HealthLawProf Blog

Judge to Unseal Documents on the Eli Lilly Drug Zyprexa

The New York Times reports that a federal judge in Brooklyn decided on Friday to unseal confidential materials about Eli Lilly's top-selling antipsychotic drug Zyprexa, citing “the health of hundreds of thousands of people” and “fundamental questions” about the way drugs are approved for new uses.  Mary WIlliams Walsh writes,

The decision by Judge Jack B. Weinstein of Federal District Court came as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions that want Lilly to repay them billions of dollars they spent on the drug. They contend that Lilly hid the side effects of the drug and marketed it for unapproved uses.

The confidential documents were produced by Lilly in response to a related lawsuit filed by patients who said that Zyprexa had caused excessive weight gain and diabetes. The papers were placed under a protective court order soon after the suit was filed in 2004.

“Lilly’s legitimate interest in confidentiality does not outweigh the public interest in disclosure at this stage,” Judge Weinstein wrote.

A spokeswoman for Lilly, Marni Lemons, said the company would not appeal the decision to make the documents public but that it would appeal the judge’s certification of a class action.

The issue of confidential information arose in 2006, when some of the Zyprexa papers were provided to a reporter for The New York Times, Alex Berenson. He wrote front-page articles based on evidence they contained that Lilly executives had kept information from doctors about Zyprexa’s links to obesity and high blood sugar.

Eli Lilly denied having withheld such information and said that the documents Mr. Berenson had seen were “cherry-picked” to give a one-sided view.

The publication of sealed information led Judge Weinstein to issue a sharply worded ruling last year, stating that Mr. Berenson had engaged in a conspiracy with a doctor and a lawyer and that they had used others “as their agents in crime.”

The judge said the sealed documents belonged to Lilly and ordered the doctor, David S. Egilman, and the lawyer, James B. Gottstein, to return them. Dr. Egilman had been serving as an expert consultant for the plaintiffs at the time, and Mr. Gottstein was working on Zyprexa litigation in Alaska.

Since then, insurance companies, unions, medical researchers and other publications have filed formal requests for copies of the documents. Many of the papers were entered into open court proceedings in Alaska, and copies of some have been posted on the Internet.

In his ruling on Friday, Judge Weinstein repeated that the information had been “obtained illegally” by The Times but also cited “this country’s general policy of accessibility of court records.”

Dr. Egilman said on Friday that he felt vindicated.

“The public can now decide for itself what these documents stand for,” he said.

Mr. Gottstein said he still disputed Judge Weinstein’s rulings that he had obtained the documents illegally.

“I think I did get them properly,” he said, adding that the new order unsealed only a small number of the Zyprexa documents that Lilly has provided to the court. “There are a lot of other documents that are hidden.”

The Science of Happiness

The Los Angeles Times gives the phrase "pursuit of happiness" a run in the Times' reflection of happiness as a process rather than a goal.  Marnell Jameson writes,

If recent scientific research on happiness -- and there has been quite a bit -- has proved anything, it's that happiness is not a goal. It's a process. Although our tendency to be happy or not is partly inborn, it's also partly within our control. And, perhaps more surprising, happiness brings success, not the other way around. Though many people think happiness is elusive, scientists have actually pinned it down and know how to get it.

For years, many in the field of psychology saw the science of happiness as an oxymoron. "We got no respect," says Ed Diener, a professor of psychology at the University of Illinois, who began studying happiness in 1981. "Critics said you couldn't study happiness because you couldn't measure it." In the mid-1990s, he and a few other researchers started to prove the naysayers wrong. As a result, Americans now have an abundance of consumer books, academic articles, journals and associations to help them find happiness.

"Many of us have material things and our basic needs met, so we are looking for what comes after that," says Diener, co-author with his son, Robert Biswas-Diener, of the forthcoming "Happiness: Unlocking the Mysteries of Psychological Wealth." "Materialism isn't bad. It's only bad if we use it to replace other things in life like meaningful work, a good marriage, kids and friends. People are recognizing that those who make money more important than love have lower levels of life satisfaction."

In recent months, the following titles have hit bookstore shelves: "What Happy Women Know," "The Happiness Trap," "The How of Happiness: A Scientific Approach to Getting the Life You Want" and "Happiness for Two."

Christine Cardone, executive editor of psychology books for Wiley-Blackwell, whose titles include Diener's forthcoming book, points to 2000 as the tipping point: Happiness science began to mushroom and flood society with new, positive ways of thinking. That year, Martin Seligman, then-president of the American Psychological Assn., started the positive psychology movement, which focuses on what makes people mentally healthy. That concept got out to the media, spawning more interest and research. Meanwhile, neuroscientists were discovering better ways to measure what's going on in the brain.

"Popular interest in happiness is only one driver," says Seligman, a psychology professor at the University of Pennsylvania and director of the Positive Psychology Center there. "The books are coming out because the science is coming out." Academic publications have enjoyed a similar boon. Between 1980 and 1985, only 2,125 articles were published on happiness, compared with 10,553 on depression. From 2000 to 2005, the number of articles on happiness increased sixteenfold to 35,069, while articles on depression numbered 80,161. From 2006 to present, just over 2 1/2 years, a search found 27,335 articles on happiness, more than half the 53,092 found on depression.

The field of happiness also now has its own publications -- the Journal of Positive Psychology and the Journal of Happiness Studies -- and its own professional organization, which Diener started last year. The International Positive Psychology Assn. for academics and scholars already has 3,500 members.

The trend shows no signs of slowing. Sonja Lyubomirsky, a professor of psychology at UC Riverside and author of "The How of Happiness: A Scientific Approach to Getting the Life You Want," believes that's because happiness is like the Holy Grail. "People around the world want it. If you ask people what they want for their children, they'll say for them to be happy. It's in our Declaration of Independence. It matters to and affects everyone."

