The Xenodiaries



This is information I had found and reported on about xenotransplantation (the use of animal parts, tissue, and cells) in research and animal clinical trials. I sourced and explained the information on various ME/CFS pages and forums, and to researchers starting on Sun 6/12/2016 11:01 AM. This information was done by Novartis in the UK in the 90's. Norvartis tried to stop these documents from coming out but the records were eventually published. There are many documents and records here that show they were realizing the dangers of the use of animals parts and cells. They were worried about the workers who were coming in contact with these animal xenograft experiments as well. One worker did not fair well after having blood from a xenograft splash them in the eye. Xenotransplantation is the use of "any" animal part, tissue or cell in research and medicine. Many xenografts are currently used in cancer research. Xenografts are the grafting of human and animal cells.

http://www.xenodiaries.org/summary.htm


INTRODUCTION
Horrific reality of vivisection revealed by sensational legal victory

Uncaged Campaigns has achieved an astonishing legal success by winning the right to publish the Diaries of Despairreport and over a thousand pages of confidential documents. Uncaged Campaigns argued successfully that it was in the public interest to reveal the shocking truth behind one of Britain's most extreme programmes of animal experiments in recent history.
Grotesque experiments

Between 1994 and 2000, hundreds of higher primates were subjected to grotesque 'xenotransplantation' experiments. Hearts and kidneys from genetically engineered piglets were transplanted into the necks, abdomens and chests of monkeys and baboons captured from the wild.

The primates were then injected and force-fed massive doses of immune-suppressing drugs in a vain attempt to prevent the alien organs from being rejected. The results were truly appalling.

The research was conducted by a biotechnology company, Imutran Ltd, which is a subsidiary of the multinational drug firm Novartis Pharma AG, in collaboration with the University of Cambridge. The experiments took place at the controversial Huntingdon Life Sciences laboratories.
Unique revelations

The report and campaign are called 'Diaries of Despair' in recognition of the severe suffering inflicted on hundreds of primates revealed in the researchers' own detailed records.

The leaked confidential documents give a historically unprecedented insight into the disturbing world of vivisection. The main initial goal of the Diaries of Despair campaign is for the establishment of an independent judicial inquiry to investigate the incriminating evidence of Government malpractice and collusion, and to prevent such cruelty from being repeated.
A new era

The historic victory came after an arduous High Court battle. The Diaries of Despair were originally exposed by Uncaged Campaigns in September 2000, gaining national media coverage. Within a week however, Imutran had gained a temporary injunction banning Diaries of Despair, and a 'David and Goliath' struggle ensued as the company attempted to keep the information out of the public domain.

In autumn 2002, the Defendants were lining up a court hearing, claiming that Imutran and Novartis had failed in their duty to disclose key documents related to animal suffering and their relationship with the Government. The full trial was expected to take place in spring 2003.

In April 2003, a new Court order ratified an out-of-court settlement: Imutran and Novartis had surrendered in their attempt to suppress the Diaries of Despair.

Dan Lyons, author of Diaries of Despair and a joint Defendant with Uncaged Campaigns, comments:

"We have consistently argued throughout the proceedings that the clear evidence of horrific animal suffering and Government misconduct means that there is an overwhelming public interest in the publication of these confidential documents. Ironically, the fact that we have been forced to win a legal battle to publish the evidence simply confirms the scandalous implications of the documents.

"Now, for the first time in history, the public can discover the true scale of misery and distress caused by vivisection, and the corrupt politics that allows such atrocities to take place. We're entering a new era in the debate about animal experiments."

http://www.xenodiaries.org/report.pdf

PART I

SETTING THE SCENE: XENOTRANSPLANTATION, ETHICS AND THE REGULATION OF PRIMATE VIVISECTION

Diaries of Despair 5 CHAPTER 1

Introduction

1.1 Controversial research

Xenotransplantation is the transplantation of live organs, tissues or cells between different species. Such transplants are also referred to as xenografts.

