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attending staff

Covance

Covance Inc. formerly Corning Incorporated, with headquarters in Princeton, New Jersey, is a contract research organization, (also known as a clinical research organization or "CRO"), providing drug development and animal testing services. According to its website, it is one of the largest companies of its kind in the world, with annual revenues of over $1.4 billion, operations in 20 countries, and over 9,000 employees worldwide. It provides the world's largest central laboratory network, and employs a global team of clinical trial professionals and cardiac safety experts. It became a publicly traded company after being spun off by Corning, Inc. in 1997.

A division of the company, called Covance Research Products Inc. (CRP), based in Denver, Pennsylvania, offers antibody products and antibody development services to the research community. CRP also deals in the import and sale of laboratory animals. It is the largest importer of primates in the U.S. and the world's largest breeder of laboratory dogs. According to its website, CRP provides canines, rabbits, and non-human primates for testing purposes. CRP has created and trademarked new breeds of animals, including the "Mini-Mongrel" dog. The company also imports wild-caught primates. Covance's animal testing programs and facilities are AAALAC-accredited, 2000 registered, OLAW-assured, and USDA research registered. Furthermore, all CRP programs and facilities are overseen by attending staff veterinarians and AALAS-certified technicians.

The company has been the subject of controversy following allegations of primate abuse in its laboratories in Germany and the United States, and a potential outbreak of the Ebola virus.

History

In the late 1980s and early 1990s, Corning Incorporated acquired numerous best-of-class drug development companies, some with roots dating back to the 1940s. Covance began when Corning Glass Works consolidated its life sciences division in 1977. During this time, Corning acquired a small stake in Hazleton Laboratories Corp. This move lead to the full acquisition of Hazleton by Corning in 1987, followed by the acquisition of clinical testing company G.H. Besselaar Associates in 1989 and SciCor Inc. in 1991. These companies were merged under the subsidiary, Corning Lab Services, Inc., which later included Microtest Ltd., a molecular toxicology center. In January 1997, Corning spun off these businesses as two publicly traded, independent companies called Covance Inc. and Quest Diagnostics Inc..

The company's primary focus is serving the pharmaceutical and biotechnology industries. As part of its clinical and non-clinical development services, Covance provides testing services to the environmental, food, and nutritional supplement industries, and provides custom antibody products and services to the research community for neurological disorders. It also offers cell type-specific marker antibodies for neuroscience; suites of products for both Alzheimer’s and Parkinson’s disease; and an online antibody store including phospho-specific and secondary antibodies.

Covance also provides commercialization services to pharmaceutical, biotechnology and medical device companies. Reimbursement and health economics consulting services are offered through its Market Access Services division, and post-approval services are provided through the company’s periapproval services group.

Ebola scare

In October 1989, 100 cynomolgus macaques (Macaca fascicularis) were imported from Mindanao Island in the Philippines through Amsterdam and New York to Hazleton Research Products (now Covance), Primate Quarantine Unit in Reston, Virginia. A second shipment from the same supplier arrived on November 8. Shortly afterward, some of the monkeys were found to be carrying a filovirus virus, which was suspected to be either another subtype of the Ebola virus or a new filovirus of Asian origin. This attracted significant media attention.

In January 1990, the same Philippines supplier sent a shipment of 100 macaques to Hazleton's Texas Primate Center in Alice, Texas and another 100 to Hazleton's Reston Unit. Between February 1 and March 15, 46 of 52 monkeys in one of the quarantine rooms died, showing the same symptoms as before. The Centers for Disease Control decided the monkeys were infected with simian hemorrhagic fever and Ebola.

In March 1996, 100 macaques from the same supplier were shipped to Hazleton in Alice, Texas. Two monkeys tested positive for the Ebola virus. No human illness were reported in connection with these incidents.

Animal welfare concerns

LD50 tests

Documents obtained from Hazleton in Yorkshire in 1984 by animal rights activists offered information about LD50 tests the company conducted on rabbits in 1980, which reportedly showed that Paraquat was applied to the intact and abraded skin of New Zealand white rabbits. The animals were said to have had difficulty breathing, some were unable to move, and some suffered from anal bleeding and bleeding from the penis. Former research chemist Robert Sharpe writes that, in the early 1980s, Hazleton in Harrogate stated that they had expertise in ‘non-standard’ tests in the field of inhalation testing and explosive gases, and used ‘non-standard’ animal ‘models,’ such as Japanese and Bobwhite Quails, Light Sussex Hens, Ring Necked Pheasants and Starlings, Rainbow Trout, Mirror Carp and Fathead minnows.

Alleged primate abuse

Münster, Germany

In 2003, the British Union for the Abolition of Vivisection sent German journalist Friedrich Mülln undercover into the German Covance facility in Münster, Europe's largest primate-testing center. There, Mülln obtained photographs, video, and other evidence of alleged abuse of monkeys and other non-human primates. The laboratory in Münster specializes in reproduction toxicology and primate toxicology, which includes testing on pregnant primates. It is believed to be one of the largest users of non-human primates in Europe.

