HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Wednesday, August 24, 2005

Aspirin Withdrawal

Thanks to Professor Douglas Mossman for this article from medscape.  He points us to a recent study that has been published in the Archives of Neurology that highlights the importance of aspirin therapy for those who are at risk for stroke.  The study shows that withdrawing aspirin significantly increases the risk of stroke.

"Aspirin, or acetylsalicylic acid, is widely used to prevent ischemic vascular disease," write Alexandre Balzano Maulaz, MD, from Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and colleagues. "Clinical and experimental data suggest that a rebound effect occurs four or fewer weeks after interruption of aspirin therapy."

Cases consisted of 309 patients with ischemic stroke (IS) or transient ischemic attack (TIA) undergoing long-term aspirin treatment before their index event, and 309 control subjects who had not had an IS in the previous six months were matched for age, sex, and antiplatelet therapy. The investigators compared the frequency of aspirin therapy discontinuation during the four weeks before a cerebral ischemic event in patients and during the four weeks before interview in control subjects.

Both groups had a similar frequency of risk factors, except for coronary heart disease (CHD), which was more prevalent in IS or TIA patients (36% vs 18%; P < .001). Thirteen IS or TIA patients and four control subjects had discontinued aspirin. After adjustment in a multivariable model, aspirin interruption yielded an odds ratio for IS or TIA of 3.4 (95% confidence interval, 1.08 - 10.63; P < .005).

"These results highlight the importance of aspirin therapy compliance and give an estimate of the risk associated with the discontinuation of aspirin therapy in patients at risk for IS, particularly those with coronary heart disease," the authors write.

[bm]

August 24, 2005 | Permalink | TrackBack (0)

"Parents Barred From Teen Health Files"

That's the title of an article in today's Wall Street Journal (link good for 7 days).  Here's the essence of the piece:

Using her health plan's Web site, Ursula Scott of Seattle can view the medical records of her 2- and 5-year-old daughters, check their immunization schedules, look up test results, exchange email with a pediatrician, and make appointments for the next office visit.

But when it comes to her 16-year-old stepson, no one in the family can gain access to any aspect of his electronic medical records -- including the teen himself.

In the long-running effort to balance the rights of parents and adolescents in making decisions about medical care, technology has opened up a thicket of new legal and technical issues. The result is that teens are being left out of one of the most important advances in the administration of health care today.

A growing number of health plans, hospitals and doctor's offices are making the switch to electronic medical-record systems, in response to the Bush administration's push to make online records available to all Americans within the next decade. Such systems, like the one run by Group Health Cooperative of Seattle, which covers the Scott family, offer more than just convenience. They hold the promise of faster sharing of vital medical information, reduction of medical errors and more control for consumers over their care.

But with teens, these efforts risk running afoul of a complex patchwork of federal and state laws that allow adolescents to seek confidential family-planning and mental-health services without their parents' consent. Such laws make certain aspects of teens' health records off-limits to parents. However, electronic medical-records systems don't yet have a foolproof way to flag confidential material and hide it from parents -- something that can more easily be done with paper records. And as minors, teens can't on their own enter into the security agreements required to grant access to their online records.

Until providers can figure out how to give parents access to basic health-care information for a child, without breaking confidentiality or access rules, many are leaving adolescents out of new electronic medical-records systems altogether -- and revoking parental access to children's records as soon as they turn 13.

In a sentence, "At Dallas Children's Hospital, Chief Medical Information Officer Joseph Schneider, sums up the issue: 'Teens enter into this limbo land, where we can hide information from their parents, but we can't necessarily share it with them.'"

The article has a lot of useful material, including these links for more detailed information about adolescents' access to sensitive health care information:

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(click on image to enlarge)

[tm]

August 24, 2005 | Permalink | TrackBack (1)

Tuesday, August 23, 2005

"Bitter Pill": Analysis of News Media's Coverage of So-Called Wonder Drugs

Trudy Lieberman has written an extremely interesting article, "Bitter Pill," for the Columbia Journalism Review, concerning today's phenomenon of a drug moving almost instantaneously from medical research to miracle cure through news media.  She comments that the news media often seem more interested in the "hype and hope" than in critically appraising new drugs on behalf of the public.  She says this problem has increased significantly due to the dramatic increase in direct-to-consumer advertising, which delivers higher ad revenues to media outlets.  Lieberman opines that the press too often is caught up in the same drug-industry marketing web that also ensnares doctors, academic researchers, even the FDA, leaving the public without a reliable watchdog. 

She illustrates this phenomenon with the example of Lunesta, a new sleeping pill.  Lieberman writes that Sepracor's CEO, Timothy Barberich, told analysts that insomnia is "one of the most prevalent and growing medical needs in our society," describing insomnia as under-recognized and under-treated.  They then began selling their drug Lunesta to the public with the help of the press.  Sepracor facilitated this media treatment by offering journalists sources to call, including those with financial links to Sepracor.  Liberman also points to the National Sleep Foundation's annual poll to promote National Sleep Awareness Week.  This year the poll got a substantial amount of news coverage, with at least 24 stories, while Sepracor was dispatching 1,250 sales reps to physician's offices to educate them about Lunesta, part of a $60 million marketing push. 

