HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, October 4, 2008

Federal Court Upholds San Francisco Healthcare Program

The Los Angeles Times reports that a federal appeals panel upheld San Francisco's citywide healthcare program, concluding that the law does not violate federal regulations on employee benefit programs.  Marc Lifsher writes,

Gavel3Gov. Arnold Schwarzenegger's ongoing effort to create a universal health insurance system for California got a major boost Tuesday when a federal appeals panel upheld San Francisco's pioneering citywide healthcare program.

Ruling on a suit brought by a local restaurant association, a three-judge panel of the U.S. 9th Circuit Court of Appeals found that fees charged to employers under the 10-month-old San Francisco Health Care Security Ordinance do not violate federal laws regulating employee benefit programs.
The San Francisco ordinance, which took effect Jan. 9, requires for-profit employers with 20 or more workers to offer health insurance, set aside funds in health reimbursement accounts or pay a fee to the city's Healthy San Francisco program. Nonprofit employers with 50 or more staffers are also covered.

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October 4, 2008 | Permalink | Comments (0) | TrackBack (0)

FDA Sets Safety Threshold for Contaminant Melamine

The Washington Post reports that the FDA, concerned with the amount of melamine in food coming from china, has set 2.5 parts per million as the maximum "tolerable" amount of melamine that could be safely consumed in other foods.  Marc Kaufman writes,

Fda2Responding to concerns about the presence of the contaminant melamine in numerous foods made in China and exported to the United States and elsewhere, the Food and Drug Administration said yesterday that consuming a very small amount of the chemical poses no serious risk.

The exception, officials said, is melamine in baby formula, which has sickened more than 54,000 infants in China. The agency said it was unable to determine what a safe amount of melamine in formula might be.

The FDA set 2.5 parts per million as the maximum "tolerable" amount of melamine that could be safely consumed in other foods.

"It would be like if you had a million grains of sand and they were all white, and you had two or three that were black, that's kind of the magnitude," said Stephen Sundlof, director of the FDA's food safety program.

Several melamine-contaminated foods found in recent weeks in the United States had far more of the chemical.

Melamine levels in imported Chinese candies recalled last week in California, for instance, were as high as 520 parts per million. White Rabbit candies from China were recalled after authorities in California and Connecticut found melamine. And Friday, a New Jersey company announced that it was recalling a yogurt-type drink from China -- Blue Cat Flavor Drink -- after FDA testing found melamine.

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October 4, 2008 | Permalink | Comments (1) | TrackBack (0)

Friday, October 3, 2008

FDA: No Quick Decision on Cold Medicines for Kids

The Washington Post reports that FDA officials said they were uncomfortable with the lack of solid scientific data to support continued use of over-the-counter cough and cold medicines for young children.  Ricardo Alonso-Zaldivar writes,

Cough_syrup_3A top government health official Thursday rejected pediatricians' calls for an immediate ban on over-the-counter cough and cold medicines for young children, saying it might cause unintended harm.

But Food and Drug Administration officials at a public hearing also said they were uncomfortable with the lack of solid scientific data to support continued use of OTC remedies with youngsters, particularly from ages 2-6.

A ban, as sought by leading pediatricians' groups, might only drive parents to give adult medicines to their youngsters, said Dr. John Jenkins, who heads the FDA's Office of New Drugs.

"That is a concern for us," said Jenkins. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."

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October 3, 2008 | Permalink | Comments (0) | TrackBack (0)

California to Cover Cost of Screening for H.I.V.

The New York Times reports that Gov. Schwarzenegger signed into law a bill requiring private health insurance providers to cover the cost of HIV testing regardless of a primary diagnosis, making California the closest state to instituting routine HIV screening.  Rebecca Cathcart writes,

Removing the cost barrier is a major step toward making H.I.V. screening more prevalent and, in the process, removing the fear and stigma long attached to the test.

“This kind of test should be as routine as a cholesterol or blood pressure test,” said Assemblyman Paul Krekorian, the author of the bill. “It should be a part of basic preventative health care.”

The law, said Mr. Krekorian, a Democrat, brings California closer to the routine H.I.V. testing recommended in a 2006 report from the Centers for Disease Control and Prevention.

Last year, California stopped requiring hospital patients to give written consent before being tested for H.I.V. That change, along with this guaranteed cost coverage, Mr. Krekorian said, will eliminate the barriers to routine screening.

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October 3, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, October 2, 2008

New Law Will Require California Chain Restaurants to Display Calorie Counts

The Los Angeles Times reports that Gov. Schwarzenegger plans to sign a bill that will require food chains with 20 or more locations to post calorie information, making California the first state to enact such a regulation in the battle against obesity epidemic.  Patrick McGreevy writes,

CaloriesChain restaurants in California will have to display calorie counts with each menu item -- the first state law of its kind in the nation -- under legislation that Gov. Arnold Schwarzenegger plans to sign today.

