HealthLawProf Blog

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,

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.

Fluoroquinolones

This class of powerful antibiotics had a black box warning added to its résumé. The best-known is probably Cipro, produced by Bayer, which won fame in 2001 as an anthrax treatment, although it's mostly used for urinary tract infections. Another in wider use is Levaquin by Ortho-McNeil, used for respiratory infections.

The risks: Fluoroquinolones are associated with tendon problems, including tendinitis and, more seriously, ruptured tendons (usually the Achilles) that may require surgery and extensive rehab.

The connection is "not exactly intuitive," says Dr. Sidney Wolfe, director of health research at the consumer advocacy group Public Citizen, which campaigns actively on drug safety issues. Although no one can explain why the connection exists, evidence for it has been adding up for years, with problems often reported by patients who are over 60 or have had kidney, heart or lung transplants. This is a different group from those most apt to experience tendon troubles -- namely, thirtysomething jocks.

In the years that these drugs have been marketed, 407 ruptures were reported as of the end of 2007, as were 341 cases of tendinitis, according to Public Citizen. Adverse drug reactions are generally reported about 10% of the time, and in a case like this, where the drug is not a natural suspect, reporting may be even lower.

What happened: Public Citizen petitioned the FDA two years ago to require black box warnings on the professional labels for fluoroquinolones. The group also asked the agency to require medication guides highlighting the warning for consumers as well as "Dear Doctor" letters, alerts sent from drugmakers to doctors, advising them of the new warning. Since the FDA had not acted by January, the organization sued the agency.

Between 2001 and 2004, the FDA added warning information -- but not a black box warning -- to the professional labels provided to doctors for fluoroquinolones, updating the information in that warning as recently as 2007. The assumption is that doctors will discuss warnings with their patients. But injury reports persisted. So last month the agency decided to order black box warnings on the professional labels. It also ordered medication guides to tell patients about the new warning, and it sent out information sheets to more than 100,000 physicians and 170 medical organizations to let them know. It did not order drug makers to send Dear Doctor letters.

Will a black box warning be useful? Though some fluoroquinolone-associated ruptures occur suddenly, many are preceded by a week or two of discomfort. This implies that forewarned patients can quite possibly forestall injury if they stop taking the drug when they notice something is wrong, as the FDA advises on its professional labels. But the FDA and patient advocate groups have been concerned that not enough patients were heeding, or even noticing, earlier, lesser warnings.

"This risk has been around for a long time, and doctors know about it," says Dr. Paul Seligman, director of the FDA's safety policy and communications staff. "We needed to get patients more aware and engaged."

Will a black box warning be harmful? No one seems to think so. The FDA suggests patients switch to another antibiotic at the first sign of trouble.

Should the FDA have done more? Wolfe says the agency should have ordered Dear Doctor letters because that's the only way to be sure all doctors will know about the black box warning.

But -- speaking on his own, not on behalf of the FDA -- Seligman says black box warnings plus medication guides are sufficient and may be more effective than Dear Doctor letters. "Medication guides go out with a prescription every time it's refilled. That makes sure patients see it," he says. "Dear Doctor letters just go out once."

Dr. Frances Richmond, director of the School of Pharmacy Regulatory Science program at USC, sees why the FDA drew the line where it did. The black box warning already tells doctors to be very careful, she says. But the agency has to be careful not to get "real excited" too often. "Doctors will pay more attention to Dear Doctor letters if they just come out on occasion so they sort of imply, 'Oh, my God, this is something terrible.' "

Antiepileptic drugs

Among the drugs under review by an advisory committee to the FDA were Lyrica, produced by Pfizer; Depakote, produced by Abbott Laboratories; and Topamax, produced by Johnson & Johnson. Although classified as antiepileptic drugs, they are also prescribed for psychiatric disorders, such as bipolar disorder, as well as other medical conditions.

The risks: An analysis of 199 placebo-controlled trials of 11 drugs with a total of almost 28,000 patients found that these drugs were associated with an increased risk of suicidality (suicidal behavior or suicidal thoughts): 0.37% of patients taking one of the drugs had an incident of suicidality compared with 0.24% of patients taking placebos. Most of these incidents were suicidal thoughts, although four suicides occurred, all by patients taking a drug.

Patients taking the drugs for epilepsy were about twice as likely to have incidents of suicidality as those taking them for other reasons.

What happened: The advisory committee recommended to the FDA that medication guides should be provided to patients for all antiepileptic drugs that are taken long-term -- not just those included in the analysis -- but that a black box warning should not be required. The FDA doesn't have to follow a committee's advice but usually does.

