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Posts Tagged ‘genetic engineering

Science Policy Around the Web – February 24, 2017

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By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

An article published in Science discusses a lawsuit filed on February 13 against the U.S. Department of Agriculture (USDA) by an animal law expert at Harvard University. According to the plaintiffs, USDA violated the federal Freedom of Information Act (FOIA) when it removed thousands of animal welfare inspection reports and other records from a publicly accessible website. USDA generated records that document animal facility inspections, enforcement actions, animal censuses, and other information collected by the agency in the course of enforcing the federal Animal Welfare Act.  The law covers animals in more than 7800 facilities, including zoos, roadside circuses, and research laboratories at government agencies and academic medical centers.

The decision to remove the public access to these records may have been a response to a lawsuit involving another law, the Horse Protection Act. The plaintiffs in a 2016 Texas lawsuit accused USDA of violating their rights under the Privacy Act by posting inspection documents required by the Horse Protection Act. A resulting USDA review of all its public postings led the agency to scrub from its website documents generated under both the Horse Protection Act and the Animal Welfare Act.  In the future, the agency announced, people who want access to those records will need to file a FOIA request. The agency’s most recent FOIA report states that it takes an average of 94 days for the agency to respond to a simple FOIA request and 234 days on average for more complicated requests.

In February 13’s lawsuit, the plaintiffs invoke a section of FOIA that requires agencies to make publicly available electronically all records that it has released under FOIA which “because of the nature of the subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” (Meredith Wadman, ScienceInsider)

Science and Immigration

Grad Students, Postdocs with U.S. Visas Face Uncertainty

While U.S. courts are busy handling President Donald Trump’s travel ban on immigration from seven majority-Muslim countries, the temporary shut down of the executive order, the appeal to reinstate the travel ban, the rejection of the immediate restoration of the ban, and more appeals and rulings, graduates and postdoctoral students already in the United States are weighing their options and trying to plan rationally in an unpredictable and fluid situation.

Many scientists in the U.S. are on student or other working visas. All these visas may not be renewable, depending on future executive orders and regulations. The dilemma “simply ruins their future. It’s a catastrophe,” says a Yemeni biologist who is on a university faculty on an H-1B, a 3-year visa for professionals. For years, lawmakers in Washington have tried to reform abuses of visa regulations by companies using visas to bring workers to the U.S. to learn the ropes, and then send the trained workers to other countries where the job can be done cheaply. The H-1B system is contentious: on one side labor advocates want the exploitation of the H-1B system to stop supporting an outsourcing business model. On the other hand, tech companies like Google and Facebook say they can’t get enough visas for top foreign talent, as the cap on the number of H-1Bs issued every year means that sometimes foreign graduates from top U.S. universities, places like the Massachusetts Institute of Technology and the University of California, Berkeley, can’t get one. The travel ban already has harmed the top universities in the U.S., stranding students, faculty and scholars abroad, and making foreign schools more attractive to some of the world’s brightest students.

In papers filed in Brooklyn federal court, the schools (that include Columbia, Duke, Harvard, Johns Hopkins, Princeton, Stanford, Yale, Massachusetts Institute of Technology and several more) said that the order blocking travel from seven predominantly Muslim countries threatens their abilities to educate future leaders from every continent. They said the executive order has “serious and chilling implications” and that the ban “casts doubt on the prospect and value of studying and working here for everyone,” the papers said. (Meredith Wadman, Richard Stone, Science)

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

“Scientists should be permitted to modify human embryos destined for implantation in the womb to eliminate devastating genetic diseases such as sickle-cell anaemia or cystic fibrosis — once gene-editing techniques advance sufficiently for use in people and proper restrictions are in place. That’s the conclusion of a 14 February report from the US National Academies of Science, Engineering, and Medicine.”

The report follows a 2015 National Academies summit between scientists, ethicists, legal experts and patient groups from around the world. At the time of the meeting, given the outstanding scientific, ethical and legal questions surrounding the issue, the organizers concluded that scientists shouldn’t yet perform germline editing on embryos intended for establishing a pregnancy. However, the organizers also stated that altering human embryos for basic research was acceptable.

