Clinical Trials in NYC Orphans

by Liam Scheff

The following is evidence in the long-running investigation into the use of toxic drugs on orphans in New York City in the Incarnation Children’s Center orphanage and in New York’s major hospitals, and then in Aids medicine in general.

Background on this story – here and here.

Below is the ICC webpage as it appeared when I first looked at it, in 2003. It was taken down in early 2004, after press attention focused on the practice of using orphans in government and pharma-sponsored drug trials.

The page announces the clinical trials then in progress, as well as making some strong statements about improvement of patient health without the admittedly toxic and potentially fatal standard Aids drugs.

I think it’s clear that ICC was founded with good intentions, to assist abandoned, ill and suffering infants. But I also think that a shocking and inexcusable ethical line was crossed when the children began to be used as pharmaceutical test subjects.

I will point out that the vast majority of ICC’s wards were children of crack addicts, themselves born chemically-addicted and profoundly debilitated, according to the childcare workers, nursing staff and children from ICC that I interviewed Here ].

Further, I think, the relabeling of these children as “HIV positive” arises from the non-standardized, highly-flexible nature of HIV testing. Here is my summary of the limitations of the tests, Here is an extensive catalog of citations from the medical literature on the subject.

Beneath the ICC page is a list of drug trials1 in which ICC is listed as a participant/recruiting center. ICC was listed on the NIH trial lists through early 2005, when I was writing this piece for the NY Press.

Bold emphasis added

ICC Webpage

ICC Frontpage (2004) | ICC Page 2 (2004) |
Download a PDF of the Incarnation Children’s Center’s original website, circa 2003, 2004.

I.C.C. PROVIDES:

Residential transitional care with 24-hour nursing (i.e. “enhanced care”) for chronically-ill HIV infected children who do not need hospitalization but require “round-the-clock” medical and nursing care in a nurturing and home-like setting.

Respite care for medically-complex children whose natural or foster parents are temporarily unable to provide care.

Outpatient diagnostic and medical care for HIV-infected children.

Access to clinical trials of new medications to treat HIV-infected children, under the sponsorship of the National Institute of Allergy and Infectious Diseases.

Training and education for pediatricians-in-training, students of medicine, nursing, social work and law, parents and foster parents.

HIV support groups for parents and older children.

Services/Events – Incarnation Children Center

1996

Stephen Nicholas, M.D., Director

The Department of Pediatrics has played a significant role in the creation and support of Incarnation Children’s Center (ICC), New York City’s only residence for HIV-infected children. Located on Audubon Avenue at 172nd Street in a 4-story red brick former convent, ICC’s residential and outpatient programs have provided care for over 600 HIV-positive children since opening its doors in 1989.

In the mid-1980’s, children with HIV infection and AIDS were often homeless and foster parents were in very short supply. As a result, hundreds of AIDS boarder babies languished for months to years on hospital wards because they had nowhere else to live.

In 1987, Dr. John Nicholson, Professor and Attending of Pediatrics, after finishing a month as ward attending at Harlem Hospital, which had the greatest number of AIDS boarder babies in the city, had an idea to use Incarnation Convent, which was empty, as a home for AIDS babies.

At his prompting, a collaborative group formed: Monsignor Thomas Leonard, then a rector of Incarnation Church; Sister Una McCormack, executive director of Catholic Home Bureau, a foster care and adoption agency of the Archdiocese of New York; Dr. Michael Katz, then chairman of the Department of Pediatrics; Dr. Margaret C. Heagarty, Director of Pediatrics at Harlem Hospital; Jack Rudin of the Samuel and May Rudin Foundation; Brooke Trent, then Deputy Commissioner of the Child Welfare Administration.

This collaborative group envisioned a sanctuary of love, a home-like nurturing residence where HIV-positive children would receive the best possible nursing and medical care while awaiting placement into foster homes.

Dr. Stephen Nicholas was recruited to become the founding medical director. With his assistance and together with cofounders Sister Bridget Kiniry, M.Ed., Sr. Constance Gaynor, M.S.W., and Pamela Clark, R.N., M.P.H., the program was created.

