[Congressional Record Volume 146, Number 146 (Tuesday, November 14, 2000)]
[Senate]
[Pages S11531-S11533]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 RECOGNITION OF BRIAN KAATZ, PHARM. D.

 Mr. JOHNSON. Mr. President, I rise today to express my 
appreciation for the contributions of Brian Kaatz, Pharm. D. who has 
worked as part of my staff for the past three months as a senior 
Fellow. Brian's expertise in the area of pharmacology has made him a 
tremendous asset to my legislative staff, and I am fortunate to have 
had his assistance. When he returns to the Department of Clinical 
Pharmacy at South Dakota State University in December, I know he will 
be missed immensely by me and my entire staff.
  Fellows are often considered secret weapons to the Members they 
assist. Brian has been no exception. He came to my office with a 
distinguished professional career accompanied by a wealth of experience 
within the pharmacy industry. While his expertise lies in clinical 
pharmacy, Brian's interests range from issues involving infectious 
diseases and use of antibiotics, nutrition, health care ethics, drug 
policy and roles for pharmacists.
  Currently a Professor and Department Head of Clinical Pharmacy at the 
South Dakota State University, Brian has had a career filled with 
accomplishments. He has been president of the South Dakota Society of 
Hospital Pharmacists, a member of the committee that re-wrote the 
pharmacy practice act passed by the South Dakota legislature in 1992, 
an official delegate several times to the American Society of Health-
System Pharmacy annual meeting, and served as a consultant to several 
South Dakota hospitals and law firms. Additionally, Brian has authored 
or co-authored approximately twenty-five professional articles and is 
currently the editor of the South Dakota Journal of Medicine's 
Pharmacology Focus column, published monthly in South Dakota's 
Physician Journal. He has made numerous major presentations both 
regionally and nationally, and received several awards over the years 
for his notable career.
  Throughout the past three months, Brian has worked on a number of 
projects in my office dealing with pharmacy and health care. Brian led 
research efforts regarding a comprehensive study comparing prescription 
drug prices throughout South Dakota and the impact of rising drug costs 
on those without insurance. Many millions of Americans, both Medicare 
age and younger have either inadequate or no prescription drug 
insurance at all. There are roughly 39 million Medicare beneficiaries 
in this country, one third of whom have no prescription drug coverage. 
At a time, when drug prices are rising at rates far greater than the 
rate of inflation and seniors around this country are forced to choose 
between buying food or pills, we have an inadequate Medicare program 
that provides no coverage for prescription drug costs. The study that 
Brian spearheaded provided me with crucial data and real life stories 
depicting the impact of this issue for South Dakotans, young and old 
alike. Brian's research furnished my office with up-to-date and 
unbiased information that enabled me to communicate effectively with my 
constituents, especially pharmacists, during this time. Unfortunately, 
Congress was not able to come to an agreement on how we provide 
Medicare beneficiaries with prescription drug coverage, therefore the 
information that Brian compiled for me will be critically important as 
I work on this issue in the 107th Congress next year.
  Brian also facilitated discussions with the Government Accounting 
Office, GAO, on two subject matters involving direct-to-consumer 
advertising of prescription drugs and conflict of interest matters 
involving the Food and Drug Administration's Advisory Committee 
members. The research Brian conducted in these two areas will provide 
me with the basis for further discussions with GAO and congressional 
committees seeking hearings into these matters. Brian previously 
authored and co-authored two articles specifically on the subject of 
direct-to-consumer advertising and has completed extensive research in 
this field.
  I ask to have the contents of these two articles printed in the 
Record following completion of my statement.
  One of the most important tasks as a Senator is to communicate with 
your constituents back home. Balancing my

[[Page S11532]]

duties in Washington with my schedule in South Dakota is often 
challenging due to uncertainties of the Senate schedule. Brian's 
established relationship with the South Dakota Pharmacist's 
Association, South Dakota Board of Pharmacy and several national 
pharmacy organizations was extremely crucial to his work with my 
office. He was able to advance discussions surrounding several issues 
with these groups which will aid me tremendously in my future work with 
prescription drugs, roles of pharmacists and other health policy 
matters.
  Brian can take pride in his career and dedication to health care 
issues. He is a recognized health care expert, an educator, an author, 
an advocate and a friend. I wish to express my deep gratitude to Brian 
for a job well done. I wish him the very best in his future endeavors.
  The articles follow.

