Close Concerns Weblog

NYT Kolata on moving straight to drugs

New York Times journalist Gina Kolata wrote a fantastic piece in today's paper about the fact that it's taken awhile, but we're finally moving faster... straight to drugs, for newly diagnosed patients with diabetes. This has taken a long time. At one point, the average time between diagnosis and first drugs for patients with type 2 diabetes was seven years. Now, highly respected Dr. David Nathan of Mass General advises doctors, start patients on metformin right away. Between (and in) the lines, basically he seems to be saying that so few people are successful on the diet and exercise regimen that patients should really, from a public healthcare perspective, be put on a drug straight away so that the diabetes is treated immediately after diagnosis. We see this as a postive for all diabetes therapies, since it's all about earlier, more aggressive therapy - and we love the idea of arresting the disease earlier and earlier in the disease process - anything to put the brakes on long term complications. Onward!

October 17, 2006
Prospects
When Advice on Diabetes Is Sound, but Ignored

By GINA KOLATA
Ask any diabetes specialist whether people can protect themselves from Type 2 diabetes through diet and exercise and the answer will be a resounding yes. It has been shown three times, in studies in three countries, one of them the United States.

Weight loss and exercise can do more than just stave off diabetes, diabetes specialists will tell you. They can result in lower blood pressure, lower levels of cholesterol, less sleep apnea, more vigor and, in general, a better life.

But if you ask how likely it is that people at high risk of diabetes will follow the advice to diet and exercise, or about using a drug instead, you will get a different sort of answer.

It is a classic conundrum in medicine: if doctors know that patients can help themselves without taking drugs, but they also know that patients are not likely to follow this advice, what should they do?

Should diabetes specialists even bother to advise patients to try helping themselves through diet and exercise first, before prescribing drugs?

A large federal study, completed several years ago, seemed to make a compelling case that they should. A third of its 3,234 participants were assigned to a low-fat, low-calorie diet and told to exercise for 150 minutes a week. The others were given a placebo or were given metformin, a diabetes drug available as an inexpensive generic.

After an average of three years, just 14.1 percent of those in the diet and exercise group had developed diabetes. In contrast, 28.9 percent of participants taking the placebo had diabetes, and 21.7 percent of those taking metformin.

But the diet and exercise program was nothing like what an ordinary person might expect. The participants got extensive individual counseling and group support, at a cost of $1,356 a person the first year and $672 in each subsequent year. Even so, they shed only about 12 pounds after four years, or 4 percent of their initial weight. Most were continuing with their exercise program, though. If a large health plan decided to offer the same program for its members at risk for diabetes, the plan’s price for every member would rise by 1 percent, said Dr. David Eddy, the medical director of Archimedes Inc., a health care consulting company. Over 30 years, 61 percent of the people at risk would develop diabetes, as compared with 72 percent if no such program were instituted.

Last month, another study showed that a newer diabetes drug, rosiglitazone, might be more effective than either metformin or diet and exercise. Over three years, it reduced the risk of developing diabetes by 60 percent in people with elevated blood sugar levels.

Both drugs are relatively safe. Patients may lose about five pounds if they take metformin; other than that its major side effect is gastrointestinal disturbances, like a sense of fullness or soft bowel movements. Patients may gain about five pounds with rosiglitazone, about half of which is from fluid retention. That increases the risk of heart failure in people with heart disease.

But with the drugs’ effectiveness in preventing diabetes, maybe, some specialists say, doctors will soon view blood sugar as they do blood pressure or cholesterol. As soon as they spot an abnormally high level, they will whip out their prescription pads.

Already, health authorities have ventured along that path. International treatment guidelines once said that the first step for patients with full spectrum Type 2 diabetes was to exercise and lose weight. Only after patients had tried that and utterly failed were doctors to prescribe drugs.

As of August, however, the guidelines have changed.

