Science Policy For All

Because science policy affects everyone.

FDA stem cell therapy crackdown: a stem-free clinic

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By: Belinda Hauser, Ph.D.

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source: pixabay

The building blocks of life are stem cells, they don’t kill or cure anything, but they promote regeneration. Stem cells are classically defined as an undifferentiated cell capable of giving rise to more stem cells or differentiating into any cell type. Stem cells have given scientists insight into understanding how cells function and dysfunction in development. Moreover, research in stem cell development has lead to promising treatment possibilities; it is believed that stem cells have the potential to repair or replace damage caused by age, injury or disease. However, stem cell therapies have been controversial, arising from the practice of isolating and culturing stem cell derived from human embryos, and later, introducing pluripotent stem cells from previously differentiated cell types. This controversy is entrenched in both political and ethical debates, broadly affecting the regulation of cord blood harvesting, human cloning and clinical trials.

Today, common stem cell therapy uses include blood transplants or bone marrow transplants. The Food and Drug Administration (FDA) has only approved hematopoietic progenitor cells, derived from umbilical cord blood, for use in the United States. Harvesting of cord blood is considered safe for the mother and baby since the blood is collected after birth. Stem cells collected from the blood of the cut cord are used to treat a variety of diseases including blood cancers such as leukemia, and lymphomas, and blood diseases of the immune system. Given the scarcity of approved options, patients desperately seeking therapy may turn to treatments that are illegal and potentially harmful. The FDA has gone to great lengths to evaluate the potential risk associated with new and current products through both animal and human studies in order to ensure safety in the use of biological products. Thereby, to determine the effectiveness and safety of new investigative products, well-controlled human studies must be designed and executed. This attention is applied to all clinical trials and is well documented. For example, the federal government requires all clinical trials to be cited and it is standard protocol for the National Institutes of Health (NIH) to list all clinical trials being conducted via Clinicaltrials.gov. This promotes awareness and gives consumers an opportunity to be well informed of all trials being conducted.

Preceding the FDA’s goal to develop and license stem cell therapies for patients and prevent consumer exploitation is their concern for consumer safety and education. In March 2017, the FDA provided materials to clarify the benefits and risks of stem cell therapies. They warned that when injected, unproven stem cell treatments present the risk of mobility of implanted cells, i.e. metastasis, risk of excessive proliferation, i.e. tumor growth, contamination, stem cell failure, or reaction of the injection site. Therefore, new investigative products must go through a rigorous protocol to determine their effectiveness and safety in well-controlled human studies.

In August 2017, the FDA cracked down on unscrupulous stem cell clinics, announcing increased enforcement of regulations and oversight of stem cells clinics across the country. For example, the FDA seized five vials of (live) smallpox virus vaccine from the California stem cell treatment centers in Rancho Mirage and Beverly Hills, California.  A Florida clinic, now called U.S. Stem Cell Clinic of Sunrise, Florida, caught the attention of the FDA after stem cell treatments it delivered to women with macular degeneration, an eye disease, caused permanent damage. Staff member used stem cells from fat isolated from each patient’s stomach and then injected cells into their eyes. A common practice of clinical trials is to pay human subject-volunteers to participate in studies. However, to receive this unproven treatment patients were required to pay $5,000 to receive the stem cell injections. Permitting patients to pay for participation is a topic of ethical debate for even the most scrupulously designed trials. The FDA issued a notice warning U.S. Stem Cell Clinic for marketing products without FDA approval and condemning their exploitation of consumers. An inspection performed  by FDA investigators found evidence of significant deviations from good manufacturing practices in manufacturing of at least 256 lots of stem cell products produced by the clinic. In an attempt to impede the investigation, the U.S. Stem Cell Clinic attempted to refused access of the FDA investigators to the employees of the clinic.  Ultimately, the clinic was cited for failure to establish appropriate written procedures to prevent contamination, risking infection of human subjects. It is required that U.S. Stem Cell Clinic comply and correct the failures stated in the warning letter. If the clinic fails to address the outlined issues, actions will be taken by the FDA, these include seizure, injunction and or prosecution.  Moreover, U.S. Stem Cell Clinic  administered the product both intravenously and directly into the spinal cord of patients hoping to treat a number of serious diseases (Parkinson’s disease, amyotrophic lateral sclerosis (ALS) heart disease, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD), all without FDA review or approval. In fact the FDA has not approved any biological products manufactured by U.S. Stem Cell Clinic for any use.

