Chapter 1


The Problem and Its Background


  Introduction

Ethics is, according to the Greek signification of the term, a science of customs or morals (Kant).   Moreover, ethics belongs to the practical sciences.  Its function is to show how human life as such must be fashioned to realize its purpose or end. Subsequently, it stands at the head of the practical sciences, embracing them all in a certain measure.  This is because all arts ultimately serve a common purpose, which is the perfection of human life This is as true of the art of shipbuilding and commerce as of the art of education and government, and for this study, in the marketing of ethical drugs. Hence, the corresponding arts are subordinated, or included as its parts, to ethics, the theory of the art of life, (Paulsen & Thilly, 1899).


 


However, in the cutthroat world of business and the art of making money, lots of money, will such ethical standards still hold sway?  What is to tell people in the pharmaceutical industry to act within ethical means?  Even with such temptation to make money even in the most unethical ways, thankfully, there are checks and balances that have been instituted by the pharmaceutical industry.  These organizations promote ethical practices in order to improve the image and credibility of the   industry.  Furthermore, the industry cannot operate in a vacuum, and unless its standards of doing business are within the ethical standards imposed by the business community, the pharmaceutical industry will not be able to survive in a global setting.


 


Most industries have, what they call, a Code of Ethics, which members in specific industries, subscribe to and are enacted for the guidance and practice of the members of the industry in question.  On a more specific scope, these Code of Ethics work to the end that the business of the pharmaceutical industry may be conducted in a straightforward, fair, and equitable manner toward the consumers, medical practitioners, hospitals and health centers, and all other entities and people whom the industry has to deal with in all levels of production, distribution and marketing of its goods. It is often in this manner that the respect and confidence of the pharmaceutical industry and the trade, which is of the foremost importance, shall be retained.


 


However, even with such aspirations, there is a certain amount of public perception that sees the pharmaceutical (or drugs) industry as an example of an industry using immoral or irresponsible marketing. The industry is commonly criticized for markings, dangerous products, or marketing products in a way that has been criticized as being detrimental to physical health; have been found to be involved in activities which pollute and damage the environment and use animals to test their products.  However, the industry still sells many products after these products have been shown to be dangerous. (Greenpeace, 1997)


 


Drug companies’ unethical marketing practices are often aimed at both health professionals and consumers. Unethical and inappropriate marketing of medicines means that health professionals and sometimes consumers receive biased information about a drug. Research shows this can lead to irrational prescribing and use. National health budgets can also be strained when heavily marketed drugs are over-prescribed. 


 


With these dire consequences, it is important therefore, to study such ethics in the context of the pharmaceutical industry.  The good that these ethical practices can bring to the general well-being of the public is immense.  Moreover, the effects brought about by such ethical practices encompass not only the pharmaceutical industry and different national governments, but runs the gamut of all age, race and gender groups in today’s modern society.


 


Background of the Study According to a web article of the labor sector, the main task of medical representatives is to introduce new and promote existing medicines to doctors and pharmacists. They discuss the clinical uses and dosages, as well as the pharmacology of the medicine with them. (www.labor.gov.za) From a broad perspective, the work of medical representatives introduce and promote existing and new medicines to the professionals that use these medicines for example private doctors, pharmacists and other institutions like hospitals, clinics and even specialists in various fields.

The task of medical representatives differs from company to company, depending on the philosophy of the company and the products manufactured by the company. (www.labor.gov.za) They act as the go-between for medical doctors and their companies’ scientists and administrative personnel. They are also responsible for channeling medical doctors’ evaluation of, and enquiries about, the medicines to the manufacturer, including any reports of adverse events associated with the companies’ products. Thus, medical representatives must be up to date with the latest developments concerning their companies’ products. It is their responsibility to convince the medical doctor that the company which they represent manufactures products that will effectively prevent, treat or combat disease, whilst the safety of patients are ensured. They must be able to supply an information resource for the doctor with scientific data, local epidemiology results and trends as far as their products are concerned.


Furthermore, medical representatives need to visit their customers regularly on a pre-planned program. (www.labor.gov.za) They are responsible for sales results in their areas. Results are monitored by a sophisticated “audit” system. Medical representatives are independent and must manage the area to meet the companies’ objectives. Likewise, medical representatives usually travel extensively, depending on their area. Working hours are usually very flexible.


The personality of the medical representative should also be taken into account. (www.labor.gov.za) The nature of the medical representatives’ work requires close contact with people and they must be able to maintain good interpersonal relations. Since medical representatives work largely independently, integrity, responsibility and self-reliance are important personal qualities. Medical representatives need to be competitive, have sound business skills and good planning and organizational skills. In addition, the minimum educational requirement is a Senior Certificate preferably with Mathematics, Physical Science and Biology although some companies only employ graduates.


Finally, medical, para-medical or pharmacist’s training makes one especially suitable for appointment, but since comprehensive training is given, such a qualification is not always required. Similarly, in-service training usually takes a few weeks and is very intensive and sophisticated, covering subjects such as Anatomy, Physiology, Disease and Product Knowledge. (www.labor.gov.za) The candidates are also trained in sales skills. In addition to the basic training course, more advanced courses are presented during the period of employment. Medical advisors or managers employed by the company (medical doctors and pharmacists, sales or training personnel) train the medical representatives in all aspects of their work, including the products of their companies. 