         [From the South Dakota Journal of Medicine, Dec. 1998]

   Direct-To-Consumer Advertising of Prescription Drugs: An Ethical 
                              Perspective

                            (By Brian Kaatz)

       There is no doubt to anyone who reads this that the 
     detailing and promotion of prescription drugs is big 
     business. Thousands of sales representatives are employed and 
     millions of dollars are spent annually to explain the 
     putative advantages of certain products over others.
       Notably, the effort by pharmaceutical manufacturers to 
     expand market share of certain targeted prescription drugs 
     has traditionally been directed solely to health 
     professionals. This has changed in a big way.
       Newspapers, magazines, and television are inundated with 
     prescription drug promotions aimed at attracting the 
     attention and interest of the public. Advertisements are 
     intended to stimulate the individual interest of patients, 
     which then potentially will result in inquiries (or demands) 
     directly to physicians for that product. This approach may 
     seem entirely satisfactory to the general public, but it is 
     potentially problematic from several standpoints.
       Even under the best of circumstances, most clinicians will 
     admit that their knowledge of new drug products is far from 
     complete. Ideally, a perspective of when or if to use a new 
     product will come from careful surveillance of the primary 
     literature, consultation with a respected and knowledgeable 
     colleague, or from an unbiased, current review of a specific 
     category of drugs. Many physicians pragmatically approach a 
     new drug intending to be ``neither the first nor last'' to 
     use it. This approach could understandably be thwarted if a 
     number of patients persistently request a particular product 
     as a result of the tried-and-true marketing approach of 
     repetitive media encounters and high product visibility.
       A patient may not be understanding if her physician tells 
     her that he has no experience with a drug when at the same 
     time the patient has seen it advertised maybe 20 times in the 
     last two weeks. What is wrong with my doctor? Doesn't he 
     watch TV?
       The result may be subtle pressure or even coercion to 
     prescribe the drug in question.
       Tens of millions of dollars are spent advertising drugs 
     like Claritin, Rezulin, Zocor, and Pravachol. Apparently, 
     this approach has been especially successful since August of 
     1997, when the FDA allowed televised advertisements to be 
     exempt from detailed descriptions of drug risks. This ruling 
     at least relieved the viewing public from the sometimes 
     bizarre, oblique ads that were seen prior to this, when 
     requirements limited drugs to a name but no detail as to its 
     use. Even relatively astute observers were sometimes confused 
     about the intent of these commercials.
       Now, patients and other interested parties are referred to 
     the Internet or other sources ``for more information,'' 
     though they obviously are already headed down the road of 
     special interest in that drug.
       Beyond the easy questions that would ask, why can't these 
     tens of millions of dollars be used to lower drug costs, or 
     be put into research for new and safer pharmacologic 
     entities, what of the ethics of direct-to-consumer 
     advertising?
       Patient autonomy has been argued elsewhere as being the 
     preeminent ethics principle. There is a strong case for 
     patients knowing as much as they can reasonably understand 
     about disease processes and medication risks and advantages. 
     There is also a strong case for patients being actively 
     involved in their own therapeutic journeys and fully 
     participating in these kinds of decisions. But can we relate 
     direct-to-consumer advertising with true patient autonomy? Is 
     advertising valuable in the effort to develop autonomous 
     decision making? There is a case for answering these 
     questions in the negative.
       It must be remembered that patient autonomy does not begin 
     and end with the simple act of a patient making a decision. 
     To the contrary, autonomous decision-making occurs only when 
     there is a fully informed decision-maker. Autonomy is based 
     upon that important element. Thus, one can readily see that a 
     brief, colorful advertisement by itself offers little in the 
     way of full disclosure and does not contain the complete 
     tools necessary to make an autonomous decision.
       It perhaps is particularly important in these situations 
     for doctors to maintain a healthy beneficent attitude which 
     could result in a patient receiving a drug with which his 
     physician is familiar and comfortable, rather than the one 
     that is most persistently on prime time. It is not a 
     disservice to attempt to dissuade a patient who is only 
     partially armed with knowledge from committing to long term 
     therapy with a potentially suboptimal drug. And it is not 
     true autonomy that is being exerted when a patient presses 
     for that drug. What might at first glance seem like autonomy 
     lost is actually beneficence gained.

