WASHINGTON - More than 11 million Americans could be inadvertently taking the wrong heart medication. The trend reveals an even more problematic issue within American healthcare.
New research published this month in Annals of Internal Medicine found that risk calculations of people being assessed for atherosclerotic cardiovascular disease were off by, on average, 20 percent.
Black men in particular were at risk of being misestimated.
That means a significant number of patients could be over- or undertreated. This can be dangerous.
Overtreated people could be taking medication unnecessarily, subjecting themselves to potential side effects as well as throwing money away.
On the other hand, undertreated people are likely not receiving the proper treatment they actually need to prevent things like heart attack and stroke.
In the case of heart disease, there’s a sliding scale of treatment options, including aspirin, blood pressure medication, and statins. Researchers found that because a significant number of patients were considered to be at high risk through miscalculations, the number of people being recommended one or all of these therapies should likely be reduced.
The widespread use of statins among Americans is a hotly debated issue in particular. As researchers in the BMJ point out, the benefits of statins for people with a high risk of cardiovascular disease are undisputed. But for those with a lower risk, statin therapy could be unnecessary, even dangerous.
The problem, say researchers, lies in how risk is calculated for disease.
Risk calculators are commonplace in healthcare. They give doctors a simple measurement of health to help guide the risks and benefits of a medication therapy.
In fact, these calculators are now so easy to find, universities like Harvard even have them available on the internet for people at home to use. They work by feeding variable data into an equation — in this case, a Pooled Cohort Equation (PCE) — to assess a patient’s risk for a given outcome. Here, it’s heart disease.
Common variables for calculating risk of heart disease would include a person’s age, race, sex, height, weight, and health factors including family history, diabetes, and smoking.
Generally, risk calculators are a valuable tool for healthcare. But researchers found that when the data and the statistical analysis becomes outdated, risk estimates can be skewed, resulting in suboptimal care.
“The big message from [this research] is that the way we do these things needs to continue to evolve, and we need to continue to collect better data and do better calculations so that we can continue to improve the level of care,” said Dr. Charles Dinerstein, a senior fellow at the American Council on Science and Health.
Dinerstein compares the practice of keeping PCE and risk assessment guidelines up to date like any other infrastructure project.
“If we don’t do it, we’re going to wind up having a medical system that resembles our bridges that are in various levels of decay,” he said.
Current PCE guidelines were last updated in 2013. They’re updated by the National Institutes of Health, specifically the National Heart, Lung and Blood Institute.
However, what researchers discovered was that some of the data used even in these current guidelines was more than 60 years old.
According to senior author Dr. Sanjay Basu of Stanford University, one of the data sets used was based on people between the ages of 30 and 62 in 1948.
“A lot has changed in terms of diets, environments, and medical treatment since the 1940s,” Basu said in a statement. “So, relying on our grandparents’ data to make our treatment choices is probably not the best idea.”
Basu and his team found that by updating both the data sets and the PCE, risk estimates had improved accuracy.
Their research also found that if certain groups aren’t well represented in a data set, their risk assessment will likely be off.
In older data sets, African-Americans weren’t well represented, resulting in risk of heart attack and stroke being underestimated.
“So while many Americans were being recommended aggressive treatments that they may not have needed according to current guidelines, some Americans — particularly African-Americans — may have been given false reassurance and probably need to start treatment given our findings,” Basu said.
Women and other minority groups may also not be represented well in key data sets.
“Women present with heart attacks differently,” Dinerstein said. “For a long time, they were not part of any of the studies for a variety of reasons. So, their heart disease was largely ignored, because no one thought it was there.”
“If you’re not well represented in the study, there’s going to be some bias in the results,” he said.
Risk calculators serve as guidance to a doctor, but don’t dictate standard of care. Because they’re based on groups — and can be miscalculated, as illustrated by this new research — speaking with your doctor about your own individual needs is of utmost importance.
“As long as you have a conversation with your physician and can find out whether he’s working with the guidelines that are there and whether he agrees or disagrees with how you’re being treated within it, I think your needs are met,” Dinerstein said.
“The most personalized medicine you can get is having a conversation with your doctor.”