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Archive for September 2015

Science Policy Around the Web – September 29, 2015

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By: Cheryl Jacobs Smith, Ph.D.

Photo source: capitol via licence

Legislative Policy

Congress moves closer to averting government shutdown with Senate vote

Amidst the controversial language to de-fund Planned Parenthood in a continuing resolution (CR) to keep the federal government solvent, the Senate pushed ahead with a stopgap spending bill to keep federal services running for a few more months – and with no cuts to Planned Parenthood. An earlier link post by Sara Cassidy, M.S., Ph.D. reported that some in Congress were pushing for budget legislation that would de-fund Planned Parenthood written into the CR to fund the National budget. That particular addition to the legislation threatened that the CR would not be passed by the September 30th deadline resulting in a government shutdown. However, since John Boehner, 53rd Speaker of the House, announced his resignation at the end of October, Republican leaders joined by Democrats went forward with a short-term funding measure to keep the government operating without cuts to Planned Parenthood. On Monday, the Senate overwhelmingly advanced the government funding bill by a 77-19 vote. Final passage in the Senate is likely to come Tuesday. The House is expected to vote Wednesday. (Lisa Mascaro, Los Angeles Times)


FDA OKs Novo Nordisk Diabetes Drug Tresiba

The U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s anti-diabetic drug, Tresiba on Sept. 25. The Denmark-based company behind Tresiba is pleased with the FDA’s approval. “We are very happy with FDA’s decision to approve Tresiba and Ryzodeg as we believe these products offer significant benefits and important treatment options for people with type-1 and type-2 diabetes”, said Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk. Sørensen added that this approval is a milestone for the company. Tresiba was initially disapproved by the FDA due to the lack of data on the risk for heart problems. Tresiba is a long-acting insulin used to control blood sugar levels of type-1 and type-2 diabetics and can last up to 42 hours. Living with type-1 or type-2 diabetes is similar to other chronic disorders where the care and maintenance of the disease encompasses every minute of the day. This longer-acting insulin promises to give some relief. Another positive aspect about the passage of Tresiba is that Novo Nordisk’s North America’s chief medical officer, Todd Hobbs said that “We want to do everything we can to make it as affordable and as broad of an access as we can.” (Julienne Roman, Tech Times)

Environmental News

After a year of stonewalling, Volkswagen finally came clean

Volkswagen stunned two senior officials with the U.S. Environmental Protective Agency (EPA) by admitting the automaker hacked its own cars to deceive U.S. regulators about how much their diesel engines pollute and exceed EPA emission regulations. U.S. officials exposed the deception on September 18, triggering Volkswagen’s admission that it had installed software in its cars to detect when they were being tested and alter settings to conceal the true emissions of 11 million cars sold worldwide. As a result, Volkswagen, the world’s largest automaker by sales, faces EPA fines that could reach $18 billion. (Reuters)

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September 29, 2015 at 11:00 am

Science Policy Around the Web – September 25, 2015

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By: Elisavet Serti, Ph.D.

Image courtesy of NIH Image Bank

Drug Policy

The new hepatitis C virus bottleneck: Can delaying therapy be justified?

Chronic Hepatitis C infection affects more than 3.2 million people in the United States, resulting in severe liver disease, cirrhosis, hepatocellular carcinoma and death. The FDA approval of the new anti-Hepatitis C direct acting antivirals marked a revolution in HCV therapeutics; it is now possible to offer patients safe and highly effective (more than 90%) alternatives to pegylated interferon and ribavirin. However, the high cost of these new treatment regimens has proven to be a major obstacle to their delivery. Twelve weeks of anti-Hepatitis C oral treatment costs between $80,000 and $95,000, and it has been estimated that total health care costs related to Hepatitis C therapy could soon reach $27 billion per year. As a consequence, many state-funded and private insurance programs have restricted access to direct acting antiviral-based therapy to patients with advanced fibrosis and extra-hepatic manifestations. In Texas, Medicaid has elected not to cover this type of therapy at all.

