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Science Policy Around the Web – July 1, 2016

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By: Daniël P. Melters, Ph.D.

Image source: Scientia Salon blog

Research Participant Protection

National Academy of Sciences advises White House to rewrite Common Rule

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

Science Funding

Interdisciplinary research proposal are less frequently funded

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

Cancer MoonShot

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

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

Natural Resources

Large helium reserves found in Tanzania

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

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

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July 1, 2016 at 2:00 pm

Global disparities in cancer treatment and recent policies to address cancer care

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By: Nivedita Sengupta, Ph.D.

photo credit: phalinn via photopin cc

According to American Cancer Society more than 8 million people worldwide die from cancer every year. The number of deaths worldwide from communicable diseases like malaria, HIV and AIDS is insignificant compared to the number of global deaths from cancers which is expected to cross the 13 million mark by 2030, making cancer the leading cause of death worldwide. Cancer as a non-communicable disease has long been considered a disease of developed countries, where people are more likely to succumb to long-term chronic diseases rather than dying from infectious diseases. However, according to statistics from the World Health Organization (WHO) and American Cancer Society, of the 14.1 million new cancer cases reported worldwide in 2012, 6.1 million were from developed countries compared to 8 million in developing countries – and these numbers are still rising. The number of new cancer cases in developing countries is predicted to rise to 13.1 million by 2030. These discrepancies between developed and developing countries are also apparent in childhood cancers. Childhood cancers account for less than 1% of the total cases in developed countries but about 4% in developing countries. Considering that reliable data on incidence are only available for a fifth of the world population consisting of people in mostly high-income countries, the actual statistics on cancer in developing countries may be even higher making cancer a significant and growing health burden in developing countries.

Escalation of cancer cases in developing countries over the past years has resulted in an increase in cancer-related health care costs, building up a global financial burden due to cancer. In 2010, $290 billion was spent to treat 13.2 million new cancer cases worldwide and this spending is projected to increase to $458 billion by 2030. Despite a wealth of data on how to diagnose and treat cancer, funding for cancer remains a low priority in context of health spending for both developing countries and for the nations providing donations. Only 5% of global resources devoted to cancer are spent in developing countries. In 2014, total global funding for development assistance for health was $35.9 billion, and only 2% of that amount was allocated for assistance in the area of non-communicable diseases of which cancer is only one aspect. This sets up an untenable situation as developing countries do not have the resources to tackle the rising human cost of cancer within their borders and necessitates significant global interventions and funding.

One potential in-country way to combat and prevent many of the deaths from cancer could be by raising awareness of the signs and symptoms of cancer among the general population, as well of awareness of proven ways to prevent cancer. A 2007 study on breast cancer in Malaysia found that 52.2% of newly diagnosed patients have stage III and IV cancers due to a lack of awareness of the signs and symptoms of cancer leaving them to seek treatment further into the disease progression. Most of these women were from rural Malaysia, with little or no education. Earlier screening for these and other cancers could help prevent cancer deaths. The major cancer types found in the developing countries are breast, cervical and colorectal cancer. Many of these cancers respond to treatment if detected early and treated adequately. However due to lack of cancer diagnosis facilities, by the time cancer is detected in these poor people it progresses to a stage where palliative care becomes the only option. In another example, potentially up to 20% of cancer deaths in developing countries could be prevented by immunization against HBV and HPV infections. Public-private global health partnerships like GAVI Alliance have partly facilitated the availability of HPV vaccines in the poor countries such as Kenya, Ghana, Madagascar, Malawi, Niger, Sierra Leone and the United Republic of Tanzaniato. However, poor people living in the middle income countries like China, Malaysia, India and Brazil are excluded from this initiative due to their country’s slightly higher income.

