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Diabetes 2 drug warnings

Posted by medconsumers on September 23, 2012

Type 2 diabetes has reached epidemic proportions in the U.S., we are told. The high blood sugar levels that define this disorder are linked to a higher than normal risk of heart attack, stroke, and many nerve complications. Unfortunately, the drugs prescribed to lower this risk come with complications of their own. Aggressive lowering of blood sugar levels has severe, potentially fatal consequences. A recent study found that — of all medications—insulin and oral diabetes drugs are the second most common cause of emergency department visits and hospitalizations!

That the treatments for diabetes 2 might be worse than the disease has been an issue for years. click here  So has the possibility that the treatments are prescribed too intensively.  click here Then there’s the expanded definition diabetes 2 that, not surprisingly, had drug industry’s behind-the-scenes guidance. click here  Today’s post, however, deals solely with the potential overtreatment of people, aged 65 and older.  It is based on a new online first commentary in Archives of Internal Medicine.

A co-author David Aron, MD, Case Western Reserve University School of Medicine, Cleveland, explained in a telephone interview why a diagnosis of diabetes 2 in old age could be problematic:  “The benefits of better glycemic [blood sugar] control takes roughly up to about ten years to develop, so it’s only beneficial to someone who has a longer life expectancy.”  Put another way, the whole reason for diabetes 2 drug therapy is the lowering the diabetic’s increased risk for a long list of horrors including stroke, amputation, blindness, stroke, heart attack, and others.  But the rate of these complications does not begin to drop until the diabetic has been on drug therapy for about ten years.  Ever heard that before?

Intensive use of drugs to lower blood sugar levels is another problem for diabetics over age 65. The drugs prescribed for diabetes 2 range from metformin alone—thought to be the safest—to the riskier combination of insulin plus an oral drug class of medications called sulfonylurea. Age 65 is the point at which many people begin to develop other serious health problems that make them more likely to experience complications when the drug therapy causes the blood sugar to go down to dangerously low levels (hypoglycemia).  Dr. Aron’s commentary identifies a list of conditions that put older diabetics at risk for hypoglycemia.

Ominously, at the top of the list is: treatment with the combination of insulin plus a sulfonylurea drug (click here for brand names). The list also includes “chronic kidney disease, cognitive impairment or dementia, neurologic conditions that may hamper the ability to speak or respond to a hypoglycemic event, and conditions associated with weight loss, appetite disturbances, or altered medication metabolism.” Yet Dr. Aron has this caution, “I wouldn’t want concerns about hypoglycemia to be seen as a license to avoid appropriate treatment for diabetes 2.”

Now for the test result at which overtreatment and hypoglycemia complications become a possibility: The diagnosis of diabetes 2 is based primarily on the hemoglobin A1C test, which can also measure how well the treatment is working.  The A1C test shows the average blood sugar levels of the past three months. The A1C result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. For people without diabetes, a normal A1C level can range from 4.5 percent to 6 percent.

Dr. Aron and his co-author Leonard Pogach have identified 7 percent as the A1C level as significant for certain people with diabetes 2. Once the patient’s A1C level goes below 7 percent, they say, the potential for overtreatment kicks in for people over the age of 65 who are at high risk for hypoglycemia.  Their commentary is part of the “Less is More” series published regularly by Archives of Internal Medicine, a medical journal with the mission of addressing the problems of unnecessary medical care.

Alarmingly, Drs. Aron and Pogach describe the A1C test as not very accurate (no matter the age of the patient), “There is even greater inaccuracy in many point-of-care A1C tests,” they wrote, referring to blood tests administered in a doctor’s office, as opposed to a free-standing laboratory.

Dr. Aron was asked for more information about how people would know whether their test results could be trusted as the basis for long-term drug therapy “Yes, it’s scary,” he said. When pressed further,  “No test is 100% accurate,” he hedged, “And there is a National Standardization Project currently working on improvements (click here).”

Take-home messages:  Pay attention to your A1C test results and keep copies. If your A1C goes below 7%, talk with your doctor about lowering the dose.   Become an expert on diabetes 2, hypoglycemia and the controversies that dog both topics.  Learn more about the drugs you are taking.   Read the links within this post and “Related posts” below.

Non-pharmaceutical steps to take:  Improve your diet by eating real food, as opposed to fast or processed foods (read “Food Rules“).  Don’t forget regular aerobic exercise (read “You can be fat and fit“).  Do both and you might be able to avoid drugs.

