HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, August 23, 2008

Eight States Cut From System that Tracks Rate of H.I.V.

The New York Times reports that officials at the Centers for Disease Control and Prevention said Friday that eight states and Puerto Rico will no longer receive federal money for an advanced HIV monitoring system that showed that the annual infection rate in the nation was 40 percent higher than previously estimated.  Shaila Dewan writes,

Red_ribbon_2The change will lower the number of jurisdictions using the system to 25, from 34, just as health departments are struggling to react to the news, released earlier this month, that the spread of AIDS is far worse than they had thought.

The jurisdictions that lost financing were Georgia, Illinois, Maryland, Missouri, Ohio, Oklahoma, Pennsylvania, Tennessee and Puerto Rico.

Terry Butler, a spokeswoman for the National Center for H.I.V., S.T.D. and TB Prevention at the centers, said that the total money for the system — which is awarded to applicants on a competitive basis — would remain the same, but that the remaining 25 participating states and cities would receive more. Ms. Butler said those participants had the most reliable systems and could help the centers produce the best estimates.

The system uses a new test that distinguishes recent infections from old ones, helping epidemiologists track them in something much closer to real time than was previously possible.

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

Protections Set for Antiabortion Health Workers

The Washington Post reports that the Bush administration announced plans to implement a controversial regulation designed to protect doctors, nurses and other health-care workers who object to abortion from being forced to deliver services that violate their personal beliefs.  Rob Stein writes,

Pregnant_womanThe rule empowers federal health officials to pull funding from more than 584,000 hospitals, clinics, health plans, doctors' offices and other entities if they do not accommodate employees who refuse to participate in care they find objectionable on personal, moral or religious grounds.

"People should not be forced to say or do things they believe are morally wrong," Health and Human Services Secretary Mike Leavitt said. "Health-care workers should not be forced to provide services that violate their own conscience."

The proposed regulation, which could go into effect after a 30-day comment period, was welcomed by conservative groups, abortion opponents and others as necessary to safeguard workers from being fired, disciplined or penalized in other ways. Women's health advocates, family planning advocates, abortion rights activists and others, however, condemned the regulation, saying it could create sweeping obstacles to a variety of health services, including abortion, family planning, end-of-life care and possibly a wide range of scientific research.

"It's breathtaking," said Robyn S. Shapiro, a bioethicist and lawyer at the Medical College of Wisconsin. "The impact could be enormous."

The regulation drops the most controversial language in a draft version that would have explicitly defined abortion for the first time in a federal law or regulation as anything that interfered with a fertilized egg after conception. But both supporters and critics said the regulation remains broad enough to protect pharmacists, doctors, nurses and others from providing birth control pills, Plan B emergency contraception and other forms of contraception, and explicitly allows workers to withhold information about such services and refuse to refer patients elsewhere.

"The Bush administration's proposed regulation poses a serious threat to women's health care by limiting the rights of patients to receive complete and accurate health information and services," said Cecile Richards of the Planned Parenthood Federation of America. "Women's ability to manage their own health care is at risk of being compromised by politics and ideology."

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August 23, 2008 | Permalink | Comments (1) | TrackBack (0)

Friday, August 22, 2008

Researchers Continue to Question the Wide Use of HPV Vaccines

The New York Times reports on the continued debate on whether the two advertized vaccines against cervical cancer, Gardasil and Cervarix are actually effective or worth the cost given the insufficient amount of evidence.  Elisabeth Rosenthal writes,

Gardasil_vaccineTwo vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer.

The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

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

Jump in US Measles Cases Linked to Vaccine Fears

The Los Angeles Times reports that many people are foregoing measles vaccinations because of fears linking the vaccine to autism.  The Los Angeles Times writes,

Measles_vaccineMeasles cases in the U.S. are at the highest level in more than a decade, with nearly half of those involving children whose parents rejected vaccination, health officials reported Thursday.

