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Leaked Documents Expose Horrors and Failures of Animal Transplant Experiments

UK Scandal Could Bring Down Xenotransplantation Industry

A scandal, which could only be described as the Watergate of the biotechnology industry, made headlines in Britain today. The Daily Express ran the explosive story on what is perhaps the largest leak of secrets from within a multinational corporation engaged in controversial biotechnology research.

Internal documents, leaked from the Swiss multinational Novartis AG Pharma - a primary investor in controversial animal-to-human organ transplantation (xenotransplantation) - revealed glaring technical failures and horrific animal suffering in pig-to-primate experiments sponsored by the company and its British subsidiary, Imutran, Ltd..

"These documents are a damning indictment of the state of xenotransplantation research and the companies and scientists involved, both from an ethical and scientific standpoint," says Alix Fano, Director of the Campaign for Responsible Transplantation (CRT), a group promoting a ban on xenotransplantation. "If ever there was a time for investors to take their money and run away from an industry, that time would be now," she says.

Uncaged Campaigns, the British advocacy group which received the extensive caché of leaked documents from an anonymous source, published a 150-page report online today, Diaries of Despair: The Secret History of Pig-to-Primate Organ Transplant Experiments, at www.xenodiaries.org. The report calls for, among other things, an end to all animal-based xenotransplantation research, including the genetic engineering of pigs as source animals, an end to the importation of wild African primates for experimentation, and an official judicial inquiry to investigate the findings.

The website contains downloadable files of most of the leaked documents, including 39 draft study reports describing xenotransplantation experiments commissioned by Imutran and conducted by the controversial contract research laboratory, Huntingdon Life Sciences, in Cambridgeshire. Other documents include correspondence, meeting minutes, feasibility studies and internal reports concerning aspects of, and plans for, xenotransplantation research. All is being submitted to Government ministers, regulatory bodies and Parliamentary committees in London.

Dan Lyons, Uncaged Campaign Director, and author of Diaries confirms that the documents reveal: a failure to overcome the intrinsic biological obstacles to xenotransplantation, despite headlines to the contrary; inadequate Government regulation; incompetence in the conduct of research; and severe animal suffering endured by higher primates (recorded by the researchers themselves).

In the experiments, juvenile baboons and cynomolgus monkeys are transplanted with genetically engineered piglet hearts and kidneys: over a quarter of the primates die as a result of the surgery.

The survivors are heavily dosed with cocktails of toxic anti-rejection drugs, but die from complications related to drug side-effects, infection, rejection, hemorrhage, and organ failure, most within hours or days of their surgeries. Diarrhea, vomiting, body tremors, weakness, swelling, wounds seeping blood and pus, collapses, rapid involuntary eye movements, breathing difficulties, grinding of teeth - are some of the other recorded list of agonies these animals endure.

Documents suggest that 473 higher primates have been killed in Imutran's xenotransplantation research program thus far; though Uncaged uncovered evidence that another 160 primates, including 80 wild-caught baboons, were killed in a 1995 research program involving the transplantation of hearts from cynomolgus monkeys into the necks of baboons.

In one shipment of cynomolgus monkeys to Imutran in August 1998, three animals were found dead with blood seeping from their nostrils after an arduous voyage of 48 hours. Welfare experts suggest that their crates were poorly ventilated and too small for the monkeys to turn around and lie down freely in.

At least 520 errors and omissions in the conduct of pig-to-primate studies were noted in the documents, including organ weights not recorded, unlabelled and uncovered veterinary medications, inadequate surgery records, a quadruple overdose, the illegal re-use of animals, conflicting pathology reports, the accidental freezing of a kidney during transplantation surgery, and the leaving of a swab inside a primate which resulted in his death. Seven baboons in one study appeared to have been experimented upon despite a warning that they "must not be worked on due to positivity for Herpes B."

According to Lyons, the documents demonstrate that, after five years of research, Imutran has improved the average survival time of monkeys with functioning pig kidneys from two to just four weeks. The success rate of heart xenotransplantation is even less tangible, with the average survival revealed as being eleven days. Lyons claims that Imutran has published only a fraction of its research in scientific journals, but the level of "success" indicated in these articles - in terms of criteria such as average survival times and the condition of the primate recipients - may now be called into question.

"Novartis is sponsoring xenotransplant research all over the U.S.," says CRT 's Fano. "Given the explosive and distressing nature of the information uncovered in the U.K., the U.S. Department of Health and Human Services (HHS), and/or the U.S. Congress have an ethical and fiscal responsibility to step in and halt all U.S. xenotransplant research, including clinical trials, immediately. Moreover, the Secretary's Advisory Committee on Xenotransplantation, currently being assembled in the U.S. to advise HHS Secretary Donna Shalala on xenotransplant policy, should close up shop now, before it wastes any taxpayer money," says Fano.

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http://www.xenodiaries.org