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17th September 2002
1. First Ever Campaign for Cancer Predictive Test To Market
2. Experts urge genetic test controls
3. UK scientists must bank embryo stem cells: regulator
4. Genetic defects found in cloned animals
5. HHS Seeks Science Advice to Match Bush Views
6. Estonians invest in ambitious gene bank
7. US Debates Necessity of Genetic Discrimination Law
8. Clinic shuns new IVF gene checks
9. DNA database 'has to cover everyone'
10. Bringing the genetic lab to you
11. Rule raises genetic discrimination concern
First Ever Campaign for Cancer Predictive Test To Market
Posted on Thursday 12 September, 2002
Press Release Source: Myriad Genetics, Inc.
Myriad Genetics Launches Direct to Consumer Advertising Campaign For
Myriad Genetics, Inc. (Nasdaq: MYGN - News), today initiated an intensive
five-month advertising campaign to raise awareness of cancer prevention
options among women with a family history of breast cancer or ovarian
cancer. The first-of- its-kind campaign will focus on Atlanta and Denver,
using television, radio and print media to carry its message of hope
help to those at high risk of cancer.
Denver and Atlanta comprise 3.2% of the target population, consisting
women in the United States between the ages of 25 and 54, with a strong
family history of breast or ovarian cancer. Market research among 300
high-risk women representing this population, conducted prior to the
campaign, indicated that 85% would contact their doctor about having
test. An impressive 94% agreed with the statement that "[the BRACAnalysis(r)
test] is a service that I would want my child/mother to use." The
availability of the test was important enough that 62% of the women
felt that, "This service would motivate me to switch to a healthcare
professional providing it."
Since the introduction of the BRACAnalysis test for susceptibility to
and ovarian cancer, Myriad has focused its marketing and education
on cancer specialist physicians and cancer centers. This effort has
knowledge base in the cancer care community about the appropriate use
remarkable new technology that is predictive medicine. However, cancer
specialists serve those who have been diagnosed with the disease, and
greatest potential for the technology is in the prevention of cancer.
achieve this potential, Myriad must reach those with a family history
breast or ovarian cancer who do not themselves have cancer. A media
that is directed to women with a family history of breast cancer or
cancer is the most appropriate way of raising awareness among this
individuals that stands to benefit the most.
The campaign is designed to alert women with a family history of cancer
recent advances in cancer prevention and early disease detection. It
longer appropriate for these women to simply consider breast cancer
destiny, even in the context of a strong family history of the disease.
Medical interventions have been shown to be effective in lowering the
of cancer in these individuals. Resources and education are available
through physicians and from Myriad directly to learn more and take
"Be Ready Against Cancer"(TM).
Advertisements are scheduled to run during major television shows, including
"ER," "The Practice," "CSI: Miami" (premiere), "Providence," "Oprah,"
& Kelli" and "The Today Show." Print media will include regional
publications such as Better Homes and Gardens, The Ladies' Home Journal
Women's Health Monitor. In all, the campaign is projected to reach
of homes in the selected markets an average of 16.5 times each.
Media guides for Denver and Atlanta highlighting the September schedules
the advertisements are available and the broadcast advertisement is
available for preview at www.myriad.com .
Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development of novel therapeutic products derived from its proprietary
genomic and proteomic technologies. The Company has established two
owned subsidiaries. Myriad Pharmaceuticals, Inc. develops and intends
market therapeutic compounds, and Myriad Genetic Laboratories, Inc.
and markets proprietary predictive medicine and personalized medicine
products. Myriad has established strategic alliances with Bayer, Eli
Hitachi, Novartis, Oracle, Pharmacia, Roche, Schering AG, Schering-Plough
The discussion in this news release includes forward-looking statements
are subject to certain risks and uncertainties. Such statements are
management's current expectations that are subject to risks and
uncertainties that could cause actual results to differ materially
those set forth or implied by forward-looking statements, including,
limited to uncertainties as to the extent of future government regulation
Myriad Genetics' business, uncertainties as to whether Myriad Genetics
its collaborators will be successful in developing, and obtaining regulatory
approval for, and commercial acceptance of its products, the risk that
markets will not exist for products that Myriad Genetics develops or
markets exist, that Myriad Genetics will not be able to sell products,
it develops, at acceptable prices. These and other risks identified
Company's filings with the Securities and Exchange Commission, including
Company's Annual Report on Form 10-K for the fiscal year ended June
2001. All information in this press release is as of September 12,
Myriad undertakes no duty to update this information unless required
Experts urge genetic test controls
Posted on 10 September, 2002
Will pharmacies sell gene test kits?
