|This is a news clipping service from Human Genetics
The articles selected do not represent HGA's policies but are provided
information purposes. For subscription details, please refer to the
28th November 2002
1. Experts wary of human clone claims
2. Delhi's rich adopt gender selection of the poor
3. Time for a New Pair of Genes?
4. Protein therapies spark scrutiny
5. GM Stem-Cell Patent Jumps Through EPO Hoop
6. DNA patterns produce ultimate personalised gift
7. Nordic genes for would-be moms
Experts wary of human clone claims
November 27, 2002
ROME, Italy -- Experts have greeted with scepticism the claims by an
doctor that a woman was 33 weeks' pregnant with a cloned baby boy.
Dr Severino Antinori has claimed without proof in the past that several
women are carrying cloned babies -- for example in March, 2001 saying
would produce a human clone in 18 months. There has been no evidence
this has happened.
The doctor who clones Dolly the sheep, Professor Ian Wilmut of the Roslin
Institute in Edinburgh, Scotland, said people should be "extremely
sceptical" of Antinori's claims.
Wilmut said Antinori had said he had cloned large number of pigs and
primates, but no one had seen them and no scientific paper had been
Michael Le Page, biomedical news editor of New Scientist magazine, told
it was very difficult to know what to believe when Antinori had become
for making bold comments.
"If anyone has cloned a human baby I would be surprised if they would
an immediate announcement," he said.
Le Page said cloning was illegal in some countries, like the UK, so
cloned baby was announced and a year later was found to be retarded
way the doctors involved would look "a bit silly."
Dr Sandy Thomas, director of Britain's Nuffield Council on Bioethics
examines ethical issues arising from developments in medicine, told
the absence of any evidence it's impossible to judge whether it is
happen or not."
But Dr Thomas if a child was to be born she said she had a number of
concerns. First, if it were born in a country where there was no regulation
its would show the need for regulation in that country.
"Second, our experts tell us we don't know enough about cloning to apply
technique to humans. It goes against normal development and there are
to be a high rate of deformities."
John Kilner, president of the U.S. think tank the Center for Bioethics
Human Dignity, said: "While there are well-founded reasons to be sceptical
of Dr. Antinori's claim that a woman is due to give birth to a clone
he reminds us that there are those who would continue this dangerous,
"Such experiments subject human beings produced through cloning to a
risk of death and deformity. The best way to ensure that cloning is
pursued is to pass a comprehensive ban on human cloning.
"The United States should do this as soon as possible and continue to
the case for a comprehensive ban treaty in the United Nations.
"Regardless of the health and well-being of the clone upon birth, all
nations should affirm the child's human rights. The risk of doing nothing
Antinori told a news conference in Rome on Tuesday that a woman was
weeks' -- more than eight months' -- pregnant with a cloned baby boy
that the child was developing in an "absolutely healthy" way.
In April, Antinori claimed that he knew of three pregnancies -- then
ninth, seventh and sixth weeks of development -- involving cloned babies.
said on Tuesday that the oldest of these was about to be born.
However, according to his statement in April, the longest pregnancy
have passed nine months in mid-November. Antinori would not explain
discrepancy on Tuesday.
He also refused to specify if he had any role in the alleged clonings.
did say that he would not be involved in the delivery of the baby,
he had given a "cultural and scientific contribution" to a consortium
scientists involved in the pregnancies. He refused to identify the
scientists. Other groups are claiming to be working on cloning a human.
Antinori refused to identify the woman who was to give birth in January
give her nationality. When asked where she was going to give birth
only "countries where this is permitted." Cloning has been declared
in many countries.
Antinori, who runs a private fertility clinic in Rome, gained attention
the 1990s when he used donor eggs and hormones to help post-menopausal
to have children.
Experts have repeatedly dismissed Antiniori's claims and say they doubt
he is capable of achieving a cloned pregnancy.
Delhi's rich adopt gender selection of the poor
November 27, 2002
by Catherine Philp
WHEN Bhanvi Kumri found out that the child she was carrying was a girl,
burst into tears. "I wanted to get rid of it," she said. Her first
been a girl and when she became pregnant a second time, she prayed
would be a boy. "A girl is OK, but a boy is a necessity in India."
In the end she had the baby, but she and her wealthy politician husband
vowed that next time they would not leave it to chance. Four months
a swanky Bombay fertility clinic, she underwent in vitro fertilisation
weed out female embryos and implant two males, the future heirs to
Aniruddha Malpani, who treated Bhanvi, is an unapologetic crusader for
he calls "family balancing" although he admits he has yet to treat
seeking to have a girl. "People used to kill baby girls," Dr Malpani
"This technology means they don't have to do that anymore."
