Saturday, May 28, 2011

Health - The Health Consumer: For Those With Diabetes, Older Drugs Are Often Best

Health - The Health Consumer: For Those With Diabetes, Older Drugs Are Often Best

The Health Consumer: For Those With Diabetes, Older Drugs Are Often Best

Posted: 27 May 2011 10:10 PM PDT

WHEN it comes to prescription drugs, newer is not necessarily better. And that’s especially true when treating diabetes.

One in 10 Americans has Type 2 diabetes. If the trend continues, one in three will suffer from the disease by the year 2050, according to the federal Centers for Disease Control and Prevention.

Most Type 2 diabetes patients take one or more drugs to control blood sugar. They spent an estimated $12.5 billion on medication in 2007, twice the amount spent in 2001, according to a study by the University of Chicago. (That figure does not including drugs that diabetics are often prescribed for related health conditions, like high blood pressure and high cholesterol.)

Why the increase? More diagnosed patients, more drugs per patient and an onslaught of expensive new drugs, according to Dr. G. Caleb Alexander, assistant professor of medicine at the University of Chicago and lead author of the study. Since 1995, several new classes of diabetes medications have come on the market. Diabetes drugs are important to the pharmaceutical industry, more lucrative than drugs for many other chronic diseases, Dr. Alexander noted in an interview.

Simply put, many of these drugs help the body produce less glucose or more insulin, the hormone that shuttles glucose into cells for use as energy, or they increase the body’s sensitivity to its own insulin.

Patients and health care professionals have long hoped that as pharmaceutical companies found ways to help the body lower blood sugar, they would produce safer and more efficient alternatives to older medications. But a true breakthrough doesn’t seem to have happened yet.

A report released in March by the federal Agency for Healthcare Research and Quality and conducted by researchers at Johns Hopkins University reviewed data from 166 studies to evaluate the effectiveness and risks of various diabetes medicines. The researchers concluded that drugs that have been around for years are more effective at lowering blood sugar and often work with fewer side effects than the newest drugs. And because so many older drugs now are available as generics, they often cost just a fraction of the price of newer brand-name drugs.

Low-cost treatment is imperative to turning back the diabetes epidemic, said Dr. Wendy L. Bennett, assistant professor of medicine at Johns Hopkins University School of Medicine and the lead author of the A.H.R.Q. study. Experts estimate that only 25 percent of diabetic patients are getting the treatment they need, and expense is a big reason. Even well-insured patients may reel when confronted with the $6,000 a year it takes on average to manage the disease (not counting the costs of such complications as heart disease, stroke, and liver and kidney damage).

Becoming educated is the most important thing a person with diabetes can do to help stem the cost of medications as well as avoid complications, said Dr. Bennett. Here, three crucial things you should know.

Step 1: Fight diabetes with lifestyle changes.

Cost: Free or low cost.

If you are pre-diabetic or recently diagnosed, you may be able to dodge the expense of drug treatment with exercise and a better diet and by quitting smoking. None of this has to cost a fortune, and in any event healthier foods and, if necessary, a gym membership or other exercise program are well worth the investment. Even if you are taking medication, these lifestyle changes can help the medicine work better and longer.

For more information go to www.cdc.gov/diabetes and the Web site for the American Diabetes Association, www.diabetes.org.

Step 2: If you need to begin taking a drug to control blood sugar, start with metformin, the most common and one of the least expensive diabetes drugs.

Cost: $36 for 100 pills (500 milligrams); usually taken twice a day. Prices may be even lower at Wal-Mart, Target and other discount pharmacies.

Metformin almost always works as a first-line drug, except for patients suffering from severe kidney disease, said Dr. Bennett. What’s more, metformin generally does not cause hypoglycemia, a common and dangerous side affect of many diabetes drugs.

It also does not seem to cause weight gain, as some other diabetes drugs do, said Dr. Bennett. “The last thing you want if you’ve been diagnosed with diabetes is additional weight,” she added.

A study published in Consumer Reports Health in February 2009 also found that older, less expensive diabetes drugs were just as effective as the new ones. Better yet, they have established safety records, while some newer diabetes drugs have been found to increase cardiovascular and other health risks.

“The expensive drugs are third- and fourth-line drugs,” said Dr. Marvin Lipman, chief medical adviser for Consumer Reports Health and a practicing endocrinologist in Westchester County, N.Y. “If you don’t get results with the less expensive drugs, you go to those. But you shouldn’t start there.”

Avoid: Certain newer diabetes drugs have been associated with heart failure and other risks.

Avandia, for example, has been linked to an increased risk of heart attacks. In September 2010, after years of debate, the Food and Drug Administration severely restricted Avandia’s availability, allowing it to be prescribed only to patients in a special program who had not responded to other drugs and were taking the medicine under a doctor’s strict supervision. This month the agency expanded those restrictions to include related drugs Avandamet and Avandaryl, which also contain rosiglitazone, the active agent in Avandia.

Step 3: Choose combination drugs from among inexpensive generics.

Cost: Glimepiride, $13 for 100 pills (1 milligram). Glipizide, $64 for 100 pills (5 milligrams).

Most diabetics will have to eventually take more than one drug to keep blood sugar under control. The good news here from the Johns Hopkins study is that inexpensive metformin is also quite effective in combination with other generics, such as glimepiride and glipizide.

“Most combinations worked equally well, so when you’re adding a drug, you could choose a generic to save costs,” said Dr. Bennett. She added, however, that some drugs used with metformin might increase the risk of side effects such as hypoglycemia or weight gain. Patients should discuss each drug’s pros and cons, as well as cost, with their doctors.

Avoid: Do not start with one of the more expensive drugs in combination with metformin. In some cases, patients ultimately may need a combination of both generics and the newer drugs, but this usually becomes appropriate only after a less expensive combination has been used for some time or if the patient isn’t responding to the less expensive combination, said Dr. Bennett.

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Goodbye Food Pyramid, Hello Dinner Plate

Posted: 27 May 2011 11:23 PM PDT

Whatever you do, don’t call it a pie chart.

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Chris Graythen/Getty Images

The first lady, Michelle Obama, has led the push for increased exercise and healthy eating.

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Officials said the  current food pyramid, above, was confusing.

The Obama administration is about to ditch the food pyramid, that symbol of healthy eating for the last two decades. In its place officials are dishing up a simple, plate-shaped symbol, sliced into wedges for the basic food groups and half-filled with fruits and vegetables.

The circular plate, which will be unveiled Thursday, is meant to give consumers a fast, easily grasped reminder of the basics of a healthy diet. It consists of four colored sections, for fruits, vegetables, grains and protein, according to several people who have been briefed on the change. Beside the plate is a smaller circle for dairy, suggesting a glass of low-fat milk or perhaps a yogurt cup.

Few nutritionists will mourn the passing of the pyramid, which, while instantly recognized by millions of American school kids, parents and consumers, was derided by nutritionists as too confusing and deeply flawed because it did not distinguish clearly between healthy foods like whole grains and fish and less healthy choices like white bread and bacon. A version of the pyramid currently appearing on cereal boxes, frozen dinners and other foods has been so streamlined and stripped of information that many people have no idea what it represents.

“It’s going to be hard not to do better than the current pyramid, which basically conveys no useful information,” said Walter C. Willett, chairman of the nutrition department at the Harvard School of Public Health. Dr. Willett said he had not seen the new logo.

The new symbol was designed to underscore a central mantra of the federal government’s healthy eating push: make half your plate fruits and vegetables. And it is expected to be a crucial element of the administration’s crusade against obesity, which is being led by the first lady, Michelle Obama.