In a recent Hepatology editorial, the editors wondered about the potential burdens of this Hepatitis C therapy bottleneck that leads to exclusion of the majority of chronic patients due to high costs. The editors argue that “while persons with advanced fibrosis are clearly at higher risk for short-term complications, it is not clear that persons with lesser degrees of fibrosis are not at risk for harm.” A recent meta-analysis has demonstrated that rates of fibrosis progression may be far more accelerated than previously thought. This means that the option of delaying therapy runs the risk of progression to cirrhosis and development of hepatocellular carcinoma. The editors argue that delaying therapy could introduce the added burden of implementation of hepatocellular carcinoma or portal hypertension screening. Also, chronic Hepatitis C has been associated with a variety of extra-hepatic manifestations like diabetes, cardiovascular disease, psychiatric disorders, depression, renal dysfunction and rheumatologic conditions. This means that we should factor these extra-hepatic complications when calculating the cost effectiveness of the new Hepatitis C therapies. For these and several other reasons, the American Association for the Study of Liver Diseases (AASLD) – Infectious Diseases Society of America (IDSA) HCV guidance recommends that all infected persons should be treated.  (Tracy G. Simon and Raymond T. Chung, Hepatology)

Biomedical Research

Is the Alzheimer’s protein contagious?

A study recently published in Nature concluded that human transmission of amyloid-b pathology and cerebral amyloid angiopathy is possible. In simpler terms, they concluded that Alzheimer’s disease can be transmissible person-to-person, under special iatrogenic (or medical treatment) routes. The researchers examined the brains of eight people that had died of iatrogenic Creutzfeldt-Jakob disease (CJD) as a result of treatment with human cadaveric pituitary-derived growth hormone contaminated with prions. Prions are misfolded proteins with incubation periods that can exceed five decades. Human transmission of prions has occurred via medical and surgical procedures worldwide as well as via cannibalism in Papua New Guinea. Although treatment with cadaveric-derived growth hormone stopped in 1985, iatrogenic CJD continues to be found.

The researchers showed evidences of amyloid-β spread in the brains of these subjects, which is responsible for the development of Alzheimer’s disease, supporting the theory that the contaminated growth hormone injections could have contributed to the development of iatrogenic Alzheimer’s disease as well. It has never been reported in the past that amyloid-β protein can be transmittable through other medical procedures, such as brain surgery or blood transfusion. These results and their interpretation spurred criticism from several neuro-specialists and researchers who noted that the prions causing CJD can also trigger the formation of amyloid deposits in these brains. Still, there is no epidemiological connection between the contaminated growth hormone injections and the development of Alzheimer’s disease (Emily Underwood, Science Latest News).

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September 25, 2015 at 9:00 am

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Science Policy Around the Web – September 22, 2015

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By: Kaitlyn Morabito, Ph.D.

photo credit: 2-cell via photopin (license)

Embryonic Research

U.K. researcher applies for permission to edit embryo genomes

Stirring up an old controversy about “designer babies”, a scientist at the Francis Crick Institute in London has applied for “a license to edit the genes of human embryos” from the UK’s Human Fertilization and Embryology Authority (HFEA). In an effort to research early human development, researcher Kathy Niakan would like to use genomic editing to better understand this process. The use of genomic editing of embryos would be solely for use in the laboratory and not used for reproduction. This application comes on the heels of calls from the scientific community to evaluate the risks and benefits of using these emerging and established techniques in embryonic research as well as develop new guidelines for their use. In the US, this research would be not be illegal, but would not be eligible for funding from the National Institutes of Health due to federal law. (Gretchen Vogel, ScienceInsider)

Public Health

Experimental Ebola drug ZMapp gets fast track status from FDA

With the Ebola epidemic still raging in West Africa, the Federal Drug Administration (FDA) has fast tracked approval of ZMapp, an antibody-based Ebola drug that initially made headlines for its experimental treatment of Dr. Kent Brantly and Nancy Writebol.  In total, the drug was used in nine infected patients in Africa, the US, and Western Europe.  However, the efficacy of the drug cannot be evaluated since it was not administered in a controlled clinical trial.  The drug has been shown to be effective when given within forty-eight hours of infection in monkey studies.  ZMapp consists of three monoclonal antibodies that were generated in mice and acts by binding to the virus to prevent attachment and entry into new cells.  ZMapp will need to be shown to be both safe and able to induce an immune response in human before it will be given approval by the FDA. (Debra Goldschmidt,

