NYC Fails to Protect Its Foster Children in AIDS Trials

Late last week, the Vera Institute of Justice released its 500-page detailed report regarding New York City's foster children and their participation in HIV/AIDS clinical trials from the late 1980's through 2001. These trials tested medications for treating the symptoms of HIV/AIDS in children. http://www.vera.org/publication_pdf/clinicaltrials-appendix.pdf

The report provides us with an opportunity to catalogue the numerous deficiencies in NYC's efforts to protect foster children during these clinical trials, and it exposes the lack of adequate data available to us today as we seek to understand and correct these deficiencies.

The New York Times suggested in its January 27, 2009 article that allegations about poor procedures and a lack of protection of foster children in clinical trials have been refuted by the Vera report. http://www.nytimes.com/2009/01/28/nyregion/28foster.html?_r=1&scp=1&sq=foster%20childen%20hiv&st=cse The New York Times clearly misunderstood the report.

Alarming Failure to Protect Our Children

Based on information available to it, Vera states in its report that of the 25 children who died while participating in the medication clinical trials none died as a result of the medication provided to them in those trials. But, Vera's lack of access to the medical records of the deceased foster children raises questions about their ability to accurately determine the causes of death of these children. See Page 225 of the report.

The report reviewed the experiences of 532 foster children, but there are another 264 foster children for whom Vera received insufficient information to determine whether those 264 children were or were not participants in clinical trials. Moreover, for twenty-two of the foster children who participated in the trials, Vera hasn't received adequate information to determine whether these children were ever even infected with HIV. See Page 203 of the report.

Of the 532 foster children, 98 participated in the clinical trials without the approval of the Commissioner of the NYC Administration for Children's Services. The Commissioner's approval was required for the participation of foster children in any clinical trials. See Page 239 of the report.

Twenty-one percent of the children, or 112 children, participated in clinical trials despite the fact that their parents had not signed the required informed consent documents. For at least seven children, the person who signed an informed consent form was not legally authorized to do so. Kinship foster parents, parents without parental rights, and child welfare staff signed the forms in contradiction of the policies in place to protect the children. Even when forms were signed by legally authorized individuals, those individuals likely were often confused about the nature of the trials to which they were consenting. Many informed consent forms contained technical language difficult for people without a medical background to understand. Often, the informed consents from legally authorized individuals were obtained in violation of federal rules for obtaining such consents. These violations include handwritten notes for informed consent in lieu of official documents, consent accepted over the phone, coercive tactics used to obtain consent, and consent sought or obtained from parents who may not have been competent to provide it. See Pages viii to ix of the report.

Three of these children were enrolled in a phase I clinical trial even though Children’s Services’ policy barred participation in phase I trials. Phase I trials are the first stage of testing in human subjects. These trials are designed to assess the safety and tolerability of a drug. Approximately half of the trials could have been phase I (32 of 65 treatment trials). Vera was unable to identify any phase for 18 of the 65 treatment trials, and they could not determine whether the foster children participated in the phase I or the phase II aspect of 14 phase I/II trials. See Pages 355 to 357 of the report.

Data Deficiency

For 30 percent of the foster children, some part of the child welfare file was lost or destroyed. Records often did not contain documentation required by state regulations. See Page ix of the report.

Only the New York State Department of Health (NYSDOH) has the right to conduct or authorize a review of medical and clinical trial records of foster children who participated in HIV/AIDS trials—even when hospitals agree to have the files reviewed. NYC Administration for Children’s Services asked NYSDOH to permit it to review this information. The NYSDOH refused those requests. See Page xii of the report.

Because Vera was not permitted to review Internal Review Board (IRB) minutes from the hospitals where clinical trials were conducted, Vera was unable to determine whether or not independent advocates were required for compliance with federal regulations and Children’s Services policy in many trials. See Page 257 of the report. The federal government reviewed the IRB minutes from Columbia University Medical Center's IRB and determined that Columbia failed to follow federal regulations with regard to determining the need for independent advocates. See Page 127 of the report.

Preventing Future Failures

Our city and our state must make the protection of our foster children a high priority, while aggressively undertaking efforts to treat the symptoms of AIDS and prevent the spread of HIV amongst our children. We must demand that New York City and New York State work together to correct the alarming deficiencies discovered and revealed in the Vera report. Our children deserve better protection.

