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Science Policy Around the Web – March 31, 2015

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By: Julia Shaw, Ph.D.

An Ebola treatment unit in Guinea. Photo by Samuel Hanryon/MSF

Ebola Drug and Vaccine Trials

Scientists Argue over Access to Remaining Ebola Hotspots

In contrast to previous outbreaks which were much smaller and relatively quickly contained, the current Ebola outbreak in West Africa is the worst the world has seen, causing close to 25,000 cases and 10,000 deaths. Although tragic, the scale of the outbreak should benefit the development of future vaccines and treatments for Ebola as studies advance through phase I safety studies to begin phase III efficacy testing. However, as the epidemic winds down, tensions are mounting as multiple organizations seek to complete their large-scale vaccine and drug studies.

Researchers at the National Institutes of Health (NIH) are hoping to move a vaccine study from Liberia, where new cases are few and far between, to Guinea, which reported 45 new cases last week. Yet Guinea is already host to a vaccine trial sponsored by Doctors Without Borders (MSF) and the World Health Organization (WHO) which began vaccinating last Monday. While Clifford Lane of NIH suggests “a country like Guinea is big enough to do at least two studies,” Peter Smith, an epidemiologist and chair of the board of the Norwegian Global health and Vaccination Research Program (which is co-funding the MSF/WHO vaccination trial) stated, “it would not be feasible to successfully run both trial in Guinea at the same time (unless there is a radical change in the epidemiology of the disease in Guinea and disease rates increase. . .).” The two sides have yet to meet in person to discuss the options. An assistant director-general at WHO, Marie-Paule Kieny, noted that “A compromise could be to run the two trials one after the other.” Lane contends that the ring-vaccination study approach adapted by WHO-MSF does not adequately assess longer term protection and that the NIH’s randomized controlled trial is a better approach “to get the most effective vaccine as quickly as possible to the largest number of people possible” and should not be delayed. Similarly, an NIH-led trial to test the therapeutic antibody cocktail, ZMapp, is expanding from Liberia to Sierra Leone where researchers from the University of Oxford have already begun a therapeutic trial of TKM-Ebola, another treatment which uses small interfering RNAs to limit viral replication. Lane is working with the government of Sierra Leone to provide patients with access to ZMapp which has shown better results in animal studies compared to TKM-Ebola. According to Lane, the government of Sierra Leone decides what treatment units will participate, and Port Loko, site of the TKM-Ebloa study, is currently not included in the list. However, if  ZMapp is introduced into treatment units that already have trials underway, Peter Horby, lead investigator of the TKM-Ebola study, says this would “jeopardize ongoing trials and lead to conflict.” (Kai Kupferschmidt, ScienceInsider)

Scientific Peer Review

Major Publisher Retracts 43 Scientific Papers Amid Wider Fake Peer-Review Scandal

United Kingdom-based BioMed Central, publisher of 277 peer-reviewed journals, recently retracted 43 papers due to “fabricated” peer reviews. Peer review is the process by which experts in a scientific field anonymously read and critique a submitted manuscript, judging whether it should be published based on scientific merit. Unfortunately, the process can be weakened or manipulated by poor reviewers, cronyism and outright fraud. In an investigation that began last year, BioMed Central’s associate editorial director for research integrity, Jigisha Patel, describes suspicions that surfaced due to a pattern of unusual e-mail addresses among reviewers and the discovery that the same author was reviewing different, highly specialized topics. Ultimately it was found that the scientists identified as reviewers had not actually written the reviews; someone else had simply used their names. A retraction associated with the articles states, “A systematic and detailed investigation suggests that a third party was involved in supplying fabricated details of potential peer reviewers for a large number of manuscripts submitted to different journals.” The pressure to publish may open the door for these third party agencies that offer language and publication assistance. According to Patel, “if authors are naïve and want to get their manuscripts published, they can be exploited.” The Committee on Publication Ethics, which includes over 9,000 journal editors, issued a statement calling attention to the “systemic, inappropriate attempts to manipulate the peer review processes of several journals across different publishers,” indicating this type of fraud is widespread and in no way limited to BioMed Central. (Fred Barbash, The Washington Post)

Pharmaceutical Regulation

Makers of Generic Drugs Challenge F.D.A. Plan for Updated Warnings

In 2013, the Food and Drug Administration (FDA) proposed requiring generic drug companies to update their labels if previously unknown health risks are discovered. Currently, generic drug producers cannot alter labels to reflect new health warnings unless it is ordered to do so by the FDA, while brand-name manufacturers do make changes as risks are discovered and the changes are later approved by the FDA. Public Citizen, a consumer advocacy group, supports the proposed rule, noting that the FDA lacks the resources to monitor changes for the numerous generics on the market. The drug industry counters that the proposed rule would make them vulnerable to expensive lawsuits resulting in increased costs. They further argue that they lack the full range of data available to the FDA from the brand-name producer and other sources with the end result being confusion as companies making the same drug might have different warning labels. The director of the health research group at Public Citizen, Dr. Michael Carome, admits generics are a great benefit to the public but maintains, “. . . because they dominate the market, it’s critical that they have full incentives to engage in robust monitoring of safety.” In response to the strong resistance from the generic industry including threats to sue, the FDA has reopened the period for public comment on the proposed rule until April 27th. (Sabrina Tavernise, The New York Times)

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Written by sciencepolicyforall

March 31, 2015 at 9:00 am

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