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Science Policy Around the Web – February 5, 2016

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Environment, science and society

Congress approves bill to ban plastic microbeads in skin care products

Plastic microbeads used in a variety of personal-care products from soaps to face washes will be phased out starting in 2017. Microbeads are tiny plastic particles used as an abrasive in many beauty products such as facial scrubs, soaps, and toothpastes. These beads do not dissolve and can remain in the environment for decades.

The Microbead-Free Waters Act of 2015 was introduced by Congressmen Frank Pallone, Jr. (NJ-6), Ranking Member of the House Energy and Commerce Committee, and Fred Upton (MI-6), Chairman of the Committee. It is believed that “these tiny plastic particles that are polluting our environment are found in products specifically designed to be washed down shower drains,” said Pallone. “And many people buying these products are unaware of their damaging effects on the environment.” This view is in alignment with research that shows how these beads slip through wastewater treatment systems and into waterways. Sherri A. Mason, an environmental chemist at the State University of New York in Fredonia, estimates that 11 billion microbeads are released into the nation’s waterways each day.

At the state level, states such as Illinois and California already have passed microbead bans while more than half of the states are considering them. However, the growing number of state and local laws with conflicting restrictions and timelines helped to motivate the sponsor of the bill in the Senate. The federal legislation will prohibit the manufacture of products containing plastic microbeads as of July 1, 2017, and phase out sales of the product over the next two years. The federal law will take precedence over state laws that are starting to phase out microbeads over similar concerns. (Congressional Research Service)

CRISPR technology

UK scientists gain license to edit genes in human embryos

A team of British scientists has received permission to edit genes in human embryos for scientific studies. Although there is currently a voluntary moratorium observed by scientists worldwide on DNA alterations that could be passed down to subsequent generations, the proposed studies would not contradict them because the altered embryos will not be implanted into a womb.

On February 1st, the British regulatory agency that oversees reproductive biology, the Human Fertilization and Embryology Authority, approved an application by Kathy Niakan, of the Francis Crick Institute in London, to utilize a new genetic editing technique called Clustered regularly-interspaced short palindromic repeats or CRISPR (or CRISPR/Cas9) to alter human embryos. This CRISPR system enables researchers to precisely remove specific DNA sequences.

In the United States, Congress has banned the government from supporting research where a human embryo is destroyed. This ban, however, does not apply to privately or state funded researchers. “This type of research should prove valuable for understanding the many complex issues around germline editing,” said George Daley, a stem-cell biologist at Boston Children’s Hospital in Massachusetts. “Even though this work isn’t explicitly aiming toward the clinic, it may teach us the potential risks of considering clinical application.” (Ewen Callaway, Nature)

Federal Research Funding

White House wants $1 billion for Vice President Biden’s cancer moonshot. Where will it come from?

In his next upcoming budget, President Barack Obama will ask Congress for $755 million for cancer research. This will bring the total price tag of Vice President Joe Biden’s cancer “moonshot” to $1 billion. However, it is still not known if Congress will agree to this new funding proposal for 2017. In addition, it is also not known how much existing money will be reshuffled at the National Institutes of Health (NIH) in order to support this year’s moonshot plans.

Currently, the White House plans to immediately fund the Moonshot initiative with $195 million in “new cancer activities” at NIH for the 2016 fiscal year. Most of this spending is predicted to occur at the National Cancer Institute (NCI) which already received a $264 million boost in new money this year as part of the overall $2 billion NIH budget increase. Although researchers are “very excited and enthusiastic” about the initiative, they have questions about exactly where the money will come from, says Jon Retzlaff, managing director for science policy and government affairs for the American Association for Cancer Research in Philadelphia, Pennsylvania. Bolstering certain NCI programs partway into the fiscal year may force the institute to divert funds from other programs.

Currently, Biden plans to continue the moonshot’s financial momentum in the White House’s FY 2017 budget request to steer $75 million to the U.S. Food and Drug Administration for moonshot activities, and $680 million for NIH. If this request will be approved by Congress is still up in the air, Retzlaff notes. This is because the budget request calls for using “mandatory funds” to pay for these increases. Mandatory funds are not directed through the regular annual appropriations process, but instead the money comes from dedicated sources approved by Congress. Using mandatory funds preempts congressional oversight which is generally not supported by lawmakers. If approved, this additional funding will represent an increase of about 15% over what the federal government is already spending on cancer research, the nation’s second leading cause of death. (Jocelyn Kaiser, Science magazine)

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February 5, 2016 at 9:00 am

Science Policy Around the Web – October 31, 2015

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By: Courtney Pinard, Ph.D.