During its first two years, ICC became the Ellis Island for homeless children with AIDS. One hundred and sixty children were admitted to ICC from all five city boroughs. During this period, ICC worked with the Child Welfare Administration and a large number of foster care agencies to encourage foster parents to accept HIV-positive children. As a result, foster parent recruitment increased at an astonishing rate.

After three years, a surplus of foster parents existed for all but the sickest children. New York City’s AIDS boarder baby crisis had ended. ICC had played a pivotal role in this success story. Having accomplished its goal, ICC would have happily closed its doors had it not been for an unexpected discovery.

Pediatric AIDS was first recognized in 1982-83. Early in the epidemic, HIV disease of childhood was considered to be down-hill course leading to death. But in the late 1980’s, before AZT was available, many very ill children admitted to ICC got dramatically better with proper nurturing and high-quality medical and nursing care.

As the importance of convalescent care became clear, many of the sickest HIV-infected children in the city began to be referred to ICC for temporary care.

In 1992, an outpatient clinic for HIV-positive children was established; the same year, with funding from the National Institute of Allergy and Infectious Diseases, the clinic became a sub unit of the Columbia University Pediatric AIDS Clinical Trials Unit, directed by Dr. Anne Gershon, Professor of Pediatrics.

In addition, ICC from its earliest days has worked in close collaboration with the Harlem Hospital Pediatric AIDS Program, directed by Dr. Elaine Abrahms, Associate Professor of Clinical Pediatrics.

Today ICC is an internationally-recognized model of community-based care for children with HIV/AIDS. It’s 1996-97 operating budget is $2.0 million for the residential program and $*756,899 for the clinic program ($286,087 of which is for clinical trials*). A staff of 70 provide a full array of medical, nursing, child care, social, nutritional and developmental services.

Approximately 70 volunteers supplement staff activities. The Friends of Incarnation Children’s Center, a newly-organized non-profit organization for publicity and fund-raising, raised $334,818 in 1996, of which $100,000 was donated by The May and Samuel Rudin Family Foundation for the support of Columbia University medical staff salaries.

ICC medical personnel include three pediatricians, two research nurses, two-field nurses, one senior clerk and one part-time psychologist.

During 1996, ICC’s average residential census was 88.6%, with 42 children admitted for an average length of stay of 82 days.

During clinic sessions each week, 1438 evaluations were given in the past year to 133 HIV-positive children, 118 children were referred for HIV testing. Under the direction of Dr. Nicholas, 34 children are currently participating in 7 clinical trials, including

[_Note: Zidovudine is also known as AZT. Studies on AZT_ ]

  • ACTG 219 (Pediatric Late Protocol);
  • ACTG 240 (zidovudine vs. D4T);
  • ACTG 245 (comparison of didanosine, zidovudine and nevirapine in children/adolescents with advanced HIV diseases);
  • ACTG 254 (atovaquone/azithromycin vs. trimethoprim/sulfamethoxazole to prevent serious bacterial infections);
  • ACTG 300 (zidovudine/3TC vs. didanosine/zidovudine/didanosine);
  • ACTG 327 (a continuation of ACTG 240),
  • and a Roche-sponsored trial of DDC monotherapy.

ACTG 338 (zidovudine/3TC vs. D4T/ritonavir vs. zidovudine/3TC/ritonavir), the first phase II pediatric trial of a protease inhibitor, will start in early 1997. The ICC clinical trials subunit was awarded funding from NIAID for an additional three years (1197-2000).

Dr. Nicholas was promoted in 1996 to Associate Professor of Clinical Pediatrics and Associate Attending. He was listed among The Best Doctors in New York in New York Magazine, and in the 1996-97 edition of The Best Doctors in America.

[end document]

1 ICC’s Drug Trials

NIH/Pharma-Sponsored Drug Studies at ICC

Download as Zip File – ICC NIH Clinical Trials

The following is a list of studies in which ICC is listed as a participant/recruitment center. This is not the end of the list, however, because children at ICC are treated at the major hospitals in the New York metropolitan area, and can be enrolled in studies there as well.

