December 13th, 2013
Dispatch From the Wild Frontier of the Statin Wars
Larry Husten, PHD
The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC U.S. guidelines. But nowhere is the battle more intense right now than in Australia, where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks and strokes over the next five years.
The show was a two-part documentary (click here for part one and part two) broadcast in October on the Australian ABC network about dietary fat and cholesterol.
The program, wrote Amy Corderoy, the health editor of the Sydney Morning Herald, “claimed the causal link between saturated fat, cholesterol and heart disease was ‘the biggest myth in medical history’… [and described statins] as toxic and potentially deadly.”
Catalyst delved into a raging debate: has dietary guidance telling us to avoid fats pushed us towards more harmful sugar and carbohydrates instead?
But the program also went a step further, arguing cholesterol was just an innocent bystander in the body’s attempts to deal with the sugar-damage. It was not a big leap to claim statins were dangerous, and the research supporting them fraudulent.
…
Catalyst focused heavily on the opinions of U.S. experts – one of whom believes vaccines can cause autism and another who promotes chiropractic and chelation for heart problems – while downplaying the conclusions of other expert groups.”
The program contained numerous quotes from cardiologist Rita Redberg, who has been a leading critic of statin overuse, especially when used for primary prevention. Redberg made clear that statins may be valuable for some patients who already have heart disease. But her views were accompanied by “experts” who were much more removed from the mainstream, including lengthy appearances, with little or no counterbalance, from extreme cholesterol skeptics like Beatrice Golomb and Stephen Sinatra.
The show initially came in for criticism from the Australian National Heart Foundation. Now, the Heart Foundation reports that “an alarming number of people with high cholesterol have stopped or changed their cholesterol medication as a direct result of” the program. The Heart Foundation surveyed more than a thousand Australians receiving statins and recorded alarming findings:
- 22% stopped, stopped then restarted, or reduced their medications.
- 12% “started taking natural remedies.”
- 9% completely stopped taking their medication.
“…almost half of those who completely stopped their medications didn’t consult their GP,” said the CEO of the Heart Foundation. “What is most worrying is that of the people who have stopped taking their medication, one in four have previously had a heart event, such as a heart attack or stroke… It should be clear that statins are life saving for people who have already had a heart attack, and people should not go off their medication without seeing their GP.”
Extrapolating from the survey findings, the Heart Foundation calculated that as many as 55,000 Australians may “have stopped their medication as a direct result of the show.” Of these, about 40% had either had a heart attack, a stroke, established heart disease, or have multiple risk factors for heart disease.
The Heart Foundation said that the estimate of 2,000 or more additional heart attacks and strokes was “a very conservative estimate.”
Statins For Primary Prevention Get A Boost
On the heels of the news from Australia, a comprehensive review in JAMA lends strong support to the use of statins in primary prevention. The review by Fiona Taylor and colleagues concluded that
When used for primary prevention, statins are associated with lower rates of all-cause mortality, major vascular events, and revascularizations compared with placebo. Statin therapy is not associated with increased rates of life-threatening adverse effects such as cancer.”
Here are the relative risks, 95% confidence intervals, and the number need to treat for 5 years:
- All-cause mortality: RR 0.86, CI 0.79- 0.94, NNT 138
- Combined fatal and nonfatal CVD RR 0.75, CI 0.70-0.81, NNT 49
- Combined fatal and nonfatal coronary heart disease events: RR 0.73, CI 0.67-0.80, NNT 88
- Combined fatal and nonfatal stroke: RR 0.78, CI 0.68-0.89, NNT 155
In an accompanying editorial, Jennifer Robinson writes that “the accumulated evidence should convince those with a philosophical aversion to statin therapy for primary prevention to reconsider their stance.”
In a viewpoint published earlier this month in JAMA, John Ioannidis discussed the implications of the new guidelines and the expanded population now eligible for statins that “eventually would lead to massive use of statins at the population level; i.e., ‘statinization.’ It is uncertain whether this would be one of the greatest achievements or one of the worst disasters of medical history.”
Hat tip: Marilyn Mann
8 Responses to “Dispatch From the Wild Frontier of the Statin Wars”
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There are always people who will not let the facts alter their preconceived baseless ideas. Statins, like any drug has risks but so does driving your car. When used appropriately, both have enormous benefits.
Without getting into the nitty-gritty of the statin argument, I find Dr. Hyman’s comment very telling. As much as I agree with his general comment about the benefit of drugs “when used appropriately,” I have a problem with his “competing interests” statement in which he implies that his apparent good health is related to the fact that he takes rosuvastatin 4 days a week. Unless there are additional pertinent facts in his medical history that Dr Hyman has not revealed to us, this statement seems to be based on the same kind of “preconceived baseless ideas” that he criticizes in others.