The sale of over-the-counter genetic tests in the UK should be strictly
controlled, experts have warned.
The Human Genetics Commission is currently considering what restrictions,
any, should be placed on genetic tests. They have warned that genetic
testing is complex and must be overseen by specialists.
Dr Lindsay Prior, a reader in sociology at Cardiff University, told
meeting that giving the public easy access to genetic testing may do
harm than good.
"The public may be tricked into paying a lot of money for these tests
may not do them much good and may in fact mislead them," he told BBC
Genetic testing involves an analysis of a DNA sample. But when doctors
trying to assess the risk of breast cancer, for example, they will
about family medical history.
Any over-the-counter tests are unlikely to include this sort of assessment.
Dr Prior warned that checking family history is often as important
as a DNA
"As far as complex conditions like breast cancer or colorectal cancer
concerned you need both sides of the picture," he said.
"The low-tech and hi-tech parts are important. However, commercial
organisations are only interested in selling the test."
Dr Prior also told the meeting that allowing members of the public
genetic test kits from pharmacies and other outlets raised serious
"If an individual finds out something about themselves then it will
implications for their brothers and sisters and any children they may
to have," he said.
The Human Genetics Commission is currently consulting on proposals
restrictions on genetic testing. That process closes in October.
"The Human Genetics Commission is right to ask these questions because
commercial organisations get into these areas quite quickly without
through the implications," Dr Prior said.
But he added: "There should be careful restrictions on the sale of
tests of any kind.
UK scientists must bank embryo stem cells: regulator
Posted on 11 September, 2002
By Richard Woodman
LONDON (Reuters Health) - Britain will force scientists working on
stem cells to donate their cell lines to the national stem cell bank,
head of the body that regulates embryo research said on Wednesday.
Suzi Leather, chair of the Human Fertilisation and Embryology Authority,
said the authority would only licence such research on condition that
sample of any cell lines created is placed in the bank.
"It is not lawful in this country for embryonic stem cells to be generated
without a licence from the authority," she told a stem cell conference
London that was picketed by a small group of "pro-life" students who
destroying embryos for research purposes was unacceptable.
The meeting was organised by the Medical Research Council (MRC). The
announced earlier this week that the bank would be set up by the National
Institute of Biological Standards and Control, which expects to be
the first cell lines within 12 months.
Leather told Reuters Health that the regulation obliging researchers
donate their cell lines to the bank was designed to ensure that the
benefited and in order to maintain public confidence. "This is absolutely
critical. We don't want a repeat of what happened with genetically
She added that the authority was "working closely with the MRC to ensure
that adequate provisions are in place for overseeing the subsequent
stem cells and that the public will benefit as directly as possible
outcomes of this research."
The authority also planned to publish more details of the research
licences on its Web site because it was "important that people know
embryo research is being carried out and with what intended public
Leather added that a balance would have to be struck between greater
transparency and protecting the confidentiality of researchers.
MRC chief executive Professor Sir George Radda said the new regulation
apply only to embryonic stem cells--not adult or fetal stem cells.
He said it was clearly essential to protect the intellectual property
bank donors and details of how best to do this would be worked out
MRC's technology transfer company.
Genetic defects found in cloned animals
Posted on 10 September, 2002
United Press International
Scientists have found further evidence that cloned
animals tend to harbor genetic defects that will disrupt
their development and lead to abnormalities, strengthening
the rational that reproductive cloning of humans should be
banned. However, the researchers noted the technology still
could be used safely for therapeutic cloning techniques,
such as producing embryonic stem cells to treat diseases
ranging from Parkinson's to diabetes. "Cloned animals have
major dysregulation of multiple genes so they are not
normal at all," principal investigator of the study Rudolf
Jaenisch, a biologist at the Whitehead Institute for
Biomedical Research, told United Press International.
