Re: "human patent"

Tue, 17 Oct 1995 12:54:23 -0400

The following is a response from Dr. Jonathan Friedlaender to the message
previously posted by RAFI concerning "patenting a human." That original message
was so distorted, it is only fair to examine the response. This is reposted
(with permission and minimal editing) from the human biology list.

Author: Jonathan Friedlaender <V5065E@VM.TEMPLE.EDU> at NOTE
Date: 10/16/95 10:45 AM

This is a summary (as of this morning) of what I know about the RAFI charges.
As far as I am concered, this can go out to whomever you want to send it to.
I am very upset about this entire flap, primarily as it concerns the fate of
the Institute of Medical Research in Papua New Guinea, secondarily the progress
of the Human Genome Diversity Project, and thirdly my own reputation. What is
not understood to the moment is how outrageous RAFI has been in spreading what
can, most generously, be called gross distortions about all concerned. And to
date no one has been willing to call them on it. That time has come.

Some background.
1. The IMR, Carol Jenkins, and the Hagahai.
The IMR in Papua New Guinea is an exemplary organization, and the Papua New
Guinea government has been extremely wise to support it. Their staff is
international - meaning Australian, American, African, Indian, and Papua New
Guinean, among others - and they have an outstanding record of biomedical
research achievement and public health education. A few examples include the
identification and cure of a formerly widespread and lethal disease ("pigbel"),
very important malaria research, ongoing and important public health education
efforts in nutrition, tuberculosis, AIDS, and ecological degradation. Their
Director, Michael Alpers, recently received a coveted tropical medicine award
and Carol Jenkins, a medical anthropologist with primary training in cultural
anthropology, has received considerable recognition for her work in a number of
areas. She is an international authority on AIDS epidemiology and education,
works extensively for the WHO, and currently has support from the MacArthur
Foundation for her work with the Hagahai in a remote part of Papua New Guinea.
These are the researchers being attacked as biopirates by RAFI, and who RAFI is
threatening to take to the World Court in the Hague. The Hagahai are a very
small population (a "Fringe Highlands" group) in PNG that were contacted a few
years ago by an IMR expedition with Jenkins involved. It is more correct
to say that the Hagahai contacted the outside world, in despair, since
their numbers were declining rapidly and they sent men to other villages to get
western medical aid to fend off extinction. The IMR has provided various
services to them over the past few years, part of which involved figuring out
what diseases, western and otherwise, they had been exposed to that could be
responsible for their heavy mortality rates (eg. flu, t.b., measles, etc.). In
the course of this, NIH researchers found that some Hagahai were infected with
a viral strain (of HTLV-1) that had not been seen before. A patent application
was filed on this viral variant found in the pooled blood sample from about 20
Hagahai (contrary to RAFI's claim, no one has ever tried to patent a Hagahai's
genes, much less a Solomon Islander).

The Gene Patent Application.

In coordination with the NIH, a patent on the HTLV-1 variant found in the
Hagahai pooled sample was filed (a second, on a related variant found in a
Solomon Islander, was also filed about the same time). This
was done at a time, under NIH Director Healy in the Bush Administration, when
there was a clear policy to patent newly identified gene segments, human and
otherwise. This was a very controversial stance, nationally and international-
ly, and caused a number of resignations of scientists who disagreed with the
policy, including James Watson. Geneticists working for the NIH, or with NIH
funding, were obliged to file patent applications as they found them. As part
of the applications, cell lines containing these segments had to be deposited
at the American Type Cultue Center in Rockville, Maryland, and that while the
applications were under review, no one could access those cell lines.
I understand that the patent application specifies that neither Jenkins, the
IMR, nor the government of PNG stand to gain financially from the patent - but
that 50% of any potential profit would go to the Hagahai themselves. When they
heard that some of them had an infection (apparently benign) that was
interesting to western doctors and might be worth something, and that a legal
paper was being drawn up to ensure that they would share in any profits, they
were eager that it go through. Jenkins signed the document at a
meeting of the Amer.Assoc.of Physical Anthropologists, with witnesses, and with
great approbrium for her role. Parenthetically, people in PNG are very
familiar and comfortable with the idea of residual rights in such things as
songs and trees, and general "compensation." A patent is not some peculiar
idea that only westerners can understand (whether or not it is legitimate in
this instance).
The PNG patent case was approved during the past year, with the Hagahai's
strong support, while the related case of the Solomon Islands HTLV-1
application was abandoned in favor of a continuation (equivalent, I'm told, of
putting on the back burner), and,finally,withdrawn by the NIH. A NIH official
said that the reason the PNG case was not withdrawn was because of the
assurance of Jenkins that the Hagahai expressly wished to pursue it.