“We need to get consumers’ attention,” said Robert C. Post, deputy director of the Department of Agriculture’s Center for Nutrition Policy and Promotion. He would not discuss details of the icon in advance of the official unveiling. But he said it was meant to be a “visual cue” that would prompt “consumers to say, ‘I need to be a little more concerned about what I choose to build a healthy day’s diet.’ ”

Some who have seen the logo compared it with a pie chart, though dessert is hardly the association that the administration would like to conjure up. Others likened it to a pizza cut into slices (equally unpalatable for officials). One person said it called to mind a painting by the artist Mark Rothko, who was known for canvases with blocks of color. Those who had seen it would speak only on the condition of anonymity because they were not authorized by the administration to discuss it.

Dr. David Kessler, a former commissioner of the Food and Drug Administration, who said he had heard descriptions of the new plate, suggested that if the symbol succeeded in getting people to eat significantly more fruits and vegetables, that alone would be an achievement.

“The reality is that very few of us eat like what has been suggested” in government guidelines for healthy eating, Dr. Kessler said. “There’s a world of difference between what’s being served and what’s on that plate.”

He called the plate a major improvement over the pyramid. “It conveys the message simply in a way that we all can understand,” he said.

The plate symbol is meant to help educate consumers about the government’s latest dietary guidelines, which were released in January.

Dr. Post said the U.S.D.A. had spent about $2 million to develop and promote the logo, including conducting research and focus groups and creating a Web site. Some of that money will also be used for the first year of a campaign to publicize the image. He said the agency would use the plate to get across several basic nutritional messages, including urging consumers to eat smaller portions, switch to low-fat or fat-free milk and drink water instead of sugary drinks.

The food pyramid has a long and tangled history. Its original version showed a hierarchy of foods, with those that made up the largest portions of a recommended diet, like grains, fruit and vegetables, closest to the wide base. Foods that were to be eaten in smaller quantities, like dairy and meat, were closer to the pyramid’s tapering top.

But the pyramid’s original release was held back over complaints from the meat and dairy industry that their products were being stigmatized. It was released with minor changes in 1992.

A revised pyramid was released in 2005. Called MyPyramid, it turned the old hierarchy on its side, with vertical brightly colored strips standing in for the different food groups. It also showed a stick figure running up the side to emphasize the need for exercise.

But the new pyramid was widely viewed as hard to understand. The Obama administration began talking about getting rid of it as early as last summer. At that time, a group of public health experts, nutritionists, food industry representatives and design professionals were invited to a meeting in Washington where they were asked to discuss possible alternative symbols. One option was a plate.

When several participants at that meeting said it would be better to create an improved version of the already familiar pyramid, an administration official rejected that idea, telling the group, “We can’t go back,” according to one person who attended the meeting. The person, who requested anonymity because the deliberations were intended to be confidential, said it was clear that the “marching orders were obviously to come up with something new.”

That “something new” will be plated up on Thursday.

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F.D.A. Approves Drug to Treat Hospital Scourge

Posted: 27 May 2011 11:55 PM PDT

As a young infectious disease researcher in 1971, Dr. Sherwood L. Gorbach received an urgent call for help from a drug company. Some patients treated with the company’s antibiotic in New Zealand had developed severe cases of diarrhea and bowel inflammation, and some had died.

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Lois S. Wiggs/CDC

This is a micrograph of Clostridium difficile, a persistent bacterium that might be the leading hospital-acquired infection.

Dr. Gorbach ended up devoting much of his career to tracking down the cause of that outbreak and pursuing treatments. On Friday, 40 years after he began his quest, the Food and Drug Administration approved a drug he helped develop.

The drug, called Dificid, is the first new medicine in 25 years approved to treat diarrhea caused by Clostridium difficile, a nasty and persistent bacterium that one study suggests may have surpassed the better known MRSA as the leading hospital-acquired infection.

In clinical trials, Dificid, also known as fidaxomicin, proved better than the only approved drug in keeping patients free of symptoms 25 days after the end of treatment. The new drug was developed by Optimer Pharmaceuticals, where Dr. Gorbach, now 76, is the chief scientific officer.

Infections and deaths from C. difficile — the name means “difficult” — have increased sharply since the 1990s, in part because of the spread of a more virulent strain. It is estimated that several hundred thousand Americans are infected each year. Up to 1 percent of patients must have their colons removed and about 5 percent die.

While most of those infected are elderly people in hospitals or nursing homes, younger adults and children can also be infected, and there are cases that arise outside the hospital.

Problems usually start when people are treated with antibiotics for some other infection. That can kill off many of the harmless bacteria in the intestines, allowing C. difficile, which is resistant to most antibiotics, to take over.

Two drugs are now used to treat C. difficile, one of which — metronidazole, a generic antibiotic also sold by Pfizer as Flagyl — was never actually approved for this use. The other is Vancocin, an oral form of the antibiotic vancomycin, which is sold by ViroPharma and was approved in 1986.

While the drugs usually clear the diarrhea, it can come back, often more than once.

“When patients get better and are discharged and have another recurrence, it sets them back to Square 1,” said Lynne V. McFarland, an expert at the Puget Sound veterans affairs hospital in Seattle.

Dificid might help reduce those recurrences.

In two clinical trials involving a total of about 1,100 patients, both Dificid and Vancocin cleared the diarrhea in more than 85 percent of patients by the end of the 10-day treatment period. But in later weeks, roughly 25 percent of the Vancocin users had a recurrence compared with only about 15 percent of the Dificid users.

The net result was that 25 days after the end of treatment, about 70 percent of those treated with Dificid were still free of disease compared with 57 percent of those treated with Vancocin, according to Dificid’s label.

The main side effects are nausea, vomiting, abdominal pain and gastrointestinal hemorrhage.

Dificid is the first approved product for 13-year-old Optimer, which is based in San Diego. Cubist Pharmaceuticals will help market the drug, which is a tablet taken twice a day.

Eun K. Yang, an analyst at Jefferies & Company, has predicted annual sales could reach $159 million by 2015.

Vancocin had sales of $259.6 million in 2010, up 22 percent because of price increases, while the number of prescriptions declined. ViroPharma has said that C. difficile infections in the United States may have leveled off or declined since 2008.

Optimer declined to disclose the price of Dificid until a conference call with analysts on Tuesday. But the drug is likely to be at least as expensive as Vancocin, which costs $1,000 or more for a course of treatment.

A high price might limit Dificid’s use to the most severe cases. Generic versions of Vancocin could be approved in the coming year, which would hurt sales of Dificid.

For Dr. Gorbach, the approval was a coda to a career spent mostly as a professor of medicine and public health at Tufts University.

It was there that he and colleagues identified toxin-producing clostridia as the culprits in the New Zealand outbreak. Upjohn, the manufacturer of the antibiotic involved, paid for the research. The finding was published in The New England Journal of Medicine in 1978.

In 2003, Dr. Gorbach was asked for advice by another pharmaceutical company, Optimer. He grew excited when he learned that hamsters treated with fidaxomicin had remained healthy even after treatment stopped.

“All the other drugs, when you stop the treatment, they all die within two or three days,” he said.

In 2005, while keeping his post at Tufts, he joined the company.

“This was an opportunity for me to see a drug through that could really make a difference in people’s lives,” he said. “It’s thrilling to be part of this and see the full circle.”

For First Time, Unicef Reveals Differences in Prices It Pays Drug Companies for Vaccines

Posted: 27 May 2011 11:20 PM PDT

The United Nations Children’s Fund on Friday publicly listed for the first time the price it pays for vaccines.

The decision — which immediately revealed wide disparities in what vaccine makers charge — could lead to drastic cuts in prices for vaccines that save millions of children’s lives.

Unicef paid $747 million for vaccines last year, buying over two billion doses for 58 percent of the world’s children.

Newer procurement agencies like the Global Fund to Fight AIDS, Tuberculosis and Malaria routinely reveal what they pay for drugs. But vaccines — shots or drops that prevent disease — have been largely exempt because Unicef has avoided confrontation with its suppliers, posting only the average prices it pays; and donors had not demanded more details.

