ABUSE OF DANGEROUS LICIT AND ILLICIT DRUGS

PSYCHOTROPICS

THURSDAY, AUGUST 10, 1978

HOUSE OF REPRESENTATIVES,

SELECT COMMITTEE ON NARCOTICS ABUSE AND CONTROL,

Washington, D.C. The Select Committee met, pursuant to notice, at 10:15 a.m., in room 2212, Rayburn House Office Building, Hon. Lester L. Wolff (chairman of the Select Committee) presiding.

Present: Representatives Paul G. Rogers, James R. Mann, Billy L. Evans, J. Herbert Burke, Benjamin A. Gilman, and Robert K. Dornan.

Staff present: Joseph L. Nellis, chief counsel; William G. Lawrence, chief of staff; Howard Wallach, staff counsel, and Skipp Orr,

researcher.

Mr. WOLFF. The committee will come to order.

This morning we are meeting on the question of psychotropic drugs. Despite substantial efforts by the executive and legislative branches of the Federal Government since 1963, the abuse of manufactured psychotropics continues at an alarming rate. Deaths due to crossaddiction between pills and alcohol consumption continue to plague our society. Some of the increases in casual and overprescribed pilltaking in our country may be the result of overadvertising, overpromotion, and other selling activities of the pharmaceutical industry. Accordingly, today the committee will address the issue of advertising practices in the psychotropic drug industry and along these same lines how these drugs are prescribed by those in the medical profession.

In previous hearings, this committee has expressed particular concern over drug use and abuse among women and among the elderly. In fact, at one point in our examination of drug abuse among the elderly, we came upon the position that at this point in our society we question severely whether or not we are creating a whole generation of elderly zombies, a group of people who are being overprescribed so that some can exercise a measure of control over these people.

Today we will attempt to determine the extent to which the major psychotropic drug firms direct their advertising efforts at these two groups, the women and the elderly, and at other special population groups.

The committee believes that there are a number of examples of advertising pieces in which firms producing psychoactive drugs press claims that are at best disputatious. Drug firms often represent their products as a panacea for all ills that are usually a result of tension

and stress. These advertisements are later reinforced by the drug detailmen or salesmen, who, although they have a minimal pharmacological background, have become, along with advertisements and the Physicians' Desk Reference, the primary sources of drug information for doctors.

We are not only concerned with the advertising practices of the major drug firms but also in the manner by which these mood-altering drugs are dispensed. Valium, produced by Hoffmann-La Roche, is the most commonly prescribed drug in the United States today. Undoubtedly, these kinds of drugs are prescribed for legitimate reasons. However, statistics also indicate that many physicians are in the practice of administering psychoactive drugs not only as a result of the salesmanship efforts put forth by the drug firms but also due to patient requests and constraints of time. This type of evidence raises a plethora of social questions: In what direction is our Nation headed with respect to remedying everyday tension and stress and frustration that we have through the use of some sort of palliative? Have we become a totally chemically dependent Nation? Is this the answer to the social ills that plague this Nation? Is it vital to the American people that psychotropic drugs be used as a primary coping mechanism for the problems of the elderly, for the problems of those who are under great stress as a result of social conditions?

I am pleased to be able to welcome Mr. Irwin Lerner, vice president of marketing for Hoffmann-La Roche and am hopeful that he will be able to help us in answering some of the questions that I have suggested.

In addition, Dr. Leonard Schifrin of the College of William & Mary will testify as to the nature of advertising in the psychotropic drug industry. These gentlemen will be, as I understand it, on the panel this afternoon.

We are also fortunate to have Mr. Charles Brannan, a former pharmaceutical detailman for Hoffmann-La Roche, to address issues relative to drug detailing practices.

Dr. Robert Maronde and Dr. Jonathan Cole will speak to the character and extent of psychotropic drug prescribing, and Ms. Sue Boe of the Pharmaceutical Manufacturers Association will represent the industry's perspectives on these topics.

Again, I would like to welcome all of you to this hearing. Because of the pressures that are upon us right now of having the House in session and trying to pass a tax bill, some of my colleagues here are being taxed to the ultimate, and maybe someone here could prescribe a solution to their problem that is other than just medication, because we in the Congress are trying to attend to the Nation's ills at the same time.

I would hope, however, that there is not a widespread distribution or disbursement of some of these psychotropics to the Members of Congress as has been indicated in the recent Anderson column.

I might say that maybe that would account for some of the decisions being made by Congress.

But, I don't mean to be facetious at this point. I am just trying to apologize for the fact that a number of my colleagues are not present this morning.

However, we have with us Mr. Charles Brannan, a former detailman with one of the pharmaceutical companies.

Will you step forward, please, Mr. Brannan.