“We recommend starting patients on metformin immediately,” said Dr. David M. Nathan, who directs the diabetes center at Massachusetts General Hospital and is a member of the group that formulated the new guidelines. “Don’t start with lifestyle alone, even for newly diagnosed people. Most end up failing the lifestyle recommendations.”

He added: “What classically happened was that the patients would take three months and try to diet. It wouldn’t work. Then they joined a health club. It didn’t work. Then they take another three months and try some more. By the time they were on effective therapy, they had had diabetes for years and years.”

In developing the new guidelines, the group reasoned that the consequences of untreated diabetes — which can include heart attacks, strokes, kidney failure, blindness and amputations — are too dire to allow high blood sugar levels to persist.

But that does not necessarily mean that drugs should be the first choice for people with so-called prediabetes, who have elevated blood sugar levels but have not yet developed the disease.

Or so says Rena Wing, a professor of psychiatry and human behavior at Brown University Medical School. Dr. Wing helped develop the diet and exercise program for the federal study of prediabetes.

Drugs, she said, should be a last resort for people with prediabetes. The answer to the problem of poor compliance with diet and exercise programs is to develop better ways of encouraging people to follow them, she said.

“If you have a problem that can be solved with a lifestyle change, you have to work on how to do that, how to bring it to people,” Dr. Wing said. “We have to change the system.”

For example, she said, there could be lists of effective programs for weight loss and exercise so doctors would stop telling patients to simply “lose weight” and say instead, “Join this program.”

Yet, if people know that a drug can solve their problem, how much incentive is there to change their diet and exercise patterns?

“The behaviorists say that if you have a medication available, you can hang up the idea that the patients will try lifestyle,” Dr. Nathan said.

Still, he said, “as a realist, it seems to me that the truth is that whatever your thoughts are on the importance of self-control and willpower and profligacy, and that we shouldn’t be such pigs, that we should exercise more, the truth is that we are what we are.”

Dr. Nathan added, “We have recognized that although lifestyle can be miraculously effective, it often isn’t, because people won’t change.”

Trend toward healthful snacks continues in schools

Trend Toward Healthful Snacks Continues in Schools

Five leading snack-food manufacturers announced an agreement last Friday to offer more healthful snacks in school cafeterias and vending machines.  The initiative, which was coordinated by former President Bill Clinton and the AHA, established voluntary guidelines limiting the amount of calories and fat/sugar content of school snacks.  Although critics are questioning the voluntary nature of the agreement, the companies — Dannon, Kraft Foods, Mars, PepsiCo and the Campbell Soup Company—have already announced specific changes that they plan to implement.  For example, Dannon is reducing the sugar content of its Danimals drinkable yogurt by 25% and Mars has created a new line of nutritious snacks, according to the NYT. 

While it is difficult to estimate the direct impact that these changes will have—there are over 70 snack food producers that supply schools and unhealthy options will continue to abound—the initiative is certainly a step in the right direction.  It marks another major success for the alliance between Clinton and the AHA, which negotiated a similar agreement in May with the three largest soft drink suppliers to schools, and is an encouraging signal that food manufacturers are recognizing health as an increasingly relevant factor in the bottom line.  Furthermore, the attention the agreement has received will hopefully put pressure on competing suppliers to adopt similar strategies in the near future.   

See below for a recent WSJ article on the agreement:

Raising risk awareness... how effective is it?

No matter the strength or persistence of human will, ultimately, the human body is its own decision maker. Countless internal mechanisms regulate the systems of the body and control the incidence of aberrant events before they develop into full-blown breakdowns. Yet even as the body works to maintain normal functioning, the cognitive mind remains entirely unaware of such threats to the system and the physiological safeguards designed to thwart them.