Overall, the challenge of regulation and compliance continues to loom over all stem cell clinics in the U.S.; however, the FDA is dedicated to enforcing continuous regulation, while educating and protecting U.S. consumers. The building blocks of life are stem cells, manipulated properly, they have the ability to treat disease without posing unacceptable risk. Safely figuring out how will take time.

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January 17, 2018 at 11:43 am

Science Policy Around the Web – January 12, 2018

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By: Maryam Zaringhalam, Ph.D.

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Emergency Preparedness/ Public Health

CDC plans session on ‘preparing for the unthinkable’: a nuclear detonation

On January 4, the Centers for Disease Control and Prevention (CDC) announced a grand rounds — or training session — entitled “Public Health Response to a Nuclear Detonation.” The event’s web page notes: “While a nuclear detonation is unlikely, it would have devastating results and there would be limited time to take critical protection steps. Despite the fear surrounding such an event, planning and preparation can lessen deaths and illness.” While the announcement followed a Twitter exchange between North Korean leader Kim Jong Un and President Donald Trump, CDC officials maintain that planning for the grand rounds has been underway for months. The Tweet also triggered an uptick in sales for potassium iodide, a drug that can be taken to prevent the absorption of radioactive iodine in the thyroid. The last CDC training focused on radiological and nuclear disaster preparedness was offered by the CDC in 2010, so this session will be an opportunity to share what public health programs at the federal, state, and local level have done to prepare in the intervening years. The session will be webcast live on January 16 and is geared towards research and public health professionals, but can also be viewed by interested members of the public.

(Helen Branswell, STAT News)

Public Health

Hospitals In States That Expanded Medicaid Less Likely To Close

The Affordable Care Act included a provision for expanding Medicaid programs to cover all people with household incomes up to 138 percent of the federal poverty level. In 2012, the Supreme Court left individual states to decide whether or not they would opt into Medicaid expansion. For the 31 states and the District of Columbia that chose to expand Medicaid, the federal government pledged to cover 100 percent of the cost for newly eligible enrollees in the first few years, with a provision that the share would eventually decrease to 90 percent. According to a new study, hospitals in Medicaid-expansion states were six times less likely to close than hospitals in the 19 states that did not expand.

Researchers at the University of Colorado tracked hospital closures and financial performance in the period between 2008 (four years before the ACA went into effect) and 2016. They attributed the favorable performance of hospitals in expansion states to the increased population of lower income people with insurance. As a result, Medicaid payments to hospitals increased and less hospital care went uncompensated because an uninsured patient could not afford to pay their bills.

The effect was most pronounced in rural hospitals, which often struggle to stay open. Hospital closure in rural communities can have large economic consequences. Mark Holmes, director of the Rural Health Research Program at UNC, told STAT: “Hospitals are usually the largest, or the second-largest, employer in a community… Losing an employer of 150 people with good jobs is like losing a manufacturing plant.”

While ACA repeal failed last year, Republican members of Congress are still pressing to roll back Medicaid expansion. Some lawmakers have suggested a block grant system, which would cap state spending on Medicaid at a set cost and allow states to spend the money however they would like. On Thursday, January 11, 2018, the Center for Medicare & Medicaid Services (CMS) issued a letter to state Medicaid directors that opens the door for states to require adults to be actively employed as a condition for coverage. The findings of this report, published Monday in the journal Health Affairs, therefore remain salient in the ongoing debate around health care.