Maryann Napoli, Center for Medical Consumers©

Related posts

Risks of diabetes 2 treatment  A meta-analysis of 13 randomized controlled trials  found that drug therapy does not reduce mortality and might, in fact, slightly increase mortality. Study participants were middle-aged and older.  Drug industry’s role in expanded definition of diabetes 2 is described, so there is reason to think that overdiagnosis explains part of the diabetes 2 “epidemic.”

Weight loss and diabetes 2   Former American Diabetes Association official takes issue with the organization’s standard advice about weight loss and the disturbing trend toward labeling people as prediabetics.

Posted in Chronic Conditions, Diabetes 2, Diet & Exercise, Drugs, exercise, Heart, heart disease, Type 2 Diabetes, unnecessary treatment | Tagged: , , , , , , , , , | 1 Comment »

New book about exercise

Posted by medconsumers on May 10, 2012

You may be exercising to improve your health, your memory, your strength, your endurance, or for the pure pleasure of it all. By now, there’s a mountain of research to show the best ways to achieve these goals while minimizing the chance of injuries. Gretchen Reynolds, who writes the “Phys Ed” column for the New York Times Well Blog, has distilled it all for her new book, “The First 20 Minutes.” Many myths were busted along the way.

The book’s title refers to the latest research that shows the greatest health and fitness benefits from exercise are conferred within the first 20 minutes of a routine that combines low- and high-intensity exercise,  alternating at about one-minute intervals.  This type of workout, called “high-intensity fitness training,” can be applied to different forms of aerobic exercise—cycling, walking, etc.

Runners, for example, would start out with a slow jog and then alternate jogging at a normal speed with running at the fastest speed possible. This, says Reynolds, will prolong your life and provide the greatest reductions your chances of developing heart disease, diabetes 2, osteoarthritis. You continue to get benefit with longer workout, but at a slower rate. (You will also get the same benefits from walking, but it will take longer —20 to 30 minutes, five times a week.)

Actually, high-intensity fitness training was the least appealing part of an excellent book that is aimed at everyone from marathon runners to people like me who don’t want to move at high speed.  Each chapter addresses a single topic like endurance, the brain, avoiding injury, nutrition, and ends with a bullet list summary that allows readers to skip whole sections and cut to the chase.

Reynolds is at her most enjoyable when debunking the myths that surround exercise, nutrition, and injury prevention.  By now, most of us have probably heard that stretching before vigorous exercise is useless and perhaps even counterproductive. It lives on, of course, because it takes time for the word to get out.  And regular exercise will not result in much weight loss. Many of us can’t let go of that one, either. “Why exercise doesn’t inevitably make people skinny is one of the more intriguing and vexing issues in physiology,” writes Gretchen Reynolds.

Here’s a sampling of gems from “The First 20 Minutes:”

-Unless you have a congenital defect, running is not bad for your knees.  What’s more, the incidence of knee arthritis in “not necessarily high,” according to a study of longtime runners who were followed for two decades when most were in their fifties or sixties.

-The squat is extremely effective as a body strengthener. It activates the body’s biggest muscles, those in the buttocks, back, and legs. And doesn’t require a gym, a coach or equipment.

-Running for a half-hour doubles the number of brain cells involved in memory, but running has an extremely high injury rate.

-Any kind of movement can improve memory, even everyday activities—cooking, gardening, cleaning, walking around the block—performed by sedentary elderly people showed improvements in memory compared to elderly people who were completely sedentary.

-The importance of improving the body’s core strength has been disproven.

-Healthy people who eat eggs for breakfast consume fewer calories the rest of the day than people who eat bagels or other high-carbohydrate foods.

-Despite the popular notion that slow exercise burns more fat than longer, more rigorous exercise, it doesn’t.

-If you need an alternative to stretching before vigorous exercise (and many people don’t), warm up for a few minutes with an easy version of your planned exercise.

-Massage after strenuous exercise may feel good, but it impairs removal of lactic acid from tired muscles following exercise and interferes temporarily with blood flow to the sore muscles.

-Forget the sugary sports drinks and water. Low-fat chocolate milk provides the ideal ratio of carbohydrates and protein to boost fuel replenishment after a hard workout.

The book ends with a description of a term coined by exercise physiologists, “active couch potatoes,” which probably describes most people who exercise regularly.  Their day might include an hour at the gym or a run in the park, but most of the other waking hours are spent sitting—in front of a computer, watching TV, driving, etc. The body is not meant to be so physically inert. Reynolds’s final message is call to arms: Just “Move it!” Stand up from the computer every now and then; pace around the room while talking on the phone. Simply standing up for two minutes every 20 minutes will counter the negative health effects of sitting for prolonged periods.

