It would be better to go straight to a more personalized approach
to medicine, gene pioneer Craig Venter and colleague Susanne Haga
said.
"It is what I call race-based medicine," Venter said in a telephone
interview.
They praised the U.S. Food And Drug Administration (news
- web
sites) for trying to formulate guidance that would take genetics
into account when testing drugs, but said using simple notions
of race was not the way to go.
"They should be applauded for trying to go beyond white males,"
Venter, who led one team that sequenced the human genome (news
- web
sites), said in a telephone interview.
"But our argument is they are not going far enough in that direction."
Venter, who now heads the nonprofit Center for the Advancement
of Genomics in Rockville, Maryland, has long argued that genetics
do not support social and cultural ideas of race.
Several teams of scientists have found that there are more genetic
differences among Africans from different regions, for example,
than there are between Africans and Europeans.
In January the FDA issued draft guidance to industry suggesting
that official Office of Management and Budget classifications
for race and ethnicity be used in gathering information for clinical
trials.
GENES CAN AFFECT DRUGS
It noted that different groups respond differently to medical
products.
"For example in the United States, whites are more likely than
persons of Asian and African heritage to have abnormally low levels
of an important enzyme (CYPD2D6) that metabolizes drugs belonging
to a variety of therapeutic areas, such as antidepressants, antipsychotics
and beta blockers," the FDA says in the draft guidance.
"Other studies have shown that blacks respond poorly to several
classes of antihypertensive (high blood pressure) agents."
But Venter said this does not mean that all blacks will respond
poorly to such drugs, or even most blacks. The races are highly
mixed in the United States.
"Geographical origin (ancestry) appears to be more relevant
than a person's self-identified race," Venter wrote in a commentary
in Friday's issue of the journal Science.
The FDA agrees that many of the differences can be accounted
for by cultural issues and habits, such as diet, but wants racial
factors studied so the differences can be better understood.
Venter and Haga agree but say self-reported race is irrelevant.
"It would be inaccurate to check off any one box on the U.S. census
if you African-American or Caucasian because to some degree we
all admixed," Haga said in a telephone interview.
"Six million people have actually changed, between censuses,
their racial classification, so we are using social constructs
to try and define very important scientific issues," Venter added.
So in theory, guidelines could eventually be issued saying black
people should get one drug and whites another. But if a black
patient lacks the specific genetic makeup lying behind such theory,
he or she might get the wrong drug.
"If there is a genetic variable behind a predisposition to disease
among a population, it doesn't mean all those in the population
are going to have the disease," Haga said.
Better to design individual genetic tests to use on a patient-by-patient
basis, they said.