Below are summaries of an opinion piece and an editorial responding to a report (.pdf) from the Indian Parliamentary Standing Committee on Health and Family Welfare on India’s drug regulatory agency, the Central Drugs Standard Control Organization (CDSCO).
“A vaccine against one of the most neglected yet fatal tropical diseases is being tested for the first time in a clinical trial in India and the U.S.,” IRIN reports. Visceral leishmaniasis (VL), “also called kala-azar or black fever, infects an estimated half million persons or more annually,” and “[i]t is found most commonly in India, Nepal, Bangladesh, Brazil and Sudan,” the news service notes. “A total of 72 volunteers are participating in the trial, but scientists say it will take years of testing to roll out an affordable vaccine to the 200 million people globally at risk of VL infection,” IRIN writes, adding, “The WHO has warned that VL is spreading to previously unaffected countries due to co-infections of HIV and leishmaniasis, while the Intergovernmental Panel on Climate Change (IPCC) has said climate change can also spur the spread of the disease” (5/9).
The National Institutes of Health’s (NIH) National Center for Advancing Translational Science (NCATS) — a new plan to help speed drug development by making abandoned experimental drugs available to researchers who can look for alternative uses — “is an indication that the Obama administration and the medical research enterprise are thinking out of the box,” Michael Manganiello, a partner at HCM Strategists, writes in a Huffington Post “Politics Blog” opinion piece. Manganiello — who says the drug AZT, which originally was developed to treat cancer, helped him live long enough to reap the benefits of new drugs developed in the mid-1990s to treat HIV infection — joined HHS Secretary Kathleen Sebelius and NIH Director Francis Collins this week in launching the initiative, which he says “is a step in the right direction and it is critical that industry collaborate with patient groups and their constituents.”
The New York Times and the Financial Times examine concerns expressed by AIDS activists and members of an FDA panel that last week recommended Gilead Sciences’ antiretroviral drug Truvada be approved for pre-exposure prophylaxis (PrEP) to prevent HIV among healthy people at risk of contracting the virus. According to the New York Times, “Such a pill has long been a goal of research, something that might help stem a global epidemic that is still causing two million new worldwide cases each year, including 50,000 in the United States” (Grady, 5/14). The Financial Times says some have concerns over the real world efficacy of the drug; whether its approval would encourage reckless behavior, such as not using condoms; side effects that might require additional treatment; the development of drug-resistant HIV strains; and the cost of the drug.
“The world is facing two immediate health crises concerning drugs and vaccines: affordable and reliable access to life-sparing medicines and the safety and reliability of those medicines,” Laurie Garrett, senior fellow for global health at the Council on Foreign Relations (CFR), writes in the council’s Policy Innovation Memorandum No. 21, titled, “Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply.” According to the memorandum, “Unless this issue is addressed, millions more lives and the credibility of medicines and vaccines will be lost. The Groups of Eight (G8) and Twenty (G20) countries should take the lead, as a matter of urgency, in promoting cooperation among national safety regulators, tougher legal frameworks, and regional networks of surveillance and prosecution” (May 2012).
“If you had $75 billion to spend over the next four years and your goal was to advance human welfare, especially in the developing world, how could you get the most value for your money?” Bjorn Lomborg, an author and director of the Copenhagen Consensus Center, asks in this opinion piece in Slate Magazine’s “Copenhagen Consensus 2012” section. “That is the question that I posed to a panel of five top economists, including four Nobel laureates, in the Copenhagen Consensus 2012 project,” he writes, noting, “The panel members were chosen for their expertise in prioritization and their ability to use economic principles to compare policy choices.”
“In the sobering annals of disaster prevention, genetic manipulation of the H5N1 influenza virus is looming as a seminal case,” John Steinbruner, director of the Center for International Security Studies at the University of Maryland, writes in an opinion piece in The Hill’s “Congress Blog,” noting that two “laboratory experiments have rendered the highly virulent avian strain transmissible among ferrets, strongly suggesting that it would be transmissible among humans as well.” He states, “If the virus could achieve efficient transmissibility while retaining anything like its current case fatality rate [of 50 percent], it could inflict global disaster of unprecedented proportions.” The actions of the U.S. National Science Advisory Board for Biosecurity, initially recommending publication of redacted versions of the two studies then reversing that decision, “implicitly concedes that the U.S. alone cannot exercise comprehensive jurisdiction,” Steinbruner writes.
In a guest post on the Global Health Technologies Coalition’s “Breakthroughs” blog, Jamie Elizabeth Rosen, media and communications manager at Aeras, interviews Steven Reed, founder, president, and chief scientific officer of the Infectious Disease Research Institute (IDRI), “a 120-person non-profit biotech committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty.” Aeras, “a non-profit biotech focused on developing vaccines against TB,” has partnered with IDRI to develop a novel tuberculosis (TB) vaccine candidate, Rosen notes and summarizes Reed’s responses to questions regarding TB vaccine development (Taylor, 5/29).
Trade officials met last week at the U.N. World Intellectual Property Organization “to make progress on a proposal that would allow poor countries to provide inexpensive generic versions of lifesaving medications, rather than rely a single version of the same drugs under expensive patent monopolies,” but the U.S. “remained steadfast in rejecting proposals aimed at lowering the prices of existing medicines in poor countries,” the Huffington Post reports (Carter, 5/29). At the 18th session of the Standing Committee on the Law of Patents (SCP), delegates considered two proposals, according to Intellectual Property Watch. The news service notes that a South African proposal (.pdf), submitted on behalf of the African Group and the Development Agenda Group (DAG), would have assisted developing nations adapt their patent schemes “to make full use of the flexibilities available in the international patent system in the interest of public health,” and a U.S. proposal (.pdf) “warned against any weakening of patent protection as a solution to the lack of availability of medicine in developing countries” because, “the delegate said, less patent rights would be detrimental to innovation” (Saez, 5/25).
In a letter (.pdf) dated April 25, Amy Patterson, associate director for science policy in the office of the director of the National Institutes of Health, “has refuted criticism of the way a meeting held to allow a biosecurity advisory group to review controversial bird flu studies was handled,” denying “the agenda was crafted to achieve a predetermined outcome,” the Canadian Press/Winnipeg Free Press writes. Patterson was “responding to a harsh critique of the meeting from Michael Osterholm, a member of the U.S. National Science Advisory Board for Biosecurity [NSABB],” who, in a letter (.doc) to Patterson dated April 12, criticized “the agenda and speakers list” of the March 29-30 meeting, the news service writes (Branswell, 5/4).