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Science Policy Around the Web – June 28, 2016

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By: Sterling Payne, B.Sc.

Licensed via Creative Commons

Bioengineering and Human Trials

First CRISPR clinical trial gets green light from US panel

Since its discovery, CRISPR-Cas9 has become one of the hottest and most sought-after techniques and area of research in science. Whether owing to its ease of use, wide accessibility, or myriad modifications, the research and public health worlds are captivated by CRISPR. Almost one week ago, on June 21st, the National Institutes of Health (NIH) opened the door for the first use of CRISPR in humans as a potential therapeutic in a clinical trial. The trial in question focuses on the use of T-cells to fight cancer by introducing exogenous genetic material via CRISPR-Cas9, followed by the infusion of the cells into cancer patients.

This is not the first time that a gene-editing technique has been used to edit human cells. In 2014, Carl June, an immunologist at the University of Pennsylvania and scientific adviser on the current trial, led a trial that used zinc finger nucleases to edit T-cells in hopes of preventing viral infection. However, the recent approval of this single CRISPR proposal will most likely pave the way for many more, and in a short amount of time. The advancement of CRISPR-Cas9 in the past few years and its potential use in humans is staggering. However, an influx of clinical trials involving this technique will pose more policy discussions and questions to assure scientists and the public that the technique is being used humanely and ethically. It will be interesting to see how the definitions of what is humane and ethical in the eyes of policy-holders potentially changes in the coming years thanks to CRISPR. (Sara Reardon, Nature News)

Brexit and Research

Researchers deplore U.K. decision to leave the European Union 

On June 23rd, 2016, the electorate of Britain voted in a referendum to leave the European Union, creatively named the “Brexit”. Fast forward several days, and the consequences of the vote on multiple levels – such as global markets, immigration, employment, timelines and next steps – are still being determined. At it’s core, the U.K.’s decision to leave was not largely based on research science. However, multiple British science authorities are flabbergasted by the decision, a majority of whom believe was a mistake.

With Britain’s decision to leave the EU, it will be interesting to see how policymakers deal with the inevitable battles in terms of funding, personnel, and travel. One particular talking point is the fate of the U.K.’s standing in the Horizon 2020 program, a massively financed research initiative with 9 billion British pounds of funding over seven years (2014-2020). The initiative provides a means of support for collaboration across different European countries, and if the U.K. would like to continue as a player in the initiative, they will have to make a decision now and start preparing the necessary documents necessary to become an “associate”, for example. Policymakers have a long, winding road ahead of them in order to ensure the survival of the myriad collaborations and research projects headed by Britain. (Daniel Clery, Science News)

Patent Law

The Supreme Court decision that’s shaking up biotech 

The Supreme Court recently rejected the request to hear an appeal from Sequenom (San Diego, CA), a biotech. company specializing in prenatal testing. Sequenom’s test, MaterniT21, relies on the presence of fetal DNA in the plasma of the mother, allowing for a non-invasive method of analyzing the fetus for certain conditions such as Down’s syndrome (trisomy 21). The patent for the test remained intact until 2013, where in a case against Ariosa Diagnostics, a lower court ruled the patent as invalid. The Supreme Court’s failure to hear Sequenom’s appeal means that the previous ruling stands, and that poses a problem with implications far beyond a single biotech company.

Sequenom turned to the Supreme Court for thorough consideration and a final decision on whether or not their patent remains valid, although it does rely on the naturally occurring process of fetal DNA showing up in plasma. The highest justice’s silence in this situation creates an ambiguity around all patents in the biosciences. At what point does novelty evanesce into nature? Should patents, the protectors of intellectual property, really be granted in a case where natural processes are required to retain their validity? These are the types of questions that are being asked as a result of the Court’s silence, and that could plague future investments in biotechnology, a field that is highly represented by startups. (Douglas C. Pizac, AP/STATnews)

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June 28, 2016 at 2:30 pm

Science Policy Around the Web – June 30, 2015

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By: Eric Cheng, Ph.D.

