HealthLawProf Blog

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,

The 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.

Julie Scofield, the executive director of the National Alliance of State and Territorial AIDS Directors, said that over all, money for tracking H.I.V. infections and trends had decreased and that states were struggling to keep up. Ms. Scofield estimated that the money lost by the nine jurisdictions was about $3 million.

“Surveillance funding is starving at the C.D.C.,” Ms. Scofield said. “Their ability to say that they’re going to have ongoing reliable reports of incidence is somewhat questionable unless you have funding for that.”

The alliance has called for a $35 million increase in surveillance financing.

The new H.I.V. report did not use data from all 34 jurisdictions, only the 22 with data that met scientists’ standards, Ms. Butler said. Future monitoring will use data from all 25 jurisdictions.

But Ms. Scofield said that using fewer jurisdictions would make more extrapolations necessary to get national estimates for infection rates.

Dr. Carlos del Rio, the co-director of the Emory Center for AIDS Research in Atlanta, said Georgia’s loss of money was unfortunate.

“If you’re trying to find an enemy like H.I.V.,” Dr. del Rio said, “you want to have as much information as you possibly can.”

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,

The 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."

Leavitt said he requested the new regulation after becoming alarmed by reports that health-care workers were being pressured to perform duties they found repugnant. He cited moves by two professional organizations for obstetricians and gynecologists that he said might require doctors who object to abortions to refer patients to other physicians who would provide them.

An early draft of the regulation that leaked in July triggered a flood of criticism from women's health activists, family planning advocates, members of Congress and others. Concern focused on fears that the definition of abortion could be interpreted to include many forms of widely used contraception.

"Words in that draft led some to misconstrue the department's intent," Leavitt told reporters during a telephone news conference. "This regulation . . . is consistent with my intent to focus squarely on the issue of conscience rights. This specifically goes to the issue of abortion and conscience."

But when pressed about whether the regulation would protect health-care workers who consider birth control pills, Plan B and other forms of contraception to be equivalent to abortion, Leavitt said: "This regulation does not seek to resolve any ambiguity in that area. It focuses on abortion and focuses on physicians' conscience in relation to that."

Both supporters and critics said the language remains broad enough to apply to contraceptives, as well as many other areas in medicine.

"I think this provides broad application not just to abortion and sterilization but any other type of morally objectionable procedure and research activity," said David Stevens of the Christian Medical and Dental Association. "We think it's badly needed. Our members are facing discrimination every day, and as we get into human cloning and all sorts of possibilities, it's going to become even more important."

Leavitt stressed that there was nothing in the regulation that would prevent any organization from providing any type of care.

"There is nothing in this rule that would in any way change a patient's right to a legal procedure," he said.

The regulation, which would cost more than $44 million to implement, was aimed at enforcing several federal laws that have been on the books since the 1970s and were aimed primarily at protecting doctors and nurses who did not want to perform abortions in the wake of the Supreme Court's Roe v. Wade decision, Leavitt said.

But critics said they remained alarmed at the scope of the regulation, which could apply to a wide range of health-care workers. For example, the regulation would cover "participating in any activity with a reasonable connection to the objectionable procedure, including referrals, training, and other arrangements for offending procedures.

"For example, an operating room nurse would assist in the performance of surgical procedures; an employee whose task it is to clean the instruments used in a particular procedure would be considered to assist in the performance of the particular procedure," the regulation states.

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,

Two 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.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Dr. Richard Haupt, medical director of Merck, called these concerns “very theoretical,” noting that continuing research and monitoring suggested that immunity would be longlasting and that the vaccine would not lead to problems with other strains.

He added that cervical cancer was “just the tip of the iceberg” and that HPV caused a huge amount of expensive and stressful testing in developed nations that could be avoided with vaccination.

The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The second paper published this week, a study by Jane J. Kim and Dr. Sue Goldie of Harvard, looks at the issue of costs and concludes that the vaccines will be cost effective only if used in certain ways. In particular, the researchers say the vaccines will be worth the cost only if they prove to protect girls for a lifetime, and if current methods for screening for cervical cancer using Pap smears can be safely adjusted to reduce costs there. Further research is required in both areas.

“I believe the vaccine is a great advance, but we have to implement it properly to get the benefits, and that hasn’t happened,” said Dr. Philip Davies of the European Cervical Cancer Association.

