New Study Challenges NIH on Cholesterol

Independent researchers sponsored by the Veterans Administration have called into question the National Institute of Health’s 2004 update of the national cholesterol guidelines. I wrote about this issue extensively during 2004 after the guidelines came out
(click here, for instance), in part because I was part of a group of over 30 physicians and researchers demanding that NIH create an independent panel to re-review the evidence. Eight of the nine authors of the 2004 guidelines had financial ties to statin manufacturers.

To quickly recap, those guidelines called for aggressive use of statin drugs, which lower cholesterol, in people who are at risk of having a heart attack or stroke. For people who had already suffered an attack, the guidelines called for getting the "bad" cholesterol as low as 70. That would take a lot of statins.

We were, of course, ignored. But in a review published in this October’s Annals of Internal Medicine, University of Michigan researcher Rodney A. Hayward and two colleagues, who reported no ties to industry, said the “current clinical evidence does not support” the idea that aggressive statin therapy to achieve very low cholesterol levels in people at risk of heart attacks and strokes “is beneficial or safe.”

Today's New York Times reported on the Hayward review, and I thank them for that. But reporter Roni Rabin countered Hayward’s review with a quote from Sidney C. Smith Jr., a University of North Carolina professor and former president of the American Heart Association. In giving Smith’s credentials, the Times failed to note that Smith received “institutional research support” from Merck, a manufacturer of statin drugs, while he was contributing to the guidelines.

Of course, the point isn't to go nana-nana-boo-boo over who's getting money from whom. As this latest review points out, NIH wrote guidelines for which their is no clinical evidence proving there will be a benefit. It also points out that there is no clinical evidence proving that people can safely take the level of statin drugs needed to reach very low levels of cholesterol.

That's worrisome. NIH needs to retract the guidelines, and immediately sponsor a clinical trial that tests both propositions: Does reducing cholesterol levels down to very low levels improve outcomes for people at risk of heart disease? And can the level of statin drugs needed to get there be taken safely?

You'd think a taxpayer-supported institution would demand answers to those questions before endorsing guidelines written by researchers with extensive ties to the companies that sell cholesterol-lowering drugs.