July 19, 2008
U.S. Hits Weight Marker: 1 in 4 Officially Obese
The Chicago Tribune and the Washington Post report on the Centers for Disease Control and Prevention's newest study regarding American obesity. Mississippi remains the most obese state. Deborah L. Shelton, Judith Graham and Robert Mitchum for the Chicago Tribune write,
Americans, who have been getting fatter for decades, reached an unwelcome milestone in a report released Thursday: More than one in four of us are obese.
The U.S. Centers for Disease Control and Prevention reported that the number of adults who say they are obese jumped 2 percent between 2005 and 2007—from 23.9 percent in 2005 to 25.6 percent in 2007. That doesn't include people who are overweight.
A different CDC survey—a gold-standard project in which researchers actually weigh and measure survey respondents—put the adult obesity rate at 33 percent for adult men and 35 percent for adult women in 2005 and 2006.
"It's alarming," said Dr. Robert Kushner, professor of medicine at Northwestern University's Feinberg School of Medicine and an expert on obesity, fitness and lifestyle. "As a country, it means we have a whole population of individuals developing increased risk for chronic illness—diabetes, high blood pressure, heart disease, stroke, cancer. All of these are related to obesity."
Obesity is defined as a body mass index (a measure of weight related to height) of 30 or more. For a 5 foot, 4 inch tall person, that means carrying an extra 30 pounds.
In Illinois, 24.9 percent of adults were obese in 2007, up from 24.3 percent in 2005. That compares to about 10 to 14 percent of adults in the state in 1990. As a region, the Midwest (25.3 percent) stands just behind the South (27 percent) as housing the most obese adults in the U.S.
The CDC findings, published in Thursday's Morbidity and Mortality Weekly Report, provided the latest state-by-state data from the agency's Behavioral Risk Factor Surveillance System.
The fact that rates differ by state suggests that environment plays a major role, said Dr. David Shoham, assistant professor of preventive medicine and epidemiology at Loyola University Stritch School of Medicine. Environmental factors include lack of affordable, healthy foods and safe places to exercise.
Oak Park resident Stephanie Salas, 36, has struggled with obesity her entire life.
Salas grew up eating convenience foods and watching TV. Her brother has struggled with his weight and has been diagnosed with diabetes.
"I had tried absolutely everything—every fad diet, everything in a pill, everything in a bottle, everything off the TV—and nothing worked," Salas said.
At University of Illinois at Chicago, Salas met with a team of health professionals who helped her get her weight under control. She lost 80 pounds over the last year through diet and exercise and other lifestyle changes.
"I truly have become a different person, physically, mentally and spiritually," Salas said. "I'm not depressed, and I don't feel sorry for myself any more."
Click here to read the Washington Post's article: "Mississippi remains most obese state, CDC reports"
Your Shower Curtain Might Be Bad for You
US News reports on a study indicating that PVC-containing shower curtains may be harmful to health. Adam Voiland writes,
As part of an ongoing campaign against polyvinyl chloride, a Virginia-based environmental advocacy group today called on manufacturers and retailers to phase out its use in shower curtains. To buttress its case, the group, the Center for Health, Environment and Justice, released the results of a small study indicating that PVC-containing shower curtains are capable of emitting scores of volatile organic compounds, as well as phthalates, lead, and other potentially harmful materials, into people’s bathrooms. A previous study, conducted by Environmental Protection Agency researchers, also found that plastic shower curtains can emit toxic compounds into the air.
There’s still debate among scientists about just how serious the health effects are that have been associated with exposure to some of the chemicals highlighted as dangerous, especially at low doses. However, CHEJ, which has particularly strong concerns about the environmental and health toll in communities with factories that manufacture PVC, urges consumers to avoid using PVC shower curtains, as well as many other PVC products, particularly those that are flexible.
For people who are concerned about their shower curtains, there are alternatives. IKEA phased out PVC shower curtains 11 years ago, switching to ethylene vinyl acetate. Target, the country’s fifth-largest retailer, has also committed to replacing many of its shower curtains with EVA. The company has said that 88 percent of its shower curtains would be PVC free by spring of 2008. Bed Bath and Beyond, JCPenney, and Macy’s are shifting toward PVC-free shower curtains, according to the report, but have not set goals or a time frame for completely eliminating the products.
Manufacturers are not required to label shower curtains, but some do list “PVC” or “vinyl” on the packaging. The recycling code “3” or sometimes “V” also indicates the presence of polyvinyl chloride. Numerous online retailers, such as EcoChoices, Pristine Planet, and Greenfeet, sell shower curtains--primarily cotton or hemp--that are free of PVC. Without good ventilation, however, mildew can be a problem with cotton and hemp products. In response to such problems, Healthgoods sells a recycled polyester plastic shower curtain that it claims is superior to the fabric options.
For a comprehensive list of other products that may contain PVC, you can check this compilation from CHEJ. In the past, U.S. News has written about other problematic chemicals in certain plastics, such as phthalates and bisphenol A. Here’s how you can avoid the former, as well as the latter.
July 18, 2008
F.D.A. Lifts Tomato Warning
The New York Times reports that the Food and Drug Administration has lifted the warning against eating raw tomatoes, one of the foods attributed to the salmonella outbreak that began in April. Bina Venkataraman writes,
The Food and Drug Administration revoked its warning against eating certain kinds of raw tomatoes Thursday, even though officials said they had yet to pinpoint the source of the nation’s largest foodborne outbreak in the last decade.
Meanwhile, the agency continues to advise the elderly, infants and those with weak immune systems not eat raw jalapeño or serrano peppers.
Tomatoes believed to be responsible for initial illnesses in the salmonella outbreak that began in April are no longer on the market, officials said in a telephone press conference. For more than a month, federal investigators have been testing tomatoes, with a focus on those grown in Florida and Mexico, to find the origin of the contamination. The agency had warned consumers to avoid certain raw red plum, red Roma and red round tomatoes and products containing them.
“We found no evidence of Salmonella Saintpaul, the outbreak strain, during those investigations,” said Dr. David Acheson, the agency’s associate commissioner for foods.
And jalapeño peppers, although they have been linked to some cases, do not explain all of the illnesses, said Dr. Robert Tauxe of the Centers for Disease Control and Prevention.
Earlier epidemiological studies linked tomatoes to the salmonella outbreak that has now sickened more than 1,200 people in 42 states and the District of Columbia. Officials said Thursday that the outbreak was ongoing, but appeared to have reached a plateau in mid-June with 33 people becoming ill per day.
The F.D.A. is sending investigators to a packing plant in Mexico that they suspect could be the site of the contamination, Dr. Acheson told reporters. A single packing shed or irrigation system could be responsible for contaminating different types of produce with the bacteria, he added.
Clinton Foundation Sets Up Malaria-Drug Price Plan
The Wall Street Journal reports on Bill Clinton's new plan that aims to stabalize malaria drug prices. Mark Schoofs writes,
Former President Bill Clinton's foundation is set to unveil a pricing agreement Thursday that it hopes will make malaria drugs available to millions of poor people.
The agreement points to the sophistication needed to harness market forces and get lifesaving medicines to countries where treatable diseases still take a staggering toll.
First-line malaria drugs -- known as ACTs, for artemisinin-based combination therapies -- present a tricky problem: the volatile cost of the powerful antimalarial plant extract artemisinin. During the past few years, the price of that key ingredient has fluctuated from as little as $150 a kilogram to as much as $1,100, according to Chinese producers.
Such instability makes it difficult for those in the market -- from artemisinin producers to pharmaceutical companies to the health ministries that often buy the drugs -- to plan. That can make pharmaceutical companies wary of reducing prices for fear of another price spike and deter generic-drug makers from entering the market and fostering more-competitive pricing.
The agreement Mr. Clinton plans to announce aims to limit price fluctuations. It creates a consortium of two Chinese raw-artemisinin suppliers, two Indian companies that convert artemisinin into the active pharmaceutical ingredient and two Indian generic-drug companies. Among other things, the deal puts a ceiling on the price of the raw artemisinin in return for a guarantee that other consortium members will purchase large proportions of their artemisinin from the two participating suppliers, unless nonmembers can offer equal-quality product at an undisclosed discount.
The deal also reduces the price of one drug, known as ASAQ, by about 30%.
Scheduled to join Mr. Clinton at the presentation is Novartis AG Chief Executive Daniel Vasella. The Swiss drug company has been supplying the overwhelming majority of ACTs in the developing world -- 66 million treatment courses last year alone -- at an overall loss that Dr. Vasella said exceeds $100 million, including research-and-development costs. Mr. Clinton is expected to thank Novartis for supplying the drug and for not raising the price despite the artemisinin price increase.
Novartis isn't part of the consortium, but Dr. Vasella lauds the effort to make malaria drugs more available. His main caveat is that the Clinton agreement "doesn't address the need for new drugs and the incentives for innovators to engage more."
"How was it possible that we have a product that completely transformed malaria treatment, saving 500,000 lives? It's only possible by innovation," Dr. Vasella said.
