Thursday, April 14, 2011

Health - Reporter’s File: A Generation of Autism, Coming of Age

Health - Reporter’s File: A Generation of Autism, Coming of Age

Reporter’s File: A Generation of Autism, Coming of Age

Posted: 13 Apr 2011 12:57 PM PDT

As the explosion of children who were found to have autism in the 1990s begins to transition from the school to the adult system, experts caution about the coming wave.

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Ben Sklar for The New York Times

John Hart, 24, has severe autism. He is nonverbal and communicates through hand gestures, touch and typed responses. His mother, Ann, often serves as a voice for her son.

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“We estimate there are going to be half a million children with autism in the next 10 years who will become adults,” said Peter Bell, executive vice president for programs and services of the advocacy group Autism Speaks.

Services for adults with autism exist, but unlike school services, they are not mandated, and there are fewer of them. Combined with shrinking government budgets, the challenges are daunting.

“We are facing a crisis of money and work force,” said Nancy Thaler, executive director of the National Association of State Directors of Developmental Disabilities Services. “The cohort of people who will need services — including aging baby boomers — is growing much faster than the cohort of working-age adults that provide care.”

To help parents navigate this difficult journey, in January Autism Speaks introduced a free Transition Tool Kit for parents and their adolescent children with autism. The kit includes information about such critical issues as community life, housing, employment and developing self-advocacy skills. The tool kit can be customized by state for those who register online.

“There is a time you have to get over this hump where you are essentially acknowledging that your child is going to have autism for the rest of his life,” said Mr. Bell, the father of an 18-year-old son with autism. “Our hope with this kit is to help parents to start planning and not get frozen.”

Many young adults with autism have transitioned into large residential systems, whether group homes or institutions, offering round-the-clock services. But waiting lists can be long. And increasingly, in an effort to stem costs, states are moving away from the group home model into family-based care, a trend that started about 10 years ago.

“If an individual needs 24-hour services, the staffing ratio is one to one,” said Charlie Lakin, who heads the Research and Training Center on Community Living at the University of Minnesota. “That means fewer people will get served, resulting in long waiting lists for other families.” Nationwide, 59 percent of people who receive autism services are living with their families, according to Mr. Lakin.

Living with one’s family may not always be best for a person with autism. Nor is it what many families, who assume their grown child will move into a group home, for example, envision for their future. But options are limited, and given the high demand for out-of-home residential services, Mr. Lakin said, “families really need to think about a longer and more central involvement in their adult child’s life than they have in the past.”

The good news is that many states are providing more support for people with autism who live with their families. They are also giving families greater flexibility and control over budgets with so-called consumer-controlled services, which reimburse families that hire friends or relatives, rather than outside caregivers, for regular care.

Connecticut and Arizona, for example, pay for care provided by family members, a growing trend. Other states, like Pennsylvania, have programs in which contracts are issued for people with autism to live with other families. And Vermont and New Hampshire pioneered a model of providing funding directly to families.

Some families have pooled their own money and entered into cooperatives with other families, a challenge that can take years. Families with children who have developmental disabilities “are relentless advocates and have been the most successful at garnering resources and services,” Ms. Thaler said. “I think it may be the vulnerability of people with developmental disabilities that evokes in families and professionals a level of extraordinary empathy that makes them powerful advocates.”

Among the most powerful advocates are siblings of those with developmental disabilities. “Sibs have always played a really important role; we just haven’t identified them as sibs,” Mr. Lakin said. “We’ve identified them as agency leaders and social workers occupationally. But the real impulse of their work is that they were a sibling.”

Don Meyer, the founder and director of the Sibling Support Project and the creator of Sibshops, a network of programs for young siblings of children with special needs, said: “Parents need to share their plans for their special-needs child with their typically developing kids. After Mom and Dad are no longer there, it is likely it will be the brothers and sisters who will ensure their sibling leads a dignified life, living and working in the community.”

Mr. Lakin said: “It’s really about having people live the best life they can, in the place and with the people they want to live with. There’s no magic to that.”

Bring on the magicians.

Publish date: 4/13/2011

Consults: Ask the Experts About Autism

Posted: 14 Apr 2011 04:34 AM PDT

Recipes for Health: Shrimp and Brown Rice Soup

Posted: 14 Apr 2011 12:10 AM PDT

This irresistible soup is inspired by a Southeast Asian dish traditionally made with Thai jasmine rice. The recipe is adapted from one in “Hot Sour Salty Sweet,” by Naomi Duguid and Jeffrey Alford.

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Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

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2 shallots, finely chopped

4 large garlic cloves, minced

1/2 teaspoon freshly ground black pepper

2 tablespoons Vietnamese or Thai fish sauce

1/2 pound peeled, deveined shrimp, finely chopped (about 3/4 pound in the shell)

2 quarts water; or use half chicken or vegetable stock, and half water

1 cup sprouted brown rice

2 stalks lemon grass, trimmed and minced

2 tablespoons peanut oil or canola oil

For garnish:

2 tablespoons dry-roasted peanuts, coarsely chopped

1 cup cilantro leaves

2 cups bean sprouts

Minced bird or serrano chilies

Lime wedges

Sprouted brown rice is a packaged product that you can find in natural foods stores with other packaged grains. The grains are sprouted, then dried. It looks and cooks like regular brown rice.

1. Mix together the shallot, half the garlic, the pepper, 1 tablespoon of the fish sauce and the shrimp. Set aside.

2. Combine the remaining garlic and the lemon grass in a mortar and pestle, and grind to a paste. Alternatively, mince in a mini-chop.

3. Combine the water or stock and water, remaining fish sauce and rice in a soup pot, and bring to a boil. Stir in the garlic and lemon grass paste, and reduce the heat. Taste the water and add salt if desired. Cover and simmer 40 minutes until the rice is tender.

4. Heat the oil over high heat in a wok or skillet, and add the shrimp mixture. Stir-fry until the shrimp begins to turn pink, about one minute. Add one ladleful of liquid from the soup pot, stir together, then transfer the contents of the wok or pan to the soup. Bring back to a simmer, and simmer five minutes. Taste and adjust seasonings.

5. Serve, garnishing each bowl with cilantro, chopped peanuts, bean sprouts and chilies if desired. Have guests squeeze lime into their bowls.

Yield: Serves six.

Advance preparation: You can make this several hours before serving. Remove from the heat, refrigerate if leaving for more than an hour, and reheat just before serving.

Nutritional information per serving: 222 calories; 1 gram saturated fat; 2 grams polyunsaturated fat; 3 grams monounsaturated fat; 61 milligrams cholesterol; 28 grams carbohydrates; 2 grams dietary fiber; 657 milligrams sodium (does not include salt to taste); 11 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

As Generics Near, Makers Tweak Erectile Drugs

Posted: 13 Apr 2011 09:30 PM PDT

Facing generic competition for its “little blue pill,” Pfizer recently started selling a chewable form of Viagra in Mexico. It is called Viagra Jet, and Pfizer says it may also market it to other nations in the developing world, if not the United States.

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Cialis is projected to become the top-selling of the three drugs in the world this year, passing Viagra.

Levitra, another erectile dysfunction drug, is now sold as a dissolvable tablet in nine European countries and may come to American pharmacies as soon as this month under the name Staxyn. That new form of the drug, which fizzes and dissolves in seconds, is marketed in a pocket-size, midnight-black box for men who prefer to take it discreetly, without water.

The third drug for erectile dysfunction to reach the market, Cialis, now eight years old, is racing ahead of the others because of two ideas that have proven extremely popular: an everyday pill and a 36-hour “weekender.” Cialis is projected to become the top-selling of the three drugs in the world this year, passing Viagra.

The market for drugs to correct erectile dysfunction has passed $5 billion a year from sales to tens of millions of men. And it is increasingly being driven by novel applications to compete with the lower-priced generics on the horizon.

“ ‘Gimmick’ is a strong word, but all of this is designed to create new brand identities,” Dr. Joseph P. Alukal, an assistant professor and director of reproductive health at the New York University School of Medicine, said. “A newer product, less expensive, and a new form of taking it — all that might convince more people to try it.”

Research is also under way in Brazil on a faster-acting form of the drugs, which increase blood flow by relaxing smooth muscle cells. While the existing pills enter the bloodstream indirectly by way of the stomach, intestines and liver, this form would enter more directly, dissolving in a capillary-rich space under the tongue and increasing the blood flow within 10 or 15 minutes. The research in Brazil involves generic Viagra, but Pfizer says it is not sponsoring the work.