Prakash Kakodkar, a gynaecologist in Bombay who admits to carrying out
sexselective abortions long after they were outlawed, goes further,
that it is women who benefit through sex selection. "If a woman isn't
to produce a male, she's badly treated and you want to help her," Dr
Kakodkar said. "Girl children are also very badly treated if they are
India's preference for male children is nothing new and the history
female infanticide in rural villages is long and brutal, with girl
smothered, drowned or simply abandoned by poor families desperate to
The bias is deep-rooted, born of traditions such as dowry-giving, the
of daughters to their husbands' families after marriage and the belief
only a son can light his parents' funeral pyre.
Now, however, officials are detecting an alarming new trend: the spread
the gender imbalance up the social scale, assisted by new technology
available to the increasing number of Indians with money to burn. The
is that the most influential classes are setting the trend for practices
contributing to a dramatic sex imbalance that could throw up all manner
social ills in years to come.
The ratio of girls to boys in India has been on a steady slide throughout
the past century, but when census officials compiled the results of
latest survey, they were met with a rude surprise. The most pronounced
in the number of girls under the age of six was no longer in rural
in the cities. And not just any neighbourhoods, but in the wealthiest
enclaves, where the educated elite live.
In the past decade, the number of girls under six in Delhi has slipped
945 per 1,000 boys to 865. Yet areas that include some of the most
neighbourhoods showed as few as 796 girls.
"We were shocked by the results," Suman Prashar, a senior census official,
said. But the conclusions were not hard to draw. "These are the areas
best-equipped with medical technology and these wealthy, educated people
misusing it to ensure they don't have girls."
The preimplantation genetic determination method used by Bhanvi is legal,
present, but the method most couples use to guarantee a male heir is
"kitty parties" - social gatherings in the leafy enclaves of south
wealthy housewives swap names of medical practioners willing to break
law to perform ultrasound sex testing and sex-selective abortions.
A recent crackdown has made doctors more cautious, but has also had
effect of driving prices up.
A prominent sign outside the Chopra ultrasound clinic in Delhi's smart
Jorbagh suburb proclaims that no sex testing is done there, but that
not stop the flood of inquiries from the city's ladies-who-lunch.
"One excuse they'll give is that their husband is going to London on
business and he wants to know whether to buy blue or pink clothes,"
Chopra, a doctor, said. "They may be educated, but they have the same
cultural mindset as villagers who abandon their babies in rice fields
Already villages in Haryana and Punjab, the traditional bastions of
infanticide, are suffering the consequences of two decades of systematic
eradication of females, with young men forced to buy in brides from
elsewhere or even share a wife with their brothers. Sexual violence
on the rise amid frustrated single men. It may only be a matter of
until upscale society is struck by its own set of consequences.
"We'll feel it in about 20 years' time when these children come to marry,"
Promilla Kapur, a sociologist, said. "The rigidity of the caste system
have to melt, but it will do nothing to improve the situation of women
because the problem springs from the fact they are undervalued."
The saddest thing, campaigners say, is that it is educated women themselves
who are helping to perpetuate the old attitudes. "What are they saying
themselves if they are so desperate for sons?" Ms Prashar asked in
exasperation. "And when it's the influential classes that are doing
it's extremely worrying. What hope is there for the rest?" Happily
with her male twins, Bhanvi was unrepentant about her own contribution
India's gender time bomb. "Whatever is available, one buys," she shrugged.
"If you want a boy, you buy a boy."
And as the Indian middle class swells year by year, more and more are
queueing to do so.
Time for a New Pair of Genes?
November 27, 2002
By Kristen Philipkoski
Families who share a history of heart disease or breast cancer would
jump at the chance to erase that hereditary trait.
Today that's still a fantasy, but advances in genetic research could
that possibility by altering genes in utero.
Bioethicists say changing the DNA of future generations in order to
genetic diseases raises serious ethical questions, and the National
Institutes of Health has funded a study to evaluate when, if at all,
hereditary genetic changes might be appropriate.
Some critics are surprised the NIH would fund even the evaluation of
"I think it's a matter of real concern that people are now paving the
do germ line genetic engineering," said Stuart Newman, a member of
Council for Responsible Genetics and a cell biologist at New York Medical
"They might be simply asking, 'Well, what are the pros and cons?' But
it's like saying 'What are the pros and cons of torture?'" he said.
