HealthLawProf Blog

Health Savings Accounts Are on Their Way

According to an article in today's LATimes, the administration is planning to move swiftly to approve more Health Savings Accounts (HSAs) and put an end to the current employer-provider health insurance model.  The LATimes reports,

"Emboldened by their success at the polls, the Bush administration and Republican leaders in Congress believe they have a new opportunity to move the nation away from the system of employer-provided health insurance that has covered most working Americans for the last half-century.

In its place, they want to erect a system in which workers — instead of looking to employers for health insurance — would take personal responsibility for protecting themselves and their families: They would buy high-deductible "catastrophic" insurance policies to cover major medical needs, then pay routine costs with money set aside in tax-sheltered health savings accounts."

The article provides a good introductory overview to HSAs and some of the pros and cons of the growing push to switch to this form of insurance for all Americans.  I am not a fan of the accounts and wasn't aware that they had become so popular with certain segments of society.  The LATimes states that the adminstration is farther along in its planning for HSAs than it is on social security reform so we may be seeing proposals for change in the near future.  [bm]

109th Congress Health Issues

The AMNews has a brief overview of some of what are expected to be the big health law topics in the 109th Congress.  Of course, tort reform is at the top of the agenda for many lawmakers, as well as medicare and medicaid reforms and potential cut-backs. [bm]

CMS' Final Rules for Drug Benefit and Medicare Advantage Published in Fed. Reg.

Friday's Federal Register contains two important final rules from the Centers for Medicare and Medicaid Services:

• Medicare Advantage, the successor to the late and unlamented Medicare+Choice program, 70 Fed. Reg. 4587–4741 (HTML) (PDF)
• Medicare Prescription Drug Benefit, 70 Fed. Reg. 4193–4585 (HTML)  (PDF)

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U of Mich Law School Opens Pediatric Advocacy Clinic

The University of Michigan Law School recently announced the creation of The Pediatric Advocacy Clinic.  The clinic offers students the opportunity to work with medical professionals to help low-income families with legal issues, including:

•  Applying for food stamps or cash assistance.

•  Litigating against landlords of substandard housing that cause health problems.

•  Providing referrals and representation for victims of domestic violence.

•  Navigating the special education system to ensure children receive legally required services.

The school says that the clinic is "one of the first known law school-connected, medical-legal collaborative clinics of its kind in the nation—offers advice and representation to those in need."   The clinic is the result of a collaboration between the law school's clinical assistant professor Anne Schroth and associate dean for clinical affairs Bridget McCormack, as well as between the law school and the Michigan Poverty Law Program, the U-M Ypsilanti Health Center, and the U-M C. S. Mott Children's Hospital.  [tm]

Study on Fidgeting and Weight Loss

The Washington Post reports on a recent study by researchers at the Mayo Clinic that shows that people who fidget burn about 350 more calories a day!  The Post reports,

"The most detailed study ever conducted of mundane bodily movements found that obese people tend to be much less fidgety than lean people and spend at least two hours more each day just sitting still. The extra motion by lean people is enough to burn about 350 extra calories a day, which could add up to 10 to 30 pounds a year, the researchers found.

'There are these absolutely staggering differences between people who are lean and people who are obese," said James A. Levine of the Mayo Clinic, who led the research published in today's issue of the journal Science. "The amount of this low-grade activity is so substantial that it could, in and of itself, account for obesity quite easily.'"

NPR's All Things Considered has a very detailed story on this study.  Participating in the study did not sound like much fun - the participants had to wear special underwear with sensors to monitor all body moverments.  A picture of the underwear may be found at the NPR website. [bm]

Health Law Professor Sues for Discrimination

This item comes from Brian Leiter's Blog, Leiter Reports (always an interesting and informative read).  He provides an overview of Professor Peter Hammer's complaint against the University of Michigan School of Law for discrimination against him as an openly gay man.   Professor Leiter also provides links to the complaint and some observations about current and past tenure practices at law schools.  [bm]

Upcoming Global Health Conference

The University of Washington School of Law Global Health and Justice Project and the Pactific Northwest enter for Health, Law and Policy are hosting a conference concerning international law, patent law and human rights issues impact health law in the United States.  The conference will focus on such questions as:  What are the pupoulations that are most at risk of human rights abuses and how does this affect individual and population health?  Does patent law really impact access to medical innovations, including new pharmaceuticals?  How do trade and trade law affect our health?  Featured speakers include Leonard S. Rubenstein, the Executive Director of Physicians for Human Rights, and Sofi Grustkin, the Director of the Program on International Health and Human Rights at Francois-Xavier Bagnoud Center for Health and Human Rights.