The undercover footage shows staff making monkeys dance in time to blaring pop music, handling them roughly, and screaming at them. The monkeys are shown isolated in small wire cages with little or no natural light and no environmental enrichment, and living with high noise levels caused by staff shouting and playing the radio. In response, Covance maintained that clips showing different technicians working in different buildings had been edited together, resulting in a sequence of events that did not take place.

Primatologist Dr. Jane Goodall described the living conditions of the monkeys as horrendous. "To see a monkey alone in a cage like that, with nothing to do so that they go completely crazed with boredom and sadness probably, it's deeply, deeply disturbing." Primatologist Stephen Brend told BUAV that using monkeys in such a stressed state is "bad science" and that trying to extrapolate useful data in such circumstances is an "untenable proposition."

The ensuing publicity in Germany gave rise to the "Close Covance" (Covance Schliessen) animal rights campaign there, as well as campaigns launched in Britain by the BUAV, and in America by PETA. Nature reported that the company was in danger of losing its license.

According to the European Biomedical Research Association, the local authorities in Munster inspected Covance after the video footage was shown on German television, and insisted that Covance install video cameras to monitor staff working with primates. Covance appealed through the courts, which decided that video monitoring would infringe the rights of the staff. The public prosecutor's office also viewed the film and questioned witnesses. The prosecutor's office concluded that Covance "had not rendered themselves liable to prosecution," thus clearing the company of all charges.

After parts of Mülln's footage were shown on German television and in major newspapers, Covance filed a lawsuit, leading a German court to forbid further distribution of the material. The publication ban led to major protests from animal-rights advocates and anti-censorship activists. A first ruling confirming Covance's claims was partially reversed by a higher court's ruling that the right of the public to be informed on the subject prevailed over the company's privacy rights. The video footage may now be displayed publicly, albeit not in the form of the existing television edition, but it may not be used by animal-rights groups.

Vienna, Virginia

People for the Ethical Treatment of Animals (PETA) found similar conditions in Covance's Vienna, Virginia lab during an illegal undercover investigation in 2004-5.

A former study director at the Covance facility in Vienna, Virginia in the U.S., who worked there from 2002 to 2004, told city officials in Chandler, Arizona, that Covance was dissecting monkeys in its Vienna laboratory while the animals were still alive and able to feel pain.

The allegations were uncovered as part of an open-records request made by PETA in November 2006. The employee had earlier approached the city with her concerns when she learned that Covance planned to build a new laboratory in Chandler.

She alleged that three monkeys in the Vienna laboratory had pushed themselves up on their elbows and had gasped for breath after their eyes had been removed, and while their intestines were being removed during necropsies. When she expressed concern at the next study directors' meeting, the employee says she was told that it was just a reflex. She told city officials that she believed such movements were not reflexes but suggested "botched euthanasia performed by inadequately trained personnel." She says that she was ridiculed and subjected to thinly veiled threats when she contacted her supervisors about the issue.

In June 2005, Covance filed a lawsuit against PETA and its former employee for fraud, breach of employee contract, and "conspiracy to harm the company's business by deceitfully infiltrating and videotaping the company's Vienna, Virginia facility." Covance and PETA agreed to a settlement in which PETA accepted a five-year ban on any attempts to infiltrate Covance facilities.

In a March 2006 statement, Covance announced that inspections of the Vienna, Virginia facility by the Food & Drug Administration (FDA) “resulted in no findings to substantiate any claims made against the facility.” Inspections by the United States Department of Agriculture (USDA) resulted in sixteen citations ranging, according to Covance, from "administrative issues to scope of veterinary authority." The company agreed to pay a settlement of $8,720.

New code

In response to the controversy, Covance issued a statement undertaking to observe a number of principles, including treating the animals in its care with respect, abiding by all applicable laws and regulations, employing alternatives where appropriate, minimizing animal discomfort and stress, training employees, and encouraging them to report any misconduct.

Expansion

In recent years, Covance continued its expansion with acquisitions of drug development companies. Notably, in August 2005, Covance acquired GFI Clinical Services, an 80-bed clinical pharmacology business, from West Pharmaceutical Services, Inc. in order to expand the company’s Phase I clinical research offerings.

In May 2006, Covance also acquired Signet Laboratories, Inc., which is a provider of monoclonal antibodies used in the research of cancer, infectious disease and neurodegenerative disease.

On August 6, 2008, Covance purchased early drug development facilities in Greenfield, Indiana from Eli Lilly for $50-million. In a contract valued at $1.6-billion, Covance will provide Eli Lilly with drug development services for the next 10 years. Covance will also provide services to other pharmaceutical and biotechnology clients at the Greenfield site. Covance will assume ownership of the site and operations on or about October 1, 2008.

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