Newman believes that changing the genes of an embryo flies in the face
the Nuremberg Code, which states that before performing human experiments
it's necessary to get the patient's consent. Of course, since the patient
this case is an embryo, that isn't possible.
But it gets even more complicated when you consider that such procedures
don't just affect the embryo in question, but future generations as
Genes inserted into an embryo (or egg or sperm cells) would be incorporated
into sex cells, which would then proliferate the changes across generations.
Since inherited changes would be achieved specifically through embryonic
sex cell changes, Newman sees no potential for developing a safe and
effective protocol with patient consent.
Others argue that the consent issue is a non-starter, since physicians
already perform other kinds of surgeries before birth. In such cases,
parents must give consent for their children.
"If you can modify gametes (egg or sperm cells) so as to prevent serious
very disabling genetic diseases, then the risks involved in attempting
line (hereditary) change would be worth doing," said Art Caplan, director
the Center for Bioethics at the University of Pennsylvania. "That is
rationale now for in utero surgery, amniocentesis, and neonatal
interventions -- to try and prevent harm from a variety of genetic
Caplan believes that if techniques that prevent disabling inherited
become viable, caregivers are obligated to use them.
Rebecca Dresser, professor of law and ethics in medicine at the Washington
University in St. Louis, Missouri, is leading the NIH-funded study.
proposed the study partly because discussion of the ethics involved
procedures had fallen off the radar in recent years.
The Recombinant DNA Advisory Committee, the arm of the NIH that reviews
studies that combine DNA molecules of different origins, refuses to
Most likely the stall in discussions happened because scientists would
need to perfect gene therapy before they could consider using it on
embryo or gamete. Advances in gene therapy have lagged in recent years.
If nothing else, the slow progression of scientific breakthroughs in
area gives ethicists more time to ponder the implications of changing
generations of genes.
"With human inheritable interventions, we have the chance to think and
ahead, to give direction to this technology through rigorous analysis
dialogue," the American Academy for the Advancement of Science researchers
say in their introduction of a paper on inherited genetic changes.
Some critics worry that changing embryos or gametes genetically could
to "designer babies." Most ethicists agree that the procedure would
worth the risk for adding, say, the Michael Jordan gene for athletic
"(The argument) really (centers around) what are the potential benefits
potential harms, and do the potential benefits justify exposing this
child or hoped for child to risk," Dresser said.
Researchers are able to change genetic inheritance in animals -- transgenic
animals are now quite common. But the techniques for creating them
imprecise. It sometimes takes several generations to breed change,
of the animals die.
No one is arguing that these procedures should be used on humans, but
new technologies might be safer and more effective, such as gene therapy
further in the future, artificial chromosome replacement.
When researchers discovered that there are likely only about 30,000,
100,000, human genes as they had once thought, they also realized that
gene does a lot more work than they previously realized. In turn, that
therapies that alter with genes could have any number of unintended
"You'd have to have some sort of safe technique where you change a (DNA)
sequence and you don't disrupt other things effected by that sequence,"
Dresser's study, which began in April, is a two-year project. By the
she and her colleagues on the project (who include pediatricians, a
counselor, a science policy expert, several former RAC members and
advocate) will submit two papers, one scientific and one for a general
audience, on what they believe are the most important ethical considerations
in terms of changing the genes of future generations.
Protein therapies spark scrutiny: Researchers weigh potential risk
27 November, 2002
By Naomi Aoki
It's the worst fear of every drug maker - when a drug that has been
market for more than a decade and has brought in billions in revenue
suddenly begins causing a potentially deadly condition in the very
it is meant to help.
For Johnson & Johnson, it has become a reality. Earlier this year,
researchers published evidence that its anemia drug Eprex, a genetically
engineered version of the human protein erythropoietin, was causing
body's natural defenses to go haywire and attack its own red-blood
leaving a small but growing number of patients severely anemic and
lifetime of transfusions to survive.
The story of Eprex, a drug that has freed millions of patients with
and kidney disease from their reliance on blood transfusions, has sent
chills through the biotechnology industry. The issue brings into bold
how dangerous immune responses to their drugs can be and how poorly
understood they remain. Engineered versions of human proteins
likeerythropoietin, insulin, and growth hormone are the cornerstone
But Eprex illustrates how horribly awry things can go when the body
to these drugs as if they were a germ, triggering an immune attack
on the drug itself but also on the body's own version of that protein.
researchers and regulators are questioning whether similar defenses
triggered by other protein therapies could prove dangerous.