Would a black box warning be useful or harmful? Requiring a black box warning could have "unreasonable" effects, says Dr. Larry Goldstein, a professor of medicine at Duke University and acting chairman of the antiepileptic drug advisory committee. "It could make people so afraid of using the drug that patients who should be treated wouldn't be treated."

Though this is a concern held by many doctors, Wolfe thinks it's unfounded. He says most patients would use the information to their advantage, by switching to another drug or staying in touch with their doctors or counselors.

A study published this year in the Archives of General Psychiatry may have bearing on this question. It looked at the effects of a black box warning about the risk of suicidality in youths taking antidepressants.

The FDA required the warning to be added to professional labels in October 2004, after evidence was found of increased suicidal thinking and behavior early in the treatment of patients ages 18 to 24 taking certain antidepressants. (The risk was a lot higher than the risk associated with antiepileptics, Seligman says.)

The study of black box effects found that from the time the warning was ordered until the end of 2005, antidepressant use by youths fell about 10% a year. "The effects were not as large as some psychiatrists, especially child psychiatrists, had feared," says lead author Dr. Mark Olfson, professor of clinical psychiatry at Columbia University. But he says the study can't answer "the important question concerning the trade-offs between unnecessarily exposing a child to a small increased risk of suicidality and the risk of doing nothing for a child impaired by depression."

"These warnings," Olfson says, "have a potential for both benefit and harm."

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,

A 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.

That could keep out people like Sue Moore, who sells a high-quality hot dog from cattle raised on pasture, served with fresh grilled onions on top. She was invited to park her Let’s Be Frank truck at the premiere of “Star Wars: The Clone Wars” this week at the Egyptian Theater in Hollywood.

She and her partner, Larry Bain, who runs two hot dog carts in San Francisco, say that there’s nothing wrong with fast food if it’s made with good ingredients. They worry that their dogs will be shunned along with dogs made from lesser ingredients.

“Our policy makers abhor nuance and the subtle but distinct qualities that differentiate fast food from food that can be served fast,” said Mr. Bain.

The councilwoman behind the moratorium, Jan Perry, says its intent is not to crush food choices, but to encourage variety and give residents more nutritious options. Making healthy decisions about food is difficult when people have small incomes, the grocery store is five miles away and a $1 cheeseburger is right around the corner, she and supporters of the ban say.

The moratorium doesn’t mean that people who live within the affected 32-square-mile zone will be cut off from the pleasures of an inexpensive cheeseburger and hot fries. More than 45 percent of the 900 restaurants there — the highest concentration in the city — are fast food chains.

The idea is to bring new eating options to the city’s food deserts, the term now in vogue to describe poor neighborhoods whose residents have few places to buy fresh groceries.

“People do not understand what happens in a disenfranchised community,” said Councilwoman Perry, who represents neighborhoods in the area. “The fact remains, there are not a lot of food choices in South L.A.”

Since there is not much land left to develop in the area, the moratorium will allow city planners time to determine what kinds of businesses would be best in an area where rates of obesity and diseases related to it are disproportionately high.

“Anybody who believes fast food is the source of all dietary evil is, of course, being naïve,” she said. Other facets of modern life contribute to obesity. People drive more than they walk. Children play video games more often than stickball. And daily life has become saturated with opportunities to eat.

Continue reading "Los Angeles Stages a Fast Food Intervention"

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,

Over 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.

Airborne said it had already begun to change its packaging and marketing language. "It's important to note that this is a settlement over older advertising and labeling, and has nothing to do with public safety," said Airborne chief executive Elise Donahue. "We've offered a money-back guarantee for our products since 1997, and we have millions of satisfied customers. A class-action lawsuit sparked this matter. We're just one of many major consumer brands across America that are under assault by class-action lawyers."

Steven Gardner, director of litigation for the Center for Science in the Public Interest, a Washington advocacy group that was part of the class-action suit, vouched for the change but said it doesn't get Airborne off the hook.

"The fact they got away with it for years is not a reason they should not be held responsible for it," he said.

Three of the FTC's four commissioners voted to approve the deal. Commissioner Thomas Rosch dissented, saying the FTC should not have let Airborne use its existing inventory of paper cartons and display trays until Oct. 31, 2008, for fear of continuing to "perpetuate misperceptions" about the products.

The government's allegations of deceptive advertising have not hurt Airborne's standing with some local customers.

"Even if Airborne isn't doing anything for you, believing it helps," said microbiologist Stephanie Scovel-Toney, 28, of Fredericksburg.

"It may be mental, but it works for me," said Robin Roane, 46, manager of an Alexandria nonprofit. "I can't tell you the last time I had a cold."