Among the major findings of the last decade is that the pursuit of happiness is a worthy cause, Diener says. "Happiness doesn't just feel good. It's good for you and for society. Happy people are more successful, have better relationships, are healthier and live longer."

Seligman adds, "We've learned in 10 years that happy people are more productive at work, learn more in school, get promoted more, are more creative and are liked more."

And if that doesn't make you happy, here's more happy news: Around the world, happiness is on the rise.

Beyond your genes

Great if you happen to be one of the people born happy, right? Not exactly. Another major finding is that about half of our tendency toward happiness is genetic, while the rest is controlled by the individual.

Lyubomirsky and her colleagues analyzed studies on identical twins and other research and came to the conclusion that happiness is 50% genetic, 40% intentional and 10% circumstantial. "Half of your predisposition toward happiness you can't change," she says. "It's in your genes. Your circumstances -- where you live, your health, your work, your marriage -- can be tough to change. But most people are surprised that circumstances don't account for as much of their happiness as they think."

Life circumstances don't result in sustained happiness, she said, because we adapt. That new car, promotion or house feels great at first. Then we get used to it. An old but often-cited study found lottery winners were no happier than control groups after a year. That doesn't mean that getting out of a bad job or a terrible marriage won't give your happiness a boost. But sustaining that good feeling requires something else: deliberate control of how you act and think. That's the 40% intentional part that Lyubomirsky and others are most interested in.

In her research, Lyubomirsky led controlled studies to determine what behaviors positively affect happiness, and has come up with at least 12 strategies that measurably increase levels. For instance, one strategy she's tested is the practice of gratitude. In her gratitude study, she had a group of 57 subjects express gratitude once a week in a journal. A second group of 58 expressed gratitude in a journal three times a week. And a control group of 32 did nothing. At the end of six weeks, she retested all three groups and found a significant increase in happiness in the first one. (The participants who journaled three times a week showed less change, perhaps because the exercise didn't feel as fresh, she theorized.)

She and other researchers also recommend practicing forgiveness, savoring positive moments and becoming more involved in your church, synagogue or religious organization. "Not every strategy fits everyone," she says. "People need to try a few to find which ones work."

Happiness defined

Although Lyubomirsky likes to let people define happiness for themselves, clinically, she describes it as "a combination of frequent positive emotions, plus the sense that your life is good."

Seligman, who has written several books on the subject, including the bestselling "Authentic Happiness," says it's the pursuit of engaging and meaningful activities. By engaging, he means being in a state of flow or "at one with the music." You get so absorbed in what you're doing that you lose track of time. But one person's flow is another person's torture. What puts you in a state of flow is usually an activity that uses your strengths and talents. It's even better when it's part of your work.

"Meaningful" would be using what you're best at to serve others or to participate in a cause that's bigger than yourself. (To find out what you're good at, or your strengths, Seligman offers a free survey on his website, www.authentichappiness.org.)

"Your purpose doesn't have to be giant," says Dan Baker, a psychologist who founded the life enhancement program at Canyon Ranch in Tucson and is the author of "What Happy Women Know." "If you're 17, your purpose can be getting into the college of your choice. When you're a parent, it can be getting your kids off to school safely and prepared for each day. You don't have to adopt a Romanian orphan or build a church in Chile."

What happiness isn't, Diener adds, is getting everything right in your life. "A man might think, 'If I get the right education, the right job and the right wife, I'll be happy.' But that's not how it works. For instance, once basic needs are met, the effects of income on happiness get smaller and smaller. That's because happiness lies in the way you live and look at the world.

"If you have no goal other than your personal happiness, you'll never achieve it. If you want to be happy, pursue something else vigorously and happiness will catch up with you."

External factors

Although happiness is largely up to the individual, new research shows that what's going on around you -- specifically how much personal freedom you have -- also plays a role.

In a paper published in the July issue of Perspectives on Psychological Science, lead researcher Ronald Inglehart, a professor of political science at the University of Michigan, refuted the long-held belief that happiness among societies is constant. His research concluded that significant and enduring changes in happiness can occur not only for individuals, but also for entire societies.

The study, which Seligman calls the best he's seen on happiness in five years, analyzed polls taken from 1981 to 2007 by the World Values Survey. The surveys consisted of 88 countries containing 90% of the world's population, and measured happiness and overall life satisfaction. Among the 52 countries that completed all the surveys over the 17-year period, happiness rose in 45 of them, or 86%. In six countries, it declined, and in one (Australia), levels showed no change. Overall, happiness increased 6.8 percentage points.

Inglehart credits economic development, democratization and increasing social tolerance for the happiness bump. Economic gains that bring more food, clothing, shelter, medical care and longer life can result in a substantial increase in subjective well-being for poor societies, he says.

But once a society reaches a certain threshold, further economic growth brings only minimal gains. Among the richest societies, increases in income are only weakly linked with higher levels of subjective well-being.

While economic growth helps promote happiness for some, democratization and rising social tolerance contribute even more. Democracy provides more choice, which promotes happiness. Support for gender equality and tolerance of people who are different from oneself are also strongly linked, not just because tolerant people are happier, but because living in a tolerant society enhances everyone's freedom, Inglehart says.

The fact that happiness and our understanding of it are on the rise bode well. "In the future, more people will understand the nature of happiness and its process," Baker says. "They will understand that they have to take an active role if they want it."

Apparently, more people around the world are getting that message. "It's true," Seligman says. "We're happier. And more happiness in the world is a great thing."

