Clinical Trials and GI Joe

[Guest guest]

12/24/2003

From VeritasMedicine.com, Dr. Lee writes, " Clinical Trials and GI Joe " :

As if the United States military didn't have enough to do these days, it

now has to start worrying about clinical trials. While the ongoing

situation in Iraq has dominated the headlines, news this week about the

Pentagon's abuse of the clinical trials process managed to create a

stir.

How did the Pentagon get embroiled in a controversy about clinical

trials, of all things? A little background is helpful. Both human rights

' principles and US federal law now require that in order to be given an

experimental drug or treatment, a person must provide consent. No one

can be subjected to a treatment against their will.

These requirements may seem obvious to us now, but until very recently

many different groups of people underwent medical procedures against

their will or without their consent. Most famously, black Americans in

the Tuskegee syphilis trial were prevented from receiving antibiotics in

the 1940s, 1950s and 1960s. People considered to be " unfit " to have

children were sterilized against their will-including the mentally

retarded, petty criminals, and " sexual deviants, " an old moniker for any

non-heterosexual.

Our government can, and does, enforce certain medical procedures and

treatments. Children must be vaccinated against several infectious

diseases before they are allowed to attend school. Health care personnel

must be vaccinated against another set of diseases before they are

allowed to work in hospitals. And military personnel-soldiers-must be

vaccinated against diseases felt to pose a threat to a functioning army.

It is the later situation that has gotten the Pentagon in trouble. In

1998, the military began requiring soldiers to be vaccinated against

Anthrax, largely due to the risk that Anthrax could be used as germ

warfare on the battlefield. Several soldiers refused the vaccine, and

were court-martialed and severely punished for their refusal. A group of

them decided to sue the military, claiming that they were being

subjected to an experimental vaccine against their will, in violation of

human rights' principles and federal law.

The key issue here is whether the vaccine is experimental. No one

contests that the military can demand that its soldiers receive proven

vaccines to make them less susceptible to germ warfare. And, in fact,

the Anthrax vaccine in question was approved in the 1970s. However, it's

ability to protect against inhaled anthrax-the kind used in the post

office bioterror attacks of 2001-as opposed to cutaneous anthrax-the

kind humans are more likely to acquire naturally-has not been

definitively established. Thus, the soldiers claim, forcing them to take

the vaccine is, in effect, an experiment being conducted by the Pentagon

on its soldiers. And an experiment requires consent.

In a federal court ruling released on December 23rd, the judge in the

case noted: " The women and men of our armed forces put their lives on

the line every day to preserve and safeguard the freedoms that all

Americans cherish and enjoy. Absent an informed consent or presidential

waiver, the United States cannot demand that members of the armed forces

also serve as guinea pigs for experimental drugs. "

It will be interesting to see how the Pentagon responds. The issue is

not really whether this particular Anthrax vaccine is safe-although some

soldiers are worried about possible side effects, there is no evidence

to suggest that the vaccine is harmful. The critical issue is that-just

like you and me-soldiers have the right to say yes or no, without

penalty, when they are asked to volunteer for a trial of an unproven,

experimental treatment. Even in times of war, even under military

command, the clinical trials process must be played out fairly,

humanely, and with the rights of every individual respected and upheld.

http://www.veritasmedicine.com/info_center.cfm?type=ID & did=28 & cid=72576

[Guest guest]

,

I was very glad to read that they are no longer requiring the military to

take the anthrax vaccination. There are just to many Gulf War soldiers that

have unexplained medical problems that could be linked to the vaccine. Now

I wonder what will happen to those that refused to take it and were court

marshaled.

a

> 12/24/2003

> From VeritasMedicine.com, Dr. Lee writes, " Clinical Trials and GI Joe " :

>

>

> As if the United States military didn't have enough to do these days, it

> now has to start worrying about clinical trials. While the ongoing

> situation in Iraq has dominated the headlines, news this week about the

> Pentagon's abuse of the clinical trials process managed to create a

> stir.

>

> How did the Pentagon get embroiled in a controversy about clinical

> trials, of all things? A little background is helpful. Both human rights

> ' principles and US federal law now require that in order to be given an

> experimental drug or treatment, a person must provide consent. No one

> can be subjected to a treatment against their will.

