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Mr. LERNER. Thank you, Congressman Gilman.

As you have already noted, my name is Irwin Lerner. I am group vice president of Hoffmann-La Roche Inc., one of the largest researchoriented marketers of prescription drugs in the United States. I am pleased to have the opportunity to respond to the committee's interest in the manner in which we disseminate information about our products to the professional health care community.

First, however, before specifically addressing the topics you have requested that I discuss, I would like to briefly review the general nature of the Roche operation. Hoffmann-La Roche is engaged in the research, development, manufacturing, and distribution of healthcare and health-related products. These include bulk vitamins, prescription drugs, diagnostic products, and clinical laboratory services.

Our growth in the United States over the past 75 years is largely the result of imaginative and innovative research efforts coupled with responsible and responsive marketing programs. From the Roche Research Center, staffed by over 1,500 people, 300 of whom are doctoral scientists, in Nutley, N.J., our research activities have produced significant products to help health professionals combat disease and maintain health. The research and development of these products is linked to our ongoing responsibility to communicate with our professional audiences and to provide comprehensive information about the use of Roche products and services. One of the basic functions of our marketing programs, therefore, is to link community health practitioners-physicians, pharmacists, nurses

to our research data base and to share with them all we know about our products.

Along with the opportunity to market the new prescription medicines discovered through this research effort also comes the responsibility of communicating information concerning their use. Both research and marketing in our company are guided by the Roche policy which is to raise new, higher standards of therapy through original research and development and the Roche pledge, which is to make available products that offer patient benefits in efficacy, safety, and practicality.

Given the nature and application of prescription medicines, Roche is committed to the preparation and distribution of accurate, thorough, and timely information to physicians, pharmacists, and other liealth professionals, and to full compliance with the regulations which govern these activities. The purpose of this information is to advance the use of our products within their therapeutic potential for the prevention and alleviation of illness, and to do so in accord with good medical and good business practices. Roche communications complement and build upon other sources of medical and scientific information by presenting current pharmacological and clinical findings through a variety of means, balancing both the benefits and the drawbacks of the product concerned. These programs recognize, are based upon, and contribute to enhancing the health practitioner's knowledge base.

Central to our communications efforts are these basic premises :

1. The physician's right to prescribe drugs for the patient's benefit derives from professional schooling, postgraduate training, and licensure.

2. Superimposed upon basic training in medical schools and hospitals, and upon practical clinical experience, physicians are exposed to and engaged in continuing postgraduate medical education through a wide range of measures and media, be they scientific publications, medical journals, laboratory and clinical research, medical meetings, academic symposia, medical textbooks, coloquia, peer contact, staff conferences, and the like, in addition to the pharmaceutical industry's own programs.

3. Medicine is an art as much as a science, an amalgam of knowledge and practice, nurtured by the ability of each practitioner to obtain timely scientific information from a variety of sources, enabling judgmental choice from among available therapeutic alternatives.

4. The public interest is well served by a pluralistic communications system that rapidly and effectively diffuses information to professionals who prescribe and dispense pharmaceuticals.

While we utilize a variety of media to communicate information about our prescription drug products, we rely primarily on personal promotion by company representatives, advertising in medical journals, and direct mailings to physicians. Regardless of the communications channel selected, the message communicates the efficacy, safety, warnings, precautions, and general usefulness of the product, stated within the context and technical requirements of the most recent supportive documentation and Government regulations. It should be noted that prescription drug promotion is the only form of promotion which deals exhaustively with the negative aspects of the product.

The basis of our professional communications program is a thorough understanding of the informational needs and therapeutic goals of the health care professional. To this end, extensive marketing research is conducted to gather information concerning patient demographics and symptomatology, and patterns of prescribing. In addition, we conduct extensive monitoring of diagnostic techniques, alternative therapeutic approaches, clinical studies, and a host of other factors that may impact utilization of particular drug products. It is from this large set of informational input that the communications program emerges. Specific pharmaceutical advertisements, for example, often are created to expressly reflect the demographic and symptomatic characteristics of those patients already receiving the medication or those individuals considered by informed medical opinion to be at risk for the condition treated by the medication.

Before beng published by Roche, promotional material must pass through a rigorous and lengthy multiple review system. It typically takes 4 months or more to prepare a promotion piece, be it a medical journal advertisement or a salesperson's visual aid. During this period, the material is subjected to medical, legal, regulatory, and marketing scrutiny and approval through the varius stages of its evolution from concept to graphic to finished layout to final proofs.

In addition to our multiple review sysem, we also subject much of our promotion material to extensive field testing by both internal marketing research personnel and outside consultants. The primary objec

tive of this pretesting is to obtain reactions from health professionals in the audience to whom the promotion is directed in order to insure that the message is clearly stated and correctly perceived. Our goals are to maximize the validity and the comprehension of the communication while minimizing the potential for misunderstanding or misinterpretation, and to appropriately tailor the communication to fit the various promotional media utilized.

Mr. Gilman. If the gentleman will permit me to interrupt, you may summarize if you choose, Mr. Lerner, and we will put the entire statement in the record.

Mr. LERNER. Believe it or not, Congressman, I am trying to do that. I will try to do so even more.

Mr. GILMAN. Thank you. Your entire statement will be included in the record at this point.

[Mr. Lerner's prepared statement appears on p. 234.]

Mr. LERNER. Medical journal communications are designed to provide the busy practitioner with information that can be readily assimilated yet still convey the advantages and limitations of the product. In addition, because medical publications differ in the size and interests of their circulation, the selection of the specific journals utilized is another facet in the process of communicating useful information congruent with the needs of the particular physicians for whom the message is intended.