The latest iteration of this ongoing CRISPR debate moves the bar a little further. The report recommends restricting the technique to severe medical conditions for which no other treatment exists. Eric Lander, president of the Broad Institute of MIT and Harvard, said, “It’s a very careful, conservative position that’s just a little bit beyond an absolute bar.” In the report, the committee also called for international cooperation, strict regulatory and oversight framework, public input into decisions and long-term follow-ups of children who have edited genomes. The report adds that for now, genome editing should not be used for human enhancement, such as improving a person’s intelligence or giving them super-strength.

The report drew immediate criticism from a California-based non-profit organization called the Center for Genetics and Society. “This report is a dramatic departure from the widespread global agreement that human germline modification should remain off limits,” said Marcy Darnovsky, executive director of the center. “It acknowledges many of the widely recognized risks, including stigmatizing people with disabilities, exacerbating existing inequalities, and introducing new eugenic abuses. Strangely, there’s no apparent connection between those dire risks and the recommendation to move ahead.” (Sara Reardon, Nature)

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February 24, 2017 at 11:23 am

Science Policy Around the Web – December 20, 2016

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By: Liz Spehalski, PhD

Source: Flickr, under Creative Commons

In-Vitro Fertilization

UK Approves Mitochondrial Replacement Therapy Trials For Assisted Reproduction

The UK Human Fertilization and Embryology Authority (HFEA) has given the green light to allow mitochondrial replacement therapy, a type of assisted reproduction that can help families to avoid passing on genetic diseases. The method is controversial because the embryos contain genetic material from three people: two eggs and one sperm. The decision has been widely anticipated and comes after years of debate and a change in the country’s laws in 2015.

Mitochondria are responsible for generating more than 90% of the energy required by the body to sustain life and support organ function. When mitochondria fail, cells generate less and less energy, resulting in cell injury and cell death. The parts of the body that require the most energy; the heart, brain, muscles, and lungs, are the most affected by mitochondrial disease. Mitochondrial disease is difficult to diagnose due to its wide range of symptoms, which can include seizures, strokes, developmental delays, blindness, and heart problems.

Mitochondrial replacement therapy involves exchanging damaged mitochondria for heathy ones by transferring only the nuclear DNA from one egg or fertilized embryo from the mother into a donor egg, whose mitochondrial DNA is intact but nuclear DNA is removed. The technique has already been performed in Mexico and the Ukraine, and John Zhang, a physician at New Hope Fertility Center in New York City, has said that a baby boy conceived by the technique in Mexico seems healthy to this point. Recent work with eggs from affected women, however, found that some of the defective mitochondria from the mother’s egg was transferred to the embryo along with the DNA, raising questions about the effectiveness of the treatment. Currently, congressional action has blocked the FDA from allowing mitochondrial replacement procedures to be attempted in the United States.

On December 15, the HFEA announced that it would allow clinics to apply for licenses to conduct limited trials of the technique, with the goal of preventing mothers from passing down mutations in mitochondria. “Today’s historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,” said HFEA chair Sally Cheshire. An HFEA spokesperson projected that the UK’s first child with three people’s DNA could be conceived as early as March 2017. (Ewen Callaway, Nature News)

Biotechnology

Commerce Secretary Announces New Biopharmaceutical Manufacturing Institute

Penny Pritzker, US Secretary of Commerce, announced on Friday a new institute to be added to the Manufacturing USA Institute; the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The institute is the eleventh of Manufacturing USA Institute, the first funded by the Department of Commerce (DOC), and the first awarded under the Manufacturing USA “open topic” competition, in which industry was encouraged to propose institutes allocated to any manufacturing area that is not already being tackled.

While pharmaceutical manufacturing relies on chemistry, biopharmaceuticals are a drug product manufactured in or isolated from biological sources. They include vaccines, blood and blood components, stem cell and gene therapies, recombinant proteins, among other biologics. Many of these products are widely used for the treatment of an array of diseases such as cancer, autoimmune disorders and infectious diseases, generating billions of dollars worldwide.