The Mexican experiment with Viagra Jet will show whether the chewable form of the drug has promise in other countries, particularly developing markets, Susan O’Connor, Pfizer’s vice president of global commercial development, said in an interview. Studies showed most Mexican men who used Viagra ground it up to make it easier to swallow or in the belief it would start acting faster.

In explaining why the drug is being test-marketed in Mexico, Ms. O’Connor cited “patient preference, found in market research.” Mexico is the biggest market for Viagra in the developing world, with about $55 million in sales last year. At this point, Pfizer does not have plans to bring Viagra Jet to the United States, she said.

In America, Pfizer is battling to keep low-price generic competition off the shelves a year from now, when the drug’s patent expires. The generic pills would cost only a fraction of the $10 or more that each pill now costs.

Bayer, meanwhile, has introduced the dissolvable form of its Levitra drug in Austria, France, Hungary, Germany, Spain, Poland, Sweden, Denmark and Britain, where it went on sale in late March. The drug is called Levitra ODT, for orodispersible tablets. It comes in a thin black package the size of a half-dozen stacked credit cards, with four pills on a card that slides out.

“It’s pocket-friendly, discreet and gives the product a playful edge over its competitors,” Thomas Proske, global brand manager for Levitra at Bayer Healthcare, said in a statement.

The same pill was approved in the United States last June under the brand name Staxyn.

It will be available in pharmacies this month, according to Jess Macnaught, marketing executive with Burgopak Design and Packaging, the London company that designed the new black package. GlaxoSmithKline and Merck have licensed American rights from Bayer, but they declined to reveal when the drug would be introduced. Last year, they said Staxyn would reach the market in late 2010.

Worldwide sales of erectile dysfunction drugs grew 6.9 percent in 2010, to about $5 billion, and 4.7 percent in 2009, according to the industry data firm IMS Health.

Dr. Alukal of New York University said he thought Staxyn could be sold for a much lower price than what Levitra and other pills now cost, in part to compete with a generic Viagra. No price has been revealed.

“I guess it could be easier to ingest, so it could expand its market somewhat, but in the end the bigger issue would be cost,” Dr. Alukal said. He said the companies, for whom he does not consult, had talked about lower pricing, perhaps to under $10 a pill.

But for now, Pfizer, the company that started it all, is focusing its attention on protecting the pricing power and brand integrity of Viagra.

Patrick Ford, a former F.B.I. agent who leads the company’s security operations in the Americas, says Viagra is the most counterfeited product in the world. His agents pose as buyers, collect evidence and bring fraud cases to prosecutors, and he says fake Viagra may be unsafe. Pfizer and other pharmaceutical companies are working with Victoria Angelica Espinel, the government’s intellectual property enforcement coordinator, a position President Obama appointed her to in 2009.

Pfizer is also using its legal firepower against would-be generic competitors. Pfizer has two patents for Viagra, one for its chemical, expiring in 2012, and the other for its use against impotence, expiring in 2019. Pfizer sued Teva Pharmaceutical Industries, the biggest generic-drug company, in March 2010 under the “use” patent. The suit is pending in a Virginia federal court.

MacKay Jimeson, a Pfizer spokesman, said the company was confident it would keep the 2019 patent protection, but industry analysts disagree.

“ ‘Use’ patents are not highly probable of being upheld in court,” said C. Anthony Butler, a Barclays Capital pharmaceuticals analyst. “Most if not all analysts assume the expiry of the drug upon expiry of the composition of matter patent.”

The chemical patent expires on March 27, 2012. Pfizer may be able to extend it another six months, to September 2012, under a federal law called the Best Pharmaceuticals for Children Act. The law is meant to encourage drug companies to study children’s uses, often a difficult and unprofitable area.

In this case, what would be studied is not Viagra for children, but Revatio, a formulation of the same chemical, sildenafil, which is approved for pulmonary arterial hypertension, a rare and dangerous condition affecting hundreds of children in the United States. Mr. Jimeson said the company was working closely with the Food and Drug Administration to discuss the pediatric studies of Revatio and the potential for an extension on the chemical patent, which would also protect Viagra and its prices.

Many men, though, have waited years for a lower-priced Viagra and their wish may come true next year.

Other researchers are testing new uses for Viagra that Pfizer says it is not financing. Boston University is studying it with testosterone gel in men 40 to 70. Laboratório Teuto Brasileiro, in Brazil, where the patent expired last year, has filed a notice of intent to test it in a tablet that dissolves under the tongue and has an effect in 10 minutes or so. Pfizer owns 40 percent of the lab but says that it did not initiate the study.

Eli Lilly, meanwhile, says it has no plans to try chewable or dissolvable or any other forms of its Cialis tablets, and why should it? Cialis sales have steadily increased since it was introduced in 2003, to $1.7 billion last year, close to Viagra’s $1.9 billion. The health care investment house Leerink Swann estimates that Cialis sales will edge past Viagra in 2011 and far surpass the iconic blue pill in 2012.

Shawn Heffern, Lilly’s United States marketing director for Cialis, says, “I couldn’t be more happy.”

Study Finds Drop in Deadly V.A. Hospital Infections

Posted: 14 Apr 2011 10:38 AM PDT

ATLANTA — An aggressive four-year effort to reduce the spread of deadly bacterial infections at veterans’ hospitals is showing impressive results and may have broad implications at medical centers across the country, according to the first comprehensive assessment of the program, which was released Wednesday afternoon.

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Jeff Swensen for The New York Times

A study suggested great benefits from measures like washing hands, wearing gloves and screening all patients for deadly bacteria.

The study of 153 Veterans Affairs hospitals nationwide found a 62 percent drop in the rate of infections caused by methicillin-resistant Staphylococcus aureus, or MRSA, in intensive care units over a 32-month period. There was a 45 percent drop in MRSA prevalence in other hospital wards, like surgical and rehabilitation units.

The Veterans Affairs strategy employs a “bundle” of measures that include screening all patients with nasal swabs, isolating those who test positive for MRSA, requiring that staff treating those patients wear gloves and gowns and take other contact precautions and encouraging rigorous hand washing. The results may not be easily replicated in the private sector, but they are likely to step up pressure by further undercutting the notion, prevalent at many hospitals not long ago, that infections are an unavoidable cost of doing business.

“I think our study has shown that it is possible to make this large-scale change, even in a large system,” said Dr. Rajiv Jain, an official with the Veterans Health Administration and the study’s primary author. “If other hospitals were to follow our lead, I think it is possible to decrease these infections.”

But a second large study of intensive care cases, also published Wednesday, raises doubts about whether a key component of the veterans’ approach — the testing of every patient upon admission and discharge — is necessary or cost-effective. Taken together, the studies are likely to stoke a raging debate among infection control specialists about the wisdom of universal testing, which can be expensive and time-consuming for hospitals.

The studies were published in tandem in The New England Journal of Medicine one day after the Obama administration announced a new initiative aimed at preventing hospital infections and other medical errors. With a goal of reducing preventable conditions by 40 percent over three years, the Department of Health and Human Services plans to spend up to $1 billion made available by the 2010 health care law to improve patient safety at hospitals and avoid costly readmissions.

There have been some recent signs of progress. A study published last year found that the incidence of MRSA in hospitals in nine cities dropped by 28 percent between 2005 and 2008.

But the Centers for Disease Control and Prevention in Atlanta still estimates that one of every 20 patients will acquire an infection while hospitalized. Using data from 2002, the agency concluded that hospital infections were associated with 99,000 deaths and costs of $28 billion to $34 billion a year.

The quantification of the human toll, and the cost to state and federal health programs like Medicaid and Medicare, has spurred governments to attack the problem.

Reimbursements to hospitals may now be docked when patients develop infections or require readmission for infections and other errors. Many states mandate public reporting of hospital infection rates and other quality measures. Ten states require that patients be tested for antibiotic-resistant bacteria like MRSA upon admission to intensive care units, where the threat of infection is typically highest.

It has long been clear that patients and health care workers pass the germs to one another, and that diligent hand hygiene and other precautions can significantly reduce the risk of transmission. But compliance with guidelines has been uneven at best.

