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Posts Tagged ‘clinical trials

Science Policy Around the Web – January 24, 2017

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By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

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January 24, 2017 at 10:04 am

Streamlining Human Research by Centralizing Review: Could It Slow Things Down?

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By: Leopold Kong, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

       Human research in the United States in the form of clinical trials and other scientific studies has been regulated by Institutional Review Boards (IRBs) since 1974 after the passage of the National Research Act. The initial policies were inspired by the Nuremberg Code, a set of international research ethics principles developed in the aftermath of the second world war when Nazi medical officers conducted large-scale human experimentation atrocities. Policies that regulate IRBs in the United States are codified in the Common Rule, which mandates requirements such as membership qualifications and guidelines for protections of certain vulnerable research subjects. Although the Common Rule has not been modified since 1991, the changing face of medical research has led to recent proposals to improve the efficiency, accountability and qualification of IRBs. What has motivated change? The following situations may be illustrative.

In November 2015, the consumer advocacy group Public Citizen, and the American Medical Student Association contacted the Office for Human Research Protections (OHRP) to criticize two studies on how longer-than-21-hour shifts of first-year medical students may affect 30-day patient mortality rates. Public Citizen noted that even though the studies forced new residents to work “dangerously long shifts”, placing all involved in danger, they were readily approved by IRBs. Similarly, IRBs approved a study on the hazards of pediatric exposure to lead paint, in which researchers did not clearly reveal to households that they detected high levels of lead in their homes, resulting in neurological problems for at least one child. Also, a publication last year in the European journal Acta Informatica Medica found that only 26.5% of individuals in IRBs correctly answered 11 simple True or False questions designed to test understanding of study design and ethics. Part of the problem may be research fatigue since, according to OHRP, there are only about 3,500 registered IRBs that review more than 675,000 research protocols annually. Inefficiencies in the review process may further exacerbate the situation.

Late last year, Kathy Hudson and Francis Collins, the Deputy Director for Science, Outreach and Policy at the National Institutes of Health (NIH), and the Director of the NIH, respectively, published a Perspective in the New England Journal of Medicine on the proposed revisions to the Common Rule. In order to bring the Common Rule into the 21st century, the revisions will focus on implementing broad biospecimen consent, enhanced privacy safeguards, streamlined IRB review, and requirements for more agencies to follow the Common Rule. One of the more interesting and key revisions to improve review efficiency, the requirement for a single IRB (sIRB) for multisite studies, will be implemented on May 25, 2017. The rest of this essay focuses on this proposed change.

The time it takes for a clinical trial protocol to be reviewed by an IRB depends on the type of review, and varies from location to location. For example, a protocol can be deemed exempt, which might take only 1-2 weeks of review, expedited, which might take a few weeks longer, or be required for full review, which would take even longer. Re-evaluations are required if the protocol is sent through expedited or full reviews every year, after any changes to the method, or after any adverse event in the study. The review generally evaluates proof of human subjects’ training, consent, recruitment materials, and data collection instruments, as well as individual conflicts of interests, all of which may depend on the specific population studied and local restrictions. However, clinical trials are increasingly spread across multiple sites in order to recruit enough people for their studies. Under the current rule, each site must conduct local reviews of the same protocol independently of each other, potentially causing delays due to unneeded redundancies. “The problem that this [proposed sIRB] policy was trying to solve was that we were seeing delays and complications in moving research forward in a way that wasn’t providing commensurate protections for human research participants,” said Carrie D. Wolinetz, NIH associate director for science policy, to Bloomberg BNA.

From December 3, 2014 to January 29, 2015, the NIH received 167 comments from individual researchers, academic institutions, IRBs, advocacy groups, scientific societies, healthcare organizations, Tribal National representatives and members of the general public on the sIRB proposal. Many of the comments were highly positive and supportive of the revision. For example, the Federation of American Societies for Experimental Biology (FASEB), which represents over 120,000 researchers across 27 scientific societies, stated that “[t]his change would facilitate collaborative review arrangements and reduce the obstacles that investigators encounter when embarking on multi-center projects.” David M Pollock, the president of the American Physiological Society, added further support, commenting that the current rule results in “lack of uniformity” while the proposed changes may reduce administrative burden, and improve efficiency and quality of review.