Such responses don't surprise Gardner. "It is pretty much impossible to prove that it didn't prevent a cold if you don't get a cold," he said.

Airborne hit the market in the late 1990s with a bright yellow box and a testimonial that was hard to beat. Its creator was Victoria Knight-McDowell, a second-grade teacher near Carmel, Calif., who got tired of catching colds from her students.

She started selling in 1997, three after Congress voted to allow dietary supplement makers to claim their products have an effect on a body structure or function, such as the immune system. However, they can't claim to cure or treat illnesses without FDA approval.

The notion that a school teacher found a way to stave off germs from runny-nosed 7-year-olds proved to be advertising gold. Soon, Airborne-and-water cocktails became a favorite in-flight beverage for frequent fliers. Annual sales jumped from $21.4 million to more than $100 million in one year after Knight-McDowell appeared on "The Oprah Winfrey Show" in 2004.

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,

The 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.

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,

After 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.

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,

The 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.

Califano recommended family dinners as a simple way of decreasing the chances of drug abuse, noting that 23 percent of teens who ate fewer than three dinners a week with their family had used marijuana, compared with 10 percent when the family ate together five or more times a week.

Stephen Pasierb, the president of Partnership for a Drug-Free America, cited a lack of understanding between the generations, with parents not understanding the risks surrounding prescription drugs, in particular. "This is a very different generation of children," he said. "Prescription drugs are entrenched, and they have not moved for five years, and this generation of parents simply do not understand the problem."

Nora Volkow, the director of the National Institute on Drug Abuse, said that drug abuse has declined over the last six years, but the abuse of prescription medicine is a serious concern.

"Kids think that because these are medicines that are prescribed, they are safe," she said. "The problem is that there is very little difference between the amount they take for a high and the amount that causes an overdose."

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,

For 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.

Courts in other cases have held that because both men and women experience infertility, sex-bias protections don't apply. In this case, the court held that because only women undergo time-consuming in vitro fertilization, they may be protected by sex-bias law. Treatment for men usually takes less time.

The ruling suggests women will have to worry less about the "repercussions of taking time off for IVF," says Eugene Hollander, Ms. Hall's attorney. A spokesman for Ms. Hall's former employer, Nalco, declined to comment on the case, but it said the company is committed to treating all employees fairly. Nalco is seeking a re-hearing before a full 11-judge panel of the court. While the decision applies only in Indiana, Illinois and Wisconsin, it could influence other courts or, if a conflict arises, trigger a Supreme Court petition.

The ruling expands a trend toward recognizing infertility as a medical problem; 13 states have laws mandating insurance plans to pay for in vitro fertilization, says the Pacific Research Institute, a think tank. Also, more employees are seeking time off for treatment under the federal Family and Medical Leave Act; this law, which entitles covered workers to up to 12 weeks' unpaid time off, may apply in some cases if a doctor certifies the treatment is for a serious health condition.

Although the ruling would seem to clear the way for employees to disclose infertility treatment at work, most women keep it secret for personal reasons, assuming they have enough job flexibility to do so. Heather Gaillard, Alexandria, Va., who underwent treatment on a former job as a university administrator, says secrecy "made it easier for me to just do my job instead of having people wonder if I was pregnant, wonder if I was going to leave, etc." She cited unspecified "medical reasons" for time off and worked late to make it up.

The only reason most women disclose the procedure is to explain their absences. Susan Derex Murphy, a Skokie, Ill., teacher, told her school principal about her treatment. Getting to work after early-morning blood tests and sonograms "was always a race against the clock," she says. Sometimes, "I'd come in late or with a bad result and be in tears."

The reward, however, was worth the struggle: The birth of a daughter.

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,

Geoffrey 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.

Last month, Insmed demonstrated that its version of Neupogen, which stimulates white blood cell growth, was equivalent in 32 healthy volunteers to the original product from Amgen. But, for Insmed's version, there is no pathway for approval. And some argue the process should be different than for chemical drugs.

"With a biosimilar, that's not enough," said Andrew Fox, Amgen's director of regulatory affairs. "You need to go into larger trials for safety and efficacy. Insmed's limited data appeared to be good data. However, bioequivalence testing in healthy volunteers does not provide the necessary data on how the biologic actually works in the body, which can only be determined through more extensive clinical testing in patients where safety and efficacy are evaluated."

Two decades ago, as prices for chemical drugs skyrocketed, Congress passed the Hatch-Waxman Act, which opened the doors for generic competition after patent expiration. Once a company demonstrates that its generic is chemically identical to a brand-name drug, it can use the approval of the brand-name drug as evidence that its copycat works just as well without additional human trials.

