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Science Policy Around the Web – July 22, 2016

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By: Nivedita Sengupta, Ph.D.

photo credit: Alex E. Proimos via photo pin cc

The Common Rule and human testing

Science academies blast US government’s planned research-ethics reforms

The ultimate advancement in human health and welfare depend on research with human subjects. To achieve this, properly controlled studies with human subjects is imperative for eliminating abuse of human subjects and proper protection of the data. To address these concerns the “Common Rule” was established in 1991 influenced by the Belmont Report, a 1978 document which laid out principles for ethical research with humans, such as minimizing patient harm and maximizing the benefit to society. The ‘Common Rule’ is the current human subject regulation policies which addresses ethical issues such as informed consent, storage of study participants’ biological specimens and many others. However with technological advances over time, achieving these goals has become more complicated and thus imposes difficulties in maintaining patient privacy. Hence in September, 2015 the US government proposed revisions for regulations governing studies of human subjects.

Recently however, an independent advisory panel proposed that the US government’s proposed overhaul of  the Common Rule is flawed and should be withdrawn. On June 29th the US National Academies of Sciences, Engineering and Medicine said that the government’s proposed changes are “marred by omissions and a lack of clarity”. They indicated that it would slow down research and will do little to improve protections of patients enrolled in studies. The panel recommended that the government should appoint an independent commission to craft new rules for such research.

The changes proposed by the US Department of Health and Human Services (HHS) attempted to address concerns that have arisen since the ‘Common Rule’ was established. For instance, the HHS reforms suggests a requirement for participants’ consent to use stored samples, such as blood or tissue, for future research. But the US academies’ panel pointed that the new consent requirements would slow research unnecessarily because little harm is likely to come to a person as a result of the use of stored samples. Moreover the extra consent forms can link the samples to the person’s name and thus increasing risk of identification.

Currently HHS is reviewing more than 2,100 public comments to its proposal and many of these comments were critical. However, the US academies’ panel says that the proposal should be scrapped and HHS should start fresh by appointing an independent commission to recommend reforms for the Common Rule. Meanwhile an HHS spokesperson said that the government is still pondering over the public’s comments and the report. She adds that the proposal comes after “many years of work,” and “that starting over would require many more.” (Sara Reardon, Nature News)

Scientific Publishing

Beat it, impact factor! Publishing elite turns against controversial metric

Journal Impact factor (JIF) – one of the most promoted and controversial metric system in the field of science is currently facing negative reviews from the scientific community. Impact factor is a measure of the average number of citations that articles published by a journal in the previous two years have received in the current year which is calculated by various companies. It is solely aimed to indicate the quality of journals said Heidi Siegel, a spokesperson for Thomson Reuters, the major publisher of JIFs. However, the irony is researchers often use the JIF to judge individual papers instead and in some cases even the authors.

On July 5th, several leading science publishers posted a paper to the preprint server bioRxiv asking all journals to consider a different metric which will capture the range of citations that a journal’s articles acquire. Also the American Society for Microbiology in Washington DC announced its plans to discard impact factor from its journals and website, and also from marketing and advertising.

Stephen Curry, a structural biologist at Imperial College London and also the lead author on the bioRxiv preprint paper said that sadly many researchers evaluate papers by the impact factor of the journals and this can also influence decisions made by hiring committees and funding agencies. Curry’s team highlighted some limitations by plotting the distribution of citations (used to calculate the 2015 impact factors) for articles published in 2013–14 in 11 journals, including ScienceNatureeLife. They showed that most of the papers gathered fewer citations than the impact factor for the journal: 74.8% of Nature articles were cited below its impact factor of 38.1, and 75.5% of Science papers were cited fewer than 35 times with its impact factor of 34.7. Highly cited papers are the cause of this disconnect as Nature’s most cited paper in the analysis was referenced 905 times and Science’s 694 times. Curry and his team highly recommends the use of citation distribution curves instead of JIF as it provides a more informative snapshot of a journal’s standing.

