February 12, 2002

Contents
1.      Economics of gene patents for diagnostic testing under scrutiny
2.      Men redundant? Now we don't need women either
3.      Mouse cell transplants for Huntington's patients
4.      Australian Company Suspected of Human Bio-Piracy
 

1.
Economics of gene patents for diagnostic testing under scrutiny

Tom Abate <mailto:tabate@sfchronicle.com>

Monday, February 11, 2002

San Francisco Chronicle
Diagnostic tests based on newly discovered genes could be the first medical
and investment payoff of the genome age.
But will the same gene patents that encourage research restrict access by
pricing new procedures out of reach?
A small but growing chorus of critics is beginning to suggest just that,
most recently in a Feb. 7 article in the journal Nature.
"Gene patents affect the cost and availability of clinical-diagnostic
testing," wrote the authors, which included Stanford University bioethicist
Mildred Cho.
In addition to the most recent Nature study, which looked at a test
controlled by Bio-Rad in Hercules, Cho has conducted broader surveys
suggesting that nearly half of all diagnostic labs have been forced to quit
doing certain tests because of gene patents.
Questioning gene patents hits at the foundations of biotechnology. When the
industry was born a quarter century ago it wasn't clear that gene
discoveries could get the same patent protection as new chemical drugs -- or
better mouse traps.
But a 5-4 Supreme Court ruling in June 1980 paved the way for gene patents.
A few months later Genentech floated the first biotech IPO. Ever since, gene
patents and biotechnology have been as American as the flag and apple pie.
Some would like to turn back the clock and make genes, proteins and cell
lines unpatentable. "These things evolved biologically, it isn't in the
public interest to turn them into private property," said Jonathan King, a
scientist at MIT and member of the Council for Responsible Genetics, a
nonprofit group in Cambridge, Mass.
The biotech industry thinks the opposite. The diagnostics sector is
experiencing a boom, in part because patented new gene tests are expected to
command higher prices than the generic tests of the past.
But spats over the restrictions or costs imposed on gene tests have focused
attention on the patent issue.
Ashkenazi Jewish families have charged that patents inflate the costs of
tests for inherited conditions like Canavan disease (a crippling
neurological disorder) common in that community.
A test for breast and ovarian cancer has been another flash point. Myriad
Genetics of Salt Lake City holds patents on BRCA1 and BRCA2, genes that seem
to be tumor suppressors. Myriad has created tests to detect mutations in
these genes that increase the chances of developing these cancers.
Myriad sells its most complete test for $2,680. Researchers at France's
Curie Institute have challenged Myriad's patents in Europe, claiming they
are overly broad and prevent them from doing less costly tests. Health
ministers in Ontario, Canada, have instructed hospitals in that province to
ignore Myriad's patents and continue conducting their own cheaper tests.
Myriad spokesman William Hockett said Myriad's test is far more precise than
any other procedure, and can detect more than 500 different mutations in the
genes. Such precision has required an investment in DNA sequencing
equipment, computers and research going back to 1994.
"This technology is very sophisticated," Hockett said, adding that Myriad
couldn't charge significantly less for the test "unless somebody was
subsidizing it."
Paul Billings, a geneticist with the San Francisco consulting firm GeneSage,
said the biotech industry will have to set prices at levels "that don't
provoke a public revolt" against the gene patents upon which the industry
depends.