The goals of this institute will be to keep biopharmaceutical manufacturing in the USA and to scale up the production of complex biological drugs. “In communities from coast to coast, the Manufacturing USA network is breaking down silos between the U.S. private sector and academia to take industry-relevant technologies from lab to market,” said Secretary Pritzker. “The institute announced today is a resource that will spread the risks and share the benefits across the biopharmaceutical industry of developing and gaining approval for innovative processes. The innovations created here will make it easier for industry to scale up production and provide the most ground-breaking new therapies to more patients sooner.”

NIIMBL received $70 million from the US Department of Commerce, and will be getting another $129 million from a public-private consortium of 150 companies, academic institutions, and nonprofits, as well as 25 states. The University of Delaware will be coordinating the institute’s partnership with the DOC. The hope is that NIIMBL will help to advance U.S. leadership in the biopharmaceutical industry, foster economic development, improve medical treatments, and ensure a qualified workforce by collaborating with educational institutions to develop new training programs matched to specific biopharma skill needs. (Press Release, Department of Commerce)

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December 20, 2016 at 9:07 am

Science Policy Around the Web – September 30, 2016

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By: Jessica Hostetler, PhD

Source: Flickr, under Creative Commons

Human Genetic Manipulation

World’s first baby born with new “3 parent” technique

On September 27, 2016, the New Scientist reported the birth of a baby born with DNA from three people. The now five-month old healthy baby boy was born in New York to a Jordanian couple who had struggled for years to have a healthy child. The baby’s mother had genes for the lethal Leigh syndrome, a neurological disorder typically resulting in death in 1-3 years after birth, from which her first two children had died. These genes were carried in about 25% of her mitochondria, the energy producers for cells, which contain 37 genes separated from the thousands of other genes held inside the cell’s nucleus. Mitochondrial genes are only passed down from mothers through the mitochondria present in the mother’s egg before being fertilized by a father’s sperm.

The couple worked with US-based fertility expert John Zhang from the New Hope Fertility Center in New York City to undergo an approach for mitochondrial replacement therapy (MRT) called spindle nuclear transfer. Dr. Zhang transferred the nucleus of one of the mother’s eggs into a donor egg, which had the nucleus removed but contained healthy mitochondria. Several of these eggs were then fertilized with the father’s sperm to make 5 embryos with nuclear genes from both the father and the mother and mitochondria from the donor. The only healthy embryo was then implanted into the mother, and resulted in the birth of a healthy baby boy, with 99% healthy mitochondria.

This type of egg manipulation is now legal in the UK, though effectively banned in the US, so the team completed the fertility work in Mexico, which lacks clear regulations for the procedure. While several people such as Sian Harding who reviewed ethics for the UK guidelines, and legal scholar Rosario Isasi (from a Nature article), have acknowledged that Zhang’s group appears to have followed ethical guidelines, questions remain about the ethics, quality and safety of the technique.

The report was covered in a number of additional articles and commentaries, including in the New York Times, Science, and Nature. The commentaries note that researchers are eager for more information on a host of fronts such as the choice of using Mexico as the site of the work (as opposed to a more regulated and rigorous scientific environment) and the threshold of contaminating maternal mitochondria used in transfers (5%). These and other specifics are likely to come up when Dr. Zhang and team report on the case at the American Society for Reproductive Medicine meeting in October, 2016. (Jessica Hamzelou, New Scientist)

Health Policy

Why do obese patients get worse care? Many doctors don’t see past the fat

One in three Americans is obese; despite this fact, doctors and the healthcare system remain ill equipped in “attitudes, equipment and common practices” to treat obese patients. Beyond equipment issues, such as 90% of ERs and 80% of hospitals lacking M.R.I. machines built to accommodate very obese patients, research into bias against obese patients (both conscious and unconscious) shows that healthcare providers spend less time with such patients and refer them for fewer diagnostic tests. The same review reports that doctors feel less respect for obese patients and are more likely to stereotype them as “lazy, undisciplined and weak-willed,” all of which can negatively impact communication in the doctor-patient relationship, which in turn affects quality of care. In an effort to address the problem, the American Board of Obesity Medicine was founded to educate physicians about patient care and provide certification for achieving “competency in obesity care.”

