Protocol 2002A0047, In Vivo Test System To Study Pathogenesis & Therapy Of Retroviral Disease
Approved in 2002 to use 168 weanling cats and 84 adult cats the protocol is actually an extension of experiments that began in 1990 (90A0063-96A0038) and continues to today.
The lay abstract published in 2002 says
"Retroviruses are causes of immunodeficiency and cancers in cats and humans. Our work is concerned with studying the retrovirus disease process and immune response, as well as treatment. While we strive to perform as much of our work as possible using cell culture techniques, this complex and dynamic interactions involved in disease induction, host immune response and therapeutic efficacy require that this work be carried out in the whole animal. Studies of mechanisms of disease resulting from retrovirus infection yield critical knowledge needed to develop effective strategies for prevention, treatment or perhaps, cure. In these studies, we will evaluate drugs which inhibit virus infection or enhance the immune response against the virus infection. Many of these drugs have unknown pharmacologic properties in the cat. For this reason, limited studies are performed to determine the appropriate dose and manner in which to administer the drug in order to maximize its therapeutic effects in cats."
A major focus of their work "concerns the role of the thymus in pathogenesis and immune response to retrovirus infection and therefore, may require" (most of the time it does) "thymectomy/thoracotomy" (removal) "of some of the animals."
The protocol states 2 agents will be tested but the agents are not defined. Some cats will be FIV infected and some are control cats.
The study protocol says animals will be used for up to 24 months but a clarification submitted to IACUC in 2002 says, "most studies will be limited to 6 to 12 months."
These procedures have been the same since the beginning of the experiments in 1990.
It should be noted that this protocol has been used for the pilot of many other experiments at OSU. Because it is so broad Podell used this protocol to begin his initial work with cats, FIV, and Meth.
At the Dec.15th ILACUC meeting (2000) the following explanation
was provided to POET by Dr. Tallman and Dr. Yonushonis
This protocol states in their justification for number of animals to be used:
"Pharmacokinetics studies will be required to test any new drug previously
uncharacterized in the feline system. In order to determine dose-dependent
bioavailability and half-life, a total of 6 weaning cats will be used to test
any one agent. We anticipate testing 2 drugs during the 3 year duration of
this protocol, therefore utilizing a total of 12 weaning cats for pharmacokinetics
studies."
While METH is not a new drug it does fall under "uncharacterized". So under the guise of protocol 96A0038 Podell and Mathes administered METH to cats to characterize its effects.
And today in 2006, Mathes uses this protocol to characterized what happens to FIV cats on meth and AZT.
Another amendment to the protocol includes using an MRI to evaluate neuropathologic changes. Something that is currently done in human patients to understand how meth effects the brain.
But we are protesting the amendment submitted August 9, 2007 and approved by IACUC on September 14, 2007. Since receiving the amendment here are some facts taken from the amendment:
The twenty-four (24) cats (8-10 wks of age) will come from the existing protocol. No new animals will be added. Currently, Dr. Mathes has thirty-one (31) cats in his lab.The cats will be killed after 12 weeks in the study.