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Old 05-04-2005, 08:34 PM   #1 (permalink)
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Human Guinea Pigs: Government-funded researchers tested AIDS drugs on foster children

This appears to be a practice that violated the rights of children and amounted to state approved child abuse and manslaughter. If children were not appointed independent advocates to look after their individual interests, as mandated by federal law and the law in some states, is this practice that different from the research that Nazi Germany performed on children in the 1940's?
Quote:
http://www.washingtonpost.com/wp-dyn...401403_pf.html

Researchers Tested Drugs on Foster Kids

By JOHN SOLOMON
The Associated Press
Wednesday, May 4, 2005; 10:07 PM

WASHINGTON -- Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.

The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren't yet available in the marketplace.

The practice ensured that foster children _ mostly poor or minority _ received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also 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.

The research was conducted in at least seven states _ Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas _ and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records.

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.

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.

The government provided special protections for child wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in a narrow class of studies that involved greater than minimal risk and lacked the promise of direct benefit. Some foster agencies required the protection regardless of risks and benefits.

Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and "act in the best interests of the child" for the entirety of the research, the law states.

However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren't given such advocates even though research institutions many times promised to do so to gain access to the children.

Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors even though researchers signed a document guaranteeing "the appointment of an advocate for each individual ward participating in the respective medical research."

New York City could find records showing 142 _ less than a third _ of the 465 foster children in AIDS drug trials got such monitors even though city policy required them. The city has asked an outside firm to investigate.

Likewise, research facilities including Chicago's Children's Memorial Hospital and Johns Hopkins University in Baltimore said they concluded they didn't provide advocates for foster kids.

Some states declined to participate in medical experiments. Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge's order. And Wisconsin "has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system," spokeswoman Stephanie Marquis said.

Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today.

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.

Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults.

"Our position is that advocates weren't needed," said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.

If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities.

Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT _ an effective AIDS treatment _ for children.

Arthur Caplan, head of medical ethics at the University of Pennsylvania, 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.

"When you have the most vulnerable subjects imaginable _ kids without parents _ you really do have to come in with someone independent, who doesn't have a dog in this fight," he said.

Those who made the decisions say the research gave foster kids access to drugs they otherwise couldn't get. And they say they protected the children's interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves.

"I understand the ethical dilemma surrounding the introduction of foster children into trials," said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. He enrolled some Texas foster kids in his studies, and doesn't recall appointing advocates for them.

"To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time," he said. "From an ethical perspective, I never thought that was a stand I could take."

Illinois officials directly credit the decision to enroll HIV-positive foster kids with bringing about a decline in deaths _ from 40 between 1989 and 1995 to only 19 since.

NIH, the government health research agency that funded the studies, did not track researchers to determine if they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site.

A recent Institute of Medicine study concluded those Institutional Review Boards (IRBs) were often overwhelmed, dominated by scientists and not focused enough on patient protections. An ethicist who served 22 years on such boards said they lack the resources to ensure the safety of foster children.

"Over the last half century, IRBs have basically broken under the strain of some of the structural changes in research," said Gregory E. Pence, a University of Alabama-Birmingham bioethicist.

The U.S. Office for Human Research Protections, created to protect research participants after the infamous Tuskegee syphilis studies on black men, is investigating the use of foster children in AIDS research. The office declined to discuss the probe.

NIH said it considers patient safety its top priority and awaits the outcome of the investigation. "If we find that patient protections need further strengthening, we will take action to do so," spokesman John Burklow said.

AP's review found that if children were old enough _ usually between 5 and 10 _ they also were educated about the risks and asked to consent. Sometimes, foster parents or biological parents were consulted; other times not.

"Our policy was to try and contact the (biological) parents because it was fairly common when we got done the foster kid would go back to the parents," said Dr. Ross McKinney, a pediatrics AIDS expert at Duke University.

Research and foster agencies declined to make foster parents or children in the drug trials available for interviews, or to provide information about individual drug dosages, side effects or deaths, citing medical privacy laws.

Other families who participated in the same drug trials told AP their children mostly benefited but parents needed to carefully monitor potential side effects. Foster children, they said, need the added protection of an independent advocate.

"I don't believe a foster care parent can do it," said Vinnie DiPoalo, a New Jersey woman whose 10-year-old adopted son has participated in three AIDS drug trials. "There are informed consents that have to be signed. There are follow-up blood appointments.

"I think that's the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time," she said.

Many studies that enlisted foster children involved early Phase I and Phase II research _ the riskiest _ to determine side effects and safe dosages so children could begin taking adult "cocktails," the powerful drug combinations that suppress AIDS but can cause bad reactions like rashes and organ damage.

Some of those drugs were approved ultimately for children, such as stavudine and zidovudine. Other medicines were not.

Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients.