In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.

Cervical cancer, like skin cancer, can generally be caught at precancerous or non-invasive stages and treated. Because the vaccine prevents infection with only some of the cancer-causing strains, Pap smear screening must continue even in those who are vaccinated.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

Dr. Haupt said the study proved that it was best to vaccinate early. “It underscores the value of vaccinating pre-adolescent girls,” since the vaccine works fully only in girls who have not been exposed to HPV.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.

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 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.

The CDC's review found that a number of cases involved home-schooled children not required to get the vaccines. Others can avoid vaccination by seeking exemptions, such as for religious reasons.

Measles, best known for a red skin rash, is a potentially deadly, highly infectious virus that spreads through contact with a sneezing, coughing, infected person.

It is no longer endemic to the United States, but every year cases enter the country through foreign visitors or Americans returning from abroad. Measles epidemics have exploded in Israel, Switzerland and some other countries. But high U.S. childhood vaccination rates have prevented major outbreaks here.

In a typical year, only one outbreak occurs in the United States, infecting perhaps 10 to 20 people. So far this year through July 30 the country has seen seven outbreaks, including one in Illinois with 30 cases, said Seward, of the CDC's Division of Viral Diseases.

None of the 131 patients died, but 15 were hospitalized.

Childhood measles vaccination rates have stayed above 92 percent, according to 2006 data. However, the recent outbreaks suggest potential pockets of unvaccinated children are forming. Health officials worry that vaccination rates have begun to fall -- something that won't show up in the data for a couple of years.

The vaccine is considered highly effective but not perfect; 11 of this year's cases had at least one dose of the vaccine.

Of this year's total, 122 were unvaccinated or had unknown vaccination status. Some were unvaccinated because the children were under age 1 -- too young to get their first measles shot.

In 63 of those cases -- almost all of them 19 or under -- the patient or their parents refused the shots for philosophical or religious reasons, the CDC reported.

In Washington state, an outbreak was traced to a church conference, including 16 school-aged children who were not vaccinated. Eleven of those kids were home schooled and not subject to vaccination rules in public schools. It's unclear why the parents rejected the vaccine.

The Illinois outbreak -- triggered by a teenager who had traveled to Italy -- included 25 home-schooled children, according to the CDC report.

The nation once routinely saw hundreds of thousands of measles cases each year, and hundreds of deaths. But immunization campaigns were credited with dramatically reducing the numbers. The last time health officials saw this many cases was 1997, when 138 were reported.

The Academy of Pediatrics has made educating parents about the safety of vaccines one of its top priorities this year. That's partly because busy doctors have grown frustrated by the amount of time they're spending answering parents' questions about things they read on the Internet or heard from TV talk shows.

In June, the CDC interviewed 33 physicians in Austin, suburban Seattle and Hollywood, Fla., about childhood vaccinations. Several complained about patient backlogs caused by parents stirred up by information of dubious scientific merit, according to the CDC report.

Questions commonly center on autism and the fear that it can be caused by the measles shots or by a mercury-based preservative that used to be in most vaccines. Health officials say there is no good scientific proof either is a cause. Also, since 2001, the preservative has been removed from shots recommended for young children, and it was never in the measles-mumps-rubella combination vaccine. It can still be found in some flu shots.

Brown said she wrote a 16-page, single-spaced document for parents that explains childhood vaccinations and why doctors do not believe they cause autism. She began handing it out this spring, and thinks it's been a help to parents and a time-saver for her.

"People want that level of information," she said.

At least one outbreak this year of another preventable disease was blamed on lack of immunizations. At least 17 children were sick with whooping cough at a private school in the San Francisco Bay area, and 13 were not vaccinated against the disease, which can be fatal to children.

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,

The 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.”

The government has long allowed food processors to irradiate beef, eggs, poultry, oysters and spices, but the market for irradiated foods is tiny because the government also requires that these foods be labeled as irradiated, labels that scare away most consumers.

“People think the product is radioactive,” said Harlan Clemmons, president of Sadex, a food irradiation company based in Sioux City, Iowa.

The F.D.A. is considering a proposal to weaken or change this labeling requirement, a move that Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, opposes.

Advocates of irradiation say the technology can help reduce the burden of illness and the number of outbreaks.

