At the end of the day I like to think most people in pharma sales truly believe in the value of their products. And judging by the enormous effect Lipitor has had over the past 13 years, it is hard to say the community as a whole would be better off if it never went to market.

This being said, I believe more open collaboration between the FDA and pharmaceutical companies is necessary. Off-label promotion is not acceptable, but in cases where risk is not elevated, Lipitor should be an acceptable treatment as long as limited efficacy is clearly stated (which the FDA should ensure).

I’d like to collaborate on that venture! But isn’t this what we should expect from NIH (not to mention all the public money funding academic research)?

Prospective studies are definitely preferred, but I there may be some retrospective (health claims administration) data which would be useful to validate certain hypotheses. Some countries with universal coverage and robust claims data (or the US VA system which has the advantage of including clinical outcomes measures/lab results) might be able to answer some of these questions tomorrow. Maybe some folks already know these answers, they just haven’t gotten around to telling us.

We probably need to find a way to pay for “scientific liaisons” to bring our findings to practicing clinicians also…

Obviously (in pediatrics) I don’t have any patients on a statin. However, through my managed care work (and prior PhRMA time) the statins and beta blockers which prove to be most interesting and beneficial are also those with antioxidant and other apparent effects at the tissue level. I wonder if it is a case of serendipity that these antioxidant compounds just happen to lower levels of things we can measure (LDL or BP - assumed to be “bad” by association). I wonder the same about the effects of ACE Inhibitors which almost certainly offer very interesting and helpful effects for blood vessels and cardiac tissue. Most things which ultimately prove to be good and useful in medicine are “happy accidents,” and not all turn out to work the way we think they do.

What I wonder, and what hasn’t been adequately answered in my mind is this: If you treated a patient consistently with an antioxidant statin at a dose which would not necessarily get them to “goal,” and they actually took the med at least 75-80% of the time, would they gain the same survival benefit/CV event avoidance as if they “got to goal?” If the answer is “yes” why not treated everyone with risk factors at a 20 to 40mg dose of simsvastatin. I’ll bet that if someone studied CRP(or other non-specific inflammatory marker) levels prior to and after simvastatin (or atorvastatin) treatment there would be comparable reductions as seen with rosuvastatin. With an answer to that question, would it really matter what Pfizer’s marketing campaigns did? Of course they sought off-label use. However, any CV med is not used (or promoted) off-label to the extent that mental health medications are.

I still think Linus Pauling had the right idea - It is oxidation which kills us. And we also already know “Rust Never Sleeps.”

Thanks for reminding me that I forgot my Vit D last week.

http://en.wikipedia.org/wiki/Atherosclerosis

Medical practice guidelines are, in effect, ghostwritten by pharma. They cannot be trusted. This places both patients and their physicians in a serious bind. The net effect of ghostwritten medical practice guidelines is direct injury to the public’s health and the federal healthcare fisc.

Perhaps a greater concern should be the myriad pleiotropic effects of the statins, e.g. their effect on Vitamin D3 and CoQ10 levels.