EU and USA: Vivisection News Latest.

Vivisection News Latest

Non-animal research market booming

With a 15% compound annual growth rate, the market for in vitro and in silico methods of assessing safety and toxicology is projected to double by 2017. Traditional in vivo animal methods for assessing safety and toxicity continue to be replaced by alternative methods: in vitro and in silico. In addition, these alternatives are evolving into key technologies, practices, and resources for future medical applications in efficacy and precision. 

Having developed over the past 20 years into a global market recently estimated at $5 billion, in vitro and in silico products and services are now about the same size as the in vivo services (contract research organization) industry. While growth has levelled off and there have been significant reductions in some countries, the number of animals used in research globally still totals almost 100m a year. And new markets such as China could drive significant increases unless alternative methods are adopted.

Although the majority are mice, more can be done to encourage alternatives. Increased adoption of alternative methods by pharma seems inevitable as the industry focuses on increasing productivity and decreasing adverse reactions. But how fast is this uptake likely to go?  The cosmetics industry has been largely responsible for the initial technical and commercial successes, in the form of skin tissue substitutes.

Encouraged by regulatory initiatives dating back 15–20 years and public opinion pressures that have recently become more focused, these new developments ultimately enabled in 2013 the final passage in the European Union of an extremely stringent sales ban on animal testing.  This policy move may not seem especially relevant to pharma. Nonetheless, it reflects the alignment of technical (stem cells, imaging) as well as social developments (environmental concerns, consumer influence) that ultimately affect the cosmetics industry and pharma alike. Even allowing for conservative adoption by pharma, double-digit growth is expected for at least the next 5 years.


USA – Culture of negligence 

Karen Kline, senior laboratory investigator for animal-rights group Eleventh Hour for Animals, filed a complaint with the U.S. Dept of Agriculture detailing a “culture of negligence” toward animals used in University of Florida research. 

The complaint claims that the treatment of Louis, a macaque monkey euthanized in 2010, violated the Animal Welfare Act. The action follows the group’s 3-year-long battle with the university to gain access to public veterinary records, which were finally received in April.  Kline said the records revealed that researchers failed to treat Louis’ damaged hip, treating him for parasites for a year until he was euthanized. “He had a broken hip, and he wasn’t treated for it.

That’s animal abuse right there,” she said. “They are supposed to be scientists, but if they can’t fix a broken hip, what are they doing?” UF spokeswoman Janine Sikes said the university is aware of the complaint and will comply with any requests made by the USDA. “The University of Florida is subject to very stringent state and federal laws regarding the care of laboratory animals,” she said. “We take care to make sure our animals are kept in a healthy environment.” On top of the complaint, Kline also filed a lawsuit against UF for refusing to comply with an October request for public records about the treatment of 25 research primates.

Marcy LaHart, Kline’s lawyer, said the university’s attorney contacted her after the filing and said the lack of response was due to a communication error. Still, Kline said her organization is committed to informing the public about UF’s research practices.  “I need the taxpayers to see this and understand what is happening as far as the corruption in the University of Florida,” she said. “The animals need somebody to speak for them.” There’s still hope for the animals’ future, said Kari Bagnall, executive director of Gainesville’s Jungle Friends Primate Sanctuary. 30% of the primates they house at their facility are former research subjects, and the number is only growing. “We’re hoping that the trend continues,” Bagnall said. “There is definitely life after research.” 


 USA – Piglet suffocated in lab

The 2012 death of a piglet being used in a paediatric research project at Vanderbilt University Medical Centre has re-ignited scrutiny of the Nashville health institution by animal rights activists. The piglet, according to a U.S. Dept of Agriculture inspection report, suffocated and died because of a failure by an outside contractor to reconnect an air supply system.

The death, which came to the attention of federal officials in a routine inspection, is the latest controversy to surface at the facility and has led critics of the use of animals in research to call for other federal action against the medical centre, possibly including fines. A USDA official said Vanderbilt had addressed the problem and no additional action was necessary. 

The medical centre, according to a series of published studies, used piglets in examining lung development problems in babies born prematurely.  “Clearly the situation at Vanderbilt is very serious,” said Michael Budkie, executive director of Stop Animal Exploitation Now.  In his statement Budkie cited prior citations at Vanderbilt, including fines imposed in 2010 relating to the deaths of 6 animals.  Vanderbilt officials dismissed Budkie’s comments by noting that his organization opposes the use of any animal in human research projects.

John Howser, a Vanderbilt spokesman, said Budkie’s organization’s “sole mission is to stop the use of animals in research.”  “The reality is most lifesaving procedures and medications in use today, for both humans and animals, would not have been possible without the ability to conduct prior research and training in animals,” he added. 