FDA Posts List of Potential Problem Drugs

The Washington Post reports that the government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients.  Ricardo Alonso-Zaldivar writes,

The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.

Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research. "If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

The first list included some drugs whose problems have already been publicized, such as the blood thinner heparin and immune-suppressing medications that are being studied for a possible link to cancer in youngsters. Several medications administered in hospitals were listed because of overdoses linked to possibly confusing instructions. Among the drugs taken in the home, insulin and nitroglycerin were cited because of possibly confusing instructions that may be contributing to patients getting the wrong doses.

The listings will be updated for each calendar quarter.

"What's new here is that we are telling the public really at the earliest stage what we are working on," said Dr. Gerald Dal Pan, head of the Food and Drug Administration's drug safety office. "I think the public told us, 'We want to know what you are working on.' And we are responding to that."

Drugs will be placed on the list based on reports the FDA receives regularly from hospitals, doctors and patients. The list is not just a reflection of raw data, but more like what a police officer would call "probable cause." Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.

"Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list," said Dr. Paul Seligman, who is responsible for the FDA's safety communications.

Consumer advocates called the listing a positive step, but said it needs to be fleshed out.

"It's a good thing to get started but it needs to have much more detail if it's to have significant safety value," said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices. "A table with just a few words of description is quite limited."

"It's just the most basic warning system," said Diana Zuckerman, president of the National Research Center for Women and Families. "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."

Nor is it clear how drugs suspected of a problem will be removed from the list if later exonerated.

The FDA's Seligman suggested that may change. "I will be the first to admit there is some work and refinement that needs to be done on this table," he said.

The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.

"Our reservation is that patients will be abruptly stopping therapy," said Alan Goldhammer, a vice president of the organization. "One can't generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients."

Chemical in Plastic Is Connected to Health Problems in Monkeys

The Washington Post reports on a study that has found bisphenol A, a chemical found in everyday plastics, to create problems with brain function and mood disorders in monkeys.  Lyndsey Layton writes,

Researchers at the Yale School of Medicine have linked a chemical found in everyday plastics to problems with brain function and mood disorders in monkeys -- the first time the chemical has been connected to health problems in primates.

The study is the latest in an accumulation of research that has raises concerns about bisphenol A, or BPA, a compound that gives a shatterproof quality to polycarbonate plastic and has been found to leach from plastic into food and water.

The Yale study comes as federal toxicologists yesterday reaffirmed an earlier draft report finding that there is "some concern" that bisphenol A can cause developmental problems in the brain and hormonal systems of infants and children.

"There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects," John R. Bucher, associate director of the National Toxicology Program, said in a statement. "But we have concluded that the possibility that BPA may affect human development cannot be dismissed."

In a study published in the Proceedings of the National Academy of Sciences, the Yale team exposed monkeys to levels of bisphenol A deemed safe for humans by the Environmental Protection Agency and found that the chemical interfered with brain cell connections vital to memory, learning and mood.

"Our findings suggest that exposure to low-dose BPA may have widespread effects on brain structure and function," the authors wrote. In contrast to earlier research on rodents, the Yale researchers studied monkeys to better approximate the way BPA might affect humans.

"Our goal was to more closely mimic the slow and continuous conditions under which humans would normally be exposed to BPA," said study author Csaba Leranth, a Yale professor of obstetrics, gynecology and reproductive sciences and of neurobiology.

BPA, in commercial use since the 1950s, is found in a wide variety of everyday items, including sports bottles, baby bottles, food containers and compact discs. One recent federal study estimated that the chemical is found in the urine of 93 percent of the population.

The American Chemistry Council, a trade group, maintained yesterday that "there is no direct evidence that exposure to bisphenol A adversely affects human reproduction or development."

The National Toxicology Program, part of the National Institutes of Health, has no power to regulate BPA, but its findings are used by other federal agencies such as the Food and Drug Administration and the EPA, which set safe exposure limits for chemicals.

The FDA plays a critical regulatory role because it regulates the compound's use in plastic food containers, bottles, tableware and the plastic linings of canned foods.

The agency last month issued a draft report that declared BPA safe for use in food packaging and bottles, based largely on the strength of two studies, both funded by industry.

"Unfortunately the regulatory agency charged with protecting the public health continues to rely on industry-based research to arrive at its conclusions, rather than examining the totality of scientific evidence," Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said in a statement yesterday. His committee is investigating the FDA's handling of BPA.

U.S. manufacturers make about 7 billion pounds of BPA annually. A ban would affect thousands of businesses and perhaps billions of dollars in profit for its largest manufacturers.

Canada has said it intends to ban the use of BPA in baby bottles, and state and federal lawmakers have proposed a variety of BPA bans. Sen. Charles E. Schumer (D-N.Y.) is sponsoring a bill to prohibit BPA from children's products, while Rep. Edward J. Markey (D-Mass.) wants to bar it from all food and drink packaging.

"The FDA's assurances of BPA's safety are out of step with mounting scientific evidence to the contrary," Markey said yesterday. "For the sake of the health of every man, woman and child in America, we should ban BPA in food and beverage containers, especially because there are alternatives already available."

Several major retailers, including Wal-Mart and Toys R Us, have pledged to drop BPA products next year while some makers of baby bottles and sports bottles have switched to BPA-free plastic.

F.D.A. Orders Stronger Warnings on Arthritis Drugs

The New York Times reports that the FDA has ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections.  The New York Times writes,

The drugs -- Enbrel, Remicade, Humira and Cimzia -- work by suppressing the immune system to keep it from attacking the body. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it's ''a double-edged sword,'' said the FDA's Dr. Jeffrey Siegel. That's because the drugs also lower the body's defenses to various kinds of infections.

