Blacks, Latinos and intravenous drug users, the groups
increasingly afflicted with AIDS virus infections, are
significantly under-represented in federally sponsored AIDS
clinical trials, according to a Times analysis of government
statistics obtained under the Freedom of Information Act.
As of the end of August, blacks and Latinos accounted for 42%
of adult AIDS patients in the United States but only 20.4% of
patients that have been enrolled in National Institute of
Allergy and Infectious Diseases (NIAID) AIDS trials.
Intravenous drug users accounted for 27.5% of adult AIDS
patients but only 11.3% of the participants in the federal
"It has been a matter of frustration to us," said Dr. Daniel
Hoth, director of the NIAID AIDS program. "We want to change
(the participation of minorities and drug users), but you can't
just push a button in Washington and have everything change all
over the country."
The low representation of members of minority groups and drug
users means that researchers cannot gather optimal information
about new AIDS therapies for these patients, according to
leading AIDS researchers and federal officials.
"Drugs may behave differently in different racial and ethnic
groups and in women," said Dr. Richard Chaisson, director of
the AIDS service at the Johns Hopkins Hospital in Baltimore.
"Consequently, you can't generalize from studies done in
middle-class gay white men."
For example, blacks and whites have important differences in
their response to common high blood pressure drugs. Researchers
will not be able to learn if similar differences are important
for AIDS drugs unless they study the drugs in substantial
numbers of whites and minorities.
Many intravenous drug users are also treated with other drugs,
such as methadone. Researchers will not be able to learn if
AIDS drugs, such as AZT, have beneficial or harmful
interactions with methadone and other psychoactive drugs unless
they conduct studies of patients who are taking them.
In addition, members of minority groups and intravenous drug
users may be deprived of their "only opportunity to obtain
access to a promising new (AIDS) treatment" that may be very
expensive and in limited supply, according to Dr. Margaret
Hamburg, a special assistant to the director of the NIAID
Inequity of Health Care
The causes of the problem are complex. They range from an
insufficient number of AIDS clinical research centers at
hospitals and clinics that predominantly serve minorities to
inadequate recruitment efforts by researchers and the general
inequity of American health care, which favors the
The government is taking remedial steps, such as sponsoring
community programs for AIDS research and funding projects
designed to increase minority participation in AIDS drug
trials. Some universities have set up satellite research sites
at hospitals with large numbers of minorities; UCLA has
established sites at Harbor-UCLA Medical Center in Torrance and
Olive View Medical Center in Sylmar, and Harvard Medical School
has established a site at Boston City Hospital.
So far, however, these and other corrective measures have had
little overall impact. Some say stronger actions are required.
"The federal government has its way of influencing you by the
amount of money they put in your pocket," said Dr. Lawrence S.
Brown Jr., senior vice president for research and medical
affairs at the Addiction Research and Treatment Corp. in New
York City. "There need to be some incentives attached to those
dollars in terms of enrolling racial and ethnic minorities."
The organization runs clinics that treat thousands of drug
addicts, predominantly black and Latino, in Brooklyn and
The federally sponsored trials, known as the AIDS Clinical
Trials Group, are the nation's largest source of experimental
AIDS care, with a 1989 budget of about $57 million. They are
conducted at academic medical centers throughout the country,
including five in California. Since the program began in 1986,
more than 7,500 patients have been enrolled. Currently, there
are about 5,500 active participants.
The Times analysis concentrated on the 32 largest AIDS clinical
trials units, which primarily serve adult patients.
It showed that at six units, including Harvard Medical School
in Boston and Stanford University Medical Center, less than 10%
of participants in trials are black or Latino.
Dr. Thomas Merigan, director of the Stanford unit, said the
medical center's statistics reflect the location of its campus,
in an affluent suburban area. Merigan acknowledged that AIDS
research centers need "to go where the patients are . . . if we
are going to be in business in five years" but said researchers
can't "do that overnight."
At an additional 11 units, including UCLA, UC San Diego, UC San
Francisco and two units in New York City, less than 20% of the
participants are black or Latino. By comparison, the majority
of AIDS patients in New York City and about 24% of AIDS
patients in California are black or Latino.
Few Blacks Near Campus
Dr. Samuel Bozzette, clinical director of the UC San Diego
unit, said the representation of Latinos and intravenous drug
users is proportionate but blacks are under-represented because
most black residents of San Diego County do not live near the
medical center campus. Bozzette said the unit does not "have
the resources" to establish an off-campus clinic in a black
In contrast, four units have minority participation rates of
40% or more--Albert Einstein College of Medicine in the Bronx,
Cornell University Medical College and Mt. Sinai School of
Medicine in Manhattan, and the University of Miami. County-USC
Medical Center ranked fifth, with a minority participation rate
In other findings:
* For intravenous drug users, 24 of the 32 units have
participation rates of 15% or less, including three units in
New York City, where intravenous drug users represent more
than 40% of newly diagnosed AIDS patients.