And I wonder if Dr. Hyman’s “common sense” approach isn’t more indicative of how medicine is practiced in the “real world” than all the so-called “evidence based medicine” which for years has been based almost exclusively on meta-analyses of previously performed studies. I do not consider myself an expert in statistics, but I remember that back in the stone age when I attended medical school, one thing that was drummed into our heads was to beware of meta-analyses because (im)proper juggling of data could provide one with almost any desired conclusion.
It is correct that all cause mortality was significantly lowered (relative risk 0.86) but the number saved after five years treatment was only 0.76 % (5.17 % – 4.41 %). One of the authors was Fiona Godlee, the editor of BMJ. In an editorial comment in the same issue, entitled “Statins for all over 50? No” she had many objections to the new guidelines
Correction. It was the editor who wrote the comment, but the author of the meta-analysis was another Fiona.
The problem with our love affair with statins is not that statins have no value but the value is relatively small and is dwarfed by the value of other dietary and lifestyle options.
While endorsing the position of statins for most, the AHA/ACC goes further to essentially say that nothing else works. By limiting the definition of “evidence” to randomized, prospective, blinded, controlled trials combined with the false principle that the lack of proof of efficacy equals proof of lack of efficacy, we are told that statins work and nothing else does. (this is a significant problem when all available evidence for anything other than statin therapy is disregarded)
Clearly the AHA/ACC is wrong about other options to prevent heart attacks and as such if I know you are wrong about the value of diet, exercise, omega-3, niacin, and Vitamin D, it is a short walk to conclude that they are wrong about statins.
Based on a fundamental misunderstanding of the principles of statistics, the AHA/ACC consortium has concluded that omega-3, niacin, and vitamin D are of no value. We need to acknowledge that the statin industry had hundreds of millions of dollars to do studies proving the relatively modest benefit from statin therapy (a 25% reduction in heart attacks and a 13% reduction in mortality). The niacin, fish oil, vitamin D, olive oil, fruit, vegetable and nut industry will never have the funds needed to perform the type of studies that the hundred billion dollar statin industry could fund.
As the ACC/AHA only looks at randomized prospective, blinded, controlled trials, and the holistic alternatives will never be evaluated by such trials, it is inevitable that the ACC/AHA will continue to promote statin therapy to the exclusion of all other.
As a clinician, I place a large number of patients on statin therapy. I tell them that this is only a small portion of what must be done to prevent heart attacks. I follow serial coronary calcium scores to determine adequacy of treatment and promote compliance. I also use fish oil omega-3, encourage a high fruit and vegetable diet, with nuts and olive oil. If this doesn’t work, I add niacin. The result is a dramatic reduction in heart attacks and ischemic strokes with <0.05% annual risk for MI. This result is remarkable considering that my patients are of an average age of 66 with a higher baseline coronary calcium score than average for age and gender.
The AHA/ACC guidelines are not a lie but indeed a gross exaggeration of the truth. The fact that in the same breath they dispense with any non-statin therapies should create an atmosphere of distrust by any informed reader. I don't blame Australia ABC for the increased risk of MI with people abandoning treatment, I blame the old guard at the ACC/AMA who overvalue statins and disparage all other therapies with the reek of secondary gain considering how much money the statin industry has put into the academic coffers through the portal of "clinical research".
As a clinician and clinical investigator, I fully support the concept that the strongest evidence comes from RCTs, and that, in the absence of an RCT, a clinician has to “wing it” to a certain extent, depending on epidemiological data, case series, and common sense, to guide therapy.
Dr Blanchet correctly points out that the benefits of statins is modest, and that hundreds of millions of dollars have been poured into their research.
The reason I write is because Dr Blanchet left out a treatment tested in an NIH-funded RCT for secondary prevention that demonstrated efficacy, even in statin treated patients. Patients all had a prior MI. The primary endpoint was first occurrence of death, MI, stroke, revasc, or hospitalization for angina.
In the overall group, the 5-year NNT was 18. In the pre-specified subgroup with diabetes, the 5-year NNT was 7.
Had this been a pharmaceutical company trial, we would not have to discuss it in blogs. Alas, the treatment is completely generic.
I attach the link for the diabetes study, because the link to the primary manuscript requires you pay to access JAMA.
Enjoy reading it.
http://circoutcomes.ahajournals.org/content/early/2013/11/19/CIRCOUTCOMES.113.000663.full.pdf+html?sid=5a2d1235-f776-4ec7-997f-c5768a9a9bd1
Wow, what a catastrophe in Australia. I sincerely hope that the National Heart Foundation is effective in reaching the Australian public to clarify what the science shows.
Thanks for sharing the story, Larry.
William Blanchet – It sounds like you track data on your practice and are generating some very interesting observations. It would be great if you could write up your data and submit it for publication in the peer-reviewed literature.
Kind regards,
Seth