Orphans used for experimental HIV drug tests.
April 3, 2004 10:59 PM   Subscribe

"Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.

"British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities." [link]
posted by The God Complex (13 comments total)
It's a win-win situation for GlaxoSmithKline: they get the hot research now and later in life these kids will need Paxil by the bucket to cope with their problems.

Clever, these corporations!
posted by xmutex at 11:26 PM on April 3, 2004

well, it looks like they followed all the laws, got consent, and passed the bar for human experiementation, which is very high. So, some orphans with hiv and no insurance are getting free drugs. It kinda sounds bad, since they're orphans, but how many babies with hiv aren't bad off in some other way? and if you're looking for babies with hiv why not go where they are concentrated?

Having said that, we of course don't have nearly all the facts, but just because some trial is being run on a high-risk population doesn't mean the company is evil, just that they are going where the problem is most common.
posted by rhyax at 12:14 AM on April 4, 2004

Far worse things have been done in the name of science, and after all, the article says that the New York can give the equivalent of parental consent for the orphans. I'd hardly call it a scandal -- unless you believe that infants should never ever be given experimental treatment. Even then, I'd ask you to consider the potential positive effects on them as well as for humanity (ie. cost-benefit analysis).
posted by reklaw at 3:21 AM on April 4, 2004

Interesting link, thanks dude.

So let's put's the dots on the i shall we

1) babies were born HIV infected

2) therefore they were doomed to die anyway..or were they ? NY knew exactly what their living chances were or they just runned a statistical estimation ? And if so, on which data is it based ?

Let's _assume_ they were to live at best 3 years..now one may argue that, given that short of chance, giving them experimental HIV drugs was done

1) in their best interest, to slow down HIV and buy them some time (but were the drugs designed to do so ?)
2) in interest of other infected kids that are still not born
3) in interest of Glaxo

or a combination of above interests.

So far "so good" (maybe NOT so good) ...because maybe there was a chance to give the kids a chance to live longer and better ..but..

One involved giving children as young as four a high-dosage cocktail of seven drugs at one time. Another looked at the reaction in six-month-old babies to a double dose of measles vaccine

Measles vaccine ? Double time the dose ?!! Would you administer a double time dose of a vaccine to to a patient whose body is already fighting against HIV , which btw directly attack the defences of body AGAINST infections ?

If these allegations of double time doses of vaccine et al are true, I suspect the kids were done some serious wrong and were indeed considered as "expendable human guinea pigs". I would like to hear from some Mefi immunologist if any.

(If so, and if Glaxo is involved, I'd consider forcing _dissolution of Glaxo_ to send the shareholders a clear message)

On preview: reklaw pay attention to cost-benefit analysis: while it's reasonable and easy to talk about cost-benefit analysis when at worst any error in the analysis involves only money, is it always that easy to do that analysis in term of human lifes ? If somebody is to risk life or to lose life (paying cost) for the benefit of many..would you donate yourself for the process ?
posted by elpapacito at 8:16 AM on April 4, 2004

while it's reasonable and easy to talk about cost-benefit analysis when at worst any error in the analysis involves only money, is it always that easy to do that analysis in term of human lifes ?

Maybe I'm just too used to psychology's way of looking at things, but I've seen the cost-benefit analysis used to justify everything from stressing people out intensely (Milgram's experiment making people believe they were responsible for the death of a person) to giving electric shocks to primates (the executive monkey), because of the long-term benefits the experiments held for science and humanity. I can see, though, that this is hardly on the same scale. The idea of deliberately infecting the infants with diseases is rather repulsive.

In the end, I think it's basically a philosophical question: would you kill one thousand people to save ten thousand? What if you were only killing ten to save a million? If we're all happy with abortion around here (myself included), what's wrong with experimenting on a few infants occasionally for the greater good? Is it somehow more wrong because a corporation is doing it?
posted by reklaw at 8:47 AM on April 4, 2004

There are proven treatments for infants, and these babies were not condemned to an early death at all: Even a single nevirapine dose to the baby if given within 24 hours of birth may prevent infection from taking hold. Antiretroviral therapy can reduce the newborn infection rate from as much as 50 percent to less than 8 percent (what happens next is a different problem: See HIV & Breastfeeding in this issue). --from GMHC (they wouldn't have been breastfed, since they were orphaned)

and: Almost all HIV-infected children acquire the virus from their mothers before or during birth or through breast-feeding. In the United States, approximately 25 percent of pregnant HIV-infected women not receiving AZT therapy have passed on the virus to their babies. from the NIH (so only 25% of infected women pass it on to their infants, meaning that 75% of those babies might not have had it at all!!!)

