Wednesday, December 12, 2007

Actos is Dangerous Too!

If you follow the diabetes news, you probably saw reports today about a new study published in the Journal of the American Medical Association, this one, a study of the medical records of people over 65, is being reported as it if found that Avandia raised the rate of heart attacks and death. That is how the New York Times and many other news organizations are headlining this story. But that isn't actually what the study found. Here's a better report.

Study: Type 2 diabetes drugs raise heart risks: Chicago Tribute based on study published in JAMA

The crucial piece of information here is that, in a study of patient records of people over 65 taking various diabetes drugs both TZD drugs, Avandia and Actos, appeared to cause significant increases in death and heart problems.

I can't help but wonder if the way this story is being reported--with many news outlets making it sound like only Avandia causes excess heart deaths--is because Takeda, the maker of Actos, is advertising heavily in the media now that Avandia has been so thoroughly discredited. Are the media downplaying the suggestion that Actos too may be dangerous to keep this big-money advertiser?

In reports like those of the New York Times the article claims that Avandia alone is identified as dangerous because most of the patients taking TZD drugs in this study were on Avandia so there wasn't enough data to draw firm conclusions about Actos.

But we know that Actos, like Avandia, causes heart failure. It carries a black box warning to this effect in its prescribing information, as required by the FDA.

Heart failure means that the muscle of the heart has weakened. Research has found both TZD drugs appear to cause heart failure in people who did not have it before starting the drug. This may be because Avandia and Actos can cause intense water retention and swelling, which can stress a marginal heart.

We also know that Actos, like Avandia, causes thinning of bones leading to osteoporosis and fractures in older women. I discussed that in this previous blog post.

Sadly, most doctors have responded to the media blizzard of bad news about Avandia by switching their patients to Actos. That is probably because they don't have the time or inclination to research the safety of Actos on their own and depend too heavily on media reports and drug company salespeople for guidance on what drug to prescribe.

ADA Won't Recommend Against TZDs
In related news, Diabetes in Control reports that the latest ADA practice recommendations still recommend TZD drugs, despite the evidence against them.

This should come as no surprise, given the huge contributions the drug companies make to the ADA and the long track record the ADA has amassed of working to ensure that people with diabetes eat high carb diets full of their sponsors' junk foods that raise their blood sugar so that these patients need to take their other sponsors' expensive (and dangerous) drugs.

The ADA really should be renamed, "The American Association of Those who Profit from Diabetes." That is who they serve, not the people who HAVE diabetes.

What Does This Mean For You?
If you are a person with Type 2 diabetes you need to understand that both Avandia and Actos work by affecting the PPAR-gamma receptor. They both cause water swelling and this swelling is probably what strains the heart. They both also cause dramatic weight gain, because the way that they appear to work is that they push the body to create new fat cells which lower blood sugar by storing excess glucose in the form of fat in those new fat cells. They weaken bones because the receptor they affect also controls the rate that the body destroys bone cells, and the way they affect it makes for more bone destruction.

The drug companies claimed for years that both these drugs rejuvenated beta cells. This has never been proven. They also claimed that these drugs lessened the amount of metabolically dangerous belly fat. This to turned out to be a result of (intentional) misrepresentation of data. The ratio of belly fat to butt fat decreases with these drugs--but only because these drugs pack so much more new weight on the butt!

Meanwhile, with none of their supposed benefits proven--the ones that motivated doctors to put so many people on these expensive drugs--the heart and bone problems of these drugs have become apparent.

If your doctor assures you Actos is safe, remind him or her that it causes the same increase in heart failure as Avandia and causes the same bone thinning. Remind him or her that the only reason we don't have as much data pointing to the dangers of Actos the way we do about Avandia is that it never has had the market penetration or scrutiny that Avandia had.

Will we ever know the truth?
It's very unlikely Takeda will be funding any large scale controlled studies investigating the safety of Actos. Why kill the goose laying the platinum eggs? No one else has the kind of money it takes to fund the kinds of studies that will discover the long-term health damage Actos causes. And even if they do, do you really want to take this drug for the 10-12 years it would take for the real cost of using it to be proven beyond doubt--years during which your bones erode, new fat cells accumulate, fluid build up and stresses you heart, and who knows what is happening to other parts of your body that use this same PPAR-gamma receptor?

Let's Get Back to Basics
The reason we lower our blood sugars is to maintain our health. Any drug that improves blood sugar by increasing mortality is a bad drug. Any drug that improves blood sugar by causing osteoporosis--a major killer of older women--is not a good drug.

And the really sad part is that neither Avandia OR Actos lower blood sugar all that much. The typical A1c drop people see when taking this drug is around 1%--but that is when their A1c starts out at 9% or 10%. And the price people pay for this very small decrease in A1c is to pack on weight--in the form of new fat cells--that does NOT go away even if they stop taking the drug.

It is all so unnecessary! I get mail all the time from people who have brought their A1cs down from as high as 16% to the 5% range simply by cutting down their carbs to where they no longer are spiking over 140 after a meal.

This strategy has no dangerous side effects, and the only people who will tell you that cutting carbs is dangerous are those who are ignorant of the findings of current medical research.

As long as you eat enough protein, your body can manufacture every one of the grams of glucose your brain needs. Any dietitian who does not know this is ignorant and dangerous. Lowering your carbohydrate intake to where your blood sugar is normal or near normal will also improve your lipids. And low carb diets will not damage your kidneys unless, perhaps, you have end stage renal disease. Again, anyone who tells you differently is merely repeating old wives tales and is not familiar with what science has found.

The key to safety with low carb dieting is that you have to cut your carbs low enough to keep your blood sugars in the normal zone--under 140 mg/dl. Do that, and you will see dramatic improvements in your A1c--improvements much better than what you can get with either Actos or Avandia.

And if you do need a drug to lower your insulin resistance, Metformin has a much longer history of safe use and it is more effective than the TZDs.

If you can do it, regular exercise may also improve your insulin resistance better than TZDs.

There is simply no reason to take a drug that will erode your bones, strain your heart, and make you fatter, when there is a much safer way to control your blood sugars.

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