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FOOD, DRUGS, AND COSMETICS

Take ipecne. That is a drug introduced many years ago as a cure for amoebic dysentary. It enjoyed a great repute for many years. In other words, it represented the general agreement of medical opinion. Then it went out of repute, and dropped clear out as a treatment for amoebic dysentary. The use of it only continued with some various homeopathic and eclectics, but it was entirely out of repute with the balance of the physicians. Then suddenly the slant turned the other way and now and for a number of years ipocac and its two alkaloids are firmly established as the most efficient agents that we have for the combatting of amoebic dysentary.

They also use malaria germs as a cure for paralysis. They will give a man malaria to cure the paralysis, and cure the malaria some other way.

Senator COPELAND. I am worrying a lot about this line 22. It is an extremely difficult thing to get a general agreement among medical men, almost as hard as it is to get a general agreement as to any legal proposition.

I have wondered about that, and have suggested at various times whether or not we might not use the language that the general agreement as to the classes resulting from scientific or clinical diseases, or something like that. I know how difficult it would be, but Mr. Campbell this morning, I think, got down to a percentage of 80. That would be a high percentage.

Dr. BEAL. Yes.

Senator COPELAND. Fifty-one percent would bo high. (Laughter.] Dr. BEAL. We are confronted with this situation, that we have no definite method of determining therapeutic value.

Now, that seems strange to the layman who has followed popular literature, and who thinks that we have some kind of a magic wand, and that we can put the drug on it, and determine whether it would be a good medicine or not, or he may have heard of animal experimentation, say with the guinea pig.

The study of the guinea pig method is limited, because some will thrive on certain things that are deadly to men, and some humans can cat the kind of foods which are deadly to guinea pigs. There is a lack of parallel action between the guinea pig and the man. When we try a drug on the guinea pig, and that is all, and if we want to know what it will do to the man, it has to be tried on the man, and doctors have been very falsely blamed for experiments on their patients.

In a sense, every administration of a dose of medicine is an experi ment. Your patient is a test tube, and you put the medicine in it and test the tube and see what happens, but you are guided by the fact that the physician himself has had a long period of clinical experience; that he has behind him a record of generation aftor generation of physicians who employed the same drugs in the same way, who stood by the bedside and have observed the fluctuating tide of life as it responded to these different remedies. He has something to go on. But he must depend upon the clinical experience of himself and his colleagues, past and present.

I heard something today which seemed to me rather pitiful, considering the source from which it came, that we should disregard the old knowledge of medicine. Some of the most valuable knowledge that we have concerning drugs and the action of medicines on the human system runs back to the days of Hypocrates and Diascatos.

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Some of the most certain data that we have, some of the most standard medicines that we have in the Pharmacopoeia, have been there from the days when the first practitioners of medicine in Egypt were known and they still give results; and, as for myself, if I had my life in danger, or that of one of my friends, I would a good deal rather trust the treatment of the case to an old-fashioned doctor who has had wide acquaintance, actual experience with the treatment of patients, than to the man who has just come out of the guinea-pig laboratory, because I have stood behind the prescription counter and have filled prescriptions by the guinea-pig doctor and proscriptions written by the competent but still inexperienced practitioner, and I know what happened to the patients who took those different prescriptions. [Laughter.]

Senator COPELAND. I think that we ought to say, in defense of Dr. Emerson, that he really did not intend, I judge, to reflect on those ancient remedies which are still considered to be good. What he was talking about was temporary medical opinion and temporary drugs.

Dr. BEAL. My personal opinion is that he really did not intend to say what his expressions indicated.

Now, instead of leaving it to the general agreement of medical opinion, it would have to be determined by the Secretary of Agriculture, and I suggest that it would accomplish the same end and be much simpler if we should strike out all of that complicated language and insert the following:

"A drug shall be deemed to be misbranded when any part of the labeling is contrary to the opinion of the Secretary of Agriculture.

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Another very important feature of section 8 is found in paragraph (b), which enumerates a list of drugs designated as "narcotic or hypnotic substances" and their derivatives "by actual or theoretical chemical reaction", the quantity or proportion of which must be declared on the label and accompanied by the statement, "Warning— may be habit forming."

