Accountability Demanded – NYC Foster Children AIDS drug trials

Codes of ethical research and Federal regulations for the protection of children were grossly violated; children suffered harm, many died. The efforts of AHRP to hold the medical research community and government bureaucrats accountable for exploiting vulnerable children in unethical research practices is gaining momentum. Our complaint about a series of AIDS drug experiments that were conducted on many hundreds of babies and children of color in New York City has triggered two federal investigations and protests by community representatives.

Two City Council members are calling on the New York City Department of Investigation to probe a series of clinical trials that gave potentially toxic experimental AIDS drugs to 465 HIV-positive foster kids. Councilmen Bill Perkins (D-Harlem) and Charles Barron (D-East New York) made the request at a press conference at City Hall on Sunday, April 24, in the wake of the administration’s stunning revelation on Friday, that the number of kids involved in trials was far greater than the 75 to 80 previously reported. [See Newsday below]

Constitutional lawyer, John Whitehead, of The Rutherford Institute calls these inhumane experiments “Mengele’s Legacy.” [See below]

A well-documented Fox News column raises questions that demand answers [see below]

Since the Code of Federal Regulations prohibits the use of children who are wards of the state from being subjected to experiments involving greater than minimal risk, we add the following questions:

  • Who authorized the illegal use of children in experimental drug trials?
  • Which institutional review boards approved the experiments‹and how did they justify their approval?
  • Who waived the federal requirement that every child who is a ward of the state must be protected by a personal advocate to ensure that each child’s best interest is seved by the child’s participation in research?
  • Why were the sick children not given the best available standard treatment?
  • Was there a limit to how many experiments an individual child could be subjected?
  • What adverse events did children suffer during the trials or within 6 months after?
  • How many children were subjected to surgical insertion of feeding tubes?
  • How many children’s health deteriorated during the experiments–how many children died?
  • How many children were critically ill before the trials–how many were “presumed” to be ill?
  • How much money did NIH provide for these pediatric drug experiments‹
  • and did the AIDS institute know that foster care children were used as subjects?

Those responsible had better provide answers sooner rather than later.

Contact: Vera Hassner Sharav

http://www.foxnews.com/index.html
Transparency Crucial For Accountability
By Wendy McElroy
Wednesday, April 27, 2005

New York City’s Administration for Children’s Services has announced an “independent review” of the controversial AIDS-drug trials conducted between 1988 and 2001 on children in its foster care.

The highly experimental and toxic drugs were administered to infants as young as 4-months old. For over a year, medical-rights watchdogs and some media voices have demanded transparency on the experimental drug trials. Why has it taken so long?

Transparency is the key to dissolving criticism, but transparency is precisely what has been lacking. Perhaps because disclosure is a slippery slope into accountability.

On Feb. 29, 2004, The New York Post ran an expose entitled “AIDS Tots Used as ‘Guinea Pigs.'” It claimed that about 50 wards of ACS had been used to test multiple combinations of AIDS medication. (The Post later revised that number to 100 in the light of new data. ACS has now raised the number to “about 465” children.)

The article ended, “Officials…refused to talk to The Post.”

On March 10, 2004, FOX News ran my column, “When Mother is a Bureaucracy,” in which I asked:

  • How many children were involved?
  • What were the results of the trials?
  • Were children removed from foster parents who refused treatment, including from a nurse experienced with treating AIDS in children?
  • Were feeding tubes involuntarily inserted into the abdomens of children who refused oral medication?

The FOX editorial ended, “For once, a child welfare system must have the courage and decency to open itself to public scrutiny.”

At the same time, the Alliance for Human Research Protection (AHRP) – self-described as “a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices” – filed a complaint against ACS with the FDA and the federal Office of Human Research Protections. The complaint accused the ACS of violating federal regulations.

The specific federal regulations that ACS was accused of violating? 45 CFR 46.409 and 21 CFR 50.56, intended to protect wards of the state from medical experiment involving “greater than minimal risk.”

The AHRP stated, “Phase I and Phase II experiments involve the greatest level of risk and discomfort for children insofar as they test the safety and toxicity of the drugs as well as maximum dose tolerance.” In short, the risks seem to have been greater than minimal.

The complaint against ACS ended, “We ask for…full disclosure of the adverse effects suffered by these children; disclosure of institutional and physician conflicts of interest; and the children’s condition following their participation.”

The story received considerable attention from media abroad. For example, last November, the BBC aired a documentary titled “Guinea Pig Kids: Vulnerable NYC foster children forced to test AIDS drugs.” The documentary also pointed an accusing finger at the drug companies, such as GlaxoSmithKline, who supported some of the tests. ACS stonewalling continued. No information about the children’s condition before and after the experimentation was revealed, which raised questions about the public value of such ‘secret’ testing.

On July 6, John B. Mattingly was appointed as Commissioner of NYC- ACS. It is Mattingly who announced that the Vera Institute of Justice, a New York-based nonprofit research group, would conduct an investigation and that a panel of national health care experts would review its findings. In doing so, Mattingly defended the appropriateness of the testing.

