Is this situation "bad?" It's very hard to tell. Drugs like Valium are really much safer than most other drugs. Huge doses, taken alone, are not lethal. They have few side effects other than drowsiness or incoordination or slight intoxication at excessive dosages. They generally mix well with other drugs. They cause physical or psychological dependence very rarely. Although there is much talk in the media about Valium abuse, there is almost no published data on the topic. The high rates of Valium appearance in NIDA's DAWN-emergency room-data system probably reflect its widespread use and its use in suicidal attempts (where it's quite benign) not real abuse in the heroin sense.

It's true that occasional patients-I've seen only 3 in the last 3 years-have trouble getting off Valium after taking it in moderate amounts (e.g. 40 mg. or more a day) for a year or two. The question of how much Valium for how long causes dependence is unanswered and clearly needs study. Individuals prone to abuse other drugs will abuse drugs like Valium for recreational purposes but serious addiction to Valium seems quite rare.

The other question is whether there are other "better" or more effective treatments available for patients now being prescribed Valium. On the drug side, depressed anxious patients generally do better on antidepressants and anxious schizophrenics do better on antipsychotic drugs.

On the non-drug side, a variety of forms of psychotherapy are provided by both medical and non-medical psychotherapists. Unfortunately there is little evidence that psychotherapy is as good as Valium in relieving anxiety and little or no evidence that short or long term psychotherapy makes people better able to cope with their problems or become more mature or self-actualizing people. I believe that some patients treated by some psychotherapists do very well but bet that Valium does better on the average. The "reality" problems which may or may not be responsible for a patient's anxiety may, in fact, be permanent and unsoluble even by Freud himself. Perhaps reduced taxes or a better economy would do more than psychotherapy or Valium to reduce the prevalence of anxiety.

Further, there simply aren't enough psychotherapists to treat everyone now getting Valium. Psychotherapy at $40-$60 an hour is probably not a "best buy" compared to Valium. The non-psychiatric physicians who prescribe the great preponderance of antianxiety drugs are not equipped by training or available time to do more than brief counseling or referral to a psychotherapist and probably shouldn't be. Most patients coming to a primary care physician with complaints of anxiety have, in fact, made a choice in selecting a medical, drug, approach to their problem and will refuse psychotherapy. All in all, psychotherapy is a real alternative for only a fraction of anxious patients.

Antianxiety drugs are probably best used for brief periods and, in fact, most use is of this sort. Some patients really are chronically very anxious and need long-term drug treatment, but there are probably patients-in unknown proportions-who are left on drugs like Valium for too long.

Much has been made of the evil nature of drug company ads for antianxiety drugs. I find it hard to believe that such ads have any great impact on people as intelligent and well educated as doctors. My guess is that they chiefly serve to remind M.D.'s that a given drug exists. Everybody I know who reads medical journals either is irritated at the presence of ads in between scientific articles or ignores them. I believe journals are necessary; without drug company ads most could not survive. The ads are a necessary irritation, not a malignant force in our society.

Probably doctors could be taught more clinical pharmacology in medical school, though the growth of semi-compulsory continuing education for physicians may be helping to train practicing M.D.'s in this area. Drug company detail men are, in my experience, better than the ads. They are often reasonably well-informed and can answer some questions M.D.'s have, to balance their obvious biases toward their company's drug. Again doctors have to be assumed to be aware of the bias of detail men unless the government wishes to fund "non-denominational" detail men to serve as a balancing force.

I suspect that more public information about drugs would help in fact, Wayne Evans and I have recently produced a book entitled "Your Medicine Chest" designed to do this kind of job for all kinds of drugs. However, even here, it is hard to tell whether more information will help patients be better, more intelligent pill consumers. The Patient Package Insert is a nice idea but needs careful field study. It could lead patients to reject drugs they really need or it could, like the anti-smoking campaigns, have little effect at all.

It's been suggested that M.D.'s may sometimes leave prescription pads around where they can be stolen and used to forge prescriptions. I suspect that most M.D.'s are quite careful in this area, but have no way of knowing for sure. Again, this could be studied systematically. For drugs like Valium pharmacists will usually accept a telephoned prescription if the M.D. follows up by mailing the store a written prescription. The pharmacist asks for the doctor's narcotics license number. I assume that a really skillful drug abuser could deceive a pharmacist, but again I have no way of knowing how common this is.

I gather the issue has also been raised about patients in nursing homes being over-sedated with drugs. I suspect that this can happen, but again I can't tell how frequently. I know from my experience at McLean that there are patients with senile dementia who are agitated, confused and very obstreprous, even dangerous if not given drugs and can't be tolerated by relatives or nursing homes if not on drugs. Without medication they would have to be on locked wards in state hospitals; with medication they may be quiet, withdrawn and sedated; for some patients you simply can't find a drug or a dose which leaves the patient organized, functional and alert. It's a real problem, made worse by ethical and regulation restrictions against doing systematic studies of newer drug therapies in these patients who are unable to give informed consent.

As to my own use of drugs, my practice is unusual because I see almost only patients referred by other psychiatrists for drug therapy and see mainly depressed or schizophrenic patients and almost never use Valium or related drugs as the main drug therapy though I occasionally add it in patients who also have anxiety uncontrolled by more specific drugs. I believe drugs are often necessary to control distress before a patient can utilize psychotherapy to work on marital or other personal or interpersonal problems. Many of my patients are, inevitably, psychotherapy failures.