Maryann Napoli, Center for Medical Consumers©
Related post:
You can be fat and fit

Posted in Alzheimer's disease, Book Reviews, Diabetes 2, Diet & Exercise, Heart, heart disease, Men's Health, Women's Health | Tagged: , , , , , , , | Leave a Comment »

What’s so bad about red meat?

Posted by medconsumers on March 25, 2012

OK.  If you need more reasons to cut back on the red meat in your diet, here they are: You will not only cut your chances of getting heart disease and cancer but you  will also have a shot at living longer. All the better, if you lay off the processed red meat like bacon and hot dogs (yes, pork is red meat). And now for the bonus: All of the above are also good for Mother Earth. The new information here is the living longer part.

The link between red meat consumption and an increased risk of chronic disease is already well documented. Now researchers, led by Dr. An Pan, Harvard School of Public Health, may have cleared up the uncertainties about increased mortality. They drew on data generated by two large diet/lifestyle studies that—together—followed over 122,000 U.S. health professionals who initially did not have cancer or heart disease.

One is the Nurses’ Health Study (1980 to 2008) and the other is the Health Professionals Follow-up Study (1986 to 2008). Both studies have about 28 years of follow-up. All participants answered extensive food frequency questionnaires every four years. They were asked, for example, how often they ate a standard serving of protein, defined as 3 oz (which is the size of a deck of cards).

The researchers documented 23,926 deaths, of which 15,910 were attributed to cardiovascular disease and 9,464 to cancer. The upshot: “Red meat consumption is associated with an increased risk of total, cardiovascular, and cancer mortality.” One standard serving of unprocessed red meat was associated with a 13% increase in the total death rate. One serving of processed red meat like sausage and salami escalates the risk to 20%.  (It should be noted here, that the 13% and 20% increases look worse than they truly are because the annual death rate in the 28-year duration of this study was low. The death rate each year was roughly 1% to 1.5%.)   [Note: For clarifications related to the number of servings, see comments below this post from a co-author of this study.]

In the one study that included both men and women, those with a high intake of red meat were less likely to be physically active and were more likely to smoke, drink alcohol, and have a higher body mass index. What’s more, they ate a larger quantity of food and had lower intakes of whole grains, fruits, and vegetables.

Because high consumption of red meat inevitably displaces other foods, the researchers provided this estimate based on healthy sources of protein like fish, poultry, nuts, legumes, low-fat dairy, and whole grains: A standard 3-oz serving of protein from this list is associated with a 7% to 19% lower risk of death.

Anticipating that many people do not want to give up red meat entirely, the researchers measured the advantage of just cutting back. If a person ate no more than 42 grams of red meat daily (a 6-oz. steak), the researchers estimate that 9% of the deaths in men and nearly 8% in women could be prevented. (And if you’re wondering where grass-fed beef  fits into this picture, it didn’t. Even today, only a small percentage of the U.S. population eats grass-fed beef.)

This study was published recently online in Archives of Internal Medicine. It was supported by grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute.

The invited commentary was written by Dean Ornish, MD, whose life’s work has concentrated on researching and promoting non-pharmacological approaches to the prevention of chronic disease. Dr. Ornish praised the study as, “The first large-scale prospective longitudinal study showing that consumption of both processed and unprocessed red meat is associated with an increased risk of premature mortality from all causes as well as from cardiovascular disease and cancer.”

Click here for Dr. Ornish’s healthy way of eating, based on an emerging consensus among nutrition experts.

Now for the environmental costs of eating red meat.  Dr. Ornish points out that animal agribusiness generates more greenhouse gases than all forms of transportation combined.. And that quarter-pound cheeseburger Americans love so much: It takes 26 oz of petroleum and leaves a 13-lb carbon footprint.

“In addition to their health benefits, the food choices we make each day affect other important areas as well. What is personally sustainable is globally sustainable. What is good for you is good for our planet,” he concludes.

Maryann Napoli, Center for Medical Consumers©

Related posts

Fried foods are not bad, if…

Posted in Cancer, Chronic Conditions, Diet & Exercise, Heart, heart disease | Tagged: , , , , , , , , , | 7 Comments »

Weight loss won’t prevent diabetes

Posted by medconsumers on January 15, 2012

Rare is the public announcement that a long-standing medical recommendation has been found to be impossible to follow. That’s what happened—albeit unofficially— at a recent press briefing when Richard Kahn, PhD, announced that weight loss is not the sure-fire preventive measure for avoiding diabetes 2. Studies show that hardly anyone can lose enough weight to meet the universally recommended goal. And even those who get there halfway usually regain the weight within a few years.

