HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, June 11, 2005

Italy and Fertility Law Referendum

Italy is not having an easy time with its new restrictive fertility law as news about tomorrow's  referendum on the law demonstrates.  According to the New York Times,

As Italy's most powerful men - from politicians to bishops - debated the ethics of the country's restrictive fertility law this week, Lorena Pennati lay gingerly in a hospital bed here, rubbing the sore spot where doctors had just removed nine of her eggs.

   

Because of the law's strict limits on the use of eggs, sperm and embryos - the subject of a contentious national referendum here this weekend - Ms. Pennati, 34, is embarking on what doctors universally regard as substandard infertility treatment.

Since the law passed last year, the only treatment now permissible in Italy produces less than half as many pregnancies as the usual care does in many cases, a new study shows. As a result, doctors say, Italians with money now travel for treatment - to Spain, Switzerland or Ukraine.

In her quest for a baby, Ms. Pennati had undergone weeks of painful and risky injections to produce the eggs that will be now be combined with her husband's sperm. As millions of Italians head to the polls on Sunday to decide whether to repeal some parts of the law, Ms. Pennati is scheduled to have the embryos placed in her womb. The chance of a pregnancy is very low, she knows.

"Everyone presents this as a political or religious position, but no one looks at this from the point of view of women and how it touches their lives," Ms. Pennati said, her husband huddled at her bedside. Perhaps no political issue since the 1981 vote on abortion has fired public passion and divided the country like the coming referendum, tearing rifts in political parties and setting off public debates between politicians and their wives.

The law, the most restrictive on medically assisted fertility in Europe, closely controls the creation and use of human embryos. Doctors cannot test embryos for genetic defects or freeze them in order to better a woman's chances of pregnancy, a method Ms. Pennati probably would have used were it not for the law. Researchers cannot use them to perform stem cell research.

. . . .

For the referendum to count, at least half of the nearly 50 million Italian voters must vote, a high bar. Indeed, in a strategic attempt to jettison the referendum and keep the infertility law intact, Italian prelates have told parishioners to head to the beach instead of the polling places on Sunday and Monday, so that the quorum will not be met.

Whichever side wins, the political fallout has already been significant. Gianfranco Fini, Italy's foreign minister and the head of one of Italy's major conservative political parties, is facing an in-house rebellion after announcing that he would vote to overturn part of the law. Francesco Rutelli, a leader of the center-left opposition drew howls of protest when he said he would abstain.

Normally outspoken politicians like Prime Minister Silvio Berlusconi have so far refused to take a public position. (He says only that his wife favors repeal.)

Some Italians said they were appalled that Roman Catholic Church leaders and elected officials would encourage people not to vote. "It's absurd that they would urge us not to exercise the most democratic instrument the citizen has," said Licio Zanetti, 44, a stockbroker.

June 11, 2005 | Permalink | TrackBack (0)

Parents v. Doctors

It is always hard to read about situations where parents disagree with doctors over treatment for their children.  Parents and doctors in Texas are unfortunately struggling over treatment decisions for a child with Hodgkin's disease.  In today's New York Times update, it appears that the case has taken a sad turn as the parents have decided on treatment but only after learning that their child's disease has returned.  According to the Times,

A bitter standoff between the parents of a 12-year-old and Texas social workers and doctors over radiation treatment ended on Friday on a somber note with a medical report that the girl's Hodgkin's disease, which had seemed in remission, had reappeared.

The parents, Michele and Edward Wernecke, lost custody of their daughter Katie a week ago, after opposing radiation therapy as unnecessary. When the new test results were announced at a hearing in juvenile court, the parents quickly complied and agreed through their lawyers to let doctors set the course of treatment, which could resume in days.

. . . . .

The agreement on treatment appeared to douse another hot spot in the field of patients' rights. Coming on the heels of the polarizing right-to-die case of Terri Schiavo, Katie's case raised the provocative question of when parents lose their rights to control a child's medical treatment. Under Texas law, parents may withhold medical treatment from a terminally ill child, but not in lesser situations.

"If the benefits of treatment are clear and clear harm can result from withholding care, ethically the state has the right to step in," Dr. Robert Klitzman, co-director of the Center for Bioethics at Columbia University, said.

