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Science Policy Around the Web – October 19, 2018

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By: Ben Wolfson, Ph.D.

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Source: Pixabay

Climate Change

 

Climate Change prompts a rethink of Everglades management

The Florida Everglades is a large area of tropical wetlands that has received significant attention due to the degradation of its unique ecosystem by urban development. The Everglades were designated a World Heritage Sitein 1979 and Wetland Area of Global Importancein 1987, and in 2000 Congress approved the Comprehensive Everglades Restorative Plan (CERP) to combat further decline and provide a framework for Everglades restoration.

For the past 18 years, these efforts have been directed towards curtailing damage from urbanization and pollution. However, as outlined in a congressionally mandated report released on October 16th by the National Academies of Science, Engineering, and Medicine, new strategies may be necessary. In the biennial progress report, an expert panel called for CERP managers to reassess their plans in light of new climate change models. The report focuses on the 7 centimeters of sea level rise seen since 2000, and points out that Southern Florida is especially at risk from climate change and is expected to experience a 0.8-meter rise in sea level by the year 2100.

It is clear that as more is learned about the realities of climate change, the goals and methods of conservation projects are shifting, and past strategies must be adapted to fit the realities of a warming world.

(Richard Blaustein, Science)

Animal Research

NIH announces plan for chimp retirement

 

In 2015, the NIH announced that it would no longer support biomedical research on chimpanzees, two years after pledging to significantly reduce the numbers of chimpanzees used in research. These decisions were made based on a combination of reduced demand for chimpanzees in research and the designation of captured chimpanzees as an endangered species in 2015.

On Thursday October 18th, the NIH announced the next step in the process of retiring research chimps. While research was stopped in 2015, many of the chimpanzees had nowhere to go and remained housed at laboratories. One federal chimpanzee sanctuary, Chimp Haven, exists in Keithville, Louisiana, however lack of space and the difficulty of relocating some animals has slowed their transition to better habitats.

In the Thursday announcement NIH director Francis Collins outlined the guidelines for future chimpanzee relocation. These include streamlining medical records and determining whether chimpanzees are physical healthy enough to be relocated. Many of the chimpanzees are at an advanced age, meaning they have developed chronic illnesses similar to those experienced by humans. However, Collin’s emphasized that there must be a more acute medical problem for relocation not to take place. In addition both the research facility and Chimp Haven must agree that the former research chimpanzees are capable of being relocated, and disagreements will be mediated by a panel of outside veterinarians.

Collins additionally stressed that while transfer to Chimp Haven is the ideal outcome for all retired chimps, those housed at NIH-supported facilities do not live isolated in cages or in laboratories and are housed in social groups with appropriate species-specific accommodations.

The development of these clear guidelines will expediate chimpanzee relocation while emphasizing chimpanzee health and comfort.

(Ike Swetlitz, Statnews)

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October 19, 2018 at 3:25 pm

Science Policy Around the Web – July 17, 2018

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By: Saurav Seshadri, PhD

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source: pixabay

Animal cruelty

New digital chemical screening tool could help eliminate animal testing

An algorithm trained to predict chemical safety could spare over 2 million laboratory animals per year from being used in toxicological screening.  Researchers at the Johns Hopkins University Center for Alternatives to Animal Testing (CAAT) report that their model reproduced published findings at a rate of almost 90% – higher, on average, than replication studies done in actual animals.  The model pools information from various public databases (including PubChem and the European Chemicals Agency or ECHA) to extract ~800,000 structural properties from ~80,000 previously tested chemicals, which can be used to assign a chemical similarity profile to a new compound.  The model then uses a supervised learning approach, based on previous results, to determine what toxicological effects would likely be associated with that compound’s profile.

The principle employed by the tool, i.e. predicting the toxicity of unknown compounds based on structural similarity to known compounds, is called read-across and is not new.  It was a core goal of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), an effort by the ECHA in 2007 to gather toxicological information about all chemicals marketed in the EU.  However, limited data (only ~20,000 compounds) and legal hurdles (ECHA claimed that its data was proprietary and prevented an earlier version of the algorithm from being released) delayed the publication of a machine learning-empowered read-across tool until now.  As it stands, the prospective availability of the tool is unclear: the authors intend to commercialize it through a company called Underwriters Laboratories, but claim to have shared it with other academic and government laboratories.

Another key question is how the tool will be received by regulatory agencies, particularly the Environmental Protection Agency (EPA).  In 2016, Congress passed legislation mandating thorough and transparent evaluation of chemical safety, and encouraging reduced animal testing.  To these ends, US agencies are already developing databases (such as ToxCast) and predictive modeling tools (e.g. this workshop organized by the Interagency Coordinating Committee on the Validation of Alternative Methods) – whether this model could be integrated with ongoing efforts remains to be seen.  While the authors point out that complex endpoints like cancer are still beyond the scope of the tool and will require in vivo testing, subjecting animals to tests for eye irritation and inhalation toxicity may soon, thankfully, be a thing of the past.