Siegel, who heads the office that oversees arthritis drugs, said the FDA became concerned after discovering that doctors seemed to be overlooking a particular kind of fungal infection called histoplasmosis. Of 240 cases reported to the FDA in which patients taking one of the four drugs developed this infection, a total of 45 died -- about 20 percent.

The infection, which mimics the flu, is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body.

Siegel said the investigation began with a single case of a woman taking one of the drugs who died of histoplasmosis. Delving into the case, doctors at the FDA found that the woman had been sick with the fungal infection for a long time. ''This case led us to be concerned that there may be other situations in which physicians may not recognize histoplasmosis,'' said Siegel.

FDA officials searched the agency's database and found the 240 cases of patients taking the medications who had also developed the fungal infection. Of those, at least 21 appeared to involve a late diagnosis, and 12 of them -- more than half -- ultimately died.

Siegel said the FDA's order Thursday means that the risk of histoplasmosis will be flagged in a ''black box,'' the strongest warning information in a drug's prescribing literature. The four medications already have black box warnings about the risk of infections, but the language varies from drug to drug.

Patients should call their doctors if they develop persistent fever, cough, shortness of breath or fatigue, which can be signs of the fungal infection.

And the FDA is also urging doctors to consider aggressive use of antifungal drugs in patients who develop such symptoms, even if the infection has not been confirmed by a laboratory test. Siegel said such a decision should not be taken lightly, since antifungal drugs can also have dangerous side effects. Doctors should consider stopping treatment with the immune-suppressing drugs if patients develop infections.

The four drugs belong to a class known as TNF-alpha blockers, and are considered a mainstay for treating rheumatoid arthritis, a disabling disease in which the immune system attacks the joints. They are also used to treat Crohn's disease, juvenile arthritis, certain types of psoriasis, and other immune system disorders. All are taken by injection.

Separately, the FDA is investigating a possible link between the four medications and cancer in young patients. The agency said earlier this year it has received 30 reports of cancers, mainly lymphomas, in patients who began taking the medications when they were 18 or younger. That investigation is expected to take the rest of the year.

Three of the drugs, Enbrel, Humira and Remicade, are considered blockbusters, with sales of over $1 billion annually for each. Cimzia is newer and less widely used.

Humira is made by North Chicago, Ill.-based Abbott Laboratories Inc; Cimzia by Belgium-based UCB; Enbrel by Thousand Oaks, Calif.-based Amgen Inc. and Madison, N.J.-based Wyeth; and Remicade by Horsham, Pa.-based Centocor, a unit of Johnson & Johnson.

Abbott shares fell $1.29, or 2.3% to $56.64 Thursday afternoon; Amgen fell $1.73, or 2.7 percent, to $61.37; Wyeth fell $1.12, or 2.6 percent to $41.47; and Johnson & Johnson fell 79 cents to $70.73.

Turf War: California Sues Artificial-Grass Makers Over Lead Content

The Los Angeles Times reports that California Atty. Gen. Jerry Brown and other law enforcement officials allege that three makers of artificial turf deliberately failed to disclose that their products contain lead.  Lead, which is used to give a natural green hue to the artificial turf, has been identified by state agencies as a carcinogen.  Marc Lifsher writes,

California's attorney general wants to put a new spin on the old admonition "Don't step on the grass!"

The warning could read "Don't roll on the artificial turf" if Atty. Gen. Jerry Brown and local law enforcement officials prevail in a lawsuit filed late Tuesday against three top makers of the green plastic playing fields and grasslike indoor-outdoor carpeting.

The complaint filed in Alameda County Superior Court alleges that the three manufacturers violated California's Proposition 65 environmental law by knowingly failing to disclose that their products contain lead.

The lawsuit, which has been joined by Los Angeles City Atty. Rocky Delgadillo and Solano County Dist. Atty. David W. Paulson, names Beaulieu Group of Georgia, AstroTurf of Georgia and FieldTurf USA Inc. of Florida.

All three companies said they were working with California officials to settle the lawsuit and stressed that their products were safe.

AstroTurf, an artificial-turf pioneer, said in a statement that it "has demonstrated its industry leadership by proactively developing new products that are below the most stringent standards for lead in consumer products."

Joe Fields, chief executive of FieldTurf's Canadian parent company, said that his artificial turf recently got a clean bill of health from the Centers for Disease Control and Prevention and the U.S. Consumer Product Safety Commission.

Lead, which is used to give a natural green hue to the artificial turf, has been identified by state agencies as an ingredient that can cause cancer, damage to male and female reproductive systems, and birth defects in developing fetuses.

Children and other individuals can ingest harmful levels of lead by absorbing it through the skin or by rubbing the ersatz grass and then touching food or their mouths, the suit contends.

The state attorney general's office said it found excessive lead levels in some of the artificial-turf samples tested from the three companies.

Although artificial turf presents little or no danger when it is new, lead levels rise to potentially harmful levels as it gets older, said Deputy Atty. Gen. Dennis A. Ragen, the state's lead attorney on the lawsuit.

"As it ages, it forms more dust," he said, and could contain levels of lead that are more than 20 times what's allowed by Proposition 65.

The state, Ragen said, is negotiating with the three companies and is optimistic that a legal settlement can be reached that requires the products to be reformulated so that no lead is used in the manufacturing.

Most companies targeted by Proposition 65, known as the Safe Drinking Water and Toxic Enforcement Act of 1986, are eager to change their products rather than be forced to sell them with a warning that they contain chemicals "known to the state of California" to cause cancer or birth defects.

"The bottom line is this is 2008. Why are you making something with lead deliberately put into it?" Ragen said. "You need to find some substitute to make the color stable."

