Politics. At a press conference called years ago to update the press on the condition of baseball legend, Mickey Mantle, after his liver transplant, one member of the press inquired about the condition of the donor. The surgeon’s reply is legendary, “You must be a sports reporter.”
Much of the story of COVID-19 has been covered by political reporters – most science and health reporters have long ago been determined expendable in a consolidating media environment – and that has shaped the public’s understanding for the worse. For many, the complexity of a tenacious, often deadly, virus and need for careful, rational public health policy was reduced to a series of little bell-shaped curves on the New Your Times home page.
What politics giveth, so too can it taketh away.
That task starts with eliminating the signs and symbols on which politicians and those that follow them around depend. Knowing full well, that White House reporters and the public at large and not going to hold President Joe Biden to account for a shortage of vaccines around the world if the people of New Jersey are satisfied.
After bending not one, but two, AdComms to their will, the White House is making good on their promise to have boosters available to most Americans this fall. To the extent they are used, they can diminish the breakthrough infections that are more common than anyone at the CDC wants to admit but dutifully appear in all those little bell curves.
When outbreaks do appear, the ~ $2B in rapid antigen tests the administration has ordered from BD, ABT and QDEL will allow for self-care outside of the public health reporting system, making those bell curves even smaller.
It is great public health policy or even “following the science?” Hardly. Is it good politics? Definitely
Policy. COVID-19’s final victim, when outbreaks are finally reduced to a manageable scale, will likely be the decades old process of evaluating and clearing medicines for public consumption. While BIIB’s Aduhelm approval inspired the biopharma equivalent of, “I'm shocked, shocked, to find that gambling is going on in here,” it is an open secret that quite a few therapies make their way to the public with very little data to support it.
The accelerated approval pathway had already become a bit suspect as drug companies frequently failed to produce the clinical evidence promised for the approved indication. The FDA has only just recently begun demanding it. The citizens petition idea was well intended in an era before technology allowed drug companies or their willing advocates to flood the FDA with appeals and anecdotes, overwhelming advisors.
Finally, as COVID has demonstrated, the very structure of the process designed to collect the information necessary to answer questions about safety and efficacy has come up short. Historically, people who participate in clinical trials tend to live within a short drive from a major research university. They are also willing to take the risk they receive the placebo instead of the therapy. A research university’s overriding interest in grant income, rather than health outcomes, has frequently allowed them to look the other way when evaluating the quality of their study population.
When Clinical Research Organizations and research hospitals closed and slowed, they turned to digital and remote solutions. That shift begs the question, “If remote and digital collection of clinical data are possible during pandemic-time, why not all the time? As premarketing applications roll in, dependent in part on digital and remote data collection and other innovations, the FDA and other federal regulators are going to have a hard time ignoring it. So too has the precedent of real-world evidence been set with the FDA’s reliance on Israel’s RWE to support approval of COVID-19 boosters.
As Christine Lemke, Co-founder of Evidation Health, pointed out at the What’s Next for Health Care conference a few weeks ago, what they call Person Generated Health Data is collected seamless and continuously outside a health care facility, making the development of synthetic control arms possible and improving the quality of the study population.
The idea of distributed clinical trials is an idea whose time has come. It remains to be seen if the FDA and others can adapt.
Power. Woven through the objections to approving COVID-19 vaccine boosters for what amounts to the general population, is a subtext of global health priorities. An entire generation of public health leaders, supported by the priorities of organizations like the Gates Foundation, consider the battle against disease a uniting force across that vast terrain of differing political systems and economies.
Former CDC Director Tom Frieden has argued strenuously against approving boosters for lower risk populations and equally hard in favor of technology transfer. So too have the recently departed FDA vaccine regulators, Phillip Krause and Marion Gruber, asserted that vaccine supply should be delivered to the unvaccinated first.
For all the campaign trail talk about returning to and supporting the World Health Organization, the Biden Administration is planning to deal with the reality – political and public health - on the ground first while waving a hand in the general direction of Geneva.
Biden’s trade representative will continue to slowly and methodically negotiate the terms under which the mRNA vaccine technology can be transferred to low/lower income countries.
Very slowly.
Meanwhile the White House has agreed to purchase 500M additional doses to low/lower income countries, bringing total pledged donations to 1.1B. At the same time, the White House has shifted responsibility to other developed nations to meet the WHO’s goal of a world-wide vaccine rate of 70% by this time next year, knowing full well such an achievement is probably unlikely without the aggressive participation of the U.S.
The EU and WHO thought the “America First” crowd had been dispatched but it appears they may have overestimated President Biden’s level of interest.
Have a great rest of your weekend.
Emily Evans
Managing Director – Health Policy
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