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FOOD, DRUGS, AND COSMETICS

Mr. CAMPBELL. I was saying that in diseases such as influenza, medical science knows nothing of a specific cure, and I think the chairman will support me in the statement that the medical fraternity knows of nothing that will prevent or cure this disease. The most that the medical fraternity can do is to let the disease run its course, and to give you medicines which will operate as anodynes until the disease has run its course.

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The CHAIRMAN. I think that is a fair statement of facts.

Mr. CAMPBELL. Under such circumstances you should not be sold a remedy labeled as a cure for that disense unless it is a cure for that disease. You have the right to buy it intelligently. You should have the right to buy it with full knowledge of the fact that it will not operate as a cure if it is merely palliative. This particular paragraph proposes such a requirement. I might say that this particular paragraph, perhaps with the one relating to advertising, has been responsible for most of the widespread protests against this bill. It has developed the most bitter expressions of opposition. It is the opposition of those manufacturers who for years have made a rich living by preying upon the deluded public, whom they have deceived and defrauded from time immemorial. By playing upon their fears and superstitions, they have prepared and sold to the sick so-called medicines which are of little or no value in the treatment of diseases for which they are recommended. It is this group of manufacturers that have objected so strenuously to this part of the bill. It only for information. Manufacturers must make some label statement which will prevent the purchaser, the prospective buyer, from believing it to be a cure when it is only a palliative. That is about all this paragraph will do.

The CHAIRMAN. As a matter of fact, is that not the practice of the department now?

Mr. CAMPBELL. At the present time if a statement is made or the label of a medicine for the treatment of various diseases, and the medicine itself is of no value in the treatment of these diseases, and it can be shown that the manufacturer of the product knew that it had no value in the treatment of these diseases its shipment in interstate commerce would be a violation of the law; but proof of all these things is absolutely required in our testimony. What we are anxious to do in the protection of the public is to remove certain of the existing restrictive provisions and thus make possible better control of this situation. The language in the succeeding item (2) makes it unnecessary to show that the manufacturor knew the limitations of his product. It would no longer make ignorance a defense,

Senator MCNARY. You have made a very clear explanation and it may be a very good provision, but in the case of a difference of opinion among medical experts as to whether the medicine is a cure or a palliative, you go to the court for a final decision?

Mr. CAMPBELL. Yes. If there is a difference of medical opinion we would not go to court, because in order for the Department to take action, under the terms of this language, there must be shown; first, an agreement of medical opinion; and, second, that the claims mado are contrary to it.

The CHAIRMAN. I think in your later section on page 13 you have made a list of those diseases?

Mr. CAMPBELL. Those are incurable diseases.

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The CHAIRMAN. You come now to no. 2.

Mr. CAMPBELL. Let me point out to you what the effect of the entire paragraph (a) is. It gives to the 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 labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear 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 labeling bears any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion.

"

I am not discussing further the terms "ambiguity" or "inference.” I think we have gone into that sufficiently. You will notice that the item goes further; it requires that the remedial claims be not contrary to the general agreement of medical opinion.

Senator MCNARY. How is that competent? How is that general agreement of medical opinion obtained?

Mr. CAMPBELL. That can be obtained very easily. We obtain it in this fashion now; when we consider products whose labeling shows them to be treatments for various diseases, we determine the composition of those products, their ingredients, and go to the medical fraternity, generally, and learn their opinion of the truthfulness of such remedial claims. We encounter differences of medical opinion. If we do encounter such differences and there are, for instance, 80 percent of the physicians consulted who say that the product was a treatment under the outlined directions for use and 20 percent of them said it was not, there would be no case which the Department could bring. The reverse figures could be used. If 20 percent of them were to say it was an effective remedy and 80 percent that it was not, there would be no violation of the law.

Senator McNARY. What is the percentage at which it becomes a violation of the law?

Mr. CAMPBELL. It must be almost 100 percent general agreement of medical opinion.

Senator MCNARY. Is that not impossible to acquire?

Mr. CAMPBELL. It is possible. I think with respect to a great many products it is. Here is a 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 liniment. But this is a horse lini ment, and was prepared for use on horses.

The CHAIRMAN. Have you got any way to have that defined for and confined to horses?

Mr. CAMPBELL. The iden originally was, possibly, to have that done, but the formula for this liniment was sold to a manufacturer who began immediately to market it as a treatment for tuberculosis, cancer, locomotor ataxia, and other diseases, in fact for almost every imaginable disease. You can see by inspection how many diseases are listed.

The CHAIRMAN. In fact, what you mean by medical opinion is the conclusion resulting from scientific and clinical tests?

Mr. CAMPBELL. Oh, certainly. Senator, there would be no difficulty in finding out what the general agreement or the consensus of medical opinion is about the value of that liniment, composed of ammonia, 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 physician who would testify that it was properly labeled, and he was brought forward as a defense witness in the trial of that case. Subsequently he was expelled from the local medicul association. He was deprived, I believe, of his license to practice. There has been a tremendous amount of misunderstanding about the requirements of this section. That misunderstanding has been very adroitly developed and fostered. We have heard statements that you could not go to a drug store and buy aspirin tablets without getting a physician's prescription. Nothing is more absurd; nothing is more ridiculous or far-fetched.

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The CHAIRMAN. When it is bought as a specific, not as a cure. Mr. CAMPBELL, Aspirin is an anodyne and dulls pain. It ought to be sold with that understanding, and I think it is generally sold with that understanding.

