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Posts Tagged ‘Stem Cells

Science Policy Around the Web – July 6, 2018

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By: Kelly Tomins, BSc

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Genetic privacy

Could DNA Testing Reunite Immigrant Families? Get the Facts.

Since the enactment of the Trump administration’s “zero tolerance” immigration policy, over 2300 children have been separated from their families at the border. The policy caused widespread outrage throughout the US, and over 400,000 people protested the policy at the “Families Belong Together” march last week. Although the policy has since been redacted, the government has shown little transparency on how they plan to reunite families. Could DNA testing be a solution?

DNA testing companies, MyHeritage and 23andMe, seem to think so. They have offered thousands of testing kits to help reunite migrant children to their families. Scientifically, these tests are very reliable, and can detect direct relations by 99.9% accuracy. However, the science is the least complicated aspect of this situation.

Consent and privacy are several of the most troubling aspects of the use of these tests. Due to medical privacy rules, children would need a designated legal guardian or representative to have their DNA tested, which is clearly a problem. In addition, adults likely cannot give informed consent, especially since they are in distressing conditions and many do not speak English. Migrants may feel pressured to have the sequencing done if they believe it is the only way to be reunited with their children. DNA sequencing reveals private information about health and paternity, and sequencing data stored in databases has been used to genetically track criminals. It is difficult to imagine that detainees would be given enough information about DNA sequencing and its’ implications to make an informed decision.

Despite these concerns, according to an unnamed federal official, DNA testing has already begun. Jennifer K. Falcon, communications director for RAICES, a nonprofit in Texas that offers free and low-cost legal services to immigrants and refugees, is extremely against DNA testing in this context. In addition to her concerns regarding consent, she argues that the government will have access to extremely personal data that could be used for future surveillance. Although 23andMe and MyHeritage have assured that the genetic data will only be used for reunification, it is unclear what will happen to the DNA samples and data afterwards.

Beyond the ethical and logistical hurdles in this case, DNA sequencing is not a quick fix. 23andMe state on their website that sample processing takes 6-8 weeks. It would also be a logistical nightmare to obtain and match DNA samples from all the detainees currently in custody, especially when matching results from two different genetic testing companies. Critics point out that registering the identity and locations of migrant parents and children would have circumvented the need for such invasive testing. Although genetic tests are cheaper and more accessible than ever, they require unique consideration to address issues of privacy and consent.

(Maya Wei-Haas, National Geographic)

Endangered species

Rhino Embryos Made in Lab to Save Nearly Extinct Subspecies

Thousands of northern white rhinos once inhabited the grasslands of east and central Africa, but habitat loss and poaching led to the population’s swift demise. All hope for the survival of the rhino subspecies seemed lost when the its’ last remaining male, Sudan, died earlier this year.  There are now only two surviving individuals of the subspecies, a mother-daughter pair named Najin and Fatu, both of whom are infertile. Remarkably, a new breakthrough in reproductive technology has reignited the possibility of saving this subspecies.

In a recent study published in Nature Communications, Dr. Thomas Hildebrant, a wildlife reproductive biologist, and his team show for the first time that rhino embryos can be created using in vitro fertilization (IVF). Although there are no remaining living males of the subspecies, there are four samples of frozen sperm that could potentially be used for reproduction. The research group created four hybrid embryos by combining frozen northern white rhino sperm and eggs from southern white rhinos. The scientists plan on implanting these hybrid embryos into surrogates, to see if they survive to birth. If that is successful, the scientists aim to extract eggs from the remaining female northern white rhinos and create pure-blood northern white rhinos in the lab.

Since there is a limited supply of northern white rhino gametes (only four sperm samples and two egg samples), Hildebrant and his team are also pursuing a technology called induced pluripotent stem cells (iPSC). iPSC are a type of stem cell that can be created from adult cells, such as skin or blood. These iPSC can then be reprogrammed into various cell types. iPSC have already been created from northern white rhinos, and scientists are now figuring out how to convert them to sperm and eggs. Since the San Diego zoo has skin cells from 12 northern white rhinos, the future conversion of these cells into gametes could provide more genetic diversity to any future population.

While many conservation scientists applaud the use of technology to save the subspecies, many wonder whether the resources should rather be spent protecting habitats for remaining rhinos on-the-ground. In a study in Nature Ecology and Evolution, scientists show that de-extinction efforts can lead to a net biodiversity loss, since resources could be spent on endangered species. As Dr. Bennett, a conservation scientist at Carleton University, puts it “if the person is couching de-extinction in terms of conservation, then she or he needs to have a very sober look at what one could do with those millions of dollars with living species — there’s already plenty to do.”

(Steph Yin, New York Times)

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July 6, 2018 at 3:11 pm

FDA stem cell therapy crackdown: a stem-free clinic

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By: Belinda Hauser, Ph.D.

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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 – October 10, 2017

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By: Kseniya Golovnina, PhD.

