Safety--Testing Drugs on Children
Lapius was supine on his commodious recliner picking
through a stack of medical journals and throwaways at his side, and I lay on
the couch trying to glean the Sunday Times. Suddenly he started to
chuckle, interrupting my concentration. Had the situation been reversed
he would have imperiously ordered me from the room. I ignored his
laughter, and was working my way back into the column when he said, “The Food
and Drug Administration has worked itself into a corner.”
“How?” I asked, without
taking my eyes from the page.
“They’ve become so
stringent about testing new drugs before allowing them to be sold to the
public, that they may be depriving a large and deserving portion of the public
from receiving important medications.” We were going to have a
conversation whether I liked it or not so I put my paper aside.
“How so?” I asked.
“Well, as you know,
Harry, every new drug has to work its way through animal testing, in both acute
and chronic experiments, and finally there should be a clinical trial as to
efficacy. To do this they give samples of the drug to duly licensed
physicians who then mete them out to volunteers, and record the side effects if
any, and the good they do, if indeed they do. But they have no way of testing
children, so they can’t properly permit some of these substances to be
administered to children.”
“Why not?”
“Because a child can’t
legally volunteer to be a subject for experimentation, and it’s not likely that
a parent would grant permission for a child to enter such a program.”
“But if the drugs are ok
for adults, surely in smaller doses they would be ok for children, wouldn’t
they?”
“Who knows.
There’s no way of finding out. After all, children are at a stage of
rapid growth. Each of their body cells is the forerunner of many
generations of cells that they will be made of when they are adults. Thus
in a child if you genetically alter one cell, you may be causing genetic damage
in thousands of future daughter cells, whereas in an adult, damage to one cell
isn’t so serious.”
“Do you believe that?”
“Not entirely, but who
can tell. Anyway, I enjoy their predicament. They’ve become a bit
pompous, the Food and Drug boys. You know, there are many drugs on the
market now that can be used for diseases for which they are not approved.
This has been shown by doctors in many clinical trials. But if a doctor
tries one of these for a purpose not specifically stated in the brochure that
accompanies each drug, and if it causes side effects, the doctor might have a
hard time defending himself in a malpractice suit.
“That’s ridiculous.”
“Of course it is.”
“What’s the doctor
suppose to do?”
“Perhaps when the
situation arises when he feels he must prescribe something not specifically
authorized, the doctor should take the patient into his confidence and explain
the possible benefits and risks, then have the patient sign a waiver.”
“A sticky wicket.”
“To be sure. It’s
another example of a third party interfering with the doctor-patient
relationship. The doctor has sole responsibility for the patient, but the
third party takes over some of the authority for the care of the patient.”
I was getting
steamed. “That’s terrible. I think something should ---.”
Lapius shut me up with a wave of his arm.
“That’s enough prattling now, Harry. Get back
to your funnies. Can’t you see I have important work to do?”