Another significant problem needing attention is a lack of proper infrastructure (in terms of equipment and people) for cancer treatment in developing countries. Currently, treatment options in developing countries are very limited and expensive. In developed countries people can have better health care coverage and access to up-to-date cancer care facilities and treatment, in addition to dedicated cancer research centers and specialists. Most developing countries have limited treatment centers with proper infrastructure and oncologists. According to the International Atomic Energy Agency (IAEA), even though 85% of the world’s population resides in developing countries, the average number of pieces of therapy radiation equipment in developing countries is only 0.4 units per million inhabitants, compared to more than six units per million inhabitants in developed countries. The few developing countries who are privileged enough to have access to radiotherapy equipment face considerable financial burdens in then providing the necessary training, equipment set-up and maintenance, protocols and quality control for proper usage of these machines for cancer treatment. Oncology and palliative care training is limited in medical schools and very few doctors and nurses can afford to have training outside their country resulting in lack of sufficiently trained staff in developing countries to deal with the increasing load of cancer cases.

Even treating cancer patients at all can be difficult in developing countries. Apart from expensive cancer drugs themselves, pain medications for palliative care like morphine are not easily available in these countries. Statistics show that 99.9% of cancer patients in developing countries are dying with untreated pain. 84% of the morphine used globally goes to the developed countries, leaving just 16% for the rest of the world. This is not because of limited morphine production but rather mainly because of onerously complicated and expensive narcotic supply regulations set by the International Narcotics Control Board (INCB). The structure of surveillance and accountability requirements implemented by INCB makes it almost impossible for poor nations to comply because of poor infrastructure and lack of educated people to handle issues necessary to comply with the regulatory needs. Moreover, country specific regulatory laws make it harder for the doctors to prescribe these medicines. All patients in need of pain relief could be helped if proper laws are implemented to gain access to pain medication and palliative care.

Drug companies themselves can help to address these health disparities in developing countries. On March 31st 2016, GlaxoSmithKline (GSK) CEO Andrew Witty announced a series of new patent policies designed to make innovative GSK medicines available to more people living in under-developed and developing countries. The new polices have a special focus on improving access to cancer drugs specifically. In the policy, GSK plans to stop filing for patents on its molecules in 50 of the least developed and low-income countries. In developing lower-middle-income countries, GSK will continue to file for patents but will grant licenses to generics manufacturers. This will enable easier access to cheaper generic versions of GSK’s drugs in those countries for the treatment of cancer. Furthermore, GSK will submit patents on future cancer drugs it develops to the United Nations-backed Medicines Patent Pool (MPP). The MPP deals in large-scale licensing agreements between drug developing companies and generics manufacturers thus enabling greater access to medicines in up to 127 developing countries. GSK has been applauded for this venture and the initiative also reveals the growing awareness among people regarding the magnitude of disparities in cancer care around the world. However experts says that a lot more still needs to be done in terms of improving access to needed medications. Ironically, most of the world’s poor live in ‘middle income’ countries such as China, India and Brazil that are not included in these polices and therefore will not gain anything from these new measures.

To reduce the death burden due to cancer in developing countries significant funding is needed, and one key challenge is how to obtain that funding. International advocacy is required to mobilize the international community and individual governments to take action. A number of influential international advocates like the UN, WHO and IARC are already active and trying to form partnerships with international health professionals, non-government organizations (NGOs), and funding organizations to bridge the gap between funding and treatment. By taking the necessary steps in proper direction to strengthen cancer prevention, early detection, treatment and palliation, much can be done to help improve cancer control in developing countries.

Written by sciencepolicyforall

May 23, 2016 at 9:00 am

Science Policy Around the Web – April 6, 2016

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By: Sterling Payne, B.Sc.

Artificial Intelligence

To Beat Go Champion, Google’s Program Needed a Human Army

“It may be a hundred years before a computer beats humans at Go — maybe even longer,” Dr. Piet Hut communicated to New York Times’ George Johnson in a 1997 conversation. The event prompting their discussion was the victory of IBM’s Deep Blue over grandmaster Garry Kasparov in a series of chess games. Dr. Hut’s prediction was bested by about 80 years by AlphaGo, the product of Google’s DeepMind. AlphaGo recently secured a victory against 9 dan Go champion Lee Sedol in a 5-game match hosted by Google. By nature, Go as a game is more complex than chess; less stringent gameplay guidelines don’t offer a surefire way to determine which player is at an advantage. Rather than powering through an analysis of thousands upon thousands of potential moves each turn, AlphaGo utilizes a novel combination of machine-learning methods to determine which board configurations are more advantageous, and positively reinforces correct decisions via thousands of matches played against itself. The product of this is an artificial intelligence (AI) that more closely represents human intuition, at least in the small scope of the Chinese board game.

