One of my blogs last week focused on new cholesterol management guidelines issued jointly by the American Heart Association and the American College of Cardiology. These new recommendations essentially lowered the threshold for treatment, and mean that many more individuals are now suddenly eligible for treatment with statins. This move seems out of step with increasing evidence that statins are highly unlikely to benefit the vast majority of people who take them (particularly those at low risk of cardiovascular disease). We should not forget, either, the fact that they can cause serious side effects in about 20 per cent of people.
This week, the British Medical Journal carries an editorial that raises the issue of transparency in the setting of cholesterol and other guidelines . Written by Edward Davies, the BMJ’s US news and features editor, the editorial tells us that the new guidelines “have been subject to fierce criticism since their release”.
At least some of the criticism has come about as a result of the conflicts of interest that are known to exist in some of the committee members responsible for drawing up the guidelines. It turns out that 8 of the 15 committee members had ties to the pharmaceutical industry that might have compromised them in some way. The author of the editorial asks, “Can we no longer find 15 experts in the entire United States without financial links to industry?”
It’s a good question, I think, and one that demands an answer. I’m wondering if the pharmaceutical industry so ‘stitched up’ academics, the medical profession and ‘key opinion leaders’ that hardly anyone without conflicts of interest is left? I suspect not. More likely, I reckon, there are mechanisms in place to ensure those who are warm to the industry and its objective are ‘chosen’ to be on panels where they can have their say and exert their influence.
The conflicts of interest issue was the focus of another recent piece in the BMJ . It contains the opinions of David Newman, a physician researcher at the Icahn School of Medicine at Mount Sinai in New York City. In the piece, he expresses concern regarding the conflicts of interest and is also critical of the way the panel presented their case. He is quoted as saying:
Relative risk reductions are meaningless to patients. Even 16 year old girls will see a reduction in heart attacks, but they virtually never have heart attacks to begin with. And the problem is compounded by the committee’s failure to offset those putative benefits with the harms of testing and treatment.
Newman goes on to say:
We need to tell patients the actual numbers. For patients without diabetes or a prior heart attack or stroke who are treated with statins for five years, 98% will see no benefit; 1.6% will be spared a heart attack and 0.4% a stroke—and importantly, there will be no difference in overall mortality. At the same time, 2% of individuals treated with statins will develop diabetes and 10% will have muscle damage.
We need to be honest and tell patients all of this and let them decide if the benefits outweigh the harms for them.
Now, that’s the sort of transparency I like.
1. Davies E. Cardiovascular risk guidelines and transparency. BMJ 2013;347:f7022
2. Lenzer J. Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers BMJ 2013;347:f6989