Washington Times: VA testing drugs on War Veterans!!!

[Kilmer17]

Correction, not before the FDA examined it. The side effects of the drugs were kown to the FDA before the study started and the FDA informed the VA of the side effects 2 weeks into the study.

What I don't understand is who was doing the study? Who paid the 30$!! I think they are the yet to be uncovered scum bags. What exactly where they studying, and why did they target soldiers with PTSD.

Maybe because it's a drug for PTSD?

Could it be that simple?

[Tulane Skins Fan]

You think the guys thought they were getting paid by drug companies (or whoever stroked the check) for something else?

I think it's obvious they knew they were part of it.

If not, I'll certainly change my stance.

I dont know... I think its at least possible that they thought they were covered under their government insurance and were entitled to some extra benefits by it... especially considering the article says they were not informed about the risks associated with the drugs.

It may turn out that they all knew what they were getting into though, or that they were at least given enough info to make an informed consent. I don't know. To me, the article is unclear as to what the story is, or even whether there really is a story.

[JMS]

Is it clear that these guys KNEW that they were part of a trial? Or did they just believe they were getting drugs that may or may not help them.

They knew they were in a trial, just not one involving drugs with serous mental side effects..

bottom line to me is that the article is a little ambiguous, but it raises questions.

It wasn't ambigous at all.

One of the nation's premier medical ethicists said the VA's behavior in the anti-smoking study violated basic protections for humans in medical experiments.

"When you're taking advantage of a very vulnerable population, people who have served the country, and the agency that's responsible for their welfare isn't putting their welfare first, that's a pretty serious breach of ethics," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

[JMS]

Maybe because it's a drug for PTSD?

Could it be that simple?

No, the article says the drug was to help people stop smoking. The known side effects of the drug would seem to suggest that soldiers with PTSD would be mroe suseptable to the side effects, so potentialy better subjects if the actual study was to observe the side effects.

That's the only reason I can think of as to why they targetted soldiers who were already diagnosed with PTSD for the study... almost 1000 in all.

[Kilmer17]

JMS, I want to make sure I understand your thought here.

You actually think that the administration KNEW that these drugs caused serious mental side affects. And that they decided to do a trial to test for something and not tell the soldiers about it. So in essence, they already knew the result, but paid these guys 30 bucks just to **** them up?

Really?

[jpillian]

Seems like a bad idea to offer ANY clinical drug testing to someone suffering from PTSD. I'd think that right there would skew the results if they are attempting to determine what side effects might result.

[Kilmer17]

Seems like a bad idea to offer ANY clinical drug testing to someone suffering from PTSD. I'd think that right there would skew the results if they are attempting to determine what side effects might result.

Unless the point of the trial was to find out the affects on people with PTSD.

"People should not take XXXX if they are pregnant, might get pregnant, etc"

How do you think they know that?

How else can they tell what the side affect will be on people diagnosed with PTSD if they dont test on them?

[JMS]

JMS, I want to make sure I understand your thought here.

You actually think that the administration KNEW that these drugs caused serious mental side affects. And that they decided to do a trial to test for something and not tell the soldiers about it.

Not quite.

I think the administration has a proven track record of appointing people to important office who's only qualification is they are friendly to the administration.

I think it's pretty obvious that best case the person in charge at the VA is incompetent. Worst case he's got a beach house or a nice job post government appointment paid for by a drug company.

I think it's a fact that soldiers in this study with diagnosed PTSD were targeted. I think it's a fact that they were not able to give informed concent. I also think it a fact that a fee of $30 a month is chicken feed when talking about human testing.

And Yes I believe the people conducting the study knew exactly what they were doing. To believe otherwise would be to believe in coincidence on a pretty unbelievable scale.

I want to know who those folks were conducting the study....

So in essence, they already knew the result, but paid these guys 30 bucks just to **** them up?

Really?

I think they knew that giving drugs which side effects included psychosis and suicidal behavior to soldiers who suffered from PTSD they would likely see that behavior. I also think the only reason for targeting soldiers with diagnosed PTSD would be if you were studing those side effects speficially which you were trying to induce.

Wouldn't be the first time in my lifetime the military conducted F'ed up research on their own..., Wouldn't be the third time in my life time for that matter.

The government has a controversial history of using military personnel as human research subjects.