The conference will be held February 25-26, 2005.  For more information, click here. [bm]

Leavitt Confirmed as HHS Secretary

Mike Leavitt was unanimously confirmed yesterday by the Senate for the top post at Health and Human Services (HHS).  He should face some fairly tough issues, including the alleged Medicare and Medicaid cuts that President Bush is already hinting he will ask for in his 2006 budget.  In addition, he will face numerous issues concerning the new Medicare prescription drug program as well as Food and Drug Administration concerns over the approval and regulation of prescription drugs. [bm]

New Managed Care Article

Professor Nan Hunter of Brooklyn Law School has posted a drafat of an article concerning the due process issues surrounding the new managed care adjudication.  I did not realize how popular this private adjudication had become.  It is a very enlightening article and an intelligent and interesting read.  The abstract is below.

Abstract:     
This article examines how legal, political and economic change has produced a new adjudicatory mechanism for resolving disputes between patients and managed care organizations. In 43 states, external review laws allow patients whose claims for care or reimbursement have been denied by MCOs to "appeal" through a system that uses private judging companies to review the MCO decisions. Most of the claims concern whether a particular treatment is medically necessary, and the external review companies employ a mix of legal and health professionals to make those judgments. In essence, regulation of this critically important aspect of MCOs has been outsourced to a small but growing industry niche, which provides "due process lite" for patients.

The article begins by describing how a substantive standard of deference to medical authority in tort law leaked into and defined process aspects of health law as well. Then, because of the transformation to managed care models for service delivery, the old deference model fell victim to economic constraints. External review laws were enacted as part of the backlash against the abruptness of that transformation. They emerged from political coalitions searching for a new mechanism of accountability for the private sector.

Second, the article revisits procedural due process theory, which was a vibrant field of scholarship 25 years ago, but which today is virtually moribund. I describe how external review laws illustrate the use of dispute resolution procedures to achieve accountability and the emergence of accountability as a primary process value. I also argue that a second process value reflected in the new external review systems - deliberativeness - may be of equal or greater significance than the right to a hearing, the traditional flash point for debates about process.

Third, I articulate both the link between procedure and regulation, and also the connection between regulation by procedure to theories of governance. Specifically I argue that we can understand the use of adjudicatory process as one technique of governing at a distance, a method through which preferred policies and norms can be advanced indirectly, by non-governmental as well as governmental actors, rather than by direct, command-and-control state policies. [bm]

You can find the draft article here.

Slandering Your Doctor

In a novel case testing First Amendment rights,two dental practicioners have filed suit in a Florida trial court to stop a disgruntled former patient from criticizing their care on her web site, dentalfraudinflorida.com.

On the site, Ms. Prentice complains in detail about what in her opinion was the terrible care she received from Dr. Leonard Tolley and Dr. Richard Kaplan and describes her ordeal as a personal tragedy.  In response, the dentists argue the site is slanderous, a "public nuisance" and violates state law requiring that state disciplinary complaints be kept confidential if they are dismissed.  Prentice and her lawyer claim that her opinions are protected by the First Amendment. 

Disgruntled patients, however, are not the only ones using the internet to disseminate information.   Various medical groups and doctors have created sites posting the names of patients who are viewed as litigation risks.  For further information, please click here.  [bm]

Sarbanes Oxley and Non-profits

As those of you who serve on non-profit boards may already be well aware, many such boards have been considering adopting various portions of the Sarbanes-Oxley Act.  Enacted in 2002, the Sarbanes-Oxley Act, the corporate governance reform law passed in the wake of the Enron Corp. and WorldCom Inc. scandals is aimed primarily at pubic companies.   However, recent scandals in the non-profit world have shaken that community and caused a general review of their corporate practices.   According to a recent study by the accounting firm Grant Thornton LLP reported that 48 percent of the nation's nonprofits have made voluntary changes to their governance practices since the passage of Sarbanes-Oxley.  This includes rewriting corporate charters, redrafting conflict-of-interest policies, and, in some instances, performing costly examinations of their internal controls.

All indications are that more regulation of non-profits will occur soon.  Federal and state regulators have indicated a greater willingness to regulate non-profits. In November, California enacted the first governance law for nonprofits, which, among other things, requires charities doing business in the state with revenues above $2 million, to form audit and compensation committees. And last summer, the IRS announced that it was launching an investigation into nearly 2,000 nonprofits. In addition, Charles Grassley ( R-Iowa), chairman of the Senate Finance Committee, announced that his committee is working on a bill that would impose several governance reforms on nonprofits; the legislation is expected to come up for a full committee vote early this year.

For further information, please see this article.  [bm]

Euthanasia Notes From All Over

• Today's Houston Chronicle has an article about a futility dispute between the attendings at Texas Children's Hospital and the mother of a 4-month-old who has been diagnosed with "thanatophoric dysplasia, a condition characterized by a narrow chest, small ribs, underdeveloped lungs and disproportionately short arms and legs . . . Thanatophoric dysplasia belongs to a family of genetic disorders that includes dwarfism, but this particular form is almost always lethal, said Ericka Peasley, a genetic counselor who serves on the medical advisory board of Little People of America, an advocacy group. . . . Infants with the condition usually are stillborn or die shortly after birth from respiratory failure."  According to the story, "Texas Children's officials said the baby is not conscious and doesn't move" and is on ventilator support.