>

> These requirements may seem obvious to us now, but until very recently

> many different groups of people underwent medical procedures against

> their will or without their consent. Most famously, black Americans in

> the Tuskegee syphilis trial were prevented from receiving antibiotics in

> the 1940s, 1950s and 1960s. People considered to be " unfit " to have

> children were sterilized against their will-including the mentally

> retarded, petty criminals, and " sexual deviants, " an old moniker for any

> non-heterosexual.

>

> Our government can, and does, enforce certain medical procedures and

> treatments. Children must be vaccinated against several infectious

> diseases before they are allowed to attend school. Health care personnel

> must be vaccinated against another set of diseases before they are

> allowed to work in hospitals. And military personnel-soldiers-must be

> vaccinated against diseases felt to pose a threat to a functioning army.

>

> It is the later situation that has gotten the Pentagon in trouble. In

> 1998, the military began requiring soldiers to be vaccinated against

> Anthrax, largely due to the risk that Anthrax could be used as germ

> warfare on the battlefield. Several soldiers refused the vaccine, and

> were court-martialed and severely punished for their refusal. A group of

> them decided to sue the military, claiming that they were being

> subjected to an experimental vaccine against their will, in violation of

> human rights' principles and federal law.

>

>

> The key issue here is whether the vaccine is experimental. No one

> contests that the military can demand that its soldiers receive proven

> vaccines to make them less susceptible to germ warfare. And, in fact,

> the Anthrax vaccine in question was approved in the 1970s. However, it's

> ability to protect against inhaled anthrax-the kind used in the post

> office bioterror attacks of 2001-as opposed to cutaneous anthrax-the

> kind humans are more likely to acquire naturally-has not been

> definitively established. Thus, the soldiers claim, forcing them to take

> the vaccine is, in effect, an experiment being conducted by the Pentagon

> on its soldiers. And an experiment requires consent.

>

> In a federal court ruling released on December 23rd, the judge in the

> case noted: " The women and men of our armed forces put their lives on

> the line every day to preserve and safeguard the freedoms that all

> Americans cherish and enjoy. Absent an informed consent or presidential

> waiver, the United States cannot demand that members of the armed forces

> also serve as guinea pigs for experimental drugs. "

>

> It will be interesting to see how the Pentagon responds. The issue is

> not really whether this particular Anthrax vaccine is safe-although some

> soldiers are worried about possible side effects, there is no evidence

> to suggest that the vaccine is harmful. The critical issue is that-just

> like you and me-soldiers have the right to say yes or no, without

> penalty, when they are asked to volunteer for a trial of an unproven,

> experimental treatment. Even in times of war, even under military

> command, the clinical trials process must be played out fairly,

> humanely, and with the rights of every individual respected and upheld.

>

> http://www.veritasmedicine.com/info_center.cfm?type=ID & did=28 & cid=72576

>

>

[Guest guest]

Yes, a, I agree. I think that's one vaccination that should be

optional. The whole issue is such a big mess.

Despite the claims by some parties, including those as recently as

yesterday by the FDA, that the vaccine is " safe and effective, " I have a

hard time believing that. The data is just not there. If the vaccine is

so safe and effective, why in late 2002 did the US award a couple of

contracts to two parties (to the tune of about $23 million) to come up

with a new anthrax vaccine?

Also, it was painfully obvious just after the anthrax mail incidents in

late 2001 that the US didn't have a good understanding of or experience

with inhalation anthrax (HHS Secretary Tommy 's comments about

the first anthrax victim possibly becoming infected because he was an

outdoorsman who drank from a stream come to mind - and, come to think of

it, I'm getting a deja vu feeling with the " mad cow " news lately, but I

don't want to bore anyone with pages on that). I'm sure there has been a

lot of study and learning going on since that time, but I'm still not

convinced that the current vaccine is a good idea.

After subjecting millions of people to the possible risks of the

vaccine, would it even work against inhalation anthrax, especially a

weaponized form? Also, anthrax isn't a contagious disease. An exposed

soldier wouldn't spread it to others. Of course there are operational

and strategic concerns, but at least contagion isn't one of them.

