A closer look at Covance - East Valley Tribune: Chandler

A closer look at Covance

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Posted: Sunday, November 19, 2006 5:31 am | Updated: 2:05 pm, Fri Oct 7, 2011.

Lab technicians in scrubs and surgical masks remove the small gray monkeys one by one from the dozens of cages lining the laboratory walls inside Covance’s Madison, Wis., facility.

Their thick black gloves protect them from the cynomolgus macaque monkeys’ claws and teeth while waiting their turn at a table where the monkeys are given a drug or chemical being tested.

Some monkeys are fitted with collars that secure them in a boxlike restraint that holds the animals’ heads in place. A technician then pries the monkey’s mouth open to make way for a syringe full of pink fluid.

Other monkeys are placed in clear plastic tubes — about a foot-and-a-half long and about 4 inches in diameter — to keep them still while technicians make an injection into their legs.

The procedures takes a few minutes before the animals are returned to their cages.

The scene, observed by a Tribune reporter, looks similar to a portion of a video mailed to 23,000 Chandler residents in late September that animal rights groups claim is evidence Covance abuses research animals. The video is part of a campaign to keep the drug-testing company from building a planned facility in Chandler.

The video, along with a year of organized opposition that has included regular protests and letter and e-mail campaigns, has brought a global controversy to Chandler over the company’s use of animals for testing.

Company officials say the video, surreptitiously obtained by an undercover operative with the animal rights group People for the Ethical Treatment of Animals, or PETA, is edited and portrays Covance’s work out of context.

The Tribune recently visited Covance’s Madison campus, where the company conducts laboratory tests on animals and humans on behalf of clients that include pharmaceutical companies. Covance officials don’t plan the Chandler operation to be as large as Madison’s, but point to the facility as an example of what they want to bring to Arizona. The Tribune was allowed to observe many of the procedures shown in PETA’s video, but under strict conditions set by Covance, including not to divulge any proprietary information or attempt to take any photographs inside the facility.

COVANCE IN MADISON

Unlike in the East Valley, where Covance has become known primarily for its preclinical business involving animal testing, Madison-area residents interviewed by the Tribune knew the company primarily for its frequent advertisements for volunteers to participate in clinical trials. Of 20 people randomly approached in downtown Madison, only two knew the company uses animals.

Covance’s 1-million-square-foot facility in Madison is the largest animaltesting facility in the world and houses, among other things, the company’s preclinical and clinical testing operations.

The company is among Madison’s top employers with about 1,200 employees working at its campus in that city’s northeastern section. Behind the main building sits the 115th Fighter Wing of the Wisconsin Air National Guard, which shares its runways with the Dane County Regional Airport. Other neighbors include a campus of the Madison Area Technical College and a handful of office and industrial parks.

The Madison facility includes offices, labs, animal quarters and a human-testing clinic.

“This is very similar to what you’ll see in the Chandler facility,” said Steve Barkyoumb, vice president for toxicology services for Covance.

On the upper levels where the labs are located, everyone seems busy. Employees dressed in white lab coats or scrubs quickly move up and down the grayish-blue cinder-block hallways.

Each testing room’s door has a large window where visiting clients can observe ongoing tests. Clients are often on-site during the first day of dosing. Inside these rooms, animals — specifically bred for testing — live in cages. In the monkeys’ quarters, some cages are modified to allow the animals access to their neighbors in other cages. At dosing times, the animals are taken from the cages and placed in restraints to receive a pinkish liquid either by syringe or sometimes through a tube run through the nose directly to the monkey’s stomach.

“We can’t train the monkeys to take a pill,” Barkyoumb said.

When it’s not dosing time, the animals have toys and are fed various fruits and other treats.

“They love it when you pop the popcorn for them in the room,” said Nancy Centanni, director of toxicology operations at the Madison facility.

Down the hall live the beagles. Originally bred as a hunting dog, the beagle has become the standard among dogs used for laboratory testing. Like the monkeys, the beagles live in cages large enough to turn around and stretch out.

Employees in these sections wear ear protection, especially at feeding time when the barking dogs wait for their serving of Science Diet dog food.

TESTING NEW DRUGS

Tests are specifically designed for the particular drug or chemical being tested. But typically, tests last a couple of days to two years. It depends on what compound is being tested and at what developmental stage.

And while each test is different, they generally include observing animals’ behavior during dosing as well as specific medical examinations, including electrocardiograms, blood draws and eye exams, said Donna Clemons, director of North American veterinary services at Covance.

“The majority of our testing ends in necropsy,” Centanni said, referring to the animal version of an autopsy. The necropsy is done to determine the effects of a compound on the animal’s vital organs.

The employees who handle the animals during the dosing stages of preclinical trials don’t euthanize them. The company found it’s too hard on the technicians who sometimes form attachments on the animals, Centanni said.

To Covance officials and many others in the bioscience community, the unpleasant reality of euthanasia is necessary to develop new drugs. Covance officials claim the company has been involved in testing one of three drugs on the market.

“The bottom line: people and animals would get sick more often, stay sick longer and die much sooner than they do today” if animals were not used in the drug development process, according to one Covance presentation.

The point, they say, to animal testing is to determine whether a prospective drug is safe to test on humans. If a drug is destined to fail, pharmaceutical companies want it to fail fast.

At least 90 percent of the animal testing conducted by Covance involves developing drugs.

And tests at the facility don’t involve infectious diseases. Data collected at Covance help clients determine if their product is safe for humans and what, if any side effects can be expected once in-human trials begin.

