By: Eric Cheng, Ph.D.
Europe overhauls rules for ‘first-in-human’ trials in wake of French disaster
Following the disastrous clinical study in Rennes, France in January 2016 that resulted in the death of one volunteer and the hospitalization of five more, efforts are being taken by the European Medicines Agency (EMA) to improve identify and reduce risks in human clinical trials. EMA proposed changes to the current guidance on first-in-human clinical trials in a new concept paper which has been released for public comment.
The current guidelines for “first-in-human” (FIH) studies on healthy volunteers date to 2007 after a similar tragedy in London in 2006. Nine volunteers were hospitalized with severe adverse events after receiving a monoclonal antibody named TGN1412 for the first time.
The concept paper states that the role of pharmacology and toxicology data in estimating the therapeutic dose, increases in dosing, and stopping criteria need to be addressed in the revised guideline. Also, other subjects will be addressed which include new instructions for decision-making processes and stopping rules, rolling review of emerging human data during the study, communication to authorities and subjects, and guidance on the type of scientific information to be included in a trial application. The deadline for comments on this concept paper is September 30, after which it will publish a draft revised guideline later this year.
These changes are a direct response to the French clinical trial which has been criticized for its lax design. The trial protocol allowed the study to move to additional phases without external review such as an analysis of pharmacokinetic data of the previous cohort. The prosecutor is still investigating whether involuntary manslaughter charges are warranted in the case. (Hinnerk Feldwisch-Drentrup, ScienceInsider)
Cleaner air may be driving improvements in Chesapeake Bay water quality
A new study suggests that cleaner air may be the main driving force on the improvement in water quality in the Washington, DC metro area, including the Chesapeake Bay.
The Chesapeake Bay is the nation’s largest estuary. For decades it has suffered from excessive nutrient and low oxygen conditions. Although land-based management practices and improvements to wastewater treatment plants have helped to improve water quality in the Chesapeake Bay, researchers have found that improvement in air quality is the primary driver of improvements in water quality in the area studied – the Upper Potomac River Basin which covers 12,000 square miles in Maryland, Virginia, West Virginia, Pennslvania, and the District of Columbia. It is believed that these region-wide water quality benefits were due to the implementation of the Clean Air Act of 1990.
“The recent water quality successes in the Chesapeake Bay restoration are apparently driven more by air quality regulation rather than by water quality control efforts,” said study author Keith Eshleman, professor at the University of Maryland Center for Environmental Science’s Appalachian Laboratory. “These air quality regulations were intended to address human health issues and acid sensitive streams. No one thought you would have this positive impact on water quality. It was totally unanticipated.”
One cautionary note is that the apparent reversibility of the process means that a relaxation in air quality regulation would lead to a reversal in the direction of watershed water quality across the basin. (Keith N. Eshleman and Robert D. Sabo, Atmospheric Environment)
Science and Society
Turkish academics targeted as government reacts to failed coup
After the failed July 15th coup attempt, the Turkish government has disrupted higher education. As part of a massive political purge, educators across the country have been suspended from their roles. “They are restructuring academia,” says Caghan Kizil, a Turkish molecular biologist based at the Dresden University of Technology in Germany who has been in close communication with colleagues in Turkey. “People are very scared and not hopeful.”
In the span of a few days, more than 45,000 civil servants in the military and judiciary have been fired or suspended. In addition, it appears that some 15,000 staff members of the ministry of education also were fired, with 21,000 teachers losing their professional licenses, and more than 1500 university deans were all but ordered to resign. Turkish academics currently abroad have also been ordered back by the government. “They want to take the universities under their full control,” says Sinem Arslan, a Turk doing a political science Ph.D. at the University of Essex in the United Kingdom. “Academic freedoms will no longer exist. I don’t think that anybody will be able to work on research areas that are considered taboo by the government or write anything that criticizes the government.”
The motives behind this new crackdown is currently not known. However, the truth may emerge from an unexpected source – Wikileaks. This whistleblower site released nearly 300,000 emails allegedly written from Turkish government officials going back as far as 2010. Time will tell if this new information will shed light on the motives behind the new crackdown on education and research in Turkey. (John Bohannon, ScienceInsider)
Have an interesting science policy link? Share it in the comments!