FDA Commissioner Califf Says Business Of Health Is Booming In US But Patients’ Outcomes Aren’t Improving

At a hearing last month, Food and Drug Administration (FDA) Commissioner Robert Califf pointed to the fact that the US is one of the greatest inventors in the world of medicines and other healthcare technologies, but in last place for life expectancy among other high- income countries.

What’s conspicuous about this factoid is that the US spends the most in the world on healthcare – both in absolute and relative (per capita) terms. Of course, the provision of healthcare isn’t the sole cause of rising life expectancy. Other factors play a role, too, including baseline characteristics of health, such as levels of obesity and socioeconomic determinants of health. Nonetheless, healthcare contributes greatly to improvement in life expectancy. As such, clearly, something’s not right in the US The money that’s being spent isn’t leading to the desired outcomes.

During the hearing, Califf elaborated on what he considered to be a catalyst for a flawed healthcare system. “I’m in love with the term sub-optimization,” Califf said. He went on to define sub-optimization as a system with many parts that are incentivized to optimize their own growth, often driven by profit motives, but the system as a whole is less than the sum of the parts in terms of producing overall well- being.

Califf’s statement describes US healthcare well, and not just the pharmaceutical side. There are plenty of profits for stakeholders, whether in the drug channel – drug companies, pharmacy benefit managers, wholesalers, pharmacies, insurers – or elsewhere in the system, such as hospitals and clinics. Yet, the overall system isn’t delivering optimal levels of outcomes.

Public health, in particular, appears to be sputtering in the US Here, public health refers to health of the population as a whole; in other words, the branch of medicine that deals with population-wide disease prevention, epidemiology, and hygiene (for example, clean water, ventilation).

Where profits can be made in public health, they certainly are. Take, for instance, Covid-19 vaccines. Pfizer/BioNTech and Moderna have made a bundle. Indeed, developing, manufacturing, and supplying vaccines have gone incredibly smoothly. Efficient distribution, however, was an issue early on. And since then, on the demand side, there have been persistent problems, which public health authorities have failed to address adequately. These include first and foremost disseminating inconsistent public health messages about vaccines’ efficacy and safety: Not properly informing the public what vaccines do and don’t do, and what the implications are, for example, for the continued need for mitigation measures, such as masking and distancing, in certain settings.

Recently, public health officials have also done a very poor job raising awareness of the need for boosters, especially among vulnerable groups. The US’s extraordinarily poor uptake of boosters in at-risk groups compared to peer nations is an example of public health failure.

And so, despite the availability of Covid-19 vaccines, so many Americans died in 2021 that the nation’s life expectancy dropped for a second year in a row, according to a new analysis.

US life expectancy fell by approximately 6 months in 2021, adding to a dramatic drop of almost two years in 2020. Given the availability of vaccines, “the finding that instead we had a horrible loss of life in 2021 that actually drove the life expectancy even lower than it was in 2020 is very disturbing,” says Dr. Steven Woolf, a professor of population health and health equity at Virginia Commonwealth University.

While certainly not the only reason for such alarming life expectancy numbers, a sub-par public health system bears some of the blame. The US healthcare system lacks a cohesive structure and coordination among the various parts to achieve the desired public health outcomes.

As a further illustration, consider the Covid-19 treatment Paxlovid (nirmatrelvir). The supply and distribution systems for this product have been inadequate.

The rapid development and authorization of Covid-19 treatments should have done more to lessen the impact of the massive surge of Omicron cases during the winter. Unfortunately, acute shortages in some states – or in some jurisdictions within states – have led to major problems. And, these issues coexisted with other states – or jurisdictions within states – having surpluses.

The good news is that the Biden administration is widening access to Paxlovid by doubling the number of locations at which the therapeutic is available. From now on, pharmacies will be able to directly order the drugs from the federal government. Currently they depend on states to access the pills.

But, of course, had more attention had been paid to allocation mechanisms beforehand, distribution problems could have been prevented.

A common theme of deficiencies in public health is ill-conceived or simply unplanned allocation of resources. The total amount of money spent on healthcare isn’t the issue. America already spends vast sums on healthcare. It’s about optimizing the money being spent.

There are no easy fixes to what Califf asserts is a uniquely American problem. For many stakeholders, like most health insurers and pharmacy benefit managers, but also many drug companies, the business of healthcare has never been better. Nevertheless, outcomes of the people the system is trying to serve are not getting better.

The interests of the market and public health don’t necessarily align. Generally, there’s less money to be made in public health, which means the government must step in, not only to address market failures but also to establish an improved public health system at the federal and state levels.

However, judging from the winding down of current Covid-19 funding and the meager sums Congress is appropriating towards (future) pandemic preparedness, there would appear to be no sense of urgency on the part of the federal government.


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