Re: "human patent"

Bill Aal (waal@WAAL.SEANET.COM)
Fri, 20 Oct 1995 01:19:19 +0000

> Date: 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.

I have been following these issues for some time and read both the
RAFI initial release and Jonathan Friedlander's response with some
interest. It seems tha t Friedlander himself is distorting the RAFI
position and doesn't answer the specific moral and political
challenges that RAFI is raising. I am not connected with RAFI,
however I do belong to the Washington Biotechnology Action Council,
an organization committed to citizen input to the regulatory process
surrounding biotech issues.

> 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.

> 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.
I think that the issue is not to sling mud about, but to examine
carefully the situation at hand.
> 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.

The RAFI statement said nothing about the reputation of the IMR's
reputation in the academic, medical or other communities. It did say
that the patent has provoked anger in the Pacific, and is a matter of
deep concern everywhere. It further pointed out that Friedlander
himself is committed to blood sampling in the Pacific region and that
there is an effort to impliment a "Liforms Patent-Free Pacific
> These are the researchers being attacked as biopirates by RAFI, and who RAFI is
> threatening to take to the World Court in the Hague.

RAFI is not in the release attacking the IMR, but the patent
application about a life form.

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).
As far as I can tell the facts of the patent application were clearly
acknowledged in US patent 5,397,696
> 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