Photo credit: Novartis AG via photo pin cc

Reproducibility

How Prevalent is Scientific Bias?

Scientists and clinicians conducting clinical trials must abide by rigorous standards to safeguard against biases. Biomedical animal research has not been held to the same standards, and advocates of robust science have argued that this lack of scientific rigor is why more than half of pre-clinical studies are irreproducible. A recent study published at the University of Edinburgh in the U.K. shows that animal researchers are not using the same standards to prevent bias in study design. Such standards include 1) using randomized trials to prevent scientists from, for example, assigning unhealthy animals to the control group to boost a drug’s effect on the treatment group; 2) ensuring that researchers are blinded when accessing outcomes of an experiment; 3) calculating the correct sample size before starting an experiment; and 4) disclosing any conflicts of interest. The authors of the study examined 2500 papers published between 1992 and 2011 on drug efficacy, and the results were dismal. Only 30% of papers analyzed outcome in a blinded manner, 25% stated randomizing animals to groups, 12% included a conflict of interest statement, and less than 1% of papers reported calculating the needed sample size in advance. When the authors looked at whether institute quality or journal impact factor predicted bias, they found no correlation. The U.K. study is one out of many studies on the topic of scientific rigor that have resulted in growing concern from scientists and the public about irreproducible results in pre-clinical biomedical research.

According to an NIH commentary published last year, the reasons for why scientific bias in animal research is so prevalent are complex and have to do with the attitudes of funding agencies, academic centers, and scientific publishers. Authors of the commentary, Francis Collins and Lawrence Tabak, discuss these attitudes: “Funding agencies often uncritically encourage the overvaluation of research published in high-profile journals. Some academic [centers] also provide incentives for publications in such journals, including promotion and tenure, and in extreme circumstances, cash rewards.”

Given the continuing budget restraints, and Congress’ awareness about the reproducibility problem, national funding agencies have started to act. The NIH, for example, organized a workshop with over 30 basic/preclinical science journal editors to put together principles and guidelines to enhance research rigor and reproducibility. One such principle is “Transparency in Reporting”, and includes the bias safeguarding standards described above. Strengthening pre-clinical biomedical research will only occur when scientists and policy makers at funding agencies, academic institutions, and journals work together to put these principles into practice, and acknowledge that the “publish or perish” attitude rampant in the scientific culture needs to change. The situation and solution was described succinctly in a recent Nature Editorial on cognitive bias: “Finding the best ways to keep scientists from fooling themselves has so far been mainly an art form and an ideal. The time has come to make it a science.” (Martin Enserink, ScienceInsider)

Big Data

Proposed Study to Track 10,000 New Yorkers

A new proposed longitudinal study will attempt to monitor thousands of households in New York City over the span of decades. Information will be gathered in intimate detail about how people in these households lead their lives, including information about diet, exercise, social activities and interactions, purchases, education, health measures, and genetics. This ambitious project is called the Kavli Human Understanding through Measurement and Analysis (HUMAN) project, and aims to quantify the human condition using rigorous science and big data approaches to understand what makes us well and what makes us ill. According to project leaders, existing large-scale data sets have only provided detailed catalogs of narrow aspects of human health and behavior, such as cardiovascular health, financial decision-making, or genetic sequencing. By measuring the feedback mechanisms between biology, behavior, and our environment over decades, researchers believe that that much more will be understood about how these factors interact to determine human health over the life cycle. For example, according to articles written by scientists in support of the project, the new data could measure the impact of cognitive decline on performing activities of daily living, on family members and caregivers, and on healthcare utilization or end-of-life decisions. A further goal of the project is to provide data to policy makers in order for them to develop evidenced-based public policies.