Here we see illustrated the common mistake of the layman, namely, that the word "narcotic" is synonymous with the word "habitforming", whereas as a matter of fact there are dozens, and perhaps hundreds of drugs, as for example, the oils of lemon and orange and other common and essential oils which have well defined narcotic properties, but are not in the slightest degree habit forming.

Another objectionable feature of this paragraph is the inclusion of "theoretical chemical derivatives." Anyone familiar with the hypotheses of chemical substitution is aware of the fact that almost any chemical compound can be conceived as theoretically a derivative of almost any other compound, even though they cannot be so derived in practice.

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Another objection I have to this section is that it authorizes the Secretary to add to the list of habit-forming drugs such other substances as as he may find to possess narcotic or hypnotic proper ties." There is a confusion of the words "narcotic" and "hypnotic with "habit forming", and yet there is a very wide difference; we have dozens of drugs, we have hundreds of drugs, which are distinctly narcotic in their properties; but they are not in the slightest degree habit forming.

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You know what the oil of peppermint is, and that is a narcotic, as the oil of lemon is, or the oil of the orange, all of the common essential oils, but not one of them has the slightest habit-forming characteristics. Therefore this should have been preceded by the language "habit forming", then narcotic drugs.

As to these particular drugs included in this list, with one or two exceptions they are fairly well selected, but they should never be found in medicinal preparations without their presence in quantity and proportion being stated on the label.

Now, this got in by accident, but it is there:

The Secretary is hereby authorized, by regulations prescribed after notice and hearing, to designate as narcotics or hypmoties within the meaning of this parugraph such other substances as he may find to possess narcotic or hypnotic properties.

Of course, we know that Judge Campbell would exercise that language rationally or properly, and we hope that his successors may do so, but there is no absolute certainty, and it is specifying acts which shall constitute crime, or turning over to an administrative officer of the Government the specifying of such acts, which should not be done.

If Congress does not want us to sell a particular drug, let it say so. There are not so many which are habit forming, and they can be stated in less language than is required to confer absolute authority on the Secretary of Agriculture in this respect.

Senator COPELAND. Of course, Doctor, the purpose of a Senatorial hearing is to apply the acid test to the language in the form of a bill.

I do not know who wrote it. I did not write it.

Dr. BEAL. Some professor evidently did. [Laughter.]

Senator COPELAND. Do not misunderstand me. I am for the bill, but I do think we should add what you have suggested before "narcotic" or "hypnotic "-habit forming. That sounds sensible to me, but we must not be too harsh on those who actually produced the original act.

Br. BEAL. If you knew how harsh they were on some of us. [Laughter.]

Senator COPELAND. We are here to try to modify the language and make it more scientifically accurate, if we can.

Dr. BEAL. They never put cushions in their gloves when we visited thom.

Senator COPELAND. There has not been a lack of that as far as you are concerned, Doctor.

Dr. BEACH. I wish also to call attention to another serious defect in this last mentioned authority conferred on the Secretary of Agriculture.

We have, as the honorable chairman is well aware, a number of large manufacturing establishments in this country who are spending hundreds of thousands of dollars in the attempt to develop new drugs which assuage or control pain, or produce hypnotism or sleep, but possessing none of dangerous qualities that many of our known drugs possess.

Now, under this particular authorization of the Secretary, the work of many experts, research chemists, spending many hundreds of thousands of dollars, might be wiped out of existence.

FOOD, DRUGS, AND COSMETICS

We do believe, Mr. Chairman, and we believe it very thoroughly and sincerely, that the protection of the public health is paramount to every other interest, but we also want that interpreted in connection with this further statement, that where health can be equally well or better protected while at the same time taking care of the legitimate commercial or industrial matters, that that is preferable to one which is universally destructive and which does not at all take into consideration any of the byproducts of such legislation as we may adopt.

Senator COPELAND. You remember this morning that Mr. Campbell spoke about some scientific committees. I think that he has in mind-certainly I have that there shall be written into this bill a provision for the raising of such committees, to have it specifically stated that this organization and that organization and the other organization shall be represented, because it stands to reason that the Secretary of Agriculture would be a qualified physician or a pharmacist only once in a thousand years.