Currently, these attitudes can lead health care providers to misdiagnose symptoms as being obesity-related instead of fully investigating other, potentially life threatening causes. Drug dosing may often be incorrect for obese people, particularly for cancer drug regimens for which obese individuals have worse outcomes across the board. Many orthopedists refuse joint hip and knee replacement surgery for obese patients unless they lose weight, though a review committee from the American Association of Hip and Knee Surgeons recommends a measured approach including options for surgery in some patients after the risks are discussed. The problems obese patients face may be exacerbated by the risk-averse hospital culture where adverse event scores affect Medicare reimbursements; thus pushing hospitals to avoid helping higher-risk patients. Beyond this there is a distinct lack of guidance from drug makers for correct dosing of anethesia drugs, with only a few examples, for instance a report from Dr. Hendrikus Lemmens out of Stanford University. Dr. Lemmens notes that 20-30% of obese-patient stays in intensive care after surgery are due to anesthetic complications and are likely frequently caused by drug dosing errors. Providing quality healthcare will likely only increase as the numbers of obese patients continue to increase in the US. (Gina Kolata, New York Times)

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September 30, 2016 at 9:00 am

Science Policy Around the Web – August 5, 2016

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By: Fabrício Kury, MD

Genetic engineering

‘Gene drive’ organisms should be tested in field trials, not widely released, experts say

While the Zika virus shows spread into the US, with mosquito-borne transmission having been reported in Miami, the scientific community is eager to kick-start the use of the new biotechnology called Gene Drive. This technique allows for the creation of genes that cheat the trial of chance and get passed on to nearly 100% of the offspring. This way, it is possible to alter the genome of entire populations of species, for example, by making populations of Aedes mosquitoes unable to transmit the Zika or Malaria viruses — if not plainly kill all the Aedes.

The danger of Gene Drive is our lack of knowledge about the impact of drastic alterations in the behavior or biology of one species, and also the consequences from the quick removal of a pervasive species from an ecosystem. The slow progress of Zika into the U.S. through warmer and wetter edges such as Florida and Puerto Rico seems like a window of opportunity for attacking the spread of the disease while it is still relatively isolated. However, the National Academies of Sciences, Engineering and Medicine call for tightly controlled experiments before wide use of the gene drive. As MIT Media Lab professor Kevin Esvelt put it, “there is a nontrivial chance that [the genes] will spread from a single organism released into a wild population into most or all members of the local population — and very possibly into every population of the target species around the globe.” (Ike Swetlitz, STAT news)

Technology and Healthcare

Why lawmakers are trying to make ransomware a crime in California

Ransomware is a type of malware (a “virus”) that can make money for a hacker very quickly. The ransomware program encrypts files in the target computer, then demands a ransom, usually to be paid in cryptocurrency (the most popular is Bitcoin) which can be hard to track, to release the key that decrypts the files. Hospitals are perfect targets for ransomware attacks because they are often big institutions, are mostly unprepared to defend themselves against cybercrime, and hold precious data in its computers. Most often, ransomware makes the system of computers functionally “locked inside a black box” or completely unable to be used, creating mounting losses and outright risks that outweigh the price of the ransom.

This includes the medical data that is kept private inside those computers and becomes locked behind the ransomware’s military-grade encryption. Other times, the cyberattack consists of “kidnapping the privacy” of the patients. Here the hacker makes a copy of the data and requests a ransom not to release it to the public. In 2015 alone, 113 million patients had some or all of their health records stolen, and the hospital hacks showed increase of 600%. It has been called “The Year of the Hospital Hack.” Moreover, according to the FBI, ransomware as a broader industry is on the rise. In the first three months of 2016, victims of ransomware lost more than $209 million, compared to $25 million in the entire 2015. (Jazmine Ulloa, Los Angeles Times)

Affordable Care Act Effects

How I Was Wrong About ObamaCare

The strategy implemented by the Patient Protection and Affordable Care Act (PPACA, “ObamaCare”) for the purpose of controlling health care costs is one that strives for paying for healthcare by value provided instead of service provided. The promoted understanding, as summarized by former health policy advisor to the Obama administration Dr. Ezekiel Emanuel, 2011, is that such force will pressure the health care industry to undergo vertical consolidation into Integrated Delivery Systems. These systems, whose likes could be named as Kaiser Permanente, Geisinger Health Care System, and Intermountain Healthcare, are consolidations of all types of providers (physician, imaging, therapy, nursing, surgery, home care, specialty care etc.) and strives to be at least internally coordinated to provide the best value per cost, since its payment is not completely tied to the number of procedures or services performed.

