No WHA Endorsement of Genetically Engineered Smallpox

Governments Express Concern over Recommendations and the Committee that
Produced Them

Geneva, 20 May (Edward Hammond, The Sunshine Project, and Lim Li Ching,
Third World Network) -- Concern over the recommendations of a WHO
advisory committee to allow research involving genetic engineering of
the smallpox virus was expressed by the majority of countries that spoke
on the subject at the World Health Assembly (WHA) on Thursday and Friday
(19 and 20 May 2005).

The WHO member states were worried about the risks of creation of more
dangerous forms of the variola (smallpox) virus and by laboratory
accidents or accidental release of the virus into the environment. Many
sought the establishment of a new date for destruction of remaining
smallpox virus stocks.

Responding on behalf of the WHO Secretariat, Assistant Director General
of Communicable Diseases Dr. Asamoa-Baah said that the Secretariat took
special note of the "concerns and caution" raised by many countries.
With regard to the recommendations of the advisory committee,
Asamoa-Baah said that WHO especially welcomed the countries' views that
the committee be asked to revisit and review the recommendations.

It was not immediately clear whether there would be further action by
the WHA on the issue or how the WHO Secretariat will address the wide
variety of concerns raised about the smallpox recommendations, including
the process by which they were produced. Many countries had expressed
concerns over the proposed research and would expect their concerns to
be taken on board, and a mechanism set up by which this could be done.

The agenda item "destruction of variola virus stocks" has been one of
the WHA's most controversial issues. Contrary to the title of the item,
the WHA was actually considering a set of recommendations from the WHO's
Advisory Committee on Variola Virus Research (VAC, for “variola
advisory committeeâ€√) that would dramatically expand research on live
smallpox virus, rather than destroy the last remaining stocks of the
virus, as previous sessions of the WHA have resolved to do.

Many scientists and NGOs oppose the committee's recommendations, which
include the genetic engineering of the smallpox virus to express a green
fluorescent marker protein; the expression of the smallpox virus genes
in other orthopoxviruses; the simultaneous handling of the smallpox
virus and other orthopoxviruses; the in vitro synthesis of variola virus
DNA and mutagenesis of orthopoxvirus DNA; and a dramatic relaxation of
restrictions on the distribution of the virus DNA to other
laboratories.

The destruction of the virus has been postponed several times. Instead
the programme of research has expanded. The present recommendations are
the first to involve genetic engineering, and would dramatically expand
the distribution of the virus DNA to other laboratories.

Seven countries made interventions on Thursday, and sixteen more spoke
on Friday.

As expected, the two countries that hold the virus stocks (Russia and
the US) spoke in favour of prolonging the period of research and
supported the committee's recommendations.

Russia endorsed the recommendations for more research and said it wished
to continue to utilize live smallpox virus in research on diagnostics,
an area of research that WHO has concluded no longer requires live
virus.

The US stated that it "agrees entirely with Russia" on the matter of
diagnostics research, adding that it thinks that more sequencing of the
Russian smallpox collection should be done. Noting the possibility of
undeclared smallpox stocks, the US said that its research is not
finished and that setting a new date for destruction, as many countries
urged, would be "arbitrary" and "not at all warranted".

Apparently smarting from repeated references by other countries to lab
accidents, the US characterized the chances of an accident as
"incredibly small" and claimed that existing smallpox stocks are held at
"the absolute highest standards of biosafety and biosecurity". It is
unclear, however, to what standards the US referred to because there are
no international laboratory biosafety or biosecurity standards, nor does
the US have domestic laboratory biosafety standards.

Australia expressed support for the controversial recommendations,
including the genetic engineering of smallpox and wider distribution of
smallpox DNA. On the issue of Russia's desire to continue to use live
smallpox virus to develop diagnostics, Australia's answer was
ambiguous.It said that diagnostic tests could be validated with smallpox
scabs from monkeys, a position that seems to encourage US work injecting
monkeys with large amounts of smallpox virus, research that is
particularly dangerous and which has not yielded the desired results (a
useful monkey model of human smallpox infection). Australia did,
however, share the WHO Director General's concern that smallpox genes
should not be inserted into related poxviruses.

In contrast to the strong support for the committee's recommendations by
these three countries, many other countries expressed concerns ranging
from expression of caution to requests that the research on live
smallpox virus be stopped.

In a detailed intervention, China underscored the public health risks of
the virus escaping from the lab and called for strengthening WHO
oversight of smallpox virus research. It noted that existing vaccines
and control strategies could respond to emergencies and that the
benefits of destroying remaining virus stocks are greater than those of
continued research with the live virus. China called for the WHA to set
a deadline for destruction of remaining virus stocks.

Iran took the floor reiterating China's observation that existing
vaccines can be used in the event of a smallpox outbreak. Recalling
recent laboratory accidents involving tularemia (in the US) and SARS (in
Taiwan, Singapore, and China), Iran argued that the risks posed by
escape of smallpox virus were too high to justify continued research on
the eradicated disease and strongly endorsed destruction of the
remaining virus stocks.