NFL Head Trauma

87 of 91 tested ex-NFL players had brain disease linked to head trauma

According to a study by the US Department of Veterans Affairs and Boston University, ninety-six percent of tissue samples tested for chronic traumatic encephalopathy, CTE, were positive.  CTE is a brain disease thought to be caused by trauma to the head and has become a headline regarding the safety of NFL players.  The samples came post-mortem from NFL players who were concerned that they may be suffering from CTE, so the overall prevalence in former NFL players is unknown.  Although publicized as being found mainly in athletes involved in repetitive brain trauma, CTE strikes non-athletes as well including people who experience grand mal seizures and abuse.  CTE can only be diagnosed post-mortem and is defined by the build-up of tau protein in the brain leading to neurological symptoms.  This is not the first time the NFL has addressed this issue, and have previously settled with former NFL players to cover medical expenses for disorders associated with repeated head trauma.  Additionally, the NFL has been working to decrease head trauma through changing regulations and evaluation procedures. (Jason Hanna, Debra Goldschmidt and Kevin Flower,

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September 22, 2015 at 9:00 am

Science Policy Around the Web – September 18, 2015

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By: Sara Cassidy, M.S., Ph. D.

photo credit: via photopin cc

Legislative policy

Turmoil in Congress could lead to government shutdown and a stall in scientific research

Planned Parenthood has received a lot of negative press surrounding a video of a high-level executive talking about fetal tissue collection and sale. Despite the fact that Planned Parenthood is completely within the law regarding such sales, and fetal tissue research (typically in the form of stem cell research) is also legal and funded by the NIH (in the form of grants to university researchers), and has real promise in saving individuals with devastating disease, some in Congress are using anti-abortion grandstanding and the threat of de-funding Planned Parenthood to hold up passage of a continuing resolution (CR) to keep the government solvent. If a CR is not passed by Sept 30th, the government will likely experience a shutdown similar to the one experienced in 2013.

The government shutdown impedes science in a variety of different ways. When the government is unfunded, NIH cannot enroll new patients to the clinical center including children with cancer. In 2013, the FDA was forced to furlough approximately 45% of its employees, which jeopardized food safety, since they were no longer able to inspect food manufacturers or monitor food imports. And the government shutdown was felt in science beyond the DC metro area. Scientists applying to the federal government for grants and funding to conduct research, who would have otherwise had their applications reviewed in October, had to wait until January for review. The Washington Post estimates the likelihood of a government shutdown on Oct 1st as “well over 50%”to 70%.

Women in STEM

Miss Vermont uses the talent portion of Miss America 2016 to promote STEM

Alayna Westcom didn’t tap dance or sing for her talent in Atlantic City on Sunday night (9/13/15), she chose beakers and chemicals in an effort to wow the crowds with chemistry. Westcom has a B.S. in forensic science from Bay Path University and an M.S. in medical laboratory science from the University of Vermont. More recently, she completed an internship with the Vermont state medical examiner’s office. Westcott plans to attend medical school after her tenure as Miss Vermont with the goal of becoming a medical examiner herself. Since her victory as Miss Vermont 2015, she has traveled the state sharing her love of STEM with school children, hoping reach 10,000 by the end of the year. Her chemistry demonstration in last night’s competition mixed potassium iodide, hydrogen peroxide, and soap to produce a foamy eruption called “elephants toothpaste”. You can see the demonstration at the 2015 Miss Vermont pageant here. While Miss Vermont was not crowned Miss America on Sunday, her elevation of science was a welcome addition to the talent competition.

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September 18, 2015 at 9:00 am

Science Policy Around the Web – September 15, 2015

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By: Julia Shaw, Ph.D.

photo credit: Vaccination via photopin (license)


How did Polio Pop Up in 2 Polio-Free Countries: Ukraine and Mali?

A total of three new cases of polio appeared this month in two countries that were thought to be polio-free. Two children from Ukraine, where the vaccination rate is about 50%, and one Guinean infant in Mali fell ill due to a mutated form of one of the poliovirus strains used in the oral polio vaccine (OPV). Polio is a highly contagious disease that replicates in the gut before entering the bloodstream from where the virus can then infect the nervous system, causing paralysis or death. Because the virus can spread through feces, children living in areas with poor sanitation are particularly vulnerable. Like the injected vaccine, OPV protects against systemic infection and nervous system damage; but unlike the injected vaccine, OPV also generates protective immunity in the gut, effectively preventing transmission after at least three doses. In addition, because it is easier and less expensive to administer, lower-income countries usually prefer the OPV. According to officials at the World Health Organization (WHO), the OPV has prevented over 650,000 polio cases per year over the past 10 years. However, because the vaccine is generated from a weakened form of live poliovirus, the vaccinated can shed virus in their stool for 6-8 weeks. Although very rare, it is possible for the weakened virus strain to replicate and mutate over time to a point where it again becomes virulent and able to cause paralysis as happened in these recent cases. In under-immunized communities, vaccine-derived polioviruses can circulate from person to person long enough for a reversion to virulence to occur. Ukraine is considered under-immunized due to vaccine supply and logistics as well as a significant anti-vaccine attitude among the public. Mali has infrastructure problems that complicate distribution and in Guinea, surveillance and immunization rates have dropped due to the Ebola crisis, creating potential “gaps” in the polio-immune population. Because of these vulnerabilities, a large-scale outbreak response is planned in both countries that is designed to quickly immunize as many children as possible; step-up surveillance; train health workers; trace and test contacts of the paralyzed children; and educate the community on the importance of vaccine vigilance. (Diane Cole, NPR and Michael Toole, The Conversation)