That won’t come as a surprise to anyone has ever tried dieting. What made this press briefing noteworthy, however, is the fact that Dr. Kahn was the chief scientific and medical officer of the American Diabetes Association for 25 years. His study raises questions about the centerpiece of the ADA’s standard diabetes prevention message: “Maintain a healthy weight “(along with increased physical activity). This is the advice that is also given to people diagnosed with prediabetes, a newly created “disease” that indicates they almost have diabetes 2 (more on that later).  According to the ADA, which receives funding from the pharmaceutical industry, there are 79 million Americans who have prediabetes. All are likely to be put on long-term drug therapy once the weight-loss attempts fail or never get off the ground.

At the press briefing, Dr. Kahn, now a professor of medicine at the University of North Carolina, Chapel Hill, described his paper in this month’s issue of the public policy journal Health Affairs, which is primarily devoted to diabetes.  He has based his conclusion about weight loss on the very clinical trials that set the standard for diabetes prevention. Perhaps Dr. Kahn is the first to notice that most of the study participants, all of whom were initially either overweight or obese, regained the weight after the trials were over.

“When you look at the published studies, you see that a substantial amount of weight loss is necessary and hardly anyone can meet the intended goal, explained Dr. Kahn.  “People who participate in the standard community weight loss programs lose about 3-4% of their body weight, but they don’t get an appreciable delay in the onset of diabetes until they reach 7.5% weight loss. So you see they are not coming close to delaying or preventing diabetes.”

Based on the best of the diabetes prevention trials, here’s an estimate from Dr. Kahn’s paper for what a 4% weight loss would actually do for people in terms of health and cost-effectiveness: “If overweight or obese people could maintain for life a 4% reduction in weight at minimal financial cost, there would be a modest 1% reduction in heart attacks and strokes after 20 years. Rates of some microvascular complications [e.g., blindness, neuropathy, foot amputations] would also decline, but it would take at least 20 years—during which time weight loss was continuously maintained—for such an intervention to achieve cost-effectiveness.”

Dr. Kahn was the only author at the press briefing whose paper was not favorable to prevention. Several promoted a nationwide diabetes prevention program. “This would be a waste of resources,” said Dr. Kahn. “Instead we need a better understanding of the biological processes that cause so many people to put on weight.  I don’t think we know enough about energy balance, specifically energy intake vs. energy expenditure. Our bodies regulate that very, very closely, and we just don’t know enough about the components of that [process], or why this imbalance occurs in some people and not others. We eat all the time, food is all around us, food is cheap and maybe our bodies can’t adapt to this environment.”

Until obesity researchers come up with answers, drug therapy is the way to go once diabetes develops, according to Dr. Kahn’s paper,  “We can greatly reduce the likelihood of serious complications through early detection and proper medical management.” (Novo Nordisk, the company that makes diabetes drugs, was thanked by the editor of Health Affairs for partially funding this month’s issue.) However, Dr. Kahn expressed reservations about putting people on drug therapy when they are diagnosed with prediabetes,  “The use of metformin or other glucose-lowering medications might help prevent diabetes, but initiating such therapy prior to the onset of diabetes is basically equivalent to diagnosing the disease at a lower glycemic [i.e., blood sugar level] threshold and therefore deserves more discussion.”

Additional  information about prediabetes and exercise

More and more physicians have begun to treat prediabetes with drug therapy, though there is no evidence to show that this is safe or effective.  One can see tacit support for this practice on the ADA website which states, “Before people develop type 2 diabetes, they almost always have prediabetes—blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes.”  Read this about the pharmaceutical industry’s role in expanding the definition of diabetes 2 and why the current threshold for starting drug therapy is dangerously low for people with diabetes 2.  click here   And this about exercise, “You can be fat and fit.” 

Maryann Napoli, Center for Medical Consumers©

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, exercise, Type 2 Diabetes | Tagged: , , , , , , , | 8 Comments »

The end of cholesterol…

Posted by medconsumers on August 15, 2011

It’s somewhat like observing the first signs of spring. Lipitor, the last of the block-buster cholesterol-lowering statin drugs, is about to go off patent, so you look around for signs that the affected drug companies have found a way to keep revenues up. Lovaza, a prescription-only capsule of omega-3 fatty acid may well fit the bill. It’s time to scare us about another blood lipid — triglycerides. After all, the statin drugmakers have gone about as far as they can go with the dangers of high cholesterol.

