Liam Scheff. E-mail : email@example.com
In May 2003, I began my investigation of the Incarnation Children’s Center (ICC), an orphanage in New York City’s Washington Heights that was being used by government (N.I.H.) and pharmaceutical companies as a test center for the standard AIDS drugs – AZT and its analogues, Nevirapine, and the various protease inhibitors. ICC received funding from both government and corporate sponsors to enroll its wards, primarily abandoned children of drug (crack cocaine and heroin) abusers, in NIH clinical trials(1).
What follows in this series are five excerpts of my October, 2003 interview with ICC’s medical director Dr. Katherine Painter. In the interview, Dr. Painter provides information about:
1. Who gets into ICC and why.
2. The backdoor through which ICC’s wards were used in government/pharma-sponsored Clinical Trials.
3. The measures taken to enforce ‘adherence’ to the drug regimen.
4. And a hint of the toxicity of the drugs (ie. their ability to “suppress” bone marrow and cause anemia).
On a personal note, I found it very uncomfortable to talk with the doctor, and to listen to her, as she seemed totally removed from what she was saying; dissociated, in a real sense; inured against the horror of what she was describing, of what she was participating in. Three and a half years later, I still find it almost impossible listen to.
Here Dr. Painter describes the role of ICC, as a referral foster home for children being treated hospitals in the major metropolitan area. She explains her role as the primary physician at ICC, and also hints at the primary reason that children are remanded to ICC – failure to adhere to the drug regimen.
Listen to Primary Care Physician
LS: ICC works as kind of like a magnet for, now, you said this last time, there are about 5 or 6 hospitals, you said [Columbia] Presbyterian, and…
Dr. Painter: Oh there are… yeah, five is probably an underestimate, there are a number, you know, NYC has a large number both of adult and pediatric HIV cases, as do many of the urban centers northeast coast.
LS: So you take people from Columbia Presbyterian…
Dr. Painter: We get referrals from any of the outpatient HIV clinics, and most of those in the 5 boroughs and some of the surrounding communities like Westchester or Long Island, for the most part are clinics that are set up within medical centers.
LS: And you’re, but you’re the primary care physician at ICC
Dr. Painter: Yes, Medically, legally at any nursing home, when a patient is admitted to a nursing home, the attending physician at the nursing home is their, um, is their physician for treatment and medical decision making advice – and um…
LS: And that’s you.
Dr. Painter: And the patient can continue to be involved with other physicians, and care providers technically, consultatively, the reality of that is that, because our, you know, mission, our, work really is very different than what a geriatric nursing home – is set up to do and of course the regs and the setup and the history of nursing homes, largely, reflects the overwhelming predominance of geriatric nursing home needs but because what we’re doing is hoping…
You know, Very few children infected with HIV or with Aids, um, need to spend the rest of their lives in a nursing home, um, in that our work, our interventions are designed to be intensive, but over a short to moderate term.
So that the child, um when they’re medically stabilized, um or able to adhere to medications, with the involvement and support of their caregiver, can return um, to their home or a home if they’re in foster care.
So That means that we continue to work very closely and maintain ongoing relationships and medical visits of the patients with the clinics that refer to us.
Here Dr. Painter explains the backdoor through which ICC’s population is entered into drug trials. Even though ICC wasn’t listed as an NIH recipient as of 2002, their wards were able to be used in government/pharmaceutical drug trials.
The children in ICC got to the orphanage through referrals from the major hospitals in the New York Metropolitan Area (Columbia Presbyterian, St. Mary’s, SUNY, Roosevelt, etc.), and so it is at these hospitals that the children are enrolled in drug studies. The study drugs are then maintained and enforced at the ICC, by their medical and nursing staff.
When I began investigating the ICC, I found 27 studied listed at the government clinical trial database (2) with about 7 or 8 listed as “currently recruiting.” (3, 4) That number dropped after media coverage increased following my first expose.
After the BBC film was released in Europe in late 2004 (5, 6), that number dropped further. I noted two studies “still recruiting” in early 2005. The page now lists no studies still recruiting specifically at the ICC.
As of January, 2006, the total number of studies specifically listing ICC as a participant stands at 36 (1), nine more than the 2003 listing. But but the backdoor use – enrolling children at Columbia Presbyterian, Harlem and neighboring hospitals, as described in the previous section – no doubt increases that number significantly.
Dr. Painter tended to view the inclusion of these orphans in government/pharma drug trials as a positive event, and used terms like “expanded-” and “progressive access programs” as euphamisms for “human drug trial,” or “experiments with extraordinarily toxic synthetic chemicals in abandoned drug orphans,” which I think more accurately describe the situation at ICC.
Listen to Clinical Trials
[bold emphasis added]
LS: When I was doing research, I found that the government’s clinical trial database lists these things going on, these trials with these new vaccines, and also a lot of different Aids drugs that have already been used, but in different combinations.
Dr. Painter: Right,
LS: And ICC is part of that, and [Columbia] ]Presbyterian is part of that. [clinical trial database]
Dr. Painter: Um, yes and no – we previously also had as part of ICC’s work, an outpatient , community-based, HIV focus or specialized clinic, um, when we were re-licensed, three years ago. [in 2000]
We started in ‘89 as a group foster home, providing enhanced medical care for HIV infected children, we started out as a group foster home under Catholic Home Bureau, which is a foster care agency under the Catholic Charities arm of the Archdiocese of NY.
In 2000, in July of 2000, we were re-licensed, um, under the Department of Health, so now out of the social services arm of the state, but as a article 28 skilled nursing facility or S.N.F.
Let’s see, so what was I saying. so in terms of treatments or research…So in terms of treatments and research access to clinical trials for any patients, adult or pediatric, is available through, um, a number of clinics and many clinics-based medical centers participate in the adult, um, let’s see, Aids…A – C – T -G…Aids Clinical Treatment Group, um, program, which develops, um, studies and investigates the clinical effectiveness and safety of new medicines.
And in children the corresponding arm is the – PACTG – or the Pediatric Aids Clinical Treatment Group, and again, many clinics that refer to us are participating in clinical trials programs.
So if a child is on a treatment protocol, they would undergo that monitoring, testing, protocol entry, supply of an experimental drug through um, their outpatient clinic – and we can um, maintain um, that treatment here.
So If a child is on an experimental drug, the um, clinic site, um, supplies the drug to the child, um, and their caregiver of course is the one who actually picks it up, either the nursing aid who accompanies them from a store or their parent or caregiver, and brings it back, picks it back to us if, if it’s not a drug that’s available through a pharmacy.
Currently the children who’ve been recently here who’ve been on newer therapies have been on T20 or Fuseon, and it’s now available through a progressive access program from a pharmacy, which is Hoffman Laroche – and previously until very recently was the children who were receiving it were in an um, expanded access, um, clinical protocol.
Up next: Part Two, in which Dr. Painter describes the importance of “adherence” to the drug regimen, and the lengths she and the ICC medical staff go to enforce it.