One attempt to spur innovation was introduced in February 2007, when the Bill and Melinda Gates Foundation and five countries began funding "advance market commitments," in which donors such as the U.K. and Italy would guarantee that they would buy enough vaccines of various types to lure companies to invest in developing them. But the approach remains untested while its supporters iron out the legal framework. Cutting prices and stimulating new research are only parts of the challenge; many developing-world health systems can't deliver the treatments effectively.
The Clinton Foundation's malaria work builds on previous efforts. In 1996, when lifesaving AIDS drugs first appeared, activists pressured patent-holding pharmaceutical companies to reduce prices and pushed the U.S. government to stop opposing the use of patent-busting generic drugs in poor countries. The stark cost difference between generic and branded versions helped pressure the major drug makers to slash prices in poor nations.
Still, by 2003, AIDS drugs were reaching only a tiny fraction of people, because poor countries weren't buying them partly out of fear that they lacked the resources to properly administer lifelong regimens. The result: Although millions of people were wasting away from the disease, there was little market demand for the drugs that could save them.
In its first major price-slashing effort, the Clinton Foundation effectively catalyzed demand, working with African governments to develop plans to deliver the drugs on a mass scale and then using that demand to bargain with generic-drug companies to reduce prices through economies of scale. Another key: Rich countries ponied up millions of dollars to help poor ones buy the drugs.
To address the malaria market, the Clinton Foundation tapped 31-year-old Inder Singh, who holds five educational degrees, including an M.B.A. from the Massachusetts Institute of Technology. He worked on two Silicon Valley start-ups before starting two businesses of his own. He soon realized that, for malaria, the challenge was to manage demand.
After the World Health Organization in 2004 recommended that ACTs be used as first-line malaria drugs, demand skyrocketed. It takes a year or more for the Artemisia annua plant to mature, which led to hoarding and price gouging, Mr. Singh said. The resulting price increase attracted Chinese farmers who flooded the market, leading to subsequent oversupply and a plunge in price.
Creating reliable demand forecasts helped the foundation cobble together the pact being announced Thursday. The agreement solves another problem: multiple purity specifications that are measured by different methods. The Clinton Foundation coordinated the establishment of a single quality standard within the consortium.
Merck to Start Vioxx Settlement Payouts in August
US News reports on Merck & Co.'s recent $4.85 billion settlement with former users of its painkiller, Vioxx. Linda A. Johnson writes,
Merck & Co. will start cutting checks for former users of its withdrawn painkiller Vioxx next month after announcing Thursday that it will fund a $4.85 billion settlement expected to resolve roughly 50,000 lawsuits.
The decision marks the beginning of the end of the four-year legal saga, which began when cardiovascular side effects forced Merck to pull Vioxx off the market in 2004, triggering tens of thousands of lawsuits, sullying its once-spotless reputation and forcing out its then-chief executive.
The Vioxx case has cost Merck at least $6.8 billion, including more than $1.53 billion through March 31 on legal costs for defense research and individual trials, most of which it has won.
Vioxx, which was launched in 1999, brought Merck revenue of $2.5 billion at its peak in 2003 and a total of at least $11 billion.
On Thursday, Whitehouse Station, N.J.-based Merck said more than 97 percent of eligible claimants - 48,550 out of 49,960 - have enrolled in the settlement program, surpassing threshold levels the company required for the deal to proceed. Therefore, Merck said that on Aug. 4 it will waive its right to walk away from the deal reached with plaintiffs' attorneys last fall.
"I'm just glad that it's almost over," said Evelyn Irvin Plunkett of Palm Coast, Fla., who sued Merck in 2003 over the May 2001 heart attack death of her first husband, Richard "Dickie" Irvin. "It's just been a long, hard fight."
Plunkett's family had gone through a mistrial, then lost to Merck at a retrial and won the right to a third trial before being allowed to join in the settlement. She does not know how much she will receive.
Settlement amounts can run from the minimum of $5,000 up to a few million dollars. Payments will be decided by a complicated formula that factors in how serious a claimant's injury was, how much Vioxx was taken and how many other risk factors the person had.
"Long-term users of Vioxx who had a very severe injury will be well compensated," said lawyer Andy Birchfield, who served on the plaintiffs' steering and negotiating committees.
He said the number of plaintiffs participating shows the settlement is a good one.
"This is a great day for the plaintiffs injured by Vioxx who will within weeks begin to receive compensation for their injuries," said lawyer Chris Seeger, a member of the plaintiffs steering committee. "I couldn't be happier for my clients."
"We're very pleased to be reaching this milestone because we feel it confirms the program is a good one and a fair one," said Ted Mayer, Merck's chief Vioxx lawyer.
Roughly 700 more plaintiffs are considering participating, so Merck has extended the deadline for them to enroll until Oct. 30, he said. About 700 others have not been located by their attorneys.
Former Vioxx users, or their survivors, are eligible for part of the settlement if the patient suffered a heart attack, stroke or death. They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of Nov. 9, 2007, the date the settlement was reached.
To ensure that the settlement ended the bulk of the lawsuits, the company had required participation from at least 85 percent of eligible claimants in four groups: those who had used Vioxx for more than 12 months, had a heart attack, had an ischemic stroke or died.
Merck will put $4.85 billion into the settlement fund over time, with the first $500 million payment scheduled for Aug. 6. The company took a charge for the full $4.85 billion last year.
Eligible claimants who enrolled by March 31 and allege a heart attack or sudden cardiac death could then receive an interim payment, expected to be made by the end of August.
Interim payments to people alleging Vioxx caused an ischemic stroke are to begin in or after February 2009.
Mayer said several thousand additional claimants don't have injuries eligible for the settlement and have been ordered by judges to produce expert reports supporting their claims.
"We expect to be making motions to dismiss a large number of those claims during the coming weeks and months," he said.
Merck also faces about 260 potential class-action suits, alleging either harm or financial losses related to Vioxx, that still must be resolved.
Merck withdrew Vioxx from the market on Sept. 30, 2004, after its own research showed the once-blockbuster arthritis pill doubled the risk of heart attack and stroke.
U.S. District Judge Eldon E. Fallon in New Orleans, who has been coordinating much of the litigation, said it's one of the country's biggest multidistrict litigation cases - those assigned to one federal judge for pretrial purposes and possible settlement.
Congressional Committee Will Probe Health Insurers that Cancel Sick Members' Coverage
The Los Angeles Times reports that a congressional committee will investigate health insurers' practice of canceling coverage when policyholders get sick. Lisa Girion writes,
The problem first came to light in California, but witnesses testifying before the House Oversight and Government Reform Committee suggested that it was more widespread.
The problem affects the individual insurance market, in which 14 million Americans, including nearly 3 million Californians, purchase medical benefits on their own.
In light of proposals to expand the individual market, the committee's chairman, Rep. Henry A. Waxman (D-Beverly Hills), said the individual market demanded more scrutiny, especially of cancellation practices.
Waxman pointed to one case in which he said a consumer lost his insurance because he failed to disclose headaches on his application for coverage.
He "was terminated because the insurer said he should have known that occasional headaches would later be diagnosed as multiple sclerosis," Waxman said.
The committee would begin its probe by sending questions and requests for documents to major insurers.
"I understand that insurance companies need to protect themselves from fraud," Waxman said. "But that is not what happened in California, Connecticut and across the country. Insurers are using technicalities or trumped-up 'misrepresentations' to rescind policies after individuals get sick and accumulate hundreds of thousands of dollars in medical bills."
Stephanie Kanwit, a lawyer for America's Health Insurance Plans, told the committee that rescission of coverage is a rarely used tool that is necessary to ensure that people who lie about their medical conditions do not taint the risk pool for honest consumers. If people who are unhealthy obtain insurance at the preferred premiums given to healthy people, she said, it drives up prices for everyone else.
"To assure them affordable coverage, individual insurance is generally underwritten, which means employing a process to assess risks and classify them according to their degrees of insurability so that the appropriate rates may be assigned," Kanwit said. "Without such underwriting, most people who purchase insurance in the individual market would pay considerably more for their health insurance premiums."
Inflation and Oil Prices Send Costs of Medical Supplies Soaring
The Chicago Tribune reports on the increase in costs of medical supplies as a result of inflation and oil prices. Bruce Japsen writes,
Inflation is racing through the economy at a pace not seen in years, touching even the medical gloves used by hospitals, as manufacturers cope with high oil prices.
The cost of living in June shot up at the fastest rate in 17 years, with the Labor Department reporting Wednesday that consumer prices jumped 1.1 percent, a much faster clip than anticipated.
Inflation is corrosive to paychecks, cutting deeply into consumers' earning power, but the phenomenon hurts even more in an economy struggling to maintain growth. Inflation also hurts companies when they can't pass on higher costs because of competitive pressure.
Much of the inflation pressure now is due to oil prices, and its impact is most obvious at the gas pump, though high food prices are also hurting shoppers at the grocery store. While oil prices have dropped steeply the past two days, they remain at historically high levels.