[bm]

June 11, 2005 | Permalink | TrackBack (0)

Friday, June 10, 2005

Canada's Stem Cell Research Moves Forward

Wow!  The U.S. does not appear to be keeping up with the rest of the world in terms of our biomedical research.  According to an article in the Globe and Mail,

Canada's first two batches of human embryonic stem cells have been approved by an international regulator, opening the way for scientists to explore potential treatments and cures for a variety of diseases.

As reported in The Globe and Mail last month, a team of Toronto scientists was the first to develop the batches, or lines, of stem cells, which seem to have retained the ability of the original stem cells to turn into various tissue types.

The lines were certified by Britain's International Stem Cell Initiative, which standardizes the world's stem-cell lines.

    *     *    *    *

Canada's law governing stem-cell research, passed last year, is one of the strictest in the world. It makes it a criminal offence to clone or create a human embryo for research. The only human embryos Canadian scientists may use for stem-cell research must come from couples willing to donate them for that purpose. The embryos that were the origin of the two Canadian cell lines were surplus donated by couples undergoing in-vitro fertilization.

The lines were developed according to the stem-cell guidelines of the Canadian Institutes of Health Research, a federal research-funding agency. Unlike the traditional method of harvesting the cells from frozen embryos, the lines were generated from fresh embryos.

"In this particular case, the parents [seeking to have a test-tube baby] decided not to freeze [the surplus embryos] and decided to donate specifically for stem-cell research," Dr. Nagy said.

There are not enough data to establish which source, fresh or frozen, is better to establish cell lines, he added. However, Canadian research groups trying to extract stem cells that have been frozen for several years have had no success.

[bm]

June 10, 2005 | Permalink | TrackBack (0)

NPR on Merck and Vioxx

Thursday evening, National Public Radio's "All Things Considered" had a detailed overview of some of the internal documents that they have been able to obtain concerning Merck's knowledge concerning Vioxx and its potential for causing heart problems.  Merck doesn't look too good and the manner in which they allegedly treated some researchers is rather shocking.  Click here for a read of the story if you missed it.  [bm]

June 10, 2005 | Permalink | TrackBack (0)

Thursday, June 9, 2005

Cost of the Uninsured

USAToday contains an article discussing the recent report from Families USA showing that the uninsured cost the average worker $340 and the average family $920 in extra insurance premuims each year.  Families USA is an organization that promotes universal health insurance.  According to the article,

The study, prepared by Ken Thorpe, a professor at Emory University, concluded that about $1 out of every $12 spent on health insurance premiums indirectly pays for health care provided the uninsured.

The uninsured pay out of pocket about a third of the costs for their health care, the group said. Hospitals rely on charitable donations, government programs and the private sector to cover the rest.

Paul Ginsburg, an economist, said hospitals are having more success negotiating reimbursement rates with private insurers, and they take into account their costs for uncompensated care, he said.

"Ten years ago, I might have been skeptical about a study like this, but in 2005, I'm not," said Ginsburg, president of the Center for Studying Health System Change, an organization that provides non-partisan analysis.

Increased costs could prompt employers to cut back on the health insurance they now provide. "It's a vicious circle that will not end until we as a nation take steps to solve the underlying problems," the advocacy group said.

According to the article, not everyone sees a problem with the current cost structure:

Uwe Reinhardt, a professor at Princeton University, said universal health coverage would raise costs even more for those currently insured.

Reinhardt said the uninsured would be likely to go to a doctor more frequently if they had coverage. He's skeptical that taxpayers would be willing to pay the added cost.

From the purely economic perspective, "leaving the uninsured is a bargain" for the insured, he said.

Thanks to Professor Fred Harris for this article.  [bm]

June 9, 2005 | Permalink | TrackBack (0)

Speciality Hospital Debate

The Specialty Hospital Debate: Beyond the Medicare Moratorium

Executive Summary

                     On June 8, an 18-month moratorium imposed on certain specialty hospitals that serve Medicare patients will expire.

                     The rationale for the moratorium was to address concerns voiced by traditional community hospitals that the competition posed by physician-owned specialty hospitals would hurt their ability to offer quality care to all of their patients.

                     Specifically, the moratorium is on the referral of Medicare patients to new, physician-owned specialty hospitals (particularly those specializing in cardiac, orthopedic, and surgical care).