Anticipating privacy and cybersecurity concerns inherent in such an invasive study, Kavli HUMAN project researchers have established a Privacy & Security Advisory Council, comprised of members in the private, public, and academic sector. The Advisory Council includes bioethicists and patient privacy advocates. In addition to establishing the Advisory Council, project leaders conducted an opinion survey of diverse group of Americans asking whether they 1) think the study should be done, and 2) if they would be willing to participate. The results of the survey suggested that nearly 80% think that the study should be done and more than half were willing to participate. When questions arise about the ethics of collecting such information, Kavli HUMAN project researchers publicly argue that corporations already track Americans’ spending habits, location, and use of technology, and that “people’s data can be better used to serve them, their communities, and society.” (ScienceInsider, Kelly Servick)

Nutrition and Cancer

A Diet High in Red Meat and Processed Meat Increases Risk for Colorectal Cancer

The World Health Organization International Agency for Research (IARC) announced on Monday that eating too many processed meats are cancer-causing and eating too much red meat is “probably carcinogenic to humans.” Red meat is defined as all types of mammalian muscle meat, such as “beef, veal, pork, lamb, mutton, horse, and goat,” and processed meat is defined as meat that “has been transformed through salting, curing, fermentation, smoking, or other processes to enhance flavor or improve preservation.” The IARC reviewed 800 studies that looked at the association of cancer with consumption of red or processed meat in people around the world, of diverse ethnicities and diets. Results of this analysis revealed that the positive association between red and processed meat consumption and cancer was strongest for colorectal cancer. The Global Burden of Disease Project, an independent academic research organization, estimates that 34,000 cancer deaths per year worldwide are attributable to diets high in processed meat. Studies show that meat processing techniques and cooking this kind of meat at high temperatures can lead to the formation of carcinogenic chemicals, and that these compounds appear in parts of the digestive tract. Specifically, the agency said its experts concluded that each 50 gram portion of processed meat eaten daily increased the risk of colorectal cancer by 18 percent. Red meat was not as strongly associated with cancer as processed meat. Some public health experts criticized the bravado of the IARC announcement. In response to public inquiries, they have published a FAQ page where they state that smoking and asbestos are more likely to be causal for lung and other types of cancers. The announcement did not mark a new discovery, since the original report has been out for several years; it was meant to attract public attention and help countries looking to WHO for health advice. According to the director of IARC, “these findings further support current public-health recommendations to limit intake of meat.” (NPR; Anahad O’Connor, New York Times)

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October 31, 2015 at 9:00 am

Science Policy Around the Web – April 17, 2015

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By: Cheryl Jacobs Smith, Ph.D.

photo credit: MJ/TR (´・ω・) via photo pin cc

Genomics in Medicine

Personalizing Cancer Treatment With Genetic Tests Can Be Tricky

Since the New Year, President Obama, backed by National Institutes of Health Director, Dr. Francis Collins, has rejuvenated an initiative to use the human genome to make more informed medical decisions in health care. Since the completed endeavor to sequence the human genome was published in 2001, scientists and physicians have used this information to better understand the underlying complexities of human behavior, health, and disease. As a consequence, many areas in medicine use human genetic information as a diagnostic to guide treatment regimens.

More and more oncologists, or cancer doctors, are relying on genetic tests of a patients’ tumor to help guide cancer treatment. However, given the complexity of our genome coupled with our limited understanding of the millions of A, T, C, and G’s encoding our genetic information, oftentimes much of the information generated from genetic tests can be ambiguous. Researchers writing in Science Translational Medicine say there is a way to make these tests more meaningful.

One of the main issues with genetic testing of tumors is that they harbor mutations and it is unclear which mutation is the key to killing the cancer cell, thus, making a therapeutic decision difficult. In this regard, the researchers suggest not only conducting genetic tests on the cancer of the patient, but also conducting genetic tests on healthy, normal tissue of the patient. In this way, physicians and researchers can detect cancer-specific mutations as these mutations would only be present in the cancer, but not the normal, healthy tissue.

This is not to say that current genetic tests conducted on cancer are not trustworthy. They, indeed, are quite reliable at identifying mutations that are clearly linked to certain cancers. This group asserts that in those cases where this approach does not work, that additional sequencing of the normal, healthy tissue as a means of comparison may help improve the diagnostic quality of those tumors that produce ambiguous results. The future of cancer diagnostics is a booming, changing, field and much is to remain to be seen in regards to consistency of tactic used. (Richard Harris, NPR)

Federal Research Funding

Controversy awaits as House Republicans roll out long-awaited bill to revamp U.S. research policy

The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act of 2007, or America COMPETES Act, was signed by President Bush in 2007 and it became law on August 9, 2007. The COMPETES Act sets funding targets for select physical science agencies: the National Science Foundation (NSF), the National Institute of Standards and Technology (NIST), and two offices with the Department of Energy (DOE): the Office of Science, and the Advanced Research Projects Agency-Energy, or ARPA-E.

