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In preparing one of the medicines we give our patients we use cocaine but this is put into a solution which is alkaline in reaction and is from 6 months to years old before it is dispensed.
Every book I have ever seen which deals with the subject says that cocaine is quickly decomposed if put into an alkaline solutionthat is, it begins to decompose in a few minutes and the decomposition progresses rapidly. Every physician, pharmacologist, and chemist in this room knows this is true.
Many years ago we were notified that we must put a cocaine label on the bottle, which we did. Some years later, a gentleman came to our office and notified us that he was from the Food and Drug Department in Washington and that his duty was to notify us that if we did not at once quit mislabeling our preparation he would have to arrest me. His statement was that the Department had just finished analyzing 22 specimens and that there was not a trace of cocaine in a single one. Our answer was that in the files in Washington he would find not onė but a whole sheaf of letters from us saying there was no cocaine in the finished product and explaining why.
One department says we must label it as containing cocaine, another department says we must not. Under this bill we would probably be required to put on a label saying, “ May be habit forming. If we did this we would be liable to arrest and imprisonment for fraud, for it can be easily proven that this preparation, which contains no cocaine, has been in use for 43 years and has never yet caused an addiction. I can assure you that the Government and our friends the enemy have fine-combed the country many times seeking
I have several pieces of property. I even have some stocks and bonds, but by far the most valuable thing I possess is my formula. If this bill becomes a law you will confiscate my business. As an economic proposition that would probably be of small consequence except to me, but it would mean that thousands and tens of thousands who are now comfortable would have to go back to the tortures of asthma and hay fever.
Each of you Senators will probably receive from our patients a few personal letters. These will be from patients whom you know personally. I am sure they will convince you of the good we are doing. If, however, you desire further information, we will be pleased to have 1,000 of our patients send you letters, and then, if you are not satisfied, we will send you 10,000, and still if you are hungry for information, we will be pleased to have them send you 50,000 more.
We object to bill 2800, particularly, and, first, section 6, on page 7, because it says there it would be misbranded or false and misleading if it was not supported by substantial medical opinion.
Now, we have doctors among our patients. When the doctors themselves get asthma in their own tubes, they come to us. We have today some of the outstanding medical men in America as our patients.
Yet we are certainly persona non grata with the official organization of the doctors, as was demonstrated here yesterday when it was reported by Dr. Beal that he had been informed that there were some
doctors out in Ohio who were sending out a preparation that contained cocaine. Now, the doctor who wrote that letter in Chicago, or wherever it was written, knew just as well as I know that there is no cocaine in our preparation. He knows it because we have told it to him, and if he knows his pharmacology and his chemistry, he could not help but know it, and he knows it by his own examinations because he has published it in his own official organ. That statement cannot be possibly justified, and yet that is what we are up against.
Now, then, we could appeal to physicians who are our patients to come over here and testify for us, but we are too considerate of their feelings and their positions to ask them to do it, because we know, from personal experience, that being persona non grata with the American Medical Association is not a pleasant position to occupy, and we know also from further experience that any physician who would come to our assistance in the slightest degree would immediately be classed among such people as we are.
Now, then, the next thing is a demonstrable scientific fact: How can we demonstrate that we can relieve asthma and hay fever? Within the last 3 weeks I submitted to a prominent physician in the city of Washington this statement: I said, “We can demonstrate that we can relieve asthma by such people as these.”
And I handed the doctor a paper containing a long list of names, every one of which you gentlemen would recognize instantly, everyone in the room would recognize instantly if I should name them. I said, “ There is a list of a few of our patients in Washington. We do not have to go to the House or Senate to find people who will know what they are talking about when they speak of our preparations.". His reaction was to contemptuously flip the paper back to me saying, “ I should just as soon take the word of so many street sweepers as the word of that many Senators or others in the Government.” So you see while I am classed very low in some particulars you gentlemen are not classed much higher in intelligence than I am.
On page 10, beginning at line 18, it says-
(a) If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative.
