HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Wednesday, July 28, 2010

No More Finger Sticks: Implantable Blood Glucose Monitor Is Great News For Diabetics

A new implantable blood glucose monitor that is in the works is good news for diabetics who have to do finger sticks four times a day. According to the Great Beyond,

[r]esearchers have developed an implantable sensor that can monitor blood-sugar levels and send the data wirelessly to an external receiver. The team has used the device in pigs for over a year, and is hoping it will work successfully in humans with diabetes. Diabetics have to routinely measure their blood glucose by pricking their fingers and reading the levels with a small meter, in order to keep the blood sugar in check.

'Four finger sticks per day to measure glucose levels is the current standard of care, but blood glucose can go on significant excursions between sticks,' says David Gough, an author of the study from the University of California in San Diego. 'In contrast, the long-term implanted glucose monitor would provide continuous monitoring day and night.'

The sensor could aid diabetes patients to adjust the timing and dosage of insulin, as well as minimizing the risk of potentially life-threatening hypoglycaemia—low blood sugar—resulting from too high a dose of insulin or the insulin absorbing too fast. It could also help type-2 diabetes patients to balance their diet and exercise plans.


July 28, 2010 | Permalink | Comments (0) | TrackBack (0)

Sunday, July 25, 2010

Britain Plans to Decentralize Health Care

Britain's new coalition government is proposing "the most radical reorganization of the National Health Service, as the system is called, since its inception in 1948." The NY Times reports that  

[p]ractical details of the plan are still sketchy. But its aim is clear: to shift control of England’s $160 billion annual health budget from a centralized bureaucracy to doctors at the local level. Under the plan, $100 billion to $125 billion a year would be meted out to general practitioners, who would use the money to buy services from hospitals and other health care providers.

 The plan would also shrink the bureaucratic apparatus, in keeping with the government’s goal to effect $30 billion in “efficiency savings” in the health budget by 2014 and to reduce administrative costs by 45 percent. Tens of thousands of jobs would be lost because layers of bureaucracy would be abolished.

In a document, or white paper, outlining the plan, the government admitted that the changes would “cause significant disruption and loss of jobs.” But it said: “The current architecture of the health system has developed piecemeal, involves duplication and is unwieldy. Liberating the N.H.S., and putting power in the hands of patients and clinicians, means we will be able to effect a radical simplification, and remove layers of management.”

July 25, 2010 | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 21, 2010

Regulations for California's Green Chemistry Initiative Released For Comment

 

Hat tip to the new Food Liability Law blog and its guest blogger Lee Smith who explains that

California is on the cusp of approving draft regulations that are proposed for California’s new Green Chemistry Initiative (GCI). Green chemistry, per the initiative, is the process for reducing or eliminating the use of hazardous materials by transitioning away from managing toxic chemicals at the end of the lifecycle, and instead reducing or eliminating their use from the start. In other words green chemistry seeks to provide incentives to remove hazardous ingredients and chemicals from products sold in California.

The statutory basis for the GCI in California was AB 1879 (2008 Cal. Stat. Chapter 599), which provides statutory authority for the California Department of Toxic Substances Control (DTSC) to adopt regulations for identifying and prioritizing “Chemicals of Concern” within consumer products and for evaluating safer alternatives to toxic chemicals. Another bill, SB 509 (2008 Cal. Stat. Chapter 560), establishes an online Toxics Information Clearinghouse to provide information about the toxicity and hazard traits of chemicals used in California. The bills also create mechanisms to provide guidance and oversight through a new Green Ribbon Science Panel of experts and by expanding the role of the Environmental Policy Council, made up of heads of the California Environmental Protection Agency boards and departments.

