The "patenting" of indigenous cell lines is of consideration here
and an article concerning cell lines published in 1990 in _The Washington
Post_ illustrates a possible scenario. Mr. Greely has given permission to
pass his comments along to Native-L:
O'siyo, Mr. Greely.
Our recent correspondence prompted me to dig up this excerpt from an
article in _The Washington Post_, 1 July 1990 entitled "The Human Body Shop"
by Andrew Kimbrell." It appears to directly relate to "cell line patents"
and I am curious as to your reaction. I believe this is a perfect example of
what the Genome Project has to guard itself against if it is to properly
protect indigenous populations. As before, if you care to comment, am hoping
we can pass this along to Native-L:
[ I believe Andrew Kimbrell has written a book by this same title. --Gary ]
"The biotechnology revolution has dramatically altered the value of
body parts. Genetic engineers splice, clone and recombine material, often
using human cells as "miniature factories" to produce profitable cell lines
and other products. The Supreme Court gave added impetus to this trend in a
controversial 1980 decision that established that new living matter -
including human matter - could be patented just like a drill press or
toaster. This lead to the patenting of microbes, plants and most recently
the first patent on a genetically engineered animal. This climate has
produced a variety of peculiar legal cases. In one, John Moore sued the
University of California claiming that he is entitled to a share of the
profits the university is gaining from a cell line developed from his
tissues. In 1976, Moore was diagnosed with an extremely rare form of
cancer, hairy cell leukemia, and his spleen was removed. The doctor
performing the operation and his technician developed and patented a cell
line from a sample of Moore's spleen and assigned the patent to the regents
of the University of California. The cell line was predicted to have a
long-term market value of $3 billion. Hundreds of thousands of dollars have
already been paid to the developers. Moore sued in 1984. Two years later
the trial judge dismissed his complaint as failing to state a legally
cognizable claim. Moore appealed and in July 1988, the California Court of
Appeals reversed the lower court and held that Moore had a property right
in his own bodily tissues. The court stated, "The essence of a property
interest - the ultimate right of control - therefore exists with regard to
one's human body." The court also held that Moore's consent to surgery did
not imply consent for commercial exploitation of his tissues. Judge
Rothman, writing for the majority, said the "defendant's position that
plaintiff cannot own his tissue, but that they [the University] can, is
fraught with irony. Apparently defendants see nothing abnormal in their
exclusive control of plaintiff's excised spleen, nor in their patenting of
a living organism derived therefrom. We cannot reconcile defendants'
assertion of what appears to be their property interest in removed tissue
and the resulting cell-line with their contention that the source of the
material has no rights therein." The university has appealed the case to
the California Supreme Court. A decision is expected next month [August,
1990], but the case will likely end up at the U.S. Supreme Court.
(Note: The California Supreme Court ruled in July, 1990 that John
Moore was not entitled to share in profits from a drug developed from
tissue taken from his spleen. Moore's doctor has so far received stock
worth approximately $3 million from the Cambridge, Mass. company (Genetics
Institute) who developed the resultant drug. Genetics Institute and Sandoz
Pharmaceutical Company have jointly given approximately $440,000 in
research grants to UCLA. In rejecting Moore's claim the court held that a
patient must be fully informed of a doctor's economic interest in his
tissues and that Moore can sue his doctor for failure to do so.)
"The current confusion over biologic sales has prompted a growing
debate over regulation. Some advocate the creation of a "free market."
According to Lori Andrews of the American Bar Association, "Donors,
recipients and society will benefit from a market in body parts." Legal
scholar Roy Hardiman, arguing on behalf of for-profit sales, writes: "The
advent of biological technology has made the body valuable property...
