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to pharmacopoeial standards. There certainly should be some provision whereby the use of initials “U.S.P.” or “N.F.", or the proper initials for the Homeopathic Pharmacopæia should be forbidden except in connection with drugs named in those authorities.
Senator COPELAND. Wouldn't that be a misbranding, if it was so used ?
Dr. WOODWARD. Here is what happened in England, where the Pharmacopoeia is created by an official body. Of course, their title is British Pharmacopoeia, or B.P. There was a firm in England, Barrett's Proprietaries, Ltd., a firm of manufacturing chemists of Blackburn. The General Medical Council and the Attorney General applied for an injunction to restrain this firm from using the initials, “B.P.” in their advertisements and price lists and on their cartons, in respect to preparations which were not included in the British Pharmacopoeia. Barrett's Proprietaries, Ltd., admitted that they had used the initials “ B.P.” in respect of preparations not in the British Pharmacopæia, but they pleaded that no person who was aware that the initials “B.P." sometimes referred to that work would ever associate the device used by them with British Pharmacopæia preparations. Moreover, to the general public the initials “ B.P.” stood for various things, other than British Pharmacopoeia.
In that case, the judge remarked that the General Medical Council was not given a monopoly of the term “ British Pharmacopeia if one chose to call a ship or anything else by that name, no action would lie.
Senator COPELAND. The other day, Dr. Beal, on line 14, page 5, in the same connection criticized the use of the word " simulates." He wanted it to be changed to read “if its name is the same."
Dr. WOODWARD. I heard the criticism and the argument. I think the word "simulates ” is a very good word. Senator COPELAND. Well, he wanted it changed to read“ or fraud
66 ulently conveys the impression that it is a name recognized.”
Dr. WOODWARD. “ Simulate”, seems to me, is adequate.
Now, in connection with the labeling of drugs, discussed particularly in section 6, beginning on page 7 at line 15, I am not here to defend the American Medical Association, because I believe it needs no defense, but I would like to say a word with respect to a preparation that was named here a few days ago—and I am very glad that the matter was brought up—and that is Tucker's Asthma Specific. Dr. Robinson, who spoke on behalf of the Tucker's Asthma Specific, pointed out that it contained no cocaine; in other words, that the cocaine was introduced into the drug at the time of manufacture, but it was decomposed before the drug was sold ; that at the time of sale it contained no cocaine.
It doesn't require any technical knowledge to know that the derivatives of that cocaine remain in that bottle of Tucker's Asthma Specific, and so long as any derivative of opium or cocaine remains in the bottle, that bottle is subject to the provisions of the Harrison Narcotic Act.
Now, under the Harrison Narcotic Act, the narcotic can be sold either on an order form or on the basis of a prescription issued by a physician in the course of his professional attendance. There is no representation that Tucker's Asthma Specific is sold on the
basis of an order form, but the representation is that it is sold on the basis of physicians prescriptions.
In other words, Dr. Robinson, his son, and possibly his wife, all licensed physicians in Ohio, by correspondence all over the country, acting on a series of symptoms, will issue their own prescription, and sell their own remedy.
It is an evasion of the Harrison Narcotic Act that I have never been able to solve, and the activities of the American Medical Association with respect to Tucker's Asthma Specific have had no reference in the world to wringing from Dr. Robinson and his associates any knowledge of the formula, but to seeing that that particular preparation containing a derivative of opium or cocaine was placed on the same basis as other derivatives.
We have taken the matter of these sales up with various offices, and I have a letter from a former Commissioner of Internal Revenue in which he said it seemed to him to be a good thing for the public welfare. He declined to interfere.
We are not interested in Dr. Robinson's formula. Our sole interest is in protecting the public against the use of a drug that comes within the purview of the Harrision Narcotic Act. If Dr. Robinson has built up a clientele of 150,000, without advertising, I leave you to draw your own conclusions. During the great influenza epidemic a correspondent wanted me, as health commissioner of Boston, to dispense to the public a mixture of port wine and tincture of laudanum-a wine glass of port wine with 5 drops of the tincture of laudanum every 2 hours until the patient felt better.
