April 22, 2006
At Covance, People Volunteer for Cash, Causes
By By Judy Newman 608-252-6156, The Wisconsin State Journal
Apr. 22--You've probably heard the commercials and seen the ads: Healthy, nonsmoking men and women -- participate in a "research study" and earn $2,200.
Covance is what the pharmaceutical industry calls a contract research organization, or CRO. It coordinates and collects data from early tests of drug candidates on humans and animals, records any side effects and reports the results to its customers, who range from the world's biggest pharmaceutical companies to new academic spinoffs.
Madison is one of three sites where the human drug trials are conducted; the others are Evansville, Ind., and Leeds, England.
Overseeing those clinical research units and their 440 employees is Mary Westrick, a native of suburban Chicago (La Grange Park, Ill.) with a doctorate in pharmacology from Purdue University.
"I start where the people come in," says Westrick, 50, global vice president and general manager of clinical pharmacology.
On a recent day at the company's two-year-old clinical research center, several drug-test volunteers hung out in the roomy lounges, watching a wide-screen television or Web surfing at a bank of computers.
Others were sprawled on the beds of their neat, boxy rooms -- four beds to a room, equipped with desks, a TV and VCR -- where study technicians were taking a sample of their blood.
There's one locked bathroom for each two rooms. Volunteers get a key and a cup from staffers; urine is collected and poured into communal jugs for tests.
Covance's big campus near the Dane County Regional Airport already employs 1,360 (of 7,300 worldwide). Now, Covance is wrapping up a $57 million expansion that could add more than 100 jobs over the next few years.
Q: Readers may imagine Covance as a dingy place where people go if they are down on their luck. But your new clinic is bright and sunny and looks a little like a college dormitory. And the food is provided by upscale caterer Kitchen Hearth.
A: And they don't just get food, they get the FDA (U.S. Food & Drug Administration)-mandated high-fat diet. For breakfast, that's two eggs fried in butter, 4 ounces of hash browns, 8 ounces of whole milk, two strips of bacon and toast with butter.
Blood tests check to see how much of the drugs have been absorbed by the body. Some drugs dissolve in fat while others dissolve in water.
Q: Who are the participants?
A: The average age of volunteers is in the late 20s, and two-thirds of them are male. A lot of folks are in entry-level jobs; a lot are under-employed, working in two or three part-time jobs. We (also) get authors (and) self-employed people. We probably dose about 1,000 volunteers a year (at the three sites).
Q: The ads list tests that range from $2,200 for a five-day stay to $5,500 to two stays of up to 11 days each plus an outpatient visit.
A: We pay a standard day rate of $150 to $200. People do our trials, obviously, for money, but there usually is an altruistic component -- they have a sister with (a disease, or) their mother died of multiple sclerosis. They'd like to contribute.
Q: How hard is it to get into a study?
A: It's not as easy as you think -- you've got to prove you're healthy. Young men, if they're very heavily muscled, may be over the weight limit. We do a full panel of laboratory tests, from electrolytes to blood sugar, a full physical exam, electrocardiogram and more. If you have a history of asthma -- sometimes even hay fever -- it can knock you out (of a test). No smoking, no alcohol or drugs. You can't even take acetaminophen within a week of coming here. The caffeine restriction is usually 48 hours, and you can't have chocolate, either.
Q: How often are blood samples taken?
A: The standard is 14 blood samples in the first 24 hours. It's not as bad as it sounds. We've got the best phlebotomists (personnel who draw blood samples). . . . Our goal is to go in the same hole all the time so when you come out of here, you don't have all these sticks (marks).
Q: Do you ever find health problems that people didn't know about?
A: We found a young lady, 23 years old, with type-1 diabetes. She had no clue. We found a man with an abdominal aortic aneurysm -- we got him into surgery within a day.
Q: Isn't it potentially dangerous to take a drug that has not been prescribed and that you know nothing about?
A: There's always the risk of the unknown. Our informed-consent form says you're one of the first to take this drug. We test a range of products, for osteoporosis, migraines, new antibiotics, HIV drugs. But the drugs are not as toxic as levels were years ago. Volunteers may only take a single dose that usually clears out of their system in three to five days.
(A drug test conducted in England in March by Parexel International Corp., Waltham, Mass., left six volunteers seriously ill. Westrick says Covance's Madison operation has had no such problem. "We've called 911 a couple of times, but it was always for our staff," she says.)
Q: Do you also conduct food testing here?
A: Yes, one day you might see them testing apples for pesticide residue; the next day you may see them slicing up a Big Mac and analyzing the fat and carbohydrate content. They test dog food. They test products covered in plastic wrap to make sure there's no residue coming off the food.
Q: What drew you to the field?
A: Our tag line is: "Bringing miracles of medicine to market sooner," and I really believe that. I have two brothers and a nephew with type-1 diabetes, a sister with multiple sclerosis and a sister with fibromyalgia. My father is about to start dialysis. I see up close and personal what they need. They're more productive, for longer, (thanks to drugs).
Even if every drug didn't make it to market, I would know I kept a lot of bad drugs off the market.
Mary Westrick Global vice president and general manager of clinical pharmacology at Covance
Company headquarters: Princeton, N.J.
Annual revenue: $1.2 billion
Industry: Drug development services
Employees: 1,360 in Madison; 7,300 worldwide
Established: 1987 as a unit of Corning
Madison operations: 3402 Kinsman Blvd. -- 31 acres near the Dane County Regional Airport with more than 500,000 square feet of laboratory and office space, including three building expansions and additions in the last four years
Animal rights advocates protest Arizona land buy
Covance has been under fire in the Phoenix area after buying land in the suburb of Chandler.
Animal-rights activists have staged protests over the past few months in an effort to keep the New Jersey company from building laboratories that would conduct animal tests. And musician Paul McCartney sent a letter to the governor of Arizona saying he does not want Covance to set up an animal testing lab in the state where he owns a ranch.
"Arizona has a special place in my heart," McCartney wrote to Gov. Janet Napolitano, because it is where his first wife, Linda Eastman, spent her last days before dying of breast cancer in 1998.
Susan LaBelle, Covance vice president of global marketing in Madison, said plans have not yet been finalized for the Chandler site.
"Covance conducts government-required medical research to find medicines for diseases like breast cancer, diabetes, heart disease, Alzheimer's and many others," LaBelle said. "This is the kind of life-saving research we hope to do at our proposed facility in Arizona, which ultimately benefits people like Mr. McCartney, his family, his friends and his fans around the world."
In late March, the company said an extensive review by the U.S. Department of Agriculture of several hundred allegations by PETA (People for the Ethical Treatment of Animals) of animal mistreatment at Covance's Vienna, Va., labs resulted in 16 citations. They ranged from "administrative issues to scope of veterinary authority," Covance said. The company agreed to a settlement of $8,720, although it disagreed with some of the citations.
In other Covance news, the company announced last week that it will buy eight testing sites from Radiant Research, a Bellevue, Wash., drug-testing company, for $65 million.
Copyright (c) 2006, The Wisconsin State Journal
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