Beaulieu attorney Peter Farley says he hopes to reach a friendly settlement with California. He stressed, however, that his company makes only an indoor-outdoor type of product and does not sell artificial turf used on athletic fields and stadiums.

The state decided to take action against the three companies after it received a legal notice from an advocacy group, the Oakland-based Center for Environmental Health, that it intended to file a private lawsuit on the lead warning issue against Beaulieu and other artificial-turf manufacturers.

"Our testing on products from dozens of companies shows that artificial turf can contain high amounts of lead that can easily come off onto children's hands when they play on turf fields," said Michael Green, the center's executive director. 

Irradiating Iceberg Lettuce, Spinach Effective But Not Fail-Safe; Critics Cite Consequences

The Los Angeles Times reports that the FDA's latest ruling that spinach and iceberg lettuce can be irradiated weighs food safety against concerns about vitamin loss and cleaner farming practices.  Elena Conis writes,

For many consumers, the prospect of eating produce zapped with ionizing radiation doesn't sound all that appetizing, conjuring up images of mushy fruits and wilted leaves -- not to mention fears over safety. Last month's ruling by the Food and Drug Administration that food manufacturers can now irradiate fresh spinach and iceberg lettuce to kill bacteria came with reassurances that the process wouldn't result in food any less appealing or healthful than non-irradiated varieties.

Research indicates that that may all be true. But critics say the new rule ignores the source of the problem -- sloppy agricultural practices -- and could give consumers a false sense of security.

One might imagine that washing would take care of most bacteria on a piece of fruit or a vegetable -- including the forms of E. coli and salmonella implicated in recent food-borne disease outbreaks. But the microbes that spurred the Washington, D.C.-based Grocery Manufacturers Assn., an industry group, to request the current ruling are known as internalized bacteria -- so called because they've taken up inside the plant's tissues and can't just be washed off.

Food irradiation, on the other hand, does penetrate deep. The process uses high-energy particles, usually in the form of gamma rays (generated by radioactive cobalt) or electron beams (similar to those in a television set). The particles break up water molecules in the plant, which then release free radicals that damage cell walls and DNA of any reproducing bacteria nearby.

Contrary to popular perception, the food doesn't retain radiation any more than, say, skin does after a day in the sun -- which is to say, not at all. It heats up a bit during treatment, then the radiation dissipates -- and no radioactive compounds enter the food.

When the radiation dose is kept low enough, the plant's own cells remain largely intact. When it's too high, however, the whole plant suffers. Irradiated food's reputation suffered a blow half a century ago, says Brendan Niemira, acting research leader with the U.S. Department of Agriculture's in Wyndmoor, Penn. Early experiments to develop an eternally shelf-stable head of lettuce resulted in leaves that were limp, colorless and bland.

Back then, scientists were dosing food with up to 10 grays of radiation. (A gray is a measure of how much energy is absorbed: It corresponds to one joule of energy per kilogram of matter.) The FDA's new rule allows food manufacturers to dose spinach and iceberg lettuce with up to 4 grays, enough to kill germs and without withering plant material.

The agency already allows food makers to irradiate meat, poultry, spices and some types of shellfish. In fact, irradiation is widely used on the spices in processed foods, said Anuradha Prakash, professor of food science and nutrition at Chapman University in Orange. (Irradiated whole products, such as ground beef, must bear an internationally recognized symbol, known as the radura, or state that they've been treated with radiation.)

The recent decision to expand irradiation to lettuce and spinach was based in part on studies demonstrating irradiation's effectiveness at killing harmful microbes. For example, Niemira's studies, which focused on spinach and lettuce, showed that irradiation was up to four times as effective at ridding the greens of internalized E. coli when compared with washing with water or a chlorine solution. He also showed that irradiation is particularly effective at reducing the amount of E. coli stored up in iceberg lettuce.

But critics argue that effectiveness aside, irradiation has unwanted side effects -- including the creation of chemicals such as furans and 2-alkylcyclobutanones, which may be toxic in very high doses, and the destruction of vitamins and minerals. Plus, says Bill Freese, science policy analyst with the Washington, D.C.-based advocacy group Center for Food Safety, "food irradiation masks the unsanitary conditions of industrial agriculture."

Irradiating food can create chemical changes, but these are little different from such] changes yielded by processing, Prakash says. Compounds such as furans are also generated by cooking, she says. Ones unique to irradiated foods, such as 2-alkylcyclobutanones (which in some studies, but not others, have been shown to damage DNA) are generated at very low levels. Decades of animal feeding tests, Prakash adds, suggest irradiated foods don't contain chemical levels that pose any risk to health.

Decades of testing have also shown, however, that dosing food with gamma rays or electron beams can destroy vitamins and minerals, including vitamin C and thiamine. The FDA's rule acknowledged that irradiation can reduce levels of vitamin A and folate in spinach. One study, for example, showed that irradiating fresh spinach with 2.5 grays of radiation led to a 10% loss in folate levels. But because fresh spinach isn't a major source of these two vitamins in the average American diet -- that is, because most Americans don't eat much of the stuff -- the agency concluded that irradiation would "not have an adverse impact on the nutritional adequacy of the overall diet."

"It's deceptive," Freese says. "An irradiated product looks normal but has invisible reductions in vitamins and nutrients." Freese says that the source of bacteria in food-borne outbreaks is often traced to farms where livestock are raised in crowded, unsanitary conditions, and that the current ruling does nothing to address this. "It's an attempt to fix the problem at the end of the line, instead of going to the source," he says.

The Grocery Manufacturers Assn., which has also asked the FDA to rule on irradiating other types of lettuce, as well as tomatoes, carrots and cabbage, considers irradiation a valuable tool. "It's the best and only step [in the production process] to ensure a pathogen-free product," says Brian Kennedy, the association's director of communications.

