Is Unregulated GE Research on
Vaccines & Disease A Public
Health Threat

GM & Bio-weapons Control Must Go Together

Talk presented to Workshop on Bio-weapons and GM, during the Fifth
Review Conference of the Biological Weapons Convention, Geneva,
20 November, 2001, by Dr. Mae-Wan Ho

The basic tools and materials for making bio-weapons are the same as
those used in 'legitimate' GM applications. There is little or no effective
defence against bio-weapons, and GM may be worse. While bio-weapons
are made under strictly contained conditions, many dangerous experiments
are being done without adequate safety precautions, and hazardous GM
products released into the environment as if they were safe. We urgently
need to bring both GM and bio-weapons under peaceful international control.

The Biological Weapons Convention to stop proliferation of biological
weapons came into force in 1975 and now has 144 state parties, but it
lacks provision to monitor and verify compliance. That is particularly
serious in the era of genetic engineering, when new and dangerous
pathogens can easily be created in small research laboratories. Monitoring
is difficult because genetic engineering is used for "legitimate" purposes
such as vaccine production or research on how bacteria and viruses
cause diseases.

Biological weapons have been back on the agenda ever since it transpired
that USSR had been active in bio-weapons research towards the end of
the cold war. Earlier this year, the US government drew up plans to
engineer a potentially more potent variant of the deadly anthrax bacterium
in order to assess whether the vaccine now being given to millions of American
soldiers is effective against a more deadly version of the bacterium [1].
Russian scientists have created such a super-bug in 1995, by splicing a gene
from Bacillus cereus, a food borne pathogen, into the anthrax bacterium.

Unfortunately, there is little or no effective defence against biological
weapons. Events following the anthrax attacks are showing up huge
inadequacies in coping with bio-warfare [2]. Vaccines are no
protection, and may be worse than useless. Vaccines cannot be made
against unknown diseases. Of the known diseases, the most feared are
smallpox and anthrax. But vaccines stocks are depleted and deteriorating,
as are antidotes for treating adverse reactions due to vaccines.

The side effects of smallpox vaccines include an often fatal reaction
known as vaccinia necrosum that destroy flesh and muscle, encephalitis
(inflammation of the brain), aggressive eczema, and in people suffering
from immune damage such as those infected with HIV, a dangerous
pox infection. Today, there are hundreds of thousands in the US with
weakened immune systems from HIV and other viruses, as well as from
drugs used to treat cancer and prevent rejection of organ transplants. Such
people could become ill from the vaccine and infect others, precipitating an
epidemic.

Moreover, vaccines cannot be tested for efficacy and safety in the absence
of a substantial population of the afflicted.

The Food and Drug Administration is attempting to overcome this deadlock.
It published and requested comments on a proposed rule for approving new
drugs and biological products developed to prevent serious or life-threatening
conditions based only on evidence of effectiveness derived from animal
studies. In other words, in a state of emergency, human beings will
have to be guinea pigs. Large pharmaceutical companies are currently being
compelled to manufacture some 300 million doses of smallpox vaccine as an
unlicensed "investigational new drug".

Efforts by the Pentagon to vaccinate 2.4 million military personnel with the
anthrax vaccine have run into stubborn opposition by soldiers, sailors
and airmen who maintain that a disproportionate number of those taking the
shots have suffered dangerous side effects. This vaccine has been implicated
in Gulf War syndrome and deaths.

An article in Nature Genetics warns that, compared with chemical and
nuclear weapons, "biological weapons pose by far the greatest threat, because
they can be as lethal as nuclear weapons and are easier to obtain" [3].

New knowledge of the human and other genomes is making it possible to
enhance antibiotic resistance and virulence of pathogens. Pathogens
could be made harder to detect, diagnose and treat simply by recombining
parts from several pathogens. Researchers in Australia who inadvertently
transformed the relatively harmless mouse-pox virus into a lethal pathogen,
also showed how that could be done: by incorporating a gene that undermines
the immune system [4]. Predicted for decades, the possibility of targeting
specific human populations and ethnic groups may be getting closer to reality,
although no race-specific genes have been identified thus-far, and
hopefully never will.