 [From the Journal of Medical Humanities and Bioethics, Spring/Summer 
                                 1987]

  The Physician and the Pharmaceutical Detail Man: An Ethical Analysis

                 (By Jerome W. Freeman and Brian Kaatz)

       The principal focus of medical practice should be the 
     patient's interest. The physician's conduct in the clinical 
     realm should consistently reflect this. Arguably, this ideal 
     is not always realized. An example of a circumstance in which 
     the patient's interest does not predominate occurs in the 
     context of the physician's interaction with pharmaceutical 
     companies. These companies have a variety of marketing 
     techniques directed at physicians in order to promote 
     prescription drugs. This essay will explore the ethical 
     implications of one aspect of these marketing programs--
     namely, the role of pharmaceutical salespersons. These men 
     and women have a variety of titles including ``sales 
     representative,'' ``medical sales liaison,'' and ``detail 
     man.'' The latter term is commonly used, apparently as a 
     reflection of these representatives' efforts to provide 
     physicians with details or data about drugs.
       Before attempting to assess the ethical implications of 
     pharmaceutical companies' marketing techniques, a specific 
     inquiry into the goals and ideals of medical practice is 
     warranted. Most physicians take for granted the notion that 
     the patient's interest is of primary importance and that 
     moral dilemmas in medicine are appropriately resolved through 
     a patient-centered ethic. Kass reflects this view when he 
     notes that ``loyalty to the patient must be paramount, first, 
     because the mysterious activity of healing depends on trust 
     and confidence, which is lodged by the vulnerable and 
     dependent patient with the physician, in the very act of 
     submitting to his care.''
       The basis for such a patient-centered ethic derives from, 
     and is consistent with, basic ethical principles. Veatch' 
     characterizes these principles as the ``basic social 
     contract,'' and he points out that diverse ethical systems 
     frequently arrive at a similar core of basic principles and 
     derivative rules. Often such principles include autonomy, 
     nonmaleficence and beneficence. On the basis of such 
     articulated principles, society can proceed to define the 
     nature of relationships between a profession and society. 
     Veatch argues that this process can establish that a contract 
     or covenant exists between the physician and society and 
     between the physician and the individual patient. This 
     covenant arguably mandates a patient-centered ethic in 
     medicine, guided by adherence to those basic ethical 
     principles society has defined and endorsed.
       Of these major principles, autonomy dictates that the 
     physician treat the patient with dignity and respect and that 
     the patient be allowed to participate in his or her own 
     health care decisions. Nonmaleficence warrants that the 
     physician endeavor to avoid causing the patient harm through 
     his actions. The sense of this principle, thought to derive 
     from the Oath of Hippocrates, is often quoted in the Latin 
     phrase primum non nocere (first, do no harm). Beneficence 
     stipulates that the physician work actively to benefit the 
     patient by contributing to his or her health and welfare.
       In this ethical framework, it is possible to characterize 
     the impact that pharmaceutical marketing techniques have on 
     the physician-patient relationship. The pharmaceutical detail 
     man promotes his company's products to physicians in a number 
     of ways. He or she frequently calls on physicians in their 
     offices and also meets with them in the hospital. Often in 
     hospitals the representatives from various pharmaceutical 
     companies participate in a rotational schedule for operating 
     a drug display in a prominent location, usually near the 
     physicians' entrance. A detail man frequently has one or two 
     drugs to promote actively, and literature and visual displays 
     which describe these agents. Each salesperson argues why his 
     or her drugs are better than competitors' formulations. In 
     addition to a verbal message and printed information, the 
     detail man often has various ``gifts'' for the physician. 
     Pens or writing pads inscribed with a particular drug name 
     are common. Gifts also include free texts, medical equipment 
     (such as reflex hammers and penlights), and medical bags 
     (typically given to graduating medical students). Drug 
     samples are frequently offered. In addition, the detail man 
     may coordinate more elaborate gratuities such as cocktail 
     parties, refreshments at medical meetings (such as those of 
     state medical association groups) and the sponsorship of 
     medical symposia. Specific examples of such marketing 
     efforts are illustrative.
       One of our community hospitals was approached by a drug 
     salesperson to participate in a study involving an antibiotic 
     that was on the market. This drug's utilization had been 
     minimal because of increased cost to the patient and the fact 
     that it offered no

