Thank goodness. We finally have the last word on statins that will forever lay the risk/benefit debate to rest. At least that is according to the authors of a recent review titled “Interpretation of the evidence for the efficacy and safety of statin therapy.” (DOI: http://dx.doi.org/10.1016/S0140-6736(16)31357-5)
This review study was touted as the end-all, be-all word on statins. It concluded that the benefits of statins have been underplayed while the adverse events have been overplayed.
The study quoted a 15% benefit from statins with only a 2% risk of side effects. According to the main author, this was supposed to silence all statin naysayers, end all debate and finally prove for good that the benefits of statins far outweigh the risks, even for those at low risk for cardiovascular disease.
Did it work? Of course not. If it did, I wouldn’t likely be writing about it.
Let The Debates Rage
For starters, when should the debate about anything be over? When should we ever stop questioning the status quo? When should we stop looking for new scientific findings to help promote our health? I hope we can all agree the answer is a resounding NEVER.
The day we stop questioning things is the day robots take over and deliver cookbook style healthcare to the masses. No thanks.
Debates are healthy. Debates are educational. Debates are built on free speech. Let’s agree to not stop that please. We can talk about the responsibility of the media in reporting scientific findings, but let’s keep the science free of censorship.
40 Million Statin Prescriptions
Statins are no strangers to debates. The pro vs. con statin debate has waged for decades. Statins have been used with less controversy in secondary prevention (in people who have already had heart attacks, stents or bypass surgery), but their use in primary prevention (those who have never had a cardiovascular event) has appropriately met with much more controversy.
The controversy intensified in 2013 when the revised ACC/AHA guidelines dramatically increased the number of low-risk patients who were now “statin eligible.” Prior guidelines stated statins were not beneficial for anyone with less than a 20% risk of developing cardiovascular disease over the next 10 years.
The new guideline lowered the statin threshold to anyone with a 10-yer risk of developing cardiovascular disease of 5% or more. There are now an estimated 40 million Americans without cardiovascular disease should consider taking statins.
Why the change? Was there new data that made the committee change the guidelines? Surprisingly, there was not. Instead, it was a review of old data.
The 2012 meta-analysis by the Cholesterol Treatment Trialists (CTT) Collaboration (Lancet 2012;380:581-590) reviewed trials involving over 170,000 participants. By statistically crunching the data, they concluded that statins were indeed beneficial even in those at low risk for cardiovascular disease. They concluded that statin benefits “greatly exceed any known hazards of statin therapy.”
Not So Fast
An independent analysis of the same data concluded that there was absolutely no mortality benefit for those with <10% 10-year risk, and in order to prevent 1 heart attack, you would need to treat 140 people for 5 years.
In addition, the incidence of adverse events was drastically minimized in the clinical trials. Almost all of the studies were pre-designed with a run-in period.
Run-in periods work like this. Say we recruit 200 people for a drug trial. We give all 200 of them the drug for 3 months. This isn’t part of the trial yet. This is the “run-in period.” If 100 of them get side effects, those 100 are disqualified from the trial. The remaining 100 people who did not get side effects are now the trial subjects. 50 get a placebo, and 50 get the drug. We follow them for the duration of the trial.
The trial purposely excludes anyone who might have side effects.
As a real word example, the TNT trial (a trial popularly used to promote statins) excluded 35% of all participants during their run in period because they had side effects from the statins.
So when the CCT trial claims statin side effects are far less than 1%, that is the best case scenario from trials designed to limit the reported side effects. In real world estimates, the adverse events range closer to 30-40%.
Now reexamine Dr. Collins’ clams that the benefits far outweigh any risk. Suddenly it is not as clear, is it?
The Bigger Picture:
Statins are a hot-topic example of a larger debate in medicine, the debate between the less-is-more camp and the more-is-better camp. It applies to statins, to chemotherapy, to CT scans, to cancer screening, and almost every aspect of medicine.
The less-is-more camp tends to focus more on lifestyle and non-prescription therapies. They value “do no harm” above a small possibility for benefit. They are disturbed by the over-involvement of pharmaceutical companies in funding and designing drug trials and sponsoring the physicians who create the guidelines.
The more-is-better camp believes in the limitless potential for medicine. They are willing to risk adverse events to ensure no potential benefit is left unexplored. They believe cost to the individual or society should not deter even the smallest chance for benefit.
Both factions are right and both are wrong. Both use the scientific literature to back their approach, and both believe they are doing what is best for their patients. That is what makes this debate so difficult. For the most part, they both feel they are doing “the right thing.”
The Art vs. The Science of Medicine
Sure, some healthcare providers are financially motivated. Some do more to get paid more, and some promote treatments from whatever company pays them the most.
But the overwhelming majority of physicians are simply trying to do their best for their patients. They simply weigh the trade-offs with differing levels of importance.
This is where the “art” of medicine becomes more important that the science. P-values can only tell us so much. It is how we interpret them for our patients that matters most.
Said another way, a statistically significant finding may not always mean a clinically significant finding for you. That is for you decide with the guidance of your healthcare provider. It is not for your doctor to decide for you.
Despite Dr. Collin’s wishes, the statin debate is far from over. The benefit vs. risk balance in people without cardiovascular disease is suspect at best.
If your doctor has prescribed a statin, make sure you have a good understanding of your risk of heart disease, how much the statin can reduce that risk, how much it reduces your risk of death, and what are the real world risk of side effects.
In the end, you may feel it is worth taking. In many cases you may not. That is for you to decide, not your doctor.
Who Wins the Statin Debate?
Twenty years from now when medical historians look back, who will they declare the winner of the great statin debate of the 2010’s?
Hopefully the winner will be the patients’ health.
Hopefully the open debate will help patients and providers alike realize that healthcare is not always about statistics and p-values.
Healthcare is about human interactions, about understanding the wants and fears of each individual, and about using the totality of evidence to help make the correct decision for each person in that moment.
As of now, there is still no role for robots in delivering this style of healthcare.