HealthLawProf Blog

Call for Papers: The Cleveland-Marshall Journal of Law and Health

The Journal of Law and Health is actively seeking scholarly articles on health-related topics for Volume 23, to be published during the 2009-2010 academic year. We are interested in any and all health-related topics, and encourage both legal scholars and active practitioners to submit articles of 20-60 pages in length.  Articles, cover letters, and curricula vitae should be sent to [email protected] or [email protected].  

 

About the Journal of Law and Health:

The Cleveland-Marshall Journal of Law and Health is an interdisciplinary publication that advances health law and policy. The Journal is staffed and edited entirely by students who have demonstrated their potential for scholarly writing either through class rank or acceptable performance in a summer writing competition sponsored by the Journal. Founded in 1984 by Karen E. Rubin and James E. Powell, the Journal has attracted nationally recognized authors and advocates in the field of law and health.  It is indexed and published on LexisNexis, Westlaw, PubMed, and HeinOnline.

The Journal of Law and Health is a traditional, yet innovative periodical. Articles are drawn from all disciplines that offer a perspective on the legal aspects of medicine and health sciences. This pan-disciplinary format allows flexibility in both the type and length of articles published.

While retaining a scholarly format, the Journal encourages publication of the innovative idea, the bold statement, and the unique point of view.

For any additional information, please contact the editors-in-chief:

 

Eric Steiger

[email protected]

 

Stefanie Baker

[email protected]

Has Statin Use by the Wealthy Created New Social Disparities In Cardiovascular Health?

Since the 1980s, cholesterol levels of the wealthy have declined at twice the rate of those of the poor. Why? A new study suggests that statins, which are expensive drugs that are highly effective in reducing cholesterol and improving heart health, are more widely available to higher income people. Thus, access to statins may have contributed to expanding social disparities in the treatment of cardiovascular disease. 

The study, called Changing Health Disparities and Fundamental Cause Theory:  Fundamental Cause Theory, Technological Innovation, and Health Disparities: The Case of Cholesterol in the Era of Statins was published in the September issue of Journal of Health and Social Behavior and is the work of Virginia W. Chang, MD, PhD, of the Philadelphia Veterans Affairs Medical Center and the University of Pennsylvania, and Diane S. Lauderdale, PhD, of the University of Chicago.

Cardiovascular disease is the leading cause of death in the United States. However, death from cardiovascular disease has decreased drastically since the 1980s. It is estimated that one-third of this decrease is related to pharmaceuticals, including statins.

As reported in ScienceDaily, Dr. Chang, lead author of the study and Assistant Professor of Medicine and Sociology at the University of Pennsylvania explains that

[i]ncome disparities in lipid levels have reversed over the past three decades. … High cholesterol was once known as a rich man's disease, because the wealthy had easier access to high fat foods (e.g., red meat). Now wealthy Americans are least likely to have high cholesterol, because they are more likely to be treated with statins, an expensive but highly effective pharmaceutical treatment to lower lipid levels.
                                                        ***
Though statins have a longer-run potential to reduce disparities by making it easier for everyone to lower cholesterol relative to lifestyle changes, they have yet to diffuse widely across all income levels.

[KVT]

A Dangerous Shortage of Domestic Violence Services

More than 10 percent of victims of domestic abuse report that they were unable to receive help they needed according to a study published by the Health Affairs Web site.

 

The study, published on September 22, 2009, was performed by Rahda Lyengar of the London School of Economics and Political Science and Lindsay Sabik of Harvard University. According to the abstract, 

[t]he results analyze the information gathered from federally funded local domestic violence programs in the U.S.about the calls each received over one 24-hour period (September 13, 2006). According to the data, 48,350 people reported contacting the agencies. Of these, 5,183 respondents could not be helped due to a lack of a program's resources. Unmet requests included those for emergency shelter, transitional housing, and non-residential services, such as one-to-one counseling, safety planning and legal services.

As reported in the Sunday Health Policy Update of Health Affairs, Dr. Iyengar states:

These community-based organizations are often the last resort before the emergency room for victims of domestic violence. … Clearly more funding of domestic violence programs is needed to meet as many requests for support as possible. Our research has identified a special need for more transitional housing, since shelters with transitional housing report much lower rates of victims returning to their abusive partners.

 

[KVT]

Costs Continue To Climb For Job-Based Insurance

According to the yearly survey by the Kaiser Family Foundation and the Health Research & Educational Trust (HRET), premiums for employer-sponsored health insurance rose to $13,375 annually for family coverage in 2009 - with employees on average paying $3,515 and employers paying $9,860. The survey was published online in Health Affairs on September 15, 2009.

