Gov't Undermines Search for Heart Disease Treatments

New research into COVID-19 has revealed some troubling findings. Even mild cases can lead to lasting heart complications.

Comparing test data collected before and after a group of patients in their mid-30s contracted mild cases of COVID, researchers noticed an increase in arterial stiffness and cardiovascular inflammation. That means they may face "a widespread and long-lasting pathological process" that places them at elevated risk of cardiovascular issues.

Heart disease is already America's leading cause of death, claiming roughly 700,000 lives per year. Add to that potentially increased risk among the millions and millions of Americans who have had COVID, and the need for more investment in the research and development of novel drugs is clear.

Unfortunately, the Biden administration has taken the opposite tack. Its Inflation Reduction Act gives the government the power to set drug prices, starting with 10 in 2026 and increasing from there every year.

For the small-molecule medications so important to treating cardiovascular disease, price controls can kick in as soon as nine years after the Food and Drug Administration approves a new drug. Those looming future price controls are already starting to disincentivize research.

Drug development is a long-term bet with a low-probability payoff. Each newly approved drug costs on average more than $2 billion to bring to market. That figure takes into account the fact that roughly 1 in 10 drugs entering clinical trials secures a thumbs-up from the FDA.

In other words, a single success covers the costs associated with nine failed drug-development attempts. But that model won't work if the government effectively taxes the successes with price controls. Research into new therapies will grind to a halt.

Which is precisely what's happening. In the wake of the IRA's passage, the drug manufacturer Eli Lilly and Co. cut plans for a small-molecule blood cancer drug, citing the legislation's price-control provisions.

"We just couldn't make the math work," Lilly CEO David Ricks said. In recent weeks, other drug manufacturers have echoed these sentiments and taken similar steps.

For heart disease, the math is even tougher. Despite the staggering death toll, research in this area is relatively underfunded. In 2022, the National Institutes of Health contributed less in grants, contracts, and other funds to heart disease than it did to cancer or Alzheimer's.

Last year, the FDA authorized one drug connected to heart disease — but over a half-dozen for cancer.

Given the prevalence of cardiovascular diseases, drugs that successfully treat them will likely be targets for the Inflation Reduction Act's price controls. That's in part because drugs that treat rare diseases are exempt from price controls, as are those that don't cost the government a lot of money or have been developed by small biotech companies.

Potential cardiovascular blockbusters are unlikely to qualify for those exemptions. And that may lead to drugmakers de-prioritizing cardiovascular research.

The Biden administration's enthusiasm for price controls is especially ironic given their relentless drumbeat for health equity. Black Americans are more likely to die from heart disease than white Americans — and are more likely to contract it at earlier ages. In addition, per the American Heart Association, research into women's cardiovascular disease has lagged for years.

So the administration's own policies are undermining the medical innovation that would most help underrepresented groups.

As the latest research into the impact of COVID shows, the world could use more effective cardiovascular therapies. The IRA's destructive price controls will slow the development of those therapies.

Pfizer CEO Albert Bourla recently said that drug companies may take legal action against the federal government to try to stop those price controls from coming into effect. Good. They need to be scrapped.