Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘bioethics

How Science Policy Affects Pandemic Pathogen Research

leave a comment »

By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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

Written by sciencepolicyforall

April 21, 2017 at 8:47 am

Science Policy Around the Web – September 30, 2016

leave a comment »

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)

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

Written by sciencepolicyforall

September 30, 2016 at 9:00 am

Broadening the Debate: Societal Discussions on Human Genetic Editing

leave a comment »

By: Courtney Pinard, Ph.D.

Licensed via Creative Commons

In one of the most impressive feats of synthetic biology so far, researchers have harnessed the ability of bacteria to fight and destroy viruses, and have been able to precisely and cheaply edit genetic code using a genetic technology called clustered, regularly-interspaced short palindromic repeats (CRISPR) and CRISPR-associated endonuclease protein 9 (Cas9). CRISPR has been used to find and detect mutations related to some of the world’s most deadly diseases, such as HIV and malaria. Although CRISPR holds great promise for treating disease, it raises numerous bioethical concerns, which were sparked by the first report of deliberate editing of the DNA of human embryos by Chinese researchers. Previous blog posts have described scientific discussion surrounding the promise of CRISPR. At least three scientific research papers per day are published using this technique, and biotech companies have already begun to invest in CRISPR to modify disease-related genes. However, the use of CRISPR, or any genetic editing technology, to permanently alter the genome of human embryos is an issue of concern to a much broader range of stakeholders, including clinicians, policymakers, international governments, advocacy groups, and the public at large. As CRISPR moves us forward into the realm of the newly possible, the larger global, social and policy implications deserve thorough consideration and discussion. Policies on human genetic editing should encourage extensive international cooperation, and require clear communication between scientists and the rest of society.

There is no question that CRISPR has the potential to help cure disease, both indirectly and directly. CRISPR won the Science Breakthrough of the Year for 2015, in part, for the creation of a “gene drive” designed to reprogram mosquito genomes to eliminate malaria. Using CRISPR-Cas9 technology, investigators at the Universities of California (UC) have engineered transgenic Anopheles stephensi mosquitoes to carry an anti-malaria parasite effector gene. This genetic tool could help wipe out the malaria pathogen within a targeted mosquito population, by spreading the dominant malaria-resistant gene in 99.5% of progeny. The gene snipping precision of CRISPR can also treat certain genetic diseases directly, such as certain cancers, and sickle cell disease. CRISPR can even be used to cut HIV out of the human genome, and prevent subsequent HIV infection.

There are limitations of CRISPR, which include the possibility of off-target genetic alterations, and unintended consequences of on-target alterations. For example, the embryos used in the Chinese study described above, were non-viable, less than 50% were edited, and some embryos started to divide before the edits were complete. Within a single embryo, some cells were edited, while other cells were not. In addition, researchers found lack of specificity; the target gene was inserted into DNA at the wrong locus. Little is known about the physiology of cells and tissues that have undergone genome editing, and there is evidence that complete loss of a gene could lead to compensatory adaptation in cells over time.

Another issue of concern is that CRISPR could lead scientists down the road to eugenics. On May 14th 2015, Stanford’s Center for Law and the Biosciences and Stanford’s Phi Beta Kappa Chapter co-hosted a panel discussion on editing the human germline genome, entitled Human Germline Modification: Medicine, Science, Ethics, and Law. Panelist Marcy Darnovsky, from the Center for Genetics and Society, called human germline modification a society-altering technology because of “the potential for a genetics arms race within and between countries, and a future world in which affluent parents purchase the latest upgrades for their offspring.” Because of its potential for dual use, genetic editing was recently declared a weapon of mass destruction.

In response to ethical concerns, the co-inventor of CRISPR, Dr. Jennifer Doudna, called for a self-imposed temporary moratorium on the use of CRISPR on germline cells. Eighteen scientists, including two Nobel Prize winners, agreed on the moratorium. Policy recommendations were published in the journal Science. In addition to a moratorium, recommendations include continuing research on the strengths and weaknesses of CRISPR, educating young researchers about these, and holding international meetings with all interested stakeholders to discuss progress and reach agreements on dual use. Not all scientists support such recommendations. Physician and science policy expert Henry Miller disagrees on a moratorium, and argues that it is unfair to restrict the development of CRISPR in germline gene therapy because we would be denying families cures to monstrous genetic diseases.