Worried doctors are troubled by the trend fueled by unfounded fears that vaccines may cause autism. The number of cases is still small, just 131, but that's only for the first seven months of the year. There were only 42 cases for all of last year.
"We're seeing a lot more spread. That is concerning to us," said Dr. Jane Seward, of the Centers for Disease Control and Prevention.

Pediatricians are frustrated, saying they are having to spend more time convincing parents the shot is safe.

"This year, we certainly have had parents asking more questions," said Dr. Ari Brown, an Austin, Texas, physician who is a spokeswoman for the American Academy of Pediatrics.

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

Thursday, August 21, 2008

F.D.A. Allows Irradiation of Some Produce

The New York Times reports that for the first time the FDA has allowed produce to be irradiated at levels needed to protect against illness causing one of the most significant food safety actions done for fresh produce in many years.  Gardiner Harris writes,

Fresh_produceThe government will allow food producers to zap fresh spinach and iceberg lettuce with enough radiation to kill micro-organisms like E. coli and salmonella that for decades have caused widespread illness among consumers.

It is the first time the Food and Drug Administration has allowed any produce to be irradiated at levels needed to protect against illness.

“This is probably one of the single most significant food safety actions done for fresh produce in many years,” said Robert Brackett, chief scientist for the Grocery Manufacturers Association, which petitioned the agency in 2000 to allow manufacturers to irradiate a wide variety of processed meats, fruits and vegetables and prepared foods.

Advocates for food safety condemned the agency’s decision and asserted that irradiation could lower nutritional value, create unsafe chemicals and ruin taste.

“It’s a total cop-out,” said Patty Lovera, assistant director of Food and Water Watch. “They don’t have the resources, the authority or the political will to really protect consumers from unsafe food.”

Dr. Laura Tarantino, director of the Office of Food Additive Safety at the F.D.A., said the agency had found no serious nutritional or safety changes associated with irradiation of spinach or lettuce.

“These irradiated foods are not less safe than others,” Dr. Tarantino said, “and the doses are effective in reducing the level of disease-causing micro-organisms.”

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

Lower Drinking Age Is Criticized

The Washington Post reports that several university officials across the nation are encouraging a lower drinking age in an effort to lower alcohol abuse. Susan Kinzie and James Hohmann writes,

Bottles2On the face of it, the notion seems counterintuitive, but to the presidents of some of the nation's most prestigious colleges, it makes a lot of sense: Lowering the legal drinking age might get students to drink less.

But any chance for the academic leaders to begin a public discussion of their theory -- that allowing people as young as 18 to drink legally might promote moderation -- has been lost in a wave of criticism from health experts, transportation officials, government leaders and opponents of drunken driving.

Safety advocates say the legal drinking age of 21 saves about 900 lives every year. And Laura Dean-Mooney, president of Mothers Against Drunk Driving, said people look to college presidents "for their leadership role on their campuses. It just seems like they didn't do enough homework to look at the science on this."

Other critics said the university leaders are trying to avoid being held liable for enforcing the drinking age and are kicking the problem to others. "I'm an alumnus of Dickinson College and can't believe they signed on to this initiative," said Jonathan Adkins, a spokesman for the Governors Highway Safety Association. "They are really just punting on the issue and leaving the high school principals to deal with it. Very disappointing."

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

Wednesday, August 20, 2008

Job-Seeker Files Gender Bias Suit Against the Library of Congress

The Washington Post reports that the Library of Congress is being sued in a sex discrimination case after a former Army commander says an official at the Library of Congress rescinded a job offer upon learning she was making the medical transition from being a man to being a woman.  Del Quentin Wilber writes,

Gavel4Diane Schroer, a 52-year-old former Army Special Forces commander, testified yesterday in federal court that she was "disappointed and dismayed" when an official at the Library of Congress rescinded a job offer even though she was the star candidate.

The offer, for a job as a terrorism research analyst, was pulled the day after Schroer told her future boss that she was making the medical transition from being a man, David, to being a woman, Diane.