“Very high triglycerides [TG], or too much fat in the blood, are a “very serious medical condition,” say the Lovaza ads. Then comes the scary but vague, “having too many triglycerides in your blood may lead to future health problems.” And here’s the best part: “Lavaza has not been shown to prevent heart attack or stroke.” (Occasionally, the FDA requires drug ads to be honest.)

Are high TG really dangerous to health? “Not particularly is the short answer,” responded cardiologist Vikas Saini, MD, president of the Lown Cardiovascular Research Foundation,  which is affiliated with the unique second-opinion consultation center near Boston. In a telephone interview, Dr. Saini explained that when you pool the results of observational studies, there may be a little extra risk to having very high TG, but no one knows whether lowering TG will reduce the risk of cardiac events. Usually, elevated TG comes with high blood sugar and low HDL (good) cholesterol, so it’s hard to tease out the independent effect of TG alone. “I view high TG as a signal that that a patient’s energy balance is out of whack. In the vast majority, high TG is due to inactivity, weight gain, and a diet too high in carbs, specifically simple sugars and sweets.”

The statin drugmakers have always given lip service to lifestyle changes, knowing full well that many of us would prefer to pop a pill. The statin companies already made a bundle successfully marketing a drug that benefits only a tiny minority who take it (click here) and are unlikely to walk away from the goldmine without finding some way it can be reworked into another goldmine. One company has already tried—and failed—to get the FDA to allow the sale of its statin over-the-counter. (The FDA sees this as too risky without doctor supervision, but it could come around as pressure to reduce drug costs intensify.)

GlaxoSmithKline (GSK), maker of Lovaza, seems to have another plan. First, it can rightfully claim to be the only producer of fish oil capsules to have tested its product against a placebo to the FDA’s satisfaction. And as of four years ago GSK bought the right to make a generic version of the statin Mevacor after it lost patent protection.

GSK is positioning itself to produce a combination statin/fish oil drug and has already passed the FDA-required tests. (Agency standards aren’t all that rigorous; approval was based on two trials that went no longer than 16 weeks and showed TG went down and LDL cholesterol improved.) Once the combination drug becomes available, all GSK has to do now is make us think that purchasing its costly fish oil plus a statin in one pill is more convenient than taking them separately.  And perhaps an insurance company or two will pay a portion of the tab. This wouldn’t be the first time an off-patent statin was reworked into an expensive combination drug.  Remember Vytorin?   (See “Why is anyone taking Zetia or Vytorin?”)

“Fish oil is good,” says Dr. Saini, “but as a prescription drug [Lovaza] is likely to be more expensive than the over-the-counter fish oil capsules and/or eating fish high in omega-3 fatty acid [blue fish, mackerel, lake trout, anchovies, etc.], but then again I haven’t done any price comparison.”

Yes, but.   As with all dietary supplements, fish oil supplements do not have to meet any quality standards. The companies that make fish oil supplements are not required to conduct clinical trials to prove safety, effectiveness, or even that the product actually contains fish oil.  We can thank GSK for its tests which showed that the adverse effects like belching, indigestion and taste perversion, occurred in 3% more of the people on Lovaza, compared with those on the placebo. And the FDA-required label for Lovaza warns of fish oil’s potential effect on prolonged bleeding, advising physicians to monitor people taking anticoagulants or other drugs affecting coagulation (e.g., aspirin, NSAIDs, warfarin, Coumadin).

If you want to take a fish oil supplement, see which products were found to be the most trustworthy, according to the independent testing of ConsumerLab.Com (subscription fee is required).

Maryann Napoli, Center for Medical Consumers©

Posted in Alternative Medicine, Chronic Conditions, Diet & Exercise, Drug ads, Drugs, exercise, Heart, Men's Health, statins, unnecessary treatment, Women's Health | Tagged: , , , , , , , , , | 1 Comment »

Risks of treating diabetes 2

Posted by medconsumers on August 8, 2011

In keeping with the theme of this website—reporting the lack of evidence for common medical treatments—attention this week goes to drugs for type 2 diabetes. A new meta-analysis of the best studies on this topic shows strong hints that these drugs may cause more harm than good when intensive glucose (blood sugar) lowering is the goal. At best, there is a small reduction in non-fatal heart attacks among people treated intensely, at worst, an increase in cardiovascular deaths and deaths from all causes. All because blood sugar was intentionallly reduced to extremely low levels—ironically, in an effort to save type 2 diabetics from an early demise.