The study of intensive care units released Wednesday, for instance, found that health care workers wore gloves only 82 percent of the time when such precautions were specified, donned gowns only 77 percent of the time and washed their hands after only 69 percent of patient contacts. The lead author, Dr. W. Charles Huskins of the Mayo Clinic in Rochester, Minn., noted that those numbers were “not woefully bad,” as previous studies had found hand-washing compliance to be as low as 50 percent.

Focusing on MRSA and another virulent bacterium, vancomycin-resistant enterococcus, the study found no significant difference in infection and colonization rates between intensive care units that tested patients as a matter of course and those that did not.

As with the veterans’ hospitals, the study of intensive care units found that universal testing detected large numbers of patients with infections or bacteria present whose status would not otherwise have been known. But units that did not conduct universal testing, and where doctors simply ordered screening if symptoms presented, had similar rates of infection.

The study, of 9,000 cases in 2005 and 2006, was the first exploration of the question in a randomized controlled trial, the gold standard of epidemiological research.

Dr. Huskins and his colleagues had hypothesized that universal testing, and the expanded use of gloves, gowns, hand-washing and other precautions, would make a difference. They were surprised by the results, and posited that additional techniques, like antiseptic bathing of patients and more rigorous cleaning of rooms, might be necessary.

“Universal screening with the use of isolation precautions, at least as we studied it, is not likely to be a highly effective strategy across the board,” Dr. Huskins said.

Dr. Jain of the Veterans Health Administration said he had concluded precisely the opposite after watching the agency replicate the success of the model he helped pioneer at a Pittsburgh hospital. Although his study could not demonstrate it scientifically, he said he was convinced that testing all patients upon admission had been “a very significant component.”

The veterans’ hospitals also have encouraged cultural changes aimed at empowering front-line workers, whether nurses or janitors, to innovate ways to control infection. Dr. Jain said the testing of every patient had itself reinforced that cultural shift.

“Testing every patient brings the infection control initiative into the thinking of the entire staff,” he said. “The staff takes more ownership, not only of hand hygiene and other precautions but also of doing whatever is necessary to prevent the spread of these infections.”

Infection rates at the veterans’ hospitals had been static in the two years before the new approach was implemented systemwide in 2007. The hospitals then saw significant decreases in every form of MRSA-related infection. Dr. Jain said each hospital spent between $160,000 and $300,000 a year to employ a prevention coordinator and lab technician and to purchase testing supplies, gowns and gloves.

Dr. John A. Jernigan, an authority on hospital infections with the Centers for Disease Control, said it was not clear how to reconcile the two studies.

“But one message these studies, taken together, do convey is that MRSA is too complex a problem to be controlled with any single intervention,” said Dr. Jernigan, who participated in both studies. “The overriding message of the V.A. study is that hospitals can make a difference, and that’s important because it shifts the conversation from if it can be done to how it might best be done.”

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In Japan, Aftershocks Are Also Felt From Within

Posted: 14 Apr 2011 06:01 AM PDT

TOKYO — Aguri Suzuki, a 44-year-old real estate agent, says she sometimes thinks the ground is shaking even when it is not. When she sees a tree branch swaying in the wind, she worries there has been an earthquake.

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Elementary school children crouched under their desks in Onagawa, Japan, during an aftershock on Tuesday. 

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A spokesman for the Tokyo Electric Power Company after a news conference on Monday in Tokyo on the situation at the Fukushima Daiichi plant.

Doctors here say they are seeing more people who are experiencing such phantom quakes, as well as other symptoms of “earthquake sickness” like dizziness and anxiety.

And it is no wonder. As if the threat of radiation from a crippled nuclear power plant were not enough, Tokyo and the region to its northeast have been under a constant barrage of aftershocks since the magnitude 9.0 earthquake that set off a devastating tsunami on March 11. Two earthquakes were felt in Tokyo on Wednesday morning, three on Tuesday, a large one on Monday and a very large one of magnitude 7.1 last Thursday.

Over all, there have been 400 aftershocks of magnitude 5.0 or greater in northeastern Japan since March 11. That is as many sizable quakes in one month as Japan typically experiences in two and a half years, according to the Japan Meteorological Agency.

The quakes are complicating efforts to control the Fukushima Daiichi nuclear power plant. For instance, the quake on Monday knocked out cooling at the Fukushima plant for nearly an hour.

Every time a sizable quake occurs, the first question on many people’s minds is whether the nuclear plant has been further damaged and whether a new cloud of radiation is on the way. A spokesman for the Tokyo Electric Power Company, the plant’s owner, is then hustled onto television to reassure viewers.

Government officials are becoming concerned that in the rush to cool the reactors and prevent hydrogen explosions, the plant’s vulnerability to another tsunami has been overlooked.

“A week ago we thought the major risk was a hydrogen explosion,” a senior official in the office of the prime minister said Tuesday. “I think the major risk at the moment is an aftershock and tsunami.”

Hidehiko Nishiyama, the deputy director general of Japan’s nuclear regulator, the Nuclear and Industrial Safety Agency, said at a news conference on Wednesday evening that three measures are being considered that would allow electricity and cooling at the plant to remain intact even after a tsunami measuring 15 meters, or 49 feet. Right now the site can withstand a tsunami of only about 18 feet, he said. One measure is to interconnect the external power lines that have been built to the power plant, so that if one power line is broken, the others can still carry electricity to the various reactors.

A second measure is to put a generator on a small hill inside the plant site, and the third is to place a fire pumper engine on the hill that could send water into the reactors and spent fuel pools even if electricity was interrupted.

Japan, which sits atop four colliding tectonic plates, has a long history of earthquakes and some sophisticated technology to deal with them.

A detection system transmits warnings of some pending quakes a few seconds in advance to television broadcasters and to many cellphones. In recent weeks it has not been unusual to see nearly all the people in a restaurant or a train suddenly look at their cellphones at the same time.

Yurekuru, a free app for the iPhone that delivers such warnings (its name might be translated as “the shaking is coming”), now has 1.5 million users, compared with only 100,000 before the March 11 quake, according to RC Solution, the app’s developer.

Geologists say the frequency of the aftershocks has declined since March 11 and will continue to decline, but will still remain higher than normal for a long time. “There is an increased frequency and it will last for at least five or ten years,” said Ross S. Stein, a geophysicist at the U.S. Geological Survey in Menlo Park, Calif., who has studied the situation in Japan.

The March 11 quake was so strong that a Japan Coast Guard monitoring instrument on the floor of the Pacific Ocean near the epicenter moved 24 meters, or about 79 feet, eastward. The city of Sendai, whose airport was inundated by the tsunami, moved about 13 feet, according to Shinji Toda, a professor at Kyoto University.

Such large movements have shifted stresses in the earth, increasing the likelihood of quakes on some fault lines while reducing the likelihood on others, including the one involved in the 1923 Tokyo earthquake.

But over all, Dr. Stein said, the risks have increased. “There’s this very broad turn-on of seismicity that extends 300 miles from the rupture zone,” he said.

Satoko Oki, an assistant professor at the University of Tokyo’s earthquake research institute, said that an aftershock of the March 11 quake could reach magnitude 8.0.

There is some precedent. The 2004 quake of magnitude 9.1 near Sumatra, Indonesia, which spawned a tsunami that killed more than 200,000 people, was followed three months later by one measuring 8.6 and later by four more huge ones.

But the 8.8 magnitude earthquake in Chile in early 2010 has not yet produced an aftershock larger than 7.1, Dr. Stein said.

To be sure, the spate of earthquakes has not caused the same panic and mass exodus as the fears of radiation in the first week after the nuclear crisis began. Still, with levels of radiation in the Tokyo air having sharply fallen since then, some people interviewed on the street said they worried about the aftershocks more than radiation.

Dr. Hideaki Sakata, director of the Mejiro University Clinic, who is treating Ms. Suzuki, said that feeling the ground shaking when it is not is similar to the continued feeling of swaying when one first gets off a boat onto solid ground.

Dr. Kazuhiro Soeda, an ear, nose and throat specialist in Utsunomiya, outside Tokyo, who also treats patients having trouble dealing with the aftershocks, said: “People are getting too sensitive. This is something we’ve never experienced before.”

Makiko Inoue, Kantaro Suzuki and Ken Ijichi contributed reporting.

