Tuesday, June 14, 2011

Health - F.D.A. Unveils New Rules About Sunscreen Claims

Health - F.D.A. Unveils New Rules About Sunscreen Claims


F.D.A. Unveils New Rules About Sunscreen Claims

Posted: 14 Jun 2011 12:45 PM PDT

WASHINGTON — After 33 years of consideration, the Food and Drug Administration took steps on Tuesday to sort out the confusing world of sunscreens, with new rules that specify which lotions provide the best protection against the sun and ending claims that they are truly waterproof.

The F.D.A. said sunscreens must protect equally against two kinds of the sun’s radiation, UVB and UVA, to earn the coveted designation of offering “broad spectrum” protection. UVB rays cause burning; UVA rays cause wrinkling; and both cause cancer.

The rules, which go into effect in a year, will also ban sunscreen manufacturers from claiming their products are waterproof or sweatproof because such claims are false. Instead, they will be allowed to claim in minutes the amount of time in which the product is water resistant, depending upon test results.

And only sunscreens that have a sun protection factor, or SPF, of 15 or higher will be allowed to maintain that they help prevent sunburn and reduce the risks of skin cancer and early skin aging.

The rules have been under consideration since 1978, when “Boogie Oogie Oogie” was a hit on the radio and most beach lotions were intended to encourage tanning, not protect against it. But federal regulators said they had yet to decide whether to end an SPF arms race in which manufacturers are introducing sunscreens with SPF numbers of 70, 80 and 100 even though such lotions offer little more protection than those with an SPF of 50.

Still, dermatologists said they were thrilled.

“Now, we’ll be able to tell patients which sunscreens to get,” said Dr. Henry W. Lim, chairman of dermatology at Henry Ford Hospital in Detroit and a spokesman for the American Academy of Dermatology.

The rules will transform the $680 million domestic market for sunscreens, which has been growing rapidly because of an aging population and growing worries about skin cancer. And the final regulations are a stark change from a proposal the agency released in 2007, which would have created a star-based system for UVA protection. Under that system, sunscreens would have provided an SPF number for UVB protection and one to four stars for UVA protection.

The agency received more than 3,000 comments on that proposal, with many asserting that allowing products to offer differing levels of protection against UVB and UVA rays would be confusing. So the agency ditched the stars and instead will tell manufacturers that if they wish to label their products as offering “broad spectrum” protection they must make their defense against UVB and UVA radiation proportional.

“We think this is going to be much easier for the consumer to understand,” Dr. Janet Woodcock, director of the F.D.A.’s drug center, said in an interview. “All they’re going to need to do is pick an SPF number and then make sure that it’s broad spectrum.”

Any product that fails to offer proportional protection or has an SPF of 2 to 14 must include a warning that the product has not been shown to help prevent skin cancer or early skin aging. The new rules will standardize the testing that manufacturers must conduct for UVA protection.

The agency had proposed allowing manufacturers to use SPF numbers no higher than 50, but that remains only a proposal for which the agency will seek further comment. In particular, the government is asking whether there are special groups of people who would somehow benefit from having a product with an SPF of more than 50.

“Right now, we don’t have any data to show that anything above 50 adds any value for anybody,” Dr. Woodcock said.

Dr. Warwick L. Morison, a professor of dermatology at Johns Hopkins University and chairman of the photobiology committee for the Skin Cancer Foundation, said he was disappointed that the F.D.A. failed to ban SPF numbers higher than 50 because such products expose people to more irritating sunscreen ingredients without meaningful added protection.

“It’s pointless,” Dr. Morison said.

More than two million people in the United States are treated each year for the two most common types of skin cancer, basal cell and squamous cell, and more than 68,000 receive a diagnosis of melanoma, the most deadly form of the disease. Sunscreens have not been shown to prevent the first case of basal cell carcinoma, but they delay reoccurrences of basal cell and have been shown to prevent squamous cell and melanoma.

The F.D.A. announced that it was re-examining the safety of the roughly 17 sunscreen agents approved for use in the United States, although it has no information to suggest that they are not safe. Tuesday’s announcement will do nothing to speed the approval of more sunscreen agents. There are roughly 28 such agents approved in Europe and 40 in Japan, and some in the industry complain that the best ingredients have yet to reach American shores.

Some consumer and environmental groups have expressed concern that the ingredients in some sunscreens have been made so microscopic that they could be absorbed through the skin into the body, but Dr. Woodcock said that the F.D.A.’s own tests had found no cause for such concerns.

