The Craft of the Wise.

In December 1997 Channel 4 showed a Dispatches investigative television documentary I co-produced with Rosie Thomas. It was on one of the most serious topics I have ever investigated. What we found was more serious than the Mad Cow outbreak - but perhaps because our program went out just before Christmas, the newspapers did not cover it. The following is a copy of the leaflet I wrote to go with the program. Please distribute. Jani Roberts.

Channel 4 Television

Dispatches

Contaminated polio vaccines

 

Foreword

In 1997, an international scientific workshop held in Washington DC heard report after report that a monkey virus &endash; simian virus 40 (SV40) &endash; had been found in many human cancers of the brain, bone and lining of the lungs. This virus had reached the human population between 1955 and 1963 through the contamination of millions of doses of polio vaccine. Recent research has shown that even people who have never been exposed to this polio vaccine are at risk.

This leaflet explains how all this came about and what it means for human health. It concludes with a list of organisations that can be contacted for further help and information.

Introduction

In 1961&endash;2, the Medical Research Council in Britain reported that a monkey virus &endash; simian virus 40 (SV40) &endash; that caused cancer in hamsters was contaminating the polio vaccine given to millions of people around the world. However, SV40 was then presumed not to harm humans. When, in 1972, the New England Journal of Medicine reported that the virus had been detected in human brain cancers, no alarm was taken. Then in 1996, a number of scientists reported finding SV40 in many human cancers of the bone, brain and lung lining, and that the virus causes 'severe chromosome damage' in human cells.

These research findings were finally taken very seriously. In January 1997, the first international scientific workshop on SV40, sponsored jointly by the US government's major health agencies, was held in Washington DC. Over 100 scientists from around the world attended &endash; as did a senior representative of the UK's Department of Health and film producers commissioned by Channel 4's Dispatches.

Many at this conference now believe that the most likely source for the monkey virus contamination of the human population was the millions of doses of polio vaccine distributed around the world between 1955 and 1963, including in the UK. That the polio vaccine had been contaminated was actually admitted in Parliament back in 1988, but at that time the government said it believed the virus to be harmless in humans. But research from many laboratorities was presented at However, in the opinion of the 1997 conference, that indicated that SV40, &endash; now endemic in the human population, could &endash; could have a role in causing thousands of human cancers.

It is hoped that this leaflet will answer any questions you may have.

What is a vaccine and how does it work?

All vaccines work by stimulating the body's natural immune system to produce antibodies that will protect us from specific illnesses. The stimulus used is a weakened or killed version of the virus or bacterium responsible for the targeted disease.

Most of the common vaccines given during childhood &endash; such as those for polio, measles, mumps and rubella (German measles) &endash; use a living virus but only after it has been 'attenuated', or weakened, by various methods such as heating or being transplanted many times from cell to cell. With attenuated vaccines, care has to be taken to ensure that the virus (or bacterium) is sufficiently weakened so as not to cause the severe form of the disease, while at the same time being strong enough to confer immunity. Great care also has to be taken to ensure that the vaccines are not contaminated in any way.

How did the polio vaccine come to contain monkey viruses?

When the polio vaccine invented by Dr Jonas Salk first became available on a large scale in 1955, there was a rush to use it to help eliminate what could be a terrible disease in children and young people. As the virus needed for the vaccine grew well in the kidney tissues of monkeys, there was a great demand for these kidneys. They were taken from many thousands of Indian Rhesus monkeys imported into the US and Europe.

It was very quickly discovered that Rhesus monkey viruses were getting into the polio vaccine. However, health authorities initially did not think that this was dangerous because the Salk polio vaccine most commonly used in the 1950s and early 1960s was based on killed polio viruses. It was presumed that the method used to kill the polio viruses would also kill all the monkey viruses contaminating the vaccine.

This presumption continued throughout the 1950s despite the discovery in 1956 by US government scientist Dr Bernice Eddy that some agent in the monkey kidneys appeared to be causing cancers in hamsters into which it had been injected. By 1958, this agent had been identified as SV40 (that is, the 40th simian virus identified). It was also reported that this virus was not found in samples from humans unexposed to the polio vaccine but was found in 7 of every 13 people inoculated against polio. SV40 soon also became very well known in laboratories for its ability to 'jump species' &endash; that is, its ability to live in species other than monkeys.

