Growing Pains

Daily Observer

November 9, 1973

FDA Growing Pains and Drug Efficacy

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 effective. 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 diffused 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 aspirin 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?”