HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, August 16, 2008

Behind the FDA's "Black Box" Warnings

The Los Angeles Times discusses why Cipro and similar antibiotics are given the FDA's strictest label, while epilepsy drugs Lyrica, Depakote and Topamax may have escaped.  Karen Ravn writes,

Cipro Two groups of drugs were under the Food and Drug Administration spotlight last month. Both have been associated with rare but serious side effects, and both were candidates for a "black box" warning, the strongest the FDA issues short of taking a drug off the market. Although one was hit with this safety advisory, the other may have escaped. We look at these drugs and their different fates.

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August 16, 2008 | Permalink | Comments (0) | TrackBack (0)

Los Angeles Stages a Fast Food Intervention

The New York Times reports on the continued controversy over Los Angeles' decision to stop new fast food restaurants from opening in South Los Angeles. Kim Severson writes,

La_fast_foodA new weapon in the battle against obesity was rolled out last month when the Los Angeles City Council decided to stop new fast food restaurants from opening in some of the city’s poorest neighborhoods.

Even in a country where a third of the schoolchildren are overweight or obese, the yearlong moratorium raises questions about when eating one style of food stops being a personal choice and becomes a public health concern.

The Sisyphean struggle against poor diets has included booting soda from schools, banning trans fat and, more recently, sending New Yorkers into dietary sticker shock with a law that requires calorie counts be posted on menus, right next to the prices.

But this appears to be the first time a government has prohibited a specific style of restaurant for health, rather than aesthetic, reasons.

Jonathan Gold, the LA Weekly food critic who won a Pulitzer Prize last year, said he understands the spirit of the freeze, which is an urban planning measure meant to keep the neighborhood, South Los Angeles, from being swallowed up by drive-though fast food restaurants. (A separate measure by the city provides economic incentives for new grocery stores and restaurants with table service.)

Fast food chains, he said, are like jellyfish in the ocean: with too many in one area, nothing else can thrive.

But he worries that the law could keep out places of more culinary interest. South Los Angeles has the best barbecue in the city, he said, and it has a growing number of cooks from Mexico and Central America making lamb barbacoa and pupusas. “Anytime you try to ban something, there’s a lot of bycatch,” he said.

The moratorium’s definition of a fast food business is any stand-alone restaurant that dispenses food, to stay or to go, and that has “a limited menu, items prepared in advance or prepared or heated quickly, no table orders, and food served in disposable wrapping or containers.” It is up to the city’s director of planning to decide which places fit that definition.

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August 16, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, August 15, 2008

Airborne Coughs Up Millions to Settle Suit

The Washington Post reports that Airborne Health will add $6.5 million to funds it has already agreed to pay to settle a related class-action lawsuit. That suit, which alleged that Airborne falsely claimed its products could cure or prevent colds, was settled earlier this year for $23.5 million.  Consumers who bought Airborne products between 2001 and 2008 have until Sept. 15 to apply for a refund for as many as six purchases, the FTC said. Claims will be paid by Oct. 15, 2008, the company said in a statement.  Annys Shin writes,

AirborneOver the past decade, millions of consumers, including Oprah, have come to swear by Airborne -- fizzy orange tablets containing vitamins, herbs and minerals that its makers for years said keeps cold germs at bay.

Gena Crowe of Fairfax says she doesn't get on a plane without it. "If I feel like a sore throat is coming on," she said, "it seems to take it away."

Airborne, however, when used as directed does not prevent class-action lawsuits, charges of deceptive advertising -- or, according to the government, the common cold.

"There is no credible evidence that Airborne products . . . will reduce the severity or duration of colds, or provide any tangible benefit for people who are exposed to germs in crowded places," said Lydia Parnes, director of the Federal Trade Commission's Bureau of Consumer Protection, which filed a complaint against Airborne's makers.

The remedy prescribed by the FTC is for Airborne to pay consumers back for as many as six purchases, a nationwide total of as much as $30 million.

Under a settlement announced yesterday, the privately held Airborne Health, based in Bonita Springs, Fla., will add $6.5 million to funds it has already agreed to pay to settle a related class-action lawsuit. That suit, which alleged that Airborne falsely claimed its products could cure or prevent colds, was settled earlier this year for $23.5 million. Consumers who bought Airborne products between 2001 and 2008 have until Sept. 15 to apply for a refund for as many as six purchases, the FTC said. Claims will be paid by Oct. 15, 2008, the company said in a statement.

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August 15, 2008 | Permalink | Comments (0) | TrackBack (0)

Amerigroup to Pay $225 Million to Settle Case

The Wall Street Journal reports that state and federal prosecutors said Thursday, August 14, 2008, that Amerigroup Corp. has agreed to pay $225 million to settle claims that it defrauded the Illinois Medicaid program.  Brent Kendall writes,

Amerigroup_corpThe federal government and the state of Illinois alleged that Amerigroup systematically avoided enrolling pregnant women and unhealthy patients in their Medicaid managed-care program in Illinois, which served low-income people.