Group Faults the F.D.A. on Oversight of Devices

Posted: 12 Apr 2011 10:17 PM PDT

The Food and Drug Administration is allowing some high-risk devices like artificial hips to be sold without strenuous testing, despite promises that it would address regulatory issues affecting them, a federal watchdog group plans to testify on Wednesday.

The group, the Government Accountability Office, found that the F.D.A. has taken some recent steps to determine if certain high-risk medical devices should undergo more testing before being sold. But in the meantime, it is continuing to approve dozens of such devices annually with scant review, exposing patients to risks.

An official with the office is expected to give the testimony on Wednesday at a hearing before the Senate Special Committee on Aging. The office will also present its preliminary findings of what it concluded were shortcomings in how the F.D.A. oversees recalls of troubled devices.

A spokeswoman for the F.D.A., Karen Riley, said that officials there had not seen the G.A.O. testimony and so could not respond directly to it. She added that F.D.A officials planned to testify at the hearing. The panel is also expected to hear from patient advocates and industry representatives.

Among other issues, the Senate hearing is expected to examine the approval and marketing of a now-recalled artificial hip sold by Johnson & Johnson known as the A.S.R., or Articular Surface Replacement. An article last December in The New York Times detailed how the medical products giant continued to sell the hip despite repeated reports by physicians abroad that it was faulty.

The F.D.A. permitted Johnson & Johnson to sell the artificial hip without conducting clinical trials. A few years after implant, it began disintegrating in patients, shedding metallic debris that has left some patients crippled.

According to reports by doctors in England, the device may fail prematurely in about 50 percent of the patients receiving it.

The F.D.A. has two separate procedures for approving medical devices.

For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.

But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.

In 2009, the G.A.O. issued a report recommending that the F.D.A. reclassify such devices either into the high-risk category, the one requiring more testing, or in lower-risk categories that do not require testing. The agency has started to do so, but to date it has not made final decisions for nearly all those products.

At the start of the Obama administration, F.D.A. officials indicated that they would take an aggressive approach to the regulation of medical devices. But in more recent months, they appear to have backed away from that stance.

The F.D.A. has asked the Institute of Medicine to review its device approval process. That group is expected to issue its report later this year.

Reshaping Medicare Brings Hard Choices

Posted: 13 Apr 2011 04:20 AM PDT

WASHINGTON — President Obama has deep disagreements with House Republicans about how to address Medicare’s long-term problems. But in deciding to wade into the fight over entitlements, which he may address in a speech Wednesday afternoon, the president is signaling that he too believes Medicare must change to avert a potentially crippling fiscal crunch.

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President Obama, who attended an event on Tuesday in the East Room of the White House, has faced criticism from Republicans over the Medicare program. Now, he must work with them as they propose reshaping it.

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So the real issue now is not so much whether to re-engineer Medicare to deal with an aging population and rising medical costs, but how.

Even before they debate specific proposals, lawmakers across the ideological spectrum face several fundamental questions:

Will the federal government retain its dominant role in prescribing benefits and other details of the program, like how much doctors and hospitals are paid and which new treatments are covered? Will beneficiaries still have legally enforceable rights to all those services?

Will Medicare spending still increase automatically with health costs, the number of beneficiaries and the amount of care they receive? Or will the government try to limit the costs to taxpayers by paying a fixed amount each year to private health plans to subsidize coverage for older Americans and those who are disabled?

Public concern about the federal deficit and debt has revived interest in proposals to slow the growth of Medicare, including ideas from Mr. Obama’s deficit reduction commission. Here are some leading proposals:

¶Increase the age of eligibility for Medicare to 67, from 65.

¶Charge co-payments for home health care services and laboratory tests.

¶Require beneficiaries to pay higher premiums.

¶Pay a lump sum to doctors and hospitals for all services in a course of treatment or an episode of care. The new health care law establishes a pilot program to test such “bundled payments,” starting in 2013.

¶Reduce Medicare payments to health care providers in parts of the country where spending per beneficiary is much higher than the national average. (Payments could be adjusted to reflect local prices and the “health status” of beneficiaries.)

¶Require drug companies to provide additional discounts, or rebates, to Medicare for brand-name drugs bought by low-income beneficiaries.

¶Reduce Medicare payments to teaching hospitals for the cost of training doctors.

In debate last year over Mr. Obama’s health plan, Republicans said repeatedly that he was “raiding Medicare” to pay for a new entitlement providing insurance for people under 65. The Senate Republican leader, Mitch McConnell of Kentucky, said the Democrats were using Medicare as a piggy bank. Senator Jim Risch of Idaho said, “We are talking about a half-trillion dollars that is being stolen from Medicare.” Senator Charles E. Grassley of Iowa said the cuts “threaten seniors’ access to care.”

Now it is Republicans, especially House Republicans, proposing to cut the growth of Medicare, with a difference.

“Any potential savings would be used to shore up Medicare, not to pay for new entitlements,” said Representative Paul D. Ryan, Republican of Wisconsin and chairman of the House Budget Committee.

The House is expected to vote this week on his budget blueprint for the next 10 years.

Mr. Ryan points to Medicare’s prescription drug coverage as a model. That benefit, added to Medicare under a 2003 law, is delivered entirely by private insurers competing for business, and competition has been intense. Premiums for beneficiaries and costs to the government have been much lower than projected.

Republicans rarely mention one secret to the success of Medicare’s drug program. Under presidents of both parties, Medicare officials have regulated the prescription drug plans to protect consumers and to make sure the sickest patients have access to the drugs they need.

Many Democrats like Medicare as it is: an entitlement program in which three-fourths of the 47 million beneficiaries choose their doctors and other health care providers, and one-fourth have elected to enroll in managed-care plans. These Democrats acknowledge that care could be better coordinated, but say that could be done in the traditional fee-for-service Medicare program, without forcing beneficiaries into private health plans offered by insurance companies.

Marilyn Moon, a health economist and former Democratic trustee of the Medicare trust fund, said serious discussion of changes in Medicare was warranted, and she noted that the government spent more than a half-trillion dollars a year on the program. Still, Ms. Moon said, it would be preferable to shore up Medicare without “the philosophical sea change” sought by Republicans, who would give private insurers more latitude to decide what benefits are available and what services are covered.

Obama administration officials said Tuesday that Medicare could save $50 billion over 10 years by reducing medical errors, injuries, infections and complications that prolong hospital stays or require readmission of patients.

In any program as big as Medicare, which accounts for one-fifth of all health spending, even decisions about small, seemingly technical questions can have vast consequences for beneficiaries, the health care industry and the economy as a whole.

Gradually raising the eligibility age, for example, would save $125 billion over 10 years, the Congressional Budget Office says.

But it would increase costs for people who would otherwise have Medicare. Some of those 65- and 66-year-olds would obtain insurance from Medicaid or from employers, as active workers or retirees, thus increasing costs for Medicaid and for employer-sponsored health plans.

If Congress decided to make a fixed contribution to a private health plan on behalf of each Medicare beneficiary, lawmakers and lobbyists could spend years debating how to set payment rates and how to adjust them, based on increases in consumer prices or medical costs or the growth of the economy.

Those decisions would directly affect beneficiaries. Under the House Republican proposal, the Congressional Budget Office said, beneficiaries “would bear a much larger share of their health care costs,” requiring them to “reduce their use of health care services, spend less on other goods and services, or save more in advance of retirement.”

The history of Medicare is filled with unsuccessful efforts to rein in costs. Private health plans entered Medicare with a promise to shave 5 percent off costs, but ended up costing more than the traditional Medicare program. For two decades, Congress has tried to limit Medicare spending on doctors’ services, but the limits have proved so unrealistic that Congress has repeatedly intervened to increase them.

Bad X-Rays Found Again at a Brooklyn Hospital

Posted: 13 Apr 2011 11:33 AM PDT

Long after a major Brooklyn hospital said it had stopped over-radiating premature babies, state inspectors have found that some inappropriate X-rays were still being administered as recently as January, state records show.

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Claudia Hutton, a spokeswoman for the New York State Department of Health, said state regulators suspected that similar cases were occurring at other hospitals. The department is deciding whether to conduct spot checks around the state to determine the extent of the problem.

The inspection at the Brooklyn hospital, the State University of New York Downstate Medical Center, in March, was prompted by an article in The New York Times in February, revealing that in 2007 the hospital had discovered that premature babies — the most vulnerable of all patients — were frequently subjected to whole-body X-rays when only chest exams had been ordered. These errors had never been reported to state health officials.