In March 2010, DTSC made public a conceptual process flowchart that established the framework for the regulatory process. The second step created and made public an outline of the Draft Regulations for Safer Consumer Products. This outline proposed a framework for scientific and systematic prioritization of chemicals and products of concern, preparation of alternatives assessments and development of DTSC’s regulatory responses. The next step was the development and release of the draft regulations that occurred in June.. The draft regulations specify the processes for DTSC to scientifically and systematically identify and prioritize chemicals and consumer products, for manufacturers to conduct alternatives assessments and for DTSC to impose regulatory responses for alternatives selected by manufacturers. To get a feel for the regulations, the conceptual model can be found here. The conceptual model is complex, as are the regulations, which have resulted in comments, both pro and con. Essentially the regulations apply to “all consumer products made available for use in California;” judging by the litigation that has occurred with respect to Proposition 65, this sentence provides coverage beyond the manufacturer-retailer-consumer relationship that is usually the target of this type of regulation.

“Make available for use in California” means that a person sells, offers for sale, distributes, leases, offers to lease, supplies, or otherwise transfers control overthe disposition of a consumer product directly to a California consumer; or to another person without maintaining sufficient control over the distribution, sale, lease, supply, or other transfer of the consumer product by that person to prevent the use of the consumer product by a California consumer.”

“Sell or offer for sale” means any transfer or offer to transfer for consideration of title or the right to use, by lease or sales contract, including, but not limited to, transactions conducted through sales outlets, catalogs, or the Internet, or any other similar electronic means.” CHAPTER 53 OF DIVISION 4.5 OF TITLE 22, CALIFORNIA CODE OF DRAFT REGULATIONS Sec. 69301.2 Definitions.

Products that are identified as violating the initiative cannot be sold in and must be recalled from the California market. Under the sections concerning identifying products of concern, full disclosure of the chemical makeup of the products is required. Several lists of chemicals are to be compiled including Chemicals of Concern and Chemicals under Consideration. To provide an idea of the complexity, without going into detail, the outline for 61 pages of regulations is 21 pages long.

The list of “Chemicals of Concern,” includes carcinogens, mutagens, neurotoxins and compounds that disrupt hormones, persist in the environment or accumulate in human bodies. DTSC would pick priority products that are heavily used by children, pregnant women, the elderly and other sensitive populations.

Manufacturers, suppliers and importers would have to certify to the state and to retailers that their products on the list are free of chemicals before they would be able to sell them in California. In some cases, they would also perform assessments to find safer alternatives.
There are already comments from the industry that the regulatory process is unworkable and from the environmental camp that the initiative should go farther to protect public. Comments have been submitted by various groups. The Administrative Procedures Act process calls for public hearings and a 45-day public comment period. Specific information about the APA process will be announced when the final draft regulation is available for review.

July 21, 2010 | Permalink | Comments (0) | TrackBack (0)

Tuesday, July 20, 2010

New Gel Can Reduce Risk of HIV Infection by Nearly 40%

According to a story by the Kaiser Daily Global Health Policy Report

[a] microbicide gel containing Gilead's HIV drug tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by nearly 40%, according to a study unveiled at the International AIDS Conference-AIDS 2010, Reuters reports (Ingham, 7/19).

The Centre for the AIDS Programme of Research in South Africa (CAPRISA) trial showed that the gel "curbed the risk of infection by the human immunodeficiency virus (HIV) by 39 percent overall, but by 54 percent among those women who used it most consistently," Agence France-Presse reports (7/19). "The gel also reduced the risk of contracting genital herpes by 51 percent, a factor which could slow the spread of HIV even further, given that people with genital herpes have double the risk of getting HIV," according to the study, HealthDay News/U.S. News & World Report writes (Gardner, 7/19).

"The clinical trial of the microbicide – a 1% concentration of the drug incorporated into a colorless, odorless gel and distributed in a plastic applicator – was organized by the husband-and-wife team of Dr. Quarraisha Abdool Karim and Dr. Salim S. Abdool Karim of the Center for the AIDS Program of Research in Durban, South Africa," the Los Angeles Times reports.

As detailed in the study, published online Monday in the journal Science, researchers "enrolled 889 sexually active women between the ages of 18 and 40 in the South African province of KwaZulu-Natal; about half received the gel with microbicide and half a placebo. The women were told to use the gel in the 12 hours before they expected to have sex and in the 12 hours afterward. The researchers collected applicators to monitor compliance," according to the newspaper (Maugh, 7/20).