In contrast, intravenous drug users represent 25% or more of
study participants at four units--the State University of New
York at Stony Brook, the University of Massachusetts Medical
School in Worcester, Albert Einstein, and Robert Wood Johnson
Medical School in New Brunswick, N.J.
Many researchers believe that current or previous intravenous
drug users, by the very nature of their addiction, may be less
suitable for drug trials than other potential participants. For
instance, they may be more prone to miss appointments or
medication doses and to seek pain medications from their
physicians. As a result, researchers may need to give them more
personal attention to assure successful participation.
But Stanford's Merigan, who has studied the issue, said such
concerns are often blown out of proportion. While many
intravenous drug users are reluctant to enroll in AIDS trials,
most of those who enroll turn out to be "excellent"
participants, he said.
* Women represent 6.8% of the participants in the trials,
compared to 8.9% of all adult AIDS patients. In part, the
lower percentage of women in the trials reflects the fact
that most women infected with the human immunodeficiency
virus (HIV), the cause of AIDS, are minority group members or
intravenous drug users.
Hoth said there is no "systematic exclusion of women" from the
federal trials, except for restrictions that women of
childbearing age must not be pregnant and use contraception.
This view was disputed by Iris Long, who directs an AIDS
treatment registry that monitors trials in New York City and
northern New Jersey. Long said that the women who have AIDS are
almost all poor, and that "poor women do not have access" to
the teaching hospitals where the trials are primarily
* More than half of the nearly 300 children in federal AIDS
trials are black or Latino. Nationally, blacks and Latinos
account for about 75% of pediatric AIDS patients.
In general, members of minority groups are under-represented in
clinical trials of many diseases, compared to their proportion
of the general population. But the problem is considered
particularly significant for AIDS, because HIV infections are
disproportionately common in minority groups. Moreover, many
HIV-infected members of minority groups acquired the virus
through intravenous drug use or sexual contact with an
intravenous drug user.
The primary purpose of clinical research studies, according to
Hoth, is not to provide patients with access to experimental
drugs but to find out as "expeditiously as possible" which
drugs work. On the other hand, as Hoth explained at the
international AIDS conference in Montreal in June, "clinical
trials represent hope," and "it is only equitable that there
should be equal access to clinical trials."
From a practical standpoint, the patients who are recruited
into research trials are those who receive primary health care
at the hospitals where the trials are conducted. But financial
and geographic barriers may prevent many HIV-infected
individuals from seeking care at elite academic medical
In addition, poor patients, intravenous drugs users and
patients without health insurance often do not have personal
physicians at all. As a result, they are unlikely to learn
about the trials that might benefit them, according to many of
the researchers and government officials interviewed.
Some drug studies pay patients to participate, but the
federally sponsored AIDS trials do not. The AIDS clinical
trials units do receive federal funds to pay for their
patients' medications and medical care, but they may still be
"reluctant . . . to accept responsibility" for patients without
health insurance or a personal physician, according to Hamburg
Several of those interviewed explained that a research center
might have to provide primary health care for patients who do
not have personal physicians. Moreover, if an AIDS patient
without health insurance developed pneumonia and needed to be
hospitalized, the trials unit might need to use research funds
to pay for the hospitalization, thereby decreasing the total
number of patients it could enroll in studies.
Many affluent academic medical centers also have general
policies that discourage the admission of "uncompensated"
patients. Enrolling a patient with health insurance might seem
more attractive, because the insurance would likely pay for
hospitalizations as well as routine physician visits.
Serve Own Patients First
"The major universities have done a good job of serving white
gay men, but have done less well serving blacks and Hispanics,
particularly intravenous drug users," said Chaisson of Johns
Hopkins. "The hospitals who (were) funded take care of their
own patients, who happen to have insurance. They make an effort
to recruit other patients, but they take care of their patients
As an example, Chaisson said he had discussed a proposed study
of tuberculosis prevention in AIDS-virus infected individuals
with about 70 other federally funded AIDS researchers during an
AIDS clinical trials group meeting in July. The study would
primarily enroll minorities and intravenous drug users; many
middle-class whites have never been exposed to the bacillus
that causes tuberculosis, and thus are not at risk. "Only three
of the institutions said they had the patient population or
interest in participating," Chaisson said.
Another recruitment difficulty is that many minorities, unlike
many middle-class whites, do not view research as a "clearly
defined benefit," according to Carole Levine, executive
director of the Citizens Commission on AIDS in New York City.
For example, many blacks still have vivid memories of the
infamous Tuskegee syphilis experiment. Between 1932 and 1972,
the U.S. Public Health Service deliberately withheld treatment
from more than 400 black men with syphilis to gather data on
the unchecked progression of the disease, which can lead to
severe disability and death.
"A lot of (minorities) are suspicious of being used as guinea
pigs even when they are not being used as guinea pigs," said
Dr. Bruce Soloway, a family physician at Bronx-Lebanon Hospital
in New York City, which serves a minority population
particularly hard-hit by the epidemic.
"Real-life barriers" such as a lack of child care or
transportation are also very significant, Levine said. Unlike
medication and medical care, such expenses are usually not
covered. Because participants undergo frequent tests and
examinations, these expenses can be quite significant.
