Info Service on Health Issues (January 07/05)
WHO Board urged to act on worrying smallpox research trends
indications that the US is expanding or intending to expand research
with smallpox virus outside of WHO control and that WHO may be back-pedalling
on some of its previous decisions, have led NGOs to call for a strong
resolution on smallpox on the part of the Who Executive Board which
meets this week in Geneva.
following story is reproduced with the permission of South-North Development
Monitor (SUNS) #6174, 23 January 2007.
Health: WHO Board urged
to act on worrying smallpox research trends
By Lim Li Ching*, Kuala Lumpur,
22 January 2007
The WHO Executive Board,
meeting this week in Geneva, has been urged by NGOs to produce a strong
resolution on smallpox (variola), including fixing a new date for the
destruction of existing stocks, banning genetic engineering experiments,
and strengthening WHO control over variola research.
This is in light of increasing indications that the United States is
expanding or intending to expand research with the smallpox virus and
with variola genes, including the synthesis and use of variola virus
genes outside of WHO-authorized repositories.
There are three worrying trends that should lead to strong action by
the WHO Board, say two NGOs following the smallpox issue, the US-based
Sunshine Project and the Malaysia-based Third World Network:
-- A laboratory linked to the US government and whose work includes
designing weapons of mass destruction for the US army has initiated
experiments with variola virus genes engineered into other organisms,
using smallpox genes that are not from a WHO-authorized repository,
but synthesized by a company.
-- A US government biosecurity committee has proposed that domestic
US legal restrictions on possession of variola virus be repealed, which
would effectively allow possession of the virus.
-- The WHO advisory committee overseeing the remaining stocks of smallpox
virus and research using it seems to be backpedaling on some of its
previous decisions. Prompted by disagreement over if and how the WHO
should control synthesized variola genes, it is also reviewing the rules
restricting the distribution of smallpox DNA and the type of research
allowed. Critics fear that, given the committee's previous attempt to
weaken these rules, this could be a dangerous move.
The WHO Executive Board is meeting on 22-30 January in Geneva and will
consider a draft resolution on smallpox, which was deferred from the
Fifty-ninth World Health Assembly (WHA) in May 2006. Then, the WHA was
unable to agree on the text of a resolution on destruction of variola
virus stocks, which are held in WHO-authorized repositories in the US
Many developing countries, led by Africa, had sought a resolution to
establish a new destruction date (June 2010) for the virus, a prohibition
on genetic engineering, annual substantive WHA review of virus research,
and strengthened WHO oversight.
Despite lengthy discussions, agreement was not reached at the WHA. The
US refused to consider fixing a new destruction date, and developing-country
offers of a compromise were also rejected. The issue was then passed
on to this week's Executive Board meeting to resolve.
While smallpox was generally eradicated in 1977, the US and Russia still
retain the virus. These remaining stocks were slated for destruction
in 1999, but the two countries balked at the WHA resolution calling
on them to destroy the virus.
Since then, the destruction date has been again postponed from 2002,
and after that there has been an indefinite extension of the destruction
order, until the US and Russia complete an ambitious research agenda
on smallpox, limited to public health purposes.
Moreover, the WHO's decision to leave oversight of smallpox research
in the hands of a largely unbalanced advisory committee, known as the
Advisory Committee on Variola Virus Research, has contributed to the
The need for a strong resolution on smallpox has never been greater,
say NGO critics. Since the WHA in 2006, two events have come to light
that have heightened concerns that WHO control over variola virus is
Firstly, Sandia National Laboratories, part of the US Department of
Energy, has initiated experiments with variola virus genes engineered
into other organisms.
Sandia did not obtain the smallpox genes from a WHO-authorized repository.
Instead, they were synthesized by a company and then used by Sandia
in at least four experiments.
As Sandia's mission includes the design and testing of Weapons of Mass
Destruction for the US armed forces, it is unclear if and how the research
with variola virus genes was construed to be within the public health
bounds established by the relevant WHA Resolutions.
Secondly, a US government biosecurity committee has proposed that domestic
US legal restrictions on possession of variola virus be repealed. The
de facto effect of this recommendation would be to legalize possession
of variola virus.
