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FOOD, DRUGS, AND COSMETICS
Tnko ipecnc. That is n drug introduced many yonds ngo as a ouro for anochic dysentary. It enjoyed a great ropute for many years. In other words, it reprosented the general agreement of medical opinion. Then it went out of repute, and dropped clear out as a treatment for nmoebic dysentary. The uso of it only continued with some various homicopathic and eclectics, but it was entirely out of repute with the balance of the physicians. Then suddenly the slant turned the other wny and now nnd for a number of years ipocnc and its two alkoloids are firmly established as the most ellicient ngents that we have for the combatting of amoebic dysentary.
They also use molarin gorms as a cure for paralysis. They will give a man malarin to curo the paralysis, and cure tho malaria some
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, alniost as hard as it is to get a general agreoment as to any legal proposition.
I have wondered about that, and liavo suggested at various times whother or not we might not use the langungo that tho goneral agreement as to the classes resulting froin scientific or clinical diseases, or something like that. I know how difficult it would bo, but Mr. Campbell this morning, I think, got down to a percentage of 80. That would be a high percentage.
Dr. BEAL. Yos.
Dr. Bral. We are confronted with this situation, that we have no delinite method of determining therapeutic value.
Now, that seems strange to tho lnymon who has followod popular literature, and who thinks thnt we havo some kind of a magic wand, and that we can put the drug on it, and determine whether it would be a good inedicine or not, or ho 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 aro deadly to men, and some humans can cat the kind of foods which nrc deadly to guinea pigs. Thore is a lack of parallol action betwcon tho kuinen pig and the man. Whon wo try a drug on the guinea pig, and that is all, and if wo 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 ponto, overy administration of a dose of medicino is an expori. ment. Your patient is a test, tube, and you put the medicine in it and test the tubo and see what hoppons, but you are guidod by the fact thnt the physician himself hns had a long poriod of clinical exporionco; that bo hng behind him n record of gonoration aftor gonerntion of physicians who employod tho Anno drugs in the amo way, who stoori by the bodside and liave obsorved tho fluctuating tide of liso ns it responded to these different romodies. Ho has somothing to
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 camo, that we should disrogard the old knowlerige of modicine. Sonin of the most volunblo knowlodgo that wo havn concerning drugs and the action of modicinos on tho human system runs back to the days of Ilypocrntos and Diaschtos.
FOOD, DRUGS, AND COSMETICS
Some of the most certain data that we have, some of tho inost standard medicinos that wo huvo in the Pharmacopoein, have boon there from the dnys when the first practitioners of medicine in Egypt were known and they still give results; and, us for myself, if I had my life in dungor, 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, uctual experience with the treatment of patients, than to ihe man who has just como out of the guinea-pig, laboratory, because I have stood behind the prescription counter and have filled presoriptions by the guinea-pig doctor and proscriptions written by ihe coinpotent but still inexperionced practitioner, and I know whut hupponed to the patients who took thono difforent proscriptions. (Laughter.]
Sonator COPELAND. I think that we ought to say, in defense of Dr. Emorson, that ho roally did not intend, I judge, to relloct on those ancient remedies which are still considered to be good. What he was talking about wus temporary medical opinion and temporary drugs.
Dr. BEAL. My personal opinion is that he really did not intend to say what his expressions indicatod.
Now, instond of leaving it to tho 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 simplor if wo 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.'
Another very important foature of section 8 is found in paragraph (b), which enumeintos a list of drugs designatod as “narcotic or hypnotic substances" and their derivatives by actual or theoretical chernical reaction", the quantity or proportion of which must be declared on the label and accompanied by the statement, “Warningmay be habit forniing.
Hero we see illustrated the common mistuke of the layman, namely, that the word "narcotic" is synonymous with the word "habito forming.", whereas as a inatter of fact there are dozens, and perhaps hundrods of drugs, as for example, the oils of lemon and orange and othor common and essential oils which have well dofined narcotic properties, but are not in the slightest degree habit forming:
Another objoctionable feature of this paragraph is the inclusion of “theoretical chemical derivatives." Anyono' fanuliar with the hypotheses of chemical substitution is awaru of the fact that almost any choinical compound can be conceived as thooretically a derivative of almost any other compound, even though they cannot be so derived in practico.
Another objection I have to this soction is that it authorizos the Secretary to add to the list of habit-forining drugs such other substances as "as ho muy find to possess narcotic or hypnotic propertios." Thero is a confusion of the words "narcotic" and "hypnotic" with "habit forining”, und yet there is a vory wide difference; we have dozens of drugs, we have hundreds of drugs, which are distinctly narcotic in thoir properties; but they are not in the slightost degree habit forming
FOOD, DRUGS, AND COSMETICS
You know what the oil of peppermint is, and that is a narcotic, as the oil of lemon is, or the oil of the ornnge, all of tho coinnion essential oils, but not one of them has the slightest habit-forming characteristies. 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 nevor 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 herchy authorizerl, lvy regulations prescribed after notice and hearing, to designate ar inrrotick or hyjmoties within the meaning of this paru. graph such other substances in die may find to possess unrcotic or hypnotic properties.
