HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, January 22, 2005

Shocking News: Vioxx and Celebrex Overprescribed!

A recent study by doctors at Stanford University and the University of Chicago found that both Vioxx and Celebrex, heavily marketed as "super-aspirin," had been prescribed for millions of patients who were not at risk for gastrointestinal bleeding, the main reason patients were told to switch from aspirin to COX-2 inhibitors.

With data from the National Center for Health Statistics, the study concluded that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs, and that those who were switched had to pay more for their drugs. According to the study, COX-2 inhibitors cost 10 to 15 times as much as the drugs they replaced.  The study may be found in the  January 24th issue of the Archives of Internal Medicine.

As you are all well aware, Merck recalled Vioxx last year because the drug has been linked to an increased risk of heart attacks and strokes.  More recently, studies have shown that Celebrex, manufactured by Pfizer, may pose similar risks to patieints. 

January 22, 2005 | Permalink | Comments (1)

Maternal Brain Death (Recent Addition to SSRN Database)

Maternal Brain Death, 30 Am. J. L. & Med. 453 (2004).  Abstract

Medical technology and sceintific knowledge enables health-care providers to maintain a brain-dead pregnant woman on life-support for the successful delivery of her fetus. However, the legality of such practice as well as its ethical implications remain unclear. The article examines the various aspects of this postmortem procedure. First, the permissibility of such an action is analyzed through discussion of other legal situations dealing with some similar aspects, namely abortion-law and Human tissue gift law. Following this, the major issues arising in this dilemma are being discussed. These issues include the moral and legal status of the fetus, on the one hand and of the dead, on the other hand; interest to life; pragmatical obstacles derived from the proposed procedure, the legal requirement of consent, physician-patient relationship and the status of next-of-kin in such situation. The article concludes with some practical guidelines for health-care providers, lawyers and other interested people at large.

[tm]

January 22, 2005 | Permalink | Comments (0)

OTC Status of 'Morning After' Pill Again Before FDA

_1441898_pill_black300 As reported in the Wall Street Journal (subscription required), "Fierce arguments have gone on inside and outside the Food and Drug Administration, which may decide as soon as this week whether pharmacies can sell the emergency contraceptive, known as "Plan B" -- which prevents pregnancy when taken 72 hours after unprotected sex -- without a prescription to women age 16 and older."

The drug was turned down as an over-the-counter drug last spring:

"Some staff have expressed the concern that this decision is based on nonmedical implications of teen sexual behavior, or judgments about the propriety of this activity," said the memo by the FDA's acting drug chief, Dr. Steven Galson, who last spring rejected the first application for Plan B's sale over the counter. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."

[tm]

January 22, 2005 | Permalink | Comments (0)

Friday, January 21, 2005

More on Single-Payer Health Insurance

When the topic is national, universal health care coverage, the go-to people and groups are the usual blue-state suspects: Physicians for a National Health Program, NOW, National Health Care for the Homeless Council, the Massachusetts Nurses Association, American Medical Students Association, Congress of California Seniors, and Sydney Wolfe of Public Citizen's Health Research Group, to name only a few.  But you have to figure the idea is starting to get some traction when it attracts the attention and support of an overflow crowd of rural docs in Colorado.  You can read about it in a recent article in The Denver Post.  Here's how it starts:

Rocky White is an unlikely radical.

A Nebraska-bred country boy, a Republican- voting, ranch-owning, small-town doctor, he hardly fits the profile of a wild-eyed revolutionary.

But White and a handful of cohorts are, in fact, trying to foment upheaval.

The revolution they are proposing: a national health-insurance program.

Nothing short of that will fix what White calls "our god-awful broken system."

White says he didn't jump to this conclusion.

He was pushed.

Pushed by the same forces that plague health care across the country: steep insurance premiums; soaring prescription-drug costs; 45 million Americans without health insurance; bureaucracy; and Medicare and Medicaid reimbursements that don't cover costs.

If anything, these problems are accentuated in rural, and overwhelmingly poor, parts of the country like the San Luis Valley in Colorado:

That is what drove White to join forces with Dr. Gladys Richardson, an unabashed liberal, a woman who could hardly be more different from White.

In August, they invited virtually every health care provider in the five-county valley to hear their pitch for national health insurance.

The response was so huge they had to move the evening meeting from White's office to the largest conference room in the largest hotel in Alamosa.

