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Archive for December 2015

Science Policy Around the Web – December 29, 2015

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By: Emily Petrus, Ph.D.

photo credit: DSC03602.JPG via photopin (license)

Biotechnology

And Science’s Breakthrough of the Year is …

Designer babies used to be the stuff of science fiction, however now they are potentially within reach. As such, Science’s 2015 “Breakthrough of the Year” is ….. CRISPR. CRISPR is a method originally discovered in bacteria which has launched us into a new era of gene editing. Although other methods of inserting, deleting, and switching genes on and off have been around for some time, CRISPR is more efficient, less expensive and easy to reproduce in a variety of species, including human embryos. This new technology means that being able to edit out harmful genes or splice in beneficial genes into human babies is technologically possible; however, this raises serious ethical implications in the policy realm.

A summit earlier this month in Washington, DC (December 2015) organized by the National Academy of Science and others from China and the UK confronted the issues surrounding the ethics and legality of editing human genomes. Conclusions from the summit included a call for extensive basic/preclinical research into the effects of editing human embryos and germline cells, but these experiments should not be used to establish a pregnancy. In addition, gene editing used in humans to target diseases – such as modifying red blood cells in Sickle Cell Anemia or deleting the Huntington’s Disease gene from reproductive cells also should be carefully studied before implementation. Germline editing is especially fraught with ethical issues, as altering human DNA for offspring equates to evolution on the generational scale. The deletion of “undesirable” traits could enhance social inequality. Overall the summit concluded that gene editing may have potential benefits, but a yearly summit designed to address the sure to come legal and ethical issues is imperative to carefully implement this new technology. Finally although we are able to edit our genes, in the end, do we want to? (John Travis, Science)

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December 29, 2015 at 9:00 am

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Science Policy Around the Web – December 22, 2015

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By: Allison S. Burrell, MS, MPhil

Photo credit: via pixabay.com

Nuclear Policy and Science Diplomacy

When Scientists Do What Diplomats Can’t

Scientists are playing a role in ongoing nuclear negotiations with Iran’s Atomic Energy Organization and the United States, as well as five other PN+1 countries. An agreement was signed in July 2015, and as of September, new bids by the US Senate have not been able to hinder the deal from moving forward. As this deal is implemented, economic sanctions against Iran currently in place will be slowly lifted in exchange for increased controls on Iran’s nuclear-weapons program. Science diplomats partner with political diplomats to ensure a proper understanding of the scientific details underlying the economic negotiations underway. This type of partnership is essential, and science diplomacy has been integral in international politics related to atomic weapons since the Manhattan Project back in 1945.

Scientists travel the world communicating and sharing their science through topic-specific conferences. This creates an international community of scientists, where borders are blurred and science is the common language. US secretary of Energy’s Ernest Moniz, and Iran’s head of the Atomic Energy Organization, Ali Akbar Salehi, both went to MIT, although at different times. But their common ground in physics and nuclear engineering allowed for a more personal relationship during these heated economic negotiations. It is proposed that the language of science is what brought the Iranian atomic negotiations back on track, accomplishing what political negotiations alone could not. Those who oppose the Iranian deal fundamentally disagree with the politics, yet still praise scientists’ role in negotiations. Scientists alone can’t be expected to understand the intricacies of political negotiations. Science diplomacy is slowly becoming a more popular term. The international editor for Science magazine, Richard Stone, believes that scientists “can come together and bond over a common cause…no matter where they are [from]”, and this is a strength that can be harnessed in the international diplomatic forum. (Audra Wolfe, The Atlantic)

Biosafety, Biosecurity and Risk

A more systematic approach to biological risk

In the past few years there have been worrying events that lay out the question of the status of biosafety and biosecurity in the U.S. Just last year, vials labeled variola, aka smallpox, were found in a freezer at the National Institutes of Health, and later determined to be viable. These pathogens, such as anthrax, smallpox and avian flu, have strict handling and storage protocols, which were not properly followed. In response to these events, as recently as October 2015, the White House laid plans, through a memorandum, to improve U.S. biosecurity and biosafety. Managing biological risk is a top priority, yet not much has changed since the well-known 1975 Asilomar meeting, which discussed the potential guidelines for using recombinant DNA.

