HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, September 27, 2008

F.D.A. Reviewing Deaths in Anemia Drug Study

The New York Times reports that federal health officials, on September 26, said that they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients.  The New York Times writes,

EprexSixteen percent of patients who were treated with the drug, Eprex, had died three months after the study began, compared with 9 percent who were given a placebo, the Food and Drug Administration said in a statement.

The study was testing whether Eprex could improve brain function in stroke patients, an unapproved use of the drug.

The 522 patients were given relatively high doses of Eprex for three days or a placebo. Most were not anemic, the drug agency said.

Eprex is known generically as epoetin alfa. Johnson & Johnson also sells epoetin alfa under the name Procrit. Amgen sells a version under the name Epogen.

The blockbuster drugs are part of a class called erythropoiesis-stimulating agents, or ESAs, which are approved for treating patients with kidney disease and cancer.

The safety of ESAs came under scrutiny in recent years after other studies found tumor growth or shorter survival for some patients given high doses.

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

China’s Milk Scandal Now Seen as Risk in Europe

The New York Times reports that European Union regulators, on September 25, ordered rigorous testing of imports containing at least 15 percent milk powder after concluding that food containing tainted milk powder from China may well be circulating in Europe and putting children at risk.  Elisabeth Rosenthal writes,

Infant_milk_powder_from_chinaThe action, announced by the European Food Safety Authority and the European Commission, significantly expands the potential geographic reach of a milk adulteration scandal in China to now include a range of foods sold around the world. The Europeans said cookies, toffees and chocolates were the major concerns.

The World Health Organization and the Unicef also expressed concern on Thursday about the Chinese milk contamination and the implications for other foods. In the United States, some consumer groups called on the Food and Drug Administration to restrict imports of foods that may contain suspected dairy ingredients from China.

In China, milk products contaminated with the industrial chemical melamine have sickened more than 50,000 young children in recent weeks and created a spiraling government scandal.

While it is illegal to import dairy products and baby formula from China into the European Union, European nations can and do import many processed foods containing milk powder as an ingredient that are manufactured outside of Europe. Such products could contain milk powder from China.

In 2007, the European Union imported from China about 19,500 tons of confectionary products, including pastries, cake and cookies, and about 1,250 tons of chocolate and other prepared foods containing cocoa.

“Children who consume both biscuits and chocolate could potentially exceed the T.D.I. by up to more than three times,” the European Food Safety Authority said Thursday, referring to the tolerable daily intake of melamine that the agency regards as safe. Levels above that could result in kidney stones, Ian Palombi, a spokesman for the agency, said in a telephone interview.

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

Friday, September 26, 2008

Goal of CDC Vaccine Program Sets Record: 86% of Americans Told to Get Flu Shot

The Washington Post reports that the CDC is targeting 86% of the population for flu vaccination, a record setting number of people, with a similar record breaking number of flu vaccines made available this fall.  David Brown writes,

Flu_shot_wwwwashingtonpostcom_assocA record-setting amount of influenza vaccine is available this fall for a record-setting number of people being advised to get it.

That was the message yesterday from officials at the Centers for Disease Control and Prevention and several private organizations, who convened in Washington to urge Americans to get flu shots.

The number of people targeted for flu vaccination has grown steadily in recent years and now constitutes 86 percent of the population.

For the first time, the federal government is recommending this year that children 5 to 18 years old get vaccinated, along with the previously targeted group of 6 months to 5 years. That will add about 30 million children to the number advised to get the shots.

CDC recommends that children ages 6 months to 8 years get two flu shots a month apart, because a single shot may not be enough to fully protect them.

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

Aid Plan Aims to Help Poor Farmers Reach Markets

The Washington Post reports that The Bill and Melinda Gate Foundation has created the Purchase for Progress Program that will transform rural agriculture in undernourished parts of Africa and Latin America by helping small farmers sell their surplus crops at competitive prices.  Philip Rucker writes,

Gate_foundation_logo_wwwgatesfoun_3In an ambitious move to combat the global food crisis, the Bill and Melinda Gates Foundation on Wednesday unveiled an experimental public-private initiative that could transform rural agriculture in undernourished parts of Africa and Latin America by helping small farmers sell their surplus crops at competitive prices.

Rather than only delivering food to hungry nations, this partnership between the world's richest philanthropy and the U.N. World Food Program promises to help build a sustainable farming infrastructure across the developing world.

The Purchase for Progress program will give poor farmers, many of them women with little or no access to commercial markets, a chance to move beyond subsistence living with opportunities to sell their milk, grains, produce and other products to reliable buyers. During a five-year pilot period, it hopes to increase the incomes of 350,000 farmers in 21 countries and give them a path out of poverty.

