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FOOD, DRUGS, AND COSMETICS
be made according to the art of the apothecary. Some of our people manufacture these, and many of them, especially the retailer, sell cosmetics, and we just want to call your attention to the fact that the powers conferred here are in very general terms. There is not set forth a list of the dangerous drugs which ought to be interdicted.
We are agree that they should be interdicted, and are willing to do what we can to interdict them.
It does not prescribe the lines of legal authority within which the Secretary of Agriculture must operate, within which his regulations may be effected. It turns the whole subject over to him without let or interforence, and, so far as the language of the text is concerned, he can declare anything on earth as an improper ingredient in a cosmetic.
Remember that some dermatologists have gone so far as to declare in very emphatic language that the application to the skin of such harmless substances as talcum, starch, or bland fatty oils, are injurious to the user, and it might be that some day there may be someone in the Drug Administration who might subscribe to that particular idea and exercise that power, so that now we are simply calling your attention to this blanket authority without any restriction or limitation, and we wish you to consider in your wisdom as to whether or not that should be permitted to stand.
Senator COPELAND. But you are not giving us any language yourself to help us in the matter.
Dr. BEAL. We are proposing, with your permission, at a later date to submit one or more drafts embodying these various suggestions.
In other words, I start out with this premise, that the present Food and Drugs Act, which has operated so efficiently and is faulty only because of later developments, can be made effective in destroying every one of these abuses, abou; which we all know and some of which have been presented to us today.
The reason that it has not been as effective in controlling advertising matter inside the carton and surrounding the package is because its terms were not extended to that. We did not understand that when we wrote the original law. Human nature is like a toy balloon; you squeeze it in one place and it expands somewhere else. We pretty effectively controlled the falsehoods on the actual labels, but they simply expanded their falsehoods into the newspapers and the circular matter which accompanies the package.
Senator COPELAND. I take it that your view about this particular thing is that you want to take into consideation the average person, and you want to got some elasticity, so that where there is supersensitivity, that it will not be counted against the manufacturer. Am I right in that?
Dr. BEAL. Yes, sir; as relating to the section that I just referred to. If I may continue, I wish to call your attention to section 6, misbranding, general provisions.
Paragraph (a) of section 6 provides that a food, drug or cosmetic shall be deemed to be misbranded-
"If its labeling is in any particular false, or by ambiguity or inference creates a misleading impression regarding any food, drug, or cosmetics.'
That is beautiful language; fine language, and to a layman it seems to be perfectly clear, but when we examine it from the viewpoint of its practical application to the labeling of drugs, it is highly ambiguous,
FOOD, DRUGS, AND COSMETICS
and liable to lead to many misleading interpretations and unwarranted inferences.
Senator COPELAND. Suppose that we were to take the present law as interpreted by the court decisions: Would you have any objection to that language?
Dr. BEAL. Not the slightest. Many of the expressions in here are practically the same as those in the existing food and drugs act. They are not dangerous there. Why? Because all of the parts of the act must be construed together and the dangerous possibilities in one provision are properly cared for by safety provisions, but here in this new act we find a whole host of new provisions not hitherto tried in this or any other country, so far as I know.
We are afraid; we are scared; we do not know what is going to happen; but we do know what has happened in certain parallel instances where unlimited power has been placed in the hands of an executive.
We might not always be fortunate enough to have Judge Campbell in the Food and Drugs Bureau, or Franklin Roosevelt in the White House; and the proper way to control the power is to limit it when it is granted, so it cannot be abused.
Senator COPELAND. I am in the fullest accord with that statement.
As applied to drugs, this language fails to distinguish between falsity or fact which can be proved by material evidence and falsity of opinion which in many cases can neither be proved nor disproved.
The language is ambiguous for the reason that it is based upon the theory that one of the most uncertain and indefinito of subjectsthe description of the therapeutic application of drugs can be subjected to the same rigid rules of interpretation as can be applied to problems in physics and inorganic chemistry.
In the latter cases, when the factual data are established, the reactions can be predicted with certainty and accuracy, whereas the therapeutic valuation of drugs must always be largely a matter of opinion.