Hoth said the federal government has "no formal policy" on
providing child care and transportation for AIDS study
participants but is studying the issues.
Many minorities are also reluctant to leave their communities.
As an example, Soloway said he had encouraged at least 50 of
his patients over the last several years to enroll in federal
AIDS Trial 019, the study which demonstrated that the drug AZT
is effective in forestalling AIDS in some asymptomatic
Although the research site, at Albert Einstein, was only
several miles away, only one patient enrolled. "It is only two
or three miles, but for some (of my patients) that is farther
than they can possibly go," Soloway said.
Soloway added that trials at the five clinical trials units in
Manhattan "might as well be in Los Angeles," as far as his
patients were concerned. "The precondition of doing research in
these groups is to bring research to the patients, not the
other way around."
The Times analysis also highlighted the lack of adult AIDS
clinical trials units in five of the 13 metropolitan areas with
the largest number of AIDS cases--Houston, Philadelphia,
Atlanta, Dallas, and San Juan, Puerto Rico.
The lack of an adult clinical trials unit is most striking in
Houston, which has had more than 3,000 AIDS cases. Houston now
ranks fourth in AIDS cases, behind New York, Los Angeles and
San Francisco. Dallas, with 1,750 cases, ranks 12th.
In Pennsylvania, NIAID established AIDS clinical trials units
in Pittsburgh, which has had about 400 AIDS cases, and Hershey,
a town of 13,000 people 100 miles west of Philadelphia. By
comparison, no center was established in Philadelphia, although
it has five medical schools. Philadelphia has had about 2,200
AIDS cases and ranks ninth in AIDS cases nationally.
When asked about these findings, NIAID's Hoth said geographic
factors were "not taken into consideration" when most of the
grants were initially awarded in 1986 and 1987. "We felt the
most important thing for the country was to get the
scientifically best centers to get answers about which (AIDS)
drugs work," he explained.
In addition, Hoth said, the demographics of the epidemic, which
at first primarily struck white gay men in San Francisco, New
York City and Los Angeles, has shifted toward minorities and
intravenous drug users and other metropolitan areas.
Hoth said the federal institute is now turning its attention to
demographic and geographic factors. Earlier this month, for
example, Hoth met with Texas investigators about the
possibility of establishing an AIDS clinical trials unit there.
Asked if demographics will be considered when grants to AIDS
clinical trials units come up for renewal in 1991, Hoth said:
"You better believe that demographics will be a factor."
Over the next year, the federal government will spend between
$5 million and $10 million on projects designed to increase
minority participation in AIDS drug trials, Hoth said. It has
plans to expand the number of minority health professionals in
In addition, the NIAID AIDS program has hired Dr. George
Counts, a senior infectious disease specialist who is black,
from the University of Washington in Seattle, as chief of a new
clinical research management branch. One of his key tasks is to
make sure that the AIDS clinical trials units do a better job
of recruiting minorities and intravenous drug users.
Another widely publicized program, federally funded AIDS
community research programs, may also help, but it is still in
the planning stages. Although $6 million is available to fund
between 10 and 20 community programs, the government has yet to
announce which programs will be funded.
A WALK FOR AIDS
About 12,000 people walked in Hollywood, raising $1.8 million
to fight AIDS. Metro, Page 1.
AIDS CLINICAL TRIALS
Blacks, Latinos and intravenous drug users are substantially
under-represented in ongoing federally sponsored trials of new
AIDS drugs. As of Aug. 28, 20.4% of the 7,659 patients who have
been enrolled in National Institute of Allergy and Infectious
Diseases (NIAID) trials were black or Latino. By comparison,
about 42% of adult AIDS patients in the United States are black
or Latino. In the trials, 11.3% of the enrolled patients were
previous or current users of intravenous drugs. By comparison,
27.5% of all adult AIDS patients report previous or current
intravenous drug use. Women represent 6.8% of the enrollees in
the trials, compared to 8.9% of all adult AIDS patients.
Academic medical centers vary widely in the percentages of
blacks, Latinos, intravenous drug users and women they have
enrolled in federal AIDS clinical trials. These are the
statistics for 32 of the 46 federally sponsored AIDS clinical
trials units. Smaller pediatric and hemophilia test sites are
NOTES: Statistics cover all patients enrolled in NIAID clinical
trials since the program began in 1986, including patients who
stopped participating, completed studies or died. Demographic
information was available for about 92% of these patients;
percentages of blacks, Latinos, intravenous drug users and
women are based on the patients for whom demographic
information was available.
SOURCES: Nancy Blustein, Treatment Research Program, Division
of AIDS, NIAID; U.S. Centers for Disease Control; California
Office of AIDS.
CAPTION: Table: AIDS CLINICAL TRIALS
DE INTRAVENOUS DRUG USERS; BLACKS--HEALTH; HISPANICS--HEALTH;
MINORITIES--HEALTH; MEDICAL RESEARCH; MEDICAL TREATMENTS;
EXPERIMENTS; DRUG TESTS; HEALTH STATISTICS