                     To help it determine the impact specialty hospitals have on overall patient care, Congress mandated studies by the Medicare Payment Advisory Commission (MedPAC) and the Department of Health and Human Services (HHS).  Both studies were due March 8, 2005.

                     In its report to Congress, MedPAC recommended reforms to the payment system used to reimburse hospitals for Medicare patients in order to make the system more fair.  MedPAC estimated that its reforms would substantially benefit many community hospitals.  MedPAC also suggested that the moratorium be extended for an additional 18 months.

                     Importantly, the MedPAC report did not base its moratorium extension recommendation on a finding of financial harm to the community hospitals as a result of competition from the specialty hospitals.  Indeed, it produced no evidence of such harm.  Rather, it suggested that the moratorium be extended only for the purpose of allowing both Congress and the Secretary of HHS time to consider and implement its payment-reform recommendations.

                     In its report, CMS also recommended reform of the Medicare payment system and called for a six-month study period to allow time to begin implementation of the reforms.

                     Based on the current lack of evidence of harm from specialty hospitals, extension of the moratorium is not warranted.  However, it would be beneficial to the community hospitals, in particular, for Congress to implement payment reforms along the lines of those recommended by MedPAC and CMS.  This is the more appropriate response to the concerns raised by the community hospitals than an extension of the moratorium, and is more likely to result in achieving the paramount goal of assuring quality health care for all Americans.

Jennifer M. Sincavage

Health Policy Analyst/Counsel

Republican Policy Committee

June 9, 2005 | Permalink | TrackBack (0)

Wednesday, June 8, 2005

Judge Posner and the Duty to Retire

The rather provocative Judge Posner has posted on his blog a commentary concerning old age and when to retire.  He suggests the following test:

I wish to make a suggestion that would achieve the principal benefits of mandatory retirement without the principal costs. It is simply this: beginning at age 70, require every life-tenured professor and every life-tenured judge to take a test of mental acuity every five years. (I use these simply as examples of "light" jobs from which the occupant is unlikely to be forced to retire by the demands that the job places on him.) The test results would be available to the members of the professor's department or the judge's court but to no others. The results would not be a basis for a determination of incapacity; they would not even be admissible in a competence hearing. The expectation rather is that a poor test result would persuade the individual, perhaps by persuading his colleagues who would in turn persuade him, or persuade members of his family to persuade him, to retire voluntarily.

The design of such a test would of course be difficult. It could not be just an IQ test, because the abilities that enable a person to score high on such a test are not necessarily essential to competent performance in a given job, even an intellectual job. Older people, moreover, as Aristotle was the first to explain, can to an extent substitute experience for mental agility as a means of solving problems; and an IQ test is not a test of experience--it is supposed to abstract from experience. And experience is not only, or even primarily, knowledge; it is know-how, a trained intuition--qualities that may be inarticulable and therefore difficult to test for. But not impossible. The professor, or the judge, can be given a problem in his or her field and asked to indicate the solution--for the judge, the question might be: what is the correct decision in the following case? Or, for the professor of English, what is the meaning of this poem?

Well, gosh - why limit it to old age - perhaps anyone with tenure should be required to prove their worth every so many years.  Only kidding!  For more discussion about Judge Posner's ideas and a variety of responses, see TaxProfBlog.  [bm]

June 8, 2005 | Permalink | TrackBack (0)

Iowa Conference on Schiavo

Here is an announcment for today's conference at Iowa on the Schiavo case:

Law School Conference Examines Schiavo Case Issues

A conference examining the legal perspectives of the Terri Schiavo case, sponsored by the University of Iowa College of Law, will be Wednesday, June 8, from 9:30 a.m. to noon in Levitt Auditorium in the Boyd Law Building.

Providing perspectives on the issues will be law professors William Buss and Sheldon Kurtz. Buss is an expert on constitutional law, while Kurtz is an expert on health care law and estate planning.

They will examine the various constitutional, health care and estate planning legal issues associated with the case of Terri Schiavo, the brain-damaged Florida woman whose case generated headlines earlier this year when her husband sought to have her feeding tube removed against her family's wishes.

The conference is part of the Phillip G. Hubbard Law School Preparation Program, an annual program held by the UI College of Law that brings together 25 undergraduates who are from groups historically underrepresented in the law. The program provides the fellows a month-long introduction to law school and the legal profession.