However, many of the comments displayed reservations and harsh criticism. For example Harry W. Orf representing Massachusetts General Hospital was skeptical that the costs to move into the sIRB system would outweigh the benefits, commenting “there is currently little research or data to demonstrate that these potential benefits will materialize.” In much stronger terms, Curtis Meinert from the Johns Hopkins Bloomberg School of Public Health stated,” [t]he expectation is that the change will save money. Good luck on that. The reality is that the change will increase costs given what IRBs of record have to do to acquire the necessary assurances and certifications. The expectation also is that the single IRB will shorten the time to start, good luck on that one also.” Meinert and others, including the Human Subjects Protection Branch at Walter Reed Army Institute of Research, pointed out that the time it takes to start a study is mainly determined by other factors such as the time it takes for investigators to agree on a protocol, not IRB review. Meinert also warns that, “A likely unintended effect of the one IRB requirement is to further diminish the means and incentives for individual investigators to propose and initiate multicenter studies..” Finally, some communities also viewed the revision as a threat to local autonomy and representation. For example, Bill John Baker, the Principal Chief of the Cherokee Nation, commented, “Tribal IRB members have firsthand knowledge of local tribal customs, cultural values, and tribal sensitivities. If Tribal IRB members are not able to participate […] our citizens are affected by persons who are not sensitive to their distinctive needs.”

Analysis of all comments made regarding sIRB by the Council on Government Relations indicated that 51% opposed the proposal while 42% supported it and 6% offered qualified support. Interestingly, most commercial IRBs, which might be more favorably biased towards the needs of industry sponsors, supported this change. A breakdown of the numbers indicates that while the majority of advocacy groups, professional societies, disease registries and individual researchers supported the change, 89% of universities and medical centers, the organizations that are directly involved with clinical trials and representing thousands of researchers and medical support staff, opposed it. “The spirit of the changes are well intended, but it fails to address the fact that roles and responsibilities of the IRB have expanded beyond those initially dictated when the use of IRBs were first formed“ says Annika Shuali, certified clinical research coordinator at the University of Virginia.

Clearly, reforms are needed to update the aging IRB system. In theory, centralization through the sIRB may improve efficiency. However, in practice, the complexities and details of conducting clinical trials at specific sites such as resolving individual conflicts of interest, being compliant with local regulations, and accounting for the specific rights of certain populations make centralization extremely difficult. To address these site-specific issues, local IRB’s may still need to be in place, but now required to communicate to the sIRB, potentially increasing administrative burden, which undermines the original motivation to streamline review. Hopefully, the sIRB revision to be implemented next year will be further revised to address the critiques from the majority of the community.

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December 3, 2016 at 11:46 am

Science Policy Around the Web – October 25, 2016

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By: Nivedita Sengupta, PhD

Source: pixabay

Clinical Trials

EMA becomes first major drugs agency to publish clinical-study reports online

On 20th October, the London-based European Medicines Agency (EMA) published details of the full clinical-trial data that it received from pharmaceutical companies, some 100 clinical reports, about two EMA-approved medicines, carfilzomib, a cancer drug, and lesinurad, a gout treatment. The disclosures make the EMA the first major drug regulatory agency to completely publish the results of clinical investigations that drug developers submit while applying for the agency’s approval to market medicines in the European Union. “These clinical study reports (CSR) are much more detailed than the papers that drug firms publish in scientific journals. It includes both positive and negative results, and details of drugs’ adverse effects,” says Larry Peiperl, the chief editor of PLoS Medicine.

Under the rules the EMA brought in six years ago, it had released results of such studies only if third parties asked for them using freedom-of-information requests. However, those rules allowed some drug firms to drag the agency to court to try to prevent their data from being released, arguing it as commercially confidential. However, patients and clinicians have waited long, and about 700 medical and patient organizations had lobbied for clinical data release under the All Trials campaign. “The EMA’s CSR policy adopted in 2014 will benefit both academic research and the practice of medicine as a whole,” says EMA executive director Guido Rasi. It will help academicians to independently re-analyze data even after a medicine has been approved, and will help drug developers to learn from the experiences of others.

The EMA intends to release all CSRs in applications that were submitted since 1st January 2015. It will only edit some commercially confidential information like individual patient data before release. After the clearance of backlog, the EMA says that it will offer public access to around 4,500 clinical reports each year.