By law, prosecutors said, Amerigroup was required to enroll all eligible beneficiaries.

A former Amerigroup employee was the first to file charges against the company, alleging that, in a bid to maximize profits, Amerigroup engaged in a calculated plan to discriminate against Medicaid-eligible patients with expensive medical conditions. Government lawyers later intervened in the whistleblower's case.

The whistleblower, Cleveland Tyson, will receive $56 million, a 25% share of the settlement.

Denying the charges, Amerigroup said it adopted its enrollment policies in response to state officials who expressed concern that the company was enrolling too many women who were late into their pregnancies.

An Illinois jury entered a $334 million judgment against Amerigroup in 2006, but the company, backed by insurance and business groups, filed an appeal.

Thursday's settlement, which formalizes an agreement reached on July 22, ends the case and in essence gives Amerigroup a 33% discount on the jury verdict.

Amerigroup Chairman James G. Carlson said the company settled the case to remove significant legal and financial uncertainties.

"Our responsibility to our shareholders, associates, members, providers and government partners is to close this chapter now and move toward the future," Mr. Carlson said.

August 15, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, August 14, 2008

After Donda West Death, California Senate Approves New Rule for Elective Surgery

The Los Angeles Times reports that as a result of rapper Kanye West's mother, who died of complications related to cosmetic surgery, a new measure has been passed in California that will require patients to be given physical exams before elective surgery.  Patrick McGreevy writes,

SurgeryAfter the death of rapper Kanye West's mother after plastic surgery, the state Senate today approved a requirement that patients be given a physical exam before elective surgery.

Sen. Mark Ridley-Thomas (D-Los Angeles) said the measure was in response to the 2007 death of Donda West, mother of the rap musician, of complications related to cosmetic surgery. The family believes that a physical exam would have uncovered coronary artery disease.
"Many of us are concerned about the quality of care extended to those who receive elective surgery," Ridley-Thomas said.

The vote on AB 2968 was 37 to 1.

August 14, 2008 | Permalink | Comments (0) | TrackBack (0)

Teens Cite Ease of Access To Drugs

The Washington Post reports that according to a survey published today, a growing number of teenagers say it's easier to illegally obtain prescription drugs than to buy beer.  Holly Watt writes,

Pills6The National Center on Addiction and Substance Abuse at Columbia University asked: "Which is easiest for someone your age to buy: cigarettes, beer, marijuana, or prescription drugs such as OxyContin, Percocet, Vicodin or Ritalin, without a prescription?" Nineteen percent of teenagers found it easier to purchase prescription drugs than cigarettes, beer or marijuana, compared with 13 percent a year ago. A quarter of the teens said it is easiest to buy marijuana, with 43 percent of 17-year-olds saying they could buy the drug in less than an hour.

The study also found that a large group of parents do not know where their children are in the evening and identified a group of "problem parents" whose actions increased the abuse of illegal and prescription drugs among 12-to-17-year-olds.

Joseph Califano, chairman and president of the center, said there are basic steps parents could take to avoid being "passive pushers." The statistics showed that 34 percent of teenagers abusing prescription drugs, like OxyContin and Vicodin, obtained them at home or from their parents. "Fifty years ago, people would lock up the liquor," he said in a telephone interview. "Maybe there should be a lock on the medicine cabinet now."

Elizabeth Planet, the center's director of special projects, who coordinated the study of 1,002 12-to-17-year-olds from April to June, highlighted the difference in behavior reported by parents and their children. "Half of the teenagers were saying they were out on school nights, but only 14 percent of the parents knew that they were out," she said. "There are lots of factors at play here. Parents are not paying attention. There are parents who are out in the evening themselves. There are parents out at work."

The correlation between allowing teens out late on school nights and the likelihood that people in their presence would be smoking and drinking was dramatic. Half of all teenagers allowed out after 10 p.m. said that they spent time with people smoking and using drugs, while 29 percent of those who returned home between 8 p.m. and 10 p.m. reported the same behavior.

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August 14, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, August 13, 2008

Women Battling Infertility Find a Friend in the Court

The Wall Street Journal reports that a federal appeals court in Chicago held that women who need time off work for infertility treatment may invoke the Pregnancy Discrimination Act as potential protection against adverse action. Sue Shellenbarger writes,

Pregnant_womanFor women struggling with infertility, the unpredictable and time-consuming treatment process can wreak havoc with work schedules, causing conflicts with bosses and triggering reprisals or layoffs. Now, a federal appeals court has come down on the side of women, fortifying legal protections on the job.