Downstate officials said they had promptly put an end to the risky X-ray practices. But last month, state inspectors reviewed chest X-rays of premature babies taken late last year and early this year and found 27 instances of infants’ irradiated beyond the chest area without proper shielding. Some premature infants were over-radiated multiple times, inspection records show.

“We were disappointed to find so many X-rays in our sampling that did not have adequate shielding to protect infants from being exposed to excess radiation,” said Dr. Nirav R. Shah, the state health commissioner. “Additional training and monitoring must be put into place to rectify this situation.”

In a brief statement released on Tuesday by Ronald Najman, a Downstate spokesman, the hospital said that in the wake of the inspection, it had addressed the issues raised by regulators “to ensure that we provide quality care to our patients.” The statement did not say why the problems had continued after radiologists at the hospital said they had stopped the original improper scanning practices.

Children are particularly vulnerable to radiation’s effects because their cells divide quickly and because they face an ever-increasing number of radiological procedures over their lifetime as new medical uses are found for radiation. X-rays are invaluable in diagnosing internal complications. But minimizing exposure is important because most scientists believe the effects of radiation are cumulative, meaning the more radiation one receives, the greater the chances of developing cancer later in life.

The state inspection on March 9 found “neonatal imaging was not provided in accordance with physician orders and the facility policies and procedures,” according to a statement of deficiencies sent to the hospital on March 21.

The first case cited in the report involved a baby born prematurely at 26 weeks who received five chest X-rays over a period of two months in which the radiation was not properly limited, or coned, to the chest area. For example, one “showed the patient’s neck, chest, abdomen, the upper arms and a small section of the right thigh.”

A second baby who was to have a chest X-ray had an image taken that included “the entire head, left arm, right arm, chest and abdomen,” the report said.

According to the state, one radiologist explained the wide areas of irradiation by saying that “technologists were sometimes instructed at the bedside by physicians to include additional areas of interest in the chest X-ray.”

Ms. Hutton, the state health department spokeswoman, said that explanation was unacceptable when the official medical record called only for a chest X-ray. “You shouldn’t be taking X-ray views not ordered by the doctor,” she said, “and if the doctor ordered them, they should be in the chart.”

According to the inspection report, the 27 improper X-rays were found among 542 chest images reviewed by state inspectors.

Ms. Hutton said if a fine was imposed, it would probably be a small one. “We just want compliance,” she said. “This is not a revenue stream for us.”

The hospital’s failure to report the problems in 2007 rankled state regulators. “You could have called us and said, ‘We just found something really bad,’ ” Ms. Hutton said. “We had to learn about the issue from The New York Times.”

The Times article quoted extensively from internal e-mails at Downstate, including one from 2007 in which Dr. Salvatore J. A. Sclafani, the radiology chairman, wrote that he was “mortified” to find that the same premature infant had received about 10 whole-body X-rays when only a simple chest X-ray had been ordered. “Full, unabashed, total irradiation of a neonate,” Dr. Sclafani said, adding, “This poor, defenseless baby.”

Dr. Sclafani recently took a leave from his position to do research.

Downstate officials told The Times during the winter that back in 2007, the hospital had instituted procedures intended to minimize exposure to radiation. The steps included reducing the radiation dose administered to pediatric patients undergoing CT scans and eliminating CT scans that were not absolutely necessary.

According to doctors familiar with Downstate procedures, those steps did reduce exposure to radiation from CT scans.

Michael C. Latham, Expert on Nutrition in Developing World, Dies at 82

Posted: 13 Apr 2011 08:18 PM PDT

Michael C. Latham, an expert on international nutrition and tropical health who waged a long campaign against the use of infant formula and for the practice of breastfeeding in developing countries, died on April 1 in Boston. He was 82 and lived in Newfield, N.Y.

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Cornell University

Michael C. Latham in 1995.

The cause was pneumonia, his son Mark said.

Dr. Latham, who directed the Program in International Nutrition at Cornell University for 25 years, first encountered the problems of nutrition in the developing world while practicing medicine as a young doctor for the British colonial service in Tanganyika (now Tanzania).

After the country had gained its independence, he stayed on and was appointed the director of the nutrition unit of the public health ministry. He became alarmed at efforts by Western companies to expand their marketing of infant formula to underdeveloped countries, where high birth rates promised a growing consumer base, and he became one of the first and most forceful public health scientists to sound a warning.

In many poor countries, he pointed out, mothers mixed powdered baby formula with contaminated water, leading to diarrheal diseases. To make the formula last longer, they often used too little of the powder, depriving their babies of vital nutrients.

Bottle feeding was “incredibly difficult and extremely bad,” Dr. Latham wrote in a 1976 report with Ted Greiner, but “the media onslaught is terrific, the messages are powerful and the profits are high.”

“High also is the resultant human suffering,” they wrote.

Dr. Latham’s cause, taken up by several health groups, led the World Health Organization in 1981 to develop a set of guidelines, the International Code of Marketing of Breast-milk Substitutes, which was intended to govern the behavior of private companies. He was a prominent figure in the boycott of Nestlé, a leading manufacturer of infant formula, which agreed in 1984 to abide by the marketing code.

The ideal food for infants, Dr. Latham argued, was breast milk. Its benefits, he wrote, were not limited to improved physical and mental development. It could also potentially curb population growth, he argued, since parents who were confident that their children would thrive would be more likely to have smaller families. In 1991, he helped found the World Alliance for Breastfeeding Action to explain and promote the benefits of breastfeeding around the world.

Michael Charles Latham was born on May 6, 1928, in Kilosa, Tanganyika, where his father was a doctor in the British colonial service. After earning a medical degree from Trinity College, Dublin, in 1952, he worked in hospitals in Britain and the United States before returning to Tanganyika to practice medicine in rural areas. During intermittent leaves, he earned a diploma in tropical public health from the London School of Hygiene and Tropical Medicine in 1958.

After leaving Tanzania in 1964, he taught nutrition at Harvard, where he received a degree in public health in 1965. In 1968 he was recruited by Cornell as a professor of international nutrition. He turned the university’s small Program in International Nutrition into one of the world’s largest training centers for nutritionists, many of whom went on to work in international agencies and public health departments around the world.

His research led to improved programs on infant nutrition, the control of parasitic diseases in humans, and the supply of micronutrients to poor populations.

Dr. Latham often did consulting work in Africa, Asia and South America for organizations like the World Health Organization, the United Nations Food and Agriculture Organization, Unicef and the World Bank.

In addition to his son Mark, of Somerville, Mass., he is survived by his second wife, Dr. Lani Stephenson, and another son, Miles, of Trumansburg, N.Y.

He was the author of two important books on international nutrition, “Human Nutrition in Tropical Africa” (1965) and “Human Nutrition in the Developing World” (1997), as well as a family memoir, “Kilimanjaro Tales: The Saga of a Medical Family in Africa” (1995), which drew on the journals kept by his mother, Gwynneth Latham.

Mixed Martial Arts Makes Inroads in Baseball Training

Posted: 13 Apr 2011 05:42 PM PDT

Mixed martial arts may be illegal as a competitive sport in some states, but several baseball players are incorporating its fighting methods into their training routines.

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Yankees catcher Russel Martin used mixed martial arts training to help him get in shape for the season and recover from injury.

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Dan Henderson has helped train baseball players.

Adam Dunn of the Chicago White Sox, Brad Penny of the Detroit Tigers and Russell Martin of the Yankees have used the sport’s punches and kicks to improve their throwing and swinging. In addition to improving overall fitness, Martin said, mixed martial arts can make an athlete mentally tougher.

“You tolerate the pain and get through it,” he said. “Mentally, I know I’m in a good place because I worked hard.”

Mixed martial arts is a combination of karate, judo, jujitsu, boxing, wrestling and tae kwon do. The sport is also popular in Brazil and Japan. Pay-per-view telecasts in the United States began in 1993, with the Ultimate Fighting Championship staging the most lucrative matches.

Unlike Martin, Dunn and Penny guard the secrets of their workouts as if they were team signs.

Penny acknowledged training with Dan Henderson, a star M.M.A. competitor, but he declined through a Tigers spokesman to discuss his training. Dunn declined through the White Sox media-relations office.

Henderson said that he had had Penny practice the kicks and punches used in M.M.A., but there was no sparring.

