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 analogs, 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.
PRIMARY CARE PHYSICIAN
Here Dr. Painter describes the role of ICC, as a referral foster home for children being treated in 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.
Download a PDF of the Incarnation Children’s Center’s original website, circa 2003, 2004, announcing its studies with orphans.
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 studies 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 exposé.
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.
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 Fuzeon, and it’s now available through a progressive access program from a pharmacy, which is Hoffman La Roche – and previously until very recently was the children who were receiving it were in an um, expanded access, um, clinical protocol.
In this section, Dr. Painter explains that the growing cause for being in the orphanage is not illness, but refusal to take the various AIDS drugs.
Resistance to the drugs was strong in many children, because, according to the childcare workers, nurses and former ICC residents I interviewed from 2003 through 2005, (7 8 ) the drugs made many children immediately ill; severe nausea, vomiting and diarrhea were the predictable after-effects of ingesting the various chemicals.
Failure to take or enforce the drugs was and remains sufficient reason for the state to remove children from parental custody and remand them to the ICC, or to a foster home. This was not only the case with the mothers and guardians I have interviewed in New York, but also in Canada, California, and Europe.
Dr. Painter: I often say that what we’re asking of our patients and our families in our recommendation, um, for their regimens and their level of adherence is actually something that is beyond 100 percent – patients are being asked to take all of their medicines all the time, whether they have them on hand or have run out, whether the pharmacy has filled and delivered the script, whether the clinic has responded for a request for a refill promptly, whether the medicines make you sick, whether you’re at home or away, whether you’re ill with an inter-current illness.
For children, it’s additionally challenging because an adult or an older child or adolescent can make the decision to take medicines, um, based on, um, what they know about their diagnosis, what the medicines do, um, for children who are younger or children who are developmentally delayed, or children with mental health problems, um, that um, independent decision to adhere to medicines may not be possible and so then you’re, um, faced with a situation of a caregiver or parent needing, trying, being advised to give medications to a child who, he doesn’t know or is not able to appreciate why they need medicines, why they need to take it all the time, why they need to take it if it tastes bad or upsets their stomach, um, it can be difficult.
So, we are having an increasing number of, um referrals over the last, um, oh several years for, um, primarily for helping to assess and intervene with medication adherence difficulties that patients and families are experiencing.
For children really, you’re not really treating an individual patient – you’re treating the individual patient plus the, um, their family or, caregiver.
LS: How do you get people to adhere?
In this segment, Dr. Painter describes the chief problem of the drugs as their “significant, lingering bitter aftertaste.” This was clearly code for what was described to me by patients, nurses, child care workers as the daily and hourly vomiting, nausea and diarrhea, that occurred after taking the drugs. (This is the same description offered by many adult gay men who are on the drugs).
Dr. Painter clearly explains the processes of forcing ‘adherence’ in children who are reluctant, or unable, to swallow the medicines. The First “intervention,” as she called it, is an “N.G. Tube,” a tube inserted through the nose, and pushed down the throat into the stomach, through which the ground pills are given.
For continued refusal, a “G-Tube” is considered appropriate. In this, a child undergoes a surgery in which a tube is inserted through the abdominal wall directly into the stomach. From then on, the ground drugs are pushed, by syringe, into the stomach. “Do not refuse,” seems to be the message (9).
LS: I know that the medications are hard to take and I do know that they have loads of side effects, I think that’s kind of well established [slight laugh].
Dr. Painter: The issues that come up with kids with hard to take is sometimes the formulations; a young child can’t usually swallow, um, large pills. Many of the HIV medications, like protease inhibitors are actually large pill size…
Dr. Painter: …Horse pill size, and often multiple pills, um, so sometimes the formulations available for children who can’t swallow, um, pills or who can’t swallow larger pills are a liquid or a powder formulation and they, um, sometimes are not very palatable.
LS: hm. How do you get….how do you…
Dr. Painter: [Laughs] …for a medication called Ritonavir…uhm…
LS: …Ritonavir is…
Dr. Painter: …Ritonavir is a protease inhibitor, one of the first, um, available in a pediatric liquid formulation, uhm, it tastes very mediciney, um, and it has a significant, sort of bitter, lingering aftertaste, um, that persists.
People do a variety of things, um, Mixing it straight up with Hershey’s chocolate syrup or strawberry syrup, or um, placing it in some other palatable food, um, some children can, can with, um, you know, habit become used to and accepting of a medicine that’s not, um, so good tasting and others can’t.
For some, um, cases, it can be appropriate to consider if a child can’t tolerate, um, or can’t swallow, um, medicine, um, whether it would better administered, um, through a G-tube a gastrostomy tube.
So for some cases, for, um, younger children with more significant um, illness, um, that’s an appropriate, um intervention to help them comply with medication.
LS: Is that the nose one or the stomach one?
Dr. Painter: No, that’s the stomach one. An N.G. tube is a naso-gastric, it’s appropriate for short term interventions, um, but it has to be changed approximately weekly from one side of the nose to the other with a new tube to um, minimize the side effect of sinusitis infection, um, and um, it has to be checked each time you use it by listening as you push through the tube – that the air bubbles you’re hearing are in the stomach area, and not into the lung area, because it can become, um, displaced.
LS: Oh my…
Um, So that’s an appropriate short-term intervention. A G-tube is a from the outside skin through a small opening to the inside of the stomach.
LS: Now how does that…When I was looking at the brochure that I have, I know I saw that and I had to go ask, uh, and do some research and say ‘what’s this?’ How do…when are are kids, uh…when is it deemed that…
Dr. Painter: …it’s appropriate.
LS: Yeah, necessary or appropriate?
Dr. Painter: I think that when other interventions to help a child take a medicine by P.O. [parenteral orifice], or by mouth, have failed.