Dr. Marcia Angell, former editor-in-chief of The New England Journal of Medicine, says that "the public is being allowed to believe that drugs are safer and more effective than they really are... Journalists, as well as the public and physicians, have bought hook, line, and sinker the idea that these drugs are getting better."   Through her research published in the book, The Truth About the Drug Companies, she found that of the 415 drugs approved between 1998 and 2000, only 14% were truly innovative, 9% were drugs that had been modified in some way, and 77% were copies of medicines already on the market.   She says that the news media has been ignoring the middle ground between the pharmaceutical industry covered in the business pages or consumer health reporting in the health sections.   She urges that more attention be paid to the area of corporate marketing and sponsored scientific research that connects the bottom line to the latest "breakthrough."   The article also discusses the coverage of Vioxx and other cox 2 pain relievers, and how poorly the public was served by medical coverage of this "super aspirin." My research assistant, Lindley Bain, provided invaluable help with this post.  [tm]

August 23, 2005 | Permalink | TrackBack (0)

Study Shows Wide Variance in Hospitals Failing to Deliver Essential LifeSaving Treatments

According to data recently gathered by the federal government, doctors and hospitals fail with alarming frequency to deliver essential lifesaving treatments for some of the most common causes of death, including heart attack, pneumonia, and heart failure, according to an article in the N.Y. Times.   Even though the treatments are not controversial or complicated, they have been very difficult to deliver reliably in the complex setting of the hospital.   The article points out that there is a 30 percent increase in the survival rate for patients who take aspirin in the first 24 hours after a hear attack, and yet hospitals neglected to give aspirin to more than 12,000 people, 1 of every 16 heart attack victims, in the first half of 2004.  One in eight patients who should have received beta blockers did not. 

Some hospitals claim this is a failure of documenting the treatment, and not that patients did not receive treatment.  However, the American Hospital Association says that "[i]f the medications and tests are delivered and there's no documentation, that itself is a quality problem."   This new report comes from the program Hospital Compare, in which 3,500 hospitals participate in exchange for a bonus in Medicare payments.  In the state-by-state comparisons contained in the report card issued by Hospital Compare, Massachusetts led the states in basic heart attack care, delivering the appropriate therapy 97 percent of the time.  Arkansas was last with 85 percent compliance.  The hospital-level comparisons showed even greater variance in compliance with some at 100 percent and others at 50 percent. 

Jean Rico, St. Vincent Medical Center's VP for quality services, says, "Physicians are much more willing to change their practice patterns now. . . . They know that more and more outcomes of care are being publicly reported."  St. Vincent delivered the appropriate care 64 percent of the time.   Dr. Ashish Jha of the Harvard School of Public Health says that "there hasn't been a clear incentive for them to put processes into place to make sure these treatments are given consistently. . . .  [W]e haven't known what's been going on in hospitals, until now."   See the twin studies on hospitals' performance in the New England Journal of Medicine. 

My research assistant Lindley Bain provided invaluable assistance with this post. [tm]

August 23, 2005 | Permalink | TrackBack (0)

Health Law & Lobbying Hit All-time High

Whatever else you can say about the Medicare drug benefit legislation and the mountains of interpretations it has spawned -- and you could say a lot -- one effect of the law, which doesn't actually kick in until next year, is that it has generated a lot of employment for health care lobbyists and lawyers.  According to an article by Robert Pear in today's N.Y. Times, lobbying work in the health care sector now leads all other industries, including defense:

Last year alone, the health care industry spent $325 million - more than any other sector - in its efforts to influence Congress and federal agencies, according to Political Money Line, a nonpartisan group that studies reports filed with Congress by lobbyists and their clients.

Drug companies led the way. They reported spending $86.9 million on lobbying last year, followed by hospitals with $55 million and doctors with $35.4 million.

And health lawyers aren't far behind the gravy train:

As the costs of Medicare and Medicaid soar, federal prosecutors and members of Congress are investigating fraud and abuse with new zeal. Many health care companies find they need more lawyers and lobbyists to cope.

In a recent advertisement recruiting lawyers for its Washington office, Sidley Austin Brown & Wood, one of the nation's largest law firms, said its health care practice had "experienced tremendous growth."

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August 23, 2005 | Permalink | TrackBack (0)

Monday, August 22, 2005

Impact of Free Samples

Dr. Doug Mossman points out an interesting article on Medscape.  It discusses a recent study in the American Journal of Medicine demonstrating that free samples do have an impact on a resident physician's prescribing practices.  According to the article,

Access to drug samples may influence resident physician prescribing, potentially increasing patients' costs, according to the results of a randomized trial reported in the July 28 issue of the American Journal of Medicine.

