[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.53]

[Page 289]
                        TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
                               
PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents
Subpart D_Additional Safeguards for Children in Clinical Investigations
Sec.  50.53  Clinical investigations involving greater than minimal risk and
no prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subjects' disorder or condition.

    Any clinical investigation within the scope described in Sec. Sec. 
50.1 and 56.101 of this chapter in which more than minimal risk to
children is presented by an intervention or procedure that does not hold
out the prospect of direct benefit for the individual subject, or by a
monitoring procedure that is not likely to contribute to the well-being
of the subject, may involve children as subjects only if the IRB finds
and documents that:
    (a) The risk represents a minor increase over minimal risk;
    (b) The intervention or procedure presents experiences to subjects
that are reasonably commensurate with those inherent in their actual or
expected medical, dental, psychological, social, or educational
situations;
    (c) The intervention or procedure is likely to yield generalizable
knowledge about the subjects' disorder or condition that is of vital
importance for the understanding or amelioration of the subjects'
disorder or condition; and
    (d) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians as set forth in
Sec.  50.55.


http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.
gpo.gov/cfr_2007/aprqtr/21cfr50.53.htm
"We don't have a clue how to help your kid, but even if we did we sure as hell wouldn't do anything to save her.  Don't be ridiculous, where's the money in that?  We also have some stuff that we already know perfectly well what it will do, we've killed hundreds of rats with it.  We really want to shoot it into your kid's body and then, um, take notes, yeah, that's it.  Take NOTES.  Very scientific. 

You just need to know up front there's no chance in hell this will help her, it could easily take her from you much sooner than she would have gone otherwise.  In any case, once she gets this shot there's no way she'll be able to have one of those amazing spontaneous recoveries, so just get over it.  What would you want that for anyway?  You've already said goodbye to her in your heart, right?  It's better to just get it over with."
 
-010-

Sec.  50.53 
Clinical investigations involving greater than minimal risk and
no prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subjects' disorder or condition
High Risk & No Benefit.  Sounds reasonable.  Not.

Imagine being informed that scientists want to inject you with something that is very dangerous and will not help you in any way.  It could kill you.  To a reasonable person this would seem to be an unreasonable request.  Why would anyone agree to this?  To what end?

No one is in a hurry to die, even people who are critically ill.  For many who are in the process of dying, life becomes incredibly precious, and many hold out hope. Sometimes critically ill people recover, many times they don't.  In any case, every moment spent with loved ones is the most valuable thing on earth.  But here come men who are respected by their peers, respected by their industry, who are asking you to place yourself in harms way with no potential benefit to you.  Why would they do that?

The claim will be that allowing yourself to be a guinea pig in the name of science and research will make you a hero of sorts.  Someone who risked their lives to advance science in the hope that benefit might come in the future to others.  Will anyone know your name for doing this?  Will anyone appreciate your sacrifice?  They're asking you to die.  Are they offering you or your family anything in exchange for such sacrifice? Anything of equal value?  No, your reward is supposed to be feeling good about doing it. 

What is their reward?  Are they in it to "feel good" about themselves?  Would any of those men in white coats even be there if they weren't receiving extremely generous financial compensation? If their money was cut off in mid question, wouldn't they just get up and walk away?  They would.  Your uncompensated contribution to science makes theirs flimsy in comparison.  Your life, their money.  How insulting can anyone get?

Why are you being bothered with this now?  Because they perceive you're dying?  Is it acceptable to ask all people to risk their lives for science or is it only okay to ask sick people?

The message is clear.  Sick people don't count.  They're expendable.  They don't deserve the same consideration given to the living who are healthy.  This is a statement of their ideas about the value of human life.  To science, a life that is struggling with an illness is a life without value.  The question is, who are they to decide the value of anyone's life?

Is it up to a group of like minded men, people who's only concern is to advance their own careers, to decide the value of human life?  Isn't the whole aim of medical science supposed to be to prolong life?  Who's life are they interested in prolonging if not yours?  It can't be both now, which is it?  You can't claim to do your work in the aim of protecting health and prolonging life if it comes at the price of killing people off.  This is a zero sum game. 

Unless of course in their minds the exchange is worthwhile.  Sacrificing a valueless life in order to save one with value.  So the official position of medical science is that there are some lives worth saving, and some lives not worth saving.  How do they determine which are which?  Should they even be in this position?  Aren't all lives of equal value?  Aren't all sick people deserving of life saving treatments?
And what could prevent their abusive attitude from ceasing to consider all possibilities to save your life?  What would motivate them to keep trying, if deciding your death is unavoidable means they can use you to experiment on.  This is their goal after all.  This is their strongest motivation.  Is it yours?

If medical science believes that there are two kinds of people, those who deserve life and those who don't, shouldn't they let us know that?  Shouldn't we be made aware of which side of the line they deem us to be on?  It's a fair question.  It must be asked of men who take it upon themselves to deem some lives worthless, a decision they make based on no criteria but their own points of view.  The points of view of the people they deem worthless and their families points of view are irrelevant.  So who died and made men in white coats God?

These men may be respected by their peers, lauded by their industry, welcomed into the halls of government and corporate power, but how does everyone else feel about them?  Do we respect them?  Do we laud them?  Do we hold them in the highest esteem, or must they rely on their inner sanctum for such declarations of their wonderfulness?  Indeed, they must.  All the accolades, the lofty positions and titles, the recognition, financial rewards and institutionalized arrogance is granted back and forth among their own.  It does not come from the people.  It does not come from the healthy, and it does not come from the sick.  It does not come from those who sacrifice themselves to benefit others.

Are we to allow this mutual admiration society to establish our own thoughts and feelings about their value to society? If their accolades and rewards came to them by virtue of the people who must turn to them for health care, would they have such arrogance?  Would they be so highly paid?  Would they tell us to our faces that some of us don't matter because others matter more?  Would you and I elevate them to God like status and never correct them when they're wrong?  Because they're often wrong.  They're men like all other men.  They are not our superiors.  They are simply members of a private club that seems to think it has the right to ask people to die so they may test their lab experiments in the aim of eventually making some large corporation even more obscenely wealthy.  Is that something anyone would choose to die for, and at absolutely no benefit to themselves?

Who will remember your name if your life ends because of that dangerous injection or treatment?  Who will be saying, "Thank you forever to Tom Smith, thank you always to Mary Brown, for these people's noble selflessness has allowed us to market this latest drug and we shall be richer than ever before"?  They won't remember your name five minutes after you're dead.  How could you mean anything to someone who is asking you to die for their benefit?

Would there ever be a time that "scientists" doing experimentation on human beings would say there was no potential benefit to doing their favorite thing in the whole wide world?   Define "benefit".  Again, is this up to them to decide?  They will always find personal benefit in this situation.  It reeks of personal benefit.   This is a crisis of ethics, in the very last place we'd ever have wanted to see one.  Ethics in medicine are not optional.  Without them the world is divided into those who are worthy and those who are not, and those who are not are never in the position to decide anything. 
 
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