HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, August 30, 2008

U.S. Can Block Mad Cow Testing, Court Rules

The Washington Post reports that the Bush administration can prohibit meat packers from testing their animals for mad cow disease, according to a federal appeals court ruling Friday.  Matt Apuzzo writes,

Gavel3The dispute pits the Agriculture Department, which tests about 1 percent of cows for the potentially deadly disease, against a Kansas meat packer that wants to test all its animals.

Larger meat packers opposed such testing. If Creekstone Farms Premium Beef began advertising that its cows have all been tested, other companies fear they too will have to conduct the expensive tests.

The Bush administration says the low level of testing reflects the rareness of the disease. Mad cow disease has been linked to more than 150 human deaths worldwide, mostly in Great Britain. Only three cases have been reported in the U.S., all involving cows, not humans.

A federal judge ruled last year that Creekstone must be allowed to conduct the test because the Agriculture Department can only regulate disease "treatment." Since there is no cure for mad cow disease and the test is performed on dead animals, the judge ruled, the test is not a treatment.

The U.S. Court of Appeals for the District of Columbia Circuit overturned that ruling, saying diagnosis can be considered part of treatment.

"And we owe USDA a considerable degree of deference in its interpretation of the term," Judge Karen LeCraft Henderson wrote.

The case was sent back to the district court, where Creekstone can make other arguments.

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

Red Alert on Energy Drinks

The Los Angeles Times reports that turning to some energy drinks for a caffeine jolt might be a high-risk habit for teens.  Rahul K. Parikh writes,

Energy_drinksRecently, one of my colleagues, a pediatric gastroenterologist, told me about a teenage boy who had come to see him because of severe stomach pain he'd had for about two months. The boy had been referred by his primary care doctor, who had evaluated him for several possible causes, including infections and ulcers. That doctor had also recommended or prescribed a variety of medications to relieve the pain, but to no avail.

The specialist performed an endoscopy, in which a camera is inserted into a patient's esophagus and down into the stomach and upper part of the small intestine.
The findings were impressive: severe inflammation, bleeding and ulcerations in a part of the small intestine called the duodenum, the portion of the intestine closest to the stomach.

When the medical team's members went back and got further history, they learned that the teen had been drinking several Redline energy drinks a day. Energy drinks, including Red Bull, Rockstar and Full Throttle, have become extremely popular over the last decade because they can give lift when needed, such as when studying for finals or partying into the wee hours. The energy drink industry is worth about $2.5 billion in the United States, according to a 2006 report in Fortune magazine, and it has grown 700% since 2000, earning manufacturers millions of dollars, primarily by marketing to teens and young adults.

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

Friday, August 29, 2008

U.S. Weighs Food Allergy Labels

The Washington Post reports that health officials in the US and Canada are debating on setting standards for food labels to better warn consumers with allergies.  The FDA will discuss this at a public hearing on Sept. 16.  Lauren Neergaard writes

Food_labelsIt's one of the biggest frustrations of life with food allergies: That hodgepodge of warnings that a food might accidentally contain the wrong ingredient.

The warnings are voluntary - meaning there's no way to know if foods that don't bear them really should. And they're vague: Is "may contain traces of peanuts" more reliable than "made in the same factory as peanuts?"

Now health officials in the U.S. and Canada are debating setting standards, amid increasing concern that consumers are so confused they're starting to ignore the warnings.

"Really, the safest thing you can do is make all your food at home from scratch, period," says Margaret Sova McCabe of Sanbornton, N.H., whose son Tommie, almost 8, is allergic to peanuts, dairy, wheat and five other ingredients.

But she doesn't find that practical - and repeatedly has spotted longtime favorite "safe" foods suddenly bearing new warnings that accidental contamination is possible after all.

"Sometimes we buy the product anyway, and sometimes we don't," says McCabe, who is a law professor and questions how often the warnings signal liability protection rather than true risk.

"What does this really mean? Can I count on it, as a consumer, to really have any meaning?" she asks.

