Great strides have been made in the field of cardiology in recent years. However, according to a new study just out, people with diabetes remain dangerously at risk for heart-related problems like angina and heart attack. The results of the study have been published In the latest issue of the Journal of the American Medical Association (August 2007).

It's quite disturbing to read the numbers on this. Example? For every hundred diabetics who experience severe heart attack, just over eight will die within thirty days. For non-diabetics, that number goes down to around five. I could go on, but you get the picture.

The solution? Says the author of the study, Dr. Elliott M. Antman: "We need aggressive strategies to manage the diabetic population. What we need to do is everything to halt the epidemic of diabetes and find through research what therapies are most helpful for diabetic patients. We've got to do better for those patients." Hear, hear.

But what should those "aggressive strategies" be? And how do you implement them? That's the sticking point. The Washington Post caught the American Diabetes Association's Larry Deeb in a moment of remarkable frankness, saying he really doesn't know what can be done to get cardiologists and endocrinologists working together on this. C'mon, Larry. That's not exactly encouraging news for all the people out there with diabetes!

The votes of yesterday's advisory panel on Glaxo's Avandia demonstrate how dysfunctional this government can be. I was just reading up on the details. There were two key votes. On the question: does Avandia increase risk for heart attack, the vote was 20 to 3 in agreement. Yet, incredibly, the same panel also voted overwhelming - 22 to 1 - to keep Avandia on the market.

Coverage on the subject in today's New York Times described the meeting as "extraordinary" in that US Food and Drug Administration officials were openly in disagreement with each other as to what steps to take. As I mentioned yesterday, one of those officials, Dr. David Graham, said the drug should be withdrawn. However, Dr. Robert Meyer, another FDA high-up-official, disagreed.

Let's recap: Glaxo knew Avandia might cause heart trouble and informed the FDA of this. The FDA did nothing. An article in the New England Journal of Medicine (May 2007) stated the drug increased the risk of heart attack. The FDA twiddled its thumbs. Now this? The drug may stay on the market at the behest of the same FDA officials who voted in agreement that it poses a heart risk. Has the world gone mad? The sooner we get some reform at the FDA, the better off we will all be.

Also worth noting: the Times reports that Dr. Steven Nissen, whose NEJM article sparked the controversy, says he would have voted to remove Avandia from the shelves. Also quoted was Dr. Sidney Wolfe of Public Citizen, a drug safety advocacy group. Observed Dr. Wolfe: "If Avandia were up for approval today based on what we know now, it would be rejected."

Earlier today I blogged about the Avandia advisory panel which met today. As of earlier today, the word was an FDA official, David Graham, had issued a written preview of the comments he intended to make. In it, Graham stated his view that GlaxoSmithKline's diabetes drug Avandia is dangerous and should therefore be removed from sale.

Now comes breaking news from the Associated Press that the panel will recommend, against the wishes of many - Dr. Graham included, that Avandia stick around. According to the AP, government health advisers have argued that, hey, sure Avandia may cause increased risk of heart attack, but let's just keep it out there. What?! As of writing, the AP was still waiting for a tally of how the panel voted on the issue, but word is a majority voted against recommending a ban.

The FDA's patient representative for the panel was quoted as saying studies indicating Avandia causes heart trouble "have very significant weaknesses and are inadequate for us to make that kind of decision." In short, the FDA seems to be saying Avandia causes heart damage, but the study-based proof is not strong enough for a ban. Talk about your contradictory messages! Baffled? Disgusted? Join the club.

Details are emerging from today's advisory committee meeting on Glaxo's Avandia. First up was a presentation by Dr. Robert Ratner of Washington's MedStar Research Institute outlining the unprecedented spread of type 2 diabetes. Ratner emphasized the inadequacy of current drug therapies for diabetes and the strain on the health system caused by the disease. The possible implication: Avandia does more good than harm right now, so let's keep it as an option.

