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Wed 11 May, 2005 11:09 am
yet another sample of human rights.
QUOTE]Israeli doctors experimented on children
Chris McGreal in Jerusalem
Wednesday May 11, 2005
The Guardian
A leading Israeli doctor and medical ethicist has called for the prosecution of doctors responsible for thousands of unauthorised and often illegal experiments on small children and geriatric and psychiatric patients in Israeli hospitals.
An investigation by the government watchdog, the state comptroller, has revealed that researchers in 10 public hospitals administered drugs, carried out unauthorised genetic testing or undertook painful surgery on patients unable to give informed consent or without obtaining health ministry approval.
At one hospital, staff pierced children's eardrums to apply an experimental medication yet to be approved in any country. At another, patients with senile dementia had their thumbprints applied to consent forms for experimental drugs.
Israel's health minister, Dan Naveh, said he was "shocked" at what he described as a failure of his department and some of Israel's hospitals.
Dr Jacques Michel, the former director of Hadassah hos pital who triggered the comptroller's inquiry with a public warning about the abuses in 2001, yesterday called for the prosecution of the doctors.
"These doctors should be punished very severely because they really are criminals," said Dr Michel, who is head of the committee that approves medical experimentation at Hadassah, which is not among the accused hospitals.
"They should be stripped of their licences to practise and they should be prosecuted. If you don't show by example that the medical profession does not accept this kind of conduct the phenomenon will go on and on.
"It's not an isolated phenomenon. It spread through different institutions."
The state comptroller, Eliezer Goldberg, found that patients were often not properly informed about the experiments they were agreeing to and, in some cases, not told at all.
Every Israeli hospital has a medical ethics committee to oversee adherence to the 1964 Helsinki code on experimentation. But the comptroller said the committees routinely failed to apply their own regulations and that the health ministry was negligent in enforcing standards.
Mr Goldberg described a series of incidents at Harzfeld geriatric hospital as "extremely grave", including the cases of a 101-year-old woman and another aged 91 who supposedly consented to experimental drugs without their families being informed.
Researchers applied the thumbprints of seven other patients at Harzfeld to consent forms that they were too senile to read or sign.
"At this age, 25-30% of these people are not fit to give informed consent because they suffer from dementia or senility," said Dr Michel.
In other cases, doctors were unable to produce the consent forms they said that patients had signed although the law requires researchers to keep the documents for 15 years.
Kaplan hospital conducted painful clinical trials on patients to draw urine samples by needle, a procedure normally reserved for extreme circumstances. The comptroller found that 40% of the patients who signed consent forms - five of them with a fingerprint - were mentally unfit to do so.
Mr Goldberg said two women died from infections, but their deaths were not reported to the ministry nor was a legally required investigation committee set up.
The comptroller said that in some cases the deaths of patients who were part of clinical trials were not immediately reported, which undermined attempts to establish whether the experiments were to blame.
Dr Michel believes some doctors bowed to incentives from pharmaceutical firms to test experimental drugs.
"I don't have to explain the enormous power of the pharmaceutical industry to direct research according to its priorities," he said.
Mr Goldberg described how one researcher was also the medical director of a company that initiated the clinical trial he was responsible for.
The health ministry said it has already taken steps to tighten supervision following the comptroller's report.[/QUOTE]
And meanwhile, in America...
Quote:After a year of stonewalling, the New York City Administration for Children's Services has announced that it would seek "an independent review" of the AIDS drug trials that were conducted on children in the agency's foster care program.
ACS acknowledges that "around 465 HIV-positive children were enrolled in drug tests between 1988 and 2001."
The children were used to test highly experimental drugs in Phase I and Phase II trials in which babies and children in foster care were used to test the safety of various AIDS drugs and vaccines that were tested in multiple combinations.
A complaint file by The Alliance for Human Research Protection with the FDA and the federal Office of Human Research Protections in March 2004 has resulted in two continuing investigations. See:
http://www.ahrp.org/ahrpspeaks/HIVkids0304.php
The focus of the AHRP complaint was that the use of foster care children in experimental drug trials are prohibited under federal regulations. The ACS and the NYS Department of Health overreached their authority when they targeted foster care children for the trials.
No information has been given about the children's condition before and after the experiments, nor has either ACS or the National Institutes of Health AIDS division provided information about the adverse effects the children may have suffered from the highly toxic drug cocktails that they had been given. Allegations have been made that the children who refused or could not swallow the drugs had a tube surgically inserted in their stomach to ensure compliance.
There seems to be two issues here:
Testing experimental drugs on people who are suffering from disease (as in the foster kids and the geriatric patients)
And testing techniques by creating the problems (puncturing eardrums to test therapies) or using unnecessarily painful techniques for some reason (urine testing by needle).
The second problem deserves prosecution, without doubt.
The first instance is a bit grayer, to me.
boomerang wrote:The first instance is a bit grayer, to me.
The point is that none of the patients were in a state to give permission for this testing and in many cases probably did not even know that they were guinea pigs. Abusing the hapless and helpless is what is the moral issue here.
This stuff really gets to me... it seems to happen more than we know, though.
Where the "gray" comes in is to whether the treatments might have some positive benefit to the person being tested.
I don't know what they were trying on the people in Israel so I'll use the example of the HIV drug tests on foster kids.
Each of the kids did indeed have HIV.
The medications had been tested on adults but doctors had no way of really knowing what the same medications would do for kids or what kind of dosing might help -- or hurt.
Still, without any kind of treatment, the kids would become sicker and perhaps die.
Most drug trails in America rely on people who are willing to volunteer in exchange for hope that the drugs will help them -- people line up to participate in tests.
When my father was in his 50s he was diagnosed with early onset Alzheimers. We would have loved to have had any kind of hope of staving off the disease and would have enrolled him in trails if there were any available at that time. However, he could not have made that decision for himself because.... well.... he had dementia.
So, yes, I do think that there are areas where the person's actual consent might not be entirely necessary. Consent of the family should always be required though.
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