Essence Magazine, February 2007

SPECIAL REPORT

The New York City AIDS Experiment

By Kristal Brent Zook, Photography by Nitin Vadukul

Inside New York City's Administration for Children's Services headquarters on William Street in Manhattan, there is a vaulted room known to staffers as the Bubble. Hundreds of records are housed there: fat file folders containing vital information about each of the foster children, most of them African-American and Latino, ages 6 months and younger, who were enrolled in experimental HIV/AIDS clinical trials conducted from 1988 to 2001. The records, overflowing with information about the well-being of the children, fill about 60 lateral file cabinets.

Dig deeper and it's quite possible that these files also contain answers to many other questions that are now being asked — or, in some cases, shouted angrily — by parents, children's advocates, community activists and local politicians: questions about whether the experimental drugs harmed the children and how, or if, some died as a result of the treatments. The fact that some of the files were destroyed in a fire, ESSENCE learned, could mean there is a possibility that many questions may never be answered.

Clinical Trials and Tribulations

In the late 1980's and early 1990's, hundreds of children in New York City were dying of AIDS. A total of 321 newborns were infected with HIV in 1990, the year the virus soared among infants. Something had to be done. "We fought to get people of color into clinical trials," recalls Debra Fraser-Howze, founding president and CEO of the National Black Leadership Commission on AIDS, the oldest agency addressing AIDS in Black communities. "At that time they only had gay White men enrolled, and activists rightfully argued for inclusion," says Fraser-Howze, who now chairs an advisory committee investigating the clinical trials. In response, some doctors, aware that AZT for adults had just been approved, began testing foster children — mostly from the poor communities of Harlem and the Bronx, where many of the children were dying — in clinical trials during the early 1990's.

Not everyone was happy with this arrangement. For years foster parents and biological family members alleged that some children were being enrolled against their will and without proper parental permission. Other families claimed they were bullied into giving their children HIV drugs, and when parents no longer felt it was safe to continue administering medicine, they stood to lose their children. "Something seriously went wrong, well-intentioned though it may have been," said New York City Council Member Bill Perkins during public hearings held in 2005. "We can't duck it. We can't sugarcoat it." Sharman Stein, the director of communications for the Administration for Children's Services (formerly known as the Bureau of Child Welfare), says: "This is an issue that took place almost 20 years ago, long before the current administration was at ACS. We are doing our absolute best to address these questions."

The ACS initially said that only 76 children had taken part in the studies. That number skyrocketed to 465, however, when neglected files were reportedly found in an agency warehouse. In interviews with ESSENCE, Children's Services officials acknowledge the number of children now known to have been involved in trials has climbed to 526.

A Mother's Lingering Fears

Speaking in forceful tones and with a heavy West African accent, Regina Musa, a 58-year-old retired home health care aide from the Bronx, sits in a kitchen chair next to a large swirling fan one August evening as her 13-year-old granddaughter watches television in the next room. Musa explains her struggle to regain custody of her HIV-positive grandson, who she says was taken from her home twice and has been in foster care for the past three years.

Musa says the family's troubles began when the boy's mother, Veronica Momodu, decided to stop giving him HIV treatment. She believed his HIV medications were causing an allergic reaction that included rashes and chills. The family also believes that the drugs did permanent damage to the boy's speech and learning abilities.

After her daughter stopped giving the boy HIV medicine, Musa says her grandson was taken away. "They rushed in, asking, 'Where are the children? Where are the children?'" she says, recalling that evening back in 1999. Upstairs, Momodu was with her daughter, then 5, and son, who was about 3 months old. According to Musa, authorities took the children away while two city officials informed her that she would hear from Children's Services. Within two weeks, both mother and grandmother were served a court summons and charged with medical neglect. Lucky for them, Musa says, they were able to pull together their limited funds to hire a private attorney, who eventually got the charges dropped. The boy was brought home within months.

About three years later, the boy was removed from the family home a second time when Momodu took him in for a routine checkup at New York University's Bellevue Hospital. Lynn Gannett, who once worked in the field of AIDS testing but later became a vocal critic of the drug trials, testified as a witness in Momodu's case and also confirms the family's story. Both Musa and Gannett say there was a pediatrician who wanted to enroll the boy in a clinical trial and that, over a series of visits, the doctor asked Veronica for permission, telling her she would receive $25 per week. They explain that the doctor became angry when Momodu refused, and promised her that she would regret her decision. Based on everything they've learned, Musa and Gannett believe the boy was placed in foster care and enrolled in a clinical trial.

Despite repeated visits to family court, Gannett says that Momodu's parental rights were terminated and she was never given an opportunity to explain herself or allowed access to her son's medical records. "They never could have gotten away with this with a middle-class Caucasian family who could have afforded to hire high-powered attorneys," says Gannett.

