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Archive for October 2017

Science Policy Around the Web – October 31, 2017

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By: Michael S. Tennekoon, PhD

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Forensic DNA testing

Using DNA to Sketch What Victims Look Like; Some Call it Science Fiction

CSI on Steroids”. That is how the latest forensic tool used by law enforcement agencies has been described. It is called phenotyping. But is it all that it promises to be?

Phenotyping is a technique that uses human DNA, from materials such as skin or blood, to predict an individual’s appearance. By analyzing the genetic sequence, scientists can look for genes that code for physical characteristics such as skin color, eye color, geographic ancestry, and many others. This information is then plugged into a computer algorithm to predict an individual’s appearance. Today, dozens of law enforcement agencies from New York to Louisiana use phenotyping for cases where traditional forensics has resulted in no leads.

However, critics argue that this technique is reaching far beyond its means, especially as there is a lack of peer-reviewed research to back up its claims. Indeed, Parabon Nanolabs, one of the pioneering companies that offers phenotyping to law enforcement agencies, has yet to publish the methods underlying its techniques. Furthermore, Dr. Yaniv Erlich, a computer scientist that studies genetics at Columbia University, states that apart from basic predictions like human ancestry, phenotyping of faces is “on the verge of science fiction.”

In addition to concerns about the reliability of phenotyping, there are other ethical and legislative concerns. For example, the New York Civil Liberties Union points out that using ancestry to identify potential suspects in a criminal case will place many innocent people without any connection to the incident under suspicion. Theoretically, this could be used in a similar way to ‘stop and frisk’. These concerns are in addition to the already well-documented susceptibility of DNA testing to human error and bias.

States are still in the process of establishing laws and guidelines to regulate DNA testing, including phenotyping, for use in criminal cases. For example, in New York, one must have authorization from state officials before DNA testing is done.

Ethical issues not withholding, supporters such as Deputy Chief Katranakis, who is the commander of the New York Forensics Investigation Division believe that phenotyping offers more benefits than drawbacks, especially for cases where there are no other alternatives. However, as the use of phenotyping becomes more prevalent, caution must still be urged when weighing the contribution of phenotyping to criminal cases.

(Ashley Southall, The New York Times)

 

 

Research Misconduct

The Cookie Crumbles: A Retracted Study Points to a Larger Truth

Generously, the chances for a PhD student to get a job in academia are less than 15%. Therefore, the pressure to publish has never been higher. Some would argue that, because of this pressure to publish, there is an increased quantity of lower quality research. Perhaps unsurprisingly then, there is a big problem of researchers failing to replicate studies in the social sciences, and there has been a sharp increase in the number of the papers that have been retracted over the past decade.

On Friday, October 20th, another study which appeared to offer a cheap and simple tool for the fight against national obesity has just been retracted as well. The study suggested that simply placing cartoon Elmo stickers on apples could nudge more children to pick an apple over cookies when offered the choice. However, other researchers noted discrepancies with the numbers in the paper, which led to the submission of a replacement article by the original authors. However, the problems continued when it became known that the study was actually performed on children much younger than originally reported (3-5 years old rather than 8-11 years old, as reported). This situation is exacerbated by the fact that these concerns may also have impacted other published reports from the same lab.

Studying ways to change complex eating behaviors in children is no easy task. Children are considered a vulnerable population and there are several additional regulatory requirements for doing work specifically with children. Examples include parental permission, working on school premises, and getting additional approval from Institution Review Boards to name but a few. However, these hurdles are no excuse to bypass scientific rigor. Given the ease by which scientific findings can reach the masses through social media and the press, scientists must take on the responsibility to be extra vigilant to ensure their findings are accurate, or risk losing the public’s trust and ultimately public funding for the wider scientific community.

(Aaron E. Carroll, The New York Times)

 

Climate Change

Fighting Poverty Might Make it Harder to Fight Climate Change

At first glance, the goal of tackling poverty appears noble and completely unrelated to tackling climate change. However, new research shows that eradicating poverty may indeed make it harder to tackle climate change. Why? If extreme poverty is eradicated, people may travel more and increase their energy consumption, thus creating a larger carbon footprint.

