FDA: Safety--Testing Drugs on Children
Daily Observer
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 the 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?”