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November 18, 2013

Another Potential Boondoggle for "Big Pharma"?

By Dave Lefcourt

This week a controversy has developed over a new set of guidelines published by the Amer.Heart Ass'n & College of Cardiology for lowering cholesterol along w/a calculator meant to assess risks. Two Harvard Med.Sch.Profs took issue w/the report w/ their data showing the calculator over predicting risk by 75 to 150% saying overestimation of risk will lead to considerable overprescription, (a potential boondoggle for Big Pharma).


From http://www.flickr.com/photos/9106303@N05/2257853913/: Tales of Big Pharma Horror
Tales of Big Pharma Horror
(Image by Mike Licht, NotionsCapital.com)
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Caricature of "Big Pharma" Doctor mixing a compound with Death whispering in his ear

Over the past several days a huge controversy has developed over a new set of "guidelines"   for lowering of cholesterol along with a "calculator" meant "to help doctors to assess risks" [1] in their patients need to take statin drugs i.e. Lipitor, Crestor et al.

The "guidelines" and "calculator" were developed and their findings published by the American Heart Association and the American College of Cardiology last week.

It appears two Harvard Medical School professors, Dr. Paul M. Ridker and Dr. Nancy Cook took issue with the published report having pointed out problems they saw a year earlier that the "calculator" sent to them to review "was not working among populations it was tested on by the guideline makers".

Apparently the earlier problems discovered by the two Harvard professors were never passed on to the researchers working up the "guidelines".

So when Ridker and Cook saw the final "guidelines" and "calculator" in final form last week they realized the problems they found earlier remained.  

On Saturday at the annual meeting of the AHA during a closed door session with its members as well as the college of cardiology, Ridker "showed them his data and pointed out the problem".

Incredibly his data showed their published report had the "calculator" over-predicting risk by 75 to 150 percent.

In a separate report of their own to be published tomorrow Ridker and Cook write in the "Lancet", a major medical journal, "Miscalibration to this extent should be reconciled and addressed before these predictive models are widely implemented. If real, such systemic overestimation of risk will lead to considerable overprescription".

Ah yes, "overprescription" as that is the operative word here whereby those who don't need the drug and not at risk are prescribed it anyway.

Could this "overprescription" for millions of people be a boondoggle for the big pharmaceutical companies particularly if the "guidelines" and "risk calculator" findings by the AHA and college of cardiology remain essentially unchanged or modified only slightly with millions of those who don't need the drug and not at risk are prescribed it anyway?

It's hard to know exactly the connections between medical doctors, their professional organizations, the government and the huge pharmaceutical drug manufacturers. Do practicing physicians sit on the boards of big Pharma? Should we expect collusion or are these suspicions unfounded?

If we look at the "Affordable Care Act", aka "Obamacare" it should not be lost on anyone that with no single payer, Medicare type health system other than for seniors over 65, the private health care industry stand to increase their profits in the hundreds of billions once the snags and snafus of Obamacare's first month and a half of operation are smoothed out.

  So increasing the population of those "supposedly" needing statins because they fall within the "guidelines" and a "calculator" of suspect, flawed findings as they greatly overestimate risk, will still be a boon for the big Pharma crowd.

As we know, the cost of prescription drugs in the U.S. is substantially higher than in Canada and Europe.      

  So it seems natural to be skeptical when there's a cloud over a prescription drug issue in America as there would be over any substantive issue or problem in the country. And whether its prescription drugs or illicit drugs or any of the other myriad issues we have, there is always the need when looking critically at the issue or problem and that's "follow the money".

It's unfortunate everything of consequence in America needs to be seen in that light but that's the reality so a healthy dose of skepticism is warranted whenever high level pronouncements are made.

Let's hope Ridker and Cook's exposing the flaws in the findings of the American Heart Association and American College of Cardiology will be accepted and millions of people will be exempted as not being at risk and the big drug outfits will have less oodles of $ in their Christmas stockings.  

[1] "Risk Calculator for Cholesterol Appears Flawed", by Gina Kolata, "The New York Times", November 17, 2013.

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