Researchers reported some children had to be taken off the drug because of "serious toxicity," others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly.

At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn't appear to be "directly attributable" to dapsone but nonetheless were "disturbing."

"An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained," the researchers concluded.

Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions _ nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.

New York City officials defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities. Nonetheless, they are changing their policy so they no longer give blanket permission to enroll children in preapproved studies.

"We learned some things from our experience," said Elizabeth Roberts, assistant commissioner for child and family health at the Administration for Children's Services. "It is a more individualized review we will be conducting."

Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers.

"We talk about it. Then they come the next time. There is no rush," explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children.

Kline, the Texas researcher, added: "I never wanted a parent or guardian to ever say 'yes' simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family."
___

Researcher Rachel Landau in Washington and reporter Carla K. Johnson in Chicago contributed to this story. On the Net:

Documents associated with this story are available at:

http://wid.ap.org/inv/foster.html

National Institutes of Health: http://www.nih.gov
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Old 05-04-2005, 10:25 PM   #2 (permalink)
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I doubt that this is any different than Nazi Germany. Reading this does surprise me though. There's actually something out there that's so despicable that our wonderus government can take credit for. Lying about WMD's was bad, but human lab rats? Disgusting.

Of course, we all know what the ramifications will be from all of this. Nothing. This article will be the only thing you will ever hear of this issue. After that, it'll be swept under the rug. Courtesy of the six major corporations that control the media in this country that happen to support the current government.
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Old 05-05-2005, 06:25 AM   #3 (permalink)
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We have such a loving government.

"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."

Ya, I bet.
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Old 05-05-2005, 07:35 AM   #4 (permalink)
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Wow. This is so scary. What the hell is were they thinking?

And you know, I was born in Chicago's Children Memorial Hospital. I can't believe they would allow this to happen - it's a top-notch place.
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Old 05-05-2005, 07:37 AM   #5 (permalink)
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What's the big deal? Some poor kids gained access to some of the most cutting edge AIDS medicine available. If anything this should be praised.
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Old 05-05-2005, 08:14 AM   #6 (permalink)
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Don't be so quick to pull the Dr. Josef Mengele card. Let's take a rational look at this.
Quote:
The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren't yet available in the marketplace.

The practice ensured that foster children _ mostly poor or minority _ received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also 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.
So, foster care agencies sought treatment for HIV infected children, at a time when most, if not all, treatment was experimental? Hey, don't get me wrong. It sucks for sure. But, what else were they to do? To me, it sounds like a quintessential no win scenario. If they just did nothing, and just allowed the children to die of AIDS, then they are cold heartless bastards who just stood by and watched as children died. "Couldn't they have at least tried to do something?" But, actually do try to do something that may help, or not (who knows), and you are labeled as a succesors of the Angel of Death of Auschwitz.
Now, had they knowingly, and intentionaly, infected the kids with HIV, in order to conduct experiments...then I'd howl like a banshee. As it is, all I can do is look upon it as a huge shit sandwich.
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Old 05-05-2005, 08:26 AM   #7 (permalink)
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This touches close to home. I work in research integrity and this sort of thing should NEVER be happening anymore. And with places like Johns Hopkins implicated...this is going to be (and should be) a HUGE deal.
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Old 05-05-2005, 09:15 AM   #8 (permalink)
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Quote:
Originally Posted by Bill O'Rights
So, foster care agencies sought treatment for HIV infected children, at a time when most, if not all, treatment was experimental? Hey, don't get me wrong. It sucks for sure. But, what else were they to do? .
To me the problem is not that they tested, the problem is that they tested "often without providing them a basic protection afforded in federal law and required by some states"
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Old 05-05-2005, 11:04 AM   #9 (permalink)
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To test without asking permission or giving them a choice is no different from Nazi concentration camps.
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Old 05-05-2005, 11:53 PM   #10 (permalink)
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Quote:
Originally Posted by astrahl
To test without asking permission or giving them a choice is no different from Nazi concentration camps.

Except for the fact that these children weren't being forced to dig the graves of their fellow children that were just gassed. And they weren't having genocide commited against them. And they were being given medical treatment that was better than what many people could get in regular hospitals. So actually, it's nothing like concentration camps. Less hyperbole and more reality might be the way to go.
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Old 05-06-2005, 03:34 AM   #11 (permalink)
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Denying the person the CHOICE to participate in the research is what is at issue, not the surrounding environment.
This is my JOB.
I work to ensure that the rights of clinical research participants are protected and this is a gross violation of those rights.
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Old 05-06-2005, 09:02 AM   #12 (permalink)
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Quote:
Originally Posted by astrahl
Denying the person the CHOICE to participate in the research is what is at issue, not the surrounding environment.
This is my JOB.
I work to ensure that the rights of clinical research participants are protected and this is a gross violation of those rights.
IIRC, a child doesn't have the ability to make that choice anyway, at least according to laws.That choice falls on their legal guardian. And if they used foster kids, these children's guardian is the state, so the right to give or deny treatment would pass to the gov't.
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Old 05-06-2005, 09:28 AM   #13 (permalink)
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That is called a conflict of interest. If the government is sponsoring the testing, they cannot consent for people in their own care.
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Old 05-06-2005, 10:00 AM   #14 (permalink)
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"This appears to be a practice that violated the rights of children and amounted to state approved child abuse and manslaughter."