I know that there are osteopaths who think if this bill passes they will be required to close up shop. There is no provision whatever to that effect. Such result is as far from the thought behind this bill or requirements of this paragraph as it is possible to be. There is nothing to that whatever. This has no possible relationship whatever to the creation of such a situation; this has no bearing on the differences of medical thought as expressed by different schools of medicine. The only thing the item does say is, if the labeling of the product is contrary-and note the significance of the word "contrary"-to the general agreement of medical opinion, it is a 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 was falsely labeled, that it would not have any effect whatever on the diseases which it was claimed to cure; also it was imperative that we prove that the manufacturer knew that it was not effective as a cure. We could not in the first battle prove that the manufacturer knew that it was of no value. We were only able 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 as a treatment for tuberculosis. We showed that subsequently that person died from tuberculosis. Then, after her death, this person's son continued to write the testimonials in the name of his deceused mother, and we proved that they both received munificent donations from the manufacturer. That was ground to justify the jury in believing that the manufacturer acted fraudulently and knew that his product was worthless, notwithstanding his emphatic assertion of his personal conviction that the product was a cure for the various diseases listed on the bottle label.

Here is another product known as Banbar. It is recommended for the treatment of diabetes. This product is essentially a brew of horsetail weeds to be found in some sections growing along the railroad tracks. It was produced not by a person with medical knowledge, but by a former salesman 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

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longation of their lives in insulin, but they were persuaded to forego that, and become patrons of the manufacturer of this worthless nostrum Some pitiful testimonials were submitted by the people who had been persuaded to buy and use this product. Subscquently some of these individuals died.

We tried that case. The Government lost. It lost because of the limitation of the law as it exists now, making it necessary for us to show that the manufacturer knew that his product was not a treatment for diabetes. Under present circumstances, a 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 either of no more therapeutic value than a glass of water or as lethal as strychnine, sell it to the people of this country as a cure for every disease which man might have, and be within the terms of the law. His ignorance is his defense. The same product put out by some manufacturer with knowledge of medicine would be an offense under the law. But the effect on the public in either 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 be done now. I think it is extremely important.

There will be interesting arguments, and there are going to be extensive references in the discussion here to this paragraph and its manner of operation. Under the terms of the present law we first undertook to control these medicinal products under the general misbranding provision. We took action against a caucer cure. The indictment was quashed on motion of the defendant and the case eventually went to the Supreme Court The Supreme Court affirmed 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 sentence in the present law, page 17, section 8, reading, "That the term 'misbranded' as used herein, shall apply to all drugs or articles of food, or articles which enter into the composition of food, the package or label of which shall bour any statement, design, or device regarding such article.”

Mr. Justice Holmes rendered the majority opinion of the court, and after a scholarly dissertation characteristic of him, on the logical and idiomatic meaning of words, he concluded with this statement:

It (Congress) was much more likely to regulate commerce in food and drugs with reference to plain matter of fact, so that food and drugs should be what they professed to be, when the kind was stated, than to distort the uses of its constitutional power to establish criteria in regions where opinions are far apart.

The whole purpose of that decision was merely to disclose the intent that Congress itself had in mind. The court held that Congress intended to have the language of the act apply to the identity of particular products, drug products, to statements made about matters of fact, such as what ingredients were there, rather than to the remedial 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 minority opinion rendered by Mr. Justice Hughes. I shall read two excerpts from it:

The argument is that the curative properties of articles purveyed as medicinal preparations are matters of opinion, and the contrariety of views among medical practitioners, and the conflict between the schools of medicine are impressively

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FOOD, DRUGS, AND COSMETICS

described. But, granting the wide domain of opinion, and allowing the broadest range to the conflict of inedical views, there still remains a field in which statements as to curative properties are downright falsehoods and in no sense expressions of judgment. This field, I believe, this statute covers.

Justice Hughes concludes with this statement:

I entirely agree that in any case brought under the act for misbranding-by a false or misleading statement as to curative properties of an article--it would be the duty of the court to direct an acquittal when it appeared that the statement concerned a matter of opinion. Conviction would stand only where it had been shown that, apart from any question of opinion, the so-called remedy was absolutely worthless, and hence the label demonstrably false; but in such case it seems to me to be fully authorized by the statute.

The 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 language did not undertake to regulate in any way therapeutic statements. The minority opinion was that it did undertake to regulate therapeutic statements in that field where questions of opinion were not involved because the statements were absolutely false; so much so that no difference of medical opinion could exist. As Mr. Justice Hughes said, conceding all the scope necessary for the entertainment of differences of opinion, certainly, there does come a point in this scale in which there are no differences of opinion, in which there is a unanimity of opinion about the worthlessness of a product. All we are asking in this particular paragraph in this bill, is that language be employed which will create no doubt in the mind of the court as was done in this case about the legislative intent. Let

o say that immediately after the Supreme Court decision was rendered, there was no power left within the Department for the rogulation of patent medicines. We could not give consideration at all to romedial claims of any nature. It was no offense for any manufacturer to market a 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 satisfactory solution. It holds that such products will be deemed to be misbranded--

The CHAIRMAN. Where do you find that?

Mr. CAMPBELL. In section 8, on page 18 of the present law.

The CHAIRMAN. Somebody wanted to know when we will adjourn. We will adjourn not later than 1:30 and reconvene not later than 2:30. Mr. CAMPBELL. That language is:

That for the purposes of this act an article shall also be deemed to be misbranded: In the case of drugs, if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent.

It is imposed upon the Department of Agriculture the duty of proving that the manufacturer in telling a lie about his product, knew that he was telling such a lie. This was what we could not do in the case of this diabetos nostrum. What we are 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 determine whether it is or is not of valuo.

The CHAIRMAN. That would be subject to court appeal?

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