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FOOD, DRUGS, AND COSMETICS
Mr. CAMPBELL. I was buying that in liseuses such as influenza, medical science knows nothing of a specific cure, and I think the chairman will support ine in tho statement that the medicul frutornity knows of nothing that will provent or cure this disease. The most that the medical fraternity can do is to let the disease run its course, and to givo you medicines which will operate ils anodynes until the disoase has run its course.
The CHAIRMAN. I think that is a frir statoinent of facts.
Mr. CAMPBELL. Under such circumstancos you should not be sold a ruinedy labeled as a curo for that disonso unless it is a cure for that discaso. You have the right to buy it intelligently. You should have the right to buy it with full knowledgo of the fact that it will not opornte us a cure if it is inorely pullintive. This particular paragraph proposos such a requirement. I might say that this particular paragraph, perlaps with the ono relating to udvortising, hus beon rosponsiblo for most of the wislospiroul protosts against this bill. It has dovolopou the most bittor exprossions of opposition. It is tho opposition of thoso manulucturer's who for yours linvo mado a rich living by proying upon the doluded public, whom they have deceived and defrauded from time imunomoriul. By playing upon their fours and superstitions, they have prepare and sold to the sick so-called medicines which are of littlo or jo value in the treatment of diseases for which thoy are recommendeel. It this
of manufacturors that huve objocted so strenuously to this part of the bill. It only provides for slight information. Manufacturers must inako somo lubel statement which will prevent the purchuser, the prospectivo buyer, from believing it to be a cure when it is only a palliativo. That is about all this parugruple will do.
The ChallMAN. As a matter of fact, is that not the proutice of the department now?
Mr. CAMPBELL. At the prosent time if a statement is made or tho lubel of a medicine for the troutment of various diseases, and the modicine itself is of no value in the trentment of these disenses, and it can bo shown that the manufacturer of the product know that it hud no value in the troutinont of these diseases its shipment in interstato commerco would be a violation of tho luw; but proof of all theso things is absolutely required in our testimony. Wint we are anxious to do in the protection of the public is to remove certuin of the existing restrictive provisions and thus mako possible better control of this situation. The languago in the succeeding itom (2) makes it unnocessary to show that the manufacturor know the limitations of his product. It would no longer munke ignorance a defense.
Senator McNary. You have mudo a very clour explanation and it may be a very gooil provision, but in the case of a difference of opinion among medical oxperts as to whether the medicine is a "uro or r palliative, you go to the court for å linal clocision?
Mr. CAMPBELL. Yes. If there is a dislorence of medical opinion wo would not go to court, beralise in order for the Department to tako nction, under the terms of this lungunge, there must be shown; first, an ngroanent of medical opinion; und, second, that the claims mado aro contrary to it.
Tho CHAIRMAN. I think in your later soction on page 13 you havo inade a list of those diseases?
Mr. CAMPBELL. Those aro incurable diseases.
FOOD, DRUGS, AND COSMETICS
The Chairman. You come now to do. 2.
Mr. CAMPRELL. Let me point out to you what the effect of the entire paragraph (n) is. It gives to tho consumer but slight protection. I am trying to show how that is. That language declares a drug shall be deemed to be misbranded, "if its Inbeling bear's the name of any disease for which the drug is not a specific cure but is a pollintive, and fails to hear in juxtaposition with such name and in letters of the same size and prominence a statement that the drug is not a cure for such disease; or if its Inbeling hear's any representation, directly or by ambiguity or inference, concerning the cflect of such drug which is contrary to the general ngreement of medical opinion.
I nin not discussing further the terms "ambiguity" or "inference." I think we have gone into that susiciently. You will notice that the item goes further; it requires that the revielial clains be not contrary to the grncral ngrecment of inediend opinion.
Senator McNany. Ilow is that competent? How is that general agreement of medical opinion obtnined?
Mr. CAMPRELL. That can be obtained very easily. We obtain it in this fashion now; when we consider products whose Inbeling shows them to he trentinents for various disenses, we determine the composition of those products, their ingredients, and go to the medical fraternity, generally, and learn their opinion of the truthsulness of such remedial claims. "We encounter differences of modical opinion. If we do encounter such disforences and there are, for instance, 80 percent of the physirinns consulted who say that the product wns n treatment under thö outlined directions for use nnd 20 percent of them said it was not, there would be no cnsc which the Department could bring. The roverse figures could be used. Is 20 percent of them were to sny it wis an effective remedy and 80 percent that it was not, there would be no violation of the law.
Senator McNARY. What is the percentage nt which it becomes a violation of the Inw?
Mr. CAMPBELL. It must bo alniost 100 percent general ngreomont of inedical opinion.
Senator McNary. Is that not impossible to acquiro?