Given this potential conflict, researchers from the University of Maryland in College Park modeled what the impact of eradicating poverty would be on climate change. The authors found that eradicating extreme poverty (i.e. increasing income from less than $1.90 a day to between $1.90 and $2.97 a day) would not jeopardize current targets for tackling climate change. However, lifting everyone to the next income level (the global middle-income level defined as living on $2.97-8.44 per day) would have a significant impact (an extra 0.6°C of warming) on climate change.

This leaves the global society in the precarious moral position of deciding what level of poverty is acceptable to ensure the sustainability of the planet. If we not only want to eradicate poverty, but also wish to bring everyone to the middle class, we would need to dedicate almost 7 times more resources than we are currently towards tackling climate change.

However, all hope is not lost. Clean energy, if it becomes cheaper than fossil fuels, would be a viable option for developing nations to use to fuel economic growth and hence would reduce future carbon emissions. There are some encouraging signs that this may be a possibility. In recent years, while the global economy has grown, carbon-dioxide emissions have not followed suit. Amazingly, emissions in the United States, Europe and China have actually fallen—though the amount of carbon-dioxide accumulated in the atmosphere has increased. In the meantime, however, the authors of the current study call for lifestyle changes, such as taking public transportation, living in smaller houses, and eating less meat.

(Allie Wilkinson, Science Magazine)

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October 31, 2017 at 8:43 pm

Science Policy Around the Web – October 27, 2017

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By: Cindo O. Nicholson, Ph.D.

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source: pixabay

The Opioid Crisis

Engulfed in opioid deaths, Ohio turns to science

The state of Ohio has been the most plagued by the opioid scourge in the United States. It suffered the most opioid-related overdoses in 2014, and the number of opioid overdoses have since increased by 32% according to the state’s health officials. The increase in opioid-related overdoses is not due to a lack of effort on Ohio’s part. In fact, the state spent nearly $1 billion on measures like prevention, law enforcement, and treatment, but all to no avail.

In May of this year, the state of Ohio has embraced a new strategy to curb its opioid crisis – technology. The state has passed a request for $20 million to boost the development of new technologies that will stem the tide. While the three-phase, prize-base Ohio initiative is still accepting applications, technologies vying for funding can be broadly grouped into two categories, non-opioid compounds or devices for treating pain and chemical compounds that effectively reduce the withdrawal symptoms of those already gripped by addiction. Non-opioid technologies for pain treatment that are seeking funding include, an implantable mesh of a special polymer, loaded with sufficient doses of non-opioid pain relievers, allowing the controlled delivery of pain medication and a wearable device that uses electric pulses to calm nerves that are sending pain feedback to the brain.

A compound that has already been FDA approved for use in helping recovering addicts manage withdrawal symptoms that could be immediately put to use in Ohio is Probuphine. Probuphine is an implant that consists of a partial opioid receptor agonist buprenorphine linked to a polymer. When worn, the Probuphine implant provides a low dose of the chemical over a six-month period.

These measures are not a “cure-all” as their success will be dependent on patients’ adherence to strict drug regimens. Also, patients will need to resist the urge to discontinue their follow-ups with doctors upon having early success with these interventions. Nevertheless, there is hope that more research and development of effective non-opioid pain therapies and therapies that can minimize the withdrawal symptoms will significantly reduce opioid overdoses in Ohio. The success of this approach in Ohio will serve as model for other states and countries, and show how policies in support of scientific research can benefit communities.

(Alfonso Serrano, Scientific American)

Genomics Policy

The Navajo Nation is considering a new policy to allow genetic research

Tribal leaders of the Navajo Nation are considering put in an end to a fifteen-year moratorium on studying the DNA of its people. The Navajo Nation is an independent Native American territory occupying 71,000 square kilometers (27,413 square miles) of land on portions of Arizona, Utah, and New Mexico. Like many Native American Nations, the Navajo were concerned about the potential for misuse and privacy infringements of genetic research performed by scientists from outside the community. Additionally, in the early 2000s the Navajo Nation’s department of health did not feel they had enough expertise to pursue genetic research and wished to develop their own research policies.

Now, the Navajo Nation will open its first oncology center in Tuba City, Arizona. This will be a major help to Navajo people living on the reservation who currently have to drive hundreds of kilometers to get specialized care. It also has also elicited a reconsideration of the moratorium on genetic research. If the moratorium on genetic research is lifted, it would allow the collection of blood and other tissue samples for further study. The Navajo Nation’s department of health is collaborating with traditional leaders, tribal officials and other delegates to draft a policy that would allow approval of genetic research, and maintain control of DNA samples.