Now, then, we have been accused of most everything on the calendar from saying that our treatment was a specific cure to murder—and I mean that literally, we were once brought into court because we labeled our preparation as a specific relief for asthma. We definitely say that it is a specific for asthma. We were brought into the courts on that proposition, and after the courts spent several days hearing the evidence in the case they said, Without question, this is a specific treatment for asthma, and to this day we label it asthma specific.
If this bill becomes a law, I don't know what effect it would have on us, whether they could go back and bring us into court again on that label or not, but anyhow we at present have a statement, have a decision of the court, the court in Columbus, Ohio, the Federal court, that it is a specific.
Now then, on page 11 there are named a number of drugs, among them being cocaine. There is no cocaine in our preparation, ac
cording to our statement and according to the statement of the Food and Drugs Department, but where we would be, I don't know. I don't know if they want a cocaine label on it. I have no objection in the world to putting it on there. I don't say that it accomplishes any good, and I am sure I could explain to you where it is a most dangerous thing to do.
Now, then, if in New York City or some place else there are men who are doing vicious things, such as some of the things that are shown over here in the Chamber of Horrors—and I was astounded when I got over there to see what was in the Chamber of Horrors and reading the list of those things I never had heard of a single one of them, and when I saw them I found that it was some things over here in some of our big cities. Now, then, if some people are doing something that is vicious, they can and should be suppressed. I am as heartily in favor of suppressing them as any of you should be. But why, in order to catch a few rats in New York, should you burn my laboratory and my office when I am doing good for the people of this country, and when, if you wish, I can bring the evidence of 150,000 people to prove it?
I certainly object to disclosing my formula, and if such a thing should be required, without hestitation I should have to stop business.
Now, gentlemen, this is just a few of the things that I would like to say to you, but you are kind enough to give me, an individual, this much time. I would be most happy to answer any questions. Senator VANDENBERG. You say you have never done
Dr. ROBINSON. We have never spent a nickel in any manner, shape, or form. We have never up to this minute asked anybody to become our patient. If somebody hears of us through some other patient we are delighted to treat him. We give everybody the very best service we can. The fact that some 150,000 people come to our little town and have come to see us is pretty conclusive evidence to me that they are satisfied with what we are doing for them. Our treatments would cost them perhaps $2 to $4 a year. While I am an old-school physician, a regular, my wife happened to be a practicing homeopathic physician and we had many arguments as to the virtue of the infinitesimal doses of the homeopaths, and her final argument usually is, “ Take the dose of medicine you are using in your treatment of asthma and the doses in my homeopathic medicine are bigger than the doses you are giving in your asthma specific.” But the fact of the matter is that so far as it relieves asthma I don't care whether it is homeopathic or allopathic, or whatever it may be, so long as the patient gets relief and they are satisfied.
Senator VANDENBERG. I think you have very effectively broken your advertising rules.
Dr. Robinson. The only advertising we ever have had- I probably should qualify that in this particular-ever so often one of our good enemies publishes an unfavorable comment about us, and the result is that within the next 2, 3, or 4 weeks we get from 15 to 25 extra physicians as patients, and some two or three or four or five hundred extra people who hear of it through having happened to see the article on the table of the doctor.
Senator Murphy. May I inquire why you are persona non grata with the American Medical Association ?
Dr. ROBINSON. Some years ago I wrote to the A.M.A. and stated our
case as frankly as I could, and the answer was if I would come to Chicago and give them my formula and process of manufacture they would be perfectly delighted to approve my preparation. answer was: That is the most valuable piece of property I possess; and when you give all of your property and your income to the people generally, then come to me, and we will consider the advisability of my giving you my property.”
I can get their approval overnight, so this letter said, if I give them my property. But, gentlemen, I have to make a living the same as they do. You may find people who criticize us, but you certainly cannot find them among our patients.
Thank you, gentlemen, very much.
