Dr. May also refers in his article to an example of serious conflict between promotional material and scientific information appearing in the same issue of the Journal of the American Medical Association. A synthetic progesteroid compound called Norlutin was advertised in the March 5, 1960 Journal without any reference to side effects. In the same issue of the magazine, a Dr. Wilkins reports on 36 cases of female pseudohermaphraditis in infants born of mothers who during pregnancy had been given Norlutin. Again quoting Dr. May:

"The same advertisement for Norlutin has continued to appear
regularly in the J.A.M.A. for the ensuing 3 months since the
article by Wilkins appeared in that Journal; in spite of his
'During the past year or two, Norlutin has caused fetal
masculinization with sufficient frequency to preclude its use
or advertisement as a safe hormone to be taken during pregnancy.'"

This sort of dangerous advertising will be dealt with by the provisions

of the bill which provide for full documentation in advertisements of adverse as well as supportive data the provision requiring the distribution of lists of drugs with potentially harmful effects - all this will protect the doctor from misleading or inadequate information and in turn protect the patient the doctor serves. Potent drugs inevitably have dangers of one sort or another. You may further sales, but certainly not the public's health by disregarding, omitting or minimizing hazards.

health

Drugs are a unique and vital commodity dealing with sickness and

life and death. Vigorous action must be taken by the Federal Government to resolve the issues brought to the attention of this subcommittee last year during its hearings. The individual alone is powerless to deal with it. Nor I very sanguine or hopeful of recent suggestions made by organized groups within the medical profession for voluntary policing and supervision.

The federal legislation proposed in this bill will bring a sense of security and orderliness to the ethical drug field which is surely lacking today. It will allow doctors to prescribe with freedom and confidence. It will assure the public that it is paying reasonably for what it gets and getting fairly what it pays for. For those who have the medical welfare of the community at heart, this bill holds no fears.

FOR RELEASE

PM'S JULY 20, 1961

STATEMENT BEFORE SUBCOMMITTEE ON ANTITRUST AND MONOPOLY,

COMMITTEE ON THE JUDICIARY, OF THE U.S. SENATE

by

Harry F. Dowling, M. D.
Chicago, Illinois

July 20, 1961

My name is Harry F. Dowling. I have been a physician for 30 years. I have carried on research in the field of infectious diseases and have tested a number of new drugs in this field, particularly sulfa drugs and antibiotics. I am Professor and Head of the Department of Medicine at the University of Illinois College of Medicine. However, the opinions that I shall present will be my own.

I should like to consider several of the provisions in the proposed "Drug Industry Antitrust Act" as they apply (1) to physicians, (2) to patients, (3) to retail druggists and (4) to the manufacturers of pharmaceuticals.

Let us take first the effect of the proposed Act upon the practice of medicine by the physician. Much of the testimony given before the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary showed that the physician needed more authoritative information about drugs, especially new drugs, and that he needed to have it brought to his attention more promptly and efficiently than at present. In my opinion, several of the provisions in the proposed Act would accomplish this. The first and one of the most important of these is the authority given to the Secretary of Health, Education and Welfare to evaluate the efficacy of a new drug.

Drugs may be placed in three categories insofar as efficacy is concerned. In the first category are those drugs whose efficacy is obvious as soon as the first few patients have been treated with it. Penicillin is such a drug. When patients with serious infections caused by the staphylococcus were first treated with penicillin every one

responded dramatically with a rapid drop in temperature and general inprovement, whereas without penicillin they would have taken weeks or months to get well and some would not have recovered at all. When this Lappened it was obvious that penicillin was a highly efficacious drug. A drug such as penicillin would be approved for efficacy by the Food and Drug Administration on the basis of a relatively few cases.

A second group of drugs is composed of those that are efficacious, although extensive tests are needed to show it. It is a well-known fact that if the physician gives a patient a drug and tells the patient or otherwise implies to him that this drug is going to make him better, an appreciable percentage of the patients will indeed feel better and will insist that the drug has caused the improvement. This is the so-called placebo effect. Thus if a new tranquilizer drug were to be tested, a certain number of patients should be given an inert substance which looked exactly like the tranquilizer, and neither they nor the doctors evaluating the drug should know who received the dummy and who received the real drug. Only by this method could the efficacy of such a drug be tested properly. This is an extreme case because the evaluation depends almost entirely upon the subjective impression of the patient, but testing in a large series of patients would be necessary for many drugs even though the evaluation did not depend upon subjective impressions. For instance, a drug introduced in recent years for the purpose of bringing the heartbeat back to a regular rhythm when it has become irregular is called procaine amide. But the heartbeat sometimes returns to its normal rhythm spontaneously, and on the contrary procaine amide does not always restore the normal rhythm. It was therefore necessary to test procaine amide in