In summary, I think the Valium overuse problem is probably much exaggerated, but clearly needs research rather than legislation or further regulatory controls.

PREPARED STATEMENT OF IRWIN LERNER, GROUP VICE PRESIDENT, HOFFMANN-LA ROCHE INC., NUTLEY, N.J.

Mr. Chairman and Members of the Select Committee: My name is Irwin Lerner. I am Group Vice President of Hoffmann-La Roche Inc., one of the largest research oriented 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 health care and health related products. These include bulk vitamins, prescription drugs, diagnostic products, and clinical laboratory services. The growth of Hoffmann-La Roche 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, and 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 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.

From the Roche Research Laboratories and the Roche Institute of Molecular Biology have come significant contributions to the treatment of infectious disease, mental and emotional disorders, cardiovascular disease, parkinsonism and cancer, and to greater understanding of the synthesis of proteins, the biochemistry of nutrition and the fields of degenerative diseases, auto-immune disease, connective tissue diseases and the whole aging process. More will come, for we continue to support our long-term commitment to research.

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.

To paraphrase a preface by FDA to proposed revisions in medical advertising and labeling regulations over 10 years ago-sound professional communications are essential to good health in America today.

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 health 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 enchancing the health practitioner's knowledge base.

Central to our communications efforts are these 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-scientific publications, medical journals, laboratory and clinical research, medical meetings, academic symposia, medical textboks, colloquia, peer contact, staff conferences, and the like, in addition to pharmaceutical industry 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 communications system that rapidly and effectively diffuses information to professionals who prescribe and dispense pharmaceuticals.

Our communications efforts help to keep physicians fully updated on a broad health front, including developments in diagnosis and patient management, as well as our drug products, by providing information promptly, accurately, completely and consistently. Our programs help to ensure the widest beneficial application of our prescription drugs, thus contributing to maintenance of a high level of health care for the American public, to a reduction in the toll taken by disease, and to an improvement in useful and productive function.

While Roche utilizes a variety of media to communicate information about its 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 the product.

The basis of our professional communications program is a thorough understanding of the informational needs and therapeutic goals of health care professionals. 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 individuals considered by informed medical opinion to be at risk for the condition treated by the medication.

The development of promotional material at Roche is characterized by professionalism. All parties involved in the process, internal and external, continually share the task of developing promotional programs which can meet the informational needs of the physician, satisfy the increasingly sophisticated questions regarding drug therapy, and successfully fulfill the demanding requirements of regulations.

Before being published by Roche, promotional material must pass through a rigorous and lengthy multiple review system. It typically takes four 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 various stages of its evolution from concept to graphic to finished layout to final proofs.

In addition to our multiple review system, we also subject much of our promotion material to extensive field testing by both internal Marketing Research personnel and outside consultants. The primary objective of this pretesting is to obtain reactions from health professionals in the audience to whom the promotion is directed in order to ensure that the message is clearly stated and correctly perceived. Our goals are to maximize the validity and 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.

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-to-date 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 dialogue between Roche and its audiences.

The nonpersonal promotion practices described serve to complement the efforts of the Roche sales representatives, for it is the face-to-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 staffed by physicians and pharmacists, and the opportunity to discuss Roche products and services with the Roche medical staff on a 24-hour 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. Within his or her own geographic area, the Roche representative has the responsibility to relate with medical professionals in a manner which well encourage the appropriate utilization of Roche products and services for the ultimate benefit of the patient.

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 Roche's products under the guidance of the Department and his field manager. 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 prod

ucts, 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.

The Roche sales representative's training 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 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 (i.e., scoring 80 percent or better in each section), he or she is no longer "qualified" to promote the product in question and is given a remedial education program prior to retesting. In addition to the Advanced Qualification Program, we also involve representatives in an Intern Rotation Program which constitutes participation in an intern program at a select hospital for a two-week period. This program has been designed to increase the representative's knowledge and understanding of medical situations as they present to the physician and the criteria which apply to the selection of treatment from available options. Testing is an integral part of this experience and has demonstrated its value in terms of greater understanding of patient management considerations.

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 media-journal advertising, direct mail, sales promotion-in 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 responsible to the interests of your Committee by reviewing briefly the roles of research and professional communications at Roche. 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.

PREPARED STATEMENT OF SUE BOE, ASSISTANT VICE PRESIDENT, CONSUMER AFFAIRS, PHARMACEUTICAL MANUFACTURERS ASSOCIATION

Mr. Chairman and Members of the Committee: I am Sue Boe, Assistant Vice President, Consumer Affairs of the Pharmaceutical Manufacturers Association on whose behalf I am appearing today. With me is Bruce J. Brennan, PMA Vice President and General Counsel. PMA is a non-profit trade association whose 127 members are engaged in the discovery, development and manufacture of prescription and ethically promoted drugs, medical devices and diagnostic products.

We appreciate the opportunity to present our views on the effects of certain promotional practices on the use of psychotropic substances.

It is frequently noted that retail prescriptions for antianxiety agents have more than doubled since 1964 to over 100 million annually. This growth has caused some to conclude that these drugs are over-prescribed to treat conditions for which their use is unwarranted. Yet, these statistics do not necessarily indicate an increase in per capita usage since they are not explicit as to whether