The research that forced US and UK authorities to act was published in March 1961 in the British medical journal, the Lancet. This showed that SV40 survived the process that killed the polio vaccine and was alive and active in the vaccine. Of 20 British children who had received the Salk polio vaccine, 13 tested positive for SV40, but none of the children who had not had the Salk vaccine tested positive. By this stage, many millions of doses of contaminated polio vaccine had been administered worldwide to children, young adults and expectant mothers.

Confirmatory research by the UK Medical Research Council was published in the Lancet in June 1961: 12 children who had received three doses of the Salk polio vaccine were tested &endash; and 11 of them were positive for SV40.

When was the link between cancer and SV40 discovered?

At about the same time that the survival of active SV40 in polio vaccine was confirmed, reports were also surfacing that SV40 caused cancers. In March 1961, Dr Eddy sent a paper to the medical journal Virology in which she demonstrated that injection of newborn hamsters with Rhesus monkey kidney cell cultures caused cancers in 109 out of 154 cases (Virology did not publish this until 1962). Soon came news that SV40 might be responsible for cancer in humans as well as in laboratory animals. The 1961&endash;62 Annual Report of the Medical Research Council stated: 'There have been recent reports that it [SV40] causes a change in behaviour of human cells grown in tissue culture: a change which may or may not be neoplastic [cancerous] in character. Further intensive studies of the virus are obviously called for.'

In 1962, American research papers were published showing that human tissue became cancerous when exposed to SV40. Then in 1972 in the US, a virus related to SV40 was isolated for the first time from human brain cancers. No follow-up research was done in the UK.

Has the UK government confirmed that the British polio vaccine was contaminated with SV40?

Yes. On 19 July 1988, the Minister for Health was asked in Parliament 'whether polio vaccine used in the UK in the late 1950s and the early 1960s was contaminated with SV40 and what effects this known enhancer of genetic change in other micro-organisms is considered to have in its recipients?' He answered: 'I am advised that some of the polio vaccine used in the UK at that time contained SV40. However, I am also advised that there is no evidence of adverse effects on recipients.'

The Minister added to this in an answer to a follow-up question: 'There has been no separate continued observation of those people in the UK who might have received vaccine contaminated with SV40.' This has been the situation up to the present.

Who manufactured the contaminated polio vaccine used in the UK in the 1950s?

The American companies Parke Davis, Pitman-Moore and Connaught Laboratory all supplied the UK in the 1950s with at least 20 million doses of polio vaccine of which over 6 million doses may have been contaminated with SV40. The vaccine was manufactured in the UK by both Glaxo and Burrough Wellcome and their supplies may have been similarly contaminated. In 1959, Pfizer also started manufacturing polio vaccine for recipients in the UK.

Does polio vaccine still contain SV40?

It does not &endash; and has not, to the best of our knowledge, since 1963.

Steps were taken in 1961 to eliminate the SV40 contamination from all freshly manufactured polio vaccines. These measures included ending the use of Indian Rhesus monkeys and instead using African green monkeys. The latter are free of SV40 contamination in the wild, but since they rapidly become infected in laboratory conditions, they need to be constantly monitored after capture.

In addition, from 1962 the injected Salk vaccine was replaced by the orally administered Sabin type, which contains a living 'attenuated' polio virus. This vaccine cannot infect people with SV40 simply because it is taken by mouth: the human gut filters out all SV40 viruses, thus preventing them from infecting us.

However, even after SV40-free vaccine became available, the US authorities did not simultaneously withdraw batches of contaminated polio vaccine that had already been released. Since it had a two-year shelf life, some contaminated vaccine was available as late as 1963.

Was SV40 the only monkey virus to contaminate the polio vaccine?

Several other monkey viruses have been found in polio vaccine, most notably simian immunodeficiency virus (SIV), which has only been screened out since 1987. This virus is endemic among African green monkeys, the species currently used in the manufacture of UK and US polio vaccine. A herpes-like monkey virus is also filtered out. Another possible contaminant is SCMV (simian cytomegalovirus), isolated in 1994 from human brain tissues taken from patients who had suffered from previously unexplained encephalitis and chronic fatigue syndrome. This virus is also likely to come from African green monkeys, the species used nowadays in the manufacture of polio vaccine. Very little research has been done on any of these viruses.

We have focused on SV40 as it is the most understood of the monkey viruses. Because it is used in medical experiments requiring a virus that can jump species, its DNA has been fully analysed and so it is easily identified. It is also the monkey virus that has attracted most research into its links with human diseases. A number of other monkey viruses &endash; such as SV29, SV39, SV28 and SV38 &endash; are known to reproduce in human tissues.

Can polio vaccine be made without using monkeys?