Momodu eventually succumbed to an illness and died in 2004. Musa now has custody of her granddaughter and fought for — and won — visitation rights with her grandson. Each week she hails a gypsy cab to a nondescript green building in the Bronx, where her grandson lives with a foster family. Now a thin boy of 8 with large eyes and a protruding belly, her grandson seems to be okay, she says, other than the fact that he is "too skinny" and his speech is delayed. The boy became eligible for adoption in 2005. Musa claims that no one from Children's Services even bothered to tell her the news. Officials there admit they do not actively seek to update extended family members once a child is ready for adoption.

Even if they had, she admits, she has no money to hire a lawyer to help her get him back.

Another Knock at the Door

Jacqueline Hoerger, a soft-spoken HIV pediatric nurse, tells another story of loss. Hoerger, who now lives in Canada, says she worked at incarnation Children's Center in Harlem, one of the private agencies taking part in the clinical trials, from 1990 to 1994, where she administered the experimental drugs to foster children. But over time she began to wonder if the treatments were really working.

In 1998, Hoerger became a foster parent of two HIV-positive sisters, ages 3 and 6. She followed the prescriptions that the doctors ordered and, for a year and a half, gave them regular cocktail combinations of HIV drugs. But something wasn't working. Despite providing the best foods for the children, sending them to special schools, and making sure they had plenty of rest, the older girl "was completely hyperactive and would not eat," Hoerger says. "Her younger sister overate but would not talk, move or play."

After attending a lecture given by a New York physician who questioned the efficacy of certain HIV/AIDS medications, Hoerger spent months researching and weighing her options. "I didn't take it lightly," she says. "It meant going up against an entire medical establishment." She decided to stop administering the medication and, after about two months, noticed that the changes in the sisters were dramatic. "The older girl's appetite increased," Hoerger recalls. "All of a sudden she loved food and could taste it and eat and keep it down, and she calmed down and was able to function at school. She was seen by a psychologist both before and after I stopped the medication, and the psychologist was amazed by the improvement."

But, as with Regina Musa, there was a knock at the door. In 2000 both children were removed from Hoerger's home by two social workers. On a form, "medication administration" was the reason given for their removal. Hoerger believes that the girls were put on medication and placed back into the foster system.

"I went to court to find out if I could get visitation rights, but I couldn't get anything," Hoerger says. She was initially charged with neglect or child abuse, but says the case against her was dropped in 2001. Even now, talking about the girls remains painful, she says, pointing out that they should be teenagers today.

When asked to comment on the allegations of these families, ACS Commissioner John Mattingly says that while he has looked into some of the individual cases that were featured in media reports, he is not at liberty to discuss cases by name because of confidentiality requirements. "We haven't found any children who were removed because they were not a part of a clinical trial. However, we have found situations where a foster family stopped giving medicine to a child, and the child became gravely ill. Based on the judgment of a medical probe, the children were then removed from the foster family."

A Doctor Speaks Out

High above the city, in a spacious corner office on Lenox Avenue in Harlem, Stephen W. Nicholas, M.D., cofounder of the AIDS Pediatric Unit at Harlem Hospital, is wearing a cartoon necktie with smiling children's faces in all shades of brown and beige. It was here that Nicholas saw some of the city's earliest AIDS infected children. Overwhelmed and unable to provide alternative housing, the system back then simply allowed the newborns to stay on at hospitals indefinitely. After pleading unsuccessfully with state and local agencies to provide housing for the children, Nicholas and his partner, Elaine J. Abrams, M.D., came up with the idea of creating New York's first and only AIDS-only pediatric-care residence. Columbia University Medical Center, the Catholic Archdiocese, Children's Services and the New York State Department of Health all collaborated to establish Incarnation Children's Center, which opened its doors to 165 infants in March 1989.

Despite initial criticism from the community, the center received a well-publicized visit from Princess Diana, says Nicholas, which helped establish its credibility. That same year the Food and Drug Administration approved AZT for use in HIV positive adults despite some controversial claims that the drug was toxic. Based on this approval, Nicholas forged ahead with clinical trials of AZT among the babies under his care.

In all, a total of 18 drugs were used during the trials at Incarnation, which Nicholas oversaw until 2001. For some children, Nicholas told ESSENCE, AZT was given alone. For others the drug ddI (Videx) was administered. And for a third group both drugs were given in combination. "We found that the combination was better than either one alone," he says. He also calls allegations that AZT is toxic and ineffectual, particularly for children, "preposterous. That's like saying the sky is really not blue."

By 2000, the number of children under age 20 who died of AIDS in New York City that year had dropped to 13, compared with more than 100 in 1990. And for that reason, Nicholas stands by his decision to use experimental treatment. Despite criticism, he says he wouldn't do anything differently. "What is frustrating is a group of kids that nobody wanted were given love and treatment and now pediatric AIDS is on the way out," says Nicholas.