Judged according to the leading authorities of the so-called “regular school of medicine", the claims of eclectic and homeopathic physicians as to the virtues of their peculiar remedios are false, while eclectics and homeopaths hold the same opinion as to many of the remodios employed by the regulars.
Then along comes the osteopath, who says that the beliefs of the whole outfit are false and mistaken. [Laughter.]
Not only do the various schools of medicine differ in their valuation of remedies, but physicians of the same school are frequently at variance in their estimation of the same agents, and if a large number of textbooks on therapeutics are compared, scarcely any two of them will be found to be in complete agreement as to the therapeutic usefulness of idontical drugs.
Because of these uncertainties, it follows the ovident effect of this language would be to make the opinion of the Secretary of Agriculture the standard for the determination of falsity, ambiguity, and misleading inferences. You might place before him all of the material that we have, and if he puts his hand on one of them and says: "This is the authority that wo accept", then he has himself fixed the standard of falsehood, ambiguity and misleading impressions.
FOOD, DRUGS, AND COSMETICS
I will now pass to section VIII-misbranding of drugs.
The first sentence of paragraph (a) of section VIII provides that 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 which such names and in letters of the same size and prominence a statement that the drug is not a cure for such a disease.
I think it is too bad that the people who drafted this language did not call somebody in who knew something about the moaning of these terms before they were included in this paragraph.
This language is radically defective, in that it includes various terms of very indefinite and uncertain meaning, and which therefore should never be used in punitive statute without the addition of limiting definitions.
The term "disease", "specific cure", and "palliative" do not possess any exact and definite meaning in law, in modical science, or in the English language, as set forth in generally accepted dictionaries.
Take the word, "disease." I examined a loading medical dictionary under the term "discase." It gave three or four genes al definitions, no two of which corresponded to each other, and then there followed with a column and a half of special definitions of "dise 190 according to the manner in which it was applied.
The combination "specific cure", is rarely employed in medicine, though the word "specific" is used with various meanings.
Though usage is not entirely uniform, the tendency is to employ the word "specific" when unqualified by other words, as the designation of an agent capable of destroying or preventing the reproduction of organisms, which are the cause of certain well defined diseases.
In this sense, quinine alkaloid is a specific for malaria, arsphonamine a specific for syphilis, and the number of drugs which can be truly termed specific in this sense is limited by the number of diseases, known to be caused by the number of specific organisms.
As applied to eclectic medicines, which are also extensively employed by physicians of the so-called regular school, the word "sp cific" is used in the sense of special or particular, meaning that the remedy is specially or particularly adapted for use in the treatment of named affections without intending to imply that they are certain. and complete cures therefor.
As applied to the specific medicines of homeopathic physicians, the adjective has a meaning somewhat similar to but not entirely identicul with the sense in which it is empoyed by the eclectics.
The word "palliative", though not capable of so many diff·reo interpretations, has the terms "disease" and "specific cure', and nevertheless far too indefinite for inclusion in statutory law without limiting definitions. It might be interpreted as a merely soothe application to a painful part, as a remedy which alleviated the symptoms without affecting the course of the affection; as an agent which, although not a complete cure, is nevertheless appropriate in the treatment of a stated ailment.
I have referred to homeopathic medicines. I know some people smile when I mention homeopathic medicines and physicians, but I have been connected in one capacity or another with the pharmacy and drug business since the third day of July 1876, and I havo hol
FOOD, DRUGS, AND COSMETICS
an opportunity to see a number of various homeopathic physicians, and I do know of some very remarkable cures being effected by homeopathic medicines, after the medicines applied by the regulars had apparently failed.
So, Mr. Chairman, we think that this language either should be limited by the proper application of definitions, or stricken from the bill entirely, and we call your attention to the fact that under this section as written, the same drug may be legal if we adopt one set of interpretations of these various works, or illegal if we adopt another.
Now the particular sense which is going to be applied is going to be that of the Secretary of Agriculture, or his designated official. It may be true that we may proceed into court and ask that these rulings be set aside, but remember that we do not pass laws with the understanding that they are to be in such a condition that we will have to go to a court to have them nullified in order to secure justice.
Senator COPELAND. May I ask, Doctor, if you regard this as better or worse language, if this labeling bears the name of any disease in the treatment of which the drug is not generally accepted as the specific?
