Monday, February 28, 2005
NPR's Diane Rehm show had a very good program this morning on the avian flu situation. Guests included Dr. Nancy Cox, chief of the Centers for Disease Control and Prevention influenza branch, and director of the World Health Organization's Collaborative Center for Influenza Reference and Research; Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases/NIH; and Mei Fong, staff reporter of The Wall Street Journal. They reiterated the major risk factors discussed in this week's New Yorker piece by Michael Specter -- i.e., that a "perfect storm" scenario for a world-wide pandemic requires three things: (1) a virus that is capable of crossing over from one animal species to man (this has already been established); (2) the virus must be one that is not simply benign in a human host (ditto: the human death rate for this virus appears to be 70-76%); and (3) the virus must mutate into a form that is capable of efficient transmission (i.e., by shaking hands, sneezing, coughing, etc.). This third factor is the still an open question. Dr. Fauci, in particular, provided a useful perspective on the array of possible public-health responses to the appearance of avian flu in this country, should that occur.
Meanwhile, for those of us who could benefit from a public-health law refresher, the CDC has a useful public health law site and has recently concluded a 27-week series on basic public health law readings that I can strongly recommend. Here's the list:
- Epilogue: "Redefining Public Health," a speech by William H. Foege, MD, MPH
- Reading No. 26: Revision of the World Health Organization's International Health Regulations, by David P. Fidler
- Reading No. 25: Illinois House Bill 5164 (2004)
- Reading No. 24: The Draft Model State Emergency Health Powers Act (December 21, 2001)
- Reading No. 23: Chapter 10: "Legal Authorities for Interventions During Public Health Emergencies"
- Reading No. 22: Louisiana v. Gamberella (1993)
- Reading No. 21: Food and Drug Administration v. Brown & Williamson Tobacco Corp. (2000)
- Reading No. 20: Queenside Hills Realty Co., Inc. v. Saxl
- Reading No. 19: McCarthy v. Boozman (2002)
- Reading No. 18: Brown v. Stone (1979)
- Reading No. 17: New York v. New St. Mark's Baths (1986)
- Reading No. 16: "The Path of the Law," by Oliver Wendell Holmes, Jr. (1897)
- Reading No. 15: Camara v. Municipal Court (1967)
- Reading No. 14: Altman v. City of High Point (2003)
- Reading No. 13: Jew Ho v. Williamson (1900)
- Reading No. 12: In re Halko (1966)
- Reading No. 11: People v. Strautz
- Reading No. 10: Benning v. State of Vermont, 161 Vt. 472; 641 A.2d 757(1994)
- Reading No. 9: State of Iowa v. Hartog, 440 N.W.2d 852 (1989)
- Reading No. 8: Bill of Rights, New Hampshire Constitution
- Reading No. 7: Lorillard Tobacco Co. v. Reilly
- Reading No. 6: Wisconsin Statutes Chapter 250, Health: Administration and Supervision
- Reading No. 5: Pelman v. McDonald's Corp., No. 02 Civ. 7821 (S.D.N.Y. 2003)
- Reading No. 4: Chapter 1: "The Law and the Public's Health: The Foundations"
- Reading No. 3: Chapter One of " Public Health Law (3rd Edition) " (1947) by James A. Tobey
- Reading No. 2: Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905)
- Reading No. 1: The United States Constitution
February 28, 2005 | Permalink
The CNN Health website, as well as many others, are reporting that the makers of a new multiple sclerosis drug have voluntarily pulled it from the market today after one patient died and another developed a serious disease. According to CNN,
Experts said the announcement by Biogen Idec Inc. and Elan Corp. marks sad turn of events for MS sufferers who have endured a more than centurylong search for effective treatments for the incurable disease.
The news came three months after the government approved the drug, called Tysabri. Stocks of both Massachusetts-based Biogen Idec Inc. and Ireland-based Elan Corp. tumbled on the announcement.
The companies said they will investigate the effects of the medication further, and they are not giving up hope that the drug may eventually return to the market.