Japan urged rapid conclusion of ongoing research and called for
transparency. Japan said that the results should be "the property of all
nations and human beings".

South Africa reminded delegates of the WHA's previous commitment to
destroy the remaining live virus stocks, held in the US and Russia.
Taking a strong stance, South Africa called for research on the live
virus to be stopped. It proposed the establishment of a 'task team',
with better balance and broader representation than the Variola Advisory
Committee (VAC). The 'task team' would evaluate the status of work with
live smallpox virus and its oversight.

South Africa called for a review of all the VAC recommendations,
including the genetic engineering of smallpox and the wider distribution
of smallpox DNA, as well as that to permit expression of smallpox genes
in related poxviruses. South Africa sought a new report to the WHA on
recommendations and the committee.

The Netherlands said that it was “quite concerned about the dangersâ€√
of the proposal for research involving genetic engineering of the virus.
It was not satisfied that adequate safety protections are in place. It
questioned the need to genetically engineer smallpox and called for an
independent body to oversee research. It asked that a report on
reconsideration of the recommendations be submitted to the WHA through
the WHO's Executive Board.

Canada reminded delegates that any research on smallpox should remain
geared to precise results and be time-limited. Canada insisted that any
live virus research "must be essential for public health". In this
respect, Canada, was concerned that US research on antivirals (linked to
the proposal to genetically engineer smallpox) would be lengthy and
costly, asking "Is this really essential for public health?"

Like many other delegations, Canada was concerned about laboratory
accidents. It also raised the concern that genetic engineering
experiments could result in a virus that is more dangerous than smallpox
virus. It asked that the matter be referred to the Executive Board and
to next WHA meeting. Canada called for prompt destruction of the virus
once there is no public health reason to maintain it, and said it
supports China's request that WHO follow up on the issue of fixing a new
date for the destruction of smallpox virus stocks.

The Pacific island nation of Tonga weighed in with a lengthy
intervention. Referring to the committee's proposal to distribute the
smallpox DNA to other laboratories, it said there were many brilliant
and responsible scientists all over the world but there are a few who
may be different and that there is a possibility that some scientists
could use DNA to reconstruct the smallpox virus and this could possibly
fall in the hands of terrorists. Tonga observed that “one bad apple
can make historyâ€√ and that "too many hands on smallpox virus will
enhance the possibility of bioterrorism". Could the committee say that
it is not possible? Tonga was thus very worried about the possibility.

Tonga also said that it is not convinced that the prohibition on the
synthesis of smallpox DNA, mentioned in the Secretariat report, was
strong enough. Tonga called for existing stocks of the smallpox virus to
be targeted for destruction sooner rather than later and for it to be
made a crime against humanity for any person or laboratory to hold on to
the smallpox virus.

Cuba said a number of countries feared the possibility of lab accidents
or bioterrorism, and thus wanted to maintain reserves of the vaccine.
It said there should be a final date set for the destruction of the
smallpox virus. There was a risk of genetic mutation of the virus, for
which there is no effective vaccine.

Egypt briefly stated that it supports the recommendations of the
advisory committee.

Saudi Arabia noted that sufficient sequencing and diagnostics research
has been conducted and that smallpox virus should no longer be retained
for these purposes. Saudi Arabia said that all research and manipulation
using live virus should end, and that a date should be set for
destruction of the virus, as previously mandated by the WHA.

Pakistan said it could agree to the retention of virus stocks for a
limited period. However, it was concerned about lab accidents and called
for the virus repositories to be open to full inspection, for a
comprehensive system of oversight, and for research results to be
published.

The UK supported ongoing research for the development of vaccines and
antivirals, adding that such research be outcome oriented and time
limited. However, the UK "strongly" shared the WHO Director General's
biosafety and biosecurity concerns about the committee's proposals, and
said it has implications for members states. The UK said we need to be
assured that all research is under WHO control and that live smallpox
virus should not be proliferated.

Zimbabwe supported South Africa's call for a more representative 'task
team' to reassess live smallpox virus work and its oversight and that
developing countries be added onto the team. It supported greater
research transparency and for the WHA to be kept informed.

Thailand reminded the WHA of its previous resolutions calling for
destruction of remaining stocks. Thailand expressed reservations about
the ill-defined limits of permissible research in the Secretariat's
report. It was also concerned about the proposed wider distribution of
smallpox DNA and said that such distribution should be decided by WHO on
a case-by-case basis.

Some other countries (France, Germany, Greece, and India) spoke up on a
related issue (the proposal to maintain reserve stocks of smallpox
vaccine) but did not refer to the recommendations for expanded smallpox
research.

Responding on behalf of the WHO Secretariat, Dr Asamoa-Baah said the
Secretariat took note of the Russian, Australian and US interventions.
It also took special note of the "concerns and caution" articulated by a
large number of countries (which he named). He added that the
Secretariat especially welcomed the views, that with regard to the
committee recommendations, that we ask the committee to "revisit and
review their recommendations".

The Chairman of Committee A, in which the discussion took place, then
noted the Secretariat reports and closed the discussion on the agenda
item.

_______________________________________________
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