“Wegmans is fully committed to offering product that is safe to our customers,” said Jeanne Colleluori, a spokeswoman for Wegmans, a supermarket chain based in Rochester that is the only major retailer of irradiated beef. If irradiated spinach and lettuce become available, Wegmans will “offer it as a choice so that customers can try it,” Ms. Colleluori said.

Critics say that not only does radiation make food less nutritious and potentially toxic but that the process also does not eliminate the risks of food-borne illnesses. An analysis by the Centers for Science in the Public Interest found that most outbreaks of illnesses associated with salad are caused by viruses, which are not affected by the doses of radiation approved by the F.D.A.

Food-safety advocates, food producers and even farm groups agree that the government should mandate certain agricultural and processing practices that would limit the risk of all food-borne illnesses and increase the speed with which outbreaks are traced back to sources.

“The agency is choosing to have a high-tech expensive solution to a problem that needs a more thorough approach and one that really starts on the farm,” Ms. Smith DeWaal of the science center said.

Federal officials say they continue to study the science behind proposals to require good agricultural practices. In the meantime, irradiation could help, Dr. Tarantino of the F.D.A. said.

“This is not a magic bullet,” she said. “It’s not a solution for everything. It’s one more option that people can use.”

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,

On 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."

As parents ship their children off to college this month, university officials are bracing for a round of alcohol-fueled parties and binge drinking. They say they have tried banning keggers and have promoted alcohol counseling, but problems persist. It's time for a new approach, they say.

In addition to the Dickinson president, academic leaders involved in the effort include those of Duke University and Dartmouth College as well as several Washington area schools, such as the University of Maryland and Johns Hopkins University. Their effort, the Amethyst Initiative, proposes to reopen a national discussion on an issue that hasn't been seriously debated in three decades.

Amid the backlash, the 115 university leaders in the group said their proposal is being distorted. They said that they are not necessarily advocating that the age be lowered but that the issue needs to be part of the debate because alcohol abuse at colleges has gotten so bad.

"We want to encourage an honest and constructive dialogue among educators, lawmakers, parents and students," Duke President Richard H. Brodhead said. "If what we are doing now doesn't work, then we have an obligation to ourselves, and to society, to explore what might."

Full-time traditional-age college students drink more than people the same age who aren't in college, according to the National Council on Alcoholism and Drug Dependence, which estimates that 1,700 18-to-24-year-old students die every year from alcohol-related injuries.

"It's a very serious problem on college campuses, and it just seems to get worse and worse," said William Kirwan, chancellor of the University System of Maryland.

Although polling has shown that the public strongly opposes lowering the drinking age, there has been some consideration of it this year, "way more so than in the past," said Matthew Gever, a policy associate with the National Conference of State Legislatures.

Minnesota, Kentucky, South Carolina, Wisconsin and Vermont have considered bills. In Minnesota, a measure that would have let anyone 18 and older drink in bars and restaurants failed. In Vermont, legislators set up a committee to study the topic. The bills in Kentucky, South Carolina and Wisconsin, also unsuccessful, were aimed at changing the rules for members of the military.

Gever said the argument for the military has been, "If they're over there in Iraq and have been shot at, they may as well be able to have a beer when they get back home."

It was during the Vietnam War that the push to make alcohol legal for 18-year-olds most recently took hold. But in 1984, Congress mandated a 10 percent penalty on highway appropriations for any state with a drinking age below 21.

And that's why the chances of changing the drinking age are "very, very, very small," Gever said. "The political popularity of federal highway money far outweighs the popularity of letting 18-year-olds drink."

Not on Facebook, maybe -- where pro-Amethyst groups sport Sam Adams or Budweiser labels -- and not on campus.

"In college, you're free for the first time ever. There are no rules," said Walter Ray-Dulany, a fifth-year doctoral student at the University of Maryland in College Park. "In high school, there are rules. And maybe it's better to start drinking when there are rules."

Amy Austin, 18, a U-Md. sophomore, said that girls often get sick from drinking too much during sorority rush parties and other gatherings but that fellow students are reluctant to get them help because the girls are underage.

Lowering the drinking age, she said, "would do a lot to make college campuses safer."