There are myriad ways the impact of high oil prices touches consumers—or is likely to soon—and the medical supplies used by hospitals and sold in drugstores are one example.
Consumers can see the results at retail outlets such as Walgreen Co. stores, where the retailer says a box containing 120 of its store-brand latex gloves has almost doubled in price. A customer who could get two boxes for $9.99 a year ago now pays a sale price of $7.99 for one box. Oil is used in the manufacture of gloves.
Medical manufacturers, distributors and hospitals all are coping with rising prices, and they are making crucial decisions about whether to raise customer prices or hang tough and eat the higher costs to protect relationships or fend off competitors.
From the thousands of gloves used each day to plastic bed pans, blood bags, syringes and tubing used for delivering medications to patients, prices for many everyday medical products are under pressure because they rely on petroleum, industry players say. In some cases, suppliers like Mundelein-based Medline Industries Inc. are seeing costs double or triple for products.
"The price of oil is going to work its way into many, many things in the health-care system," said Todd Swim, a worldwide partner with the Chicago office of Mercer, an employee benefits consulting firm that advises large companies on their workers' health-care issues.
While a single glove can amount to pennies, that cost adds up for a hospital. Medline says it's not uncommon for a 200-bed hospital to use 16,000 gloves a day, or about 6 million a year at a cost of $200,000 a year. A hospital that paid $2.70 two years ago for a box of 100 latex gloves might pay $3.50 to $3.80 today.
Rising costs spreading through the economy led Ben Bernanke, chairman of the Federal Reserve, to offer a new warning Wednesday about the significant risk to the nation's economic outlook. Energy prices are partly to blame, with gasoline prices jumping 35 percent in the last year.
"Upside risks to the inflation outlook have intensified lately," Bernanke told lawmakers in Washington.
In the hospital business, suppliers say they are experiencing price hikes for disposable protective apparel such as gowns and drapes thanks to price hikes in polypropylene. Meanwhile, foam used to make stretchers or beds and oil-based resins used to make syringes and other medical products are triggering price hikes.
As one example, the hundreds of thousands of gowns hospitals may use to protect patients, medical staff and visitors from germs and bodily fluids are made from polypropylene fabrics. Such gowns, which used to cost 50 cents each, have jumped by 40 percent, to 70 cents each, Medline said.
Both Deerfield-based Baxter International Inc. and Lake Forest-based Hospira Inc., which make IV systems and medication bags, have been telling investors and Wall Street analysts that managing the fuel hikes is becoming more difficult.
"So far, strategically we have made the decision to absorb those costs," Baxter Chief Financial Officer Robert Davis told Wall Street analysts at a recent conference. "And pretty soon if we are not passing those through at some point, we'll have to continue to evaluate whether that's doable."
Because hospitals sign long-term contracts with manufacturers and buy in large volumes that allow them to negotiate better deals, the immediate impact for some customers has been somewhat muted, but administrators are looking for alternatives.
In the case of gloves, Loyola University Medical Center in Maywood said housekeeping and food/nutrition staffs have switched from latex gloves "to less expensive vinyl gloves," a hospital spokesman said.
July 17, 2008
Senate Agrees to $50 Billion AIDS Plan
The Washington Post reports on a new bill passed by the Senate that will spend $50 billion over the next five years, mostly to fight AIDS in the developing world. Paul Kane writes,
The Senate approved legislation yesterday that would triple funding to fight AIDS and other diseases around the globe, rejecting efforts to pare down the bill's $50 billion price tag.
On an 80 to 16 vote, the Senate dramatically increased the U.S. contribution to a global fund to combat AIDS, tuberculosis and malaria. President Bush, who requested $30 billion over the next five years, has agreed to the larger amount for a program he started in 2003.
"We've made tremendous strides, but our work is not nearly finished. Two million people died last year of HIV-AIDS. Over two and a half million people died of malaria and TB," said Senate Foreign Relations Committee Chairman Joseph R. Biden Jr. (D-Del.). He praised Bush's "bold" support for AIDS funding, launched in the 2003 State of the Union address, calling it his greatest achievement as president.
Once a politically contentious issue, fighting AIDS has become popular at both ends of the ideological spectrum. During the debate, Sen. John F. Kerry (Mass.), the 2004 Democratic presidential nominee, praised former senator Jesse Helms (R-N.C.), a conservative icon who died July 4, for his decision in 2000 to support global AIDS funding.
Some Senate conservatives were divided over supporting the costly program, though they acknowledged its success.
"This is by far the only true foreign policy program that's working. The dollars are actually making a difference," said Sen. Tom Coburn (R-Okla.), a staunch opponent of most government spending.
"HIV is a death sentence, no question about it. If you go untreated, you're going to die," Coburn added.
According to the Office of the U.S. Global AIDS Coordinator, the money has provided services in poor nations that have prevented 194,000 HIV infections among infants.
But Sen. John Cornyn (R-Tex.) said the funding should have been reduced to $35 billion over five years. He noted that the initial program cost $15 billion.
"There should be a limit," Cornyn said. "It's one thing to say you'll support it at $15 billion; it's another thing to say you'll support it at $35 billion. To me, it's entirely another thing to support it at $50 billion."
Cornyn was one of 16 Republicans to oppose the bill. Amendments to reduce its cost were rejected by large bipartisan majorities.
The program originally focused on 15 poor nations, but the legislation would expand it to help provide prevention and treatment services in more than 100 countries.
The House has passed its own version of the bill, but Biden said there are only minor differences between the two and predicted a final version would soon be crafted and sent to the president for his signature.
One key difference in the bills is a House provision that would allow funding for family planning programs in poor nations.
Increased HIV Risk Found in Genetic Mutation
The Los Angeles Times reports on a newly discovered genetic mutation that renders Africans and African Americans 40% more susceptibe to HIV infections. Researchers say the discovery offers a partial explanation for the disproportionate spread of the virus among Africans and African Americans. Thomas H. Maugh II and Karen Kaplan write,
A genetic mutation that originally protected Africans from a virulent form of malaria now renders them 40% more susceptible to HIV infections, offering a partial explanation for the disproportionate spread of the virus among Africans and African Americans, researchers reported today.
The mutation, however, has an unusual benefit. It also slows progression of HIV, the virus that causes AIDS, giving patients an extra two years of life, said Dr. Sunil K. Ahuja of the South Texas Veterans Health Care System, lead author of the paper in the journal Cell Host & Microbe.
The genetic variation is the first found to increase susceptibility to HIV and the first linked to people of African descent, said virologist Robin A. Weiss of University College London, a coauthor of the paper.
About 90% of Africans have the mutation, and it could account for as many as 11% of HIV infections on that continent, the researchers said. Sub-Saharan Africa accounts for about 75% of the world's 33 million people infected with HIV.
The mutation also affects about 60% of African Americans and could partially explain why HIV is more common among blacks than whites in the United States. Blacks make up 13% of the U.S. population but account for nearly half of all newly diagnosed infections.
The study appears to confirm the theory that the risk of contracting HIV is not solely connected to behavior, said Phill Wilson, chief executive of the Black AIDS Institute, an HIV/AIDS think tank in Los Angeles.
"Black gay men's behavior is no more risky -- and often less risky -- than white gay men, yet their vulnerability is so much greater," Wilson said.
Ahuja cautioned, however, that social factors -- such as poverty, lack of access to healthcare and sexual behavior -- were probably more important contributors to the risk of HIV infection.
The mutation in question involves a single letter of DNA in the gene for a receptor found on the surface of red blood cells known as the Duffy antigen. Virtually all Caucasians have the antigen, but 90% of Africans and 40% to 50% of African Americans do not.
Because the malaria parasite Plasmodium vivax relies on the Duffy antigen to enter red blood cells, its absence offers protection against the disease. A precursor of P. vivax may have caused a lethal form of malaria thousands of years ago, which would have helped the mutation sweep through the population, researchers think.
Today, a different parasite, Plasmodium falciparum, is the predominant cause of the most fatal form of malaria.
Some laboratory research had shown that the Duffy antigen mops up HIV in the bloodstream, potentially reducing the likelihood that the virus can infect the immune cells that are its primary target.
To explore this possibility, the team studied the medical records and stored blood of 814 black Air Force personnel who were HIV-negative and 470 who were HIV-positive. The fact that all were servicemen eliminated many of the socioeconomic variables that might have confounded the analysis.
Researchers found that airmen without the Duffy antigen were 40% more likely to be infected with HIV -- and if they were infected, they lived longer by an average of two years. That surprised the researchers because typically anything that increases the risk of an infection is also likely to speed the progression of the resulting disease.
David Goldstein, a Duke University population geneticist who studies HIV genetics, said the unusual finding made him hesitant to embrace the result until it could be replicated in other studies -- a task he said he intended to pursue.
Goldstein added that African Americans, the subjects of the study, had an especially diverse genetic heritage that made it more difficult to link a particular gene to HIV susceptibility.
