Monthly Archives: December 2014

Will the National Security Council Spearhead Government Effort to Combat Antibiotics Resistance by New Superbugs?

The President’s Council of Advisors On Science And Technology (PCAST) issued a report in September to the president on the increasing resistance of killer bacteria to existing antibiotics and the threat it poses to the United States and the rest of the world. The report received minimum fanfare but was referenced in today’s NY Times article “Superbugs Kill India’s Babies and Pose an Overseas Threat” concerning the increase in antibiotic-resistant bacteria in India and the threat this poses to the rest of the world. The PCAST report reviews the growth of this problem of drug-resistant bacteria and offers potential solutions.

The PCAST report starts off with us imagining a world without antibiotics, like it was at the turn of the 20th century when “…as many as nine women out of every 1,000 who gave birth died, 40 percent from sepsis. In some cities as many as 30 percent of children died before their first birthday. One of every nine people who developed a serious skin infection died, even from something as simple as a scrape or an insect bite…” And the list goes on. We’ve grown accustomed to having antibiotics at our beck and call. Infection? Run to the doctor and get a shot. Magically you’re cured. Only that’s now changing. In India, according to the Times article, as many as 58,000 babies die annually from infections caused by these so-called superbugs which thrive in India’s sewers, rivers, and people due to poor sanitation. While this is only a fraction of the infant deaths in India, the number is increasing dramatically every year. More importantly, now some of these bugs have migrated to Europe and the US to join those that we already have here. Furthermore, these new so-called superbugs are virtually immune to all existing antibiotics.

This issue of the growing number of so-called superbugs is not new but it’s rising in importance. According to the PCAST report the CDC estimates the cost to our economy of the health care related to these infections at $20-35B. This will only go up as more of these superbugs appear and become more common. This issue has arisen from the overuse of antibiotics in humans and in agriculture. Furthermore, there are few new antibiotics in the pipeline because of the difficulty in creating these drugs, the long and expensive development and testing process required , and the lower profit numbers associated with antibiotics.

The limitation in the profit making ability of antibiotics is not to be taken lightly. Most of the superstar drugs today are lifestyle drugs in the sense that they don’t cure you but they control symptoms over your lifetime. They’re medicine you’re likely to be on for the rest of your life. A recent Tuft study estimated the cost of bringing a drug to market at more than $2.5BLifestyle drug development costs can be recovered over years, as opposed to drugs like antibiotics which involve a short twenty or thirty pill prescription and you’re done. We can see the impact of the costs for short run drugs in lifesaving cancer drugs that are taken for a relatively short time by a limited number of people and cost hundreds of thousands per year. In contrast, the “lifestyle” drugs taken over many years, e.g., cholesterol control, heart, and arthritis drugs, cost in the $5000/yr range. The expenditures for developing both types of drug are relatively similar. It’s the number of people using them and the length of time they’re used that result in the different prices to the user. There is some concern that the development and clinical costs for antibiotics may be still higher, making it even more difficult to recover costs.

The PCAST report recommends appointing a member of the National Security Council as Director for National Antibiotic Resistance Policy (DNARP), who would report to the president to help coordinate a top-level government-wide Task Force on Combating Antibiotic Resistant Bacteria (TF-CARB) that is co-chaired by the Secretaries of Agriculture, Defense, and Health and Human Services. They will be tasked with developing steps to address the antibiotic-resistant bacteria that include:

  • Expanding the surveillance of antibiotic use. The report indicates that 50% of antibiotic prescriptions are not needed and that is “a major contributor to rising antibiotic resistance.” This effort will include funding support for improved data gathering by local public health organizations to report on the use of antibiotics and to gain better data on the scope of the problem.
  • Increasing the longevity of existing drugs by better managing their use, addressing outbreaks, and working to reduce the growth in antibiotic-resistant organisms. This includes addressing the issue of the use of antibiotics in agriculture.
  • Increasing the rate at which new drugs to combat these infections are developed. This includes adding additional direct federal funding to support R&D, using non-traditional organizations such as DARPA (the Defense Advanced Projects Agency), addressing the costs and time required to approve these drugs, creating new economic incentives to pharmaceutical companies, and offering prizes (similar to the X prize) for new diagnostics.

Some may feel this is another power grab by the government and that it can be simply addressed by market forces. Well, the fact is, the market hasn’t responded yet because of the cost and profit issues mentioned earlier. The PCAST working group included members of the agricultural, biotech, and pharmaceutical industries from such organizations as AstraZeneca, Iroko Pharmaceuticals, GSK, Norvartis, and Smithfield Foods. To wait for the market to respond will be too late. The reduced effectiveness of antibiotics is rapidly becoming a major public health issue that will eventually impact all of us, especially our children and grandchildren. Hopefully, this effort will not be stymied by the rancor and partisanship in Washington.