It's no secret that alcohol permeates college life. Will Porter, a 21-year-old economics major at U-Md., said that one of the favorite games in his fraternity is for 10 guys to pass around a handle of bourbon until it's gone. About a month ago, he said, he drank seven shots of whiskey and six glasses of Jack Daniels and Coca-Cola at a bar near campus. He doesn't remember much else.

Now, he said, he's going through court-ordered alcohol treatment. His second Alcoholics Anonymous meeting is Sunday.

"A lot of people get a real thrill out of the fact it's illegal -- that causes them to drink more," he said. But he said he's not sure that changing the drinking age would matter.

"I don't think it'd change the partying or drinking," he said. "I just think it would change the number of fake IDs people use."

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,

Diane 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.

Schroer, of Alexandria, had a prestigious military career that ended in retirement in 2004 after seven years in the Army's Special Forces command. After the Sept. 11, 2001, terrorist attacks, Schroer became director of a 120-member classified organization that tracked and targeted international terrorists. She routinely briefed the country's top officials, including Vice President Cheney.

In court yesterday, Schroer testified that she had interviewed for the job at the Library of Congress's Congressional Research Service under the name of David. After being offered the job in December 2004, Schroer went to lunch at a Chinese restaurant with Charlotte Preece, the woman she thought would be her future supervisor.

During lunch, Schroer told Preece she was undergoing the medical transition to become a woman. She also showed Preece photographs of what she looked like dressed as a woman to allay concerns Preece might have had about her workplace attire.

The lunch seemed to go well -- until they were headed out and Preece told Schroer that "you have given me a lot to think about," the retired Army colonel testified.

Preece's tone, Schroer testified, "was ominous."

The next day, Preece called to tell Schroer that "after a long and sleepless night, I have determined you are not a good fit and not what we want," Schroer testified.

Schroer is represented by the American Civil Liberties Union and filed suit in 2005. Schroer is seeking the job offer that was rescinded and damages, which are legally capped at $300,000, said one of her attorneys, Arthur B. Spitzer, legal director of the ACLU of the National Capital Area.

The Library of Congress, represented by Justice Department attorneys, has argued that Schroer cannot sue because the Civil Rights Act does not protect transsexuals or prohibit discrimination on the basis of gender identity.

In court papers, Justice attorneys wrote that Preece rescinded the offer because she needed to fill the position quickly and was worried that Schroer's transgender status would require a long background check to obtain a required security clearance. Preece also was concerned that Schroer "might be unable to maintain high-level contacts in the military intelligence community" and "might not be viewed as credible" by members of Congress, the lawyers wrote.

Preece, who is expected to testify, also worried that the gender transition would divert Schroer's attention from her work, the lawyers wrote.

Under questioning by one of the ACLU attorneys, Sharon M. McGowan, Schroer said she has started a consulting firm. Schroer has contracts or subcontracts with a variety of federal agencies, including the U.S. Coast Guard and Department of Defense, she said.

Becoming a woman has helped her focus on work, she said.

"If anything, since my transition, things have been a lot clearer," Schroer said. "It feels like a big distraction has been removed from my life."

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,

Americans 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.

Health-care costs are limiting expenditure on daily necessities. Of those facing mounting medical bills, 39 percent used all their savings, 30 percent incurred large credit card debt, and 29 percent said medical bills left them unable to pay for basic necessities such as food, heat or rent.

The survey found a sharp rise in the number of people spending more than 10 percent of their income on health care. Among people with annual income below $20,000, the figure more than doubled to 53 percent from 26 percent in 2001.

The survey found that 28 percent of working-age adults in 2007 were without insurance at some time during the previous year, up from 24 percent in 2001.

The insured also are facing increasing woes: 61 percent of those with medical debt or bill problems were insured at the time they needed medical attention.

Those without adequate insurance increased to 14 percent of the population in 2007 from 9 percent in 2003.

This was the foundation's fourth biennial survey since 2001. The foundation mentioned salient features of health-care plans of both Sens. John McCain and Barack Obama but struck a nonpartisan note.

The survey showed that the health-care gap between poor and moderate-income families is narrowing, and that even middle- and high-income groups are going without medical insurance at some time during the year.

Half of those with incomes below $20,000 went without insurance during 2007, up one percentage point from 2001. But the figure among moderate-income ($20,000 to $40,000) families increased to 41 percent from 28 percent. Among middle-income ($40,000 to $60,000) families, the figure rose to 18 percent from 13 percent. And among those with incomes above $60,000, it rose to 8 percent from 4 percent.