Jaenisch's team looked at 10,000 genes in cloned mice and
found hundreds of genes important to development were not
correctly expressed in the animals, he said. Overall, about
one out of every 25 genes was not expressed correctly in
the placenta. Abnormal gene expression also was observed in
the liver but at a lower rate. This ultimately impacts the
animal's development and causes all kinds of malformations,
he said, and it probably explains why many clones die
early, are obese or have other problems. Hans Scholer,
director of University of Pennsylvania's Center for Animal
Transgenesis and Germ Cell Research in Philadelphia, agreed
the research "supports the notion that you shouldn't clone
humans." Scholer himself reported research in May that
found a single gene was vital to cloning success. Because
the animals appeared normal yet exhibited genetic defects,
it should send a message to Severino Antinori, the
controversial Italian physician who claims to have
impregnated three women with cloned human embryos, Scholer
told UPI. "It says, 'even if you show us the face of a
beautiful baby, behind the face there might be a terrible
problem,'" Scholer said. "If Antinori claims he has a
healthy clone, I would think he lied." Jaenisch said.
Antinori has claimed the cloned babies are expected to be
born in December and January. Robert Lanza, vice president
of medical and scientific development at Advanced Cell
Technology of Worcester, Mass., which conducts reproductive
cloning in animals, also concurred. The new study is
"further scientific grounds to ban all human reproductive
cloning," he told UPI. "This definitely raises a red flag
for anybody who would want to use cloning for reproducing
The cloning process -- which involves transferring DNA
from a single cell of an animal into an egg cell and
creating a relatively exact copy of that animal - - does
not adequately reprogram the genes for proper development.
In other words, the cloned animals showed genetic defects
because the procedure does not replicate normal
reproduction, Jaenisch said, although it is not yet
understood how cloning interferes with the reprogramming
process. Jaenisch pointed out the research has no bearing
on therapeutic cloning, which appears to pose no safety
risks. Therapeutic cloning takes tissue derived from
embryonic stem cells and places it in a fully-grown animal
to treat disease. The inserted cells function normally and
there does not appear to be any problem, he said. His group
reported earlier this year they had used therapeutic
cloning to cure a mouse of an immunodeficiency disease. "I
agree 100 percent with (Jaenisch) on that," Scholer said.
Embryonic stem cells derived from therapeutic cloning
would be grown into specific types of cells such as heart
or brain cells, he said. If a tissue sample turns out to be
faulty or have defects, "you just throw it away. But you
can't do this with entire organisms" that have arisen from
cloning. "This is pretty much in favor still of therapeutic
cloning but at the same time it is closing the door on
reproductive cloning," Scholer said. The research will be
published this week in the online edition of the
Proceedings of the National Academies of Science.
HHS Seeks Science Advice to Match Bush Views
By Rick Weiss
Posted 17 September, 2002
The Bush administration has begun a broad restructuring of the scientific
advisory committees that guide federal policy in areas such as patients'
rights and public health, eliminating some committees that were coming
conclusions at odds with the president's views and in other cases replacing
members with handpicked choices.
In the past few weeks, the Department of Health and Human Services has
retired two expert committees before their work was complete. One had
recommended that the Food and Drug Administration expand its regulation
the increasingly lucrative genetic testing industry, which has so far
free of such oversight. The other committee, which was rethinking federal
protections for human research subjects, had drawn the ire of administration
supporters on the religious right, according to government sources.
A third committee, which had been assessing the effects of environmental
chemicals on human health, has been told that nearly all of its members
be replaced -- in several instances by people with links to the industries
that make those chemicals. One new member is a California scientist
helped defend Pacific Gas and Electric Co. against the real-life Erin
The changes are among the first in a gradual restructuring of the system
that funnels expert advice to Health and Human Services Secretary Tommy
That system includes more than 250 committees, each composed of people
scientific, legal or academic expertise who volunteer their services
The committees typically toil in near anonymity, but they are important
because their interpretation of scientific data can sway an agency's
approach to health risk and regulation.
The overhaul is rattling some HHS employees, some of whom said they
seen such a political makeover of the department since Ronald Reagan
office in 1981.
HHS spokesman William Pierce said he could not provide a tally of the
of committees that had been eliminated or changed so far, but he denied
the degree of change was out of the ordinary for the first years after
change of administration.
He acknowledged that Thompson has irritated some HHS veterans with his
down" approach to reshaping the department, but he defended Thompson's
prerogative to hear preferentially from experts who share the president's
"No one should be surprised when an administration makes changes like
Pierce said. "I don't think there is anything going on here that has
gone on with each and every administration since George Washington."