This report organises and interprets an extensive cache of leaked documents that afford an extraordinary and unique insight into arguably the most controversial programme of animal experimentation in the United Kingdom in modern times: xenotransplantation research. The material includes 39 draft reports describing xenotransplantation experiments on higher primates commissioned by the UK biotechnology company Imutran Ltd and conducted by Huntingdon Life Sciences at their Cambridgeshire laboratories. Other documents include correspondence, meeting minutes, feasibility studies and internal reports concerning many aspects of the conduct of and plans for xenotransplantation research.

The experiments have predominantly involved the transplantation of hearts and kidneys from genetically-engineered pigs into two species of higher primates, baboons and cynomolgus monkeys. Following transplantation, the primates have been administered experimental cocktails of drugs in an effort to suppress their immune systems and thus prevent rejection of the pig organs. Through conducting this research, Imutran, the Cambridge-based biotechnology subsidiary of the multinational drug firm Novartis, hope to develop a package of treatments consisting of transgenic pig organs and accompanying immunosuppressive therapies to sell through health care providers to patients with malfunctioning organs.

Quite apart from the revelations of the acquired documents, xenotransplantation research has been controversial because:

If xenotransplantation ever proved successful, the use of genetically-modified pigs as sources of organs would signify a novel form of suffering, exploitation and death deliberately inflicted by human society on nonhuman animals.

The extensive use of higher primates in procedures that have caused very high levels of suffering.

Complex species differences between non-human primates and human beings that render results gained by experiments on the former unreliable as a guide to the human situation.

The contracting of this research programme to Huntingdon Life Sciences, a commercial research company whose track record includes breaches of animal welfare and Good Laboratory Practice regulations.

Diaries of Despair 6

The profoundly difficult problems faced in trying to overcome the rejection of

pig organs by the human immune system.

Serious doubts exist about the physiological and biochemical compatibility of pig organs with the human body.

The potential of xenotransplantation to introduce novel infectious organisms such as retroviruses into the human population, thereby causing new pandemics with echoes of HIV/AIDS.

The existence of alternative methods of tackling the health problems of organ failure such as preventative health measures, increasing the pool of human donors, mechanical devices or growing new organs from human cells.

The distributive justice of xenotransplantation: whether it represents the most efficient and most equitable use of scarce health resources.1

The commercial motivation behind the research, which adds up to an attempt to dominate a market that is predicted to be worth $11 billion by 2010.2

2.2 The “regulation” of animal experiments

The law that regulates animal experimentation in the UK is the Animals (Scientific Procedures) Act 1986 (A(SP)A). To conduct experiments on animals, an individual must apply for and receive a personal licence from the Home Office, the government department that administers the Act. A personal licence holder may then submit to the same department what is known as a ìproject licence applicationî for a particular programme of animal research. Project licences may be complex and large, and one project licence holder, who has overall responsibility for the procedures carried out on animals within the project, may have several personal licence holders working under him/her in the course of the project. Establishments that host programmes of animal experimentation must have gained a Certificate of Designation. There are conditions attached to all three approvals, the breaching of which is supposed to jeopardise the possession of the pertinent licence, and also result in a possible criminal conviction. Additional regulatory processes must be completed in certain cases, such as the acquisition of primates for research from overseas suppliers and the importation and use of wild-caught primates. The use of primates from overseas suppliers ñ some of them taken from the wild - are central aspects of the licensing of xenotransplantation research and will be discussed below.

The 1986 Act requires the Home Secretary to weigh the likely adverse effects on the animals against the benefits likely to accrue as a result of the programme specified in the project licence application. In practice, it is the Home Office Animals (Scientific Procedures) Inspectorate which scrutinises applications, although the advisory Animal Procedures Committee (APC) makes recommendations on particularly sensitive applications, one of which is the primate xenotransplantation research programme. Recommendations from the Inspectorate or the APC will usually be acted upon by civil servants in the Home Officeís Animals, Byelaws and Coroners Unit (ABCU), rather than actually be seen by the Home Secretary himself. The ABCU does, however, act on behalf of the Home Secretary, and it is the Minister who must take overall responsibility for the execution of the 1986 Act, even though the Secretary of State will rarely see or consider applications.