(John Daley, NPR)

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January 12, 2018 at 5:39 pm

Science Policy Around the Web – January 5, 2018

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By: Emily Petrus, PhD

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Reflections

Nature’s 10: Ten people who mattered this year

As we kick off a new year of discovery amidst an unpredictable social and political landscape, it helps to reflect on those who made big changes in science in 2017. Nature Magazine put together a list of the top 10 “people who mattered” this year, which runs the gamut from lawyers, patients and of course, scientists.

Academic scientists hailed from most corners of the globe and a variety of fields:

  • US geneticist David Liu (Broad Institute and Harvard University, Cambridge MA, USA) was recognized for pioneering work in gene editing. CRISPR-Cas9 is one of the hottest ways to accurately and easily edit genes. Liu’s team created new enzymes from scratch that can rewrite genetic code, swapping AT pairs to CG pairs – a team in China used this technique to cure human embryos of a blood disorder.
  • Marica Branchesi (Gran Sasso Science Institute, L’Aquila, Italy) plays a pivotal role in coordinating astronomers and physicists who study gravitational-wave research. 70 teams of scientists from all over the world shared their equipment and data on August 17, 2017 to watch two neutron stars collide in a galaxy far away. Without Branchesi’s efforts this important event would have been inadequately monitored, leaving some questions unanswered.
  • Pan Jianwei (University of Science and Technology of China, Hefei, China) is a physicist developing quantum teleportation, which can be used to create encryption keys. Jianwei’s group beamed these keys from a satellite to Beijing and Vienna, enabling groups to videochat with compete security – the photons become distorted if hackers try to intercept the signal. This technology lays the groundwork for quantum internet to be available worldwide.
  • Victor Cruz-Atienza (National Autonomous University of Mexico, Mexico City, Mexico) studies earth’s seismic activity. In 2016 he published a paper simulating how different soil structures are affected by earthquakes, using Mexico City’s ancient lake basin as an example. His calculations were validated after the 7.1 magnitude earthquake in September 2017. Cruz-Atienza’s goal is to raise awareness about upcoming earthquake threats and help countries prepare for them before they hit.

Other members on the list brought unique skills to the table to help scientists continue their work.

  • Khaled Toukan (Chairman of the Jordan Atomic Energy Commission, Acting Director of the Synchrotron-light for Experimental Science and Applications in the Middle East) paved the way for physicists to obtain and share valuable equipment in a turbulent region of the world. His skilled diplomatic interactions steered the project to completion through 20 years of funding upsets and political upheaval.
  • Lassina Zerbo (Comprehensive Nuclear-Test-Ban Treaty Organization, Vienna, Austria) is dedicated to reducing nuclear conflict. 2017 has been rife with nuclear threats, as hostile barbs are routinely traded between the US president and the North Korean leader. Zerbo coordinates a worldwide system to share information which detect data about the earth’s hydroacoustic, infrasound, seismic and radionuclide activity. This is helpful for monitoring who is doing nuclear testing, but also for tsunami detection and studying whale migration.
  • Jennifer Byrne (Children’s Hospital at Westmead, Sydney, Australia) is a cancer geneticist and flawed paper detective. Scientists must publish frequently, and the number of dubious scam journals has increased in recent years. Both factors contribute to flawed and fraudulent literature which muddy the waters in a field based on a trust that what is published is true. Byrne and a computer scientist have developed a software (Seek & Blastn) which could be used by journals to detect misconduct prior to publication.

Rounding out the list is the inspirational posterchild for novel cancer therapies, Emily Whitehead, who was recognized for her role in getting CAR-T cell therapy approved by the FDA. The dubious distinction of using creative ways to dismantle the EPA from the inside was awarded to Scott Pruitt.