• Mustard gas was tested on the military during World War II,
  
• Radiation during the early Cold War period,
  
• LSD in the 1960s,
  
• herbicide in Vietnam and Panama,
  
• chemical and biological warfare drugs during the Gulf War,
  

In most of those cases, few if any military test subjects were informed of the potential health consequences of the exposure.

"We have a phrase to describe this phenomenon - the disposable soldier syndrome," said Richard Weidman, former VVA director of government relations.

The most infamous government experiment is the Tuskegee Syphilis Study conducted by the U.S. Public Health Service from 1932 through 1972, which used 400 poor and uneducated black male sharecroppers who carried the sexually transmitted disease. The men were purposely undiagnosed and untreated for a disease that already had progressed to late stages, and were studied through autopsy. The government effectively blocked the unwitting participants, who also were drafted in 1940 to serve in WWII, from receiving medical treatment for symptoms they were told were caused by "bad blood."

Of the participants, 28 men died of the disease, 100 others died from complications brought on by syphilis, and the disease spread to 40 wives and 19 children.

WHO conducted the STUDY!!!!...

[Kilmer17]

And if they were tested without their knowledge, I'll change my tune 180 degrees.

But I'll ask again.

How else can we find out what the side affects are if we dont test?

And 30 bucks is way too cheap IMO. But it's a market. If not enough sign up at 30 bucks, then they'd have to raise it. But as long as they get enough at 30 bucks, why should they pay more? And if they pay more, how much will that raise the price of the drug down the road?

[Special K]

Of course, it's all the Bush administration fault...

1. Patients enrolled in clinical trials are OFTEN TIMES offered incentives, (e.g. money). There is no ethical problems with incentives.

2. I don't know if you understand the Internal Review Board (IRB) process, but if they approved the study (which they did), informed consent was recieved from each patient prior to the initiation of the study.

3. I really don't think you understand the IRB process b/c is DOES take a lot of time to get ANYTHING reviewed and approved by them. You have to run it by them before you do ANYTHING, including changing wording or deviating from the trial in any manner whatsoever.

[Special K]

I think it's a fact that soldiers in this study with diagnosed PTSD were targeted. I think it's a fact that they were not able to give informed concent. I also think it a fact that a fee of $30 a month is chicken feed when talking about human testing.

How do you know informed consent wasn't obtained JMS?

[JMS]

And if they were tested without their knowledge, I'll change my tune 180 degrees.

But I'll ask again.

How else can we find out what the side affects are if we dont test?

And 30 bucks is way too cheap IMO. But it's a market. If not enough sign up at 30 bucks, then they'd have to raise it. But as long as they get enough at 30 bucks, why should they pay more? And if they pay more, how much will that raise the price of the drug down the road?

There are ethics involved in medical testing. Central is the concept of informed consent. If the VA did not informe the soldiers they were using drugs which induced psychosis and suicidal behavior; the soldiers could not give informed consent.

To my way of thinking, The VA had no business conducting a study for drug companies on vulnerable soldiers with side effects wich included psychosis and suicidal behavior, regardless...

The VA's job is to look after the wellfare of the troops, not help out the drug companies on their live human testing.

[Special K]

There are ethics involved in medical testing. Central is the concept of informed consent. If the VA did not informe the soldiers they were using drugs which induced psychosis and suicidal behavior; the soldiers could not give informed consent.

You clearly don't understand what informed consent is.

[JMS]

How do you know informed consent wasn't obtained JMS?

The article states the soldiers weren't informed until the three month study was nearly completed, even though it's documented the FDA informed them two weeks into the study.

Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February.

It's plausible that the VA did not know the side effects of the drugs they were giving the troops. Not defendable, they should have known; as they have plenty of doctors on staff, but plausible. It's not plausible that the drug company did not know the documented side effects of the drug which they were using in a study which specifically targeted soldiers with Post Tramatic Stress Disorder.

Either way the soldiers were not told of the side effects before the study so they couldn't give informed consent.

[JMS]

You clearly don't understand what informed consent is.

Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. The individual needs to be in possession of relevant facts and also of his or her reasoning faculties,

:doh:

One of the nation's premier medical ethicists said the VA's behavior in the anti-smoking study violated basic protections for humans in medical experiments.

"When you're taking advantage of a very vulnerable population, people who have served the country, and the agency that's responsible for their welfare isn't putting their welfare first, that's a pretty serious breach of ethics," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

[JMS]

How do you know informed consent wasn't obtained JMS?