“Likelihood of ‘success’”

In 1995, Imutran claimed that they would be ready to commence clinical trials of xenotransplantation the following year. The imminence of clinical trials appears to have been put forward by Imutran in support of an application to conduct primate experiments. However, the profound and inscrutable biological obstacles to pig-to-human organ transplants have confounded significant progress. Five years later, in April 2000, Novartis have set Imutran an 18 month limit to achieve substantial progress in survival times and management of xenograft rejection. The improvements required appear to demand a quantum leap in progress, far surpassing that achieved in the previous five years at the cost of hundreds of primates lives, their severe suffering, and the lives of thousands of pigs.

In the meantime, Imutran have been publishing papers highlighting their longest survivors, while claiming that the primates tolerate the procedures and drug regimens well. We believe that the evidence presented here raises serious doubts about these assertions of ësuccessí.

Furthermore, over a quarter of the primates vivisected have died as a result of technical failures in the surgical procedure. At least three more animals died as a result of complications arising from biopsies.

“How the data generated will be used”

If the company reaches its survival targets, Imutran intend to submit the data generated from these studies in support of future applications to conduct xenotransplantation clinical trials, probably in the U.S.. However, as mentioned above, the company appears to be having ìsevere problemsî with the condition of the data. This may be related to possible shortfalls in GLP referred to above.

8.2 Recommendations

Taking into account this discussion of the relevant features of the cost-benefit analysis, we suggest that xenotransplantation research should never have been licensed in the first place. The argument against the licensing of such research has grown in weight as the biological barriers and the potential public health hazards, as well as the extent of animal suffering have been confirmed in practice.

We therefore recommend that all licences to conduct xenotransplantation research on animals be revoked immediately, and we highlight the need for an independent judicial enquiry to examine the Home Officeís initial decision to licence this research and their subsequent failure to halt it.

To sum up, these are our urgent recommendations:

The revocation of all licences to conduct xenotransplantation research on animals.

A prohibition on the use of primates in research

The revocation of Huntingdon Life Sciencesí Certificate of Designation

and rehoming of animals currently incarcerated therein.

An investigation by the Good Laboratory Practice Monitoring Authority

into the conduct of the whole research programme.

Most importantly, an independent judicial enquiry should be instituted to

investigate possible breaches of UK and European law that may have taken place during the course of this research; and the conduct of the Home Office throughout this whole affair.

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Here are many archive records from 2000 to 2008

http://www.xenodiaries.org/archive.htm

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The Legal Battle

1. Introduction – justified exposure of a horrific scandal

2. The public interest
(i) Primate suffering

(ii) Virus risk
(iii) Home Office misconduct

(a) Deliberate underestimation of animal suffering
(b) ‘Rubber stamping’: the Inspectorate’s private view of the regulatory framework
(c) Direct concealment of regulatory violations from Parliament and public (d) Covering-up for Huntingdon Life Sciences
(e) Breaches of absolute legal limits on suffering
(f) The cost/benefit assessment

(iv) Imutran inaccuracies
(a) Hyping xenotransplantation

(b) Secret suffering (v) Illegal severe suffering?

3. Chronology of legal battle

1. Introduction
Justified exposure of a horrific scandal

Five days after the original disclosure of the Diaries of Despair on 21 September 2000, Imutran Ltd obtained a temporary injunction from the High Court in London banning the publication of the report and the entire haul of leaked documents. The injunction did allow the documents to be disclosed to specified Government bodies. Imutran had claimed that the Defendants, Uncaged Campaigns Ltd and Dan Lyons (director of Uncaged Campaigns and author of the Diaries of Despair report) had:From the very beginning, we had defended our right to freedom of expression on the grounds that there was an overwhelming public interest in the publication of the Imutran documents because they revealed a number of extremely serious ethical and political concerns, particularly:

invasive and painful experiments on higher primates

the risk of dangerous viruses being spread to humans by Imutran/Novartis’ experiments

http://www.xenodiaries.org/legal.pdf

DIARIES OF DESPAIR
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There are several links within their website.  http://www.xenodiaries.org/index.html

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