(Heidi Ledford, Davide Castelvecchi, Elie Dolgin, Sara Reardon, Elizabeth Gibney, Nicky Phillips, Alexandra Witze, Nature)

Biosecurity

U.S. lifts research moratorium on enhancing germs’ danger / NIH lifts 3-year ban on funding risky virus studies

The US is a great place to do research for many scientists, and the outlook is even brighter in 2018 for a select group of viral researchers. Studying how viruses work is an important undertaking – we can prepare for pandemic outbreaks, develop vaccines, and sometimes use viruses to delivery DNA for gene therapy. However, in 2011 researchers in the Netherlands and The University of Wisconsin in Madison published a study in which they made the H5N1 bird flu easier to transmit between ferrets. This type of study is called “gain of function” and is usually a way for scientists to make viruses even more deadly or transmittable. If this sounds like the zombie apocalypse to you, it did to HHS lawmakers too; they paused funding in 2014 for this type of research. On December 19, 2017 the pause was lifted after a lengthy process of putting new policies in place.

The pause was to allow the National Science Advisory Board for Biosecurity and the HHS to craft clear new rules and regulations that all grants will have to pass before being permitted to work with research involving enhanced potential pandemic pathogens (ie deadly viruses). Grants which make it through the peer review process then experience a secondary review by a panel who will determine if the project’s benefits outweigh the risks, and make recommendations for funding and/or request modifications. In addition, such dangerous research will only be permitted in facilities which are properly equipped to handle such biosafety concerns.

Biomedical research moves at a fast pace, so most proposals that were submitted before the freeze are now obsolete, requiring researchers to submit fresh proposals, following the new guidelines. This may sound tedious and most researchers may not relish new hoops to jump through, however nobody wants a deadly pathogen released due to limited oversight. Even the CDC managed to send live anthrax, bird flu, and botulinum toxin (which causes botulism) to other labs five times over the course of a decade. The pause in funding came at the request of epidemiologists and other scientists who felt there weren’t enough regulations from a safety or ethical standpoint to support funding for gain of function types of viral research. If researchers can prove that their projects pose a limited risk and will produce valuable benefits to our knowledge of public health, their research can resume once more.

(Jocelyn Kaiser, Science) (Lenny Bernstein, The Washington Post)

 

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January 12, 2018 at 1:27 pm

Science Policy Around the Web – December 15, 2017

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By: Leopold Kong, PhD

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Science funding

Indian research labs face financial crisis

In June 2015 at Dehradun, India’s Ministry of Science and Technology mandated that India’s Council of Scientific and Industrial Research (CSIR), should generate half its funds from external sources to support their research activities.  The ‘Dehradun Declaration’ resulted in all CSIR labs resolving to turn research projects into ‘for-profit’ ventures over the next two years and develop a revenue model in a business-like manner with a clear cost-benefit analysis. The CSIR is India’s largest public sector research and development organization, employing over 4600 scientists across 38 premier laboratories.  Two years after the decision, Indian research labs face a looming financial crisis. In an email earlier this year to CSIR lab directors, CSIR Director General Girish Sahhni wrote that after covering a roughly 15% increase in salaries, pensions and employee benefits, only $31 million out of the total $681 million budget for the 2017 fiscal year will be left to support new research.  Furthermore, only 15% of CSIR’s budget is supplemented through successful marketing of its discoveries, which is far from the mandated 50% that may take another three years according to the latest projections.  “There is no ready market for CSIR technologies,” says Dinesh Abrol, a science policy expert at the Institute for Studies in Industrial Development in New Delhi and a former CSIR scientist. “These are all pipe dreams and pipe dreams will not work.” ‘It is too ambitious a time-period. We need to change the culture of our organization as most of us are currently focusing on scientific research. We cannot switch gears to take up work on industrial applications or research overnight,’ says one CSIR scientist who did not want to be named. ‘Barring a few, most CSIR labs cannot raise money from private companies as we don’t have capabilities such as technology marketing, intellectual property or negotiating abilities with industries.’  Nonetheless, India has seen tremendous growth in recent years in translational STEM sectors such as the pharmaceutical industry, which was worth $18.8 billion in 2010 and is currently worth $41.1 billion in 2017.  The Indian government also plans to develop 20 existing universities into ‘world class’ research institutions with $1.54 billion of funding.  In a more optimistic tone, Dr. Srivari Chandrasekhar, Director of the Hyderabad-based CSIR-Institute of Chemical Technology, commented “All good fundamental science research leads to applied research and CSIR is a unique agency which has competence to perform translational research in our country. Innovative solutions to industrial problems are nothing but great science. The scientist is happy only when his fundamental research is used by industry for a product formation.”

