clinical benefit, established the first treatment for HIV infection and launched the era of effective therapy for HIV/AIDS. Their work significantly advanced this field, directly impacting on the development of new and better strategies to prevent and treat HIV disease in this country and around the world.

Congratulations, Bob!

Wednesday, May 30, 2007

China's ex-regulator of food and drug gets death penalty

And I thought we took food and drug regulation pretty seriously over here! This is from the AP (courtesy of The Boston Globe), and thanks for the tip to Peter Leibold, the EVP at American Health Lawyers Association:

China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system targeting unsafe food products.

The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods -- from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.

The Beijing No. 1 Intermediate People's Court convicted Zheng Xiaoyu for taking bribes in cash and gifts worth more than $832,000 when he was director of the State Food and Drug Administration, the official Xinhua News Agency said. The court then issued the death penalty, the report said.

Tuesday, May 29, 2007

Dutch reality tv: who will get my kidney?

According to AP this morning (courtesy of the Chicago Sun-Times), the BNN television network in The Netherlands plans to go forward with its reality program, "Big Donor Show," in which a terminally ill 37-year-old woman will interview and choose from among three transplant candidates. The network says they intend the show to serve as a public-service message about the number of Dutch patients (2,000) who die each year while waiting for a kidney transplant. Really? It's not about the cruel exploitation of desperate, dying people in order to boost ratings? Really? Really?

Monday, May 28, 2007

Emergency research protocols expand

It was controversial when the FDA amended its version of the Common Rule (21 CFR Part 50) in 1996 to add a provision that allows for emergency research when true informed consent isn't possible (§ 50.24) -- the first time human subjects could be legally enrolled in research without their consent. The FDA defended the move as a modest exception for the relatively rare instances in which research would be stymied because of the impossibility of obtaining consent that would otherwise be required. As an article in yesterday's Washington Post makes clear, such research is getting considerably less rare, renewing the decade-old debate about whether the FDA's exception is really needed or is encouraging, as BU's George Annas says, " lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible."


Department of full disclosure: I have been a member of a consultation group in Dallas in connection with the emergency research discussed in this article ("Clinical Trial of the Active Compression-Decompression (ACD) and Inspiratory Threshold Valve (ITV) Devices vs Standard CPR").