(Vanessa Zainzinger, Science)

 

Gene editing

Controversial CRISPR ‘gene drives’ tested in mammals for the first time

A potentially transformative application of the CRISPR gene editing technology has been given a dose of reality by a recent study.  A gene drive is an engineered DNA sequence encoding a mutated gene as well as the CRISPR machinery required to copy it to the animal’s other chromosome, thereby allowing the mutation to circumvent normal inheritance and spread exponentially in a population.  Researchers quickly recognized the potential of this approach to control problematic populations, such as malaria-carrying mosquitoes, and proof-of-concept studies in insects have been successful.  However, until gene drives could be proven effective in mammals, their applicability to invasive rodent populations has been unclear.

Now, researchers at UCSD have shown that the approach can work in mice, but with possibly insurmountable caveats.  In order to achieve efficient copying of the mutated gene, the team specifically turned on the DNA-cutting enzyme Cas9 during meiosis, when dividing sperm and egg cells are biased towards using gene insertion to repair DNA breaks.  Using this approach, they were able to boost inheritance of a mutation that produces a white coat in normally dark mice, from 50% to 73% of offspring.  However, due to differences in the mechanisms of sperm and egg production between mice and insects, the effect was only seen in females; even in these, differences in the timing of Cas9 activity between different strains of mice led to inconsistent phenotypes in the offspring (i.e., grey coats).  Ultimately, the low efficiency observed precludes any realistic application to population control in the wild.

This cautious result may be welcomed by opponents of gene drive technology: environmental activists, fearing the uncontrollable effects of an accidental release, had called for a moratorium on gene drive research at the UN Convention on Biodiversity in 2016.  However, this call was rejected, and groups such as GBIRd (Genetic Biocontrol of Invasive Rodents) are dedicated to finding responsible ways forward.  One example is to restrict use of modified mice to islands, which may be too populated for large-scale pesticide use but still geographically self-contained.  Another compromise, suggested by the authors, is to use the method to speed up production of polygenic disease model mice.  Overall, like CRISPR in general, it appears that population-level gene editing will need substantially more research before it can realize its dramatic potential.

(Ewen Callaway, Nature)

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July 17, 2018 at 5:09 pm

Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

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source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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March 27, 2018 at 12:27 pm

Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

Source: pixabay

Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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June 10, 2017 at 11:33 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

Science Policy Around the Web – June 10, 2016

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By: Nivedita Sengupta, Ph.D.

photo credit: Tc Morgan via photopin cc

Animal Welfare and Biotechnology

US government issues historic $3.5-million fine over animal welfare

The US Department of Agriculture (USDA) fined Santa Cruz Biotechnology, a major antibody provider, over alleged violations of the US Animal Welfare Act. The penalty so far is the largest in USDA’s history accounting to US $3.5 million.

As one of the leading producer of monoclonal antibodies, the company extracts antibodies from animals such as goats and rabbits for research after injecting the animals with proteins to stimulate antibody production. After inspection of the company’s facility in California, USDA found evidence of mistreatment of goats and rabbits in their facility. Agency inspectors reported goats with untreated coyote bites and massive tumors, and rabbits housed in cruel conditions. They also discovered that Santa Cruz Biotech was keeping 841 goats in a hidden facility. In 2007, USDA lodged three animal-welfare complaints against Santa Cruz Biotechnology. Before a scheduled hearing on the USDA complaints, more than 5,000 goats and rabbits disappeared from Santa Cruz’s facilities and the incident was completely ignored by the company. Santa Cruz would not confirm whether the animals were killed or sold.

The news of animals disappearing lead to a public outcry and scientists turned to social media to boycott Santa Cruz’s products. Dr. Stephen Floor, a biologist at the University of California, Berkeley, commented that his lab has since sought out other antibody providers. Even though the quality and type of antibodies varies widely and researchers tend to stick with products from a single company to ensure that their experiments are replicable, they definitely also want to ensure that animal rights are protected.

After contesting the government complaints, an agreement was made on 19th May in which the company “neither admits nor denies” that it violated US animal-welfare regulations. However according to the settlement agreement Santa Cruz Biotech will pay the fine as part of the settlement. It also includes permanent revoking of Santa Cruz Biotech’s government license to sell, buy and trade or import animals. Moreover it demands the company to cancel its registration to operate as a research facility that uses animals. So far Santa Cruz Biotech and Covington & Burling, a Washington DC law firm representing the company have not given any comments regarding the settlement. However the settlement ends the long running investigation and also points at the fact that not only proper regulations, strict vigilance is also needed to protect the laws. (Sara Reardon, Nature News)

Mosquito Control Policies

US reviews plan to infect mosquitoes with bacteria to stop disease

The United States (US) Environmental Protection Agency (EPA) is under process of reviewing an application from the biotechnology start-up MosquitoMate to use the bacterium Wolbachia pipientis as a tool against the Asian tiger mosquito Aedes albopictus. MosquitoMate plans to market Wolbachia as a pesticide to kill only mosquitoes and leave other insects untouched. The EPA sought for public-comments on this matter before making the decision.