Yes, without a doubt. At least one major drug company sells two forms of polio vaccine: one grown in cloned human tissue (an established vaccine manufacturing method, also used to produce rubella vaccine), the other in monkey kidney tissue. The human tissue-grown polio vaccine comes with no risk of cross-species virus contamination. However, the wild monkey tissue-grown version is reportedly slightly cheaper to make.

The World Health Organisation recommends three manufacturing processes for polio vaccine:

1 Wild monkey kidneys. The company SmithKline Beecham manufactures most of the polio vaccine for the UK by this method.

2 Cloned human tissue. This method is utilised in some European countries and in Canada. The US Connaught Laboratory makes polio vaccine both by this method and from wild monkeys, selling human tissue-based vaccine in Canada and monkey tissue-based vaccine in the US.

3 Cloned monkey tissue. This method is safer than using tissue from wild monkeys. Suitable cloned tissue stocks are maintained by WHO for use in manufacturing polio vaccine.

While permitting all three methods, the World Health Organisation points out that the first carries the greatest risk of viral contamination. Therefore it recommends that, if this method is used, rigorous screening and animal testing should also be adopted.

What does SV40 do in humans?

In 1996, a scientist in Texas reported that SV40 causes 'severe chromosome damage in virtually every human fibroblast [cell producing collagen fibres in connective tissue] in which it is expressed.' Recent experiments carried out in laboratories around the world and reported at the 1997 SV40 conference in Washington also indicate that it causes severe damage to human chromosomes. In particular, it appears to turn off the p53 gene that controls the multiplication of cells and thus eliminates part of our protection against cancer.

SV40 has now been found concentrated in certain human cancers. For example:

in 33&endash;50% of bone cancers

in 60&endash;80% of certain brain cancers

in 60% of mesotheliomas &endash; a cancer of the lung lining, which claims some 1,200 victims a year in the UK alone.

It is possible that we will find that SV40 plays an even larger role, perhaps by helping to cause cancers without becoming concentrated in them. For example, SV40 has not been found in human breast cancers, but a 1996 report of German research using laboratory animals stated that SV40 'induces breast cancer with a high efficiency' in 100% of breastfeeding and 70% of virgin animals, while not making all the cells transformed positive for SV40.

Can SV40 work with asbestos and other environmental factors to cause cancers?

This is still being investigated. Mesolthelioma &endash; cancer of the lining of the lungs &endash; has long been associated with exposure to blue asbestos, and it is now found to be associated with SV40 in about 60% of cases. It could be that SV40 facilitates the production of this cancer by switching off the p53 gene and thus leaving the body more vulnerable to factors such as asbestos that are known to cause cancer. This has important legal ramifications for companies currently being fined millions of dollars by the courts for exposing workers to the dangers of asbestos. They could now argue that the legal responsibility must be shared by those responsible for the SV40 presence in the polio vaccine.

The only published British research on SV40 was presented by Alan Gibbs at the 1997 SV40 workshop in Washington. He stated that an examination of nine mesothelioma tumours held at his Welsh hospital showed four to be contaminated with SV40.

If SV40 has now been screened out of the vaccine, surely we are now safe from it?

Unfortunately this does not seem to be the case. The virus now seems to have become endemic among the human population. For instance, it has been found in brain tumours in children not exposed to the contaminated vaccine, and the best theory for why this has happened is that it was passed from mothers to children. In addition, at the SV40 workshop in Washington, Professor Mauro Tognon of Verona, Italy, reported having found SV40 in 8 out of 20 samples of 'healthy' human semen.

What can be done to counter the damage done by SV40?

Hope was held out by a leading into this virus, Michele Carbone, at the SV40 workshop. Now that we know how SV40 affects the human chromosome, he said, we may be able to devise ways of turning the p53 gene back on, perhaps by vaccination. But research on this is at a very early stage.

Resources Organisations

The Informed Parent

PO Box 870

Harrow

Middlesex HA3 7UW

Tel: (0181) 861 1022

e-mail: easy@dircon.co.uk

Contact: Faith Easy

This organisation has researched the medical literature about SV40 in order to 'promote awareness of vaccination issues to preserve the freedom of an informed choice'.

JABS

1 Gawsworth Road

Golborne

nr Warrington

Cheshire WA3 3RF

Tel: (01942) 713 565

Fax: (01942) 201 323

e-mail: jabs@argonet.co.uk

Contact: Jackie Fletcher

A support group for individuals who have been vaccine damaged.