“We use focus mitts,” Henderson said, referring to the oversize padded gloves that he wears while athletes kick and punch them. “Physically, it works different muscles than players tend to use in their own sport. The training gives them something different to push themselves through.”

Henderson said the workouts could indirectly help Penny’s strategy on the mound.

“It might give Brad a little more confidence when he’s pitching inside,” Henderson said. “And he’s prepared in case anyone rushes the mound.”

Jay Glazer, a football analyst for Fox Sports who runs MMAthletics with Randy Couture, a mixed martial arts star, has trained N.F.L. players in the sport. Glazer said his clients included Ryan Grant, Jared Allen, Clay Matthews and the Atlanta Falcons team.

While the workouts for the football players emphasize wrestling and hand-fighting techniques, Glazer said the routine for baseball players concentrated on emulating the movements of their sport.

Ryan Rowland-Smith, a left-handed pitcher in the Houston Astros organization who battled arm and back injuries the last couple of years with the Seattle Mariners, worked with Glazer in the winter. “I’m in the best shape of my life, for sure,” said Rowland-Smith, a surfer while growing up in Australia.

Glazer said: “In the case of Ryan, we look at film and break it down frame by frame and come up with a combination that mirrors his pitching delivery. A knee, a punch, followed by a kick. We have him do a ton of that for his hips. Power comes from his core, his hips and his legs, even though he uses his arm to pitch.”

Mentally, Glazer said, the mantra is the same for baseball players as it is for N.F.L. players.

“Own your space,” Glazer said several times. “We get the players thinking like a cage fighter. When the door shuts, it’s time to break that man’s will across from you. For Ryan, as a pitcher, it’s that 60 feet 6 inches that you own.”

Rowland-Smith said the rigors of M.M.A. training made it easier to tolerate physical and mental challenges on the mound.

“If you have some small injuries or you’re not feeling 100 percent, nothing can compare with what you go through with the training, so you can fight through it,” he said.

Martin, a catcher, worked with Jonathan Chaimberg, who trains Georges St.-Pierre, the U.F.C.’s welterweight champion. Martin said he was searching for a way to regain his All-Star form after two injury-marred seasons with the Los Angeles Dodgers.

After a few months of six-days-a-week M.M.A.-style training sessions with Chaimberg in Montreal, where he lives, Martin increased his endurance and explosiveness and lost body fat. He said his upper-body routine was called the big rope.

“It’s a thick rope that you attach to a base of a wall and has a loop,” he said. “You create waves with the rope, and it’s like a 20-second sprint, a 10-second rest. You don’t do it for a long period of time. You do it for five minutes, get a good workout in and work on your conditioning.”

It seems to be helping. Martin is hitting .300 with three homers and eight runs batted in.

Bobby Valentine, an ESPN baseball analyst, has managed in the major leagues and in Japan, where one would think mixed martial arts training is popular among players. But that is not the case, he said.

“It’s more prominent in the States,” said Valentine, who said he believes the training is beneficial.

He added: “Most mixed martial arts instructors teach balance, quickness and awareness of your surroundings. There are a few cases in Japan, but most players just play baseball over there.”

INSIDE PITCH

The Yankees’ scheduled game Tuesday against the Baltimore Orioles at Yankee Stadium was postponed because of rain and was not immediately rescheduled. Manager Joe Girardi said that A. J. Burnett (2-0), Tuesday’s scheduled starter, would pitch Wednesday, and Phil Hughes (0-1) would start Thursday. Girardi said he planned to start Freddy Garcia for the first time later this week; Girardi added that the date had yet to be determined. ... Reliever Pedro Feliciano, who has been sidelined with tightness in his left triceps, played catch, but Girardi said the session “did not go well.” Feliciano will have another test Wednesday. “It’s a concern,” Girardi said of Feliciano, who had to cut short a similar throwing session March 27. “We were hoping after these two weeks that he’d be able to take the next step.” DAVE CALDWELL

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Magazine Preview: Do Cellphones Cause Brain Cancer?

Posted: 14 Apr 2011 11:20 AM PDT

On Jan. 21, 1993, the television talk-show host Larry King featured an unexpected guest on his program. It was the evening after Inauguration Day in Washington, and the television audience tuned in expecting political commentary. But King turned, instead, to a young man from Florida, David Reynard, who had filed a tort claim against the cellphone manufacturer NEC and the carrier GTE Mobilnet, claiming that radiation from their phones caused or accelerated the growth of a brain tumor in his wife.

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“The tumor was exactly in the pattern of the antenna,” Reynard told King. In 1989, Susan Elen Reynard, then 31, was told she had a malignant astrocytoma, a brain cancer that occurs in about 6,000 adults in America each year. To David Reynard, the shape and size of Susan’s tumor — a hazy line swerving from the left side of her midbrain to the hindbrain — uncannily resembled a malignant shadow of the phone (but tumors, like clouds, can assume the shapes of our imaginations). Suzy, as she was known, held her phone at precisely that angle against her left ear, her husband said. Reynard underwent surgery for her cancer but to little effect. She died in 1992, just short of her 34th birthday. David was convinced that high doses of radiation from the cellphone was the cause.

Reynard v. NEC — the first tort suit in the United States to claim a link between phone radiation and brain cancer — illustrated one of the most complex conceptual problems in cancer epidemiology. In principle, a risk factor and cancer can intersect in three ways. The first is arguably the simplest. When a rare form of cancer is associated with a rare exposure, the link between the risk and the cancer stands out starkly. The juxtaposition of the rare on the rare is like a statistical lunar eclipse, and the association can often be discerned accurately by observation alone. The discipline of cancer epidemiology originated in one such a confluence: in 1775, a London surgeon, Sir Percivall Pott, discovered that scrotal cancer was much more common in chimney sweeps than in the general population. The link between an unusual malignancy and an uncommon profession was so striking that Pott did not even need statistics to prove the association. Pott thus discovered one of the first clear links between an environmental substance — a “carcinogen” — and a particular subtype of cancer.

The opposite phenomenon occurs when a common exposure is associated with a common form of cancer: the association, rather than popping out, disappears into the background, like white noise. This peculiar form of a statistical vanishing act occurred famously with tobacco smoking and lung cancer. In the mid-1930s, smoking was becoming so common and lung cancer so prevalent that it was often impossible to definitively discern a statistical link between the two. Researchers wondered whether the intersection of the two phenomena was causal or accidental. Asked about the strikingly concomitant increases in lung cancer and smoking rates in the 1930s, Evarts Graham, a surgeon, countered dismissively that “the sale of nylon stockings” had also increased. Tobacco thus became the nylon stockings of cancer epidemiology — invisible as a carcinogen to many researchers, until it was later identified as a major cause of cancer through careful clinical studies in the 1950s and 1960s.

But the most complex and most publicly contentious intersection between a risk factor and cancer often occurs in the third instance, when a common exposure is associated with a rare form of cancer. This is cancer epidemiology’s toughest conundrum. The rarity of the cancer provokes a desperate and often corrosive search for a cause (“why, of all people, did I get an astrocytoma?” Susan Reynard must have asked herself). And when patients with brain tumors happen to share a common exposure — in this case, cellphones — the line between cause and coincidence begins to blur. The association does not stand out nor does it disappear into statistical white noise. Instead, it remains suspended, like some sort of peculiar optical illusion that is blurry to some and all too clear to others. (A similarly corrosive intersection of a rare illness, a common exposure and the desperate search for a cause occurred recently in the saga of autism and vaccination. Vaccines are nearly universal, and autism is relatively rare — and many parents, searching to explain why their children became autistic, lunged toward a common culprit: childhood vaccination. An avalanche of panic ensued. It took years of carefully performed clinical trials to finally disprove the link.)

The Florida Circuit Court that heard Reynard v. NEC was quick to discern these complexities. It empathized with David Reynard’s search for a tangible cause for his wife’s cancer. But it acknowledged that too little was known about such cases; “the uncertainty of the evidence . . . the speculative scientific hypotheses and [incomplete] epidemiological studies” made it impossible to untangle cause from coincidence. David Reynard’s claim was rejected in the spring of 1995, three years after it was originally filed. What was needed, the court said, was much deeper and more comprehensive knowledge about cellphones, brain cancer and of the possible intersection of the two.