The meta-analysis included 13 randomized controlled trials with a combined total of over 33,000 type 2 diabetics given drugs to get their glucose levels down to what is defined as normal. The analysis of these trials was conducted by an international team of researchers and published recently in the British Medical Journal. To make sense of the findings, I turned to one of its co-authors, James M. Wright, MD, PhD, University of British Columbia, Vancouver, who acknowledged they were surprising. “One would expect that lowering glucose levels to normal [with drugs] would make people live longer; but we could find no reduction in mortality in these trials,” he explained. “If anything, mortality was increased by 4% in the people treated intensively [below normal].”

What exactly is “normal” and why was intensive lowering of glucose levels considered a treatment goal? To put the new findings in perspective, here’s the back-story for how type 2 diabetes became a common diagnosis:

-In 1998, the definition of diabetes was changed from a fasting blood sugar of 140 mg/dL to a blood sugar of 126 mg/dL, thus making millions of formerly healthy Americans into type 2 diabetics overnight and, not incidentally, candidates for long-term drug therapy. In time the A1C blood test, which provides a three- to four-month picture of past glucose levels, would be considered the better measure for assessing type 2 diabetes and the need for treatment.

-Most of the physician experts who served on the panel that expanded the definition of type 2 diabetes had financial ties to companies that make drugs for the condition. click here By 2009, an equally conflicted international panel of experts announced “the goal of therapy is to achieve a hemoglobin A1C of 6.5% or less.” click here  Unfortunately, there is no evidence to prove this current recommendation is safe or effective.

-Lowered thresholds for normal initially seemed to make sense. Observational studies showed type 2 diabetics die of heart disease at rates two to four times higher than people without it. Diabetics also have more heart attacks and strokes. What’s more, risks start to increase at glucose levels lower than what had previously been defined as normal.

-Will glucose-lowering drugs also lower the chances of dying a premature death or having a heart attack or stroke? The first clinical trial designed to answer that question, the ACCORD trial, had to be stopped 18 months ahead of schedule in 2008. More deaths had occurred in the participants treated intensively, compared to those treated to normal blood glucose levels. There was also higher rate of hypoglycemia in the intensively treated people, 10% of whom required medical care.

This disturbing recent history brings us full circle to the new meta-analysis of the 13 clinical trials (one of which is the ACCORD). The 18,315 study participants of these trials who had been treated intensively (to A1C of 6.6%) were compared with the 16,218 treated less intensively (to A1C of 7.5%). All participants were taking the usual drugs prescribed for type 2 diabetes; those treated intensively were more likely to use combinations of drugs and higher doses. The meta-analysis produced this alarming conclusion: “The overall results do not show a benefit of intensive glucose lowering treatment on all cause mortality or cardiovascular death. A 19% increase in all cause mortality and a 43% increase in cardiovascular mortality cannot be excluded.”

Dr. Wright, co-author of the meta-analysis and practicing physician, was asked how he treats his patients. “My target is a HbA1C of 7% to 8%, never lower,” he responded. “If a patient comes to me with a 7.9% A1C test result, I would say that’s fine. “When someone on drug treatment has a 6.5% A1C, I would stop one of the drugs. When you get into the lower range—that is, below 7% there’s an increased risk of causing hypoglycemia, which can be severe and life threatening. The only exception would be the person on diet alone where hypoglycemia is not a risk and where you would encourage the patient to continue their diet and exercise to maintain the level of 6.5%.”

Added September 22, 2012 : Soon after this post went up on our website, this review was published in the Cochrane Library. It did not find any significant reduction in either death from any cause or death from heart disease when intensive glycaemic control  was compared with conventional control.

Maryann Napoli, Center for Medical Consumers©

For more on this topic, read “Diabetes 2 drugs: risks without benefits”. and this “How risky is having diabetes 2?”.

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, Heart, Type 2 Diabetes | Tagged: , , , , , , | 2 Comments »

G’bye to low-fat diets

Posted by medconsumers on July 21, 2011

Is it just me? Or are we all hearing less and less about the importance of the low-fat diet? First, it was advised only for people who’ve had a heart attack. In time, the low-fat diet would be recommended for everyone, even children, as a good way to avoid heart disease. Eventually, there would be some serious back-peddling where it concerned babies and toddlers who, as it turns out, need lots of fat in their diets. Then there were those hard-to-explain population studies that show a lower incidence of stroke among people on high-fat diets. here’s one  Over the last decade—without any official retraction from the government or the cardiology organizations—there is less emphasis on the importance of the low-fat diet. It’s long overdue.