With its 4-1 victory over Sedol, AlphaGo demonstrated extreme proficiency in the game of Go, but in only that. While inarguably an astounding accomplishment and significant leap in the field of computer science, AIs like AlphaGo have a long way to go before they can replicate the intuition of the human mind, which is far expandable beyond an ancient board game. In terms of policy, the very methods used to create AlphaGo could also find their ways into hospitals and healthcare facilities in the near future. With the advent of artificial intelligence in the workplace, extra considerations will have to be taken by patients and care providers alike in terms of personal information, data management, and general communication. (George Johnson, The New York Times) (Will Knight, MIT Technology Review)

Federal Cancer Research

Blue Ribbon Panel Announced to Help Guide Vice President Biden’s National Cancer Moonshot

The Cancer Moonshot Initiative , headed by Vice President Joe Biden, plans to put an end to the disease that has plagued millions of humans for hundreds of years. Armed with a $1 billion budget over the next five years, the initiative’s primary aim is to speed up cancer research such that a decade’s worth of discoveries can occur in half that time. Two of the main areas where such discoveries will fall are detection and treatment. A task force to handle financial matters and progression of the initiative was announced in February, and just yesterday (April 04, 2016), the National Cancer Institute unveiled their Blue Ribbon Panel, a special selection of various leaders in the fields of cancer research and patient advocacy, to direct efforts of the initiative to where they are likely to make the largest impact.

As a society, our knowledge of cancer has grown considerably since the turn of the century; Cancer is no longer thought of as a single disease that affects people, rather, it is the product of multiple genetic mutations and cellular microenvironments, painting a unique disease landscape for each person it affects. Members were chosen such that the panel represented multiple walks of science from immunology to bioinformatics, as well as cancer prevention and treatment. Already armed with capital and a team to guide finances and general progress, the Cancer Moonshot Initiative has taken another giant step forward with the addition of the Blue Ribbon Panel. The full member list of the Blue Ribbon Panel and the original announcement are linked here. (News Releases, National Institutes of Health)

Biotechnology

Biology software promises easier way to program living cells

With computer programming, the programmer gives the computer a set of instructions in one (or more) of several different programming languages. These instructions include logical operations such as true-false statements (i.e. “if this is true, then do this”) and various loops (i.e. “while this is true, do this”). At the end of all of this, sits a program, executed by the computer to provide some sort of output, whether it be ordering a data set, turning on a light, or spinning a motor. Dr. Christopher Voigt and his lab at MIT have taken these principles and applied them to their new software Cello, a programming language capable of producing working circuits in living systems. Cello requires the user to input commands, such as a function they would like a given cell to perform and under what conditions it should perform said function. After the input is compiled, the end result is a DNA sequence or “circuit” that, when placed inside a cell, can fulfill the function(s) specified by the user. In a paper recently published in Science (April 01, 2016), Alec Nielsen and colleagues used cell to generate 60 different DNA circuits, 75% of which worked as expected the first time when introduced into Escherichia coli cells.

As synthetic biology continues to grow and gain popularity throughout the research world, it is of increasing importance to think about what policies and potential restrictions should be set in place. Engineering de novo biological systems and functions can be extremely powerful, yet, if left in the wrong hands, could have significant consequences as with any equally commensurate technique (e.g. CRISPR-Cas9). (Erika Check Hayden, Nature News)

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April 6, 2016 at 12:00 pm

A Moonshot for the 21st Century

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By: Ian McWilliams, Ph.D.