Eprex is a worst-case scenario. But already, there is growing controversy
about whether antibodies triggered by certain multiple-sclerosis drugs
render patients immune to the entire class of therapies, including
Cambridge-based Biogen Inc.'s top-selling Avonex.
''No doctor in his right mind wants to immunize a quarter of his patients
an entire group of therapies,'' said Dr. Tim Vartanian, an assistant
professor of neurology and neuroscience at Harvard Medical School.
The biotech industry's top players - from Biogen to California-based
Inc. to New Jersey-based Johnson & Johnson - have devoted an increasing
amount of resources to understanding and preventing the immune reactions.
Regulators have begun to demand more information on immune reactions
considering drugs for approval and monitoring those already on the
And as researchers and regulators struggle to balance the benefits
drugs against their potential risks, the burden on companies developing
protein-based drugs promises to grow.
''We're walking a fine line,'' said Dr. Amy Rosenberg, director of the
division of therapeutic proteins at the Food and Drug Administration's
Center for Biologics Evaluation & Research. ''We don't want to
development. We want to get good drugs out there for the public. But
them to be safe. They have to be safe.''
Researchers have long known that protein therapies could trigger the
natural defenses. Recognizing subtle differences even in drugs genetically
engineered to be identical to substances found in the body, the immune
system sometimes produces neutralizing antibodies to fend off what
as foreign invaders. But the effect of the antibodies has varied among
drugs. And in many cases, the science remains unclear.
For years, the antibodies have been suspected of reducing or eliminating
drug's potency over time. But until recently, researchers have not
considered them a potential safety concern. Because the mission of
immune system is to protect the body, scientists reasoned that it would
turn on itself. They simply didn't believe neutralizing antibodies
genetically engineered version of a human protein would cause the body
attack its own version of that protein.
Then, in 1998, an experimental drug being developed by Amgen, the world's
largest biotech company, did just that. The drug, an engineered version
the human protein, known as MGDF and which spurs the production of
platelets, was hailed as a potential blockbuster. But after three years
testing in more than 1,000 people, researchers noticed that some patients
mounted an immune attack on their own platelet-producing cells, leaving
vulnerable to excessive bleeding. Amgen dropped the drug.
''It was stunning,'' said Dr. Burt Adelman, executive vice president
research and development at Cambridge-based Biogen. ''The conventional
wisdom had been that this was a theoretical risk. This was Amgen; these
excellent scientists; and nobody saw it coming. If you're in my business,
it's really unnerving.''
Less than a year later, French physician and researcher Dr. Nicole
Casadevall began seeing a similar phenomenon in patients taking Eprex,
is only sold outside the United States. The immune attack on the native
of erythropoietin was devastating because there is no backup systems
the body when the protein fails to do its job.
Until then, cases of red cell aplasia caused by erythropoietin products
been extremely rare. In the decade before, only two cases were linked
Eprex and two to Epogen, a version of erythropoietin sold in the United
States by Amgen. As of July, the number of suspected cases of red cell
aplasia caused by Eprex had grown to 160, and answers remained elusive.
believes the problems are linked to manufacturing changes made shortly
before the problems began. The company continues to sell the drug.
Per Peterson, J&J's head of research and development, said the problem
affects the entire industry. When erythropoietin and other protein
first reached the market, they were breakthroughs in treating devastating
diseases. When the choice was either to treat a patient or not, Peterson
said, the formation of neutralizing antibodies in response to therapy
theoretical concern. But as more drugs have come to market, he said,
issue becomes more significant.
''As always in medicine, it comes down to a question of risk vs. benefit,''
Peterson said. ''If 20 percent of your patients are dying each year
renal disease and you see one out of 10,000 patients who no longer
to erythropoietin, you go back to transfusing that patient and worry
the others who are dying. As a practical matter, it can't be a top
It is only in the last few years, now that you have a choice of drugs
you can ask, `Is one safer than the other?'''
The question is the subject of much debate in multiple sclerosis. Since
1993, three drugs that are variations of the human protein beta interferon
have reached the US market. The drugs are more similar than they are
different. But Avonex has the lowest rate of neutralizing antibody
formation - 5 percent compared to more than 20 percent for its competitors,
Serono's Rebif and Berlex's Betaseron.
The failure of MGDF marked the beginning of a shift in the FDA's attitude
toward immune responses in reviewing the safety of drugs, said Rosenberg
the FDA. That shift has only been cemented by the recent experience
Europe with Eprex. The agency is asking for more information on antibody
responses before allowing protein therapies to be tested in people,
especially in cases where the drugs could interfere with the action
native proteins that serve a critical function in the body.