"This is not your grandmother's food aid," said Josette Sheeran, executive director of the World Food Program. "This is a revolution in food aid, where food aid becomes a productive investment that not only feeds today but produces solutions for tomorrow."

Funded largely by the Gates Foundation, the program is part of the foundation's broader $900 million investment in agricultural development, with many of its efforts made in concert with foreign states and public institutions. The initiative is the latest example of how software giant Bill Gates, who stepped down this summer from Microsoft, is committing his time and fortune to trying to create a results-oriented brand of philanthropy focused on taking risks to achieve lasting impact.

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

Thursday, September 25, 2008

Medicare Officials Advise Seniors to Shop Around

The Washington Post reports that federal health officials encouraged Medicare participants on Thursday to shop around for their prescription drug coverage next year because it could include significant price increases or changes regarding which drugs the plans will cover.  Kevin Freking writes,

MedicareOverall, the landscape for prescription drug coverage won't look dramatically different next year. The typical beneficiary will still have dozens upon dozens of plans to choose from, but most people will see an increase in their monthly premiums if they stay with the same insurer.

For those enrolled in the 10 most popular drug plans, the cost increases will range from 8 percent to as much as 64 percent, according to an analysis by Avalere Health, a consulting firm.

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

Federal Health Official to Step Down

The New York Times reports that Dr. Elias A. Zerhouni, director of the National Institutes of Health, who shook up the agency when he barred scientists from consulting for drugmakers, announced that he would leave at the end of October.  Gardiner Harris writes,

Zerhouni_wwwnytimescom_chris_kleponDuring his six-year tenure, Dr. Zerhouni pushed scientists to focus more on patient care and less on basic research, and he forced the agency’s independent institutes to cooperate on common projects. But he also faced a stagnant budget that has curtailed research around the country and demoralized scientists.

In a conference call with reporters, Dr. Zerhouni said he planned to write about his time at the health agencies before accepting another job.

“I know there’s speculation that I’m going back to Johns Hopkins,” Dr. Zerhouni said. “That’s not been decided by me at all. I want to finish here, take a few weeks, maybe write a bit and evaluate what I want to do next.”

One of the few prominent Arab-Americans in the Bush administration, Dr. Zerhouni is an Algerian immigrant who came to this country more than 30 years ago with $369 in his pocket and became a multimillionaire after inventing numerous devices as a radiologist at Johns Hopkins University.

Dr. James Thrall, chairman of the radiology department at Massachusetts General Hospital, said that Dr. Zerhouni got the health institutes to focus “on the big problems, big issues and big opportunities.”

“Uniquely among all the recent people to hold that position, he got the battleship to turn in a different direction,” Dr. Thrall said of Dr. Zerhouni.

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September 25, 2008 | Permalink | Comments (1) | TrackBack (0)

Wednesday, September 24, 2008

Congress Approves Mental Health Bill

The Washington Post reports that Congress approved legislation yesterday that would require private insurers to provide the same level of benefits for mental illness as they do for physical maladies, a change lauded by advocates as a great shift in the nation's understanding of mental health.  Lyndsey Layton writes,

Mental_health_bill "We've always had a stigma, sort of like mental illness is a character flaw," said Rep. Patrick J. Kennedy (D-R.I.), who has struggled with drug and alcohol addiction and co-sponsored the House version with Rep. Jim Ramstad (R-Minn.), a recovering alcoholic. "But now science has moved forward, and we can see the complexities in the brain that lead to eating disorders, compulsive disorders. All these connections are being made, the science is just becoming so firm. And it destroys the myth that this stuff is a choice."

The measure has received strong bipartisan support in the House and Senate and has the backing of business, insurance companies, health advocates, the medical community and the White House. But its passage into law was not ensured last night.

The remaining obstacle appeared to be ironing out differences in how to pay the cost to the federal government -- estimated at $3.4 billion over 10 years, in the form of forgone tax revenue. Lawmakers also needed to resolve whether the final bill should be a standalone measure or part of a larger package of legislation.

The House approved the language in a standalone bill, while the Senate wrapped it into a $150 billion package of popular tax cuts, including a one-year patch for the alternative minimum tax, and extensions of expiring tax provisions including tuition credits and state and local sales tax deductions (for states that do not have an income tax), as well as research and development tax credits.

It is unclear whether a joint agreement can be reached in the few days remaining before Congress recesses.

"The Senate has devolved to the point where almost nothing is moving now," one senior Senate staff member said. "The issue is whether this gets caught up in the bigger inertia of the Senate."

