 |
| Gil Siegal: Databases of medical records
and genetic information “will enable individualized medicine
as opposed to today’s medicine.” |
Posted April 28, 2004
Gene Databases, Organ
Transplants Raise Ethical Questions, Siegal
Says
Health initiatives that require participation from the public, such
as organ transplants or research that requires broad access to patients’ medical
data or even DNA, raise ethical problems but should strive to operate
for a nation’s greater good of long-term health, said Gil Siegal
of the Haifa Schools of Medicine and Law. At a U.Va. Forum on Health
Law and Policy April 22, Siegal discussed ways in which governments
and private companies are employing such initiatives and how they are
trying to increase voluntary participation.
The debate offers a new twist on an old story: tension between collective
goals and benefits and individual autonomy, or as Siegal posed the
question, “Is the public more than the aggregate of
the individuals?”
Siegal said the government of Iceland is cooperating with a private
company, deCode genetics, to create databases of medical records and
genetic information to study prevalent diseases and develop more potent
and efficient drugs. The collected information could allow researchers
to match genetic variables to environmental effects, lifestyle, nutrition,
and metabolism.
“It will enable individualized medicine as opposed to today’s
medicine,” Siegal said.
The medical records database operates under an opt-out program, in
which citizens who do not want their records included in the study
must choose to opt out of the program. The gene database is an opt-in
program, where participants choose to volunteer their DNA.
With Iceland’s small population of 280,000, birth records going
back twelve generations, and limited immigration, researchers think
the medical database could offer a wealth of information. Only about
10 percent have opted out of the medical records program since its
inception and 15,000 have volunteered their DNA so far. Iceland’s
government contracted with deCode genetics, an American company, which
in turn contracted a Swiss pharmaceutical company to exploit the Icelandic
genetic database. “Does the government have the proxy to make
such a contract?” Siegal asked.
Other nations, such as Sweden, Canada, and the United Kingdom are
overseeing similar programs. In Iceland, leaders passed the Iceland
Database Act outlining rules governing such databases. The Act requires
medical files and genetic samples to remain exclusively in Iceland,
the database must meet security standards mandated by a commission,
the company must bear all costs of processing and maintaining the database,
and deCode’s researchers must reside in Iceland to keep talent
local. Furthermore, the Ministry of Health must possess a regularly
updated copy of the database, and the government must have access to
statistical data from the database for use in health reports, planning,
and policymaking. A special committee also acts as a supervisory party.
For reasons of confidentiality, technical feasibility, and to avoid
legal liability, information gleaned from the databases is not shared
with individual participants.
Such collective action encourages solidarity, Siegal said, and promotes
the ideal of equality and empowered citizenship—called “new
genetic citizenship” by some. On the other hand, such collective
action may engender loss of individualism, liberty, and privacy. Some
fear the results could encourage profiling or stigmatizing of certain
groups. As it stands, private companies may be profiting from collective
information gathered from the public, and they perhaps should share
benefits of such projects with participants, Siegal said. He added
that there’s some evidence participants in Iceland were caught
up in the drive for the national database mainly because they thought, “we’re
going to find the Viking genes”—raising concerns of the
resurgence of nationalism.
What might explain the public, ethical, and legal attitudes toward
such programs? Siegal said the United States and Europe define the
principles of bioethics differently. The United States is focused mainly
on autonomy, with beneficence, justice, and non-malfeasance coming
second, while Europe is concerned with human dignity, solidarity, and
precaution, with solidarity often given primacy. “It’s
a true cultural difference,” he said, pointing to the extraordinary
caution Europe effaced over genetically modified crops.
Such differences also play out in whether countries design an opt-in
(associated with autonomy), or opt-out (associated with solidarity)
system for organ donors. The United States’ opt-in system allows
people to choose to be donors, but over 6,000 people on the organ donor
waiting list die each year. The monetary costs of the opt-in system
also are high: $14 billion is spent on dialysis alone, according to
2001 data, up from $250 million in 1979. Furthermore, many people who
need transplants don’t even get on the list because they have
no chance of getting one. Despite a 90 percent national approval rate
for organ donation, only 15 percent of Americans sign a donor card,
which may not withstand family wishes anyway. For those who have not
signed cards, families are given the final say, resulting in “too
many refusals.” The United Kingdom and Israel also have an opt-in
system, but Belgium, France, Singapore, and Finland all presume citizens
consent to donate organs unless citizens opt out of the program.
