четверг, 7 октября 2010 г.

U.S. Waivers After Threats of Lost Health Coverage

The waivers have been issued in the last several weeks as part of a broader strategic effort to stave off threats by some health insurers to abandon markets, drop out of the business altogether or refuse to sell certain policies.

Among those that administration officials hoped to mollify with waivers were some big insurers, some smaller employers and McDonald’s, which went so far as to warn that the regulations could force it to strip workers of existing coverage.

At a time when the midterm elections are looming and Republicans have been vocal in campaigning against the law, reaction to the rollout has been closely watched.

To date, the administration has given about 30 insurers, employers and union plans, responsible for covering about one million people, one-year waivers on the new rules that phase out annual limits on coverage for limited-benefit plans, also known as“mini-meds.” Applicants said their premiums would increase significantly, in some cases doubling or more.

These early exemptions offer the first signs of how the administration may tackle an even more difficult hurdle: the resistance from insurers and others against proposed regulations that will determine how much insurers spend on consumers’ health care versus administrative overhead, a major cornerstone of the law.

Several leading insurers, including WellPoint,AetnaandCigna, have also objected to new rules requiring them to cover even those children who are seriously ill, warning that they will stop selling new policies in some states because the rules do not protect them from having to cover too many sick children.

“The hardest part of health reform is always going to be the transition,” said Peter T. Harbage, a former state health official who is a policy consultant in Sacramento. He predicts more insurers and employers will lean on the government to delay or weaken the new regulations.“I think this pressure just increases until we get to 2014,” he said, referring to the year that the law will fully go into effect.

How much the administration can, or should, compromise in ways that could dilute the effect of the new law in the next few years is a subject of much debate, depending on the politics from state to state or the economic dynamics in a particular market.

Policy experts say much of the authority to enforce the new law rests with the states, and they say the federal government may have little ultimate control over whether insurers will keep offering coverage in specific markets.

Nancy-Ann DeParle, the director of the Office of Health Reform at the White House, acknowledged that the concessions given to companies and insurers reflected attempts to avoid having people lose their current coverage before the full law goes into effect while meeting the aim of improving that coverage.

“It is a balancing act,” Ms. DeParle said.“The president wants to have a smooth glide path to 2014.”

The waivers issued so far include the policies offered by McDonald’s to its fast-food workers, typically capped at just a few thousand dollars, sold by a profit-making company owned by Blue Cross and Blue Shield plans. As a result of the administration’s efforts, McDonald’s says it is“confident that we’ll continue to provide health care coverage for our 30,000 hourly restaurant employees.”

Aetna and Cigna have also received waivers to continue selling limited-benefit policies, according to the list released by theDepartment of Health and Human Services, as have small employers like Sanderson Plumbing Products and Guy C. Lee Manufacturing. HealthMarkets, which offers policies through MEGA Life and Health and other insurers, says it also plans to apply for a waiver for some of its plans.

Some states, like Iowa and Maine, have already said they might seek additional authority from federal officials to exempt some insurers, at least for a time, because of the potential disruption if carriers leave the market over the new standards on medical spending.

“We have some very small carriers in the state,” said Susan E. Voss, the Iowa insurance commissioner, who said she favored letting state regulators decide whether some carriers should be given more leeway. The state has already lost some carriers, including thePrincipal Financial Group, which announced its decision last week.


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среда, 6 октября 2010 г.

In Crick’s Letters, Rivalry Among DNA Sleuths Comes to Life

The letters were written during a 26-year period when Crick informally guided the progress of molecular biologists around the world in establishing how DNA operates in living cells. An article on the letters was published Wednesday in the journal Nature, focusing on those related to the discovery of DNA’s double helix structure in 1953.

“We are really between forces that may grind all of us to pieces,” the physicist Maurice Wilkins wrote after a disastrous attempt by Crick and his colleagueJames D. Watsonto build a model of DNA based in part on data gathered by Rosalind Franklin.

Ignoring the intimations of doom, Crick responded to Dr. Wilkins in flippant style, referring to his poaching another lab’s problem and to his friend’s inability to get along with his colleague Dr. Franklin.“So cheer up and take it from us that even if we kicked you in the pants it was between friends,” Crick wrote in December 1951.“We hope our burglary will at least produce a united front in your group!”

Crick’s scientific career was delayed by wartime work designing mines, and at the time he was studying for his Ph.D. atCambridge Universityand was not supposed to be working on DNA at all. The problem belonged to Dr. Wilkins at the University of London. But he, too, was sidelined because the head of his laboratory, John Randall, had made him give up his DNA material and graduate student to a new hire, Dr. Franklin.

The debacle of the wrong structure was set up by Dr. Watson, who had attended a lecture Dr. Franklin gave about her work on DNA but misremembered a critical measurement. Based on it, he and Crick built a model of DNA’s structure and proudly invited the London group up to Cambridge to inspect it.

