Friday, January 25, 2008

A Hidden Infomercial for Avandia and Zyprexa?

For a little sleight-of-hand drug marketing, see this opinion column (which I am grateful to fellow blogger Roy Poses for calling to my attention):

On its face, it seems pretty benign. That is, it bashes greedy lawyers, and so who can object to that? The claim is that beware the Internet, since you might go on line looking for serious medical information about drugs and diseases, and you may be seduced into believing junk that is actually posted by trial lawyers trolling for clients for class-action suits against big drug companies. Indeed, say the writers, the danger is that these junk websites will kill people by scaring them from taking life-saving pills that they really need.

Now, what is an example of this so-called junk information? Well, two drugs are mentioned by name, Avandia and Zyprexa. Both are portrayed as having bewen slammed by allegations based on dubious research methods, as really great drugs that have been unfairly tarred.

What are the facts? Avandia is said in the article to be thoroughly proven to be effective in treating diabetes, but only alleged to cause excess heart risks. That's a lot of a stretch. Avandia lowers blood sugar. But there is a lot more to treating diabetes effectively than lowering blood sugar--as much as the industry would like to sell us surrogate markers that in turn help them sell drugs. The real question is: does Avandia lower the risk of the serious complications of Type II diabetes, such as heart disease? The fact is, first, that Avandia has never been shown to be effective in this long term way; and second, that controlling blood sugar, per se, has been proven to be ineffective in reducing one's risks of almost all serious diabetic complications. So, if there is hardly any proof that Avandia is effective in lowering risk of diabetic complications, and now there is a suggestion that it might actually increase risk, and also just happens to be extremely expensive, why the heck would anyone take it? (Of course there are exceptional cases where it may in fact be an excellent drug, all things considered, which is why doctors were invented, and of course you should listen to yours.)

Zyprexa was heavily marketed for many years as the new generation antipsychotic. It was supposed to have two big advantages over the old-fashioned anti-psychotics. First, it was said to work much better. Second, it was said to avoid the horrible side effects of the older drugs, most commonly, the Parkinson's-like symptoms in the syndrome called tardive dyskinesia. It took a long time for the real scientific data to make its appearance through all the fog of company marketing; but it then developed that both of these claims were false. The new generation drugs work about as well as the old. The new drugs do cause some cases of tardive dyskinesia. But even worse, the new drugs cause you to blow up like a blimp with weight gain, causing very serious health problems especially in older patioents. (Many gain so much they become diabetic. But of course, not to worry in that case; you can just start taking Avandia.) There's worrisome evidence that the companies tried to suppress the bad news about Zyprexa and its cousins, just as we now know that the companies sat on the bad news about ezitimibe (Zetia, Vytorin) for lowering cholesterol.

Where did this report come from, on which the pro-drug op-ed is based? It's from Center for Medicine in the Public Interest: That organization is sort of a branch of a PR firm that handles numerous drug-company accounts, and says in its mission statement that it seeks to promote the positives of medical technological innovation. One of the positives of technological innovation in medicine is that it may or may not make patients better; but it sure as heck improves the bottom line of the company that can successfully market it to us.

(Now, just to provide a bit of balance here, I went on the CMPI website and I did see a couple of news items that were unfriendly to drug company interests. One reinforced the recent FDA advice not to buy over-the-counter cold preparations for little kids. The other admitted that drug company marketing had gotten a bit of a black eye over the way that Zetia and Vytorin were shilled.)


james gaulte said...

Dr. Brody

I must not understand what you meant by the following"that controlling blood sugar, per se, has been proven to be ineffective in reducing one's risks of almost all serious diabetic complications".
Did the DIPP trial not demonstrate that the major microvascular complications of type 1 diabetes were reduced significantly by tight blood sugar control? I realize that you were discussing type 2 diabetes but even so I am not sure what data proves controlling blood sugar to be ineffective which is a much stronger statement than saying it has not been proven it to be effective.

Howard Brody said...

Dr. Gaulte: I am here relying on the UKPDS study which followed a large group of type II diabetics for roughly 10 years. The study found, after correcting for a variety of problems that I cannot go into here, that tight control of blood sugar did not lead to a reduction in any of the macrovascular complications of diabetes (heart attack, stroke, amputations). They were, after a lot of huffing and puffing, able to find some subtle retinal changes that were reduced in the tight control group, but it was not clear that these changes were even clinically meaningful. By contrast, controlling blood pressure led to a huge reduction in diabetic macrovascular complications, and the drug metformin also led to a major improvement in mortality and morbidity (apparently for reasons aside from its blood-sugar-lowering effect).

james gaulte said...

I guess my point is that with the type 1 diabetics in DIPP, things were simpler and one could look more directly at the effect of blood sugar control on small vessel related disease and there definitely seemed to be a beneficial effect.Things are so much more complicated with type 2 diabetes in the UKPDS study that it is very hard or impossible to tease out what exactly brought about what beneficial effect if any.They are really in many ways two different diseases. Thanks for your thoughts.
James Gaulte

Howard Brody said...

Dr. Gaulte: You have hit the nail on the head; Type I and Type II diabetes do indeed seem almost to be different diseases. I do not dispute at all that it has been shown that tight glucose control in Type I diabetes is a very high priority and produces excellent health outcomes. Thanks, Howard