AIDS Drug Trial report–Slipshod Journalism– NY Times
Sat, 23 Jul 2005
Please join our effort to tweak the New York Times to practice what their banner states: “All the News that’s fit to print” That surely means fair and balanced reporting about contentious issues that pit the weak and vulnerable against the powerful. —
Perhaps some of you will take the time to send your comments to the New York Times– It just might help bring about much needed change–
(copies of your comments would be appreciated)
Byron Calame (email@example.com); firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com; firstname.lastname@example.org; email@example.com
Contact: Vera Hassner Sharav
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
New York Times
Re: “Belated Charge Ignites Furor Over AIDS Drug Trial” (alternate title, “Reports on AIDS Tests on Foster Children Lead to Charges of Racism”), by Janny Scott and Leslie Kaufman Sunday, July 17, front page. http://www.nytimes.com/2005/07/17/nyregion/17trials.html
This article unfairly casts doubt on the motives and credibility of everyone who criticizes the morality of setting aside federal regulatory safeguards that restrict the enrollment of children in foster care – legal wards of the state or municipal government–in medical experiments. The article appears to be a slipshod effort to vindicate the New York City Administration of Children Services (ACS) and the medical institutions that approved the enrollment of foster children in experimental, phase I and II, AIDS drug and vaccine trials. Such trials are NOT designed to offer a potential direct benefit to the subjects who incur therein the highest level of risks. Federal regulations restrict the enrollment of foster children in any experiments involving greater than minimal risk to protect them from harm and exploitation (45 CFR 46.409).
When it is deemed necessary to include foster care children in research involving greater than minimal risk, Federal regulations require that the institutions who conduct such trials must provide each child with an independent advocate to “act in the best interests of the childŠfor the duration of the child’s participation in the research.” (45 CFR 46.409(b))
A complaint citing evidence of institutional failure to comply with federal research safeguards was filed by me on behalf of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) on March 10, 2003 with the Food and Drug Administration and the federal Office of Human Research Protections (OHRP) prompting investigations by both agencies. (See: https://www.ahrp.org/ahrpspeaks/HIVkids0304.php)
The complaint identified the regulatory restrictions, citing a series of Phase I and II drug and vaccine experiments in which foster children were subjected to risk, pain and discomfort. The facts that have been uncovered thus far – primarily by an Associated Press investigation – have validated our concerns and corroborated the information that we disseminated about the trials and the enrollment of foster care children.
The Associated Press reported that the experiments:
(1) “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.”
(2) “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.”
(3) “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.”
(4)”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.”
(5) In the dapsone study, “overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained.”
See: “Researchers Tested AIDS Drugs on Children” https://www.ahrp.org/infomail/05/05/04.php
AP’s investigative reporter, John Solomon, confronted ACS with his finding that 465 children in New York City’s foster care program had been enrolled in AIDS drug and vaccine tests – not 89, as ACS had maintained. Only then did ACS revise its claim, acknowledging that 465 children had been enrolled in the trials.
Solomon’s investigation further uncovered evidence that New York City “could find records showing 142 – less than one-third – of the 465 foster children in AIDS drug trials” received “independent advocates to monitor their well-being even though city policy required them.” Furthermore, Solomon found that these trials had been conducted in at least seven states – elevating the issue to one of national proportion.
A preliminary letter of findings by OHRP (May 23) further validated our concerns about the failure of the research centers involved to provide an independent advocate – as required under federal regulations. On June 16, AP reported:
“OHRP’s ruling is the first that federal research involving AIDS drugs and foster children violated federal protections. It was prompted by a complaint filed last year by the Alliance for Human Research Protection, an advocacy group in New York which raised concerns about a New York Post story documenting AIDS drug testing at a Catholic charity foster home in the city.”
“Columbia University Presbyterian Medical Center in New York, where several foster children were enrolled in drug studies in the 1990s, failed to obtain and evaluate whether it had proper consent, information and safeguards for the foster kids.” See: http://www.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf
Scott and Kaufman failed to report the findings of Solomon’s investigative AP report or to cite it. Neither do they cite a single physician or ethicist who has criticized the experiments – as any balanced and fair news report should. The AP cited Arthur Caplan, Director of the Center for Bioethics, University of Pennsylvania, who 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.”
