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It may say “as needed” on the prescription, but that's not because there are no instructions by the physician to the patient.
Dr. FREEDMAN. You know, through “PRN" I have helped patients learn that they really don't need to have the “insurance” of having a sedative when they travel
. Now you know, I'm sure yourself, that many people feel that when they are in special situations if they just knew they had something in reserve to help them, that's what they want. Well, in helping this person to regulate his Valium intake-it was not excessive—but I saw no reason why he should always have a few reserve pills around—I said, “Why don't you and I discuss what situations you tend to elect to try to use pills," and I began to give him the authority and the responsibility for telling me how he was using it less and less and for what occasions. That man actually has gone without prescriptions now for 2 or 3 years after believing for several years it was his "right" and his need.
So sometimes PRN is a very good way to get the patient to be an active collaborator in identifying when he needs to use a drug and in that respect many patients—most, I believedo control their use of medications quite conservatively.
Mr. WOLFF. The only reason I asked the question is I felt we were contributing to the abuse of the substance by letting the individual really do the prescribing for themselves.
Dr. FREEDMAN. You sometimes are doing just the opposite. You're training him to identify those situations, to evaluate them, and in controlling them to depend less both on drugs and on other kinds of input.
Mr. WOLFF. I have a number of other questions. I want to ask one final question.
At one other point in your statement, Dr. Boyle, you say, The American Medical Association supports efforts designed to eliminate improper prescribing, and we believe the principal means for achieving such a result is to provide unbiased, valid and current information to physicians on the risks and benefits of particular drugs in various treatment situations. This information reaches physicians from many sources, including peer review and medical care evaluation studies as well as the scientific literature.
We heard two gentlemen before criticize some of the advertising done by the pharmacutical companies. They appear in your journal, the AMA Journal.
Dr. BOYLE. The advertising appears in the Journal. We have no criticism of drug advertising.
Mr. WOLFF. Well, they did.
Dr. BOYLE. Well, that may be, but they are looking at this from a different point of view.
Mr. WOLFF. I'm talking about the quality of the advertising that appears in the Journal which has an effect upon the prescribing
practices of the doctors.
Dr. BOYLE. Well, first of all, I was talking about a couple different things, Mr. Chairman. The content of the advertising today is completely regulated by the FDA. What's contained in the advertising is something that has the approval of the Federal Food and Drug Administration.
Mr. WOLFF. We understand that. It's not the actual content, but it's the atmosphere that's created by the characterization in some of
the advertising of the pharmaceutical companies. We saw a number of examples of this.
Dr. BOYLE. I was coming to that part of the question.
Dr. BOYLE. The second aspect of this is that the drug industry in advertising is competing with its brand name for its share of the market when that drug is being appropriately prescribed. The place where physicians get their information about which situations require drug therapy and which drugs to use is in a totally different form. That begins, first of all, in medical school and I would indicate to you that if a student graduated from a medical school, from any medical school in the United States, with as few as 6 hours of instruction in pharmacology, that student could not be licensed in the State of California because the curriculum requirements in that State far exceed that by I don't know how many hours it is, but it's a considerable number. They start in medical school. It continues on through all of the phases of continuing education on through their internship-residency program, on into medical practice where they continually receive information with respect to drugs that are available, classes of drugs that are available to treat specific illnesses.
Now when you get down to advertising, what the drug industry is trying to do is say, OK, if you're going to say benzodiazepine, use Valium rather than some other brand. That's why, as far as we're concerned, that kind of advertising is not unacceptable. It has little or no influence on physician prescribing practices for those particular preparations.
Mr. WOLFF. If it has no influence on physician prescribing practices, then obviously the industry wouldn't be paying money to be advertising in your journal.
Dr. BOYLE. First of all, I think the drug industry probably recognizes that at least a part of their advertising is a contribution to continuing education, in that it allows us to help publish the journal. That's one thing
Second, I did say that we think it's perfectly appropriate for a company to be competing with its brand for that share of the market. If there is need for a specific drug, for benzodiazepine, for example, I see nothing wrong with the company who manufactures that saying if you're going to use a drug, use ours.