He is currently on assignment administering HIV drugs to children in the Dominican Republic. His goal there, he explained before relocating last July, is "to achieve the same success that we've achieved here."

The allegations against Children's Services and some 29 private agencies involved in the trials — including Catholic Home Bureau and Incarnation Children's Center — are serious. Among the allegations: a failure on the part of researchers to secure consent from legal guardians and biological kin as well as a failure to provide independent advocates to properly monitor the children.

There are even frightening questions about whether all the children enrolled were truly HIV-positive or sick at the time they were given the potentially dangerous drugs and whether the drugs were medically sound, based on what was known about them at the time. Children's Services confirmed to ESSENCE that some children who were in the clinical trials still receive medications that have now been approved by the FDA and are no longer experimental.

For some, the investigation calls to mind painful memories of the Tuskegee syphilis experiments secretly conducted on African American men from 1932 to 1972. Many also believe that the little-known foster care clinical trials would never have been brought to light if it hadn't been for the work of an independent investigative journalist named Liam Scheff, who first published an on line article about them in 2004. His piece, highly criticized by Children's Services and doctors involved in the trials, led to the making of Guinea Pig Kids, a 2004 BBC documentary that was widely circulated among New York City community activists and advocates. Members of an activist group calling itself the December 12th Movement were especially vocal after seeing the film, demanding public hearings and accountability and rallying outside the home of New York City Democratic Council member Bill de Blasio, calling for a formal investigation.

As public outcry has grown, the federal government has also been forced to address its role in the matter. In May 2005 the House Committee on Ways and Means met to discuss the trials at almost the precise moment that a stunning national review by the Associated Press discovered that similar research had taken place in at least six other states — Colorado, Illinois, Louisiana, Maryland, North Carolina and Texas — between 1988 and 2001.

At that same time, officials at the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services, turned up the heat when it wrote a letter to Columbia University Medical Center, cautioning that it had violated federal regulations in its HIV clinical trials on foster children. A contract between Children's Services and the Vera Institute of justice, a New York City nonprofit research organization hired to investigate the allegations, was signed a month later. But in the months that have passed since that time, answers have been slow to come, and the patience of many is wearing thin.

Many Unanswered Questions

At city council hearings in December 2005, questions put to Children's Services went unanswered or were referred to the Vera Institute, the investigating organization, which said it would not have definitive answers until sometime in 2007.

In a quarterly report a Vera official noted that of the children who entered the clinical trials, about 17 percent died while in care — a rate that investigators characterized as "far higher than typically seen among foster children who are not believed to be infected with HIV."

Though officials recognized the medications are powerful and pose a potential risk, neither Children's Services nor Vera has been willing to speculate on actual causes of death in the children. It is too early to say whether the cause of death in these cases was the illnesses themselves or the medications that were administered, warns Timothy Ross, Vera's Child Welfare, Health and Justice program director. Trying to pinpoint the exact cause is going to be difficult, adds Anne Lifflander, M.D., senior research associate at Vera, since some of the effects of the treatment are the same as those of the disease.

Fraser-Howze of the National Black Leadership Commission on AIDS maintains, however, that the children should never have been involved in the beginning phase of the trials. "When you're trying to find out the danger of something, you don't generally do it with children."

According to Fraser-Howze, a key issue is that researchers did not do a close enough examination of the process of seroconversion, by which new-born babies may test positive for HIV antibodies for up to 18 months due to the lingering presence of the mother's antibodies, but after which time test results may show a return to normal levels.

Although Vera was given access to records kept by the roughly 29 private foster care agencies, it cannot possibly hope to do a complete investigation without hospital records, research records and death certificates — some of which are currently being held by attorneys haggling over terms.

Meanwhile, the federal investigation is also stifled. The OHRP, the human services agency, warned in its letter to Columbia that the university's institutional review board did not follow proper procedures in determining how the children would be selected, nor did it outline properly its methods for obtaining parental or guardian consent. However, the agency's director of the Division of Compliance Oversight, Kristina Borror, softened that finding considerably in a phone interview with ESSENCE.

The agency was not saying that researchers did not obtain consent, she noted, but simply that they did not get sufficient information from their review board.

Still, in February 2006 the agency concluded its investigation of Columbia University Medical Center altogether and quietly closed the case without ever deciding either way whether consent was obtained or whether the children were properly monitored. While these questions, Borror told ESSENCE, were within the scope of its investigation, no specific wrongdoing was found.

"How in God's name the OHRP can walk away is beyond me," says Fraser-Howze, who's helping lead the investigation. "It's very possible that we may not know the whole truth in the end."

Kristal Brent Zook is a contributing writer for ESSENCE.

Source: Essence magazine captured on the website of Eugene Weixel