The agency is also asking for more information about sunscreen sprays to ensure that consumers get adequate quantities from spray bottles and to explore what happens when those products are inhaled. “You could imagine a child getting a sunscreen sprayed on and turning their face into the blast and breathing it in,” Dr. Woodcock said. “It’s a question of safety.”

The new regulations will do nothing to prevent the most common problem with sunscreens lotions, which is that consumers fail to use enough of them. The rules become effective in one year, although manufacturers with less than $25,000 in annual sales will have two years to comply.

Senator Jack Reed, Democrat of Rhode Island, said the new rules were important. Mr. Reed proposed legislation mandating that the F.D.A. finally adopt the sunscreen proposals it floated in 2007.

“The F.D.A. has been sitting on these proposals for many, many years,” Mr. Reed said. “This is a major step, and I’m glad they’ve done it.”

 

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The Big Picture: A City Tries to Slim Down

Posted: 14 Jun 2011 10:38 AM PDT

LOUISVILLE — This city’s Broadway displays its own array of neon signs — two dozen fast-food restaurants, as diverse as McDonald’s and the local Indi’s — beckoning along a 2.8-mile corridor bookended by low-income neighborhoods on the front lines of a multimillion-dollar battle against obesity.

The Big Picture

An Urban Diet

Articles in this series are examining the campaigns and research efforts to combat obesity.

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The street symbolizes one of many hurdles facing officials here working to put a severely overweight population on a diet. After all, Kentucky is where Colonel Harland Sanders first made his famous fried chicken and a hotel invented the Hot Brown, a turkey-bacon sandwich drowning in Mornay sauce.

In many ways, Louisville’s experience in fighting obesity is little different from that of a dieter stepping on and off a scale. Successes on one front are countered by setbacks on another, and signs that the needle has moved overall are slight and mostly anecdotal.

More than six in 10 people in metro Louisville are still considered seriously overweight, in a state that ranks seventh in the nation for obesity. The rates continued to rise through 2008, while the percentage of the population reporting any physical activity outside of work fell despite public campaigns advocating more walking and biking.

More recent developments underscore the tug of war over food and weight. On one hand, KFC has announced plans for its first nonfried menu, alongside leaflets listing the calorie, fat and salt content of its entire line (as required by the new federal health act).

Behind the scenes, its corporate parent, Yum Brands, was quietly lobbying the state government to turn Kentucky into one of the few states that allow the use of food stamps in its restaurants, which include Pizza Hut and Taco Bell, according to documents unearthed by The Courier-Journal newspaper in Louisville.

“It turns my stomach, the push for using food stamps for fast-food purchase,” said Dr. Adewale Troutman, director of the public health practice at the University of South Florida. “It makes the unhealthy option the easier one.”

As director of the Louisville health department until last fall, Dr. Troutman presided over a campaign that has come to involve nearly every city agency, from the mayor’s office to the sewer department.

The city’s efforts to combat obesity, how and where it is spending money to fight it are instructive at a time when federal dollars are becoming more scarce and budgets are pinched. Cities are increasingly vying for nonprofit and government financing now available as concerns about the obesity epidemic have been underscored by Michelle Obama and others.

To obesity warriors, trying to assess how best to spend the money and demonstrate progress may not be clear for 10 years or more, prompting calls for patience.

“The changes to our physical and social environments that have contributed to the epidemic were gradual and have had decades to gain momentum,” said Risa Lavizzo-Mourey, chief executive of the Robert Wood Johnson Foundation. “We have to expect that this won’t be a quick fix.”

The foundation began its fight against obesity here in 2003 with a grant that, among other things, helped establish the city’s first bicycle lane and ensured that the redevelopment of a low-income housing project included small “pocket” parks, improved traffic patterns and wider and safer sidewalks.

Based on that early progress here and elsewhere, the foundation announced in 2007 that it would spend $500 million to try to reduce childhood obesity rates. Louisville received about $400,000, bringing the foundation’s total investment here to nearly $740,000. It also leveraged its private grants to receive almost $8 million from the Centers for Disease Control and Prevention.

In some of the low-income neighborhoods, there are small signs that awareness of obesity as a problem has increased.

For instance, a local corner store in the Smoketown neighborhood has begun selling plastic tubs of cut fruit as snack food, and orange traffic cones and tape protect freshly poured concrete curb cuts aimed at making walking easier.

At the Presbyterian Community Center’s annual pre-Christmas breakfast, the demand for eggs now outstrips that for bacon — though whether the change can be chalked up to new neighborhood eating habits or the recent arrival of several Somali families is anyone’s guess.

“It’s kind of become a movement,” Bill Gatewood, the center’s executive director, said. “We still have a long way to go, but you do see some changes.”