(Sanjay Kumar, Science)

Research Misconduct/The Environment

Investigation finds Swedish scientists committed scientific misconduct

In 2016, Swedish scientists Oona M. Lönnstedt and Peter Eklöv published a ground shaking report in the journal Science on the adverse effects of microplastic polysterene particles on the European perch. They found that exposure to plastic particles had a significant negative impact on hatching success rates, growth rates, feeding preferences, response to olfactory threat cues and innate behaviors.  The results were heralded as “an important step”, that could potentially “guide mitigation efforts” of microplastic pollution. However, soon thereafter, two colleagues of the scientists claimed the study was “a complete fantasy”, since they never saw either Lönnstedt or Eklöv at the Ar Research Station in 2015, where the study was purportedly done.  Subsequently, a group of five ecologists and physiologists joined with the whistleblowers to sort through the mounting evidence of fraudulence. “Of course I did these experiments,” Lönnstedt told Science and suggested the accusations were fueled by “jealousy” on the part of one of the whistleblowers. “If you compare my CV with her CV … then yeah, there is a big difference,” she said.  An initial probe into the matter was dismissed, but a second, more in-depth study led by a panel at the Central Ethical Review Board (CEPN) concluded on December 7th that the two were guilty of “misconduct in research”. In an interview with Science after CEPN’s decision, Eklöv expressed disappointment towards his former postdoctoral mentee Lönnstedt: “This is a person I very much trusted, and now it’s been shown that she was dishonest, not only to me but also to the whole scientific community.” At a key point during the investigation, when more data from the study was requested, Lönnstedt had given the excuse that her laptop had been stolen.  Looking back, Eklöv said, “I also confronted her about that several times. She was devastated. She was sitting here in my office completely devastated about this computer. … We talked about it, and I thought it could have happened; I could not exclude that. But it seemed strange, of course.” Although the contested report has been retracted since May 26, 2017, the paper has been cited 46 times so far this year according to google scholar.

(Quirin Schiermeier, Nature News)

 

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December 15, 2017 at 3:56 pm

Science Policy Around the Web – December 12, 2017

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By: Mike McKenna, BA

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source: SalFalko via flickr

The Scientific Workforce

House G.O.P. Tax Writers Take Aim at College Tuition Benefits

If House Republicans get their way with tax reform, graduate students could be hit where it hurts the most – their pockets. Without a single hearing or vote of support from the Democrats, on Nov 16, the House passed the most extensive tax reform bill in the past three decades. Included in the bill is a provision to treat tuition waivers as taxable income. According to figures cited in the New York Times, over 145,000 graduate students receive free education, often through tuition waivers. NPR reports that of those 145,000 graduate students, 60 percent of them are in STEM related fields. These waivers, which often come along with a stipend, are typically tied to positions graduate students fill, such as teaching assistants or research assistants, and cover the cost of a student’s graduate training. Currently, graduate students only pay taxes on money from university stipends, which is treated like normal income.

How hard will the tax hike hit grad students? If the House bill becomes law, the hike could take away up to a third of their income. For example, the New York Times reports that for a student at the Carnegie Mellon College of Science, which give students a $43,000 tuition waiver and a $29,400 stipend, they may pay close to an extra $10,000 in taxes a year. Instead of only having to use 10 percent of their stipend to pay taxes, graduate students would be committing around 40 percent of their stipend to Uncle Sam.