ICC functions as a magnet structure for children in the major metropolitan area. Patients from the five burroughs, and more than a half dozen hosptials are taken into ICC, most often, I was told by ICC’s medical director, Dr. Katherine Painter, for issues relating to “adherence.” That is, refusal to take the drugs.

Studies funded by Pharmaceutical Companies:

  • Glaxo Wellcome (now GSK)
  • Bristol-Myer Squibb
  • Genentech
  • Biocine
  • Pfizer
  • Protein Sciences Corporation,
  • And the NIH, NIAID, NICHD and other government agencies – that’s tax dollars, mine and yours.

Terms used in the studies:

  • “Recruiting” = ongoing studies that are taking new participants.
  • “No longer recruiting” = Ongoing studies that are not taking new participants.
  • “Completed” = a study that is over.
  • “Terminated” = a study that was ended early.
  • Lipodystrophy – bodily deformation from Aids drugs, especially protease inhibitors

Also Note: Studies with:

  • HIV-negative (“seronegativity”)
  • “Presumed HIV-infected Infants”
  • Healthy (“asymptomatic”) 1 month olds
  • With “7 drugs, some at higher than usual doses” in “4 to 22 year olds.”
  • Also, the many vaccine studies in these children.

ClinicalTrials.gov

Search results for ( incarnation AND hiv ) [ALL-FIELDS] are shown below.

Include trials that are no longer recruiting patients.

36 studies were found.

[Zip File]

1. No longer recruiting A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Conditions: HIV Infections; HIV Seronegativity

2. Completed A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection

Condition: HIV Infections

3. No longer recruiting A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group

Conditions: HIV Infections; Measles

4. No longer recruiting The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Conditions: HIV Infections; HIV Wasting Syndrome; Lipodystrophy

5. Completed Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs

Condition: HIV Infections

6. Completed A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV

Condition: HIV Infections

7. Completed A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Condition: HIV Infections

8. No longer recruiting Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems

Condition: HIV Infections

9. No longer recruiting A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

Condition: HIV Infections

10. No longer recruiting A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

Condition: HIV Infections

11. Completed Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Condition: HIV Infections

12. Recruiting The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV

Condition: HIV Infections

13. No longer recruiting Long-Term Effects of HIV Exposure and Infection in Children

Conditions: HIV Infections; HIV Seronegativity

14. Completed A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

Condition: HIV Infections

15. No longer recruiting A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

Conditions: HIV Infections; Pregnancy

16. Completed A Randomized Comparative Trial of Zidovudine (AZT) Versus 2’,3’-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Condition: HIV Infections

17. Terminated “The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

Conditions: Herpes Simplex; HIV Infections; Chickenpox

18. Completed A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2’,3’-Didehydro-3’-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Condition: HIV Infections

19. No longer recruiting A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Condition: HIV Infections

20. No longer recruiting A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Conditions: HIV Infections; Pneumococcal Infections

21. No longer recruiting A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Conditions: Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections

22. Completed Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Conditions: HIV Infections; Pregnancy

23. Completed Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

24. Completed A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Condition: HIV Infections

25. Completed A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

Condition: HIV Infections

26. No longer recruiting A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

Condition: HIV Infections

27. No longer recruiting Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

Condition: HIV Infections

28. No longer recruiting A Study to Compare Two Different Anti-HIV Drug Regimens

Condition: HIV Infections

29. No longer recruiting A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

Condition: HIV Infections

30. No longer recruiting A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Condition: HIV Infections

31. No longer recruiting A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Conditions: Cytomegalovirus Infections; HIV Infections

32. No longer recruiting Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

Condition: HIV Infections

33. No longer recruiting Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox

Conditions: HIV Infections; Chickenpox

34. Completed Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems

Condition: HIV Infections

35. Completed A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Condition: HIV Infections

36. Completed Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Condition: HIV Infections

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services

Copyright, Privacy, Accessibility, Freedom of Information Act

3 thoughts on “Clinical Trials in NYC Orphans

  1. A National Scandal: AIDS Drug Experiments on Foster Care Children – Assoc Press

    Wed, 04 May 2005

    On March 10, 2004, The Alliance for Human Research Protection filed a complaint with the FDA and the federal Office of Human Research Protection about a series of AIDS drug experiments conducted on New York City children in foster care. That complaint prompted two separate investigations by the FDA and OHRP which are still on-going.