Being able to collect genetic material and maintain them on the reservation would allow research to be conducted on the reservation which now has tribe members that are geneticists, bio-ethicists and other types of medical experts. Lifting the moratorium would allow Navajo scientists and medical experts to research genetic and environmental factors underlying other diseases exhibited by members of the Navajo population.

Ultimately the success of whatever new policy adopted by the Navajo Nation should increase the availability of specialized and personalized care for its people. It would lay the groundwork for regulating the use of genetic material requested from Navajo repositories by scientists outside of the territory. In addition, the success of a new policy for genetic research would serve as a model for other Native American territories seeking to establish their own policies on genetic research.

(Sara Reardon, Nature)

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October 27, 2017 at 5:05 pm

Science Policy Around the Web – October 24, 2017

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By: Jennifer Patterson-West, Ph.D.

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source: Max Pixel

Healthcare

Under Trump Rule, Nursing Home Residents May Not Be Able To Sue After Abuse

In October 2016, the Centers for Medicare and Medicaid Services (CMS) listed a final rule that prohibited pre-dispute agreements binding patients to arbitration. Subsequently, the American Health Care Association (AHCA) along with a group of nursing homes sued the CMS resulting in a preliminary injunction on the ruling. In June 2017, revised requirements for long-term care facilities that eliminated the prohibition were released by the CMS.

NPR journalist, Ina Jaffee, highlighted the major limitations of the revised requirement.  Jaffee points out that the new rule will make lawsuits by nursing home residents nearly impossible. The long-term implication is that many victims of negligent care will not have their cases heard by a jury.

The revised requirements require that “all agreements for binding arbitration must be in plain language” and that “the agreement must be explained to the resident and his or her representative in a form and manner they understand.” Senior counsel Kelly Bagby with the American Association of Retired Persons (AARP) notes that the requirement for plain language may be besides the point if that patients are required to sign these agreements.

An elder law attorney, Wendy York, noted that patients are given large stacks of papers to signs without fully comprehending the implications of what they are signing.   These patients are often recovering from a trauma, major surgery, or under the influence of mind altering medications while filling out paper work.  The new ruling would require that the “resident acknowledge that he or she understand the agreement,” however an agreement can be required for admission thereby limiting the option of a resident to refuse the agreement if they are in need of care without access to better accommodations.

These rulings could have larger implications on patient and patient advocate’s legal recourse after receiving substandard treatment. Although the new rules are an improvement on the status quo, they do not go as far as those previously proposed.  Unfortunately, it is our most vulnerable citizens that will have more limited protection under the current ruling. However, when the new rules will go into effect remains to be seen.

(Ina Jaffee, NPR)

 

Genetic Testing

A baby with a disease gene or no baby at all: Genetic testing of embryos creates an ethical morass

Increasing affordability of genomic testing has given people more access to information regarding their own genes and those of their potential offspring. Ethicists and experts are trying to consider the implications of genetic information moving into the hands of consumers. How can or should this information be used to make real-life decisions?

With respect to reproductive medicine, preimplantation genetic testing (PGT) can be used to evaluate potential diseases or disorders in in vitro fertilized (IVF) embryos.  In a 2013 federal report on fertility clinic success, PGT testing was reported for approximately 5% of IVF conceptions. However, experts suspect this figure underestimates the frequency of PGT testing and report that requests are growing. A survey of experts by STAT news relayed that “requests to transfer embryos with genetic anomalies are rare.”

The number of diseases that are tested for in prospective parents and embryos are expanding, some of these diseases have a more severe health impact than others. The question now is where to draw the line? Beyond the scope of severe diseases, patients may want to select an embryo with a specific trait.  In these cases, the physician has to decide what is within the ethical bounds of reproductive medicine.  For example, some members of the deaf or dwarfism community reject the notion that their DNA is categorized as a “genetic anomaly” and may desire a child that shares these traits.

Currently, there are no U.S regulation for these cases. However, regulations in the United Kingdom prohibit the transfer of embryos with severe abnormalities. To provide a foundation for clinicians facing these questions, an opinion was recently published from members of the American Society for Reproductive Medicine outlining potential rationales for providers to assist or decline to assist the transfer of embryos with genetic anomalies.