Current meetings to address new biotechnology issues are still coming up short. Emerging biosafety and security issues cannot be treated solely as technical issues, but must also be represented from a governance standpoint. The National Institutes of Health, being the largest scientific funding agency in biological research, is currently evaluating a risk-benefit analysis of gain-of-function research, just as the National Academies of Science are evaluating gene editing and gene drives. Without outside governance, the end results run the risk of being biased towards success at any cost. Since the people making the decisions are specialists, they are also often involved in conducting the research, creating a conflict of interest. There is something to the thought, that if you are too close to a problem/project, you can’t see mistakes or alternatives.

There are committees or boards, such as the National Science Advisory Board for Biosecurity (NSABB), or the Presidential Commission for the Study of Bioethical Issues (PCSBI), that help with overseeing guideline creation for new biotechnologies. But these committees lack authority to impose rules that highlight biosecurity and risk. Mechanisms that are effective at regulation lie mostly in blocking or rescinding public funding, or inflicting fines. Transparency, through public reporting, is lacking, and this hinders investigations looking into improving risk strategies.

The advancement of scientific discovery is inevitable, and in order to protect our future, political and scientific realms must meet in a new arena, thus fostering a side-by-side collaboration of political and technical expertise. Science diplomacy, even on a national level, is key to moving forward with biosafety and biosecurity regulations. A new oversight position, as well as a coordinating committee, should be created in the U.S. government; that which focuses on anticipating and managing biotechnological risks, and works closely, through accountability and transparency, with the NIH, other federal agencies, and organizations intimately involved in emerging biotechnologies. (Megan J. Palmer, Francis Fukuyama and David A. Relman, Science Magazine)

Federal Funding for Science

Congress ready to give NIH its biggest increase in 12 years

The National Institutes of Health, a world leader in biomedical research and funding, has experienced budget cuts across the board over the past decade, in line with other federal institutions. Although biomedical research is arguably one of the most important science endeavors to invest in the security of our future health, a budget increase has not been seen in over 12 years. A new federal spending bill is up for vote in Congress, and was introduced on December 16, 2015. If it passes the house, and the Senate, the NIH will receive a $2 billion funding increase. But a bipartisan compromise will be necessary to get this all the way to Obama’s desk to be signed into law.

Some of the hottest research topics receiving new funding with this bill are as follows: $200 million is allocated for a new presidential Precision Medicine Initiative, $350 million for Alzheimer’s research, $85 million for the BRAIN Initiative, $303 million in the effort to combat antibiotic-resistant bacteria, and $91 million towards opioid abuse programs.

NIH released a strategic plan of growth for the agency over a four-year period. How the new funding will be used towards this end is yet to be determined, since it was released before knowledge of the potential funding increase. Amazingly, even with the funding growth, adjusted for inflation, the NIH’s purchasing power is not comparable to its peak in 2003. Republican representative Tom Cole of Oklahoma wants a new goal for the future; to not just increase the budget this year, but in years to come as well.

Policy changes associated with the new spending bill include a hold on the Obamacare medical device tax for two years. The current restrictions preventing the CDC from researching gun violence, in effect for about 20 years, will not be lifted. The new legislation will limit e-cigarettes pre-market reviews. And new policy on genetically engineered salmon dictates that it will not be sold until new labeling guidelines are in place. (David Nather and Dylan Scott, Stat News)

Update: This spending bill passed both the house and the senate, and was signed into law by President Obama.

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December 22, 2015 at 9:00 am

Science Policy Around the Web – December 18, 2015

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By: Valerie Miller, Ph.D.

