Senator NELSON. You can criticize all kinds of advertising. But here is a tax-exempt organization circulating to the public all over the United States a pamphlet which would require a fairly sophisticated person to discern as an ad, when the only indication after he gets through reading, if he bothers to read the fine print, is the phrase "First in a series published as a public service by the Pharmaceutical Manufacturers Association." If this was the only thing I ever saw, my interpretation would be that the Pharmaceutical Manufacturers Association selected an article written by an independent source that they thought was pretty reliable and favorable to their industry, and decided to spread it around the country. It would not occur to me from just glancing at these words that it was prepared by the PMA. I might wonder who the author was, but ordinarily not. So I do not see how the public is going to know that this piece that is being circulated is in fact a piece of advertising. And if it is advertising, at least you should alert the people of that fact. Now, it seems to me that as a tax-exempt organization, you have a double responsibility, a higher responsibility to the public than some of those who are not tax exempt. Mr. STETLER. We have the same responsibility as far as not deceiving, whether we are tax exempt or not. And there is no intention here to deceive. Just two points. I say again that this was prepared in this format at the request of people that have had experience. I can tell you one thing, one final thing on this, as far as we are concerned, and that is, since a question has been raised, on the reprints I am going to make sure that in future quarterly supplements, and there are going to be three more in the Reader's Digest, on the front page it is going to say "Advertising Section, reprinted from the Reader's Digest." Senator NELSON. Where is it going to say that? Mr. STETLER. Right there on the reprint, right on the front (indicating). Senator NELSON. Have you discussed this with the Federal Trade Commission? Mr. STETLER. Yes; I have. I spent an hour last Friday afternoon in Mr. Sweeney's office, and we have supplied him with all of the background and all the information. I should say one other thing. The letters that we sent out distributing these reprints clearly indicated that there was a project sponsored by the Pharmaceutical Manufacturers Association. Now, we have given him all the background. We sent out a press release. We have given him that. All this clearly identifies the PMA as a sponsor of this project. We have never tried to hide it. We have been rather proud of it. Senator NELSON. You mean to the doctors you sent it to? Mr. STETLER. We sent it to a lot of folks. We sent it to you as a Member of the Congress, to the Members of the Congress, to various State legislators. And frankly we have gotten a great number of good letters in response to it. Senator NELSON. How many of these reprints have you sent out? Mr. STETLER. There were a million reprints produced, and I think most of them have been distributed. Senator NELSON. Has every doctor in the United States received one? Mr. STETLER. I am sure he has not; no. We have had requests from some. But not a very high percentage; no. Senator NELSON. But you have printed a million of these copies? Mr. STETLER. A million of these were prepared by Reader's Digest, and supplied to us as an overrun. Senator NELSON. What is the nature of the list you are sending it to? Mr. STETLER. This was sent with a covering letter to Members of Congress, to members of State legislatures. Senator NELSON. One copy each? Mr. STETLER. On those, yes. I will read the list here. They went to our members, copies for distribution to employees, stockholders, physicians, they went to Federal and State executives, university officials, went to hospital administrators, to news media, to physicians and hospitals on request, and to pharmacists on request, and to National-State professional organizations. The physician requests have numbered 23,000. Senator NELSON. Physician requests? Mr. STETLER. Yes. Senator NELSON. How many physicians did you send it to directly? Mr. STETLER. Only to those who requested it—23,000. Senator NELSON. The patient, of course, would not see the letter. He would see this ad here which does not contain the word "advertising" in it a single time. Mr. STETLER. He would. And as I have just said, since the question has been raised, the next issue is going to be clearly identified. But I can assure you that from the source of this suggested format, and on my reading of it, I did not think it was misleading, and I still do not. And apparently the people we have heard from do not think so. Senator NELSON. What is the total cost of the series of four? Mr. STETLER. Each of these inserts in the Reader's Digest cost about $250,000. That is close to a million dollars for four. Senator NELSON. This is part of a series that will be run 4 months in a row? Mr. STETLER. It is going to be run quarterly; four times; yes. Mr. STETLER. It is a very small amount. I cannot recall. It is a small amount. It is an overrun when they run the magazine, and the reprints are inexpensive. I would say maybe a million reprints cost $5,000. I would have to check on that. Senator NELSON. Would you send the committee the amount? Senator NELSON. The reprints, or the overrun, as you called it, was printed and supplied to you by the Reader's Digest? Mr. STETLER. Right. Senator NELSON. So when you compare the front page of the two, it is clear that a positive action was taken to remove the type which says "Special Advertising Section" in the magazine, and leaves it off in the reprint; correct? Mr. STETLER. Left off. Senator NELSON. It would have to be removed? 1 Mr. Stetler subsequently stated: "We obtained a total of 1,250,000 reprints of the PMA advertising section from the November issue of the Reader's Digest. The cost of these reprints was $6,287.50." Mr. STETLER. When they did the excess run, they took that off. Senator NELSON. Well, can you believe there was any intent on the part of whoever did it, other than to mislead the public as to what it was? Mr. STETLER. I can tell you with assurance there was no intent on my part. And I am responsible for the PMA's part of it. It was their recommended format. I accepted it. And I do not attribute deception to them, and certainly there was none on our part. Senator, could I begin on this statement? Senator NELSON. I just have one other item here, and then Senator Hatfield has a question. I think with regard to this ad I ought to put something in the record at this stage. It is a letter from Wolins Pharmaceutical, and I quote: As a follow-up to our report to you of October 19, 1967, we enclose the November issue of Reader's Digest. This issue, as you no doubt know, contains an 8-page advertising section