Shanelle Hall, director of Unicef’s supply division and the driving force behind the new transparency policy, said she hoped to extend it to other goods that Unicef buys, including mosquito nets, diagnostic kits, essential medicines and ready-to-eat foods for starving children.

The medical charity Doctors Without Borders, which successfully pressed for lower AIDS drug prices in Africa a decade ago and has campaigned for the public posting of vaccine prices, declared the move a victory.

“This is going to make a huge difference,” said Daniel Berman, deputy director of the charity’s global access campaign. “As soon as the donors see the differentials, they’re going to insist that Unicef and GAVI get better prices.” GAVI, the Global Alliance for Vaccines and Immunization, collects billions of dollars from donors to help Unicef pay for vaccines.

Mr. Berman recently quit a GAVI committee to protest its resistance to revealing prices. Officials of several pharmaceutical companies sit on GAVI boards.

GAVI dragged its feet until Unicef forced the issue, he said.

Asked about that, Ms. Hall hesitated, then said: “There may have been doubts, but GAVI is now happy about it. Transparency is hard to argue against.”

Some of the price differences were stark. For example, an important compound vaccine that prevents diphtheria, tetanus, whooping cough, hepatitis B and haemophilus influenzae type B cost only $2.25 a dose from the Serum Institute of India last year, but $3.20 a dose from Crucell, a Swiss company that was just purchased by Johnson & Johnson.

“Oh my God,” Mr. Berman said when the new price list was read to him. “I had no idea the difference was so extreme. A dollar more? No wonder J & J bought Crucell. It gets 60 percent of its income from GAVI orders.”

Five companies now sell Unicef that vaccine. In earlier years, when GlaxoSmithKline was the lone bidder for the contract, it charged $3.60. (Ideally, every child gets three doses.)

Joan Howe, a Unicef spokeswoman, said the agency made the decision “in the hopes it will lead to a more competitive market and lower prices, especially for newer vaccines.”

While some vaccines, like polio, cost as little as 12 cents and are made by seven companies, the newest, against rotavirus and pneumococcal bacteria, are expensive and made by one or two.

For example, the pneumococcal vaccine is made only by Pfizer and GlaxoSmithKline, each of which gets $3.50 a dose from Unicef. However, under an arrangement called the Advance Market Commitment that was brokered by GAVI to entice vaccine companies to keep supplying poor countries, both companies get an additional $3.50 for the first six million shots. Even if a rival made the vaccine for $2, Mr. Berman said, it would get subsidies to bring it to $7.

The ideal, he said, is prices that are low, but still profitable enough to attract companies that can pass World Health Organization safety standards.

Unicef’s move is likely to push other buyers to ask for the lowest prices it gets. For example, the Pan American Health Organization negotiates the amount that poor and middle-income countries in the Western Hemisphere pay when buying in bulk through it. Like Unicef, it had been posting only average prices.

Unicef has now told all bidders that, in the future, it will publish how much it pays them. Until this week, several companies resisted its requests for permission to post what it paid.

They stalled by saying they had to consult their lawyers about antitrust consequences, Ms. Hall said. Both she and Mr. Berman noted the weak spots in that argument: prices that donors pay for drugs from the same companies were routinely posted, and antitrust complaints were more likely under the old regimen of hidden prices.

Ultimately, almost all the companies came around. The only major supplier still refusing is Novartis. A company spokeswoman said Friday that Novartis “does not disclose pricing information on its vaccines, as this information is competitive.”

Merck and Japan’s BCG Laboratory also refused, but each makes only one vaccine that Unicef buys.

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Thyroid Drug Shortage Presents Tough Choices for Cancer Patients

Posted: 27 May 2011 11:58 PM PDT

Lisa Meidl’s thyroid cancer should be easily treatable with surgery and medication. But for her and as many as 30,000 other patients, the final steps to a cure are painfully out of reach.

Forty percent of patients who need a drug used in the treatment and monitoring of thyroid cancer will not be able to get it until later this summer, according to the medication’s manufacturer. The shortage is forcing patients like Ms. Meidl, a 48-year-old journalist in Madison, Wis., to make a stark choice.

They may opt to delay treatment, or they may proceed with it despite the often miserable side effects normally allayed by the medication, including severe depression, fatigue and confusion.

For now, Ms. Meidl has chosen, reluctantly, to live with her cancer until she can obtain the drug, called Thyrogen. “The shortage has taken away my ability to put cancer behind me,” she said.

Thyrogen is a synthetic thyroid-stimulating hormone given by injection to patients who have had their thyroid glands removed; they need the drug to receive treatment or undergo diagnostic tests. Before Thyrogen became available in 1998, patients without thyroids were forced to stop taking synthetic thyroid hormone for up to six weeks before tests and treatments.

Thyrogen enables these patients to avoid the often significant side effects of hormone withdrawal. A 2007 study published in The European Journal of Endocrinology found that patients who took Thyrogen reduced the length of their workplace sick leaves by 8.1 days on average, compared with those in withdrawal. There is no comparable product available for people who need the drug.

Thyroid cancer may be a very treatable disease, but it also has a recurrence rate of nearly 30 percent, and it is the fastest-growing cancer diagnosis among women in the United States.

The shortage “is concerning,” said Dr. Herbert Chen, leader of the endocrine cancer disease group at the University of Wisconsin, who estimates he prescribes the drug to 75 percent of his patients before treatment. “We want to be able to offer the best therapies to our patients, and Thyrogen is part of that algorithm.”

The Genzyme Corporation, which manufactures Thyrogen, says the global supply will continue to be scarce until July. Alicia Secor, head of Thyrogen business at Genzyme, acknowledged frustration over the shortage and said it is a result of “inventory constraints and an inability to meet increasing demand,” as well as a transition to a new plant for its bottling and labeling operations.

Thyrogen joins a number of other cancer drugs that have recently fallen into short supply, including Cytarabine, a chemotherapy agent used to treat several types of leukemia.

Since thyroid cancer is typically slow-moving, most physicians are recommending that low-risk patients wait out the shortage.

“It would be difficult to say that delaying therapy two or three months will change the outcome of their disease,” said Dr. Susan Mandel, a professor of medicine at the University of Pennsylvania, who notes that some doctors do not use Thyrogen to treat thyroid cancer at all. “But physicians want to get patients who have just had surgery on with their lives, and instead we are telling them they can’t be treated now.”

A small number of patients simply can’t wait. Dr. John Palmer, a physician at the Regional Medical Clinic in Rapid City, S.D., recently advised two of his patients with a history of aggressive tumors to stop taking synthetic thyroid hormone, and to tolerate the harsh consequences, in order to prepare for their annual screenings.

Others like Andrea McDonald, 31, a government worker in Washington, are choosing to tough it out without Thyrogen simply because the wait for treatment is too harrowing.

“It was a horrible, unfair choice,” she said. “It doesn’t feel right to wait months to be treated for cancer.”

Study Questions Treatment Used in Heart Disease

Posted: 27 May 2011 08:12 AM PDT

WASHINGTON — Lowering bad cholesterol levels reduces heart attack risks, and researchers have long hoped that raising good cholesterol would help, too. Surprising results from a large government study announced on Thursday suggest that this hope may be misplaced.

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The study could change the way doctors treat millions of patients with heart disease. Common wisdom has been that such patients should take a statin drug like Lipitor or Zocor to lower bad cholesterol and, in many cases, the vitamin niacin to raise their good cholesterol. But in the trial, niacin provided no benefit over simple statin therapy.

The results are part of a string of studies that suggest that what doctors thought they knew about cholesterol may be wrong. Studies that track patients over time have for decades shown that patients with higher levels of high-density lipoproteins (H.D.L., or good cholesterol) tend to live longer and have fewer heart problems than those with lower levels of this cholesterol.

