If the title is a bit confusing, let me do some deciphering. In its role as the AMC (Advance Market Commitment) Secretariat, the GAVI Alliance Secretariat is seeking an additional member for its Independent Assessment Committee (IAC), this time with specific expertise in vaccine industry economics.
Nothing is sexy about diarrhea. Its advocates have been outshouted and overshadowed by the celebrity-backed “big three” in recent years, yet diarrheal disease – mostly caused by the human consumption of water contaminated by bacteria and other microbes (e.g. shigella, rotavirus, cholera, E. coli) from human feces – remains the second largest killer of children under 5 in the world (over 4,000 casualties every day).
Exactly one week ago, the FDA gave the nod to Novartis’ antimalarial drug Coartem, simultaneously granting it the first Priority Review Voucher (PRV) in FDA history. As reported in this blog several times before, the PRV program was enacted by an amendment to FDA law in September of 2007.
If the title is a bit confusing, let me do some deciphering. In its role as the AMC (Advance Market Commitment) Secretariat, the GAVI Alliance Secretariat is seeking 3 additional members for its Independent Assessment Committee (IAC), each with expertise in one of the following areas: public health, public-private finance, and vaccine industry economics.
After reading about India’s new Open Source Drug Discovery (OSDD) project this week (1), I couldn’t help but feel -- amid the current housing/financial/Wall Street/economic crisis -- at least one thing is moving in the right direction: collaborative efforts to accelerate neglected disease product development.
I'm tired of the Priority Review Voucher (PRV)-bashing. For those unaware of the PRV program, it is a new bipartisan incentive mechanism passed by Congress and signed into law in September of 2007. The legislation rewards the sponsor of a neglected tropical disease product with a tradable voucher upon its FDA approval. The voucher can then be used to obtain a priority (speedier) review for another product.
The global health community likes to throw around buzz phrases (the 10/90 gap) that point to one reality: inadequate R&D dollars for neglected diseases. While this situation has undoubtedly improved in the last decade, it is still undeniably the case, and it has led economists and others to think about plausible incentive and innovative financing mechanisms to attract industry for greater R&D investment for specific diseases.
XDR-TB, the widely untreatable, mutated manifestation of TB, is spreading; that much is known. Unknown is how much is out there, and how fast it is growing. Between 1996 and 2006, TB cases rose nearly 30%. One-fifth of new cases are resistant to at least one of the drugs available, as my colleague, Rachel Nugent, points out in the most recent issue of Foreign Policy.
The Times of South Africa recently reported the recall of two TB drugs, manufactured by Pharmascript, after the national health department found them to be substandard. Initial tests at the local WHO laboratory found they did not contain the needed amount of active ingredients, as claimed on the label, and concluded that they "would most likely not have effectively treated 'thousands' of TB patients."