And "legitimate" uses of GM have been raising serious safety concerns.

There have been numerous breaches of safety regulations in university
laboratories researching dangerous pathogens in Britain, such as
dengue fever virus, AIDS virus, TB bacteria, and lethal encephalitis virus
[5]. Many dangerous research projects are being carried out in genetic
engineering laboratories around the world.

A lethal mousepox virus was created in Canberra Australia, in a genetic
engineering experiment to design a contraceptive vaccine for mice [4].
In Marburg Germany, a mutant Ebola virus, created in the course of
investigating the virus' ability to cause disease, was significantly
more lethal to cells than the natural virus [6]. Researchers in Kyoto
University Japan and in other laboratories have created 'SHIVs', hybrids
between the human and monkey AIDS virus containing human
interleukin genes that suppress immune response against viruses, in
order to investigate the role of the interleukins in AIDS disease [7].
At the same time, GM crops engineered with interleukin genes are being
grown in open field trials [8]. One SHIV used in monkeys mutated into a
pathogen so powerful that it kills rhesus macaques in weeks [9]. But this
pathogen is now used as an AIDS vaccine challenge in all United States
NIH-funded research. Genetic engineers are creating new viruses in the
process of cloning, or just to show it can be done [10]. The safety of
genetic engineered vaccines is being called into question.

Evidence is accumulating that AIDS vaccines based on the HIV
glycoprotein not only undermine the immune system of individuals but
are also likely to create deadly viruses and bacteria that can spread
through entire populations [11]. These vaccines are being used effectively
as slow bio-weapons in mass clinical trials around the world, as Dr. Veljkovic
and I have warned in a letter to Dr. Gro Bruntland, Director General of the
WHO [12]. A live GM vaccinia-rabies vaccine for wild life has infected a
woman resulting in serious illness [13]. The hazards of gene therapy research
are beginning to unfold since the death of teenager Gelsinger from a clinical
trial two years ago [14]. The common gene therapy vector that killed him
from toxic shock is now found to cause cancer in mice [15].

Earlier, the most common gene transfer vector used in plants was found
to transfer genes into the human genome, with the potential to cause
genetic damage including cancer [16].

The soil bacterium Bacillus thuringiensis, from which endotoxin (Bt)
genes are extracted and widely incorporated into GM crops as bio-pesticide,
was found to be a very close relative of the anthrax bacterium [17].
Furthermore, at least some Bt genes are toxic or allergenic for human
beings [18].

The events surrounding the foot and mouth disease outbreak in the UK,
which started in February this year, suggest that it may be linked to tests
of GM vaccines against the foot and mouth disease virus in 'simulated'
bio-warfare emergencies [19]. There was an early report that the anthrax
strain involved in the US attacks was genetically modified [20], though this
has not been confirmed.

GM experiments are in some respects worse than biological weapons. For
every biological warfare agent, it is possible to know its biological
origin, its mode of action, where it is produced and where it is released,
providing the BWC Protocol can be agreed. But in the case of accidental
creation of deadly pathogens in GM experiments, or contamination with GM
microorganisms, none of these parameters is known, and in most cases cannot
even be predicted. In the event of disease outbreaks, diagnosis will be delayed,
and more people will get ill and die.

Moreover, bio-warfare agents are made under strictly contained conditions,
whereas potentially dangerous agents are being inadvertently widely released
into the environment or into human populations as though they were safe.

Genetic engineers are playing genetic Russian roulette with GM viruses and
bacteria. The barrel of the gene gun is pointed at all of us: humans, domesticated
plants and animals and wild life included.

There is an urgent need for goodwill on all sides, to bring both bio-weapons
and genetic engineering under peaceful international control.

To support this statement, please e-mail your intention and details to
m.w.ho@i-sis.org. Visit ISIS website for the list of current signatories

1. "U.S. Germ Warfare Research Pushes Treaty Limits" by Judith Miller,
Stephen Engelberg and William J. Broad, New York Times, September 4,
2001.

