David's New Book

Sunday, May 3, 2020

What Have We Learned?

Those who cannot remember the past are condemned to repeat it. (George Santayana).

Never let a good crisis go to waste. (Churchill?, Emanuel?).

It’s tough to make predictions, especially about the future.  (Y. Berra).


We are still at the beginning of a tragic, horrible pandemic that is both robbing us of lives, of our livelihoods, and disrupting the very fabric of daily life. Sometime, hopefully in the not too distant future, we will need to look at how this tragedy unfolded and come to grips with what we could have done to make it, at least, somewhat less tragic. The fact that several countries and societies were able to escape the worst of the pandemic provides us with opportunities to learn and to act. So does our long history of scientific warnings that just such a thing could occur along with years of guidance on how to prepare – all of which were ignored – for decades.

So, it is with something less than optimism that I try and understand whether we, as a national or even global society, are capable of changing in a way that will alter our approach to public health. The problem I see is not new.  Its old.  Its usually green. And it’s made of paper (and cloth). We need to invest money now to prevent or manage a public health threat that might occur sometime in the future. Our history in this regard is not encouraging. 

My lack of optimism is fed by our recent experience with the problem of emerging antibiotic resistance and our failure to provide the financial incentives required to address this public health threat. Anyone who has been reading this blog for the last several years will be familiar with the issues.  Ditto for anyone who follows John Rex’s publications and blog. Mainstream media even picks up the topic from time to time. But to summarize – bacterial resistance to antibiotics is a growing problem worldwide. While relatively small numbers of patients have infections that are so resistant they are difficult to treat, these numbers are growing.  At the same time, our antibiotic pipeline is dismally inadequate to provide for new therapies for these resistant infections. One major reason for this situation is the fact that there is no real market for new antibiotics because, luckily, the numbers of patients with highly resistant infections are too low to support sufficient revenues from new therapies.  This has discouraged both large pharma and investors from research and development of new antibiotics.  Our meager pipeline today is provided almost entirely by small biotechs.  So far, almost all of those who have successfully developed a new antibiotic active against resistant infections have gone bankrupt (or the equivalent) shortly after commercialization. 

Why do I bring this up in the context of learning from the covid pandemic? Last week the Government Accountability Office released another report on antibiotics and antibiotic resistance. This government watchdog group has written a number of these in the past looking at the FDA and its role in the use of antibiotics in animal husbandry and our lack of ability to adequately monitor antibiotic use in human populations.  The latest report, similar to previous efforts, focused on the federal approach to addressing antibiotic resistance.  They covered a number of areas including surveillance of emerging resistance, the potential role for diagnostics in detecting and treating resistant infections, efforts to improve antibiotic use, and, most importantly for me, the insufficiency of federal efforts to incentivize antibiotic research and development.  For this latter point, they highlighted the need for the very incentives we have been discussing for years – market entry rewards, transferable exclusivity vouchers, or even value-based reimbursements (as an appropriately lower priority). The GAO faults the Department of Health and Human Services essentially for failing to lead and failing to provide a strategy to achieve the needed incentives. The response from HHS - HHS did not concur with the recommendation that it develop a strategy that includes the use of postmarket financial incentives to encourage the development of new treatments for antibiotic-resistant infections, citing its ongoing analysis to understand whether postmarket incentives should be included in such a strategy. This does not inspire confidence since these incentives and the need for such incentives have been the subject of innumerable conferences, reports and peer-reviewed publications. 

Will we have learned that our hospitals must be prepared?  That they must have sufficient surge capacity? Have we learned the potential importance of our Strategic National Stockpile?  Have we learned that the ability to rapidly design and deploy diagnostic testing is critical to success for the next pandemic? Have we learned that early testing and contact tracing is essential to avoiding the kind of mitigation by social distancing that has paralyzed the global economy? 

We can only hope that the recent GAO report and the HHS response will not exemplify our willingness to learn from the covid pandemic. If we do not act, the pronoun “we” is the key.  Our government is, in fact, us. If we do not force our representatives to act, they may well ignore our history and force us to re-live it. 

 

3 comments:

  1. I too am pessimistic. The free market is a powerful idea mostly. America's irrational faith that it fixes all problems and is at its best when it is free from government interference is a fairy tale. National defense, whether it is preparing for war at sea or for a pandemic, is a government function. As you aptly expressed, we must elect representatives who understand the imperative to act and to challenge the myth that free markets address all problems.

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  2. Free market always works... if the free market creates a balance. You need to generate something to sell in- you won't generate it if it is perceived worthless. Government needs to do one thing - costs little - deincentize old innovation at the expense of new invention. The laws were created to do this - but sometimes old things remain too long and new becomes devalued and deincentized. I don't think more institutions are needed to solve the problem - it is more simple that people make it out. The reality is - are we ready to deincentize old antibiotics. This is the question - my guess is no. Until that time - there really is not much discussion without a tonne of federal funding for a problem that still isn't fixed. This will waste money.

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  3. Do you mean taxing the use of generic amoxcillin, cephalexin, trimethoprim, cipro, levo, doxycycline, daptomycin, linezolid? The taxation would have to be massive to correct the free market solution, at a time when the general public is in an outrage about the cost of prescription drugs. We come to the same pessimistic conclusion, and I don't see how taxing or disincentivizing generics is in any way the 'free market' in action. My view is that public health (and the universal healthcare that is surely coming) has a legitimate interest in subsidizing production of new antibacterials that address the MDR crisis. What is the 'free market' solution for preparing for the next pandemic? Exactly.

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