But irradiation, though it could cut down significantly on internalized bacteria, is no guarantee that spinach and iceberg lettuce will be 100% pathogen-free. Its effectiveness depends on the amount of bacteria in the plant to begin with, Niemira says. The greater the starting number of bacteria, the more likely that some will remain after treatment.

And though it takes hundreds of millions of E. coli bacteria to make a person sick, in the case of salmonella, it takes only a handful. That means irradiation will never be a substitute for clean farming practices.

Concerns Linger Over Safety of Chemical Used in Baby Bottles

The Wall Street Journal reports that government experts on Wednesday released a final report on the safety of a chemical used in plastic baby bottles, saying they have "some concern" the chemical is linked to health and developmental problems.  Jared A. Favole writes,

The chemical, bisphenol-A, or BPA, makes plastic hard and shatterproof, and is used in hundreds of consumer products from plastic baby bottles to CDs.

The report, released by the Department of Health and Human Services" National Toxicology Program, doesn't say BPA should be banned but that more research is necessary to understand how the chemical affects human health.

"There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects," said NTP Associate Director John Bucher, Ph.D. "But we have concluded that the possibility that BPA may affect human development cannot be dismissed."

Concerns over the chemical's safety have heightened in recent months, prompting more than a dozen states to consider legislation banning BPA in some children and food products. Concerns about BPA also drove Wal-Mart Stores Inc., among other retailers, to say it would stop selling baby bottles containing the chemical. Canada has said it intends to ban the use of BPA in baby bottles.

The Food and Drug Administration said last month, based on current science, that there isn't enough evidence to support banning the chemical from baby and food products. The agency's assessment relied on part of a draft of the report released today. The FDA is holding a hearing on Sept. 16 to discuss BPA.

The report is similar to a draft the National Toxicology Program released in April. There are, however, a few key differences.

The final report says experts have "minimal concern" BPA exposure will affect the development of mammary gland or accelerate puberty in females. The draft said there was "some concern," which is a more elevated concern. Officials lowered the concern after a group of experts reviewing the draft said there wasn't enough evidence to support the earlier level of concern, said Michael Shelby, an associate director at NTP.

The NTP used a five-level scale of concern, ranging from negligible concern to serious concern. "Some concern" falls in the middle.

The NTP's report relies on a wide-array of research involving numerous laboratory studies, though most of the research was from academia, Shelby said. The program's findings contradict some industry studies that say there is minimal concern BPA affects human development.

Doubts Grow Over Flu Vaccine in Elderly

The New York Times reports on a study that questions the statistical evidence of the flu vaccine's effectiveness and suggests the flu vaccine may not be as effective in warding off the virus in the elderly as once thought.  Brenda Goodman writes,

The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly.

A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths.

The latest blow was a study in The Lancet last month that called into question much of the statistical evidence for the vaccine’s effectiveness.

The authors said previous studies had measured the wrong thing: not any actual protection against the flu virus but a fundamental difference between the kinds of people who get vaccines and those who do not.

This contention is far from universally accepted. And even skeptics say that until more effective measures are found, older people should continue to be vaccinated, because some protection against the flu is better than none.

Still, the Lancet article has reignited a longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people. “The whole notion of who needs the vaccine and why is changing before our eyes,” said Peter Doshi, a doctoral candidate at M.I.T. who published a paper on the historical impact of influenza in May in The American Journal of Public Health.

The Lancet paper, by Michael L. Jackson and colleagues at the Group Health Center for Health Studies in Seattle, was based on an analysis of medical charts of thousands of elderly members of an H.M.O.

The study found that people who were healthy and conscientious about staying well were the most likely to get an annual flu shot. Those who are frail may have trouble bathing or dressing on their own and are less likely to get to their doctor’s office or a clinic to receive the vaccine. They are also more likely to be closer to death.

Dr. David K. Shay of the Centers for Disease Control and Prevention, a co-author of a commentary that accompanied Dr. Jackson’s study, agreed that these measures of health and frailty “were not incorporated into early estimations of the vaccine’s effectiveness” and could well have skewed the findings.

Not everyone is sold on the significance of the Lancet study. “I think this is another study that provides interesting findings and raises questions,” said Dr. Kristin Nichol, chief of medicine at the Veterans Affairs hospital in Minneapolis. “I don’t think we know yet what the final word is on influenza vaccinations in the elderly.

“I really feel, and I feel very strongly about this, that the public health message should be that vaccines are effective,” she continued. “I don’t think that science is necessarily best hashed out in the media.”

Dozens of studies since 1960 have supported the view that the vaccine is a powerful protector of the elderly, cutting their risk of dying in winter from any cause by almost 50 percent and reducing the risk of hospitalization by nearly 30 percent.

Those findings came from observational studies, in which scientists make inferences about the effect of a treatment on a population by comparing what happens to a group that has the treatment with what happens to an apparently similar group that does not.

There has been only one large study that compared the flu vaccine with a placebo for two random groups of older people in which neither the patients nor the scientists knew which group was receiving which injection. It came to a different conclusion from the observational studies.

Conducted by Dutch researchers and published in 1994 in The Journal of the American Medical Association, it found that in those 60 to 69, the vaccine prevented influenza about 57 percent of the time. In those over 70, the vaccine prevented the flu just 23 percent of the time, though the estimate is imprecise because the study was not designed to look at this age group.

But the influenza vaccine was never put through more placebo-controlled trials, which are considered the gold standard in medical evidence. “I think the evidence base we have leaned on is not valid,” said Lone Simonsen, an epidemiologist and visiting professor at the George Washington University School of Public Health and Health Services in Washington who was not connected with the Lancet study.