Senator COPELAND. What they wanted me to do was give them free whisky.
Dr. WOODWARD. If I had given all comers 2 ounces of port wine with 5 drops of laudanum every 2 hours, I am sure I should have been a very popular health officer and no doubt I should have worked up a clientele of more than 150,000 very promptly.
Ecgonine, the drug that results from the breaking down of cocaine, is within the purview of the Harrison Narcotic Act. There is no reason why Tucker's Asthma Specific should not be regulated by that act.
Senator COPELAND. Doctor, if you will pardon me. I am not clear exactly-probably you are not in your mind—as to how we are going to meet that problem.
Dr. WOODWARD. You mean the Tucker's Asthma Specific?
Dr. WOODWARD. All they need do is enforce the law. The law says you must sell that opium and cocaine, and the compounds and derivatives thereof in either of two ways. A man who is registered under the Harrison Narcotic Act gets certain order forms from the Government, and he is bound to use an official order form to buy any narcotic for his own use. A physician, in the course of his professional service, is at liberty to prescribe, and his patient thereupon, on the basis of that prescription, can get the medicine, or a physician can administer in the course of his professional practice, or he can dispense in the course of his professional practice, but it is no part of the professional practice of a physician to prescribe for patients all over the United States by mail, to prescribe narcotics.
Dr. Robinson told me, in a conversation not long ago, that he had a United States license to practice medicine. I assured him he was mistaken, because there was no such license and there could be no such license. He promised me that he would go back to his office and look it up. I am sure he did not find any.
Now, it is unlawful for him to practice medicine in the States where he is not license, and the fact he happens to reside in Ohio, when his patients are in Louisiana or Oregon, does not make the offense any less, but never having been in the State, he cannot be brought from Ohio for trial, because he is not a fugitive from justice.
I think it is a matter of law enforcement, enforcement of the law as it now stands. I only want to indicate we are not persecuting Dr. Robinson. We have no interest in this other than the public interesi.
The CHAIRMAN. Do you know what his formula is, Doctor?
Dr. WOODWARD. I know from his own statement that they put in 5 grains of cocaine with some alkaline preparations, and in the course of time, when the material ripens, as they say, the cocaine is broken down, and it leaves residues of the cocaine, which is known as ergonine. I believe the coronine, a derivative of cocaine, comes within the Harrison Narcotic Act.
The CHAIRMAN. You referred to practicing in Louisiana and the other States. Do you mean by that he should not have the right to send medicine from one State to another, or write a prescription, and so on?
Dr. WOODWARD). I mean if he dispenses, quite aside from th matter of practicing medicine, if he dispenses narcotics outside of the collection district in which his office is, he must register in that other collection district
The CHAIRMAN. Does the same thing apply to these persons who recommend and sell devices and appliances that are used ?
Dr. WOODWARD. It is only under the Harrison Narcotic Act that that strict requirement prevails.
I will say this, in view of the fact, that we are represented as such a heartless crew, in respect to this preparation, that something might be said with respect to one who owns such an allegedly valuable remedy for the relief of human suffering, who insists on keeping it secret instead of letting the medical profession the country over and the world over use it for the relief of human suffering.
The CHAIRMAN. Do you think every man who discovers a remedy or a treatment ought to tell the general public all about it and let everybody else profit?
Dr. WOODWARD. As a general proposition, that is the position taken by the American Medical Association, with this provision: A physician is not expected to take out a patent on any device or remedly for his personal profit.
Now in the case of a drug such as insulin, where the manufacture and distribution is a highly specialized business, no exception is taken to taking out a patent so as to control the manufacture and see that it is properly manufactured under that patent, but the persons who take out the patent derive no personal pecuniary benefit from it. I don't know how the insulin patent was handled, but I do know of patents that have been obtained in the United States, with absolutely no objection which the patentee has assigned to a
trust or a foundation to administer, and that trust or foundation licenses manufacturers who are properly equipped, and uses the money that it derives from the royalties, either for the purpose of the control of the product or for the promotion of science, but the patentee derives no benefit.
Now, coming to a trivial matter, one that may be trivial but ought to be considered, there seems to be confusion in places in the act with respect to the use of the terms “label” and “labeling."