Photo credit link: Affordable Care Act via photopin (license)

Health policy

Affordable Care Act survives Supreme Court challenge

On June 25, 2015, the Supreme Court upheld a key provision of the Affordable Care Act that allows the federal government to provide subsidies to people in all 50 states, and not just the 16 states that administer their own online insurance exchanges. This ruling means that people in states without their own exchanges can still get federal subsidies for the purchase of health insurance allowing an estimated 6.4 million people to keep their health care coverage, according to the Kaiser Family Foundation. Without access to subsidies, millions of Americans would have been at risk of failing to meet the mandate that requires every American to buy health coverage. This ruling affirmed that the legislation that created the Affordable Care Act intended to improve the health care system and to provide support to all who needed help to buy health insurance.

Two of the court’s conservatives, Chief Justice John G. Roberts Jr. and Justice Anthony Kennedy, joined the court’s four liberal Justices in rejecting the lawsuit in a 6-3 vote to side with the Obama administration. “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them,” Roberts wrote for the majority. While Justice Antonin Scalia, who wrote in dissent, called the majority’s reasoning “quite absurd” and “interpretive jiggery-pokery.”

President Obama made a statement on the recent ruling, saying the Affordable Care Act “is here to stay.” (Robert Barnes, Washington Post)

Federal research funding

Senate panel approves $2 billion raise for NIH in 2016

A Senate appropriations subcommittee voted to approve $32 billion in funding for the National Institutes of Health (NIH) for the 2016 fiscal year, representing an increase of $2 billion from 2015. This increase in funding could be the largest increase since 2003. Senator Roy Bunt (R-Mo.), chairman of the Senate Labor, Health and Human Services, and Education and Related Agencies Appropriations Subcommittee commented that “this year’s Labor-HHS appropriations bill prioritizes programs that will provide a significant benefit to all Americans and, most importantly, provides the National Institutes of Health with a $2 billion increase to make critical life-saving medical treatments and high-quality cures available to all Americans.”

The Senate panel approval will match the $200 million request by President Obama for the development of the Precision Medicine Initiative along with a $100 million increase for new funding to combat antibiotic resistance from the previous fiscal year. Other highlights include a $350 million increase for the National Institute on Aging, the lead Institute researching Alzheimer’s disease, and an additional $70 million for the BRAIN Initiative to map the human brain. These increases to every Institute and Center are intended help NIH to continue their development of new therapies, diagnostics, and preventative measures to enhance health, lengthen life, and reduce illness and disability. (Jocelyn Kaiser, ScienceInsider)

Environment and public health

House Advances Chemical Safety Reform Bill, Teeing Up Senate Vote

The U.S. House of Representatives passed legislation to overhaul the nearly 40 year old Toxic Substances Control Act (TSCA). This bipartisan bill aims to improve chemical safety. Some updates include the determination of risk by the Environmental Protection Agency (EPA) based on scientific evidence of its health impact instead of the cost of regulation. For new chemicals, the bill would shift the burden to industry to show that the substances they manufacture are not unreasonably risky. Other provisions in the bill would increase transparency by preventing industry efforts to keep safety data secret by declaring them confidential business information. This would allow EPA to more easily share chemical information with states, doctors, and first responders. These new reforms will help address an outdated law to protect human health and the environment from significant risks while also protecting commercial and competitive interests of the United States chemical industry and the national economy. (Kate Sheppard, Huffington Post; Puneet Kollipara, ScienceInsider)

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June 30, 2015 at 9:00 am

Science Policy Around the Web – February 16, 2014

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photo credit: sarihuella via photopin cc

photo credit: sarihuella via photopin cc

By: Kaitlyn Morabito

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

U.S. launches new global initiative to prevent infectious disease threats  – Participants from 26 countries, including the U.S., met on Thursday to launch a new world-wide public health program.  The focus of this initiative is to detect, treat, and contain newly emerging and known infectious disease agents where the outbreak starts to prevent global spreading of diseases such as West Nile virus, Dengue virus, tuberculosis and polio virus.  This program involves establishing a network of disease detecting laboratories, increasing vaccination campaigns and setting up emergency response teams. This global strategy of rapid detection, treatment and containment is more cost efficient than efforts by individual counties once the disease has spread. (Lena H. Sun)

Myriad Wins First Round in Cancer Gene Testing Battle  – Last June, the Supreme Court ruled that companies can not patent naturally occurring human genes, challenging Myriad’s patents on the BRCA genes used in breast cancer screening tests.  Following this ruling, many competitors released their own tests for the BRCA genes, prompting lawsuits from Myraid.  Myraid argues that the ruling does not apply to the related patents on the BRCA testing kits.  Last week, one of the competitors, Gene By Gene, settled with Myraid, agreeing to stop selling the kits within the US.  Lawsuits against other competitors are still pending. (Eliot Marshall)