The Food and Drug Administration will ask those same questions at a public hearing on Sept. 16, a first step toward developing what it calls "a long-term strategy" to clear the confusion.

"Advisory labeling may not be protecting the health of allergic consumers," the FDA acknowledged.

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August 29, 2008 | Permalink | Comments (1) | TrackBack (0)

New Oversight, Stiffer Penalties Approved for Snooping into Patient Records

The Los Angeles Times reports that the California Senate is moving to clamp hospital files shut following breaches of celebrities' confidential files.  Patrick McGreevy writes,

Files2Alarmed by breaches in which UCLA Medical Center employees snooped in the confidential records of celebrities including Britney Spears, Farrah Fawcett and California First Lady Maria Shriver, state lawmakers moved Tuesday to clamp hospital files shut with new oversight and stiffer penalties.

Legislators also approved a bid to extend healthcare coverage to those with preexisting medical conditions.
The Assembly did not meet Tuesday. But the state Senate approved a measure that would require hospitals to draft a plan to safeguard patient information and set up a new state Office of Health Information Integrity with power to review plans and violations and assess fines of up to $250,000 against people who violate patient privacy.

A companion bill, which the Senate has yet to act on, would allow fines of up to $250,000 against healthcare providers in case of breaches.

"Our current system of protecting patient privacy has not served as a sufficient deterrent to stop repeated and damaging breaches of patient confidentiality," said Sen. Elaine Alquist (D-Santa Clara), author of the companion bill.
Alquist noted that one person at UCLA viewed confidential patient information more than 900 times.

Monica Wagner, a deputy director of the state Department of Public Health, said 30 snooping cases have been reported statewide in the last two years, and more are believed to be occurring but go unreported.

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

Thursday, August 28, 2008

H.I.V. Is Spreading in New York City at Three Times the National Rate, a Study Finds

The New York Times reports that HIV is spreading in New York City at three times the national rate.  Sewell Chan writes,

Red_ribbonThe virus that causes AIDS is spreading in New York City at three times the national rate — an incidence of 72 new infections for every 100,000 people, compared with 23 per 100,000 nationally — according to a study released on Wednesday by the city’s Department of Health and Mental Hygiene.

The findings, based on a new formula developed by the federal Centers for Disease Control and Prevention, estimated that 4,762 New Yorkers contracted H.I.V. in 2006, the most precise estimate the city had ever offered.

But the city stressed that because the method of estimating infections was new, it could not be said definitively whether the number of new infections in the city had increased or decreased from previous years.

Blacks, and men who have sex with other men, are the groups at greatest risk of contracting H.I.V., the study found. A summary of the new data:

Men accounted for 76 percent of new H.I.V. infections and women for 25 percent. (The figures exceed 100 percent because of rounding.)

Blacks made up 46 percent of the newly infected; Hispanics, 32 percent; and whites, 21 percent. (Figures for other racial or ethnic groups were not provided.)

Those under age 20 made up 4 percent of the newly infected; those 20 to 29 years old, 24 percent; those 30 to 39 years old, 29 percent; those 40 to 49 years old, 29 percent; and those 50 and older, 15 percent.

Sex between men was the main cause in 50 percent of new infections; high-risk heterosexual sex in 22 percent; intravenous drug use in 8 percent; and unknown or uncertain causes in 18 percent.

Manhattan accounted for 35 percent of new infections; Brooklyn, 26 percent; the Bronx, 19 percent; and Queens, 17 percent.

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

Salmonella Outbreak Is Over, Federal Health Officials Say

The Wall Street Journal reports that the CDC has stated the salmonella scare that started in May is now over. The Wall Street Journal writes,

JalapenoThe Centers for Disease Control says the salmonella outbreak that sickened more than 1,440 people appears to be over.

A joint investigation by CDC and the Food and Drug Administration found strong evidence that jalapeno peppers were a major carrier of the bacteria, and that serrano peppers were also a carrier. The salmonella strain that caused the outbreak was traced back to a produce distribution center in Texas, and to a farm in Mexico that grew peppers.