Universal health-care insurance, the foundation argued, is key to improving health care, and its design would dictate its effectiveness.

President Karen Davis said the foundation has been conducting annual surveys of health-care experience in other countries since 1998, including Australia, Canada, the Netherlands, Germany, New Zealand and Britain. "The U.S. stands out for being the only country . . . that reports significant fractions of the population not getting needed care," Davis said.

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,

Violations 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."

The report detailed a death at a La Mesa hospital in which a worker failed to turn on a ventilator for a patient who was being transferred. Another patient in Los Alamitos died after falling from a wheelchair with no seat belt on, and a Santa Ana hospital lost a patient from a medication overdose.

At Doctors Medical Center in San Pablo, a registered nurse improperly inserted a catheter into a patient's neck vein on Sept. 1, and the patient died as a result of an air bubble from the tube. The report found the nurse had not completed a required anatomy class or the hospital's training on protocol.

Defending himself in the report, the unidentified male nurse told investigators, "I am the pro of the hospital. The other nurses call me to put in IVs that they cannot get in."

A message seeking comment from the medical center was not returned Monday.

In other cases, patients had surgical instruments or sponges left inside their bodies during surgery, requiring a second surgery to retrieve the items. The report also found some patients experienced surgical awareness during their procedures due to improper anesthesia.

The state has issued 61 such penalties to 42 hospitals, Billingsley said.

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,

The 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.

"In experienced hands, it can be done more," said Dr. Sidney Smith, heart disease chief at the University of North Carolina at Chapel Hill and a past president of the American Heart Association, who wasn't part of the study. "This approach, when done by experienced operators, has advantages."

Angioplasty is prized as a quick, minimally invasive way to restore blood flow in a clogged artery. A tiny balloon is inflated at the site of the blockage, pushing back the clog. Doctors often also insert a mesh tube called a stent to keep the artery propped open. It can be done during a heart attack, to alleviate worsening symptoms that signal a heart attack is imminent, or for nonemergency relief of recurring chest pain.

Who's the best candidate for an angioplasty versus other treatments is hugely controversial. But once that decision has been made, the new study addressed whether the through-the-wrist route works as well.

Cardiologists have preferred working through the femoral artery in the groin because it is a larger blood vessel than the wrist's radial artery, easier to tug catheters through. When the procedure's over, heavy pressure _ often a sandbag _ is applied for several hours until the puncture site quits bleeding and essentially seals itself. But heavy bleeding and related complications are a risk, happening in anywhere from 2 percent to sometimes as many as 10 percent of patients.

Catheters have gradually gotten smaller and more flexible, and previous small studies had suggested the wrist approach could be safer because that puncture site can be bandaged. In one earlier study, the wrist method even trimmed hospital costs because patients were discharged sooner.

So Duke University researchers turned to a national registry _ analyzing more than half a million angioplasties performed at 600 U.S. hospitals between 2004 and 2007 _ to see how often wrist angioplasties are done, and the results.

One key caveat: These were first-time, non-emergency cases.

But just 1.3 percent of the angioplasties were done through the wrist. Both methods were equally effective at clearing heart arteries, lead researcher Dr. Sunil Rao reported in the Journal of the American College of Cardiology: Cardiovascular Interventions.

The wrist method cut the bleeding risk by nearly 60 percent: Nearly 2 percent of patients treated the usual way bled, compared with slightly fewer than 1 percent of those treated via the wrist.

The method may be gaining steam: In early 2007, the researchers measured a sudden jump, as the wrist method accounted for about 3.5 percent of angioplasties performed then.

Rao himself uses wrist angioplasty almost exclusively, but it takes extra training that many cardiologists haven't received.

Still, the heart association's Smith said training isn't difficult, and the need may be growing: Obesity can limit traditional access, plus more patients today have disease-damaged leg arteries.

"The procedure is not one that would be recommended for everybody," Smith cautioned. But, "there are definitely groups of patients where this can be done with the same results and fewer complications."

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,

The 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.

Byetta competes against blockbuster drugs from GlaxoSmithKline PLC and Takeda Pharmaceuticals in the $24 billion global market for diabetes medications, according to health care research firm IMS Health.