Mr. CAMPBELL.. It is possible. I think with respect to a grout many products it is. Jlere is n horse liniment. It is alright so far as liniments go. For purposes of this exhibition, I attach no significance to my designation of it as a horse linin.ent. But this is a horse linie ment, and was prepared for uso on horses. | The CHAINMAN.' Ilave you got nny wny to linve thint defined for and confined to borscs? | Mr. CAMPRELI.. Tho iden originally wos, possibly, to have thint done, but tlie formula for this liniment was sold to a mannincturer who began immedintely to market it as a treatment for tuberculosis, cancer, locomotor ntaxin, and other diseases, in fact for almost every imaginable disease. You can see by inspection how inany disenses are listed.
Tho CHAIRMAN. In fact, what you mean by medical opinion is the conclusion resulting from scientific and clinical tests?
Mr. CamrRELL, Ohi, cortainly. Senator, there would be no dif. ficulty in finding out what the general ingreement or the consensus of medical opinion is nbout the value of thnt liniment, composed of ammonin, eggs, and turpentine, for the treatment of tuberculosis.
FOOD, DRUGS, AND COSMETICS
It is a matter of extreme case to do so. I know of but one plıysician who would testify that it was properly labeled, and he was brought forward 119 al defense witness in the trial of that caso. Subsequently ho was expelled from the local modicul association. To wils deprivod, I believe, of his licenso to practice. There lins been a tremendous ainount of misunderstanding about the requirements of this soction. That misunderstanding has been very adroitly developed and fostered. Wo have heard statements thint you could not go to a drug storo and buy nspirin tablets without getting a physician's prescription. Nothing is more absurd; nothing is more ridiculous or far-fetched.
The Chairman. When it is bought as a specific, not is a cure.
Mr. CAMIBELI. Aspirin is an anodyne and dulls pain. It ought to be sold with that inderstanding, and I think it is generally sold with that understanding.
I know that there are osteopaths who think is this bill passes they will be required to cluso 11p shop. There is no provision whintovor to that effect. Such result is as far fron the thought behind this bill or roquirements of this paragraph is it is possible to be. There is nothing to that whatever. This is no possible relationship whatever to the creation of such a situntion; this has no bearing on the dif, ferences of medical thought is expressed by different schools of medicine. The only thing the item doos say is, is the labeling of tho product is contrary—and note the significance of tho word "contrary"-to the general agreument of medical opinion, it is u violation of the law.
Here is a product which it would affect. In connection with this liniment, the Department spent 10 years and $75,000 to bring about that modification of the label which you see by comparing the two bottles. It was imperative that we prove in court that the product wils falsely labeled, that it would not have any effect whatevor on the diseases which' it was claimed to curo; ulso it wns imperative that we prove thut the inanufacturer knew that it was not effective
Wo could not in the first buttle provo that the munufacturer know that it was of no value. We wero only uble to do it in our subsequent battles when we obtained evidence in connection with one of the testimonials which he incorporated in this circulars. It relates to the experience of one who had been taking his product us a treutmont for tuberculosis. We showed that subsequently that person died from tuberculosis. Then, after her death, this person's son continuod to write the testimonials in the name of his deceused mother, and wo provod ibut they both received munificent donations from the manufacturer. Thut wus ground to justify the jury in believing that the manufacturer ucted fraudulently und knew that his product was worthless, notwithstanding his oniphatic assertion of his porsonal conviction that the product was a cure for the various diseases listod on the bottle label.
Here is another product known as Brmbar. It is recommended for the treatment of diabetes. This product is essentially n brow of horsetril weeds to be found in some sectious yrowing along tho railroud tracks. It was produced not by a person with medical knowledge, hut by a former sulesinan of shirts. It has been sold widely. Unfortunately, it has been used extensively by the victims of diabetes. These sufferers did have available an effective agent for the pro
FOOD, DRUGS, AND COSMETICS
longation of their lives in insulin, but they were persunded to forego that, and become patrons of the manufacturer of this worthless nostrum. Some pitiful testimonials were submitted by the peoplo who had been persuaded to buy and use this product. Subscquently some of these individunds diod.
We tried that onse. The Governinent lost. It lost becauso of the limitation of the law as it esists now, making it necessary for us to slow that the manufacturer knew that liis product was not in treatinent for dinbetes. Under present circumstances, n denizen of Central Africa, knowing nothing about administering to the sick, other than that imparted by the practices of a witch doctor, could land in this country, put up an article cither of no more therapeutic value than a glass of water or is lethal ns strychnine, sell it to the people of this country as a cure for very discaso which man night hove, and be within the terms of the Inw. His ignorance is his defenso. The same product put out hy sojne manufacturer with knowledge of medicine would be in ossense under the Inw. But the crrect on the public in cither case would be the same. "Through this provision of the bill, it would be possible to give far more protection to the public than can bo done now. I think it is extremely important.