July 20, 2010 | Permalink | Comments (0) | TrackBack (0)

Proposed BIll Gives FDA Mandatory Recall Powers

Hat tip to Pharmalot for highlighting a proposed bill to give the FDA mandatory recall powers:

In light of the Johnson & Johnson recall scandal, the House Committee on Oversight & Government Reform has, as promised, introduced a bill to give the FDA mandatory recall powers. The move comes after Ed Towns decried the way J&J’s McNeil Consumer Healthcare unit responded to repeated quality control problems that led to the recall of tens of millions of over-the-counter pediatric meds (back story here, here and here).

Under the legislation, which amends the Federal Food, Drug and Cosmetic Act, the FDA would have the authority to demand a recall when there is an indication that a drug has been adulterated, misbranded, or exposure to a drug may cause serious adverse health consequences or death to humans and animals (here is the bill). The J&J products, which the healthcare giant is scrambling to produce elsewhere while its Fort Washington, Pa., plant is shutdown indefinitely, were found to have a musty smell, metallic flecks or too much active ingredient. Towns accused the McNeil unit of conducting a phantom recall in hopes that regulators and consumers would not be alerted to the problems.

July 20, 2010 | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 14, 2010

SSRN Top Ten Health Law Downloads Between May 15 and July 14, 2010

The following are the top ten SSRN downloads for Health Law for the period between May 15 and July 14, 2010:

Rank

Downloads

Paper Title

1

197

Over-Parenting
Gaia Bernstein, Zvi H. Triger,
Seton Hall University - School of Law, The College of Management School of Law,
Date posted to database: April 13, 2010
Last Revised: June 9, 2010

2

153

The Weirdest People in the World?
Joe Henrich, Steven J. Heine, Ara Norenzayan,
University of British Columbia, University of British Columbia (UBC), University of British Columbia (UBC),
Date posted to database: May 11, 2010
Last Revised: May 13, 2010

3

108

The European Regulatory Response to the Volcanic Ash Crisis between Fragmentation and Integration
Alberto Alemanno,
HEC Paris - Law Department,
Date posted to database: May 19, 2010
Last Revised: May 30, 2010

4

100

Insurance in Sociolegal Research
Tom Baker,
University of Pennsylvania Law School,
Date posted to database: May 11, 2010
Last Revised: May 11, 2010

5

86

Human Rights and Intellectual Property: Mapping the Global Interface
Laurence R. Helfer, Graeme W. Austin,
Duke University - School of Law, University of Arizona - James E. Rogers College of Law,
Date posted to database: May 20, 2010
Last Revised: May 26, 2010

6

78

The Health-Related Tax Provisions of PPACA and HCERA: Contingent, Complex, Incremental and Lacking Cost Controls
Edward A. Zelinsky,
Benjamin N. Cardozo School of Law,
Date posted to database: July 2, 2010
Last Revised: July 11, 2010

7

76

Unethical Female Stereotyping in Reproductive Health
Rebecca J. Cook, Simone A. Cusack, Bernard Dickens,
University of Toronto - Faculty of Law, Unaffiliated Authors - affiliation not provided to SSRN, University of Toronto - Faculty of Law,
Date posted to database: May 6, 2010
Last Revised: May 21, 2010

8

69

Six Secret (and Now Open) Fears of ACTA
Peter K. Yu,
Drake University Law School,
Date posted to database: June 15, 2010
Last Revised: June 20, 2010

9

68

Ensuring Government Accountability During Public Health Emergencies
Fazal Khan,
University of Georgia - School of Law,
Date posted to database: May 21, 2010
Last Revised: June 28, 2010

10

66

Employment-Based Health Insurance: Is Health Reform a ‘Game Changer?’
David A. Hyman,
University of Illinois - College of Law,
Date posted to database: June 16, 2010
Last Revised: June 16, 2010

July 14, 2010 | Permalink | Comments (0) | TrackBack (0)

36% of Physicians Don't Believe in Reporting Impaired Colleagues

It is unfortunate, but not surprising, that 36% of physicians state that they may not report an impaired colleague. Researchers from the Mongan Institute for Health Policy at Massachusetts General Hospital surveyed 1,891 doctors in various specialties in Physicians' Perceptions, Preparedness for Reporting, and Experiences Related to Impaired and Incompetent Colleagues.

