HUMAN TISSUE TRADE HAS ETHICAL, COMMERCIAL....
...AND MILITARY IMPLICATIONS
International collection and trade in human cell lines and tissues is
growing rapidly and has substantial and unanticipated commercial and
military implications, according to a study released today by the Rural
Advancement Foundation (RAFI). Thousands of human tissue samples
collected from indigenous people and isolated communities around the
world are now being evaluated by the biotechnology industry, academic
researchers, and government institutions, Edward Hammond, principal
author of the RAFI study says.
In its March/April report (RAFI Communique, New Questions About
Management and Exchange of Human Tissues at NIH / Indigenous Persons
Cells Patented), RAFI identifies more than a score of indigenous peoples
who have been the subject of blood sampling in recent years and whose
tissues are now being exchanged among medical researchers in several
countries. Most disturbing, according to RAFI Executive Director Pat
Roy Mooney is that there appear to be no policy or protocol barriers -
or ethical consideration - to the routine exchange of foreign human cell
lines between civilian researchers in the U.S. Government and their
military counterparts. RAFI has learned that the National Institutes of
Health (NIH) not only share research facilities with biological warfare
medical units at Fort Detrick (near Washington, DC) but that human
material is routinely exchanged - sometimes without formal material
transfer agreements. Fort Detrick is not only the home of medical units
engaged in biological warfare research, it is also the home of the U.S.
Defense Intelligence Agency (DIA) unit charged with monitoring medical
data gleaned from foreign populations.
FOREIGN HUMAN CELL LINE PATENT: RAFI's [??] of the escalating commercial
interest human tissues (including immortalized human cells) arose from
an ongoing inquiry into last year's patent by NIH of the human cell line
of a 20 year old Hagahai man in Papua New Guinea (see Internet sources
below). RAFI sought proof of the NIH and U.S. State Department claim
that it had the consent of the Hagahai and the request of persons in
Papua New Guinea. Despite numerous requests, including FOIA, to date
NIH cannot provide a single piece of paper substantiating any of its
claims, says Hammond. Further, RAFI has learned that another NIH patent
claim on human cells from the Solomon Islands that the State Department
said had been dropped is still being called a trade secret by NIH. The
State Department told diplomats that NIH had dropped the claim; but we
were advised by NIHs Freedom of Information Office that information
about the cell lines is being withheld on grounds that they are a trade
secret, added Hammond.
In the course of its investigation, RAFI was startled to find that the
U.S. Navy had collected similar human samples from indigenous people on
the Indonesian side of New Guinea and that it had obtained related
samples from the Philippines and Peru. NIH scientists cited as
co-inventors in the Pacific patent claims were also involved in
extensive studies of human materials collected from indigenous
communities in Colombia and several other parts of the world. The
Atlanta-based Centers for Disease Control (CDC) has also been active in
sampling human cell lines from around the world.
BIOLOGICAL WARFARE: The breakthrough for RAFI came at Easter in April
when news reports circulated that one of the co-inventors of the Solomon
Islands patent claim, Dr. Carleton Gajdusek, a Nobel Laureate for his
medical work in the Pacific, was arrested on charges of sexually abusing
a child. Over the years, Gajdusek had brought more than 50 children
from Papua New Guinea and Micronesia to the U.S., where they lived at
Gajdusek's house while attending school. In the course of their
investigations, the FBI searched Gajdusek's NIH office at Fort Detrick.
We remembered that Fort Detrick is not only famous for its Ebola
research but also for its long history as the military's primary
biological warfare research center and medical intelligence headquarters
for the Defense Department, Mooney recalls. We sought assurance from
NIH and Fort Detrick that there were strict protocols and policies
preventing the transfer of NIHs cell lines and data to biowarfare
workers. Edward Hammond continues the story, "Instead, we were referred
to Science Applications International Corporation - a private company
that manages the Fort Detrick facility for both NIH and the military.
SAIC made it clear that no such policies or protocols existed and that
human tissue exchange was common." NIH and military authorities and Fort
Detrick then confirmed this.
COMMERCIAL CONNECTIONS: SAIC is a privately-held company whose Board is
largely comprised of individuals who have held very senior posts in
defense and intelligence agencies. Among recent Board members are the
current and former Defense Secretaries and CIA Directors. SAIC also has
commercial relations with at least one major gene sequencing company
which has thousands of patent applications on file for human genetic
materials. SAIC appears actively involved in the global search for
significant human genes and viruses of interest to the pharmaceutical
industry. Fragments of human DNA have sold for as much as $70 million
and some human cell line patents have been valued at more than a billion
dollars, Hammond notes. The trade in human genetic material - especially
that of indigenous peoples - is rapidly accelerating, and is really just
beginning. With new biotechnologies the pharmaceutical industry can
exploit human genetic diversity the same way that plant breeding
companies exploit crop genetic diversity.
ACTIONS RECOMMENDED: RAFI is rushing to make its study available today
because the annual meeting of the World Health Organization (WHO) takes
place this week in Geneva. National medical authorities meeting in
Geneva need to know that when they collaborate with academic or
government medical researchers on human cell line studies that material
could be commercialized and patented by foreign governments or
corporations and that human tissues involved could be used by U.S.
Biowarfare scientists, Mooney insists, As a U.N. Agency, WHO must review
and strengthen its ethical codes for medical research.
The RAFI report also urges the Convention on Biological Diversity - the
legally-binding international accord adopted at the 1992 Earth Summit -
to accept its legal responsibility for human biological diversity and to
establish strict regulations regarding its collection, exchange and
investigation. Finally, RAFI calls upon the Fourth Review Conference of
the Biological Weapons Convention in Geneva in November to ensure that
civilian medical research is kept separate from biowarfare research. It
is impossible to distinguish between offensive and defensive biowarfare
research, Mooney says. In the meantime, RAFI believes that until proper
protocols are in place there should be no further collection or exchange
of human tissues across international borders and that initiatives such
as the Human Genome Diversity Project - an international effort to
collect and immortalize human cell lines from indigenous communities -
should not be allowed to proceed.
Contacts: Edward Hammond, RAFI-USA Pittsboro, NC tel: (919) 542-1396
fax: (919) 542-0069
Pat Roy Mooney, RAFI Ottawa, ON tel: (613) 567-6880 fax: (613) 567-6884
E-mail inquiries to: rafi@nando.net
For further information on the World Wide Web, please check:
http://www.charm.net/~rafi/rafihome.html