STATEMENT BY GEORGE W. McCOY, NATIONAL INSTITUTE OF HEALTH, UNITED STATES PUBLIC HEALTH SERVICE, WASHINGTON, D.C.
Mr. McCoy. I am only here to call your attention to one feature in S. 2800, and that is that the permit factories, on pages 18 and 19, which is in effect, provides for a system of factory permits which would permit complete duplication of the work carried out by the Public Health Service under the provisions of the act of July 1, 1902, entitled "An act to regulate the sale of viruses, serums, antitoxins, and analogous drugs in the District of Columbia, to regulate interstate traffic in said articles, and for other purposes."
This S. 2800 provides for a similar system of licenses under the name of permits to be enforced through the Agricultural Department, and I can readily see it would bring about a situation which would be a duplication of work and effort and perhaps some conflict of authority
I have no further comments to make on it. I wanted to bring this to the attention of the committee.
I thank you.
The CHAIRMAN. Do you have anything you want to file?
STATEMENT BY J. P. SNYDER, NORWICH, N.Y., OF THE NORWICH
Mr. SNYDER. My name is J. P. Snyder. I am chief chemist for the Norwich Pharmacal Co., and as such I am called upon to serve in the position of controlling a complete line of pharmaceuticals according to the Food and Drugs Act. Consequently, I have been extremely interested in the various bills that have been presented before the different bodies, and at the outset I would say that I am extremely favorable to the McCarran-Jenckes bill. However, I understand we are here today to discuss S. 2800, and I want to point out one or two things in S. 2800 and offer constructive amendments which I think you will be inclined to adopt.
Section 4 (b) of S. 2800, introduced by Senator Copeland, lines 5 to 11, on page 6, reads as follows:
No drug shall be deemed to be adulterated under subdivision (g) of this paragraph if its 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, as determined by the tests or methods of assay applicable under this paragraph.
The paragraph, although expressed in somewhat different words, does not differ materially from a similar provision in the present Food and Drugs Act.
It is an excellent provision of the law and one which has served the people of the United States admirably since in many instances it has placed in their hands medicinals of a higher quality or purity than would otherwise have been possible.
Numerous illustrations of this situation might be related. However, I will not burden you with but one, as this will prolably suffice.
Shortly following the introduction of one edition of the Pharmacopæia, manufacturers of antitoxin were able to greatly improve their process for the production of diphtheria antitoxin. Not alone were they able to greatly increase the potency of the product but they clevised means of getting rid of certain impurities, thereby making it less dangerous when injected.
The variation clause in the present law permitted manufacturers to at once place the improved diphtheria antitoxin upon the market, labeling it to show the difference from the official product of the Pharmacopeia.
If the law had not wisely provided for this advance in the science of medicine, it in all probability would have been lost for some time to the American public since probably years would have elapsed before the change could have been incorporated into the Pharmacopeia.
It would seem that the intent of S. 2800 was to permit the public to obtain full advantage of any improvements in the science of medicine without waiting years for the Pharmacopæia or National Formulary Committees to act.
Unfortunately, however, we find the variation clause as given in section 4 (b) of S. 2800 is entirely voided by section 8 (f) on page 12, lines 16 to 18, which reads:
Sec. 8. A drug shall be deemed to be misbranded
(f) If its name is the same as, or simulates, a name recognized in an official compendium and it is not packaged and labeled as prescribed therein.
Accordingly, while it is evidently the intent of this law to permit variation such as was illustrated with diphtheria antitoxin, article (f) of section 8 prohibits such improvements in medicinal products by providing they must be labeled as prescribed in an official compendium, if it bears the same or a similar name.
Article (f) of section 8 should be amended so that it will conform to the variation clause as given in section 4, article (b). This can be accomplished by adding on page 12, line 18, after the word “therein ”, the following:
Except as provided in section 4 (b).
(f) If its name is the same, or simulates, a name recognized in an official compendium and it is not packaged and labeled as prescribed therein, except as provided in section 4 (b).