Two PPACA-derived value-based reimbursed programs were launched in 2012 — the smaller and more cautious Pioneer Accountable Care Organizations, reserved for groups of providers with more experience in integrated health care delivery, and the larger and more ambitious Shared Savings Program Accountable Care Organizations. Their data has been released along the past year. The data shows that, along the first performance year of the Medicare Shared Savings Program, 58 ACOs generated $705 million in savings, feat which earned them $315 in bonuses as per the program’s workings, leaving net $260 million in savings to CMS. In April this year, the first study of the official CMS claims data indicated that the better savings were among the ACOs classified as small groups of providers. This is understood as evidence against the “Kaiserification” of healthcare as envisioned by Dr. Emmanuel, since the savings come not from having all providers as employees of a big conglomerate, but instead in giving more autonomy and power to the health care provider at the forefront of the contact with the patient. (Bob Kocher, Wall Street Journal)

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August 5, 2016 at 11:00 am

Science Policy Around the Web – March 25, 2016

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By: Nivedita Sengupta, Ph.D.

Photo source via pixabay

Genetically Engineered Foods

Policy: Reboot the debate on genetic engineering

Genetic engineering (GE) is a highly controversial topic of debate in current days partially because of its increasing impact on day to day living. In recent years, a great deal of advancement has been made in the field of GE as established by the development of sophisticated modern tools like CRISPR. This has led to increasing concern among people regarding GE and food safety laws.

One of the issues with respect to food safety laws was to determine whether the focus of the regulatory policies should be the process by which GE organisms are made or the GE products themselves. Most people in favor of product-based regulation believe that GE organisms are no different compared to the conventionally bred organisms. In United States, since mid-1980s, GE products have been overseen by the Coordinated Framework for Regulation of Biotechnology (CFRB). According to the CFRB, product-based regulation is the science-based approach and hence GE organisms could be covered by existing policies without any need for formulating new laws. Thus they could be simply channeled into particular government agencies depending on whatever category they fell into.

However, in the process of regulating GE products, the agencies realized that the process of engineering is important as well. The agencies recognized that from a scientific standpoint, a product’s traits, harmful or beneficial, depend on the process by which it is made. For example, in human gene-therapy trials, new methods for delivering genes have removed the need for potentially harmful viral vectors. Thus, product and process issues are not distinct in regulation. Though regulating GE products rather than the process is accepted in many countries beyond the United States, other countries like Brazil and Australia have laws which mandates the regulation of the mechanisms by which the GE products are developed.

The inconsistency of views among GE developers and regulators in product-versus-process arguments demands a fresh start on formulating regulatory policies involving GE. It’s time to consider a mix of product and process issues to order to identify product groups which are likely to be of concern and require regulation. These efforts should be focused on keeping in mind the polarization of product-versus-process and science-versus-values framings so that the government can form a system which will be based on information provided by science as well as the concerns and values of citizens. (Jennifer Kuzma, Nature Comment)

Infectious Diseases

Dengue vaccine aces trailblazing trial

Vaccine development is a long and complex process which can take decades to be available for clinical use. Scientists at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, have developed a vaccine which may be the most potent vaccine available to date for preventing dengue infections. These researchers employed a ‘human challenge’ strategy during the development and testing of this vaccine, a method which fell out of favor during the last century. ‘Human challenge’ involves deliberately infecting healthy volunteers with a weakened form of the disease causing virus. Concerns about the safety of deliberately infecting people has limited the use of human challenge studies and usually researchers test developing vaccines on people who are already at risk of contracting the disease of interest.

