Suspect Animal Deaths at Drug Labs

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Suspect Animal Deaths at Drug Labs

By JM Pickett, Expert Briefings, Tuesday, December 18, 2012

The US Department of Agriculture plans to inspect facilities run by three companies that conduct animal research for pharmaceutical products – Merck, Wuxi Apptec and Charles River Laboratories – following reports of deaths of more than a dozen animals in their labs over the past three years, including rabbits, monkeys and a dog.

The inspections will be made in response to complaints filed recently by an animal-rights group, Stop Animal Exploitation Now, a spokesman for the USDA Animal and Plant Inspection Health Service tells us. The group, by the way, obtained reports that were submitted by each of the companies with the USDA in which the animal deaths were noted and explained.

“As is our standard policy when we receive complaints, we will look into these matters closely to determine if there is anything out of compliance with the Animal Welfare Act regulations,” the spokesman says. He notes these will be so-called focused inspections, which are conducted to examine specific issue in response to a complaint, as opposed to a routine issue.

The group charges the deaths illustrate an ongoing trend that demonstrates a lack of concern for animal welfare. “The US is facing an epidemic of negligence within corporate labs,” says SAEN executive director Michael Budkie. “These facilities not only kill animals through carelessness, they also endanger public safety.” SAEN contends the companies violated the Animal Welfare Act.

SAEN regularly monitors drugmakers and conract research organizations for indication that animals are being treated poorly or worse. Last year, for instance, publicized a USDA inspection report showing Bristol-Myers Squibb (BMY) accidentally killed a crab-eating macaque when its cage was being sanitized, but the primate remained locked inisde (back story).

In the latest episodes, Charles River (CRL) annual reports to the USDA from 2009 through 2011 listed gavage errors, which refers to using tubes to administer test compounds, in connection with the deaths of nine animals – four rabbits, four monkeys and a dog – over that three-year period (see here, here and here). SAEN believes the company should be fined up to $180,000, or $10,000 per violation for each animal.

At Merck, a 2011 report details the death of two monkeys (read here), and SAEN asks the USDA to fine the drugmaker $40,000. And 2010 and 2011 annual reports filed by Wuxi Apptec noted the deaths of several rabbits apparently died from sepsis caused by an overdose of a bacteria that was implanted as part of experimental testing (see this and this). SAEN is seeking $80,000 in fines.

A Charles River spokeswoman send us this statement: “The survival rates for major diseases are at an all-time high thanks to the discovery of new drugs. Charles River’s work is an essential component of the research that has led to these discoveries and has played a vital role in medical advances for humans as well as animals. Charles River has a deep commitment to animal welfare, and we make every effort to exceed national standards for the care of the animal models under our stewardship.”

And a Merck (MRK) spokeswoman send us this statement: “Animal research is indispensable to our mission to discover, develop and provide innovative products and services that save and improve lives around the world. Merck takes animal research very seriously and is dedicated to ethical treatment of all animals used in development of medicines and vaccines. As we pursue development, we also use alternative non-animal methods wherever scientifically appropriate. When animals are used, our standards for animal care meet or exceed applicable local, national and international laws and regulations.”

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