In the first decision of its kind at the federal appeals-court level, a three-judge panel in Chicago found women who need time off work for infertility treatment may invoke the Pregnancy Discrimination Act as potential protection against adverse action. The ruling came in a case involving Cheryl Hall, a secretary who was laid off after taking time off for in vitro fertilization, then asking for more. Without ruling on the merits of her case, the court last month set a precedent by giving Ms. Hall a green light to sue her former employer for pregnancy-related bias.

The erratic nature of infertility treatment can be frustrating for employers, interfering with planning, meetings and business travel. Some procedures require women to report to a clinic several days each month for blood tests or sonograms. Retrieving eggs from a woman's uterus is usually done with a general anesthetic, requiring recovery time. Some doctors order bed rest after embryos are transferred to the uterus. Women who have long commutes to work or a clinic, as Ms. Hall did, may need extended time off.

Ms. Hall's physician ordered her to stay in bed for several days after an embryo transfer in 2003; she took about 20 days off, court papers show. The procedure failed and she was approved for a second leave to try again; "my boss knew everything that was going on with me," Ms. Hall says in an interview. But her supervisors singled her out for layoff before the second leave, citing absenteeism for infertility treatments, court papers show.

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August 13, 2008 | Permalink | Comments (0) | TrackBack (0)

Biotech Campaigns for Easier Access to Generic Drug Market

The Washington Post reports on a Richmond firm that wants Congress to revamp the FDA approval process.  Kendra Marr writes,

Fda1Geoffrey Allan has been giving Congress a lesson in biotechnology.

He's explained protein structures and how they work. He's reviewed how drugs are absorbed into the body.

If lawmakers understand the difference between chemical and biologic drugs, Allan reasons, they'll be more invested in his cause: getting quick approval for generic biotech drugs. Today the generics market for chemical drugs like aspirin is booming, but there is no way to get cheaper copies of pricey biologics, for complex life-threatening diseases like cancer, into patients' hands.

Allan, who has worked in the drug industry for 28 years, has a lot at stake. As chief executive of Insmed -- a small Richmond biotech whose goal is to be the first U.S. company to develop a portfolio of biotech generics, or "biosimilars" -- his company's success rides on Congress overhauling the laws to permit competition that would result in lower biologic drug prices.

"You have to talk to people and educate people to expand the possibilities in this field," he said.

The difference between chemical and biologic drugs lies in manufacturing. Chemical drugs are small, simple molecules. Because these drugs are made with tightly controlled chemical recipes, a lab test can easily confirm that a generic such as acetaminophen is identical to the original product Tylenol.

Biologics are much larger and more complex. Biotech companies manipulate living cells into mini-factories to produce the desired molecules for drugs. Any divergence in production processes can change the entire function of the product, potentially jeopardizing patient safety. It's impossible to create perfectly identical products -- hence the term biosimilar -- and tricky to compare divergences.

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August 13, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, August 12, 2008

States Fail to Report Health Provider Sanctions

The Washington Post reports that many states fail to notify federal authorities once they have terminated health care providers out of their Medicaid programs, allowing these terminated providers to continue getting payments from federal health programs.  Kevin Freking writes,

Health_careIn violation of federal law, states routinely fail to notify federal authorities when they've kicked health care providers out of their Medicaid programs for incompetence, fraud and other reasons, government investigators have found.

The lack of notice makes it easier for barred providers to set up shop in other states and to continue getting payments from federal health programs.

The inspector general for the Health and Human Services Department maintains the list of health care providers prohibited from getting any federal health reimbursements. Last year, the IG's office added 3,308 people and organizations to that database, but probably could have added many more, according to a survey that investigators conducted recently.

Investigators surveyed the states to find out how often their Medicaid programs sanction a provider in a way that would in the vast majority of cases merit a spot in the IG's exclusion database. An astounding 61 percent of the 4,319 sanctions imposed by state Medicaid agencies in 2004 and 2005 could not be found in the federal database.

States with high match rates tended to be states that took action against more than 100 health care providers, though that wasn't always the case. Alabama, Louisiana and Texas had the highest match rates. More than 80 percent of the providers suspended from their state Medicaid programs could be found on the national list.

However, the two states that suspended the largest number of providers, New York and Florida, had the lowest matching rates, 21 percent and 9 percent respectively.

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August 12, 2008 | Permalink | Comments (0) | TrackBack (1)

California Lawmakers Weigh Ban on Chemical Found in Baby Bottles

The Los Angeles Times reports that California lawmakers are considering enacting restrictions on plastic baby bottles and infanct formula cans, which would require that all products or food containers designed for children 3 years and younger contain only trace amounts of the chemical, bisphenol A.  Samantha Young writes,

Baby_bottleResponding to growing consumer anxiety, California lawmakers are considering enacting what could be the first statewide restrictions on a chemical found in plastic baby bottles and infant formula cans.