    Articles in The New York Post and a documentary by BBC raised the alarm among the African-American and Latino community in NY-some of who have been protesting weekly in front of Incarnation Children’s Center, the site of some of the drug experiments.

    The Associated Press AP has just released its investigative report: the problem is a national scandal–the experiments were conducted in “at least seven states — Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas — and involved more than four dozen different studies.

    AP’s investigation found that 13,878 children had been enrolled in pediatric AIDS studies funded by the government since the late 1980s. Of these, officials estimated that 5 percent to 10 percent were in foster care. Their age ranged from infants to late teens.

    “More than two dozen Illinois foster children remain in studies today.”

    Those who conducted the experiments in violation of federal regulations, are supported by taxpayers – thus they have a public responsibility which they violated. The children who were targeted to serve as human drug testing subjects – mostly poor children of color – were not afforded the protection of a personal advocate – as is mandated by federal regulations. (45 Code of Federal Regulations 46.409)

    The institutional culture of arrogance is demonstrably in evidence at both medical research centers and government agencies: “Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.

    And officials of NYC Administration of Child Services “defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities.”

    The children are reported to have suffered painful side effects “such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.”

    In one study testing the drug dapsone, “at least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn’t appear to be “directly attributable” to dapsone but nonetheless were “disturbing.”

    “overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained,” the researchers concluded.

    “Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions — nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.

    At least three states declined to use children in foster care in medical experiments: Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system,” spokeswoman Stephanie Marquis said.

    Not addressed in the AP report is the amount of money that these trials generated for the institutions involved in the experiments.

    ***The NYC Council, general welfare committee is holding a hearing about the unethical experiments conducted in NYC. The hearing will take place at City Hall at 11:15.

    For information and to register to speak, call: Ms. Jackie Sherman at 212-788-7015

    Contact: Vera Hassner Sharav
    212-595-8974

    http://www.latimes.com/news/nationworld/wire/ats-ap_top13may04,0,7330019.story

    Researchers Tested AIDS Drugs on Children
    By JOHN SOLOMON
    Associated Press Writer

    11:08 AM PDT, May 4, 2005

    WASHINGTON – Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.

    The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren’t yet available in the marketplace.

    The practice ensured that foster children — mostly poor or minority — received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown.

    The research was conducted in at least seven states — Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas — and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records.

    Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.

    In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.

    The government provided special protections for child wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in a narrow class of studies that involved greater than minimal risk and lacked the promise of direct benefit. Some foster agencies required the protection regardless of risks and benefits.

    Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and “act in the best interests of the child” for the entirety of the research, the law states.

    However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren’t given such advocates even though research institutions many times promised to do so to gain access to the children.

    Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors even though researchers signed a document guaranteeing “the appointment of an advocate for each individual ward participating in the respective medical research.”

    New York City could find records showing 142 — less than a third — of the 465 foster children in AIDS drug trials got such monitors even though city policy required them. The city has asked an outside firm to investigate.

    Likewise, research facilities including Chicago’s Children’s Memorial Hospital and Johns Hopkins University in Baltimore said they concluded they didn’t provide advocates for foster kids.

    Some states declined to participate in medical experiments. Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system,” spokeswoman Stephanie Marquis said.

    Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today.

    Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly caused by experimental treatments.

    Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults.

    “Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.

    If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities.

    Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT — an effective AIDS treatment — for children.

    Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children because researchers felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults.

    “It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.

