HealthLawProf Blog

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

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

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

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

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

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

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

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

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

Red Alert on Energy Drinks

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

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

The specialist performed an endoscopy, in which a camera is inserted into a patient's esophagus and down into the stomach and upper part of the small intestine.

The findings were impressive: severe inflammation, bleeding and ulcerations in a part of the small intestine called the duodenum, the portion of the intestine closest to the stomach.

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

The staple ingredient in energy drinks is caffeine -- lots of it. If you're wondering how much caffeine energy drinks have compared with other beverages, here's your answer, according to the caffeine database at www.energyfiend.com:

8 ounces of tea (brewed): 47 milligrams

12 ounces Coca-Cola: 34 milligrams

12 ounces Sunkist: 41 milligrams

8 ounces coffee: 108 milligrams

8 ounces Red Bull: 80 milligrams

8 ounces Redline RTD: 250 milligrams

Those who love caffeinated beverages such as coffee probably, at one time or another, have experienced the heartburn they can cause. This is a known effect of caffeine. In excess, such drinks can irritate the lining of the gut, leading to severe pain. As with this teenager, they can tear you up on the inside.

Though his situation is probably a rarity, reports of serious medical events because of caffeine are increasing. A recent three-year study of calls to a Chicago poison center found more than 250 cases of caffeine-supplement overdose, with 12% of those requiring hospitalization. Nearly two-thirds of the hospitalizations involved the intensive care unit. Symptoms included insomnia, palpitations, tremors, sweating, nausea, vomiting, diarrhea and chest pains. The average age of patients was 21. Another poison center study focused on Redline. Nine cases requiring hospitalization related to this specific drink were reported in the California Poison Control System database in a two-year period, with severe symptoms involved.

Besides traditional forms of caffeine, many energy drinks include caffeine-containing substances such as guarana, a South American plant whose seeds are crushed and added as a stimulant. Other common ingredients include ginseng (thought to increase endurance, although studies have never proved it), carnitine (a protein thought to improve muscle performance, but again, that claim remains unproved) and other snake oil we don't know a whole lot about. All of these ingredients are classified as nutritional supplements by the Food and Drug Administration, meaning they can be sold over-the-counter without any trials to demonstrate their effectiveness or safety.

The label on Redline recommends consuming no more than one a day. Clearly, though, few consumers seem to notice the small print (and there's little motivation to make it larger, because a four-bottle pack of Redline can cost about $15).

There seem to be two lessons here. For starters, getting high on energy drinks can be hazardous to your health. Second, parents and those of us who work with children need to be aware of how popular the drinks have become. As with other high-risk behaviors such as drinking alcohol and smoking, we may need to clearly ask and counsel young people about their risks.

As for the Redline-guzzling teenager, he was given medication to relieve his gastritis -- and strictly forbidden to consume caffeinated products.

U.S. Weighs Food Allergy Labels

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

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

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

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

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

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

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

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

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

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

Canadian authorities have gone a step further, saying accidental-allergy warnings are "misleading consumers" and advising food makers to begin clarifying them even as Health Canada researches a formal policy.

The food industry recognizes there's confusion. The Grocery Manufacturers of America has been working to set new guidelines on the warnings for more than a year, but declined comment before next month's meeting.

About 12 million Americans have food allergies. Severe ones trigger 30,000 annual emergency-room visits, and 150 to 200 deaths a year.

Starting in 2006, a U.S. law required that foods disclose in plain language when they intentionally contain highly allergenic ingredients such as peanuts or dairy.

Left out of the law are accidental-allergy warnings _ for foods that might become contaminated because they were made in the same factory, or on the same machines, as allergen-containing products. The FDA has said that a quarter of inspected food factories have the potential for such a mix-up.

More and more foods bear precautionary labels, but there's a disconnect. The Food Allergy & Anaphylaxis Network, an influential consumer group, counts at least 30 different ways that the warnings are worded _ and consumers too often falsely assume that one food is riskier than another because its label sounds scarier.

Three-quarters of parents of food-allergic children surveyed by the group in 2006 said they would never buy a food with an accidental-allergy warning, down from 85 percent in 2003, when such labels were novel.

The FDA's own surveys found the allergic pay more attention to warnings that a food "may contain" an allergen than those "made in the same factory" labels.

