Growing Pains
S.Q. Lapius
was busy riffing the pages of the Physicians Desk Reference. Every now
and then he would stop to scribble a few notes.
“Increasing your word
power, Simon? Supplementing your therapeutic armamentarium?”
“Nonsense. I only use
a select number of drugs. This volume obviously contains more medications
than any one doctor can assimilate. But they fall into only a few
classes, as you know.”
“I know, I know.
So what are you doing?”
“I’m checking a rumor I
heard today.”
“What rumor is that?”
“Someone told me that Antivert, a proprietary drug used for attacks of dizziness,
vertigo to you, no longer contains nicotinic acid.”
“I could have told you
that. It was deleted months ago.”
“On what basis?” Lapius asked.
“As I understand it, it
was deleted because the Food and Drug Administration no longer believes that
the nicotinic acid is necessary. That is, the FDA concluded that the
antihistamine alone is enough.”
“That’s interesting,”
said Lapius. “With everyone grousing about the
high cost of medications, the cost is forced higher now by making the physician
write two prescriptions where one formerly would have been enough.”
“But suppose the
government is correct?”
“The combination isn’t
harmful. Why not let the marketplace decide the effect.”
“You don’t mean that
Simon. That isn’t scientific.”
“Neither is the FDA
scientific. After all, if a doctor prescribes a drug that satisfied the
patients and the patients improve, that, over the long haul, is adequate reason
to allow the medication to be used. But the FDA has assumed police
powers, arbitrarily knocking drugs off the market. Edrisal,
Daprisal, medications useful for menstrual cramps,
which seemed to help many women, are no longer available. Dimethylsulfoxide,
otherwise known as DMSO was killed by the FDA before its full potential could
be developed. All research in it has virtually stopped. Yet, the
last reports on it were that it had diffuse anti-inflammatory effects, and
could penetrate the skin with ease and possibly act as a vehicle to carry other
medications through the skin.”
“And I think it also
caused eye damage --.”
“Nonsense. Suppose
it did. Aralen, the anti-malarial, which is
helpful in rheumatoid arthritis also causes eye damage. But the doctor
must be trained to know the toxic effect of drugs and to prescribe them only
when the benefits outweigh the risks. Aralen is
not approved in the country for use in rheumatoid arthritis, but the Europeans
use it. It is a hell of a lot safer than gold salts which we use in this
country. Sulfasuccidine is off the
market. That was good for gastrointestinal complaints.”
“Sulfasuccidine
– goodness, Simon, how far back are you going. That disappeared more than
twenty years ago.”
“And more’s
the pity,” rumpled Lapius. “In addition, the
FDA insists that before a new drug can be put on the market, efficacy must be
proved. I don’t see how you can prove efficacy in all drugs. What
measures can you use to prove the efficacy of tranquilizers? Certainly
animals can’t tell you whether or not they feel better, and even if they do,
what does that have to do with man? A few snorts make people feel better
too. How, in reality, can the efficacy of some drugs be tested other than
by allowing the material onto the market and letting the public judge its
effects. The public is no dunce.”
“I don’t know about
that. Look how many patients come in asking for vitamin B12. Yet
you and I know that it is only effective in pernicious anemia.”
“You may know that,
Harry. I’m not so sure. Why should a patient insist on B12 shots
and undertake the expense of a weekly schedule if it does them no good.”
“Psychological effect,
probably.”*
“You can’t prove that
any more than you can prove that it helps them. After all, it was the
combined opinions of patient and practitioner that developed digitalis,
quinine, and the rauwolfia medications. Roots and herbs are the
forerunners of many of the medicines we use today in a more refined form.
Had the FDA been around we never would have been allowed to discover
them. I insist that the only function of the FDA is to establish safety
standards.
“It is the function of
the medical schools to train the doctors in safe use of medications. Any
other policy will prevent the emergence of new and useful remedies.
“Today, due to FDA
regulations, it takes about 7 years to bring a new drug to market, much of
which period is concerned with attempts to prove efficacy. The
pharmaceutical industry is being throttled by unreasonable demands and the
number of new drugs has diminished to a trickle.”
“But what about the
thalidomide story. There is a perfect example of how the FDA saved the
country from a calamity. Look how many babies were born with dwarfed limbs
and other teratogenic defects because pregnant mothers received Thalidomide.”
“That may be true,
Harry. But on the other hand, because of the Thalidomide episode, the
world has become aware that many other drugs given during pregnancy have
teratogenic effects. Hadn’t Thalidomide been tried somewhere, the
awareness of the sensitivity of the fetus to drugs given the mother might never
have arisen. Now fetal studies are included in all evaluations of new
drugs. Thalidomide may have been a blessing in disguise.”**
“The fact is, Harry,
that physicians use dangerous drugs like digitalis, quinidine, insulin, and
countless others, with considerable care. There is no reason why
dangerous drugs should be suppressed merely because they are dangerous.
The purpose of having a medical profession is to insure that dangerous drugs
are properly used so that their beneficial qualities are maximized and the
risks minimized. But certainly this can’t be controlled by a committee of
non-practitioners. If this remote control of the practice of medicine is
allowed to continue, the art and science of medical therapy will be
destroyed. Ugh – I’m getting a headache.”
I brought Lapius two aspirins with a glass of water. He popped
them into his mouth and swilled the water quickly. “Aspirin is a case in
point. It knows when you have a headache, it can lower temperature, it
might prevent platelet aggregation, it can cause ulceration of the stomach, and
incite abnormal bleeding. Do you think for a moment that this drug could
ever have survived the specifications laid down by the Food and Drug
Administration?”
* Subsequent medical
literature suggests that Vitamin 12 has some effect on the brain, so perhaps
patients claiming it made them feel peppier were way ahead of the profession
** Thalidomide is
used as a therapeutic adjunct in certain tropical diseases, considered the drug
of choice in Leprosy and now useful in cancer, hepatitis and autoimmune
disease.