Energy Security

DOE releases new energy technology report

The Department of Energy (DOE) released their Quadrennial Technology Review (QTR) on Thursday, September 10th. Over 700 energy experts contributed to the over 400-page review that found “enormous, underappreciated, and underexploited” ways to both conserve and increase our energy supply. In comparison to its 2011 predecessor, which was the first QRT report, this version is broader in its scope and depth. A main target for energy conservation was buildings, which account for 76% of all electricity use and 40% of all energy use in the United States. Adoption of Energy Star equipment could reduce consumption by an estimated 20% and emerging technologies that promise greater energy efficiency could potentially slash energy use by 35%. The United States leads the world in the combined production of oil and gas. The report stresses the need to improve carbon dioxide capture technologies to offset the burning of these fossil fuels. While the administration’s Secretary of Energy, Ernest Moniz, and White House science adviser, John Holdren, attributed the approximately 10% reduction in emissions since 2007 to a decrease in coal consumption and concomitant 3-fold increase in wind and 20-fold increase in solar energy generation, the QRT highlighted the potential of wind power. The report suggested that increased turbine hub height and use of advanced computer programs to predict wind farm location could help wind-power provide 35% of the country’s electricity by 2050. A modern and secure energy grid capable of tracking energy flow as well as improved batteries for computing support and energy storage were also key to the QTR’s vision. In addition, Moniz emphasized the need for new, advanced materials and technologies in order to maintain energy security and limit climate change. (Emily Underwood, ScienceInsider)

Health and Aging

Federal researchers urge older adults to aim for much lower blood pressure

A study supported by the National Heart, Lung, and Blood Institute (NHBLI), a component of the National Institutes of Health, was ended prematurely after preliminary results showed a striking benefit to reducing systolic blood pressure to 120 or less. The Systolic Blood Pressure Intervention Trial (SPRINT) enrolled adults over 50 who had a history of cardiovascular disease and systolic blood pressure of 130-180. Half of the patients were treated to keep their blood pressure at 140, which is the current clinical recommendation for adults (advocated by the NHBLI in 2013), the other half were given “intensive treatment” with an average of 3 medications to reduce blood pressure to 120. In the latter group, risk of heart attach, stroke, and heart failure dropped by one-third and risk of death dropped by 25% compared to those maintaining blood pressures at 140. But according to Randall M. Zusman, director of the division of hypertension at the Corrigan Minehan Heart Center at Massachusetts General Hospital, many blood pressure medications levy significant side effects. Physicians will need to evaluate patients on an individual basis, taking into account age, health, and lifestyle before attempting to more aggressively reduce blood pressure. Aside from medication, diet, exercise, and relaxation techniques are all known to lower blood pressure. In reference to the study, Gary H. Gibbons, director of the NHBLI, stated, “This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50.” (Lenny Bernstein, The Washington Post)

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September 15, 2015 at 9:00 am

Science Policy Around the Web – September 11, 2015

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By: Agila Somasundaram, Ph.D.