Authored by the panel’s chair, Representative Lamar Smith (R–TX), there are provisions to the reauthorization act that scientists are likely to find interesting.

  • NSF spending: The bill would authorize $126 million less than President Obama requested but $253 more than NSF’s current budget. It relocates NSF’s budget to the natural sciences and engineering at the expense of the geosciences and the social and behavioral sciences. To add injury to insult, additional cuts from the geosciences and the social and behavioral sciences are expected.
  • DOE R&D: At least in 2016, the bill funds most Office of Science programs but the budget remains flat in 2017. Cuts will occur in the more applied renewable energy programs and new energy technologies. Interestingly, funding will boost in the areas on fossil and nuclear energy.
  • Peer review: Since Smith became chair in 2013, this has been a major area of debate regarding how NSF reviews the 50,000 or so requests for funding it receives from scientists every year. Apparently Smith and the NSF Director, France Córdova, have agreed upon legislation that will not “[…]alter[ing] the Foundation’s intellectual merit or broader impacts criteria for evaluating grant applications.”
  • NSF’s portfolio: This section of the bill gives NSF the responsibility “to evaluate scientific research programs undertaken by [other] agencies of the federal government.” This language apparently wants NSF to judge other research agencies about how they are facilitating their research programs. This is quite an awkward and broad demand. It still remains to be seen how this will play out.
  • Large new facilities: This section of the bill tries to rein in “wasteful spending” by requiring the NSF to correct any problems identified by an independent audit on a project’s expected cost before starting construction. However, the bill also restricts spending from contingency funds “[…] to those occurrences that are foreseeable with certainty … and supported by verifiable cost data.” This is interesting language given the need of a contingency fund is to fund unexpected occurrences.
  • Administrative burden: This part of the bill supports reducing administrative oversight in the form of government oversight and regulations. The bill argues that administrative costs are high and costly and these monies could be used to fund research. Instead, the bill will have the White House science advisor convene an inter-agency panel.
  • NIST: The bill increases NIST’s budget; however, falls short of President Obama’s request.

The good news is that the COMPETES bill has finally been reauthorized. However, controversy awaits as to the effectiveness of the reauthorized bill. (Jeffrey Mervis and David Malakoff, ScienceInsider)

Climate Policy

Climate change: Embed the social sciences in climate policy

The Intergovernmental Panel on Climate Change (IPCC) needs to broaden its perspective by adding more social scientists. The organization is akin to a moth to a flame— focusing attention on a well-lit pool of the brightest climate science. But the insights that matter are not readily viewed and are far from the bright light of the debate. The IPCC has involved only a narrow slice of social-sciences disciplines: economics. The other social sciences were mostly absent. Bringing the broader social sciences into the IPCC may prove challenging, but it is achievable if they adapt a strategy that reflects how the fields are organized and which policy-relevant questions these disciplines know well. The IPCC has proved to be important. But presently, it is too narrow and must not monopolize climate assessment. In the future, reforming the organization will benefit the conversation surrounding climate change greatly and move contentious work into other forums. (David Victor, Nature)

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April 17, 2015 at 9:00 am

Science Policy Around the Web – March 3, 2015

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By: Cheryl Jacobs Smith, Ph.D

photo credit: Flickr heart via photopin (license)

Science and Health Policy

Younger Women Hesitate To Say They’re Having A Heart Attack

Each year more than 15,000 women under the age of 55 die of heart disease in the United States. Interestingly enough, younger women are twice as likely to die after being hospitalized for a heart attack as men in the same age group. In a small study in Circulation: Cardiovascular Quality and Outcomes, Lichtman and her colleagues investigated why younger women delay getting help. The researchers conducted in-depth interviews with 30 women, ages 30 to 55, who had been hospitalized after a heart attack. It turned out that many had trouble recognizing the symptoms of a heart attack. Many women cited that they had not ‘experienced the Hollywood heart attack’. This is in part due to early clinical research into heart disease where the clinical subjects were men. Only when the studies started to include women did researchers and clinicians identify that there are gender-specific symptoms to a heart attack. Men experience the ‘Holly wood heart attack’ where women experience vague symptoms like nausea or pain down their arms. Moreover, several women reported that their doctors initially misdiagnosed the pain. This within itself highlights the unconscious bias of female hysteria that dates back to ancient times. Hopefully this study increases awareness of what social factors impact how heart disease is diagnosed in women and spurs additional studies to validate their findings. Heart disease is the third leading cause of death for women ages 35 to 44, and it’s the second leading cause of death for women 45 to 54, according to the Centers for Disease Control and Prevention (Cancer is the No. 1 cause). Therefore, it is of utmost importance to better educate both clinicians and the general public of the differences in heart disease symptoms between men and women. (Maanvi Singh, NPR)