placed by the Pharmaceutical Manufacturers' Association. We offer it as additional and continuing evidence that the PMA is going out of its way to malign generic name drugs and undermine public confidence in them. We draw your particular attention to page M-4, second column, to the article's reference to tolbutamide. We were not aware that tolbutamide was available under its generic name. The patent is owned by Upjohn, circa 1957, and the drug is produced and sold in the United States only by Upjohn under the name Orinase. It is one of the fifty most prescribed drugs. Wolins has no knowledge of it ever being offered in this country under its generic name; in fact, we believe that we are safe in saying that no other brand name manufacturer in the U.S. produces it either. We wonder why the PMA has to go all the way to Canada to find an example of an unsatisfactory generic name drug? Canada, of course, does not impose the strict manufacturing controls in operation in the United States. Yet 50 million people were exposed to this distorted presentation. Mr. STETLER. We are prepared to illustrate in our testimony some very specific examples in the United States. Senator NELSON. All right. One more thing about the example of tolbutamide. I want to put in a letter in the record to the Canadian Medical Journal by Arnold K. Carter, M.D., of Windsor, Ontario, in which he comments on the case of tolbutamide used as an example in the Reader's Digest article: The firm replied at once that the tablets submitted were not of their manufacture, as judged by physical appearance, but that they would analyze them and report. The findings, which I received shortly, were as follows: These tablets contained 500 mg. of tolbutamide but did not disintegrate after 45 minutes in gastric juice followed by 63 minutes in intestinal juice. They are completely outside the limits set by the food and drug regulations for tablets sold in Canada. This is the exact example you are using-then the drug being used manufactured in Canada did not meet Canadian standards, and certainly did not meet ours, so it certainly cannot be an indictment of generic drugs as such. Mr. STETLER. Senator, this drug was sold in Canada. Whether it met standards or not, it was available as a generic product. I am sure it is easy after it passed through the patient for somebody to say it did not meet standards. (The letter referred to follows:) To the EDITOR: [From the Canad. Med. Ass. J., Jan. 12, 1963, vol. 88] SUBSTITUTION FOR BRAND-NAMED DRUGS The serious consequences of a request by one of my diabetic patients that his druggist be allowed to supply a cheaper drug to refill my prescription for a brandname tolbutamide prompts this communication. I believe it has a significant bearing on the present controversy about generic drug prescribing and might well alert some of my fellow physicians to hazards inherent in this practice. This patient who had been controlled for 11 months on diet and 1 g. daily of tolbutamide (Mobenol) inexplicably went out of control recently, his fasting blood sugar rising rapidly to 287 mg. %. At that time the patient noted tolbutamide tablets intact in his stools and brought one tablet in to me. He was then asked to bring in the remainder of his prescribed tablets, and since his case record still specified that he was taking Mobenol, these were forwarded to the manufacturer, together with the passed tablet. At the same time the patient was hospitalized and his diabetes mellitus was controlled on the former dosage of tolbutamide. The firm replied at once that the tablets submitted were not of their manufacture, as judged by physical appearance, but that they would analyze them and report. The findings, which I received shortly, were as follows: "These tablets contained 500 mg. of tolbutamide but did not distintegrate after 45 minutes in gastric juice followed by 63 minutes in intestinal juice. They are completely outside the limits set by the Food and Drug Regulations for tablets sold in Canada." In other words, although these tablets contained the labelled quantity of drug, they were to all intents and purposes quite useless. This episode has, therefore, resulted in temporary lapse in control of the patient's diabetes, and also necessitated the expense and inconvenience of a period of hospitalization in order to regain control. It has also resulted in subsequent investigation of the pharmacy concerned by the Ontario College of Pharmacy inspector which revealed a notation on the prescription concerned that permission to substitute a cheaper brand had been obtained from myself by telephone through my nurse. This case, which has been a traumatic experience for the patient and myself, of course, does not necessarily indict all or even the majority of unbranded drugs as being suspect. However, since diabetes is one of the few areas of therapeutics where failure of response to a drug can be observed clinically and measured objectively, I consider this instance most significant and revealing. It makes one wonder how many product failures occur in other circumstances where results are less obvious or dramatic. Until existing regulations allowing the import into Canada, distribution and sale at discount prices, of unassayed drugs are altered, I will henceforth not prescribe any drug without specifying a brand or manufacturer. WINDSOR, ONTARIO. Senator NELSON. Senator Hatfield. ARNOLD K. CARTER, M.D. Senator HATFIELD. Mr. Chairman, I would like to pursue this for just one or two moments, because as I understand, Mr. Stetler, you said earlier that the Reader's Digest approached you on this possible advertisement, and that it was drawn then in conjunction with an advertising company? Mr. STETLER. Yes, sir. Senator HATFIELD. Mr. Chairman, I suggest that perhaps you have focused upon something that might involve even the Reader's Digest, that perhaps we might have them before our committee for the simple reason that if you look a few pages later, you will find another advertisement, a single-page advertisement which is not perforated, but purely a part of the magazine-it is not listed with a page number, because it, like this particular advertisement that we are talking about, precedes the actual articles that are listed in the index. It uses the same format as a regular article, like on page 111-I just choose this at random. It says this article is "Cool Talk About Drugs." That is a regular article. But on this one it says "Advertisement-Doctors find way to shrink painful hemorrhoids and promptly relieve pain, itching, in most cases, by Dr. James Henry Weston." Then it talks about-and I want the full page in the record, if you will, please "the effectiveness of this treatment has been convincingly proved by leading doctors in New York City, Washington, D.C., and a Midwest medical center." (The article referred to follows:) |