 

National Vaccine Information Center

Suite 206, 512 W Maple Avenue

Vienna

Virginia 22180

USA

e-mail: info@999shot.com

Website: www.909shot.com

Contact: Barbara Loe Fisher

An American organisation that raises funds for research into SV40 and sells an information pack on this issue.

 

Asbestos-Related Disease Association

80 Raymeer Drive

Bestwood

Nottingham NG5 5FS

Tel: (0115) 927 5108

: (0115) 903 7791 (24-hour helpline)

Self-help group for all with an asbestos-related health problem, formed to help the victims and their families in every way possible.

BACUP: British Association of Cancer United Patients, Their Families and Friends

3 Bath Place

Rivington Street

London EC2A 3JR

Tel: (0171) 696 9003

For general enquiries about cancer, not for information on SV40.

Further reading

If you want to investigate the medical literature on the subject of SV40, the following are the main papers, in chronological order:

Eddy, B, Morris et al., Virology 3, 1957, p. 380 (accepted for publication 3 December 1956).

Sweet, B H and Hilleman, M R, 'The vacuolating virus SV40', Proceedings of the Society of Experimental Biological Medicine 105, 1960, pp. 420&endash;7. This reports that, from 1958, SV40 viruses had been 'repeatedly encountered'.

Goffe, Alan, Hale, James and Gardner, P S, Letter, Lancet, 18 March 1961.

Eddy, B, Morris, Borman, G S, Grubbs, G E et al., 'Identification of the oncogenic substance in Rhesus monkey kidney cultures as SV40', Virology 17, 1962, pp. 65&endash;75.

Shein, H M and Enders, J F (of the Harvard Medical School), 'Transformation induced by Simian Virus 40 in human renal cell cultures', Proceedings of the National Academy of Science (US) 48, 1962, pp. 495&endash;500.

Weiner, L, Herndon, R and Narayan, O, 'Isolation of virus related to SV40 from patients with progressive multifocal leukoencephalopathy', New England Journal of Medicine 286, 1972, pp. 385&endash;90.

Martin, W J, Ahmed, K N, Zeng, L C, Olsen, J-C, Seward, J G and Seehrai, J S, 'African green monkey origin of the atypical cytopathic "stealth virus" isolated from a patient with chronic fatigue syndrome', Clinical Diagnosis of Virology 4, 1995, pp. 93&endash;103.

Lednicky, J A et al., 'Natural simian virus strains are present in human choroid plexus and ependymomo tumors', Virology 212, 1995, pp. 710&endash;17.

Carbone, M et al., 'SV40 large T antigen and p53 in human pleural mesothelioma', Journal of Cellular Biochemistry 19A (supplement), p. 321.

Ray, F Andrew, 'Simian Virus 40 large T antigen induces chromosome damage that precedes and coincides with complete neoplastic transformation', Oncogene, 1996, pp. 15&endash;24.

Carbone, M et al., 'SV40-like sequences in human bone tumors', Oncogene 13, 1996, pp. 521&endash;35.

Pepper, Jasani, Navabi, Wynford-Thomas and Gibbs, 'Simian virus 40 large T antigen primar specific DNA amplification in human pleural mesothelioma tissue', Thorax, November 1996.

 

Published in 1997 by

Channel 4 Television

124 Horseferry Road

London SW1P 2TX

 

Produced by Broadcasting Support Services to accompany Dispatches: Contaminated Polio Vaccine (an Investigative Media Productions/Hindi Picture film for Channel 4), first shown on Channel 4 in December 1997

Writer: Janine Roberts

Editor: Paula Snyder

Editorial consultant: Nancy Duin

Design:

Printer:

 

Distributed by Broadcasting Support Services

Broadcasting Support Services provides follow-up services for viewers and listeners and runs long-term helplines.

To find out more about off-screen services for Channel 4 viewers

telephone (0990) 44 66 99 for a free catalogue of booklets in print

go to 4-Tel page 340

visit the Channel 4 website at www.channel4.com

 

For further copies of this publication, please send a cheque or postal order (made payable to Channel 4 Television) for £1.00 (including postage & packing) to:

DISPATCHES: POLIO VACCINE

PO Box 4000

London W12 8UF or Cardiff CF5 2XT

Alternatively, you can telephone (0990) 44 66 99.

 

If you would like to find out about health courses or other local learning opportunities, you can ring Learning Direct on (0800) 100 900. Lines are open from 9am to 9pm Monday to Friday and from 9am to noon on Saturday. All calls are free.

 

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