Fusion energy milestone reported by California scientists  – Scientists at the National Ignition Facility, part of the Lawrence Livermore National Laboratory, are a step closer to creating a fusion reactor.  In their experiment, more energy was released from the fuel core than went into the fuel core.  However, there is still a long way to go before scientists create a fusion reactor.  The fuel core absorbed only a small fraction (about 1%) of the energy from the lasers, so the overall input energy is more than the output energy. (Joel Achenbach)

 

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February 16, 2014 at 10:27 am

Science Policy Around the Web – June 21, 2013

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By: Jennifer Plank

photo credit: ZaldyImg via photopin cc

photo credit: ZaldyImg via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

HPV Vaccine is Credited for Fall of Teenagers’ Infection Rate – Despite low vaccination rates in the US, the incidence of high risk HPV infection, the virus that causes the majority of cases of cervical cancer, in girls aged 14-19 was cut in half between 2006 (when the vaccine was introduced) and 2010. This comes a surprise to public health experts because only approximately 1/3 of teenaged girls in the US have been vaccinated, as compared to 80 percent vaccination rates in Denmark and Britain. One possible explanation for the drop in HPV infection despite low rates of vaccination is “herd immunity”  which means that vaccinated individuals in the population reduce the total number of infections and overall, HPV becomes less prevalent. At the current vaccination rate, approximately 45,000 future cases of cervical cancer in girls who are under the age of 13 will be prevented. (Sabrina Tavernise)

SARS-like Virus has High Mortality Rate in Saudi Arabia – To date, 32 out of 49 individuals infected with a new SARS-like respiratory virus, called MERS-CoV, have died, resulting in an unusually high 65 percent mortality rate. Findings published in the New England Journal of Medicine indicate that the virus is spread by person-to-person contact and can spread quickly in a hospital setting. The majority of MERS-CoV infections have occurred in Saudi Arabia, however, there have been instances reported elsewhere. All instances of infections have been linked to travel to the Middle East. MERS-CoV has an incubation time of 5 days (similar to SARS), during which, the virus is highly contagious. (Meeri Kim)

ASBMB Gives Mixed Review to the Supreme Court Decision on Gene Patenting – Last week, the Supreme Court unanimously ruled in favor of the Association for Molecular Pathology (Association for Molecular Pathology v. Myriad Genetics) and overturned the patents on the BRCA1 and BRCA2 genes. The American Society for Biochemistry and Molecular Biology (ASBMB) has mixed feelings on the ruling: while the ASBMB agrees with overturning the patents on BRCA1 and BRCA2, they do not agree with the ruling that because cDNA is not naturally occurring, it is patentable. (Chris Pickett)

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June 21, 2013 at 10:20 am

Science Policy Around the Web – June 4, 2013

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By: Jennifer Plank

photo credit: NCinDC via photopin cc

photo credit: NCinDC via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Supreme Court upholds Maryland law, says police may take DNA samples from arrestees – On Monday, the Supreme Court decided the case King v. Maryland and ruled that police officers can collect DNA samples upon arrest just as it takes mugshots and fingerprints. The case originated in 2009 when John King was convicted of a 2003 rape after a DNA sample was obtained following an assault charge. The Supreme Court ruling will reinstate the rape charge against King. Justice Kennedy, who wrote the opinion for the majority, stated that the ruling is limited in scope- DNA can only be collected from suspects who are arrested for “serious crimes”. (Robert Barnes)

Greece’s 200% increase in HIV shows how dangerous austerity can be for public health – European health and finance officials met in March to determine how healthcare systems are doing following severe budget cuts. Evdoxia Andrianopoulou, a Greek financial ministry official, presented data showing the steep budget cuts made to the Greek healthcare system. Included in budget cuts was the reduction of the mosquito spraying program, and consequently, an increase in the number of malaria outbreaks. Additionally, the number of new HIV infections increased 200 percent due to a reduction in funds for Greece’s clean needle program.  (Michael Scaturro)

