Monday, June 15, 2020

Reach Out - Leave the Echo Chamber

Last week, a special issue of the American Chemical Society Infectious Diseases journal focusing on antibiotics was published.  This issue is a great collection of science, research efforts and opinions that will be of interest to all. It was guest edited by Mark Blaskovich. The articles are all open access – I contributed two viewpoint papers.  One drawback, once again, is that the special issue is laser-focused on those already interested in antibiotics, the pipeline of new drugs, and the crisis of emerging resistance. It does not, and probably cannot (given the journal’s raison d’ĂȘtre) draw in those readers we need most – those in fields of medicine outside of infectious diseases. We need interest and action from internists, oncologists, pulmonologists, intensivists, transplant specialists, surgeons, emergency medicine docs and their respective professional societies. I have blogged about our echo chamber in the past, and things seem not to be changing. If we cannot convince our colleagues that there is a serious and growing threat to their ability to continue to treat bacterial infections, then we cannot expect governments to believe us either. 

Why is this so hard? In one of my viewpoint articles, I discuss some of my own experiences caring for patients with various infections - from those that responded dramatically to penicillin to those completely refractory to everything in the toolbox. But these patient encounters are not isolated to infectious diseases physicians and microbiologists. They involved surgeons and intensivists. I can think of myriads of other patients with challenging bacterial infections that I did not discuss where I interacted with a host of other specialists and subspecialists.  All of them will probably remember those very difficult cases whether the end was tragic or not. I certainly still remember them. 

Of course, one reason it may be difficult to recruit those in other areas of medicine to our cause is the matter of patient numbers.  Us infectious diseases specialists see these challenging patients all the time.  It’s our job. But surgeons, for example, only see those for which they consult us. And those numbers, hopefully, are small. Therefore, it is more difficult for them to see today’s need and the looming threat of tomorrow. We must rise to the occasion to help them see that the rare difficult to treat patient they saw this year will become the one they see every month then every week in coming years if we don’t act now. They must unite with us in common cause.

Today, we are struggling with a pandemic viral infection. Those of us who are ID physicians will recognize the failure of all of the effort that went into pandemic planning at least at the beginning of the pandemic. Now that we are catching up (I hope), will we be able to recognize this failure?  Will we learn that sometimes those with special expertise and knowledge can provide useful guidance in preventing catastrophes that threaten our future health and that of generations to come? Our failure to deal with the antibiotic market crisis and its inevitable consequence of a failing pipeline of new and useful products does not have to be the end.  We can still alter the future by investing now as we should have done to prepare for a pandemic like covid. This, however, is a lesson that I am not sure that we have learned. For short term thinkers, investment in the future is a severe challenge. But this is an argument that we must make and do so in the strongest terms. To do that, we need the help of colleagues outside of our infectious diseases bubble. 

This is a job for the infectious diseases professional societies. In perusing the IDSA website, I find precious little in the vein of outreach to other professional societies. There are guidance documents established with other societies, but they are often years in the making and without the kind of outreach that we are discussing here today. 

In the absence of sufficient efforts from our own professional society, I am going to ask that all of you in our echo chamber discuss the problem of the antibiotic pipeline, the market and emerging resistance with your non-ID colleagues. Explore with them the possibility of joining our cause. Reach out to IDSA as well – I can’t be the only one preaching this line of argument. 

If we are not successful soon, we may be dealing with years of drought in the face of emerging resistance. 

Monday, June 1, 2020

Now Will Europe Pull it Together?

Could Europe’s recent moves to provide bailout monies Europe-wide have implications for incentives for antibiotic R&D? A few months ago, Christine Ardal and colleagues published a paper discussing the European approach to these incentives. In their paper, they noted that decisions around drug pricing and everything related to drug reimbursement were the responsibility of the various national authorities and not the European Commission. They did suggest that the European Medicines Agency, the European regulatory agency from drugs, could identify products that would qualify for any incentives that might be available. They suggested that individual countries could contribute to the European Investment Bank to support a regional incentive. Ardal et al also pointed out that Europe assumed that their responsibility for such in incentive on a global scale would be about 30% based on antibiotic market data. I wrote an editorial response to their paper where I suggested that incentives for antibiotic R&D would have to be a European responsibility since that was the only authority with enough financial clout to provide effective incentives for the region. Relying on the contributions of individual countries, I suggested, would not be sufficient. Ardal et. al. did note that transferable exclusivity vouchers would be possible in Europe, but that any “guardrails” that might be required to limit the size of the reward would still be a decision of the national authorities. This, in my view, renders that approach impossible. Further, I noted that even if Europe could agree to provide an incentive that amounted to 30% of what is required, there might be no point since the participation of countries outside of Europe and outside Europe’s control would also have to agree to participate. I suggested that Europe as a region could take the lead in providing a more substantial incentive for antibiotic R&D if for no other reason than to protect their vulnerable populations.

Enter the coronavirus pandemic. According to the New York Times, “The European Commission, the bloc’s executive branch, on Wednesday proposed that it raise 750 billion euros, or $826 billion, on behalf of all members to finance their recovery from the economic collapse brought on by the virus, the worst crisis in the history of the European Union.” “’This is about all of us and it is way bigger than any one of us,’ Ursula von der Leyen, the commission president, told European Parliament members in a speech in Brussels. ‘This is Europe’s moment.’”

In my editorial, I cited Flora Lewis’ book, Europe, A Tapestry of Nations, in discussing the balance between lines of national sovereignty and European union. Since the establishment of the European Union in 1993, and its precursor, the European Economic Community back in 1958, all aspects of finances and health including taxes, health insurance, drug pricing and others were responsibilities of the national authorities. This changed little with the introduction of the Euro to a portion of European Union countries in 1999. But here we are today, 27 years after the formation of the European Union, with the first steps of Europe into federalism. And with federalism comes the ability to commit Europe, with all its member nations, to common financial activities for the good of all. Incentives for antibiotic R&D should be one of the first European priorities of this new federalism.