A new Cochrane review of all relevant clinical trials shows that the evidence supporting the low-fat diet is thin…and always has been. In fact, the reviewers found no good research to answer the most basic of questions: Are monounsaturated (e.g., olive oil, canola oil, nuts, avocados, etc) or polyunsaturated fats (plant foods and oils) healthier than saturated (animal) fats? The review acknowledges the negative, but unintended, consequences of telling the healthy public to reduce fat intake. It led many Americans to consume more carbohydrates, particularly starchy, sugary refined foods.

Ten years ago, the first Cochrane review of all low-fat diet/heart disease prevention studies was published in the British Medical Journal. Here is how the findings were expressed at the time:

“Despite decades of effort and many thousands of people randomized [into clinical trials], there is still only limited and inconclusive evidence of the effects of modification of total, saturated, monounsaturated, or polyunsaturated fats on cardiovascular morbidity and mortality.”

The existing research hasn’t improved much in the intervening ten years. The new Cochrane review, which is an updated version of the 2001 review, was published recently in the Cochrane Library (online subscription-only library). The Cochrane reviewers identified 48 studies with a combined total of 65,508 participants, including studies published in the last decade. No studies proved that people would live longer, avoid a stroke or heart attack, or showed anything else that might motivate people to alter the fat content of their diets.

As with all Cochrane reviews, the best studies are identified and results are combined. In this case, all the bad outcomes you might like to avoid—heart and vascular disease, cardiovascular death, heart attack, stroke, angina, and the need for heart surgery—-were also combined. Once that was done, an unimpressive 7% reduction in bad outcomes was noted among the study participants on a reduced fat diet, compared with those randomly assigned to continue their usual diet. Generally speaking, diet studies are difficult to conduct and costly. And they usually don’t last very long. Two years is the longest duration of any study in this review and it largely accounts for the aforementioned 7% reduction. Yet the Cochrane reviewers saw this small reduction as a good sign that some form of a low-fat diet might be shown to be heart healthy had the participants been followed several years longer.

This updated Cochrane review entitled, “Reduced or modified dietary fat for preventing cardiovascular disease,” was conducted by Lee Hooper, PhD, University of East Anglia in the U.K. and colleagues at other British universities. The review did not disprove the idea that the low-fat diet is best for the heart. Rather, it found no strong evidence to support this longstanding public health message, which no doubt led many healthy people with high cholesterol to take cholesterol-lowering statin drugs unnecessarily. (Ever since the early 1990s, healthy people with elevated blood cholesterol are usually told to go on a low-fat diet.  It has long been known that two out of three of them will fail to get it down to normal with a low-fat diet and exercise. Statins are the next step—see current ads for Lipitor.)

What’s the take-home message from this Cochrane review? Uncertainty is the short answer. Unfortunately, the low-fat message to the public was delivered with a certainty that never existed. It has probably made many people take all other nutrition advice with a grain of salt.

In the early days of dietary fat studies, researchers relied heavily on the less definitive form of research called population studies, aka observational studies.  The researchers observed that people in some countries with low dietary fat intake also had low rates of heart disease and came to the conclusion that the low-fat diet is the key to avoiding heart disease.  As time went on, researchers tried to tease out factors, other than fat intake, that could account for a country’s lower rate of heart disease, for example, red wine drinking in France.  The next step is the type of study used in medical treatment research—participants are  randomly assigned either to go on a low-fat diet or stay on their usual diet, for example, the aforementioned two-year study in the Cochrane review.

Where do we go from here? You can’t go wrong eating real food. If you’re not sure what that means, read Michael Pollan’s Food Rules. If you want to know more about how the low-fat diet became standard medical advice, read our 2008 review of  Good Calories, Bad Calories by Gary Taubes.

Maryann Napoli, Center for Medical Consumers©

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Cancer prevention rethink

Posted by medconsumers on April 14, 2010

A widely promoted cancer prevention recommendation has been downgraded. Eating lots of fruits and vegetables daily will only slightly reduce your chances of developing cancer, according to a new study called the European Prospective Investigation into Cancer and Nutrition, published in the Journal of the National Cancer Institute. It followed 142,605 men and 335,873 women who provided extensive information about their dietary habits and lifestyle. Cancer incidence and mortality data were also collected. After nearly eight years of followup, there was only a “very modest” decrease in cancer incidence among those with a high intake of fruits and vegetables.