Some drug firms are still resisting the release of their data by the EMA. In the latest legal battle this July, an interim judicial EU court order blocked the EMA from releasing toxicity studies on a veterinary medicine called Bravecto (fluralaner), and clinical-study reports on Translarna (ataluren), a treatment for Duchenne muscular dystrophy. The two drug firms concerned, Intervet and PTC Therapeutics, argued that the release of data would infringe on their rights to protect commercially confidential information. However, the EMA has appealed against both decisions on 29th September, and says that it sees the cases as a test of its policy. (Alison Abbott, Nature News)

Biotechnology

In a first, mouse eggs grown from skin cells

For the first time, stem cell researcher Katsuhiko Hayashi of Kyushu University in Fukuoka, Japan, and colleagues have reprogrammed fibroblasts from the tip of an adult mouse’s tail to make eggs, which upon fertilization grew into healthy mice. Earlier, adult body cells were reprogrammed to generate stem cells (induced pluripotent stem cells – iPSCs), which were further induced into becoming a wide variety of other cells but never eggs. Egg cells are much trickier as they represent ultimate flexibility which can create all the bits and parts of an organism from raw genetic instructions. “This is very solid work, and an important step in the field,” says developmental biologist Diana Laird of the University of California, San Francisco. This major development could make it possible in near future to study the formation of gametes — eggs and sperm — an unknown process that takes place inside fetuses. Moreover, if the experiments gets extended to human cells, it could make eggs easily available for research and may eventually lead to infertility treatments.

In this experiment, Hayashi and colleagues made artificial ovaries by extracting ovarian support cells from albino mouse embryos, which were then mixed with primordial germ cell‒like cells created from tail-tip skin cells from a normally pigmented mouse. After 11 days of maturation followed by fertilization, the eggs were transplanted into the uteruses of female mice. Six pups with dark eyes were born, indicating that they came from the tail-tip eggs and not eggs accidently extracted from the albino mice along with the ovarian support cells. The baby mice grew up apparently healthy and have produced offspring of their own.

As ovarian cells from mouse embryos were still needed to support the growth of eggs in vitro this could be a potential problem when trying to replicate the experiments in humans. “It’s yet unclear how support cells in ovaries foster egg development. Researchers can’t yet reproduce the supporting cells in the lab and so need to get those cells from embryos,” Hayashi says. (Tina Hesman Saey, ScienceNews)

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October 25, 2016 at 10:55 am

Science Policy Around the Web – September 27, 2016

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By: Nivedita Sengupta, PhD

Source: pixabay

Alzheimer’s Disease

Larger studies are under way to test whether the promising early data holds up

Recent clinical trials reported that the drug “Aducanumab” might remove toxic amyloid-β proteins thought to trigger Alzheimer’s disease from the brain. In the study involving 165 people, 103 patients received the drug once a month for 54 weeks and the other group received a placebo. Patients receiving infusions of aducanumab experienced a reduction in the amount of amyloid-β in their brains, which was in accordance with the findings of a pretrial mouse study in which the drug cleared amyloid-β plaques from the animals’ brains. “This drug had a more profound effect in reversing amyloid-plaque burden than we have seen to date,” says psychiatrist Eric Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, Arizona.

Whether aducanumab works to ameliorate the memory and cognitive losses associated with Alzheimer’s is currently under phase III clinical trials. Scientists have debated for years whether accumulation of amyloid-β causes memory loss and other symptoms of Alzheimer’s. This trial is in favor of the “amyloid hypothesis”, and suggests that elimination of the protein might alleviate the symptoms. In the past, other Alzheimer’s drugs have looked promising in early-stage trials, but ended in failure and even caused deaths of patients because of brain inflammation. Aducanumab also showed abnormalities on brain-imaging scans but it was in less than one-third of the patients. Hence, to avoid death of participants, researchers closely monitored such anomalies in these Alzheimer’s trials. All of the reported imaging abnormalities eventually disappeared in about 4 to 12 weeks, and no patients were hospitalized.

Patients who received higher doses of the drug, or who had genetic risk factors for Alzheimer’s, were more likely to develop the brain anomalies. Accordingly, Biogen — the company that makes aducanumab —adjusted the drug’s dosage and the monitoring schedule for people with genetic risks for Alzheimer’s in its phase III trials.