During his final State of the Union address, President Obama announced that he was appointing Vice President Joe Biden to head a new initiative to cure cancer. The goal of this new “moonshot” is to “accelerate our efforts to progress towards a cure, and to unleash new breakthroughs for other deadly diseases.” Achieving these goals will be difficult, but the need for a cure is abundantly clear. According to the Center for Disease Control, cancer is the second leading cause of death in the United States, with over 1.6 million new cancer diagnoses and almost 600,000 deaths due to cancer in 2015 alone. President Obama poignantly expressed the need for scientific advancement in cancer research “for the loved ones we’ve all lost, for the family we can still save, let’s make America the country that cures cancer once and for all.”

The Office of the Vice President has since assembled a Cancer Moonshot Task Force that convened for the first time on February 1st. This committee brings together numerous executive branch departments and agencies, including the National Institutes of Health, National Cancer Institute, Department of Defense, Department of Energy, Department of Veterans Affairs, and many more. With the help of oncologists, cancer researchers, and advocates, the committee will help direct federal investments towards fighting cancer. After the meeting, Dr. Francis Collins, director of the National Institutes of Health, and Dr. Douglas Lowy, acting director of the National Cancer Institute, took to Twitter to continue the conversation. Collins and Lowy answered questions regarding the focus of this initiative and reiterated the Vice President’s call for a comprehensive approach to bring “all the cancer fighters together.”

Like the first moonshot to land a person on the moon, this announcement echoes the call for innovation from both the public and the private sectors. Biden’s plan to double the rate of progress largely rests on increasing clinical trial participation and advancement of new, cutting-edge approaches to cancer treatment, such as re-directing a patient’s own immune system against their tumors. Biden noted that “we’re at an inflection point – and the science is ready.” With approximately 5 percent of cancer patients enrolling in clinical studies, this is one potential pathway to increase involvement of cancer patients and survivors to better understand the disease. Biden has indicated that prevention and earlier detection will also be priorities. Other research opportunities include cancer vaccines and generation of therapies that target specific mechanisms utilized by tumors. He also hopes that by facilitating data exchange and encouraging communication between cancer centers, more researchers can capitalize upon the vast sources of data currently available.

This is not the first time a president has called for a cure for cancer. In 1971, President Richard Nixon called for a “War on Cancer”. This effort led to The National Cancer Act, which allocated special budgetary authority to the National Cancer Institute. Many hoped that a cure could be identified by understanding the underlying cause of cancer, but ultimately, the war has not been won. We have learned much about cancer since 1971, and it is now well accepted that cancer is not a single disease, but rather a collection of many diseases, even hundreds, with a wide range of causes. In a recent Q&A that Joe Biden hosted on his Facebook page, he even acknowledged that “multiple disciplines are needed to attack this disease.” Now that the complexity of cancer is better appreciated and it is clear that an individualized approach will be necessary, the Cancer Moonshot hopes to take advantage of a multidisciplinary approach, including genetic analysis of individual tumors, to keep the momentum going. With new studies like the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH), great efforts have been put forward to find the right drug(s) that will target the right disease based on molecular characterization. Additionally, Lowy announced that a pediatric version of the NCI-MATCH trial is set to start later this year.

While reinvigorated efforts to improve cancer treatment sound promising, this new initiative faces many challenges. The White House has requested that an additional $1 billion be allocated to increase resources. The White House also announced that $195 million will be immediately available, but it is not yet clear if this money will come from a reallocation of funds in the FY2016 budget. And with less than a year left of Obama’s presidency, many worry that this initiative may not be sustainable. Indeed, although Biden has indicated that he plans to propose continuing support for the Cancer Moonshot in the FY 2017 budget, he will no longer be in office to help direct the use of those funds.

“Now, as I’ve said from the start, I don’t claim to be a cancer expert,” admits Biden, “but I do have something to offer when it comes to being a catalyst and bringing folks together.” The resulting concerted effort by government, private, and public sectors aim to do the unimaginable – cure cancer. The original moonshot brought diverse groups together to achieve a seemingly impossible goal to walk on the moon, but only time will tell the success of this moonshot.

Written by sciencepolicyforall

February 10, 2016 at 9:00 am

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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.

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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)

Have an interesting science policy link?  Share it in the comments!

Written by sciencepolicyforall

April 17, 2015 at 9:00 am

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