AHA Warns of Stagnating CVD Gains, Barriers to Access, and Dismal Drug Pipeline
The AHA wants to shake up business as usual to make greater strides toward efficient, cost-effective, and sustainable CVD prevention and treatment.
The American Heart Association (AHA) is issuing a Presidential Advisory regarding the challenges facing physicians, researchers, and policy makers in the fight against cardiovascular disease, highlighting stagnating trends as a wake-up call that “business as usual” is no longer working for the prevention and treatment of CVD.
Despite a substantial reduction in CVD mortality over the last 50 years, declines have leveled off and remained basically flat in the past 15 years, according to the AHA. In fact, while reductions in CVD mortality have slowed for all races and ethnicities, there has been a noticeable and concerning increase in CVD mortality among certain groups, particularly rural, middle-age, non-Hispanic white Americans.
“The incidence of cardiovascular disease is rising, and this is a battle that we haven’t won yet,” John Warner, MD (UT Southwestern Medical Center, Dallas, TX), chair of the AHA presidential advisory, told TCTMD. “We have made so much progress in the treatments of cardiovascular disease that sometimes you can get lulled to sleep because we have made these amazing improvements in mortality and there’s been therapeutic advances that have been substantial over the last 70 years, but there’s still a lot left to do.”
In the new report, which was published online January 24, 2019, ahead of print in Circulation, Warner, AHA chief executive officer Nancy Brown, and Mark McClellan, MD, PhD, and Robert Califf, MD (both Duke University, Durham, NC), say there are “missed opportunities at every step in the prevention and treatment of cardiovascular disease.”
For example, there are “concerning” trends regarding the increasing prevalence of risk factors, such as diabetes, obesity, and hypertension, and the AHA emphasizes the need for greater upstream prevention rather than downstream treatment. In doing so, they highlight a recent study showing the benefit of a pharmacist-led intervention in barbershops for addressing blood pressure and the importance of lifestyle changes. Getting a diagnosis is also critical, they add. Roughly 20% to 40% of all MIs occur in patients with previously undiagnosed cardiovascular disease, and while hypertension and hyperlipidemia are easy to diagnose, both risk factors go undetected in large swaths of the US population.
The AHA also notes there is a failure to use proven first-line treatments, pointing out that anywhere from 43% to 67% of patients prescribed statins are not taking the lipid-lowering medications 15 months after starting treatment. Similarly, more than half of patients with atrial fibrillation are not taking oral anticoagulation. In addition, there is a failure to use advanced, albeit expensive, medical therapies—such as the PCSK9 inhibitors and LV assist devices—and a lingering problem with disparities in access to advanced treatments across gender, racial, socioeconomic, and geographic lines.
Just One CVD Drug Approved in 2017
The future of drug development looks bleak, too, with only one new cardiovascular agent approved in 2017 and a limited number of drugs being tested in late-phase research, according to the AHA. Although CVD remains the leading cause of death worldwide and in the US, investment in cardiology research is dwarfed by the money spent on cancer research. Among the 7,293 drugs in development in 2017, just 563 were for cardiovascular disease.
“I worry the intense cost of actually developing a therapy and applying it to a broad population of people, with the expectations that clinical trials must meet around safety and [applicability] to a very diverse population, might prevent companies from taking formative ideas and advancing them to next stage of scientific development,” said Warner.
Given the challenges in the CVD field, the AHA, along with Duke University, established the Value in Health Care Initiative—Transforming Cardiovascular Care. This is an advisory group composed of health leaders from diverse perspectives (patients, doctors, payers, government, and industry) that is seeking to increase access to, and affordability of, CVD care.
“We’re trying to get people working together to see how their work might be improved by working with others, and to think about new models of care, including access and reimbursement, in ways that make it better for patients,” said Warner. “It’s a patient-centric effort, and hearing from patients at the beginning framed our work. It’s not easy to be a patient, and we need to do something to simplify their care and make it more understandable and more accessible.”
In the Presidential Advisory, the AHA states that physicians also must get better at providing supportive care, such as high-quality palliative care, to improve the patient’s experience, reduce complications, and limit the unwanted use of expensive healthcare services and/or procedures.
McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a Presidential Advisory from the American Heart Association. Circulation. 2019;Epub ahead of print.
- McClellan reports having an ownership interest in Alignment Health Care, Cigna, and Johnson & Johnson; having consultant/advisory board relationships with Cota, MITRE, Alignment Health Care, Cigna, and Johnson & Johnson; and having other relationships with the Health Care Payment Learning and Action Network and the Accountable Care Learning Collaborative.
- Califf reports having an ownership interest in Verily Life Sciences and having a consultant/advisory board relationship with Amgen.
- Warner and Brown report no relevant conflicts of interest.