However, Ludo Waltman, a bibliometrics researcher at Leiden University in the Netherlands, thinks that citation distributions are more relevant than impact factors for making decisions in hiring and promotion. But he feels that impact factors can be useful for researchers in some cases. Nonetheless anti-impact-factor campaigners believes that it will take time and pressure from various directions to diminish the influence of impact factor as it has become a cultural thing in the scientific field. (Ewen Callaway, Nature News)

Brain research advancements

Human brain mapped in unprecedented detail

Neuroscientists have long sought to divide the brain into smaller pieces to better appreciate how it works as a whole. On July 20th,  Nature published the new unprecedented map of the brain’s outermost layer — the cerebral cortex — subdividing each hemisphere and valley-like folds into 180 separate areas. Ninety-seven of these areas have never been previously described despite showing clear differences in structure, function and connectivity from the neighboring areas.

“Until now, most brain maps were based on a single type of measurement which provides an incomplete view of the brain’s inner workings” says Thomas Yeo, a computational neuroscientist at the National University of Singapore. This new map is based on multiple MRI measurements which measures the flow of blood in response to different mental tasks, which Yeo says “greatly increases confidence that they are producing the best in vivo estimates of cortical areas.”

The map was constructed by a team of people led by neuroscientist Mathew Glasser at Washington University Medical School. They collected imaging data from 210 healthy young adults participating in the Human Connectome Project, an National Institutes of Health-funded initiative to map the brain’s structural and functional connections. They collected information of cortical thickness; brain function; connectivity between regions; topographic organization of cells in brain tissue; and levels of myelin — fatty substance that speeds up neural signaling. The borders on the map was delineated by areas which showed significant changes in two or more of these properties. Analysis of all the data confirmed the existence of 83 previously reported brain areas while identifying 97 new ones. Scientists further tested the map generated by Glasser and his team, and found it accurate by looking for these regions in the brains of additional 210 people. But the size of the areas varied from person to person and these differences may reveal new insights into individual variability in cognitive ability and opens up the possibility to explore further the unique intersection of individual talents with intellectual and creative abilities.

But the map is limited in some important ways as it reveals little about the biochemical basis of the brain and about the activity of single neurons or small groups. However, Glasser says that “We’re thinking of this as version 1.0, that doesn’t mean it’s the final version, but it’s a far better map than the ones we’ve had before.” (Linda Geddes, Nature News)

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Written by sciencepolicyforall

July 22, 2016 at 9:00 am

Science Policy Around the Web – February 16, 2016

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By: Julia Shaw, Ph.D.

Photo Credit: Kara Wall

The Environment

NYC waters are teeming with plastic particles, study finds

A recent study, conducted by the environmental group NY/NJ Baykeeper, has concluded that the waters around New York City are a “soup of plastic.” Inspired by a similar study of the Great Lakes, NY/NY Baykeeper collected water samples from the East River, the Hudson River in New York Harbor area, and the Passaic River and Raritan Bay in New Jersey and analyzed them for their plastic content. This study found an average of 256,322 plastic particles per square kilometer, with approximately 165 million plastic bits floating in the Harbor area. Plastic microbeads used in exfoliating skin care products contributed tens of millions of particles alone. The Microbead-Free Waters Act of 2015, which goes into effect in July 2017, will require companies to cease selling microbead products. Carcinogenic chemicals can also adhere to plastic particles, and be ingested by fish and shellfish mistaking the particles for food. As a result, city and state officials are advising women who are or may become pregnant and children to avoid eating seafood caught in the waters around New York City. A spokeswoman for the mayor said reducing plastics and other waste is a priority for the administration, which is working to put in place a ban on plastic-foam food containers as well as engaging in a public awareness campaign encouraging the use of reusable bags, mugs, and bottles in place of disposables. (Karen Matthews, Phys.org)