A USDA spokesman, Michael Booth, said Vanderbilt had undertaken corrective measures after the incident and the agency planned no further action.  He noted that those measures included the installation of a backup tank and signage warning against unauthorized personnel disconnecting the air supply.  Past findings involving Vanderbilt animal research include a 2012 USDA report citing a primate that suffered a fractured tibia. The animal was euthanized.  The same report cited the university for research animals being left without water for up to 48 hours. 

A 2011 report cited the university for having a researcher who was not listed as an approved surgeon performing brain surgery on a research animal. The animal suffered immediate complications requiring additional procedures, according to the report.  In 2010 Vanderbilt was hit with an $8,156 fine after a Galago monkey was tossed into a washer along with some bedding. The monkey died.

Vanderbilt was also cited at the same time in the death of 5 hamsters after they were injected with an improperly mixed chemical. Howser, Vanderbilt’s assistant vice chancellor for news and communications, said the university “remains firmly committed to the highest standard of care and the most humane protocols for all animals necessary to conduct research and training.”


UK England – Cruelty free products for London

The London Assembly has passed a motion supporting Cruelty Free International’s campaign to end the use of animals in household product testing and calling on the Authority to begin the process of moving towards using Leaping Bunny certified cleaning products.

The motion, which was introduced by Green Assembly Member Jenny Jones and seconded by Labour member Joanne McCartney states:

This Assembly welcomes the commitment by the Government to ban the use of animals to test household products, and supports Cruelty Free International in its campaigning to end such testing.

This Assembly calls on the Greater London Authority, the Metropolitan Police Service, the London Fire Brigade and Transport for London to only purchase cleaning products, where suitable products are available and subject to best value considerations, which have been certified by Cruelty Free International as not tested on animals under the Humane Standards for use in all buildings for which they are directly responsible for cleaning.

Where cleaning is conducted on their behalf by an outside contractor, this condition should be added to the next tender specification when it is published.”


EU / Italy – EU. may punish Italy for stalemate on animal research

A legislative stalemate over animal research could become costly for Italy.

On 23rd Jan, the European Commission asked the E.U. Court of Justice to impose a fine of more than €4.5m per month for failing to incorporate a 2010 E.U. directive on animal testing into its national laws. A new law on animal tests has been the subject of a fierce debate in Italy.  EU. directive 2010/63 aims to harmonize the protection of animals in research across the EU and minimize their use by requiring alternatives to be used when available.

All 27 EU. member states were supposed to have “transposed” the directive in national legislation by 10th Nov 2012. 6 other countries—Finland, Bulgaria, Hungary, Romania, the Netherlands, and Poland—have failed to do so, for various reasons.

A spokesperson for the Environment Directorate-General says the commission may ask for punishment for those countries, too; their cases don’t all move at the same speed, he says. Whether a fine is actually imposed is up to the court. In Italy’s case, the directive’s transposition has become entangled in a struggle over the future of animal testing in the country. A draft law that is now wending its way through the political system would put far-reaching limitations on animal testing that go well beyond those required by the EU, and some wonder whether it is in compliance with the E.U. directive. If not, that could cause further problems for the country in the future.

The latest development in the political process came on the same day the commission referred Italy’s case to the court, when the Senate’s Committee on Health and Hygiene approved the current draft bill. The bill still has to go to a committee at the Chamber of Deputies before it comes back to the government for the president’s signature. Scientists say the law would damage scientific research in the country, and they recently launched a petition in protest. But the current version of the bill would postpone until 2017 three controversial bans: on drug abuse research involving animals; xenotransplantation; and breeding dogs, cats, and nonhuman primates for scientific purposes.

Countries are allowed to have more restrictive rules than those in the EU. directive only if they were already in place before Nov 2010. This is not the case for Italy, which could expose the country to a so-called infringement procedure by the commission. Emilia Grazia De Biasi, chair of the Senate’s Health and Hygiene Committee, has asked the government to assess whether the new law would be compliant with the EU. directive.  Italy should just transpose the directive without further modifications, as most countries have done, says Roberto Caminiti, a physiologist at the University of Rome La Sapienza and chair of the Committee on Animals in Research for the Federation of European Neuroscience Societies.

Postponing the most controversial restrictions in the law is “a clumsy attempt to have the best of both worlds,” he says. Caminiti says Italian politicians don’t know or care enough about science to resist the animal rights movement and blames media for spreading “misinformation” about animal research.  Ilaria Capua, a former avian influenza researcher and now a member of the Chamber of Deputies, agrees that Italy should respect its obligations within the EU and pass a law that is compliant with the directive.

Not doing so—and incurring a fine—is “expensive nonsense,” Capua says. But Michela Kuan, a biologist and a member of the animal rights group Lega Anti Vivisezione in Rome, says Italy’s problems weren’t caused by animal rights activists or the political debate, but by the animal research lobby. Kuan hopes that the 3-year delay will be taken out of the legislation. 

Science 27th January





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