I don't know what to think of the drug manufacturer's vigilence here. I don't have the data here but it seems to me that the quick reaction may be a little too quick. [bm]
February 28, 2005 | Permalink
The Supreme Court will hear arguments today in the Spector v. Norwegian Cruise Line Case. The question presented to the Court concerns whether Title III of the Americans With Disabilities Act applies to cruise ships, and foreign-flagged cruise ships in particular. Title III forbids discrimination in public accommodations. A brief overview of the case is available from SCOTUSblog, which also has a link to the briefs. For a more in-depth review of the case and its issues, please see the National Council of Disability website. [bm]
February 28, 2005 | Permalink
Sunday, February 27, 2005
The New York Times reported earlier this week on a Kansas prosecutor's request for certain abortion records from two Kansas medical clinics. The article states,
Attorney General Phill Kline, a Republican who has made fighting abortion a staple of his two years in the post, is demanding the complete medical files of scores of women and girls who had late-term abortions, saying on Thursday that he needs the information to prosecute criminal cases.
Mr. Kline emphasized statutory rape at a news conference here but also spoke obliquely of other crimes that court documents suggest could include doctors' providing illegal late-term abortions and health professionals' failing to heed a state law that requires the reporting of suspected child sexual abuse.
"When a 10-, 11- or 12-year-old child is pregnant, under Kansas law that child has been raped, and as the state's chief law enforcement official it is my obligation to investigate child rape in order to protect Kansas children," Mr. Kline said. "There are two things that child predators want, access to children and secrecy. As attorney general, I'm bound and determined not to give them either."
I agree with the individual in the story who states that they don't like seeing medical records used to determine whether crimes have been committed. Surely, there are other law enforcement methods available. For a further discussion of this case, and some of the politics involved, please see Ezra Klein's blog, February 26, post entitled, "What's the Matter with Kansas Now?" [bm]
February 27, 2005 | Permalink
If you are still recovering from the news that some of the drug advisors that voted to keep various cox-2 drugs on the market also had ties to the pharmaceutical industry, well, you should brace yourself for yet another pharma story . . . .
According to Science Daily, a UCLA study uncovered the fact that nearly 1/3 of drug ads in medical journals did not contain references supporting medical claims. The researchers explained their reasons for conducting such a study in addition to their findings. Science Daily reports,
"Previous studies have shown that physicians' drug prescribing is influenced by pharmaceutical ads. We wanted to see what documents were being used to substantiate the claims and how accessible these were to physicians who may want to verify the research findings," said lead author Dr. Richelle Cooper, assistant clinical professor, Division of Emergency Medicine, David Geffen School of Medicine at UCLA.
Two UCLA investigators independently reviewed 438 ads from 10 American medical journals from 1999 and also reviewed a random sample of 400 references in journal articles from the same publications for comparison.
Researchers found that out of 438 pharmaceutical ads, 126 (29 percent) offered no references in support of medical claims. The most commonly cited references in the ads included journal articles (55 percent) and data-on-file (19 percent), which is a reference to an unpublished company document. Other sources included books; prescribing information such as the Physician's Desk Reference, which annually provides information on drug usage, warnings and drug interactions; government documents; or an Internet site.
You can read the full study in Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ. 2005;72: February 15. [Free full-text]
For further comments, see Majikthise, Caveat Medicus, from February 24, 2005. She is a wonderful blogger and has some great insight into this story having worked previously as a medical writer.
Thanks to Majikthise for this story and her illuminating comments. [bm]
February 27, 2005 | Permalink
I apologize that I have not been blogging regularly this week. I have pink eye and a rather nasty cold thanks to my beloved son, so I have been out of commission. I am feeling a little better today and will try to catch up on some of the exciting news in health law.
This first piece is just a bit of fun (although not so much for the parties involved). With an eye catching headline like: "Court: Man May Sue Over Surprise Pregnancy, But Sperm Were Hers to Keep" - even someone with pink eye takes note. The story as reported by AP continues:
A man who says his former lover deceived him by getting pregnant using semen obtained through oral sex can sue for emotional distress but not theft, an appeals court has ruled.