Mr. WOLFF. You do have a review board, however, do you not, for advertising in your journal ?
Dr. BOYLE. We have a managing editor who reviews advertising from the standpoint of taste, accuracy of content, and its conformity with applicable laws.
Mr. WOLFF. I have seen the symbol that has appeared on consumer products that says, “As accepted for advertising in the Journal of the American Medical Association."
Dr. BOYLE. Well, that would be the same as saying "as accepted for advertising in the Saturday Evening Post.” We have no control over that. However, such an activity would constitute an unauthorized use of our name. In the past, and in the future, we take all appropriate legal action to halt this type of activity.
Mr. WOLFF. That symbol is taken as almost a seal of approval on a particular product.
Dr. BOYLE. I don't really know that that has any influence onas a matter of fact, you can note my ignorance of that in that I'm not aware of that seal.
Mr. WOLFF. I must tell you, having come out of the advertising bușiness, I have some little experience with this. The little experience that I have is that when we took a product that had—I won't say questionable value, but there were some questions as to the acceptance by the public of a particular item, and we were able to get it advertised in the AMA Journal and we were able to put that seal on it, it was like the Good Housekeeping seal that appears on that particular product.
Dr. BOYLE. First of all, I think we have gone beyond the point that I was trying to make earlier and I think it's a more direct answer to your question. The advertising in the Journal is of accepted products. These are products that have been approved by the FDA. Otherwise, they would not be able to market them or distribute them. The ad vertising is with respect to the brand name of that product. As far as the indications for therapy are concerned and the decisions physicians will make to use a given brand of medication or use a given class of medication, has nothing whatsoever to do with the advertising. What it comes down to whether or not one is going to use one brand as opposed to another brand name identification. I'm certain that advertising might have something to do with brand selection, but I don't know very many whose choice of a particular drug is affected by these ads.
Mr. WOLFF. The point I'm trying to get to—and then I'll pass on the questioning to Mr. Rogers-what I'm trying to get to is the emotional approaches that are used in the advertising that set the stage or set an aura of acceptance for a particular product as the answer, in some cases, to the social problems that exist within society today. It's presented as the "sugar coated pill” that will answer all the problems of society. That is what is objectionable on a purely ethical basis. I feel there is a responsibility of the editorial board or whoever is involved, to see to it that there are certainly some restrictions, if necessary, placed upon these purely emotional approaches that take you into a field that goes far beyond the field of prescribing medicine.
Dr. BOYLE. I think if that's a question I'll have to come back to the observation, Mr. Chairman, that that is not the way in which the decision is made to prescribe or not prescribe a medication. The emotional appeal, I would say, is probably something that just doesn't appeal. The average physician is not really turned on by that type of approach. In fact, the younger physicians coming out of training have a great deal of antipathy to some of these approaches to marketing health care products.
As far as the taste in advertising is concerned, I think that most people just ignore ads that are in poor taste. So that's probably why we don't have more of a response than that.
Mr. WOLFF. If they were ignoring it they would not be continuing to advertise, I assure you, because they have to get results out of their advertising. Otherwise, the budget doesn't pay off.
Counsel just reminded me of one other point. Are there any restrictions that you place or any qualifications you have for detailmen who visit your members ?
Dr. BOYLE. Do we have restrictions as far as detailmen?
Mr. WOLFF. Do you have any qualifications? Do you have any recommendations?
Dr. BOYLE. We have a number of policy statements that have been adopted by our house of delegates and by a variety of our councils of the American Medical Association directly with respect to the detailing and marketing of drugs. In particular, the American Medical Association is unalterably opposed to the use of gimmicks, to the use of giveaways, to the illicit use of samples that are given to physicians. We would prefer that physicians only receive products upon their request. We do not consider it ethical practice for people to accept gifts and that sort of thing as an inducement for the use of a given product.
Mr. GILMAN. Would the gentleman yield?
