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FOODS, DRUGS, AND COSMETICS

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in the paint industry should use a zinc oxide which complied with thte requirements of the pharmacopoeia; but as it is, with this variation clause in, that is permissible.

Senator COPELAND. What do you suggest in its place!

Dr. BEAL. I do not suggest anything in its place, but I just want to lay that as a preliminary to this statement. In line 8 and line 9. or say, 7, 8, and 9

Senator COPELAND. Page 6

Dr. BEAL. Page 6, yes; beginning with line 6,

If label bears, in juxtaposition with the name of the drug, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the appropriate official compendium.

Now, that would be very much improved, in my estimation, if it could be replaced by the following, taken from the McCarranJenckes bill, page 11, which reads as follows:

But a drug subject to this paragraph shall not be deemed to be adulterated hereunder, notwithstanding

Senator COPELAND. Will you pardon me, Doctor? What page is

that?

Dr. BEAL. Page 11.

Senator CARAWAY. Line!

Dr. BEAL. Line 4, beginning at line 4, McCarran-Jenckes bill.

But a drug subject to this paragraph shall not be deemed to be adulterated hercunder, notwithstanding it differs from such standard therefor, if its principal label plainly and correctly indicates wherein its actual standard differs from such forced standard, when such standards are determined by the test or methods of assay applicable under this paragraph.

I would consider that very much preferable language. As it appears in your bill, Senator Copeland, it only permits variation from the strength, quality, and purity, and does not permit a variation from the description. Now, description would include the color and taste, and various other things.

Senator COPELAND. Then you would omit from S. 2800 the language on lines 5 to 11, inclusive, and replace it by the material on page 11, lines 4 to 10, of the McCarran-Jenckes bill?

Dr. BEAL. I think there would be a very great improvement, Senator.

On page 10 of S. 2800, a matter which has already been discussed by several witnesses this afternoon, lines 19 to 23, inclusive, relating to misbranded drugs:

If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected.

This is intended to be a criminal statute. Everything in it should be plain and clear. It should be clear, even to the members of this committee. You should not pass it on the strength of the advice of the so-called "experts" that these are technical words which will be taken care of at the proper time and place. You should be sure that you understand just what this language means. Now, for example, before I took the train to come here, I picked up a medical dictionary, Steadman's Medical Dictionary, cleventh revised edition,

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a very standard work. For the word "disease" I found 6 general definitions and 55 special definitions, according to the manner in which it was qualified. Under the word "specific" I found 3 general definitions, and 2 special definitions. Under the word "cure", I found 3 general definitions, and 9 special definitions. Under "palliative " I found two definitions. Under "palliation" I found none. This language here is so indefinite, without being properly qualified, that by combining these various definitions as you find them in the dictionaries you could exclude practically any medicine, even the most valuable, from the market, or by taking them in another sense, or by combining the other senses, you could admit almost any medicine.

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Now, I want to call your attention to the fact that in section 2-of this proposed act, there is a set of definitions, clearly defining such words as 66 "drug person as interstate commerce and so on-words which are already found in other statutes and in many decisions; words which have a well-established common meaning, but here we have words which, so far as I know, do not occur in any other legislation. They are new in legislation. Now, you take a specific cure." I have never yet found that combination in a recognized medical work, although it no doubt does occur or has occurred in medical journals, but as nearly as I can gather it a "specific cure" refers to something like the alkeloid quinine in the treatment of malaria, which is caused by a specific organism; the treatment of syphilis by mercury or arsoníum, which are specifics for the subject. Taking all the specifics which we know which can actually be called specifics, it was said here today there are only 3 or 4. I do not know how many, but I would say there are less than a dozen, fewer than a dozen which could truthfully be called specific cures. That means that anything outside of those would have to be abeled according to this palliation process. Now, if you have a headache, and you go to the drug store and you want a headache cure, you want to know that it is a headache cure, that it is an appropriate remedy for headaches. If you have the foot ache, you want something that is known to be a foot-ache cure, and a footache remedy, but under this language as it now stands he would not dare label it a headache cure, because there is no specific cure for headaches; many cures, many remedies which, properly taken, will remove the headache, and so on down the list. They are not specific cures, but they are proper remedies. They do reach the spot when properly used. They are followed by recovery. Therefore, I would recommend that this language be changed to the language found on page 12 of the McCarran-Jenckes bill, lines 5 to 12, where it is stated:

IT IS Tabel is false in any particular; or if its label, while not false, is actually and injuriously misleading to the purchasing public in any particular. But no drug shall be deemed to be misbranded under this paragraph because of any representation regarding its value or effect, if such representation is supported by substantial medical opinion or by demonstrable scientific facts, as the case may be.