MEDIA CONTACT: Tom Snee, 319-384-0010, tom-snee@uiowa.edu.

June 8, 2005 | Permalink | TrackBack (0)

Tuesday, June 7, 2005

Cruise Ships and the Disabled

Yesterday, the Supreme Court provided a welcome partial victory for the disabled by recognizing the application of Title III of the Americans with Disabilities Act to at least some aspects of the operation of foreign cruise ships.  The entire opinoin is available here, here, here and here.  You may also find commentary on the disability law blog, the New York Times, and at SCOTUSblog.  [bm]

June 7, 2005 | Permalink | TrackBack (0)

DOJ Issues New Ruling on HIPAA

In a surprising ruling, the DOJ has issued a new ruling that dramatically limits who may be prosecuted for violating every health attorneys favorite law -- the Health Insurance Portability and Accountability Act.  According to the New York Times,

An authoritative new ruling by the Justice Department sharply limits the government's ability to prosecute people for criminal violations of the law that protects the privacy of medical records.

The criminal penalties, the department said, apply to insurers, doctors, hospitals and other providers - but not necessarily their employees or outsiders who steal personal health data.

In short, the department said, people who work for an entity covered by the federal privacy law are not automatically covered by that law and may not be subject to its criminal penalties, which include a $250,000 fine and 10 years in prison for the most serious violations.

The reasoning is that federal regulations establish the standards for medical privacy. The regulations apply just to "covered entities," including insurers and health care providers. Thus, only covered entities can be prosecuted for criminal violations of the law.

This interpretation is set forth in an opinion written by the office of legal counsel at the Justice Department. The opinion, dated June 1, is binding on the executive branch of the federal government, but not on judges. It was prepared over the last 16 months to answer questions from the criminal division of the Justice Department and the Health and Human Services Department.

The ruling was a surprise to many lawyers. Robert M. Gellman, an expert on privacy and information policy, said, "Under this decision, a tremendous amount of conduct that is clearly wrong will fall outside the criminal penalties of the statute," the Health Insurance Portability and Accountability Act of 1996.

If a hospital sells a list of patients' names to a firm for marketing purposes, the hospital can be held criminally liable, Mr. Gellman said. But if a hospital clerk does the same thing, in defiance of hospital policy, the clerk cannot be prosecuted under the 1996 law, because the clerk is not a "covered entity."

Very interesting -- announced the same day that we hear that more people's financial records have suspiciously gone missing - I am not sure that this is the time to cutback on who may be covered by the our privacy laws.  (I do not yet have a link to the report but will update you when I do. [bm]

June 7, 2005 | Permalink | TrackBack (0)

New Developments in Contraception

The BBC reports that scientists are working on a new contraceptive pill that would work without hormones and thus, without some of the complications as well.  The BBC report states,

A University of Cambridge team has discovered a molecule, STAT3, that helps embryos implant in the womb. They say a drug that blocks STAT3 should act as a contraceptive without disrupting hormones, or raising the risk of blood clots, as the Pill does. Details are published in Proceedings of the National Academy of Sciences.

The Cambridge team has shown that STAT3 plays a key role in signalling to the cells lining the womb that they should allow the embryo to attach. Without that signal an embryo would not attach to the womb wall, and a pregnancy would be impossible.

This looks like very promising research and not just for birth control.  I look forward to hearing more about this.  Thanks to Matt Malloy for the hat tip on this article.  [bm]

June 7, 2005 | Permalink | TrackBack (0)

New Supreme Court Nomination Blog

Yikes!  I guess I was hoping that we would not have to face this anytime soon  -- but the folks at SCOTUSblog have fearlessly determined that we need a new blog to deal with a potential opening on the Supreme Court.  To help keep us all better informed, it has set up Supreme Court Nominations blog.  Enjoy and try not to be too frightened by some of the choices.  [bm]

June 7, 2005 | Permalink | TrackBack (0)

Monday, June 6, 2005

Disturbing News on Pharma's Lack of Post-Marketing Review

According to a recently released report from Rep. Ed Markey ((D)Mass.), most pharma companies using FDA’s “accelerated approval” process (for drugs for patients with life-threatening illnesses) have failed to perform the legally-required post-marketing studies after their drugs have begun being marketed to physicians and consumers. Half of the companies have not even begun the required studies, even though on average they’ve been marketing the approved drugs for more than a year. The FDA has failed to respond to this situation. Markey’s report, courtesy of National Health Lawyers Assoc., is at: http://www.healthlawyers.org/hlh/docs/Markey_fdarpt.pdf