When the Hatch-Waxman Act passed, the biotech industry was young, and lawmakers didn't think to give the Food and Drug Administration an abbreviated review process to swiftly approve biosimilars. Now, escalating health-care expenditures have prompted Congress to consider one. Last year, two bills were introduced into the House and are still pending. Then, in March, representatives drafted yet another.

A recent Congressional Budget Office analysis of a Senate bill, which passed unanimously last year in committee, found that biosimilar competition would reduce expenditures on biologics by about $200 million by 2013 and about $25 billion by 2018. These savings would represent about 0.5 percent of national spending on prescription drugs, at wholesale prices, over the next decade.

Continue reading "Biotech Campaigns for Easier Access to Generic Drug Market"

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,

In 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.

About a dozen states submitted incomplete data or reported not taking any action against health care providers in 2004 and 2005. Among them were California and Michigan, two states with large Medicaid populations.

Jeff Nelligan, a spokesman for the Centers for Medicare and Medicaid Services, said the agency agrees there's room to increase the number of referrals from the states. It will "strive to reduce the barriers that may currently exist," he added.

In all, 47 states responded to the survey. State officials frequently said they were unclear about what kind of information was supposed to be forwarded to the HHS inspector general.

"It would be handy to have a little cheat sheet that clearly stated refer these cases with this info," an unidentified state official wrote.

Another state official wrote that until they had responded to the inspector general's survey, "no coordinated effort existed ... to make referrals."

Reasons for exclusion from federal health programs include convictions for fraud and patient abuse, licensing board sanctions and default on federal health education loans. Under law, no federal payment can be made for anything that an excluded person furnishes, orders or prescribes.

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,

Responding 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.

Wal-Mart Stores Inc. and Toys "R'' Us Inc. say they will stop selling baby bottles made with the chemical next year, and the maker of the hard-plastic Nalgene water bottles announced in April that it would stop using the chemical.

At least 11 other states have considered bills to restrict it.

California's bill was approved earlier this year by the state Senate and it is awaiting a vote by the Assembly. It's not yet clear whether Gov. Arnold Schwarzenegger will sign it if the Legislature sends it to him.

The bill's author, state Sen. Carole Migden, said California is simply following in the footsteps of retailers that are voluntarily pulling products from store shelves.

"I think manufacturers who make money should do all they can to make their products safe," said Migden, D-San Francisco. "This is just one step. It ought to be banned for everything."

Bisphenol A is found in dental sealants, the linings of food cans, CDs and DVDs, eyeglasses and hundreds of other household goods. The chemical industry, grocery retailers, bottled water companies and food processors say it has been used safely for more than 50 years.

A spokeswoman for the canned goods industry said the California bill is vague and could lead to unintended consequences. It could lead to a blanket ban on some canned foods, since their containers often have bisphenol A in their linings, and parents might blend the contents to feed infants, said Colleen Coghlan, spokeswoman for the Washington, D.C.-based Can Manufacturers Institute, which opposes the bill.

The American Chemistry Council also has been lobbying against it. "Many common, everyday products could disappear from grocery stores all across California," says a mailer sent out by the council.

Migden responded to the advertising blitz by amending her bill to emphasize that food and beverage containers designed for the general population would not be affected.

She said only manufacturers of baby food and beverages intended for young children would have to reduce the chemical in their packaging to 0.5 parts per billion by 2012, a standard now being met in Japan. Baby bottles and cups could have just 0.1 parts per billion or less of the chemical beginning Jan. 1.

None of the bills considered in 11 other states has passed so far, said Scott Hendrick, a policy associate at the National Conference of State Legislatures who is tracking the legislation.

In Maryland, a bill by Del. James Hubbard stalled in committee after what supporters described as heavy lobbying from the chemical industry. "I think they've been discredited now," Hubbard said, referring to opponents.

The Minnesota Legislature came close to approving a bisphenol A ban this year as part of a broader chemical bill. Bisphenol A was removed from the legislation after Gov. Tim Pawlenty expressed reservations, said Lindsay Dahl, coordinator of Health Legacy, a coalition of public health groups based in Minnesota. Pawlenty eventually vetoed the slimmed-down version of the law.

Schwarzenegger signed legislation last year banning a common chemical known as phthalates in baby products and toys. But he told lawmakers at the time that a "product-by-product" ban was not the most effective way to craft state policy on potentially unsafe chemicals.

The Schwarzenegger administration created a "green chemistry" initiative in 2007 to study how California should regulate chemicals, an approach favored by industry and many scientists.