Yet when University of Nebraska researchers tested nearly 200 products with various accidental-peanut warnings, they found that peanuts were more likely to have sneaked into products labeled "made in the same facility."

And Health Canada researchers recently discovered that some chocolate labeled as possibly containing "traces" of peanuts or tree nuts in fact contained up to six times the amount that the government considers a trace level.

Contributing to consumer mistrust are puzzling warnings, like canned or frozen vegetables with nut precautions. Just last week, allergy network founder Anne Munoz-Furlong was stunned to receive a basket of fresh fruit with a warning that it might contain nuts or milk.

"Right now everybody's making up their own rules," Munoz-Furlong says _ and she's pushing FDA for clear standards to help consumers understand which foods to avoid.

In Canada, the government's review is just beginning, but meanwhile it recommends foods bear one of two labels: "May contain X allergen" or "Not suitable for consumption by persons with an allergy to X."

Back in New Hampshire, the McCabes show how tricky label reading is. Tommie has loved a particular nondairy soy yogurt since infancy. When it began bearing an accidental-allergy precaution, his mother toured the factory and was relieved by how the equipment was cleaned. But last week, she noticed the label had changed again, to say the yogurt might also contain live cultures based on milk.

It "maybe illustrates how difficult it can be when you have food allergies to stay on top of that information," McCabe said.

New Oversight, Stiffer Penalties Approved for Snooping into Patient Records

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

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

Legislators also approved a bid to extend healthcare coverage to those with preexisting medical conditions.

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

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

"Our current system of protecting patient privacy has not served as a sufficient deterrent to stop repeated and damaging breaches of patient confidentiality," said Sen. Elaine Alquist (D-Santa Clara), author of the companion bill.

Alquist noted that one person at UCLA viewed confidential patient information more than 900 times.

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

Earlier this month, the state said there was evidence that in the case of UCLA, 127 employees peeked at celebrities' records.

The safeguarding bill, AB 211 by Assemblyman Dave Jones (D-Sacramento), passed Tuesday, 29 to 7. The Assembly has not voted on it.

Some of the Republican lawmakers who voted against it, including Sen. Roy Ashburn of Bakersfield, said they support patient privacy but worry that a hospital fined $250,000 would pass that cost on to patients.

In addition, said Sen. Sam Aanestad, a Grass Valley oral surgeon, "we shouldn't be establishing another bureaucracy." He noted that medical and dental boards already exist to review misconduct.

The administration of Republican Gov. Arnold Schwarzenegger co-sponsored both bills.

Dale Tate, a spokeswoman for UCLA Medical Center, said the hospital is not permitted to take positions on legislation. She said the institution has taken steps to address the problem of confidentiality breaches, including worker education, improved computer safeguards and more audits.

The Jones bill, which is supported by the California Hospital Assn., would hold individual employees accountable for rogue behavior in cases in which hospitals have done everything possible to keep records private.

"Those breaches should never have happened," said Jan Emerson, a spokeswoman for the hospital association.

Alquist's measure, SB 541, would increase fines against individuals and health facilities for serious medical errors from the current maximum of $50,000 to a limit of $125,000. The Assembly has already approved it.

In the Senate on Tuesday, lawmakers also approved AB 2 by Sen. Mervyn Dymally (D-Compton), which would extend healthcare coverage to those considered medically uninsurable because of preexisting medical conditions.

The bill would require insurance companies to either insure those people or pay into a state account that would subsidize insurance for them.

Sen. Sheila Kuehl (D-Santa Monica) said there are more than 1,000 Californians on a waiting list to get such coverage.

Aanestad said the current health insurance system needs fixing, but the legislation could increase costs for patients.

"The cost is going to be passed on to consumers," he said.

The Senate rejected a bill that would have required a review of fire retardants used in automobiles, cribs, toys and other products to determine whether they are toxic and should be banned or restricted.

The bill, SB 706 by Assemblyman Mark Leno (D-San Francisco), received 18 votes, three shy of the number needed for passage, after it was strongly opposed by chemical companies and other businesses.