Senator CORELAND. You would be willing to have that read "to such representation as is not supported by substantial medical opinion", would you not!

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Dr. BEAL. Yes. So far as I can see, there would be no particular difference. Now, there, members of the committee, is a statement that is definite and you can understand it, and anyone can understand it. It fixes the obligation of the manufacturer or of the producer to such an extent that there is no sense for his evading it. There is no excuse for dishonest drugs, no good excuse for it whatever. This fixes his responsibility so that he can understand it, so that he can follow it, and so that he can be successfully prosecuted if he does not meet the requirements.

Senator MURPHY. Lines 5 to 12 on what page of the McCarran bill? Dr. BEAL. McCarran-Jenckes bill, page 12, lines 5 to 12, inclusive. I strongly urge upon this committee the importance of rejecting this indefinite dangerous language, which is found in S. 2800, and substituting the language I have just quoted.

Passing to page 11 of S. 2800, at the top of the page, a list of the narcotic and hypnotic drugs, the presence of which is to be stated on the label, "plainly stated on the label "

Senator COPELAND. Where is this now!

Dr. BEAL. At the top of page 11, S. 2800, a list here of 17 named drugs. There are really only about 12, because cocaine is found in cocoa; codein is one of the alkaloids of opium, heroin is an artificial alkaloid derivative of opium, and morphine is a derivative of opium. Now, first I wish to raise the same question which was raised by my friend, Professor Jordan, of Indiana. This is not an objection, but it is a question I want to put up to you. Is it advisable to advertise to defective specimens of humanity that there are other hypnotic and narcotic drugs, in addition to morphine and opium and its alkaloids, and cocaine? Almost all of the weaklings know that these are habit-forming drugs, but they are so guarded that they cannot be obtained except through smugglers, but here, now, you are advertising a very lengthy list of new drugs which they can use. Take, for example, paraldehyde. Why, you can get a glorious jag and a magnificent hangover with paraldehyde.

Senator COPELAND. You ought not to tell the Senate that.

Dr. BEAL. Well, I have been presuming, Senator, that you would have other facilities.

Senator COPELAND. We shall have on the 1st of March. The District is a little behind New York.

Dr. BEAL. That is merely a question. As representing the drug industries, we do not object to the placing of these, the naming of these substances on the label. If you say, "Go on ", go on they do; and there is some language contained here, in lines 5 and 6, to which we very strongly object. It goes on to say, after naming these, or any other narcotic or hypnotic substance which is habitforming."

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If you know of any substance, if anybody can tell you of any substance, narcotic, habit-forming substance, which should be named, put it here, and we will put it on the label; but don't make us liable to a fine of $10,000 and 3 years in the penitentiary for putting some drug in there which somebody will claim, and might possibly be able to prove, to be a habit-forming drug. Now, some people say, "Why, belladonna is a habit-forming drug." Others say, "Nonsense, it is nothing of the sort." So I might go on down the list.

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We do not want to be put to that jeopardy. If you know of any other habit-forming drug, name them here, and we will carry out the provisions safely.

Senator COPELAND. Well, Doctor, after my last conversation with you, that is what we tried to do; but apparently we then had a blanket provision in this line 5. Now, you would strike that out, would you not!

Dr. BEAL. I would strike that out entirely.

Senator COPELAND. Have we now in the list, preceding line 5, or have we included all the substances which we ought to include, with present knowledge!