He has to depend on somebody, and I know enough about the Department, and the food and drugs organization, to realize that they welcome the inclusion in the bill of an arrangement for a committee such as I have indicated.

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Dr. BEAL. That is why we are here. We have been chasing them all over the city of Washington to find out what is in this bill.

Senator COPELAND. You have it here now, and let us fix it up and get it right.

Dr. BEAL. Unfortunately, I sat so far back in the room this morning that I could not hear Judge Campbell's very excellent and illuminating address.

Senator COPELAND. I assure you, Doctor, on that point, and Mr. Campbell will correct me if I am wrong, that he clearly intimated or directly stated, that it was his intention to have such a scientific committee. Am I right or wrong on that?

Mr. CAMPBELL. Yes. I said that in meeting the obligation of the Secretary in fulfilling the administrative provisions of this particular section 10 and other sections, where he was required to make findings of fact that have the force and effect of law, it was the purpose to make an appraisal of the scientific knowledge available on this subject, on the question of food standards, by the designation of committoes qualified because of their eminence. In the consideration of drug questions, where there is a similar obligation imposed, or similar authority extended, they will function the same way.

Dr. BEAL. I think that would be a most excellent extension of the present activities of the Bureau. I do believe that if the Bureau would permit us, in pharinacy, to designate the men of standing, not only scientific standing, but of character and who would have an occasional friendly conversation with us, that we could discuss these propositions in a give-and-take manner, but nevertheless a friendly manner, and that we would not have these disputes.

I do not think that the best result is obtained in the enforcement of law by trying to slip around and catch somebody and to bring them before the courts or the public. That, of course, must be done if the man won't behave himself, but I think that an administrative officer best performs his function if he keeps in touch with the people to whom his law applies and helps them to understand it and to execute it.

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When our dear old friend Harvey W. Wiley was living, we did not have any difficulty in getting next to him and having understandings with him as to what was proper and right in the drug business.

Senator COPELAND. I am sure that you do not have any difficulty with Mr. Campbell.

Dr. BEAL. I hope we do not, or shall not. [Laughter.]

The remaining language of the paragraph leaves something to be desired in the way of clarity.

Paragraph (c) provides that a drug if not recognized in the U.S.P. of N.F. shall be deemed to be misbranded if "its label fails to bear the common name of the drug, if any there be, and (2) the name and quantity or proportion of each medicinally or physiologically active ingredient thereof."

What common name is referred to? Sometimes a drug has one common name in Portland, Oreg., and a different one in Portland, Mainc. Take our good old friend, known in Pennsylvania as "Black Snake Root." That has a different name in Ohio, still another one in West Virginia, and still others in other States, so what name should be used in that case, and I could go on and name any number of drugs which have different names in different localities, and certain names which apply to a dozen different drugs.

Take Snake Root. We have all kinds of Snake Root, all representing different species of drugs having different medicinal qualities. Then this refers to the name and quantity or proportion of each medicinally or physiologically active ingredient thereof, in plain English. This means complete formula disclosure, that is, that the complete disclosure of the ingredients and their proportions, shall be stated on the labol, and that they shall be stated in the simplest common language, in English.

You know that there is a great deal of difference between the use of English and Latin in medicine. The difference between a prescription in Latin and a prescription in English is always $0.50. (Laughter.]

These arguments for and against formula disclosure are so old that they have become classics, and we know just what arguments will be offered in favor of it, and what arguments will be offered in opposition to the proposition to print the formula on the label.

One of the old arguments in favor is that the patient should know what he is taking. That may have some measure of value to him, but how much? He would not know anything more when he did have the names of those drugs.

A really worth while argument in favor if it is this: That a physician called upon to tront a patient should have the opportunity of knowing medicinal agents have been previously administered to that patient. That is a really worth while, valid argument, that a physician should have the opportunity of informing himself as to what his patient had been previously taking.

There are also some arguments against it, and one argument is this: That a great many people have the pernicious habit of constantly wanting to experiment, and you put the formula on the back of a preparation, and they would like to know what those different drugs are. How many druggists have had a patient come in and ask to see some yellow dock root or dandelion root or wild cherry bark or something else, and you ask them why they are interested, and they will tell you that they want to take it home and use it as a tea.

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