USDA subverts Animal Welfare Act in whistleblower protection case

Ron Wood's crack-smoking experiments. A case study of waste, fraud and animal abuse

"Scientific Welfare" needs reform. Wasteful, irrelevant and cruel research underwritten by U.S. tax dollars

Retaliation Case of
Jan Moor-Jankowski, M.D.

Top Ten Lies of the Department of Agriculture
In the matter of animal welfare whistleblower - Jan Moor-Jankowski, M.D.

The History of Medical Progress written by Dr. Ray Greek, Director of the Medical Research Modernization Committee

"If I, an internationally recognized scientist and consultant to heads of state and national academies, couldnot secure protection under federal law, how can U.S. citizens believe thatanyone, let alone younger, lesser-known scientists, dare to oppose scientificmisconduct, animal abuse and the misdeeds of corrupt administrations?"- Jan Moor-Jankowski, M.D.

ACTION is part of Agency's long-standing pattern of failure to uphold the law.

The History of Medical Progress
written by Dr. Ray Greek, Director of the Medical Research Modernization Committee

Introduction | Surgical Advances | Medication Testing in Animals | Curing and Preventing Cancer |Do Animals Feel Pain? | AIDS Research with Animals
Heart Disease | Cardiovascular Disease | Childhood Diseases | Birth Defects

AIDS Research with Animals
According to some researchers, "The course of AIDS in primates is virtuallyidentical to that of humans."(Bertha Madras of the New England RegionalPrimate Center in testimony before The House of Representatives AppropriationsSubcommittee on Labor, Health and Human Services, Education and RelatedAgencies. Washington DC, US Government Printing Office, 1990, p1481-1489)But is this true? AIDS is one of the most frightening and deadly illnessesof modern time. Millions have died and millions more will die. What havethe animal models of AIDS contributed to our knowledge and treatment ofthis devastating disease?

Epidemiological research and in vitro research led to the discovery of thevirus and the mode of transmission. Mary Guinan of the CDC first statedthat the new disease must be transmitted via blood or other bodily fluids.Drs. Montagnier and Gallo both conducted in vitro research to isolate thevirus. AZT, one of the first medications used to treat AIDS was originallyan anti-cancer drug. The efficacy of AZT was first demonstrated in 1985using test tube research. It went directly to clinical trials without goingthrough the usual animal tests. One reason for this was that it was so wellknown from it's use in cancer. AZT, 3TC, protease inhibitors, ddI, ddC,d4T, Indinavir, Ritonavir, Saquinavir, Nevirapine and hydroxyurea were alldeveloped from in vitro or test tube methods. In some instances, the scientistswere studying white blood cells and had an idea for another type of attackagainst AIDS. Scientists without a vested interest in animal experimentationhave stated, "that there is no predictive animal model for HIV infectionin humans. Cell cultures offered the first treatment and the recent advancessuch as combination drug therapy were derived clinically. Test tube researchand human epidemiological studies have been responsible for the great breakthroughsin AIDS so far.

In 1988, scientists stated, "To date, adequate animal models have notbeen developed for HIV-related research. An appropriate model is one inwhich the animal can be infected with HIV and can develop diseases similarto that produced by HIV infection in humansDifficulties with animal modelspersist. Chimpanzees for example, can be infected with HIV, but, to date,have not developed AIDS.The lack of appropriate animal models for HIV researchmakes the application of animal research to humans uncertain." (PresidentialCommission: Report of the Presidential Commission on the human immunodeficiencyvirus epidemic. Washington DC, Government Printing Office, 1988, pp39-47)

Many other scientists have acknowledged the fact that animals do not sufferfrom AIDS -like illnesses the same way humans do. Despite this knowledgeprimates and other animals have been experimented on at great cost to thetaxpayer. The results have been disappointing at best. The strain of HIVused to try and infect chimps is different from the naturally occurringvirus. This has resulted in researchers thinking advances had been madeon numerous occasions, when in fact the results were not applicable to humans.For example, researchers thought HIV was slowly progressive with long latencyperiods. In humans however, it progressed rapidly with short latency periods.

The journal Science stated,"a molecular clone of the prototype SAIDSvirushas no notable similarity in either genetic organization or sequenceto the human AIDS retrovirus."

And this, also from the journal Science,"[Drs.] Tsai and Sarver arequick to point out, however, that there is a big leap from monkeys to humans:For starters, HIV-1, the main AIDS virus that infects humans, differs significantlyfrom SIV, the simian relative that was used in the tests."