Each year the Kaiser/HRET Survey of Employer Health Benefits takes a snapshot of the state of employee benefits in the United States, based on interviews with public and private employers. Our findings for 2009 show that families continue to face higher premiums, up about 5 percent from last year, and that cost sharing in the form of deductibles and copayments for office visits is greater as well. Average annual premiums in 2009 were $4,824 for single coverage and $13,375 for family coverage. Enrollment in high-deductible health plans held steady.

Workers wages went up 3.1 percent during the same period. Since 1999, premiums have gone up a total of 131 percent, far more rapidly than workers' wages (up 38 percent since 1999) or inflation (up 28 percent since 1999). For the past few years, however, the annual rise in premiums has been more moderate than the double-digit growth experienced earlier this decade. [KVT]

Consumer Reports Announces “Evidence-Based Ratings for Medical Treatments, Drugs and Natural Medicines”

Consumer Reports announced this week the debut of its web service called ConsumerReportsHealth.org. The web site offers the following:  

 

▪ Natural Medicine Ratings for over 20,000 herbs, vitamins and nutritional supplements;

▪ Treatment Ratings for over 200 common medical and mental health conditions, including allergies, depression, back pain, and high cholesterol, among many others;

▪ Drug Reviews for most prescription and over-the-counter drugs, featuring recommendations for low-cost drugs that are as safe and effective as more expensive drugs;

▪ Diet, nutrition and fitness product reviews and ratings; and,

▪ Patient Ratings of over 3,400 hospitals, to help consumers better compare and choose hospitals.

 

This new, interactive web site has several potential benefits. The most important is the help that ConsumerReportsHealth.org could offer to consumers in making day-to-day choices on how to spend limited resources to manage their health. The goal of this new web tool is to give consumers of health products and services the same expertise and independence that Consumer Reports has used to rate cars, electronics and appliances for more than 70 years. For those consumers who struggle to make sense out of all of the advertising hype that surrounds health care products, and for those who try to make provider choices with little to no information on the quality of health care services, Consumer Reports may provide an unbiased, fact-based resource.

 

This service is also important to overall quality of care. With Consumer Reports finally entering the health care scene, the evidence-based treatment movement is likely to gain even more momentum toward replacing eminence-based treatment.  

 

The third detail that jumps out from this announcement comes from both the headline that refers to dietary supplements as “Natural Medicines” and from the following description:

 

This new, interactive Web site empowers you to make better healthcare decisions on a daily basis! For example, ever wonder about the effectiveness and safety of the natural remedies you take to lose weight or soothe your cold? The Natural Medicine Ratings on ConsumerReportsHealth.org provide comprehensive, accurate information for over 20,000 herbs, vitamins and nutritional supplements, to prevent and treat a variety of conditions. [emphasis added].

Consumer Reports does its job and 'says it like it is' by calling those “dietary supplements” that are being marketed as treatments for abnormal health conditions “medicines.” This acknowledgment highlights a growing problem. There are currently far too many “dietary supplements” that are being marketed to the unhealthy and vulnerable by making health treatment, recovery or remedy claims without demonstrating through the FDA premarket approval that these products are both safe and effective.

This new Consumer Reports web site may be able to partially accomplish what the FDA has failed to do in the area of “dietary supplements” – it may act to protect at least some unhealthy, vulnerable consumers from spending limited resources on “dietary supplements” that claim to treat unhealthy conditions but that just don’t work. For more on this problem, see Post 1 in Series: The Relationship Between the Level of Government Regulation under the FDCA and the Health Status of a Product’s Targeted Population

[KVT]

Are Long-Term Risks Ignored in Calculating the Safety of Medical Treatments?

Patients who take the powerful new multiple sclerosis drug Tysabri are getting mixed messages about their risk of contracting a life threatening condition called progressive multifocal leukoencephalopathy, or PML. PML is a brain infection associated with the use of Tysabri. It appears that information regarding the level of the risk of PML given to patients on Tysabri depends on who they ask. As Keith Winstein of the Wall Street Journal reports:

Tysabri underscores a central mathematical issue in assessing risks and benefits of medical treatment -- one that has also shown up in calculating the risk of blood clots among heart-stent users, and in figuring out how beneficial chemotherapy is in treating lung cancer.

Simply put, the issue is a matter of whether to adjust for time. In other words, should the chances of contracting a harmful side effect be calculated by figuring out the simple percentage of all those taking the drug who have come down with the side effect? Or should those calculations be adjusted for the duration that patients have been treated?

The former method calculates what's called an "absolute" percentage. The latter, used widely in medical studies and by insurance actuaries, takes into account that risk changes over time: For example, someone who drives a car only one day during his lifetime is less likely to be in a crash than someone who drives for 20 years.

