Science Policy For All

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Science Policy Around the Web – April 24, 2015

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By: Danielle Friend, PhD

photo credit: DSC03602.JPG via photopin (license)

Genetic-based Drug Discovery

23andMe will invent drugs using customer data

As of March 2015, 23andMe will no longer simply be known for direct-to-consumer genetic tests. 23andMe has now made progress toward their long-term goal of influencing drug discovery. 23andMe claims to have collected DNA from approximately 850,000 consumers through marketing of their $99 kit, and the company plans to use this genetic information to identify new drug targets. Additionally, 23andMe reports that approximately 80% of the consumers that purchase the kits have agreed to allow 23andMe to use their genetic information for this research. To help lead these discovery efforts, 23andMe recently hired Richard Scheller, who formerly lead research and development at Genetech, as the chief scientific director and head of operations. In addition to these in-house efforts, 23andMe has also recently formed partnerships with pharmaceutical companies, including both Pfizer and Genetech who plan to use the genetic information to develop drugs for diseases like Parkinson’s disease. Although the partnerships with companies like Pfizer and Genetech are clearly defined to help identify drug targets for particular diseases, 23andMe plans to organize their in-house research as a broad sweep through their databases without a particular disease in mind. However, 23andMe has mentioned that they have a particular interest in metabolic and immune system disorders, eye disease, and cancer. (Mathew Harper, Forbes; Ron Winslow, Wall Street Journal)

Transparency in Clinical Trial Data

World Health Organization calls for increased transparency in clinical trials

In mid-April, the World Health Organization (WHO) released a statement recommending that findings from all clinical trials be made public regardless of the results of the study. Dr. Marie-Paule Kieny, the assistant director-general for health systems and innovation with the WHO, stated that the goals of this new mandate are to “…promote the sharing of scientific knowledge in order to advance public health.” Additionally, Dr. Kieny also stated that, “failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both [research and development] and public health interventions,” and that “it creates indirect costs for public and private entities, including patients themselves, who pay for sub-optimal or harmful treatments.” Several factors may come between completed research and the publication of results. However, unpublished results (even if negative) can lead to the perception that treatments are more or less effective than they are. The WHO mandate requires that results from clinical studies be submitted to peer-reviewed journals within 1 year after the completion of data collection, and that the work should be published within 24 months in an open access journal. The WHO also asks that “key outcomes” — limited details of the study including the number of participants, main findings, and adverse events — be made available online within a year of study completion. Although these new requirements are a step in the right direction for clinical trial transparency, it remains unclear just how the WHO plans to enforce these recommendations. (Chris Whoolston, Nature Research Highlights; Martin Enserink, Science Insider; The World Health Organization)

Ebola Clinical Trials

Lack of patients hampers Ebola drug and vaccine testing

As attention on the Ebola outbreak in Africa has increased, more resources and medical assistance have been provided. Although the number of Ebola cases has significantly decreased due to these interventions, an unexpected troubling scenario has developed: Ebola vaccine clinical trials are now having trouble testing the efficacy of their vaccines due to the lack patient populations. In fact, one company has altogether halted their trial. Chimerix, a company running a trial for their antiviral drug, brincidofovir, has decided to end the trial altogether due to a lack of patients. In fact, the World Health Organization’s weekly report from April 19 states that new cases of Ebola are now down to a total of 33. Because of the dramatic decrease in Ebola cases, the public health community faces ethical issues regarding whether more promising drugs should be prioritized and given preferential access to patients and geographical regions. (Andrew Pollack, The New York Times; Richard Harris, National Public Radio; The World Health Organization; Kai Kupferschmidt, Science)

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Written by sciencepolicyforall

April 24, 2015 at 9:00 am

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