Ahuja said he and his colleagues did not know why the absence of the Duffy antigen increased HIV susceptibility and slowed progression of the disease. One possibility is that people without the Duffy antigen have lower levels of infection-fighting chemokines in their blood.
The lower levels make infection more likely. But once infection occurs, it may limit the amount of inflammation associated with the disease, minimizing damage to the body.
How Changes in Medicare Affect Patients
The Wall Street Journal reports on how the new Medicare law will directly affect Medicare beneficiaries. Anna Wilde Mathews and Jane Zhang write,
The major goal of the new Medicare law passed this week was to block a scheduled cut in fees paid to doctors. But there's also plenty in the law that directly affects Medicare beneficiaries.
Participants in the federal insurance program for older and disabled Americans will have lower out-of-pocket costs for mental-health services. Some widely used anti-anxiety and sleep drugs that Medicare previously didn't pay for will be covered. And the law aims to boost preventive health care, including making it easier and cheaper for new Medicare participants to get a physical checkup. Most of the new benefits will be phased in over several years.
There also are cutbacks. Consumers who relied on certain private insurance plans sold under the name Medicare Advantage could face tougher restrictions on which doctors they will be allowed to see. Another change: Doctors will be strongly encouraged to begin sending prescriptions to pharmacies electronically, rather than writing them by hand.
"There are some important changes in here," says Kirsten Sloan, an official with AARP, the lobbying group for older people. "It's meaningful."
Congress approved the Medicare law late Tuesday after months of wrangling. With votes of 70 to 26 in the Senate, and 383 to 41 in the House, the bill garnered enough votes to override a veto by President Bush, whose opposition centered on some of the cutbacks to the Medicare Advantage program. The Medicare bill has a total cost estimated at around $20 billion, spread over five years.
Medicare participants getting mental-health treatment, such as visits to a psychiatrist, currently must pay 50% of the cost out-of-pocket. That compares with a co-payment of 20% for other doctor visits. The new law cuts the co-pay for mental-health services also to 20%, although the reduction phases in gradually, ending in 2014.
That change could make a big difference for Medicare beneficiaries like Karen Geer, who lives near Indianapolis. Ms. Geer, 46, spends more than $4,000 a year on therapy for her bipolar disorder, mostly on visits with a social worker that cost $80 a session. She says the therapy has helped her manage the disorder well, and she now does volunteer work in the community. But to help pay for it, Ms. Geer says she has given up getting Pap smears and other medical care.
Ms. Geer figures she'll save at least $2,500 a year if her Medicare co-payments are reduced to 20% from 50%. "I think it will make a difference," she says. "I'll have more money to use on other services I need."
Some Medicare beneficiaries have not sought needed mental-health treatment because of the high out-of-pocket cost, says Dale Klatzker, president of The Providence Center, a community mental-health clinic in Providence, R.I. The clinic, which relies heavily on public funding, sometimes can't collect the 50% co-payments from Medicare patients when they can't afford it, he says. He expects the new Medicare law to boost patient visits and their ability to pay.
The American Psychiatric Association, a professional group, says the increase in coverage should attract more psychiatrists and other mental-health-care providers into Medicare. "It's a huge step forward," adds Andrew Sperling, director of federal legislative advocacy for the National Alliance on Mental Illness, a patient advocacy group. The change to the mental-health co-payment comes as Congress aims to pass another bill later this month that would require employers and private insurers to put mental-health coverage on par with that for physical maladies.
The new Medicare law also will add two widely used classes of medicines to the Medicare drug benefit, although the change won't take effect until 2013. One class is benzodiazepines, a group of drugs often prescribed for anxiety that includes Xanax and Valium. Last year, about 51 million benzodiazepine prescriptions were written in the U.S., according to research firm IMS Health. The other drug class is barbiturates, sometimes used as sleep aids. Medicare will cover these drugs only for patients suffering from certain conditions, including a chronic mental-health condition, cancer or epilepsy.
The new law also takes a modest step toward encouraging some preventive care. Currently, Medicare will pay for new participants to get a "welcome-to-Medicare" physical within six months of joining the program. That period is being extended next year to 12 months, making it more convenient for many people. What's more, the cost of the initial physical will no longer be counted against a participant's annual deductible. Medicare's standard annual deductible is currently $135. Medicare doesn't cover routine physicals after the one you get when you first enroll.
Congress also laid the groundwork for Medicare to add future preventive or screening services. In the past, such benefits, including mammogram screenings, required a special act of Congress to be included in Medicare coverage. Now, Medicare will be able starting next year to decide on its own whether to add certain preventive treatments. Some treatments the program is expected to consider adding are intense weight-loss counseling for obesity and certain genetic tests for breast cancer. "It really embeds prevention into the Medicare program in a way that it hasn't been in the past," says Timothy Gardner, president of the American Heart Association.
Much of the new law's cost will be paid through reducing outlays for the private Medicare Advantage plans. These plans, which can have richer benefits or lower co-payments than traditional Medicare, are offered directly to consumers by private insurers. They also are generally more expensive for the government than traditional Medicare, government analysts say.
The cutback most likely to be noticed by consumers affects a type of Medicare Advantage plan called private fee-for-service, which gives consumers access to a wide range of doctors. These plans are sold under names such as Humana Inc.'s Gold Choice and UnitedHealth Group Inc.'s SecureHorizons MedicareDirect Plans.
Under the new law, starting in 2011, fee-for-service plans will have to bring doctors who accept the plans into a network, similar to the way that health maintenance organizations, or HMOs, and preferred provider organizations, or PPOs, now do. Currently, the plans allow consumers to access any doctor, although individual physicians may choose not to accept a particular plan. The network requirement will apply only in geographic areas where consumers have at least two other Medicare Advantage plan options.
America's Health Insurance Plans, an industry group, estimates the change could affect around 80% of the 2.2 million people currently enrolled in private fee-for-service plans. But a House Democratic aide says enrollment in the rejiggered plans is still expected to grow. In his veto message, President Bush said the new Medicare law will "harm beneficiaries by taking private health plan options away from them," particularly with the new restriction on the private fee-for-service plans.
Having to stick with a network looks like a disadvantage to Ernest Matthews, an 80-year-old retiree in Athens, Pa., who has a private fee-for-service plan from a unit of Universal American Corp. Mr. Matthews says a big reason he likes the plan is because it allows him to go to doctors at the Geisinger Medical Center in Danville, Pa., for his cancer treatments. "I would rate the ability to pick and choose as the No. 1 issue," he says.
A Geisinger spokeswoman says the hospital does treat patients covered by traditional Medicare.
The Medicare law encourages more doctors to write electronic prescriptions. In a carrot-and-stick approach, the law initially boosts Medicare payments to physicians who make the change. Then, in later years, it docks doctors' fees if they fail to adopt the technology. One challenge: Although around 70% of all pharmacies can receive digital prescriptions, only 31% of independent drugstores now do so, according to SureScripts-RxHub LLC, which operates the main e-prescribing network. Only about 40,000 U.S. doctors currently prepare their prescriptions digitally.
While the U.S. Spends Heavily on Health Care, a Study Faults the Quality
The New York Times reports on a new study that describes a discrepancy between the amount of money Americans pay for health care and the quality of care they actually get in return. Reed Abelson writes,
American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.
The report, the second national scorecard from this influential health policy research group, shows that the United States spends more than twice as much on each person for health care as most other industrialized countries. But it has fallen to last place among those countries in preventing deaths through use of timely and effective medical care, according to the report by the Commonwealth Fund, a nonprofit research group in New York.
Access to care in the United States has worsened since the fund’s first report card in 2006 as more people — some 75 million — are believed to lack adequate health insurance or are uninsured altogether. And within the nation, the report found, the cost and quality of care vary drastically.
The findings are likely to provide supporting evidence for the political notion that the nation’s health care system needs to be fixed. Both presumptive presidential nominees, Senator John McCain and Senator Barack Obama, argue that the country needs to get more value for its health care money, even if they do not agree on what changes would be most effective. But few people these days defend the status quo.
“It’s harder to keep deluding yourself or be complacent that we don’t have areas that need improvement,” said Karen Davis, president of the Commonwealth Fund.
The study, which assesses the United States on 37 health care measures, finds little improvement since the last report, as the cost of health care continues to rise steadily and more people — even those with insurance — struggle to pay their medical bills.
“The central finding is that access has deteriorated,” Ms. Davis said.
Even some experts who are quick to point to some of the country’s medical successes, as in reducing the deaths from heart disease or childhood cancers, for example, also acknowledge the need for change.
“We need to generate better value in this country,” said Dr. Denis A. Cortese, the chief executive of the Mayo Clinic.
In some cases, the nation’s progress was overshadowed by improvements in other industrialized countries, which typically have more centralized health systems, which makes it easier to put changes in place.
The United States, for example, has reduced the number of preventable deaths for people under the age of 75 to 110 deaths for every 100,000 people, compared with 115 deaths five years earlier, but other countries have made greater strides. As a result, the United States now ranks last in preventable mortality, just below Ireland and Portugal, according to the Commonwealth Fund’s analysis of World Health Organization data. The leader by that measure is France, followed by Japan and Australia.