Not surprisingly, doctors thought that if they could raise H.D.L. levels, their patients would benefit. So far, that assumption is not panning out. Nobody knows why.

In 2006, Pfizer halted development of a drug that raised good cholesterol levels after studies showed that the medicine increased the risks of death. And on Thursday, government scientists announced that Niaspan, an extended release form of niacin, not only did not provide any protection against heart attacks when taken with Zocor in patients with heart disease but also slightly increased their risk of stroke.

“We were stunned, to say the least,” said Dr. William E. Boden, a professor of medicine and preventive medicine at the University at Buffalo who was a trial investigator.

What is remarkable about the study is that niacin seemed to be working. Patients taking the medicine along with Zocor had higher levels of H.D.L. and lower levels of triglycerides, a fat in the blood. Despite these seeming improvements, the patients fared no better and may have done slightly worse than those taking Zocor alone. That is why the entire theory behind trying to increase H.D.L. levels in patients with heart disease may need rethinking.

The study results may be greeted as a mixed blessing by some patients. A drug many had hoped would help is now thought to be at best useless. But for many people, niacin is hard to take because it can cause flushing and headaches. Doctors have for years wheedled patients into tolerating these side effects in hopes that the medicine would save their lives. Now, they will not have to.

Dr. William M. Schreiber, a Louisville, Ky., internist, said he had stopped prescribing niacin because so many patients told him they could not abide its effects. “I’m delighted to hear that statins alone are just as good as statins and niacin,” he said.

The study is bad news for the maker of Niaspan, Abbott Laboratories, for the drug industry as a whole and even for the Food and Drug Administration. Abbott last year had $927 million in Niaspan sales, and the company spent $32 million on the study (the government spent $21 million) in the hope that it would increase sales. Instead, the results are bound to lower use of the drug.

In a statement, Dr. Eugene Sun, a vice president at Abbott, said, “Based on its long history of clinical evidence, Niaspan remains an important agent for patients with” blood lipid problems.

The study gives no comfort to other drug makers, many of which have been trying to come up with new drugs to raise levels of good cholesterol or otherwise lower heart attack risks. Statins and other drugs have proven so effective in treating heart disease that improvements are proving very tough to find.

The study is also bad news for the F.D.A., which heavily relies on laboratory results to decide whether to approve drugs.

“This study shows that approving drugs and allowing them to stay on the market on the basis of how they affect lipids and other biomarkers is not good policy,” said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “It’s time to have a new regulatory approach.”

In the trial, 3,414 participants with heart and vascular disease were given either Zocor and a placebo or Zocor and Niaspan and followed for 32 months. The trial ended 18 months early because it was found that there was almost no chance taking Niaspan would prove beneficial. Zocor and other medications did a good job of keeping patients’ bad cholesterol levels relatively low.

Researchers said patients should not stop taking Niaspan without talking to their doctors first.

“We have great evidence that lowering L.D.L. is beneficial,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. “We lack good evidence that changing H.D.L. or triglycerides does much.”

Pentagon Plans to Consolidate Military Health Records

Posted: 26 May 2011 08:20 PM PDT

For many years, service members who were leaving the military have had to worry about whether their medical records would be properly transferred from one vast computer network in the Defense Department to another in the Department of Veterans Affairs.

Now, the two departments have agreed to develop a joint computerized system for health care records that could provide a single source of data on a veteran’s health from enlistment through death, officials said.

The move is one of several that suggest the two departments are moving closer to unifying parts of their sprawling health care systems, which handle more than 15 million active-duty troops, retirees, veterans and their families.

The agreement comes after a February report by the Government Accountability Office found that the departments were lagging in developing a shared system for electronic records.

That report said both departments had spent billions of dollars upgrading their data systems in ways that did not increase coordination between their systems, and it recommended that they improve their “joint strategic planning.”

In a meeting on May 2, Robert M. Gates, the defense secretary, and Eric K. Shinseki, the secretary of veterans affairs, agreed to move ahead with developing the joint system, which had long been discussed but was the subject of some doubt until now, federal officials said.

Veterans say that under the current system, they sometimes have to carry paper copies of their military service health records to their new doctors at veterans’ hospitals. Some also complain that records transferred electronically get lost because the two computer systems are not always compatible.

“In future, that data will be completely interoperable,” said Elizabeth A. McGrath, the deputy chief management officer for the Defense Department. “We are approaching the delivery of care in a standard way.”

Ms. McGrath said a shared system should speed care for veterans, since they would not have to obtain records from the Pentagon that might be missing in their Veterans Affairs Department records.

She also said it could make it easier for researchers and epidemiologists to spot health care trends, since data collected in one system could be more easily searched. Moreover, many health problems facing veterans do not emerge until years after they leave the military, so being able to look at their full medical history could be useful to researchers.

Obama administration officials also hope that the joint system will save money, though they declined to estimate how much. “It will create efficiencies,” Ms. McGrath said.

Given the size of the undertaking, officials said it would take several years to complete. But a joint system is already under development in Chicago, where the Departments of Defense and Veterans Affairs share a medical center, the Capt. James A. Lovell Federal Health Care Center.

Peter Gaytan, executive director of the American Legion in Washington, said a joint records system would reduce the time it would take for veterans to make the transition into the Veterans Affairs health system. Jim Strickland, a veterans’ advocate, said many doctors in the veterans’ health care system did not know details about patient histories, like the medications prescribed in Iraq or Afghanistan.

“That the V.A. physicians don’t have any access at all to the previous years of treatment records and notes by other doctors and caregivers is an absurd situation,” Mr. Strickland said. “The flow or continuum of good care is suddenly interrupted.”

Mr. Gates and Mr. Shinseki have discussed significantly speeding up the time it takes for people leaving the military to get exams that determine their disability compensation. In the past, people with injuries linked to their service were examined by a military doctor and given a rating that would determine their disability benefits. Then they would receive another exam from a doctor in the veterans system, and often those ratings were different. The armed services also used different criteria in rating injured troops.

Asked And Answered | Monica Coury: Under an Arizona Plan, Smokers and Obese Would Pay Fee for Medicaid

Posted: 26 May 2011 11:20 PM PDT

Arizona, like many others states, says it is no longer able to adequately finance its Medicaid program. As part of a plan to cut costs, the state has proposed imposing a $50 fee on childless adults on Medicaid who are either obese or who smoke. In Arizona, almost half of all Medicaid recipients smoke; while the number of obese people is unclear, about one-in-four Arizonans is overweight, according to the Centers for Disease Control and Prevention. The state’s plan must ultimately be approved by the federal government. Monica Coury, spokeswoman for Arizona’s Medicaid program, discusses.

More Asked and Answered

Q. What is the current status of the state’s Medicaid program?

A. “In Arizona, there has been an increase of 30 percent in the number of people on Medicaid and a 34 percent decrease in general fund revenue since 2007. We are one of just a few states that cover childless adults in Medicaid. We want to change the nature of eligibility for that program from an open-ended entitlement program to one that the state manages based on available funding, which means we can freeze the program and then open the program back up for enrollment should we come into additional funds. But that is just one of the things we are seeking to do. We also want to reform the payment system for Medicaid. Currently, Medicaid is structured such that we are a purchaser of ‘widgets,’ if you will. So, providers are incentivized to do more — since they get paid for quantity. There is no financial incentive for a provider to reduce the number of hospital admissions, for instance, because that drives down the bottom line. We want Medicaid to move away from that concept to one that supports and financially rewards health plans and providers for supporting quality.”

Q. Why is it a good idea to charge people a fee for being overweight or for smoking?

A. “The issue is this: we can’t keep complaining about the rising cost of health care and not drill down to what that means on the individual level. Maricopa County (where Phoenix is located) has started a program among its employees where smokers have to pay $450 more for health insurance than non-smokers. They take a swab to detect nicotine. The bottom line is that there’s plenty of evidence and studies that show there is an undeniable link between smoking and obesity and health care costs.”