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     substantive therapeutic advantage. The proposal extended to 
     the physicians and hospital was to use the drug on a given 
     number of patients, at the patients' expense. Physician 
     participants in the study were to be ``reimbursed'' 125 
     dollars for each patient enrolled. This sum was designated to 
     cover ``expenses'' associated with the study.
       A second example of an elaborate gratuity system has 
     recently been utilized in our community. Selected physicians 
     were invited by a pharmaceutical company's detail man to an 
     expense-paid seminar in a popular vacation city. The meeting 
     focused on a new antihypertensive drug (at the time, this 
     drug company had the only formulation of this drug on the 
     market). The educational component of the meeting was judged 
     to be very good by the physician participants. This 
     promotional package included airfare for the physician, 
     lodging for the physician and spouse, meals, a cocktail 
     party, and an evening of dining and dancing on a chartered 
     river boat. In the year following this event, two other 
     pharmaceutical companies have offered similar meeting 
     packages to physicians in the community.
       Such promotional efforts are clearly expensive. For 
     instance, it has been estimated that each visit by a detail 
     man to a physician costs the pharmaceutical company 75 
     dollars. Despite the expense, however, drug companies have 
     found that the use of the detail man is the most effective 
     means of promoting their products. These companies often 
     prefer to characterize their detail man as ``service 
     representatives'' purveying information, rather than as 
     salespersons. One company not only requires the detail man to 
     attend four tutorials a year, but also gives pharmacology 
     tests to all its representatives quarterly. But such training 
     does not negate the fact that, in practice, detail men 
     function as aggressive, effective salespeople. Indeed, most 
     of them are at least partially reimbursed on a commission 
     basis. Their success as pharmaceutical representatives is 
     clearly dependent upon their ability to sell drugs. Those 
     drugs which representatives emphasize at any given time 
     reflect corporate decisions based on such factors as 
     competition, quotas and the patent status of the drugs.
       Given the stated nature of the physician-patient covenant, 
     the type of relationship that frequently exists between the 
     physician and the detail man is ethically troublesome. More 
     specifically, that relationship appears to violate all three 
     of the basic ethical principles previously discussed. By 
     virtue of the principles of autonomy and beneficence, the 
     patient has a right to expect that he or she will be treated 
     with dignity and respect. He or she expects to receive the 
     best possible treatment the physician can generate. The 
     patient has a right to assume that the physician's 
     therapeutic decisions are based solely on scientific medical 
     knowledge, unbiased by extraneous factors or inducements. 
     Thus, the very nature of the physician-patient covenant, and 
     the principles that underlie it, would seem specifically to 
     preclude the physician from basing a drug-prescribing 
     decision on factors other than what is objectively best for 
     the individual patient. To the extent that the physician 
     decides to try out a new drug or opt to prescribe regularly a 
     medication simply because he likes a detail man or because he 
     is consciously or unconsciously affected by his or her 
     various inducements and salesmanship, the physician would 
     seem to be violating the patient's trust. One wonders what a 
     patient's reaction would be if he or she were explicitly 
     aware that such interactions and inducements existed.
       In addition, the principle of nonmaleficence can be 
     violated by the physician-detail man relationship. Often the 
     new drug formulations which are promoted offer no meaningful 
     advantage over older drugs. Yet, in taking them, the patient 
     risks the possibility of experiencing adverse effects as yet 
     undiscovered or not well publicized (even when the drug has 
     been approved by the Food and Drug Administration). The 
     recent controversy surrounding the drug Oraflex constitutes 
     such an example. This drug was vigorously promoted as a new, 
     very effective agent for arthritic symptoms. Shortly after 
     its release, this agent was removed from the market because 
     it was associated with serious liver toxicity in some 