Neonatologists and bioethicists who have reviewed the case agreed with the physicians in the case that "it would be unethical to continue with care that is futile and prolongs [the patient's] suffering."  Under state law, disputed life-sustaining treatment may with withdrawn over the objections of the surrogate decision maker, if the hospital's ethics committee agrees with the attending physician that the treatment is inappropriate.  It is not clear from the article whether the ethics committee process was actually invoked.  Instead, the hospital has elected not to rely on the "due process safe harbor" provided by the Texas Health & Safety Code, chapter 166, and has gone to court to obtain an order.  The hospital is even paying for legal fees of the mother's attorney.  A court hearing has been scheduled for February 9.

• The January 20 Washington Times reported that the Archbishop of Canterbury, Dr. Rowan Williams, wrote an op-ed in the Times of London reiterating the opposition of the more than 70-million-member Anglican Communion to euthanasia.  Apparently the piece was prompted by the comments of "Robin Gill, a Canterbury University professor who advises Williams, [who] said publicly people should not be prosecuted for helping dying relatives in pain end their lives."

I always get nervous about blanket denunciations of "euthanasia" without a careful delineation of what is and is not being condemned, but Dr. Williams was careful to make clear that the target of his remarks was PAS and "active euthanasia":

Euthanasia is best defined as the initiating of a process whose explicit primary aim is to end life. It is not the same as continuing a medical process whose long-term effect may be to reduce the span of life, nor is it the same as embarking on a treatment that offers short-term relief at the cost of possibly accelerating overall decline. These are the commonplaces of palliative medicine. The right to be spared avoidable pain is beyond debate - as is the right to say yes or no to certain treatments in the knowledge of factors such as these. But once that has mutated into a right to expect assistance in dying, the responsibility of others is involved, as is the whole question of what society is saying about life and its possible meanings. Legislation ignores these issues to its cost.

The full text of his op-ed article can be found on the Archbishop's web site.

• The BBC reported last Sunday that an article in the Dutch Journal of Medicine reports that

Dutch doctors have reported 22 mercy killings of terminally ill babies since 1997. . . . None of the doctors involved were charged, although euthanasia for children is illegal in the Netherlands. . . .

The cases involved babies with extreme spina bifida, a disabling birth defect.

The study showed that prosecutors had decided not to file charges as long as four unofficial rules were met:

• the child's medical team and independent doctors must agree
• there is no prospect of improvement and the pain cannot be eased
• parents give their consent
• the life must be ended in the correct medical way

A survey has suggested Dutch doctors end the lives of about 15 to 20 disabled newborns a year but most go unreported.

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Charity Governance and Oversight

From our sister blog, TaxProfBlog, comes this item, which should be of interest to all nonprofit health care entities and their counsel:

Panel on Nonprofit Sector Releases Draft Recommendations for Improving Charity Governance and Oversight

The Panel on the Nonprofit Sector has released draft Recommendations for Improving Charity Governance and Oversight made by five Work Groups and an Expert Advisory Group  The Recommendations fall into four broad categories:

• Improving Transparency and Financial Management
• Improving Government Oversight and Enforcement
• Improving Governance and Self-Regulation
• Compliance Requirements for Small Organizations

The Panel comprises 24 leaders convened by Independent Sector at the encouragement of the U.S. Senate Finance Committee.  To give comments on the draft, see here.  To participate in a free national conference call about the draft to be held tomorrow (Wed., Jan. 26) at 2:00 - 3:30 p.m. EST, see here.

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Ethics of Patient Advertisement

I don't know what the ethics are concerning physician advertisements that use past successes with patients to attract new patients but I assume that Senator Coleman's office must know.  His cosmetic dentist, Dr. Milnar has run an ad on his website that shows Senator Coleman's teeth in a before and after format. 

Rawstory has a further article discussing the Senator's new smile and the dentist.  According to that website, there may have been some mistakes made in the use of the Senator's photo for commercial purposes as well as some other issues involving the Senator's payment for the dentistry. 

Quite frankly, I may be a bit biased but I think that my son has the after picture beat.[bm]

Care Coordination and Liability Concerns

Professor Mark Hall has a new article in the Annals of Family Medicine entitled, "Liability Implications of Physician-Directed Care Coordination."  It provides an interesting overview of the current liability situation for those physicians involved in care coordination with statistical data obtained from recent interviews as support for his conclusion that care coordination may lead to lower liability risk. 

ABSTRACT:

Various public and private initiatives encourage physicians to coordinate care for patients with multiple chronic conditions, but physicians may resist doing so for fear of liability. This article assesses the extent of liability risk using qualitative methods that combine legal research with key informant interviews. Some aspects of care coordination for patients with multiple chronic conditions hold potential for higher liability.