Such is the story of the earliest stages of insulin resistance, also called prediabetes, for many women, according to a recent New York Times piece. Rather than proceeding along a clear-cut cause and effect progression-course, insulin resistance emerges at the various intersections of natural processes and failed crisis-response mechanisms; as women age, hormonal changes that trigger menopause also prompt weight gain—especially around the problematic waistline, the most damaging site of fat deposits. Fat buildup in major organs predisposes aging women to prediabetes. The mechanisms that had previously stalled insulin resistance eventually lose ground to rising blood pressure, sugar and fat, leading to diabetes and heart disease. Factors such as family history or gestational diabetes further increase a woman’s chance of developing diabetes.

Unfortunately, insulin resistance—a state in which insulin no longer drives sufficient uptake of glucose from the blood—arises with next to no symptoms. A lack of specific symptoms, combined with limited popular knowledge, translates into large numbers of women who remain unaware they may be developing or at risk for developing insulin resistance. Fortunately, health centers are beginning to take action. A women’s resource center in Red Bank, NJ mentioned in the same NYT article has begun a campaign to raise levels of awareness. The center has, for example, developed new web resources including diet and lifestyle tips and a list of recommended questions to ask healthcare providers. Though we recognize that diet and lifestyle modifications can halt the progression initiated by insulin resistance, few studies demonstrate that such tactics reduce risk on a broad population-based level. In other words, from our perspective, while the information is accurate, it fails to generate widespread results. Specifically, the article mentioned a CDC study demonstrating that diet and exercise effectively reduces risk by 60% (we believe this is DPP, the results of which were published in the New England Journal of Medicine in 2002). The article failed to discuss in sufficient detail, however, the cost and effort required to produce such results. A trial that provides a model of risk reduction based upon the sponsoring of multiple specialists per trial participant may not, we think, convey the likelihood of success in “real world” solutions.

New York Times Online
Many women unaware they're pre-diabetic
By LINDA A. JOHNSON, Associated Press Writer

TRENTON, N.J. - Getting fatter around the middle? Have a family history of heart disease or diabetes? You could be headed for the same trouble, especially if you're over 40 and female.

There are no obvious symptoms from high blood sugar or the condition called insulin resistance, so few people realize it is creeping up and putting them on the path to diabetes, heart disease or both.

But insulin resistance, a type of pre-diabetes, is a growing national problem: Some experts believe half of all overweight or obese American adults are insulin-resistant.

Yet, even many women with a family history of heart disease or diabetes don't know they need to eat a healthier diet and get more exercise to avoid those problems — two of the nation's top killers.

"We think this is a very important new issue for women," said Audrey Sheppard, chief executive of the National Women's Health Resource Center. "There's very little awareness."

As women enter the years leading to menopause, the hormonal changes that trigger hot flashes and end menstruation make women more likely to add fat around the waistline than in other places. A key tipoff of looming trouble is a waistline over 34 inches, according to one expert. (For men, it's 40 inches.)

Fat also builds up in the liver and other vital organs, predisposing them to insulin resistance, a condition in which insulin no longer can inject enough glucose into the body's cells for fuel, said Dr. David Katz, co-founder of the Yale Prevention Research Center and author of several books on weight control.

The body's compensatory mechanisms eventually fail, blood pressure rises along with levels of blood sugar and blood fat — making cells even more resistant to insulin. Diabetes, heart disease or both often follow.

"That's the sequence that's occurring in tens of millions of American adults" and an increasing number of children amid the country's obesity epidemic, said Katz. "It's an enormous problem. We're just starting to get doctors' attention."

Besides a family history of heart disease or diabetes, women who had diabetes during pregnancy or who had a baby 9 pounds or heavier are at higher risk of insulin resistance.

Frequent fatigue and cravings for sweets, bread and pasta also may be linked to the problem. But Dr. Henry Kahn, a chronic disease epidemiologist with the U.S. Centers for Disease Control and Prevention, said those are vague symptoms that could have other causes.

The women's resource center, based in Red Bank, N.J., has just begun a new public health campaign targeting women aged 40 to 65 because they are at greater risk than others and often hold of the role of Dr. Mom, serving as monitor for the whole family's health.