So far, the ethical debate has been mostly among scientists and academics. In her article published last December in The Hill Congress Blog, Darnovsky asks: “Where are the thought leaders who focus, for example, on environmental protection, disability rights, reproductive rights and justice, racial justice, labor, or children’s welfare?” More of these voices will be heard as social and policy implications catch up with the science.

In early February, the National Academy of Sciences and National Academy of Medicine held an information-gathering meeting to determine how American public attitudes and decision making intersect with the potential for developing therapeutics using human genetic editing technologies. The Committee’s report on recommendations and public opinion is expected later this year. One future recommendation may be to require Food and Drug Administration (FDA) regulation of genetic editing technology as a part of medical device regulation. Up until recently, the FDA has been slow to approve gene therapy products. Given the fast pace of CRISPR technology development, guidelines on dual use, as determined by recommendations from the National Academies, should be published before the end of the year. So far, U.S. guidelines call for strong discouragement of any attempts at genome modification of reproductive cells for clinical application in humans, until the social, environmental, and ethical implications are broadly discussed among scientific and governmental organizations.

International guidelines on the alteration of human embryos are absolutely necessary to help regulate genetic editing worldwide. According to a News Feature in Nature, many countries, including Japan, India, and China, have no enforceable rules on germline modification. Four laboratories in China, for example, continue to use CRISPR in non-viable human embryonic modification. Societal concerns about designer babies are not new. In the early 2000s, a Council of Europe Treaty on Human Rights and Biomedicine declared human genetic modification off-limits. However, the U.K. now allows the testing of CRISPR on human embryos.

In a global sense, employing tacit science diplomacy to developments in synthetic biology may mitigate unethical use of CRISPR. Tacit science diplomacy is diplomacy that uses honesty, fairness, objectivity, reliability, skepticism, accountability, and openness as common norms of behavior to accomplish scientific goals that benefit all of humanity. The National Science Advisory Board for Biosecurity (NSABB) is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government. Although NSABB only acts in the U.S., the committee has the capacity to use tacit science diplomacy by providing guidance on CRISPR dual use concerns to both American citizen and foreign national scientists working in the U.S.

Under tacit science diplomacy, scientific studies misusing CRISPR would be condemned in the literature, in government agencies, and in diplomatic venues. Tacit science diplomacy was used when the Indonesian government refused to give the World Health Organization (WHO) samples of the bird flu virus, which temporarily prevented vaccine development. After five years of international negotiations on this issue, a preparedness framework was established that encouraged member states to share vaccines and technologies. A similar preparedness framework could be developed for genetic editing technology.

Institutional oversight and bioethical training for the responsible use of genetic editing technology are necessary, but not sufficient on their own. Tacit science diplomacy can help scientists working in the U.S. and abroad develop shared norms. Promoting international health advocacy and science policy discussions on this topic among scientists, government agencies, industry, advocacy groups, and the public will be instrumental in preventing unintended consequences and dual use of genetic editing technology. 

Written by sciencepolicyforall

March 9, 2016 at 9:01 am

Science Policy Around the Web – January 8, 2016

leave a comment »

By: Sophia Jeon, Ph.D.

This could be your blood! Photo source: photopin.com

Bioethics and Health Policy

Your Cells. Their Research. Your Permission?

Since 2011, the U.S. Department of Health and Human Services has been involved in a major effort to revise the Federal Policy for Protection of Human Subjects, or more commonly known as the “Common Rule,” that governs any research involving human subjects. Rebecca Skloot, the author of “The Immortal Life of Henrietta Lacks” recently wrote an opinion piece in the New York Times, encouraging the public to weigh in on what researchers can or cannot do with their biospecimens. This timely article was published just a week before the public comment period for the Common Rule closed this past Wednesday on Jan 6th.

The current Rule has a loophole where biospecimens could be used without consent as long as they are unidentifiable and cannot be traced back to the individual. This is why one of the major proposed changes to the new Rule that is receiving much attention is the concept of “broad consent.” Because the new rule will require consent whether or not the biospecimens are identifiable, broad consent allows researchers to store and use unidentifiable biospecimens indefinitely (except for the case of new sample collection, which is allowed only up to 10 years following consent) once participants give consent to any “broad” range of future, unspecified research. This is similar to a recent change E.U. has made in their legislation regarding personal health data.