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

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

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

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

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

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

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

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

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

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

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

As the health department has repeatedly noted, gay minority men were particularly at risk. For example, of new H.I.V. infections among men under age 30 who have sex with men, 77 percent were in black or Hispanic men, as were 59 percent of new H.I.V. infections among men ages 30 to 50 who have sex with men.

Over all, the study found some interesting differences between national and local rates of new H.I.V. infections.

Nearly two-thirds of the city’s new infections occurred in people 30 to 50 years old. Nationally, people under 30 accounted for 41 percent of new infections, compared with 28 percent in New York City.

Also, within New York City, whites were infected at four times the national rate, Hispanics at three times the national rate, and blacks at almost twice the national rate.

The health department said in a news release:

“The analytic technique is new, and the estimates may be imprecise, but even a rough gauge of H.I.V. incidence is a valuable tool for understanding — and combating — the spread of H.I.V. The health department’s new estimate includes 2006 incidence figures for different age groups, racial groups and both genders. By repeating the exercise for subsequent years, researchers may be able to discern increases and decreases over time, and target their prevention efforts accordingly.”

Over the past year, the health department has warned that H.I.V. infections among young gay men have risen and that unsafe sex remains common.

Salmonella Outbreak Is Over, Federal Health Officials Say

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

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

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

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

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

Diabetes Drug Tied to New Deaths

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

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

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

Byetta is Amylin’s leading product.

Ayurvedic Medicines Often Contaminated by Toxic Metals, Study Says

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

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

A fifth of the nearly 200 concoctions tested contained levels of the toxic metals that, if taken at the maximum recommended doses, would surpass California's safety guidelines.

Dr. Robert Saper, a Boston University professor of family medicine who led the study, said the findings should spur the Food and Drug Administration to start clamping down on the largely unregulated world of pills, herbs and powders classified as dietary supplements.

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

Ayurveda is a traditional Indian practice that takes a holistic approach to wellness, employing herbal medicine, meditation and exercise to promote good health. It exists alongside modern medicine in India, with its own network of clinics, hospitals and colleges serving hundreds of millions of patients.

It has spread to the U.S. and Europe with the migration of South Asians around the world and been popularized by figures such as bestselling author Deepak Chopra.

There are about two dozen ayurvedic training programs in the United States. A 2002 survey estimated that 750,000 U.S. residents have used the herbal preparations, sold under both traditional Indian names and more marketable labels such as GlucoRite and Ezi Slim.

Saper got interested in the supplements in 2003 after a man of Indian origin showed up at a Boston-area emergency room with seizures. The culprit turned out to be lead in the man's ayurvedic medicines. In an initial study published in 2004, Saper bought 70 ayurvedic products imported from India and found that toxic metals were common components.

It was an unsettling finding, because most of the preparations are intended to be taken as part of a daily regimen to improve health.

"Many, many studies are showing that even small levels of lead in the blood can increase the risk of high blood pressure, kidney dysfunction and decreased IQ," Saper said.

Ayurvedic practitioners lashed out at the research as alarmist, saying that it only showed there were problems with mixtures from India, not with U.S.-made products.

They pointed out that in India, many of these metals are purposely blended with herbs as part of the medicinal recipe. Those metallic mixtures are rarely used in the United States, they said.

In the new study, published in the Journal of the American Medical Assn., Saper and his team analyzed 193 products purchased from 25 websites for Indian and U.S. manufacturers. The vast majority supposedly contained only herbs and no metals.

About 80% of the samples showed no detectable metal content. But among the remaining samples, the toxic metals showed up at similar rates in both U.S. and Indian-made products. Of the U.S. products, 21% contained lead, 3% contained mercury and 3% had arsenic. Among the Indian-made medicines, 17% had lead, 7% had mercury and none contained arsenic.

The researchers and other experts surmised that the contamination had less to do with the manufacturing process than with the soils in which the herbs were grown.

"The raw material is all coming from India," said Kush Khanna, who runs Bazaar of India in Berkeley, a manufacturer of ayurvedic medicines started by his father in 1971.

Heavy metals showed up in 17 of the products the researchers ordered from his company.

Khanna said two labs in India routinely tested the 80 or so ingredients he imported.

The problem is that there are no unified standards for what is considered safe.

Lead levels allowed by the World Health Organization are 500 times the California limits.

"Based on WHO standards, our products are perfect," Khanna said. "They have not exceeded any limits."