(Andrew Joseph, STAT)

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October 26, 2017 at 10:05 am

Science Policy Around the Web – October 20, 2017

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By: Patrick Wright, Ph.D

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Image: By Tom Varco [CC BY-SA 3.0], via Wikimedia Commons

Drug Pricing

California governor signs drug pricing transparency law

A recently signed bill in California aims to improve transparency of future changes to drug prices. The new law requires drug manufacturers to provide a 60-day notice of any upcoming price increases of more than 16 percent over a two-year period. It comes as an attempt to assuage public and political concern over increased pricing and price gouging practices in the pharmaceutical industry. For example, a new study in the Journal of Clinical Oncology reports that for a group of 24 FDA-approved, patented, injectable anticancer drugs, the mean cost increase was 18% over a mean follow-up period of 8 years following release, substantially outpacing inflation and unaffected by the addition of competition in the market.

This legislative venture is not without reproach, however. The Biotechnology Innovation Organization, the largest biotechnology industry trade group, issued a statement condemning the California bill, arguing: “This law will neither provide meaningful information to patients nor lower prescription drug costs”. Pharmaceutical companies and drug makers have also contended that whole price increases are not representative of the actual prices paid for medicines with discounts and rebates are considered.

On the other hand, an early positive consequence of the proposed legislation is that it has encouraged some companies including AbbVie Inc to voluntarily pledge a single annual price increase of under 10 percent on branded prescription medications in contrast to the industry-standard practice of biannual, double-digit cost increases.

This law is part of a larger pursuit across states to address rising healthcare and prescription drug costs. Another recent, analogous law in Maryland (House Bill 631) is aimed at price gouging of generic medicines, those drugs created after branded medicines are no longer patented, by companies not facing competition from other distributors; a plea by a pharmaceutical industry group was turned down by U.S. District Judge Marvin J. Garbis in September. Maryland and California are not alone. According to the National Conference of State Legislatures, at least 176 bills on pharmaceutical pricing and payment across 36 states have been introduced in 2017.

(Bill Berkrot, Reuters)

 

Genetic Testing

Gene-expression study raises thorny ethical issues

A National Institutes of Health-backed consortium, known as the Genotype-Tissue Expression (GTEx) consortium, aims to accumulate data about gene sequences and activity across 44 types of human tissue, collected from approximately 1000 anonymous deceased donors. It was established in 2010 to pursue questions related to the propensity of the same DNA sequence that is present throughout a human body to give rise to varied tissues; it aims to identify the genetic factors encoded by nucleotide variants that underpin different levels of gene expression in each of these tissues. To encourage widespread participation toward this cause, the data are made freely available to qualified scientists and companies.

As part of the collection process, loved ones representing the deceased donors are asked to consent on behalf of the donor to provide a medical history and collect genetic information and tissue from the deceased. However, the study was not designed to provide the results of genome sequencing and other tests to the loved ones of the deceased donors. This raises some important ethical considerations regarding informed consent and the potential moral obligations of scientists to donor families and loved ones. Susan Wolf, a lawyer and bioethicist at the University of Minnesota in Minneapolis, stated studies such as GTEx should allow for families to be identified if downstream research discovers a mutation, for example, that would dramatically predispose relatives to cancer if inherited.

Laura Siminoff, a bioethicist at Temple University, led a study to assess the feelings of donor families in GTEx on the entire process, finding that the stress of losing a family member may have clouded the extent of analysis and research pursuits for which they had provided consent; most recalled that they had agreed to donate their relatives’ tissue for research, but little else. Siminoff suggests that the informed-consent process could be expanded to included genetic counseling in tissue-donation projects of this nature.

Currently, three federal agencies play a role in the regulation of genetic testing: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). Generally, CMS is responsible for regulating the clinical laboratories performing genetic testing to ensure testing quality. The FDA regulates the safety and effectiveness of genetic tests and pharmacogenomics (the use of genomic information to predict patient response to a particular drug), as well as genomics tools in clinical research. Finally, the FTC regulates how tests are advertised. Interestingly, the collection of biospecimens from deceased individuals is not legally classified as human subjects research under the Department of Health and Human Services policy regarding the Protection of Human Subjects, but because potentially impactful genetic information could be uncovered in the study that is of direct significance to donor families, possible ethical implications still should be considered on their behalf.