Dr. White does a nice, succinct job of describing the "health-care death spiral":

As White sees it, the spiral goes something like this: Health care costs go up; fewer people can afford insurance. More people without insurance "creates more people that have to be seen in hospitals and emergency rooms, and who are unable to afford their bills."

So hospitals charge more to insured patients. Then, insurance companies pass those increased costs on in the form of higher insurance rates. "And then ... more people are off the insurance rolls."

Draw a straight line from East L.A. to Boston, and it runs right through the San Luis Valley in Colorado.  It turns out patients, doctors, and hospitals in those places all may have more in common than they'd have ever guessed.  [tm]

January 21, 2005 | Permalink | Comments (0)

Law Firm Newsletters: Roundup

Law firms routinely post articles, newsletters, client alerts, etc. to their web sites.  Many are thinly-disguised teasers, telling just enough to interest clients (and potential clients) and giving a handy phone number that will connect the reader to a willing associate or partner who will gladly expound and expand on the published comments for no more than $500 per hour.  That said, they are occasionally a good source of information on developments deemed by health lawyers to be worthy of comment and fair warning.

That said, I offer herewith a quick overview of some of the more useful postings by these ready-to-please health lawyers, in no particular order of significance:

January 21, 2005 | Permalink | Comments (1)

Proposed Legislation to Limit Insurers' Antitrust Exemption

BNA reports that Democrats in Congress plan to pursue a very different legislative agenda when it comes to health issues than the President.  Recently, Sens. Patrick Leahy (D-Vt.) and Edward M. Kennedy (D-Mass.) indicated that they seek to reform  the medical malpractice insurance industry.   On January 13th, Leahy and Kennedy  circulated a "Dear Colleague" letter soliciting cosponsors for legislation that limits an insurance industry exemption from antitrust laws contained in the McCarran-Ferguson Act.   Both senators assert that the exemption enables malpractice carriers to collude to set higher premiums than true competition would achieve.  The proposed bill, less than two pages in length, contains the same language as unsuccessful legislation (S. 352) they offered in the previous Congress.

January 21, 2005 | Permalink | Comments (0)

Florida Business Proposal for Tort Reform - Most Radical?

Index0101_1 I have been following with interest the various tort reform measures that have been proposed around the country over the past few years.  I can honestly say that I believe the recent reform proposed by a Florida business group should win the award for the most radical changes to our legal system, not just our tort system.

The Associated Industries of Florida, sent to the Florida legislature a massive (111-page) proposed revision to Florida's tort system which would abolish punitive damages, cap attorney fees and noneconomic damages in all tort cases and grant immunity from malpractice lawsuits to emergency room doctors.   Other provisions of the legislation would repeal the Sunshine in Litigation Act, which bars state court judges from sealing judgments that conceal public hazards, further cap damages in patient abuse and neglect lawsuits against nursing homes and allow jail time for those who duck jury duty.

The Republican-controlled Florida legislature have not yet expressed an opinion on the bill.  They are eager, however, to enact further tort reform.  In recent years, they have been successful in passing bills that cap damages for awards in medical malpractice cases.   The Academy of Florida Trial Lawyers and some Democratic legislators who oppose the tort measures view this legislative package as a signal that business and industry plan to attack the plaintiff bar again this session.

So, what do Florida doctors think about this proposed legislation?  They seem to have a completely different agenda.  The Florida Medical Association has promised its members to work to protect doctors' right to practice without malpractice insurance (mmm - interesting idea - I am sure that it will improve the quality of care that Florida residents receive), to maintain the wrongful death exemption, which prevents family members of single adults who die in an accident from filing lawsuits, to restrict attorney advertising, and to enact legislation that restricts who can serve as an expert witness in malpractice cases.  [bm]

January 21, 2005 | Permalink | Comments (0)

Thursday, January 20, 2005

Medicare to Cover Expensive ICDs

News The Centers for Medicare and Medicaid Services announced yesterday that it will expand its coverage for surgically implanted heart-shocking devices for people with weakened hearts.  The devices, called implantable cardioverter-defibrillators (ICDs) sense heart rhythm abnormalities and deliver shocks to the heart when potentially fatal flutters occur.

The Medicare decision is significant not only for its cost (estimated at more than $3 billion a year), but also because it demonstrates the government's willingness to use Medicare as a way to learn more about what works and what does not in medicine.  Officials report that to receive ICD coverage, Medicare requires that the patient permit the collection of ongoing information about his/her health.  The government plans to use such research to determine who best responds to the ICDs. 