The strategy involves rearing and environmental release of mosquitoes infected with a particular strain of Wolbachia which do not allow the paternal chromosomes of mosquitoes to form properly following mating. The released male mosquitoes will mate with the wild females which do not carry the same strain of Wolbachia. As a result the fertilized eggs will fail to hatch and the pest population will dwindle. MosquitoMate has tested Wolbachia in A. albopictus in three states over the past three years. According to Stephen Dobson, founder of the company, the approach resulted in reduction of wild mosquitoes by more than 70% in those areas. Apart from A. albopictus MosquitoMate is also using Wolbachia to target Aedes aegypti, thought to be the main vector for Zika. Other countries like China are also conducting field trials of Wolbachia to regulate the mosquito population.

The ongoing releases of large mosquito population can be expensive and hence the non-profit international collaboration, Eliminate Dengue, is testing another approach that requires rearing of fewer mosquitoes. It uses a starter set of mosquitoes carrying a different Wolbachia strain to infect the wild population. This strain of Wolbachia do not interfere with the development of the offspring but the infection prompts an immune response which consumes key cellular resources, thus making them ineffective at transmitting viruses.

So far MosquitoMate’s field testing plans have not prompted any public resistance. By contrast, US residents have protested against proposed trials of genetically engineered mosquitoes developed by Oxitec of Milton Park, UK. Both Oxitec and MosquitoMate alter the male mosquitoes using lethal reproductive weapon but Oxitec modifies mosquitoes with a gene, instead of bacterium Wolbachia.

Considering the current increasing incidence of Zika and also other mosquito transmitted deadly viruses like dengue and Chikungunya, many countries are considering new options for reducing mosquito populations. “We need as many effective tools as we can get, so we need to give Wolbachia a try,” says Tom Scott, an entomologist at the University of California, Davis. (Emily Waltz, Nature News)

Heart Disease

Protective gene offers hope for next blockbuster heart drug

Rare mutations though often regarded as harmful, sometimes can be beneficial too. On May 18th, scientists at DeCODE Genetics, subsidiary of the biotechnology giant Amgen reported in the New England Journal of Medicine a genetic variant found in Icelanders which lowers the risk of heart disease by more than one third. This variant was identified by comparing genomes of thousands of Icelanders with their medical record. In this study, about 2,600 Icelanders were fully sequenced and limited genomic data and family-tree records was used for another 398,000 inhabitants. After analyzing all the genomic data it was found that 1 in 120 Icelanders has a mutation resulting in inactivation of one copy of the ASGR1 gene. People having the mutant variant have lower levels of non-high-density lipoprotein (non-HDL) cholesterol, compared to the wild type population. Moreover, in follow-up analysis on approximately 300,000 people from Iceland as well as 4 other countries also revealed that carriers of this variant were 34% less likely to develop heart disease. Besides this, the variant didn’t seem to cause any adverse health effects. So far scientists have found that as a result of the variant, a protein is inactivated which recycles a class of sugar-coated proteins. However which biomolecules are precisely affected and what results in a significantly-decreased risk of heart disease is still under study.

This rare mutation could be the basis for the next blockbuster drug for heart disease. Kari Stefánsson, a geneticist at DeCODE Genetics (bought by Amgen in 2012) in Reykjavik stated that Amgen headquarter in California has already prepared drugs which mimics the effect of this genetic variant found in Icelanders. The level of protection provided by the ASGR1 mutant variant is comparable to that offered by another human gene variant discovered earlier. The earlier gene variant also reduced cholesterol levels and the drugs developed to mimic the mutation, blocks the PCSK9 protein that influences blood cholesterol levels. Furthermore this drugs were approved by the US Food and Drug Administration last year. PCSK9 inhibitors have been advertised as the next blockbusters in cholesterol-lowering drug market.

However Kari Stefánsson argues that the ASGR1 variation reduces risk of heart-disease more substantially than expected, just on the basis of its effect on cholesterol alone. This makes the ASGR1 variation potentially more valuable. “This is a genetic discovery that is pointing to the possibility of manipulating something other than just blood lipids,” he says. “We have no drugs, really, that affect the risk of coronary heart disease that work on alternative mechanisms.” (Ewen Callaway, Nature News)

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June 10, 2016 at 11:00 am