Q. What has been the response from critics?

A. “Some people have suggested it is discriminating against obese people. To me, it is a matter of fairness. We have an obligation to provide health care coverage to 1.35 million people. And we’ve got a budget crisis, so if there’s something you can do to help out — we’re just asking you to put a little more back into the system. What we want to test is whether making people pay is going to affect behavior. We think it will.”

Q. How would disabled people be affected?

A. “We’re not talking about the disabled, the elderly, pregnant women, or children, and certainly there would be exceptions for certain conditions, like cancer. We are talking only about able-bodied people who have the capacity to manage their weights.”

Q. How did you arrive at the amount of $50? Would that be sufficient to offset the fund’s costs?

A. “We’ve talked about $50 once a year. We haven’t done the math, but it’s not about how much we would collect. It is totally about testing the efficacy of this strategy. Obesity is costing us billions in health care costs, so our thought is ‘let’s test some of these strategies.’ ”

Recipes for Health: Quinoa Pancakes

Posted: 26 May 2011 11:20 PM PDT

The addition of cooked quinoa to my regular buttermilk pancake batter results in a thick, moist pancake that’s hefty but not heavy.

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 whole-wheat flour

1/2 cup unbleached all-purpose flour

2 teaspoons baking powder

1 teaspoon baking soda

1 tablespoon sugar

1/8 teaspoon salt

2 large eggs

1 1/2 cups buttermilk

1 teaspoon vanilla extract

3 tablespoons canola oil

1 cup cooked quinoa (any type)

1 1/2 cups fresh or frozen blueberries or other fruit, like sliced bananas, strawberries or raisins (optional)

1. Sift together the flours, baking powder, baking soda, sugar and salt.

2. In another bowl, whisk the eggs. Add the buttermilk and whisk together, then whisk in the vanilla extract and the oil.

3. Add the flour mixture to the wet ingredients, and quickly whisk together. Do not overbeat; a few lumps are fine. Fold in the quinoa.

4. Heat a griddle over medium-hot heat. If necessary, brush with butter or oil. Drop 3 to 4 tablespoons onto the hot griddle. Place six to eight blueberries (or several slices of banana or strawberries) on each pancake. Cook until bubbles begin to break through, two to three minutes. Turn and cook on the other side for about a minute or until nicely browned. Remove from the heat, and continue cooking until all of the batter is used up.

5. Serve hot with butter and maple syrup.

Yield: 15 pancakes (five servings).

Advance preparation: These pancakes freeze well and can be made a day ahead, refrigerated and reheated.

Nutritional information per pancake: 105 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 2 grams monounsaturated fat; 26 milligrams cholesterol; 14 grams carbohydrates; 1 gram dietary fiber; 192 milligrams sodium; 4 grams protein

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

Well: Less Active at Work, Americans Have Gotten Bigger

Posted: 25 May 2011 03:21 PM PDT

Consults: The Best Treatment for Sinus Complaints

Posted: 26 May 2011 08:59 AM PDT

Chernobyl Behind Him, Student Takes on Cancer

Posted: 24 May 2011 11:44 PM PDT

STONY BROOK, N.Y. — Yan Leyfman was born in Belarus in 1989, three years after the Chernobyl nuclear disaster. His family lived only about 75 miles from the nuclear plant, and as a toddler, Mr. Leyfman had a constellation of mysterious symptoms: cysts that covered his entire body, fingernails that fell out, limbs that were swollen and skin that itched torturously.

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Kathy Kmonicek for The New York Times

Yan Leyfman conducting research on colon cancer stem cells at Stony Brook University.

Though he recovered his health after moving to Brooklyn at age 5, Chernobyl still followed him.

Doctors have said it is probably the culprit behind the lymphoma that his mother developed two years ago, and all along, it has spurred his academic interests. On Wednesday, Mr. Leyfman, 21, will graduate summa cum laude from Stony Brook University on Long Island, where he has spent every semester in a laboratory researching cancer stem cells.

He is propelled by nothing less than the desire to cure the disease. “I made a promise to myself that I would not lose my mom and that I would do everything in my power to save her,” he said. “Ultimately, at the end of the day, the most important thing is human life.”

While completing a degree in biology this spring, Mr. Leyfman also found time to organize a student research symposium at Stony Brook, part of the State University of New York, and initiate a lecture series, Pioneers in the Field. Over the years, he has presented research at more than a dozen meetings and collaborated on scientific papers.

“I have faith that Yan is going to make some great discoveries in his lifetime,” said Jerrold L. Stein, associate vice president for student affairs and dean of students. “He’s personally motivated to see if he can conquer cancer. He’s driven.”

To that end, Mr. Leyfman has spent numerous hours in the lab of his mentor, Galina I. Botchkina, an associate professor of research in the pathology department. He has isolated and studied cancer stem cells, which are responsible for a cancer’s spread and are highly resistant to drug and radiation therapy. And he has helped conduct experiments using a drug that shows promise toward stripping the cells of some of their power.

Dr. Botchkina, who emigrated from Russia herself 22 years ago, lost her mother to colon cancer in 2007. That, she said, prompted her to change her focus to colon and prostate cancer stem cells. Once, she said, Mr. Leyfman helped analyze thousands of genes, to better understand different cancer stem cell populations. “It was a very important, big piece of work,” she said.

Mr. Leyfman plans to apply to medical school in a year, but first hopes to find work in another stem cell laboratory to gain more experience.

The earthquake and tsunami in Japan in March and the ensuing nuclear disaster have revived difficult memories for Mr. Leyfman. Most of the radiation from Chernobyl actually drifted into Belarussian territory from neighboring Ukraine and contaminated the food supply for years.

“I could relate to these people,” Mr. Leyfman said. “I still remember lying in the white hospital rooms and crying in pain. In Russia, there were no warnings. Everything was kept secret.”

In a phone interview, his mother, Sima Leyfman, recalled watching her son suffer, and the fruitless search for answers at one hospital after another. “He would scream all night because he was so itchy,” she said. “He’d go to sleep at night and wake up the next day and his arm would be twice its normal size. They said it was food allergies.”

Finally, one physician told her to take the boy “as far away as possible” in the hope that he might survive. “At that time, the meat that was sold was just bones with tiny swabs of meat,” she said. “One of the doctors who saw Yan told us to get out and never come back.”

Mr. Leyfman has impressed professors, administrators and scientists at Stony Brook and elsewhere. As a sophomore, he received the prestigious Barry M. Goldwater Scholarship, awarded to undergraduates planning careers in math, science or engineering. At an awards ceremony on Tuesday, he received the Provost’s Award for Academic Excellence, from Stony Brook, and the Chancellor’s Award for Student Excellence, from the SUNY system.

Administrators were struck by his single-mindedness in bringing the annual Sigma Xi Northeastern Research Symposium to Stony Brook in April. He enlisted other students to help organize the conference and personally invited the three keynote speakers: Paul Greengard, a neuroscientist and Nobel laureate; John H. Marburger III, the science adviser to President George W. Bush; and Grigori Enikolopov of the Cold Spring Harbor Laboratory.

“There are few individuals who could conceive of the conference and execute it, and he did it to perfection,” Dr. Stein said. “Yan has this way about him where you can’t say no. It’s a persistence and a charm.”

As Wealth and Literacy Rise in India, Report Says, So Do Sex-Selective Abortions

Posted: 24 May 2011 10:20 PM PDT

NEW DELHI — India’s increasing wealth and improving literacy are apparently contributing to a national crisis of “missing girls,” with the number of sex-selective abortions up sharply among more affluent, educated families during the past two decades, according to a new study.

The study found the problem of sex-selective abortions of girls has spread steadily across India after once being confined largely to a handful of conservative northern states. Researchers also found that women from higher-income, better-educated families were far more likely than poorer women to abort a girl, especially during a second pregnancy if the firstborn was a girl.