Other countries worked hard to improve, according to the Commonwealth Fund researchers. Britain, for example, focused on steps like improving the performance of individual hospitals that had been the least successful in treating heart disease. The success is related to “really making a government priority to get top-quality care,” Ms. Davis said.
The presidential candidates both emphasize the need to shift the country’s health priorities, to provide more medical care that helps prevent people from developing disease and that helps control conditions before they become expensive and hard to treat. And the mounting evidence indicates that such issues are not simply political talking points, said Len Nichols, a health economist at New America Foundation, a nonprofit group in Washington that advocates universal health care coverage.
More hospital executives and doctors understand their performance could be better, Mr. Nichols said.
Dr. James J. Mongan, the chief executive of Partners HealthCare System, a big medical network in Boston, agrees that “there’s substantial room for improvement.” Dr. Mongan is one of several health care leaders who is working with the Commonwealth Fund to develop a model for a better system.
Business leaders also see a pressing need for health care changes, said Helen Darling, the president of the National Business Group on Health, which represents big employers that provide medical benefits to their workers. The report “documents that it’s been as bad as we have been thinking it is,” she said.
But Ms. Darling and others were also heartened because some areas in the report said that the United States had shown marked improvement, including the measurements hospitals use to track how well they treated conditions like heart failure and pneumonia.
“It proves once again if you have quantitative information and metrics and make people pay attention, they change,” Ms. Darling said.
But the report also emphasizes the inefficiencies of the American health care system. The administrative costs of the medical insurance system consume much more of the current health care dollar, about 7.5 percent, than in other countries.
Bringing those administrative costs down to the level of 5 percent or so as in Germany and Switzerland, where private insurers play a significant role, would save an estimated $50 billion a year in the United States, Ms. Davis said.
“It kind of dwarfs everything else you can do,” she said.
Much of the high costs are attributed to the lack of computerized systems that may link pharmacies and doctors’ offices for filling prescriptions, for example, or that may enable insurers to more efficiently pay doctors’ bills.
“An awful lot of the waste in this system is the antiquity of the information technology,” Ms. Darling said.
Karen Ignagni, the chief executive of America’s Health Insurance Plans, an industry trade group, argues that much of the higher administrative costs stem from the additional services provided by United States insurers, like disease management programs, and the burdensome regulatory and compliance costs of doing business in 50 states. A more uniform system could result in savings, she said.
Tracking Produce Proves Complex
The Washington Post provides an update on the salmonella outbreak. The Food and Drug Administration pointed to raw tomatoes, jalapeño and serrano peppers as the cause of the outbreak, but has yet to find a single contaminated tomato or pepper. Investigators blame the difficulty on tracking produce distribution as the reason. Annys Shin writes,
The salmonella outbreak of 2008 may go down in history as the case of the missing tomatoes.
More than six weeks ago, the Food and Drug Administration issued a warning about a salmonella outbreak in New Mexico and Texas connected to raw tomatoes. Since then, the agency has expanded the warning nationwide and added jalapeño and serrano peppers. More than 1,100 people have fallen ill since April, but not a single contaminated tomato or pepper has been found.
Investigators said the complexity of the produce distribution system has been their biggest impediment, and some produce industry leaders agree that tracing fruits and vegetables could be easier. Though the technology to do so already exists in the form of bar codes that appear on nearly everything we buy, it could take as long as five years before the entire food industry applies it to food safety.
Produce outbreaks are notoriously hard to trace. In at least half of all produce outbreaks, health officials have never determined what made people sick. The short shelf life of most fresh fruits and vegetables means it's less likely the items will still be in people's refrigerators when investigators come looking. Plus, there are many paths produce can take to reach consumers.
In the salmonella probe, health officials said the practice of repacking made it harder to trace tomatoes to their source. Repacking involves sorting produce for size and color to meet a customer's specifications. Fresh tomatoes are often repacked, sometimes more than once. For investigators, the practice can open a multitude of new leads. Investigators trying to find the source of contaminated jalapeños have run into "the same spider web," said David Acheson, a top food safety official at the FDA.
For some produce industry leaders, references to spider webs sound like excuses for mistakes in judgment. "We are not dealing with failure of traceability. We are dealing with the fact that the trace-back did not support the single point of contamination hypothesis," said Tom Stenzel, president of United Fresh Produce Association. "We would submit that trace-back worked; we just weren't listening carefully enough to what it was telling us."
Other industry leaders agree with regulators that the faster investigators can trace products, the quicker they would be able to prove or disprove theories, thereby limiting an outbreak's scope and financial losses for businesses.
"When we've got illness, we've got to get back [to the source] as quickly as we can. We've got to do that fast for maximum public health efficiency so we're not dealing with weeks of delay and . . . relying on paper and pencil to try to figure this out," Acheson said.
The technology to track a chili pepper or tomato from packing shed to plate has been around for some time, as anyone who has sent or received a package knows. Both sender and recipient can go online, see the major stops in the package's journey and, after it arrives, the precise time it reached its destination. The nation's largest food distributors and manufacturers use similar technology to keep tabs on their inventories. But not all businesses can afford such sophisticated systems.
"You have space-age technology operating next to horse and buggies," said Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, a Washington advocacy group. Two weeks ago, the center and the Consumer Federation of America called on the FDA to issue emergency regulations to set up a traceability system.
"There is no consistent use of standards and or technology solutions across the industry," said Gary Fleming, vice president of industry, technology and standards for the Produce Marketing Association, an industry trade group based in Newark, Del. "What a grower needs to know is different from what a distributor or a wholesaler needs to or a restaurant or retailer does."
Another hurdle to faster traceability is what happens to information about products collected by the different players along the distribution chain. Too often, they don't store their data electronically, Fleming said. Investigators in the salmonella outbreak spent the first few weeks chasing suspect tomatoes from produce aisles and restaurants, through wholesalers and distributors, all the way to farms in Florida and Mexico. To get there, they weeded through hundreds of paper records and invoices. They tested 1,700 samples without finding traces of the outbreak.
The Bioterrorism Act of 2002 required food companies, including manufacturers and wholesalers, to record who sent them a product and the next place they shipped it. The one-step-forward and one-step-back rule has improved traceability, but for some lawmakers, it isn't a comprehensive solution.
"The course of this whole investigation shows that our food tracking system is pathetic," said Rep. Diana DeGette (D-Colo.), who has introduced legislation to establish a national system for tracing all types of food, not just produce. Sen. Charles E. Schumer (D-N.Y.) has introduced similar legislation but only for meat and poultry products.
Food industry executives representing a broad coalition of growers, distributors, restaurateurs and retailers have been working on a national tracking system since January. Fleming is part of that initiative. They've come up with a solution that centers on a global trade item number or GTIN (pronounced "GEE-tin"). Everyone in the distribution chain would be required to use a bar code encoded with a GTIN and three key pieces of information: the grower or shipper who produced it, the production lot it was part of, and the date it was packed or harvested.
Such information proved invaluable in the 2006 E. coli outbreak in bagged spinach. Each bag carried a bar code that identified where and when it was packed, including the shift that did the work.
Using that information, the FDA was able to move in one day from issuing a blanket warning against bagged fresh spinach to announcing recalls of specific brands. Four weeks later, FDA and California state officials traced the outbreak strain to a specific ranch. They later concluded that wild boars running loose in spinach fields were most likely responsible for contaminating the greens.
If the GTIN system becomes universal, anyone in the supply chain would be able to quickly map out where a box of tomatoes, for example, originated and where it is in real-time -- information that becomes critical when a product needs to be isolated or recalled.
But before that can happen, Fleming said, more details need to be sorted out, such as how long it will be before businesses start using it and how to hold accountable those that don't. Some in the industry estimate it could be two to five years before the GTIN system gains widespread acceptance. The industry coalition is establishing deadlines that businesses would have to meet in adopting it.
Another issue is what role the federal government should play in overseeing such a system. Produce industry leaders such as Stenzel don't think new legislation requiring traceability is necessary. But lawmakers such as DeGette see a publicly run system as a faster, more effective approach.
"Our food distribution in this country now is really a national system, and we saw that clearly with the salmonella outbreak where you're looking across a number of states and into Mexico [for the source]," DeGette said. "If you don't have a national system administered by the Food and Drug Administration, we will still have the breakdowns we are seeing because they won't be coordinated."
July 16, 2008
Congress, Overriding Bush, Blocks Pay Cut for Doctors
The New York Times reports that Congress has overrided Bush's veto of the Medicare Bill. Robert Pear writes,
President Bush on Tuesday vetoed a bill protecting doctors from a Medicare pay cut, but both houses of Congress swiftly overrode the veto with large bipartisan majorities, so the bill is now law.
The vote in the House was 383 to 41, with 153 Republicans defying the president. In the Senate, the vote was 70 to 26, with 21 Republicans voting to override.