The reasons given for a failure to report include a belief that someone else will report, fear of retribution and a belief that reporting will not make any difference. According to the WSJ Health Blog, “[t]he authors also noted that physicians who belonged to one- or two-person practices, are a racial or ethnic minority or who graduated from non-U.S. med schools were less likely to report a physician colleague. Those at hospitals or med schools were most likely to do so."

July 14, 2010 | Permalink | Comments (0) | TrackBack (0)

Saturday, July 10, 2010

Lawsuit Threatened Over McDonald's Use of Toys to Advertise Happy Meals

The Center for Science in the Public Interest (CSPI) sent a demand letter to McDonald’s threatening to sue if the company didn’t stop using toys to market Happy Meals to young children. The Washington-based group said using toy-related promotions violated state consumer protection laws in Massachusetts, Texas, the District of Columbia, New Jersey and California.

By advertising that Happy Meals include toys, McDonald’s unfairly and deceptively markets directly to children.… Happy Meals lead children to develop a lifelong habit of eating meals that are too high in calories, saturated fat, added sugars, and sodium, and devoid of whole grains.

McDonald’s Web site lists 24 Happy Meal combinations. Considering that a reasonable lunch for a young child would contain no more than 430 calories (one third of the 1,300 calories that is the recommended daily intake for children 4 to 8 years old), not a single Happy Meal meets that target. The average of all 24 meals is 26 percent higher in calories than a reasonable lunch. In fact, one meal (cheeseburger, French fries, and chocolate milk) hits 700 calories — a whopping 63 percent higher (and more than half the calories for the entire day).

Consider the Happy Meal composed of a cheeseburger, French fries, and Sprite. That meal has 640 calories (half a day’s worth for young children), 7 grams of saturated fat (half the 14-gram recommended limit), 940 milligrams of sodium (about three-fourths of the 1,200-milligram limit), and 35 grams of sugar (about two days’ worth). Moreover, the bun is made with white, not whole wheat, flour. Although the Dietary Guidelines for Americans recommends diets centered on vegetables, fruits, whole grains, low-fat dairy, and lean protein, McDonald’s Happy Meals consist largely of white flour, fried meat, fried potatoes, salt, and refined sugars.

In a July 6 letter to the Executive Director of CSPI, McDonald’s CEO Jim Skinner defended McDonald's marketing practices by saying that “Happy Meals are a fun treat, with right-sized, quality food choices.”  Mr. Skinner went on to argue that

it seems that you purposefully skewed your evaluation of our Happy Meals by putting them in the context of a highly conservative 1,300 calorie per day requirement. …I’m sure you know this category generally applies to the youngest and most sedentary children.

July 10, 2010 | Permalink | Comments (0) | TrackBack (0)

Thursday, July 8, 2010

Children are Seeing More Television Advertisements for Fast Foods and Racial Gaps in Exposures Increase

According to a recent study assessing food advertising trends, children now see more television advertisements for fast food and fewer television advertisements for sweets and beverages than they did in 2003. In addition, the study concludes that racial gaps in exposure to all food advertising have increased.

Lisa M. Powell, Ph.D., and colleagues at the University of Illinois at Chicago studied television ratings data from Nielsen Media Research for the calendar years 2003, 2005 and 2007. The study, Trends in Exposure to Television Food Advertisements Among Children and Adolescents in the United States, will appear in the September print issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.  

The study is important in light of the findings by an Institute of Medicine (IOM) report that there is strong evidence that television advertising influences the short-term eating habits of children age 2 to 11, and moderate evidence that advertising influences their usual dietary intake, according to background information in the article. ScienceDaily summarizes the article as follows:

In 2006, 10 major U.S. food companies pledged to devote at least half of their child-targeted advertising to healthier products or encouraging good nutrition and healthy lifestyles, an effort called the Children's Food and Beverage Advertising Initiative. By 2009, 16 companies had signed on. "Given that each company defined their own better-for-you products and also had different definitions of what constituted children's programming, key questions remain," the authors write.To assess trends in food advertising before and after the initiative, Lisa M. Powell, Ph.D., and colleagues at the University of Illinois at Chicago studied television ratings data from Nielsen Media Research for the calendar years 2003, 2005 and 2007.