Aducanumab is a bright spot in the field of Alzheimer’s therapeutics after years of failed antibody and other types of drug trials. “This is the best news we’ve had in my 25 years of doing Alzheimer’s research, and it brings hope to patients and families affected by the disease,” says neurologist Stephen Salloway of Butler Hospital in Providence, Rhode Island, who was on the team that ran the initial trial. (Erika Check Hayden, Nature)

Clinical Trials

Investigators are now required to disclose all clinical trials, whether successful or not

On 16th September 2016, the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH) announced the new rules for clinical-trial disclosures. According to the new law, it is required that all researchers must report the design and results of all clinical trials whether successful or not. The revised law also empowers the government to enforce penalties for those who fail to comply. The new rule will be effective from 18th January onwards and researchers have 90 days to comply. The disappointing results of clinical trials will no longer remain unpublished, and the new rule intends to crack down on the large number of clinical trials that are conducted but never reported. Robert Califf, head of the US Food and Drug Administration (FDA) says, “A lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known.”

The old rule mandated that researchers conducting trials with human subjects had to register their study with the HHS website, ClinicalTrials.gov, before starting their work, and should follow up with information about their methods and results. But there were many exceptions and loopholes which created a lot of ambiguity. This allowed researchers to avoid reporting all the trials, particularly the failed ones. Christopher Gill, a health researcher at Boston University in Massachusetts says, “This can bias the literature and obscure important information on whether an experimental therapy is harmful. From the perspective of consumers and science, failures are as important as successes”.

Under the new rule, all trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient and researchers can no longer wait for the results of their trials to report their data. Additionally the NIH’s companion rule edicts that NIH-funded researchers have to register phase I trials and also trials that do not involve an FDA-regulated product, such as behavioral interventions. Further changes dictate reporting the details of plans to conduct trials, outlining the statistics to be used to analyze the results, and revealing any changes in the protocol over the course of the study. The final HHS rules will give regulators a greater ability to enforce existing regulations, because many studies of drugs that are eventually licensed are still not reported. (Sara Reardon, Nature)

Income Inequality

Wages for top scientists are shooting skywards while others are being left behind

Income inequality in science is in the rise and is evident in all universities across several countries. The salary gap between elite scientists and those toiling in the benches is expanding over the past few decades. Limited data on the salaries of scientists is available making it difficult to determine the full extent and causes of income inequality. “But the gap in wages has reached a point at which it could be driving talented young people away from careers in academic science”, says Richard Freeman, an economist at Harvard University in Cambridge, Massachusetts. The results of Nature‘s 2016 salary survey also support this concern.

One of the metrics used to measure disparities in salaries is the Gini coefficient in which 0 means everyone earns the same and 1 indicates maximum inequality. In 2012, economist Paula Stephan found that the Gini coefficient has more than doubled between 1973 and 2006 in most fields and faculty ranks in science, with the biggest increases in the life sciences. In contrast, it grew only 35% for full-time male earners in the United States and 18% for US households.

A major issue responsible for the rise of the Gini coefficient is the doubling of the National Institutes of Health’s budget during the late 1990s and early 2000s. This created competition among institutions for a small pool of top-ranked, grant-winning scientists. Everybody wanted to employ the most productive scientists who could bring in grants thus driving up the salaries. “One way for universities to minimize risk is to pick someone who is a demonstrated winner,” says Donna Ginther, a labour economist at the University of Kansas. Like the US, in the UK too, the salaries of top-earning professors have been pulling away from the pack since the late 1990s. An analysis of full-professor salaries in UK in July suggested that low ranking universities, to improve their REF (Research Excellence Framework – an assessment, done by UK funding agencies roughly every five years) performance, are offering high salaries to recruit researchers with high-quality papers to boost their scores. A similar trend is seen in other countries like China and Germany.

On the other end of the salary spectrum, there is little pressure to boost pay. With grants getting harder to win, labs are employing low-cost workforce to maximize research output. This labor environment benefits from the willingness of postdocs to sacrifice income for a chance at an academic research career. Even those lucky enough to land offers for tenure-track junior faculty positions find that starting salaries are not very negotiable.

High salaries at the top can attract productive workers, but low pay at the bottom signals that there may not be a good future in this career. If big rewards become concentrated among a smaller group of people in a highly competitive area, then others who could still have been productive scientists end up losing a disproportionate amount in terms of earnings and career prospects and it could keep promising people from further pursuing a research career. (Corie Lok, Nature)

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September 27, 2016 at 11:47 am

Science Policy Around the Web – July 29, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Clinical Trials

Europe overhauls rules for ‘first-in-human’ trials in wake of French disaster

Following the disastrous clinical study in Rennes, France in January 2016 that resulted in the death of one volunteer and the hospitalization of five more, efforts are being taken by the European Medicines Agency (EMA) to improve identify and reduce risks in human clinical trials. EMA proposed changes to the current guidance on first-in-human clinical trials in a new concept paper which has been released for public comment.