Although holding an exact copy of the entire virus in replication-competent
form would remain subject to regulation, possession of large amounts
of smallpox DNA and construction and manipulation of viruses almost
genetically identical to smallpox (i.e. essentially composed of variola
genes) would not be subject to legal controls or even reporting to the
government. Such viruses could pose an international public health threat.
These developments strongly suggest that an expansion of US research
with variola virus is underway, particularly with variola genes and
genetic engineering. They strengthen the argument of those who want
the WHO to fix a destruction date for the virus, ban genetic engineering
experiments, and strengthening WHO control over variola research.
Meanwhile, the WHO Advisory Committee on Variola Virus Research may
be backpedaling on some of its previous decisions.
At its seventh meeting in 2005, the Committee concluded that there is
no justification for continued retention of variola virus for the purposes
of sequencing, as the full sequence of dozens of strains has already
been obtained, or for developing vaccines, as in addition to older,
effective vaccines, new vaccines are in advanced development, which
do not require variola virus for testing or production.
It had also concluded that sufficient rapid and accurate diagnostics
have been developed, with the majority of members in broad agreement
that no additional research involving the use of variola virus is required
for this purpose.
However, following its eighth meeting in November 2006, the Committee
appears to be reconsidering these decisions.
The Committee meeting also revisited the question of modifying the rules
concerning possession and use of variola virus and its genes. These
rules touch on both genetic engineering and issues raised by synthetic
The rules were put forward in 1994 by the WHO Ad Hoc Committee on Orthopoxvirus
Infections. They ban genetic engineering of variola, the insertion of
variola genes in other orthopoxviruses, and require that variola DNA
only be provided to non-repository labs with WHO approval and even then
in tightly limited quantities.
For years, the US has sought to weaken those rules. In 2004, it almost
succeeded when the Committee recommended modification of the 1994 rules
to permit dangerous experiments involving insertion of smallpox genes
into related poxviruses and genetic engineering of smallpox itself.
Many countries raised concern about these recommendations at the WHA
in 2005 and the recommendation to permit insertion of smallpox genes
into related poxviruses was subsequently withdrawn by the Committee.
Yet, at the Committee meeting in 2006, the US again expressed its desire
to genetically engineer smallpox genes into other orthopoxviruses. This
proposal was rejected by the Committee.
But the same rules that prohibit such smallpox genetic engineering also
govern possession of smallpox genes by non-repository labs. After abandoning
its previous attempt to weaken the 1994 rules, in 2006 the Committee
has started a new process that may modify them.
This time, the effort has been reportedly prompted by synthetic biology,
specifically, disagreement over if and how the WHO should control synthesized
variola genes. Obviously, the importance of the protections at the WHO-authorized
repositories will become very limited if synthesis of variola genes
is permitted elsewhere.
The current rules state that the repositories cannot distribute smallpox
DNA without WHO approval and that recipients of such DNA cannot send
it to others. These provisions are appropriate and should remain.
In light of research using synthetic variola genes, as exemplified by
the Sandia research, NGOs such as the Third World Network and The Sunshine
Project are asking the Executive Board to include in the draft resolution
a request for an analysis and study on the synthesis of variola genes,
particularly outside of the WHO-authorized repositories, with a view
to developing a further resolution that addresses the novel risks posed
by synthetic biology. (Details and further information are in www.smallpoxbiosafety.org).
They are also recommending that the draft resolution fix a new date
for destruction of the stocks, ban genetic engineering experiments and
those involving distribution of variola DNA for non-diagnostic purposes,
as well as withdraw the temporary authorization for the retention of
variola virus for DNA sequencing, diagnostics and vaccines purposes.
Other recommendations include a request for a detailed report of all
completed, current and planned research at the two repositories, reform
of the Advisory Committee on Variola Virus Research, ensuring that approved
research proposals, research outcomes and their benefits are made available
to all Member States, and clarifying the legal status of the virus strains
held at the two repositories with respect to their ownership.
(* With inputs from Edward Hammond.)
TO MAIN | ONLINE
BOOKSTORE | HOW TO ORDER