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

Studies Show Strain of Medical Bills

The New York Times reports on a study that underscores the need for the government to address the growing unaffordability of health care as many people are leaving medical bills unpaid.  Reed Abelson writes,

Medicare_3Even as Washington and Wall Street debate the best way to avert an economic meltdown, increasing numbers of Americans are struggling with another financial crisis: the growing burden of unpaid medical bills.

Two studies released Wednesday morning provide further evidence of the toll health care is increasingly placing on working families, even for those who have health insurance. And as employees are paying more medical expenses out of their own pockets, they are having a harder time coming up with the money.

The studies, by the Kaiser Family Foundation and the Center for Studying Health System Change, were completed earlier this year before the financial markets reached their current state of crisis. But policy analysts say the findings underscore the mounting additional strain that medical care is placing on working Americans.

“The problems people are having paying for health care and health insurance are a central dimension of the economic and pocketbook concerns right now,” said Drew E. Altman, the president of the Kaiser Family Foundation, a nonprofit health research group that conducts an annual survey of employer medical benefits.

The studies, policy analysts say, underscore the need for the government to address the growing unaffordability of care, despite the distraction — and cost to taxpayers — of a proposed $700 billion bailout of the financial sector.

“This makes clear the cost of doing nothing is high and growing,” said Len Nichols, a health economist at the New America Foundation, a nonpartisan policy group in Washington that advocates universal medical coverage.

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

Tuesday, September 23, 2008

FDA Cracks Down on Eye Wash and Skin Cream

The Washington Post reports that federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks.  The Washington Post writes,

Eye_drops2The eye wash, known as a balanced salt solution, is used to keep the eyes moist during surgery. Two companies, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the Food and Drug Administration, and are not affected, the FDA said in a public notice.

But three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness, said Deborah Autor, who directs the FDA's unapproved drugs initiative. They are B. Braun, Baxter, and Hospira, she said.

The skin cream contains an enzyme called papain, derived from the tropical papaya plant. It is used for treating skin ulcers from diabetes and other causes. Although such products have been used for more than 100 years, the FDA said there are no approved versions on the market. About a dozen companies market such creams in a lucrative business worth about $50 million a year.

The agency said it has received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams, including some that said the ointment was of no help to patients and others describing life-threatening allergic reactions.

Companies making the unapproved products must file for FDA approval, or cease production by Nov. 24. Violators face FDA seizures and other legal action.

Unapproved drugs, many of which pre-date federal regulation, are a continuing problem for the FDA. The agency estimates that about 2 percent of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.

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September 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Study Finds Major Shift in Abortion Demographics

The Washington Post reports on a study highlighting the shift in proportions of women getting abortions.  The study found that the proportion of all abortions performed for white women has decreased, while the proportion for Hispanic and African American women has increased.  Rob Stein writes,

Pregnant_womenThe face of women who have abortions has shifted significantly in the past 30 years, with relatively fewer white childless teenagers and more mothers of color in their 20s and 30s opting to terminate their pregnancies, according to a report being released today.

In the first comprehensive analysis since 1974 of demographic characteristics of women who have abortions, researchers found that the overall drop in the abortion rate has been marked by a dramatic shift, declining more among white women and teenagers than among black and Hispanic and older women.

"There's been a real change in the picture of women who get abortions," said Rachel Jones, a senior research associate at the Guttmacher Institute, a private nonprofit reproductive health research organization considered to be one of the most authoritative sources on abortion trends. "This is the first time anyone has looked at this in a comprehensive way."

Jones and her colleagues analyzed annual data collected by the federal Centers for Disease Control and Prevention and by periodic surveys that Guttmacher has conducted of abortion providers between 1974 and 2004.

The analysis confirmed previous reports that the abortion rate fell to the lowest level since 1974, dropping 33 percent from a peak of 29 abortions per 1,000 women ages 15 to 44 in 1980 to 20 per 1,000 in 2004.

During that period, the proportion of abortions obtained by women younger than 20 dropped steadily, falling from 33 percent in 1974 to 17 percent in 2004. For those younger than 18, it fell from 15 percent of all abortions in 1974 to 6 percent in 2004. At the same time, the proportion of abortions obtained by women in their 20s increased from 50 percent to 57 percent, and the share done for women age 30 and older rose from 18 percent to 27 percent.

Although abortion rates have declined among all racial and ethnic groups, large disparities persist, with Hispanic and black women having the procedure at rates three to five times the rate of white women.

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September 23, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, September 22, 2008

EPA Unlikely to Limit Perchlorate in Tap Water

The Washington Post reports that the Environmental Protection Agency, under pressure from the White House and the Pentagon, is set to rule as early as today that it will not set a drinking-water safety standard for perchlorate, a component of rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children across the nation.  Juliet Eilperin writes,

Drinking_waterAccording to a near-final document obtained by The Washington Post, the EPA's "preliminary regulatory determination" -- which was extensively edited by White House officials -- marks the final step in a six-year-old battle between career EPA scientists who advocate regulating the chemical and White House and Pentagon officials who oppose it. The document estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe; independent researchers, using federal and state data, put the number at 20 million to 40 million.