The Washington Post reports that, "The plan is part of an evolving federal effort to prevent a replay of recent events in which physicians and patients were surprised to learn that some popular anti-inflammatory drugs and antidepressants have more side effects than previously recognized. Given the huge numbers of patients who receive drugs and medical devices through Medicare, officials said, long-term data collection by the program can be a powerful complement to the modest follow-up efforts made by manufacturers and the Food and Drug Administration."

The coverage decision coincides withthe  publication, in the New England Journal of Medicine, of results from a major study of ICDs sponsored by the National Institutes of Health.

It should be interesting to follow what happens with this decision.  Monitoring of the program will be required to ensure that patient participation in more than data collection research is not made a condition of receiving medical care.   In addition, I have heard from one cardiologist that some patients who have received a ICD shock have asked to have the ICD removed because, even though it saved their life, they have no wish to experience the shock again and would prefer to take their chances.  So, I wonder if Medicare will cover removal costs as well.  [bm]

January 20, 2005 | Permalink | Comments (0)

Wednesday, January 19, 2005

Bizarre Chemical Bombs

I am not quite sure what to think of this BBC article and I recognize that it
is a bit off topic, but I found it quite amazing (and amusing) how creative our military
can be.  The BBC article reports that the U.S. military investigated building
several different types of chemical bombs including the "gay bomb" which would
make enemy soldiers "sexually irresistable" to each other, and the halitotis bomb,
which would make soldiers obvious by their bad breath.  These specialized,
non-lethal chemical bombs were under consideration by the U.S. Air Force in
an effort to disrupt the enemy. 
The BBC obtained the U.S. Defense department records discussing plans for these
devices from the Sunshine Project, a  chemical and biological research monitoring
organization.  According to the BBC, "The plan for a so-called "love bomb"
envisaged an aphrodisiac chemical that would provoke widespread homosexual
behavior among troops . . .   My personal favorite project was the "Who? Me?
bomb which simulates flatulence in enemy ranks.  Apparently that bomb has
been under consideration since 1945 but was never developed due to the fact
that "people in many areas of the world do not find faecal ordour offensive, since
they smell it on a regular basis."  Plus, they didn't even consider individuals like
my young son for whom such noise and stink are quite amusing.  The good news
is that if any of these proposals had been developed, the government assures us 
that "It's important to point out that only those proposals which are deemed
appropriate, based on stringent human effects, legal, and international treaty
reviews are considered for development or acquisition."   Personally, I think that we
should develop the "why can't we all get along?" device and have no more
wars at all.  [bm]

January 19, 2005 | Permalink | Comments (0)

Cancer is Nation's Top Killer

Yesterday the American Cancer Society released its annual statistical report which showed for the first time that in the year 2002, the most recent year for which data is available, 476,009 Americans under 85 died of cancer compared with 450,637 who died of heart disease.  This marks the first time that cancer has surpassed heart disease as the number one killer in America.  Health officials report that although deaths from both have fallen, the improvement has been more dramatic for heart disease.  The single biggest reason: fewer smokers.   Health officials expressed hope that many more deaths may be prevented because a third of all cancers are related to smoking, and another third are related to obesity, poor diets and lack of exercise — all factors that also contribute to heart disease.  Thus, if people only stopped smoking, ate right, and exercised more, they might be less likely to suffer from either cancer or heart disease.  The top killers were cancer, heart disease, injuries, lung disease and strokes.  [bm]

January 19, 2005 | Permalink | Comments (0)

Norma McCorvey (Roe) Ask SCOTUS to Overrule Roe v. Wade

Court_1 In 2003 the federal district court in Dallas rejected Norma McCorvey's request to overrule the case she famously brought more than 30 years ago, Roe. v. Wade.  In 2004 the Fifth Circuit Court of Appeals affirmed, with a strongly worded concurrence from Judge Edith Jones, who is widely reported to be on the very short short-list for any upcoming vacancy on the Supreme Court, arguing that Roe should indeed be consigned to the trash heap of history.  As reported by the AP this afternoon, Ms. McCorvey has asked the Supreme Court to reverse the lower courts and overrule Roe.