I hope they can review the cases of those previously court-martialed and

dismiss the charges.

Re: [ ] Clinical Trials and GI Joe

> ,

> I was very glad to read that they are no longer requiring the military

to

> take the anthrax vaccination. There are just to many Gulf War

soldiers that

> have unexplained medical problems that could be linked to the vaccine.

Now

> I wonder what will happen to those that refused to take it and were

court

> marshaled.

> a

>

>

> > 12/24/2003

> > From VeritasMedicine.com, Dr. Lee writes, " Clinical Trials and GI

Joe " :

> >

> >

> > As if the United States military didn't have enough to do these

days, it

> > now has to start worrying about clinical trials. While the ongoing

> > situation in Iraq has dominated the headlines, news this week about

the

> > Pentagon's abuse of the clinical trials process managed to create a

> > stir.

> >

> > How did the Pentagon get embroiled in a controversy about clinical

> > trials, of all things? A little background is helpful. Both human

rights

> > ' principles and US federal law now require that in order to be

given an

> > experimental drug or treatment, a person must provide consent. No

one

> > can be subjected to a treatment against their will.

> >

> > These requirements may seem obvious to us now, but until very

recently

> > many different groups of people underwent medical procedures against

> > their will or without their consent. Most famously, black Americans

in

> > the Tuskegee syphilis trial were prevented from receiving

antibiotics in

> > the 1940s, 1950s and 1960s. People considered to be " unfit " to have

> > children were sterilized against their will-including the mentally

> > retarded, petty criminals, and " sexual deviants, " an old moniker for

any

> > non-heterosexual.

> >

> > Our government can, and does, enforce certain medical procedures and

> > treatments. Children must be vaccinated against several infectious

> > diseases before they are allowed to attend school. Health care

personnel

> > must be vaccinated against another set of diseases before they are

> > allowed to work in hospitals. And military personnel-soldiers-must

be

> > vaccinated against diseases felt to pose a threat to a functioning

army.

> >

> > It is the later situation that has gotten the Pentagon in trouble.

In

> > 1998, the military began requiring soldiers to be vaccinated against

> > Anthrax, largely due to the risk that Anthrax could be used as germ

> > warfare on the battlefield. Several soldiers refused the vaccine,

and

> > were court-martialed and severely punished for their refusal. A

group of

> > them decided to sue the military, claiming that they were being

> > subjected to an experimental vaccine against their will, in

violation of

> > human rights' principles and federal law.

> >

> >

> > The key issue here is whether the vaccine is experimental. No one

> > contests that the military can demand that its soldiers receive

proven

> > vaccines to make them less susceptible to germ warfare. And, in

fact,

> > the Anthrax vaccine in question was approved in the 1970s. However,

it's

> > ability to protect against inhaled anthrax-the kind used in the post

> > office bioterror attacks of 2001-as opposed to cutaneous anthrax-the

> > kind humans are more likely to acquire naturally-has not been

> > definitively established. Thus, the soldiers claim, forcing them to

take

> > the vaccine is, in effect, an experiment being conducted by the

Pentagon

> > on its soldiers. And an experiment requires consent.

> >

> > In a federal court ruling released on December 23rd, the judge in

the

> > case noted: " The women and men of our armed forces put their lives

on

> > the line every day to preserve and safeguard the freedoms that all

> > Americans cherish and enjoy. Absent an informed consent or

presidential

> > waiver, the United States cannot demand that members of the armed

forces

> > also serve as guinea pigs for experimental drugs. "

> >

> > It will be interesting to see how the Pentagon responds. The issue

is

> > not really whether this particular Anthrax vaccine is safe-although

some

> > soldiers are worried about possible side effects, there is no

evidence

> > to suggest that the vaccine is harmful. The critical issue is

that-just

> > like you and me-soldiers have the right to say yes or no, without

> > penalty, when they are asked to volunteer for a trial of an

unproven,

> > experimental treatment. Even in times of war, even under military

> > command, the clinical trials process must be played out fairly,

> > humanely, and with the rights of every individual respected and

upheld.

> >

> >

http://www.veritasmedicine.com/info_center.cfm?type=ID & did=28 & cid=72576