"There are few objective data describing how drug samples affect resident physicians," write Richard F. Adair, MD, and Leah R. Holmgren, MD, from the University of Minnesota and Abbott Northwestern Hospital in Minneapolis. "This is an important information gap, because drug samples are widely available in residents' clinics, and making treatment decisions based on which samples are available could affect both resident education and patient care. Although samples may provide short-term economic benefit for some patients, their primary purpose is to market new and expensive drugs."

During a six-month period in an inner-city primary care clinic, the authors observed 390 decisions by 29 internal medicine residents to begin drug therapy for patients. The residents were randomized either to not use available free drug samples or to use them at their discretion. Five drug-class pairs were chosen for study prospectively, with highly advertised drugs matched with drugs commonly used for the same indication but in less-expensive, over-the-counter (OTC), or generic formulations.

Compared with residents without access to drug samples, those with access to samples were less likely to choose unadvertised drugs (131 of 202 decisions vs 138 of 188 decisions; P = .04) and less likely to choose OTC drugs (51 of 202 vs 73 of 188; P = .003). There was also a nonsignificant trend toward less use of inexpensive drugs.

"Access to drug samples in clinic influences resident prescribing decisions," the authors write. "This could affect resident education and increase drug costs for patients."

[bm]



August 22, 2005 | Permalink | TrackBack (0)

Embryonic Stem Cells *Almost* Derived From Skin Cells

All the papers and news services are reporting this morning on an article due out later this week in the journal Science but posted to their website Sunday (see AP/Yahoo, Boston Globe, Washington Post).  According the news reports, the article describes the results achieved by researchers at the Harvard Stem Cell Institute when they fused adult skin cells with embryonic stem cells: the fused skin cells were "reprogrammed to their embryonic state."  The Institute's announcement reads:

A new study by Kevin Eggan, Douglas Melton, and colleagues offers hope that it might be possible in the future to produce embryonic stem cells without using human embryos. The Harvard Stem Cell Institute researchers will report in the Aug. 26 edition of the journal Science that it may be possible by fusing two cells together to some day produce cells with the properties of embryonic stem. The researchers caution, however, that many daunting challenges must still be overcome and the promise of their work should not be seen as a reason to slow present research efforts.

Current stem cell research has generated controversy because it involves the destruction of human embryos, or it requires women to donate unfertilized eggs. In therapeutic cloning, a nucleus from an adult cell (for instance, a skin cell) is injected into unfertilized egg whose own genetic material has been removed. The egg reprograms the skin cell nucleus to an embryonic state, allowing it to initiate the development of an early embryo without the need for fertilization. As researchers in Korea have recently shown, the resulting embryos can be used to make embryonic stem cells that are genetically identical to the skin cell donor. But that method is technically difficult, involves the use of embryos, and because it requires donated human eggs, it is unlikely that it could ever be scaled up for widespread clinical use.

The HSCI researchers have taken a quite different approach, fusing an entire skin cell to an existing embryonic stem cell. The result is a hybrid cell with two sets of genetic material, one from each parent. Using sophisticated 'DNA chip' technology, the Harvard team was able to show that cell fusion causes thousands of genes from the skin cell to be reprogrammed to an embryonic state. Even more striking, they found that the fused hybrids retain many of the properties of embryonic stem cells, including the ability to differentiate into multiple adult cells types.

This is an important result because it suggests that adult cells could some day be converted into embryonic stem cells without using human eggs and without creating cloned human embryos. But if this kind of reprogramming is really possible, it is likely to take many years and many further studies, on embryos as well as hybrid cells, before this technique offers an alternative method of producing stem cells.

The significant policy issue here is that, if the scientists can actually produce a totipotent embryonic stem cell, a plentiful source of new stem cells will have been created without the destruction of any embryos, a major limitation on federal funding rules announced by President Bush in August 2001.  And once the DNA of the fused stem cell can be stripped away, the resulting embryonic stem cell will be a genetic copy of the skin-cell donor without first creating a clone of the donor, bypassing yet another ethical obstacle to workable stem-cell therapies.  [tm]

August 22, 2005 | Permalink | TrackBack (0)

Chocolate: The New Health Food

Rumors that chocolate might actually be good for you have been circulating for quite some time.  Mars, Inc., the large chocolate manufacture, has been following up on some of the recent studies showing the health benefits of chocolate for blood vessels.  According to CNN.com

Flavanols are found in other foods, such as red wine, grapes, apples and green tea, although cocoa beans are a particularly rich source.

Mars Inc. developed the technology to visualize flavanols on a computer screen. Says Harold Schmitz, the company's chief science officer: "Now we understand cocoa well enough to start to do new things with it."

The company is starting with CocoaVia granola bars, made with a special cocoa powder that retains most of the flavanols. The bars also have plant sterols, which have been shown to help lower cholesterol.

For now, the 80-calorie, 23-gram snack bars are sold only on the Internet. The bars have a satisfyingly rich chocolate flavor, along with a slight but distinct bitter taste.