Routine or not, the restructuring offers a view into how tomorrow's
policies are being constructed -- and how the previous administration's
influence is being quietly dismantled.
One example of the recent changes is the Secretary's Advisory Committee
Genetic Testing, created during the Clinton administration after a
federal report concluded that the public was at risk of being harmed
emerging gene-testing industry.
One of the first topics tackled by the committee was how to deal with
proliferation of so-called home-brew genetic tests, which are offered
growing number of companies and doctors.
The blood tests can detect DNA variations that may increase a person's
of getting a disease or affect a patient's response to medicines.
The Food and Drug Administration has long asserted that it has the authority
to regulate these tests, but it has opted not to do so -- in part because
a lack of resources. As a result, companies are free to market tests
genes even if those genes have no proven role in disease susceptibility
any proven usefulness at all. A growing number of companies are doing
that -- at no small expense to consumers -- in some cases needlessly
alarming people with meaningless results and in other cases offering
The committee convinced the FDA to use its authority to oversee the
marketing of these tests, and the agency was developing rules when
administration took over. Suddenly the FDA's stance changed: The agency
no longer certain it had the regulatory authority in question. Oversight
plans stalled. Today the FDA is still mulling whether it has authority,
Pierce said, and last week members learned that the committee's charter,
which just expired, will not be renewed.
"This is a real turnaround. It's bad. It's terrible," said Neil A. "Tony"
Holtzman, a Johns Hopkins University professor emeritus who chaired
task force that led to the committee's creation.
Wylie Burke, who chairs the department of medical history and ethics
University of Washington and was a member of the committee, said gene-test
oversight is needed now more than ever because companies are starting
advertise tests directly to consumers and are offering questionable
over the Internet.
"People need to know what they're getting," Burke said. "We were making
headway with informed-consent issues and with categorizing levels of
It would be a shame if that does not get completed."
Pierce said the committee's demise had nothing to do with its
recommendations or regulatory approach. Rather, he said, HHS intends
create a new committee that will deal with a broader range of genetic
technologies. The department has not said who will sit on that committee.
Another example is the National Human Research Protections Advisory
Committee, created under President Bill Clinton after a series of government
reports found serious deficiencies in the federal system for protecting
human subjects in research. The call from HHS to disband "came out
blue," said committee chair Mary Faith Marshall, a professor of medicine
bioethics at the University of Kansas in Kansas City.
Some sources suggested the committee had angered the pharmaceutical
or other research enterprises because of its recommendations to tighten
conflict-of-interest rules and impose new restrictions on research
the mentally ill.
"It's very frustrating," said Paul Gelsinger, who became a member of
committee after his son, Jesse, died in a Pennsylvania gene therapy
experiment that was later found to have broken basic safety rules.
always been my view that money is running the research show," he said.
with this administration's ties to industry, I'm not surprised" to
Other sources said the committee had run afoul of religious conservatives
when it failed to support an administration push to include fetuses
federal regulation pertaining to human research on newborns. Some within
said they'd heard the department may reconstitute the committee with
purview that includes research on human fetuses or even embryos --
seen by some as part of a larger administration effort to bring rights
Consistent with that possibility, HHS officials recently told committee
members they hope to name Mildred Jefferson to a reincarnated version
committee that the department hopes to create. Jefferson is a medical
who helped found the National Right to Life Committee and who three
served as that organization's president.
Pierce said HHS had allowed the committee to expire not because of the
direction of its work but because, as with the genetic-testing committee,
the department wants to create a new panel with a broader, as yet
undetermined, charge. That committee has yet to be created or its members
Yet another committee caught up in the recent upheaval is one that advises
the Centers for Disease Control and Prevention's National Center for
Environmental Health on a range of public health issues from pollution
Thomas Burke, the Johns Hopkins public health professor who has chaired
committee for almost five years, recently learned that 15 of its 18
are to be replaced. In the past, he said, HHS had asked him to recommend
members when there were openings. This time, he said, a list of names
imposed. He was among those who were let go.
Burke said he was not offended that his own membership, which was expiring,
was not renewed. "There's constant turnover on these boards," he said.
"What's of concern though is to see so much turnover at one time, especially
at such a critical time for the CDC."