Dr. Richard O. Phillips accuses Dr. Sharon Irons of a "calculated, profound personal betrayal" six years ago, but she says they had the baby through sexual intercourse.
[ok, how did these two get to be doctors?]
The Illinois Appeals Court said Wednesday that Phillips can press a claim for emotional distress after learning Irons had used his sperm to have a baby, but agreed that however the baby was conceived, Irons didn't steal the sperm.
"She asserts that when plaintiff 'delivered' his sperm, it was a gift," the decision said. "There was no agreement that the original deposit would be returned upon request."
Ok, I always thought the pre-embryo custody cases (Davis v. Davis, J.B. v. M.B. and A.Z. v. B.Z. just to name a few) were interesting because they involve difficult questions about life and when it begins,as well as whether reproduction should occur over someone's objection. I usually have rather interesting class discussions about these topics. This case also involves someone who has had their genetic material used for reproductive purposes without their permission, and how we can define genetic reproductive material. However, I will need to read this case to see if it adds anything further to the discussion. (I mean, who would have thought - sperm may be viewed as a gift that individuals receive during sex - and an irrevocable gift at that. Once you get lawyers involved, even sex doesn't seem quite as exciting). [bm]
February 27, 2005 | Permalink
This week's New Yorker (Feb. 28 issue) has a longish piece by Michael Specter on avian flu and the chances that it might be the next global pandemic. It's well worth reading but unfortunately is not available on-line. An on-line companion piece, though, is available here. It's a Q&A with Specter and provides a quick overview of Specter's article. Caution: This piece is not going to help you sleep any better tonight. [tm]
February 27, 2005 | Permalink
Well, sure, at least in theory. At least, that's the topic of an article in today's Business section of The New York Times. The driving force behind the theory is the inexorable rise in the cost of Medicare, as projected by the Congressional Budget Office, which projects that annual Medicare expenditures will more than double over the next ten year and increase from 6+% of total federal outlays to nearly 20%. Health care goods and services in the last year of life account for 28% of the Medicare budget, a share that has held steady for a number of years.
As the article points out, there are a couple of stumbling blocks between where we are now and the eradication of nonbeneficial end-of-life treatment.
First, it is sometimes obvious only in hindsight that these were a patient's last months of life. There are some clinical markers that are helpful in this regard, but a lot of research remains to be done before our prognostic ability gets markedly better.
Second, it is not yet clear that substituting palliative care for more invasive and intensive care will save a lot of money for the program. Hospice care, for example, accounts for a tiny fraction (1.6%) of the Medicare program (and, if my memory serves, is typically provided in the last week or so of life, despite Medicare's six-month hospice benefit). Again, the research to determine how much money, if any, will be saved by a transition to greater hospice use just isn't there.
Third, forgoing high tech interventions when confronted with a life-threatening condition runs contrary to human nature. The best possible care is often equated with the most care obtainable at any price. Unfortunately, this stance ignores the human cost of such decision making in terms of increased suffering. The article quotes Arnold Relman: "Sometimes, you know that death is inevitable over the next few weeks or few months. And then there are some doctors, and some families, who just don't want to confront that, and feel that they want to and should invest everything possible - the maximum amount of resources - in fighting the inevitable. That often results in prolonging the pain and discomfort of dying."