The extensive probe found no contaminated tomatoes, but investigators say they cannot rule out that tomatoes might have been a carrier, particularly early on.

It was the largest outbreak of food-borne illness in the U.S. in the past decade.

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

Wednesday, August 27, 2008

Diabetes Drug Tied to New Deaths

The New York Times reports that four more deaths may be linked to the diabetes drug Byetta.  The New York Times writes,

ByettaThe diabetes drug Byetta, marketed by Eli Lilly & Company and Amylin Pharmaceuticals, was linked to four more deaths in patients with pancreatitis, adding to two deaths announced by federal regulators last week.

No definite relationship between Byetta and the deaths has been proved, and the Food and Drug Administration was aware of the additional deaths when it made its announcement last week, Amylin’s chief executive, Dan Bradbury, said on Tuesday. The company is talking with the F.D.A. about adding warnings on the drug’s prescribing information.

Byetta is Amylin’s leading product.

August 27, 2008 | Permalink | Comments (0) | TrackBack (0)

Ayurvedic Medicines Often Contaminated by Toxic Metals, Study Says

The Los Angeles Times reports that lead, mercury and arsenic were found in the traditionally Indian herbal mixtures at levels that would surpass California safety guidelines.  Alan Zarembo writes,

Ayurvedic_medicines2Ayurvedic medicines -- herbal mixtures dating back thousands of years in India and increasingly popular in the West -- are frequently contaminated with lead, mercury or arsenic, according to a study published today.

A fifth of the nearly 200 concoctions tested contained levels of the toxic metals that, if taken at the maximum recommended doses, would surpass California's safety guidelines.
Dr. Robert Saper, a Boston University professor of family medicine who led the study, said the findings should spur the Food and Drug Administration to start clamping down on the largely unregulated world of pills, herbs and powders classified as dietary supplements.

"It shouldn't be me trying to figure this out," Saper said.

Ayurveda is a traditional Indian practice that takes a holistic approach to wellness, employing herbal medicine, meditation and exercise to promote good health. It exists alongside modern medicine in India, with its own network of clinics, hospitals and colleges serving hundreds of millions of patients.
It has spread to the U.S. and Europe with the migration of South Asians around the world and been popularized by figures such as bestselling author Deepak Chopra.

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August 27, 2008 | Permalink | Comments (1) | TrackBack (0)

Tuesday, August 26, 2008

Cancer Test for Women Raises Hope, and Concern

The New York Times reports that the FDA is concerned about a new blood test aimed at detecting ovarian cancer at its earliest stage, saying that the data appears insufficient to back the company's claims about the test.  Andrew Pollack writes,

Ovarian_cancerA new blood test aimed at detecting ovarian cancer at an early, still treatable stage is stirring hopes among women and their physicians. But the Food and Drug Administration and some experts say the test has not been proved to work.

The test, called OvaSure, was developed at Yale and has been offered since late June by LabCorp, one of the nation’s largest clinical laboratory companies.

The need for such a test is immense. When ovarian cancer is detected at its earliest stage, when it is still confined to the ovaries, more than 90 percent of women will live at least five years, according to the American Cancer Society. But only about 20 percent of cases are detected that early. If the cancer is detected in its latest stages, after it has spread, only about 30 percent of women survive five years.

But far from greeting the new test with elation, many experts are saying it might do more harm than good, leading women to unnecessary surgeries. The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.

“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions. OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors. (All OvaSure blood samples are sent to LabCorp for analysis.)

But the F.D.A. has now summoned LabCorp to discuss OvaSure, saying the data appear insufficient to back the company’s claims about the test. “We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health,” the agency said in an Aug. 7 letter sent to LabCorp that was posted on the F.D.A. Web site. A spokesman for LabCorp, which is short for Laboratory Corporation of America Holdings, said the company looked forward to reviewing the data with the agency but would continue offering the test in the meantime.

