Feature Competing Interests

An endorsement of PCSK9 inhibitors funded by … their manufacturers

BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j712 (Published 13 February 2017) Cite this as: BMJ 2017;356:j712
  1. Nigel Hawkes, journalist, London, UK
  1. nigel.hawkes1{at}btinternet.com

How objective were consensus panel recommendations for use of expensive PCKS9 inhibitors in patients who experience side effects with statins? Nigel Hawkes reports on industry links

When cheap and effective drugs are available, who needs expensive and unproved ones? That’s the problem faced by the manufacturers of the heavily promoted PCSK9 inhibitors, which aim to do better than statins in reducing cardiovascular mortality, but at roughly 300 times the cost.

One strategy has been to play up the side effects of statins. Although the clinical trials show serious adverse events to be uncommon, many statin users complain of muscle pains. If doctors and healthcare systems can be convinced that these patients are “statin intolerant” and should be treated instead with PCSK9 (proprotein convertase-subtilisin/kexin type 9) inhibitors, the market would be increased.

So Amgen, Eli Lilley, Pfizer, and Sanofi-Regeneron—four companies that have invested in PCSK9 inhibitors—must have been pleased by the conclusions of a consensus panel set up by the European Atherosclerosis Society (EAS)1 to offer guidance on the best way to treat patients who experience muscle symptoms with statins. The EAS says that the panel comprises leading internationally recognised scientists and clinicians and the conclusions reached are based on “exhaustive systematic literature review and expert discussion.”

The panel’s conclusions, published in February 2015 in the European Heart Journal, say that patients experiencing statin associated muscle symptoms (SAMS) with three or more statins should be considered for specialist referral. “By recognising SAMS and adhering to a structured work-up, the panel anticipates that individuals with clinically-relevant SAMS will be offered alternative and/or novel therapeutic regimens that can satisfactorily address their cardiovascular risk,” it concluded.1

Industry links

The panel, whose conclusions have been widely read, was supported by grants from the four companies plus Astra Zeneca, Esperion, …

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