Another example of how Robert Wood Johnson money has come into play is the St. Peter Claver Community Garden, formerly an abandoned lot that has a waiting list for its plots and is used by the nearby middle school.

Profiles in Science | Nora D. Volkow: A General in the Drug War

Posted: 14 Jun 2011 10:05 AM PDT

From heroin and cocaine to sex and lies, Tetris and the ponies, the spectrum of human addictions is vast. But for Dr. Nora D. Volkow, the neuroscientist in charge of the National Institute on Drug Abuse, they all boil down to pretty much the same thing.

Profiles in Science

Nora D. Volkow

This is the first in an occasional series of articles and videos about leaders in science.

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This week: Your brain on drugs, underwater spiders, and sex and social media.

Jessica Kourkounis for The New York Times

DIRECTOR Dr. Nora D. Volkow in her office in Bethesda, Md. “Science and politics are intertwined,” she concedes.

She must say it a dozen times a day: Addiction is all about the dopamine. The pleasure, pain and devilish problem of control are simply the detritus left by waves of this little molecule surging and retreating deep in the brain.

A driven worker with a colorful family history and a bad chocolate problem of her own, Dr. Volkow (pronounced VOHL-kuv), 55, has devoted her career to studying this chemical tide. And now, eight years into her tenure at the institute, the pace of addiction research is accelerating, propelled by a nationwide emergency that has sent her agency, with a $1.09 billion budget, into crisis mode.

The toll from soaring rates of prescription drug abuse, including both psychiatric medications and drugs for pain, has begun to dwarf that of the usual illegal culprits. Hospitalizations related to prescription drugs are up fivefold in the last decade, and overdose deaths up fourfold. More high school seniors report recreational use of tranquilizers or prescription narcotics, like OxyContin and Vicodin, than heroin and cocaine combined.

The numbers have alarmed drug policy experts, their foreboding heightened by the realization that the usual regulatory tools may be relatively unhelpful in this new crisis.

As Dr. Volkow said to a group of drug experts convened by the surgeon general last month to discuss the problem, “In the past, when we have addressed the issue of controlled substances, illicit or licit, we have been addressing drugs that we could remove from the earth and no one would suffer.”

But prescription drugs, she continued, have a double life: They are lifesaving yet every bit as dangerous as banned substances. “The challenges we face are much more complex,” Dr. Volkow said, “because we need to address the needs of patients in pain, while protecting those at risk for substance use disorders.”

In other words, these drugs must be somehow legal and illegal, encouraged yet discouraged, tightly regulated yet easily available.

The experts are looking to the institute for scientific tools that might help by loosening the tight bonds between pain relief and addiction in the brain.

And that, Dr. Volkow told her audience with a small smile, is all about the dopamine.

She knows a little about dopamine firsthand: She is a dedicated runner and a helpless pawn in face of dark chocolate. Her most significant long-term addiction, though, has been to the science of scanning the brain with techniques that expose its workings like a map, a passion she has pursued like a guided missile since medical school.

That was in Mexico, where Europe’s 20th-century upheavals had tossed both her parents: Her mother fled Franco’s Spain, while her father, the son of Leon Trotsky’s elder daughter, joined his grandfather in exile as an orphaned teenager. Dr. Volkow and her three sisters grew up in the house in Mexico City where Trotsky was murdered in 1940, giving tours of the premises on weekends.

In medical school she read an article in Scientific American about one of the first American positron emission tomography scanners, able to photograph not only the brain’s structures but also its invisible processes. She never looked back.

“It blew my mind,” she said. After a residency in psychiatry at New York University, chosen because it owned that PET scanner, she took a job in Houston, then transplanted her research to Brookhaven National Labs on Long Island, home of groundbreaking research into dopamine and PET scanning. She and her husband, Stephen Adler, a physicist with the National Cancer Institute, now live in Bethesda, Md.

Dr. Volkow’s research career, still based at Brookhaven, has been notable for its “brilliant science,” said Don C. Des Jarlais, an expert in drug addiction who directs the Baron Edmond de Rothschild Chemical Dependency Institute at Beth Israel Medical Center in New York. Dr. Des Jarlais cited her recent widely reported study showing that cellphones alter brain metabolism as a typical example of her unusually creative scientific thinking.

A Merging of Missions

Her days now veer from reviewing raw laboratory data with her research colleagues to leading the back-to-back meetings of a government functionary, but the two roles are joined by the mantra of her time at the institute: Policy should be grounded in valid science.One recent decision in the upper echelons of the National Institutes of Health reflects a similar conclusion: The drug abuse institute and the National Institute on Alcohol Abuse and Alcoholism are on track to be merged into a joint institute on addiction still in the planning stages.