Next, in written preview comments, an official from the US Food and Drug Administration stated his belief that the diabetes drug should be taken off the market. The official, Dr. David Graham, says the heart risks posed by Avandia mean it's just not worth the risk to patients. Especially, he said, not when there are safer alternatives like Actos (by Takeda), which also stabilizes blood sugar levels.

It's a significant step that someone from the FDA publicly made this statement. But will anything come of it? Maybe not. The decision about whether or not Avandia stays on the market is not up to Dr. Graham, who The New York Times reports has a history of coming down harder on drug risks than many colleagues. (Give the guy a medal!) Thing is: there appear to be plenty of other officials within the FDA who don't agree with Graham's interpretation.

I was intrigued by a recent Swedish study reporting that people on a so-called "Stone Age" diet had more stable blood sugar levels than those on a Mediterranean diet. An intriguing claim, because it's so often said that Mediterranean-style eating is super-healthful. Let's also admit it is a delicious way to eat: yes, pasta and bread is there, but it's balanced out by tons of fresh fruits, vegetables, fish and olive oil. The Stone Age way is a bit more spare: we're talkin' meat, fish, and lots of whole grains, berries and nuts. Nary a sliver of Parmesan in sight.

However, the results of yet another study, this time from Australia, indicates Mediterranean-style eating is a good choice, especially for diabetics. Researchers from the University of Melbourne say Mediterranean-born immigrants in Australia are less likely to die from heart disease than other Australians. The researchers have concluded it's all down to dietary patterns. More than forty thousand people participated in the study over a period of ten years. The numbers revealed those who ate the most Mediterranean-style foods had a thirty percent lower risk of dying from heart disease. For diabetics, the researchers speculate, the benefits could be even higher, reducing the risk of death due to ischemic heart disease.

Results have been published in The American Journal of Clinical Nutrition. Visit Reuters for a discussion of the study.

A new report says physical activity is critical for kids with type 1 diabetes because it helps prevent heart trouble later in life. The German and Austrian researchers behind the study reached this conclusion after crunching the numbers for more than 23,000 kids between ages three and eighteen, comparing their health with activity levels. As you would expect, the most active kids had the healthiest hearts and lower levels of cholesterol and triglycerides. By comparison, thirty-six percent of children who were active only once or twice a week had high cholesterol and triglycerides.

For type 1 kids, activity levels relate to HbA1c levels: fit children had lower HbA1c levels. High HbA1c levels in childhood practically guarantee your child will experience heart problems down the road. Says lead researcher Antje Herbst: "Clearly, getting off the couch and out of doors, where they can be more physically active, is good for all kids. But for children with type 1 diabetes, the need to stay physically active is even greater due to the increased risk for heart disease."

Parents: you don't have to sign your little ones up for triathlon training, boot camp or anything like that. Vigorous exercise is not necessary to reap the benefits. Regular periods of normal play are adequate. Even half an hour a day can make a difference, the researchers say. Common sense, however, suggests this is a case where more is definitely better.

The results of this study appear in the latest Diabetes Care (August 2007).

The beleaguered US Food and Drug Administration (FDA) today released its review of the Avandia debacle. It contains a fairly damning assessment of what went wrong, one that implicates not only Avandia's manufacturer GlaxoSmithKline, but also the FDA itself.

The 436-page review confirms that Avandia does indeed increase the risk of heart problems, a claim that Glaxo has vigorously denied. (Can't wait to see how they respond to this.) The FDA reviewers concluded that the risk is also far greater than that posed by a similar drug, Actos, which is manufactured by Takeda. In addition, the FDA reviewers were dismissive of the studies conducted by Glaxo - studies that the drugmaker claimed provided proof of Avandia's safety. The report also restates the allegation that Glaxo tried to coerce a doctor into remaining silent about the risks posed to diabetics from taking Avandia.

The report goes on to find fault with the FDA's inaction and, by implication, its completely pathetic pandering to Glaxo. Now, even insiders are publicly saying FDA officials repeatedly put the interests of Glaxo above the interests, health and safety of consumers.