(Ewen Callaway, Nature)

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October 20, 2017 at 9:02 am

Science Policy Around the Web – October 17, 2017

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By: Charles Wright, Ph.D.

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Source: Public Domain Pictures

Gene Therapy

FDA experts offer a unanimous endorsement for pioneering gene therapy for blindness

Gene therapy, an approach long hailed for its potential to cure intractable genetic diseases, finally has some successes in getting regulatory approval.  Recently, the U.S. Food and Drug Administration (FDA) approved the first-ever gene therapy treatment for a fatal brain disease.

Last week, another gene therapy approach—this time for a blinding disease that strikes in early-to-late childhood—also received endorsement by a 16-0 vote from the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The vote provides encouragement for patients suffering from Leber congenital amaurosis, type 2 (LCA2), which Voretigene neparvovec (Luxterna) from Spark Therapeutics aims to treat. However formal regulatory approval is still pending . Leber congenital amaurosis, although rare with an estimated prevalence of only 1:50,000 – 1:100,000, devastates vision at an early age. Newborns may show visual impairment immediately after birth, and most LCA patients lose most of their vision by the time they reach 20-30 years of age. Voretigene neparvovec aims to treat patients with mutations in the RPE65 gene, characteristic of LCA2, through gene therapy.

The recent string of successes in gene therapy comes years after the field struggled to rebuild itself after tragedy.  In 1999, the death of a participant in a trial to treat a rare metabolic disorder forced FDA to strengthen its oversight of gene therapy trials. With the first formal FDA approval for a gene therapy awarded just months ago, the recent approvals for other treatments since then suggests gene therapy may have reached a turning point.  In the future, gene therapy may be common for a variety of diseases.

If voretigene neparvovec receives FDA approval, it will be the first gene therapy treatment for a blinding disease.

(John Carroll, Science)

The Scientific Workforce

Why I’m pushing for a postdoc union

Postdoctoral fellows face a bevy of obstacles that threaten to derail even the most brilliant and committed young scientists from a research career.  Many postdocs unfortunately become intimately familiar with them in the lab; funding, publications, and tenure-track positions elude trainees and can keep postdocs from establishing themselves as independent researchers for years.  The harsh reality of the postdoc lifestyle often causes problems outside the lab as well.  Low pay, long working hours, and relationship strain all take their toll.

In response to these issues, some postdocs try to form unions to force academia to respond.  The subject of postdoc unions often pits researchers against university administrators, and the legal standing of postdoc unionization remains in flux.  Universities may claim unionization ultimately harms postdoc employment, as supervisors may write less than glowing recommendation letters for post-docs who missed work due to labor disputes. Nevertheless many postdocs feel unions may help provide a platform for receiving the benefits they need.

Brian Weitzner at the University of Washington (UW) in Seattle proposes collective bargaining rights for postdocs employed at UW campuses across the state.  In the past several months, while he and other postdocs prepare for a vote on whether to unionize, he talked with UW postdocs who share his concerns.  Fair pay, health insurance, and protection for victims of sexual harassment in the laboratory all motivate him to seek the establishment of a formal avenue with universities for resolving these and other issues.

UW postdocs are working with a local chapter of United Automobile Workers to navigate the steps needed to form a union. Their petition to vote is currently being reviewed by the Washington State Public Employment Relations Commission.

(Brian D. Weitzner, Science Careers)

Genomics

The rise and fall and rise again of 23andMe

Four years ago, the DNA-testing firm, 23andMe, teetered on the edge of oblivion.  Then, in 2015, 23andMe made the news again when it announced regulatory approval to sell a test for a rare genetic disease directly to the public.  Now, the company offers testing for 10 genetic diseases to consumers and continues to supply genomics data to collaborators to aid in drug development.

In 2007, 23andMe first gained prominence with its home-delivered kit that consumers could use to learn more about their genome.  After the company analyzed the data, costumers would receive information about their ancestry, predisposition to disease, and other miscellaneous facts such as whether they carried DNA variants that impacted their earwax consistency or urine smell after eating asparagus.  23andMe would also pool customers’ de-identified data together to analyze and sell to other pharmaceutical companies or research collaborators.