The researchers found only two products that exceeded the WHO standards for lead content. Both mixtures were from India and purposely prepared with metals as ingredients.

In California, the Safe Drinking Water and Toxic Enforcement Act of 1986 requires that products containing certain levels of toxic metals carry warning labels. But the act has no power to ban products, and companies with fewer than 10 employees, such as Khanna's, are exempt from the labeling requirements.

The FDA does not specify any limits for metal content in dietary supplements, leaving it to the manufacturers to ensure that their products are safe.

Jennifer Rioux, a medical anthropologist who runs the Integral Ayurveda clinic in Chapel Hill, N.C., said the research underscored the need for consumers to consult with ayurvedic experts instead of buying and taking products on their own.

She noted that the study showed many medicines to be perfectly safe, but she worried that its conclusions would tar her profession.

"All people need is one study to provoke fear about an entire system of medicine," she said.

Cancer Test for Women Raises Hope, and Concern

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

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

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

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

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

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

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

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

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

Patients and advocacy groups seem divided on OvaSure, which costs about $220 to $240.

“We are hearing from people that they are very excited about it,” said Cara Tenenbaum, policy director for the Ovarian Cancer National Alliance. But the alliance urges women to wait for more data before relying on the test.

More than 21,000 new cases of ovarian cancer will be diagnosed in the United States this year and more than 15,000 people are expected to die from the disease, according to the American Cancer Society.

OvaSure measures the level of six proteins in a sample of blood, some produced by a tumor and some produced by the body in reaction to a tumor. It then calculates a probability that the woman has ovarian cancer. One of the six proteins is CA-125, which is used by itself as a test to monitor disease progression in women who already have ovarian cancer but is not good at picking up early disease.

In a study published in the journal Clinical Cancer Research in February, the test correctly classified 221 of 224 blood samples taken from women with ovarian cancer or from controls. It identified 95 percent of the cancers, and its false positive rate — detecting a cancer that was not there — was 0.6 percent.

But Dr. Beth Y. Karlan, director of the Women’s Cancer Research Institute at Cedars-Sinai Medical Center in Los Angeles, said the samples tested were not representative of what might be encountered in routine screening. There were very few blood samples from women with early stages of the most deadly type of ovarian cancer. “That’s really what we want to find,” she said.

The biggest concern is not that the test will miss cancers but that it will say a cancer is there when it is not. That would then subject women to needless surgery to have their ovaries removed.

Dr. Berchuck of Duke said only 1 of 3,000 women has ovarian cancer. So even if a screening test had a 1 percent rate of false positives, it would mean that 30 out of 3,000 women tested might be subject to unnecessary surgery for every one real case of cancer.

Teresa Hills, who had a visible mass on her left ovary, got a positive result from OvaSure. But when the ovary was removed, the mass turned out to be benign.

The false positive did not prompt unnecessary surgery because Ms. Hills was going to have the mass removed in any case. But it did cause needless anxiety.

“You can’t sleep, you can’t eat, you’re paralyzed with fear,” said Ms. Hills, a 44-year-old mother of three from Rockford, Ill. She said she lost 10 pounds in two weeks after the false diagnosis.

Dr. Lai-Goldman at LabCorp said that OvaSure should be restricted to women at high risk of ovarian cancer and that the test should be repeated if the result is positive. Those measures would limit the number of false positives.

LabCorp estimates that there are 10 million women at high risk. These include carriers of mutations in genes called BRCA1 or BRCA2, as well as women with histories of ovarian or breast cancer.

Dr. Gil Mor, the lead developer of the test at Yale, said the use of OvaSure might reduce ovarian surgeries, not increase them. That is because women with BRCA mutations often have their ovaries removed to prevent cancer. A negative result on the OvaSure test might allow such women to put off the surgery.

“They are removing the ovaries without the test,” said Dr. Mor, an associate professor of obstetrics and gynecology. “So what are we talking about here? We are trying to do the opposite and say don’t remove the ovaries.”

That logic appeals to some. Dr. Elizabeth Poyner, a gynecologic oncologist in Manhattan with a lot of high-risk patients, said she was thinking about how to incorporate OvaSure into her practice. One of her patients, a Manhattan woman with a BRCA2 mutation, said she was planning to take the test in hopes of postponing ovary removal.

