If you like controversy, statins are great drugs. If you are a statin advocate, you believe that many people should get them. If you are a skeptic, you think that the drugs are overprescribed.
The polarization of views is so extreme that the Lancet and British Medical Journal declared because their editors had opposite views on the subject. The battle was the most fiercely fought since the Norman conquest of England in 1066.
Battle lines were drawn again when recently published a paper from UCSF, which modeled the benefits of statins to determine the impact of broader use. Current guidelines recommend use of statins in patients at meaningful cardiovascular risk. But what if you treated every middle-aged person with a statin, whether or not they had any lipid abnormalities or risk factors?
Big Bang?
Treating everyone means treating an extra 50 million people in the US! According to the UCSF paper, universal treatment for 10 years might prevent nearly 1 million cardiovascular events and about 135,000 deaths.
Sounds impressive, right? It sounds like a lot of benefit for the small cost of the drug, a low likelihood of adverse effects and the bother of taking a daily pill.
There is a problem, though. Universal treatment for people at minimal risk means that a physician would need to treat more than 100 patients for 10 years to obtain an extra year of good health in one person. This marginal improvement does not meet most current standards for cost-effectiveness. The benefit is so small that it disappears if quality of life were even slightly diminished by the need to remember to take the drug daily.
And how do you get 50 million middle-aged Americans to do anything every day for 10 years?
Think about it. We can't even get an extra 50 million people to take an hour or so to vote on Election Day! And just think of the impact. If an extra 50 million people had turned out to vote on Election Day in November 2016, how many lives could we be saving over the next 10 years?
If we really wanted people to take a statin every day, we could put it in the drinking water -- just like fluorine.
But it isn't that simple.
What level of the statin in the water do you need? How do you get everyone to drink the required amount of tap water? How do you ensure that they drink the same amount every day? And how do you guarantee that only middle-aged people drink the water? We don't know the effects of 10 years of statin exposure in children, in young adults, or in the elderly.
So putting statins in the drinking water is a ridiculous idea. You actually need to get 50 million people to swallow a pill. Can that be achieved? Yes! Just call it a vitamin or a nutrient. Millions of people take those enthusiastically every day for years.
But seriously
Obviously, I am not being serious. And neither are those who propose universal treatment. The UCSF researchers engaged in an intellectual exercise and found an interesting result. There are no immediate practical implications of their work.
But this is something really ironic about all of this.
These days, physicians are supposed to be celebrating precision medicine. That means finding patient-specific characteristics that define an individual's responsiveness to a drug. Precision medicine means avoiding treatment in patients who are least likely to benefit.
Treating every middle-aged person with a statin is the polar opposite of precision medicine.
Confused? You should not be. It is medicine that has gone insane.
Disclosures
Packer has recently consulted for Amgen, Boehringer Ingelhim, Cardiorentis and Sanofi. He was one of the two co-principal investigators for the PARADIGM-HF trial (sacubitril/valsartan) and currently chairs the Executive Committee for the EMPEROR trial program (empagliflozin).