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Harbour Navigator: A Dose of Reality: Key US healthcare controversies

Harbour sails 5
Kevin Bennett | Posted on Dec 10, 2024
  • At a Jefferies’ healthcare conference recently, concerns about the U.S. subsidising global healthcare markets were highlighted, with discussions on disparities in drug pricing and reimbursement practices. Globally, vaccine fatigue and misinformation remain significant challenges, as do funding pressures across the healthcare sector.

  • The conference emphasised advancements in vaccine technologies, including mRNA and saRNA, but noted potential higher approval thresholds under Trump’s incoming administration. Experts warned that declining vaccination rates due to anti-vax advocates, individual rights groups and associated misinformation, risk the loss of herd immunity and potentially a resurgence of preventable diseases.

  • Despite potential US political appointee uncertainties, most healthcare services and drugs are backed by rigorous scientific evidence, ensuring superior health outcomes. This evidence continues to underpin vaccine safety, efficacy, and healthcare advancements globally.

We recently attended a major healthcare conference hosted by Jefferies in London. While there was a wide range of topics debated, a lot of discussion focused on Donald Trump’s nominations for several key positions in the US healthcare sector for his forthcoming administration. The most discussed proposed nominee was Robert F. Kennedy Jr. (RFK) for Head of HHS (Health and Human Services). Several presenters also highlighted previous assertions by Donald Trump that the US was effectively subsidising the rest of the world’s healthcare markets.

RFK’s views on vaccines, fluoridation, chronic disease and US food supply have been some of his most controversial, although some of his more extreme comments have reportedly moderated in recent weeks. From a healthcare perspective, his anti-vaccine opinions need to be kept in perspective.

The keynote speaker at the conference was Peter Marks, Director for the Centre for Biologics Evaluation and Research (CBER), a key department within the FDA. His responsibilities included gene and cell therapies and vaccines. Mr. Marks did not see the incoming administration having any material challenges with gene and cell therapies, but acknowledged there would be a heightened focus on vaccines. He did not see any threat to already approved vaccines, but did acknowledge the threshold for getting new vaccines approved will probably be higher, although, in his view, “good” science should always prevail. Another area at risk is the funds made available to educate and promote the use vaccines to the general population.

A perspective put forward by several of the vaccine manufacturers was that the vast majority of vaccinations in the US today are voluntary (possibly as high as 90+%), reflecting those people who accepted the risk/benefit profile provided by vaccinations. There are only a small number of states mandating any vaccination schedule for children, and limited compulsory vaccinations in the broader community (including the US military). Therefore, the US usage of vaccinations today is effectively one of personal choice.

When assessing the outlook for vaccines, Mr. Marks felt it needed to be viewed in the context of existing perception. For better or worse, he believes the anti-vax movement and associated misinformation is already close to a peak. Despite vaccines having materially benefited the population during COVID-19 (COVID), the associated messaging failed badly. Vaccine fatigue, poor communication from authorities, a perception that individual rights were abused, and all the misinformation that was generated, led to a noticeable decline in vaccine rates in the last 3-5 years. He is hopeful that a more focused discussion on vaccines can address some of these issues head on. The counter factual is that the herd immunity that has been achieved for diseases such as measles, whooping cough and polio could run the risk of being lost. If not addressed, then there are “natural consequences”, including that epidemics may increase, and unnecessary lives may be lost.

It is worth noting that vaccine fatigue is not unique to the US. The Australian National Vaccination Insights project has revealed that six in ten parents are feeling distressed about vaccinating their children since the pandemic. Moderna Australia claims vaccine fatigue and misinformation worsened during the pandemic and contributed not only to public hesitancy around the COVID booster vaccination recommendations but also to a significant challenge of relatively low influenza vaccination rates.  

Another speaker, Dr Moncef Slaoui, who headed Operation Warp Speed, Donald Trump’s initiative to develop a vaccine to combat COVID in 2020/21, also reiterated the view that vaccines were not viewed as “evil” in the first Trump administration. That said, he felt that the industry would need to clearly demonstrate the benefits of new vaccines and more rigorous data may be required (remembering that the COVID vaccines enjoyed some short cuts over previous regulatory hurdles).

This potential for a higher evidence threshold for vaccines comes at a time when a raft of new vaccines are approaching commercialisation. These include second generation and novel mRNA (messenger RNA) vaccines, saRNA vaccines (self-amplifying RNA), combined protein vaccines, enhanced booster profiles and broadening coverage, and more traveller solutions, to name but a few.

The perception of vaccines in both the new administration and general population at large, may also be a function of the external environment. If we were to get another epidemic, such as bird flu migrating across to humans, and depending on transmission and mortality rates, arguably the current anti-vax ground swell could rapidly dissipate. The science behind vaccines is extremely robust and it remains one of the core first response treatments in times of any epidemic crisis.      

Countering the perception that the US consumer is being exploited by big pharma, a number of points were made throughout the conference by various big pharma representatives. The first was that the list price for drugs in the US was virtually never paid due to the archaic reimbursement practices in the US. The actual net price was often substantially lower than generally perceived (the so-called gross/net gap). Secondly, the litigious nature of the US meant a material additional cost impost on all drug manufacturers when selling into the US. Thirdly, after Trump’s first presidency, the gap between US and European pricing has narrowed.

The consensus view is that Trump’s incoming administration may feature some “extreme” appointees, however it is difficult to envisage any fundamental change. Yes, there will be heightened uncertainty, and the ongoing financial pressures on the welfare state will see plenty of headlines, but, realistically, the vast majority of healthcare services and drugs are supported by robust scientific evidence that they lead to superior health outcomes.

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