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Endpoints News — New NIH chief stresses focus on obesity, clinical trial challenges

Endpoints News — New NIH chief stresses focus on obesity, clinical trial challenges

The new leader of the NIH is worried about obesity.

Monica Bertagnolli, who was confirmed as the new NIH director last week, said that during her first meeting with the NIH institute heads, she posed a question: “Is there anybody in this room who isn’t worried about obesity?”

“The answer is really no,” she told the Friends of Cancer Research annual meeting on Tuesday.

Her comments arrive as blockbuster GLP-1s have shown they can reduce major cardiovascular risks, among other benefits. Speaking alongside FDA Commissioner Robert Califf, Bertagnolli discussed clinical trials, declining life expectancy in the US, and the role of insurers in ensuring research gets carried out.

Bertagnolli emphasized that participation in government-funded clinical trials has remained stagnant over the past 10 years, while that for pharma-funded research has skyrocketed.

“This is great,” she said. “I mean pharma is producing amazing results for us, and we wouldn’t want to de-emphasize that in any way. But we’ve got to get the trials out and funded and available for answering all those questions that are not of significant interest to pharma. That, to me, is one of the most critically important.”

Califf said that when it comes to clinical trials for cancer research, the theory is quite advanced — it’s translating that theory into practice that has proved to be a challenge.

In response to a question about CMS’ role in generating new research in healthcare, Califf said it should be involved, though he sidestepped giving specific policy considerations as internal conversations are ongoing.

He said that while he wouldn’t expect payers to run research themselves, he does think they should consider how they can help find the answers so they know what therapies to pay for. He reiterated the need to tackle the declining life expectancy in the US, a common talking point of his, citing new research showing that life expectancy for men has dropped to 73 years, six years behind women.

He also pointed to private insurers as bearing responsibility for ensuring that confirmatory trials for accelerated approvals are carried out. He said during a meeting earlier this year with the insurance lobby AHIP, he was asked why post-approval studies take so long to conduct.

“My answer was, you tell me what you’re doing to help get them done, because when I talk to clinicians, they say the number one impediment to getting the studies done is the requirements of the insurance companies,” he said.

New NIH chief stresses focus on obesity, clinical trial challenges