With two days left to act on hundreds of bills, Schwarzenegger on Monday approved measures that could ease traffic in downtown Los Angeles with toll lanes, protect animal researchers from threats and smooth the effort to achieve cityhood for East Los Angeles. He rejected a proposal to remove "communism" as a reason for dismissal from state employment.
The menu labeling was proposed by state Sen. Alex Padilla (D-Pacoima) as a way to give restaurant customers more information about what they eat.

"The way Californians order food is about to change," Padilla said in a statement. "All Californians will soon be empowered with reliable, accessible nutrition information . . . that will help them make more informed, healthier choices."

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October 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Medicare Won’t Pay for Medical Errors

The New York Times reports that Medicare has compiled a list of ten "reasonably preventable" conditions and will not reimburse hospitals if a patient develops one of those conditions while in the care of the hospital.  Kevin Sack writes,

Medicare_3If an auto mechanic accidentally breaks your windshield while trying to repair the engine, he would never get away with billing you for fixing his mistake. On Wednesday, Medicare will start applying that logic to American medicine on a broad scale when it stops paying hospitals for the added cost of treating patients who are injured in their care.

Medicare, which provides coverage for the elderly and disabled, has put 10 “reasonably preventable” conditions on its initial list, saying it will not pay when patients receive incompatible blood transfusions, develop infections after certain surgeries or must undergo a second operation to retrieve a sponge left behind from the first. Serious bed sores, injuries from falls and urinary tract infections caused by catheters are also on the list.

Officials believe that the regulations could apply to several hundred thousand hospital stays of the 12.5 million covered annually by Medicare. The policy will also prevent hospitals from billing patients directly for costs generated by medical errors.

Because Medicare is the largest insurer in the country, its decision to refuse payment for preventable conditions has already influenced others — public and private — to set similar criteria.

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October 2, 2008 | Permalink | Comments (2) | TrackBack (0)

Wednesday, October 1, 2008

Study Finds Association Between Hepatitis B and Pancreatic Cancer

The New York Times reports on a study that shows people with pancreatic cancer are more likely than those without the disease to have been infected with the hepatitis B virus.  Denise Grady writes,

SurgeryThe finding suggests that hepatitis B — already known to cause liver cancer in some patients — may also increase the risk of pancreatic cancer, one of the deadliest types of tumor. But while the study showed an association, it did not prove cause and effect, the researchers said. More work is needed to determine whether the virus really can cause pancreatic cancer.

“We don’t want to be alarmist,” said Dr. James L. Abbruzzese, the lead author of the study and the chairman of gastrointestinal medical oncology at the M.D. Anderson Cancer Center in Houston.

Pancreatic cancer is not common, and most people have less than a 1 percent risk of ever developing it. There are about 38,000 new cases a year in this country, but the death rate is high, and most patients die within months or a few years.

By contrast, there are 1.25 million people in the United States who have chronic hepatitis B, and hundreds of millions around the world. Globally, it is a major cause of liver cancer. A vaccine can prevent the infection and the cancer. But when an unvaccinated person develops a chronic infection, it cannot be cured, though antiviral drugs may help control it in some cases.

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October 1, 2008 | Permalink | Comments (0) | TrackBack (0)

Applying Science to Alternative Medicine

The New York Times reports that the federal government is working hard to raise the standards of scientific evidence for alternative medicines to more accurately distinguish what is effective, useless, and harmful.  William J. Broad writes,

Alternative_medicines2_wwwnytimescoMore than 80 million adults in the United States are estimated to use some form of alternative medicine, from herbs and megavitamins to yoga and acupuncture. But while sweeping claims are made for these treatments, the scientific evidence for them often lags far behind: studies and clinical trials, when they exist at all, can be shoddy in design and too small to yield reliable insights.

Now the federal government is working hard to raise the standards of evidence, seeking to distinguish between what is effective, useless and harmful or even dangerous.

“The research has been making steady progress,” said Dr. Josephine P. Briggs, director of the National Center for Complementary and Alternative Medicine, a division of the National Institutes of Health. “It’s reasonably new that rigorous methods are being used to study these health practices.”

The need for rigor can be striking. For instance, a 2004 Harvard study identified 181 research papers on yoga therapy reporting that it could be used to treat an impressive array of ailments — including asthma, heart disease, hypertension, depression, back pain, bronchitis, diabetes, cancer, arthritis, insomnia, lung disease and high blood pressure.