There are concerns that not many non-scientist citizens know about this change while it is mainly the scientist community who have been giving public input for the new rule. Respecting autonomy and letting participants have control over their own tissues and cells is important but others also voice the concern that the new rule may increase the administrative burden on researchers and clinicians. (Rebecca Skloot, New York Times)

Research Workforce and Career Development

Fellowships are the future

Do you see any overworked, under-appreciated, and dissatisfied post-docs in your lab? If the answer is yes, there are many reasons for this: poor job prospects (here is how you may get around that issue); research culture that does not leave room for proper work-life balance; a lack of freedom in career development; and a feeling that you are stuck in a limbo phase where you are neither a trainee or an employee.

Currently, the majority of post-docs are treated as trainees under supervision of their PIs. Only about 16% of US post-docs are paid through a training grant or fellowship while most post-docs are supported by their PI’s grants. This means that post-docs have very little independence both scientifically as well as financially, which leaves almost no time for their own career development activities. In order to succeed as an independent scientist, or to prepare for next steps in their career, post-docs should be able to develop and pursue their own scientific interests, or explore different career options and gain relevant experience.

In last month’s issue of Nature, Viviane Callier and Jessica Polka suggest that government-funded post-doctoral fellowship awards may be the stone that kills two birds. With more post-docs who are independently funded, they argue that this mechanism would not only train post-docs to be better scientists, but also solve the problem of creating too many post-docs in the first place, as they would have to successfully compete for a limited number of fellowships. (Viviane Callier & Jessica Polka, Nature)

Technology and Regulatory Science

Brain game-maker fined $2 million for Lumosity false advertising

Lumos Labs, the company that sells a subscription-based game called Lumosity, has been fined $2 million by Federal Trade Commission (FTC) for falsely claiming that Lumosity can not only help perform better at work but also reduce cognitive impairment associated with diseases such as Alzheimer’s disease and post-traumatic stress. The money will be used to compensate consumers who purchased the game under the false impression that it would make them smarter.

There recently has been an explosive growth in number of medical mobile apps and devices that claim to enhance brain function. Unfortunately, many of these claims are unfounded or without strong scientific evidence. Since 2014, some healthcare mobile apps are considered as medical devices by the Food and Drug Administration (FDA)’s definition and therefore, FDA has authority to exercise enforcement over these apps if they are marketed, promoted or intended for use in the diagnosis, prevention or treatment of disease. Unlike FDA that mainly regulates “labeling,” FTC regulates both labeling and advertising that includes endorsements on blogs and social media. (Emily Underwood, ScienceInsider)

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

Written by sciencepolicyforall

January 8, 2016 at 9:00 am

Science Policy Around the Web – December 29, 2015

leave a comment »

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)

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

Written by sciencepolicyforall

December 29, 2015 at 9:00 am

Posted in Linkposts

Tagged with ,

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

with 2 comments

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

Science Policy Around the Web – December 1, 2015

leave a comment »

By: David Pagliaccio, Ph.D.

Photo source: pixabay.com. CC0 Public Domain.

Mobile Technology and Mental Health

These start-ups use social media for mental health

The last several years have seen an influx of new smartphone apps aiming to improve mental health. These may entail anything from mood logging/tracking to guided meditations to phone-based cognitive therapy. It has been suggested that a move towards mobile technologies may make mental health interventions more accessible, relatable, and de-stigmatized. Yet, research on social media has been somewhat conflicted, with some studies suggesting that increased connectedness through social media use reduces stress or increases self esteem, with other work suggesting that extended social media use may lead to lower self esteem as individuals compare themselves to others.