Physicians coordinating care have a broader responsibility for patients with complex conditions who have a greater chance of poor outcomes. Care coordinators may be held to a higher standard of care by adopting best practices guidelines or by making medical decisions on issues that require specialized expertise. However, other aspects lower liability risk: elderly patients are less likely to sue; care coordination should improve outcomes; and the information systems that support enhanced care coordination target the major sources of medical error in primary care. On balance, the liability risks of care coordination are commensurate with other risks in primary care practice. Liability insurers indicated no reluctance to insure physicians who coordinate care for patients with multiple chronic conditions, and no strong tendency to attribute higher risk to this role. Physicians who currently perform these or similar functions have not encountered demonstrably higher liability. On balance, there is no strong basis for physicians who perform care coordination functions to have serious concerns about liability; instead, care coordination done well may lower liability risks.

Viagra May Shrink Heart

A news article reports that doctors have discovered that viagra not only helps with erectile disfunction but also provides help to those with enlarged hearts.

"Researchers at Johns Hopkins University School of Medicine in Baltimore, Maryland have found that sildenafil citrate—Viagra—treats enlarged hearts in mice, stopping further muscle growth, reversing existing growth and treating cellular and functional damage.

"A larger-than-normal heart is a serious medical condition, known as hypertrophy, and is a common feature of heart failure that can be fatal," says study senior author and cardiologist David Kass"

Amazing how one drug can shrink certain parts and ... well ... you know the rest.  Thanks to mrsun.us for the article update.  [bm]

State Prompt Pay Claims Not Pre-empted by ERISA

From Mealey & Lexis:

NEW YORK — Because a hospital’s state law claim seeking to recover payment at an undiscounted rate after a patient’s preferred provider failed to pay the discounted amount on time does not seek to redress violations of rules that the Employee Retirement Income Security Act’s civil enforcement provisions are designed to remedy, remand to state court is proper, a New York federal judge held on Jan. 6 (NYU Hospitals Center-Tisch v. Local 348 Health and Welfare Fund, No. 04 Civ. 6937, S.D. N.Y.; 2005 U.S. Dist. LEXIS 256 (requires paid subscription)).  [tm]

State Medical Association Lacks Standing to Sue MCO Over Payments to Docs

From Mealey & Lexis:  Continuing a trend (it appears) of state medical associations who challenge MCO payment practices being poured out on standing grounds: HARTFORD, Conn. — The Connecticut Supreme Court on Jan. 11 in separate opinions affirmed the dismissal of suits brought against two managed care companies for allegedly unfair and deceptive practices related to payments made to physicians, finding that the medical society that brought the claims lacked standing to sue because their alleged harms were indirect and its physician members could bring the claims themselves (Connecticut State Medical Society v. Oxford Health Plans, No. SC17071; Conn. Sup.; 2005 Conn. LEXIS 2; Connecticut State Medical Society v. ConnectiCare Inc., No. SC 17072, Conn. Sup.; 2005 Conn. LEXIS 4). [tm]

SCOTUS Denies Review of Fla. Sup. Court's Decision on Terri's Law

The Supreme Court of the United States released its most recent cert. list this morning and denied Jeb Bush's cert. petition in the litigation over the constitutionality of Terri's Law (U.S., No. 04-757). [tm]

HHS OIG's Report on GPO Rebates and Members' Cost Reports

Department of Health and Human Services, Office of Inspector General -- AUDIT
"Review of Revenue From Vendors at Three Group Purchasing Organizations and Their Members," (A-05-03-00074 (PDF)) -- January 19, 2005

EXECUTIVE SUMMARY:

The objectives of this review were to determine (1) how much revenue three large GPOs received from vendors and what the disposition of that revenue was, (2) how members treated distributions of net administrative fee revenue received from GPOs on their Medicare cost reports, and (3) whether members properly recorded rebates received from vendors on their Medicare cost reports.  We found that the three GPOs we reviewed collected $1.3 billion representing net revenue in excess of operating costs.  The GPOs retained $415 million of the $1.3 billion in net revenue to provide reserves and venture capital for new business lines.  They distributed the remaining $898 million to members.  We also found that the GPO members we reviewed did not fully account for the net revenue distributions on their Medicare cost reports.  GPO members generally offset rebates on their Medicare cost reports as required.  We recommended that CMS (1) provide specific guidance on the proper Medicare cost report treatment of net revenue distributions received from GPOs, and (2) prepare a “frequently asked questions” or other bulletin to remind institutional providers that all rebates from vendors must be shown as credits on their Medicare cost reports.

