Europe is so far ahead of the US in its thinking on antibiotics and antibiotic resistance that we should all be ashamed.
For the last 15 years, Europe has led the way on the regulatory front making antibiotic development a top priority for its regulatory body the European Medicines Agency. None of the recent US administrations going back to Bill Clinton nor the FDA itself ever made such a statement nor have they acted in a way commensurate with this thinking.
In mid-2012, the FDA announced that it would reboot its antibiotic development guidelines to make them feasible and to target resistant pathogens. So far, I give them good marks for their efforts aside from various issues around their choice of endpoints for certain trials (see my previous blog on this on Science 2.0). But this effort has, unfortunately, been too little too late.
The result is that we still only have a small minority of large pharmaceutical companies pursuing antibiotic research and development and most of those are headquartered – guess where – in Europe. Glaxo-SmithKline (a United Kingdom company) has been in the game for a long time. Roche (Swiss) and Sanofi (French) recently rejoined the effort but seem rather lost. AstraZeneca’s (UK and Sweden) antibiotics effort faces an uncertain future with the CEO threatening to sell off the unit or to pursue “partnering” options. There are Cubist (a mid-sized pharma) and Merck in the US. While the FDA reboot might have contributed to getting Roche back into antibiotics R&D, AstraZeneca is considering abandoning the area in spite of the FDA’s recent efforts.
Both the FDA and Europe have been trying to make trials designed to win approval for antibiotics active against resistant pathogens more streamlined and less costly. Although the jury is still out on this, I believe that ultimately this will work. But it is more than clear that this will not be enough. What is missing is a clear mechanism for companies to reap a reasonable return on their antibiotic R&D investment. Once again, Europe is leading the way in thinking about this.
As I wrote in a recent blog on Antibiotics the Perfect Storm - It looks like David Cameron is following President Obama’s lead in establishing a task force to address the problem of antibiotic resistance. Of course, as I noted when Obama set up his task force – task forces are mostly a waste of time in my experience. But Cameron’s approach is different. He proposes to focus on the economics of antibiotic development. The idea is to identify ways of providing appropriate return on investment for companies who invest in antibiotic research and development. The task force is being headed by an economist, Jim O’Neill. Mr. O’Neill was the chairman of Goldman’s asset management group and is now an honorary professor at the University of Manchester. He clearly knows economics (he coined the term BRIC). Even if he doesn’t know much about bacteria or antibiotics, he is probably the right person to lead the task force envisioned by Cameron. Clearly, Cameron and O’Neill recognize that a constant pipeline of new antibiotics will be required to keep us one step ahead of the superbugs. And they recognize that the only way we will achieve this is to bring more companies into the antibiotics R&D game. I am therefore more optimistic about Cameron’s task force than Obama’s.
As I wrote in another recent post - In addition to Cameron’s task force, a
number of scientists and antibiotic experts are trying to organize a meeting
focused on the economics of a return on investment for antibiotic research and
development. The conference would be a
meeting with payers – that is large insurers like Aetna, United Health Care and
Kaiser in the US and with national authorities in Europe and in Asia. The main goal of the conference would to
provide payers with an understanding of what kind of data they would have from
feasible antibiotic trials targeting resistant pathogens, the kinds of data
that might be available outside such trials and then to have the payers respond
as to their needs for providing the kinds of reimbursements that would be
required to provide a return on the investment of pharmaceutical companies in
such products. Various payment models would be discussed (see this blog).
Another factor working against this concept is the multitude of task forces working around the idea – nibbling at its edges. There is the Transatlantic Task Force on Antibiotic Resistance (TATFAR), the President’s Council of Scientific Advisors whose report is imminent (PCAST) and the new task force put into place by David Cameron. Of these only the UK group established by Cameron is likely to broach payers – but they have a very EU focus. These efforts, in my view, distract us from the goal in many ways. We need implementation of existing ideas or a discussion that leads to implementation of new ideas. The key word here is implementation.
I don’t think we need new task forces or think tanks. I think we need to get payers to understand what is at stake and to get them to become stakeholders in this struggle.
I now believe that this meeting with payers will be critical to enticing big pharma back into antibiotics R&D because it will address the very pocketbook issues that deterred them in the first place.
It looks like this meeting will likely take place under European auspices. Once again – in the antibiotics game – its Europe 21, US 0.
Front page image credit: Vanderbilt