All-in-all, this represents a big victory for Glaxo/BigPharma's critics. It almost goes without saying that this report likely marks the end of the line for Avandia. Perhaps more significant could be the impact of the whole mess on the FDA. The review effectively highlights the shortcomings of the agency for all to see, greatly strengthening the hand of its critics - both in and outside government - who are calling for major reforms there.

Click here to read more.

Stay tuned for news of the advisory committee hearing on Avandia, which is scheduled to be held Monday.

It used to be that fat was just fat. Not anymore. Turns out that even fat is, upon close examination, more complicated than we ever realized. Did you know, for instance, that accumulations of deep belly fat are particularly harmful? Such accumulations are a risk factor for Type 2 diabetes because they are associated with increased insulin resistance, not to mention increased risk of heart attack.

One problem with deep belly fat, however, is that you can't necessarily detect it with a tape measure or by eyeballing someone's waistline. That is, you can't tell by just looking at a person how much of the fat surrounding their abdomen is deep belly fat versus the subcutaneous fat that lies just under the skin's surface. However, a new study reports that a simple blood test could solve this problem by measuring quantities of the retinol-binding protein 4, also known as RBP4, in the bloodstream. RBP4 is present in much higher levels in the bodies of those with greater amounts of deep belly fat. Not only does this mean that testing for high levels of RBP4 could be useful in assessing risk for conditions such as Type 2 diabetes or heart disease, it also opens up the possibility of treating such conditions by somehow manipulating RBP4 levels.

The study in question was conducted by scientist Barbara Kahn and colleagues from Harvard Medical School, Beth Israel Deaconess Medical Center, and the University of Leipzig, Germany. The results have been published in the journal Cell Metabolism (July, 2007). Kahn is particularly well known in the area of diabetes-related research for her work on insulin resistance in mice.

Celebrate the 4th of July! Be informed - it's patriotic. Check out an awesomely funny video from Prescription for Change. The colorful cartoon comes complete with singing and dancing prescription drug capsules, accompanied by the seriously screwed-up patients who popped pills with abandon and are now suffering the horrible consequences. (Male lactation, anyone?)

Prescription for Change is a public awareness-raising project funded by the powerful nonprofit Consumers Union. The vid's purpose: to raise awareness about inadequate prescription drug regulation in the US and to recruit public support in pushing for change. Specifically, it's about rallying support for the drug safety bill (HR2900) now before the US House of Representatives. It's not too much to ask, surely, that prescription medications be safe and affordable, and that information about drug side effects be fully explained to patients.

Diabetics be aware: a major case in point, illustrating Prescription for Change's critique of the status quo, is the Avandia scandal. The US Food and Drug Administration (FDA) failed to alert the public that Avandia, the Type 2 diabetes drug, manufactured by GlaxoSmithKline, increases the risk of heart attack. Oops.

View the cartoon by visiting YouTube. Or click here to visit the Prescription for Change website, which also features additional information about why reform is needed. You can also send an email to your Representative in support of the changes. Can Prescription for Change make a difference? Stay tuned.

The way that the US Food and Drug Administration (FDA) dropped the ball on Type 2 diabetes drug Avandia has fueled calls from both in and outside of government for FDA reform. We should all be afraid, very afraid, that a government body charged with protecting the public good on such a basic level is toothless. And that's putting it kindly.

The public radio show Marketplace just ran a two part feature on this issue. Its reporter asks the question: when did the FDA first learn about the health risks posed by Avandia (namely, increased risk for heart attack)? Also, what did the FDA know before the story broke in the media? Shockingly, Avandia manufacturer GlaxoSmithKline (GSK) informed the FDA back in 2005 that the drug raised the risk of heart attack. GSK even supplied the FDA with a copy of its internal analysis on the subject in 2006, which the FDA then confirmed with its own analysis. The FDA's explanation for its silence was that it was trying to assemble a comprehensive picture of the situation before acting. Sure. But how much longer would the FDA have sat on the Avandia issue if the story hadn't broken following the criticisms of cardiologist Steven Nissen?