But, according to the New York Times, the commissioner believes an outside investigation is required to allay the concerns raised by “some reporters” and by “a minority advocacy group.” Virtually all of the children in the tests were African-American or Hispanic.

Mattingly added, “we acknowledge the need for transparency in all of our dealings with the publicŠFor us to be effectiveŠwe must have a sense of mutual trust with those families we seek to serve.” After all, ACS is the agency charged with investigating and preventing child abuse. An “exhaustive” internal review, conducted at Mattingly’s request, has reportedly exonerated ACS.

For example, the review rejects the accusation that children not perilously ill were included in the experimental tests. By contrast, Vera Hassner Sharav, President of AHRP, claims that documents filed with the federal government show many of the foster children were only “presumed” to be HIV positive. If true, those children would not have been perilously ill.

Transparency is badly needed. An exonerating self-investigation appears to be self-serving and only raises the level of public skepticism. Moreover, although Mattingly’s announcement of an independent review was meant to calm the issue, some statements raised further concerns. For example, according to the New York Post, “Vera has also been asked to locate as many of the children as possible to ascertain their current medical conditions.”

Mattingly also indicated that records will be reviewed to see if there were more children who participated.

How exhaustive could the ACS internal review have been if the number of children involved and the long-time effects on their health are still unknown?

When an “authority” assumes control over the lives of human beings – effectively stripping them of a voice – the absolute minimum demanded of that authority should be transparency. And, yes, that does lead to accountability.

Wendy McElroy is the editor of ifeminists.com and a research fellow for The Independent Institute in Oakland, Calif.

© Associated Press. All rights reserved.
Copyright 2005 FOX News Network, LLC. All rights reserved.

Newsday Probe demanded in kid drug trials
BY GLENN THRUSH
April 25, 2005

Two City Council members are calling on the city Department of Investigation to probe a series of clinical trials that gave potentially toxic experimental AIDS drugs to 465 HIV-positive foster kids. Councilmen Bill Perkins (D-Harlem) and Charles Barron (D-East New York) made the request yesterday following the Bloomberg administration’s stunning revelation Friday that the number of kids involved in trials was far greater than the 75 to 80 previously reported.

Administration for Children’s Services chief John Mattingly has hired the nonprofit Vera Institute for Justice to look into whether the drugs were administered properly.

“We need a truly independent investigation – so why is DOI not investigating this?” Perkins said during a City Hall news conference. “Why is Mattingly allowed to set up his own investigation? Why is he being allowed to circumvent DOI?”

The investigations department probes city agencies for fraud, corruption and unethical conduct. The HIV program, which ran from 1988 to 2001, involved administering potent anti-AIDS “cocktails” whose side-effects included vomiting, diarrhea, painful skin rashes and neurological problems. The children, most of them poor and black, ranged from infants to teenagers. The Department of Investigation needs to look into why the children’s agency “repeatedly underestimated the scope of the trials” and what happened to the kids involved, Perkins said.

Children’s services spokeswoman Sharman Stein said the agency hasn’t referred the case to the investigation department because an internal probe found only “inadequate record-keeping” and not “allegations of wrongdoing.”

The trials, which involved kids at two dozen nonprofit foster care agencies, were done as part of a nationwide National Institutes of Health search for pediatric AIDS treatments. Clients were referred to the program by the Archdiocese of New York’s Catholic Charities

[CORRECTION: A story Monday incorrectly identified the Archdiocese of New York as the group referring clients to a pediatric HIV drug trial. Physicians working at a diocese facility, and not diocese officials, made the referrals. pg. A17 C 04/27/05].

It’s not clear how many kids died during the trial or whether non-AIDS drugs, including mood-altering medications, were part of the protocol, Stein said.

The Vera investigation will determine if the children’s guardians approved treatments, whether children’s personal doctors were consulted, and if the administration of the drugs was based on “sound medical knowledge at the time,” she added. Stein said her agency hadn’t yet calculated the cost of the Vera probe.

Copyright 2005 Newsday Inc.
Big Scandal Outed In NEW YORK, India News Category : American News
Published on : 4/24/2005

A big scandal is brought out in New York City, but if proven true has vital implications on two fronts. The city’s Administration for Children’s Services has hired an outside research firm to investigate allegations that the city inappropriately put foster children into medical trials for AIDS drugs in the 1980’s and 1990’s and that foster parents who objected to the trials lost custody of the children.

The two-pronged allegations entail powder-keg charges that the city tested AIDS drugs on foster children and that if a foster parent objected the children was then placed elsewhere. Most of the children in the trials were African-American or Hispanic.

Vera Institute of Justice articulated that it would form a panel of national health care experts to review the findings of the investigation. The agency’s commissioner, John B. Mattingly, articulated that he thought that children’s services had acted appropriately but that he has asked for the outside investigation to allay concerns raised by some reporters and by a minority advocacy group.
Mengele’s Legacy Lives On: Inhumane Experiments on Children in America
by John W. Whitehead, The Rutherford, 4/18/2005

Inevitably, when we hear about humans being experimented on, our minds turn to the Auschwitz concentration camp and the infamous Nazi Angel of Death, Josef Mengele. Seen as immoral and scientifically dubious, Mengele’s work included placing human beings in pressure chambers, freezing them to death, testing drugs on them and castrating them. He also injected children with lethal germs, removed their organs and limbs and performed sex change operations on them. His primary interest was twins. The Nuremberg Code, created as a reaction to the horrors of Mengele’s work, provided directives for human experimentation to protect the experimental subject from even remote possibilities of injury, disability, or death. Above all else, the Code stressed that it is necessary to obtain voluntary, informed consent from the patient.