[Whereupon, Mr. Charles Brannan was sworn.]

Mr. WOLFF. Please proceed. You may summarize your statement, and without objection the full statement will be made a part of the record at this point.

[Mr. Brannan's prepared statement appears on p. 223.]

TESTIMONY OF CHARLES BRANNAN, FORMER DETAILMAN WITH HOFFMANN-LA ROCHE INC.

Mr. BRANNAN. The committee has asked me to summarize my dissertation of about 10 pages, in which I included a little bit about my background and history.

I worked for Roche for 7 years and I expounded on the tremendous pressure placed on the individual salesmen as well as division managers, as well as the regional managers. And I went on and discussed different instances and cases at point and gave examples of the tremendous pressure that is involved.

I did want to read a mailgram that I received through Philip Shapiro, at that time division manager, from John Boyle, field sales manager of Roche. I received this February 3 of 1977. I think this summarizes pretty much the total Roche concept of the importance of Valium. After all, this product did over $300 million in sales, and when you have a product of that tremendous dollar volume and you have to continue the profits of a product like that, you promote it to the best of your ability. The object is to get the doctor to prescribe Valium.

This is from John Boyle:

I have just received an analysis from an independent audit firm that reports physician calls on an anonymous basis. In the sample of 46 physician calls, Valium was presented 18 times-considerably less than half. Total time of Valium presentations was 18 minutes-slightly over 2 minutes per presentation. What a shame for a product of such versatility, medical application, and importance to us. This report on Valium presentations could reflect a serious deviation from our strategy of Valium first on all calls except pediatricians.

The southern area has a good share of the market, but Valium new prescriptions are flat and new competition is imminent. Let's get on with the strategy of Valium number one on all calls now to keep what we've got and to assure the necessary growth in 1977.

Please send a written note to your regional manager by December 17, indicating your understanding of this directive and your commitment to Valium on every call. Your division manager will be monitoring and following up on the implementation of the strategy.

That pretty much summarizes it.

Mr. WOLFF. Let me ask you, Mr. Brannan, what you find wrong with something like that? You were hired as a salesman for this company; is that correct?

Mr. BRANNAN. That is correct.

Mr. WOLFF. And your job was to sell products that were manufactured by your company.

Mr. BRANNAN. Right.

Mr. WOLFF. What do you find wrong with the field sales manager exhorting you to sell more of the product?

Mr. BRANNAN. OK, there is nothing wrong, but after you have been doing it for 7 years and talked to your doctors for over 7 years and given maybe 10,000 presentations, and when you go in to see a doctor for the 60th or 70th time to discuss a product over a period of time and you know how doctors are busy and their patients are up the walls and when a salesman goes in to talk to a doctor and he says, "Chuck, you know I use Valium for everything, including itchy feet. I can't be expanded," and since my job is to expand him, it's hard.

Mr. WOLFF. Were you ever told to promote Valium for anything else than the purposes that it was originally set to be prescribed for? Mr. BRANNAN. That is a very complicated question, actually. Mr. WOLFF. That is the guts of the issue here, whether or not you were told to do something that is outside of ethical practice.

Mr. BRANNAN. I was told to go by the PDR or the package insert. But when a question came up which involved using the drug maybe in another area, I would not deny it and would not say, "Don't use it there," or dispute it. I would write to Professional Services, which was the company policy, in which they picked out literature to expand on the Valium indication for that question to answer itlike on side effects, overdosage. What he would receive from the company were often reprints that the salesman did not have at his disposal because we were not allowed to carry these reprints, but Professional Services would send these reprints.

Mr. WOLFF. There again, was there anything you saw in any of these reprints that was outside of ethical practice, in other words, that had anything in it that was less than the truth?

Mr. BRANNAN. Well, can I answer it with a question? If you are a salesman and your bonus and salary increase depends on your Valium sales, how would you answer the question?

Mr. WOLFF. Are you saying, then, that you deviated, on your own, for the purpose of increasing your own income? In other words, were you exploiting this for your own purposes?

Mr. BRANNAN. Well, if you didn't expand the usage of the drug, you would not increase sales and you would not increase bonuses or salaries.

Mr. WOLFF. When you are talking about expanding uses of the drugs, what are you talking about, really?

Mr. BRANNAN. Talking about getting him to use it in any way he can within the package insert.

Mr. WOLFF. Would you give us a specific example of what you mean by that?

Mr. BRANNAN. When you talk about anxiety and depression, it is a very complicated subject. The doctor says, "Can I use it for depression?" Then you go back to the package insert and read the portion where it says you can use it for psychoneurotic states. You don't totally answer the question for the doctor.

Mr. WOLFF. Isn't that what the drug was prescribed for, for anxiety, depression?

Mr. BRANNAN. Anxiety but not depression.