I was catching up on my medical reading this morning when I came across an article in The Lancet from late last month that is a real jaw dropper. The article, Are lipid-lowering guidelines evidence-based?, is in the commentary section and is a pretty devastating indictment of the whole scale prescribing of statins without any evidence that such prescribing does much good.
The article gets right to the point:
The last major revision of the US guidelines, in 2001 [the guidelines I wrote about in my recent post],increased the number of Americans for whom statins are recommended from 13 million to 36 million, most of whom do not yet have but are estimated to be at moderately elevated risk of developing coronary heart disease. In support of statin therapy for the primary prevention of this disease in women and people aged over 65 years, the guidelines cite seven and nine randomised trials, respectively. Yet not one of the studies provides such evidence.
The next paragraph I don’t agree with completely:
For adults aged between 30 and 80 years old who already have occlusive vascular disease, statins confer a total and cardiovascular mortality benefit and are not controversial. The controversy involves this question: which people without evident occlusive vascular disease (true primary prevention) should be offered statins? With about three-quarters of those taking statins in this category, the answer has huge economic and health implications. In formulating recommendations for primary prevention, why do authors of guidelines not rely on the data that already exist from the primary prevention trials?
Based on my reading of the papers underlying the recommendations for adults with CHD, I don’t feel the evidence is strong enough to make the blanket statement that for these people
statins confer a total and cardiovascular mortality benefit and are not controversial.
My reading tells me that there may be a slight (a very slight) decrease in risk for another heart attack in these people if they take statins, but the lack of reduction (in some cases even an increase) in all-cause mortality, in my mind at least, negates these minimally positive effects. And when the side effects of statin therapy are taken into consideration, the positive effects are minimized even more.
The next couple of paragraphs are unbelievable. Unbelievable in the sense that I can’t believe they are published in a mainstream journal. It almost restores my faith in the unbiased nature of the medical literature.
We have pooled the data from all eight randomised trials that compared statins with placebo in primary prevention populations at increased risk. Unfortunately, our analysis is imperfect because these trials are not solely primary prevention: 8·5% of patients had occlusive vascular disease at baseline. We used two outcomes to estimate overall benefit (benefit minus harm): total mortality and total serious adverse events (SAEs). Total mortality was not reduced by statins (relative risk 0·95, 95% CI 0·89–1·01). In the two trials that reported total SAEs, such events were not reduced by statins (1·01, 0·97–1·05) (data on SAEs from the other trials were not reported). The frequency of cardiovascular events, a less encompassing outcome, was reduced by statins (relative risk 0·82, 0·77–0·87). However, the absolute risk reduction of 1·5% is small and means that 67 people have to be treated for 5 years to prevent one such event. Further analysis revealed that the benefit might be limited to high-risk men aged 30–69 years. Statins did not reduce total coronary heart disease events in 10 990 women in these primary prevention trials (relative risk 0·98, 0·85–1·12). Similarly, in 3239 men and women older than 69 years, statins did not reduce total cardiovascular events (relative risk 0·94, 0·77–1·15).
Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30–69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event. In our experience, many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall health. This approach, based on the best available evidence in the appropriate population, would lead to statins being used by a much smaller proportion of the overall population than recommended by any of the guidelines.
That pretty much says it all. I still can’t believe my eyes. Who in mainstream medicine could risk the career damage from publishing an article like this? Who are these guys?
The first author, J Abramson, is from Harvard; the second, JM Wright, is from the University of British Columbia.
Let’s look at their conflict of interest disclosures:
JMW declares no conflict of interest. JA is an expert consultant to plaintiffs’ attorneys on litigation involving the drug industry, including Pfizer for its marketing of atorvastatin.
Now I see why these guys have the guts to publish this anti-statin paper. They don’t get funding from drug companies and one of them uses his expertise to help lawyers go after drug companies.
JMW has a history of publications critical of the overprescription of statins. Here is one. Skip down to page 7 to read his Update on statin therapy.
Now if anyone says, yeah, well where are the papers? I’m not going to believe some idiot doctor who writes a blog. I want to see it in a real medical journal, you’ll be prepared.