Monday, December 13, 2021

Covid - Thank you to industry - Please do the same for AMR.


To all those who are skeptical because they worry that a government sponsored investment in the broken antibiotic marketplace is a give-away to the pharmaceutical industry, I have one word for you – covid! 

I would like to begin and end this blog with a big THANK YOU to everyone, in industry and outside industry, who have contributed to providing the tools we need to defeat this covid pandemic!

The Pasteur Act, currently before the US congress, will provide an advance payment for critical new antibiotics – a so-called subscription. This will de-link (mostly) sales volume from revenue by providing a guaranteed revenue even if sales volume is low. This in turn will guarantee that physicians and patients will have access to life-saving antibiotics even if the numbers of patients needing such a drug are low.  It will also provide a reserve supply of products that will serve in case of a larger outbreak of infection – John Rex’s fire extinguisher.  The Pasteur Act is desperately needed if we are to have an assured pipeline of new antibiotics to address the steadily growing threat of bacterial resistance. This threat has even been accelerated during the covid pandemic given the extraordinary use of antibiotics to treat patients with secondary bacterial infections. 


I know that those involved in writing this legislation have carefully constructed the bill as a pre-paid subscription.  This was partly to assure legislators that it is not a give-away to the pharmaceutical industry. It is just an upfront payment on product the sponsor or company must provide to the US with a number of additional obligations on said company. 


My own discussions with legislators suggest that many still see this as a pharmaceutical company give-away or are clearly worried that their constituents will draw this conclusion. These congresspersons and senators are much more comfortable supporting less costly approaches like funding research and development or like supporting efforts at antimicrobial stewardship to keep our current antibiotic armamentarium viable for a longer period of time. While I agree that research funding and antimicrobial stewardship are important, without a market intervention like the Pasteur Act, the entire antibiotic R&D effort will collapse.


Investors are happy to accept government funding for the research their portfolio companies undertake.  Why not?  They have to invest less and may still hope for a profitable exit. But without some decrease in market risk, there will be no investors.  Why?  Because most of the small companies that have brought new antibiotics to the marketplace over the last decade have gone bankrupt.  Why?  Because the small numbers of patients that need their products today cannot support enough sales to provide a return on the companies’ and sponsors’ investment. If you say “that’s as it should be” you are missing the point that if investors flee the area, we will not have new antibiotics when we truly need them – back to the fire extinguisher. 


To all those who are skeptical because they worry that a government sponsored investment in the broken antibiotic marketplace is a give-away to the pharmaceutical industry, I have one word for you – covid! Look at the miracle wrought by industry to help defeat this deadly pandemic.  Before covid, my impression was that the talent, dedication, drive and genius of scientists and others working in the pharmaceutical industry were seriously under-appreciated. We need to recognize that there is often a difference between academic research and the research that is conducted in industry.  In industry there is usually a practical goal – a vaccine or a therapeutic – that teams of scientists work towards. 


And for covid, look what industry achieved.  In a never-before-heard-of effort, the industry brought safe, effective vaccines to physicians and patients within less than a year of the recognition of the pandemic.  What an incredible achievement. And look at the diagnostics (vs the CDC), monoclonal antibody therapies and small molecule therapeutics that have come and are still coming to market in an incredibly short time frame.  


If companies had the same motivation, I’m sure that we could energize antibiotic research and development to the point that our pipeline would once again be robust as it was in the 1980s. 


For covid, the government did provide help by funding research, development and manufacturing in some but not all cases. There was no need for a market intervention here given the pandemic. In the case of antibiotic resistance and our feeble pipeline of new antibiotics, a market intervention is essential.  Without it we are lost. Do we want to wait until antibiotic resistance has reached the point where hundreds of thousands of Americans are dying of resistant infection to finally address the market failure that haunts antibiotic R&D? If we wait, since antibiotics are difficult to discover and develop, there may be a longer delay before needed new therapies find their way to patients while resistance continues to extract its toll.  


OK.  The pharmaceutical industry is not entirely angelic. There are issues around pricing (especially in the US), direct to consumer advertising, etc. But the pharmaceutical industry has proven that it is capable of miracles – not just for covid but also at the beginning of the antibiotic era (e.g. sulfa drugs, penicillin). We need to provide a robust market to unleash the talent of the industry against antibiotic resistance and we need to do this now. 


I would like to begin and end this blog with a big THANK YOU to everyone, in industry and outside industry, who have contributed to providing the tools we need to defeat this covid pandemic!



Thursday, December 2, 2021

Pull Incentives for AMR - Where is Biden?

 This will be a short note . . .

We are about to dedicate an entire ASM/ESCMID session to planning for the implementation of forthcoming pull incentives.  We do this because we all agree that without significant pull incentives to address the broken antibiotics market we will all pay a high price later. But where are these pull incentives and will they arrive in time?


We just celebrated (if you say that) Antibiotics Awareness Week around the world.  The White House in the US released a statement that said nothing about pull incentives at all. It referred to antimicrobial stewardship and to the National Action Plan to Combat Antibiotic Resistance (see the Pew summary noting its lack of provision for economic incentives). While I know that many working at top levels of the Department of Health and Human Services in the US support the idea of pull incentives, without the additional support of President Biden, I’m not sure whether we will see legislation like the Pasteur Act pass in the foreseeable future. 


After reading the White House release, I turned my attention once again to Europe. I have spoken to several contacts there who are convinced that Europe will devolve any expenditures for antibiotic subscription payments to the various national authorities of the European Union. This may contradict the impression that some (including me) have drawn from public statements coming out of Brussels.  And I was just getting ready to submit my comments for the European effort. That Europe will not take on incentives as Europe but rather through the various national authorities would be a wake-up call.  A subscription model that depends on 27 national authorities agreeing on criteria and eventual awards for products is doomed from the start. If Europe cannot act as Europe from Brussels, this shuttles the responsibility back to the US (in my view).  That means that the US must pass the Pasteur Act.  And that means that Biden must get off the sidelines and lead.


I understand that covid with all its variants is taking center seat in the administration’s concerns right now – and that is as it should be. But ignoring the steadily building problem of antimicrobial resistance is just setting the table for another crisis that could be if not avoided then at least diminished in its scope and consequences. Clearly, the presidency of the US is a tough job and comes with many moving parts. That’s why we elect those we think are most competent to take on that job. Biden must step up to antimicrobial resistance. I’m afraid that without his direct support we are headed to disaster.