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.

8 comments:

Big Dave T said...

Dang. Actos is what I'm on too. I hate diabetes.

So a low carb diet is better then. Yeah, but are you advocating then a high protein diet? That's pretty controversial too.

I think I'm just going to stop eating altogether.

Jenny said...

Most low carb diets are not "high protein." If you eat a hamburger bun, and fries, and I eat a hamburger patty, no bun, no fries and a salad, the percentage of protein in my meal is much higher than in yours, but the actual amount of protein we eat is the same.

The low fat diet has been completely discredited by a lot of exhaustive and very expensive research. Some people in the medical community and many dietitians still cling to the belief that some research, somewhere might prove it healthy, but that is because the alternative is to admit that they've been giving people diets for decades that raise their blood sugar, worsen their lipids, and lead to diabetic complications.

Read Dr. Bernstein's book, Dr. Bernstein's Diabetes Solution (3rd edition). Read Protein Power. Read Gretchen Becker's The First Year Type 2 Diabetes.

The less carbs you eat, the safer it is to eat nonhydrogenated fats, including saturated fats. Most of the research about fats in the past did not distinguish between hydrogenated fats which do clog arteries and healthy sat fats that do not.

Anonymous said...

"As long as you eat enough protein, your body can manufacture every one of the grams of glucose your brain needs."

Does this mean that insulin-dependant diabetics can avoid hypo-induced unconsciousness by ingesting enough proteins, and skipping the carbs?

Jenny said...

Glenn,

If a person is dependent on insulin because their beta cells have been destoyed, they still need some insulin to be able to use any glucose.

However, people who use insulin can cut down significantly on the amount of insulin they use by limiting their carbohydrate intake.
Doing that safely means you need to understand how to match insulin dose to the amount of carbs in a meal. If you are just taking a dose because the doctor gave it to you and cut back on your carbs without modifying your insulin doses, you can cause hypos.

The book Dr. Bernstein's Diabetes Solution discusses this. Another book that talks about adjusting insulin doses is "Think Like a Pancreas."

The more educated you are about how your own blood sugar works, and the more control you take over your own treatment, the better control you can get. Busy doctors simply don't have the time to do the tweaking and twiddling it takes to get insulin doses and carb inputs right.

Anonymous said...

Low carb living is the only way to live a healthy diabetic life.

I was diagnosed a Type 2 diabetic in September,2006. I immediately adopted a low-carb eating plan. I was put on Avandamet and dropped my A1c from 14 (yes... 14!!) to 7 in a few months. When I finally was able to get an appointment with an endo he said whatever I was doing, continue the program because the Avandamet could not have brought my A1c down to that level.

I continued the low carb way of life and tried the "good patient" route, trying max doses of Metformin, Avandamet and eventually Byetta over the last year. Nothing worked! I refused to take any Avandamet after the May report surfaced, but had to fight with my doctor to try Metformin instead.

Finally, thanks to Dr. Bernstein's book and Jenny's blog, I knew to ask for 2 tests. cPeptide and GAD antibodies. It took months to convince my doctors to order tests. It was obvious they didn't believe their diagnosis or treatment could be wrong. They also didn't believe me about my carb intake and diligent efforts to control this insideous disease.

Well, surprise. I'm now officially a Type 1 and have started insulin.For the first time in over a year, my fasting BG is in the 80's and I stay below 140 all day. My goal now is to be in the 5% club! Now that I don't have to use my energies fighting the very doctors that are supposed to help me, I can concentrate on wellness.

To prevent hypos, it is more important than ever to control carbs. It is insane to eat as you choose and then cover the high carbs with insulin. That's inviting dangerous hypos into your life and a roller coaster of blood sugar readings.

Keep up the good fight Jenny. The diabetes community needs your continued input to buck conventional wisdom and the ADA.

Thank you.

Jenny said...

Lynn,

I am SO happy that I was able to help you get the right diagnosis that will help you get back into great control.

I don't know WHY it is that so many supposed experts--endos--are so woefully uninformed about the forms of diabetes that afflict non-obese adults.

The Diabetes community MUST rouse itself to action and take back control of our treatment from the ADA and it's drug and junk food company masters.

I am mulling over producing some kind of Evidence Based Fact Sheet which we could all take to our doctors around the nation (and world).

judy said...

I am on Actos. I am living in Costa Rica and it is extremely expensive here as in the USA. After reading the article about the bad things it can cause, I will stop taking it. Do I need to cut down on it or can I just stop taking it.

Thanks, Judy

Jenny said...

Judy,

Speak to a registered pharmacist about that.

Has the drug lowered your blood sugar? If so you will need to think about how you are going to keep your blood sugars under control. Stopping the drug only to have your blood sugars go way up would not be healthy, either.

Are you taking any other drugs to lower your blood sugar, or cutting back on carbs? If you haven't tried the technique described HERE give it a try. If you can take metformin, it should be helpful in controlling insulin resistance and lowering blood sugar in a safe way.