As 23andMe grew in popularity, critics became concerned that consumers were being overly impressed by advertisements indicating they could use their own genetic information to better inform personal health decisions even though many links between the DNA sequence variations reported by the test and disease remain dubious.  Alarmed by the possibility patients could make decisions about their health on information that had not been fully validated, FDA warned 23andMe it would need to provide evidence of the accuracy of the tests and ability of consumers to understand the results to continue marketing their kit as a health tool.  23andMe ignored the FDA’s warnings until the regulatory agency finally issued a cease-and-desist letter.

Since then, 23andMe decided to work with the FDA to approve the genetic tests included in its kit. The company can still only sell genetic tests directly to customers for a small number of diseases but is working with the FDA to expand its offerings to the general public.  In the meantime, the company still works with research collaborators to find new disease-relevant DNA variations, like those possibly involved in clinical depression.

Ultimately, 23andMe hopes its business model will lead to new therapies for disease.

(Erika Check Hayden, Nature)

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October 17, 2017 at 5:10 pm

Science Policy Around the Web – October 13, 2017

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By: Maryam Zaringhalam, Ph.D.

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source: pexels

Research Funding

Why gun violence research has been shut down for 20 years

The mass shooting in Las Vegas has reinvigorated the debate around gun control. In turn, scientists and policymakers have renewed the call for more support around gun violence research. According to Alan Leshner, CEO-emeritus of the American Association for the Advancement of Science, “Gun violence is not something you can solve by just intuition and common sense or ideology.” Rather, research is required to make evidence-based policies around the best possible prevention strategies.

Gun violence research, despite its mortality rate, receives less funding and fewer publications than other leading causes of death according to an article published in JAMA earlier this year. The gap is attributable in large part to the Dickey Amendment, first passed in 1996 and reauthorized every year since. The provision, named for former Congressman Jay Dickey, mandated that the Centers for Disease Control and Prevention (CDC) could not use funding “to advocate or promote gun control,” effectively banning federal research into gun violence.

Prior to the amendment’s passage, the CDC was responsible for the bulk of research around gun violence, which informed policies aimed at violence prevention. Since the Sandy Hook Elementary shooting, The Department of Justice’s National Institute of Justice has resumed funding for gun violence studies, awarding 13 grants since 2014. Still, the bulk of funding is provided by private sources, such as the Joyce Foundation, which has spent over $53 million over the last 15 years on gun violence prevention research and advocacy.

While the Dickey Amendment has been reauthorized every year since 1996, Dickey himself has reversed his thinking on the issue: “We need to turn this over to science and take it away from politics.” While Congress is considering restrictions on ‘bump stocks’ with the support of the National Rifle Association, the political winds remain unfavorable for reopening research support.

(Todd C. Frankel, The Washington Post)

 

Women in Science

Disturbing allegations of sexual harassment in Antarctica leveled at noted scientist

Last week Science broke the news about an investigation into David Marchant, an Antarctic geologist and department chair at Boston University (BU), accused of sexually harassing two of his former graduate students while they were in the field in Antarctica. The accusations speak to an alarming trend highlighted in an online survey in PLOS ONE that found 71% of 512 female respondents reported being sexually harassed during fieldwork. Marchant’s case is one in a number that have come to light in recent years, highlighting sexual harassment and gender discrimination in science.

The allegations come at a time when U.S. universities and the U.S. government are struggling to address sexual harassment. In 2011, the Obama administration clearly defined sexual harassment as a form of gender discrimination under Title IX, directing schools to evaluate harassment claims based on a “preponderance of evidence” rather than prove allegations “beyond a reasonable doubt,” as is required for a criminal conviction. On September 22, 2017 Education Secretary Betsy DeVos submitted guidance that universities should instead consider a “clear and convincing standard” of proof. On October 12, 2017 California Representative, Jackie Speier, introduced a bill that would codify the “preponderance of evidence” standard.

BU’s Equal Opportunity Office is currently investigating Title IX complaints filed by two of Marchant’s former graduate students over the last year. According to Science, they have “interviewed numerous people, elicited a 200-page rebuttal from Marchant, and received at least four letters in his support plus at least five letters supporting [the former graduate student who filed the complaint].”