Besides explaining on its Web site how uncontrolled blood sugar harms the body, the center offers tips for a healthy blood sugar level and suggests questions patients can ask a doctor.

Among research showing the benefits of a healthy lifestyle is a recent CDC study that found modestly overweight adults who worked with nutrition and exercise experts reduced their risk of diabetes by nearly 60 percent over several years, compared with a group that made no changes, said Kahn.

Lalita Kaul, an American Dietetic Association spokeswoman and professor of nutrition at Howard University Medical School, said over the last 25 years, about 70 percent of her patients at risk of diabetes have been able to control their blood sugar with diet and lifestyle changes.

The key diet changes, she said, include eating at least five servings of fruits and vegetables daily; cutting down on sugar and desserts while eating more whole grains; eating less saturated fat and using healthier cooking oils; eating salmon and other fish rich in essential fatty acids a few times a week; and avoiding prepared foods high in sodium, which pushes up blood pressure.

NYC considers ban on trans fats

Overwhelming evidence and physician consensus regarding the negative health consequences of artificial trans fatty acids has inspired the New York City Health Department to consider regulating public consumption of trans fats. The proposal under consideration would prohibit restaurants from serving foods containing partially hydrogenated oil, or trans fats. Linked mainly to heart disease, these artery-clogging ingredients are found mainly in ingredients such as shortenings, margarine, and frying oils, not to mention snacks and desserts like French fries and doughnuts.

Not surprisingly, members of the restaurant industry have expressed concern over such a proposal. The Health Department’s demands, if passed, would require cooks to reassess their recipes, to restock their shelves, and establish new modes and strategies for efficiency in the kitchen with regard to the logistics and processes of meal preparation. Restaurants would also face a fine if inspectors find banned ingredients in prepared foods. Some disgruntled voices reference the millions of Americans who use these same ingredients and qualify the Health Departments potential action as an inappropriate intervention.

Though recognizing the constraints and costs the proposal would place on the restaurant industry, representatives of the Health Department feel that the stipulations of the ban are not insurmountable—other cooking oils can take the place of trans fats, explained Health Commissioner Thomas Frieden. Furthermore, he claimed that these replacements change the taste of foods for the better, if at all, even as they greatly lessen associated health risks.

If nothing else, the discussion seems to be motivating large companies to act preemptively—a small but measurable step. Wendy’s has fully transitioned to cooking oils that contain no trans fats, Crisco now offers a zero-trans fats shortening option, and other companies such as Frito-Lay and Kraft’s has removed trans fats from various products. In other words, it seems that in removing trans fats from their products, companies that previously catered to lower-income consumers are expanding consumer choices regarding personal health. While some might consider government intervention a restriction of choice on the part of the chef and the client, one might also consider it an effort to extend healthy options to a population that traditionally has faced limited food choices, both in the grocery store and in private establishments.

Precedent for the politicization of consumer choice exists in past dialogues and policy decisions. Chicago is considering a similar ban against trans fats that would hit all establishments with annual revenues greater than $20 million, namely fast food chains. Such targeted policymaking makes sense given that fast food chains are not only among the worst offenders, but also have the resources to undertake such a drastic change. The current conversation on banning fats follows on the heels of a similar discussion regarding tobacco use, which ultimately resulted in the prohibition of smoking in public establishments in cities and towns nationwide. Amazingly, even France just announced a ban on smoking, effective in 2007.

Currently, several government institutions regulate various kinds of risk on behalf of Americans. From its inception, the FDA has acted specifically to mediate health risks. Over the past century or so, the FDA has blocked and recalled various products from the market based on health information. For example, the discovery of poisonous preservatives in part inspired the Meat Inspection Act of 1906. In 1958, the Food Additives Amendment prohibited the approval of additives shown to induce cancer in humans or animals. And more recently, in 2004 the FDA banned dietary supplements containing ephedrine alkaloids based on associated adverse events.