Corals and Fish on Jackson Reef by Matt Kieffer via Flickr Creative Commons BY-SA 2.0

Climate Change

Warming Oceans Putting Marine Life ‘In a Blender’

Lobsters are thriving in Maine, while their numbers are dwindling in southern New England. The reason? Global Warming. The higher temperatures in the north may be speeding up their metabolism, but the waters may be too warm at the southern edge of their range. This is just one example of a global trend in changing temperatures. Because the ocean temperatures have been rising, many marine species are moving to more comfortable waters. Many species are moving towards the pole, away from the Equator, at an average speed of 4.5 miles a year, about 10 times as fast as land species are moving. Scientists are developing models to study what this reshuffling of ocean ecosystems will look like, and the picture seems stark. In a recent study published in Nature Climate Change, scientists analyzed the current ranges of about 13,000 species of marine organisms. If ocean temperatures continue to rise, species will move to stay in their ‘thermal niches’. The move might be easier for some, and not so for the others, depending on the obstacles that lie in their migration paths. Scientists also project that, if this happens, by 2100, the tropics will lose a majority of their species, and there will not be new species taking their place. It’s unclear how the existing ecosystems away from the equator would be affected by the arrival of new species. Some newly arrived species may outcompete the native inhabitants, and some may go extinct. “It’s a game about winners and losers”, says Dr. Jorge García Molinos, lead author of the study. Dr. Malin L. Pinsky says that movement of fish away from the tropics might have food implications. “Seafood in many of these countries is a very important source of nutrition. Climate change could leave a gaping hole in the oceans.” (Carl Zimmer, The New York Times)

STEM Education and Funding

Intel Ending Sponsorship Of Prestigious Science Contest For High School Student

Intel, the giant semiconductor manufacturer, has been a sponsor of the Science Talent Search competition, organized by the Society For Science, since 1998. But Intel will be ending its partnership with the competition after 2017. Science Talent Search is the most prestigious science and mathematics award for high school students in the U.S. Some of the past winners have gone on to win prestigious awards such as the Nobel Prize and the MacArthur Fellowships. The decision by Intel is puzzling given that sponsoring the competition costs Intel $6 million a year, about 0.01 percent of Intel’s annual revenue, and it generates goodwill to the organization. Intel moving away from this competition does not mean it is moving away from encouraging students about STEM fields. Intel is partnering with Turner Broadcasting to create a technology-based invention reality show called the ‘America’s Greatest Makers’. (Brakkton Booker, NPR)

Reproductive Research

Preemies’ Survival Rates Improve, But Many Challenges Remain

Extreme preemies — born somewhere between 22 and 28 weeks — have a better chance of surviving now than they did 20 years ago, doctors reported Tuesday in the Journal of the American Medical Association (JAMA). But many of these babies still have severe health problems. The study was done by pediatrician Barbara Stoll and her colleges at the Emory University School of Medicine in Atlanta. The doctors found that the survival rate of preemies has risen from 70 to 79 percent between 1993 and 2012 due to improvements in treatments for these babies. Outcomes are still bad for very young preemies, born less than 25 weeks – 90 percent of babies who survive have severe health problems. While neonatologist Roger Soll of the University of Vermont College of Medicine says “The changes in outcomes are much less than might be expected given the substantial changes in practice and raise the question whether many of these changes in practice have been effective”, Stoll is more optimistic. “We hoped for small, steady improvements like this,” she says. “We are cautiously optimistic that the data show progress is being made.” Two major medical interventions have helped this progress: prenatal steroid treatments to help preemies’ lungs develop faster, and doctors’ willingness to surgically deliver extreme preemies. (Michaeleen Doucleff, NPR)

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September 11, 2015 at 12:00 pm

Science Policy Around the Web – September 10, 2015

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By: Courtney Pinard, Ph.D.

Kris Krüg via Photo Pin cc

Climate Change

California leads the way to curb greenhouse gas emissions

California lawmakers are debating a new bill to curb greenhouse gas emissions. This bill comes after President Obama’s visit to Alaska, during which he declared that the fight against climate change is an urgent national priority. The bill aims to double energy efficiency in buildings, cut petroleum use in half, and derive 50% of electricity from renewable sources in California, all by 2030. While oil industry advocates assert that the bill will result in gas rationing and a ban on minivans, there is no language in the bill to support these claims. Backers of the bill said that reductions would be achieved instead by increasing the fuel efficiency of existing cars, expanding the number of electric cars, and using innovative technologies and incentives to make buildings more energy efficient. Washington, D.C.-based Resources for the Future says these goals are both ambitious and feasible. (Adam Nagourney, New York Times; Pauline Bartonlone, NPR)


International group approves genetic editing of human embryos for basic research

A consortium on stem cells, ethics, and law, comprised of members from eight countries, decided that editing human embryos to research early human development and disease is ethically justifiable. The decision comes after a few months after Chinese scientists published the first paper describing the use of the genome editing technique, CRISPR/Cas9, in human embryos. One possible application of the technique is to introduce genetic changes in immune cells to prevent HIV infection. Although the gene changes in the Chinese study were minimal and were not used for reproductive purposes, the work ignited debate and criticism among scientists and bioethicists. Members of the consortium met earlier this week and issued the following statement: “We believe that while this technology has tremendous value to basic research and enormous potential for somatic clinical uses, it is not sufficiently developed to consider human genome editing for clinical reproductive purposes at this time.” (Gretchen Vogel, ScienceInsider)

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September 10, 2015 at 9:00 am

Science Policy Around the Web – September 4, 2015

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By: Amanda Whiting, Ph.D.