Dr. BEAL. I think so. I do not recall. I cannot recall, and some of these are exceedingly rare. Now, take peyote. Peyote is what is known as แ mescal button." I have never seen it outside of a medical museum. I doubt if you could buy it in any pharmacy in the city of Washington. It is a drug obtained from a species of cactus, and used by the Indians of the Southwest, in their religious ceremony. They either chew it or they make a strong infusion of it and drink it, and it throws them into a sort of ecstasy, and there must be very few people who use it. I have never heard of one, because if there were very many, this cactus is very rare, and they would exterminate it all in 3 months, and would end the whole business.

Senator COPELAND. But there is no objection to including that, Doctor!

Dr. BEAL. I have no objection at all.

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Senator COPELAND. What would you have stricken out, however, are the words or any other narcotic or hypnotic substance which is habit-forming "?

Dr. BEAL. Yes, sir. I can earnestly recommend that it be stricken out.

As to these habit-forming substances we are willing to name them on our label, if you think it is advisable, but we don't want to be under the jeopardy of making a mistake, putting something in which might be held to be habit-forming.

Senator COPELAND. You will observe, and have observed, of course, that the power which was in the original bill, to have the Secretary add to these lists has been stricken out?

Dr. BEAL. Yes, sir; and it was a great improvement.

Senator COPELAND. Now, let me ask you: Do you share the feeling of one of the witnesses, expressed here, about the warning: "May be habit forming"? Do you think that should be left cff?

Dr. BEAL. Well, I don't know, Senator. I have been on both sides of that question. I mean, in my own mind, I have tried to figure out whether it is more or less advantageous to notify. As a whole, I believe I would leave it in, because then it will appeal at least to the sensible, normal portion of the population. The only people who will be injured by it, if anybody is injured, would be the weak-minded or the weaklings. I think it is an unimportant detail.

Senator MURPHY. They need protection, do they?

Dr. BEAL. I beg pardon?

Senator MURPHY. Do they need protection against themselves?

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Dr. BEAL. They need protection, but not at the expense of the normal majority of the country.

Senator MURPHY. Well, then, the normal majority does not need the protection, does it?

Dr. BEAL. I think they should have notice. This puts them upon notice that they are taking a drug which might be habitforming. I don't really know, Senator, whether I would say that it should be put on or not.

Senator COPELAND. Do you understand this language, as we have it here, to mean that if a doctor writes a prescription and has it filled, that the package that he takes from the druggist must have this warning on it!

Dr. BEAL. I do not; but I understand that in past times there have been some rulings to the effect that if the medicine was compounded in the District of Columbia, or if the prescription was compounded on one side of a State line, and transferred to another, there have been some claims that this requirement would apply. I am sure if I were administering the act, I would not interpret it to apply to physician's prescriptions.

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Senator COPELAND. Well, should there be an exception made to physician's prescription. Except in medicine furnished on the doctor's prescription?"

Dr. BEAL. There certainly could be no objection to that.

Senator MURPHY. Does the Harrison Antinarcotic Act cover all these drugs!

Dr. BEAL. No, sir. It only covers, as I recall it, cocoa and its derivatives, opium, and its derivatives. Does that cover any other of these?

Senator COPELAND. I don't think so.

Dr. BEAL. I do not recall. It has been a long time since I read the other act. Then, if you will permit to pass to the lower part of the same page 11.

Senator COPELAND. Just a moment before you go on, Doctor. From your wide experience, tell us a little bit more of what you think about putting this warning on the doctor's prescription. Čertainly, on the original package, I am clear that it should be there, but what about the doctor's prescription!

Dr. BEAL. In my estimation, it would be very, very wrong to put it on the doctor's prescription. That is, you mean the compounded prescription?

Senator COPELAND. Right.

Dr. BEAL. And if I were a pharmacist, and asked to compound the prescription, I would resist a proposition of that kind to the utmost. The patient should not be advised that what the physician is giving him is capable, if misused, of generating a dangerous habit. I would strongly oppose the necessity of placing the names of these preparations on a compounded prescription.

Senator MURPHY. Under the Harrison Antinarcotic Act, it is not necessary that he put it on the prescription.

Dr. BEAL. No, sir. It is on every prescription.

Senator MURPHY. But his cue to the fact that it is a habit-forming drug, or has a habit-forming drug in it, is that he cannot get it lawfully without a prescription!

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