 

Health Policy – Cancer

Cancer Breakthroughs Are Needed In Policy As Well As Science

Since 1990, the number of cancer-related deaths and new cancer diagnosis has been on a negative decline. Although cancer discoveries and cancer treatment has been improving, new insights to how to meet the challenges of affording high-quality treatment and delivery of excellent cancer care is needed. The economic burden of cancer care in the U.S. is expected to reach more than $170 billion per year by 2020. Some say expensive medicines are the culprits. However, spending on cancer treatment as a share of overall healthcare expenditures in the U.S. has not changed significantly in 50 years. To better measure the burden of cancer treatment in the U.S., it would be beneficial to have more transparency when it comes to cancer treatment billing—not only cancer medication costs. This likely would reduce large variations in the cost of the same services between different cancer-care providers. Additionally, the U.S. Food and Drug Administration’s oncology division has teamed with academia and industry in efforts to accelerate cancer R&D—exploring “adaptive” clinical trials that steer patients to the most appropriate trials through “master protocol agreements.” With these efforts and more there is a growing consensus that cancer care and treatment needs to be reformed. Hopefully with the raised awareness this will lead to further scientific breakthroughs to reduce the overall burden of cancer care treatment and deliver the kind of outcomes that cancer patients deserve and have been patiently waiting for. (John Lechleiter, Forbes)

 

Bioethics – Ebola

Bioethics Commission: Ebola Teaches Us Public Health Preparedness Requires Ethics Preparedness

The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) advises the President and the Administration on ethical practices that promote research, healthcare delivery, and scientific innovation as a means of improving public health. The Commission decided to report its findings from the Ebola epidemic to highlight the successes and failures of the U.S. infectious disease protocol. From the perspective of Commission Chair, Dr. Gutmann, there is much to be improved. “The Ebola epidemic in western Africa overwhelmed fragile health systems, killed thousands of people, and highlighted major inadequacies in our ability to respond to global public health emergencies,” Commission Chair Amy Gutmann, Ph.D., said. “It demonstrated the dire need to prepare before the next epidemic. A failure to prepare and a failure to follow good science — for example, by not developing vaccines and not supporting health care providers — will lead to needless deaths.” “Public health preparedness requires ethics preparedness,” Gutmann said. “We need to be prepared, for example, to communicate early and often during an Ebola epidemic — drawing upon the best scientific evidence — why not to quarantine asymptomatic individuals. Needlessly restricting the freedom of expert and caring health care workers is both morally wrong and counterproductive; it will do more to lose than to save lives.” The Bioethics Commission’s seven recommendations offer targeted policy and research design suggestions. The Bioethics Commission sets a critical framework from which the U.S. can work off of to improve its education and outreach concerning future public health epidemics both domestically and abroad. (Presidential Commission for the Study of Bioethical Issues)

 

 

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March 3, 2015 at 9:00 am

Science Policy Around the Web – January 9, 2015

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By: Elisavet Serti, PhD

photo credit: sjrankin via photopin cc

Scientific Breakthroughs

Science journal publishes Top 10 Scientific Breakthroughs of 2014

On the 19th of December issue of Science, the editors listed the Rosetta spacecraft and its preliminary results as the most important scientific breakthrough of 2014. This spacecraft became known for catching up with the comet known as 67P/Churyumov-Gerasimenko beyond Mars last August. Rosetta’s short-lived lander, known as Philae, managed to touch down on the side of the comet next to a cliff, far from the initial targeted spot. The absence of adequate sunlight that would recharge its batteries gave Philae only 57 hours to collect data before its expiration. The importance of this first-ever soft landing of a spacecraft on a comet was emotional and largely symbolic since 80% of the scientific data of this mission will be generated from Philae’s mother ship, Rosetta, that will orbit around the comet throughout 2015. With this mission, scientists want to understand how comets are altered while approaching the sun and also how comets formed approximately 4.5 billion years ago.