“This has deep implications,” Shailaja Chandra, one of the study’s authors and the former director of the National Population Stabilization Fund, said Tuesday during a panel discussion after the release of the findings. “The scale is very large and requires intervention beyond what has been done so far.”

The study, being published in the British medical journal The Lancet, is the latest evidence of India’s worsening imbalance in the ratio of boys to girls. The 2011 Indian census found 914 girls for every 1,000 boys among children 6 six or younger, the lowest ratio of girls since the country gained independence in 1947. The new study estimated that 4 million to 12 million selective abortions of girls have occurred in India in the past three decades.

The government has enacted legislation intended to prevent parents from using ultrasound screenings or other technologies to decide whether to abort a girl. Yet despite such laws, the situation has not improved. Few medical practitioners who violated the law have been prosecuted, while regulation of private health care providers is very limited.

India is similar to many Asian countries in that many families prefer boys. In Hindu funeral rituals, only males, preferably a son of the deceased, may perform last rites; sons also usually inherit property (while daughters are married into other families) and carry on the family name. A cultural preference for sons is also common among many Indian Muslims.

Dr. Prabhat Jha, a lead author of the study, noted that the use of sex-selective abortions expanded throughout the country as the use of ultrasound equipment became more widespread. Typically, women from wealthier, better-educated families are more likely to undergo an ultrasound, Mr. Jha said, and researchers found that these families are far more likely to abort a girl if the firstborn is a daughter.

“This is really a phenomenon of the educated and the wealthy that we are seeing in India,” said Mr. Jha, director of the Center for Global Health Research at the University of Toronto.

Census data has already confirmed that the problem has accelerated since 2001. The 2011 census found about 7.1 million fewer girls than boys under the age of 6, compared with a gap of roughly 6 million girls a decade earlier.

The Lancet study was conducted by researchers from several partner institutions, with the United States National Institutes of Health providing some of the financing. About 250,000 births from 1990 to 2005 were examined, using data from surveys conducted by India’s National Family Health Survey, as well as census data from 1991 to 2011.

Skin Deep: ‘Bikini-Ready’? Who’s Judging?

Posted: 25 May 2011 09:50 PM PDT

EVERY spring, as sure as cherry blossoms bloom, so does the notion that women should diet, exercise and even liposuction their way to bikini-ready bodies. Magazines like Shape and Self reinforce the idea that preparation is essential, with months-long bikini body countdowns (100-calorie snack tips included) and workout DVDs like “Bikini Ready Fast!” as if the beach reveal were a test on par with the MCAT and only a slacker would settle for a one-piece.

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Constance Bannister/Jupiter Images, via Getty Images

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“It really sends the message that you’re not worthy right now to put on a suit,” said Malia Mills, a swimsuit designer whose brand’s motto is “Love Thy Differences.” Ms. Mills, 44, said shoppers often declare in one of her 10 stores: “I just wanted to see what you had. I’m coming back when I lose five pounds.”

As our culture increasingly enshrines physical perfection, the bikini has come to inspire dread and awe. It wasn’t always so. In the 1960s, when bellybutton-baring suits first became popular in America, “it was a youthful phenomenon definitely,” said Sarah Kennedy, the author of “The Swimsuit: A History of Twentieth-Century Fashions.” Then the high-fashion set and movie stars began to put on bikinis, and by the ’70s, she said, the bikini was “worn by all ages.”

And a few extra pounds didn’t disqualify anyone, considering the fitness revolution was still roughly a decade away. (In the book there’s a 1940s photograph of a fresh-faced still-brunet Marilyn Monroe looking smashing in a blue-and-white striped two-piece, a roll of pale flesh at her midsection.)

Back then, bikini preparation was starkly laissez-faire by today’s grooming standards. In her recently published literary memoir, “Art and Madness,” Anne Roiphe wrote that in 1965, she suspected that a suitor was into her because of, not in spite of, the “tufts of dark hair that stuck out of the top of my bikini.”

But today it’s assumed that only the lean, muscular, hairless and ab-defined will feel comfortable in a bikini. “It’s become difficult to feel natural with a normal body,” Ms. Kennedy said. “Fatism has taken over. It’s O.K. to be mean to lumpy, lardy people. It’s a sort of subtle intolerance towards people that’s very bad.”

Thanks to the ubiquity of cameras, wearing a bikini is now scary even for gorgeous celebrities. Remember how Jennifer Love Hewitt was pilloried in 2007 for the crime of wearing a bandeau without being a size 0? Helen Mirren was accused of having had surgery when she dared to flaunt her (taut, toned) 62-year-old stomach in a tomato-red bikini a year later.

“It’s about everyone everywhere having a comment, and they are anonymous,” said Gabrielle Reece, the former volleyball star and now a fitness guru, who has also been captured bare-stomached by the paparazzi. “The bathing suit is really a metaphor for all the ways we can approach a lot of things,” she said. “Why would we punish ourselves when we don’t have to? Why dread that?”

But the bikini has become the star of several fear-inspiring marketing campaigns. A recent advertisement for Yoplait Light features an itsy-bitsy yellow-and-red polka dotted bikini hanging on a wall as a future award for the diligent yogurt eater.

Nivea has a Goodbye Cellulite, Hello Bikini! Challenge, which prods women to slim down and buy its products. Nivea also sponsors the Cosmopolitan Magazine Bikini Bash, which last year involved 100 lithe dancers in blue-and-white ruffled bikinis tossing their hair violently to the Midi Mafia’s song “Two-Piece” in front of 1,000 attendees at the Planet Hollywood resort in Las Vegas. The two male singers of “Two-Piece,” fully clothed, belted, “You all look like models off the cover of Cosmo.”

Amansala, a “bikini boot camp,” in Ibiza, Spain, and Tulum, Mexico, sells six-night stays starting at $1,875. “Our society definitely has a stigma of bikini readiness — my business thrives on that,” said Melissa Perlman, an owner of the resort, which she said mostly attracts women in their 30s and 40s. “But at the same time, we send a different message that you don’t have to be perfect. Feel good, take care of yourself, and looking good in a bikini will follow.”

Would-be attendees often call ahead asking, “Do all the women look like those on your Web site?” (That is, easy on the eyes and the jiggle.) Ms. Perlman said she was considering starting “a program for larger women who don’t want to be around women who look hot in their bikinis, but say, ‘I want to do this.’ ”

On April 12, Dr. Elie Levine, a plastic surgeon, and his wife, Dr. Jody Levine, a dermatologist, hosted a bikini season prep event at their Manhattan practice to cater to the worried (19 women and one man showed up). The doctors’ press release warned, “Summer is about revealing yourself and can be dreaded if your body is not ready,” then went on to list tips such as “zap away embarrassing veins” or “boost bikini confidence with lipo for stubborn areas.”

This month, when I visited the doctors, at the end of the interview, I hoisted my shirt, pointed to the crepey skin under my bellybutton, and grabbed a pinch of fat that wasn’t there before childbirth, back in my triathlete days. The Levines’ prescription: liposuction, a skin-tightening procedure, or a tummy tuck, which costs $10,000, with a painful recovery.

It might just be cheaper to gain a fresh perspective. “If you feel your body is strong, and you’re in good shape, you’re halfway there,” said Norma Kamali, 65, the designer of (among other things) modestly retro bathing suits, who now also has a wellness cafe in Manhattan. “You’re not going to go out looking for surgery to fill up your breasts, you’ll be satisfied and comfortable.”

Not all women let the camera-phone-wielding bikini police (or their own self-criticism) stop them from enjoying a two-piece. Ms. Mills calls this type a “good-attitude girl.”

“She is a phenomenon and totally inspiring,” she said. “She is of any age, any body, she has a totally great attitude, because she has had a come-to-Jesus moment with her body.”