However, some individuals blame universities for creating this issue by charging high tuition prices and then providing a waiver instead of making tuition $0 for graduate students. Critics of this practice  partly attribute it to institutions wanting to collect additional funding from government grants since many grants pay a portion of graduate students tuition.  Others note that universities could reclassify tuition waivers as scholarships, which would still be not taxable. Under this plan universities could waive the requirement for graduate students to work as teaching or research assistants to receive financial assistance, but could still tie stipends to these positions.

Barring a university response, graduate students are not without hope though, as the passed Senate version of the tax reform bill does not include a provision to classify tuition waivers as taxable income. The two separate bills are currently being reviewed by a conference committee who will create a final piece of legislation. This new piece of legislation would have to pass both the House and the Senate before being signed into law by President Trump.

(Erica L. Green, The New York Times)

The Opioid Crisis

Court-mandated Opioid Rehab Rarely Meets Medical Standards

According to a recent study published in Health Affairs, the top ranked health policy journal, only five percent of individuals court ordered into rehab programs for opioid use disorder are getting the best treatment available- methadone and buprenorphine therapy. Opioids are a class of drug known for their pain relief properties. However, use of these types of drugs can also produce euphoria, contributing to why individuals misuse opioids. Opioids include prescription medications such as OxyContin, Vicodin, codeine and morphine and the illegal drug heroin. Methadone and buprenorphine, both medications classified as opioid agonist therapies, help reduce cravings and withdrawal from long-term opioid use.

Despite being the gold standard for the treatment of opioid use disorder, not even a majority of individuals outside the criminal justice system are referred to specialty treatment programs that utilize agonist therapies. The study’s authors found that only 41 percent of individuals referred by non-criminal justice sources received methadone or buprenorphine as part of their treatment. However, this is still four times higher than those in the criminal justice system, who often have little say over the type of treatment they will receive.

According to the study’s author, individuals in the criminal justice system often receive less effective treatments. The programs focus on abstinence while providing peer counseling and psychotherapy, which does not adequately address the biological maladaptation caused by opioid use.

Limitations of the study include that the analysis only examined first time clients, so perhaps repeat patients are more likely to receive medication assistance. But with such a drastic difference between methadone and buprenorphine treatment rates in individuals within and outside the criminal system, the authors note that the criminal justice system must provide more options for patients.

Driving this issue is the stigma against methadone and buprenorphine treatment by both individuals in need of treatment and by those providing treatment, who see it as replacing one drug dependency with another. But experts contest this claim, saying that medications like methadone and buprenorphine stabilize individuals by preventing the onset of withdrawal symptoms while not providing a high.

(Lisa Rapaport, Reuters)

 

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December 12, 2017 at 4:04 pm

Science Policy Around the Web – December 8, 2017

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By: Roger Mullins, Ph.D.

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Chemical Safety

Chlorpyrifos Makes California List of Most Dangerous Chemicals

Last Wednesday, the California Office of Environmental Health Hazard Assessment (OEHHA) passed a vote to add the organophosphorus pesticide Chlorpyrifos to Proposition 65, an extensive list of over 900 chemicals known to cause cancer, birth defects, or reproductive harm. While Chlorpyrifos was previously considered for inclusion on this list in 2008, updated scientific information gave the OEHHA cause for reassessment.

This new data included further information on the neurodevelopmental toxicity of Chlorpyrifos in humans and wildlife. Of particular concern to this board was its harmful effect on fetal brain development. Central to this decision was the extensive review of scientific evidence provided in the 2014 and 2016 EPA Human Health Risk Assessments, as well as new and additional findings not previously reviewed in these assessments.