National Institutes of Health watchers have already started a body count. “It will be a big loss that Nora Volkow, current N.I.D.A. director, cannot possibly be selected to head a new institute,” wrote one anonymous blogger on the Scientopia Web site. “This would be too much like N.I.D.A. ‘winning.’ ”

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Global Update: Meningitis: At 50 Cents a Dose, a Vaccine Has Success Among West Africans

Posted: 13 Jun 2011 09:50 PM PDT

A new meningococcal vaccine, just introduced in West Africa, has produced very encouraging results, according to the public-private partnership coordinating its distribution.

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This year’s meningitis season is almost over, and there have been only four confirmed cases of meningitis A in Burkina Faso, the first country to offer the shot to all citizens under 30 (above, a child was vaccinated there). Three infections were in people from Togo, where the vaccine is not used; they had crossed the border for care. The fourth was in a Burkinan who was not vaccinated.

In Mali and Niger, the vaccine was distributed in phased rollouts starting in the most vulnerable areas. No cases were detected in Mali and only four in Niger, all in unvaccinated individuals.

The results were released last week in the journal Health Affairs by the Meningitis Vaccine Project, a partnership of the World Health Organization and PATH, a nonprofit research group in Seattle. It is financed by the Bill and Melinda Gates Foundation.

“The huge expectations that we had for this vaccine are now being fulfilled,” said Adama Traoré, Burkina Faso’s health minister.

Over the last two decades, more than a million cases have been reported across Africa’s “meningitis belt” on the Sahara’s southern edge. If money is found to roll out the vaccine in that region, some experts believe that it could save 150,000 lives by 2015.

The vaccine, called MenAfriVac, costs only 50 cents a dose. It is made in India with technology donated by the United States government for token royalties. There is no market for it in rich countries, so it is supported entirely by donors.

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Recipes for Health: Fava and Buttermilk Soup

Posted: 14 Jun 2011 12:46 PM PDT

Inspired by a soup made with buttermilk and peas in Patricia Wells’s wonderful new book, "Salad as a Meal," is a refreshing chilled soup that looks beautiful in glassware.

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.

1 to 2 large garlic cloves (to taste, halved, green shoots removed)

Salt to taste (about 1 teaspoon)

3 pounds fava beans, shelled and skinned (just under 2 cups -- may use frozen double-peeled)

3 cups buttermilk

Freshly ground pepper

3 tablespoons finely minced fresh mint

2 teaspoons minced chives

1. Turn on a food processor fitted with the steel blade, and drop in the garlic cloves. When they are chopped and adhering to the sides of the bowl, stop the machine and scrape down the bowl. Reserve 1/2 cup of the fava beans; add the rest to the food processor. Add salt and pepper, and turn on the machine. With the machine running, pour in the buttermilk. Process until smooth. Taste and adjust garlic and salt.

2. Place the remaining favas in a bowl, and stir in the buttermilk and fava mixture. Stir together and chill until ready to serve.

3. Just before serving, stir in the mint. Ladle into soup bowls or glasses, sprinkle some chives on top, and serve.

Yield: Serves four.

Advance preparation: This will keep in the refrigerator for three days. Do not stir in the mint until just before serving.

Variation: Substitute fresh dill for the mint.

Nutritional information per serving: 333 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 1 gram monounsaturated fats; 7 milligrams cholesterol; 53 grams carbohydrates; 19 grams dietary fiber; 786 grams sodium (based on 1 teaspoon salt; does not include additional salt to taste); 26 grams protein

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

Well: Living Well With Parkinson's

Posted: 14 Jun 2011 09:06 AM PDT

Letters: Mental Gymnastics (1 Letter)

Posted: 13 Jun 2011 06:20 PM PDT

To the Editor:

Re “Brain Calisthenics for Abstract Ideas” (June 7): Repetitive exercises help the brain to recognize abstract ideas more quickly, but as a senior, I find they also have helped my mental acuity and improved my memory, not unlike the flexibility gained from my daily gym workouts. Yes, my keys continue to disappear with frightening regularity, but my skill at locating them has improved — and so has my dexterity while texting my frustration.

Ruth Kramer Ziony

Los Feliz, Calif.

Science Times welcomes letters from readers. Those submitted for publication must include the writer’s name, address and telephone number. E-mail should be sent to scitimes@nytimes.com. Send letters to Science Editor, The New York Times, 620 Eighth Avenue, New York, N.Y. 10018.