Researchers are excited by the potential of flavanols to ward off vascular disease, which can cause heart attacks, strokes, diabetes, dementia and hypertension. Vascular diseases are linked to the artery's inability to make a simple but fundamental chemical called nitric oxide. Flavanols appear to reverse that problem.

"The pharmaceutical industry has spent tens, probably hundreds of millions of dollars in search of a chemical that would reverse that abnormality," Hollenberg said. "And God gave us flavanol-rich cocoa, which does that. So the excitement is real."

Now, if only my health insurance plan would pay for my chocolate habit . . . . [bm]

August 22, 2005 | Permalink | TrackBack (0)

Sunday, August 21, 2005

Pedophiles and Star Trek

Rather surprising article on the Huffington Post concerning a characteristic that many pedophiles share - a love of star trek.  It states,

The LA Times recently ran a story about the Child Exploitation Section of the Toronto Sex Crimes Unit, which contained a mind-boggling statistic: of the more than 100 offenders the unit has arrested over the last four years, "all but one" has been "a hard-core Trekkie." Blogger Ernest Miller thought this claim was improbable. "I could go to a science fiction convention," he explained "and be less likely to find that 99+ percent of the attendees were hard-core Trekkies." While there may be quibbling about the exact numbers, the Toronto detectives claim that the connection is undeniable.

In fact,Star Trek paraphernalia has so routinely been found at the homes of the pedophiles they've arrested that it has become a gruesome joke in the squad room. (On the wall, there is a Star Trek poster with the detectives' faces replacing those of the crew members). This does not mean that watching Star Trek makes you a pedophile. It does mean that if you're a pedophile, odds are you've watched a lot of Star Trek.

This is not the first time Star Trek has been linked to bizarre sexual practices. Those involved in the Heaven's Gate mass suicides in Rancho Sante Fe in March 1997 also purported themselves to be avid Star Trek fans. One may recall that the cult forced its members to wear unisex clothing, had a strict policy of celibacy, a ban on all sexual thoughts, and eight of the members had surgically castrated themselves.

So why would sexual deviants be attracted to Star Trek? The link between Star Trek and pedophilia is obscure, even to the detectives in the sex crimes unit: "It has something to do with a fantasy world where mutants and monsters have power and where the usual rules don't apply," Det. Constable Warren Bulmer told the LAT. "But beyond that I can't really explain it." Explain it or not, one thing is clear: the detectives identify the pedophiles with the mutants and monsters and themselves with the crew of the Enterprise. But, in fact, the detectives probably have more in common with the pedophiles than they think, because the pedophiles, too, are almost certainly identifying with the crew of the Enterprise, and not with the mutants and monsters.

[bm]

August 21, 2005 | Permalink | TrackBack (0)

Saturday, August 20, 2005

iPODs and Hearing Loss

Well, you knew that the fun could not last, it turns out that listening to iPODs or other MP3 players, particularly at the volumes at which many people listen, can cause hearing loss.  This BBC article details some of the latest findings,

The surge in sales of iPods and other portable music players in recent years could mean many more people will develop hearing loss, experts fear.

If the volume through headphones is too high, there is a real risk of permanent damage to hearing, they say.

Sydney's National Acoustic Laboratories found a quarter of personal music system users in a random sample listened to music at dangerous volumes.

The Royal National Institute for Deaf people urged awareness of the risks.

Millions now own MP3 players - Apple has sold more than 20 million iPods.

A recent study by the Royal National Institute for Deaf People (RNID) found 39% of 18 to 24-year-olds listened to personal music players for at least an hour every day and 42% admitted they thought they had the volume too high.

The RNID regards 80 decibels as the level at which hearing is threatened - 20 less than a pneumatic drill.

Some MP3 players can reach 105 decibels. EU iPods have a sound limiter to comply with noise safety levels, however sometimes users hack through this in order to listen to it louder.

The RNID said it was possible that any rise in popularity of personal music players might lead to more cases of hearing loss in the future.

[bm]

August 20, 2005 | Permalink | TrackBack (0)

Friday, August 19, 2005

Merck's Biggest Hit (So Far): $253 Million

In most law school curricula, there's a fairly clear divide between med mal and health law, a divide that is largely reflected in the membership of the ABA Health Law Section and the AHLA, as well as here at HealthLawBlog.  So today's jury verdict of $253 million for the plaintiff in the Vioxx trial in Angleton, TX (see Bloomberg's article on it) would be of only passing interest here except for one thing: what it tells us about Big Pharma in the early years of the 21st Century.  An early attempt to put the verdict in a larger context of drug safety and the regulatory environment is Katrina Vanden Heuvel's "editor's blog" over on The Nation's website[tm]

August 19, 2005 | Permalink | TrackBack (0)

Eating Chips and Breast Cancer

Harvard has released a new study showing that children's consumption of certain trans fatty foods, such as chips, at an early age may increase the risk of breast cancer later in life.   The TImes UK reports,

Eating chips as a young child may increase the risk of contracting breast cancer as an adult, research in America has claimed.