And it’s um, deemed important that a child be able to regularly adhere, receive a medication.
Very often, sometimes the needs for administering medications may, um, occur with the additional need to supplement the child’s nutrition – so some children, in addition to receiving med through a G-tube, receive supplemental formula feedings, through a G-tube if they have failure to thrive.
LS: How do you put in a tube?
Dr. Painter: How do you put in a tube…Well, you, um…a surgeon does that – and it’s fairly a well-tolerated and relatively simple surgical procedure.
A percutaneous endoscopic gastrostomy placement, or PEG, is a procedure, where, in the O.R. [operating room], under anesthesia, the surgeon, um, passes a endoscopy tube which allows them to visualize the inside of the stomach and, um, determine correct placement for the tube and then from the outside, um, while they’re visualizing the inside of the stomach, they, um, place the tube surgically…it’s a, a…generally well-tolerated procedure.
LS: So They cut through the stomach lining—or…?
Dr. Painter: Well, right, yeah, you’re actually cutting through the skin, through the abdominal wall musculature, and then through the um, stomach. It creates a very small hole, perhaps the size of, in diameter, a quarter inch. It takes several weeks to heal well, so it’s initially a bit tender.
But then a small tube is held in place through that stoma through that opening, and on the outside is basically the area where you can connect a syringe or a feeding tube, and when not in use can be closed.
Um, it only extends from the skin – I don’t know if you’ve had the opportunity to see, um, any – less than about a half and inch. It’s often – some typed of gastrostomy tubes are called buttons.
And then on the inside, On the other side of the tube is a device that holds it in place on the inside of the stomach, keeps it from coming out, um, through the stoma or the small hole between the outside and the inside of the body.
So…in some cases that’s a balloon, a small, it’s called a balloon, but um, part of the device on this inside is filled with sterile water to expand to a size that can’t be pulled back through the stoma to the outside.
LS: So, … uhh… you’ll forgive me.. I’m not a surgeon. it makes me a little grossed out but, um, uh, now so if a kids refusing to take, or won’t take or can’t take the medication, they might get one of these.
Dr. Painter: Mm hmm, in some cases.
[end of segment]
VIRAL LOAD, TCELLS AND AZT
In this section, Dr. Painter offers the justification for the practice of forced and surgical drugging. It is based on T-Cell and Viral Load counts, which Dr. Painter describes as based on an “evolving understanding.”
Dr. Painter at first deflects the idea that the primary drug used in Aids patients, AZT, is extremely toxic, but then states that one of the problems it causes is “bone marrow suppression.” That is, it destroys your blood-producing tissue (10).
In case of AZT toxicity, she suggests lowering the dose, or giving additional drugs to try to replace the missing neutrophils (protective white blood cells) and red bloods cells destroyed by the drug.
LS: Now some of the drugs given are the…what are the AZT type of drug, and some are the protease type of drug. Now I know from, you know, knowing lots of guys, adult gay men, who, um, that these are, you know, really fraught with risks, and they do have loads of really detrimental including fatal side effects.
Dr. Painter: …uuuuhhhmm…
LS: Well, I, this is just kind of clinically known, I mean…
Dr. Painter: Do I agree with that strong of a statement? I think you’ve probably overstated the case. I think, um, treatment criteria are continuing to evolve and we now understand, um, more and more, um, completely in adults and we’re, we’re um, evolving, um, with our understand in children of what level of virus and what uh, number of CD4 T-cells, um, merit treatment, and, um…
It’s for the current recommendations, um, and they vary betweenm um, particular, um, uh, groups that have made the recommendations, such as the, uhm, International Aids Society USA, uh, recommendations panel, or the Department of Health and Human Services or some internationally similar groups, for instance in Britain…
With some minor variations of a general criteria, for instance right now in adults is that if an adult, who is asymptomatic, okay, from their HIV infection, doing well clinically, um with a virus load that is at or below 55 thousand, and, uh, T-cells that are, uhm, at or above 200 to 350, and that’s where there is a little bit of difference in some of the recommendations, whether you choose the 200 or the 350 number, um…
For adults with lower viral load, and lower CD4 number, they um, may, not need…to initiate…treatment, um, and have continued monitoring of their health, their viral load and their CD4 number.
Because with um, advances in um, our understanding of HIV and treatment, um, it’s clear that a person’s risk of serious opportunistic um, disease, um, is, and their risk of progression to Aids-defining illness is determined by their viral load and their cd4 number, and uh, those seem to be the numbers at which we can balance the uh, need for treatment with, uh, avoiding, if treatment is not needed, uh, one, um, being on a medicine chronically, and two, the potential side-effects from medications.
Yes, any medicine has side-effects,
LS: Right, well, but…
Dr. Painter: In any clinical endeavor, the aim is to, um, determine the balance between the illness, um, and the very real risk, of the illness, if it progresses, and certainly Aids – HIV and Aids, untreated, is a terminal diagnosis. That needs to be remembered.
LS: Well, well…
Dr. Painter: And so, the, the side effects of the medicines, um, are increasingly, um, well-understood, and can be monitored and can be, um, either treated with changes in the medicine, addition of other medicines…
For instance, the bone marrow suppression that is sometimes seen, resulting in anemia or low white counts for patients on um, AZT, and that’s the older name, the new initials are ZDV for Zidovudine, uhm, one, can be monitored, by, um, CPV circulating plasma volume counts (11), every, oh few months, and if necessary, can sometimes the Zidovudine, can be continued, or perhaps at a reduced dose, or perhaps with, um, support of the bone marrow by a drug called G-CSF (12), which helps increase the neutrophil component of the white count, or in the case of anemia, um, Epogen (13, 14), which helps increase the red count.
[end of transcript]