Dr. Franklin saw immediately that it was mistaken and pointed out the error. Worse consequences were to follow. Hearing of the failed attempt, Dr. Randall complained to Lawrence Bragg, the head of Crick’s laboratory. Dr. Wilkins’s fear of“forces that may grind all of us to pieces” was not misplaced: Dr. Bragg told Crick to get back to his thesis work and stop building models of DNA. The ban was reversed a year later only when Dr. Bragg learned that Pauling, his longtime rival, was also hot on the trail of the DNA structure.

Crick’s correspondence during the formative years of molecular biology was long thought to have been destroyed. Crick told others in 1976 that an overly tidy secretary had thrown all his early letters away. His colleague Sydney Brenner, with whom he shared an office in Cambridge for 21 years, believed the same. Dr. Brenner once showed the author Horace Judson boxes of his unsorted correspondence, explaining it had survived, unlike Crick’s, only because he had been too lazy to file it.“And that’s why the girl never destroyed it,” he said, Mr. Judson reports in his book“The Eighth Day of Creation.”

But it turned out the secretary did not destroy Crick’s correspondence. Dr. Brenner, who is now at the Salk Institute in La Jolla, Calif., recently donated all his files to the Cold Spring Harbor Laboratory on Long Island, where Dr. Watson still works. Looking through Dr. Brenner’s archives, Alex Gann, director of the laboratory’s publishing unit, recognized that they included Crick’s missing correspondence, which evidently had not been discarded but merely was commingled with Dr. Brenner’s papers.

Dr. Gann and Jan Witkowski, director of the Banbury Center at Cold Spring Harbor, write in their article in Nature that the recovered correspondence“gives us a more nuanced sense of the interactions between the principal players in this most famous of scientific stories.”

Robert Olby, a historian of science at theUniversity of Pittsburghand Crick’s authorized biographer, called the rediscovered trove“a rich source of passages that are the live words of the actors at the time, spoken in the heat of the moment.” Dr. Olby’s biography,“Francis Crick, Hunter of Life’s Secrets,” was published last year, its subject having forbade its appearance during his lifetime.


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вторник, 5 октября 2010 г.

Really? - Should You Clean Produce With Soap and Water? - Question

Scientists have found some effective household measures that can eliminate germs and pesticides. The simplest? Rinsing with tap water, which works as well as a mild soap solution or fruit and vegetable washes.

In studies at the Connecticut Agricultural Experiment Station in 2000, for example, scientists compared pesticide removal methods on 196 samples of lettuce, strawberries and tomatoes. Some were rinsed under tap water for a minute; others were treated with either a 1 percent solution of Palmolive or a fruit and vegetable wash. Tap water“significantly reduced” residues of 9 of 12 pesticides, and it worked as well as soap and wash products, the studies found.

Water temperature was not the key; friction was.“The mechanical action of rubbing the produce under tap water is likely responsible for removing pesticide residues,”scientists wrote.

For micro-organisms, try rinsing produce with a mild solution of vinegar, about 10 percent. Ina 2003 studyat theUniversity of Florida, researchers tested disinfectants on strawberries contaminated with E. coli and other germs. They found the vinegar mixture reduced bacteria by 90 percent and viruses by about 95 percent.

THE BOTTOM LINETo remove pesticides and germs, rinse produce with a vinegar solution, then wash with tap water for at least 30 seconds.

ANAHAD O’CONNORscitimes@nytimes.com


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понедельник, 4 октября 2010 г.

Personal Health - Vegetable Consumption Lags, Despite Benefits

For many of us, that was a litany of childhood, an 11th commandment— often followed by“or no dessert.” I even know a mother who tried reversepsychologyon her son—“You can’t have your vegetables until you’ve finished your meat” (or chicken or fish)— though I can’t testify to its success.

As evidence of the health benefits of vegetables has accumulated, public health scientists, nutritionists, federal health experts, growers and marketers, teachers and physicians have been urging— and urging and urging— that Americans eat more of them.

Producers have gone to great lengths to encourage vegetable consumption by a public increasingly pressed for time and overly focused on fast food and takeout. Farmers’ markets are springing up all over the country, with enticing displays of locally grown produce. Supermarkets feature ready-to-eat and ready-to-cook vegetables— spinach, salad greens, complete salads, broccoli florets, peeled baby carrots. Simple, tasty recipes are often part of the produce display. Even the major fast-food purveyors have made an effort, introducing salads as side and main dishes; McDonald’s now sells more salads than any other eating establishment.

Yet last month came the discouraging word from the nationalCenters for Disease Control and Preventionthat Americans have fallen far short of the goals set a decade ago to increase consumption of vegetables. In 2009, just 26 percent of adults had three or more servings a day (including those who count a tomato slice and a lettuce leaf on a burger as a vegetable serving). That was half the percentage public health officials had hoped for.

And it falls even shorter if you look at the current recommendations: at least four to five vegetable servings daily. Please note the definition of a serving: half a cup of cut-up or cooked vegetables, one cup of fresh greens, half a cup of cooked dried beans, or, if you must, six ounces of vegetable juice.