Thanks to the Huffington Post for this link. bm]

Researchers at the Harvard Medical School say that for every portion of chips eaten per week in the pre-school years, the risk of breast cancer is increased. The data comes from a long-running study into the health of 80,000 nurses who have been followed for decades by a team from the research institute. The Nurses’ Health Study has already produced many links between diet and disease, some disproved by further and better research.

The latest paper, in the International Journal of Cancer, used data from 582 women with breast cancer and 1,569 women without the disease in 1993.

The researchers looked at the diets of the women when they were aged between 3 and 5, using information from their mothers, who were asked how often their daughters ate or drank various products.

The risk of getting breast cancer by the age of 60 is about one in 25. Karin Michels and colleagues estimated that eating chips just once a week before the age of 5 would raise that to about one in 20 — an increase in risk of 27 per cent.

The team said that while eating potatoes was not associated with increased risk, the preparation of French fries — frying in fat high in saturated fats and trans-fatty acids — may be of relevance.

August 19, 2005 | Permalink | TrackBack (0)

The Health Care Choice Act

I had not previously heard of this proposed legislation.  It is called, The Health Care Choice Act, sponsored by Rep. John Shadegg of Arizona, and would increase the availability of private  health care plans.   The New Republic online has an article by Jonathan Cohn (free with registration) discussing this proposed legislation that exposes some of its drawbacks - apparently it would take away any state regulation of insurance.  For an excellent and extra commentary on the Act and the New Republic article, see the Washington Monthly.  [bm]

August 19, 2005 | Permalink | TrackBack (0)

Thursday, August 18, 2005

Race Still Matters: 3 Studies in NEJM

The NEJM published three "special reports" in today's issue, all pointing to persistent racial differences in access to care:

The articles (which are available only to paid subscribers) are summarized in this morning's Washington Post:

Black Americans still get far fewer operations, tests, medications and other life-saving treatments than whites, despite years of efforts to erase racial disparities in health care and help African Americans live equally long and healthy lives, according to three major studies being published today.

Blacks' health care has started to catch up to whites' in some ways, but blacks remain much less likely to undergo heart bypasses, appendectomies and other common procedures. They receive fewer mammograms and basic tests and drugs for heart disease and diabetes, and they have fallen even further behind whites in controlling those two major killers, according to the first attempts to measure the last decade's efforts to improve equality of care.

Together, the research paints a discouraging picture of the nation's progress in closing the gap for one of the fundamental factors that affect well-being -- health care -- during a period when blacks have made progress in areas such as income and education.

"We have known for 20 years that we have a problem in our health care system: that blacks and whites do not receive equal care. We had hoped all the attention paid to this topic would result in some improvement. What we found is we have not made much progress," said Ashish K. Jha of the Harvard School of Public Health, who led one of the studies published in the New England Journal of Medicine. "This should be a call to action to make the changes needed to make sure people get equal care."

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August 18, 2005 | Permalink | TrackBack (0)

Maryland Jails Mom Who Tested Positive for Cocaine

In a move that harkens back to South Carolina's prosecutorial initiative against cocaine-positive pregnant women, Maryland has sentenced to 2-1/2 years a woman who, along with her newborn, tested positive for cocaine, according to this morning's Baltimore Sun.  The ACLU, which represents the woman on appeal, says:

"Nobody thinks it's a great idea to take cocaine while pregnant," said ACLU attorney David Rocah. "But the unanimous view of medical and public health professionals and drug treatment professionals is that if you want to stop people from doing that, the way to do that is to provide them with meaningful access to drug treatment and not criminally prosecute them."

This is a hard lesson for prosecutors to accept, but the courts have been pretty clear about the legal obstacles to such prosecutions:

Similar attempts to criminalize drug use by pregnant women became common in the United States during the crack scare of the late 1980s and early 1990s. But in dozens of cases, courts struck down criminal convictions as unconstitutional or beyond lawmakers' intent.

An exception is South Carolina, where about 70 women have been prosecuted for using drugs during pregnancy, according to a spokesman for the attorney general there. In 2001, the U.S. Supreme Court limited South Carolina's ability to mount such prosecutions by deeming drug tests administered without the mother's consent inadmissible in court.

It will be interesting to see what the Court of Appeals does with this one.  According to the article, "One of the ACLU's main arguments against Cruz's conviction is that Maryland law defines reckless endangerment as conduct by one person that causes substantial risk of harm to another person, but that the term "person" does not legally include a fetus. In 1990, Maryland legislators rejected a bill that would have made prenatal drug use by women a felony." 

FYI: In 2003, Texas amended its penal code so that "individual" means "a human being who is alive, including an unborn child at every stage of gestation from fertilization until birth" (Penal Code § 1.07(a)(26)).  The legislature was careful, however, to make sure that the chapter on offenses against the person (including our reckless endangerment statute) "does not apply to conduct charged as having been committed against an individual who is an unborn child if the conduct is . . . committed by the mother of the unborn child" (id. § 22.12).  [tm]

August 18, 2005 | Permalink | TrackBack (0)

Misuse of Medical Research Funds Said to be Rampant

The August 17 Wall Street Journal (requires paid subscription) ran a front-page story on a suit against Cornell and 11 senior faculty for allegedly misusing NIH funds.  The suit -- apparently a civil False Claims Act suit by a pediatrician at Cornell -- claimed that the money (which was intended to pay for nursing care for children enrolled in research studies) was diverted to pay for care for paying patients and for adults, and that some of the claimed studies were actually "phantom" studies.  Cornell settled with the government for $4.4 million. 