The New York City Health Department certainly does not have the jurisdiction of the FDA. However, the proposal under consideration is a response to an obvious local need to stem the growing health threat posed by cardiovascular disease, a condition with grave, but preventable, physical, emotional and financial costs. While some may think ban hits at the heart of American life—outlawing items from fried chicken to apple pie—as Walter Willett, the esteemed chairman of the Department of Nutrition at the Harvard University School of Public Health, emphasized, the proposal under consideration in New York City could save tens of thousands of lives.

New York Times Online
NYC mulls ban on trans fats in eateries
By DAVID B. CARUSO, Associated Press Writer

NEW YORK - Three years after the city banned smoking in restaurants, health officials are talking about prohibiting something they say is almost as bad: artificial trans fatty acids.

The city health department unveiled a proposal Tuesday that would bar cooks at any of the city's 24,600 food service establishments from using ingredients that contain the artery-clogging substance, commonly listed on food labels as partially hydrogenated oil.

Artificial trans fats are found in some shortenings, margarine and frying oils and turn up in foods from pie crusts to french fries to doughnuts.

Doctors agree that trans fats are unhealthy in nearly any amount, but a spokesman for the restaurant industry said he was stunned the city would seek to ban a legal ingredient found in millions of American kitchens.

"Labeling is one thing, but when they totally ban a product, it goes well beyond what we think is prudent and acceptable," said Chuck Hunt, executive vice president of the city's chapter of the New York State Restaurant Association.

He said the proposal could create havoc: Cooks would be forced to discard old recipes and scrutinize every ingredient in their pantry. A restaurant could face a fine if an inspector finds the wrong type of vegetable shortening on its shelves.

The proposal also would create a huge problem for national chains. Among the fast foods that would need to get an overhaul or face a ban: McDonald's french fries, Kentucky Fried Chicken and several varieties of Dunkin' Donuts.

Health Commissioner Thomas Frieden acknowledged that the ban would be a challenge for restaurants, but he said trans fats can easily be replaced with substitute oils that taste the same or better and are far less unhealthy. "It is a dangerous and unnecessary ingredient," Frieden said. "No one will miss it when it's gone."

A similar ban on trans fats in restaurant food has been proposed in Chicago and is still under consideration, although it has been ridiculed by some as unnecessary government meddling.

The latest version of the Chicago plan would only apply to companies with annual revenues of more than $20 million, a provision aimed exclusively at fast-food giants.

A few companies have moved to eliminate trans fats on their own. Wendy's announced in August that it had switched to a new cooking oil that contains no trans fatty acids. Crisco now sells a shortening that contains zero trans fats. Frito-Lay removed trans fats from its Doritos and Cheetos. Kraft's took trans fats out of Oreos.

McDonald's began using a trans fat-free cooking oil in Denmark after that country banned artificial trans fats in processed food, but it has yet to do so in the United States.

Walt Riker, vice president of corporate communications at McDonald's, said in a statement Tuesday that the company would review New York's proposal.

"McDonald's knows this is an important issue, which is why we continue to test in earnest to find ways to further reduce (trans fatty acid) levels," he said.

Under the New York proposal, restaurants would need to get artificial trans fats out of cooking oils, margarine and shortening by July 1, 2007, and all other foodstuffs by July 1, 2008. It would not affect grocery stores. It also would not apply to naturally occurring trans fats, which are found in some meats and dairy.

The Board of Health has yet to approve the proposal and will not do so until at least December, Frieden said.

The U.S. Food and Drug Administration began requiring food labels to list trans fats in January.

Dr. Walter Willett, chairman of the Department of Nutrition at the Harvard University School of Public
Health, praised New York health officials for considering a ban, which he said could save lives.

"Artificial trans fats are very toxic, and they almost surely causes tens of thousands of premature deaths each year," he said. "The federal government should have done this long ago."