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Health Care According to Frist

The New England Journal of Medicine has an article written by Dr. William Frist, you may know him better as Senate Majority leader Frist.  Since everyone wants to know what the 109th Congress may do with regard to health care, the article may provide some insight.  I was rather surprised that Senator Frist seems to be a supporter of a mild form of universal health care.  Indeed there was much for me to agree with in his piece. [bm]

Thoughts on the Vioxx Litigation

In this week's New Yorker, James Surowiecki has a short article on the issues surrounding the tort system and its role in determining which drugs are on the market.  He uses the Merck/Vioxx upcoming litigation to express his concerns about the tort system.  He states,

"Questions about Vioxx’s potential risks have been common since its introduction, six years ago, especially after a 2000 trial suggested that the drug increased the risk of heart disease. Merck did not hide these data, and beginning in 2002 the drug’s label included a warning about the possible cardiovascular risks. Some critics, however, have suggested that the company soft-pedalled the dangers. Internal company documents show that Merck employees were debating the safety of the drug for years before the recall.

From a scientific perspective, this is hardly damning. The internal debates about the drug’s safety were just that—debates, with different scientists arguing for and against the drug. The simple fact that Vioxx might have risks wasn’t reason to recall it, since the drug also had an important benefit: it was less likely to cause the internal bleeding that aspirin and ibuprofen cause, and that kills thousands of people a year. And there’s no clear evidence that Merck kept selling Vioxx after it decided that the drug’s dangers outweighed its benefits. . . .

Obviously, there’s something wrong with a system that discourages the careful weighing of costs against benefits—we want companies to learn as much as they can about the downsides of their products. But companies like Merck, which spend hundreds of millions on ads targeting consumers, have themselves to blame, too. Instead of getting people to think about drugs in terms of costs and benefits, these ads encourage people to think of medicine in the same way they think of other consumer goods. It would be one thing if Merck had marketed Vioxx only to people who really needed it—people who couldn’t take ibuprofen or aspirin safely. Instead, the company marketed it aggressively to everyone, so that some twenty million Americans had Vioxx prescriptions. That’s why the potential damages against Merck are so vast. If juries have a hard time accepting a risk-benefit trade-off when it comes to drugs, it’s in part because the drug companies have convinced them that no such trade-off has to be made."

The entire article makes for an interesting read.  As our nation considers tort reform, the question becomes should we cap damages or should we engage with manufacturers and the public to educate them about the trade-offs and the science behind certain pharmaceutical products.  In addition, the FDA may want to strenghen some aspects of its review of these products and their ads. [bm]

Cuts in Medicaid Predicted

For those you following the budget deficit and President Bush's promise to cut that deficit in half - it looks like some of that savings will come from cuts in the Medicaid program.   According to a variety of anonymous jWashington D.C. sources, some of the President's proposals include providing states more flexibility to use federal Medicaid funds, but also to reduce doctor's reiumbursements, trim fraud, and to limit the program's growth on a per-patient basis.

Medicare Drug Benefit Final Rules Issued

HHS announced that it posted the final rule implementing the Medicare pharmaceutical benefit in last Friday's Federal Register.  HHS' press release is here: http://www.hhs.gov/news/press/2005pres/20050121.html/. (Nothwithstanding, the rinal rule is not in Friday's Federal Register, but when it does appear we'll post the cite.)  [tm]

Estimating the Costs of New Drug Development: Is it really $802m? (Recent Additions to SSRN Database)

"Estimating the Costs of New Drug Development: Is it really $802m?," by Christophers Adams & Van V. Brantner (Bureau of Economics, FTC).  Abstract:

This paper replicates DiMasi et al (2003) drug development cost estimates using their published survey cost estimates along with information from a publicly available data set. The results suggest that the expected cost of developing the average drug is even higher than the DiMasi et al (2003) estimate of $802m (in 2000 dollars). The paper estimates the capitalized out-of-pocket cost per new drug to be between $839m and $868m (in 2000 dollars). The paper similarly estimates the expected cost of the average new drug with certain characteristics such as primary indication. It is shown that the expected cost of developing the average HIV/AIDS drug is $479m, while the expected cost of developing the average rheumatoid arthritis drug is twice that, at $936m. For one large pharmaceutical company the expected cost of developing an average drug is $521m, and for another large firm the cost is almost four times that number, coming in at $2,119m. The results support DiMasi et al's claim that the average cost to develop a new drug is over $800m while also suggesting that for some drugs the costs can be much higher or much lower. The results suggest that drug development costs can be influenced by numerous factors including regulatory policy as well as the pharmaceutical firm's own strategic decisions. The results further suggest that a great deal of care must be taken before using these numbers in public policy debates or interpreting them as a measure of actual drug development costs.

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FTC Settlements with Pharm Companies

The FTC's Bureau of Competition recently posted summaries of its FY 2004 settlements with pharmaceutical companies.  Among the highlights:

1) 19 of the 22 agreements filed in FY 2004 involved agreements between brand and generic manufacturers, with the remainder occurring between two generic manufacturers;
2) 14 of these 19 agreements resolved patent infringement litigation between brand and generic manufacturers; and
3) no settlement included a payment from the brand to the generic manufacturer in exchange for the generic’s agreement not to market its product.

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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. 

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.

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OTC Status of 'Morning After' Pill Again Before FDA

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."