More than 700,000 patients with type 2 diabetes have used the injectable drug since it was launched in June 2005. It is jointly developed and manufactured by San Diego-based Amylin and Eli Lilly.

Byetta's $636 million in sales made up about 80 percent of Amylin's total revenue last year. The drug accounted for just 3 percent of Eli Lilly's sales. The companies are developing a long-lasting version of Byetta that could be injected once weekly, instead of twice daily.

Robert Baird & Co. analyst Thomas Russo cautioned investors that concerns about pancreatitis could affect the FDA's review and requirements for the new version. Russo rates Amylin "outperform," but said in a note to investors he could revise that rating as more information becomes available.

Shares of Amylin Pharmaceuticals fell $4.45, or 13 percent, to $29.76 Monday, while Indianapolis-based Eli Lilly dipped 73 cents to $48.05.

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,

Two 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.

The recent setbacks led many AIDS scientists to reflect on the frustrating, complicated courses of their endeavors. Still, a certain smugness could be detected among some researchers, who still expect their trials to produce favorable findings, even though such success is far from guaranteed. Initial results from trials of a daily pill that would prevent H.I.V. may be ready next year.

In explaining the recent failures of vaccine and other trials, many scientists blamed public naïveté, saying laypeople do not understand that research gains usually come in increments and that progress often follows a zigzag course.

But that view overlooks the flaws in the process itself. Many researchers write papers as if they knew what they were doing from the outset, when, in fact, serendipity plays an important role.

Failure can have different meanings for scientists and the public.

Some scientists view failure as a momentary setback on the road to success. But that can be determined only in retrospect, and only if success is achieved. The public may see failure as bad science. Not necessarily so: scientists can learn from any trial if it is well designed and well executed. But how much the recent failures can contribute to future trials is uncertain.

There were calls for innovation and recruiting more young investigators to the AIDS field. As Alan Bernstein, executive director of the Global H.I.V. Vaccine Enterprise in Manhattan, put it, “The engines of discovery are new people.”

Dr. Bernstein noted that recruiting new workers should be less of a problem than in the past because of an explosion of interest on university campuses about global health.

Since its discovery in 1981, AIDS has rivaled the worst epidemics in history. An estimated 25 million people have died, and 33 million are living with H.I.V.

An important handicap in tracking and controlling the epidemic has been an inability to get timely and accurate data about current transmission of the virus. Rough estimates have come from calculating backward, from when AIDS was diagnosed to when the virus first entered the body. That interval can vary but usually is about 8 to 10 years.

Dr. Jorge Saavedra, director of the Mexican national AIDS program, underscored the imperative for such information by saying that “if you do not follow the epidemiology of H.I.V.” and the scientific evidence, “then we will lose the fight against H.I.V.”

Now, a new test developed by the Centers for Disease Control and Prevention promises a greater ability to pinpoint hot spots of new infections and to control them more quickly, at least in developed countries. The test needs to be refined for use in poor countries, the disease centers said.

While many participants applauded development of the test, they also criticized the federal agency for an eight-month delay in reporting its success.

The best weapon against H.I.V. would be a vaccine. But despite the hubris of leading scientists who predicted quick marketing of a vaccine after the virus was discovered in the mid-1980s, none is on the horizon.

Last year, the most promising vaccine candidate failed in trials.

“Development of a vaccine is still more of an art than a science,” said Dr. Tadataka Yamada, an official of the Bill and Melinda Gates Foundation in Seattle. He added, “No one country, any one scientist, any one team of scientists will develop the vaccine.”

A major obstacle is the inability to identify precisely what components of the immune system are responsible for combating H.I.V. For other vaccines, scientists look to the so-called correlates of immunity, which include antibodies that neutralize the virus and other substances that protect against it.

Since the Toronto conference in 2006, about two million people, mostly in poor countries, have started receiving antiretroviral drugs. But the need is far greater: in the same period, five million people became infected.

“The lack of secure and reliable drug supplies is the Achilles’ heel of antiretroviral programs,” said Gregg Gonsalves of the AIDS and Rights Alliance for Southern Africa. “Central medical stores in many countries often cannot handle this task.”

Reports of the number of people being treated in poor countries are now based on estimates. Mr. Gonsalves urged regular reporting of reliable national data to the World Health Organization.

