The results of two recent trials have the potential to change the practice of cardiology.
But that's about all they have in common.
One was a government-funded effort that examined a low-cost, low-tech – but very clever – way to reach millions of men who are at high risk of heart disease and help them prevent one of the most common afflictions in the U.S.: high blood pressure.
The other looked at a new cholesterol medication that is so costly that one expert estimates it would cost $2.6 million over three years to save a single life.
Comparing these two studies brings up interesting ethical questions about how to best tailor care to prevent cardiac problems.
The first study was eye-opening. Published in the New England Journal of Medicine, it looked at a new approach to treating high blood pressure. The setting: 78 barbershops in Los Angeles. The participants: 319 African American men, primarily living alone and of low income.
The men were split into two groups. One group was advised by their barbers to follow standard care, which means seeing a doctor to have their blood pressure checked and, if necessary, treated.
The second group of men frequented barbers who were trained in health promotion and worked with specially trained pharmacists. Rather than having to go to a drugstore, the men saw these pharmacists right where they got their hair cut. What's more, the pharmacists – supervised by physicians – could prescribe and monitor the men's blood pressure medications.
This second group had strikingly better blood pressure control than the men who were advised to go see a doctor. A blood pressure of less than 130/80 mmHg was achieved among 63 percent of the participants in the barber shop group, versus just 12 percent of the traditionally treated group.
Pharmacists made taking medicines more convenient by bringing treatment to the community. The intervention was tailored to black men and endorsed by trusted community members — their barbers. Because many of the men in the study lived alone, this community support was key to help their health.
The second trial involved the use of the cholesterol-lowering medication called Praluent. This injectable medication, given every two weeks under the skin, has been shown to lower cholesterol. Called Odyssey Outcomes, this study showed that people who had recent heart attacks and were put on this medication along with a statin (a common cholesterol medicine) had a decreased chance of dying, when compared with taking a statin alone.
But here's the fine print: It's only a small decrease.
So far, the use of Praluent has been limited because it is so expensive. Insurance companies demand a rigorous approval process to be sure it is really necessary, and the paperwork required of physicians, nurses, and staff has been stifling.
Far fewer people are potentially affected by the Odyssey study than the barbershop trial. Yet the Odyssey study received a lot more press. One recent headline summarized Wall Street's reaction: "Odyssey Outcome: Making Regeneron's stock great again." Cardiologists have been excited to have a new medication to recommend after someone has had a heart attack and want an easier approval process.
The implications of these two trials are staggering, ethically and economically.
The barber shop trial cost 8.5 million dollars and was funded by the government. That's a lot of money to me and you. But consider the potential to save lives and money through better prevention.
According to recently released blood pressure guidelines, almost half of all Americans have high blood pressure, and many remain untreated. This costs our society more than $47 billion a year, including the cost of health care, medications and missed work days. African American men and women have the highest rates of untreated hypertension. This low-priced intervention works by empowering the community and pharmacists to work together to deliver needed care.
I have been working in the Temple University Hospital cardiology clinic every Thursday for the last two years, proctoring fellows and seeing patients, many of whom are in the same demographic group that the barbershop project studied. I have seen how essential communication, trust between patient and provider, and making it easier for patients to get care are for our patients. Part of our job is to find ways to make them care more about their health, and this barbershop study is outside of the box in that regard, another reason why I was impressed.
The Odyssey trial was funded by two companies, Regeneron and Sanofi, involved more than 18,000 patients, and had to be many times more expensive, though the drugmakers have not made the cost public. Sanjay Kaul, an expert on objectively analyzing trials, calculated that preventing one cardiac event using these medications at their present cost, over a period of three years, would cost about $2.6 million. Yet, most of the reaction from the medical community has been dismay directed toward insurance companies for not wanting to cover this cost, not anger at the drug companies for charging so.
Insurers' reluctance is likely due to the drug's price: $14,000 per patient, per year. It's interesting that the companies have offered to discount the drug by at least 20 percent if insurers stop requiring doctors to get prescriptions preapproved, which means burdensome paperwork explaining why the patient can't use less expensive medicine. This would, of course, make it much more appealing for doctors already drowning in piles of paper, and would likely put many more people on Praluent.
The ethical question that links these two studies is how to best spend our health-care dollars. Should more money go to low-cost interventions that help prevent heart disease in many people like the barber shop initiative, or directed toward survivors of heart attacks who are lucky enough to have good insurance coverage? Should pharma companies be funding expensive trials, then charge what the market can bear, hoping for a return on their investment? I do not know the answer to these questions, but the hoopla around these results suggest this debate will continue into the future.