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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]

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:

• Interim Reports To The 79th Texas Legislature: V&E Preliminary Picks For Principal Health-Related Legislative Plays.  (Vinson & Elkins)
• SNF Consolidated Billing Revisited: CMS issues new instructions in an effort to clear up confusion over consolidated billing requirements for Part A Medicare patients.  (Epstein, Becker & Green; PDF)
• Parallel Trade in the EU and US Pharmaceutical Markets.  (Arnold & Porter; PDF)
• The New Form 1023: What Does It Mean for Charitable Organizations? (McDermott, Will & Emory)
• What to Do When Facing Peer Review.  (Epstein, Becker & Green; PDF)
• Medicines for Children: Parts I & II (Arnold & Porter; PDF)
• Medicare Prospective Payment System for Inpatient Psychiatric Hospitals and Units (McDermott, Will & Emory)
• Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products.  (Arnold & Porter; PDF)
• New California Law Requires Pharmaceutical Companies to Adopt Comprehensive Compliance Programs in Accordance with OIG Guidance and PhRMA Code. (Epstein, Becker & Green)

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.

Florida Business Proposal for Tort Reform - Most Radical?

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]

Medicare to Cover Expensive ICDs

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]

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]

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]

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

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]

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]

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]

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]

FTC Aims to Undo Chicago Hospitals' Merger

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]

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]

Please Take This Survey

West 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.

Balitmore Sun Series: "If I Die"

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]

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":

• "Red Beard" (1965)
• "The Hospital" (1971)
• "Article 99" (1991)
• "State of Emergency" (1993)
• "Miss Evers' Boys" (1997)
• "The Elephant Man" (1980)
• "Panic in the Streets" (1950)
• "Spellbound" (1945)
• "Death and the Maiden" (1994)
• "Guess Who's Coming to Dinner" (1967)

[tm]

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]

Lilly v. The British Medical Journal

Today's New York Times provides a detailed overview of the recent dispute between Eli Lilly and Company, a large pharmaceutical company that manufactures Prozac as well as several other well-known drugs, and the British Medical Journal, one of the leading medical journals, which publilshes not only medical studies but also news.  In early January, the Journal reported that Lilly did not dislcose certain studies about Prozac before the FDA back in the late 1980s when it was seeking approval for the drug.  Lilly responded quickly by rebutting the alleged non-disclosures point-by-point.  Now, the ball is back in the British Medical Journal's court and it does not appear that they are ready to back off their story.  It is unclear who is correct, but it should be interesting to follow and see who is correct about the disclosure of the information.  [bm]

Ethics Complaint Sides with Kentucky Governor on Death Penalty

The AMA prohibits physicians from direct participation in administering the death penalty.  (See Ethics Op. E-2.06.)  So, when Kentucky governor Ernie Fletcher, M.D., signed the death warrant on inmate Thomas Clyde Bowling, did he violate this tenet of medical ethics?  Four Kentucky inmates petitioned the state's Board of Medical Licensure for an answer to that question.  The Jan. 13 Louisville Courier-Journal reports that the medical board

decided that Gov. Ernie Fletcher did not violate medical ethics by ordering the execution of a death row inmate.

With no public discussion, a state Medical Licensure Board committee unanimously agreed that Fletcher, a physician, did not violate guidelines that bar doctors from participating in executions.

The committee, which examined the issue at the request of four death-penalty opponents, said Fletcher was acting as governor, not as a doctor, when he signed a Nov. 8 death warrant for Thomas Clyde Bowling.

Although it is probably politically predictable, the board's decision takes a curiously legalistic slant on this ethical problem.

But medical ethics experts questioned whether a doctor who becomes a governor can separate his two roles.

"I would hold the view that as long as he continues to call himself a physician, he's bound to the ethics of that position," said Dr. Clarence Braddock, a professor of medicine at Stanford University.

Paul Lombardo, a law and medical ethics professor at the University of Virginia, said drafters of the AMA guidelines probably meant to ban physicians from activities such as administering drugs during an execution by injection.

"I don't believe the medical association rules generated to stand in the way of physician participation in an execution really contemplated this situation," he said.

That may be, but the text of the AMA's prohibition on physician participation is quite broad:

Physician participation in execution is defined generally as actions which would fall into one or more of the following categories: (1) an action which would directly cause the death of the condemned; (2) an action which would assist, supervise, or contribute to the ability of another individual to directly cause the death of the condemned; (3) an action which could automatically cause an execution to be carried out on a condemned prisoner.