Photo source: pixabay.com

“Farmaceuticals”

US government approves (drug-producing) transgenic chicken

On December 8th, 2015, the US Food and Drug Administration (FDA) approved Kanuma (sebelipase alfa), a recombinant enzyme marketed by Alexion Pharmaceuticals, which is meant to treat patients with a rare inherited enzyme disorder known as lysosomal acid lipase (LAL) deficiency. LAL deficiency prevents the breakdown of fatty molecules in the body, leading to fat accumulation in the liver, spleen and vasculature. Kanuma was given priority review, and the FDA moved quickly for its approval, due to Kanuma’s orphan-drug status and designation as a break-through therapy, as there were no therapies available for LAL prior to Kanuma’s approval. Kanuma is unique because it’s made by genetically engineered chickens, which produce the drug in their eggs. Several other ‘farmaceuticals’ have entered the US market ahead of Kanuma, including genetically modified goats that produce the anticoagulant antithrombin in their milk, as well as a drug produced in the milk of transgenic rabbits that treats hereditary angioedema. The FDA regulates the entire chicken, not just the eggs, because all of the chickens’ cells contain modified DNA. Part of this regulation asserts that the altered DNA is not harmful to the chickens nor will these chickens adversely affect the environment. Additionally, unlike the recently approved, genetically engineered AquAdvantage salmon, Kanuma-producing chickens will not enter the food supply. (Rachel Becker, Nature News)

Climate Policy

Nuclear power must make a comeback for climate’s sake

In wake of the landmark climate agreement reached during the COP21 Paris climate negotiations, four prominent climate scientists are advocating for the use of nuclear energy in order to help reduce carbon emissions. James Hansen, former NASA climate scientist; Tom Wigley, climate scientist at the University of Adelaide; Ken Caldeira, climate scientist at Carnegie Institution for Science; and Kerry Emanuel, professor of atmospheric science at MIT, argue that nuclear energy has great potential to be part of the climate change solution and energy system transformation, especially for large countries like China. As the goal of nations is to stabilize atmospheric carbon dioxide levels at 450 parts per million and limit the global rise in temperature to 2 degrees Celsius, the scientists contend that all carbon-reducing energy options need to be considered, including the use of nuclear energy. However, they note that very few nations have discussed the potential of nuclear in their carbon emission reduction pledges, and given the time needed to build nuclear power plants, nations should look into this option immediately.

Other scientists, such as Mark Jacobson, professor of civil and environmental engineering at Stanford University, are concerned that using nuclear energy would create more pollution, because the mining of uranium for use in nuclear reactors is carbon-emitting, and because of the possibility of taking several decades to get nuclear power plants up and running. Instead, he believes that the world can meet the temperature and atmospheric carbon dioxide parts per mission goal using only renewable energy, because the technology to harness wind, water and solar energy already exists. Jacobson calculates that developing renewable energy would net 22 million jobs while ensuring energy security, and that the current fossil fuel-based energy system could be replaced entirely by 2050 worldwide. (Gayathri Vaidyanathan, Scientific American)

Sustainable Food?

The more humanely a fish is killed, the better it tastes

Many people are concerned about consuming sustainable seafood, but few ask about the way in which the fish they eat are killed. In a new study to appear in the January 1st, 2016 edition of Food Science, a team of researchers showed that meat from rainbow trout stressfully-slaughtered by asphyxiation above water tasted worse and had a shorter shelf-life than rainbow trout slaughtered with a swift strike to the head, which is considered to be a more humane method of slaughter. Researchers detected break-down of fatty acids, such as omega-3s, in the fillets of stressfully-slaughtered fish after 75 days in the freezer. By day 135, twice as many fatty acid break-down products were detected in the asphyxiated fish. To determine differences in taste, the team asked four experts in detecting “marine off-flavors” to judge the samples. By day 105, the judges reported a rancid smell and bitter taste in the fillets from asphyxiated fish, but detected no off-flavors or smells in swiftly-killed fish. The researchers speculated that a higher concentration of hydroperoxides that accumulate during stress may have caused the asphyxiated fish fillets to go bad more quickly. They hope that their study will encourage fishers to employ a swifter method of slaughter. (Brendan Bane, Science Shot)

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December 18, 2015 at 9:00 am

Science Policy Around the Web – December 15, 2015

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By: Rebecca A. Meseroll, Ph.D.