Because the FDA is supposed to be our public health watchdog, these questions will ultimately prove far more significant than questions about what GSK knew and when. Big Pharma - like all business enterprises, large and small - is focused on the bottom line. It's up to the FDA to look out for the rest of us. Yet many in our government believe in letting market forces prevail; that in a healthy economy, little government oversight is necessary. Fact is, this just doesn't work. Are you scared yet?

Happy July 4th!

For those of you following the Avandia story in the news, you're probably wondering how the patients currently taking Avandia are feeling. Are they flushing the pills down the toilet? What about the patients enrolled in GlaxoSmithKline's current Avandia clinical trial -- are they dropping out like flies? If you are unfamiliar with the Avandia debate, news broke last week that Avandia, a popular diabetes drug, may increase the risk of heart attack. A 43% higher risk.

It may depend on the specialty of your doctor. BusinessWeek has reported endocrinologists tend to be more skeptical of the study, noting its weaknesses compared to original, more rigorous clinical trials. Many cardiologists and drug safety experts give the study more weight, and remain worried about Avandia's potential cardiac danger. Doctors on the frontline are concerned patients may stop taking the drug without medical consultation as many are confused and frightened.

Dr. Nissen, the whistle-blower on Avandia and leader of the fight to withdraw Merck's arthritis drug Vioxx due to safety issues, acknowledges there are real limitations in his analysis, but he points out Glaxo's own data found a 30% increase in the risk of heart attack from Avandia. Nissen was alarmed enough to release his meta-analysis showing a 43% increased risk versus waiting for the results of Glaxo's 4,400-patient, eight-year clinical trial named RECORD, which is specifically measuring cardiovascular outcomes of Avandia.

Critics say Nissen went too far out on a limb this time as a meta-analysis examining 42 Avandia trials with varying research methodologies is not terribly reliable.

Central obesity is associated with insulin resistance through factors that are not fully understood. Researchers studied the effects of three different diets on body fat distribution, insulin sensitivity and peripheral adiponectin gene expression.

Adiponectin is secreted from fat tissue into the blood. The presence of adiponectin can result in improved insulin sensitivity and glucose tolerance, and can assist in mobilizing sugar out of the blood The hormone plays a role in the suppression of the metabolic derangements that may result in type 2 diabetes, obesity, atherosclerosis and non-alcoholic fatty liver disease.

The study involved 11 volunteers who were the offspring of obese type 2 diabetic patients with noticeable abdominal fat deposits. The volunteers were considered insulin resistant and they maintained average hemoglobin A1c levels of greater than 6.5% without medication. All subjects underwent three dietary periods of 28 days each in a crossover design: a) diet enriched in saturated fat (SAT), b) diet rich in monounsaturated fat (MUFA; Mediterranean diet) and c) diet rich in carbohydrates (CHO). Weight, body composition and resting energy expenditure remained unchanged during the three dietary periods. However, when patients were fed a CHO-enriched diet their fat mass was redistributed towards their abdominal region and their periphery fat accumulation decreased compared with a diet MUFA-rich and high SAT diets. Changes in fat deposition were associated with decreased levels of adiponectin after meals and lower insulin sensitivity.

The results of this study conclude a diet rich in monounsaturated fat prevents central fat redistribution and a decrease in after meal adiponectin levels. These findings support the belief that a carbohydrate-rich diet in insulin-resistant subjects exacerbates the insulin resistance. The moral of the story is: to enhance insulin sensitivity - look for a diet rich in monounsaturated fats and less dense in carbohydrates. Chances are if you've tinkered around with your food pyramid - you already knew the results of this study.

Any headline that features die is bound to grab your attention. The headline appeared in an article published by The Scotsman. What the title lacks in sensitivity it makes up for in reader feedback. Both, statistically eye-popping and universally alarming, I give you extracts from the article and a few passionate responses from readers. How does it make you feel?