Allow, then, a thought experiment: what if Susan Reynard was given a diagnosis of astrocytoma in 2011 — but this time, we armed her with the most omniscient of lawyers, the most cutting-­edge epidemiological information, the most powerful scientific evidence? Nineteen years and several billion cellphone users later, if Reynard were to reappear in court, what would we now know about a possible link between cellphones and her cancer?

To answer these questions, we need to begin with a more fundamental question: How do we know that anything causes cancer?

The crudest method to capture a carcinogen’s imprint in a real human population is a large-scale population survey. If a cancer-causing agent increases the incidence of a particular cancer in a population, say tobacco smoking and lung cancer, then the overall incidence of that cancer will rise. That statement sounds simple enough — to find a carcinogen’s shadow, follow the trend in cancer incidence — but there are some fundamental factors that make the task complicated.

Siddhartha Mukherjee (smukherj2011@gmail.com) is an assistant professor of medicine in the division of medical oncology at Columbia University. He is the author of “Emperor of All Maladies: A Biography of Cancer.” Editor: Ilena Silverman (i.silverman-MagGroup@nytimes.com).

Is Sugar Toxic?

Posted: 14 Apr 2011 06:12 AM PDT

On May 26, 2009, Robert Lustig gave a lecture called “Sugar: The Bitter Truth,” which was posted on YouTube the following July. Since then, it has been viewed well over 800,000 times, gaining new viewers at a rate of about 50,000 per month, fairly remarkable numbers for a 90-minute discussion of the nuances of fructose biochemistry and human physiology.

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Lustig is a specialist on pediatric hormone disorders and the leading expert in childhood obesity at the University of California, San Francisco, School of Medicine, which is one of the best medical schools in the country. He published his first paper on childhood obesity a dozen years ago, and he has been treating patients and doing research on the disorder ever since.

The viral success of his lecture, though, has little to do with Lustig’s impressive credentials and far more with the persuasive case he makes that sugar is a “toxin” or a “poison,” terms he uses together 13 times through the course of the lecture, in addition to the five references to sugar as merely “evil.” And by “sugar,” Lustig means not only the white granulated stuff that we put in coffee and sprinkle on cereal — technically known as sucrose — but also high-fructose corn syrup, which has already become without Lustig’s help what he calls “the most demonized additive known to man.”

It doesn’t hurt Lustig’s cause that he is a compelling public speaker. His critics argue that what makes him compelling is his practice of taking suggestive evidence and insisting that it’s incontrovertible. Lustig certainly doesn’t dabble in shades of gray. Sugar is not just an empty calorie, he says; its effect on us is much more insidious. “It’s not about the calories,” he says. “It has nothing to do with the calories. It’s a poison by itself.”

If Lustig is right, then our excessive consumption of sugar is the primary reason that the numbers of obese and diabetic Americans have skyrocketed in the past 30 years. But his argument implies more than that. If Lustig is right, it would mean that sugar is also the likely dietary cause of several other chronic ailments widely considered to be diseases of Western lifestyles — heart disease, hypertension and many common cancers among them.

The number of viewers Lustig has attracted suggests that people are paying attention to his argument. When I set out to interview public health authorities and researchers for this article, they would often initiate the interview with some variation of the comment “surely you’ve spoken to Robert Lustig,” not because Lustig has done any of the key research on sugar himself, which he hasn’t, but because he’s willing to insist publicly and unambiguously, when most researchers are not, that sugar is a toxic substance that people abuse. In Lustig’s view, sugar should be thought of, like cigarettes and alcohol, as something that’s killing us.

This brings us to the salient question: Can sugar possibly be as bad as Lustig says it is?

It’s one thing to suggest, as most nutritionists will, that a healthful diet includes more fruits and vegetables, and maybe less fat, red meat and salt, or less of everything. It’s entirely different to claim that one particularly cherished aspect of our diet might not just be an unhealthful indulgence but actually be toxic, that when you bake your children a birthday cake or give them lemonade on a hot summer day, you may be doing them more harm than good, despite all the love that goes with it. Suggesting that sugar might kill us is what zealots do. But Lustig, who has genuine expertise, has accumulated and synthesized a mass of evidence, which he finds compelling enough to convict sugar. His critics consider that evidence insufficient, but there’s no way to know who might be right, or what must be done to find out, without discussing it.

If I didn’t buy this argument myself, I wouldn’t be writing about it here. And I also have a disclaimer to acknowledge. I’ve spent much of the last decade doing journalistic research on diet and chronic disease — some of the more contrarian findings, on dietary fat, appeared in this magazine —– and I have come to conclusions similar to Lustig’s.

Gary Taubes (gataubes@gmail.com) is a Robert Wood Johnson Foundation independent investigator in health policy and the author of “Why We Get Fat.” Editor: Vera Titunik (v.titunik-MagGroup@nytimes.com).

The New Old Age: Medicare on the Table

Posted: 14 Apr 2011 08:25 AM PDT

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Resistance to Jaitapur Nuclear Plant Grows in India

Posted: 14 Apr 2011 08:28 AM PDT

MADBAN, India — When a farmer named Praveen Gawankar and two neighbors began a protest four years ago against a proposed nuclear power plant here in this coastal town, they were against it mainly for not-in-my-backyard reasons.

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They stood to lose mango orchards, cashew trees and rice fields, as the government forcibly acquired 2,300 acres to build six nuclear reactors — the biggest nuclear power plant ever proposed anywhere.

But now, as a nuclear disaster unfolds in distant Japan, the lonely group of farmers has seen support for their protest swell to include a growing number of Indian scientists, academics and former government officials. “We are getting ready for bigger protests,” Mr. Gawanker said.

While the government vows to push ahead — citing India’s energy needs — Indian newspapers recently reported that the environment minister wrote Prime Minister Manmohan Singh to question the wisdom of large nuclear installations. And a group of 50 Indian scientists, academics and activists has called for a moratorium on new projects. “The Japanese nuclear crisis is a wake-up call for India,” they wrote in an open letter.

Opponents note that the area was hit by 95 earthquakes from 1985 to 2005, although Indian officials counter that most were minor and that the plant’s location on a high cliff would offer protection against tsunamis.

The heated debate shows how the politics of nuclear energy may be changing, not only in the United States and Europe but in developing countries whose economies desperately need cheap power to continue growing rapidly.

For Indian officials intent on promoting nuclear energy, the partial meltdowns and radiation leaks at the Fukushima Daiichi power plant in Japan could not have come at a worse time. Currently, India gets about 3 percent of its electricity from the 20 relatively small nuclear reactors in the country. But it is building five new reactors and has proposed 39 more, including the ones here in Madban, to help meet the voracious energy needs of India’s fast-growing economy.

Only China, the other emerging-economy giant with a ravenous energy appetite, is planning a more rapid expansion of nuclear power. Beijing has indicated that it, too, plans to proceed cautiously with its nuclear rollout.

By 2050, the Indian government says a quarter of the nation’s electricity should come from nuclear reactors. And the project here would be the biggest step yet toward that ambitious goal. The planned six reactors would produce a total of 9,900 megawatts of electricity — more than three times the power now used by India’s financial capital, Mumbai, about 260 miles up the coast.

So far, workers on the site are simply digging trenches, as a dozen police officers provide round-the-clock watch. Protesters, including Mr. Gawankar, have been arrested at various times, and state police officials have banned gatherings of more than five people in the villages near the site.

Prime Minister Singh has been so committed to atomic power that he staked his government’s survival in 2008 on a controversial civil nuclear deal with the United States. That agreement, completed last year, opened the door for India to buy nuclear technology and uranium fuel from Western nations that previously would not sell to it because of India’s refusal to sign the Nuclear Nonproliferation Treaty.

Most of India’s reactors have been indigenously developed, but it is now building two reactors with Russian help. The proposed nuclear plant in Madban will use a new generation of reactors from the French company Areva. Projects using technology from the United States, and from Japan, are also planned.

Government officials have said that India will conduct more safety reviews to make sure its existing reactors and new proposals are safe. But they reiterated their commitment to nuclear projects, including the one in Madban, which has been named the Jaitapur Nuclear Power Plant, after a nearby village.

Many Indian scientists, though, remain distrustful of India’s nuclear establishment. And they criticize the decision to use Areva’s new reactors, saying they are unproved.

Heather Timmons contributed reporting from New Delhi.