On a national level, the findings of earlier EPA risk assessments resulted in a national ban on homeowner use as far back as 2000. The recent 2014 and 2016 reports further cemented the evidence for pervasive neurodevelopmental toxicity and also highlighted the danger of dietary exposure from residues in drinking water and crops. An all-out ban on Chlorpyrifos was proposed in 2015, revoking all pesticide tolerances and cancelling its registrations, but this was ruled out by the current Environmental Protection Agency (EPA) in 2017. This pesticide is still under registration review by the EPA, which re-evaluates their decision on a 15-year cycle.

Inclusion on California’s Proposition 65 list does not amount to a ban within the state, though products containing Chlorpyrifos will have to be labeled as such starting in late 2018. This action on the state level stands in contrast to federal decisions, and is a revealing lesson in regard to the complexity of national response to scientific evidence.

(Sammy Caiola, Capital Public Radio)

Gene Drives

US Military Agency Invests $100m in Genetic Extinction Technologies

Gene-drives, an emerging powerful gene-editing technology, have been drawing considerable attention and controversy for their proposed use in disease vector control. This method involves the release of an animal that has been genetically modified into a wild population, with the aim of breeding in genes that have been designed to reduce the species’ ability to spread disease. These introduced genes are preferentially inherited, resulting in their eventual dominance in the population. For example, a gene could be designed and introduced to provide resistance to a particular parasite or reduce fertility. This technique is proposed for use in controlling mosquito-borne diseases such as malaria and the Zika virus, as well as to halt the spread of invasive species.

Controversy over this technique however also hinges on its strengths. The primary concerns are the likelihood of animals with favorable modifications crossing over international borders, downstream effects on dependent species, and the possibility of irreversible harm to the ecosystem if the technique is misapplied. Appropriately, much of this concern comes from fellow scientists. In light of this, scientists and policy-makers alike have been proactive about addressing the safety and ethical issues presented, coming up with a set of specific guidelines to advance quality science for the common good. These entail an effort to promote stewardship, safety, and good governance, demonstrate transparency and accountability, engage thoughtfully with affected communities, stakeholders, and publics, and foster opportunities to strengthen capacity and education. Consensus on these issues is intended to help move this promising field forward in the face of growing public scrutiny.

Recently, a trove of emails from US scientists working on gene drive technology was acquired under the Freedom of Information Act and disseminated to the media. Some of these emails revealed the Bill and Melinda Gates Foundation’s engagement with a public relations company to influence the UN moratorium on the use of this technology. The Foundation has long been a financial supporter of the Target Malaria research consortium that seeks to develop gene drives for the eradication of Malaria. The concern surrounding the release of these emails realizes the common fear of scientists involved in research with the potential to fall under the public eye, as ironically, even attempts to recruit expertise in portraying your research favorably may be seen as damning.

This will inevitably be true of any powerful emerging technique to come in the future as well. With the advance of science’s ability to address problems effectively, there will be obstacles towards implementing new technologies and addressing concerns from the communities they may affect. Some of these will be valid and cause for moratorium and introspection, and some will be more attributable to sensationalism. Understanding and navigating these differences will be an increasing and ever-present concern for policy-minded scientists.

(Arthur Neslen, The Guardian)

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December 8, 2017 at 1:35 pm

Science Policy Around the Web – December 1, 2017

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By: Kelly Tomins, BSc

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source: pixabay

Fake Drugs

Health agency reveals scourge of fake drugs in developing world

The World Health Organization (WHO) released two concerning reports detailing the prevalence and impact of substandard and falsified medical products in low and middle income countries. Although globalization has led to the increase in e-commerce of medicine, making life-saving treatments available to a broader population, it also created a wider and more accessible market to dispense fake and harmful medicines for profit. Despite this, there was a lack of a systematic method of tracking falsified medicines on a global scale. Thus, the WHO created the Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS). With this program, medicine regulatory authorities can enter information about fraudulent drug incidences into a centralized database, making it easier to understand global trends and to possibly identify the source of harmful products. The WHO also conducted an extensive literature search of nine years’ worth of medicine quality studies to assess rates of fake medicines.

