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?”