The bill won more support on Tuesday than when it was first approved. The tally in the House last month was 355 to 59, with 129 Republicans voting for passage. The crucial vote in the Senate was 69 to 30, with 18 Republicans voting yes.
The measure is the fourth bill to be enacted over the president’s veto, and two of those were farm bills.
Mr. Bush has been getting his way on many foreign and national security issues, obtaining money for the Iraq war, persuading Congress to pass new wiretapping legislation and fending off restrictions on harsh interrogation techniques like waterboarding.
But Democrats have gained the upper hand on many domestic issues, passing a water projects bill over the president’s veto and forcing the White House to accept new education benefits for veterans who fought in Iraq and Afghanistan.
After experiencing many setbacks on health legislation in recent years, Democrats rejoiced in a resounding victory on Tuesday.
The vote “renews the light of hope for those who need our help the most, senior citizens who depend on Medicare,” said Senator Harry Reid of Nevada, the majority leader.
The House speaker, Nancy Pelosi of California, said: “Seniors’ organizations and disabilities groups support this legislation. Just about every health-care-providing group in our country supports this legislation, except one, and that is some in the health insurance industry. I guess the president is voting with them and not with America’s seniors.”
The political dynamic was illustrated by Representative Marilyn Musgrave of Colorado, a conservative Republican who boasted that she was voting against the wishes of her party. “I am proud to continue my fight against the White House on behalf of Colorado doctors and seniors,” Mrs. Musgrave said. The votes on Tuesday ended a long string of victories for the health insurance industry.
In his veto message, Mr. Bush said he objected to the bill because it would cut federal payments to Medicare Advantage plans and slow the growth of such plans, offered by insurance companies as an alternative to traditional Medicare.
“I support the primary objective of this legislation, to forestall reductions in physician payments,” Mr. Bush said. “Yet taking choices away from seniors to pay physicians is wrong.”
Many independent studies have found that the private plans, sold by insurers like Humana and UnitedHealth, cost the government more per person than traditional Medicare. But Mr. Bush said that reducing payments to the plans would force them to “reduce benefits to millions of seniors.”
The bill also sets strict standards for the marketing of private plans, to curtail high-pressure sales tactics that have prompted complaints from beneficiaries and state insurance regulators.
The main purpose of the bill is to cancel a 10.6 percent cut in Medicare payments to doctors that took effect on July 1.
Little-noticed provisions of the bill would reduce the beneficiary’s co-payment for mental health services and increase assistance to low-income people on Medicare. In addition, the bill would delay a competitive bidding program for suppliers of medical equipment like oxygen tanks and power wheelchairs.
Competition “should be expanded, not diminished,” Mr. Bush said.
The American Medical Association and AARP, the advocacy group for older Americans, lobbied for the bill, deluging members of Congress with messages warning that doctors would be less likely to take Medicare patients if their fees were cut.
Four Republican senators switched sides and voted for the bill on Tuesday. The senators — Christopher S. Bond of Missouri, Richard G. Lugar of Indiana, and Thad Cochran and Roger Wicker of Mississippi — had voted against consideration of the bill on three previous occasions.
Representative Lois Capps, Democrat of California, said the veto showed that Mr. Bush “would rather cozy up to his friends in the insurance industry than improve access to health care for seniors and those with disabilities.”
But Representative Jim McCrery, Republican of Louisiana, said the bill “just kicks the can down the road” and does not fix fundamental flaws in the formula for paying doctors. In 18 months, Mr. McCrery said, doctors will face a 20 percent cut in their Medicare payments.
Vision Insurer to Ask Justices to Restore Its Tax Exemption
The New York Times reports that the country's largest eye-care insurance program plans to ask the Supreme Court to reconsider its tax exemption. Stephanie Strom writes,
The country’s largest eye-care insurance program plans to ask the Supreme Court to decide whether the Internal Revenue Service properly revoked its tax exemption in 2003, company executives said Tuesday.
The proposed filing, by VSP Vision Care of Rancho Cordova, Calif., highlights a major debate in the nonprofit arena over what activities deserve tax exemption when most nonprofit groups charge fees for services and products to supplement their income from charitable donations.
Nonprofit health care providers in particular have struggled to distinguish themselves from their for-profit counterparts in recent years as federal lawmakers have questioned why they deserve tax exemptions. State courts have also stripped exemptions from nonprofits, like substance abuse centers and nursing homes, saying they were no different from tax-paying companies providing similar services.
“We think this case calls into question the tax-exempt status of a number of tax-exempt organizations,” VSP’s general counsel, Thomas Fessler, said Tuesday. “It’s not just VSP at risk here. It’s other hospitals, other health-maintenance organizations, nursing homes, clinics — there’s a lot of confusion out there.”
Lawyers specializing in nonprofit legal matters agreed, but said they still doubted that the Supreme Court would hear the challenge.
Perhaps the best-known case among nonprofits was Bob Jones University v. United States, in which the Supreme Court upheld the I.R.S.’s refusal to grant tax exemption to the private university because it banned interracial dating and marriage.
Nonetheless, VSP’s challenge is regarded as important in the nonprofit world, and the company has retained Kenneth W. Starr, the former solicitor general and Whitewater independent counsel, to prepare for a hearing.
“It’s a big deal,” said Bruce R. Hopkins, a lawyer who has written several books on nonprofit law. “There are lots of very similar organizations out there, so the implications of the I.R.S. move shook things up a bit.”
Kaiser Permanente, Delta Dental and AARP are among organizations very much like VSP, which was established in 1955 and granted tax exemption in 1960. Five years ago, after an examination of VSP’s finances and operations from 1996 to 1998, the I.R.S. revoked its tax exemption.
In a 2002 letter to the company, the I.R.S. said that VSP’s “social welfare activities, in relation to its total activities, are minor, incidental and insignificant.”
VSP’s president and chief executive, Rob Lynch, said the only difference between the company today and at its founding was that it is now a national organization rather than a regional one.
“We provide access to vision care for all segments of our society,” Mr. Lynch said. “We do provide coverage to employers, but to all types, public or private, ranging in size from the federal government to employers with two people, and we offer coverage to those who can afford it and those who participate in Medicare, Medicaid and Schip,” the State Children’s Health Insurance Program. Some employees of The New York Times are covered by a VSP program.
VSP also runs several charitable programs, like Sight for Students, which provides vision care and glasses to low-income, uninsured children — services the company valued at $92 million since 1997; and Mobile Eyes, which sends two mobile clinics around the country to provide vision care after disasters and in community outreach programs.
“We don’t offer our programs through commercial outlets like LensCrafters and Wal-Mart,” Mr. Lynch said, “and over one-third of the providers in our network are in medically underserved areas.”
VSP has paid some $47 million in taxes while the case has moved through the courts. A federal district judge in California ruled in favor of the I.R.S. in 2005, and that decision was upheld this year by the United States Court of Appeals for the Ninth Circuit.
The district judge’s decision was issued on a motion for summary judgment rather than after a trial. So, said Mr. Fessler, the general counsel, “VSP has never had its day in court.”
Understanding Autism: Gene Clues Suggest Autism Strikes When Brain Can't Learn Properly from Early Life Experiences
The Los Angeles Times, the Washington Post, and Time Magazine report that new gene discoveries may suggest that autism strikes in a brain that can't properly form new connections. AP Medical Writer, Lauran Neergaard, writes,
Harvard researchers have discovered half a dozen new genes involved in autism that suggest the disorder strikes in a brain that can't properly form new connections.
The findings also may help explain why intense education programs do help some autistic children — because certain genes that respond to experience weren't missing, they were just stuck in the "off" position.
"The circuits are there but you have to give it an extra push," said Dr. Gary Goldstein of the Kennedy Krieger Institute in Baltimore, which wasn't involved in the gene hunt but is well-known for its autism behavioral therapy.
The genetics suggest that "what we're doing makes sense when we work with these little kids — and work and work and work — and suddenly get through," he said.
But the study's bigger message is that autism is too strikingly individual to envision an easy gene test for it. Instead, patients are turning out to have a wide variety, almost a custom set, of gene defects.
"Almost every kid with autism has their own particular cause of it," said Dr. Christopher Walsh, chief of genetics at Children's Hospital Boston, who led the research published in Friday's edition of the journal Science.
Autism spectrum disorders include a range of poorly understood brain conditions, from the mild Asperger's syndrome to more severe autism characterized by poor social interaction, impaired communication and repetitious behaviors.
It's clear that genes play a big role in autism, from studies of twins and families with multiple affected children. But so far, the genetic cause is known for only about 15 percent of autism cases, Walsh said.
So Walsh's team took a new tack. They turned to the Middle East, a part of the world with large families and a tendency for cousins to marry, characteristics that increase the odds of finding rare genes. They recruited 88 families with cousin marriages and a high incidence of autism, from Jordan, Saudi Arabia, Kuwait, Oman, Pakistan, Qatar, Turkey and the United Arab Emirates. They compared the DNA of family members to search for what are called recessive mutations — where mom and dad can be healthy carriers of a gene defect but a child who inherits that defect from both parents gets sick.