Global Health

Zika Virus Test is ‘Weeks, Not Years’ Away, WHO Says

Though first discovered almost 70 years ago in Uganda in 1947, the Zika virus has not been well-studied. However, the latest outbreak of Zika in Latin America is about to change that. On February 1st the World Health Organization (WHO) declared Zika virus a global public heath emergency. Zika virus is related to other mosquito-vectored viruses including those that cause dengue, yellow fever, and West Nile, but no test specific for Zika is commercially available. However, ten companies have developed assays to either directly detect viral particles in the blood or to detect specific antibodies raised against the virus. According to the W.H.O. assistant director general for health systems and innovation, Dr. Marie-Paule Kieny, these assays bode well for the first commercial tests being available in a matter of weeks following independent validation and regulatory approval. Symptoms of infection include fever, rash, joint pain, and red eyes, yet the most startling consequences are an apparent link to the neurological disorders microcephaly and Guillain-Barre syndrome in babies born to women exposed to the virus while pregnant. The government of El Salvador has advised women to delay any pregnancies until 2018, and the Centers for Disease Control and Prevention and the WHO are recommending pregnant women avoid travel to areas where the virus is actively circulating. Because the virus also appears capable of sexual transmission, the WHO further advises couples living in endemic areas to use condoms. Two early vaccine candidates, one from the National Institute of Allergy and Infectious Diseases (NIAID) and another from an Indian pharmaceutical company, Bharat Biotech, are being developed, yet Dr. Kieny cautions that “vaccines are still at least 18 months away from large-scale trials.” (Sewell Chan with contributions from Donald G. McNeil Jr., The New York Times)

Biomedical Ethics

Karolinska Institute vice-chancellor resigns in wake of Macchiarini scandal

Anders Hamsten, vice-chancellor of Stockholm’s Karolinska Institute (KI) has stepped down amidst ongoing controversy surrounding the work of surgeon Paolo Macchiarinini, a visiting professor at KI from 2010 through October 2015. A recent documentary that aired on Swedish public television re-ignited interest in the case, which involved the implantation of artificial trachea into eight patients, six of whom have since died. While originally hailed as a great success for regenerative medicine, questions have been raised concerning the accuracy of Macchiarini’s published papers describing the effectiveness of the technique. Hamsten led an investigation into Macchiarini’s work last year following the submission of whistleblower reports detailing suspected research misconduct by the surgeon, however, Hamsten cleared Macchiarini of all charges. In November, KI awarded Macchiarini a new 1-year contract. In a recent article published in the Swedish newspaper Dagens Nyheter, Hamsen reversed his opinion stating, “[I]t seems very likely that my decision in this case was wrong. I realize it will be difficult for me to continue working as Vice Chancellor of Sweden’s most successful university with credibility and effectiveness.” The Macchiarini misconduct case is set to be reopened and responsibility for the inquiry transferred to the Central Ethical Review Board of Sweden. (Gretchen Vogel, ScienceInsider)

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Written by sciencepolicyforall

February 16, 2016 at 9:00 am

Science Policy Around the Web – December 11, 2015

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By: Kimberly Leblanc, Ph.D.

Kris Krüg via Photo Pin cc

Climate Change Policy

In symbolic move, Congress votes to gut Obama climate plans

Early last week, the U.S. House of Representatives approved two measures that would block the Environmental Protection Agency’s (EPA’s) first-ever limits on carbon dioxide emissions from new and existing power plants. Just two weeks prior, the senate approved the same two measures, S.J. Res. 23 and S.J. Res. 24. In addition, a number of states, industry groups, and companies have taken the fight to the courts, asking judges to overturn EPA’s rules for new power plants. The legislative and judicial push is in response to Obama’s Clean Power Plan. The plan includes two EPA regulations that will limit greenhouse gas emissions from the power sector. One regulation sets carbon dioxide emissions limits for new and future power plants. The other, effective since August, sets similar limits on existing power plants, but offers options that states can choose between to achieve the emission limits. These options are ranging from energy-efficiency measures to renewable energy to emissions trading. The power plan seeks to cut CO2 emissions from the power sector by 30% from 2005 levels by 2025. Obama plans to veto the bills, so the votes are largely a symbolic gesture, a way to send a message to the global leaders meeting in Paris at the United Nations Conference on Climate Change that U.S. lawmakers may not carry out any deal. (Puneet Kollipara, ScienceInsider).