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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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Science Policy Around the Web – July 21, 2017

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By: Rachel F Smallwood, PhD

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Cancer

Engineered Cell Therapy for Cancer Gets Thumbs Up from FDA Advisers

A panel of advisers has recommended that the FDA approve chimeric antigen receptor T-cell (CAR-T) therapy for treatment of acute B-cell lymphoblastomic leukemia. The committee unanimously agreed that the risk to benefit ratio was favorable enough to proceed with approval of the drug (tisagenlecleucel), manufactured by Novartis. CAR-T therapy utilizes a patient’s own immune cells to find and attack cancer cells. In a recent trial in humans, 82.5% of patients went into remission following treatment with the drug; there have also been promising results from its use in glioblastoma treatment. The treatment would specifically be for pediatric and young adult patients who did not respond well to initial treatments or who relapsed from being in remission.

Despite have strong positive effects, there are potential risks posed by CAR-T therapy. In the study mentioned above, almost half of the patients experienced an inflammatory reaction called cytokine release syndrome. Although all of those cases were treatable, the condition can be life-threatening. Novartis also reported neurological problems. Other CAR-T trials have had several deaths due to brain swelling, but those were in adult populations and were some differences in the therapies.

The FDA often does take the recommendations of its advisers, but there is much to consider in this decision. It would essentially be approving a living drug that is individualized to each patient; the patients’ own blood cells are sent to a manufacturing center, where they are genetically engineered to target leukemia cells. The cell population is then allowed to proliferate, and the entire process takes around twenty-two days. This process presents a quality assurance and control problem to the FDA. However, the target population typically has a poor prognosis and very few options, so the panel considers the potential for increased survival and quality of life to be worth the risks. (Heidi Ledford, Nature News)

Stem-Cell Therapy

Unapproved Stem-Cell Treatments Touted on Federal Database Clinicaltrials.Gov

ClinicalTrials.gov is an online database, curated by the National Library of Medicine and the National Institutes of Health, that logs clinical studies occurring around the country and allows them to be searched by patients, family members, healthcare providers, and researchers. The information on the site is provided by the researchers or sponsors of the individual studies themselves. It allows patients and healthy people to become aware of opportunities to participate in medical research. These studies involve a wide range of treatments, including drugs, devices, behavioral therapies, and procedures.

A recent study found that the database is being abused by clinics advertising for stem cell trials. These trials target individuals looking for treatment for a variety of conditions, and all of them charge for participation. There are very few FDA-approved stem cell therapies, and most clinics that utilize stem cell therapies assert that they do not need FDA approval since they are practicing medicine and do not substantially alter the stem cells (although that is disputed).  Since the researchers themselves indicate in the database whether they need FDA approval, there is little oversight to ensure these studies are correctly representing the risks and benefits of their treatment.

Although a disclaimer was added this spring that informs visitors that the presence of a trial in the database does not indicate government endorsement of it, many people do not realize that they could potentially be participating in a for-profit procedure that does not have the proper oversight to ensure patient safety. In one such case, three women were blinded who paid to receive stem cell therapy for macular degeneration. Most legitimate research studies will not require payment for participation, although travel and lodging costs associated with participation may be incurred.

While many patients may receive treatment at one of these clinics without an adverse event or even with a positive result, critics of these types of clinics are calling for regulation of entries into the ClinicalTrials.gov system. They assert that a federal resource for medical research should not be used to advertise for for-profit clinics that are utilizing therapies that have not been studied or reviewed for safety and efficacy. (Laurie McGinley, Washington Post)

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July 21, 2017 at 10:08 am

Science Policy Around the Web – June 13, 2017

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By: Nivedita Sengupta, PhD

By Mikael Häggström, used with permission. [Public domain], via Wikimedia Commons

Stem Cell Therapy

Texas on Track to Become First State to Explicitly Back Stem Cell Therapies

On 30th May, Texas passed a bill  authorizing unapproved stem cell therapies, making Texas the first state to openly recognize experimental treatments. The bill will make the use of unapproved stem cell therapies legal for patients and is currently awaiting the approval of Governor Greg Abbott, who already supports the measure. Experimental stem cell therapies for terminal and chronic conditions have struggled for years to gain support without much success. Until now, no state has provided legal validation for these kind of therapies and the current stem cell procedures are mostly done under strict regulations.

Amendments were added to the bill, which require that the treatments be delivered by doctors with the approval of an institutional review board, which deals with human research. It will also add another amendment that will allow patients to have authority to sue in case the treatments go wrong. Many scientists and advocates opposed the measure stating that unapproved stem cell therapies can be harmful rather than beneficial. They state that though the amendments add protection to the patients, there are a few aspects of the bill that make them uncomfortable. Two other bills focused on patient access to experimental therapies, also known as “right-to-try” policies, failed to pass in the Texas Senate. (Andrew Joseph, STATNews)

Research Funding

NIH Scraps Plans for Cap on Research Grants

US National Institutes of Health (NIH) decided to drop the controversial proposal of capping the number of grants that an investigator can have at a time. The initial capping attempt was suggested to gather funds for younger researchers by NIH in May. The proposal was based on studies that suggested that a lab’s productivity decreases once it holds too many grants. Younger scientists often face more difficulties in obtaining NIH RO1 grants compared to their older more experienced colleagues. As a result, many researchers applauded the NIH’s effort to provide more funding for younger scientists. Yet the capping proposal received major adverse response from the scientific community stating that the NIH’s interpretation of the productivity study data does not apply to all labs, especially to the collaborative lab groups with four or five R01s that are more productive than labs with only one. Researchers also complained that the proposed point-based scoring system will also make collaborations difficult thus hampering productivity in the long run.