Photo source: pixabay.com

Climate change

Global climate change accord reached

After years of discussion and two weeks of intensive negotiations, representatives from 195 nations reached an historic accord on climate change on December 12th in Paris.  A major goal of the agreement is to maintain global temperatures at or below 2°C above pre-industrial temperatures, primarily by transitioning from fossil fuels to clean energy alternatives.  As the earth has already warmed approximately 1°C since pre-industrial times, it is crucial that action is taken to reverse the trend.  Although individual nations’ current climate pledges are not expected to fully meet this goal, many scientists see the accord as a means of gaining momentum to enact policies to prevent the terrible outcomes that rising global temperatures would deliver.

Of course, the agreement does require actual follow-through by individual governments in order to be effective.  The plan will utilize a system of global peer pressure to encourage nations to meet their goals by requiring that countries meet every five years beginning in 2023 to report on progress.  In the United States, for example, the fear of international shame may not be enough to force the hand of climate change skeptics in Congress who would likely vote against future legislation aimed at decreasing global temperatures.  Despite the imperfections of the agreement, the successful passage of this pact has led to a great deal of excitement, especially in the scientific community, and should provide a huge step forward in worldwide cooperation for improving environmental health. (Coral Davenport, New York Times; Jeff Tollefson & Kenneth R. Weiss, Nature)

AIDS research funding

NIH ends fixed funding for AIDS research

Last week, the National Institutes of Health (NIH) announced it will not continue allocating a set 10% of its budget to HIV/AIDS research, a policy which has been in effect since the early 1990s.  HIV and AIDS treatments have vastly improved in recent years and mortality rates are down, thus research into the disease is not seen as being such a pressing issue as it once was.  Francis Collins, the Director of the NIH, agrees with patient groups and Congressional representatives who have found it problematic that AIDS gets proportionally so much more research funding than other diseases that take a greater toll on the population and healthcare spending.  In addition to cutting the reservation of 10% of its overall budget, another $65 million, which comprises about 2% of the HIV/AIDS grants portfolio, will be freed up for new priorities in HIV/AIDS research.  The NIH will focus on preventing HIV, via vaccine development or other treatments, and finding a cure for the disease, instead of funding projects more tangentially related to HIV infection.  The current funding reduction and refocusing are expected to take place in the next fiscal year.  Although the HIV/AIDS research community is generally supportive of ensuring the highest priority research is funded, there is some concern that HIV/AIDS research funding will be passed over for increases if the NIH budget is raised in the future. (Jocelyn Kaiser, ScienceInsider)

Drug prices and regulation

Shkreli plans to spike price of Chagas disease drug

Martin Shkreli, a former hedge fund manager and current CEO of Turing Pharmaceuticals, rose to infamy earlier this year when his company acquired the rights to the decades-old toxoplasmosis drug Daraprim and then abruptly raised its price per pill from $13.50 to $750.  After public outcry, he pledged to lower his proposed price raise, but then withdrew that pledge, and he has recently said he should have raised the price of Daraprim even higher.  Shkreli is now poised to spike the price of another old drug, benznidazole, which treats Chagas disease, a parasitic infection most commonly encountered in Central and South America that can persist for many years and eventually cause cardiac and gastrointestinal trouble.  Last month, Shkreli acquired the biotechnology company KaloBios Pharmaceuticals and is currently awaiting FDA approval for KaloBios to be the sole distributor of benznidazole in the United States.  If KaloBios receives approval, Shkreli says he will raise the price of a course of treatment to between $60,000 and $100,000.  The CDC estimates that approximately 300,000 people in the United States have Chagas disease, although the vast majority of them are undiagnosed.  It is unclear how much of a market KaloBios would actually have for benznidazole, since the diagnosis rate is so low, but even if there is no market, the company could potentially sell the rights to the drug to turn a quick profit.  KaloBios is facing competition for FDA approval from Elea Laboratories, an Argentine company that currently supplies benznidazole.  These practices by Shkreli call into question whether current regulations aimed at increasing research and development of drugs for neglected diseases are actually effective or whether they are more frequently being abused as money-making schemes.  If the latter is true, new regulations may need to be put into place to prevent gaming of the system. (Andrew Pollack, New York Times)