Letters: Palliative Prerogatives (3 Letters)

Posted: 13 Jun 2011 06:20 PM PDT

To the Editor:

Re “Law on End-of-Life Care Rankles Doctors” (Personal Health, June 7): As a practicing general internist and educator and someone who advocates for palliative care, I too am “rankled” by the concept that a law mandating that physicians discuss any health topic with every patient will effect change, improve outcomes or cut costs. The New York State law does not provide a framework to address the issue systematically or to educate patients (the other half of this equation), but it will add one more unproven checkbox to office and hospital notes. New Jersey has a similar law mandating that patients be queried about a living will or advance directive. Some are open to the discussion, but many elderly patients with medical issues specifically say they have no interest in discussing their mortality, and family members often share their denial.

Michael P. Carson, M.D.

Neptune, N.J.

To the Editor:

Jane Brody argues that physicians should offer options, including information regarding palliative and hospice care, to patients who would benefit little, if at all, from more aggressive treatment. I agree; however, this discussion should occur before a person reaches the end of life. Advance directives, including living wills and durable powers of attorney for health care, should be a part of everyone’s medical record and kept in the possession of close relatives or friends who could advocate for people who might be incapacitated and unable to make their own decisions.

Carole York

Lakewood, Calif.

To the Editor:

While I very much concur with Dr. James Tulsky’s position about the importance of allowing patients with a terminal illness to hold on to hope while at the same time addressing treatment decisions, I have learned through the journey of my closest friend, who is living with Stage IV breast cancer and has a determined will to live for as long as possible, that the use of language by professionals — doctors, social workers, support group leaders — can be a powerful force in preserving hope. In listening to their patients, professionals must take their lead from them, rather than imposing their agendas.

Shelley Meyers

Bloomfield, Conn.

Science Times welcomes letters from readers. Those submitted for publication must include the writer’s name, address and telephone number. E-mail should be sent to scitimes@nytimes.com. Send letters to Science Editor, The New York Times, 620 Eighth Avenue, New York, N.Y. 10018.

Letters: Praying for Health (1 Letter)

Posted: 13 Jun 2011 06:20 PM PDT

To the Editor:

Re “Prayer as a Health Aid Grows More Common” (Vital Signs, June 7): I am stunned that the researchers are “surprised” by their findings and that they “guess” that more people seem to be praying about their health because of 9/11. Could this finding instead have anything to do with the fact that 50 million Americans do not have health insurance, and millions more have inadequate insurance? I’m one of those people who “pray” that I don’t get sick.

Nancy Haiduck

The Bronx

Science Times welcomes letters from readers. Those submitted for publication must include the writer’s name, address and telephone number. E-mail should be sent to scitimes@nytimes.com. Send letters to Science Editor, The New York Times, 620 Eighth Avenue, New York, N.Y. 10018.

Recipes for Health: Spaghetti With Fava Beans, Bread Crumbs and Marjoram

Posted: 13 Jun 2011 01:13 PM PDT

This recipe is inspired by a dish from southern Italy made with fresh peas rather than fava beans. Substitute one for the other, depending on what you find at the market. In the original peasant recipe, bread crumbs stand in for cheese, but I’ve given you the option here of Parmesan or pecorino.

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.

2 1/2 pounds fava beans, shelled and skinned

Salt

3/4 pound spaghetti

2 tablespoons extra virgin olive oil

1/2 cup fresh bread crumbs, preferably whole wheat

1 to 2 tablespoons fresh marjoram (to taste)

Freshly ground black pepper

Freshly grated Parmesan or pecorino (or a combination) for serving

1. Bring a large pot of water to a rolling boil over high heat. Salt generously, and add the spaghetti. After five minutes, add the skinned favas. Cook over high heat, stirring occasionally so the pasta doesn’t stick together, until al dente, about 10 minutes.

2. Meanwhile, in a small skillet, heat the olive oil over medium heat, then add the bread crumbs, marjoram, salt and pepper. Cook, stirring, until crispy, three to four minutes. Turn off the heat, and set aside.

3. When the pasta is cooked al dente, remove 1/2 of the cooking water and transfer to a large serving bowl. Drain the pasta and fava beans, and add to the bowl. Add the bread crumb mixture, toss together and serve, passing the cheese at the table.

Yield: Serves four.

Advance preparation: You can skin the favas and prepare the bread crumbs several hours before cooking and serving the pasta.

Nutritional information per serving: 589 calories; 2 grams saturated fat; 2 grams polyunsaturated fat; 5 grams monounsaturated fats; 0 milligrams cholesterol; 99 grams carbohydrates; 14 grams dietary fiber; 172 grams sodium (does not include salt to taste); 27 grams protein

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

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