Despite the existence of this code and subsequent medical ethics codes, Mengele’s legacy lives on. This time, the culprit is none other than the United States government through its involvement in numerous questionable and immoral human research programs. Lest you think that the scientific community and government agencies would not carry out immoral experiments on humans, particularly children, think again. For example, the federal Environmental Protection Agency’s forays into human experimentation recently came to light after the Washington Post reported that the EPA had approved a two-year study in which families who use pesticides in Duval County, Fla., would be paid to continue using them and to monitor their children’s exposure. Each family would be paid $970 in order that scientists might discover how children’s bodies absorb hazardous chemicals. Although scientists may not know the full effects of these poisonous chemicals, they do know that children are at greater risk than adults. Yet rather than advising parents to keep children away from pesticides, the government is paying them to poison their children. Thankfully, after U.S. Senators Barbara Boxer (CA) and Bill Nelson (FL) threatened to block the full-time confirmation of Stephen Johnson, the EPA’s acting administrator, if the experiment were not cancelled, Johnson ended the Florida pesticide program on April 8, 2005.

However, the pesticide study is not the only unethical experimentation in U.S. history. It is simply the most recent case. At a prenatal clinic at Vanderbilt University Hospital from 1945-49, nearly 830 poor, pregnant Caucasian women were given a drink containing radioactive iron. They were told the drink would be good for their fetuses. Within an hour, the radioactive material was circulating in the blood of the unborn babies.

The list of criminal experiments does not stop at endangering the unborn. During the 1940s and 1950s, the U.S. government was involved in many radioactivity tests in which humans, especially young children, were used as guinea pigs. Most notable was the MIT and Quaker Oats-sponsored testing at the Fernald School in Waltham, Mass., in which mentally retarded students were fed cereal containing radioactive iron in order to trace iron absorption. However, neither the students nor their parents were informed of the use of radioactive materials or the possible health risks.

From 1948 to 1954, Johns Hopkins conducted an experiment on 582 third graders, testing the effects of Nasal Radium Irradiation. Although it is now known that this procedure places the participant at greater risk for cancer, the government still has not contacted the participants to warn them of this risk. During the 1950s and 1960s, mentally retarded children between the ages of 3 and 11 at Willowbrook State School were intentionally infected with hepatitis. The early test subjects were fed extracts of the feces of an infected patient, and later subjects were injected with the virus in order for researchers to be able to study the hepatitis virus. In the 1960s, the D.C. Children’s Center in Laurel, Md., used mentally retarded children as test subjects. They were given a diet pill called NeoBazine, which contains thyroxin, a drug that causes tremors, nervousness, insomnia and tachycardia. The FDA later found that this drug was not safe for use.

As recently as 1989-1991, Kaiser Permanente of Southern California and the Centers for Disease Control treated 1,500 poor black and Latino inner-city children in Los Angeles with experimental measles vaccines. The same vaccination was given to infants in Mexico, Haiti and Africa by the World Health Organization. It was discontinued after a large number of those tested died.

In a series of articles written for the New York Press in July 2004, Liam Scheff reported on experiments at Incarnation Children’s Center in New York, where AIDS drugs were being tested on HIV-positive children, the majority of whom are orphans. Although the HIV test is not always accurate, once the children test positive, they are considered terminal patients and subjected to debilitating and experimental drugs. Despite the fact that these drugs can be torturous for the children, those carrying out the experiments seem to feel justified in doing so because the children will most likely die anyhow.

For some reason, people are more apt to allow cruelty in the name of medical research. Yet human experimentation makes a mockery of the Hippocratic Oath, which doctors swear to uphold. There is obviously no true moral viewpoint here. The Golden Rule of treating others with the concern and kindness you would like them to show you seems to have fallen on deaf ears in certain sectors of the medical industry. And one can only wonder, “What kind of mind operates on this level?”

When the world learned the truth about Josef Mengele’s horrific experiments, he was immediately branded a monster. However, a few years later, similar experimentation was being sanctioned by the powers that be in America and carried out on unsuspecting American citizens. As the Alliance for Human Research Protection points out, these barbaric practices continue even today, “while government agencies maneuver to weaken legal protections prohibiting the exposure of human beings to experimental drugs, vaccines and procedures without their voluntary informed consent.” And with the demise of investigative reporting, these human rights violations are rarely published and gain little public notice.

Unless we reaffirm our commitment to the dignity and rights of all human beings‹and teach this principle in our homes and schools and continue into the highest levels of our public institutions and government, such experiments will continue. And we will have little right to condemn or object to the inhumane practices of other countries.

Constitutional attorney and author John W. Whitehead is founder and president of The Rutherford Institute and author of the award-winning Grasping for the Wind.