The article suggests this is only the tip of the iceberg:

The Cornell case exposes what some scientists call a dirty little secret of university medical research: the misuse of taxpayers' funds. The NIH last year funneled $20 billion to campus researchers, an amount that has doubled since the late 1990s. Now, a string of multimillion-dollar settlements by leading universities is showing how vulnerable the system has become to abuse.

Since the beginning of 2003, Northwestern University, Harvard University, Johns Hopkins University and the University of Alabama at Birmingham have agreed to civil settlements. In each case, the government alleged that the universities pledged to do one thing with their NIH money and then spent it on something else. This spring, the Mayo Clinic, Rochester, Minn., agreed to pay $6.5 million to settle charges it diverted money from one grant to other grants running short of funds. The institutions agreed to upgrade their accounting practices, but admitted no wrongdoing. All the cases except Harvard's began with whistleblowers; Harvard itself first alerted authorities to potential problems.

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August 18, 2005 | Permalink | TrackBack (0)

Physicians' RICO Suit Against MCOs Goes Forward

There's an interesting piece today in the on-line American Lawer about a federal lawsuit against 10 managed care companies claiming that they rigged their software so that legitimate claims for medically necessary and appropriate services were sytematically denied, adding as much as $10 billion to the companies' bottom line over the years.  For their part, the defendants argue that their automated review procedures are are needed to spit out claims for which "the form was filled out incorrectly or because doctors are padding their bills. In a survey reported in the Journal of the American Medical Association in 2000, 39 percent of physicians admitted that they exaggerated the severity of patients' conditions, made up symptoms or altered diagnoses on claims." Here's a quick recap of the litigation history of the case:

The doctors brought their claims under the Racketeer Influenced and Corrupt Organizations Act and had some early success. In 2002 Moreno let the RICO claims go forward. The next year Whatley's team settled with Aetna Inc. and CIGNA Corp., two of the three largest health insurers. Aetna agreed to pay the doctors $500 million; CIGNA, $325 million. Both carriers agreed to modify their practices. They will, for example, no longer ignore exams like the one that Abidin performed.

In 2004 the case hit a setback when the U.S. Supreme Court ruled, 8-0, that insurers could force the doctors in their networks to arbitrate the RICO claims. To keep the case -- and the possibility of triple damages -- alive, Whatley's team switched tacks. The doctors dropped all their claims against the insurers with whom they had contracts, in order to avoid a binding arbitration clause in those contracts. Now the doctors are suing those insurers with whom they did not have a contract -- their insurers' competitors.

Klein, the insurers' lawyer, says the move was transparent. "They sue everybody else for conspiring with the company who they actually have the contract with," says Klein. "It's an absurd proposition." Yet the 11th U.S. Circuit Court of Appeals approved the doctors' reformulation of their case in November 2004; then, on May 31, the Supreme Court declined to intervene a second time, moving the case toward trial. Since that time, four smaller defendants have settled and have agreed to modify their practices. Health Net Inc., Prudential Insurance Company of America, Anthem Inc., and Wellpoint Health Networks Inc. will also pay a total of $200 million before legal fees.

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August 18, 2005 | Permalink | TrackBack (0)

More Public Hospitals Lost Than Private in Recent Years

Modern Healthcare's Daily Dose reported yesterday that "[t]he number of U.S. public hospitals declined at a faster rate than private hospitals from 1996 to 2002, especially in suburban areas, and public hospitals treated patients for longer lengths of stay."  Here are the numbers:

The number of public hospitals in the suburbs of the nation's 100 largest cities fell 27% to 98 in 2002 from 134 in 1996. The number in the cities themselves dropped 16% during the same period, to 70 from 83. The number of private hospitals also shrank in both the top 100 cities and their suburbs, although not as rapidly . . . .  The loss of private hospitals was 4% in suburban areas, as the total fell to 741 in 2002 from 772 in 1996, and 11% in the cities, as the total fell to 575 from 647.

The numbers are from a study by State University of New York Downstate Medical Center, New York.  The report's "Summary and Conclusions" section is well worth reading in its entirety:

Our conclusions reflect analysis of hospital utilization and capacity in the 100 largest cities and surrounding suburban areas for the years 1996 to 2002.

The results by hospital ownership showed that the role of public hospitals, while highly significant as a safety net provider in both cities and suburbs, appears to be diminishing, as measured by their larger percentage losses and declining volume of total and Medicaid admissions in the largest cities. The analysis by community poverty levels revealed vast city-suburban differences in the distribution of hospital services and resources across low, medium and high poverty groups relative to their proportions of population. These patterns and trends raise questions about the future of the hospital safety net and its ability to adequately serve the most vulnerable residents, particularly in high poverty cities and suburbs, and about the appropriateness of the level of hospital resources concentrated in low and high poverty suburban areas.

