GENTECH archive 8.96-97
Plethora of genetic privacy bills in usa
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- Subject: Plethora of genetic privacy bills in usa
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- Date: Sat, 12 Apr 1997 00:41:33 +0200
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A PLETHORA OF GENETIC PRIVACY BILLS FLOODS
BioWorld via Individual Inc. : WASHINGTON _
Before cloning grabbed the spotlight,
genetic discrimination was the biotech
ethics issue capturing the most public
Even though the future potential for
cloning a human has played on the public
imagination of late, the risk of losing
health insurance or employment as a result
of "flunking the gene test" _ as National
Human Genome Research Institute Director
Frances Collins calls it _ remains very
much in the here and now.
Both federal and state legislators in 39
states have proposed a variety of
legislation ranging from granting people
ownership of their genetic information to
requiring informed consent for any use of
the genetic information. As well- meaning
as these provisions appear, many of them
could bring medical research to a grinding
"The potential for genetic information to
be used to discriminate against people was
really the first bioethics issue to show up
as a priority for us one and a half years
ago," said Carl Feldbaum, president of the
Biotechnology Industry Organization (BIO).
"Genetic privacy is essential to our
industry, but we need to be very careful
how genetic privacy laws are written in
order to protect research."
As a result, BIO and the Pharmaceutical
Research and Manufacturers of America
(PhRMA) joined forces to educate
legislators both in Washington and in
individual states about the untoward
consequences their bills may have on
The risk to research was first realized
last year, when a bill unanimously passed
in the New Jersey state legislature that
would have granted ownership rights to
genetic information. Intense lobbying by
BIO and PhRMA resulted in Governor
Christine Todd Whitman vetoing the bill and
the provision was eliminated.
Establishing that people own their genetic
information may seem a reasonable way to
assure that individuals maintain control
over that information, but as Ann Oman,
vice president for communications at PhRMA,
noted, "The provision could inhibit
clinical trials and ultimately result in
preventing patients from having access to
these clinical trials."
The problem with granting ownership of
genetic information and the samples from
which the information was derived is that
it would mandate record-keeping to identify
the sample and the donor. Such a provision
would not only be extremely expensive, but
would conflict with the goal of protecting
privacy because all samples would have some
sort of potentially accessible "deed"
associated with them.
In addition, if property laws were brought
to bear on medical samples and genetic
information, there could be a torrent of
litigation over the rights blood relatives
have over medical information obtained from
other family members as well as royalty
litigation for drugs developed from
information obtained in clinical trials.
Nevertheless, this year, New Mexico,
Nebraska, Maryland and Florida among others
had bills proposed that would have granted
The vast majority of the 91 state bills
(some of which are dead) that addressed
issues related to genetic information
viewed it as a separate issue from medical
information. Both BIO and PhRMA oppose such
efforts to dissect genetic information away
from general medical information.
Because most diseases have a genetic
component, Feldbaum pointed out that
genetic information is part of the
continuum of medical information. For
example, a person's cholesterol level is
determined by both eating and exercise
habits and by the persons genetic
predisposition to high cholesterol. That
predisposition can be easily inferred from
an accurate family history. As such,
Feldbaum noted that any distinction between
genetic and non-genetic information is
likely to be arbitrary at best.
"Genetic information is extremely difficult
to separate from medical information," Oman
agreed. "That is why we support privacy
protections for all medical records."
Many of the state bills also had provisions
that would require the destruction of
samples used for genetic tests in order to
prevent someone from testing the sample
without the person's knowledge. Such a
provision flies in the face of current FDA
regulations regarding samples collected
during clinical trials.
A related provision found in several state
bills requires that researchers obtain
informed consent for every use of a stored
sample. Oman noted that would stymie a
great number of epidemiological studies
that use anonymized information.
"Any legislation must protect anonymized
data bases," Oman said. "It is vital that
scientists have access to this type of
Feldbaum noted that most legislators are
amenable to changes in their bills when
they learn that the bills could jeopardize
research in their states. Nevertheless,
monitoring and contacting every state over
problematic bills requires a Herculean
effort. Both PhRMA and BIO would like to
see federal legislation that protects the
privacy of medical information.
"Right now, we have a patchwork of laws
that provide inconsistent protections
depending upon which state you live in,"
Feldbaum said. "We need a blanket law that
standardizes this across the country."
At the federal level, Sen. Pete Domenici
(R-N.M.) proposed bill S. 422 that would
prohibit genetic discrimination. Feldbaum
noted that expanding the Domenici bill to
encompass protections for all medical
information remains a high priority at BIO.
"We continue to work with Domenici's staff
on this bill," Feldbaum said. "But we have
not yet convinced him of the need to
include all medical information into his
[Copyright 1997, American Health