“I’d really like a couple of more years to have the heart health and the bone health and all the benefits that come from having estrogen naturally,” said the woman, who is in her early 40s and spoke on the condition she not be identified because she had not told some relatives that she has the mutation.

But Dr. Julian C. Schink, director of gynecologic oncology at Northwestern University, said it would be “playing Russian roulette” to put off ovary surgery unless OvaSure detected cancer. “We just don’t have any data to show this test will turn positive before the disease turns metastatic,” he said.

The test is also not intended to detect the recurrence of cancer. Jean McKibben, a retired schoolteacher from Centennial, Colo., said her test result suggested zero probability that her cancer had returned. But scans then found a tumor. Only later did Ms. McKibben learn that the test does not work for women whose ovaries have been removed.

The ovarian cancer detection field has had disappointments before. Four years ago, the F.D.A. intervened to effectively stop the marketing of another complex ovarian cancer screening test developed by a company called Correlogic Systems. The test, called OvaCheck, had also spurred great hope, but never made it to market as experts questioned its validity.

With the number of genetic and other tests proliferating, the agency has been under pressure to assure that the tests are accurate. Two years ago, the agency said it intended to regulate complex tests, like OvaSure, that measure multiple proteins or genes and use a mathematical formula to compute a result. But it has not finalized the policy.

Peter J. Levine, president of Correlogic, said the company was developing a new ovarian screening test and would apply by the end of the year for F.D.A. approval. He said it would be unfair if LabCorp did not need approval.

Another company, Vermillion, applied to the F.D.A. in June for approval of a test, called OVA1, aimed at determining whether ovarian masses are cancerous.

Dr. Daniel Schultz, who oversees diagnostic tests for the F.D.A., said the agency was trying to balance demands for greater oversight of tests against concerns that regulation could impede development of needed diagnostics.

“We understand that concerns have been raised regarding the impact that F.D.A. regulation would have on this whole field,” he said.

Even if OvaSure is validated, or a better test is developed, questions will remain on whether screening is useful, similar to controversies that have arisen about prostate cancer screening.

Dr. Berchuck of Duke said it had not been proved that a test that detects cancer early would cut deaths from the disease. It could be that cancers detected early were the less aggressive ones that would not have killed the woman anyway.

Some experts say women should pay more attention to symptoms, like pain and bloating. But these symptoms can also be caused by other conditions.

The Canary Foundation, which finances research on early cancer detection, is focusing on developing better imaging techniques. Transvaginal ultrasound, which is sometimes used now, is not that good at detecting early disease.

“Too much of the dialogue has been on how good is the blood test,” said Don Listwin, a Silicon Valley executive who started the foundation after his mother died from ovarian cancer that was diagnosed late. “They thought it was a bladder infection.”

Mr. Listwin said mammograms and the P.S.A. test were fairly unreliable in detecting breast and prostate cancer, respectively. Yet they can be used for screening because a positive test result can be followed by a needle biopsy to confirm whether cancer is present.

But it is difficult to do a biopsy of the ovary because of its location, so a positive blood test result might lead directly to surgery. If imaging could be used for confirmation, he said, then even a somewhat inaccurate blood test might suffice for screening.

Number of Uninsured Declines, as Poverty Rate Holds Steady

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

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

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

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

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

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

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

For example, after adjusting for inflation, last year's median household income of $50,233 was not significantly different from the figure for the year 2000, which was $50,557. "The American work force is baking a bigger economic pie, but the slices haven't grown at all," said Mr. Bernstein.

The welcome news on health insurance coverage was tempered by the fact that private coverage continued to erode. Government programs -- such as Medicaid for the poor -- picked up the slack, resulting in the overall reduction in people without health insurance.

"A lot of the fall is due to the increase in public coverage," said David Johnson, who oversees the Census division that produced the statistics. The number of uninsured children also fell in 2007, after an increase in 2006 that had interrupted years of progress in getting more kids covered.

The report, released two days into the start of the Democratic National Convention and a week ahead of the Republican National Convention, comes as the two political parties debate the need for reform of U.S. health insurance policy. (See related section.)