Research from Edinburgh University reveals the number of people diagnosed with type-2 diabetes will soar by 60% within the next ten years. This is mainly due to the obesity crisis, with current estimates showing a quarter of the population is likely to be classed as obese by 2018. Doctors say they are treating an increasing number of teenagers for type-2 diabetes, which traditionally only develops in older people. Being overweight is a strong factor in becoming a type-2 diabetic, which can lead to complications of diabetes like blindness, amputations, cardiovascular disease and kidney failure. Diabetes and complications therein are estimated to costs the NHS nearly a tenth of its yearly budget. With future expectations of diagnosis -- the strain on the NHS will get worse. Andy Kerr, the health minister, admitted diabetes would prove to be a time bomb if the Executive's healthy eating initiatives failed. But he ruled out screening children for diabetes or rationing healthcare for people diagnosed with type-2 because of their unhealthy lifestyles.

And now for the comments:

Commenter #3 says I daresay the Scottish obesity/diabetes problems predates devolution.
Commenter #9 says, The statistical analysis regarding type 2 diabetes is flawed; the medical profession have been guilty in prescribing drugs and reissuing prescriptions for drugs that are only safe for short periods. One such drug has had its usage limited by the authorities within the past 3 years in Scotland and has only been reclassified in England and Wales in the past 6 months. This drug is now listed as causing type 2 diabetes, how many more are there out there? Hence the statistical analysis is being used to cover a grave error that is to be covered up.
Commenter #20 says, Perhaps we should take a closer look at why our kids are obese. They are marooned in the house for most their lives and when they actually do go out mum or dad are suckered into driving them everywhere. Tackle the fear which causes this situation and you are half way to solving the obesity problem of our youngsters.

All things considered, what if this headline was featured in the New York Times or more revealing - the 5 o'clock news? How would you react to it?

Pomegranate juice was shown to reduce the risk of arthrosclerosis in diabetics who participated in a study conducted over three months. The pomegranate juice also appeared to slow the absorption of unhealthy LDL cholesterol by immune cells.

People with diabetes have increased risk for atherosclerosis, contributing to coronary heart disease, heart attacks, strokes, and other circulation problems. The results of this study suggest that the antioxidants found in pomegranate juice may be beneficial in reducing these heart-related risks associated with diabetes. The sugars in pomegranate juice are attached to unique antioxidants, which actually make these sugars protective against atherosclerosis. Researchers examined the effects of drinking a concentrated pomegranate juice that is the equivalent to about a 6-ounce glass of freshly squeezed pomegranate juice for three months in 10 healthy adults and 10 adults with type 2 diabetes (who were not dependent on insulin therapy). Drinking pomegranate juice did not affect overall cholesterol levels, but researchers found it reduced the uptake of LDL (bad) cholesterol by immune cells, which is a major contributing factor to atherosclerosis.

Albeit a little tart, the reputation of the pomegranate falls heavily on the sweet side. One pomegranate delivers 40% of an adult's daily vitamin C requirement. Food manufacturers' favor using pomegranate extracts instead of the juice because it contains no sugar, calories, or additives. Factor in the folic acid, the free-radical destroying antioxidants, and the overall health benefits of the Chinese apple and ask your arteries if it's worth a 6 ounce glass. I'm guessing the answer is yes.

Bariatric surgery is the term for operations to help promote weight loss by making it difficult for the patient to consume a lot (or even a normal amount) of food. It offers a viable solution of mitigating type 2 diabetes, if not curing it entirely. In 2004, a major study showed that after 10 years, diabetes disappeared in 36% of patients who had the surgery, compared with 13% who did not.

Bariatric surgery is an increasingly popular option for people who can't lose enough weight by diet and exercise. The number of such surgeries has quadrupled since 2000, reaching 177,600 this year. For morbidly obese patients with type 2 diabetes, bariatric surgery results in a cure rate of 80-98%. About 90% of type 2 diabetics are overweight. In terms of just diabetes alone, the cure rate of serious illness after surgery is greater than 80%.

Bariatric surgery is nothing to take lightly. Although it is a serious procedure, it gives type 2 diabetics a token of hope they may never have to rue the day of diabetic complication like blindness, amputations, neuropathy, stroke, heart attack, and life itself. Is the risk worth the reward?