The bill would require that all products or food containers designed for children 3 years and younger contain only trace amounts of the chemical, bisphenol A.
There is little dispute that bisphenol A can disrupt the hormonal system, but scientists differ on whether the very low amounts found in food and beverage containers can be harmful.

The National Toxicology Program, a partnership of federal health agencies, said in a recent draft report that there is "some concern" that the chemical can cause changes in behavior and the brain, and that it may reduce survival and birth weight in fetuses. The conclusion was based on animal studies.

However, the Food and Drug Administration's associate commissioner for science, Dr. Norris Alderson, told Congress in June that there was no reason for consumers to stop using products that contain the chemical.
Despite the uncertainty, consumer concern has prompted some governments and retailers to act.

Congress is considering legislation to ban it in children's products, and Canada has announced it intends to ban the use of the chemical in baby bottles.

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August 12, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, August 11, 2008

Half of Overweight Adults May be Heart-Healthy

The Washington Post reports on a new study finding that half of overweight adults have normal blood pressure and cholesterol levels, while an equal number of trim people suffer from some of the ills associated with obesity.  Lindsey Tanner writes,

Overweight_adultYou can look great in a swimsuit and still be a heart attack waiting to happen. And you can also be overweight and otherwise healthy. A new study suggests that a surprising number of overweight people - about half - have normal blood pressure and cholesterol levels, while an equally startling number of trim people suffer from some of the ills associated with obesity.

The first national estimate of its kind bolsters the argument that you can be hefty but still healthy, or at least healthier than has been believed.

The results also show that stereotypes about body size can be misleading, and that even "less voluptuous" people can have risk factors commonly associated with obesity, said study author MaryFran Sowers, a University of Michigan obesity researcher.

"We're really talking about taking a look with a very different lens" at weight and health risks, Sowers said.

In the study, about 51 percent of overweight adults, or roughly 36 million people nationwide, had mostly normal levels of blood pressure, cholesterol, blood fats called triglycerides and blood sugar.

Almost one-third of obese adults, or nearly 20 million people, also were in this healthy range, meaning that none or only one of those measures was abnormal.

Yet about a fourth of adults in the recommended-weight range had unhealthy levels of at least two of these measures. That means some 16 million of them are at risk for heart problems.

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August 11, 2008 | Permalink | Comments (0) | TrackBack (0)

New Focus on Children at AIDS Seminar

The New York Times reports that an independent, international study group urged governments and donors to develop new approaches to alleviate the plight of children in areas hard hit by the AIDS epidemic at the International AIDS Conference in Mexico.  Lawrence K. Altman writes,

Red_ribbonThe global response to the AIDS epidemic has short-changed children, health workers at the International AIDS Conference said here on Wednesday.

Although governments and donors provide large amounts of money for H.I.V. treatment in the developing world, too little of that money reaches children, said Linda Richter, a psychologist in South Africa who delivered the first plenary lecture on children in the history of the conference.

She also said that despite increased efforts to reach pregnant women, too few of them were receiving the antiretroviral drugs that could prevent infection in their infants.

And while the news media have often highlighted the plight of children who have lost parents to AIDS, Dr. Richter said, “children orphaned by AIDS are, sadly, only the tip of the iceberg of H.I.V.-affected children.”

All children in communities severely affected by H.I.V. require psychological, nutritional and other support, she said.

The conference, which ends Friday, is held every other year; this year there are more than 22,000 participants.

A report released at the conference by the Joint Learning Initiative on Children and H.I.V./AIDS, an independent, international study group, urged governments and donors to develop new approaches to alleviate the plight of children in areas hard hit by the epidemic.

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August 11, 2008 | Permalink | Comments (0) | TrackBack (0)

Health Care Costs Expected to Rise Ten Percent in 2009

The Washington Post reports on the expected increase in next year's health care costs.  Although health care costs are expected to rise more than ten percent, this increase is the lowest in six years.  Tom Murphy writes,

Health_care_2Health care costs are expected to rise more than 10 percent into next year, according to a survey of insurers by Aon Consulting Worldwide.

But that increase is the smallest Aon has seen in six years. Experts say it shows that efforts to tame costs, such as employee wellness or disease management programs, may be paying off.

"There's a variety of tactics that employers have been employing over the last 3 to 6 years that has had an impact on the market," said study director Bill Sharon, an Aon Consulting senior vice president.

Aon Consulting surveyed about 70 health insurers around the country, including companies such as Aetna Inc. and Cigna Corp. It found that actuaries expect costs to rise an average of 10.6 percent during 12-month rating periods starting this year between April and September.

That represents a slight drop from last year's forecast of 10.9 percent and a bigger fall from 2002, when health care costs were expected to rise by more than 16 percent.

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August 11, 2008 | Permalink | Comments (1) | TrackBack (0)