Harvard Study Questioning Cholesterol Drugs in Low-Risk Cases Survives Oxford Challenge

The verdict is in on a bruising spat between big-name researchers at Harvard University and the University of Oxford over a paper questioning the value of prescribing cholesterol-lowering drugs to people at low risk of heart disease.

The decision goes to Harvard—and that’s not great news for pharmaceutical companies that make the medications.

The dispute began last October, when Harvard Medical School lecturer John Abramson and colleagues from California and Canada published an analysis in the BMJ—formerly known as the British Medical Journal—concluding that the multibillion dollar class of cholesterol-lowering statin drugs conveys no overall health benefit in low-risk cases. The drugs include best sellers such as AstraZeneca’s Crestor and Pfizer’s Lipitor.

The paper was a direct shot at the Oxford-based Cholesterol Treatment Trialists’ Collaboration, known as CTT, which in 2012 published its findings that statins significantly reduced the risk of death among members of the same low-risk group. Abramson’s paper was based on the data published by the CTT group.

Rory Collins, an Oxford professor of medicine who heads the CTT collaboration, found a mistake in Abramson’s analysis that overstated the side-effect risk of statins. He was right and a correction was published in May. But Collins demanded that the entire paper be retracted.

Abramson acknowledged the error in the side-effect rate but insisted his paper’s main point—that statins do not reduce the risk of overall mortality for people with less than a 20 percent risk of cardiovascular disease over the next decade—remained accurate.

A panel of experts appointed by BMJ Editor in Chief Fiona Godlee agreed with Abramson in a report (PDF) released on Friday.

The panel—headed by Iona Heath, a past president of the Royal College of General Practitioners—said it was unanimous in its decision that the Abramson paper should not be retracted. It concluded “that the calculations in the paper had been largely sound” and that the error regarding side-effect rates was “insufficient to justify retraction of the whole article.” Nothing in the paper suggested “that the authors had acted malevolently or fraudulently,” the panel concluded.

The debate over who should get statins comes as sales of the drugs declined 11 percent last year, to $29 billion. Expanding the use of the drugs to healthier patients would be one way to offset declining sales.

Attempts to contact Collins for comment were unsuccessful. The panel report reveals just how upset the Oxford researcher was by the Abramson paper. In a letter to Godlee, he said a retraction was necessary “to rectify the harm that has been caused—perhaps resulting in large numbers of unnecessary deaths, heart attacks and strokes among patients at elevated risk—by misleading doctors and the public with gross over-estimates of the rates of side-effects with statins.”

For his part, Abramson on Friday called on the CTT group led by Collins to make its raw data—assembled from industry-sponsored clinical trials—available to outside researchers. It was a call echoed by the panel, which said “current debates on the appropriate use of statins would be elevated and usefully informed by making available the individual patient-level data that underpin the relevant studies.”

    Before it's here, it's on the Bloomberg Terminal.