Thanks for this informative update go to Steve Latham, Professor of Law and Director, Center for Health Law & Policy, Quinnipiac University School of Law, Lecturer in Business Ethics and Law Yale School of Management.  [bm]

June 6, 2005 | Permalink | TrackBack (0)

Supreme Courts Says No Legal Weed for Sick

In an opinion by Justice Stevens, the Supreme Court held that Congress had the authority to make it a crime to grow and use marijuana purely for personal medical purposes when recommended by a doctor. The Court overturned a Ninth Circuit ruling that the federal Controlled Substances Act of 1970 exceeded Congress' Commerce Clause power when applied to medical marijuana used under California law. SCOTUSblog provides a quick summary of the decision and the dissent.

To facilitate discussion about the case, SCOTUSblog has set up a megablog.  It should be interesting to see how people react.  I am not surprised by the decision.  It seems hard for me to believe that the DOJ would decide to prosecute someone like Angel Raich - she seems to be the ultimate sympathetic medicinal marijuana user. [bm]

June 6, 2005 | Permalink | TrackBack (0)

Avian Flu Recommendations

Today's New York Times has an editorial by Senators Barack Obama and Richard Lugar concerning the avian flu pandemic.  Some of their recommendations include the following: 

It is essential for the international community, led by the United States, to take decisive action to prevent a pandemic.

So what should we do? Recently, the World Health Organization called for more money and attention to be devoted to effective preventive action, appealing for $100 million.   * * * *

Among the parts of that framework could be these:

Increasing international disease surveillance, response capacity and public education and coordination, especially in Southeast Asia.

Stockpiling enough antiviral doses to cover high-risk populations and essential workers.

Ensuring that, here at home, Health and Human Services and state governments put in place plans that address issues of surveillance, medical care, drug and vaccine distribution, communication, protection of the work force and maintenance of core public functions in case of a pandemic.

Accelerating research into avian flu vaccines and antiviral drugs.

Establishing incentives to encourage nations to report flu outbreaks quickly and fully.

So far, A(H5N1) has not been found in the United States. But in an age when you can board planes in Bangkok or Hong Kong and arrive in Chicago, Indianapolis or New York in hours, we must face the reality that these exotic killer diseases are not isolated health problems half a world away, but direct and immediate threats to security and prosperity here at home.

Effect Measure, a public health blog, has been calling for the United States to take a more active role in the avian flu pandemic and has some terrific resources for those who would like to learn more.  [bm]

June 6, 2005 | Permalink | TrackBack (0)

Op-ed on Nosocomial Infections

Guest op-editorialist Betsy McCaughey writes in this morning's New York Times that "[h]ospital infections kill an estimated 103,000 patients a year."  That's more than the number of deaths estimated to be the result of avoidable medical error in the landmark (and still controversial) 1999 IOM study, To Err Is Human.  Other countries' experiences with infectious killers like methicillin-resistant Staphylococcus aureus points the low-tech way out of this mess: "Through the rigorous enforcement of rules on hand washing, the meticulous cleaning of equipment and hospital rooms, the use of gowns and disposable aprons to prevent doctors and nurses from spreading germs on clothing and the testing of incoming patients to identify and isolate those carrying the germ. . . .  Too few hospitals in the United States are using these precautions, though where they are used they are highly effective."

More information is available at the CDC's National Nosocomial Infections Surveillance System (NNIS) web site, wrongdiagnosis.com's website on the subject, and a three-part series that ran in the Chicago Tribune in July 2002.  Among other things, the series points out that tired and overworked staff are part of the problem, so the answer to hospital-based infections isn't simply more education and soap and water; it will require some fundamental changes in staffing and the economics of hospital care.  [tm]

June 6, 2005 | Permalink | TrackBack (0)