Ethical Biomedical Research

The truth about fetal tissue research

On December 3, the Republican-led US Senate voted to strip Planned Parenthood of government funding. On November 27th, a gunman killed three people at a Planned Parenthood clinic in Colorado Springs, Colorado. According to one law enforcement official, the shooter said “no more baby parts” after his arrest. These events are a reaction to covertly filmed Planned Parenthood videos, in which senior physicians bluntly discussed their harvesting of fetal organs from abortions for use in research. In 2014, the National Institutes of Health (NIH) funded 164 projects – 0.27% of the NIH’s budget – that used human fetal tissue for research. While the use of fetal tissue may be discomforting, the tissue, which is obtained legally with informed consent and without profit and which would have otherwise been discarded, has already led to major medical advances.

Vaccines for hepatitis A, German measles, chickenpox and rabies were developed using cell lines grown from tissue from two elective abortions that were performed in the 1960s. German measles “caused 5,000 spontaneous abortions a year prior to the vaccine,” said Dr. Paul Offit, an infectious-disease specialist at Children’s Hospital of Philadelphia. “We wouldn’t have saved all those lives had it not been for those cells. Fetal tissue was “absolutely critical” to the development of a potential Ebola vaccine that has shown promise, said Dr. Carrie Wolinetz, the NIH’s associate director for science policy. Fetal tissue has also been critical to the development of mouse models with humanized immune systems that have led to significant advances in HIV research, drug discovery, and vaccine development. Fetal tissue is being used to make significant advancements in research into cancer, autism, schizophrenia, juvenile diabetes, Huntington’s disease, eye development and disease, Hepatitis C, and more. Scientists point out that if there were better alternatives, they would turn to them. But those techniques are still being refined, and some fields are likely to remain reliant on fetal tissue, such as the study of fetal development.

The question for many scientists is what the fallout of the controversy will be. Since July, four bills that would criminalize or otherwise restrict the research (H.R. 3171, H.R. 3729, H.R. 3215, H.R. 3429) have been introduced in the US Congress, and lawmakers have launched similar efforts in a dozen state legislatures. (Missouri, Arizona and North Dakota already ban the research.) Overall, scientists think hard on the ethics of their work. “We are not happy about how the material became available, but we would not be willing to see it wasted and just thrown away” says Larry Goldstein, a neurobiologist at the University of California San Diego School of Medicine. (Meredith Wadman, Nature magazine and Scientific American, see also Scientists say fetal tissue remains essential for vaccines and developing treatments, by Collin Binkley and Carla K. Johnson, Associate Press, PBS News )

Research Funding and Bias

Research group funded by Coca-Cola to disband

The Global Energy Balance Network, a group of researchers spanning several U.S. universities whose research focused on metabolic energy balance, announced last week that it was shutting down. The group was financially backed and created by Coca-Cola, and public health authorities had been voicing concerns for months that the group’s mission was to play down the link between soft drinks and obesity. In a statement issued in August, the group’s president, Dr. James O. Hill, acknowledged that Coca-Cola had provided the money to start the Global Energy Balance Network, but insisted that Coca-Cola had “no say in how these funds are spent” and that it “does not have any input into our organization.” But a series of emails obtained by The Associated Press and reported last week suggested that Dr. Hill had allowed Coke to help pick the group’s leaders, create its mission statement and design its website. The group’s vice president, Steven Blair, said in a recent video announcing the new organization “Most of the focus in the popular media and in the scientific press is, ‘Oh they’re eating too much, eating too much, eating too much’ — blaming fast food, blaming sugary drinks and so on, and there’s really virtually no compelling evidence that that, in fact, is the cause.”

There is, in fact, compelling evidence that exercise has only minimal impact on weight compared with what people consume, although exercise has other significant health benefits. Furthermore, a recent analysis of beverage studies, published in the journal PLOS Medicine, found that those funded by Coca-Cola, PepsiCo, the American Beverage Association and the sugar industry were five times more likely to find no link between sugary drinks and weight gain than studies whose authors reported no financial conflicts. Last month, amidst the controversy, the University of Colorado School of Medicine said it would return a $1 million grant that Coca-Cola had provided to help start the organization. The University of South Carolina had also accepted $500,000 from Coke to help start the group, but a spokesman for the university did not return phone calls or messages asking what the university planned to do with the money it had taken. (Anahad O’Connnor, New York Times)

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Written by sciencepolicyforall

December 11, 2015 at 9:00 am