Trends in Hospital Ownership

Our review of hospitals by ownership in the largest cities and suburbs revealed several trends about their total numbers and composition, their average size and growth in volume of care, and their share of Medicaid patients. The downward trend in the number of hospitals and total hospital beds in large metropolitan areas continued, with public hospitals showing the largest declines (16% in cities and 27% in suburbs) and the greatest decrease in the percentage of beds. These trends also represent an acceleration in the closing or merging of urban public hospitals, which declined by only 14 percent over a 16-year period between 1980 and 1996, and a continuation of a steep drop in suburban public hospitals, which declined by 43 percent over the same 16-year period.

The remaining urban public hospitals continued to be the largest providers as measured by their average bed size, but their presence across the urban landscape is diminishing. By 2002, non-profit hospitals had essentially pulled even with public facilities in admissions per hospital. Urban public hospitals also provided less inpatient and emergency care in 2002 than in 1996, while other hospital groups saw steady growth. By 1999, for-profit hospitals had surpassed public hospitals in staffed beds and total admissions for the 100 largest cities.

Of the remaining suburban public hospitals, average bed size increased by 26 percent, from 1996 to 2002, suggesting that relatively smaller public hospitals dominated the closings (or conversions/mergers). Correspondingly, the average increase in utilization measures per hospital were large, relative to suburban for-profit and non-profit hospitals. Given that the remaining suburban public hospitals are much larger, and perhaps more vital than ever to the communities they serve, one question is whether their numbers will stabilize or continue to decline.

Hospital Ownership and Medicaid Patients

As safety net providers, public institutions have provided the bulk of hospital care for Medicaid patients. In cities, public hospitals continued to have the largest proportion of Medicaid discharges, while in the suburbs, the proportions were similar across hospital ownership groups. Urban public hospitals were the only group to have a smaller percentage of Medicaid discharges in 2002 than in 1996, while all other groups saw their Medicaid share of total  admissions increase by 4 percent to 15 percent.

We also note that public hospitals in urban and suburban areas had both the longest Medicaid ALOS, and the steepest rise in Medicaid ALOS between 1996 and 2002. The results suggest that, on average, public hospitals treat more seriously ill Medicaid patients than the other hospital types.

What do these findings say about metropolitan area hospitals and their Medicaid patients? They suggest that the landscape for Medicaid hospital care may be shifting. Remaining public hospitals may be diversifying their patient mix to improve their bottom line. These trends could also signal an increasing role for non-profit and for-profit community hospitals as safety net providers, a more even distribution of safety net care responsibilities, and/or an attempt to increase market share by attracting healthier, more profitable Medicaid enrollees.

Hospitals in Low, Medium and High Poverty Urban and Suburban Areas

Our review of hospital capacity and utilization by community poverty levels tells a dramatically
different story for urban than suburban areas. High poverty cities accounted for a somewhat larger proportion of hospital use relative to their proportion of the total urban population, while the opposite was true for low poverty suburbs. The availability of specialty services such as trauma care, and PET scanners across the urban poverty groups was generally in line with the population distribution across these groups. Only with NICU beds was capacity proportionally greater in low poverty cities relative to their percentage of urban population.

At the same time, the overall and Medicaid average lengths of stay for hospitals in high poverty cities were the highest among urban areas, suggesting that these hospitals are serving relatively sicker patients compared with hospitals in low and medium poverty cities. Other research supports the effect of an “urban health penalty,” that is, higher rates of disease and mortality in cities with higher rates of poverty.

Among suburban areas, high poverty communities represented the greatest proportion of suburban population in 2000 but had the smallest proportion of total inpatient use, outpatient use, level 1 or level 2 trauma centers, and PET scanners in 2002. The opposite was true of low poverty suburbs, which represented the smallest proportion of total suburban population, but had the largest proportions of suburban hospital use and specialty care capacity. Low poverty suburbs also saw exponential growth in the number of hospital PET scanners between 1996 and 2002 and the largest increase in NICU beds.

This lopsided distribution of hospital resources and use suggests that low poverty suburban areas may be attractive markets for hospitals. The population characteristics suggest that, on average, residents of low poverty suburbs are the most affluent residents of metropolitan America, and likely are the best insured. By the same token, hospital systems may be reluctant to expand into high poverty suburbs. Although we do not have data on uninsured rates for these areas, we noted earlier that the high poverty suburban areas averaged the largest percentages of Hispanic and foreign-born populations. Surveys have documented these groups as having among the highest uninsured rates in the country. A lack of health coverage may be a contributing factor in the relatively small proportion of hospital resources available in high poverty suburbs.

