[Hplusroadmap] Fwd: [tt] NYT: Growth of Genetic Tests Concerns Federal Panel

[Bryan Bishop]

TODO: Assemble list of all available genetic tests.

- Bryan

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Subject: [tt] NYT: Growth of Genetic Tests Concerns Federal Panel
Date: Friday 18 January 2008
From: Premise Checker <checker at panix.com>
To: Transhuman Tech <tt at postbiota.org>, paleopsych at paleopsych.org

WASHINGTON -- The science of genetic tests is marching ahead and
so are efforts to sell them directly to consumers who are willing
to send in a check and a bit of saliva to learn whether they are
at risk for a disease.

Growth of Genetic Tests Concerns Federal Panel
http://www.nytimes.com/2008/01/18/us/18tests.html

By ROBERT PEAR

WASHINGTON -- The science of genetic tests is marching ahead and
so are efforts to sell them directly to consumers who are willing
to send in a check and a bit of saliva to learn whether they are
at risk for a disease.

What is not keeping up is regulation and oversight, according to
a federal advisory panel. The panel concluded that a growing
number of the tests are being marketed with claims that are
unproved, ambiguous, false or misleading.

Millions of people have already taken the tests, a relatively new
tool that even many doctors have yet to master. Test results can
provide information to help prevent, detect and treat hundreds of
conditions including cancer, heart disease, diabetes, cystic
fibrosis and blood disorders.

The results can lead to momentous decisions. For example, women
with a family history of breast cancer rely on them in deciding
whether to have surgery to remove breasts or ovaries as a
preventive measure.

With use of the tests growing at an explosive rate, the panel
concluded that patients could be harmed. In most cases, the tests
do not pose a direct physical risk; but, the panel said, if a
test is inaccurate, patients may be given risky, unnecessary
treatments or denied treatments that would be highly beneficial.

In addition, the panel said, most doctors lack the training and
expertise needed to interpret genetic tests, and many are
unfamiliar with professional guidelines for their use. Although
professional societies play an important role in making sure
their members get up-to-date information, the panel said, "they
cannot keep up with the pace of development of genetic tests."

While the report does not focus on the ethical and social
consequences of genetic testing, it does note that companies now
market many tests directly to consumers, bypassing doctors, a
trend that it said has raised "significant ethical concerns."

Doctors themselves have expressed concern about the pluses and
minuses of tests -- like a new one that can predict whether a man
is at risk for prostate cancer -- that provide information but
leave people at sea about how, or whether, to be treated. Medical
ethicists have asked whether insurance companies might try to
limit coverage to someone who had learned that he was at risk yet
showed no signs of having a disease.

The 15 members of the advisory panel are doctors, research
scientists and lawyers who are experts in medical genetics. They
represent constituencies with a variety of reasons for being
interested in genetic testing, including universities, drug and
biotechnology companies, hospitals, laboratories and an insurance
company.

The genetic tests that were the focus of their work analyze DNA
(or its chemical cousin, RNA), chromosomes, genes, enzymes or
other proteins to detect mutations related to disease or health.
Test material is obtained from cheek swabs, blood samples,
biopsies and other tissue specimens.

Some executives in the genetic testing industry say it is capable
of regulating itself while others say they would welcome more
federal standards to provide reassurance to consumers.

Rosalynn D. Gill, chief science officer of Sciona, based in
Boulder, Colo., said the company had performed tens of thousands
of "nutrigenetic tests," sold directly to consumers over the
Internet and through other channels. The results of the tests are
used as the basis of recommendations about a person's diet and
nutrition.

"This industry is growing like mad," Dr. Gill said. "We would
welcome more federal regulation. It's unclear what regulatory
requirements apply to our products."

But Alan B. Mertz, president of the American Clinical Laboratory
Association, a trade group, said that overly stringent regulation
of genetic tests could "stifle innovation."

In any case, the advisory panel found, federal officials are
unsure how to regulate the tests and the laboratories that
perform them.

One arm of the Department of Health and Human Services, the
Centers for Medicare and Medicaid Services, regulates the
operations of clinical laboratories, including those that handle
genetic tests. Another arm, the Food and Drug Administration, has
the power to regulate genetic tests as medical devices. The
Federal Trade Commission polices advertising and marketing.

No federal agency even has a complete list of all the tests. The
panel concluded that more than 1,100 genetic tests are currently
available, although some geneticists put the number much higher.
Current genetic tests may be useful to 2 percent of the
population, the panel said, but that figure could grow to 60
percent with tests now being developed.

Federal health officials say that some genetic tests are
scientifically sound, some are highly questionable and many
appear to fall somewhere in between.

In the final draft of its report, the panel, known as the
Secretary's Advisory Committee on Genetics, Health and Society,
also said that "there is currently no requirement that test
providers disclose information to support claims about the
accuracy and validity of testing," and scientific evidence for
the value of some widely used tests is sparse. The panel said
that doctors and patients cannot be sure whether the tests will
predict or diagnose a particular disease as promised because "the
Food and Drug Administration is not currently assessing the
clinical validity of most genetic tests."

Even within the government there is debate over whether more
federal regulation is the answer. The panel found much confusion
and uncertainty about the division of labor among federal
agencies.

For instance, one genetic test, known as MammaPrint, used to
predict whether breast cancer will spread to other parts of the
body, was cleared by the food and drug agency last February.

But another genetic test, Oncotype DX, which uses a different
technique to predict the recurrence of breast cancer, has not
been submitted to the F.D.A. for review even though it has been
on the market since 2004.

Randy W. Scott, the chief executive of Genomic Health, which
developed Oncotype DX, said its laboratory was regulated and
certified by the Centers for Medicare and Medicaid Services, so
there was no need for review by the food and drug agency.
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Bryan Bishop
http://heybryan.org/