Researchers can study SAIDS, but it is not like AIDS. They can study monkeysinfected with HIV but the monkeys do not respond the way humans respond.Another difference is the way the disease is transmitted from mother toinfant. In humans, the disease is transmitted in-utero. SIV (simian immunodeficiencyvirus) in rhesus monkeys can be passed in breast milk but not in-utero.Another reason that animal experiments don't offer hope for HIV infectedpatients is that HIV differs from SIV at the very important hypervariableregion. This is an area of the actual molecule of the virus. It is difficultto use the monkey as a vaccine model since monkeys do not produce antibodiesagainst the V-3 loop portion of a glycoprotein on the outer covering, humansdo. Granted, perhaps animals can be vaccinated against immunodeficiencyviruses, but that does not mean the vaccine will be anything like what isneeded for HIV. We know we can vaccinate against viruses.

As of this writing, probably the biggest news item related to the treatmentof AIDS is the failed baboon bone marrow transplant on patient Jeff Getty.Why was this operation performed? Are there any risks to the patient orcommunity with this type of procedure? Why was this procedure performed?The FDA conducted hearings on whether or not to approve the procedure. Thecommittee however was composed of voting members, some of whom also hada vested interest either in the procedure or in xenotransplants.

The thought of transplanting a baboons bone marrow into a human filled manyinfectious disease experts with fear. Dr. John Coffin stated that,
"infection is a virtually inevitable consequence" of xenotransplantation.
He added that, "this is a very serious worry because the animals thathave been chosen for doing this, the baboon and pig, are both known to carryendogenous viruses, replication competent, but very poorly studied, thatare capable of infecting human cells."

Dr. Louisa Chapman of the CDC was at the hearing and explained at lengththat there was great danger involved in the procedure. She described previousexamples of non-human viral diseases being transmitted from primates tohumans. She stated, "baboon endogenous retroviral proviral DNA can be detected in tissues of all baboon species, as well as those of many othermonkeys." These "retroviruses may have pathogenic potential underconditions associated with xenotransplantation." She compared thisto the, "periodic emergence of new pandemic influenza strains,"which is thought "to occur by a process of re-assortment between humanand animal influenza viruses."

In other words, one of the viruses in the baboon hitherto unknown to humansmay mutate in a human recipient and become the next AIDS or Ebola. Outbreakthe movie may be Outbreak the reality. Indeed some scientists believe thatthe first case of HIV occurred secondary to a contaminated polio vaccine.Vaccines were, and to a lesser extent, still are sometimes made with animalproducts. There are reported cases of death and sickness secondary to thevaccine being contaminated with animal infections. Whether or not HIV didin fact originate with a contaminated polio vaccine is irrelevant at thispoint in time. What is relevant is the fact that scientists acknowledgethat it is possible that HIV could have entered the human species that way.
Even scientists at the University of Pittsburgh had reservations about theprocedure. Dr. Marion Michaels stated before the FDA committee,
"the donor organ, the tissue or the accompanying hematopoietic cellscan also be a source of infection. Most often these infections are latentorganisms and are often clinically silent in the donor."

The most outspoken critic may be Dr. Jonathan Allen from the institutionwhich supplies the baboons. As an expert on primate viruses he stated that, " any agent or pathogen that a baboon may harbor is also going to bemore likely to be transmitted to humans." He is concerned that thesame type of mutations that Dr. Chapman warned the committee about. He wenton to state that it is, "well established that most new emerging human infectious diseaseshave their origins in other species." He also explained to the committeethat a new virus may not be detectable by current means. The safety issueinvolved in xenotransplantation does not end with the patient. Accordingto these scientists, and others, the entire population may be at risk. Isthe benefit worth the risk? Dr. Allen concluded that,"to proceed withthis kind of procedure in the face of knowing how AIDS is transmitted, isto repeat the past because none of the types of screening processes, noneof the registries, none of the archiving of samples, none of the surveillance,none of that would pick-up on an AIDS like virus. If you proceed with this,you need to understand there is going to be a risk that you are not goingto eliminate the risk of transmitting another virus that could be as deadlyas the AIDS virus." These experiments "constitute a threat tothe general public health and not merely a complication of the risk/benefitcalculation for the individual xenogenic tissue recipientDo not use non-humanprimates as organ donors if you don't want to infect the human population."

So why did the FDA approve the procedure? In addition to having voting memberswho had vested interests in the field, one member of the committee admittedthat,"We were heavily influenced by emotional pleas on the part ofthe family of the recipient."The risk to other humans from xenotransplantationis real. Many scientists and physicians have stated that xenotransplantsare not in the best interest of the public and have encouraged caution indealing with this potentially catastrophic situation. Perhaps the most ironicaspect of the xenotransplantation and AIDS is the fact that some scientistsbelieve that AIDS originally crossed the species barrier and mutated asa result of using monkey tissue in the development of the polio vaccine.

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