And: HIV infection is often difficult to diagnose in very young children. Infected babies, especially in the first few months of life, often appear normal and may exhibit no telltale signs that would allow a definitive diagnosis of HIV infection. Moreover, all children born to infected mothers have antibodies to HIV, made by the mother's immune system, that cross the placenta to the baby's bloodstream before birth and persist for up to 18 months. Because these maternal antibodies reflect the mother's but not the infant's infection status, the test is not useful in newborns or young infants.
In recent years, investigators have demonstrated the utility of highly accurate blood tests in diagnosing HIV infection in children 6 months of age and younger. One laboratory technique called polymerase chain reaction (PCR) can detect minute quantities of the virus in an infant's blood. Another procedure allows physicians to culture a sample of an infant's blood and test it for the presence of HIV.
Currently, PCR assays or HIV culture techniques can identify at birth about one-third of infants who are truly HIV-infected. With these techniques, approximately 90 percent of HIV-infected infants are identifiable by 2 months of age, and 95 percent by 3 months of age.
-- also from that same NIH page. (Were these babies given the best and continuing tests, or was it just because they were born to infected mothers, and in a public facility without the best care, that Glaxo and Columbia assumed they'd be good guinea pigs???)

And, finally, from that same NIH page: Researchers have observed two general patterns of illness in HIV-infected children. About 20 percent of children develop serious disease in the first year of life; most of these children die by age 4 years.
The remaining 80 percent of infected children have a slower rate of disease progression, many not developing the most serious symptoms of AIDS until school entry or even adolescence.

So, only 20% of those infants were in serious danger! WTF were Glaxo and Columbia thinking!?! Infants can't give consent, and there are therapies and regimens that help them already! (And that article doesn't say how many of them died from the experiments--a really important point--these were not already-doomed babies, for the most part!!!)

Sorry for the length, but this is horrific--just horrific.
posted by amberglow at 9:04 AM on April 4, 2004

I don't agree that it is a philosophical question about killing one to save many, human experimentation should not be done with the good of others as the sole reason. It should be done with the consent of the one receiving the treatment, or their parents, or I'm willing to say their guardians, for their benefit, and secondarily for the benefit of the rest of the population.

Human experimentation is a complex ethical situation, and I think should only be done when it benefits the recipient. Institutional Review Boards are an important step (and a legally mandated one) in protocol design, and education on the part of the subject or their guardians. I don't want what I'm saying to be construed as advocating a good-of-the-many approach to human experimentation, but at the same time I do think drug trials are very important, and people getting in on them can in many cases save their lives. Is that the case here? I really can't say, there are some questionable aspects to this, but based on this very limited window into what was going on I'm not willing to condemn it. I do hope the city looks into it further though.

The sentence about the measles vaccine is troubling, I am not an immunologist, but a nearby field, and have had a pretty good amount of immunology. There is of course no good reason to give anyone with hiv and on multi-drug therapy a double-dose of the vaccination, but based on those two sentences you can't really tell if the kids that got the measles vaccination are the same as the ones with hiv, or really who they are at all. It is exceptionally vague, why would GSK care about double-dosing measles vaccinations? Is this part of the same drug trial? because it certainly doesn't seem like it. This one sentence doesn't seem to connect with the rest of the article, and I'm not willing to condemn them based on this reporters unwillingness to make any sort of scientific sense of what they're doing.

on preview: amber, i seriously hope and assume none of them died from the experiments. Any deaths in this situation that were a result of the experimentation would be completely unacceptable ethically, as there are treatments that are fairly certain not to cause death. If they followed normal procedures for the trials though there should be very little risk of death. If there were deaths however of course something is seriously wrong.
posted by rhyax at 9:36 AM on April 4, 2004

But we don't know any of that, and if the drugs tested are anything like the drugs trialed for adults with HIV, then some did die.

Even the approved drugs for treatment that people take now are very toxic. And infants born to HIV+ mothers, and orphaned, already tend to have health issues to begin with, and are not as robust as other infants.

(There are aids educators here as members--I hope they chime in with more info)
posted by amberglow at 9:44 AM on April 4, 2004

amberglow : sorry for the length ? It was good, more more !

reklaw: basically you're asking if the purpose justifies the means if I got you right ; specifically if a mean that can be judged as negative(undesiderable) justifies a purpose that can be judged as positive(desiderable).

Well I guess that, if somebody is going to carry the burden of the bad mean (death or whatever he judges negative) he and only he can be the judge and tell us if he thinks or believes that it is OK for him/her to carry the burden, because he judges the purpose as positive and outweighting the negative.

But anybody else can't be the judge, neither the one who's going to benefit from the sacrifice because he's likely to be biased , neither somebody not involved at all in the process.

In a snap: if you don't carry the burden you can judge as much as you want, but you can't decide for somebody else or have any decision power on the process.

And when it comes to kids, we notice that human infants cannot survive long without parent help, because of the complexity and risks coming from the environment in which we live and because the kid doesn't know how to sustain himself. Parents basically feed and protect the kid from risks he doesn't know how to handle and eventually take some risk for the kid if they believe he can't even evaluate the risk ; and they must carry the burden of decision and eventual consequences.