NIH director Dr. Francis Collins stated that the original idea was still a work in progress and NIH is going to put a hold on it. Instead of the cap, on 8th June, NIH announced the creation of the special fund, the Next Generation Researchers Initiative (NGRI), starting with US$210 for funding young researchers. The initiative will focus on investigators with less than 10 years of experience as NIH- funded principal investigators, and on high score grant proposals that were rejected because of lack of money. The initiative will grow up to $1.1 billion over the next five years. According to NIH principal deputy director Larry Tabak, NIH will immediately start creating an inventory of investigators who meet these criteria and expects that this approach will allow more than 2,000 additional R01 grants to be funded to younger scientists compared to the cap-based plan, which would have supported only 1600 awards. Nonetheless, the current proposal is still going to generate controversy as it will affect the older researchers because of NIH’s diversion of funding. (Sara Reardon, Nature News)

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June 13, 2017 at 7:08 pm

Science Policy Around the Web – May 12, 2017

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By: Liu-Ya Tang, PhD

Source: pixabay

Biosafety

Basic Scholarship in Biosafety Is Critically Needed

While a significant amount of money funds primary research in life sciences, the portion allotted in biosafety assessment is almost neglected, which can be detrimental to biomedical research. In a recent paper in mSphere, an open-access journal published by the American Society for Microbiology (ASM), the authors reported the status of practicing biosafety in U.S. labs and pointed out the urgent need for funding in this field.

They identified human errors as the dominant component of laboratory biosafety risk, but there was limited data to support a quantitative analysis of human failure rates. Publicly available risk assessments were only focused on mechanical failure rates. They also found that historical biosafety incident data is not adequate, and incidents reporting systems are not sufficiently standardized. So the same mistakes could likely happen in multiple labs. In contrast, other industries, such as the power and transportation industries, have been investing heavily in maintaining safety records and have benefited from doing so. The authors cite an example from the airline industry to address the importance of incident reporting system. After a flight crash outside Washington’s Dulles airport in 1974, the Federal Aviation Administration (FAA) created a no-fault system of reporting aviation incidents and mistakes. FAA has maintained this system ever since, which has helped reduce accident rates by two-thirds compared to that in the early 1970s.

Even though funding for biosafety assessment is much less than that in other industries, the consequences of a potential infectious disease outbreak can be much bigger than any other accidents. Therefore, such funding is urgently needed for three aspects: “(i) development of a national incident reporting system, (ii) primary research programs focused on human reliability assessments, equipment failures, and decontamination efficiencies, and (iii) sharing of best practices.” Investing in biosafety and biorisk management will help enhance laboratory safety practices and improve work performance of our research enterprise in the long run. (Ryan Ritterson and Rocco Casagrande, mSphere)

Human Stem-Cell Research

Attitudes Towards Stem-Cell Research in Europe, Canada and the United States

Human embryonic stem-cell research has caused many political and public debates over moral concerns while providing benefits to human health. In science policy making, public opinion has great impact. To investigate factors that affect international public opinion towards stem-cell research, Allum N. and colleagues analyzed representative sample surveys in Europe and North America, fielded in 2005, when it was a highly contested issue.

The authors found that public attitudes towards stem-cell research has been affected by government decisions, especially in the U.S. During the Bush administration, federal funding only allowed the use of a small number of existing cell lines in stem-cell research. These limitations were removed by an Executive Order from President Barack Obama that expanded NIH support for human stem-cell research. In response to government guidance, public support for stem-cell research in the U.S. rose from 40 percent in 2002 to around 65 percent in 2010. About 65 percent of Europeans and Canadians supported human stem-cell research on the condition that it is tightly regulated. The other influential factor is religion. The authors showed that in all the regions examined, approval for stem-cell research decreased with increasing religious commitment. This pattern was more pronounced in the U.S. and Canada than in Europe. But interestingly, half of even the most religious public supported stem-cell research, which indicated that perhaps the benefits of stem-cell research are being more appreciated. Overall, the majority of people in the surveyed areas hold positive attitudes towards human stem-cell research. (Nick Allum et al, PLOS ONE)

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May 12, 2017 at 11:07 am

Science Policy Around the Web – February 24, 2017

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By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

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

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

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

Science and Immigration

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

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

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

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

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

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

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

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

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

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February 24, 2017 at 11:23 am