It isn't much of a stretch to equate the governor's signing of a death warrant with (3), would it?  [tm]

Newt Gingrich takes on Health Care

The New York Times reports today that Newt Gingrich has made reforming the American medical system one of his top priorities.  Although he has been out-of-office and out of the public eye for awhile, Newt is now making his presence felt once again.  I don't agree with many of his ideas but it is good to have a conservative talking about health care without focusing exclusively on tort reform.  Newt wishes to decrease medical error through the use of information technology (less errors due to handwriting misreads) and better reporting requirements.  Borth are fairly non-controversial ideas that most people would agree about their benefits.  He is also a big fan of health care savings accounts (I am not).  The article is an interesting read and I recommend it for those desiring to learn about potential reforms that may be suggested to Congress in the near future.  [bm]

Saturday Luke Blogging

Yes, yet another picture of my son.  I have a few more exams to grade so blogging with be light this weekend.  [bm]

"VD or Not VD" Article

While I am sure that many of you have all been following the recent work and surrounding controversy of  C.A. Tripp, The Intimate World of Abraham Lincoln, the new book that claims that Abraham Lincoln may have been a bixexual,(I haven't read the book yet, only the reviews, which are quite positive), a new article on Dr. Koop's website examines recent findings by  Dr. John J. Ross who concludes that William Shakespeare suffered from mercury poisoning due to treatment for syphllis.  Dr. Ross states that the side effects of the treatment probably made it difficult for him to physically write, explaining his writing slowdown later in life, and that his suffering could also explain some of his attitudes toward women.  Other scholars claim that Dr. Ross's theory is much ado about nothing and that no proof exists that Shakespeare suffered from a venereal disease. [bm].

FDA rejcts over-the-counter Mevacor

Today the FDA recommended against over-the-counter sales of Merck's cholesterol drug, Mevacor, stating that patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life.  Even though the safety of Mevacor is well-established, advisers worried that the wrong people might take it if sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it.  The vote on the advisory committee was 20-3.

The advisers expressed concerns due to studies that simulated over-the-counter sales, which indicated that 90 percent of people who took Mevacor did not satisfy  the requirements of the label. Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.

Once again, Kevin Drum of the Washington Monthly finds a quote that reflects quite accurately the FDA's concern,.  He quotes Michelle Cottle from the New Republic:

As a nation, Americans are apparently too stupid (or stubborn) to recognize that Big Macs and Big Gulps aren't the foundation of a healthy diet, but thanks to several gazillion dollars in direct-to-consumer drug advertising, we all consider ourselves experts in pharmacology.

....No matter what kind of qualifiers, disclaimers, and helpful tips Merck scrawls across Mevacor's box (or, more likely, crams onto a package insert printed in type so tiny it will make your eyes bleed), a fair number of self-medicating geniuses will think that the best way to prevent heart disease is to take two Mevacor for every six pieces of fried chicken they plan to eat that night. Don't laugh. It will happen and happen frequently.

[bm]

Ethics Consultation: We've Seen the Future (Or Have We?)

In "When the Question is Life or Death" by Jim Ritter, the January 9 Chicago Sun-Times profiled the work of Dan Dugan, a full-time ethics consultant at Swedish Methodist Hospital.  As reported in the article:

Hospitals are required to make ethics consultations available for difficult cases, such as whether to withdraw life support, what to do with a patient who refuses treatments on religious grounds or whether a doctor should reveal to parents their teenage daughter's request for birth control.

I confess to being a little surprised to read that consultations are required for difficult hospital cases -- is there an Illinois law on this?  (Texas does have such a law.  Section 166.046(a) of the Health & Safety Code requires an ethics consultation when there is a dispute between the attending physician and the patient (or surrogate) over the appropriateness of life-sustaining care.)  Regardless, this article does a nice job of discussing the role of ethics consultation in modern medical dilemmas.  It also cites an important 2003 article in JAMA (abstract) that described the results of a multicenter, prospective randomized clinical trial to determine the effects of ethics consultations on 'nonbeneficial' life-sustaining treatments in the intensive care setting.  [tm]

CDC Reports on Racial Disparities in Health Care

The Centers for Disease Control and Prevention reports today that black Americans are far more likely than white Americans to die from strokes, diabetes and other diseases.  The CDC report revealed that in 2002, the number of potential years of life lost due to strokes, diabetes and perinatal diseases was three times higher for black Americnas under 75 than for white Americans in same age group.  The CDC report showed that the gap increased to approximately 11 times for AIDS and nine times for homicide.

For those of you interested in race and health care issues, Professor Vernellia Randall is one of the leading experts on this topic and her writings are a great resource. [bm]

Resident Hours: Lack of Sleep and Patient Safety

A new study appearing in the New England Journal of Medicine demonstrates once again that after staying up all night to care for patients, medical interns who drive home from the hospital at the end of a 30-hour shift become a threat to themselves and to the commuting public.  The report found that interns more than doubled their risk of getting into a car accident after being on call for more than 32 consecutive hours with only two to three hours of sleep.  The study is the latest in a long series of studies by researchers at Harvard Medical School and Brigham and Women's Hospital in Boston that aim to quantify the dangers of requiring doctors to work long shifts with little rest. The researchers say that working for more than 24 hours causes interns to make serious medical errors and poses a public safety hazard.