Sen. Barack Obama (D., Ill.) proposes a government health-care plan to cover millions without insurance. Sen. John McCain (R., Ariz.) has put forth a market-driven approach that focuses on revamping the employer-based health-care system by shifting responsibility to individuals.

Uninsured to Spend $30 Billion, Study Says

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

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

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

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

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

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

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

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

The new study estimates the government pays 75%, or $42.9 billion, of the amount uninsured patients can't pay -- through Medicaid, the federal-state health-insurance for the poor and Medicare, the federal program for the elderly and disabled, as well as state and local taxes.

Complicating the measure: Some doctors and hospitals donate time and forgo profit to cover poor people, and in some cases private donations cover the costs. Just how much money doctors and hospitals lose in caring for the uninsured is difficult to pin down, partly because group plans often negotiate lower payment rates than other consumers are billed. For this study, Mr. Hadley of George Mason University defined uncompensated care as the difference between how much the uninsured paid and what the providers would have received had those patients been privately insured.

While many have argued that uncompensated care will translate into higher premiums to patients with private insurance, Mr. Hadley said the impact is "very small," noting that despite an increase in the number of uninsured, hospital spending on uncompensated care has been relatively stable. That is partly because the public hospitals and clinics that most often care for the uninsured often don't have many privately insured patients to absorb the costs.

"It's more through taxes than private insurance bills," Mr. Hadley said.

Free AIDS Drugs Reduce Malawi Death Rates

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

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

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

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

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

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

(Reporting by Mabvuto Banda, Editing by Dina Kyriakidou)

Drug to Help Blood Clot Is Approved

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

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

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

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

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

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

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

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

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

Can a Troubled Economy Actually Improve Public Health?

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

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

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

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

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

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

No one -- certainly not Ruhm -- is arguing that recessions are good. For unemployed individuals and for people who fear financial disaster -- relentlessly forecast in headlines and top-of-the-hour newscasts -- the outcome is mixed. Mental health worsens even for the vast majority who maintain their jobs, as the onslaught of bad news causes anger, anxiety and depression. And prenatal problems increase, leading to more miscarriages and higher infant mortality rates.

But even as people are worrying more, they're smoking, drinking and driving less, reducing their risks of heart disease, liver disease and car crashes. People who have lost jobs likely cut back because of lost income, whereas those still employed may be cutting back as they stare down inflation and stagnant incomes.

Some may take better care in order to look better to their bosses, says Ralph Catalano, economist at the School of Public Health of UC Berkeley. "They look around and think, 'I better cool it,' " he says. "Those people may be getting healthier."

Forewarned is forearmed. The research into the effects of tough times can show worried workers which reactions are helpful and which ones make things worse. Economists look at national trends, but real people can buck those trends -- maybe by taking a lesson from their grandparents.

"We know from the old days, 50 to 100 years ago, that people who were less well off actually did better," says Dr. C. Noel Bairey Merz, director of the preventive and rehabilitative cardiac center at Cedars-Sinai Medical Center. "They were working as laborers, they ate rice and beans, and they couldn't afford cigarettes."

Doing better, in other words, means following the advice of every public health agency in the world: exercise, eat healthful food and don't smoke.

Consequences

Deaths from some diseases, such as cancer, seem to be unaffected by the ups and downs of the economy, studies generally find. That's probably in part because it takes years or decades for cancer to form -- too long a lag to be clearly tied to a temporary downturn or economic upswing.Also, the majority of cancer deaths are among people older than 65, most likely out of the workforce and less susceptible to the cost-cutting whims of an employer.

But deaths, overall, do decrease when times turn bad, Ruhm has found from studying the stats of the U.S. as well as the 23 developed nations of the Organisation for Economic Co-operation and Development, matching them to economic shifts.

To put the economic fluctuations in perspective: Ruhm notes in a May 2000 paper in the Quarterly Journal of Economics that in 1990, 1.5 million Americans older than 65 died from all causes, as well as 145,000 people 25 to 44.

Based on his calculations, a rise in unemployment of one percentage point would have predicted 2,900 fewer deaths among the young adults. It would have spared, for a while at least, 4,900 seniors. Both groups gain, but among the young -- who are far less likely to die -- the percentage of saved lives is greater: 2% versus 0.3%.

