Life expectancy in the U.S. is lagging behind other high-income countries, with a gap of three to five years, according to what Dr. Robert Califf, the commissioner of the Food and Drug Administration (FDA), told CNBC in a recent interview.
Dr. Califf believes that the spread of misinformation contributes to the decline of life expectancy, which has worsened over the past few years. The rural population, where access to a variety of information sources is limited, is particularly affected. Dr. Califf, who is now in his second term as commissioner, cited misinformation as one of his top priorities, saying that a lack of societal regulations is causing detrimental effects on health.
The Need for Better Regulation of Misinformation
Dr. Califf emphasized the need for better regulation, calling for "specific authorities at FDA, FTC, and other areas" to tackle misinformation. As the interview emphasized, the FDA has an "indirect role" in pricing medicines, but it can influence drug costs through its tools, and it can make the public aware and apply pressure to reduce drug prices. Dr. Califf hopes to strike a balance in pricing that encourages drug manufacturers to invest in research areas neglected by the industry. The commissioner also highlighted the need for effective treatments for maternal mortality, premature delivery, tobacco cessation, and nonaddictive medicines for chronic pain.
New Obesity Drugs in the U.S.
Obesity and diabetes are two of the most significant health problems facing the world today, affecting millions of people worldwide. However, recent developments in the drug industry are bringing new hope to those who suffer from these conditions.
Novo Nordisk and Eli Lilly have developed a new class of drugs that focus on the relationship between the gut and brain, which includes Ozempic, Wegovy, and Mounjaro. These new drugs are gaining attention from the industry, offering a potential solution to the growing obesity and diabetes epidemic.
Dr. Califf, a cardiologist, expressed great hope for these new medicines, which are part of a growing number of classes of medicines that address the axis between our gut and brain. He anticipates the results of outcomes trials to determine whether the medicines can reduce the risk of heart disease and stroke in obese individuals without diabetes.
If the outcomes trials show positive results, society will face some significant decisions about when to add these drugs to the advice given to the general population. However, questions remain about the longer-term safety of these drugs. While the results from Novo Nordisk's outcomes trial for Wegovy are expected this summer, executives have noted that patients must continue to take the drugs to sustain weight loss.
Dr. Califf suggests that the US could improve its data collection systems using electronic health records to track the long-term safety of these drugs. The U.K for example is currently ahead of the U.S. in this regard, but it is essential for the U.S. to catch up. Dr. Califf believes that long-term, randomized clinical trials can be conducted at a low cost if the composite of electronic health records of people on the treatment and not on the treatment is assayed.
While the drugs' long-term safety is yet to be established, Dr. Califf is optimistic that they could prove to be safer than initially anticipated, citing statins for high cholesterol and drugs for high blood pressure whose profile looks better and better over time.
Dr. Califf disagrees with the idea that patients must take the new obesity medicines indefinitely to keep weight off. He suggests that they may not have received adequate behavioral interventions. He pointed to smoking cessation as an example, where a medicine, in addition to clinical care, can help individuals succeed.
The use of these medicines has exploded, and there have been jokes about Ozempic at the Oscars and on Saturday Night Live. However, Dr. Califf notes that it is not the FDA's role to opine on off-label use of medicines. He believes that the FDA's communication should be clear about where the evidence exists for where the benefits outweigh the risks.
Dr. Califf also cautions against the use of compounded versions of the weight loss drugs provided online by unauthorized suppliers. According to him, compounding is highly regulated and should only be used in specific circumstances.