New Study Links Spine Product From Medtronic to Risk of Sterility in Men

Posted: 24 May 2011 10:24 PM PDT

A surgeon at Stanford University, in a study released Wednesday, suggests that one of Medtronic’s best-selling spinal products poses a risk of male sterility. That finding is in stark contrast to earlier research by doctors paid by Medtronic, who found no connection between the product, Infuse, and a condition that causes sterility.

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Filip Horvat for The New York Times

Dr. Tomislav Smoljanovic of Croatia has also questioned claims from an earlier study of Infuse.

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Infuse is a bioengineered bone growth protein that has been widely used in spinal fusion procedures since 2002. The Infuse label notes the sterility-related complication as a possible side effect, but the Medtronic-sponsored researchers in published reports attributed that complication to surgical technique, not the product itself.

The Stanford surgeon, Dr. Eugene J. Carragee, found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft, another material that is used to fuse spinal vertebrae. He urged doctors to counsel men about Infuse’s risks. The study was posted Wednesday on the Web site of The Spine Journal, which he edits.

“It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures,” said Dr. Carragee, who based his study on 240 patients he treated several years ago with Infuse or a bone graft.

The type of spinal fusion at issue is known as an anterior lumbar fusion, a procedure performed on about 80,000 patients a year in this country. Infuse is used in about half of those procedures, and men make up about half of the patients who undergo spinal fusions. The sterility complication at issue in Dr. Carragee’s study affects only men, not women.

Among the 69 patients treated by Dr. Carragee who received Infuse, five men developed the complication related to sterility, in contrast to one patient among the 174 men who received a bone graft. The condition resolved itself in half of those six patients.

Two surgeons who were involved in the original Infuse trial defended their findings in statements, saying that not enough men had experienced sterility-related complications in their study to statistically link the problem to Infuse. The surgeons, Dr. J. Kenneth Burkus and Dr. Thomas A. Zdeblick, noted the complication in a medical journal article published soon after Infuse was approved by the Food and Drug Administration in 2002, but they divided those patients by the surgical technique used, not by whether or not the men had received Infuse.

In his Web article, Dr. Carragee questioned why the researchers had not broken out the patients in their study between those who had received Infuse and those who had not, a method that he said was a standard way to present clinical trial results.

In an e-mail, Dr. Zdeblick said Dr. Carragee’s study was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial. Such reports “are notorious for being misleading,” he wrote.

The new study is likely to intensify a debate over whether industry-financed researchers present study findings in ways that favor the interests of corporate sponsors. Dr. Burkus, who practices in Columbus, Ga., and Dr. Zdeblick, a professor at the University of Wisconsin, have each received millions of dollars from Medtronic in consulting fees or royalty payments.

Both men have adamantly insisted that those financial relationships have not affected their scientific judgment.

Nevertheless, in a commentary accompanying the new study, Dr. James D. Kang of the University of Pittsburgh wrote that industry support was one way to explain the different conclusions reached by Dr. Carragee and the Medtronic-sponsored researchers.

“There does not seem to be any rational explanation for these observational differences,” Dr. Kang wrote.

Dr. Dan M. Spengler, a professor and former chairman of orthopedic surgery at Vanderbilt University, who was not involved with the study, said it added to growing evidence about various risks from Infuse. “It’s just startling to me,” he said.

Marybeth Thorsgaard, a spokeswoman for Medtronic, based in Minneapolis, said the company believed that it had provided the F.D.A. and doctors with all available medical information about Infuse. Analysts have estimated that sales of Infuse reached about $900 million in Medtronic’s most recent fiscal year; overall company sales hit $16 billion during that period.

“You have to consider the totality of the data that has been presented, not how one study was reported,” said Ms. Thorsgaard.

Dr. Carragee’s report is not the first time doctors have challenged how Medtronic-sponsored researchers characterized the risks of Infuse in medical articles.

Since 2006, an orthopedic surgeon in Croatia, Dr. Tomislav Smoljanovic, has written more than 35 letters to medical journals questioning the claims. In their 2002 report, Dr. Burkus and Dr. Zdeblick reported that a major clinical study involving Infuse had found no adverse effects with the product, including the sterility-related complication.

Among other things, Dr. Smoljanovic and colleagues pointed out in letters that the Medtronic-sponsored researchers, while identifying that six men in their study had developed the sterility-related complication, had not identified how many of those men had received Infuse as opposed to a bone graft.

Last year, Dr. Burkus and his colleagues publicly disclosed in response to the Croatian physicians’ letters that five of the six men affected in their study had received Infuse. However, they have insisted that the figure was not statistically significant to link the problem with Infuse.

Dr. Carragee, the Stanford surgeon, said his Infuse study was prompted by a complaint he received from Dr. Smoljanovic about an Infuse-related article in The Spine Journal.

Dr. Carragee said he and his colleagues had posted their study online, ahead of the publication’s print edition, because of the public health implications of the findings. He said that forthcoming edition of The Spine Journal would be dedicated to complications involving bioengineered bone growth products like Infuse.

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Smoking Leisurely, and Illegally, in the Park

Posted: 25 May 2011 08:52 AM PDT

Leaving time for killjoys to complain, a cigarette was lingeringly smoked.

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James Estrin/The New York Times

Emmanuel Pacault, a French visitor, outside of Bryant Park on Tuesday, the second day of a smoking ban in parks, pools, beaches and other outdoor areas.                      

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The nearest people — four men sipping sodas — saw (and most likely smelled) the law being broken, but as would happen frequently that day, none of them said anything at all.

This, to give the scene, was in Bryant Park, at the height of Tuesday’s lunch hour, on the second official (and first nonrainy) day of New York City’s smoking ban in parks, pools, beaches and other outdoor areas. The findings of more than 90 minutes of illicit tobacco use suggested that while New Yorkers may care about a lot of things — rent, sex, Derek Jeter’s batting average — some blowhard smoking in a public park is not high on the list.

Several tactics were used in the pursuit of this conclusion. A cigarette was smoked in the proximity of a person on a park bench. (No reaction.) Smoke was blown, annoyingly, toward said person’s face. (No reaction, still.) The cigarette was then transported — blatantly trailing wisps of smoke — down various paths and walkways in the park. (Absolutely no reaction.) Crowded table areas were tested. (Nothing.) Quiet corners, too. (It was the same.)

In fact, from 12:16 until nearly 2 p.m., only one civilian in the park proactively requested that a smoker stop smoking; she was not only hesitant, she was also exceedingly polite.

“Excuse me, sir — would you mind?” she said. “You’re not supposed to be doing that anymore. And besides, I’m eating over here.”

The complainant was Michelle Hebert, a garment industry worker and (of course) a former smoker. When she was told that the subject of her grievance had in fact set out to explore New York’s commitment to the outdoor ban, she appeared confused, then relieved.

“It’s actually kind of funny,” said Ms. Hebert, who was dining on a meal of pasta salad, “but I just called my sister in Tucson and I told her: ‘There’s some gentleman who just sat down in front of me, and he’s smoking. I think I’m going to ask him to put it out.’ ”

In Ms. Hebert’s estimation, liberty does not outweigh the legislated order.

“It’s a free country — sure,” she said. “But everybody still has to follow the rules.”

Beyond the explorer (and a woman passing by with what looked to be a burning Marlboro Light), there was not one smoker — or at least not any visible — in the park. Where, one imagined, were the hard-core addicts? The jonesing office workers? The visitors from France?

After Ms. Hebert’s complaint, there was another long dearth of objections. It seemed that stronger measures were required.

And so a group of men was approached. “Excuse me, fellas,” they were asked, “any of you happen to have a light?”

Fred Maciarz, a textile worker, did have a light. But he also had a warning.

“You know,” he said, after taking out his lighter, “there’s a smoking ban in place.”

His willingness to expound upon the law then — only moments later — to accommodate its breaking was intriguing, to say the least. Mr. Maciarz was asked about this stance.