Using the absolute method, the manufactures of Tysabri report that the risk of PML is one in 8,700. The actuarial method results in a risk of one in 1,200 -- much closer to the one-in-1,000 threshold that may cause doctors to become more cautious in prescribing the drug.

The two mathematical methods in calculating risks have led to prior disputes. In 2006, Boston Scientific Corp. and Johnson & Johnson disagreed over whether their models of drug-coated heart stents -- tiny scaffolds that prop open clogged arteries -- caused blood clots years after implantation.

According to this WSJ article, J&J used the absolute method and reported no increase in the percentage of patients with clots in its coated stent. Boston Scientific applied the actuarial method and reported an increase in clots with the use of its stent. This led to an impression that J&J’s stent was safer than Boston Scientific's stent. The New England Journal of Medicine analyzed both stents with the same technique and discovered the same number of clots with both stents.

Similarly in 2005, a Canadian clinical trial inaugurated the use of chemotherapy to treat lung cancer after demonstrating that the treatment reduced mortality by 31%. Half the people in the study were given chemo, and half weren't.

But the results didn't mean that chemo decreased actual lung-cancer deaths -- only that it would extend the life of patients. In fact, after eight years, the study estimated that the same fraction of people would die with treatment as without -- about half. Since people on chemo lived longer, by about 21 months, the study could truthfully report that treatment reduced the average death rate during the study. (emphasis added).

As patients with chronic medical conditions are living much longer lives, it appears that long-term exposure levels as reflected in the actuarial model should be used to quantify the risks associated with treatment options so that both physicians and their patients can make informed treatment choices. [KVT]

Lifestyle Choices and Health: Your Social Life Can Impact Your Health And Your Food Choices Can Trump Your Genetic Code To Influence Your Weight

Two new studies came out this week that have interesting implications on the association between  lifestyle choices and disease. The first is a study by Emily Sonestedt, a member of the Marju Orho-Melanders research group at Lund University Diabetes Centre published in the American Journal of Clinical Nutrition. This study deals with those who have the risk variant of the FTO gene. The FTO gene is the gene most commonly associated with overweight and obesity. Forty percent of the population have one copy of this gene. Seventeen percent have a double copy, acquired by inheriting one gene from each parent.

As ScienceDaily reports 

[t]he risk of becoming obese is 2.5 times higher for those who have double copies of the best known risk gene for overweight and obesity. However, this is only true if fat consumption is high. A low fat diet neutralizes the harmful effects of the gene…. [In other words,] the risk of obesity was dramatically increased only in the case of high fat consumption.

The second is a study performed by the Universities of Exeter and Queensland, Australia published in the Scientific American Mind. This study reveals that the quality of an individual’s social life may have a greater role in health than diet and exercise. Simply being a part of a social group may significantly reduce both the risk of simple maladies, like the common cold, as well as devastating conditions such as stroke and dementia.

As reported in ScienceDaily, Professor Alex Haslam of the Psychology Department, University of Exeter, made the following comment on this study:

We are social animals who live and have evolved to live in social groups. Membership in groups, from football teams to book clubs and voluntary societies, gives us a sense of social identity. This is an indispensable part of who we are and what we need to be in order to lead rich and fulfilling lives. For this reason groups are central to mental functioning, health and well-being.

[KVT]

Dueling Food Safety Websites

Two excellent food safety web sites were introduced this week:  Food Safety News and FoodSafety.gov.

Food Safety News is the brain child of Bill Marler, a nationally recognized food safety and food borne illness expert. The first articles posted on the site suggest that this will be an excellent resource for those who are interested in food issues. As an example, read the posted article Food Safety Acts Compared: HR 2749 vs. S 510. For more, see Bill Marler Launches OnLine Newspaper, Food Safety News

 
 

Another high recommend goes to FoodSafety.gov which was created to be the “the gateway to food safety information provided by government agencies.”

The FoodSafety.gov website explains that:

[t]he federal government will enhance www.foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications.

Special features include advice on how to avoid food safety risks that occur more often at certain kinds of events and in certain seasons, how to avoid food safety risks that are higher for specific groups of people and how to locate a state agency in a particular area. KVT

 

African Policy - Criminalize the Spread of HIV?

Two Zambia air force members claim they were discriminated against when they were discharged because they have HIV.This African case may influence how African courts respond to the HIV epidemic and shape policy. Reports the Washington Post:

Across the continent, lawmakers are considering whether to make criminals of those who infect others with HIV, allow bosses to test workers for the virus, punish women who pass it to their babies and give constitutional protections to those with HIV.

Such questions are increasingly landing in courtrooms, presenting judges with cases that mix current science, individual rights and a devastating public health crisis. One, involving two Zambia air force members who say they were unfairly discharged because they have HIV, goes to trial here next month. 