Technically, they have very different meanings, and I am not always sure from the position of the word, whether the reference is to a label or labeling. We have instances on page 8.
Senator COPELAND. Page 8.
And then on the same page in line 13, we have-
Senator COPELAND. I would not say there is any question as to line 4. Now perhaps the way I read it is an indication that I did not see the other side of it.
Dr. WOODWARD. As compared with the provision in line 13 on the same page, where the reference is to "label.”
Then if you will refer to page 10, beginning with line 18
Dr. WOODWARD. Yes; I remember the difference. There is a statutory distinction in the use of the terms. It is not clear to me that that has been followed through. I have in mind, for instance, you will have better legislation if you will turn to page 10, beginning with line 18, which reads:
A drug shall be deemed to be misbranded (a) 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.
If where means wherever the name of the drug occurs, it would be better to use the word “wherever.” That is a matter of detail.
Minimum standards are referred to on page 9, line 15. There has been some confusion, it seems to me, concerning the meaning of the term “minimum standards." Basic standards are certainly necessary. Such standards cannot represent the maximum of purity and potency. They must represent reasonable standards, such as are necessary to accomplish the purposes of the act. They are the basic standards, and as such are essential.
Senator COPELAND. You think it should be left in the bill as it is here.
Dr. WOODWARD. If the word “minimum " is objectionable, it might be paraphrased. You might say “a standard below which a food, drug, or cosmetic cannot lawfully be manufactured, distributed, or sold.” The standard thus fixed need not and should not be the lowest possible standard. It should be the lowest standard consistent with accomplishment of the purposes of the act.
On page 11, lines 5 and 6, exception has been taken to the phrase, or any other narcotic or hypnotic substance which." Senator COPELAND. What page is that?
Dr. WOODWARD. Page 11, lines 5 and 6. Exception has been taken to the phrase," or any other narcotic or hypnotic substance which is habit forming."
Senator COPELAND. Dr. Beal objected to that.
Dr. WOODWARD. Clearly, if you are going to omit that language some provision should be made for adding to this list.
Senator COPELAND. That is what we want to avoid.
Dr. WOODWARD. Heroin was introduced as a derivative of opium, which was not habit forming. We soon learned to our sorrow it was the worst derivative of opium with respect to habit forming that there is. The same thing is liable to happen again.
Reference was made by a speaker to traces of arsenic that occur in the course of nature in food and drugs. That can very readily be cared for by limiting the tolerance. The traces are so small they are very seldom found.
Senator COPELAND. Doctor, have there been any narcotic or hypnotic substances discovered within the last 250 years?
What are you laughing about?
The CHAIRMAN. Doctor, you have made a very splendid statement in many ways. We have given you an hour and a quarter. You asked for 30 minutes. There are many other people here. Would you mind turning to some other point or file a brief on the subjects that you have to discuss, if you have anything in addition to what you said?
Dr. WOODWARD. I would be glad to, but there is one matter that I would like to cover. I beg your pardon for taking such a long time. I did not realize that I was taking as much time as I seem to be taking.
The CHAIRMAN. We are not complaining, we just call your attention to the situation.
Dr. WOODWARD. I apologize. There is one matter I was going to speak of that is of some interest to the persons here who want to make a reply, and that refers to pharmacopeias, and the matter of regulation. So if we may skip everything else, and let me file a brief concerning other matters, it will give the gentlemen here who are interested in the pharmacopæias a chance to reply.
The CHAIRMAN. You can file as exhaustive a brief as you care to, doctor. We have no objection to that.
Dr. WOODWARD. I question very seriously the legality or the expediency of referring to these pharmacopæias, or any other pharmacopoeias, as standards. I know that they have been so referred to in the act of 1906 and in the State acts. I know that there are decisions which hold that a legislature cannot anticipate what the standards will be, and then adopt those future standards. Remember that the pharmacopæias and the National Formulary are prepared by private organizations determining their own membership, determining their own rules, determining their own methods of promulgation of their findings. The Congress could, of course, , adopt any existing book, whether written by an individual or spon