The researchers offered this warning about this finding: They could not be certain that the small reduction in cancer risk is due to low intake or fruits and vegetables, or the possibility that people who eat more fruits and vegetables are also less likely to be smokers, heavy drinkers of alcohol and/or regular exercisers.  

In any case, time for the American Cancer Society to tone down its recommendations of “five or more servings of fruits and vegetables to prevent cancer.” The U.S. Centers for Disease Control and Prevention has the same emphatic message on its Web site.

Maryann Napoli, Center for Medical Consumers(c)ISSN 2155-1480
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Meridia: banned in Europe, but not in U.S.

Posted by medconsumers on January 24, 2010

How long does it take to get a dangerous drug off the market? The weight-loss drug Meridia provides the latest test case. At the end of last year, the Food and Drug Administration (FDA) announced that it was looking into an early finding from a large international trial. Here’s the bad news that emerged from the trial last November: There were more heart attacks, strokes, and deaths among obese people with heart problems taking Meridia than those taking a placebo. Ironically, this trial was designed specifically to prove Meridia will not just help people lose weight, but it would also spare them the heart problems associated with obesity.

Last week, drug regulators in Europe and the U.S. reacted. The European Medicines Agency took a strong stance, advising doctors and pharmacists to stop prescribing and dispensing the European equivalents of Meridia. Obviously, the EMA thought the drug’s risks outweighed its benefit. And what did the FDA do? It took the wimpy route, asking Abbott Laboratories, maker of Meridia, to put a stronger warning on Meridia label. This is one notch better than doing nothing. Unfortunately hardly anyone, including most doctors, reads the drug label that can be 20-40 pages long. (Click here to see why.) Keep in mind that both regulatory agencies were looking at the same data from the same trial.

Known as the SCOUT trial, this large study was testing the widely held assumption that weight loss itself would automatically reduce the risk of heart problems in people who are overweight and obese. It included 10,000 overweight or obese people, aged 55 or older, who had heart disease or diabetes, or both. They were randomly assigned to take Meridia or a placebo for six years. All had been advised to make the same lifestyle changes associated with weight loss. The SCOUT trial found 1.4% greater risk of heart attack, stroke and death (combined) in the participants taking Meridia, according to the FDA’s June 30, 2009 Web site notice.

FDA watchdog Sidney Wolfe, MD, Director of the Public Citizen’s Health Research Group, assessed the Meridia-related cases on the FDA’s database for adverse reactions reports, while noting the underreporting common to all drugs. “We have found that there are now, as of June, 2009, a total of 84 reports of deaths from cardiovascular causes in the FDA Adverse Event Reactions database, including 30 in people 50 or younger. Of these 30 people, 11 were 30 or younger. It must be noted that FDA’s own estimates are that no more than one in ten adverse reactions to drugs that occur are reported to the agency,” wrote Dr. Wolfe in a December 3, 2009 letter to the FDA commissioner.

Dr. Wolfe initially petitioned the FDA to ban Meridia in 2002 because the placebo-controlled trials conducted prior to its approval showed that the drug caused increases in blood pressure, pulse rate, and palpitations.

For more information

About Dr. Wolfe’s Health Research Group, here’s its Web address.

About the FDA’s position, read its January 21, 2010 alert aimed at physicians and patients.

Update:The September 2, 2010 issue of the New England Journal of Medicine reported a study over nearly 10,000 overweight or obese older people taking Meridia or a placebeo for many years. It concluded that the drug increased the risks of heart attacks and strokes and wasn’t very effective in terms of helping people lose weight. The study participants taking the drug lost about nine pounds the first year and those taking the placebo lost about four pounds.

February 2011 Update: The FDA forced the withdrawal from the market of Merida and now has stricter rules for new weight loss drugs. To gain agency approval, manufacturers must now prove their weight loss drugs do not cause heart attacks.

Maryann Napoli, Center for Medical Consumers(c)

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Mediterranean Diet: What Accounts for the Health Benefit?

Posted by medconsumers on July 1, 2009

The Mediterranean diet is not only wildly popular around the world but also considered to be one of the most healthful diets of all that have received in-depth research attention. Yet it is unclear whether it is the wine, olive oil or some other component of the diet that largely accounts for the health benefits, chief among them is longevity.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

Maryann Napoli, Center for Medical Consumers(c)

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