Dr. Myla Lai-Goldman, chief medical officer of LabCorp, said that OvaSure had been validated in several studies and that additional data were expected by the end of this year. Diagnostic tests typically are studied further after they have reached the market, she said. Dr. Goldman said there was “tremendous interest” from physicians in learning more about OvaSure.

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August 26, 2008 | Permalink | Comments (0) | TrackBack (0)

Number of Uninsured Declines, as Poverty Rate Holds Steady

The Wall Street Journal reports that the Census Bureau has found that the number of people lacking health insurance dropped by more than one million in 2007, the first annual decline since the Bush administration took office.  The Wall Street Journal writes,

Stethescope4The nation's poverty rate held steady at 12.5%, not statistically different from the 12.3% in 2006. That meant there were 37.3 million people living in poverty in 2007.

The median, or midpoint, household income rose slightly to $50,200, marking the third consecutive annual increase.

The statistics released Tuesday don't take into account the consequences of the economic downturn that began late last year. (See Census report.)

Census said 45.7 million people -- 15.3% of the population -- were uninsured in 2007. That is down 3% from 47 million in 2006. The number of people with health insurance increased to 253.4 million in 2007, compared to 249.8 million in 2006.

The number of people covered by private health insurance, 202 million, didn't change appreciably from 2006. However, the number of people covered by government health insurance increased to 83 million, compared to 80.3 million in 2006.

"The gains that occurred last year were welcome, but unfortunately, they are too little, too late," said Jared Bernstein, a senior economist with the liberal Economic Policy Institute in Washington. "The median household is no better off now than they were back in 2000, despite their deep contribution to the nation's economic growth during this period."

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August 26, 2008 | Permalink | Comments (1) | TrackBack (0)

Monday, August 25, 2008

Uninsured to Spend $30 Billion, Study Says

The Wall Street Journal reports on a study that is likely to spark campaign debate, which finds uninsured Americans will spend about $30 billion out of pocket on medical care this year, while the government will end up covering another $56 billion in costs.  Jane Zhang writes,

Health_care_2Americans who lack health insurance will spend about $30 billion out of pocket on medical care this year, but others -- mainly the government -- will end up covering another $56 billion in costs, according to a new study.

The tab to cover all the uninsured would be $208.6 billion -- $122.6 billion more than this year's projected total -- mainly because people with insurance tend to use more health-care services, the study found.

The report from researchers at George Mason University in Fairfax, Va., and the Urban Institute think tank in Washington, D.C., is to be published Monday in the journal Health Affairs online.

With the Census Bureau set on Tuesday to release two major reports on income, poverty and the uninsured, the study is likely to spark debate on health-care reform and rising health costs.

Health-care spending accounted for 16.3% of gross domestic product in 2007, or about $2.2 trillion, and that amount could nearly double in 10 years, according to federal figures. More of the cost is expected to shift to the government, even as it seeks to shrink large deficits.

Democratic presidential candidate Barack Obama says he would seek to give coverage to nearly all Americans by requiring parents to insure their children and large employers to offer a plan or pay into a fund. His plan relies on government subsidies, including for low-income families, and would cost an estimated $110 billion a year.

Republican presidential candidate John McCain has promised to offer more choices, but also would offer subsidies to help lower-income patients with pre-existing illnesses. His plan would provide tax credits to individuals who buy private heath insurance. His campaign has offered a preliminary estimate of $7 billion to $10 billion a year for the cost.

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August 25, 2008 | Permalink | Comments (0) | TrackBack (0)

Free AIDS Drugs Reduce Malawi Death Rates

The Washington Post reports that a senior government official said today that greater access to free medicine has helped slash AIDS-related deaths in Malawi by 75 percent in the last four years.  The Washington Post writes,

Red_ribbonHIV/AIDS has been blamed for 59 percent of deaths among those aged between 15 to 59 years in the southern African country, which has a population of 13 million.

But Malawi has made progress since 2004, when it started to offer free antiretroviral therapy -- drugs that help treat immunodeficiency virus -- to thousands of patients.