New Study on Increase in Med Mal Insurance Premiums

According to the AP, a new study published in the journal Health Affairs states that doctors are gravitating to states that enact caps on malpractice awards, even though the primary cause of skyrocketing insurance premiums is not these awards.   The main focus is the effect of rising malpractice premiums and defensive medicine practices on the increasing health insurance premiums.  The authors look at the relationship between the rise in malpractice costs and the delivery of health care.  One of the authors -- Amitabh Chandra, an economics professor at Dartmouth University -- states that "the large jury awards that attract so much public attention actually are rare events and comprise a very small portion of all malpractice payments. . . . They're certainly not key drivers of malpractice insurance increases."   The study found that the number of physicians per 100,000 residents from 1970 to 2000 increased 83 percent in states that had a cap on noneconomic damages while factoring in items such as income and unemployment rate, death rates, racial composition of the community, and whether a medical school was in the area.  The study is based on information from the National Practitioner Data Bank.  The study analyzes 184,506 payments that insurers made over a 13-year period ending December 31, 2003.  The amount of the payments grew 4 percent annually which is consistent with the overall increase in health care spending during that time period.  Since the increases in premiums do not correlate dollar-for-dollar with increases in payments, other factors may explain the rising premiums such as a less competitive insurance industry or a decline in insurers' investment income. 

The National Bureau of Economic Research addresses the study and the issue in a summary of the study that reports that premiums rose by an average of 15 percent between 2000 and 2002, and physicians in certain medical specialties and geographic areas had an even more significant increase.  The study finds no evidence that changes in premiums are linked to changes in either the total number of physicians or the number of physicians working in specialty areas.  There is stronger evidence that rural physicians are sensitive to changes in premiums where a 10 percent increase in premiums results in a 1 percent decrease in rural physicians per capita. 

Frank Clemente, a spokesman for the consumer advocacy group Public Citizen, offered another explanation (on April 22, 2003).  Many of the states that have enacted caps are conservative states in the South, where there has been large population growth and doctors simply gravitate towards new business.  [tm]

June 6, 2005 | Permalink | TrackBack (0)

Sunday, June 5, 2005

CDC to Study Obesity Outbreak

In a news confernce on Friday, the CDC announced that it had just completed a study of the obesity "outbreak" in West Virginia.   The CDC also worked to clarify some of the confusion about obesity and its health effects.  The New York Times reports,

For the first time, the Centers for Disease Control and Prevention has sent a team of specialists into a state, West Virginia, to study an outbreak of obesity in the same way it studies an outbreak of an infectious disease.

* * * *

The investigative teams spent a week and a half in each place, going to schools and asking about physical education programs and about what sort of food was provided. They asked, for example, whether students "were offered at least one or two appealing fruits and vegetables every day," Ms. Kennedy said. And "would you replace regular sour cream with low-fat sour cream?"

They went to workplaces, asking whether there were policies to encourage physical activity. For example, Ms. Kennedy said, "if you choose to walk, could you have an extra 15 or 20 minutes added to your lunch break?" And, were there items like 100-percent fruit juices and bottled water in vending machines?

They went to random grocery stores and restaurants, asking whether they offered fruits and vegetables and skim or 1 percent milk. And they asked whether it was safe to walk along the roads, whether there were sidewalks and whether they were in good repair, whether there was good lighting for walking at night.

* * * *

The West Virginia data are now at the agency, being analyzed. Some preliminary information may be available in August, Ms. Kennedy said.

                            * * * *

But some statisticians said it was hard to see what could be learned from the agency's investigations.

Daniel McGee, a professor of statistics at Florida State University who has analyzed obesity data, burst out laughing when he heard about it. "My God, what a strange thing to do," he said.

"They'll find out what we all know - that the country is no longer set up for physical exercise," Dr. McGee said. And that schoolchildren "don't get a nutritious diet." And that "there is a lot of high-fat food on the shelves of every supermarket."

But, he said, "that doesn't tell you much."

"I'm sure skinny people go to those same restaurants," Dr. McGee said. "Skinny kids go to those same schools."

David DeMets, a professor of biostatistics at the University of Wisconsin, was also extremely skeptical.

"We get a lot of false positives from that kind of investigation," Dr. DeMets said. "We get people worried," but there is no way to know whether what is found - a lack of fruits and vegetables in the schools, for example - has anything to do with the obesity epidemic.

"Perhaps it is true, perhaps it is not," Dr. De Mets said.

[bm]

 

June 5, 2005 | Permalink | TrackBack (0)