It is also asking for more information from the earliest stages of human
testing rather than waiting for the data to be generated in larger,
later-stage trials. Rosenberg said the FDA is also struggling with
of how to evaluate manufacturing changes to already approved drugs.
highlighted by the Eprex case, she said, even minor changes can produce
major differences in the safety and effectiveness of drugs.
But the issue is not always clear cut. Animal studies suggested that
could cause the devastating immune response later seen in people, triggering
more stringent scrutiny of such data. In most cases, however, immune
responses seen in animals do not accurately predict how people will
Existing lab tests don't always forecast how manufacturing changes
affect a drug's potential to trigger an immune response.
''This all points to the fact that no matter how much we know in biology,
there's a lot we don't know,'' said Biogen's Adelman. ''And it comes
bite us at some of the most inopportune moments - when people's lives
GM Stem-Cell Patent Jumps Through EPO Hoop
26 November, 2002
World Markets Analysis
A patent covering genetically-modified embryonic stem cells, also known
the 'Edinburgh' patent after one of the research locations, has recently
been approved by the oral proceedings of the Opposition Division
European Patent Office (EPO), albeit with modifications. The
refers to a method of using genetic engineering to isolate stem
derive pure stem- cell cultures, originally covered embryonic stem
was therefore challenged by the governments of
Germany, Italy and the Netherlands, as well as the non-governmental
organisation (NGO) Greenpeace. According to the European Patent Convention,
human embryos cannot be patented for industrial and commercial purposes,
which, however, does not include embryonic stem cells and human germ
although still referring to modified human and animal stem cells.
DNA patterns produce ultimate personalised gift
27 November, 2002
by Andy Coghlan
Items bearing colourful patterns based on the recipient's own genetic
fingerprint are being touted as the ultimate personalised gift.
The patterns are not based on regions of DNA that could reveal a person's
genetic secrets Neil Sullivan, CEO of Complement Genomics in Sunderland,
England, conceived the idea as a sideline to his company's main business.
This includes collecting DNA for pharmaceuticals companies and paternity
Using a kit provided by the company, customers swab the inside of the
recipient's mouth to collect some cells. They then send the swabs back
a description of the kind of gift they want. Sullivan's team then extracts
DNA from the cells and analyses it to provide the basis for a pattern.
The patterns, which have so far been applied to necklaces, rugs and
glassware, resemble the DNA bar codes seen in genetic fingerprints
paternity testing or forensic examination. These patterns correspond
sequences called short tandem repeats, that are unique to each individual.
To demonstrate the technique, Sullivan's team produced a necklace that
gemstones to represent the bands in a genetic fingerprint, with slugs
silver in between, representing the distances between each band.
"It's an exclusive gift based on a unique gene profile," said Sullivan
the International Biotech Conference in London last week. "It's a one-off
that can never be replicated." He uses a pool of 10 local artists to
the different objects, which the company call DesigNAgifts.
Sullivan stresses that the DNA never belongs to the company and is taken
accordance with international legal standards. It is not entered into
databases and is destroyed after three months.
He adds that the patterns are not detailed enough to be used for paternity
testing and avoids regions of DNA that could reveal a person's genetic
Nordic genes for would-be moms
Friday, November 22, 2002
Seattle Post-Intelligencer Reporter
By Carol Smith
Scandinavian Cryobank, one of the largest sperm banks in the world,
opened a distribution branch in Seattle, site of its first U.S. operation,
for the bulk import of sperm samples from Norway, Sweden and Denmark.
"Seattle was an obvious choice because of the Scandinavian background
the population here," said Peter Bower, director of Seattle operations,
is half-Danish himself and chose Seattle because he had lived here
Also, until the cryobank opened its doors last November, Seattle had
a freestanding, commercial sperm bank.
Swedish Medical Center operates a non-profit local sperm bank as part
reproductive technology laboratories.
Before the arrival of Scandinavian Cryobank, women who didn't want to
local bank would usually request sperm from California, which is home
several large commercial banks, said Mary Forster, director of the
Swedish has had several patients use Scandinavian sperm, both since
been available locally, and prior to that by having it shipped from
Now patients increasingly use the Internet to order sperm, she said.
The sperm bank sells directly to female patients, but only if they are
clients of a fertility clinic, or have a doctor's permission.
The bank won't sell to a woman who is not being cared for by a doctor
approves of the procedure, Bower said. The sperm is shipped all over
The market for donor sperm is worth between $50 million and $100 million
year, according to Scandinavian Cryobank.
Although having a sperm bank devoted to one ethnicity is unusual, patients