Of course, we know that Judge Campbell would exercise that language rationally or properly, and wo 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.
Jl 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 langunge than is required to confer absolute authority on the Secretary of Agriculture in this respect.
Senator COPELAND. Of course, Doctor, the purpose of n Senatorial henring is to npply the acid test to the langage in the form of a bill.
I do not know who wrote it. I did not write it.
( Senator Coreland. Do not misunderstand ine. I am for the bill, but I do think we should add what you have suggested boforo "narcotic" or "hypnotic"--habit forning. Thnt sounds sensible to me, but we must not be too harsh on those who actually produced tho original act.
Dr. Beal. If you knew how harsh they were on some of us. (Langhter.)
Sonator COPELAND. We are here to try to modify the language and moko it more scientifically accurato, is wo can.
Dr. Beal. They never put cushions in thoir gloves when wo visited thom.
Senator COPELAND. There has not been a lack of that no far as you are concerned, Doctor.
Dr. Beach. I wish also to call attention to another serious defect in this last mentioned authority consorred on the Secretary of Agriculture.
We have, as the honornble chairman is well aware, A number of Jarge manufacturing establishments in this country who are spending hundreds of thousands of dollars in the attempt to dovelop now drugs which assunge 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 nuthorizntion of the Secretary, the work of many experts, research chemists, spending many hundreds of thousands of dollars, inight he wiped out of existenco.
FOOD, DRUGS, AND COSMETICS
We do believe, Mr. Chairman, and we believe it very thoroughly and sincerely, that the protection of the public henlth is parainount to every other interest, but we also want that interpreted in connoction with this further statement, that where health can be equally well or botter 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.
Sonator COPELAND. You remember this morning that Mr. Campbell spoke about somo scientific comunittoes. I think that he has in mindcertainly I lave--- that thero shall be written into this bill u provision for the raising of such committees, to havo it specifically stated that this organization and that organization and the other organization shall be reprosontod, because it stands to renson 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 wolcomo the inclusion in the bill of an arrangement for a comunittee such as I havo indicated.
Dr. Beal. Thnt is why we are here. We have boon chasing them all over the city of Washington to find out whut is in this bill. Senator COPELAND). You have it lore now, and let us fix it
and get it right.
Dr. Beal. Unfortunately, I sat so far back in the room this morning that I could not bear Judge Campbell's very excellent and illuminating address.
Sonator COPELAND, I assure you, Doctor, on that point, and Mr. Campbell will correct ine if I am wrong, that he clearly intimated or directly stated, that it was his intention to have such a scientific comınittee. 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 designution of committous qualified because of their eminence. In the consideration of drug questions, where there is a similar obligation imposed, or similar authority oxtended, they will function the same way.
Dr. BEAL. I think that would be a niost excellent extension of the prosent activities of the Buronu. I do believe that if the Bureau would permit us, in pharinacy, to designate the men of standing, not only scientific standing, but of churnctor 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 theso 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 oflicor best perfornis his function if he keeps in touch with the people to whom his law applies and helps them to understand it and to executo it.
FOOD, DRUGS, AND COSMETICS
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 (o) provides that a drug is not recognized in the U.S.P. of N.F. shall ho docmed to be misbranded if "its label fails to bear the common name of the drug, if any there be, and (2) tho name and quantity or proportion of ench medicinally or physiologically active ingredient thereof."
What common name is referred to? Sometimes a drug has one common namo in Portland, Oreg., and a disforent one in Portland, Mainc. Tuke our good old friend, known in Pennsylvania ne "Black Snake Root." That has a different name in Ohio, still another one in West Virginin, and still others in other States, so what name should be used in that case, and I could go on nnd name any number of drugs which liave different names in different localities, and certain names which apply to a dozen different drugs.
Take Snako Root. We have all kinds of Snake Root, all representing different species of drugs having differont medicinal qualities. Then thus refers to the namo and quantity or proportion of each inodicinally or plıysiologically active ingrodient thereof, in plain English. This means complete formula isclosure, thint is, that the complete disclosure of the ingredients nnd their proportions, shall be sinted on the labol, and thing they shall be stated in the simplost common language, in English.
You know that there is a great doal of difference between the use of English and Latin in medicine. The difference between a proscription in Latin and a prescription in English is always $0.50. (Laughter.)
These arguments for and ngainst formula disclosure are so old that they have becoine 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 tho old arguments in favor is that the patient should know what he is taking. That may have some sneasure of value to him, but how much? He would not know anything more when he did havo 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 tho opportunity of knowing modicinal agents havo been previously alininistered to that patient. That is a really worth while, valid argument, that a physician should have the opportunity of informing himself as to whut his patient had been previously taking.
Thero nro olso somo arguments ngninst it, and one arguinent is this: That a great many people have the pernicious habit of constantly wanting to experiment, and you put the formula on tho back of a preparntion, and they would like to know what those different drugs
Ilow many druggists have had n patient como in nnd nuk to see some yellow dock root or dandelion root or wild cherry bork or something else, and you ask them why they are interested, and they will tell
youl that they want to take it homo and use it as a tea.