This appears to be an INCIDENT that violated...there, i feel better.

"If children were not appointed independent advocates to look after their individual interests, as mandated by federal law and the law in some states, is this INCIDENT that different from the research that Nazi Germany performed on children in the 1940's?"

It's not government mandated practice, as it was in Nazi Germany. At worst its individuals breaking the law, who are currently being investigated. At best it's individuals miscalculating risk-benefit ratio; therefore determining advocates weren't needed. (though the risk-benefit ratio and need for assent should have been determined by an independent IRB, not the participating sites).

The children in the 5-10 age range were informed of the risks and given their assent. No need to make it sound like the government took their cavalry, lassoed homeless children, and forced a drug down their throat. Laws are in place to protect research participants, occasionally mistakes are made, very occasionally laws are intentionally broken.

Astrahl, this is my job as well. I have a list of questions about the way this trial was run that the article did not address. Host, whether or not the US government research operates on a level comparable to Nazi Germany is not one of them. If your overzealousness to make this comparison weren't so routine, it'd be sickening.
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Old 05-06-2005, 10:26 AM   #15 (permalink)
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consent is not a technicality. sex, medicine, whatever. i don't much care that they were children, they still had the right to help make decisions about their medical care. if the state has custody, they have the obligation to act in the interest of the child, not the medical research establishment. experimental treatment, when it's the best hope, is certainly okay. but part of that bargain is that people know what they are signing up for, accept the risks, and consent to take a chance for the good of medicine, and possibly themselves.
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Old 05-06-2005, 10:37 AM   #16 (permalink)
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Quote:
Originally Posted by matthew330
........The children in the 5-10 age range were informed of the risks and given their assent. No need to make it sound like the government took their cavalry, lassoed homeless children, and forced a drug down their throat. Laws are in place to protect research participants, occasionally mistakes are made, very occasionally laws are intentionally broken.

Astrahl, this is my job as well. I have a list of questions about the way this trial was run that the article did not address. Host, whether or not the US government research operates on a level comparable to Nazi Germany is not one of them. If your overzealousness to make this comparison weren't so routine, it'd be sickening.
1.) One messenger shot.....(me)....thankyouverymuch!

2.) THe medical providers (experimenters) "informed" children in the 5-10 age range of risks, that included putting dangerous drugs into their bodies in doses not even approved for adults, who had themselves experienced organ damage or hastened deaths as a result. They put these drug or chemical cocktail doses into the bodies of children and infants and, instead of following a clear cut federal legal and ethical criteria, they explain that they "informed them".

3.) Even at some prestigious medical instituitions now, well after the fact, the defense given by spokespersons to the AP reporter is that these "providers" do not think that appointing independent guardians is required. Where is the assurance that this illegal abuse is not ongoing?

4.) The "investigations" are not being done by criminal investigators or prosecutors, when this is a question of child abuse, suspicion of manslaughter, and the opinions of medical ethics professionals that laws intended to protect the rights of children were broken.

5.) The article clearly states that some foster children, illegally unprotected by law mandated, independent guardians, were enrolled in the riskiest, phase I and pahse II trials. Your reaction is to personalize my comparison of Nazi medical experiment abuse on children with what is reported in this AP news expose. We will let the members here judge whether your remarks or mine are appropriate.
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Old 05-06-2005, 11:19 AM   #17 (permalink)
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1. No problem
2. Starting doses for phase 1 trials are determined by exhaustive, multiple pre-clinical trials.
"That included putting dangerous drugs into their bodies in doses not even approved for adults." This is a misleading statement. They didn't jump right in and feed them high doses of unapproved drugs and watched intently with their fingers crossed. DLT's - dose limiting toxicities. Once preclinical trials determine a safe starting dose, phase 1 trials escalate dosing in pre-defined stages (i.e. - no DLT's seen at this level in ? out of ? patients, move on to next). Once say, 3 DLT's are seen in 5 patients on one cohort, the maximum tolerated dose is determined to be the dose level prior to that. Yes phase 1 trials are risky, and no there are no guarantees. The problem doesn't appear (from the limited info in the article), the trial design, simply whether or not proper procedure was followed in enrolling vulnerable subjects (i.e. - minors). The problem is whether or not independent advocates were utilized or required.