Please point out where in the article it suggests to you that informed consent was given.... .

[Special K]

I already said it. Do you know what the IRB is JMS? If IRB was involved, informed consent HAD to be given. They don't approve studies without informed consent and patient privacy parameters.

I know this for a FACT b/c I have dealt with IRB's on several occasions. Most recently, early 2008 when we had to get our pilot study approved by the IRB before we could conduct our trial.

[Special K]

From what I see this was an IRB approved study. So here's a little breakdown for what happened here:

1. Study was devised and sent to IRB for approval

2. IRB approved of study

3. Study commenced

4. 2 weeks into the study FDA alerted PI's that there was a linkage between mental health side effects and this particular drug.

5. IRB was notified

6. PI's had to wait for IRB approval to send out warning letters.

If you know ANYTHING about the IRB you can see how it took PI's FOREVER to get approval to alert patients. Everything has to go through this board before reaching the patients.

4.

[JMS]

I already said it. Do you know what the IRB is JMS? If IRB was involved, informed consent HAD to be given. They don't approve studies without informed consent and patient privacy parameters.

I know this for a FACT b/c I have dealt with IRB's on several occasions. Most recently, early 2008 when we had to get our pilot study approved by the IRB before we could conduct our trial.

Ah, so you don't have anything from the article or any scrap of actual evidence to support your claim other than your assumption that the institutional review board would not allow such a travesty....

Heres a thought,, are any human testing done in the United States which do not fall under IRB's purview? Hint, Yes.

Did the article mention that IRB was involved here.... Hint No.

[Slacky McSlackAss]

Did the article mention that IRB was involved here.... Hint No.

the VA said bureaucracy slowed down their warning because the alert letters had to be issued through an Institutional Review Board (IRB) that oversees the experiment at each VA location.

[Special K]

Here's a link to the responsibilities of the IRB, but I'd like for you to pay attention to this paragraph in particular:

Finally, consent to participate must be voluntarily given. The conditions under which an agreement to participate is made must be free from coercion and undue influence. IRBs should be especially sensitive to these factors when particularly vulnerable subjects are involved.

http://www.hhs.gov/ohrp/irb/irb_introduction.htm

Therefore, informed consent was given.

[Special K]

Ah, so you don't have anything from the article or any scrap of actual evidence to support your claim other than your assumption that the institutional review board would not allow such a travesty....

Heres a thought,, are any human testing done in the United States which do not fall under IRB's purview? Hint, Yes.

Did the article mention that IRB was involved here.... Hint No.

Please reread the article you posted.

Also, I would like to be enlightened about what human subject testing presently occurs in the U.S. without IRB approval?

[Slacky McSlackAss]

Heres a thought,, are any human testing done in the United States which do not fall under IRB's purview? Hint, Yes.

http://www.fda.gov/CDRH/DEVADVICE/ide/irb.shtml

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.

[JMS]

From what I see this was an IRB approved study.

Why would you assume that?

So here's a little breakdown for what happened here:

1. Study was devised and sent to IRB for approval

2. IRB approved of study

3. Study commenced

4. 2 weeks into the study FDA alerted PI's that there was a linkage between mental health side effects and this particular drug.

5. IRB was notified

6. PI's had to wait for IRB approval to send out warning letters.

If you know ANYTHING about the IRB you can see how it took PI's FOREVER to get approval to alert patients. Everything has to go through this board before reaching the patients.

4.

Keestman..

(1) do you think it's new news to Pfizer that Chantix, has side effects of psychosis and suicidal behavior?

In November 2007, the FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. On February 1, 2008 the FDA issued an Alert to further clarify its findings, noting that "it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms."

Mr Eliot was informed of these side effects Feb 2008. The study in question was three months long..... So the FDA knew of these side effects at least a month before the VA study occured.

They issued an announcement to that effect before the study started...

So yeah, I think it's safe to say informed concent was not given.

[Special K]

Why would you assume that?

JMS, I can't help it if you cannot comprehend the story that you read and have absolutely no clue about how clinical trials are run.

I've explained it several ways, but you can't see past your clear bias and ignorance regarding clinical trials to understand what I am saying.

If the IRB had to review warning letters sent out to patients involved in the trial, that means they were INVOLVED FROM THE ONSET of the trial.

Human subjects are protected by federal law here in America.