The current guidelines for “first-in-human” (FIH) studies on healthy volunteers date to 2007 after a similar tragedy in London in 2006. Nine volunteers were hospitalized with severe adverse events after receiving a monoclonal antibody named TGN1412 for the first time.

The concept paper states that the role of pharmacology and toxicology data in estimating the therapeutic dose, increases in dosing, and stopping criteria need to be addressed in the revised guideline. Also, other subjects will be addressed which include new instructions for decision-making processes and stopping rules, rolling review of emerging human data during the study, communication to authorities and subjects, and guidance on the type of scientific information to be included in a trial application. The deadline for comments on this concept paper is September 30, after which it will publish a draft revised guideline later this year.

These changes are a direct response to the French clinical trial which has been criticized for its lax design. The trial protocol allowed the study to move to additional phases without external review such as an analysis of pharmacokinetic data of the previous cohort. The prosecutor is still investigating whether involuntary manslaughter charges are warranted in the case. (Hinnerk Feldwisch-Drentrup, ScienceInsider)

Climate Change

Cleaner air may be driving improvements in Chesapeake Bay water quality

A new study suggests that cleaner air may be the main driving force on  the improvement in water quality in the Washington, DC metro area, including the Chesapeake Bay.

The Chesapeake Bay is the nation’s largest estuary. For decades it has suffered from excessive nutrient and low oxygen conditions. Although land-based management practices and improvements to wastewater treatment plants have helped to improve water quality in the Chesapeake Bay, researchers have found that improvement in air quality is the primary driver of improvements in water quality in the area studied – the Upper Potomac River Basin which covers 12,000 square miles in Maryland, Virginia, West Virginia, Pennslvania, and the District of Columbia. It is believed that these region-wide water quality benefits were due to the implementation of the Clean Air Act of 1990.

“The recent water quality successes in the Chesapeake Bay restoration are apparently driven more by air quality regulation rather than by water quality control efforts,” said study author Keith Eshleman, professor at the University of Maryland Center for Environmental Science’s Appalachian Laboratory. “These air quality regulations were intended to address human health issues and acid sensitive streams. No one thought you would have this positive impact on water quality. It was totally unanticipated.”

One cautionary note is that the apparent reversibility of the process means that a relaxation in air quality regulation would lead to a reversal in the direction of watershed water quality across the basin. (Keith N. Eshleman and Robert D. Sabo, Atmospheric Environment)

Science and Society

Turkish academics targeted as government reacts to failed coup

After the failed July 15th coup attempt, the Turkish government has disrupted higher education. As part of a massive political purge, educators across the country have been suspended from their roles. “They are restructuring academia,” says Caghan Kizil, a Turkish molecular biologist based at the Dresden University of Technology in Germany who has been in close communication with colleagues in Turkey. “People are very scared and not hopeful.”

In the span of a few days, more than 45,000 civil servants in the military and judiciary have been fired or suspended. In addition, it appears that some 15,000 staff members of the ministry of education also were fired, with 21,000 teachers losing their professional licenses, and more than 1500 university deans were all but ordered to resign. Turkish academics currently abroad have also been ordered back by the government. “They want to take the universities under their full control,” says Sinem Arslan, a Turk doing a political science Ph.D. at the University of Essex in the United Kingdom. “Academic freedoms will no longer exist. I don’t think that anybody will be able to work on research areas that are considered taboo by the government or write anything that criticizes the government.”

The motives behind this new crackdown is currently not known. However, the truth may emerge from an unexpected source – Wikileaks. This whistleblower site released nearly 300,000 emails allegedly written from Turkish government officials going back as far as 2010. Time will tell if this new information will shed light on the motives behind the new crackdown on education and research in Turkey. (John Bohannon, ScienceInsider)

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July 29, 2016 at 9:00 am

Science Policy Around the Web – July 1, 2016

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By: Daniël P. Melters, Ph.D.