Lobbyists Won Key Concessions in Budget Deal

Posted: 14 Apr 2011 11:48 AM PDT

WASHINGTON — At a quarter till midnight last Friday, with a deal to avert a government shutdown barely an hour old, Senator Harry Reid phoned a fellow Democratic senator, Ron Wyden, at home and startled him with some bad news. “You lost free-choice vouchers,” Mr. Wyden recalls Mr. Reid telling him.

Haraz N. Ghanbari/Associated Press

Senator Ron Wyden's health care plan was a budget deal casualty.

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Even delivered in shorthand, the call’s meaning was clear to Mr. Wyden: a health care plan he had succeeded in getting passed months earlier despite furious lobbying by big business and labor had been pulled out of the blue and killed as part of the broader budget deal struck between the White House and Congress. What was most perplexing was that it had little to do with budgets or government shutdowns.

“I was flabbergasted, just flabbergasted,” Mr. Wyden, of Oregon, said Tuesday in an interview, describing the demise of a plan that would have allowed some 300,000 workers to pick their own insurance coverage through employer-financed vouchers.

With $38 billion in cuts on the line in a $3.5 trillion budget, the clash over federal spending played out in numbers so big that most standard calculators had trouble tracking all the zeros. But in the end, a handful of relatively small-bore line items affecting particular industries attracted some of the most aggressive lobbying behind the scenes, as business interests, health care providers and others fought to hold on to, or kill, proposals that affected their bottom line.

Much public attention focused on the social issues that appeared in the spending bill in the final weeks as social conservatives tried to use it to advance their causes, particularly the unsuccessful effort by abortion opponents to cut the financing of Planned Parenthood. In the end, the budget agreement reached late Friday night banned the District of Columbia from using its own money to provide abortions for low-income women in the city — a measure with a bigger social impact than fiscal.

But there was also intense but ultimately unsuccessful lobbying by General Electric and other military contractors to revive financing for an alternate engine for a costly jet fighter project. Proponents of tougher regulations for the politically influential and beleaguered commercial college industry succeeded, for now, in beating back an effort to block restrictions on how the schools get federal aid.

An analysis by the Congressional Budget Office found that the Wyden proposal had no short-term impact on federal spending and could actually save money over the next four years.

The plan to allow some employees to “opt out” of their employer-sponsored plans and choose their own coverage drew opposition from an unusual alliance of unions and businesses. Supporters said the vouchers would give employees more options and spur competition in the marketplace. Critics contended that younger, healthier employees would leave the plans and make insurance costlier for older, less healthy workers.

The American Benefits Council — a group that represents employers and insurers and spent nearly $1 million on federal lobbying last year — wrote its members that the Wyden proposal would have a “destabilizing” impact on employer insurance plans. The A.F.L.-C.I.O., which employs a formidable Washington lobbying force, warned that the proposal would create a “death spiral” of higher costs.

But the measure also had strong supporters. Charles Kolb, president of the Committee for Economic Development, said Tuesday that Mr. Wyden, in taking a different tack to managing health care costs, “was trying to introduce the type of structural reform that the system is crying out for.”

The measure did make it into the final health care plan signed by President Obama last year — only to be cut at the eleventh hour in Friday night’s budget agreement. “This is a lost opportunity,” Mr. Kolb said.

So who axed the program?

“I wish I knew,” Mr. Wyden said. “Everyone at the table says that someone else brought it up. They all say, ‘It wasn’t me.’ ”

Democrats and administration officials insisted Tuesday in interviews that Republican leaders had moved to get rid of the Wyden plan. They acknowledge privately that were not in a position to fight it that aggressively, given that it was opposed by business and labor, and that agreeing to kill the plan was seen as a way of staving off other possible cuts in health care financing.

“There’s no question that eliminating this provision wouldn’t have been our first choice,” said an Obama administration official who spoke on the condition of anonymity in discussing private negotiations. “But these were tough, tough negotiations, and obviously no one got everything they wanted.”

Michael Steel, a spokesman for Speaker John A. Boehner, said “the program was eliminated because it costs jobs — and jobs are the American people’s top priority.”

Mr. Wyden said that regardless of who brought it up in the White House-Congressional negotiations, he suspects that the group driving the elimination of his plan was the Business Roundtable, a powerful lobbying force made up of chief executives from the country’s biggest companies. The Roundtable, which spent more than $8.2 million lobbying on a range of health care and financial issues last year, had come out strongly against the idea of letting employees pick their own insurance plans.

“This is a textbook case of the special interests prevailing — Exhibit A,” Mr. Wyden said of the demise of his health care voucher plan. “Everyone knows the Business Roundtable wanted this killed, and now they can go back with a trophy to say they protected business as usual.”

Executives from the Roundtable did not respond to voicemails or e-mails on Tuesday inquiring about the issue.

But even as Mr. Wyden was looking for ways on Tuesday to revive his voucher plan, the Business Roundtable was announcing a separate agreement with the Obama administration to sign on to a “Partnership for Patients Pledge” intended to show commitment to health care.

“We applaud the administration,” said former Gov. John Engler of Michigan, president of the Business Roundtable, “for taking this proactive step to bring together a diverse group of stakeholders — all of us committed to, and invested in, America’s health care system — to measurably improve health care quality.”

Recipes for Health: Stir-Fried Bean Sprouts With Sprouted Brown Rice

Posted: 12 Apr 2011 07:54 PM PDT

The sprouts I find most often at the supermarket are mung bean sprouts. But lately I’ve also found pea sprouts, which are more delicate and have a delicious fresh flavor. The stir-fry time is much shorter for pea sprouts, about one to two minutes total.

Recipes for Health

Martha Rose Shulman presents food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and to eat.

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1 cup sprouted brown rice, cooked (3 cups cooked rice)

1 tablespoon soy sauce (low-sodium if desired)

1 tablespoon Shao Hsing rice wine or dry sherry

2 teaspoons dark Asian sesame oil

1/4 to 1/2 teaspoon salt (to taste)

1/4 teaspoon ground pepper, preferably white pepper

1/4 teaspoon sugar

2 tablespoons peanut oil or canola oil

1 tablespoon minced garlic

1 tablespoon minced ginger

1 medium red bell pepper, cut in 1/4-inch-by-2-inch matchsticks (1 cup julienne)

4 cups bean sprouts (about 3/4 pound)

1/4 cup thinly sliced scallions

1/4 cup coarsely chopped cilantro (optional)

Sprouted brown rice is a packaged product that you can find in natural foods stores with other packaged grains. The grains are sprouted, then dried. It looks and cooks like regular brown rice.

1. Cook the brown rice, and keep warm. It takes about 40 minutes to cook, so while it’s simmering you can prepare your ingredients for the stir-fry.

2. In a small bowl or measuring cup, combine the soy sauce, rice wine or sherry, and the sesame oil. Combine the salt, pepper and sugar in another small bowl. Have all the ingredients within arm’s length of your pan.

3. Heat a 14-inch flat-bottomed wok or 12-inch steel skillet over high heat until a drop of water quickly evaporates in the pan. Add 1 tablespoon of the oil to the sides of the pan and tilt the pan to distribute. Add the garlic and ginger, and stir-fry for no more than 10 seconds. Add the red pepper, and stir-fry for one minute, then add the bean sprouts and scallions. Stir-fry for about 30 seconds. Add the salt, pepper and sugar. Toss together, and add the soy sauce mixture. Stir-fry for one to two minutes until the vegetables are crisp-tender. Stir in the cilantro, and serve with the rice.

Yield: Serves three to four.

Advance preparation: Cooked sprouted brown rice will keep for three or four days in the refrigerator. This is a last-minute stir-fry, but you can prepare your ingredients several hours ahead.

Nutritional information per serving (three servings): 391 calories; 2 grams saturated fat; 4 grams polyunsaturated fat; 5 grams monounsaturated fat; 0 milligrams cholesterol; 60 grams carbohydrates; 6 grams dietary fiber; 338 milligrams sodium (does not include salt to taste); 9 grams protein

Nutritional information per serving (four servings): 293 calories; 2 grams saturated fat; 3 grams polyunsaturated fat; 4 grams monounsaturated fat; 0 milligrams cholesterol; 45 grams carbohydrates; 5 grams dietary fiber; 254 milligrams sodium (does not include salt to taste); 7 grams protein

Martha Rose Shulman is the author of "The Very Best of Recipes for Health."

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