Meanwhile, the broader issue of gene patents and their narrower application
to diagnostic tests appear to have caught the attention of at least one
lawmaker on Capitol Hill.
Rep. Lynn Rivers (D-Mich.) has been circulating drafts of two bills she is
considering introducing. One would instruct the federal Office of Science
and Technology Policy to study whether gene patents are aiding or hindering
research.
The second bill would prevent companies from enforcing gene patents on
diagnostic tests. A staffer says Rivers is still taking comments and hasn't
decided whether to introduce either, both or neither bill.
TB BREAKTHROUGH?: Chiron Corp. signed an innovative deal last week that
could set a pattern for how corporations and nonprofits can work together to
develop medicines for Third World diseases.
The Emeryville biotech firm gave New York's Global Alliance for TB Drug
Development the rights to develop a promising experimental compound called
nitroimidazopan. It's been 30 years since there's been a new anti-TB drug
and scientists have high hopes that the Chiron compound will be a
breakthrough.
The Alliance has upwards of $40 million in funding from the Rockefeller
Foundation, the Gates Foundation and other sources. It will use those funds
to carry out animal tests and, if all goes well, human clinical trials of
the anti-TB drug. If it works, the Alliance will be free to sell the drug,
without any patent restriction or royalty fees, in Third World nations where
TB kills 2 million people a year.
Chiron wins something in return. If the Alliance proves the anti-TB medicine
safe and effective, Chiron can buy back the rights to sell a higher priced
version in the developed world. The Alliance will still be free to sell the
cheap version abroad.
"It's one of those rare win-win situations," said Craig Wheeler, president
of Chiron's biopharmaceutical division.
He explained how the deal came about. The anti-TB drug was one of the
experimental compounds that Chiron obtained when it acquired the Seattle
biotech firm PathoGenesis in August 2000. Chiron decided the TB market
wasn't large enough, in dollar terms, to warrant the costs of clinical
development and decided to see if some other firm wanted to buy the rights.
About this time the Alliance contacted Chiron and expressed interest in
developing the drug. The Alliance is a story in itself. It is one of a
handful of nonprofits that have arisen in recent years in an attempt to do
what the market system can't -- develop cheap medicines for the Third World.
The Alliance is overseen by a board that includes health officials from the
United States and South Africa, a past president of Medecins Sans
Frontieres, and drug industry executives, including Chiron CEO Sean Lance.
The Alliance recently hired former National Institutes of Health official
Dr. Maria Freire to run the operation. Rather than build a drug development
company, the Alliance will contract out the clinical work.
Development of the anti-TB drug is at a very early stage. It will be a
couple of years before the Alliance finishes the preclinical studies that
would be a prelude to human trials. And the drug could fail at any stage, as
happens all the time.
So while it's a bit early to celebrate, I find this deal incredibly
uplifting. The free market is a powerful mechanism but it has one and only
one end -- the production of profits. It depresses me to think of all the
other needs that get ignored because of the market's single-minded focus.
What a deal like this tells me is that biotech leaders, international health
officials and philanthropic groups are trying to create mechanisms to
address needs that would otherwise fall through the cracks.
I'm keeping my fingers crossed, both for the TB drug and the larger
experiment in nonprofit drug development.