Scientific Publishing

Fake Peer Review Scandal Shines Spotlight on China

On August 18th, Springer, one of the world’s largest academic publishers, announced that it was retracting 64 articles from 10 of its journals after the discovery that those papers were associated with fake email addresses and that “subsequent internal investigations uncovered fabricated peer review reports”. The fake addresses led back to study authors writing their own peer reviews and to peer review “services” which sold names and contact information for fake experts with positive reviews. The latest aspect of this controversy is that nearly all of the retracted papers were authored by Chinese academics, based on a search for retracted papers on Springer’s site. While William Curtis, executive vice-president for publishing, medicine and biomedicine at Springer said that the retractions “do not offer a representative picture of the quality and ground-breaking research being published by researchers in China”, other researchers recognize the pressure many academics are under to publish at all costs. “We don’t think that Chinese researchers are any worse than anybody else. But what we know is that the pressure to publish — for example in Western journals — is enormous in China,” said Dr. Charlotte Haug, vice-chair of the U.K.-registered Committee on Publication Ethics (COPE). Publishers are starting to implement polices to help prevent this type of abuse of the peer review system, such as no longer allowing authors to suggest reviewers for their own papers and mandating that peer reviewers communicate through institution-based email addresses only. (Felicia Sonmez, Wall Street Journal)

Biomedical Research and PMI

Giant study poses DNA data-sharing dilemma

Next month, a working group run by the National Institutes of Health (NIH) for the Precision Medicine Initiative (PMI) is set to release a project plan and observers are keen to find out the answers to one really big question – how much information about disease risk (including genetic data) will the project share with the people who participate? PMI aims to collect health data including genomic information, health records and physiological measurements from up to 1 million people in order to have a large cohort to study how genetics, environment and lifestyle influence disease risk and the effectiveness of treatments. Within this large amount of data could be trends that influence disease treatments for public health as a whole, but it could also include more specific information about individual participants and diseases/conditions they never even knew they had. Proponents of data-sharing believe that participants should at least be given the option of seeing their own data, truly making them “active partners in the process” of research, as it would allow them to further investigate findings related to their own health. Opponents believe that it would be irresponsible to just dump data onto people since the raw information can be challenging to interpret and of uncertain significance. If data sharing does go ahead, it raises new challenges such as how to actually share the data, what level of quality the data must be at to be shared (for clinical decision making vs. research), and whether data on deceased patients could be released to their families. Given the size and profile of the PMI, the decisions of this working group could have a significant effect on how biomedical research on human cohorts is conducted in the future. (Sara Reardon, Nature News)

Drug Policy

F.D.A. Warns 5 Producers of Powdered Caffeine

The Food and Drug Administration (FDA) stated that it has sent warning letters to five producers of pure powdered caffeine over concerns of public safety and overdose risks. While caffeine is legal substance that can be found naturally in coffee and tea and is added in small amounts to gum and energy drinks, a teaspoon of pure caffeine is equivalent to approximately 28 cups of coffee and a tablespoon’s worth can be lethal. According to the FDA’s statement from September 1st, “the difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small.” The statement goes on to say that “safe quantities of these products can be nearly impossible to measure accurately with common kitchen measuring tools.” Bulk powdered caffeine has been linked to the deaths of two young men in otherwise good health in 2014. Laura MacCleery, regulatory affairs director of the Center for Science in the Public Interest consumer advocacy group, celebrated the move by the FDA and hoped that this was merely the first step towards a product ban. In explaining the dangers of bulk purified caffeine she said that “[p]eople assume something this dangerous would not be sold to consumers in this form. They are used to seeing warning labels and childproof caps on aspirin. And this is just a zip-lock bag.” (Sabrina Tavernise, New York Times)

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September 4, 2015 at 9:00 am

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).


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.

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September 1, 2015 at 9:00 am