A major concern is that H.I.V. will become resistant to the existing drugs, necessitating different, costlier second-line drugs. Who will pay for these drugs?

Although the United States has licensed 25 drugs in seven classes for H.I.V., doctors do not know what combination is the best for initial treatment and when to start them.

A panel of the International AIDS Society, which runs the meetings, issued new guidelines urging earlier treatment of H.I.V. in the developed world. Because the recommendations are based on expert opinion, many called for trials to provide them with a more scientific underpinning.

The combinations of antiretroviral drugs introduced in the late 1990s have turned AIDS from a usually fatal disease into one that can be managed as a chronic disease. But a cure is elusive.

Most participants urged further efforts to develop a cure and vaccine; unless researchers make the effort no one will ever know if they can be achieved.

Ten trials of microbicides — chemicals that are inserted into the vagina or rectum to prevent H.I.V. infection — have failed.

But researchers expressed renewed optimism that new trials will show the effectiveness of a second generation that incorporates antiretroviral drugs into a gel or a vaginal ring.

Whatever means are found to improve prevention of H.I.V., health workers should pay more attention to marketing and business methods, said Dr. Peter Piot, the outgoing director of the United Nations AIDS program. Calling current public health approaches to H.I.V. prevention “amateurish,” he said public health must be marketed as effectively as commercial products.

An underlying concern among participants was the potential for a strong reaction by critics who say that AIDS consumes too great a share of the resources available for all ailments and that efforts focused on only one disease are destroying primary health systems in poor countries.

There was enthusiastic support for the legislation passed last month allowing the United States to spend $48 billion over the next five years to expand President Bush’s program to prevent and treat AIDS in a number of foreign countries. It is believed to be the United States’ most ambitious foreign public-health program. But some critics have raised questions about whether the United States is promising lifetime therapy for recipients, in effect engaging in a foreign aid entitlement program.

To this reporter, who has covered International AIDS Conferences since they began, the shift is unmistakable — from a stronger emphasis on science to more of a convention atmosphere. The change is due partly to the restricted number of scientists that the United States government sends to the meetings and to many scientists’ preference for smaller, quieter meetings that are not interrupted by protesters.

No conference has been held in the United States since 1990 — as a protest against the government’s policy to refuse visas to people with H.I.V. But the recent financing legislation removes that ban, possibly returning the conference to the United States in a few years.

Meanwhile, the next conference will take place in Vienna in 2010. And unexpected developments, good or bad, could well arise. As Dr. Piot said, the AIDS epidemic “has always come up with new surprises.”

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,

Dr. 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."

Though he chose to ask the state court for guidance, Judge Rosenbaum also may have room to maneuver under federal procedural law.

UnitedHealth cited the special litigation committee's "exhaustive" 15-month investigation into the company's past stock option practices as evidence that the panel had met the state supreme court's bar in probing the legal claims and determining that a settlement would be in the company's best interest.

"Now that the Minnesota Supreme Court has answered this important question, we look forward to the presentation of the settlement to Judge Rosenbaum and the resolution of this matter," the company said.

David Brodsky, an attorney representing Dr. McGuire, said, "We are pleased that the Supreme Court has issued its decision so that the District Court now can consider whether to approve the settlement Dr. McGuire reached in the derivative litigation last December."

Together with the $200 million that Dr. McGuire agreed to surrender when he was ousted in late 2006, the sum would be one of the biggest executive-pay givebacks in history.

UnitedHealth was one of the largest among the dozens of corporations to become ensnared in the backdating scandal, in which option-award dates were manipulated to give executives a chance to reap additional compensation.

Last month, UnitedHealth agreed to resolve another group of shareholder suits for more than $900 million, the biggest settlement of a backdating case to date.

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,

Despite 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.

The F.D.A. released its preliminary re-evaluation ahead of a September meeting where outside advisers will debate the chemical’s safety.

Many lawmakers at home and abroad are not waiting for the agency to complete its review.

Canada has announced its intention to ban the use of the chemical in baby bottles, and lawmakers in the United States have introduced legislation to ban bisphenol in children’s products.

California, New Jersey and at least 10 other states also are considering bills to restrict use of the chemical.

More than six million pounds of bisphenol are produced in the United States each year by Dow Chemical, Bayer and other manufacturers.