Between 2003 and 2007, daily average exposure to televised food ads decreased by 13.7 percent among children age 2 to 5 and 3.7 percent among children age 6 to 11, but increased by 3.7 percent among teens age 12 to 17. Ads for sweets became less frequent, with a 41 percent decrease in exposure for 2- to 5-year-olds, 29.3 percent for 6- to 11-year-olds and 12.1 percent for 12- to 17-year-olds. Beverage ads also decreased in frequency, by about 27 percent to 30 percent across age groups, with substantial decreases in exposure to ads for previously heavily advertised sugar-sweetened beverages.

However, exposure to fast-food ads increased between 2003 and 2007, with a 4.7 percent increase in viewings among children age 2 to 5, 12.2 percent among children 6 to 11 and 20.4 percent among teens age 12 to 17. The high prevalence of these ads suggests the importance of branding, the authors note. "Indeed, children have been found to recognize brand logos at very young ages and a recent study found that preschoolers exhibited significantly higher preferences for food and beverage items in branded vs. plain packaging," they write.

The racial gap in advertising also increased in this time period. By 2007, African American children saw 1.4 to 1.6 times as many food ads per day than white children, depending on their age. "In particular, African American children and teens had more than double the rate of increase in exposure to fast food ads compared with their white counterparts," the authors write.

July 8, 2010 | Permalink | Comments (0) | TrackBack (0)

Monday, July 5, 2010

The New EU Mandatory Organic Logo

As of July 1, new regulations came into effect that require the use of the European organic logo on pre-packaged organic food and beverage products. The European Commission states that the new logo is designed to provide a consumer with “complete confidence” that the goods they purchase are produced in line with EU organic farming regulations. The logo is made up of 12 stars in the shape of a leaf.

EU-organic-logo-comes-into-force_dnm_headline 
 

According to FOODnavigator.com

[w]here used, the logo must be accompanied by an indication of the place where the agricultural raw materials were farmed, stating that raw materials originate from 'EU Agriculture', 'non-EU Agriculture' or 'EU/non-EU Agriculture'. If all raw materials have been farmed in only one country, the name of this specific country, in or outside the EU, can be indicated instead.

National, region, or private labels will be allowed to appear on packaging alongside the common EU logo. Under the EU’s new regulations, products can only be labelled as organic if:

·         At least 95 per cent of the product's ingredients of agricultural origin have been organically produced;

·         The product complies with the rules of the official inspection scheme;

·         The product has come directly from the producer or preparer in a sealed package;

·         The product bears the name of the producer, the preparer or vendor and the name or code of the inspection body

·         The product does not contain GMOs

 

The new EU rules also set out conditions for organic aquaculture production of fish, shellfish and seaweed. These specify that biodiversity should be respected, and do not allow the use of induced spawning by artificial hormones.

July 5, 2010 | Permalink | Comments (0) | TrackBack (0)

Friday, July 2, 2010

Kaiser Foundation's June Update on Health Disparities

The Kaiser Foundation has posted its June Update on Health Disparities which

includes summaries of news articles on efforts to recruit multi-racial donors for the National Marrow Donor Program, cultural factors contributing to disparities in treatment among lung-cancer patients, and a medical-legal partnership that helps patients overcome legal challenges that threaten the care of patients in the Washington, D.C., area. The monthly update synthesizes news coverage from hundreds of print and broadcast news sources related to health and health care issues that affect underserved and racial and ethnic communities as well as providing summaries of relevant journal articles and other research developments in the field.

You can sign up to receive the free report via email by visiting Kaiser's online subscription site and selecting the "Minority Health" topic within the kff.org Kaiser Update section.

July 2, 2010 | Permalink | Comments (0) | TrackBack (0)