FEARS AND CONCERNS

Opponents of the planned Chandler facility say they fear the company could bring dangerous viruses and diseases here. They’ve raised questions over how the company will dispose of its wastewater and what effect the facility may have on air quality if it uses an incinerator to dispose of dead animals.

As a result, they claim property values will drop in neighborhoods in south Chandler and adjacent Gilbert.

Covance has not yet decided if it will include an incinerator at its Chandler facility to dispose of animal carcasses. In Madison, Covance uses an incinerator, known as an animal crematorium and licensed by the state of Wisconsin, about five times per month.

If Covance uses a crematorium in Chandler, it will have to obtain a permit from Maricopa County’s Department of Air Quality, which enforces federal Clean Air Act laws.

Any company looking to install an incinerator would have to have a county permit before breaking ground and would be subject to regular, unannounced inspections. The permit also includes a public input process that requires notices be published on the department’s Web site as well as in some newspapers. Public hearings also are held if requested by a resident.

For years, opponents have pointed to cases where a strain of ebola hemorrhagic fever turned up in the company’s quarantine facilities in Virginia and Texas. The particular strain first surfaced in a Hazelton Research Products’ quarantine facility in Reston, Va., in 1989 and is now known as Ebola-Reston by the Centers for Disease Control and Prevention. Hazelton was renamed Covance in 1997 when then parent-company Corning, Inc. spun off several biotech companies into the current company.

In that case, some monkeys in the facility were found to carry the virus and ultimately were all euthanized by U.S. military personnel. According to CDC reports, the strain only affected monkeys and while humans were exposed to the disease, none was infected.

The strain turned up again at the company’s quarantine facility in Alice, Texas, in 1996. The virus was found in three male monkeys and 50 were euthanized as a precaution.

Covance points out the disease turned up in quarantine facilities and not in its laboratories. They also say they have no plans for a quarantine facility in Chandler, eliminating the risk of ebola-infected monkeys coming into the city.

Opponents also have questioned whether Covance’s wastewater will carry drugs and chemicals that could later harm residents.

Covance will have to satisfy local, state and federal regulations regarding wastewater. The company will have to obtain a wastewater permit tailored with specific requirements set to deal with each particular user, said Bob Mulvey, Chandler’s assistant municipal utilities director.

“The permit also includes monitoring requirements and annual inspection requirements,” he said. “So the integrity of our drinking water system and groundwater aquifers is maintained.”

The trace amounts that would be expected from a pharmaceutical facility would be in the “parts-per-billion, parts-per-trillion range,” Mulvey said. The company also is subject to random inspections by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service, which last year fined Covance $8,720 for 16 citations, three of which involved laboratory monkeys. The rest involved administrative issues and equipment violations.

Company officials did not agree with all the citations, but agreed to settle the case to put the matter behind them, Wendell Barr, a senior vice president with Covance, has said.

The citations stemmed from a complaint filed by PETA that included videotape obtained by an undercover operative from the group.

“Covance is registered with us, and we do conduct random inspections,” USDA spokesman Jim Rogers said. Those inspections are unannounced and are similar to health-department inspections conducted in restaurants, Rogers said.

COVANCE IN CHANDLER

The controversy over Covance came to Arizona more than a year ago when the company announced plans to build a facility near Price and Germann roads in south Chandler. The large animalrights groups, as well as a handful of local residents, immediately came out against Covance’s move to Chandler.

The local opposition group, Citizens Against Covance, vowed to push for a referendum to overturn any zoning changes granted to Covance by the City Council.

The referendum threat was dashed in early October when Covance announced it had chosen an alternate site adjacent to the city’s airport that already has the necessary zoning for its project. The company now only needs to satisfy building code requirements administered by city staff members.

The site change means opponents won’t have a council decision to overturn through a referendum. Company officials have insisted that had nothing to do with the change. Instead, they’ve said switching to the larger site gives the company room for future expansions.

Opponents haven’t given up, however, and have held weekly protests during busy weekends near the Chandler Fashion Center and recently began picketing at a shopping center close to the company’s new site.

PETA, a controversial national group and outspoken opponent to the global drug tester, has distributed thousands of videos all over the world showing what it claims are examples of monkeys being abused inside Covance’s facility in Vienna, Va.

And another animal-rights group, Washington, D.C.-based Physicians Committee for Responsible Medicine, recently mailed portions of the PETA video to Chandler residents with a message from Scottsdale surgeon Deborah Wilson urging them to voice opposition to the company’s plans.

Company officials have not yet announced when construction will begin and have not yet applied for any city building permits.

But Covance’s local opponents vow to continue public protests near Covance’s new site as well as in other spots within the city. They plan to resume weekend demonstrations outside Chandler Fashion Center later this month to get their message out to holiday shoppers.

Developments

August 2005: Covance announces plans to build a large laboratory facility on a 38-acre parcel it purchased for $8 million along Price Road between Germann and Queen Creek roads. Shortly after Covance’s initial announcement, People for the Ethical Treatment of Animals, or PETA, put on its first protest in front of city offices in downtown Chandler. A local group, formed by Chandler residents who met during that first protest, have sponsored several demonstrations at the same spot as well as at Chandler Fashion Center and at a shopping center at Germann and Gilbert roads, near Covance’s new site. July

2006: Covance requests zoning changes at the Price Road site. The land is currently zoned for agricultural uses, though city land-use plans designate the area for industrial and high-tech uses.

October 2006: In a surprise announcement, Covance declared it would proceed at a new site next to the Chandler Municipal Airport that’s already zoned for industrial uses. The move meant Covance would not need city approval, other than routine building permits.

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