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December 15, 2015 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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December 11, 2015 at 9:00 am

Evolution provides us with many genetic power tools – how do we use them wisely?

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By: Daniël P. Melters, Ph.D.

The Red Queen Hypothesis in evolutionary biology: “Now, HERE, you see, it takes all the running YOU can do, to keep in the same place.” (Lewis Carroll, “Through the Looking Glass”)

DNA is a very ubiquitous molecule, sufficient to span the observable universe at least 20 times. Most of this DNA comes from viruses, either in the form of active viruses or in its inactive form incorporated in viral, bacterial, plant, fungal, and animal genomes. To limit the spread of viruses, it is not surprising that evolution has created many ways to contain the spread of these inactivated viruses. We have adopted some of these antiviral mechanisms for our own use.

The discovery of the first bacterial antiviral system, the restriction enzyme, led to the founding of Genentech and thereby the modern biotechnology industry. Despite the ease with which restriction enzymes can be used to cut and paste pieces of DNA together, they are currently limited to use in test tubes (in vitro).

A few years ago, a new genetic tool was discovered that could modify genetic material in living creatures (in vivo). Again, it was a bacterial anti-virus mechanism. This new technology is called CRISPR and its in vivo use brings with it the possibility to edit DNA in order to correct genetic diseases in patients themselves. Just as a slew of restriction enzymes with unique cutting characteristics have been found, a similar scenario seems to be happening with CRISPR with the discovery of more nucleases used to cut specific DNA sequences. The original nuclease used with CRISPR is cas9, but recently another nuclease (cpf1) was discovered. Where cas9 is efficient in deleting genes, cpf1 seems to be good for making small modifications. In the foreseeable future more cas9-like nucleases will be discovered, each with potentially their own unique characteristics, in addition to ongoing efforts to genetically engineer a better cas9 nuclease.

Ethical questions about the use of CRISPR in humans, especially in human sperm and eggs, have arisen. On December 1-3, 2015, the U.S. National Academy of Sciences in collaboration with the Chinese Academy of Sciences and the UK Royal Society, hosted a three-day international summit on the use of CRISPR in human embryos. Although germline editing is strongly discouraged pending continued technological and ethical deliberations over the next few years, it remains a scientific possibility. Based on a single Chinese study, it is still unclear if this route is realistic. After all, cloning mammals has proven much harder than feared in the 1990s, as has creating a petrol-producing algae by genetic editing. Nevertheless, this has not stopped genetic entrepreneurs like Google and Bill Gates from jumping on the CRISPR bandwagon to kick-start the second revolution in biotechnology. One big unknown factor that still remains looming over the development of both the technology and any regulation is the potential misuse of any do-it-yourself CRISPR kits.

In addition to making individual genetic changes at will like those with CRISPR, forces that work on population genetics can be employed. Again they have their roots in evolution. One such potential powerful force is gene drive. Gene drive is caused by a genetic sequence that does not obey the Mendelian inheritance rules (where there is a 50-50 shot for a gene to be passed on from parent to offspring). It is therefore possible to introduce a gene that could, for example, get rid of the malaria parasite by introducing a few GMO mosquitoes into a population of natural mosquitoes. Through gene drive over time the entire population of mosquitoes will carry the malaria-fighting gene. The implication would be that the malaria parasite would not be able to passed on to humans and thus malaria would be eradicated. This sounds like a dream scenario!