Recently, other concerns and policy issues have been raised as well. In particular, these apps do not face the same regulatory standards as other mental health treatments nor do they require development through peer-reviewed scientific studies. Instead, they may be shaped through in-house testing, which endures much less rigorous review and may be subject to serious conflicts of interest. Currently, the Food and Drug Administration (FDA) does not regulation these types of apps. As per recent guidelines, the “FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public.” While these types of apps may fall under definitions of medical devices, the FDA guidelines explicitly list apps aiming to help patients with psychiatric conditions among those which it will not be regulating at this time. Official regulations will likely need to adapt to the increasing availability of mental health apps, particularly as these mobile health technologies gain increasing prominence in private and governmental initiatives. Notably, Dr. Tom Insel, the director of the National Institute of Mental Health, recently stepped down to pursue work with Google aiming to integrate mental health into the development goals of their Life Sciences division. Mobile health technologies are also a major proposed component of the $215 million Precision Medicine Initiative unveiled this year by President Obama. Similarly, the UK’s Minister for Life Sciences created a £650,000 fund to support the development of mental health apps. Policies and official regulations will need to catch up to this explosion of mental health apps to ensure that they are appropriately researched and implemented. (Anita Balakrishnan, CNBC.com)

Medical Device Regulation

The Weird World of Brain Hacking

Non-invasive brain stimulation has been increasingly utilized in scientific studies to study brain function and cognition as well as being tested in novel therapies for a variety of conditions. Transcranial direct current stimulation (tDCS) has been of particular note as it is relatively inexpensive and easy to implement – involving small electrodes placed on the either side of the head running low current through the brain. Scientists have been exploring types of tDCS to alter neuronal activity in certain brain regions with an effort to aid in the treatment of migraines, chronic pain, epilepsy, treatment-resistant depression, and other conditions. While the Food and Drug Administration (FDA) has allowed commercial manufacturers to sell tDCS devices to American scientists for research purposes, these novel treatments are still under development and none are yet approved by the FDA for use as medical treatments.

Nonetheless, there has been a growing online community springing up around at-home, do-it-yourself uses of tDCS for cognitive advancement and self-treatment. Tutorials and discussion among lay users of tDCS have been expanding on YouTube and Reddit in particular, advising on the creation of tDCS devices from 9-volt batteries and easily accessible wiring and electrodes. This has spurred concern from scientists and regulators as this bioethical gray area grows, particularly given that the long-term uses of tDCS have not been studied. The Harvard Medical School’s Center for Bioethics recently ran a workshop discussing this trend of at-home neurostimulation, which was summarized in a report from the Institute of Medicine. Additionally, the FDA ran a workshop this month to bridge scientists, regulators, and the public in discussing ethical and regulatory concerns over the use of neurostimulation. Neurostimulation, including tDCS, will likely involve a rapidly evolving discussion over bioethics and policy among lay, scientific, and governmental stakeholders as this technology becomes increasingly accessible and as the lines between scientific research and lay uses continue to blur.  (Amy Dockser Marcus, The Wall Street Journal)

STEM Education

The Congressional STEAM Caucus May Turn STEM to STEAM in the Reauthorization of ESEA – An Amendment to Add Art and Design to STEM Education

Congresswoman Suzanne Bonamici originally created the Congressional Caucus on STEAM in 2013 to advocate for adding a focus on art and design into STEM (science, technology, engineering, and mathematics) education. The original goal of the Caucus was to “host briefings and advocate for policy changes that will encourage educators to integrate arts, broadly defined, with traditional Science, Technology, Engineering and Math curriculum. The goal is to encourage the creativity needed to drive our innovation economy forward.” The Caucus was able to finally bring about these policy changes through a recent amendment to rework the Elementary and Secondary Education Act (ESEA) legislation. This amendment calls for integration of more art and design into STEM education. The amendment will go before the House and Senate for final passage early in December and is expected to likely pass in both.

While backers of the amendment hope that this STEAM approach will increase engagement and attainment in STEM and will promote more well-rounded education, concerns have been raised about this initiative. For example, it is currently unclear how art and design will be integrated into STEM curricula in a way that does justice to both sets of fields and whether we already have adequate methods for this type of more holistic education. Additionally, detractors argue that STEM education does not explicitly exclude the teaching of art and design as they are often implicit in STEM fields and projects. Instead, there are concerns that adding additional focus to art and design in STEM curricula may divert their mission or ‘water down’ their focus. Moreover, proponents of the arts have raised concerns that the focus on what art can add to science and engineering fields continues to devalue the importance of art and design and the roles that STEM can play in the advancement of art. Regardless, these policy changes will likely change the face of STEM and possibly STEAM education and funding in the future. (John M. Eger, Huffington Post Education)

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

Written by sciencepolicyforall

December 1, 2015 at 9:00 am

Posted in Linkposts

Tagged with , ,