While the UN, human rights organizations and several African nations have favored a more rights-friendly approach for those with HIV, some African countries are justifying laws criminalizing HIV as a means to reduce the spread of the disease.

Laws criminalizing the transmission of HIV have been adopted from western to southern Africa, for example, with backing from some women's groups despite human rights advocates' contention that they deepen stigma. In Botswana, protests by activists have failed to stop employers from testing and excluding infected job applicants. A recent proposal in Rwanda would require HIV tests for many -- an idea supported by observers who say that relying on people to seek testing "can deprive other people of their right to life," as one University of Pretoria researcher wrote in South Africa's Star newspaper.

School Lunches - the New "Social Justice Issue of Our Time"?

Replacing fatty, high sodium and inexpensive foods served in school cafeterias across the country should be more of a priority for Washington, advocates Ann Cooper. Cooper is currently the the interim director of nutrition services for the schools of Boulder Valley, Colorado and the founder of Food Family Farming and consultant to Whole Foods Market for school lunch campaign. There are signals that her message is being heard in Washington:

Congress is due to update and reauthorize the Child Nutrition Act, which, among other things, dictates the details of the $9.3 billion National School Lunch Program, through which some 30.5 million students receive free or reduced-price lunches (and, in many districts, breakfasts and after-school snacks). That number has been growing lately, as the tough economy has led to increased participation in the program at every grade level since 2005, according to the School Nutrition Association (SNA), a national organization based at National Harbor.

Read more from WSJ here.

Health Care Reform: Obama Will Talk Specifics

WSJ reports that President Obama is ready to talk about his specific position on the health care reform debate. Be prepared to tune into Obama's speech on Wednesday.

Until now, Obama has resisted taking firm positions on specific elements of a broad health-care bill, instead expressing openness to many ideas. But the approach has left lawmakers divided over contentious elements, such as how to rein in costs. And with a growing chorus in favor of a slower, less ambitious approach, Obama is inching toward a proposal that would bear his name and carry the political risks of sponsorship.

Pfizer Settles for $2.3 Billion: Obama Administration Serious About Cracking Down on Health Care Fraud

Washington Post reports that drug manufacturer, Pfizer, settled for a record $2.3 billion, pleading guilty to a felony charge of fraudulent marketing of drug, Bextra. This marks the first major Obama administration victory in cracking down on health care fraud, indicating that the administration is prioritizing this important issue.

The Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.

The company allegedly enticed doctors to prescribe the drug for pain relief by taking them on lavish trips, created sham requests for medical information as an excuse to send unsolicited advertising materials to physicians, and drafted articles promoting the pills without disclosing its role in preparing the stories.

Fears of Flu Pandemic - More Harm Than Help?

LA Times questions whether public health officials were too preemptive in declaring a health emergency this past April when swine flu first hit the U.S. Fear of catching H1N1 has even affected the financial market, a harm perhaps disproportionate to the true health threat:

The U.S. Department of Health and Human Services declared a “nationwide public health emergency” on April 26, when there were only 20 confirmed cases and no deaths.  The declaration prompted a huge spike in lab testing for H1N1, which in turn produced what Doshi calls a “concern bias, in which concern and anxiety may drive events more than the disease itself.”

Fears about H1N1 have been costly to the pork and travel industries, caused healthy people to endure mandatory isolation, and prompted massive government outlays for lab testing, antiviral medication purchases and expedited vaccine development. Unless things suddenly take an unexpected turn for the worse, all of that activity is probably out of proportion to the actual threat, he writes.

Even Elmo has something to say about swine flu these days, as the federal government launched a new partnership with Sesame Workshop to encourage children to maintain healthy habits:

                                               (Image from Washington Post)

"Come on! Wash your hands with Elmo! Wash, wash, wash!" the Muppet from Sesame Street sings in a public service announcement released Tuesday by the Obama administration. "Sneeze into your arm with Elmo," the character adds. "Ah-choo!"

The program has been criticized for taking the risk of H1N1 too lightly while many Americans wait on the new H1N1 vaccination, which will not be released until approximately November.

Big Tobacco Sues

Has Congress gone too far? Filed in Bowling Green, Ky, Big Tobacco is suing the FDA over a newly enacted law, which restricts tobacco manufacturers' rights to advertise. WSJ reports:

The companies object to such provisions as a requirement that cigarette makers expand the size of warning labels so that they cover the top half of the front and back of cigarette packs, and include graphic images such as diseased lungs. This change, they say, would leave manufacturers with only a small and often-obscured portion of a cigarette pack to print their own messages.

The companies also challenged a rule that restricts their ability to publicize the relative health risks of certain products such as smokeless tobacco.