However, using gene drive on mosquitoes to eradicate malaria does open a new can of worms. Both for the good – as the need to fumigate would be reduced also reducing the creation of fumigation-resistant insects, including mosquitoes – and for the bad, namely unwanted ecological consequences as a result from for instance horizontal gene transfer. Another unwanted consequence of the gene drive technology would be the near-certainty that it will spread across political borders. To handle such foreseeable international disputes, international regulatory collaboration will be required. One solution to overcome these unwanted consequences of gene drive could be use genetically engineered mosquitoes that would not be able to produce any off spring.

Whatever happens on the side of technology development, genetically modifying organisms remains controversial for the time being. Just think about the hype surrounding the recent FDA approval (after 19 years) of faster-growing “Frankenfish” for human consumption. Part of the problem resides in the highly technical details and extensive use of jargon that permeate the biological sciences. At times, it can be challenging for even scientists to keep up with the fast pace of development in the field of genetics. Once can only imagine what must then be demanded of the public and policy makers. Just look at what CRISPR itself stands for: clustered regularly interspaced short palindromic repeats. From the acronym alone, it is not clear what CRISPR does or means. Only through extensive communication between scientists and the public can a bridge be made that allows for exchange of knowledge about both the technical details and sincere concerns. The absence of many scientists on social media does not help this and actually widens the knowledge gap.

Nevertheless, various scientists have raised their voices about the potential power of gene drive as well as their professional concerns. Sure, gene drive can be used to do many things such as immunize animals that carry human diseases, control insect-borne diseases, spread pest-specific pesticides and herbicides, reduce populations of rodents and other pests, control invasive species, and aid threatened species. Yet, the power of gene drive also brings with it the fear for the unknown. What happens if a gene “goes wild” and crosses the species barriers through horizontal gene transfer? Will we be able to detect this quick enough to control it? What damage will it do if we can’t control it? Will there be any damage? For instance, cross-pollination between GMO crops and natural variants has been observed, albeit their incidences are relatively low and its broader ecological effect mostly unknown. To help curb these concerns, some solutions have been brought forward to help contain gene drive such as by designing it like Lego pieces, where only a complete set would be functional.

These concerns were considered so great that the U.S. National Academy of Sciences felt the need to create a workshop focused specifically on gene drive, in addition to the earlier international summit about the ethics of human genome editing. In short, the meeting showed that while gene drive has potential promises, both scientific and regulatory uncertainties remain, as well as fear about its potential irreversibility if it were to go wild. In other words, more research is needed covering all aspects of gene drive, including educating the public across the globe about the pros and cons.

Just as atomic energy produces both electricity and atomic bombs, thereby bridging the worlds of physics and societal needs, bacterial immune systems and evolutionary forces bridge basic biological research with applied biotechnologies. Society as a whole is moving more and more towards a society where genetics is a driving force for change – in medicine, global health, agriculture, pest-control, the judicial system and in combating terrorism. Understanding the basic principles of biology, genetics, and evolution are a must for policy makers of today and even more so of tomorrow. How else will they be able to support or debate a bill that is guided by or deals with genetic information and manipulation? After all, selective breeding and building a highly interconnected world have resulted in new species (of pets, livestock, and crops) and forced other species to adapt to changes in the environment we made (such as geographical barriers like roads and deforestation, and climate change). Therefore, careful ethical consideration of the wise use of powerful genetic tools and forces is critical, both for use in human, as well as any potential ecological implications. Gene drive as a tool has great potential, since after all, most of the DNA on earth came from the driving forces of selfish genetic elements. Evolution has provided us with many powerful tools and with great power comes great responsibility.

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December 9, 2015 at 9:00 am

Science Policy Around the Web – December 8, 2015

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By: Ian McWilliams, Ph.D.

Drug Policy and Public Heath

Applying Public Health Principles to the HIV Epidemic — How Are We Doing?

