The health care system is ignoring world’s most promising approach to preventing cardiovascular disease

Last week, the Washington Post published an op-ed by former CDC Director Tom Frieden titled, “It’s the world’s leading killer. Make it the focus of the next breakthrough.” Frieden writes, “Hypertension, the ‘silent killer,’ is the deadliest but most neglected and widespread pandemic of our time, killing more than 10 million people a year worldwide.”

I strongly endorse Frieden’s call to action, but I am baffled by his policy prescription. To reduce the global toll of hypertension, he urges the world to spend substantial sums of money on a complex mix of prevention and treatment strategies that have repeatedly fallen short. If we keep doing the same things over and over again, we’re unlikely to achieve a different result.

Ironically, the “next breakthrough” Frieden seeks already exists has been proven to work. It’s offered as a private service in the United Kingdom, and in July the World Health Organization endorsed the concept. However, it is not available in the United States, where heart disease kills 695,000 annually and imposes $240 billion in costs. Strokes claim an additional 150,000 lives and generate $56 billion in costs.

In the 20^th century, preventive measures accounted for nearly half of the reduction in U.S. cardiovascular mortality. Unfortunately, modern medicine has not built on this success. In a 2015 essay, Frieden noted, “Blood-pressure control, which can save more lives than any other clinical intervention, is successful in only about half of Americans.” Worldwide, the problem is even bigger. According to the WHO, “Nearly half of people with hypertension globally are currently unaware of their condition.” If countries did a better job of reducing hypertension, the WHO estimates that “76 million deaths could be averted between 2023 and 2050.”

Instead of leading the world in blood pressure control, the U.S. is falling behind. A study of cardiovascular health in middle-aged U.S. adults found that between 1999 and 2020, rates of hypertension failed to improve among higher-income adults and worsened among low-income adults. Between 2000 and 2019 blood pressure-related deaths of Americans aged 35 and older increased across the board, particularly among Americans 35 to 64, according to the Centers for Disease Control and Prevention.

Either we aren’t trying hard enough or we’re trying the wrong way. The first explanation seems unlikely. After all, we’ve promoted blood pressure screening for decades, and testing stations and low-cost monitors are widely available. Patients identified as “hypertensive” on screening are promptly referred for treatment. If lack of effort isn’t the problem, perhaps we should alter our approach.

Twenty years ago, two U.K. preventive medicine experts, Nicholas Wald and Malcolm Law, proposed a dramatically different strategy. Rather than “measure blood pressure in all and reduce it in some,” they urged physicians to “lower blood pressure in all [over age 50] and measure it in some.”

Their idea is based on the fact that age is the strongest risk factor for heart attack or stroke, other than already having had one. As early as age 20, a person’s risk of heart attack or stroke roughly doubles every seven years. In a recent commentary, Wald noted that “an age cut-off of 50 would detect over 90% of the people who, in the absence of preventive medication, would experience a first heart attack or stroke.”

Because treating so many people would be a formidable task, Wald and Law sought to make it as easy as possible. Rather than individualize therapy, they proposed that everyone over age 50 or 55 take a daily “polypill” composed of three inexpensive low-dose generic blood pressure medicines, a generic statin (to lower cholesterol), folic acid, and possibly low-dose aspirin. (Later versions omitted folic acid; aspirin remains an option.)

As unorthodox as this sounds, it works. Numerous studies have found that a daily polypill safely and reliably lowers blood pressure and serum cholesterol, regardless of a patient’s starting level. Its impact on outcomes is dramatic. A 2021 meta-analysis of three large international studies involving more than 18,000 participants found that compared with usual care, a once-daily polypill decreased heart attacks, strokes, and cardiovascular deaths by 38%. When low-dose aspirin was added, the reduction approached 50%!

In 2022, a large U.S.-based study examined whether a daily polypill could benefit people who have already had a heart attack or stroke (and are therefore at very high risk of having another one). Among 2,500 patients followed a median of three years, those randomized to a daily polypill had substantially fewer events than those in the usual care group. On the strength of the evidence, the World Health Organization recently added a cardiovascular polypill to its list of essential medicines.

Despite these developments, leading doctors, our pharmaceutical industry, and key decision-makers at federal regulatory and research agencies are unconvinced. To them, it seems, the idea of putting four or more medications into a single pill and treating millions of people without first conducting diagnostic workups is too radical a departure from the way medicine has long been practiced.

But this is precisely why researchers conduct randomized controlled trails. It’s important to note that the dramatic decrease in heart attacks, strokes, and other serious outcomes the polypill achieved were in comparison to usual care, not a placebo. The simplicity of the approach, its low cost, and ease of compliance probably account for the pill’s effectiveness.

Economics may also play a role in reluctance to embrace the polypill. If America adopts the strategy, there will be winners and losers. The winners include older adults and patients with limited access to care, their families, employers, and taxpayers. The losers (in a financial sense) include interventional cardiologists and radiologists, acute care hospitals, pharmaceutical companies, health care investors and countless middlemen. Research by RAND (which I was involved in) and other groups has shown that in the U.S. health system, the surest way path to a substantial return on investment is to develop products that increase health care spending, not reduce it.

To resolve the impasse, we need one more large, U.S.-based, clinical trial of the polypill versus usual care for primary prevention of heart attacks, strokes and sudden cardiac death. Ideally, it should enroll a diverse population of women and men, 50 to 59 years of age, and follow them for three to five years. Because the polypill contains inexpensive generic medicines, no pharmaceutical company will take this on. A federal research agency or philanthropy will need to sponsor the trial.

If it confirms prior findings, the polypill should be accepted by America’s doctors. With U.S. health care consuming $4.5 trillion annually and adult life expectancy lagging that of 56 other countries, we must find a better way to prevent cardiovascular disease. If our nation embraces the polypill approach, the rest of the world could follow. Millions of lives might be saved.

Art Kellermann is a health policy researcher, former medical school dean, and former CEO of an academic health system. His views are his own. He has no conflicts of interest to disclose.