"I honestly felt a little surprised and shocked," Schroer testified during the first day of the trial in her discrimination lawsuit against the Library of Congress. Choking back tears, Schroer added that "every day, I wish the phone rang and they said, 'We made a mistake.' "

Schroer, who has completed the medical process of becoming a woman, is pursuing a sex discrimination case against the Library of Congress under the Civil Rights Act. The bench trial before U.S. District Judge James Robertson is expected to last about a week, and a ruling might not come until well after that, while the judge considers the facts of the case, as well as arguments over the reach of the law.

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August 20, 2008 | Permalink | Comments (0) | TrackBack (0)

Rising Medical Costs Pinch More Americans, Study Finds

The Washington Post reports on a study finding that rising medical costs and lack of insurance are causing more Americans to either forego medical care or accumulate medical debt.  Sopan Joshi writes,

Stethescope2Americans are struggling to pay medical bills and are accumulating medical debt at an increasing rate, according to a survey released today.

"A perfect storm of negative economic trends is battering working families across the United States," said the survey by the Commonwealth Fund, a private foundation that supports independent research on health care.

"Health-care costs are climbing much more rapidly than incomes or the growth in the overall economy," said Sara R. Collins, assistant vice president of the foundation and one of the authors of the study. As gas and food prices have soared and real estate values have fallen, the federal minimum wage is now $3 an hour lower, in real terms, than it was 40 years ago, the study said.

"What is notable is how these problems are spreading up the income scale," Collins said.

Two-thirds of the working-age population was uninsured, underinsured, reported a medical bill problem or did not get needed health care because of cost in 2007.

More than two in five adults in the 19-to-64 age group reported problems paying medical bills or had accumulated medical debt in 2007, up from one in three in 2005. Their difficulties included not being able to afford medical attention when needed, running up medical debts, dealing with collection agencies about unpaid bills, or having to change their lifestyle to repay medical debts.

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August 20, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, August 19, 2008

California Fines 18 Hospitals for Shoddy Care that Endangered, Killed Some Patients

The Los Angeles Times reports that eighteen hospitals in California were fined for state health code violations in which patients received shoddy care that in some cases led to deaths.  Shaya Tayefe Mohajer writes,

Hospital_sign_2Violations included an improperly inserted catheter, a ventilator that wasn't turned on and surgical tools left inside patients after operations.

The fines made public Monday stem from investigations by the California Department of Public Health.

The hospitals were fined $25,000 for each violation — the latest of dozens of penalties the state has issued in recent years to more than 40 hospitals.

"The number of penalties will decrease and the quality of care will dramatically improve as hospitals take action to improve," said Kathleen Billingsley, director of the health department's Center for Healthcare Quality. "The entire intent of these fines is to improve the overall quality of care in California."

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August 19, 2008 | Permalink | Comments (1) | TrackBack (0)

New Study Backs Angioplasty Through the Wrist

The Washington Post reports that a new study shows performing an angioplasty via the wrist can significantly lower the risk of bleeding and discomfort for some patients.  Lauren Neergaard writes,

SurgeryThe best path to a clogged heart may be through the wrist. About a million artery-clearing angioplasties are performed in the United States each year, and the usual route is to thread a tube to the heart through an artery in the groin.

Now a major study shows going through the wrist instead can significantly lower the risk of bleeding - without the discomfort of lying flat for hours while the incision site seals up.

Just one in 100 angioplasties is done via the wrist, and the approach isn't for everyone. But Monday's study promises to spur more specialists to use the method.

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August 19, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, August 18, 2008

FDA Working on New Warning Label for Amylin, Eli Lilly Drug Byetta After Deaths Reported

The Los Angeles Times reports that federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings.  Matthew Perrone writes,

Byetta2The Food and Drug Administration said Monday it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.

Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.

The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. None of those cases were fatal, but Byetta's makers agreed to add information about the reports to the drug's label.

However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.

Amylin and Eli Lilly said in a statement that patients taking Byetta have shown "very rare case reports of pancreatitis with complications or with a fatal outcome." The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients. The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.

The FDA said doctors should consider prescribing other medications to patients with a history of pancreas problems.