Their dual analysis showed that falsified medicines are heavily prevalent, particularly in low-and -middle income countries. They estimate that an incredulous 10.5% of medicines in these countries are falsified or substandard, representing $30 billion in wasted resources. Low income countries are the most vulnerable to this type of exploitation, given their higher incidence of infectious disease and their likelihood of purchasing cheaper alternatives to more reliable and tested medicines. In addition, these countries are more likely to lack the regulatory framework and technical capabilities to ensure safe dispensing of medicines. However, reports of fake drugs were not limited to developing countries. The Americas and Europe each accounted for 21% of the reported cases, highlighting how this is a global phenomenon.

Antimalarials and antibiotics are the two products most commonly reported as substandard or falsified, with 19.6% and 16.9% of the total reports respectively. These findings are especially concerning given a recent finding that the number of malaria infections increased the past year, despite a steady global decrease from 2000-2015. In addition, the number of deaths from the disease have not decreased for the first time in 15 years. By providing an insufficient dose to eradicate the malaria parasite from the body, the use of substandard or falsified antimalarials can foster the emergence of drug-resistant strains of malaria, like those recently found in several Asian countries. Overall, the WHO estimates that falsified products may be responsible for 5% of total deaths from malaria in sub-Saharan Africa.

Despite the clear need for action to ensure drug safety around the world, there are an abundance of challenges to making this possible. The supply chain of drug manufacturing, from the chemical synthesis of the drug, to the creation of packaging and the shipping and dissemination, can span multiple countries with extremely variable regulatory procedures and oversights. The need for strengthened international framework and oversight is necessary to ensure patients receive the drugs they think they are getting and preventing hundreds of thousands of deaths each year.

(Barbara Casassus, Nature)

Biotechnology

AI-controlled brain implants for mood disorders tested in people

Mood disorders have been traditionally difficult to treat due to the often-unpredictable onset of symptoms and the high variability of drug responses in patients.  Lithium, a popular drug used to treat bipolar disorder, for example, can cause negative side effects such as fatigue and poor concentration, making it more likely for patients to elect to stop treatment. New treatments developed by the Chang lab at Massachusetts General Hospital and Omid Sani of UCSF hope to provide real-time personalized treatments for patients suffering from mood disorders, such as depression and PTSD. The treatment utilizes a brain implant that can monitor neural activity, detect abnormalities, and then provide electrical pulses to a specific region of the brain when needed. These electrical pulses, known as Deep Brain Stimulation (DSB), have already been used to treat other disorders such as Parkinson’s disease. Other groups have tried to use DSB in the past to treat depression, but patients showed no significant improvement. In those studies, however, the pulses were given constantly to a single portion of the brain. What is unique about this treatment is that the pulses are only given when necessary, or when the implant receives signals that the brain is producing abnormal neural activity. The researchers have also found ways to map various emotions and behaviors to specific locations in the brain. They hope to utilize that information in order to more finely tune a person’s behaviors. In addition, the algorithms created by the labs to detect changes in the brain can be modified for each patient, providing an alternative to the one-size-fits all pharmacological approaches currently used.

Despite the promising and appealing aspects of this personalized treatment, it also raises several ethical issues regarding privacy and autonomy. First off, with such detailed maps of neural activities, the patient’s mind is practically an open book to their doctor. They have little agency of what emotions they would want to share or, more importantly, hide. Also, the patient may feel a lack of autonomy over their treatment, as the implant itself decides when the patient is displaying an unwanted mood or behavior. The algorithms could also potentially change the patient’s personality for worse by limiting the spectrum or intensity of emotions that a patient can feel. Any type of manipulation of brain activity could be viewed as worrisome from an ethical standpoint, and although promising, this proposed treatment should undergo intense scrutiny in order to maintain autonomy for the patients.

(Sara Reardon, Nature)

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December 1, 2017 at 4:03 pm