The headlines were dramatic and unequivocal:
"Cholesterol drug causes risk of heart attack to plummet" - Fox News.
"Cholesterol-fighting drugs show wider benefit" - The New York Times.
"Cholesterol drug cuts heart risk in healthy patients" - The Wall Street Journal.
The New York Times article summarized the exciting news in a front-page story saying that "millions more people could benefit from taking the cholesterol-lowering drugs known as statins."
That's big medical/business news, because statins are already the bestselling drugs in the world, with sales in excess of $20-billion (U.S.).
Quoting some of the world's top heart researchers, media reports touted the importance of a blood test for C-reactive protein. That's because those benefiting from statins had high levels of CRP (a marker for inflammation) rather than high levels of LDL cholesterol, which is usually the criterion for statin prescription.
The news stories were based on research published last week in the prestigious New England Journal of Medicine and presented, with much fanfare, at the annual convention of the American Heart Association.
Like much reporting on medical research (and drug research in particular), however, there is more (or, more accurately, less) to these stories than meets the eye.
The principal finding in this study was that participants who took a statin pill recorded a 50-per-cent reduction in the risk of heart attack, stroke, surgery and death compared with those who took a placebo (a sugar pill).
Who wouldn't be wowed by those numbers? Who wouldn't want that miracle drug?
But the benefits are relative risk reductions.
When you look at the raw data in the study, they reveal that 0.9 per cent of statin users had cardiovascular problems. By comparison, 1.8 per cent of those taking a placebo had heart problems.
There were 17,802 participants in the study, yet there were only 83 cardiac events among statin users, compared with 157 in the placebo group. That's 50 per cent fewer.
Are those really "dramatic" findings? Do statins really make heart attack risk "plummet"?
According to a cautionary editorial in the New England Journal of Medicine (which received virtually no mention in news reports), 120 people in this study needed to be treated with a statin for two years to see a benefit in one person.
That's a lot of people taking a pricey drug ($3 Canadian a day) for no benefit - not to mention that there are risks.
While researchers (and journalists who report on studies) love to highlight benefits of drugs, they too often gloss over risks.
Like all drugs, statins have side effects. The drug used in the study, rosuvastatin (brand name Crestor), has been associated with muscle deterioration and kidney problems.
In the study, those taking statins had a higher risk of developing Type 2 diabetes - 3 per cent compared with 2.4 per cent of those taking a placebo. That's a 25 per cent higher relative risk among people with very little heart disease to begin with.
As noted earlier, researchers (and news stories) suggested that, based on the findings, the number of patients taking statins could and should expand dramatically.
But is that really what the research tells us, even in its most optimistic interpretation?
The study involved exclusively men older than 50 and women older than 60 who did not have high cholesterol or histories of heart disease or inflammatory illness. All the people in the study needed to have low cholesterol and high CRP.
Initially, researchers recruited 90,000 people in those age groups, but more than 80 per cent of them were deemed ineligible. This is a very select population.
To say, by extrapolation, that these "dramatic" (read: modest) benefits apply to the general population is erroneous.
Similarly, while it is true that about half of all heart attacks and strokes occur in people whose cholesterol is not considered high, does that mean everyone should get a blood test to measure levels of C-reactive protein? Hardly.
Yes, there is more heart disease among people with high levels of CRP, but the jury is still out on what this means.
Some scientists believe that because CRP - secreted in response to inflammation - is present in plaque, it increases the risk that the plaque will burst, leading to blood clots that cause heart attacks. But other researchers think that CRP levels are, at best, a telltale sign of heart disease, a bit like grey hairs are a sign of aging - not its cause.
The CRP test is expensive at almost $50. And it's worth noting that one of the principal authors of the new research holds the patent on the test and makes money every time it is used.
When you cut through all the hype and the self-interest, what we know is this: Statins reduce levels of HDL cholesterol. This is beneficial to people who have had a heart attack or other serious heart problems.
But for otherwise healthy people, high CRP levels or not, the potential benefits of taking statins are marginal, and the risks are not insignificant.
Hardly the stuff of dramatic newspaper headlines.