Instead, of examining the facts and the moral issues, Scott and Kaufman methodically attempted to discredit all of the various critics. The Times story served to lend the appearance of legitimacy to the self-serving claims made by those who broke the rules, who denied foster children the protection of an independent advocate. The ACS attorney who approved and was in charge of the project is quoted stating: “the agency had acted slowly and carefully, aware o the need to protect a particularly vulnerable population.”
The unsubstantiated claims of the physicians involved in the experiments are transcribed as if they were Gospel: “They say hundreds, perhaps thousands, of children benefited; many of those were children not in foster careŠBecause of what we did, we were able to keep them aliveŠ” The Times article promotes the false claim that these foster children were receiving “lifesaving” treatments, when many were, in fact used to test experimental phase I and phase II drugs and vaccines. Contrary to the evidence uncovered by the AP, that children died in the experiments, the Times relied on hearsay: “Numerous doctors interviewed said they knew of no foster child who died as a result of the trials.”
A comparison between the solid journalism of the AP reports with the Scott / Kaufman article reveals shoddy, biased reporting by the latter.
It is particularly galling that the reporters, Scott and Kaufman, who approached me as a credible source of information and availed themselves of my expertise and guidance when they were assembling information about a subject with which they were entirely unfamiliar, should slant the report in an effort to discredit the information I provided – even as it has been borne out by independent investigations. They have attempted to marginalize me and to undermine my credibility for speaking truth to power.
Not only did I provide these reporters with information and contacts, but I literally had to instruct Janny Scott how to access and download documents from a government website (www.clinicaltrials.gov) containing the bare-bones information about the trials. Scott called numerous times to say she was unable to access the 36 trials that I had downloaded, suggesting that she come to my home to compare our disparate retrievals. She contacted me while I was traveling to help sort out how to proceed. When I alerted her about the OHRP letter of findings, she called to ask, “what does the letter mean?” Evidently, neither Scott nor Kaufman have had experience in deciphering linguistic soft-peddling by government agency bureaucrats when a powerful institution is found to have been non-compliant with regulations. Their NYT article refers to the OHRP letter as having been issued in June when it was, in fact, dated May 23.
This is an egregious example of journalists acting as public relations spokespersons in the attempt to deflect and whitewash transgressions by powerful institutions – government and academic. The article both failed to reveal the damaging evidence and to address the moral issues involved by casting aspersions on the handful of critics. For Scott to try to cast doubt on my credibility and to trivialize my professional services – which are used to assess and disseminate credible information about medical research abuses and conflicts of interest – is dishonest and a likely breach of journalism ethics. I am a law librarian by profession.
The following public policy questions were not addressed by the Times article:
1. Do local government agencies, medical centers, and physicians have the right to facilitate research by overriding federal safety requirements that were enacted for the protection of disadvantaged, vulnerable children who are wards of the state?
2. Are disadvantaged minority children in foster care entitled to the protections specified in federal regulations or are they fair game for enrollment in high risk drug trials whenever researchers are hard-pressed to fill a need for human subjects?
3. What prevented the institutions conducting the AIDS drug and vaccine trials from complying with federal regulations by appointing an independent advocate?
4. Did the interest of the research collide with the best interests of the children?
If these reporters are up to doing careful homework, they will find clues to answer these questions as set forth by the principles of the Nuremburg Code (www.cirp.org/library/ethics/nuremberg) and the Declaration of Helsinki of the World Medical Association (www.cirp.org/library/ethics/helsinki). One would hope and pray that the moral values of NYT reporters and editors place a priority on protecting vulnerable children from those in positions of power and influence who would take liberties with their best interests.
If the Times cannot be relied upon to present a fair report relating to legitimate criticism about the conduct of medical research which put vulnerable, non-consenting human beings at high risk of injury or death, it will certainly lead the largely African-American population whose children were affected to conclude that the Times reflects an elitist culture.
The grossly inadequate, biased report about a case that is reverberating on both sides of the Atlantic requires immediate correction. The issues addressed require reporting that is wise and sensitive to a people whose often devalued existence has historically led to their use as guinea pigs in risky medical experiments going back at least to the infamous Tuskegee syphilis experiment and continuing to this day to EPA sanctioned lead-poisoning and pesticide experiments. Should not the Times seek accountability for public decisions that affect the life safety of vulnerable minority children?
Vera Hassner Sharav
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
New York City
cc: Victor Navasky and Michael Hoyt, Columbia Journalism Review