So what’s so good about vegetables anyway? First, vegetables are loaded with vital nutrients: potassium,beta-carotene(the precursor of vitamin A), magnesium,calcium, iron,folate(a B vitamin) andvitaminsC, E and K, as well as antioxidants andfiber. Despite an ill-conceived effort years ago to“package” vegetables’ nutrients in a supplement, there is no good way to consume them short of eating the foods that contain them.

And unless they are drowned in butter or a high-calorie sauce or dressing, vegetables provide those nutrients at minimal caloric cost, an important attribute in a society whereobesityis ballooning out of control.

Curbing weight gain can reduce the risk ofType 2 diabetes, now rampant in America and an important cause of heart disease,kidney failureand premature death.

Fiber, Potassium and More

Vegetables provide dietary bulk, filling the stomach and reducing the appetite for higher-calorie foods. The fiber in vegetables helps reduce blood levels of heart-damagingcholesteroland is a major antidote forconstipationanddiverticulosis.

The potassium in tomato products, dried beans, sweet potatoes, spinach, Swiss chard and winter squash can easehigh blood pressure, a major risk factor for heart disease and stroke, and may also reduce the risk of developingkidney stonesand bone loss.

Folate is a critical nutrient duringpregnancyto prevent spinal cord defects; it also helps the body form red blood cells.Vitamin E, an antioxidant, protects against the deterioration of essential fatty acids and premature cell aging, andvitamin Cis important for healthy gums and teeth, healing of wounds and absorption of iron.Vitamin Kaids in blood clotting (note, however, that people taking blood thinners must curb their intake of foods rich in this nutrient).

The vitamin A formed from beta-carotene is vital to the health of the eyes and skin and may help prevent infections.A Harvard study of 73,000 nurses, published in 2003 in The American Journal of Clinical Nutrition, linked a carotenoid-richdietto a reduced risk of coronary artery disease, anda Swedish studyfound that it cut the risk ofstomach cancerin half.

Two othercarotenoids, lutein and zeaxanthin, can reduce the risks ofmacular degenerationandcataracts, common causes of vision loss as people age. These nutrients are found in dark green leafy vegetables, like spinach and kale, which are packed with other valuable vitamins and minerals.

Lycopene, another carotenoid, may reduce the risk ofprostate cancerandwas also linked to a reduced risk of cardiovascular disease in women. Lycopene is best obtained from processed tomato products. (Tomatoes, of course, are technically fruits, as are squash and other“vegetables” with seeds. The foods we usually think of as fruit have plenty of nutritional value but tend to have morecaloriesthan vegetables— and may not supply all the same nutrients.)

Several other vegetables, not all of them popular among Americans, have also been linked to protection againstcancer. These are the so-called cruciferous vegetables: broccoli, cauliflower, cabbage, kale, collard greens and brussels sprouts.

Then there are the allium vegetables, onions and garlic, thatresearchers in Milan have linkedto protection against cancers of the colon and rectum, ovary, prostate, breast, kidney, esophagus, mouth and throat.

Last year The Nutrition Action Healthletter, published by theCenter for Science in the Public Interest, an advocacy group based in Washington, ranked vegetables according to nutrient content. Kale led the list, followed by spinach, collard greens, turnip greens, Swiss chard, canned pumpkin, mustard greens, sweet potato, broccoli and carrots.

Others among the“superstars” listed were romaine lettuce, red bell pepper, curly endive, brussels sprouts, butternut squash, green pepper, peas and bok choy.

Except for sweet potato (100 calories in one medium potato) and peas (70 calories per half cup), none of these (when unadorned by fat) have more than 40 calories a serving, and most have only 20 or 30 calories.

Suggestions Welcome

Given that so many professionals have failed to raise the consumption of vegetables among not-so-health-conscious Americans, how can we make a difference? Fresh ideas are needed, and I invite readers to e-mail suggestions toscitimes@nytimes.comfor possible inclusion in a future column. (Please include the word“Brody” in the subject line.)

Who knows? One of you may succeed in keeping Americans healthier and curbing our runaway health care costs.


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суббота, 2 октября 2010 г.

Antipsychotic Drugs - Side Effects May Include Lawsuits

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatoryschizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more thana half-million youthstake antipsychotic drugs, and fullyone-quarter of nursing-home residentshave used them. Yet recent governmentwarnings saythe drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of theFalse Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs—Bristol-Myers Squibb,Eli Lilly,Pfizer,AstraZenecaandJohnson&Johnson— has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill,Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which theFood and Drug Administrationhas approved them— mostly, schizophrenia andbipolarmania— and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer.“Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers— despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, aHarvardmedical professor and researcher.“When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs— now known as antipsychotics— were first developed in the 1950s for use inanesthesiaand then as powerfulsedativesfor patients with schizophrenia and other severepsychoticdisorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range ofinvoluntary body movements,ticsandrestlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the’90s and sold to doctors more broadly, on the basis that they were safer than the old ones— an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been“greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of thepsychiatrydepartment atColumbia University. Such assertions, he says,“may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds,“the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree.“They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has writtentwo booksabout psychiatric medicines.“They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects likedrowsiness, nausea,weight gain, involuntary body movements and links todiabetesare listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.


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