"I am happy that AIDS related deaths have decreased by over 75 percent over the last four years in comparison with the AIDS related deaths we had in 2003-2004 because of increased free treatment," said Mary Shawa, Malawi's principle secretary for HIV & AIDS.

Malawi has had about 800,000 AIDS related deaths since 1985, when the first case was reported. As of March this year, the government has put 159,111 people on free antiretroviral drugs and 106,547 of those are still alive.

"This represents a 67 percent survival rate. But we still need to do more, because those who did not make it may have died because they started the treatment late or did not have access to proper nutrition," said Shawa.

(Reporting by Mabvuto Banda, Editing by Dina Kyriakidou)

August 25, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, August 24, 2008

Drug to Help Blood Clot Is Approved

The New York Times reports that the Food and Drug Administration approved Nplate for patients with a disorder that causes the body to attack its own platelets.  The New York Times writes,

Amgen_logoOn Friday, federal regulators approved a biotechnology drug from Amgen that treats a rare blood-clotting disorder.

The Food and Drug Administration approved the drug, Nplate, for patients with a disorder that causes the body to attack its own platelets, tiny components of blood that help with clotting. The condition, which can cause bruising and bleeding after minor injuries, affects about 140,000 people.

Regulators said Nplate is the first drug that directly encourages platelet production by stimulating the patient’s bone marrow.

The F.D.A. approved the drug based on two studies that showed that it increased patients’ platelet count over six months. Patients received weekly injections of Nplate, a genetically engineered version of the protein that encourages platelet production.

“The Nplate approval is the result of 15 years of research into understanding how platelets are produced in the bone marrow,” Amgen, based in Thousand Oaks, Calif., said.

Regulators said they would require all patients who receive the drug to enroll in a long-term safety study because of some risks associated with it.

During its review of the drug, the F.D.A. questioned its potential to cause bone-marrow abnormalities and dangerous blood clots. In addition, four patients in studies of the drug developed leukemia.

The F.D.A. said in its announcement that more studies “will be needed to determine whether the development of leukemia may relate to the use of Nplate.”

August 24, 2008 | Permalink | Comments (0) | TrackBack (0)

Can a Troubled Economy Actually Improve Public Health?

The Los Angeles Times reports on a study that suggests recession can lead to healthier populations when people decide to cut down on risky behavior.  Susan Brink writes,

Riding_uphill As more people watch their home equity erode, put off retirement because their nest eggs are taking a dive, and bike or bus to work to save gas money, many are thanking their lucky stars that they still have a job to commute to.

Unstable times breed worry and stress, so there should be worry and stress aplenty right now. Nearly 8 in 10 Americans believe the country is headed in the wrong direction, according to a Gallup poll in August, and with the national unemployment rate up to 5.7% in July -- make that 7.3% in California -- millions of gainfully still-employed people who thought they were safe and secure might fear a Dickensian poorhouse closing in on them.

You'd think that the health of the nation would suffer as well, what with emotional stress and less money for medical appointments, gym memberships and healthful food. And in certain ways, health does worsen in times of economic uncertainty. Medical science has accumulated a solid body of research showing that poverty and unemployment lead to higher rates of obesity and more cases of diabetes, asthma, kidney disease, cardiovascular disease, some cancers -- the list goes on.

But strange as it may seem, bad times can also be good for health. Forget individual health for a minute. This is about the macro picture, the health of entire societies. And there statistics show that as economics worsen, traffic accidents go down, as do industrial accidents, obesity, alcohol consumption and smoking. Population-wide, even deaths from heart disease go down during recessions.

"Deaths go down when unemployment goes up," says Christopher J. Ruhm, professor of economics at the University of North Carolina at Greensboro, who for the last few years has been publishing counterintuitive and controversial papers on the economy and health. Put total mortality numbers on a spreadsheet, he's found, and the population's physical well-being improves as just about every measure of economic health dips.

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August 24, 2008 | Permalink | Comments (0) | TrackBack (0)