Image source: Scientia Salon blog

Research Participant Protection

National Academy of Sciences advises White House to rewrite Common Rule

In order to protect participants of clinical studies from being harmed by the very same studies, a set of regulations was set-up for this purpose. These regulations are called the Common Rule and most researchers will encounter the Common Rule when they submit their proposal for ethical review with their local Institutional Review Board (IRB). The rules (45 CFR 46) that apply today were drafted back in 1991 and have not been updated since. Thus last year the U.S. Department of Human and Health Services (HHS) proposed a major revision. The proposal was greeted with criticism and on June 29th, 2016 the National Academy of Sciences, Medicine, and Engineering (NAS) joined the critics. According to the NAS, the HHS proposal is “marred by omissions, the absence of essential elements, and a lack of clarity.” Therefore, NAS made bold suggestions to the Obama administration withdraw the proposed revision to the Common Rule and create a independent national committee modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to essentially rewrite the Common Rule from scratch. (Rob Stein, NPR News)

Science Funding

Interdisciplinary research proposal are less frequently funded

Although interdisciplinary research is frequently praised and encouraged, funding such projects has proven to be difficult. The latest report by an Australian group is similar to those conclusions drawn by the U.S. National Institutes of Health (NIH) before it launched the Roadmap for Medical Research in 2004 to stimulate interdisciplinary research. What makes the most recent Australian study stand out is the metric they developed to determine how interdisciplinary a proposal was. This metric is called “interdisciplinary distance”. The measure assigns a value between 0 and 1 on the basis of the information included in the proposal. A value of 0 represents a proposal that only covered one discipline, whereas all other proposals would receive a value up to 1 depending on how distant and abundant the disciplines were. The method is similar to a biodiversity metric that takes into account the distance between species on an evolutionary tree and their relative abundance in an ecosystem. The group then analyzed over 18,000 proposals submitted to the Australian Research Council Discovery Programme between 2010 and 2014. Betsy Wilder from the NIH Office of Strategic Coordination wants to use the new metric to see if the Roadmap has made progress in funding interdisciplinary research over the last 10 years. (Elena Bozhkova, Nature News)

Cancer MoonShot

Vice-President Biden threatens to cut funding to non-compliant medical research institutes

During the 2016 State of the Union, President Obama revealed his latest biomedical initiative: the moonshot to cure cancer. This initiative is led by Vice-President Joe Biden. The goal of this initiative is to stimulate collaborative research to accelerate the potential of combination immunotherapy as the next generation standard for cancer treatments. The goal is to initiate randomized Phase II clinical trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020. On June 29th, 2016, Biden attended the National Cancer Summit at Howard University. Here he made comments following a STAT investigation revealing frequent lapses in reporting clinical trials. If this is found to be true, Biden promises to cut funding. This falls in line with new rules imposed by the National Institutes of Health that will help crack down on institutions that lapse, not just individual investigators. In addition, the Food and Drug Administration (FDA) will soon be able to impose a $10,000/day fine to non-compliant companies. All together, this is a push to make clinical trials funded with public money be part of the public record and thereby facilitate collaborations and accountability. (David Nather and Charles Piller, STAT news)

Natural Resources

Large helium reserves found in Tanzania

Everyone knows helium for one of two things: 1) keeping balloons afloat and 2) making people sound funny. Nevertheless, helium is a remarkably important gas, especially in medicine and science. To keep the magnets of an MRI machine cool, it requires helium. To keep the Large Hadron Collider at CERN running, it needs helium. Helium is also used in other industries that require superconductivity. It is a naturally occurring gas that is formed from decaying uranium and thorium, but this is a slow process. Furthermore, helium does not react with anything (ergo its important role in cooling) and is very light. As a result, helium escapes to the atmosphere quickly and cannot be retrieved. The great demand on helium has led to several moments of shortages. It has been vital to discover a new deposit on helium.

To date, helium was only extracted as a by-product of oil and gas drilling, but these deposits only contain a small amount of helium. By understanding how helium is released from rocks, a team of researchers have devised a method to explore for helium in a new and specific way. Just like other gasses, released helium has to be trapped by underground formations. Using the same kind of seismic studies in oil and gas exploration, helium can be recovered. An area in the Tanzanian part of the East African Rift was proposed to be a prime candidate region to find helium. Indeed, a large amount of helium was discovered there. As much as 1.5 billion cubic meter of helium is thought to be trapped. This is more than twice the amount that is currently stocked at the Federal Helium Reserve near Amarillo, TX. This reserve supplies 40% of the helium used in the U.S. (Henry Fountain, NY Times)

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July 1, 2016 at 2:00 pm

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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Written by sciencepolicyforall

June 28, 2016 at 2:30 pm