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 [1]. 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 [2]. 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.
References:
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
“We should not forget, either, the fact that they can cause serious side effects in about 20 per cent of people.”
We should not overlook that stains result in effects in all that take them. They do not just interfere with the synthesis of cholesterol, but constrain production of other vital biochems that are down-stream products that mevalonic acid is supposed to result in.
The side effects blight 100% of people, physiologically speaking, the discrepancy between 100% and 20% is accounted for by whether the effects manifest themselves in detectable symptoms the patient can describe to the physician.
I remember for a good while my father wanted to take a statin. It wasn’t due to lowering cholesterol. His desire to take them was due to the reported help given for preventing Alzheimer’s disease. We don’t hear much about that much any longer. And if anything seems more has come out on a possible side effect of statins being memory loss. Believe The Space Doc even wrote a book on that issue, with his struggles along with others loosing their memory.
The doctor at the time turned my father down for the statin. Said he didn’t believe it would be helpful. This was years ago when it happened, and recall at the time we were all surprised at the response. It was a new doctor, and thought dad would get what was wanted. I remember dad wasn’t happy about what he was told, but in hindsight was a good move.
Saw in the news today that a new found benefit for statins has been discovered. This time they fight cancer, or at least it is the latest and greatest benefit being touted. Time will tell.
“High cholesterol fuels the growth and spread of breast cancer”
http://medicalxpress.com/news/2013-11-high-cholesterol-fuels-growth-breast.html
The side effects blight 100% of people, physiologically speaking, the discrepancy between 100% and 20% is accounted for by whether the effects manifest themselves in detectable symptoms the patient can describe to the physician.
And even if they do describe those symptoms, the reply the physician may well give is:
a) It’s nothing to do with the statins.
b) It’s just your age, what do you expect?
c) Statins are wonder drugs.
d) All of the above.
Thank you for posting the straightforward comments of David Newman. Too often, when speaking of statins’ “benefits,” we are told very generally that “people with heart disease” will benefit but the statistic–showing a very small actual benefit for a very specific population–is not quoted.
I’ve just read the article about cholesterol by Natasha Campbell-McBride MD by following the link on your post and just wanted to thank you for it. It’s a great article, readily accessible by anyone not trained in med/science. It’s answered questions that have puzzled me, such as the link between diabetes and cholesterol levels. Now I understand that the problem is NOT high cholesterol as such but that it indicates that damage is being done by elevated blood glucose and resulting inflammation.
I left off my statin almost a year ago and adopted a low carb (50 grs per day) high sat. fat diet. Since then, I have lost weight, my HbA1c has dropped dramatically to ‘normal’ levels, I am no longer depressed, my thinning hair has grown back and I feel 100% BETTER perhaps because I now get a proper night’s sleep because I’m not having to leap out of bed 6 times a night with excruciating muscle cramps in feet and legs.
This article has lifted the slight anxiety I felt about my cholesterol level (risen from 4.6, probably too low, to 6.2, though the breakdown figures seem okay), by emphasising the IMPORTANCE of controlling my blood glucose levels now that I understand the “whys and wherefores”. I have felt a fair bit of pressure to continue the statin from my doctor and diabetic nurse, culminating in the scary question “so you are REFUSING the statin?” before it was deleted from my treatment plan.
One thing the article didn’t mention is the importance of Co-enzyme Q10 which I began to take shortly after beginning statins 12 years or more ago. Quite by chance I read an article by you, Dr. John, in the Observer about the importance of supplementing with Q10 owing to the risk of muscle weakness. Well, I’m a tennis player and shortly after starting the statin my grip was such that the racket would spin in my hand on contact with the ball. In addition, my heart beat, heard through my pillow at night, instead of the nice steady “lib dub” had become “Schlerp scherlp.” The Q10 corrected both of these problems.
Why don’t doctors tell patients about the importance of supplementing with Q10? I suppose it might introduce another layer of (expensive) prescribing.
Thank you so much, Dr. John, for all your interesting and illuminating posts. They have become a bit of a highlight of my week.