If there is an answer to any of this, it seems to turn on the availability of better research that translates into evidence-based medicine. Without it, the culture shift that is needed before there will be progress on this issue just won't happen. [tm]
February 27, 2005 | Permalink
Saturday, February 26, 2005
I guess by now everyone's either seen "Million Dollar Baby" or read about it. "The Aviator" may be the odds-on favorite, but MDB is at least in the running. If you're still trying to figure out what's up with MDB, here's a good discussion of the euthanasia issue. And Art Caplan has a take on this, as well. [tm]
February 26, 2005 | Permalink
Friday, February 25, 2005
Reader Christina Solis has pointed to this NPR report on the government of Thailand's regulation of cock-fighting as a mechanism to reduce the chances of chicken-to-human transmission: "Disease experts say that could start a flu pandemic that would kill millions of people around the world." [tm]
February 25, 2005 | Permalink
Thursday, February 24, 2005
Some years ago, it was the Gilgunn case (unreported, but still famous). Now Massachusetts General Hospital is back in court in another futility dispute. According to an article in the Boston Globe (for which, many thanks to reader Jay Cortellini), Barbara Howe has ALS and has been an in-patient at MGH for five years. At least since 2003, the hospital has wanted to withdraw life-sustaining treatment from Ms. Howe:
[D]octors have said that Howe is ''locked in" her own body, and in June 2003, the head of the hospital's end-of-life committee, Dr. Edwin Cassem, a Jesuit priest and psychiatrist, wrote that ''the patient's status has surpassed an acceptable limit endangering her integrity, dignity, humanity, and basic human rights."
The hospital says the patient has recently taken a turn for the worse, and that ventilator support "is inappropriate and harmful, indeed inhumane." Everyone is back in court to find out who has the authority to decide whether Ms. Howe continues to live on the vent. [tm]
February 24, 2005 | Permalink
I don't know if you have been following the many stories (see here, here, here and here) about the Bird Flu, but it does appear that the it is still around and spreading, and thus should be something that we all learn about quite soon. Some are predicting that if it becomes highly contagious in humans, the resulting epidemic would be worse than SARS. Radio Free Europe reports on a World Health Organization (WHO) conference:
UN officials are warning that the bird-flu outbreak in Asia poses the "gravest possible danger" of becoming a global human threat. At a conference under way in Ho Chi Minh City chaired by the World Health Organization (WHO) and the United Nations' Food and Agriculture Organization, the current situation of the virus is being assessed -- and many experts say the bird-flu virus has become more complex and could develop into a human virus.
WHO's Western Pacific regional director, Shigeru Omi, raised concerns. "It is now being found in animals such as cats and tigers, that were not previously considered susceptible to influenza A viruses," Omi told Reuters. "Not only that, it is more pathogenic than the strain found in Hong Kong in 1997. This suggests that the virus is evolving in ways that increasingly favor the start of a pandemic.""The important thing for all of us is that if the [avian flu] virus becomes highly contagious among humans, the health impact in terms of deaths and sickness will be enormous, and certainly much greater than SARS."
February 24, 2005 | Permalink
If you have interest in not-for-profit hospital litigation (or perhaps have to keep an eye on such cases), the following link may prove helpful: http://www.nfplitigation.com/NotForProfit/disclaimer.aspx
Thanks to Jim Tomaszewski for the weblink. [bm]
February 24, 2005 | Permalink
Wednesday, February 23, 2005
Interesting story from the AP (courtesy of Yahoo!): "Children's Hospitals in Renovation Boom." The story refers to a 2003 study that tracked over $2.3 billion in renovations and other new construction at only four facilities.
Of particular note to health lawyers:
The boom stems from changes in U.S. health care that have given children's hospitals a larger share of a shrinking market, said Lawrence McAndrews, president of the National Association of Children's Hospitals. With managed care's emphasis on hospitalizing only the sickest patients, most children needing hospital care are now sent to children's hospitals.
Children's hospitals are "repackaging" themselves to attract patients and top doctors, and children-centered features are a key ingredient, McAndrews said.
