Thursday, August 21, 2008
The New York Times reports that for the first time the FDA has allowed produce to be irradiated at levels needed to protect against illness causing one of the most significant food safety actions done for fresh produce in many years. Gardiner Harris writes,
The government will allow food producers to zap fresh spinach and iceberg lettuce with enough radiation to kill micro-organisms like E. coli and salmonella that for decades have caused widespread illness among consumers.
It is the first time the Food and Drug Administration has allowed any produce to be irradiated at levels needed to protect against illness.
“This is probably one of the single most significant food safety actions done for fresh produce in many years,” said Robert Brackett, chief scientist for the Grocery Manufacturers Association, which petitioned the agency in 2000 to allow manufacturers to irradiate a wide variety of processed meats, fruits and vegetables and prepared foods.
Advocates for food safety condemned the agency’s decision and asserted that irradiation could lower nutritional value, create unsafe chemicals and ruin taste.
“It’s a total cop-out,” said Patty Lovera, assistant director of Food and Water Watch. “They don’t have the resources, the authority or the political will to really protect consumers from unsafe food.”
Dr. Laura Tarantino, director of the Office of Food Additive Safety at the F.D.A., said the agency had found no serious nutritional or safety changes associated with irradiation of spinach or lettuce.
“These irradiated foods are not less safe than others,” Dr. Tarantino said, “and the doses are effective in reducing the level of disease-causing micro-organisms.”
The Washington Post reports that several university officials across the nation are encouraging a lower drinking age in an effort to lower alcohol abuse. Susan Kinzie and James Hohmann writes,
On the face of it, the notion seems counterintuitive, but to the presidents of some of the nation's most prestigious colleges, it makes a lot of sense: Lowering the legal drinking age might get students to drink less.
But any chance for the academic leaders to begin a public discussion of their theory -- that allowing people as young as 18 to drink legally might promote moderation -- has been lost in a wave of criticism from health experts, transportation officials, government leaders and opponents of drunken driving.
Safety advocates say the legal drinking age of 21 saves about 900 lives every year. And Laura Dean-Mooney, president of Mothers Against Drunk Driving, said people look to college presidents "for their leadership role on their campuses. It just seems like they didn't do enough homework to look at the science on this."
Other critics said the university leaders are trying to avoid being held liable for enforcing the drinking age and are kicking the problem to others. "I'm an alumnus of Dickinson College and can't believe they signed on to this initiative," said Jonathan Adkins, a spokesman for the Governors Highway Safety Association. "They are really just punting on the issue and leaving the high school principals to deal with it. Very disappointing."
Wednesday, August 20, 2008
The Washington Post reports that the Library of Congress is being sued in a sex discrimination case after a former Army commander says an official at the Library of Congress rescinded a job offer upon learning she was making the medical transition from being a man to being a woman. Del Quentin Wilber writes,
Diane Schroer, a 52-year-old former Army Special Forces commander, testified yesterday in federal court that she was "disappointed and dismayed" when an official at the Library of Congress rescinded a job offer even though she was the star candidate.
The offer, for a job as a terrorism research analyst, was pulled the day after Schroer told her future boss that she was making the medical transition from being a man, David, to being a woman, Diane.
"I honestly felt a little surprised and shocked," Schroer testified during the first day of the trial in her discrimination lawsuit against the Library of Congress. Choking back tears, Schroer added that "every day, I wish the phone rang and they said, 'We made a mistake.' "
Schroer, who has completed the medical process of becoming a woman, is pursuing a sex discrimination case against the Library of Congress under the Civil Rights Act. The bench trial before U.S. District Judge James Robertson is expected to last about a week, and a ruling might not come until well after that, while the judge considers the facts of the case, as well as arguments over the reach of the law.
The Washington Post reports on a study finding that rising medical costs and lack of insurance are causing more Americans to either forego medical care or accumulate medical debt. Sopan Joshi writes,
"A perfect storm of negative economic trends is battering working families across the United States," said the survey by the Commonwealth Fund, a private foundation that supports independent research on health care.
"Health-care costs are climbing much more rapidly than incomes or the growth in the overall economy," said Sara R. Collins, assistant vice president of the foundation and one of the authors of the study. As gas and food prices have soared and real estate values have fallen, the federal minimum wage is now $3 an hour lower, in real terms, than it was 40 years ago, the study said.
"What is notable is how these problems are spreading up the income scale," Collins said.
Two-thirds of the working-age population was uninsured, underinsured, reported a medical bill problem or did not get needed health care because of cost in 2007.
More than two in five adults in the 19-to-64 age group reported problems paying medical bills or had accumulated medical debt in 2007, up from one in three in 2005. Their difficulties included not being able to afford medical attention when needed, running up medical debts, dealing with collection agencies about unpaid bills, or having to change their lifestyle to repay medical debts.
Tuesday, August 19, 2008
The Los Angeles Times reports that eighteen hospitals in California were fined for state health code violations in which patients received shoddy care that in some cases led to deaths. Shaya Tayefe Mohajer writes,
The fines made public Monday stem from investigations by the California Department of Public Health.