In some of the families, they found large chunks of missing DNA regions that followed that recessive rule. The missing regions varied among families, but they affected at least six genes that play a role in autism.
Here's why this matters: All the genes seem to be part of a network involved in a basic foundation of learning — how neurons respond to new experiences by forming connections between each other, called synapses.
In the first year or two of life — when autism symptoms appear — synapses rapidly form and mature, and unnecessary ones are "pruned" back. In other words, a baby's brain is literally being shaped by its first experiences so that it is structurally able to perform learning and other functions of later life.
"This paper points to problems specifically in the way that experience sculpts the developing brain," explained Dr. Thomas Insel, director of the National Institute of Mental Health, which helped fund the work.
Some earlier research had pointed to the same underlying problem, so these newly found genes "join a growing list to suggest that autism is a synaptic disorder," he said.
If that sounds discouraging, here's the good news: The missing DNA didn't always translate into missing genes. Instead what usually was missing were the on/off switches for these autism-related genes. Essentially, some genes were asleep instead of doing their synapse work.
"I find that hopeful" because "there are ways that are being discovered to activate genes," Walsh said. "This might be an unanticipated way of developing therapies in the long term for autism: Identifying these kids where all the right genes are present, just not turned on in the right way."
At Kennedy Krieger, Goldstein thinks the work may provide a gene-level explanation for why some children already are helped by intense therapy.
"We have trouble getting through to these children, but with repeated stimulation we can do it," he said. "These are circuits that have an ability not so much to recover but to work around the problem."
Click here for the Washington Post's article: Mental Activity May Affect Autism-Linked Genes
Click here for Time Magazine's article: New Clues to Autism's Cause
July 15, 2008
Bush Vetoes Bill Protecting Doctors From Medicare Cuts
CNN reports that Bush has vetoed last week's approval of the Medicare Bill, which would have prevented cuts in Medicare payments to doctors. Prospects of a veto override in the Senate are unclear. CNN writes,
The bill would reverse a 10.6 percent cut in Medicare payments to doctors. The cuts in Medicare payments -- part of a scheduled cost-saving formula -- went into effect July 1, although the Bush administration said it would hold off processing claims until mid-July to give Congress time to reach a compromise on the legislation.
The House of Representatives last month passed the bill 359-55 -- considerably more than the 290 votes needed to override a veto.
The prospects for a veto override in the Senate are murkier.
A filibuster held up the bill before being broken by a 69-30 vote Wednesday. Sixty-seven votes are needed to override Bush's veto. But there's no guarantee that all the senators who voted to end the filibuster would vote to override the veto.
Similar cuts were scheduled to go into effect on July 1 in previous years, but Congress always voted to stop the cuts.
While the debate was raging over the bill, a major doctors' group said the cuts could lead to a "meltdown" of the government's health care system for the elderly.
At the heart of the dispute is the decision by Democratic lawmakers to pay for the "doctors' fix" by cutting funds for Medicare Advantage, a program administered by private insurance companies that is generally favored by Republicans and opposed by Democrats.
The program, which has more benefits than traditional Medicare, is also more expensive.
Republicans -- joined by the insurance industry -- fear Democrats are trying to weaken the Medicare alternative by draining funds away from it.
The Medicare system pays for the health care of roughly 40 million elderly Americans. Rising health care costs have made Medicare a growing part of the federal budget, and the stress on the system is increasing as more baby boomers reach retirement age.
The American Medical Association, a powerful doctor's group, said its members may be forced to reduce service to Medicare patients if the cuts go into effect.
According to a recent association survey, 60 percent of physicians will be forced to limit the number of new Medicare patients they can take on if the cuts go into effect.
"We stand at the brink of a Medicare meltdown. ... For doctors, this is not a partisan issue -- it's a patient access issue," AMA President Nancy Nielsen said in a statement after last week's Senate vote.
The AMA ran radio and TV ads over the July Fourth congressional recess targeting 10 Republican senators, seven of whom are up for re-election.
The AARP, the nation's largest organization of retired persons, and other groups also are weighing in against the cuts.
Gerald Harmon, a family physician who practices in Pawleys Island, South Carolina, said the cuts could lead to doctors taking fewer Medicare patients, making it difficult for the program's elderly patients to get the care they need.
"This Medicare access problem is a real issue, not just a political football," said Harmon, who said 35 percent of his patients were eligible for Medicare. "It affects your dad, when he's sick. It affects my patients in my practice. This has to be addressed."
Amgen, Johnson & Johnson Come to Truce in Oncology Marketing Suit
The Wall Street Journal reports on the $200 million settlement between Amgen and Johnson & Johnson after a two-and-a-half year battle over marketing of rival oncology products. Marilyn Chase writes,
Amgen Inc. agreed to pay $200 million to settle an antitrust lawsuit by Johnson & Johnson's Ortho Biotech Products unit, putting to rest 2 1/2 years of legal wrangling over Amgen's sales of its oncology products.
Ortho, based in Bridgewater, N.J., had filed suit in October 2005 alleging that discounts and incentives offered to oncology clinics buying Amgen's blood-cell-boosting products Aranesp, Neupogen and Neulasta constituted anticompetitive business practices.
Amgen denied and continues to dispute suggestions that such incentives constitute unlawful conduct. Ortho markets Procrit, which competes with Aranesp.
Under the settlement, Ortho's litigation in New Jersey District Court was dismissed. Amgen, based in Thousand Oaks, Calif., admitted no wrongdoing under terms of the agreement.
Ortho in a statement said the settlement will result in an after-tax gain of about $120 million to Johnson & Johnson's third-quarter results.
An Amgen spokesman said the company didn't change its sales practices in response to the lawsuit, but that it reviews its contracts in response to market conditions and will continue to do so to remain competitive.
"We are pleased to have reached a settlement that puts this litigation behind us," said Amgen Chief Executive Kevin Sharer in a statement. Ending the expense and uncertainty of the suit is in shareholders' best interests, he said.
Aranesp, part of a family of drugs known as erythropoietin-stimulating agents, boosts red-blood-cell production in patients with anemia due to chemotherapy and kidney disease. Sales of such products have fallen recently on concerns over cardiovascular risks and cancer progression.
Neulasta and Neupogen are used to treat or prevent a plunge in certain white blood cells and risk of infection due to cancer treatment.
Amgen 's world-wide sales of Aranesp totaled $761 million in the first quarter of 2008. Combined world-wide sales of Neulasta and Neupogen totaled $1.086 billion in the same period.
Under its current contracts, Amgen grants its customers certain Aranesp rebates based on share of sales. Neulasta rebates are also based on meeting a threshold of sales. Customers are offered an opportunity to obtain higher rebates if they purchase both Neulasta and Aranesp under what is called the Amgen Portfolio Contract.
Amgen hasn't made any decision whether to modify its current contracts but is expected to review them.
DNA Testing Industry Wrestles with California Law
The Los Angeles Times reports that as a result of violating two types of California laws, the California State Department of Public Health ordered thirteen DNA testing companies operating in California to stop performing genetic testing. Consumer complaints about the accuracy and cost of genetic testing services advertised online fueled action by the state. Four of the thirteen companies have already been suspended. Karen Ravn writes,
Is there a heart attack in your future? Or just the heartbreak of psoriasis or male pattern baldness? Companies offering genetic tests directly to consumers have proliferated. Send them your DNA, in a swab of your cheek or a bit of your spit, and they'll tell you what your genes tell them -- about your ancestry, characteristics, likelihood of developing a number of diseases and conditions.
Some test for mutations in particular genes that are linked to diseases, such as cystic fibrosis or breast cancer. Others take a big-picture approach, offering wide-scale scans of your genome.
On June 9, the state Department of Public Health sent letters to 13 testing companies operating in California telling them they were breaking California law and ordering them "to cease and desist performing genetic testing without licensure or physician order." Of the 13, five are in California, and the others are in other states or outside the country.
As of July 10, four have suspended business in California. But nine of the companies, believing they are in compliance with the law, are still up and running.
Now, as consumers are left wondering what the standoff means for them, policy experts wonder what it means for the industry long-term.
What exactly happened?
In its letter to the 13 direct-to-consumer genetic testing companies, the public health department told them they were violating two types of California laws: ones that require licensing of clinical laboratories located in California or that test biological specimens originating in California (such "specimens" include the cheek swabs or spit samples used in genetic tests); and ones that require any clinical laboratory tests offered directly to consumers to be ordered by a physician, unless the tests are specifically exempted by law. "Genetics tests are NOT exempt," the letters emphasized.
Why did the health department do this right now?
The action stemmed from "numerous" consumer complaints about the accuracy and cost of genetic testing services advertised online, says Lea Brooks, public information officer for the health department, adding that the department continues to receive complaints as well as inquiries from consumers.
Rick Weiss, a senior fellow at the Washington, D.C.-based Center for American Progress, a think tank that studies policy issues, sounded skeptical, saying: "One has to wonder whether these supposed complaints came from actual clients or from, say, some academic biochemist or a competing company not doing business in California."