There will be interesting arguments, and there are going to be extensive references in the discussion liere to this porngraph and its manner of operation. Under the terms of the present. Inw we first undertook to control these medicinal products under the general misbranding provision. We took notioni ngninst 11. caurer cure. The indictment was quashed on motion of the defendant and the case eventually went to the Supreme Court The Supreme Court allirnied the decision of the lower court, holding that the terms of the act applied in nowise to remedial claims. That opinion was one which took into account particularly that portion of the sontence in the present Inw, page 17, section 8, reading, "That the term 'misbranded' os used herein, shall apply to all drugs or articles of food, or articles which enter into the composition of food, the packnge or label of which shall boor any statement, design, or device regarding such article."
Mr. Justice Holmes rendered the majority opinion of the court, and after a scholarly dissertation characteristic or him, on the logical and idiomatic meaning of words, he coucluded with this stateinent:
It (Congress) was much more likely to prgilate comincrco in food and driiga witli reference to plain matter of fact, no that food and drugs should be what they prosesseri to be, when the kind was einter, than to distort thic uses of its constituitional power to establish criteria in regiona wlivre opinions are far apart.
The whole purpose of that decision wiis merely to cliselvac the intent that Congress itself had in mind. The court lield that Congress intended to have the langungo of the sot apply to the identity of particular produrls, drug products, to statements mado about inuiters of fact, such as whai ingredients were there, rather than to the remedinl claims. Congress, according to the statement of Justice Holmes, was not disposed to go into regions where opinions are far apart and establish criteria by which traffic in such products could be controlled.
There was a strong ininority opiniosi rendered by Mr. Justice Flughes. I shall read two cxcerpts from it:
The argument is that the curtive properties of articles purveyou as medicinal preparations are matters or opinion, and the contrariety of views Among medical practitioners, and the conllict between the schools of medicine are impressively FOOD, DRUGS, AND COSMETICS
described. But, granting the wide domain of opinion, and allowing the broadent range tu the conflict of inedical views, there still remuins a lield in which stuloments as to curitive properties are downright fulmeloods and in no sense expres. sions of judgment. This field, I believe, this stututo covory.
Justico Hughes concludos with this staternent: I entirely agree that in any cane brought under the act for misbranding-by a false or misleading stateinont us to curative properties of an article--it would be thu duty of the court to direct an acquittal whon it appeared that the staternent concerned a matter of opinion. Conviction would stund vuly where it had been shown that, apart from any question of opinion, the so-called remedy was alsolutely worthless, and hence the label demonstrably fulse; but in such caso it seems to juu l be fully authorized by the statute.
To CHAIRMAN. Give us the citation.
Mr. CAMPBELL. United States Reports, 221 U.S. 488. The point I wish to stress here is that the majority opinion of the court was of the belief that the langunge did not undertako to regulato in any way therapoutic statements. The minority opinion was that it did undertake lo regulate therapeutic stutements in that field where questions of opinion were not involved because the stulements were absolutely false; so inuch so that no difference of medical opinion could exist. As Mr. Justice Hughes anid, concoding all the scope necessary for the entertuinment of differences of opinion, certainly, there doos como a point in this sculo in which there aro' no difforonces of opinion, in which there is a manimity of opinion about the worthlessness of product. All wo uro usking in this particular paragraph in this bill, is that lungungo bo omployed which will create no doubt in the mind of the court us was done in this cuso about the legislative intont. Let mo suy .ut immodiately after the Supreme Court decision wus rondered, there wils 10 power lost within the Dopurunent for the rogulation of patent medicines. We could not give consideration at all to ronoliul cluinis of uny nature. It was no ofronse for any
manufucLurer to mark ti worthless product as a cure for any disease. We could do nothing about it. Then Congress passed the Shirley amendment in 1912. That amendment did not prove to be a satisfuctory solution. It holds that such products will be deemed to bo inisbranded
The CHAIRMAN. Where do you find that?
The CHAIRMAN. Somebody wanted to know when we will adjourn. We will udjourn not later than 1:30 and reconvene not later thun 2:30.
Mr. (AMIHELL. That lungtinge is Tlint for the purposes of this act an article shall also be deemed to be misbranded: In the case of druge, if its pinokuge or label shall bear or contain uny statement, design, or device regarding the curutive or therapentie oiteet of such article or any of the ingredients or silstances contained therein, which is false nud fraudulent.
It is imposed upon the Department of Agriculture tho duty of proving that the ninnufucturer in telling a lie about his product, know that he was telling such a lie. This was what we could not ilo in tho CHAO of this linbetos nostrum. Whut wo aro asking for in this paragraph is relief from that restriction. That is all that is involved in this provision. It will require the manufacturer of a drug product to dotermine whether it is or is not of valuo. The CHAIRMAN. That would be subject to court appeal?