The hospitals were fined $25,000 for each violation — the latest of dozens of penalties the state has issued in recent years to more than 40 hospitals.
"The number of penalties will decrease and the quality of care will dramatically improve as hospitals take action to improve," said Kathleen Billingsley, director of the health department's Center for Healthcare Quality. "The entire intent of these fines is to improve the overall quality of care in California."
The Washington Post reports that a new study shows performing an angioplasty via the wrist can significantly lower the risk of bleeding and discomfort for some patients. Lauren Neergaard writes,
The best path to a clogged heart may be through the wrist. About a million artery-clearing angioplasties are performed in the United States each year, and the usual route is to thread a tube to the heart through an artery in the groin.
Now a major study shows going through the wrist instead can significantly lower the risk of bleeding - without the discomfort of lying flat for hours while the incision site seals up.
Just one in 100 angioplasties is done via the wrist, and the approach isn't for everyone. But Monday's study promises to spur more specialists to use the method.
Monday, August 18, 2008
The Los Angeles Times reports that federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings. Matthew Perrone writes,
The Food and Drug Administration said Monday it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.
Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.
The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. None of those cases were fatal, but Byetta's makers agreed to add information about the reports to the drug's label.
However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.Amylin and Eli Lilly said in a statement that patients taking Byetta have shown "very rare case reports of pancreatitis with complications or with a fatal outcome." The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients. The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.
The FDA said doctors should consider prescribing other medications to patients with a history of pancreas problems.
The New York Times reports that the focus during the International AIDS conference in Mexico this year was particularly on the longer haul, with stronger advocacy and financing to advance prevention and treatment. Lawrence K. Altman writes,
Two years have passed since the 16th International AIDS Conference in Toronto, and the contrast between that meeting and the 17th, which ended here this month, was humbling.
Though the meeting this month had its circuslike elements, the mood was much more sober. No major breakthroughs were announced, and cutting-edge research findings were rare. The great strides that many researchers thought they were on the verge of making in 2006 — in vaccines, microbicides and herpes-suppressive drugs to reduce H.I.V. transmission — have failed to materialize.
The focus here was on the longer haul. There were renewed calls for strong advocacy and financing to sustain gains already made, like promoting more antiretroviral therapy in poorer countries, along with male circumcision and behavior modification.
While Mr. Gates did not attend, Mr. Clinton did. He called the conferences important in part “because they enable us to measure our progress since the last meeting, to openly acknowledge continuing problems, to evaluate the positive and negative new developments.”
With no magic bullet in sight, he said, the need now is to combine efforts to advance prevention and treatment.
Sunday, August 17, 2008
The Wall Street Journal reports that the Minnesota Supreme Court on Thursday, August 14, 2008, said a federal judge has little leeway to review or reject a stock-options backdating settlement between UnitedHealth Group Inc. and former Chief Executive William McGuire, increasing the likelihood that the deal will be approved. Vanessa Fuhrmans writes,
Dr. McGuire agreed in December to forfeit about $420 million of stock-option gains and retirement pay to settle shareholder and Securities and Exchange Commission complaints related to how stock-options were awarded by the Minnetonka, Minn., health-insurer.
But U.S. District Judge James Rosenbaum delayed finalizing the agreement when he asked the state's highest court to clarify how much power he had to review its merits.
In particular, he asked how much deference should be given to a special litigation committee appointed by UnitedHealth's board to review shareholder claims filed on the company's behalf.
In its reply to Judge Rosenbaum, the Supreme Court said that under state law, a court must defer to a special litigation committee's decision to settle such suits if it is clear that the panel's members are independent and impartial and that its "investigative procedures and methodologies were adequate, appropriate, and pursued in good faith."
Before signing off on the deal, Judge Rosenbaum still has the discretion to determine whether the committee meets those criteria.
The panel, however, comprises two former Minnesota Supreme Court justices whom the court noted were "individuals drawn from far outside the corporate ranks."
The New York Times reports that the FDA has concluded that the trace amounts of bisphenol A found in food containers are not a threat to infants or adults. The New York Times writes,
Despite safety concerns of parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday.
Scientists at the Food and Drug Administration said the trace amounts of bisphenol A that leach out of food containers were not a threat to infants or adults. The plastic-hardening chemical is used to seal canned food and make shatterproof bottles.
The agency’s draft report is the latest in a growing pile of assessments of bisphenol, which has been used to package food for decades.
The agency previously declared the chemical safe, but agreed to revisit that opinion after a report by the federal National Toxicology Program said that there was “some concern” about its risks in infants.
Based on a review of animal studies, the government working group said bisphenol could cause changes in behavior and the brain, and that it might reduce survival and birth weight in fetuses.
About 93 percent of Americans have traces of bisphenol in their urine, according to the Centers for Disease Control and Prevention.
But the F.D.A.’s report concluded that those levels were thousands of times below what would actually be dangerous to adults or children.
Saturday, August 16, 2008
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.
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.
Friday, August 15, 2008
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.
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.
Thursday, August 14, 2008
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.
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.
Wednesday, August 13, 2008
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.
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.
Tuesday, August 12, 2008
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.
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.