It’s NIGH Time

Last week, the Global Health Technologies Coalition (GHTC), a Gates Foundation-funded “advocacy” organization based in Washington, DC, added to the pile of reports on the US government global health policy by releasing “Saving Lives and Creating Impact” (GHTC report).  The GHTC represents a group of 40 nonprofit organizations “working to increase awareness of the urgent need for technologies [i.e., products such as therapeutics, vaccines, and diagnostics] that save lives in the developing world.”  This is a worthy goal but I can’t help but wonder about the effectiveness of an organization that purports to advocate for more products for improving health in the developing world and for “incentives to encourage private sector investment” in creating those products, but has no private sector (for-profit) members or advisors (Members and Steering Committee).  Unfortunately, the authors of the report start with two premises from the conventional wisdom of the non-profit global health advocacy field:

-“the US government has long played a [meaningful, substantial, important?] role” in the development of new global health products; and

-there is “insufficient commercial market to attract private industry” to develop global health products.

So, not surprisingly, they arrive at the conclusion that the solution is for the US government to do more of what’s it is doing now, especially in funding non-profits like academic researchers, non-profit product development groups (PDPs), and advocacy groups.  I read the report and came to a different conclusion.

To their credit, the authors do a good job in gathering together all the bits of the wide-ranging US government’s global health technology development effort.  Many agencies are involved in some way (hey, it’s the government where coordination and cooperation are not rewarded), primarily, USAID, FDA, DoD, CDC, and NIH.  Of the approximately $1.6 billion spent annually on global health research and development, the majority is doled out the by NIH (87%) and is spent at the early stages of development (66% preclinical and 20% on clinical) and mostly on the big three global diseases (HIV/AIDS at 57%, tuberculosis, 12%, and malaria, 10%), leaving 21% for the remaining twenty or so neglected (hence the name) and noncommunicable diseases.  The authors also do a good job in providing details on the sponsorship of the development of 43 products applied to global health between 2000 and 2010 (Table 1), and I counted US government involvement of any type in 24 (56%).  In the report’s text, four products are highlighted to demonstrate the importance of the governments role:  a vaccine for meningitis, a diagnostic system for finding drug-resistant TB infections, next generation HIV preventatives (microbicides), and improved TB drugs.

Since I wrote posts on the first two products, I think I am reasonably well-informed about their development, and, unlike the authors, my take is the that government role, while important (all help is important), was an participant, not as a leader or a catalyst.  Specifically, in the development of the meningitis vaccine (called MengAfrVax), FDA licensed a method of conjugating or attaching the basic parts of the vaccine together to the vaccine developers (the Meningitis Vaccine Project led by the non-profit, PATH) and transferred the technology to the manufacturer, the for-profit Serum Institute of India who committed to a low-priced final product (Watch Out Big Pharma? 12/16/10).  This was helpful, but the FDA expertise is regulation, not manufacturing, and the technology may have been available elsewhere.  I wrote about the TB diagnostic system in three posts (ReDux 1/6/11, ReDux Part II 1/13/11, TB Dx:  Getting There 3/1/12) and noted that the NIAID was involved by funding a university team that discovered the markers of drug resistance (in this case, DNA sequences), but the core of the product was the diagnostic platform developed by the company, Cepheid.

While the report’s authors mention the involvement of for-profits (companies) in product development, they don’t note the extent of involvement, which is greater than the US government’s (I counted 39 products or 84% of the total in Table 1) or attempt to figure out why in these cases, there was no “market failure.”  The authors also mention two programs in which the government can and does directly fund product development with companies, the Small Business Innovation and Research or SBIR program and the Cooperative Research and Development Agreement or CRADA program), but state, without support, the lack of company involvement is due to a lack of incentives and that SBIRs are “poorly suited” to stimulate company participation.  Interestingly, the authors mention that 40% of all SBIRs result in products, leading me to wonder if the percentage of SBIR awards leading to global health products is higher or lower.  I gave my opinion on the role of SBIRs in global health product development in one of my earliest posts (SBIR Drop in the Bucket 11/5/09) and argued that the government is not using this effective tool enough and that the funding can fill an important gap in supporting prototype development.  Maybe the authors may have benefited from more research on and input from the private sector.  Also interesting is their mention that there are more than 360 global health products in development and US government involvement in about half; I would have appreciated the same analysis they applied to existing products to these pre-products.

The report’s authors conclude with several recommendations that the US government:

  • maintain or increase its funding of global health technology development [why not redirect, especially away from the already well-funded diseases of the wealthy and away from basic research and toward organizations that are product-oriented?];
  • focus on more translating research into products [like on product development, testing, and maybe also manufacturing and distribution]; and
  • increase funding of the PDPs [some do a good job and others don’t, see posts Too Big To Flail 1/5/12 and Commercialization a Going Concern 5/27/10]; and
  • as a bone to the for-profits, “review programs that support industry translation  for their suitability for companies working on global health products” [why didn’t the authors review these programs themselves?].

My recommendation is that the GHTC advocate for the formation of a National Institute for Global Health (NIGH) funded by a proportional re-allocation of the funding of the other NIHs.  The NIGH will also have a healthy SBIR program (about 50% rather than the standard 2% of its budget) and will take the lead in “guiding” other government agencies involved in global health technology development toward supporting more product development.  I also recommend that the GHTC get more input from those who developing global health products and putting them into commerce where they are accessible to the people who may benefit from them.

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