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Tests on animals don’t apply to humans, so it’s bad enough that drug companies do them at all. But it gets worse...
In the beginning, the victims were playful beagles who wriggled with pleasure in the arms of the lab workers. They didn’t know that they would soon be deliberately poisoned with a drug and that over a weeks-long torturous period, they would sicken, drool, vomit and convulse, finally becoming too ill even to stand up. Then they were killed and cut into pieces to be studied.
For six months, a PETA investigator came to know these beagles. He worked undercover in the contract laboratory that was paid to poison them. What he found devastated him and should bring shame to the governments of the U.S., Canada, the European Union and Asia: The drug had already been tested on animals! The chemical forced into the dogs’ stomachs has been on the market for decades and is widely used in surgeries and for chronic pain control. But in order to market the drug in Japan, the pharmaceutical company was ordered by the Japanese government to conduct the painful tests all over again.
| We can’t let animals continue to be tortured simply because government officials can’t figure out how to talk to each other. |
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We set out to find out how such wasteful, cruel and repetitive experiments, which kill tens of thousands of animals every year, could be legal. We were surprised to discover that these duplicative tests were supposed to have ended more than a decade ago! In 1990, the International Conference on Harmonization (ICH) was established to standardize guidelines for the registration of pharmaceuticals among the European Union, Japan and the United States. The U.K., Japan and the U.S. and their respective pharmaceutical associations are parties to the ICH. Canada is an “observer” to the ICH and is represented by Health Canada and the Drugs Directorate at ICH meetings. But animals continue to die in needless tests for drug registrations because of small differences in regulations that the ICH still has not ironed out.
Armed with our documentation, PETA wrote to the top 10 pharmaceutical companies in the U.S., asking what we and our members could do to move the harmonization process along. Most of the companies told us that there is fierce nationalism in Japan, the United States and other countries, i.e., “If it wasn’t tested ‘here,’ it wasn’t tested at all.” But we can’t let animals continue to be tortured simply because government officials can’t figure out how to talk to each other. We need your help now to make it stop.
We have withheld the name of the company investigated since we are currently in talks.
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Drug Companies Agree Rules Are Flawed
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“You have raised some important points about regulatory requirements for animal testing, particularly that small differences in such requirements between countries or agencies may lead to duplicative or unnecessary testing.”
—Laurence J. Hirsch, M.D.
Merck & Co. |
FROM OUR INVESTIGATOR’S JOURNAL
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 November 16, 2000
“At about 9 a.m., they were dosed with oral capsules. Blood was drawn from each animal at 15 minutes, 30 minutes, one hour, two hours, four hours, eight hours and 12 hours after dosing. At the half-hour post-dose, many of the dogs in Group Four started to become inactive, first growing lethargic and salivating heavily and then lying down....T.M., the study director, came in. He said that these were useless tests and that the animals did not need to go through this because the drug has already been approved by the FDA. However, he said that since the drug was going to Japan, it had to be tested again.”
November 20, 2000
“One of the dogs in Group Three isn’t eating at all. He seems extremely depressed. His neighbor to the left becomes very agitated at the start of dosing, even before it is his turn to be dosed. He salivates to the point that slobber is dripping off his chin, and he shakes it off and tries to wipe it off with his paws.”
 December 12, 2000
“The dogs are so miserable after being dosed. When I go into the room to observe them after dosing, it is so quiet, and most of them are drooling and have very little energy but are usually wagging their tails anyway. It is as if they are making their best attempt to be friendly and get my attention, but they have so little energy. They don’t jump up against the cage bars or jump around.
They just sit or mostly lie down.”
 January 10, 2001
“The dog was really hyper when they went to euthanize her. Afterwards, Dr. T. picked her up by her legs and carried her over to a necropsy table where the woman made two cuts right at the top of the inside of both back legs, and this apparently is to bleed the dog out. She made a few more cuts around the abdominal area and then went to work removing the eyes. After she cut out the eyes, she cut off both ears. After that, she went to work on the major internal organs. She seemed to take a piece of just about everything. Finally, she cut the top of the skull off and removed the brain.”
April 20, 2001
“I asked T.M. about the *** drug, specifically why we had run the dog tests even though it was already approved in the U.S. He said that this was a $50 billion-plus drug that the company wanted to introduce into Japan but that Japan required slightly different specifications for approval so it had to be tested again.”
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Help Us Stop This!
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 Please write to Dr. Ryoko Miyazaki-Krause and ask her to work now to end the duplicative testing of pharmaceutical drugs that are to be sold in other countries.
Dr. Ryoko Miyazaki-Krause
International Conference on Harmonization, c/o IFPMA
30, rue de St-Jean, B.P. 758 1211 Genève 13
SWITZERLAND
Fax: +41 22 338 3230
E-Mail: ich@ifpma.org
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