Even if five justices were prepared to overrule Roe today, is this the vehicle for them?  It's hard to see how Ms. McCorvey can overcome the objections that her FRCP 60(b) motion for relief from judgment is simply 30 years too late and the case is now moot.  Lyle Denniston has a link to the cert. petition over on SCOTUSBlog[tm]

January 19, 2005 | Permalink | Comments (0)

HHS Secretary Nominee Leavitt and Negotiating for Drug Prices

During his sentate confirmation hearing yesterday (which clearly is not receiving as much attention as Dr. Rice's), Michael Leavitt, President Bush's nominee for HHS Secretary discussed some of his views concerning Medicare and Medicaid.  CBS reports that in the hearing before the Senate Health, Education, Labor and Pensions Committee, Mr. Leavitt expressed opposition to the federal government negotiating drug prices on behalf of seniors in Medicare.  He further stated that he believed that the Medicaid program needed reforming.  Finally, he also focused on the importance of appointing a new commissioner for the FDA quickly.

  For further information, the full hearing is available on C-Span here.  [bm]

January 19, 2005 | Permalink | Comments (0)

FTC Announces Final Settlement in Price-Fixing Case

On Friday, Jan. 14, the FTC announced its final approval of a consent decree in a price-fixing case, White Sands Health Care System, LLC.  In essence, most of the health providers in the Alomogordo, including most of the physicians and all of the CRNAs, were charged with negotiating with managed care organizations and other third-party payors in a manner that amounted to price-fixing and concerted refusals to deal.  All of the pleadings and related documents in the case can be found here. [tm]

January 19, 2005 | Permalink | Comments (0)

Tuesday, January 18, 2005

CDC's Public Health Law Site Adds New Reading

As part of its on-going public-health eductional efforts, the CDC's Public Health Law Program website offers 26 readings in public health law.  This week they added No. 21, FDA v. Brown & Williamson Tobacco Corp. (U.S., 2000).  I think that, taken together, the CDC readings constitute a fine intro public-health-law curriculum.  Are there any readers who think CDC's missed something important, or has place its thumb too heavily on the scales in favor of one topic or another?  [tm]

January 18, 2005 | Permalink | Comments (0)

FTC Aims to Undo Chicago Hospitals' Merger

Ftclogo From HealthLeaders' legal news:

Federal regulators are targeting what they say is an elusive culprit contributing to the soaring hospital costs of recent years: mergers. In February, the Federal Trade Commission will seek to undo the January 2000 takeover of Highland Park Hospital, in suburban Chicago, by Evanston Northwestern Healthcare Corp. The FTC accuses Evanston, which already ran two hospitals in the area, of antitrust violations, saying it used its postmerger "market power" to impose huge price increases on insurers and employers.

The source for this story is a piece in Monday's Wall Street Journal (requires paid registration).

Pleadings and motions are on-line in FTC Docket No. 9315[tm]

January 18, 2005 | Permalink | Comments (0)

Cuts in Medicare

The New York Times reports today that the Medicare Payment Advisory Commission has voted to recommend a cut in Medicare payments promised to hospitals and a freeze in payments to nursing homes and home care agencies in 2006.  The Commission also recommended a 2.7 percent increase in Medicare payments to doctors.

According to the Times, the Commission has a great deal of influence with Congress and the Bush administration is likely to welcome its recommendations at a time when it is making domestic spending cuts a priority.   The hospital community has criticized the report, claiming that it will be used to cut the budget rather than as a way to consider the efficient delivery of health care services.

The Commission also expressed some concern about doctors providing diagnostic imaging services such as x-rays, CAT scans, PET scans, magnetic resonance imaging, ultrasound, echocardiography and other imaging.  Due to what the Commission members felt was poor quality testing, it recommended that the Secretary of Health and Human Service develop new standards for doctors billing Medicare for such services.  Such standard-setting would be a first for Medicare and may cause some irritation among physicians.  [bm]

January 18, 2005 | Permalink | Comments (0)

Please Take This Survey

Foundation Press LogoThompson-West LogoWest Publishing Company and Foundation Press, sponsors of this blog and our Law Professor Blogs Network, have asked that we help identify our readership through this on-line survey.  They (and we) would like to figure out the mix of professors, judges, lawyers, librarians, students, and others who read this blog.  The survey takes less than a minute to complete.  Thanks in advance for your help.

