- The US government needs to boost funding for research and design a nationally coordinated way to test experimental drugs in the future, a leading clinical researcher said.
- “I hope that America sits up and confronts this as a Sputnik moment,” said Dr. Kevin Tracey, CEO of the Feinstein Institutes for Medical Research at Northwell Health, New York’s largest healthcare provider.
- Tracey was a panelist on a recent roundtable of Business Insider’s annual selection of 10 people transforming healthcare, joining a handful of other leaders to discuss the industry’s future.
- Visit Business Insider’s Transforming Business homepage for more stories.
The coronavirus pandemic has stress-tested the entire US healthcare system, particularly in how scientists figure out whether or not experimental drugs help the sick.
And the leader of the research arm of New York’s largest healthcare provider said it’s time to rethink the clinical trial system, as well as the federal government’s funding priorities in supporting research.
“I hope that America sits up and confronts this as a Sputnik moment,” said Dr. Kevin Tracey, CEO of the Feinstein Institutes for Medical Research at Northwell Health, speaking on a recent roundtable of Business Insider’s healthcare transformers.
Sputnik was a satellite launched into space by the Soviet Union in 1957, a scientific accomplishment that stunned the US and spurred subsequent boosts in investing in science and technology. While that national embarrassment ultimately led to the US becoming a scientific force around the world, that funding interest has waned in the 21st century, Tracey said.
“What’s happened in the last 20 years is we have not kept up with inflation in our investments in research from the federal government, and we were unprepared for COVID,” Tracey said.
Northwell has treated about 150,000 COVID-19 patients in the past six months, Tracey said. About one in 10 hospitalized patients end up enrolling in a clinical trial across Northwell’s 23-hospital chain, he added.
In March, Tracey played a key role in quickly mobilizing trials for coronavirus treatments. Since then, most of Northwell’s trials have come to a halt due to a lack of patients. Around the US, many studies have produced confusing, limited, or incomplete findings that only muddied the picture of what drugs work and which don’t.
Notably, there’s still no game-changing treatment that can dramatically change patient outcomes.
Tracey spots limitations in the way we study drugs
Tracey ticked off the limitations one by one for a handful of coronavirus drugs that have received emergency use authorizations from US regulators despite mixed or limited evidence.
Thousands of patients have received convalescent plasma but without any control group to compare results against.
Crucial studies of remdesivir, including at Northwell, were stopped short before showing a meaningful reduction in deaths. A large trial run by the World Health Organization subsequently found no mortality benefits from using remdesivir, and the global health group has recommended against the drug’s use, even as the Food and Drug Administration issued a full approval for the drug. Gilead Sciences, which makes remdesivir, has criticized the WHO study.
A powerful generic steroid called dexamethasone has been one of the best surprises of the pandemic, with UK researchers finding the drug greatly lowered the chances of dying among the sickest COVID-19 patients. But Tracey said even that study leaves open “1,000 questions on dosing, timing, patient population, and controls.”
He called for a level of national coordination on clinical trials going forward that can prioritize drugs to test and lead these trials to their completion. Meaning instead of the company-site model, where a drug sponsor works with a particular institution, researchers, and companies would work together.
‘We have to confront this’
“You have to do randomized clinical trials that go all the way to the end with appropriate controls,” Tracey said.
While vaccines have been an unprecedented scientific success story, with at least two candidates showing overwhelming levels of protection in late-stage studies, Tracey said it’s critical that researchers figure out a better drug-testing system.
“I think we have to confront this because the vaccines, even if they are close to perfect, we’re still going to have to know how to treat these patients and we need to coordinate that better,” he said.
Amid the pandemic, several pharmas have changed their research to be more futuristic, tapping the internet and connected devices like the iPhone to study patients without bringing them into hospitals. It’s fueled a new crop of startups like Science 37, which hope to make trials faster and more effective.
“From an industry perspective and then from a healthcare perspective, we were all very unprepared for this,” Rob Goodwin, a vice president for global product development at Pfizer, told Business Insider in June. Goodwin is helping Pfizer, a $222 billion drugmaker, update its trials process.