University-based research and neglected diseases

Back in 1999, the organization Médecins sans Frontières (MSF or “Doctors Without Borders”) received the Nobel Peace Prize and did something a bit surprising with it: they spent it on drugs.

Or, more precisely, they invested in a new Drugs for Neglected Diseases Initiative (DNDi) that sought to develop an alternative model for the research and development (R&D) of new drugs for neglected diseases. By “neglected” we mean diseases that are only caught by people too poor to pay for medications: illnesses like malaria, visceral leishmaniasis (VL), sleeping sickness (human African trypanosomiasis, HAT), and Chagas disease. These sicknesses are currently treated by medications that are  too expensive, no longer produced, highly toxic, or ineffective.

Over a decade later, DNDi and other initiatives have highlighted some stark failures in the R&D process. Many of us were under the impression that R&D initiatives needed to further fuel private sector incentives for drug development. We were surprised to see the data on how the private sector patent-based pharmaceutical industry did indeed have high profits as a percentage of revenue (typically far higher than the average Fortune 500 industry) and per their tax records were not putting that revenue into R&D as much as they were funding marketing, executive salary and the like:

Looking further, an inquiry into the  inventors of 252 new drugs approved by the US Food and Drug Administration from 1998 to 2007 revealed that between a quarter and a third of did their innovations through university labs rather than industry; and if you narrowed the list of drugs to those that weren’t “me too” minor derivatives but truly novel therapeutically-significant innovations, the fraction attributable to university labs was even higher.

So it was appropriate that recently the group Universities Allied for Essential Medicines, a student-led organization run across several college campuses internationally, has looked into strategies to align university-based pharmaceutical research with population needs (e.g., rather than focusing on developing highly-profitable drugs like Viagra and hair-loss treatments that have little to do with public health…as much as I might need the latter). [Full disclosure: I worked with the organization in the past].

The group has done some interesting work, such as designing new patenting and licensing protocols for universities so that taxpayer-funded, university-based research can actually be licensed to pharmaceutical companies but ultimately still have legal provisions that allow low-income country populations to make use of them.

But their recent work also includes investigating whether the last few years of efforts to increase research into neglected diseases has actually sparked progress on university campuses.

Sadly, the answer–for most universities–is no. In their recent release of a “report card” on university research, the group finds that few universities are doing much of anything on neglected disease research.

The universities were graded on a number of criteria (take a look at their detailed methodology), including whether they invest in medical research that addresses neglected diseases, and whether they license their health technologies to for-profit companies in ways that ensure treatments reach developing world patients at affordable prices. The organization looked at the 60 highest-funded universities based on FY 2011 funding figures from the NIH and CIHR’s publicly available funding databases (RePORTER and Funded Research Information, respectively, as well as a few other public sources). They also evaluated 14 specific metrics of where research funds were going, based on self-reporting from university officials in response to standardized survey questionnaires. The metrics were standardized, and normalized with respect to degree of institutional funding, in order to produce fair comparisons between differently-sized universities.

Overall, the University of British Columbia came out on top (scoring an A- on its report card), particularly as it’s engaged in a number of licensing efforts to keep its inventions accessible to the poorest groups. Sadly, my university (Stanford) got a “C” (tying with Berkeley…boo).

From the university researcher point of view, a key challenge in “soft money” schools is to gain grants to conduct research on these diseases. And while the Gates Foundation and a few other initiatives provide venues to do so, the universities’ excuse is that there aren’t sufficient funds available, the NIH excuse for not funding these diseases is that they don’t affect Americans (and their foreign budget is dwindling), and the private funders are left to shore-up the remaining budgetary space. So we have proposed some alternative strategies. Of course, low funding levels don’t forbid universities from enacting open licensing strategies when they conduct research that’s of potential benefit to those who can’t afford to pay for medications–a key reason why alternative licensing mechanisms shouldn’t have a low barrier to adoption, since they affect neither university finances nor make meaningful dents in the revenues of for-profit manufacturers (since the poorest aren’t part of the market share anyway).