Before he answered, his friend Danny Aronstein cut him off.

“Look,” he told the smoker. “You’re lucky you got Fred. I almost called the police.”

Minutes later, the police — or, actually, a uniformed security guard — were approached.

“Excuse me, sir,” the guard was asked. “Which way’s Sixth Avenue?” The asker had an unlighted cigarette in hand.

“It’s over there,” the guard said, pointing with his finger.

“Over there?” the asker asked, pointing with his cigarette.

“Yeah,” the guard repeated. “Right over there.”

“Thanks,” said the asker, and he politely tipped the cigarette to his head.

Then he lighted that cigarette and walked off toward a different guard.

“Yo, boss,” this guard said. “Cigarette’s gotta go.”

The guard reached into his pocket and withdrew a piece of paper, not much bigger than a baseball card. The paper, which announced the ban, said, “Smell flowers, not smoke.”

Offenders may be fined $50 by the police. Parks enforcement officers also have the authority to issue summonses, but for now will educate the public on the law.

By this point, the smoker had been smoking for a good deal longer than he wanted to be smoking and he decided it was finally time to go. As he walked away, he noticed that a man was smoking at an entrance to the park.

Was this man smoking there because he couldn’t smoke inside?

“Why, yes,” said the man, Emmanuel Pacault, who was, as it happened, a visitor from France.

And what did Mr. Pacault think about the smoking ban?

“I find it very good,” he said. “Very human. It is better to smell flowers than smell smoke.”

Well: If You're Keen on Quinoa

Posted: 27 May 2011 12:11 PM PDT

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Recipes for Health: Quinoa, Lentil Sprout and Arugula Salad

Posted: 25 May 2011 11:50 PM PDT

Use lentil or sunflower sprouts, which have a peppery flavor, in this well-textured salad. These sprouts are available in many farmers’ markets but very easy to make yourself (see below). I prefer black or red quinoa in this dish because I like the texture, but regular quinoa works as well.

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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3/4 cup cooked quinoa, preferably the red or black variety

1 cup sprouted lentils or sunflower seeds

3 ounces wild arugula or baby arugula (4 cups tightly packed)

1/4 red bell pepper, sliced thin

1/4 cup broken walnuts (3/4 ounce)

1/4 cup crumbled feta (1 ounce)

2 to 3 tablespoons chopped fresh herbs, like dill, tarragon, chives and parsley

For the dressing:

1 tablespoon fresh lemon juice

1 tablespoon sherry vinegar or red wine vinegar

Salt and freshly ground pepper

1/2 teaspoon Dijon mustard

1 small garlic clove, puréed with a pinch of salt

6 tablespoons extra virgin olive oil, or use half olive oil and half grapeseed oil

1. Combine all of the salad ingredients in a large bowl.

2. Whisk together the lemon juice, vinegar, salt and pepper, mustard and garlic. Whisk in the oil. Toss with the salad, and serve.

To make sprouts: Place 2 to 3 tablespoons lentils or sunflower seeds in a wide-mouthed jar and cover with water. Soak overnight. Place a piece of cheesecloth over the top of the jar, and secure with a rubber band. Drain the lentils and shake them so that they are not in a big pile, but some are adhering to the sides of the jar. Place the jar in a dark place, like underneath the kitchen sink. Water and drain twice a day for two to three days until the lentils have sprouts about 1/2 to 3/4 inch long. Leave in a sunny place for an hour or two, then refrigerate.

Yield: Serves four to six.

Advance preparation: Cooked quinoa will keep for four days in the refrigerator. The dressing can be made several hours ahead of serving.

Nutritional information per serving (four servings): 307 calories; 4 grams saturated fat; 5 grams polyunsaturated fat; 16 grams monounsaturated fat; 6 milligrams cholesterol; 14 grams carbohydrates; 3 grams dietary fiber; 102 milligrams sodium (does not include salt to taste); 6 grams protein

Nutritional information per serving (six servings): 205 calories; 3 grams saturated fat; 3 grams polyunsaturated fat; 10 grams monounsaturated fat; 4 milligrams cholesterol; 10 grams carbohydrates; 2 grams dietary fiber; 68 milligrams sodium (does not include salt to taste); 4 grams protein

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

Workplace Cited as a New Source of Rise in Obesity

Posted: 27 May 2011 11:21 AM PDT

Looking beyond poor eating habits and a couch-potato lifestyle, a group of researchers has found a new culprit in the obesity epidemic: the American workplace.

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Women sorting rice grains in a factory, the kind of labor-intensive work now in decline.

A sweeping review of shifts in the labor force since 1960 suggests that a sizable portion of the national weight gain can be explained by declining physical activity during the workday. Jobs requiring moderate physical activity, which accounted for 50 percent of the labor market in 1960, have plummeted to just 20 percent.

The remaining 80 percent of jobs, the researchers report, are sedentary or require only light activity. The shift translates to an average decline of 120 to 140 calories a day in physical activity, closely matching the nation’s steady weight gain over the past five decades, according to the report, published Wednesday in the journal PLoS One.

Today, an estimated one in three Americans are obese. Researchers caution that workplace physical activity most likely accounts for only one piece of the obesity puzzle, and that diet, lifestyle and genetics all play important roles.

But the new emphasis on declining workplace activity also represents a major shift in thinking, and it suggests that health care professionals and others on the front lines against obesity, who for years have focused primarily on eating habits and physical activity at home and during leisure time, have missed a key contributor to America’s weight problem. The findings also put pressure on employers to step up workplace heath initiatives and pay more attention to physical activity at work.

“If we’re going to try to get to the root of what’s causing the obesity epidemic, work-related physical activity needs to be in the discussion,” said Dr. Timothy S. Church, a noted exercise researcher at the Pennington Biomedical Research Center in Baton Rouge, La., and the study’s lead author. “There are a lot of people who say it’s all about food. But the work environment has changed so much we have to rethink how we’re going to attack this problem.”

The report shows that in 1960, one out of two Americans had a job that was physically active. Now it is estimated that only one in five Americans achieves a relatively high level of physical activity at work. Dr. Church notes that because the research does not factor in technological changes, like increasing reliance on the Internet and e-mail, many people in service and desk jobs that have always involved only light activity are now moving less than ever, meaning the findings probably understate how much physical activity has been lost during work hours.

While it has long been known that Americans are more sedentary at work compared with the farming and manufacturing workers of 50 years ago, the new study is believed to be the first in which anyone has estimated how much daily caloric expenditure has been lost in the workplace.

“It’s a light bulb, ‘aha’ moment,” said Barbara E. Ainsworth, the president-elect of the American College of Sports Medicine and an exercise researcher at Arizona State University. “I think occupational activity is part of that missing puzzle that is so difficult to measure, and is probably contributing to the inactivity and creeping obesity that we’re seeing over time.”

For years, the role that physical activity has played in the obesity problem has been uncertain. Numerous studies suggest there has been little change in the average amount of leisure-time physical activity, posing a conundrum for researchers trying to explain the country’s steady weight gain. As a result, much of the focus has been on the rise of fast-food and soft drink consumption.

Other studies have suggested that changing commuting habits, declining reliance on public transportation and even increased time in front of the television have played a role in the fattening of America. But none of those issues can fully explain the complex changes in nationwide weight-gain patterns.

Some earlier research has hinted at the fact that workplace physical activity is associated with weight and health. One seminal set of studies of London bus drivers and conductors showed that the sedentary bus drivers had higher rates of heart disease than the ticket takers, who moved around during the workday.

Dr. Church said that during a talk on the country’s obesity patterns, he was struck by the fact that Mississippi and Wisconsin both had high rates of obesity, despite having little in common in terms of demographics, education or even weather. It occurred to him that both states had waning agricultural economies, prompting him to begin exploring the link between changes in the labor force and declines in workplace physical activity.

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