Between 1996 and 2002, these high poverty areas also saw the greatest decline in the number of suburban hospitals, which may exacerbate access problems, particularly for those with limited or no insurance and limited transportation options. Perhaps as an indicator of unmet need for primary care as well, hospitals in high poverty suburbs had the greatest increase in emergency department visits of all city or suburban poverty areas. The findings raise questions about whether residents in high poverty suburban areas, especially those who are poor or uninsured, will become increasingly dependent on nearby city public hospitals. This contention has already surfaced in Dallas, where the president of the city's public hospital stated that indigent or uninsured patients residing in five surrounding suburban counties accounted for 16 percent of the hospital's $1.2 billion in uncompensated care in 2002. This situation in Dallas and other cities creates the potential for a backlash among urban taxpayers about the care of suburban residents in their public hospitals.

Finally, the financial situation of hospitals in both urban and suburban high poverty areas raises concerns about their future–more so than with facilities in low and medium poverty cities and suburbs. Hospital operating margins were generally the lowest among hospitals in high poverty cities and suburbs. Hospitals in these areas also saw the smallest increases in net revenues and the smallest rise in Medicaid net revenues, and yet they have the greatest dependence on this payer.

Implications for Availability and Access to Care

What do these results by ownership and poverty say about the future of hospital care in urban and suburban areas? Although it is not possible to draw conclusions about the specific roles and changes of each community's hospital safety net, the continued losses of public hospitals in both cities and suburbs inject uncertainty as to where the sickest of the poor and the uninsured will access care in the future.

The fallout from these changes in cities may differ significantly from the suburbs. In large central cities, the size of public and other primary safety net institutions, their constituency, their presence as an employer and the political issues surrounding their status suggest that communities are more likely to demand a careful assessment of impact, as well as a viable, alternative safety net plan. Suburban areas losing their public or primary safety net hospitals may be less likely to have the strong constituencies found in central cities. As a result, there may be a less vocal and concerted effort to assure a viable alternative is available. Ultimately, regional cooperation may be required to ensure adequate financing and access to hospital care for the area's poor and uninsured, particularly in metropolitan areas with a high poverty central city or high poverty suburban area.

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August 18, 2005 | Permalink | TrackBack (0)

More on Medicaid

The New York Times has an article today discussing the debate occurring over whether to raise Medicaid co-pays.  It states,

The Bush administration clashed with doctors on Wednesday over the merits of a proposal to charge higher co-payments to Medicaid recipients, with doctors warning that the fees could deter some poor people from seeking necessary medical care.

   

The debate came at a meeting of a federal advisory panel appointed by the administration to help rein in the growth of Medicaid, which provides health insurance to more than 50 million low-income people.

Congress may use the panel's advice as a basis for legislation this fall.

Under the current Medicaid law and rules, co-payments for most adults cannot exceed $3 for goods and services like prescription drugs, visits to doctors and outpatient hospital visits. For children younger than 18, co-payments are not allowed.

The panel, known as the Medicaid Commission, is considering an option that would allow states to charge higher co-payments, $5 for adults and $3 for children.

Michael J. O'Grady, a member of the panel who is also an assistant secretary of health and human services, said the higher co-payments would make beneficiaries more "price-sensitive" and would not impose an undue burden.

"We are talking about the price of a pack of cigarettes," Mr. O'Grady said. He noted that the maximum co-payments had not been changed since the early 1980's.

This doesn't look good for the future of Medicaid . . . . [bm]


August 18, 2005 | Permalink | TrackBack (0)

Medical Malpractice

The L.A. Times recently ran some interesting pieces on need for tort reform.  Although not specifically focused on medical malpractice, it does provide an overview of some of the efforts by business to "reform" our tort system and points out that these reforms are based on a number of urban legands.  The article states,

Merv Grazinski set his Winnebago on cruise control, slid away from the wheel and went back to fix a cup of coffee.

You can guess what happened next: The rudderless, driverless Winnebago crashed.

Grazinski blamed the manufacturer for not warning against such a maneuver in the owner's manual. He sued and won $1.75 million.

His jackpot would seem to erase any doubt that the legal system has lost its mind. Indeed, the Grazinski case has been cited often as evidence of the need to limit lawsuits and jury awards.

There's just one problem: The story is a complete fabrication.

It is one of the more comical tales in an anthology of legal urban legends that have circulated widely on the Internet, regaling millions with examples of cluelessness and greed being richly rewarded by the courts. These fables have also been widely disseminated by columnists and pundits who, in their haste to expose the gullibility of juries, did not verify the stories and were taken in themselves.

Although the origins of the tales are unknown, some observers, including George Washington University law professor Jonathan Turley, say their wide acceptance has helped to rally public opinion behind business-led campaigns to overhaul the civil justice system by restricting some types of lawsuits and capping damage awards. . . .

The LA Times has further articles on this topic available here and here (with registration).  The ever-helpful Ezra Klein posts a link to the story with commentary as well as to an earlier piece that he wrote concerning de-bunking the medical malpractice aspects of tort reform.  [bm]

August 18, 2005 | Permalink | TrackBack (0)