Report proposes new and focused approaches to developing drugs, diagnostics and vaccines
A pharmaceutical company develops a long-awaited drug that represents the last hope for hundreds of thousands of people sick with drug-resistant tuberculosis, but doesn’t register it in any of the countries where the burden of the disease is greatest.
While the World Health Organization recommends treating hepatitis C patients everywhere with breakthrough direct-acting antiviral drugs, the price of the drug is 67 times more expensive than gold, putting it out of reach across high-income, as well as low- and middle-income countries.
Studies show the potential effectiveness of a vaccine against Ebola in 2010, but when the outbreak in West Africa begins in 2014, speeding through capital cities in the region, and traveling the world, ultimately taking more than 11,000 lives, the vaccine has not begun even basic human safety trials.
These are some of the examples offered in a report released this week by Médecins Sans Frontières Access Campaign, examining the impacts of priorities currently driving pharmaceutical research and development, as well as ways to enable, incentivize and ensure innovations that address the most pressing, but currently neglected infectious disease challenges globally. The report, Lives on the Edge: Time to Align Medical Research and Development with Peoples Health Needs, examines the “cold logic” that has led to the lag in treating and diagnosing children with HIV and tuberculosis, fallacies behind patent monopolies and high drug prices, and failures of existing systems to spur innovation that meets public health needs. It also offers the example of the Drugs for Neglected Diseases initiative, a nonprofit, public health need-driven organization MSF co-founded with six other international organizations in 2003,
It uses the experience of that organization in developing six new treatments to highlight the difference between the nonprofit’s costs for developing a new drug — from $113- to $169 million — and estimates based on information supplied by big pharma of costs from eight to 10 times that amount. It also offers the example of its successful Meningitis Vaccine Project, in which affordability was a planning principal, rather than an afterthought.
In addition, the report examines how systems intended to spur, or at least enable, innovation fail. It urges that the public sector leverage its research support to attain greater transparency, and a commitment to access from industry. It also calls for reforms to the U.S. Food and Drug Administration’s Priority Review Voucher Program. The program, launched in 2007 is intended to reward development of products targeting neglected diseases with vouchers to speed review for approval of subsequent products, but has failed to link development to access, and to ensure that it rewards new research rather than the new registration of existing products.
Finally the report also offers throughout the direct observations of field practitioners, describing the frustration and futility, of as one worker fighting Ebola in Sierra Leone put it, “fighting a forest fire with spray bottles,” and the increasing impacts on high-income countries of failures to equip responses to diseases in low-income countries.