Science Policy For All

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Science Policy Around the Web – September 1, 2015

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By: Daniël P. Melters, Ph.D.

Picture source: Dr. Torsten Wittmann, UCSF via Nikon’s Small World, 2003 Photomicrography Competition

Clinical Stem Cell Regulations

China announces stem-cell rules

Long-awaited regulations by the Chinese government meant to curb rogue stem cell clinics offering unproven treatments have been announced. Overall, these new regulations have been welcomed by stem-cell scientists in China and the rest of the world. The measures offer a straightforward path towards clinical studies. China’s stem cell clinics have been subject of criticism by Chinese government and the scientific community, but these clinics keep offering desperate patients costly, and most likely, ineffective treatments. These were often labelled as clinical trials as a cover to charge patients.

The new measures outline requirements for such studies, including obtaining a patient’s informed consent and using clinical grade stem cells that have been approved by an independent body. Only authorized hospitals will be allowed to carry out such stem cell treatments. These hospitals will be forbidden to charge patients or advertise their treatment options. Researchers who plan to do a pilot study, will have to register with the Chinese health ministry and show documentation in line with pharmaceutical companies trying to get a drug approved in the US. The mechanism laid out for clinical studies looks pretty similar to those in other countries, and more rigorous than some. But the measures might not apply to military hospitals, or to private clinics affiliated with military hospitals, which have in the past fallen outside health-ministry jurisdiction in China. Despite the general optimism, there is one major concern. The new measures are unclear in how it will be enforced. (David Cyranoski, Nature News).

CRISPR and GMOs

Genetic Modification Market

Alphabet, soon-to-be Google’s mother company, might enter the genetic modification market, a business that seems far away from the advertisement-supported search engine. Recently, Google has invested in the CRISPR genetic modification company Editas Medicine via its ventures. Combined with a report from The Information website and contemplations by one of its leaders, Linus Upson, about genetically modified mosquitoes, and it is not too surprising that Google is thinking about this direction. Their goal seems to be in line with the British-based company Oxitec: eliminate disease-carrying mosquitoes to improve human health globally by using genetically modified mosquitoes.

Although the potential of GMO mosquitoes to combat diseases like malaria and dengue are established, the use of CRISPR makes some scientist cautious. CRISPR can be used to employ a technology called “gene drive”. Recently, a group of leading scientists wrote a paper calling for caution in deploying this technology broadly. The main fear: that gene drive has the potential to genetically modify an entire population into GMOs and do it many times faster than naturally evolving species, via a mutagenic chain reaction. To introduce these genetic changes, CRISPR is currently the most obvious technology of choice.

Whether or not Alphabet will produce a viable product, their interest in genetic editing technologies should be a clear sign to the legislatures in Washington, DC that existing regulations need to be updated, and new regulations be introduced to guarantee the safety of people and our environment.

Scientific Reproducibility

Earlier this week, a study was published in Science repeating 98 original psychology papers. Brian Nosek, a social psychologist and head of the Center for Open Science in Charlottesville, Virginia, selected 98 papers from three psychology journals to independently replicate the published results. Only 39% of the 100 repeats were successful. This number is derived from the team’s subjective scaled assessments for success or failure. Furthermore, the team tested if the original studies indeed did find significant results, and 97% of the original studies did, but only 36% were the same results as published. In addition, the team found that the average size of the effects found in the replication studies were only half of that what was reported. Although this study is only a very small sample of all the psychology studies published each year, it is important to realize that scientist should be less confident about their claims.

Nosek’s work is part of the Reproducibility Project which started in 2011 amid many reports of scientific misconduct and retractions, in part as a result of the blog Retraction Watch, founded in 2010. Not only are psychology studies subjected to validation by replication, a similar study in on the way in the field of cancer biology, where critical experiments are reproduced by independent groups who will only use the published protocols. The first results of such verification trials has also call for a critical analysis of preclinical cancer research standards. The team leader of the current psychology replication study does propose a potential solution: in addition to the Transparency and Openness Promotion Guidelines, the scientific community should devote 3% of scientific funding to replication studies. Currently, it is about zero.

Have an interesting science policy link?  Share it in the comments!

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Written by sciencepolicyforall

September 1, 2015 at 9:00 am

One Response

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  1. ASCB recently published its Task Force report on reproducibility in life sciences: http://www.ascb.org/reproducibility/ including several recommendations.

    meltersd

    September 1, 2015 at 4:50 pm


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