NIH fact sheet lays out sequester impact – Following implementation of sequestration, the NIH has detailed how the Institutes will absorb the $1.55 billion budget cut. The cuts were applied across all institutes and programs meaning that every niche of biomedical research will feel the cuts. Briefly, the NIH will award approximately 700 fewer grants, training grant stipends will be frozen, approximately 750 fewer patients will be admitted to the clinical center, and ongoing grants will have their budgets reduced 4.7%. The intramural program will have to implement 5% budget cuts over the second half of the fiscal year. (Jocelyn Kaiser)

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June 4, 2013 at 4:08 pm

Science Policy Around the Web – May 17, 2013

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By: Jennifer Plank

photo credit: ynse via photopin cc

photo credit: ynse via photopin cc

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Will insurance cover genetic testing, preventative surgery? – This week, Angelina Jolie was in the news following her op-ed piece discussing her preventative double mastectomy once she learned that she had a mutated BRCA1 gene. Women with a mutation in either of the BRCA genes are at an increased risk of developing breast and ovarian cancer. Due to their patent, Myriad Genetics is the only company allowed to perform genetic testing on either of the BRCA genes resulting in the test being very expensive- on average, BRCA genetic screening costs approximately $4000 when not covered by insurance. Doctors recommend that a patient with a positive result receive yearly mammograms and/or MRIs, adding thousands of dollars to the cost of preventative care. Once the Affordable Care Act is fully implemented, BRCA genetic testing will be classified as preventative care and require no out of pocket costs for the patient. (Melanie Hicken)

Scientists report first success in cloning human stem cells – 17 years after the cloning of Dolly the sheep, scientists generated stem cells from human skin cells. Until recently, human cells have been unable to be reprogrammed using “nuclear transfer”, a technique that has been effective in many other species. Dr. Shoukhrat Mitalipov, a scientist at Oregon Health and Science University, has used the technique to reprogram human skin cells into cells resembling embryonic stem cells. This new advance in technology provides another source for deriving embryonic stem cells to be used for stem cell based therapies. (Alice Park)

Supreme Court supports Monsanto in seed-patent case – In a unanimous ruling, the Supreme Court opined that farmers cannot use Monsanto’s genetically altered soybeans to make new seeds without paying the company. According to the opinion written by Justice Elena Kagan, the ruling was narrow in scope and will not automatically be extended to every self-replicating product. Normally, farmers who buy soybeans from Monsanto must sign a contract stating that they will not harvest seeds from one season’s crop to use in following seasons. This ensures that the farmers will buy new seeds yearly. However, in this case, the farmer obtained seeds through a second-hand source and determined which seeds were Monsanto’s genetically modified seeds. He then harvested seeds from those plants to use in subsequent seasons. The Supreme Court ruled that the farmer must pay Monsanto over $84,000. (Adam Litpak)

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May 17, 2013 at 5:48 pm

Science Policy Around the Web – January 24, 2013

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photo credit: patries71 via photopin cc

photo credit: patries71 via photopin cc

By: Jennifer Plank

Our weekly linkpost, bringing you interesting and informative links on science policy issues buzzing about the internet.

Agency Moves to Retire Most Research Chimps – An NIH council unanimously recommended that most of the 451 chimpanzees used for biomedical research should be retired and moved to sanctuaries.  The recommendations will be open for public commentary for 60 days. Following this time period, the NIH director Francis Collins will decide whether to implement the recommendations. The council recommends that a small colony of approximately 50 chimps be maintained for future research. (James Gorman)

Supreme Court rejects challenge to Obama stem cell policy – The US Supreme Court has refused to hear a case challenging the president’s policy to expand government funded stem cell research. The case began in 2010 when a federal judge required the NIH to halt funding of human embryonic stem cell research. Last year, an appeals court overturned the ruling. The plaintiffs in lawsuit, Dr. James Sherley and Dr. Theresa Deisher, then appealed to the Supreme Court in fall 2012. The Supreme Court justices denied the case without comment. (David G. Savage)

Work results on lethal flu strains – A year ago, scientists agreed to halt research producing deadly strains of the H1N5 avian flu virus. The conflict began over whether it was safe to publish 2 papers in which several mutations were introduced in the H1N5 genome to allow the virus to spread among ferrets. In a letter published in Nature, the 40 scientists involved in the research claimed the moratorium has served its purpose and allowed the proper authorities to review the conditions under which the research will be conducted. (Declan Butler)

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January 24, 2013 at 11:57 am