|INFO/ HUMAN GENETICS ALERT
February 12, 2002
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
Economics of gene patents for diagnostic testing under
Tom Abate <mailto:firstname.lastname@example.org>
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
In addition to the most recent Nature study, which looked
at a test
controlled by Bio-Rad in Hercules, Cho has conducted
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.
industry was born a quarter century ago it wasn't clear
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
nonprofit group in Cambridge, Mass.
The biotech industry thinks the opposite. The diagnostics
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
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
Myriad sells its most complete test for $2,680. Researchers
Curie Institute have challenged Myriad's patents in Europe,
are overly broad and prevent them from doing less costly
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
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
Paul Billings, a geneticist with the San Francisco consulting
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
Meanwhile, the broader issue of gene patents and their
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
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
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
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
The Alliance has upwards of $40 million in funding from
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
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
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
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
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
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
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
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
What a deal like this tells me is that biotech leaders,
officials and philanthropic groups are trying to create
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.
Men redundant? Now we don't need women either
Scientists have developed an artificial womb that allows
embryos to grow
outside the body
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
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
'We hope to create complete artificial wombs using these
techniques in a few
years,' said Dr Hung-Ching Liu of Cornell University's
Reproductive Medicine and Infertility. 'Women with damaged
wombs will be able to have babies for the first time.'
The pace of progress in the field has startled experts.
could end many women's childbirth problems - but they
also raise major
ethical headaches which will be debated at a major international
titled 'The End of Natural Motherhood?' in Oklahoma next
'There are going to be real problems,' said organiser
Dr Scott Gelfand, of
Oklahoma State University. 'Some feminists even say artificial
men could eliminate women from the planet and still perpetuate
That's a bit alarmist. Nevertheless, this subject clearly
Liu's work involves removing cells from the endometrium,
the lining of the
womb. 'We have learnt how to grow these cells in the
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
interior of the uterus. The cells grew into tissue and
dissolved. Then nutrients and hormones such as oestrogen
were added to the
'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
walls, and see if their cells differentiate into primitive
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.
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
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
Kuwabara's is designed to help women who suffer miscarriages
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
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
'At present, this means killing the foetus. But if artificial
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
law might well please them,' he added.
Gelfand also warned that artificial wombs could have
for working women and health insurance. 'They would mean
that women would no
longer need maternity leave - which employers could become
reluctant to give.
'It may also turn out that artificial wombs provide safer
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.'
Mouse cell transplants for Huntington's patients
16:15 11 February 02
Transplants of mouse stem cells into the brains of patients
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
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
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
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.
thinks this will be unlikely in the case of the mouse
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,
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
Other groups of researchers are transplanting fetal tissue
into the brains
of Huntington's patients. One group, in Paris, has reported
But, as Sinden points out, the number of aborted fetuses
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
chromosomal abnormalities appearing as the cells repeatedly
Sinden. The team is now adding a gene to protect the
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
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.
12 Feb 2002
Australian Company Suspected of Human Bio-Piracy
Tongan Human Rights Activists to Address Adelaide Conference
Tongan human rights activists have condemned an agreement
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
commercialisation and patenting of the genetic material
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
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
Mr. Senituli is scheduled to present a paper on the issue
Australasian Bioethics Association Conference in Adelaide
on 14 February.
The paper will be jointly presented with Margaret Boyes
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
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
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
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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