It turned out that only 40 percent of the studies used randomized controlled trials — the usual way of establishing reliable knowledge about whether a drug, diet or other intervention is really safe and effective. In such trials, scientists randomly assign patients to treatment or control groups with the aim of eliminating bias from clinician and patient decisions.

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October 1, 2008 | Permalink | Comments (1) | TrackBack (0)

Tuesday, September 30, 2008

Violations Reported at 94% of Nursing Homes

The New York Times reports that federal investigators said, in a report issued on September 29, that more than 90% of nursing homes were cited for violations of federal health and safety standards last year, and for-profit homes were more likely to have problems than other types of nursing homes.  Robert Pear writes,

Bed_with_flowersAbout 17 percent of nursing homes had deficiencies that caused “actual harm or immediate jeopardy” to patients, said the report, by Daniel R. Levinson, the inspector general of the Department of Health and Human Services.

Problems included infected bedsores, medication mix-ups, poor nutrition, and abuse and neglect of patients.

Inspectors received 37,150 complaints about conditions in nursing homes last year, and they substantiated 39 percent of them, the report said. About one-fifth of the complaints verified by federal and state authorities involved the abuse or neglect of patients.

About two-thirds of nursing homes are owned by for-profit companies, while 27 percent are owned by nonprofit organizations and 6 percent by government entities, the report said.

The inspector general said 94 percent of for-profit nursing homes were cited for deficiencies last year, compared with 88 percent of nonprofit homes and 91 percent of government homes.

“For-profit nursing homes had a higher average number of deficiencies than the other types of nursing homes,” Mr. Levinson said. “In 2007, for-profit nursing homes averaged 7.6 deficiencies per home, while not-for-profit and government homes averaged 5.7 and 6.3, respectively.”

On Monday, Mr. Levinson issued a compliance guide for nursing homes that says some homes “have systematically failed to provide staff in sufficient numbers and with appropriate clinical expertise to serve their residents.”

Researchers have found that people receive better care at homes with a higher ratio of nursing staff members to patients.

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September 30, 2008 | Permalink | Comments (1) | TrackBack (0)

Tuskegee, a Cloud Over Clinical Research

The Washington Post reports that today, minority patients are underrepresented in clinical trials. African American, Latino and Asian populations account for about one-third of all Americans, but less than one-tenth of U.S. clinical trial participants come from these groups.  Ken Getz and Doug Peddicord write,

Stethescope6As vice president for community and external affairs at the University of Chicago Hospitals, Michelle Obama has driven real change in relations between the institution and the mostly black neighborhoods surrounding it, working to lessen the distance between the hospital system and African American patients, neighbors and local businesses.

But when university researchers proposed enrolling local girls in a clinical trial testing the HPV (human papillomavirus) vaccine, which can prevent cervical cancer, Obama stopped the project. According to the New York Times, "The prospect of white doctors performing a trial with black teenage girls summoned the specter of the Tuskegee syphilis experiment of the mid-20th century, when white doctors let hundreds of black men go untreated to study the disease."

The legacy of Tuskegee is etched on the landscape of clinical research. In 1932, U.S. Public Health Service doctors enticed 399 poor black men into a study whose aim was to observe the natural progression of untreated syphilis. At the time, most treatments for syphilis were ineffective and dangerous. But by the late 1940s penicillin had become the standard treatment for syphilis -- yet the study, inexcusably, continued until 1972. Twenty-five years later, President Clinton publicly apologized to the eight surviving participants of the shocking and unethical study, saying, "What the United States government did was shameful."

Acknowledging the fact that Tuskegee remains a touchstone of African American mistrust of the medical system is essential. Yet, as Democratic presidential candidate Barack Obama has suggested about other aspects of relations between Americans of all colors, it also deserves "a serious and thoughtful conversation."

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September 30, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, September 29, 2008

Infant Formula: FDA Says What's Sold Legally in the U.S. is Safe

The Los Angeles Times reports on the FDA's assurance that infant formula is safe as the tainted products that sickened Chinese babies aren't allowed in the US, where formula-making is tightly regulated.  Jill Adams writes,

Baby_bottleBabies in China are obviously at risk from tainted infant formula. More than 54,000 children in that nation have been sickened and at least four have died in recent weeks after drinking contaminated milk products. But despite recent contamination of other Chinese products consumed by Americans, the threat from such products to children and infants in the U.S. appears minimal.

The Chinese formula in question is contaminated with melamine, a chemical powder high in nitrogen that is used in making fertilizers and durable plastics, including the unbreakable dinnerware known as melamine. The investigation in China is ongoing, but evidence suggests that melamine was deliberately added to boost, in lab tests, the apparent protein content of milk products used to make formula. The compound can cause kidney failure if ingested in large quantities.
Last week, more contaminated products turned up beyond mainland China, in Hong Kong and Macau, creating concern about how far afield contaminated goods might have traveled. The International Food Safety Authorities Network, an arm of the World Health Organization, is working to track the export of suspect products and to inform recipient countries.