December 1st marked World AIDS Day and a time to raise awareness about the fight against HIV and AIDS. With approximately 1.2 million people in the United States alone affected by the disease, much focus is given to the prevention and control of HIV. Significant progress has been made over the last two decades towards controlling the epidemic. More sensitive diagnostic tests that can detect the virus earlier and better treatments has improved the health of HIV patients and allowed them to live longer. Although US public health departments, community organizations, and other groups have made concerted efforts to provide access to treatment and eliminate transmission of this disease (as evidenced by a 36.5% decrease in deaths related to AIDS), many hurdles still remain. There are currently 45,000 new HIV infections every year and 65 percent of all Americans diagnosed with HIV are not currently on treatment.

To further combat the HIV epidemic, Thomas R. Frieden, director of the Centers for Disease Control and Prevention (CDC),  and other public health leaders recommend applying public health principles of communicable diseases such as prompt diagnosis, systematic partner notification, and accountability for treatment for all patients. In the same issue of the New England Journal of Medicine, renowned HIV/AIDS expert Anthony Fauci emphasized the importance of antiretroviral therapy (ART) in the treatment and prevention of transmission of HIV. By calling for patient empowerment, community engagement, clinical excellence, and focus on outcomes these leaders hope to unite groups with a common cause against HIV and AIDS. (Thomas R. Frieden, Kathryn E. Foti, and Jonathan Mermin, New England Journal of Medicine)

Bioethics in Research

Scientists Debate How Far To Go In Editing Human Gene

The CRISPR-Cas9 gene editing system has garnered attention for the unprecedented ease by which DNA manipulation can occur. This powerful technique has possibly opened the door to treating hereditary diseases such as Huntington’s disease, cystic fibrosis, and Tay-Sachs disease. Although this could be a potent treatment modality, germline editing of sperm, eggs, and embryos raises many ethical and safety concerns. Further compounding these concerns are reports that CRISPR can have off-target effects that could result in unintended deleterious consequences. Geneticist George Church weighed in on this matter to suggest these effects are manageable and not as dangerous as we think. Adding to the complexity of this issue are fears that the ease by which this technology can alter DNA will allow for “designer babies” and “eugenics,” where individuals will try to manipulate germline DNA to create super humans.

In an effort to address these dilemmas, the International Summit on Human Gene Editing recently convened “to discuss the scientific, ethical, and governance issues associated with human gene-editing research.” The consensus of the committee, chaired by David Baltimore, call for more “intensive basic and preclinical research” and “the creation of a ongoing forum to continue to assess the state of the research and society’s readiness.” Of note, the committee cautioned “there is a need to understand the risks” and “it would be irresponsible to proceed” in reference to somatic and germline gene editing respectively. This certainly wasn’t a ringing endorsement for human gene editing, but does allow the scientific community to further develop these gene-editing tools while actively engaging with the communities to assuage fears and define care. (Rob Stein, NPR)

Health IT and EHRs

“Unsexy Plumbing,” Integrated Data And The Future Of The Healthcare System

Electronic health records (EHR) will be an important component of a modernized health care system. Improved connectivity within health organizations will provide better access to more useful data and can support larger public health programs, such as the Precision Medicine Initiative. However, the implementation of these systems has faced many hurdles such as outdated technology that is time-consuming and incompatible with newer systems and privacy-related regulations. Many initiatives have been made to share health data in order to reduce costs, increase efficiency, and improve quality of care, but currently, less than half of doctors surveyed think that EHRs have improved patient outcomes.

To address these shortfalls, efforts from government and the private sector are attempting to ease integration of EHRs. Because the Affordable Care Act limits the amount insurance companies can spend on administrative costs, and EHRs would reduce administrative burden, many insurance providers are introducing payment incentives to healthcare providers that use EHRs. Additionally, the private sector could further drive the transition to EHRs with cloud-based solutions and improved wearable devices for data gathering. These changes will lead to better payment solutions, data analytic tools, and even better insurance plan selection. (Jason T. Andrew, techcrunch.com)

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Written by sciencepolicyforall

December 8, 2015 at 9:00 am