    “When you have the most vulnerable subjects imaginable — kids without parents — you really do have to come in with someone independent, who doesn’t have a dog in this fight,” he said.

    Those who made the decisions say the research gave foster kids access to drugs they otherwise couldn’t get. And they say they protected the children’s interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves.

    “I understand the ethical dilemma surrounding the introduction of foster children into trials,” said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. He enrolled some Texas foster kids in his studies, and doesn’t recall appointing advocates for them.

    “To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time,” he said. “From an ethical perspective, I never thought that was a stand I could take.”

    Illinois officials directly credit the decision to enroll HIV-positive foster kids with bringing about a decline in deaths — from 40 between 1989 and 1995 to only 19 since.

    NIH, the government health research agency that funded the studies, did not track researchers to determine if they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site.

    A recent Institute of Medicine study concluded those Institutional Review Boards (IRBs) were often overwhelmed, dominated by scientists and not focused enough on patient protections. An ethicist who served 22 years on such boards said they lack the resources to ensure the safety of foster children.

    “Over the last half century, IRBs have basically broken under the strain of some of the structural changes in research,” said Gregory E. Pence, a University of Alabama-Birmingham bioethicist.

    The U.S. Office for Human Research Protections, created to protect research participants after the infamous Tuskegee syphilis studies on black men, is investigating the use of foster children in AIDS research. The office declined to discuss the probe.

    NIH said it considers patient safety its top priority and awaits the outcome of the investigation. “If we find that patient protections need further strengthening, we will take action to do so,” spokesman John Burklow said.

    AP’s review found that if children were old enough — usually between 5 and 10 — they also were educated about the risks and asked to consent. Sometimes, foster parents or biological parents were consulted; other times not.

    “Our policy was to try and contact the (biological) parents because it was fairly common when we got done the foster kid would go back to the parents,” said Dr. Ross McKinney, a pediatrics AIDS expert at Duke University.

    Research and foster agencies declined to make foster parents or children in the drug trials available for interviews, or to provide information about individual drug dosages, side effects or deaths, citing medical privacy laws.

    Other families who participated in the same drug trials told AP their children mostly benefited but parents needed to carefully monitor potential side effects. Foster children, they said, need the added protection of an independent advocate.

    “I don’t believe a foster care parent can do it,” said Vinnie DiPoalo, a New Jersey woman whose 10-year-old adopted son has participated in three AIDS drug trials. “There are informed consents that have to be signed. There are follow-up blood appointments.

    “I think that’s the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time,” she said.

    Many studies that enlisted foster children involved early Phase I and Phase II research — the riskiest — to determine side effects and safe dosages so children could begin taking adult “cocktails,” the powerful drug combinations that suppress AIDS but can cause bad reactions like rashes and organ damage.

    Some of those drugs were approved ultimately for children, such as stavudine and zidovudine. Other medicines were not.

    Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients.

    Researchers reported some children had to be taken off the drug because of “serious toxicity,” others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly.

    At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn’t appear to be “directly attributable” to dapsone but nonetheless were “disturbing.”

    “An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained,” the researchers concluded.

    Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions — nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.

    New York City officials defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities. Nonetheless, they are changing their policy so they no longer give blanket permission to enroll children in preapproved studies.

    “We learned some things from our experience,” said Elizabeth Roberts, assistant commissioner for child and family health at the Administration for Children’s Services. “It is a more individualized review we will be conducting.”

    Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers.

    “We talk about it. Then they come the next time. There is no rush,” explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children.

    Kline, the Texas researcher, added: “I never wanted a parent or guardian to ever say ‘yes’ simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family.”

    * __

    Researcher Rachel Landau in Washington and reporter Carla K. Johnson in Chicago contributed to this story. On the Net:

    Documents associated with this story are available at:

    http://wid.ap.org/inv/foster.html

    National Institutes of Health: http://www.nih.gov

    FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

  2. did those kids that died ever get justice? Since when can someone get away with child abuse n murder. has any laws been changed or can these sadistic freaks that call themselves doctors do this again to other innocent babys

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