Reminds me of the boom in psych hospitals and psych units within hospitals, as investors chased the higher (non-DRG) reimbursements that were available in the late 1980's and early 1990's. That led to massive fraud and abuse charges and equally massive settlements. How much do you want to bet that we will be reading about government scrutiny of some children's hospital's recruitment and billing practices before year's end? [tm]
As reported by the Food and Drug Law Institute yesterday in its "SmartBrief," a UN panel has approved a nonbinding resolution that recommends that all member nations ban all forms of human cloning. This could potentially include cloning-for-research, as well as reproductive cloning, which would be a setback for stem-cell research if member nations follow the panel's recommendation. Nature has a good story on this development. Wired is also listed as a source for FDLI's report. [tm]
Tuesday, February 22, 2005
The New York Times today ran an article entitled, "Behind Those Medical Malpractice Rates," by Joseph Treaster and Joel Brinkley. Their conclusions won't surprise anyone who has followed the literature on this subject over the past 20 years, though it does fly in the face of the publicity machines at various state medical and hospital associations, as well as the PR juggernaut launched and promoted by President Bush, who has been on the stump this past month in support of his damage-cap legislation.
Despite the rhetoric that med mal premiums are soaring because of the cupidity of the plaintiffs' bar and the stupidity of jurors, the authors paint a different picture:
[F]or all the worry over higher medical expenses, legal costs do not seem to be at the root of the recent increase in malpractice insurance premiums. Government and industry data show only a modest rise in malpractice claims over the last decade. And last year, the trend in payments for malpractice claims against doctors and other medical professionals turned sharply downward, falling 8.9 percent, to a nationwide total of $4.6 billion, according to data.
The authors conclude: "Lawsuits against doctors are just one of several factors that have driven up the cost of malpractice insurance, specialists say. Lately, the more important factors appear to be the declining investment earnings of insurance companies and the changing nature of competition in the industry. The recent spike in premiums - which is now showing signs of steadying - says more about the insurance business than it does about the judicial system."
And do the doctors benefit from caps on damages? Apparently not:
[S]ome researchers are skeptical that caps ultimately reduce costs for doctors. Mr. Weiss of Weiss Ratings and researchers at Dartmouth College, who separately studied data on premiums and payouts for medical mistakes in the 1990's and early 2000's, said they were unable to find a meaningful link between claims payments by insurers and the prices they charged doctors.
"We didn't see it," said Amitabh Chandra, an assistant professor of economics at Dartmouth. "Surprisingly, there appears to be a fairly weak relationship.
This is an article worth reading and saving, right along with the August 2004 testimony of GAO researchers ("Medical Malpractice Insurance: Multiple Factors Have Contributed to Premium Rate Increases") and the June 2003 report of the same title. [tm]
The AP is reporting (courtesy of The Washington Post) that the 2nd District Court of Appeal has allowed the stay to expire that had been preventing Terri Schiavo's husband-guardian, Michael, from removing her feeding tube. The story reports that her parents are going to ask a Pinella County judge for an emergency stay to give them enough time to file appeal papers. The New York Times story on the grant of cert. in Gonzales v. Oregon also reports that Terri's parents are asking for a stay, and goes on to state that they are planning to file an appeal in the U.S. Supreme Court. [tm]
Just to add a further observation onto Betsy's post (below) re: today's grant of cert. in Gonzales [substituted for Ashcroft] v. Oregon, No. 04-623 . . . The Oregon Death With Dignity Act won't be reviewed directly in this case, which is a challenge to the DOJ policy of prosecuting physicians who prescribe controlled substances in accordance with the Death With Dignity Act. The 9th Circuit's opinion, which struck down the DOJ policy, is here, and the SG's petition for cert. is here. According to an article on the New York Times' web page, the case won't be argued until after the October 2005 Term begins. [tm]
Scotusblog is reporting that the Supreme Court has decided to review Oregon's Death with Dignity Act which permits physician-assisted suicide. I am surprised that they decided to grant review and I really don't know what this means for the future of the Act. It has always been controversial to some but the courts (thus far) have firmly upheld it. [bm]
Monday, February 21, 2005
On the Nightly Business Report (PBS) tonight, they did a complete show on how to control the cost of medical care. They focused on some of the President's proposals to provide consumer accounts and discussed the failure to managed care to control cost in the late 1990s. It is amazing how quickly the cost of medical care add up and the different approaches are interesting to consider. I don't mind some of the European socialization models but they do not seem to be very popular in Congress. Anyway, it was an interesting and informative show. [bm]