Representatives of the three companies contacted for this story said they knew of no complaints about their own companies. And the letters from the health department did not discuss any prices consumers had complained about.
Who got letters, who didn't, and why?
Citing an "ongoing investigation," Brooks declined to explain how the department decided which companies would get letters and which wouldn't. The 13 receiving such letters included some big names -- 23andMe, deCODEme Genetics and Navigenics. Other heavy hitters, such as San Francisco-based DNA Direct, did not receive letters. (23andMe of Mountain View and Navigenics of Redwood Shores offer broad genome scans, while deCODEme, in Iceland, tests for specific diseases, as does DNA Direct.)
Ryan Phelan, chief executive and co-founder of DNA Direct, offers her own theory. "I believe the reason we did not receive a letter is because DNA Direct has always exceeded the guidelines provided by regulatory agencies," she says.
Some of the companies that did receive letters believe much the same thing about their businesses. "We are quite confused," says Mari Baker, president and chief executive of Navigenics.
How did the companies respond?
After the letters went out, four genetic testing companies who received them called it quits in California, placing disclaimers on their websites to prevent Californians from ordering. At least one company, SeqWright, decided to withdraw from the California market, even though it didn't receive a letter. But for others, including Navigenics and 23andMe, it's full steam ahead. Those two companies say they don't do lab testing themselves, but the labs they contract with are properly licensed. And physicians order all the tests, so they believe they're in compliance with state law.
Why does the state disagree?
Health department spokeswoman Brooks declined to discuss these issues because the investigation is ongoing. But company representatives, geneticists and policy experts suggested several possibilities.
"The state might not be aware of what we're doing," says Navigenics' Baker. (It might not know, for example, that a given company does no actual testing itself, instead sending its saliva or swab samples to a licensed clinical lab.) Alternatively, "there may be some new interpretation [of the laws] we're not aware of." Or the parties may have different ideas about who can order tests. The state might believe the client's personal doctor should do it, not a doctor hired by the company to authorize tests.
If that's the case, then Kathy Hudson, director of the Pew Genetic Testing Quality Initiative at the Genetics and Public Policy Center at Johns Hopkins University, agrees with the state. She believes clients should have a relationship with the doctor who orders the test -- the kind they have with their own doctor.
Hank Greely, director of the Center for Law and the Biosciences at Stanford University, believes the level of physician involvement at companies like Navigenics and 23andMe may be sufficient to comply with state law. And the fact is, of course, that tests for pregnancy, glucose and blood cholesterol are already exempt from the requirement to have a physician.
There is some disagreement on when gene tests should be considered "clinical laboratory tests." A gene test to establish your descendants can turn up fascinating -- or disturbing -- details such as having Genghis Khan for an ancestor. But the state doesn't consider genealogy (or paternity) tests to be medical tests, so they're not subject to the laws requiring licensed labs and doctors' orders.
Navigenics and 23andMe don't believe the gene scans they provide are medical tests either. "We see our service as informational, rather than diagnostic," says Linda Avey, co-founder of 23andMe. "Our service tells customers how their risk for certain conditions is affected by their genotype but cannot tell them that they have or will get those conditions."
Genetic tests that provide information about disease risk are indeed medical tests, counters Hudson. "To say otherwise is untruthful and threatens to undermine the promise and hope we have for the real public health benefits of genetics," she says. Adds Greely, "You can't sell people on the health benefits of your service and then say it isn't about medicine."
Does this mean Californians can't order genetic tests anymore?
No. Some companies didn't receive the letters at all, and some that did are still offering tests.
Can I order a test from a company in another state or country?
No matter where a company is located, if it offers tests to Californians it's supposed to comply with California law. Some companies outside the state are still offering tests to Californians.
Where do things go from here?
The health department has legal options -- seeking injunctions, pursuing criminal prosecutions -- to stop companies from continuing to practice their businesses. It will not comment on its plans. Representatives of Navigenics and 23andMe say they would like to meet with state health officials to discuss the impasse and try to resolve it. "There could be friendly compromise, or it could end up in the courts," Weiss says.
Do we need new rules and regulations for this new industry?
Greely thinks so. "The current legislation was certainly not written with this industry in mind," he says. Hudson says the main goal of state or federal regulations should be to guarantee that tests are safe and accurate and that claims made about them are truthful. Ideally, federal laws would be written, says Dr. Robert Nussbaum, chief of the Division of Medical Genetics at UC San Francisco: "State by state would be a nightmare." There are no federal laws yet on the matter of direct-to-consumer gene testing.
Still, Weiss cautions that medical regulation has historically been up to the states, and he doubts they'll want to give up control entirely.
Guide to Genetic Testing
The Wall Street Journal provides a brief guide to understanding the costs, processes, and legal protections of genetic testing and what insurers typically cover in such testing. Jilian Mincer writes,
A new federal law and many state laws prohibit employers and health insurers from discriminating on the basis of genetic tests.
Consumers should recognize, however, that some genetic tests involve more out-of-pocket costs -- and also raise thorny questions about their benefits and desirability.
Insurers typically cover a genetic test that's definitive and could make a difference in someone's treatment, says Helen Darling, president of the nonprofit National Business Group on Health. In such cases, "it is advantageous for the [insurance] plan for these risks to be identified," she says.
For example, WellPoint -- like most insurance companies -- covers the test for BRCA1 and BRCA2 because women with the gene have a greater risk of developing breast and/or ovarian cancer, says Alan B. Rosenberg, the company's vice president of medical policy.
Women who test positive often get more frequent tests, clinical exams and mammograms. Some even chose prophylactic surgery.
In contrast, WellPoint doesn't cover tests for Alzheimer's disease, because there currently is no prevention or potential treatment.
Individuals may or may not see value in knowing they are likely to get a serious disease for which no prevention or treatment is currently available.
More Tests Than Ever
While doctors have long done prenatal screenings for chromosomal abnormalities such as Down syndrome, there are now tests available for numerous genetic disorders -- and which may indicate increased risk of disease long before symptoms appear. Testing may be used before conception or in vitro fertilization, to confirm a diagnosis, or to screen for illnesses that run in one's family. Genetic tests also can be used to gauge a patient's probable response to a medication.
The tests typically use a patient's blood, saliva or tissue. Most cost $1,000 to $2,000, says Steven Keiles, president-elect of the National Society of Genetic Counselors. But some cost much more.
The Genetic Information Nondiscrimination Act, or GINA, signed into law by President George W. Bush in May, prohibits health insurers from raising premiums or denying coverage based on genetic information. It applies to people who have genes that carry the risk of disease, but not to those who already have a disease.
The law also prohibits employers from using genetic information when making decisions about hiring, firing, promotions or job assignments.
About 47 states have their own laws that prohibit discrimination in health insurance, and about 35 states have laws against genetic discrimination in employment.
Consumers can look at their insurance carriers' Web sites for more details about coverage for genetic testing and associated counseling.
Ms. Darling recommends also getting information from sources such as the National Institutes of Health or an association affiliated with a condition, such as the American Heart Association or the American Cancer Society. Useful Web sites to visit include MedlinePlus.gov, Mayoclinic.com and nsgc.org.
Is Genetic Testing Really Worth the Cost?
As genetic testing becomes more widely understood and administered, Karen Ravn for the Los Angeles Times questions whether the costs (and hidden costs) of genetic testing are actually worth it. Ravn writes,
Everyone agrees that the science of gene testing is imperfect, but the companies offering tests directly to consumers, along with their supporters, say the information they give is valid and valuable, noting that clients can get updates as more is learned.
Critics aren't so sure that the people being tested always get their money's worth. And many believe that even when gene tests and claims about links to diseases are accurate, they may be confusing. "This kind of testing, this kind of knowledge about ourselves, is so new," says Dr. Edward McCabe, co-director of the UCLA Center for Society and Genetics. "We can get a whole lot of information, and we're not going to know what a lot of it means."
Some testing companies work hard to solve this problem. For example, Navigenics of Redwood Shores employs three highly trained full-time genetic counselors, one of whom is assigned to each client.
Still, says Dr. Robert Nussbaum, chief of the Division of Medical Genetics at UC San Francisco, no matter how well it's explained, some of the information people get simply doesn't mean much. Some DNA tests are highly predictive of disease -- for example, tests for mutations in the cystic fibrosis gene -- but others are based on flawed data or so weakly predictive that many who test negative will end up getting the disease, while many who test positive will not (an example would be tests for risk of Type 2 diabetes).
In such cases, Nussbaum says, "the information is basically useless." It might even be counterproductive, he adds, if someone who tests negative -- for, say, diabetes risk -- then has less incentive to adopt healthful life habits.
Even highly predictive tests can be unhelpful if they predict conditions that can't be treated or prevented, such as Huntington's disease, Nussbaum adds. They can simply make a client worried or scared.
In all, says Hank Greely, director of the Center for Law and the Biosciences at Stanford University, while some companies clearly provide useful information to their clients, "some companies provide nothing beyond a new way of wasting money."