Mr. GILMAN. Are you inferring then that when the detailmen come by the physician's office and leave him a number of samples and the physician accepts it,
that that's illicit or illegal or unethical? Dr. BOYLE. No; Í said that we would like to have people in most instances receive medication or preparations only upon their specific request. The receipt of a sample in order to be able to give somebody medication in an emergency or when there is a time when you want to be able to hand somebody a medication or to start somebody on a medication is perfectly acceptable. The average physician considers the number of samples we get as a nuisance because the problem is how to dispose of them. In California we have a very large program of collecting medications to send them to a foundation up in Santa Barbara who then puts them together and sends them to medical missionaries overseas. But the average physician considers the acquisition of samples to be a nuisance and I think that is recognized by the drug industry in that there are fewer and fewer samples submitted for one thing; second, in almost all instances, in California—I'm not sure about elsewhere in the country but I know in most instances that I'm familiar with the samples that are received are upon a written prescription request for that drug.
Mr. WOLFF. My time has expired. Mr. Rogers.
Let me ask you this: Do we really have a problem of overuse of psychotropic drugs in the Nation? What is your estimate?
Dr. BOYLE. I would say that for some individuals there is certainly an overutilization of misuse of drugs. There's no question about that, just as there are overutilization of other and (2) to see to it that the physician population is continually informed as to how they can accept the responsibility to try and identify those individuals and help them not to abuse these medications.
Mr. ROGERS. Well, are we overprescribing?
Dr. BOYLE. Well, I may have missed giving you the answer to that question, Mr. Rogers, but the answer is we don't believe that there's an answer as to whether they are under- or overprescribing. I believe that right now there's no way of knowing whether there is an excess of
drugs being used or not an excess. My opinion is, that on the average, no, we are not overprescribing.
Mr. ROGERS. What is your opinion, Dr. Freedman?
Dr. FREEDMAN. Well, I think the calibration of exactly where misprescribing is going on—and why—is our problem. It has been every time that we have tried to discuss this. We do have a resource, some of the very best of available studies which tell us where these drugs are being used and how. These studies have been conducted by the NIMH. There's one in the September Archives and one coming out critiquing all drug use surveys in the October Archives. That gets us down to the problem of stipulating abuse by a subgroup among the 20 percent of the population who have had an antianxiety drug during a year. The majority of that 20 percent is largely a law abiding, productive segment of society. So I hope we are not trying to stigmatize them.
There are I believe -a small group of people for whom the question of extended medication over months or years without review of that medication program occurs; some of these may be habituated and psychically dependent. This can represent incautious monitoring and selection of patients appropriate for extended use by the doctor; another subgroup of patients may pressure or flimflam the physician, preferring prescription drugs to street drugs; and there are a few criminal doctors—"Typhoid Mary scriptwriters” as I called them in in 1971 editorial, “Drug Abuse and Medical Leadership.” These scriptwriters are well-known to law enforcement; in Illinois they are also picked up by computer; Utah and New York have systems which flag the high-frequency prescriber who can then be further screened into the incautious, appropriate, or the abused or abusing doctor. In medical school we teach the law abiding doctor to avoid problematic prescribing—including the fact that some patients are “vulnerable” to misusing sedatives and need counsel and monitoring; we teach “preventively," as well as the range of appropriate uses of drugs. But if you really
ask me in terms of the magnitude of the national drug abuse problem to compare "abuse” within medical practice with that on the street—you investigated this on the Marihuana Commission, for example—and to identify places about which to raise alarm signals, the bulk of medical practice is not the major site nor source of abuse. As long as we have a society that doesn't expect everything from drugs, as long as we keep insisting on thoughtful and cautious doctors sensibly—and humanely- prescribing, our major emphasis on abuse cannot focus on the licit practice of medicine. I cannot find for you-or find someone who has truly sound data—a large sector of damaged people misusing licit prescriptions other than those deeply involved in or vulnerable to alcohol and substance abuse and the like. Thus if we separate that element out, while I can find pockets of overprescribing or injudicious prescribing, I can't see evidence of a large epidemic. Further—while numbers alone tell us little—there is data that the prescribing of these sedative, antianxiety medications has reached a steady, not an increasing, level. There is a more fundamental concern: Our attitudinal problem with all drugs is either to trivialize them as conveniences or, to the contrary, overestimate their power either for good or evil. There are not only patients who will misuse drugs, but patients for whom medication is not a "cop out” but