Americans who rely on U.S.-made formula have little to worry about. Although pet food and toothpaste made in China and sold to Americans have been found to be contaminated, the formula bought by American consumers is more tightly regulated by the U.S. Food and Drug Administration than those products.

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September 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Scientists Report Advance in Stem Cell Alternative

The Washington Post reports that scientists stated, on September 25, that they have overcome a major obstacle to using a promising alternative to embryonic stem cells, bolstering prospects for bypassing the political and ethical tempest that has embroiled hopes for a new generation of medical treatments.  Rob Stein writes,

Stem_cells2The researchers said they found a safe way to coax adult cells to regress into an embryonic state, alleviating what had been the most worrisome uncertainty about developing the cells into potential cures.

"We have removed a major roadblock for translating this into a clinical setting," said Konrad Hochedlinger, a Harvard University stem cell researcher whose research was published online yesterday by the journal Science. "I think it's an important advance."

The development is the latest in the rapidly advancing and politically charged field of stem cell research.

"This is a huge step forward -- it could be the breakthrough we've been looking for," said Robert Lanza, a stem cell researcher at Advanced Cell Technology in Worcester, Mass.

Embryonic stem cells are believed capable of becoming any type of cell in the body. Researchers hope to eventually use them to create replacement tissue and body parts tailored to individual patients. But the work has run into moral objections because the cells were originally obtained by destroying early-stage embryos. As a result, President Bush has restricted federal funding for such work.

Scientists last year shook up the scientific and political landscape by discovering how to manipulate the genes of adult cells to convert them into the equivalent of embryonic cells -- entities dubbed "induced pluripotent stem cells," or iPS cells -- which could then be transformed into any type of cell in the body. Subsequent work has found that the cells can alleviate symptoms of Parkinson's disease and sickle cell anemia in mice.

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September 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, September 28, 2008

Health Insurance Costs to Spike an Average 8 Percent

The Washington Post reports that the Office of Personnel Management announces Thursday, September 25, that health insurance premiums for federal employees will jump almost 8 percent, on average, in 2009, a sharp increase over the 2.9 percent increase this year and the 2.3 percent increase in 2007.  Joe Davidson writes,

Stethescope2Premiums for most workers, however, will climb even more next year -- about 13 percent -- which is the increase for enrollees in the Blue Cross and Blue Shield plans. Sixty percent of federal workers are enrolled in one of the Blue Cross and Blue Shield plans.

"We worked very hard to contain premium costs, and we were more successful with some health plans than with others," said Nancy Kichak, OPM's associate director for strategic human resources policy. The rates, she said, are the lowest possible in keeping with preservation of benefits and stability in the program.

She blamed next year's steep increase on "the cost of services" and previous estimates on health-care costs that were too low. She cited utilization of services, technology and medical inflation as contributing to the increase. "It's important for employees to shop around," Kichak said.

An OPM statement said the agency uses "firm negotiation with the health carriers to keep cost increases as reasonable as possible."

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September 28, 2008 | Permalink | Comments (1) | TrackBack (0)

Water Chlorination and 12 Other Lifesaving Innovations That Rarely Get Credit

In an interesting article from US News, a series of innovations is highlighted as revolutionizing health and sanitation for people all over the world.  But although these innovations are largely attributed to successfully improving the quality of living for people, might they also be attributed to creating inadvertant health risks?  Adam Voiland writes,

Drinking_waterOn Sept. 26, 1908, Jersey City, N.J., made public-health history when it became the first American city to chlorinate its drinking water supply. Had other municipalities not followed suit, the nation's drinking water might still be swirling with life-threatening bacterial and viral pathogens, such as cholera and typhoid. After Jersey City added chlorine to its Boonton Reservoir, deaths caused by waterborne disease plunged. The death rate from typhoid fever, for example, fell by more than 92 percent between 1906 and 1926, city records show. "There's no question that chlorinating our drinking water was one the greatest public-health advances our nation has seen," says Joan Brunkard, a researcher at the Centers for Disease Control and Prevention.

In honor of chlorination's 100th birthday, U.S. News dredged up 12 other innovations that, though often taken for granted, are constantly saving lives. Some, such as flushable toilets, haven't changed a whole lot since they were first introduced, while others, such as medical imaging, seem to evolve faster than fruit flies.

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September 28, 2008 | Permalink | Comments (0) | TrackBack (0)