January 18, 2005 | Permalink | Comments (0)

Monday, January 17, 2005

Balitmore Sun Series: "If I Die"

Rjs_cancer_book In late December 2004, the Baltimore Sun ran a series of articles entitled, "If I Die"  (free registration required). The articles chronicles the dying of 12-year-old "R.J."  It also provides information on the Initiative for Pediatric Palliative Care and its resources for patients, families, and health care professionals.  Overall, this is the type of public education from which many families would gain a lot of strength and insight, though the transitory nature of newspaper articles probably make them not the most effective forum.

Here's the Sun's precis of the series installments:

In preparing these articles, The Sun relied on medical records, R.J.'s personal journals and interviews with family, friends, physicians, teachers and others.

The Sun received permission from R.J., his mother, Michele Voigt, and the Johns Hopkins Children's Center to be present during the last four weeks of R.J.'s life, except, at his mother's request, his death.

Most of the events described in this series were witnessed by the reporter and photographer. In addition, 15 families who have lost children, as well as more than 70 health care professionals, were interviewed.

The most difficult journey
R.J. Voigt was dying. His doctors knew it. His mother knew it. Even the 12-year-old knew it somewhere deep inside himself. But medicine allows parents and children to hold on to hope for a cure. (Dec 19, 2004)

Buying time at a heavy price
Treatment gives R.J. Voigt an additional year of life -- and intense pain. Across the country, children and those who care for them struggle with hard choices as death nears. (Dec 20, 2004)

Learning how to say goodbye
As R.J. Voigt confronts his impending death, so must his mother. For the families of terminally ill children, there are no guidelines for letting go. (Dec 21, 2004)

Living on, with heartbreak
When a parent says goodbye to a child, another journey begins. Organized medicine is seeking ways to help deal with the anguish. (Dec 22, 2004)

Excerpts from the journal of R.J. Voigt
12/16/2001 (Dec 19, 2004)

Resources
Links, phone numbers and books for those who have loved ones who are terminally ill. (Dec 19, 2004)

The Initiative for Pediatric Palliative Care (IPPC) Resources
Spearheaded by the Education Development Center in Newton, Massachusetts, IPPC is a national consortium aimed at enhancing culturally respectful, family-centered care of children living with life-threatening conditions. After five years of research and development, IPPC has produced more than 25 hours of instructional material as well as QI tools. In 2005, IPPC will be scheduling a series of innovative educational retreats throughout North America in which health care professionals and bereaved family members join together to address critical issues in pediatric palliative care. For detailed information about the project, its curriculum and the planned retreats, visit www.ippcweb.org or call 617-618-2822. (Dec 20, 2004)

Pediatric Palliative Care Q&A
Questions answered by health care professionals of Harriet Lane Compassionate Care
[tm]

January 17, 2005 | Permalink | Comments (0)

Popular Culture & Medicine: Where's Hollywood When You Really Need It?

I was holding this post "in reserve" for later this week, but since Betsy's broken the ice, here's my take on the "doctors in the movies" article:

In the January 24 American Medical News, there's an interesting article on the way Hollywood currently portrays physicians and the health care system in general: "Hollywood just doesn't make movie doctors like they used to":

Wisconsin pediatrician Glenn Flores, MD. Dr. Flores has rented and watched about 150 films spanning 80 years to gauge how physicians are depicted in films. In an article in the December 2004 Archives of Disease in Childhood, Dr. Flores says money and materialism are common themes in movies about doctors. Movie physicians base treatment decisions on a patient's ability to pay, and they are hampered by inefficient bureaucracies and health care systems.

An abstract of Dr. Flores' article is here.   And, as for his 'Top 10":

[tm]

January 17, 2005 | Permalink | Comments (0)

Doctors in the Movies

The AMNews reports on an interesting article by Dr. Glenn Flores, MD. Dr. Flores  watched approximately 150 films spanning 80 years to examines how physicians are depicted in films.  In an article in the December 2004 Archives of Disease in Childhood, Dr. Flores states that "money and materialism are common themes in movies about doctors."  He cites specifically the recent films, John Q and As Good as It Gets, both of which protrary physicians who base treatment decisions on a patient's ability to pay, and who are hampered by inefficient bureaucracies.

I will be writing more about this later to share some of the ideas of Professor Pendo, Professor Hall.  They presented materials that they use in their law school classes to study society's view of the medical profession at the American Society of Law, Medicine & Ethics annual meeting last June.  It was a wonderful presentation and they have many helpful ideas that I will share with you in later posts.  [bm]

January 17, 2005 | Permalink | Comments (0)