The more that a cause of death affects primarily young people (traffic accidents, for example), the greater the effect of a shifting economy, Ruhm says. "Some dimensions of health respond more or less quickly."

Researchers have found good news in bad times for a number of diseases, specifically illnesses most affected by lifestyle changes.

* Heart disease is at the top of that list. In a March 2006 report for the National Bureau of Economic Research, Ruhm looked at federal mortality statistics from 1979 to 1998, comparing periods of higher and lower employment rates as a measure of economic conditions. He found a percentage-point reduction in unemployment was associated with a 0.75% rise in heart disease deaths -- about 3,900 additional deaths a year. The finding held across all age groups.

One of Ruhm's theories is that in hard economic times, fewer jobs mean fewer factories spewing pollution. "Short-term changes in pollution have been tied to heart attacks," he says.

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

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

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

No one -- certainly not Ruhm -- is arguing that recessions are good. For unemployed individuals and for people who fear financial disaster -- relentlessly forecast in headlines and top-of-the-hour newscasts -- the outcome is mixed. Mental health worsens even for the vast majority who maintain their jobs, as the onslaught of bad news causes anger, anxiety and depression. And prenatal problems increase, leading to more miscarriages and higher infant mortality rates.

But even as people are worrying more, they're smoking, drinking and driving less, reducing their risks of heart disease, liver disease and car crashes. People who have lost jobs likely cut back because of lost income, whereas those still employed may be cutting back as they stare down inflation and stagnant incomes.

Some may take better care in order to look better to their bosses, says Ralph Catalano, economist at the School of Public Health of UC Berkeley. "They look around and think, 'I better cool it,' " he says. "Those people may be getting healthier."

Forewarned is forearmed. The research into the effects of tough times can show worried workers which reactions are helpful and which ones make things worse. Economists look at national trends, but real people can buck those trends -- maybe by taking a lesson from their grandparents.

"We know from the old days, 50 to 100 years ago, that people who were less well off actually did better," says Dr. C. Noel Bairey Merz, director of the preventive and rehabilitative cardiac center at Cedars-Sinai Medical Center. "They were working as laborers, they ate rice and beans, and they couldn't afford cigarettes."

Doing better, in other words, means following the advice of every public health agency in the world: exercise, eat healthful food and don't smoke.

Consequences

Deaths from some diseases, such as cancer, seem to be unaffected by the ups and downs of the economy, studies generally find. That's probably in part because it takes years or decades for cancer to form -- too long a lag to be clearly tied to a temporary downturn or economic upswing.Also, the majority of cancer deaths are among people older than 65, most likely out of the workforce and less susceptible to the cost-cutting whims of an employer.

But deaths, overall, do decrease when times turn bad, Ruhm has found from studying the stats of the U.S. as well as the 23 developed nations of the Organisation for Economic Co-operation and Development, matching them to economic shifts.

To put the economic fluctuations in perspective: Ruhm notes in a May 2000 paper in the Quarterly Journal of Economics that in 1990, 1.5 million Americans older than 65 died from all causes, as well as 145,000 people 25 to 44.

Based on his calculations, a rise in unemployment of one percentage point would have predicted 2,900 fewer deaths among the young adults. It would have spared, for a while at least, 4,900 seniors. Both groups gain, but among the young -- who are far less likely to die -- the percentage of saved lives is greater: 2% versus 0.3%.

The more that a cause of death affects primarily young people (traffic accidents, for example), the greater the effect of a shifting economy, Ruhm says. "Some dimensions of health respond more or less quickly."

Researchers have found good news in bad times for a number of diseases, specifically illnesses most affected by lifestyle changes.

* Heart disease is at the top of that list. In a March 2006 report for the National Bureau of Economic Research, Ruhm looked at federal mortality statistics from 1979 to 1998, comparing periods of higher and lower employment rates as a measure of economic conditions. He found a percentage-point reduction in unemployment was associated with a 0.75% rise in heart disease deaths -- about 3,900 additional deaths a year. The finding held across all age groups.

One of Ruhm's theories is that in hard economic times, fewer jobs mean fewer factories spewing pollution. "Short-term changes in pollution have been tied to heart attacks," he says.

Continue reading "Can a Troubled Economy Actually Improve Public Health?"