Some perchlorate occurs naturally, but most perchlorate contamination in U.S. drinking water stems from improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required.

The new EPA proposal -- which assumes the maximum allowable perchlorate contamination level is 15 times what the EPA had suggested in 2002 -- was heavily edited by officials of the White House Office of Management and Budget. They eliminated key passages and asked the EPA to use a new computer modeling approach to calculate the chemical's risks.

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September 22, 2008 | Permalink | Comments (0) | TrackBack (0)

Consumer Ads for Medical Devices Subject of Senate Panel

The New York Times reports that some lawmakers and medical groups are calling for restrictions on advertisements for medical devices like artificial knees and heart stents, claiming they mislead patients.  Barry Meier writes,

Television_adsAs makers of medical devices like artificial knees and heart stents increasingly pitch their products directly to consumers, some lawmakers, medical groups and others are calling for restrictions on such advertisements, claiming they mislead patients.

The amount of medical device advertising directed to consumers on television or over the Internet — an estimated $193 million last year — represents just a small fraction of the volume of consumer advertising for prescription drugs, according to TNS Media Intelligence, a consulting firm.

But some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

“The results are irreversible because you are kind of stuck with a device,” said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco.

On Wednesday, the Senate Special Committee on Aging plans to hold a hearing about direct-to-consumer promotions of medical devices. Dr. Bozic, who was an author of a recent medical journal article critical of consumer advertising, is among those scheduled to testify.

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September 22, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, September 21, 2008

Institutionalized Medicaid Recipients Sue Florida

The Washington Post reports on a class action lawsuit against Florida by institutionalized Floridians claiming the state is illegally forcing them to live in nursing homes when they should be able to choose where they live.  They argue that nursing homes have successfully pressured politicians to make qualifying for community care more difficult.  Matt Sedensky writes,

Gavel4Charles Todd Lee spent a lifetime going backstage at concerts, following politicians on the campaign trail and capturing iconic shots of everyone from Martin Luther King Jr. to Mick Jagger to Mickey Mantle. Today, he enjoys such freedom only in his dreams.

The 67-year-old photographer has been confined to a nursing home for five years, the victim of a stroke that paralyzed his left side. And he's angry.

"Most of the people come here to die, so you want to die," he said. "It is a prison. I can't escape it."

Lee is among the Medicaid recipients across Florida challenging the nightmare of the old and disabled: to be forced from comfort and familiarity into a nursing home.

They say the state is illegally forcing them to live in nursing homes when they should be able to live where they choose. Advocates charge that nursing homes, afraid of losing money, have successfully pressured politicians to make qualifying for community care more difficult. They have filed a federal lawsuit seeking class-action status on behalf of nearly 8,500 institutionalized Floridians.

Whether the litigation gets Lee and others moved out of nursing homes remains to be seen. But at the very least, it has illuminated the frustration experienced by older people or those with disabilities who say they're shuttled into nursing homes when they are healthy enough to live at home, with relatives, or in other less institutional settings.

"There are very, very, very few people who cannot be cared for outside in the community," said Stephen Gold, a Philadelphia disability lawyer who, along with AARP attorneys and others, is representing the group. "Why should the state give a damn whether you put the money in the left pocket of the nursing home or the right pocket of the community?"

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September 21, 2008 | Permalink | Comments (0) | TrackBack (0)

Study Finds Few Pain Doctors Face Criminal Prosecutions

The New York Times reports on a new study that shows doctors are rarely criminally prosecuted or sanctioned in connection with prescribing narcotic painkillers.  Barry Meier writes,

Pills9The study, published this month in the journal Pain Medicine, found that 725 doctors, or about 0.1 percent of practicing physicians, had been prosecuted or sanctioned by state medical boards between 1998 and 2006 on charges arising from illegally or improperly prescribing narcotics. Of that group, 25 doctors specialized in pain treatment.

“The widely publicized chilling effect of physician prosecution on physicians concerned with legal scrutiny over prescribing opioids appears disproportionate to the relatively few cases,” the study reported.

The study was undertaken by the Center for Practical Bioethics in Kansas City, Mo., the Federation of State Medical Boards and the National Association of State Attorneys General.

The study’s authors acknowledged that their review, while extensive, did not account for prosecutions against doctors brought by state and local law enforcement officials.

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September 21, 2008 | Permalink | Comments (1) | TrackBack (0)