Marchant is now one of a number of senior male scientists who have been accused or found guilty of sexual harassment. These scientists span the disciplines — including astronomer Geoff Marcy, paleoanthropologist Brian Richmond, linguistics expert Florian Jaeger, and molecular biologist Jason Lieb — and have spurred a larger conversation around sexual harassment and discrimination in the scientific community. Last week, the National Academies of Science convened their fourth committee meeting on the Impacts of Sexual Harassment in Academia. The study is investigating the influence of harassment on the “career advancement of women in the scientific, technical, and medical workforce.” The committee will soon issue a consensus report, including identification of policies and practices that have been effective in combatting harassment.

(Meredith Wadman, Science)

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October 13, 2017 at 5:11 pm

Science Policy Around the Web – October 10, 2017

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By: Kseniya Golovnina, PhD.

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source: pixabay

Gene Therapy

In a First, Gene Therapy Halts a Fatal Brain Disease

 The first historic gene therapy approval by the U.S. Food and Drug Administration in August 2017 opened a new era for the treatment of serious and life-threatening diseases. One month later Bluebird Bio announced the successful start of Lenti-D therapy in the clinical trial and gave a flutter of hope to cure cerebral adrenoleukodystrophy (CALD) also known as Lorenzo’s Oil.

Adrenoleukodystrophy (ALD), a rare disorder that affects one in 21,000 male births worldwide, is caused by mutations in the ABCD1 gene that lead to the subsequent accumulation of very long chain fatty acids in tissues, including the myelin of the central nervous system. The most severe form of ALD, known as cerebral ALD (CALD), involves the progressive destruction of the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. This leads to deafness, blindness, seizures, loss of muscle control and dementia, resulting in permanent disability or death. Symptoms of CALD progress rapidly if untreated and the only current treatment is stem cell transplantation.

Gene therapy is a technique for correcting defective genes responsible for disease development.  It utilizes viruses to deliver unmutated copies of the genes, such as the ABCD1 gene, to the cells of the patient’s body. First, blood from the patient is collected by apheresis, depleting immune response T cells and enriching progenitors of all blood cells (hematopoietic stem cells, HTS). The HTS cells are then infected with a virus carrying a functional copy of the gene, before returning the cells to the body.

Bluebird Bio is now pursuing Lenti-D therapy which uses lentiviruses to deliver a functional copy of the ABCD1 gene to patients with ALD. Results published in the New England Journal of Medicine, reported that 15 out of 17 patients (88%) were free from major functional disabilities two years after the hematopoietic stem-cell gene therapy. These results demonstrate the therapy’s efficacy over the 76% benchmark established by radiotherapy-free survival at 24 months. Bluebird’s Chief Medical Officer David Davidson expressed excitement about the patients’ progress. He announced that the first four patients treated in the expansion cohort are also doing well, as measured by their amount of the functional ABCD1 gene.

(Gina Kolata, The New York Times)

Drug pricing

FDA acts to encourage generic competition for complex drugs

What kind of feelings do you have when pharmaceutical companies announce their prices for upcoming exciting gene therapies and other innovative, life-changing bio pharmaceuticals? Positive news about development and success of first-of-their-kind drugs can be undermined by anxieties that patients will not be able to afford them. High drug prices can prevent accessibility of new therapies vital for many patients, and market analysts predict rapid inflation in healthcare spending over the next few years due to the aging US population.

The FDA is conscious of the stress expensive drugs put on both patients and the entire healthcare system. Under the leadership of current Commissioner, Dr. Scott Gottlieb, one of key goals of the the FDA is to bring more competition from generics to help drive prices down. On October 2, 2017 the agency prepared draft guidance specifically aimed at copycats of complex therapies and therefore trying to clear the way for generic drug makers to the market.

Gottlieb wrote in his blog post that the agency is looking for more efficient regulatory pathways with robust reviews and communication with pharmaceutical companies for abbreviated new drugs applications (ANDAs). He highlighted that “early and better meetings between FDA and sponsors can improve development timelines. The agency acknowledged that the complexity of the approval process may be discouraging to generic drug makers. The new guidance aims to clarify these complexities by outlining how genetic makers can prove “sameness” by showing that there is no difference in response to generic drug compared with the original. This is the second update for ANDAs process and Dr. Gottlieb assured that FDA will continue to progress in this reformation.

(Linda A. Johnson, The Associated Press)

 

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October 10, 2017 at 10:11 pm

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