Direct mailings are a flexible, rapid means of disseminating up-todate and detailed information. With fewer limitations on space than medical journal advertisements, mailing formats range from letters to reprints of articles, scientific brochures, and comprehensive educational materials that more deeply probe the nature of various disease states and appropriate therapeutic alternatives. They often include response mechanisms, whereby recipients can indicate their interests, comments, or questions, and thus also serve to create a dialog between Roche and its audiences.

The nonpersonal promotional practices described serve to complement the efforts of the Roche sales representatives, for it is the faceto-face interaction between the health practitioner and our sales representatives that offers the best opportunity for detailed discussion and clarification of the what, how, where, when, and why of our products and services. Beyond this, we make available to all health professionals a direct telephone link with the Roche Professional Services Department, which is staffed by physicians and pharmacists, and the opportunity to discuss Roche products and services with the Roche medical staff on a 24-hour, 7-day-a-week basis. Among other things, this service provides access to the entire world's literature on our products.

Our representatives are highly qualified and properly motivated, and are respected by the professionals with whom they interact. These individuals are carefully selected and receive continuous training in the pharmacological, clinical, and competitive aspects of our products so that they may convey meaningful, current information to the health care community.

To prepare each individual for these tasks, Roche maintains a comprehensive training facility known as the Career Development

Department, responsible for developing appropriate programs and materials. Newly hired sales representatives participate in a medical education program for each of our products under the guidance of the department and his field manager.

The important point I want to make here is that before Roche representatives are permitted to discuss a particular product with physicians, they must become qualified on that product. This process of qualification requires completion of an intensive independent study course covering anatomy, physiology, pharmacology, the product's package insert, and competitive products, including nondrug modes of therapy. After it has been determined that the material is well understood, the representative then visits the career development department for testing and more intensive training on the complexities of patient management, therapeutic treatment goals, product distribution, applicable Federal and State regulations regarding labeling and distribution of pharmaceuticals, and the technical advantages and limitations of each Roche product or service. Once the individual is considered qualified, he or she is prepared to serve health providers as both an informational resource and as a link to the resources of the scientists, physicians, and other technical people in the home office.

But the training of our sales people does not terminate after this initial training program. Representatives are kept abreast of any significant developments relative to Roche's products, disease states, medical and technological advances, and the like, throughout their sales career at Roche. Each year, after having been qualified on all products, sales representatives are administered a lengthy advanced qualification test to verify that they have maintained an acceptable level of understanding of scientific information relative to our products and have kept abreast of new developments. If any representative does not demonstrate adequate understanding on any section of this test—that is, scoring 80 percent or better in each section—he or she is no longer regarded as qualified to promote the product in question and is given a remedial education program prior to retesting and being returned to, if you will, full service in the field.

The culmination of this extensive continuing educational process is a representative who is prepared to communicate specific product features, benefits, and limitations, including side effects, precautions, and contraindications, for the prescriber's consideration.

In summary, we believe that Roche promotion provides a needed and valuable service to the health care community and to our company. We support these efforts by investing in the available mediajournal advertising, direct mail, sales promotion—through our marketing efforts. We believe that responsible and timely dissemination of information to all segments of the professional health care community facilitates rational drug therapy which we define as the selection of the right drug product, for the right patient, in the right amount, at the right time.

Mr. Chairman, it is my objective today to be responsive to the interests of your committee by reviewing briefly the roles of research and professional communications in our company. I am hopeful that this discussion of the methods we utilize and the care we exercise in promoting the fruits of our research efforts is helpful. And I'd be happy to try to respond to any questions that you may have.

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have any

Mr. GILMAN. Mr. Lerner, I want to thank you for your testimony and for the preparation that went into it. It is certainly quite extensive and indepth. We are going to have to, unfortunately, suspend and recess our hearing for approximately 15 minutes while we answer a rollcall.

The committee will stand in recess.
Mr. GILMAN. The committee will come to order.
Mr. Lerner, do you

further comments on your statement before we get into the questions?

Mr. LERNER. Not at the moment, Mr. Chairman.

Mr. GILMAN. Mr. Lerner, did you want to comment at all on the testimony that was given this morning before we proceed with the questioning?

Mr. LERNER. Which testimony do you have in mind? I don't think I am familiar with the testimony as given. I have just had a general summary of what was presented.

Mr. GILMAN. Mr. Lerner, one of the questions that we got into this morning, or propositions, was the extensiveness of the training of professional people or physicians who are dispensing thc medications and drugs that you manufacture, and we questioned whether there was sufficient training. Were they adequately trained in order to keep up with all the new medications? Were they adequately enough trained to decide which medication to utilize?

One of the physicians who testified here this morning, Dr. Schifrin, I believe, stated there was a great deal of dependency upon the detailmen rather than upon their own education, experience, and background. What are your feelings with regard to professional training with regard to pharmacology?

Mr. LERNER. I think pharmacology is an emerging science in the field of medicine, and we among many companies of our kind in the ethical drug industry have provided significant research grants to medical schools to upgrade training in pharmacology. So from the standpoint of our philosophy vis-a-vis expanding dimensions in clinical pharmacology and upgrading the new as well as the mature physicians' skills in the area, we would support that.

In terms of a physician in private practice or in a hospital setting, it seems to me while the popular conception in the media and much of the critical attacks seem to portray the physician as a rather gullible dupe of industry blandishments and entreaties, I think it doesn't credit the practicing physician's sufficient diagnostic or therapeutic skill or ability to evaluate information given to him by the variety of information sources to which he is exposed. Yes, the detail people in our industry are a major source of information, but that does not imply they are the only source nor does it imply in any way that awareness of what the detail people are saying is synonymous with usage. I think physicians are critical, discerning. I think they test the information they get from our sales people as well as our other communications channels in a very critical way, and I think you'd agree with me that our people would not be welcome back if the information we were disseminating was not borne out in clinical experience.

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