It's as simple as that, and as far as i can tell this is not even a political argument. Your premature comparison of our govenment to Nazi germany is the only connection to this story and politics, i'm not personalizing anything - i'm addressing what is apparently your biggest concern in this matter. and trying to show why it is a completely misguided concern.
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Old 05-09-2005, 03:50 AM   #18 (permalink)
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I'm sorry if I offended your delicate sensibilities, but this is too much like the syphillis trials for me. They did something they KNEW was wrong.
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Old 05-09-2005, 08:58 AM   #19 (permalink)
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Quote:
Originally Posted by Bill O'Rights
Don't be so quick to pull the Dr. Josef Mengele card. Let's take a rational look at this.

So, foster care agencies sought treatment for HIV infected children, at a time when most, if not all, treatment was experimental? Hey, don't get me wrong. It sucks for sure. But, what else were they to do? To me, it sounds like a quintessential no win scenario. If they just did nothing, and just allowed the children to die of AIDS, then they are cold heartless bastards who just stood by and watched as children died. "Couldn't they have at least tried to do something?" But, actually do try to do something that may help, or not (who knows), and you are labeled as a succesors of the Angel of Death of Auschwitz.
Now, had they knowingly, and intentionaly, infected the kids with HIV, in order to conduct experiments...then I'd howl like a banshee. As it is, all I can do is look upon it as a huge shit sandwich.

Yes, this seems to be my opinions as well. It seems that if anyone seems to be doing anything even a little controversial with the term experiment in it, people are quick to compare them to Nazi's these days...
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Old 05-09-2005, 09:03 AM   #20 (permalink)
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Quote:
Originally Posted by astrahl
I'm sorry if I offended your delicate sensibilities, but this is too much like the syphillis trials for me. They did something they KNEW was wrong.
Now, correct me if I'm wrong, but didn't the syphillis experiment come about by the government injecting people with syphillis without any knowledge? If so, then this is nothing like that.
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Old 05-09-2005, 11:24 AM   #21 (permalink)
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No they didn't inject them, in a nutshell, violations of the Tuskegee Syphillis trial included the following:

-Informed consent was never obtained
- not to mention they were coerced by being offered free physical exams, rides to and from clinics, hot meals on exam days, and burial stipends of $50.00

-No formal protocol ever existed
-The men were never told they had "syphilis"
-Treatment for syphilis was never given (though they were promised treatment for "bad blood")
-Treatment was denied even after penicillin was discovered in the 1940's

The results:
-28 dead of syphilis
-100 dead of related complications
-40 wives infected
-19 children born with congenital syphilis

The above mentioned trial has already been compared to Nazi war crimes which led to the first of the major ethical guidlines for human subjects research (The nuremberg code). The Tuskegee trial led to the third (The Belmont Report). These are some of the most notorious voliations of ethics in research, which led to massive overhauls in the way trials were conducted.

There is only a question in the above mentioned trial of whether or not the investigators should have insured independent advocates were acting in the participants behalf. They did give assent to the study, as required by law.

So you've tried Nazi Germany, tried Tuskegee, go ahead and give Willowbrook a shot.
There's no way you work in this field if you honestly think the deficiencies in these two trials are remotely comparable.

I appreciate your concern for my sensibilities, they aren't that delicate. This appears to be another case of "the seriousness of the charge is what counts, not the truth behind it." If your going to make such a serious accusation, you really should have something better then "they KNEW what they were doing was wrong."

If you need me to repeat myself again, let me know.
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Old 05-09-2005, 12:37 PM   #22 (permalink)
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While I think that many parallels here are streched to say the best, by no means is this defensible.

1) This is NOT like Mengele or Tuskeegee. The children had already contracted a 100% fatal virus. There is no hope for prolonged life for them. While they should have been given a choice, it's illegal not to, those parallels are unwarranted.
2) They should have been given a choice. While no sane person would turn down free healthcare when they have no way of paying the price... it's a choice they have a right to make
3) Ontop of the no choice given they failed to provide the follow-up medical care promised. IMO this is the WORST infraction. There is absolutely no excuse for this.
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Old 05-10-2005, 04:23 AM   #23 (permalink)
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Ok, perhaps I went too far, but statements like this, "federally funded researchers promised in writing to provide an independent advocate to safeguard the kids' well-being as they tested potent AIDS drugs. But most of the time, that special protection never materialized," make me very uneasy about this issue.

It seems very sneaky and underhanded. Like a, who is going to care about a bunch of foster kids - type attitude.

I apologize for going off the deep end and feeling rather than thinking, but this is still a troubling issue.
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Old 05-10-2005, 05:50 AM   #24 (permalink)
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i completely agree, like i said - i have a number of concerns about the way this trial was run, as described by the article.
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