2. "Biodefence in tatters" by Mae-Wan Ho, ISIS Report, 8 November 2001
http://www.i-sis.org/Biodefense.php

3. Dando MR. Genomics and future biological weapons: the need for
preventative action by the biomedical community. Nature genetics 2001,
29,53-6.

4. "Disaster in the making" by R. Nowak, New Scientist 2001, 13, 4-5.

5. "Threat from fatal bugs as labs breach safety rules" by Antony
Barnett, The Observer, August 19, 2001.

6. Volchkov VE, Volchkova VA, Muhlberger E, Kolesnikova LV, Weik M,
Dolnik O, Klenk H-D. Recovery of infectious Ebola virus from complementary
DNA: DNA editing of the GP gene and viral cytotoxicity. Science 2001, 291,
1965-9.

7. Kosyrev, Miura T, Haga T, Kuwata T and Hayami M. Construction of
SIV/HIV-1 chimeric virus having the IL-5 gene and determination of
their ability to replicate and produce IL-5. Arch Virol 2001, 146,1051-62.

8. See "GM AIDS virus more lethal" by Joe Cummins & Mae-Wan Ho ISIS
News 11/12, October 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online)
http://www.i-sis.org/Biodefense.php

9. See "Skeptical about AIDS vaccine; testing method questioned" by
Laurie Garrett, Newsday (New York), September 6, 2001.

10. See "Genetic engineering superviruses" by Mae-Wan Ho, ISIS News
9/10, July 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online)
http://www.i-sis.org/isisnews/i-sisnews9-10.shtml

11. Veljkovi V, Metlas R, Kohler H, Urnovitz HB, Prljic J, Veljkovic
N, Johnson E and Muller S. AIDS epidemic at the beginning of the third
millennium: time for a new AIDS vaccine strategy. Vaccine 2001, 19,
1855-62; see also See "AIDS Vaccines Trials Dangerous" ISIS News1/12,
October 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online)
http://www.i-sis.org/isisnews/i-sisnews11-19.shtml

12. Letter to Dr. Gro Harlem Brundtland, Director General of WHO, from
Veljko Veljokovic and Mae-Wan Ho, 1 October 2001.

13. Rupprecht CE, Blass L, Smith K, Orciari LA, Niezgoda M, Whitfield
SG, Gibbons RV, Guerra M and Hanlon CA. Human infection due to recombinant
vaccinia-rabies glyco-protein virus. The New England journal of
Medicine 2001, 345, 582.

14. "Gene therapy oversold by scientists who disregard risks" by Angela
Ryan, ISIS News 9/10, July 2001, ISSN: 1474-1547 (print) ISSN:
1474-1814 (online) http://www.i-sis.org/gene_therapy.shtml

15. "Common gene therapy vector causes cancer" by Mae-Wan Ho, ISIS
News 11/12, October 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814 (online)
http://www.i-sis.org/isisnews/i-sisnews11-6.shtml

16. "Common plant vector transfers genes to human cells" by Joe Cummins,
ISIS News 11/12, October 2001, ISSN: 1474-1547 (print) ISSN: 1474-1814
(online) http://www.i-sis.org/isisnews/i-sisnews11-7.shtml

17. "Biopesticide and Bioweapons" by Joe Cummins, ISIS Report, 23
October 2001 http://www.i-sis.org/biopesticide&bioweapons.php

18. "Bt risks negligible?" by Mae-Wan Ho and Joe Cummins, ISIS Report,
12 November 2001 http://www.i-sis.org/btriskassessment.php

19. "Foot and mouth outbreak, GM vaccines & bio-war exercise" by
Mae-Wan Ho, ISIS News 11/12, October 2001, ISSN: 1474-1547
(print) ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews
11-5.shtml

20. "Investigators say anthrax strain was modified" by Sanjay Bhatt
and Meghan Meyer, October 10, Cox News Service, via nlpwessex@bigfoot.com