Science Policy For All

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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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Written by sciencepolicyforall

June 10, 2016 at 11:00 am

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