Megan Schwarzman, a San Francisco family physician and research scientist at the University of California, Berkeley, endorses Schwarzenegger's comprehensive approach. But she says bisphenol A should be restricted immediately because of its potential effects on children.

"We should definitely take steps to limit our exposure to the substance," Schwarzman said. "Anything we can do to reduce bisphenol A could potentially have big payoffs to protecting human health."

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,

You 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.

It's no secret that thin people can develop heart-related problems and that fat people often do not. But that millions defy the stereotypes will come as a surprise to many people, Sowers said.

Even so, there's growing debate about the accuracy of the standard method of calculating whether someone is overweight. Health officials rely on the body mass index, a weight-height ratio that does not distinguish between fat and lean tissue. The limits of that method were highlighted a few years ago when it was reported that the system would put nearly half of NBA players in the overweight category.

A number of experts say waist size is a more accurate way of determining someone's health risks, and the study results support that argument.

Dr. Robert Eckel, a former American Heart Association president and professor of medicine at the University of Colorado, said the new research may help dismiss some of the generalizations that are sometimes made about weight and health.

Study co-author Judith Wylie-Rosett emphasized that the study shouldn't send the message "that we don't need to worry about weight." That's because half of overweight people do face elevated risks for heart disease, explained Wylie-Rosett, a nutrition researcher at Albert Einstein College of Medicine in New York.

Continue reading "Half of Overweight Adults May be Heart-Healthy"

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,

The 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.

Dr. Jim Yong Kim of Harvard University said that about 6 percent to 10 percent of children needing therapy were receiving it, compared with 30 percent of adults. An important factor, Dr. Richter said, is that too few infants are being tested for the infection.

Michel Sidibe, an official of the United Nations AIDS program, said that 1.5 million children had died of AIDS in the past five years and that 15 million children had lost one or both parents to AIDS, the United Nations definition of an orphan. An estimated 2 million children under the age of 15 are living with H.I.V.

Dr. Richter said that in the developing world much of the money for children in AIDS programs went to consultants and overhead costs.

It would be more effective, and more efficient, to give money directly to families and communities, she said, adding that poor people have shown that they make good decisions about getting food and other provisions. In some cases, she said, mothers are unable to take their children for medical care because of financial barriers, including being able to pay the bus fare to treatment centers.

Other speakers said that children would also be better helped by examining the dynamics of families. Studies in Botswana and Tanzania that were cited at a news conference showed that men were often unwilling to care for the sick except when women were unavailable. Over all, the speakers said, at least two-thirds of those giving care to infected people in Africa are women and girls.

Lorraine Sherr of University College London, meanwhile, said that more needed to be done to help families cope psychologically after AIDS deaths. She said she could find only 16 published studies on bereavement in the developing world among those affected by AIDS and that in discussing fathers in affected families, researchers reported only on those who had died.

“We need to know about live fathers,” Professor Sherr said.

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 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.

But the percentage likely won't be what the average employee faces for a premium hike next year. It doesn't reflect insurance plan designs or changes an employer might make to benefits plans.

"Pretty much every employer has to do something or is doing something in an effort to bring that number down," Sharon said.

He said actual cost increases have wound up being three to four percentage points lower than preliminary estimates in the past couple of years. Still, he said Aon Consulting's survey gives employers a benchmark to use as they consider premium renewals.

Many employers have started researching their benefit options for 2009. Consultants say it's too early for predictions on next year's health care plan costs.

But Ken Ambos of Equity Risk Partners Inc. said midsize employers could see a cost increase of roughly 9 to 12 percent that they pare down to 6 to 9 percent. Equity Risk Partners is a risk management and employee benefits consulting firm

Costs are still rising to keep up with growing patient demand for services, the needs of an aging population and prescription drug and technology costs, according to Aon Consulting, a subsidiary of Aon Corp.

Overuse and misuse of services and an "out-of-control medical liability system" also contribute to increases, said Robert Zirkelbach of America's Health Insurance Plans, a trade association representing nearly 1,300 insurers.

"It is encouraging that the growth in health care costs is going down, but there is still more work to be done," he said.

Zirkelbach said health insurers have offered disease management programs and encouraged the use of cheaper generic drugs to help contain costs.

Employer wellness programs also have played a role, Sharon said. He noted that doctors, hospitals and employers all have worked to curb costs.

"When costs go up as great as this, there's a lot of market pressure brought to bear on all of the parts of the market to bring those costs down, and I think that's what's been happening over the last six years or so," he said.

Aon Consulting has forecast a steady decline in cost increases since 2002. But Sharon said this decline has grown smaller the past few years, a sign the reductions may be bottoming out.