AIDS Trials Shortchange Minorities and Drug Users

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 studies.

“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 program.

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 socio-economically advantaged.

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 Manhattan.

$57-Million Budget

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 community.

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 of 38.1%.

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 conducted.

* 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 centers.

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 of NIAID.

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 first.”

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 individuals.

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 AIDS research.

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.

These are the percentages of blacks, Latinos, intravenous drug users and women in federal AIDS clinical trials, as well as comparable statistics for adult AIDS cases in the United States and California.

%IVDRUG PATIENTS %BLACK %LATINO USERS %FEMALE Federal AIDS Clinical Trials 7,659 9.1% 11.3% 11.3% 6.8% AIDS CASES: United States 100,885 26.5% 15.2% 27.5% 8.9% California 20,917 11.3% 12.3% 13.9% 2.9%

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 not listed.

Units are ranked by the percentage of blacks and Latinos participating in trials. Units in California are in bold type. MORE THAN 40% BLACK AND LATINO

%IVDRUG PATIENTS %BLACK %LATINO USERS Albert Einstein Coll Med, N.Y. 205 14.2% 53.6% 28.6% Cornell U Med College, N.Y. 63 32.0% 20.0% 20.4% U of Miami 475 4.6% 40.7% 6.9% Mt. Sinai Sch of Med, N.Y 214 12.9% 30.3% 24.7%

%FEMALE Albert Einstein Coll Med, N.Y. 45.7% Cornell U Med College, N.Y. 9.4% U of Miami 11.3% Mt. Sinai Sch of Med, N.Y 9.9%

30% TO 39% BLACK AND LATINO

%IVDRUG PATIENTS %BLACK %LATINO USERS County--USC Med Center, LA 404 10.9% 27.2% 10.4% U North Carolina, Chapel Hill 64 37.9% 0.0% 14.3% St. Luke’s Roosevelt Hosp, N.Y. 106 12.7% 21.6% 10.4% RW Johnson Med Sch, N.J. 110 26.2% 4.7% 25.0%

%FEMALE County--USC Med Center, LA 3.2% U North Carolina, Chapel Hill 10.3% St. Luke’s Roosevelt Hosp, N.Y. 8.7% RW Johnson Med Sch, N.J. 16.7%

20% TO 29% BLACK AND LATINO

%IVDRUG PATIENTS %BLACK %LATINO USERS George Washington Med Cent, DC 121 18.7% 11.0% 1.8% Duke U Med Cent, Durham, N.C. 253 22.3% 4.5% 8.5% SUNY Stony Brook Health Sci Cent 52 18.0% 8.0% 58.3% Tulane U Med Cent, N. Orleans 251 19.4% 2.4% 14.6% Johns Hopkins Hosp, Baltimore 255 18.8% 2.5% 7.3% Case Western Reserve, Cleveland 106 17.2% 4.0% 8.0% U of Mass Med Sch, Worcester 56 7.7% 13.5% 30.8%

%FEMALE George Washington Med Cent, DC 2.8% Duke U Med Cent, Durham, N.C. 11.6% SUNY Stony Brook Health Sci Cent 23.5% Tulane U Med Cent, N. Orleans 4.0% Johns Hopkins Hosp, Baltimore 5.0% Case Western Reserve, Cleveland 8.0% U of Mass Med Sch, Worcester 25.0%

10% TO 19% BLACK AND LATINO

%IVDRUG PATIENTS %BLACK %LATINO USERS UCLA Med Center, Westwood 318 8.6% 9.0% 10.3% Indiana U Sch Med, Indianapolis 132 4.6% 12.8% 13.8% Wash. U Sch Med, St. Louis 211 13.8% 3.2% 7.8% Memorial Sloan-Kettering, N.Y. 175 6.5% 10.1% 4.3% New York U Sch of Med 322 3.8% 11.8% 5.7% Northwestern U Med Sch, Chicago 265 9.4% 5.2% 3.4% UC San Francisco Med Center 514 4.0% 9.1% 15.5% UC San Diego Medical Center 469 3.5% 8.6% 12.0% U Rochester Med Center 384 6.3% 4.9% 10.0% U Cincinnati College of Med 148 9.8% 0.7% 10.4% U of Minnesota, Minneapolis 289 7.6% 2.5% 8.3%

%FEMALE UCLA Med Center, Westwood 3.8% Indiana U Sch Med, Indianapolis 2.7% Wash. U Sch Med, St. Louis 3.2% Memorial Sloan-Kettering, N.Y. 6.0% New York U Sch of Med 3.1% Northwestern U Med Sch, Chicago 6.1% UC San Francisco Med Center 1.0% UC San Diego Medical Center 2.0% U Rochester Med Center 9.0% U Cincinnati College of Med 2.1% U of Minnesota, Minneapolis 3.2%

LESS THAN 10% BLACK AND LATINO

%IVDRUG PATIENTS %BLACK %LATINO USERS Stanford University Med Center 265 1.2% 6.3% 7.1% U of Washington, Seattle 347 1.2% 6.3% 11.7% U of Pittsburgh Sch Med 171 4.7% 0.6% 7.5% Ohio State Med Center, Columbus 163 4.5 0.6% 12.1% Penn State U Coll Med, Hershey 36 0.0% 0.0% 20.0%

%FEMALE Stanford University Med Center 0.8% U of Washington, Seattle 3.3% U of Pittsburgh Sch Med 3.5% Ohio State Med Center, Columbus 3.8% Penn State U Coll Med, Hershey 20.0%

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.