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2.
Men redundant? Now we don't need women either
Scientists have developed an artificial womb that allows embryos to grow
outside the body

Robin McKie
Sunday February 10, 2002
The Observer <http://www.observer.co.uk/>

Doctors are developing artificial wombs in which embryos can grow outside a
woman's body. The work has been hailed as a breakthrough in treating the
childless.
Scientists have created prototypes made out of cells extracted from women's
bodies. Embryos successfully attached themselves to the walls of these
laboratory wombs and began to grow. However, experiments had to be
terminated after a few days to comply with in-vitro fertilisation (IVF)
regulations.
'We hope to create complete artificial wombs using these techniques in a few
years,' said Dr Hung-Ching Liu of Cornell University's Centre for
Reproductive Medicine and Infertility. 'Women with damaged uteruses and
wombs will be able to have babies for the first time.'
The pace of progress in the field has startled experts. Artificial wombs
could end many women's childbirth problems - but they also raise major
ethical headaches which will be debated at a major international conference
titled 'The End of Natural Motherhood?' in Oklahoma next week.
'There are going to be real problems,' said organiser Dr Scott Gelfand, of
Oklahoma State University. 'Some feminists even say artificial wombs mean
men could eliminate women from the planet and still perpetuate our species.
That's a bit alarmist. Nevertheless, this subject clearly raises strong
feelings.'
Liu's work involves removing cells from the endometrium, the lining of the
womb. 'We have learnt how to grow these cells in the laboratory using
hormones and growth factors,' she said.
After this Liu and her colleagues grew layers of these cells on scaffolds of
biodegradable material which had been modelled into shapes mirroring the
interior of the uterus. The cells grew into tissue and the scaffold
dissolved. Then nutrients and hormones such as oestrogen were added to the
tissue.
'Finally, we took embryos left over from IVF programmes and put these into
our laboratory engineered tissue. The embryos attached themselves to the
walls of our prototype wombs and began to settle there.'
The experiments were halted after six days. However, Liu now plans to
continue with this research and allow embryos to grow in the artificial
wombs for 14 days, the maximum permitted by IVF legislation. 'We will then
see if the embryos put down roots and veins into our artificial wombs'
walls, and see if their cells differentiate into primitive organs and
develop a primitive placenta.'
The immediate aim of this work is to help women whose damaged wombs prevent
them from conceiving. An artificial womb would be made from their own
endometrium cells, an embryo placed inside it, and allowed to settle and
grow before the whole package is placed back in her body.
'The new womb would be made of the woman's own cells. so there would be no
danger of organ rejection,' Liu added.
However, her research is currently limited by IVF legislation. 'The next
stage will involve experiments with mice or dogs. If that works, we shall
ask to take our work beyond the 14-day limit now imposed on such research.'
A different approach has been taken by Yoshinori Kuwabara at Juntendo
University in Tokyo. His team has removed foetuses from goats and placed
them in clear plastic tanks filled with amniotic fluid stabilised at body
temperature. In this way, Kuwabara has kept goat foetuses alive and growing
for up to 10 days by connecting their umbilical cords to machines that pump
in nutrients and dispose of waste.
While Liu's work is aimed at helping those having difficulty conceiving,
Kuwabara's is designed to help women who suffer miscarriages or very
premature births. In this way Liu is extending the time an embryo can exist
in a laboratory before being placed in a woman's body; Kuwabara is trying to
give a foetus a safe home if expelled too early from its natural womb.
Crucially, both believe artificial wombs capable of sustaining a child for
nine months will become reality in a few years.
'Essentially research is moving towards the same goal but from opposite
directions,' UK fertility expert Dr Simon Fishel, of Park Hospital,
Nottingham, said. 'Getting them to meet in the middle will not be easy,
however. There are so many critical stages of pregnancy, and so many factors
to get right. Nevertheless, this work is very exciting.'
It also has serious ethical implications, as Gelfand pointed out. 'For a
start, there is the issue of abortion. A woman is usually allowed to have
one on the grounds she wants to get rid of something alien inside her own
body.
'At present, this means killing the foetus. But if artificial wombs are
developed, the foetus could be placed in one, and the woman told she has to
look after it once it has developed into a child.'
In addition, if combined with cloning technology, artificial wombs raise the
prospect that gay couples could give 'birth' to their own children. 'This
would no doubt horrify right-wingers, while the implications for abortion
law might well please them,' he added.
Gelfand also warned that artificial wombs could have unexpected consequences
for working women and health insurance. 'They would mean that women would no
longer need maternity leave - which employers could become increasingly
reluctant to give.
'It may also turn out that artificial wombs provide safer environments than
natural wombs which can be invaded by drugs and alcohol from a mother's
body. Health insurance companies could actually insist that women opt for
the artificial way.
'Certainly, this is going to raise a lot of tricky problems.'

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3.