In 2005, Dr. Simonsen, who was then at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., published a paper in The Archives of Internal Medicine that found something odd: even though the percentage of older people who got an annual flu shot more than tripled from 1980 to 2001, there was no corresponding drop in the death rate.

That paper included one of the first estimates of how many deaths are actually caused by the flu — a number hard to pin down because doctors seldom confirm flu in their patients with lab tests. Using a statistical model and the best available data, Dr. Simonsen found that influenza probably causes just 5 to 10 percent of all winter deaths in the elderly. But earlier studies had found that the flu vaccine cut an elderly person’s risk of dying by 50 percent.

“You don’t have to do a whole lot of math to realize that doesn’t add up,” said Dr. Lisa A. Jackson of the Group Health Center for Health Studies in Seattle, who has also studied the effectiveness of the flu vaccine in the elderly.

Dr. Jackson at first tried to tease out underlying differences between vaccinated and unvaccinated elderly people by using medical codes — a numerical shorthand that doctors use to classify and record what is wrong with their patients. She and other researchers reasoned that patients with codes for cancer or heart disease, for example, might be very sick, thus skewing the results. When they adjusted for those codes, however, the differences between the vaccinated and unvaccinated groups became even more pronounced. The vaccine looked even more protective.

It was Michael L. Jackson’s thesis project, at the University of Washington, that revealed the flaw in using the codes to differentiate patients.

For the project, Mr. Jackson (no relation to Lisa Jackson) and three other researchers spent almost three years reading medical charts and examining X-rays. They discovered that health-conscious people were more likely to get medical codes for things like heart disease and cancer simply because they went to the doctor more often. But when Mr. Jackson adjusted for measures of frailty — things like lung function, whether people needed help bathing or dressing, and what kinds of medications they took — he found that vaccination had little effect on older people’s risk for pneumonia, the most dangerous complication of the flu.

That finding has a biological basis. Vaccines work by priming the immune system to recognize and respond to incoming threats. Because the immune system slows down with age, older adults do not respond as well to vaccines as younger adults.

A recent study by Dr. Wilbur H. Chen and colleagues at the Center for Vaccine Development at the University of Maryland School of Medicine found that elderly participants needed four times the amount of antigens given in a standard dose of the flu vaccine to have the same kind of immune response as healthy adults under 40. They presented their findings in May at the Annual Conference on Vaccine Research in Baltimore.

Despite these findings, Dr. Shay said the C.D.C. had no plans to change its vaccine recommendations, though he added that the agency had financed studies to look for more effective influenza vaccines for the elderly.

Dr. Simonsen, the epidemiologist at George Washington, said the new research made common-sense infection-control measures — like avoiding other sick people and frequent hand washing — more important than ever. Still, she added, “The vaccine is still important. Thirty percent protection is better than zero percent.”

DNA Databases Blocked from the Public

The Los Angeles Times reports that the National Institutes of Health removes patients' genetic profiles from its website after a study reveals that a new type of analysis could confirm identities.  Jason Felch writes,

The National Institutes of Health quietly blocked public access to databases of patient DNA profiles after learning of a study that found the genetic information may not be as anonymous as previously believed, The Times has learned.

Institute officials took the unusual step Monday and removed two databases on its public website. The databases contained the genetic information of more than 60,000 cooperating patients. Scientists began posting the information publicly eight months ago to help further medical research.

Creators of the databases had taken steps to mask the identities of the patients, summarizing and aggregating the genetic information. However, the independent study released today reported that a new type of DNA analysis could confirm the identity of an individual in a pool of similarly masked data if that person's genetic profile was already known.

Such a confirmation could reveal patients' participation in a study about a specific medical condition, denying them their presumed confidentiality, experts said.

"It's possible, but the likelihood is quite low" that a patient's privacy could have been violated, said Dr. Elizabeth Nable, head of the institute's genetic oversight body, in an interview Thursday evening. "We wanted to err on the side of caution."

The unexpected scientific advance and the institute's swift reaction highlight a growing tension in the field of genetic research, several experts said. Researchers favor public access to large pools of such data to speed the pace of medical innovation, but the privacy and public policy implications of such moves are still being understood.

Most patients in the databases signed consent forms after being promised their information would remain private, Nable said. Since the databases became publicly available in January, 140 individuals or institutions have downloaded the data. There is no way to retrieve or prevent the circulation of the information already released.

The Wellcome Trust, a British charity that maintains large online genetic databases for medical research, is taking similar steps, Nable said. Trust officials could not be reached for comment.

Nable said that there is no known violation of patient privacy and that a "nefarious person" would have to already know a person's genetic profile and use a complex algorithm to confirm a patient's existence in one of the databases.

Still, some in the field portrayed the health institute's move as a significant sign that developments in genetic science are quickly outpacing the field's existing privacy protections.

"It's a big deal," said Russ Altman, chair of the bioengineering department at Stanford and editor of the journal Bioinformatics. "They worked very hard on [the new privacy protocol] and something has come up that has thrown it into doubt."

Fred Bieber, a geneticist at Harvard Medical School, said: "The lesson is that with enough genetic information, it's becoming easier to identify individuals even though their identities are presumed to be" anonymous.

The study that sparked the move, published in today's edition of the journal Public Library of Science, revealed the ability of a new type of forensic DNA analysis to identify a person's DNA even if it were found in minute quantities and mixed with that of hundreds of other people.

Currently, such highly mixed genetic samples are usually discarded as meaningless.

The authors alerted the health institute to the study's conclusions last month. They hint at the privacy implications only in the paper's final paragraphs: "Our findings show a clear path for identifying whether specific individuals are within a study based on summary level data."

