Friday, October 21, 2016

Low Expectations

I don’t know about you, but for me, this is the season of low expectations.  My brother-in-law constantly reminds me to keep my expectations low and my standards high. In this US campaign season, I find that it is increasingly hard to avoid feeling blue by continually lowering those expectations.

A good example is the result of the UN General Assembly.  The opportunity to actually do something concrete about the emerging crisis of antibiotic resistance in the absence of a robust pipeline of new antibiotics was an exciting one. But as often happens when multiple players with competing interests get together to try and accomplish something, we now play a waiting game. Although what to expect at the end of the wait is not really clear.  Recently, Allan Coukell of the Pew Charitable Trust wrote a summary of the UNGA statement. 193 countries signed a political statement that is extremely vague and does not include any commitment for financial resources to spur innovation. 13 pharmaceutical companies signed a separate statement where exploring new ways for the public and private sector to collaborate to spur innovation was a goal. The divide between industry and government seems clear.  The UNGA expects to revisit the issue in two years.
What we need now is some way to assure antibiotic developers that they will achieve a return on their investment. There are a number of ways this could be funded.  First, the savings on health care provided by having the means to treat infections will be enormous – it just requires a capital investment in our future.  Second, if more immediate funding is required, we could charge a very small tax on current pharmaceutical sales that would be dedicated to an antibiotic market fund. This tax would be applied to all pharmaceuticals without exception – but would need to be pennies or less on the dollar.

A nagging worry for me is whether, at this point in time, even if we identify a financial mechanism to assure a return on investment, pharmaceutical companies will be interested enough to return to antibiotic research. I have been asking the folks at DRIVE AB to investigate this – but have heard nothing as yet. I recently heard that Merck was skeptical of the market entry rewards that we have been discussing.  They may be more interested in pricing and reimbursement as the preferred market mechanism.  That will likely remain the way forward in the US in any case.

We need to train our antibiotic hunters of the future before we lose all our expertise to the ravages of time and the current lack of funding for antibiotic research.

And we need to continue working on new regulatory pathways for antibiotic development – especially for pathogen-specific products.

We need to raise the prices of key generic antibiotics like penicillin to avoid drug shortages.

Beyond all this, we need to improve our surveillance globally, control the use of antibiotics in agriculture, and improve our stewardship of antibiotic use in humans. But even with these steps, we will have a constant need for new, effective antibiotics and for that we need to correct our current problem of the market failure for antibiotic discovery.

I find that I am unable to lower my expectations sufficiently to avoid this current state of depression around the state of progress in global antibiotic policies that is afflicting me. A sure cure would be the commitment of at least a few national authorities to the market entry rewards that Astra-Zeneca was negotiating before their antibiotics business was sold to Pfizer. But, alas, I fear that all this is now on hold.

Tuesday, October 4, 2016

Holding our Breath

The crisis of antibiotic resistance and our failure to produce a robust pipeline of new antibiotics to combat the problem is not going away. And we’re not doing what we need to do.  We are all just holding our breaths, sticking our heads in the sand and pretending the problem will go away before we have to go to the hospital and face the crisis in a very personal way.

The CDC just published a report in JAMA looking at antibiotic use in US hospitals. The study only looks at the years 2006-2012. They found that about 55% of all hospitalized patients received at least one dose of an antibiotic during their stay.  If my memory serves, when I was in practice in the 1980s and 90s, 75-80% of patients were treated with antibiotics – so at least things have improved since then.  But the 55% number has been stable during the years of this current study.  But what changed over time was the use of certain antibiotics.   Carbapenems, B-lactam-B-lactamase inhibitor combinations, and tetracyclines (I presume tigecycline) saw increased use by 30-40% during the years of study.  Certain other classes, like the fluoroquinolones for example, saw a decrease in use over the years of study. This suggests that physicians are increasingly worried about resistance and are treating their patients as if resistance was already a problem in their hospitals – and they may well be correct. 

On the bright side, we had a historic first this year with a statement from the UN General Assembly on the threat of antibiotic resistance to global health and the global economy.  But on the downside, the statement contained no serious targets and no funding.

The US just saw its first debate between the major party candidates.  We heard about Miss Universe, taxes, ripoffs and many other important topics but not a single word on antibiotic resistance.  This total disregard has been the story of the US presidential campaign so far.

The US congress just passed a funding bill that included $1 billion for efforts to fight the Zika virus – probably too little too late.  But on the problem of antibiotic resistance, perhaps the greatest emerging health crisis we have ever faced, we got bupkus.

In Europe we look to the United Kingdom for leadership in dealing with the antibiotic resistance crisis. Dame Sally Davies, David Cameron, George Osborne, Jim O'Neill, the Wellcome Trust have all been key leaders in the fight to actually get something done before we end up in an era where simple surgery and modern cancer chemotherapy could be life-threatening because of complicating antibiotic resistant infections. What happened there?  Brexit – that’s what happened. Cameron and Osborne are gone. Dame Sally and the Wellcome are still there – but where?

The most frustrating part of this is that fixing the problem is not rocket science.  Its not like sending humans to Mars. OK – the science of discovering new antibiotics is not easy.  But, as I have stated in many previous blogs (1, 2, 3) and as the O’Neill Commission has repeatedly pointed out, we can do this.  We have already come a long way in fixing our broken regulatory system (mainly a US problem). We need to invest (yes, as in money!!!) in antibiotics to shore up our failing free market system.  We need to invest in training our antibiotic hunters of the future. We need to get smarter in our scientific approaches.

What is missing?  What is holding us back? There is clearly an absence of public awareness of the seriousness of the emerging problem. We may not see a surge in public concern until the crisis is already upon us in full force. Those in positions of public responsibility must act responsibly and with foresight.  If they don’t, our children, our grandchildren and we ourselves will pay a price too terrible to contemplate.