Life expectancy within the U.S. is between three and five years lower than the common in other high-income countries — and the gap is available in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said.
“It’s looking worse, not higher, over the past several years,” Califf told CNBC in an interview Thursday on the agency’s headquarters in Silver Spring, Maryland.
related investing news
It isn’t just the Covid pandemic contributing to the decline, he said, declaring the gap with peer nations is widening. Califf said a latest factor has joined the list of known causes of life expectancy disparities like race, ethnicity, income and education: living in a rural area, where he noted that individuals are exposed to different information sources.
“Why aren’t we using medical products as effectively and efficiently as our peer countries? A variety of it has to do with selections that individuals make due to things that influenced their pondering,” Califf said.
The commissioner is just greater than a 12 months into his second turn at the highest of the agency, one among only two top leaders of the FDA to return to the job for a separate second term. Since he left in January 2017, at the top of the Obama administration, the pandemic and rising political tensions have made combating misinformation much more complicated — and led Califf to make it one among his top priorities on the agency.
“You concentrate on the impact of a single person reaching a billion people on the web everywhere in the world, we just weren’t prepared for that,” Califf said. “We do not have societal rules which are adjudicating it quite right, and I believe it’s impacting our health in very detrimental ways.”
He said there is a need for higher regulation, including “specific authorities at FDA, FTC and other areas” to root out misinformation.
A much bigger bully pulpit
Califf spoke to CNBC a day before a federal judge suspended the FDA’s approval of abortion pill mifepristone, a call that might have broad implications each for abortion access and regulation of future drugs. The FDA commissioner spoke about multiple topics including efforts to chop drug prices, a priority for the Biden administration and lawmakers from each parties in Congress.
Food and Drug Administration Commissioner Robert Califf testifies before a Senate Health, Education, Labor, and Pensions hearing to look at an update on the continuing Federal response to COVID-19, on the U.S. Capitol in Washington, U.S., June 16, 2022.
Kevin Lamarque | Reuters
Califf noted that while the FDA doesn’t play a direct role in pricing medicines, it has tools to influence drug costs.
“We now have an indirect role, and we now have a bully pulpit to make the general public aware and put some pressure on,” he said, noting that he has previously said drug prices are set by “what you may get minus the shame factor.”
Califf recently wielded a few of that power after the agency approved the primary over-the-counter version of Narcan, an opioid overdose reversal drug. He tweeted that the FDA encouraged the manufacturer, Emergent BioSolutions, to make the drug available “as soon as possible and at a reasonable price.”
He plans to make use of that bully pulpit in a much bigger method to rein in drugmakers on pricing — while attempting to walk a fantastic line with checking a pharmaceutical industry that he noted produces lifesaving products from vaccines to statins.
“There is a balance here that we now have to achieve,” he said. “And in some areas we’re not in the proper balance at once.”
Incentives for research
Califf can be encouraging the drug industry to contemplate investments in neglected areas of research. He spoke with CNBC the day the agency withdrew approval of the one available drug for preterm birth, Makena, after a confirmatory trial didn’t confirm its clinical profit.
“The info were quite clear,” he said. “But we must always be reminded that we’re seeing an explosion of maternal mortality on this country and a whole lot of premature delivery resulting in prolonged illness and neonatal intensive care unit stays for infants.”
“We want effective treatments,” Califf said. “And the industry will not be producing much in the way in which of effective treatment.”
He also pointed to tobacco cessation products and nonaddictive medicines for chronic pain as areas “where the industry will not be really producing.”
Incentives put in place by the FDA and others in areas like cancer and rare diseases have revolutionized drug development for those conditions, and similar efforts could assist in the event of other treatments, Califf said.
“Now we have to return to those other areas and work out what to do to stimulate activity,” he said.
Recent obesity drugs
On the alternative end of the spectrum for drug industry interest are latest medicines for obesity and diabetes, like those from Novo Nordisk and Eli Lilly: Ozempic, Wegovy and Mounjaro.
Califf, a cardiologist, said he has “great hope for this class of medicine,” noting it’s one among a growing variety of classes of medicines “which are coping with the axis between our gut and our brain.”
“A variety of the things that we thought were willpower before, we’re now coming to grasp that our bellies are signaling our brain and vice versa, through endocrine pathways,” he said.
He noted he’s looking forward to results from studies generally known as outcomes trials taking a look at whether the medicines lower the chance of heart disease and stroke when utilized by people who find themselves obese but do not have diabetes.
“If that pans out, we’ll have some major decisions to make as a society,” Califf said. “When can we add the drugs to the recommendation that we’re giving to people in the overall population?”
Results from Novo Nordisk’s outcomes trial for Wegovy are expected this summer. Questions may remain in regards to the longer-term safety of taking these medicines: Novo Nordisk’s executives have noted patients must keep taking the drugs to sustain weight reduction.
Califf said the U.S. could improve its data collection systems using electronic health records to trace things just like the long-term safety of those drugs.
“If you need to know if a security signal goes to pop up, we must always have the ability to assay the composite of electronic health records of individuals on the treatment and never on the treatment, and we must always have the ability to do long-term, randomized clinical trials at a really low price,” Califf said. “We’ve not developed that system within the U.S.; the UK and Israel are way ahead of us in that regard and we’d like to catch up.”
Califf also noted it’s possible the drugs will prove to be safer than hoped. He cited statins — for prime cholesterol — and medicines for hypertension. He said the profile of those medicines “looks higher and higher over time.”
He also took issue with the concept that patients must take the brand new obesity medicines indefinitely to maintain weight off.
“It’s true in the event you stopped the drug after some time period the load would come back up, but I’m undecided these people have gotten the behavioral interventions,” Califf said.
He pointed to other areas of drugs where “people feel like they only cannot succeed,” like smoking cessation, where a medication along with clinical care means “it will not be the case that it’s very an irreversible situation where you are just going to bounce right back.”
As use of the medicines has exploded, resulting in jokes about Ozempic on the Oscars and on “Saturday Night Live,” Califf said it is not the FDA’s place to opine on off-label use of medicines.
“We won’t interfere with the practice of drugs, and we cannot do this,” he said. “We want to make our communications clear about where the evidence exists for where the advantages outweigh the risks.”
But one word of caution Califf did issue was on use of compounded versions of the load loss drugs provided online by unauthorized suppliers.
“Compounding is very regulated,” Califf said. “It should only be utilized in specific circumstances. Fraud use for weight reduction will not be one among those.”
— CNBC’s Leanne Miller contributed to this report.
Disclosure: NBCUniversal is the parent company of CNBC and NBC, which broadcasts “Saturday Night Live.”
