Dear Mayor Dunn,
I am writing to you to express my concern regarding the establishment of Covance in Chandler . I submitted an Op-ed (listed after this letter) to the local newspapers and no one would print it. I believe the papers have grown tired of out-of-state opinions, but I am writing to you as a former primate researcher (1999-2004 at the University of Wisconsin ) to give you my insights.
I viewed the undercover video-footage showing practices occurring at Covance Laboratories and wrote a letter to various congress members in 2005, expressing my concern. If Covance is indeed strictly following "all applicable laws and regulations for animal treatment” (Covance Code of Respect for Animals in Research, n.d.), then there are loopholes in the Animal Welfare Act that are allowing these stress-inducing procedures to continue.
I have witnessed the removal of multiple FDA-approved pharmaceutical drugs from the market after years of research and development because they ultimately harmed the people taking the drugs. I have therefore concluded that the results of the animal tests do not accurately predict the drugs' affects on humans.
Although the evaluation and implementation of alternatives is well underway (ICCVAM, NIECM, n.d), there is still the predominant mentality that animal research is necessary and required to help humankind. In vitro human cell research, for example, combined with computer technology and personalized medicine is a more powerful tool than extrapolating toxicity data from a different species of animal onto the human population.
Toxicity testing in primates and other animals is due to the Food and Drug Administration (FDA) Approval Process. I have done research and have written about FDA reform and am inspired by all of the alternative toxicity tests that have been developed. I know we are not far away from reforming the 2-species culture of animal testing, and believe that FDA reform will still occur within my lifetime.
Based on my knowledge of the alternatives out there, I formulated the following recommendations for the US government to take (I sent these recommendations to the congress members):
•Hire an independent party to evaluate the efficacy of animal tests performed by pharmaceutical companies. The evaluation would include a thorough analysis of all animal research test results.
•Perform a cost-benefit analysis of using in vitro, human cell testing to the cost of using animals.
•Compare the efficacy of extrapolating data from in vitro, human cell samples onto the human population to the efficacy of extrapolating data from different species of animals onto the human population
•Reform the FDA “culture” that two species of animals must be tested on to achieve proper toxicity results. The argument that two species of animals should be used stems from the fact that different species of animals will react differently to the drugs (From Test Tube To Patient, 2007).
•Eliminate procedures and practices involving stress, since stress compromises the immune system, alters metabolism and other physiological parameters.
•Focus on increasing awareness of personalized medicine since the human reaction to drugs is quite variable and a more specific approach to drug testing is necessary (Collins, 2005).
I ask you, if Covance does establish itself in Chandler , that you please ask about their animal testing techniques and read the Animal Welfare Act legislation as well as view the websites below for more information on alternatives to animal testing. Please read my op-ed below in which I discuss my concerns about the Covance primate handling techniques and how those handling techniques produce variable data. I strongly urge you to press for improved regulation and oversight of animal research and further examine alternatives to toxicity testing in animals.
Covance Code of Respect for Animals in Research and Development. Obtained July 19 from the Covance website: http://www.covance.com/animalwelfare/index.php
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM (n.d.) Obtained July 20th, 2005 from the NIH website: http://iccvam.niehs.nih.gov/home.htm
From Test Tube To Patient: Protecting America 's Health Through Human Drugs. Obtained 2/7/07 from: http://www.fda.gov/fdac/special/testtubetopatient/default.htm
Collins, F.S. (2005). Personalized medicine: a new approach to staying well. Obtained July 19, 2005 from the boston.com website: http://www.boston.com/news/globe/editorial_opinion/oped/articles/2005/07/17/personalized_medicine/
Additional Links on Alternatives
John Hopkins University : Center for Alternatives to Animal Testing http://caat.jhsph.edu/
Treatment of Primates in Research Procedures is a Critical Part of Covance Issue
How are nonhuman primates treated in modern research laboratories? Do these highly intelligent, profoundly social animals generally experience humane treatment--or are stress, discomfort, and species-inadequate housing common facts of their lives? Those questions lie at the heart of the controversy over Covance's proposal to build a new animal-testing facility in Chandler . And they also form one of the most pressing scientific and ethical problems confronting the research community today.
I come at the issue from an unusual perspective. For five years, I was a nonhuman primate researcher at a university laboratory where I worked with 97 rhesus monkeys. I learned husbandry and primate handling procedures that used restraint and negative stimuli such as nets, poles, and leather gloves to get the monkeys to comply.
But I frequently read articles about employing less-stressful handling techniques that involved positive reinforcement training in which the monkey is trained to cooperate in a procedure by using reward. The articles discussed the deleterious effects of restraint on stress levels in monkeys, as stress can affect the immune system, physiology, and metabolism. This new approach seemed to hold great promise, so I tried very hard to implement positive reinforcement techniques in our laboratory.
Unfortunately, although I made some progress, I was soon labeled as the emotional, “animal rights” employee. The labeling allowed the laboratory to ignore my concerns and keep using traditional, stress-inducing procedures. Recognizing I could no longer improve the welfare of the monkeys under my care, I had to resign so that I could speak openly about primate handling issues. It hurt to leave the monkeys, but I could not endorse a system of stressful handling procedures and species-inadequate housing.
I had touted myself as a humane researcher because I cared for the monkeys a great deal. Since the stress-inducing techniques were well-accepted practices, it seemed as though I was “just doing my job.” Now I realize that forcefully restraining a primate to collect blood, give an injection, or force feed the animal is not humane.
There's also a critical scientific issue at stake. Each monkey I worked with had a different personality and thus different ways of adapting to their species-inadequate housing area and stress-inducing procedures. Most of the monkeys displayed at least one type of abnormal behavior, including pacing, back-flipping, rocking back and forth, fur-plucking, and self-biting. When I drew blood from monkeys in a restraint apparatus, some monkeys fought against being restrained and even scratched my hands on a couple of occasions. Other monkeys would be less resistant to the procedure and would comply out of fear, displaying the fear grimace.
This variability in response due to each primate's unique personality refutes the claim that if you treat all the monkeys the same when testing drugs, studying disease progression, or simply doing behavioral studies, then the variability that arises is due to the research condition of the animal. Despite how hard one tries, a scientist cannot control for the personality of a monkey and how stressed that monkey may become in many common laboratory procedures.
I have viewed the undercover video-footage showing practices occurring in 2004 and 2005 at Covance Laboratories in Virginia , a facility that conducts research on nonhuman primates. I am appalled at this treatment, but it's important to understand that some of the disturbing research procedures captured on this tape represents standard and widely-accepted practice in the laboratory setting.
Animal researchers classify many stress-inducing procedures as “noninvasive” and leave out many details while explaining the procedure in the protocol. Forced restraint, negative stimuli (e.g. nets, leather gloves, and metal rods) and orogastric gavages (tube-feeding drugs down the throat into the stomach) induce more than momentary pain and distress in the animals.
I do not trust the toxicity results obtained from the monkeys in the Covance video. The monkeys show a variable response to restraint--some are aggressive, while others are more compliant. The stress, in my opinion, produces too much variability for the data to be of any applicable use.
I urge the citizens of Chandler to question the validity of the animal-testing data that comes out of product-testing companies such as Covance. Please view the widely used primate-handling techniques in the undercover footage at Covance and judge for yourself.
Amy Kerwin worked as a primate researcher in Madison, Wisc., from 1999 to 2004.