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August 18, 2008 | Permalink | Comments (0) | TrackBack (0)

At Meeting on AIDS, Focus Shifts to Long Haul

The New York Times reports that the focus during the International AIDS conference in Mexico this year was particularly on the longer haul, with stronger advocacy and financing to advance prevention and treatment. Lawrence K. Altman writes,

Red_ribbon_2Two years have passed since the 16th International AIDS Conference in Toronto, and the contrast between that meeting and the 17th, which ended here this month, was humbling.

In Toronto, the mood was almost giddy, with celebrities like Bill Gates and Bill Clinton drawing huge crowds as they championed the development of H.I.V. vaccines and microbicides.

Though the meeting this month had its circuslike elements, the mood was much more sober. No major breakthroughs were announced, and cutting-edge research findings were rare. The great strides that many researchers thought they were on the verge of making in 2006 — in vaccines, microbicides and herpes-suppressive drugs to reduce H.I.V. transmission — have failed to materialize.

The focus here was on the longer haul. There were renewed calls for strong advocacy and financing to sustain gains already made, like promoting more antiretroviral therapy in poorer countries, along with male circumcision and behavior modification.

While Mr. Gates did not attend, Mr. Clinton did. He called the conferences important in part “because they enable us to measure our progress since the last meeting, to openly acknowledge continuing problems, to evaluate the positive and negative new developments.”

With no magic bullet in sight, he said, the need now is to combine efforts to advance prevention and treatment.

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August 18, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, August 17, 2008

Court Bolsters UnitedHealth Settlement

The Wall Street Journal reports that the Minnesota Supreme Court on Thursday, August 14, 2008, said a federal judge has little leeway to review or reject a stock-options backdating settlement between UnitedHealth Group Inc. and former Chief Executive William McGuire, increasing the likelihood that the deal will be approved. Vanessa Fuhrmans writes,

William_mcguireDr. McGuire agreed in December to forfeit about $420 million of stock-option gains and retirement pay to settle shareholder and Securities and Exchange Commission complaints related to how stock-options were awarded by the Minnetonka, Minn., health-insurer.

But U.S. District Judge James Rosenbaum delayed finalizing the agreement when he asked the state's highest court to clarify how much power he had to review its merits.

In particular, he asked how much deference should be given to a special litigation committee appointed by UnitedHealth's board to review shareholder claims filed on the company's behalf.

In its reply to Judge Rosenbaum, the Supreme Court said that under state law, a court must defer to a special litigation committee's decision to settle such suits if it is clear that the panel's members are independent and impartial and that its "investigative procedures and methodologies were adequate, appropriate, and pursued in good faith."

Before signing off on the deal, Judge Rosenbaum still has the discretion to determine whether the committee meets those criteria.

The panel, however, comprises two former Minnesota Supreme Court justices whom the court noted were "individuals drawn from far outside the corporate ranks."

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August 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Chemical Used in Plastic Bottles Is Safe, F.D.A. Says

The New York Times reports that the FDA has concluded that the trace amounts of bisphenol A found in food containers are not a threat to infants or adults.  The New York Times writes,

Baby_bottleDespite safety concerns of parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday.

Scientists at the Food and Drug Administration said the trace amounts of bisphenol A that leach out of food containers were not a threat to infants or adults. The plastic-hardening chemical is used to seal canned food and make shatterproof bottles.

The agency’s draft report is the latest in a growing pile of assessments of bisphenol, which has been used to package food for decades.

The agency previously declared the chemical safe, but agreed to revisit that opinion after a report by the federal National Toxicology Program said that there was “some concern” about its risks in infants.

Based on a review of animal studies, the government working group said bisphenol could cause changes in behavior and the brain, and that it might reduce survival and birth weight in fetuses.

About 93 percent of Americans have traces of bisphenol in their urine, according to the Centers for Disease Control and Prevention.

But the F.D.A.’s report concluded that those levels were thousands of times below what would actually be dangerous to adults or children.

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August 17, 2008 | Permalink | Comments (1) | TrackBack (0)