Dr. BEAL. If that word "specific" would be omitted, not generally accepted as an appropriate part of the treatment, that would go a long way toward curing it. If that word "specific" is kept in there, it means that we cannot use medicines or label medicines or advertise medicines for more than half a dozen seasons.
Senator COPELAND. You are entirely right with regard to your statement, regarding the different views regarding the term "specific", but, yot, at the same time, is there a generally accepted view as to what a specific is?
It is limited, I think Mr. Campbell said here in his statement here this morning, and you repeat it, to 4, 5, or 6 diseases, and that is what Mr. Campbell had in mind.
Dr. BEAL. And those diseases are included in another section of the bill. Dr. Oliver Wendell Holmes said that if all the medicines were put into the sea, it would be better for man than for the fishes, but we are dealing with a situation where it is understood that we are going to continue to use the medicines, and do the best we can.
Senator COPELAND. After all, in formulating a bill which is intended for lay reading, as well as for reading by scientific students, we have to have language general enough and plain enough so that the wayfaring man, though a fool, need not err therein. You are more competent to judge than I am, but I believe that there is a general acceptation on the part of all schools of medicine and all students of science that there are certain specific cures, certain drugs which have a specific value, such as quinino for malaria, mercury for syphilis, and so forth. That is what I mean by saying that we could never satisfy the homeopaths, or the eclectic, when we came to any effort on our part to define the word "specific" but there is a general acceptation, nevertheless, of the meaning of the word.
Dr. BEAL. I would expect, then, that in the accompanying language of the bill it would be made perfectly clear that it was to be interpreted in that restricted meaning.
Senator COPELAND. I think you said that at a later time you were going to furnish us the language that would cover it.
FOOD, DRUGS, AND COSMETICS
Dr. BEAL. Yes; with the understanding that we are trying to build on the whole bill.' Now, some of our friends have said, "Why don't you put into this bill a provision of the kind that ought to be there?" We did try it, and I confess to you that it is an absolutely impossible task for me, and the only way to make an acceptable bill out of this, which would insure fair tests to the manufacturer as well as to the public, would be to strike out everything after the enacting clause and put in the old Food and Drug Act, and make the appropriate changes in it. I am perfectly willing to have somebody write it, so that we could accept it, but I confess my own inability to do it.
The second division of paragraph (a) provides that a drug shall be deemed to be misbranded
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.
What is the general agreement of medical opinion? Who knows what it is? Who knows where it can be found? I have not been able at any time during my connection of more than 50 years, more than half a century, with the practice of pharmacy, to be able to find, whenever I wanted to, what was the general agreement of medical opinion.
Take some matters entirely within your own recollection. When the Pharmacopoeia was last being revised, prohibition was in its heyday, and a strong propaganda was conducted to strike whisky and brandy from the United States Pharmacopoeia, and they attempted to ascertain the consensus of medical opinion upon it, taking evidence on the subject, and after vote of its members upon the question of whether or not whisky or brandy played any part in the practice of therapeutics that could not be equally well discharged by some other agents, whisky and brandy were deleted by a comparatively small vote.
Well, now, it turned out that those physicians who thought that they could find acceptable substitutes afterwards concluded that they were mistaken, and in the next Pharmacopoeia of 1920--and I should have said that the other was of 1910-whisky and brandy were voted back into the Pharmacopoeia as necessary medicinals of an overwhelming majority. [Laughter.]
Now, we have there the general agreement of medical opinionSenator COPELAND. That happens in theology, too, doesn't it? Dr. BEAL. Yes, sir. I used to be a professor in a theological school; so I know.
Senator COPELAND. You are so versatile that you are positively dangerous, Doctor.
Dr. BEAL. Thank you. Another case. Everyone knows that
liver and liver extract are today recognized as the most efficient and desirable agents in the treatment of pernicious anemia, but that has only been for a few years.
Senator COPELAND. We may not believe it next year.
Dr. BEAL. Yes. Suppose that when it was introduced, Judge Campbell would say, "You cannot get away with that here. You cannot find medical opinion in the whole United States that will sustain that. That is contrary not only to the general agreement, but the whole agreement of medical opinion, and you cannot do it."
He would have been justified. In fact, he would have been compelled under this language to execute the law in that way.