May 22, 2007

Countering Big Pharma Lies about Avandia

A reader protests that the TZD drugs, though they do cause people with diabetes to gain weight, redistribute the weight away from the abdominal area, where it is associated with insulin resistance, to other places on the body.

Well, this was part of the drug company hype used to promote the drug. They couldn't get away from the fact that this drug for a disease that is worsened by obesity increased obesity, so they came up with the idea that it created "good obesity."

Nonsense.

Here's the study, conducted by researchers from the Mayo Clinic, that showed that Actos (very closely related to Avandia) does not change the amount of visceral fat or redistribute fat the way the drug companies claim. The drug changes the waist hip ratio (the basis of that claim) by enlarging the hips by growing new fat cells.

http://care.diabetesjournals.org/cgi/reprint/26/11/3148
Effects of Pioglitazone Versus Diet and Exercise on Metabolic Health and Fat Distribution in Upper Body Obesity. Samyah Shadid, MD and Michael D. Jensen, MD (Mayo Clinic). Diabetes Care 26:3148-3152, 2003

And there is more troubling data about where those new fat cells are coming from. It turns out that in response to TZD drugs, the precursor cells that are supposed to be turning into bone are, instead, turning into baby fat cells. This is not new news, but it isn't something the drug company PR machine has let you know about. Here's a study that explains how Avandia does this. It is one of several studies linking TZD drugs with osteoporosis, especially in the older women most at risk for it.

Rosiglitazone impacts negatively on bone by promoting osteoblast/osteocyte apoptosis.
Soroceanu MA,Miao D,Mai XY, Su H,Goltzman D, Karaplis AC. J Endocrinol. 2004 Oct;183(1):203-16.


The reaction to yesterday's news was swift and predictable. The ADA and the American Heart Association (both heavily funded by Big Pharma) told patients to keep taking the drug while muttering about further studies being needed. The most recent news wire report says that Glaxo's own studies showed a 30% rise in heart attack risk. Months ago.

Reuters Story:Glaxo's own meta-analysis also showed Avandia risk

Why is the ADA telling patients to keep taking this drug? Am I the only one who sees irony in the way that ADA and AHA tell patients to take expensive Statin drugs for which the research, despite decades of searching, does not show clear evidence that they decrease heart attack risk in people who have not already had a heart attack, yet they tell patients to keep taking Avandia now that there is a lot of research suggesting that Avandia does raise the risk of heart attack and heart attack death risk significantly?

A drug that makes obese people fatter, increases the risk of heart attack, increases the risk of heart failure, increases the incidence of osteoporosis and bone fractures in women, and increases the risk of a blinding condition is NOT a drug anyone should be taking.

And yes, these drugs do lower blood sugar slightly (A1cs come down around 1%) but the point of lowering blood sugar is to decrease the incidence of complications, the most significant of which, for people with diabetes is heart disease.

Big Pharma's claim, "We have to give people a drug that gives them heart attacks to save them from heart attacks," is right up there with the Vietnam claim, "We had to destroy the village to save it."


4 comments:

Scott said...

I think even more telling was the sharply worded editorial in the New England Journal of Medicine accompanying Dr. Nissen's study which said "regulatory action by the FDA is now warranted." The editorial questioned the measure of effectiveness the FDA typically uses to approve diabetes drugs, which mostly examines how well the drugs reduce blood sugar, which is supposed to be a surrogate for improving more important outcomes, like heart disease. Although the FDA said yesterday that it has strong evidence to suggest that reducing blood sugar translates into real-world benefit for patients, an increasing number of doctors are starting to question whether A1C should be the sole outcome, or whether factors such as glycemic variability, body mass, patient compliance and perceived quality of life, etc. should receive the same attention from regulators at the FDA.

We should remember that the FDA has often not approved medicines because they believed the A1C was not reduced by a significant enough margin. Case in point: pramlintide (Symlin) which is a synthetic version of the human hormone amylin completely lacking in all T1DM patients, and many with T2DM. In his letter to the FDAS on the new drug application for Symlin, Dr. Steve Edelman noted that the agency had a rather narrow paradigm by which they evaluate a patient's clinical needs, but A1C alone is only 1 piece of the equation.

Rob said...

Jenny - reading the literature, your and other blogs I am coming to the opinion that insulin is the safest and most effective drug for people with impaired glucose function. I would use two fractional doses of long lasting at bed time and arising. Am I missing something in comeing to this conclusion? This would also allow a small increase in carbs which would make eating, cooking, and nutrition easier.

Jenny said...

Rob,

Metformin is a good, safe drug with decades of history behind it since it was used in Europe long before it was approved here. Precose is another underutilized drug.

The catch with insulin is that if you are insulin resistant, as many type 2s are, you will need a lot of it, perhaps too much for safety since it is also a growth hormone.

So you do want to do what you can to lower insulin resistance before you turn to insulin.

You can do this in many cases by cutting way back on carbs, exercising, and losing weight. Losing weight is a lot easier after you lose the carbs. If that doesn't do it, then adding metformin to lower the IR makes sense.

If after all that, you still need help, insulin would be the next step.

I personally believe that meal time insulin might be better than Lantus for a lot of people, because it is the meal time spikes spikes, not the fasting bg, that is the problem for so many of us.

But it takes intelligence to use meal time insulin and if you really get it wrong you can end up in the ER. So it is very tough to find a doctor who will support you in this approach.

Lili said...

Wow, I thought I was the only one. I was only on Actos for 3.5 weeks, but I put on 10 lbs of fat! I've always been underweight (hence why I was initially diagnosed with Type 2, right) and while my weight would fluctuate sometimes, I never gained like that. I also got fat in whole new areas! I've been trying to lose that weight for over a year now and nothing will touch it!