The Human Genome Diversity Project.

The Human Genome Diversity Project (hereafter HGDP) is a planned (not function-
ing) systematic collection of genetic, demographic, anthropological, and
epidemiological information on human populations world-wide, that has also been
subject to vitriolic criticism from RAFI, on the grounds (as best I can tell)
that it represents potential bio-piracy (making money from the genes of people
around the world - also called gene mining and bio-colonialism);and that the
(genetic) information gleaned may be used to develop insidious tools of
genocide. This potential project, along with the viral DNA patent cases just
mentioned, are seen as part of a general (US) government plot to continue
past exploitative/colonial relationships.

The HGDP has been developing a legal/ethical protocol that its members hope
will be adopted if the project gets underway. I have seen drafts, and
it provides extensive protections of people participating in the way of
property rights, preservation of individual anonymity, and a large number of
related issues. I can say that it goes well beyond heretofore common practice
in medical research investigations in such safeguards. There is a policy of
foreswearing any potential financial benefits in any potential discoveries
that might come from the project, and of developing a mechanism to ensure that
any such benefits return to the participating populations.

My involvement.
I am a Temple University professor of (biological) anthropology, recently
returned from a 3 year stint as Director of the Physical Anthropology Program
at the National Science Foundation (not the NIH, as RAFI has said). While prog
ram director, I supported the development of the HGDP, but was not (and am not)
on an HGDP committee. I have done my own research in PNG and the Solomon
Islands over the past 30 years, and am attempting to resume that activity after
my NSF stint. In September, 1994, as a result of a conversation with the
Solomon Islands Ambassador to the US, UN, and Canada, who wanted to know about
the gene patenting application on a Solomon Islander, I inquired at the NIH and
wrote a letter on its status to the Ambassador that month (9/94). I said
the Solomons case had been abandoned in favor of a continuation, and that the
PNG case was also likely to be abandoned or not allowed. It was only this past
June, when I visited the IMR in PNG, trying to establish my own collaborative
project, that I discovered that the PNG viral patent case had in fact gone for-
ward at the urging of the people concerned, as described above. RAFI has
now insinuated that I intentionally misled the Solomons Ambassador.

NIH's gene patent policy

I have had a couple of phone conversations with NIH officials on their policy
on gene and gene fragment patent policy. It is clear that the
confusion and apparent contradiction in this matter is a reflection of changing
NIH policy on this issue, from Director Healy's time to the present, under
Harold Varmus. The NIH now generally discourages DNA patents (hence,
for example, the withdrawal of the Solomons case. This is very clear in their
stance on the patenting of cDNA's.

RAFI's attacks

Members of RAFI have flooded the internet with misrepresentations of the patent
cases mentioned above and have begun attacking the IMR, the HGDP, as well as
the US federal government in a way that is truly irresponsible. I have not
been in direct contact with them, but others have tried to correct their more
serious misrepresentations/misconceptions. They will not listen. The latest
salvo is a threat to take Jenkins to the World Court in the Hague. The major
problem is that this entire situation reflects on the widespread distrust of
the scientific/technological enterprise, and of the willingness of many
to believe the worst of people with scientific knowledge. It also shows we
are too willing to accept the charges of self-proclaimed champions of all
indigenous peoples who,in this instance, are willing to distort facts that appe
ar, at first, to represent exploitation by powerful international interests.

Jonathan Friedlaender