Mouse cell transplants for Huntington's patients

16:15 11 February 02
Emma Young
New Scientists

Transplants of mouse stem cells into the brains of patients with
Huntington's Chorea could help slow the associated dementia and loss of
coordination, says UK company ReNeuron. It hopes to start clinical trials of
the technique in the US early in 2003.
Huntington's is caused by an inherited genetic mutation, which leads to a
destruction of cells in a part of the brain called the striatum. ReNeuron
has transplanted cells from its mouse neural stem cell line into monkeys
designed to act as models of Huntington's patients.
"We have shown the cell line will transplant into the monkey brain - and
that it will restore function," says John Sinden, ReNeuron's chief
scientist.
ReNeuron is developing a line of human neural stem cells for use in
transplantation experiments. But the mouse cell line could be ready for use
in people much earlier - by autumn 2002, says Sinden. Then, he says, the
company will make a formal application to the US Food and Drug
Administration to begin the trial. Regulations governing
xenotransplantation - the transplantation of cells from one species to
another - are less strict in the US than in the UK.
There are theoretical concerns that potentially deadly viruses from the
donor animal cells could be passed to the human recipients. But Sinden
thinks this will be unlikely in the case of the mouse cells.

Fetal tissue
The potential benefits outweigh the risks, he says. "We wouldn't seek to
take a xenotransplantation product into a large population of patients with
Alzheimer's, for example. But where you've got a very, very serious
condition with a relatively small number of patients that can only get
worse, and you've got something that you know works, I think it makes sense
to give it a shot."
Rejection of the mouse cells should not be a problem in the brain, where the
immune system is less active than in the rest of the body.
Other groups of researchers are transplanting fetal tissue into the brains
of Huntington's patients. One group, in Paris, has reported some success.
But, as Sinden points out, the number of aborted fetuses available for
medical use is limited. "This procedure can only be used in an experimental
way in a small number of patients," he says.
In theory, an unlimited number of cells for treatment could be generated
from the mouse, and from the human, stem cell lines. At the moment,
ReNeuron's human line is too genetically unstable, with unpredictable
chromosomal abnormalities appearing as the cells repeatedly divide, says
Sinden. The team is now adding a gene to protect the chromosomes. "We
believe we will get a genetically stable line, but it will take us some
time," he says.
The UK's Huntington's Disease Association cautiously welcomes ReNeuron's
plans. "Obviously it's very early days. And as there are no conclusive
results to date on the use of fetal cells, I'd hesitate to say we're
positive about any trials," says a spokeswoman.

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4.
12 Feb 2002
MEDIA RELEASE
 

Australian Company Suspected of Human Bio-Piracy
 

Tongan Human Rights Activists to Address Adelaide Conference

Tongan human rights activists have condemned an agreement between the
Tongan government and an Australian biotech company, Autogen Ltd., to
collect blood samples from the Tongan people.  The reported agreement was
concluded without any public debate and opens the way for the
commercialisation and patenting of the genetic material of indigenous
peoples.

The current status of the agreement is unclear.  According to the Director
of the Tonga Human Rights and Democracy Movement, Lopeti Senituli, lI was
informed by Tonga Heath officials last year that no agreement was signed
with Autogen but we have good reason to suspect that Autogen Ltd could be
trying to circumvent the Tongan publicms scrutiny by disguising its genetic
research proposal as a public health programme funded by the Australian
government.n

Mr. Senituli is scheduled to present a paper on the issue at the
Australasian Bioethics Association Conference in Adelaide on 14 February.
The paper will be jointly presented with Margaret Boyes of Sydney.

Mr. Senituli said,  lThe Tongan people believe that God is the Creator of
all living things and therefore all lifeforms should be treated in a way
that respects their intrinsic value as living generational manifestations
of Creation.  The conversion of human lifeforms, their molecules or parts
into corporate property, as Autogen is proposing is in direct conflict with
our belief in the sanctity of human life.n

He also said that the Autogen proposal is the latest phase in the
colonization of the indigenous peoples of the Pacific and their resources.
lThree centuries ago they came for sandalwood.  Today the bastards are
after our genes.n
 

Ends

For further information contact Margaret Boyes

Until 2pm Wed 13/2/02 Sydney on ph. (02) 9568-4348

>From 7pm Wed 13/2/02 on 0408-818-012

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