unfortunately the courts have yet to consider it's potential worth." He is
particularly disturbed by in the inequities that exist when corporations
make billions while donors are expected to be altruistic. Not surprisingly,
free-market adherents are calling for legislation to remove traditional
barriers to the selling of human parts. They hope that the "invisible hand"
of the market will create a greater supply of human materials and at the
same time straighten out the myriad of complex legal, social and ethical
dilemmas that advances in medical science have brought us. Others are deeply
disturbed by the specter of human-materials market patterned on the
auto-parts industry. Along with the moral aversion to treating the body as
commodity, they point out that those selling their organs, tissues, blood or
children are likely to be the economically disenfranchised; the poor could
become a "breeder class" for the affluent. This position was taken by the
New Jersey Supreme Court in the Baby M case. In a much-quoted phrase Chief
Justice Warren Wilentz stated, 'There are in a civilized society some things
that money cannot buy." Critics of the market approach also argue that there
is a public-policy advantage to treating such material as a gift. Thomas
Murray, editor of Medical Humanities Review, noted: "Gifts help to create
and sustain intimate personal relationships. In the face of impersonal
bureaucracies, gifts to 'strangers' affirm a number of vital social values
including our solidarity with others in our community and or vision of human
flourishing, individual and social, that require more than the thin
relationships established by markets and contracts." A compromise may lie
between these two portions. Free-market advocates are most convincing when
the issue is the sale of replaceable, replenishable material - blood,
various cells and tissues. Although many would wish to maintain a society
suffused with the gift ethic, this aim seems utopian once the Pandora's box
of patenting and profiting on human living matter is opened. As noted by the
court in Moore's case, it is particularly difficult to maintain a position
with their human tissues when corporations and institutions are turning
those materials into billion-dollar industries. On the other hand, the
current legislative inclination to bar a free market in irreplaceable
materials - such as kidneys, corneas and children - is based on sound public
policy. The exploitive pressure put on those who under economic coercion
might sell these unique parts of their humanity is unconscionable. Arguments
that the poor should be given a choice as to whether to sell their body
parts could be used just as easily to justify a return to allowing
individuals to sell themselves into slavery. Moreover, the open sale of
fetuses, children or organs involves a removal of traditional concepts of
the reverence owed to human life. We have no way to know - and many reasons
to fear - the consequences of degrading this reverence. Legislators, courts
and the public continue to grapple with the complex issues raised by the
body market. Meanwhile, technology advances and profits soar. Only one
outcome is certain: The issue of how far we can go in treating the body as
commodity will be one of the most profound ethical questions of the '90s."
Mr. Greely responds:
| Date: Sun, 29 Oct 1995 14:22:01 -0700
| To: jsd@dickshovel.com
| From: hgreely@leland.stanford.edu (henry t. greely)
| Subject: Re: Papua New Guinea Patents, the Human Genome Diversity Project...
|
| I know the Moore case well and referred to it in one of my postings about
| RAFI. The California Supreme Court in Moore ruled, erroneously, in my
| view, that Moore could not claim a "property" interest in a cell-line made
| from his cells, but it did say that he could sue for the failure of
| informed consent -- the researcher had not disclosed his research (or
| possibly commercial) interest in Mr. Moore's spleen. That claim in the
| Moore case was eventually settled, with Moore receiving some undisclosed
| amount of money.
|
| There seem to be at least two strands of thinking concerning the protection
| of indigenous peoples in the commercial use of gene variants from them. One
| strand broadly rejects the idea of commercial or industrial use of materials
| from indigenous peoples. The other strand does not reject the idea of such
| use, but rejects the idea of uncompensated (or unfairly compensated) use.
| (There may well be some strands in between that reject some uses but not
| others, but I have not heard that perspective clearly articulated). I don't
| have a view about which strand is right -- except that the "rightness" of
| either position should depend on the choice of the populations involved and
| not the U.S. government, the Human Genome Diversity Project, or RAFI. If
| (and these examples are purely hypothetical - I don't know what any of these
| communities actually would choose) the Hopi chose to allow no commercial
| use, the Amish chose to allow commercial use but no patenting, and the
| Lakota decided to allow any use in return for a cash payment plus royalties,
| I think they should have right to make such informed choices.
|
| The HGD Project (or at least its North American Committee, which is all I
| can speak for) proposes to handle this problem in two ways. First,
| communities/peoples will decide, collectively, whether they want to
| participate in the Project at all. If they do choose to participate, the
| informed consent process will let the participating population decide what
| they want. The Project will then enforce the population's wishes through
| both the informed consent agreement between the population and the Project
| researchers and the later contracts between the sample repository/computer
| data base and its users. That way, if a population chooses no patenting or
| commercial use, anyone gaining samples or information from the Project's
| repository would be bound to honor those choices (on penalty of being sued).
| If a population chose to allow patenting or commercial use, but only terms
| agreed upon by it, later users would be similarly bound.
|
| If Mr. Moore, as part of the informed consent for the spleen operation, had
| reached a contract with Dr. Golde, the researcher, providing either of these
| things, I believe it would have been upheld in court and the case would have
| come out differently. The nature of the informed consent is obviously
| crucial -- Moore didn't even know about Golde's research and possible
| financial interests, so he couldn't ask about commercial uses of his
| tissue. We intend to assure that participating populations will know about,
| and be given their choices about, such issues.
|
| PS -- I really like your TS Eliot quote.
Nvwhtohiyada...
http://www.infi.net/~jsd/index.html
_____________________________
"We shall not cease from exploring
And the end of all our exploring
Will be to arrive where we started
And know the place for the first time."
Little Gidding - T.S. Eliot