     patients. Moreover, the patient usually pays considerable 
     financial premium when a new drug formulation is used. 
     Invariably, the newer drugs being marketed are significantly 
     more expensive than older, and sometimes equally effective, 
     drugs whose patents have expired (rendering them much less 
     profitable to the pharmaceutical company). Again, the average 
     patient has no insight into this fact. He or she certainly is 
     not usually afforded the opportunity to decide autonomously 
     whether the drawbacks and risks of a new drug formulation 
     render it less advantageous than other, longer-established 
     drugs. And indeed, even if the typical patient is given some 
     knowledge of drug options, he or she lacks the expertise to 
     participate seriously in the decision of which drug to 
     employ. In fact, it is the physician alone who ordinarily 
     must make the determination of which drug to employ. If this 
     decision is based on sound, scientific data, the choice of a 
     new and more costly drug may clearly be justified. However, 
     to the extent that the physician does not rely on objective 
     medical data (as published in medical journals or 
     discussed at medical meetings), but rather derives his 
     information from the drug companies' own representatives, 
     a potential conflict of interest exists.
       Pharmaceutical companies might respond to this assertion by 
     observing that in our free enterprise system there is nothing 
     wrong with vigorously marketing one's products. Indeed, in 
     the open marketplace it is, of course, common to offer a 
     variety of inducements, including rebates, coupons, gifts and 
     other types of price reductions. However, this situation is 
     not analogous to the relationship between the detail man and 
     the physician. In the ordinary marketing arena, companies 
     attempt to influence the purchaser and user of various 
     products. This is categorically not the case in the 
     relationship between the physician and the pharmaceutical 
     companies. The patient is the passive, dependent recipient of 
     the physician's practice decisions. By virtue of this fact, 
     as well as the implicit covenant which exists between the 
     physician and the patient, the physician has an obligation to 
     strenuously avoid basing any prescription decisions on 
     factors other than the strict medical indications for those 
     drugs. To the extent that the physician is either 
     unconsciously or manifestly induced to use the drugs of a 
     given detail man or pharmaceutical company, in the absence of 
     strict medical indication, a significant ethical problem 
     exists.
       The implications of this analysis are clearly troublesome. 
     It would appear that the current standard of medical 
     practice, in terms of the relationship between the physician 
     and the pharmaceutical detail man, may readily promote 
     outcomes not in the patient's best interest. Since the 
     physician-patient covenant and the ethical principles which 
     underlie it warrant that the patient's interests should be 
     the prime focus of medicine, significant changes are 
     warranted in the methods which pharmaceutical companies 
     employ to market their drugs. Currently, pharmaceutical 
     companies, medical organizations and individual physicians 
     are clearly party to, as well as beneficiaries of the present 
     marketing techniques. Thus, there are powerful incentives to 
     maintain this longstanding system. The pharmaceutical 
     companies' profit makes it understandably difficult for them 
     to endorse sweeping changes in their current, successful 
     marketing practices. Many medical organizations and their 
     scientific journals are largely dependent on the advertising 
     which is purchased by the drug companies. And certainly the 
     individual practitioner, too, clearly benefits from the 
     current system of gifts and gratuities.
       Changes in the present system of drug marketing will 
     doubtless come slowly. Most likely, improvements will evolve 
     only as individual physicians become better educated about 
     these ethical concerns and committed enough to demand 
     alterations in the present marketing practices. The 
     individual physician's role in this process should not be 
     viewed as an optional one. Rather, the physician is ethically 
     mandated to work for change in this realm of drug marketing. 
     This responsibility derives from the physician's clinical 
     covenant with the patient and the moral principles which 
     underlie it.

                          ____________________