The Food and Drug Administration is empowered to uphold the federal Food,
Drug, and Cosmetic Act (FDCA). Recent findings inside Covance Laboratories,
Inc. in Vienna, VA indicate grave violations and failure to fulfil
regulations that govern laboratory practices for non-clinical laboratory
studies.

For 11 months (April 26, 2004 to March 11, 2005) an investigator from People
for the Ethical Treatment of Animals witnessed the daily fear, misery
and death of primates under Covance's head veterinarian, dubbed "Mr. Let's
Wait and See" by his own staff. In keeping with his nickname, Covance's
primary vet ignored staff complaints about a young monkey caged for four
days with a broken arm. When a junior vet eventually returned from vacation,
she had to euthanize the animal.

This incident typifies Covance's routine physical and psychological abuse of
primates. Habitual cruelty sabotages the merit and reliability of data
collected from primate studies and therefore undermines the intent of the
FDCA.

I urge you to carefully review the 200-page complaint PETA filed with the
USDA. Along with video documentation, the complaint alleges hundreds of
violations of the AWA. Covance employees operate largely unsupervised. The
lab methodically disregards standard operating procedures and sidesteps
requirements for study protocols. I sincerely hope the FDA will initiate a
thorough inquiry and pursue requisite enforcement measures.

When gratuitous animal cruelty is disclosed, government agencies need to
take swift action, rather than vilify or doubt the "messenger." Photographic
substantiation and detailed logs from PETA's 11-month probe clearly depict
Covance's disrespect for animals, science and the law.

Among numerous allegations, PETA's investigator exposed unwarranted acts of
abuse that are not in compliance with study protocols as outlined in the
FDCA:

* Frustrated technicians deliberately taunted, slapped and choked
"uncooperative" primates or harshly cursed the scared animals amid a
constant stream of deafening rock music.

* Workers drenched monkeys while hosing down enclosures with animals still
inside. Others flung monkeys into their cages after invasive procedures.

* Monkeys suffered intestinal protrusions through their rectums (chronic
rectal prolapses) due to unremitting stress and diarrhea. A barren
environment, void of mental enrichment and socialization, caused animals to
mutilate themselves.

* Monkeys perished during agonizing drug tests in which the veterinarian was
prohibited from supplying painkillers or even euthanasia. An overall lack of
veterinary supervision caused injuries to become necrotic.

* Untrained personnel performed oral gavage procedures that led to throat
lacerations and vomiting. The investigator described monkeys who clung to
cages and screamed as inept technicians forced plastic tubing up their noses
and down their stomachs. The more the animals resisted, the harder the
workers shoved, sometimes striking the sinus cavity and drawing blood. Small
monkeys were inappropriately dosed with tubes so large their noses bled
daily.

PETA's documentation not only depicts egregious abuse, but also illustrates
how Covance regularly perjures records to hide the health complications of
its study animals. Covance's inaccurate record keeping conceals the lab's
lack of properly trained personnel.

Animal research has a 92% failure rate. As reported in The Scientist, a mere
8% of (animal-tested) drugs that enter Phase 1 and 2 trials reach the
marketplace and half of products fail in the late stage Phase 3 trials
(www.biomedcentral.com/news/20040806/03, August 6, 2004).

While many researchers now fulfil study criterion with progressive and
applicable non-animal modalities, facilities like Covance continue to waste
time, money and lives on unreliable animal studies. Therefore, it is
imperative that governing bodies enforce regulations set forth to safeguard
animals and protect humans from misleading data.

Thank you,

FIRMAR:

PARA: commissioner@fda.gov

CC: myr@ci.vienna.va.us , manager@ci.vienna.va.us