NY eventually took the risks for the kids and must therefore carry the burden of errors and misjudgement they may have made ; and when I say NY I mean the people who actually decided for NY, human beings responsible of their actions. Void of responsability , I guess, is unacceptable in this case.
posted by elpapacito at 9:53 AM on April 4, 2004

The article does look a bit inflammatory. All drug studies are done to "test the toxicity" etc. All that means is, did the benefits of the drug outweigh the harms. Most children's drug regimes are based on studies on adults, which is clearly a bad idea. Therefore, more and more drug studies are being carried out on children, not secretly, but at the express order of the government and FDA. And I doubt there is a need to "demand" disclosure of the experiments- with several public agencies involved the current open-records laws should take care of that.

The ethical analysis above suggests that it is clearly more ethically concerning to do a study in a care home than with children brought in by their own parents. However, a study in a care facility would involve caretakers who are aware of the importance of the research and likely to follow instructions exactly, so that an accurate comparison between treatments can be reached. Better accuracy means better treatment in the future for everyone (increased good). I would also expect that the nuns would have an observational knowledge of effectiveness of particular treatments and so would perhaps be better situated to evaluate the ethics of a particular study than a random parent off the street would. They may also be less susceptible to financial incentives (parents will sometimes turn their children over for just about any experiment in exchange for $300). Of course they may also have institutional financial concerns, so that concern may just be a wash.

The risk analysis posted above are suggesting that the studies were comparing a treatment against no treatment, therefore leading to risk of death or long term harm. But the studies may well have been comparing one treatment against another treatment. It is possible that both treatments have been standard care for a long time and that neither have ever been studied for actual effectiveness in children.

The medical analysis posted above assumes that the double measles vaccine was a bad idea. I don't know anything about the particular theory behind that, but vaccines can cause a strengthening of the immune system more broad than the particular pathogen that the vaccine was aiming for.

What it really looks like is that more information is needed. Is the reporter going to do the work to follow through on the risk and effectiveness, legal and medical considerations and write an article that gives actual information? Or just drop the scare story and run? I'll make my assumption about reporters' ethics and the general poor quality of journalism and guess the latter.
posted by loafingcactus at 11:52 AM on April 4, 2004

cactus: Yeah I agree on the fact some journalist ethic can go as far as "report only if you don't get sued the hell out by some special interest"

..but at times journalist can also be "gently introduced" to the concept of "if my journal gets sued because of your article, you lose your job AND be damned in the journalist community as well and maybe I'll sue you for breach of some weird rule in the contract".

God bless the whistleblower anonymous insiders, I guess.

On pure curiosity by me: how does the immune system become better if I introduce , for instance, only the vaccine to a disease ? What generates the "general improvement" that makes the system better against anything and not only about the specific disease targeted by the vaccine ?
posted by elpapacito at 12:49 PM on April 4, 2004

I'm certain that I've seen theories of vaccinations increasing general immunity. Oh my, now can I support it...

On today's Google hunt I've found the following of relevance:
-An CNN article about a combination malaria-small pox vaccination giving better immunity against malaria than the malaria vaccine alone. The article mentions that this may have applications in an AIDS vaccine.
-Mary articles about children with AIDS being particularly susceptible to measles.
-This abstract about a theory of using a double-dose measles vaccine in children who are susceptible to getting measles before 9 months of age. Winner: "Aaby et al. also suggest that standard-titre vaccines reduce overall mortality by general immunostimulation." Loser: And the double-dose measles vaccine may mess that up.
-Many articles (such as this) about a combination measles-AIDS vaccine theory and about using the response to the measles vaccine to predict a response to the AIDS vaccine.
-It appears that this is also provoking conspiracy theories about an intention to infect children with AIDS using the world-wide measles vaccination program.

I didn't find what I was looking for, which was a current agricultural application that I really thought existed. I even called my Mom-the-cattle-baron and she told me she'd never heard of such a thing.
posted by loafingcactus at 2:17 PM on April 4, 2004

It is hard to tell from the article, but I think the reason for the measles vaccine study is that HIV-infected children do not generate antibodies to measles as effectively as uninfected children (Brunell et al 1995 abstract). Then it is of interest to see if extra doses of the vaccine can compensate and allow HIV positive children to have the full protection of the vaccine (Moss et al 2003 full text pdf has a review about vaccines in HIV positive children; see pages 4-5 about measles virus). On preview, this is somewhat redundant to what loafingcactus said.

As for this article as a whole, it would appear that the NIH gave clearance for these studies (as they funded the majority of them), so the real burden of ethics should be the researchers themselves as well as the ethics committees of the NIH (see here). I doubt the drug company would have given any money if there was not clearance to do the research. The majority of these studies were done by this NIH-funded group called the US Aids Clinical Trial Group without funding from GlaxoSmithKline. If there is any wrongdoing (which I am in no position to judge) then why are there not serious questions being asked about the breach of U.S. ethical guidelines by the researchers as well as the NIH? I suspect there were not any, and that this story (especially the role of the drug company) is being sensationalized.
posted by jjray at 2:30 PM on April 4, 2004

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