Transparency Crucial for Accountability

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 expos 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 public…For us to be effective…we 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 AHSP, 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.

April 28, 2005