Science Policy For All

Because science policy affects everyone.

Science Policy Around the Web – October 14, 2015

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By: Amy Kullas, Ph.D.

photo credit: Cell Culture via photopin (license)

Reproducibility in science

Researchers do not bother verifying the identity of their cell lines

Despite being warned years ago, more than 50% of biomedical researchers admitted in a recent survey that they do not confirm the identity of their established cell lines. The confirmation process includes validating the species, tissue-type, and gender of the cells. Even those researchers that had confirmed their cells were labeled correctly, most did not use the ‘gold-standard DNA-based testing method.’ Contaminated cell lines waste valuable research funds and undermine research findings.

Unfortunately, not much has changed in cell line validation or cell culture practices in the past decade. Dr. Leonard Freedman, president of the Global Biological Standards Institute, said that “while support for change is strengthening, the scientific community has still not embraced cell authentication as an expected part of the research process.” He pointed to the issue of how cell identity directly contributes to data irreproducibility and encourages journals to refuse to publish manuscripts unless the authors describe how they validated cell lines used. Nature conducted an analysis from 60 manuscripts and found that only 10% of authors had validated their cell lines. Following that dismal finding, Nature and its associated research journals implemented a policy in May requiring “authors to check the cell lines used against a database of almost 500 known misidentified cell lines and to provide details about the source and testing of the cells.” (Declan Butler, Nature News)

Biomedical funding

NIH continues to reduce award funding

The National Institutes of Health (NIH) released a notice at the beginning of October, that continuing awards for fiscal year 2016 will be funded at a lower level than previously committed (approximately 90%). However given the NIH has been slated for a billion-dollar increase, the agency may return funding to 100% of the awarded amount after a final appropriation.

Global health

Polio remains endemic only in Pakistan and Afghanistan

On September 25, 2015, the World Health Organization announced that polio is no longer endemic in Nigeria, leaving wild poliovirus only spreading in Pakistan and Afghanistan. July 2015 marked one full year without a new case of polio being reported in Nigeria, taking the country and Africa close to being ‘certified polio-free’. This was a monumental accomplishment for Nigeria because as recently as 2012, Nigeria was credited for over half of all polio cases globally. The WHO wrote: “Eradicating polio will be one of the greatest achievements in human history, and have a positive impact on global health for generations to come.” (Sona Bari, Oliver Rosenbauer, and John Butler, World Health Organization News Release)

Genetic testing and scientific patents

Australia rules a genetic sequence is not a “patentable invention”

On October 6, 2015, Australia’s highest court ruled that “an isolated gene sequence is not a ‘patentable invention.’” This ruling mirrors legislation established in the United States, South America, and most of Asia. The European Union and Canada allow human gene patenting if the biological material has been isolated by a ‘technical process’.

In 2010 a cancer survivor, Yvonne D’Arcy, challenged patents over the BRCA1 and BRCA2 genes held by the Melbourne-based Genetic Technologies and the U.S. firm Myriad Genetics. BRCA1 and BRCA2 are human genes that encode tumor suppressor proteins, which can help repair damaged DNA and contribute to the stability of a cell’s genetic material. If mutations are present in one or both of these genes, the cells are more likely to divide and rapidly change, significantly increasing a woman’s likelihood of developing breast and ovarian cancers. Myriad had used the genetic information to develop diagnostic tests over which it and its international counterpart had a monopoly.

This decision allows hospitals in Australia to be free to perform genetics testing, perhaps even to develop their own assays, without many consequences from large biotech companies. However the biotech community feels differently and views the ruling as ‘blow to innovation’ while predicting the decision to have ‘significant negative impact’ on new and innovative medicines and innovations. Though Myriad’s patents have expired, the company estimates it had spent more than $1 billion over 25 years to develop its facilities and resources and the tests used on 2 million patients. (Leigh Dayton, ScienceInsider)

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Written by sciencepolicyforall

October 14, 2015 at 9:00 am

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