HIV and AIDS Testing for Manhattan

All of us need to commit to focus attention on HIV testing and prevention in Manhattan and to demand from our elected leaders increased leadership in this area. A number of recent developments have caused me to seek to catalyze Upper Manhattan communities to advocate for HIV/AIDS testing throughout Manhattan:

1) The NYC government announced in late June 2008 its decision to test all adults in the Bronx for HIV/AIDS. The decision should be applauded, but it highlights our needs in Manhattan. Manhattan has the highest level of HIV infection and AIDS in NYC. The city government needs to focus its AIDS testing and prevention resources on Manhattan with at least as much commitment as it is demonstrating in the Bronx. The article below from the New York Daily News mentions Manhattan's needs in describing the NYC choice to begin its mass testing efforts in the Bronx. http://www.nydailynews.com/ny_local/bronx/2008/06/25/2008-06-25_aids_tests_for_500000_in_bronx.html

A 2004 report from the NYC Department of Health showed that Manhattan had 50% more AIDS cases than the Bronx and that Manhattan had far more individuals living with AIDS than any other Borough. Here is a link to that report. http://www.nyc.gov/html/doh/downloads/pdf/dires/epi-surveillance-manhattan200406.pdf

2) In late July 2008, CNN focused on the Alarming rates of AIDS in the African American community and the lack of commitment by the US Federal Government to prevention efforts in the United States. The US spends billions on AIDS prevention overseas but less than one billion dollars each year on domestic prevention. http://www.cnn.com/2008/HEALTH/conditions/07/29/black.aids.report/index.html

3) In Early August 2008, the Center for Disease Control announced that there were 40% more HIV positive individuals in the US than the CDC had previously believed. It is urgent that all in Manhattanites know their status and take steps to avoid the spread of HIV and AIDS. If the national numbers are 40% higher than previously believed, the Manhattan numbers might very well represent an even greater undercount. While we hope that Manhattan's numbers turn out to be more accurate than the CDC's national numbers of HIV infected individuals, only a strong testing regime will allow us to be certain. http://www.cnn.com/2008/HEALTH/conditions/08/02/hiv.cdc/index.html

4) Before the new, alarming CDC numbers came out, I attended, in late July 2008, a private event sponsored by the National Black Leadership Commission on AIDS (NBLCA - pronounced en-BLAK-uh or simply BLAK-uh). Its leader is the former Borough President of Manhattan, C. Virginia Fields, a dynamic and impressive leader who is certain to continue to groundbreaking fight against AIDS started by my mother-in-law, Debra Fraser Howze when she founded NBLCA more than 20 years ago. At the event, a group of young professionals from all over the NYC area were educated about the continued spread of AIDS amongst African Americans in NYC and throughout the US. NY State is the state in the US with the largest number of African Americans with AIDS, and the numbers continue to increase. Many of the other stats were astonishing even to those of us who have been associated with the AIDS fight for years. Below, and at http://www.nblca.org/aidsInfo_more.html is a sampling of these stats:

HIV/AIDS in 2005

• According to the 2000 census, blacks make up approximately 13% of the US population.
• However, in 2005, blacks accounted for 18,121 (49%) of the estimated 37,331 new HIV/AIDS diagnoses in the 33 states with long-term, confidential name-based HIV reporting.
• Of all black men living with HIV/AIDS, the primary transmission category was sexual contact with other men, followed by injection drug use and high-risk heterosexual contact.
• Of all black women living with HIV/AIDS, the primary transmission category was high-risk heterosexual contact, followed by injection drug use.
• Of the estimated 141 infants perinatally infected with HIV, 91 (65%) were black (CDC, HIV/AIDS Reporting System, unpublished data, December 2006).
• Of the estimated 18,849 people under the age of 25 whose diagnosis of HIV/AIDS was made during 2001–2004 in the 33 states with HIV reporting, 11,554 (61%) were black.
• Of persons whose diagnosis of AIDS had been made during 1997–2004, a smaller proportion of blacks (66%) were alive after 9 years compared with American Indians and Alaska Natives (67%), Hispanics (74%), whites (75%), and Asians and Pacific Islanders (81%).

AIDS in 2005

• Blacks accounted for 20,187 (50%) of the estimated 40,608 AIDS cases diagnosed in the 50 states and the District of Columbia.
• The rate of AIDS diagnoses for black adults and adolescents was 10 times the rate for whites and nearly 3 times the rate for Hispanics. The rate of AIDS diagnoses for black women was nearly 23 times the rate for white women. The rate of AIDS diagnoses for black men was 8 times the rate for white men.
• The 185,988 blacks living with AIDS in the 50 states and the District of Columbia accounted for 44% of the 421,873 people in those areas living with AIDS. Of the 68 US children (younger than 13 years of age) who had a new AIDS diagnosis, 46 were black.
• Since the beginning of the epidemic, blacks have accounted for 397,548 (42%) of the estimated 952,629 AIDS cases diagnosed in the 50 states and the District of Columbia.
• From the beginning of the epidemic through December 2005, an estimated 211,559 blacks with AIDS died.
• African-Americans have the highest AIDS case rate per 100,000 population of all ethnic/racial groups-66.4 per 100,000 population compared with 8.2 for whites. African-American males have an AIDS case rate of 125.2, over seven times the rate for white males who have a rate of 17.8 per 100,000 population. African-American women have an AIDS case rate of 49.8, over 20 times the rate for white women who have a rate of 2.4 per 100,000 population.