The dengue virus is a difficult vaccine target because of its four serotypes. Infection with one of the serotype will render a person immune against that type for life but will offer no protection against the others and may also increase the risk of acquiring hemorrhagic fever upon exposure to a different dengue serotype. The current vaccine study tested only dengue serotype 2, the most virulent serotype. 21 volunteers were injected with the experimental vaccine, and 20 volunteers with a sham vaccine. Six months later, all 41 volunteers were injected with a weakened version of the dengue virus which causes symptoms similar to a mild dengue infection, such as rash. The vaccine provided 100% protection against the challenge and only the individuals who received the sham vaccine showed mild symptoms with 80% of them developing a rash.

As all the current dengue vaccines only protect a proportion of volunteers, if these results hold up in larger populations the vaccine could be one of the most promising dengue vaccines developed. “This is a tremendous step forward, and something that has been desperately needed for 30 years,” says Duane Gubler, a disease researcher at the Duke NUS Medical School in Singapore who was not involved in this study. Moreover, he mentioned that the lack of human challenge studies is actually one of the things that made the development of dengue vaccines very difficult. Scott Halstead, a virologist and vaccinologist at the Uniformed Services University of the Health Sciences in Bethesda, Maryland stated that “this is an incredible paper that shows what is absolutely necessary to develop a vaccine against the dengue virus. It’s a really important demonstration of the kind of proof that you really need to have before you spend US$1.5 or 2 billion on a phase III [efficacy] trial.”

Meanwhile investigators have already begun a second human-challenge study to test whether the vaccine protects against dengue serotype 3, and they hope to go on to test it against serotypes 1 and 2 using human challenge strategy. Moreover, they intend to perform studies using the human-challenge strategy to develop vaccine against Zika virus, which is related to dengue. Though scientists are enthusiastic of using human challenge strategy for developing vaccines in recent future, it demands reconsideration of the policies and consideration of the past incidents on which current laws are based. (Erika Check Hayden, Nature News)

Federal Science Funding

Biological specimen troves threatened by funding pause

Collecting biological specimens is an essential part of science and conservation and collections are used to identify species, track diseases and study climate change. One such important biological specimen collection is the collection of fish samples in Burke Museum of Natural History and Culture in Seattle which serves as a repository for the US National Oceanic and Atmospheric Administration (NOAA) for the North Pacific. NOAA uses the specimens collected each year to assess fish abundance and set fishing quotas for species conservation. In another case, a collection of eggs possessed by the Field Museum in Chicago led to the famous conservation discovery that the pesticide DDT caused widespread nesting failures in birds of prey resulting in near extinction of several species.

Despite their value to science, biological specimen collections recently lost a valuable source of funding and support. The US National Science Foundation (NSF) announced that it would indefinitely suspend a program which provides funding to maintain biological specimen collections. The NSF will maintain its current grants but not accept any new proposals. Many researchers and curators have found this disheartening and are worried because the NSF is one of the only public providers of such funding and  only roughly 0.06% of the agency’s $7.5-billion is allocated for maintaining biological specimen collections. According to NSF they are soliciting feedback on the program along with evaluating the currents grants in the collections grant program. Depending on the results of evaluation, decisions will be made and it remains unclear whether the funding hiatus is temporary or permanent.

This pause however has scientists dismayed given the importance of these scientific collections. As mentioned earlier, preserved specimens play an immense role in understanding historic range of species and provide information on species invasion and extinction. Biological collections also help researchers track species carrying human diseases for containment of disease outbreak. Moreover, due to advancements in technology, the specimens can be put to use in a way which has not yet been anticipated. For example, DNA sequencing of museum specimens which were collected before DNA identification was discovered has helped to identify previously unknown species. With the sudden change in funding options many museums are considering digitizing their collections, and indeed, the NSF’s program to support digitizing collections remains unchanged.  But “there’s no point digitizing if we don’t take care of the collections themselves”, says Barbara Thiers, director of the William and Lynda Steere Herbarium at the New York Botanical Garden. “You certainly can’t get any DNA out of an image.” (Anna Nowogrodzki, Nature News)

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March 25, 2016 at 9:00 am

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

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.

Written by sciencepolicyforall

December 9, 2015 at 9:00 am