This annual list of groundbreaking scientific achievements includes advances in medicine, robotics, synthetic biology and paleontology. Interestingly, the visitors to Science’s website picked the impressive genetic achievement of incorporating two additional letters into E.coli ’s genetic code, as the top scientific breakthrough for 2014. Two researchers managed to engineer the bacterial DNA in a novel way, which includes a pair of lab-synthesized nucleotides: X and Y. These two nucleotides don’t code for anything and because they do not exist in nature, the engineered bacteria would not be able to replicate and pass on their genetic material to any offspring. The two researchers aim to use X and Y for the encoding of artificial amino acids, beyond the 20 natural ones that are encoded by the nucleotides of the “normal” DNA, that would lead to artificial protein products.   (Eric Hand and Robert F. Service, Science).

 

Federal Research Programs

National Children’s Study program is cancelled after 14 years

The National Children’s Study (NCS) was initiated in the late 1990’s by US pediatricians and other scientists that initiated a plan to follow a cohort of 100,000 children from birth to age 21, generating an unprecedented amount of biological specimens and clinical data of invaluable scientific potential. The main aim of this study was to identify the factors that shape child development and to understand how these factors lead to disease phenotypes. The Congress approved the project’s budget in 2000 and the NCS Program Office was established at the National Institute of Health (NIH) in 2003 aiming to recruit a representative sample of 100,000 pregnant women from 100 states in the largest longitudinal study of its kind in the United States.

In 2007, the initial funding of $70 million launched the first NCS centers that managed to enroll 5700 children. The recruitment plan proved to be inadequate. When the costs rose to $6.9 billion, the NCS program officers decided to close the NCS centers and rely on large contractors to run the projects. These changes were criticized by a large number of researchers, and the consequent review that was ruled by the Congress concluded that although the NCS had great potential, there were problems with its design and its management. In addition, there was no specific protocol for the study and the NIH Advisory Committee to the Director agreed with this review stating that the NCS “as currently outlined, is not feasible.” After these findings, Dr Francis Collins, the NIH director, decided to cancel the study and to close the NCS program office on December 2014. However, all existing data and biospecimens will be made available to outside researchers and the NCS funds will be redistributed to NIH institutes for related activities so that there is still potential for a positive outcome from this otherwise brilliant initiative.   (Jocelyn Kaiser, Science)

 

Research Interpretation

Should cancer patients blame their bad luck?

Despite the large emphasis placed on gene heredity or risky habits like smoking on cancer risks, random mutations that occur during ordinary cell division are responsible for the two-thirds of cancer incidence of various types (22 out of 31 cancer types). These random mutations prove to be harmful if they affect the expression of cancer-related genes, known as oncogenes or tumor-suppressor genes, leading to tumor formation. As expected, it was observed that tissues that undergo a greater number of divisions were more prone to tumors since the probability of mutations is elevated. This means that most cancer patients could simply blame their biological bad luck and not their lifestyle or their genetic background. However, there are 9 cancer types, including colorectal, skin and lung cancer, which are heavily influenced by heredity and environmental factors like smoking, prolonged sun exposure or exposure to carcinogens, thus verifying the importance of these factors in carcinogenesis.   (Will Dunham, Reuters)

 

 

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January 9, 2015 at 1:36 pm

Science Policy Around the Web – October 21, 2014

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By: Jennifer E. Seedorff, Ph.D.

photo credit: NIAID via photopin cc

Ebola Outbreak – Public Health

In the US, fear spreads faster than Ebola

Ebola is a scary, lethal virus. Luckily, “There’s a reason it’s not everywhere. It’s just not as easy to transmit as people think.” said CDC epidemiologist, Michael Kinzer. So far, the only people to become infected while living in the US are two health-care works that treated the initial patient while he was having severe symptoms, including vomiting and diarrhea. In Ebola, the amount of virus in the body is not the same throughout the course of the infection. As the disease progresses, the amount of Ebola virus present in the body and bodily fluids increases dramatically. Since Ebola is transmitted through direct contact with bodily fluids, individuals without symptoms are not contagious despite being infected with Ebola. However, fears of Ebola have led to what some believe to be overreactions, including a cruise ship that was turned away from port or a school that temporarily closed because an employee had traveled on a different flight that used the same airplane as an Ebola infected health-care worker. As Kinzer told the Guinea media this summer, “Ebola’s not transmitted by the air. Fear and ignorance are transmitted by the air.” (Joel Achenbach and Brady Dennis, Washington Post)