Dr. Dave Craig, a researcher at the Translational Genomics Research Institute and lead author of the study, said the innovation "opens a Pandora's box of questions."

Most Youths Tried as Adults Had Psychiatric Disorders

US News reports on a Chicago study that finds that more than two-thirds of youths tried as adults needed help with at least one mental illness.  From HealthDay News, US News writes,

The majority of youths who are tried in criminal courts as adults have a psychiatric disorder, researchers report.

Juveniles who are transferred to adult court, known as "transferred youths," are a growing population. Between 1983 and 1998, the number of transferred youths in the United States almost quadrupled.

In a study in the September issue of Psychiatric Services, Jason J. Washburn of Chicago's Northwestern University Feinberg School of Medicine and colleagues examined the cases of 1,715 youths, aged 13 to 18, who were processed in the Cook County Juvenile Temporary Detention Center in Chicago. Of the youths, 275 were transferred to adult court.

The researchers found that more than two-thirds (68 percent) of the transferred youths had a psychiatric disorder, and almost half (43 percent) had two or more types of disorders. The transferred youths who were eventually sentenced to prison had even higher rates of psychiatric disorders.

Another finding was that black and Hispanic males were more likely than non-Hispanic whites to be transferred, even when the researchers controlled for violent crime. This is important, since there is evidence that males from minority groups are among the least likely to receive mental health treatment, either in the community or in prison.

"This finding suggests an urgent situation in which the largest numbers of transferred youths in need of psychiatric services are also the least likely to receive them," the study authors wrote.

How Crafty Health Insurers Are Denying Care

US News reports on how people can fight back when their health plan says no.  Bernadine Healy writes,

Britain's government-run health system is under siege for restricting new therapies. The outcries became especially sharp this summer after patients and doctors got wind of plans to deny several new cancer drugs that are widely available in Europe and the United States, including Avastin and Sutent, because they aren't "cost-effective." In an op-ed in the Daily Mail, one of Britain's leading oncologists, Jonathan Waxman of Imperial College London, decried a "misguided and barbaric decision to ban four kidney cancer drugs" that double life expectancy. And that means years of life in some cases. You may think this is just a British battle over care denial in a country with rigid caps on its health purse and a penchant for rationing. Not so. In the United States, it's private insurance companies, which make hefty profits managing half of America's medical expenditures for the non-Medicare population, that in ways often hidden and arbitrary have the authority to deny coverage—and therefore, in all too many instances, care.

Outrage tends to bubble up when denials become human drama, triggering media interest. There's the 17-year-old girl who died before her liver transplant was approved. Or the people in California whose insurers canceled their policies retroactively after they got sick. What's often missed is that these cases are the tip of an opaque iceberg. An estimated 10 to 15 percent of claims are denied for various reasons, some of them technical, such as not meeting filing deadlines or failing to get pretreatment authorizations. Denials that produce the most disputes are those where insurers judge the care to be unnecessary or unproven, pitting a proverbial sick David against a multibillion-dollar Goliath. What few Davids know is that insurance contracts by law grant companies the legal right to manage a patient's care, including denying it, sight unseen, and give them the final say, if challenged. Unless the state steps in.

Many denials are iffy calls and can appear distinctly arbitrary, with one insurer saying no to a particular therapy or procedure while others reimburse for it. An FDA-approved drug might be denied because it's used off-label, even if it is shown to work in peer-reviewed reports. In cancer care, the generally expensive intravenous chemotherapy drugs given in a doctor's office are typically covered, while an equivalent, if not better, therapy taken at home orally is not. When insurance authorization is required for each new service or each hospital stay for the same serious illness, who's best to say what's medically necessary? Doctors and their staff will spend hours trying to get the approvals, but patients should be warned that if the company ultimately denies payment, for whatever reason, it's the patients who are responsible—with bill collectors ready at their door.

The problem is bound to grow as insurers make use of sophisticated data tools dubbed "denial engines," which are touted to reduce reimbursements by 3 to 10 percent. Bearing brand names like Ingenix Detection Software and Bloodhound Technologies' ClaimsGuard, they search patient records for any signs that claims have strayed outside company parameters. Weeding out fraud or speeding up processing is one thing; serving up excuses to deny legitimate coverage is another.

More than ever, people must study the details of their health plans. A few insurers, like Aetna, offer on their website a useful list of all services they won't cover—and why. And know that every insurance company is mandated to have an internal appeals process, though there is little openness to help those seeking reconsideration, such as information on similar appeals and their outcome or the data used for denial. Nor do insurers provide much detail about the professionals making decisions. Who are they? What's their experience? Are they moonlighters denying care from New Delhi? (Yes, many large insurers are now outsourcing claims adjudication to India.)

But those with the stamina to endure the many exhausting steps of internal review sometimes win. Even if you lose, completing the formal written internal appeal makes you eligible for an independent external review in 43 states and the District of Columbia. State reviews overturn about half of insurers' decisions, and in most states that's final. Nancy Nielsen, president of the America Medical Association and a former chief medical officer of a nonprofit insurance plan, says, "If health insurers are making coverage decisions that are fair and compassionate, very few will be overturned by the state's external appeal process." The numbers speak for themselves.

The lack of transparency in the face of such mighty discretionary authority is drawing the attention of state attorneys general. Andrew Cuomo of New York has launched a nationwide investigation into schemes that low-ball reimbursement and stick patients with bills insurance companies should have paid. "All too often," Cuomo says, "insurers play a game of deny, delay, and deceive." His pursuit is in full throttle and has the advantages of his bully pulpit and his power of subpoena to pierce the opaque veil that patients never can.