Kevin Drum of the Washington Monthly comments, "It's unbelievable that this system has continued as long as it has and unbelievable that it continues to be defended. Do we really need studies to tell us that people who have been awake for 30 consecutive hours probably aren't making very good decisions? And that both patients and others are suffering from this?

Would you want your mother to be looked after by a trainee who's been on her feet for 30 hours? I wouldn't."

More studies are available for your review in the latest AmNews.  [bm]

Bush Administration's CDC Provides Support for Same-Sex Marriage?

So far, the debate over same-sex marriage has focused primarily on "values" and "morality," but a recent report from the CDC may have given marriage-law reformers additional ammunition.  According to a news release from the agency, the report (“Marital Status and Health: United States, 1999-2002”) "suggests that married adults are healthier than divorced, widowed or never married adults":

• Nearly 60 percent of adults are married, 10.4 percent are separated or divorced, 6.6 percent are widowed, 19 percent are never married and 5.7 percent are living with a partner. Marital status varies greatly among race/ethnic groups: approximately 61 percent of white adults, 58 percent of Hispanic adults, and 38 percent of black adults are married, according to the survey.
   
• Married adults are less likely than other adults to be in fair or poor health, and are less likely to suffer from health conditions such as headaches and serious psychological distress.
   
• Married adults are less likely to be limited in various activities, including work and other activities of daily living.
   
• Married adults are less likely to smoke, drink heavily or be physically inactive. However, married men are more likely to be overweight or obese than other men.
   
• Adults who live in cohabiting relationships are more likely to have health problems than married adults and more closely resemble divorced and separated adults.
   
• The association between marital status and health is most striking in the youngest age group although it persists throughout the age groups studied.

If married adults enjoy a level of health that is superior to that of their unmarried peers, aren't the states' opposite-sex marriage requirements more vulnerable than ever to legal challenge?  [tm]

Regulation of Dietary Supplements Supported

The Institute of Medicine today called for tougher regulations to make sure the dietary supplement products than many Americans use are safe and do what they claim.  The Institute's 327-page report expressed concern about the quality of dietary supplements, saying "there is little product reliability" and urged that dietary supplements as well as altnerative medical procedures such as acupuncture and herbal remedies, be required to meet the effectiveness standards mandated for conventional medical treatments.  The report recommended that Congress  enact legislation to require improved quality control of supplements and to provide incentives to study the efficacy of the products. [bm]

Medical Malpractice Reform Not Viewed as Urgent Priority

A new study by the Kaiser Family Foundation and the Harvard School of Public Health reports that most Americans are much more concerned about lowering the cost of of health care and insurance, followed closely by making Medicare more financially sound and increasing the number of Americans with insurance than reducing medical malpractice awards.  In fact, reducing such awards ranked 11th on a list of 12 items. 

Three out of five said malpractice lawsuits were a very important factor in causing higher health care costs, just below the 63 percent who mentioned high profits made by drug and insurance companies.  Although Americans did not see urgency in reforming our judicial system, they did indicate that they would support legislation that required an independent specialist review a case before a lawsuit could be filed, and many supported caps on damages for pain and suffering.

UMich Receives NIH Grant to Improve Research Consents

The January 10 issue of The Michigan Daily reports that Susan Dorr Goold, the director of the University of Michigan's bioethics program and associate professor of medicine, has "received a grant for $1.5 million from the National Institutes of Health to create a program to teach researchers from any field how to better inform research candidates of what is expected of them before they consent to participate. The program seeks to thereby improve communication between researchers and participants."

“One of the things that we know nationally, even internationally, is people often don’t know what they are volunteering to do. They sign long consent forms that they may not read. Or if they do read them, they do not understand them,” said Goold. . . .

She said the motivation for the program did not derive from any specific incident at the University, but out of her desire to improve the already functioning process of informed consent.

Instead of the traditional semester-long course, Goold’s program will offer a series of scheduled conferences for researchers. The curriculum will use multiple teaching methods, including selected readings, lectures and small-group exercises where the researchers can practice obtaining consent from each other.

The class will culminate with a simulation in which researchers will attempt to obtain consent from a pretend participant, called a simulated patient instructor.

The researchers will then be assessed on their communication skills — whether they conveyed all of the relevant information and assured that the patient understood all facets of the experiment, said assistant Medical School Dean Casey White.

[tm]

The Latest Health Care Stats

As reported by numerous news outlets, Health Affairs has published a report (abstract) indicating that the rate of growth in the health care sector has fallen off for the first time in years.  Here's the summary from Kaiser's Health Policy Daily Report:

The "torrid pace of growth" in U.S. health care spending "cooled a bit" in 2003 -- in part because of state reductions in the Medicaid program and slower growth in prescription drug spending -- but the amount of spending, about $1.7 trillion, exceeded 15% of the gross domestic product for the first time, according to an annual CMS report published in the January/February issue of Health Affairs, the New York Times