MRK and SGP: Ye shall know the truth, and the truth shall send thy stock spiralling

Apparently, the editors of the NEJM read my blog (even though they stop short of calling for a BOYCOTT):

"...it seems prudent to encourage patients whose LDL cholesterol levels remain elevated despite treatment with an optimal dose of a statin to redouble their efforts at dietary control and regular exercise. Niacin, fibrates, and resins should be considered when diet, exercise, and a statin have failed to achieve the target, with ezetimibe reserved for patients who cannot tolerate these agents."

Sound familiar?

The full editorial can be seen here: http://content.nejm.org/cgi/content/full/NEJMe0801842
along with a number of other early-release articles on the subject.

The ENHANCE data are also published online (http://content.nejm.org/cgi/content/full/NEJMoa0800742
and there's really nothing new to report. We have known the results for several months now. What is new is doctors' nascent realization that they have been misled and bamboozled by the drug reps, Big Pharma, and their own long-standing, almost religious faith in surrogate endpoints (see post below). It's like you have to go through the stages of grief (Kubler-Ross) before you give up on your long-cherished notions of reality (denial, anger, bargaining, then, finally, acceptance). Amazingly, the ACC, whose statement just months ago appeared to be intended to allay patients' and doctors' concerns about Zetia, has done a apparent 180 on the drug: "Go back to Statins" is now their sanctimonious advice: http://acc08.acc.org/SSN/Documents/ACC%20D3LR.pdf

I was briefly at the ACC meeting yesterday (although I did not pay the $900 fee to attend the sessions). The Big Pharma marketing presence was nauseating. A Lipitor-emblazoned bag was given to each attendee. A Lipitor laynard was used to hold your $900 ID badge. Busses throughout the city were emblazoned with Vytorin and Lipitor advertisements among others. Banners covered numerous floors of the facades of city buildings. The "exhibition hall," a veritable orgy of marketing madness, was jam-packed with the most aesthetically pleasing and best-dressed salespersons with their catchy displays and gimmicks. (Did you know that abnormal "vascular reactivity" is a heretofore unknown "risk factor"? And that with a little $20,000 device that they can sell you (which you can probably bill for), you can detect said abnormal vascular reactivity.) The distinction between science, reality, and marketing is blurred imperceptibly if it exists at all. Physicians from all over the world greedily scramble for free pens, bags, and umbrellas (as if they cannot afford such trinkets on their own - or was it the $900 entrance fee that squeezed their pocketbooks?) They can be seen throughout the convention center with armloads of Big Pharma propaganda packages: flashlights, laser pointers, free orange juice and the like.

I just wonder: How much money does the ACC receive from these companies (for this Big Pharma Bonanza and for other "activities")? If my guess is in the right ballpark, I don't have to wonder why the ACC hedged in its statement when the ENHANCE data were released in January. I think I might have an idea.

Thalidomide, Phocomelia, and Lessons from History

In tracing the history of evidence-based medicine tonight (for a lecture I have to give on Friday), a found the story of thalidomide on wikipedia (http://en.wikipedia.org/wiki/Thalidomide ).

(While I recognize that the information provided on this site is uncorroborated, I also recognize that it has been referenced by Federal Distric Courts in various decisions - see http://www.nytimes.com/2007/01/29/technology/29wikipedia.html?ex=1186545600&en=4e6683fb4fac3044&ei=5070 - so I consider it possibility generating rather than evidence corroborating.)

This story is a tragic one of a company with a product to sell (a "treatment looking for an indication" - hmmm...) and its unscrupulous marketing of this product in the absence of evidence of both safety and efficacy.

The story of Thalidomide should serve as a stark and poignant reminder of the potential harmful effects of a marketing campaign, impelled by profiteering, gone awry.