HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, September 6, 2008

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,

ZyprexaThe 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.

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September 6, 2008 | Permalink | Comments (2) | TrackBack (0)

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,

HappinessIf 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."

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September 6, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, September 5, 2008

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,

Pills9The 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."

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September 5, 2008 | Permalink | Comments (1) | TrackBack (0)

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,

PlasticResearchers 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.

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September 5, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, September 4, 2008

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,

EnbrelThe 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.

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September 4, 2008 | Permalink | Comments (1) | TrackBack (0)

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,

Artificial_grass2California'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.

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September 4, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, September 3, 2008

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,

LettuceFor 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.

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September 3, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Baby_bottleThe 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.

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September 3, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, September 2, 2008

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,

Flu_vaccine_for_elderlyThe 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.

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September 2, 2008 | Permalink | Comments (0) | TrackBack (0)

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,

Genetic_testing3The 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.

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September 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, August 31, 2008

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,

HandcuffsThe 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.

August 31, 2008 | Permalink | Comments (1) | TrackBack (0)

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,

DeniedBritain'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.

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August 31, 2008 | Permalink | Comments (1) | TrackBack (0)