 

Infectious Diseases

US pauses new funding for controversial virus research

The White House has announced that it is pausing any funding for new Gain-of-Function studies on viruses, like influenza, MERS, or SARS, and has called for a voluntary moratorium on existing research projects. Gain-of-Function studies have been controversial both inside and outside the scientific community. These types of studies seek to understand what kinds of mutations are necessary for a virus to evolve to become more pathogenic or to be more easily transmitted in humans or mammels. Proponents argue that these studies help in pandemic planning and strategies for vaccine development. Opponents argue that these studies are generating viruses that have the potential to cause a pandemic if accidentally or intentionally released from the labs. Concerns have been elevated due to recent concerns over safety at high-level containment research labs. US policy for determining the risk/benefits and approval process for these types of gain-of-function will be evaluated by both the National Science Advisory Board for Biosecurity and by the National Academy of Sciences over the next year. (Jocelyn Kaiser and David Malakoff, ScienceInsider)

 

Cancer Research – Precision Medicine

Cancer Immunotherapy successful in Phase I/IIA clinical trial

Cancer Immunotherapy is a promising precision medicine approach for treating cancer, and was named Science magazine’s breakthrough of the year in 2013.   In a recent study, cancer immunotherapy was shown to be an effective treatment for acute lymphoblastic leukemia, a cancer of B-cells. This treatment worked well in patients who had failed traditional therapies, including some whose cancer had previously returned even after stem cell transplants. This study reported impressive, durable results six months after therapy, with 23 of 30 patients alive, 19 of 30 in complete remission, and with 15 of 30 receiving no additional therapy. In this particular version of cancer immunotherapy, a patient’s own T-cells were harvested, then genetic bits of information are added to their T-cells to help them recognize B-cells (which are the source of the cancer), the modified T-cells are given back to the patient, and then these genetically modified T-cells hunt and kill the cancerous B-cells. As with any therapy, this treatment does have side effects most, including destruction of healthy B-cells and Cytokine release syndrome, a systematic inflammatory response that can cause a high fever, a drop in blood pressure, and difficulty breathing. This study was published in the New England Journal of Medicine and was partially sponsored by Novartis which holds the license to develop this therapy. In July, the FDA designated this engineered T-cell treatment as a “breakthrough therapy” which should help expedite the development and regulatory review of this therapy. (Denise Grady, New York Times)

 

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October 22, 2014 at 3:20 pm

Science Policy Around the Web – April 24, 2014

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By: Jennifer Plank

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

Vermont Will Require Labeling of Genetically Altered Foods – Vermont has recently established the strictest guidelines regarding genetically modified foods. Beginning July 1, 2016, all foods containing genetically modified ingredients must be labeled as such, which could affect up to 80 percent of foods on the shelves of grocery stores. Due to the small number of individuals living in Vermont, it is possible that some suppliers of genetically modified foods will cease selling to grocery stores in the state. While the ruling is currently limited to food sales in Vermont, the precedent set could impact legislation in other states or at the federal level. (Stephanie Strom)

NIH Policy Change Allows Unlimited Resubmissions of Grant Applications – Last week, the NIH revised the policy regarding number of resubmissions for R01 grants. Previously, once a grant was submitted (A0), it could be revised and resubmitted one time (A1). After that submission, if the grant was not funded, another submission of the same research was not allowed. Under the new guidelines, a grant can still only technically be resubmitted one time, however, the same grant can be submitted as a new A0, which means that any grant can essentially be resubmitted an unlimited number of times. Whether this policy change will have a positive benefit on research and the funding climate is yet to be seen. (Chris Pickett)

FDA Warns Against Protocol To Remove Uterine Fibroids – Last week, the FDA issued a statement encouraging doctors to stop a surgical procedure to remove uterine growths; such removal may inadvertently spread cancer throughout the body. The procedure, known as power morcellation, is used to remove uterine growths during laparoscopic surgeries. Although the FDA urges doctors to cease using the procedure, they do not intend to ban any of the devices required to perform the operation. (Brady Dennis)

 

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April 24, 2014 at 3:40 pm

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