He mentioned another concern: One of the committee's major endeavors
been to assess the health effects of low-level exposures to environmental
chemicals, yet as first reported by Science magazine last week, several
the new appointees are well known for their connections to the chemical
They include Roger McClellan, former president of the Chemical Industry
Institute of Toxicology, a North Carolina research firm supported by
chemical company dues; Becky Norton Dunlop, a vice president of the
Foundation who, as Virginia's secretary of natural resources, fought
environmental regulation; and Lois Swirsky Gold, a University of California
risk-assessment specialist who has made a career countering
environmentalists' claims of links between pollutants and cancer.
The committee also includes Dennis Paustenbach, the California toxicologist
who served as an expert witness for Pacific Gas and Electric when the
utility was sued for allowing poisonous chromium to leach into groundwater.
The case was made famous in the movie "Erin Brockovich."
"It's in the nation's interest to avoid any appearance of a conflict
interest on these committees," said Burke, the former chairman. "To
friends of the administration . . . clearly that's what we're seeing
It's wholesale change. The complexion has changed."
HHS's Pierce said the committee remains balanced overall, and no prospective
member of any advisory committee is subjected to political screenings.
"It's always a matter of qualifications first and foremost," Pierce
"There's no quotas on any of this stuff. There's no litmus test of
At least one nationally renowned academic, who was recently called by
administration official to talk about serving on an HHS advisory committee,
disagreed with that assessment. To the candidate's surprise, the official
asked for the professor's views on embryo cell research, cloning and
physician-assisted suicide. After that, the candidate said, the interviewer
told the candidate that the position would have to go to someone else
because the candidate's views did not match those of the administration.
Asked to reconcile that experience with his previous assurance, Pierce
of the interview questions: "Those are not litmus tests."
Estonians invest in ambitious gene bank
Independent on Line South Africa
Posted September 9, 2002
Tartu, Estonia - The pilot phase of an ambitious gene bank project
aims to include blood samples of the entire Estonian population is
this week, the manager of "Estonian Gene Bank" Krista Kruuv announced
The blood samples of 10 000 donors were to be analysed within the next
months before making a gene bank comprising the entire population.
project is considered the most ambitious of its kind worldwide.
The data will be used to develop new medicines and for the early recognition
of gene associated illnesses. The donors, whose participation is voluntary,
give 50 millilitres of blood and fill out a questionnaire.
The genetic information would then be stored in a central computer.
politicians hope that this would lead to the establishment of an entire
and biotechnology branch in the Baltic country.
'We now want to see whether the model works'
In March 2001, the government in Tallinn passed a gene law creating
appropriate legal conditions which would also prevent the abuse of
"We now want to see whether the model works, whether the data is secure
whether people are properly informed", said Kruuv.
The pilot project's costs of about 2,7-million (R27-million) were
footed mainly by risk capital companies and private investors who expect
profit from the sale of the data later. - Sapa-DPA
US Debates Necessity of Genetic Discrimination Law
Posted 12 September, 2002
Health - Reuters
Legislation to bar insurers and employers from discriminating on the
of an individual's genetic information could do more harm than good,
witnesses told a US House subcommittee on Thursday. But backers of
legislation to fill in what they say are gaps in existing protections
the need is more critical than ever.
Aetna Inc. Chairman and CEO Dr. John Rowe, whose company has released
lengthy policy position on how it will collect, pay for, and use genetic
information, warned the House Judiciary Subcommittee on the Constitution
that Congress needs to differentiate between types of genetic information,
particularly between information that can predict future disease and
descriptive information, such as blood type.
Rowe also warned that Congress ought not bar insurers from seeking to
collect predictive information that could help patients stay healthy.
example, he said, "if the insurance company knows that (an) individual
high risk due to a genetic link, the individual will be able to obtain
coverage for preventive screening at more frequent intervals than
recommended for the general population."
Tom Miller, director of Health Policy Studies for the libertarian group
Cato Institute, said that allowing people to keep results of genetic
to themselves would let them unfairly manipulate the insurance market.
"One's right to privacy should not include the right to misrepresent
to the rest of the world, particularly in the case of making statements
one's health insurer or employer that one knows to be false," he said.
Miller also said that genetic discrimination legislation is a solution
search of a problem. "There is little, if any, evidence that health
are using or likely to use presymptomatic genetic information in their
medical underwriting," he said, and there are only anecdotal reports
employers trying to obtain or use such data.
But Joanne Hustead of the Georgetown University Health Privacy Project
that even if discrimination is not now occurring, the public's fear
could warrants congressional action.