BREAKTHROUGHS BLOG

September 25, 2016

Research Roundup: Clinical trial data, Mayaro virus, antimicrobial resistance, and more

Senior Program Assistant
GHTC

The US Department of Health and Human Services has published new rules intended to improve compliance to a 2007 law intended to increase the public availability of clinical trial data. The law requires researchers to register and share data from clinical trials, grants the US Food and Drug Administration (FDA) the authority to fine pharmaceutical companies up to US$10,000 per day for failure to register or report results, and allows the US National Institutes of Health (NIH) to refuse to disburse funds to noncompliant grantees. Between 2008 and 2015, violations of the law warranted more than $25 billion in fines, however, no such fines have been issued to date. Many advocates have expressed concern that the new rules are only as effective as their enforcement. Neither the FDA nor the NIH plan to hire additional staff to enforce compliance of the law.

Facebook CEO Mark Zuckerberg and his wife Dr. Priscilla Chan have committed US$3 billion over the next ten years to “cure, prevent, or manage all disease.” The couple is investing $600 million to launch the “Biohub” at the University of California, San Francisco, which will convene scientists and engineers, supporting collaboration in research and product development. The Biohub’s first two ventures are ambitious: the Cell Atlas, which will involve the characterization of every type of cell found in the human body, and the Infectious Disease Initiative, which will support research and development (R&D) for drugs, diagnostics, and vaccines against infectious diseases. The Initiative will establish a Rapid Response Team with the ability to rapidly mobilize scientists and accelerate R&D during an outbreak.

The mosquito-borne Mayaro virus, primarily found in the Amazon, has been reported in Haiti. The symptoms of Mayaro—fever and joint pain—are similar to chikungunya, however, the pain can last for nearly a year and patients often report abdominal pain as well. The virus, which was identified in a blood sample taken from a child suffering from the illness, varied from the strain responsible for the more than 40 cases reported in South America since its discovery in 1954. Researchers are particularly concerned with the presence of Mayaro in the Caribbean in light of the ongoing outbreak of Zika virus, which was discovered several decades ago but has only recently begun to spread rapidly and have a significant health impact.

A new report from the World Bank quantifying the economic impact of antimicrobial resistance (AMR) indicates that by 2050, the impact of AMR on the global economy and in particular, the livestock industry, could push nearly 30 million people into extreme poverty. Further, drug-resistant infections are much more difficult and costly to treat, and thus, AMR could increase health spending by $1 trillion per year by 2050. These findings reveal that AMR could have a much greater economic impact than the 2008 financial crisis, particularly for low- and middle-income countries.

Gonorrhea, a sexually transmitted infection resulting in nearly 90 million new infections each year, has grown increasingly resistant to antibiotics. A new cluster of cases in Hawaii suggests that the emergence of untreatable strains of the bacteria are closer than ever. Over time, gonorrhea has developed resistance to several common antibiotics including penicillin, tetracycline, and fluoroquinolones; the current treatment, a combination of the antibiotics azithromycin and ceftriaxone, is considered the last resort. The samples identified in Hawaii showed unprecedented levels of resistance to azithromycin and burgeoning resistance to ceftriaxone. While azithromycin and ceftriaxone are the only remaining drugs that are effective against the bacteria and well tolerated by humans, scientists at Louisiana State University are testing a new oral antibiotic that appeared to be safe and effective against gonorrhea in phase 2 clinical trials.

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