Pharma’s Cutting Edge

See this article.  Scott Grundy, a cardiologist at the University of Texas Southwestern who helped write the U.S. cholesterol guidelines, argued that overall the results of the study do show that Tricor was a useful addition on top of current treatment….”What we’re seeing in a lot of clinical trials when we’re working with drugs that are what I might call incremental therapy,” says Grundy, “is the studies are not as robust as were the ones with the cholesterol-lowering, aspirin and blood-pressure lowering drugs.”

With due to respect to the venerable Dr. Grundy…duh. I’m sure he meant that the results are not as robust as the early studies of the drug classes he mentions. The studies themselves being run today are just fine, as I’m sure Dr. Grundy would attest (since he helped design and conduct many of them). In any case, it would have been nice had Dr. Grundy chosen to given the press a sound bite that stressed the difficulty of add-on therapies (of any type) improving the odds of having and surviving a heart attack, given the already dramatic improvements that pharmaceutical and medical device industry products have made to cardiovascular event occurrence and survival over the previous two decades. Yes, it would have been nice.

In any event, see my previous comments on the precarious position drug makers developing PPAR-alpha/gamma dual agonists face after the recent Pargluva non-approval. I’ll discuss second-generation PPAR-alpha agonists by Lilly and others in some future issue of Pharma’s Cutting Edge, once more clinical data are available.