Siegal said doctors are afraid that the public will see them as looting
organs if consent is presumed. In one case in the United Kingdom, a
hospital was harvesting organs of deceased children without consent.
Soon after news broke about the practice, the national rate of donation
plummeted from 50 to 20 percent.
“What’s wrong with opt-out?” Siegal asked the audience.
Law professor Richard Bonnie responded, “There’s too much
chance that people’s organs would be taken without actual individual
consideration, and where people might have refused if they had thought
about it.”
Siegal said people also want the right not to make a choice. “By
forcing me to opt out, you’re forcing me to have an opinion,” he
said. But, “looking at the opt-in system, it’s failing,” he
added. “Are we glorifying ethical concepts and principles . .
. at the expense of someone dying?”
Siegal wondered whether the bigger evil was not taking organs from
someone who did consent, because their family objects, or taking organs
from someone who might have objected but did not. He suggested that
the values of solidarity coupled with reciprocity should create the
impetus for a change—nondonors are currently eligible to receive
donations themselves.
Opt-out and reciprocity structures depend on a certain amount of coercion,
he admitted. “It is coercive in the sense that you have to make
an opinion.”
However, Siegal suggested, “if something is important, they
will opt out.” He used the example of the national Do-Not-Call
Registry, in which 55 million Americans signed up to have telemarketers’ calls
blocked.
Bonnie questioned the analogy, noting, “With the Do-Not-Call
Registry, people are faced daily with the need to make a choice, so
we can be sure that they will opt out if they really don’t want
the calls. With organ donation, there’s still a significant risk
people will not focus on it.” Siegal conditioned his proposal
on ample opportunities for people to opt out, thereby exercising their
autonomy.
Siegal said in Iceland the deCode deliberations saturated the media,
with parliamentary and public debates, 700 newspaper articles, 100
radio and TV shows, polls, and referendums contributing to the spreading
of information.
Still, Siegal noted, when joining such a population database, in one
sense you surrender information that affects other people. If 500 individuals
of the Cherokee nation volunteered their DNA, it could reveal what
genetically makes the Cherokees distinct, giving up their group’s
rights. “We’re all geared on autonomy and the rights of
individuals, but this analysis is inadequate to deal with this issue,” he
said.
Questions also hover about consent—when people give their consent
to have someone study their medical records or genes, to what are they
consenting? Many studies use “blanket consent,” because
there may be uses for the information not yet envisioned. This presents
problems if the information is eventually used for non-medical research,
or to create a crime database, for example. Private companies could
start with more frivolous research to make a profit when the public
instead wants to study diabetes, Siegal explained. In debates in Israel,
some were concerned such collective information could be used to target
certain groups for bioterrorism.
For these reasons, national control of such databases may appear desirable
to some, he said. It would preserve freedom of access to HMOs, scientists,
the government, and patients, and preserve the public investment. It
may also support independent researchers and enhance public awareness
of the beneficial results from such research. But many scholars, including
Siegal, support having such databases operate as a public charity to
which the government will have access only for public-health reasons.
A genetic database “for me is a vehicle for social change,” Siegal
said. It offers a chance to create a different path for the concept
of autonomy, and the ability to reshape public attitudes, emphasizing
mutual interdependency, he said.
As the session opened to questions, law professor Thomas Hafemeister
pointed out that an improved opt-in plan might solve the organ shortage
without shifting to an opt-out system. “There’s no incentive
for people to address these issues early,” he said.
Siegal pointed out that “in the opt-out systems, there’s
no waiting list [for organs].”
The American Medical Association has recommended requiring Americans
to make a choice about whether to donate or not when they renew their
driver's licenses, file income tax forms, or perform some other task
mandated by the state.
Siegal said he preferred the question to center on “what’s
the right thing to do”—not create a neutral policy that
overlooks the fact that people are dying.
Hafemeister noted that presumed consent historically has been abused
in the United States. “We’ve done a lot of things to the
mentally ill,” he said, explaining Americans’ reluctance
to offer doctors and researchers a free pass.
Siegal said most objections over collecting medical information in
Iceland concerned the question of who had control over the data. Such
data, for example, could identify the difference between races—not
an issue raised in Europe, but “a major problem” in the
United States. Siegal noted that whites donate organs twice as much
as African-American donors, and African-Americans are more likely to
die in circumstances where their organs can be donated. “The
distrust in the African-American community is substantial,” he
said, “as is the fear of genetic discrimination. These concerns
must be addressed in order to strengthen social cohesion offered by
collective actions such as organ and DNA donation.”
• Reported by M. Wood
|