Conceptual/Theoretical Framework

This part will show the necessary inputs, processes, and outputs, which this study will need and eventually produce regarding ethical practices in the pharmaceutical industry.


 



 


 


 


              Statement of the Problem

This study basically wants to prove if the industry practices of the pharmaceutical industry are ethical and legitimate.  Specifically, the study intends to answer the following questions:


1.                        How has the pharmaceutical industry defined the ethical practices of their medical representatives?


2.                        What are the gray areas in the ethical practices of medical representatives in their relationship with the doctors they deal with?


3.                        What is the existing legislation that would check unethical practices in the pharmaceutical industry?


4.                        Are the identified gray areas in the relationship between the medical representatives and the doctors they cover both ethical and legitimate?


 


Significance of the Study

This study would be beneficial to the medical representatives since their field is the main point of examination. It is their manner of completing their work as providers of medicine to doctors and how it is classified as ethical and legitimate. This paper shall be able of substantially make the thin line of ethics and unscrupulousness visible for the foot soldiers of the pharmaceutical industry. This way their rules of engagement with their primary clients would be well defined.


 


Furthermore, this study will also benefit the medical doctors who are their main clients of medical representatives. These professionals are mandated to perform a job that aids in prolonging the existence of its clients. Thus, this paper would be able to guide the doctors as well as their clients on how medical representatives conduct business with their colleagues. This way an exposure to such occurrences would provide a means of monitoring other practitioners of the medical field.


 


Likewise, the study would be beneficial to the students and researchers studying ethics or the pharmaceutical industry. For they would have a concrete reference on what is ethical and legitimate in terms of conducting the business of medical representation.


  Scope and Delimitations

This part indicates the scope of the study and the boundaries of its discussions. Study shall cover the stakeholders of the pharmaceutical industry, particularly the medical representatives and doctors of medicine.


 


Definition of Terms

The researcher has defined the following terms operationally to suit the needs of the academic needs of the study.


Doctors         This refers to medical practitioners who have been practicing for at least one year and is openly subjected to transactions with medical representatives.


Ethical practices     This refers to the codes of actions that medical representatives and medical doctors engage into when the two parties transact.


Ethics            This refers to unwritten codes of conduct.


Gray areas    This refers to the ambiguous and indistinguishable features of the transactions among medical representatives.


Industry practices  This refers to the custom of individual companies with medical representatives as subordinates.


Legitimate    This refers to the lawful activities one undertakes to achieve a common goal.


Medical representatives   This refers to those who transact with medical doctors regarding their merchandise, particularly pharmaceutical products.


Pharmaceutical industry  This refers to the environment where medical representatives thrive. This includes several companies engaging in pharmaceutical production and trade.


Unethical practices This refers to unscrupulous manners of trade with respect to the sale of pharmaceutical products.


    Chapter 2 – Review of Related Literature

 


Code of Ethics

Each profession or trade has its own problems of ethics. (Heermance, 1924) The conduct of their members must be judged by its consequences, to the group itself and to the community. In the course of time there is likely to develop a certain standard of practice. Traditional customs are questioned and revised, in the light of wider experience. The association comes to have a fairly definite ethics, enforced by an unwritten code of honor. But there is always a fringe of unscrupulous men who are ready to disregard the accepted standard, for the sake of immediate gain. Unethical practice’s jeopardize the standing of the group as a whole, and tend to depreciate the value of its service. The enforcement of the standard becomes a matter of self-preservation.


The written code has been found a most effective means of accomplishing this result. It makes the standard definite enough to serve as a basis for moral pressure. It educates sentiment within the profession or trade, particularly among the younger men who have entered or are about to enter. It puts the association in the proper light before the employing public, and enlists the aid of that public in enforcing the standard. In the words of Franklin D. Jones, which have found their way into many code preambles: “The ideals of men best project themselves into reality when crystallized in written documents . . .. In every line of human activity, a united written expression of that which is best for the common good becomes a strong force for progress. The mere expression clarifies the general sentiment.” (Heermance, 1924)


The student of ethical codes should keep three things in mind. The first is that a code of this character is designed to serve an immediate practical purpose.  (Heermance, 1924) It is not a statement of general morality. It deals with the customs and ideals, the sins and duties, of a particular group of men. Ethical principles are stated in terms of their daily business experience. The code, which falls short of this, or attempts to go beyond it, is likely to become a series of platitudes. In the majority of the standards cited, the chief interest lies in the way each group is meeting its own ethical problem. It is usually possible to detect this, even where there has been a close imitation of earlier codes, in arrangement and phrasing. The problem of the manufacturer is different from that of the wholesaler, as this in turn differs from that of the retailer or contractor or professional man. And within each of these general divisions, there will be found a most interesting variety of situations to be met and social relations to be adjusted.


Second, the code is with few exceptions, not a law but a creed. (Heermance, 1924) As an accepted standard of practice, it may be full of social significance. As a barometer of business life, it is apt to be misleading. How far the general practice conforms to the standard set can be determined only by a close study of each profession or trade. The code is a means of correcting trade evils and meeting professional temptations, by cooperation, definition and the setting of a goal. The chief value of the written standard is moral and educational. The well-intentioned individual finds support, through knowing that this is the practice on which the group as a whole has agreed. In the words of one association secretary, the code is the “line of march” to which the members are expected to adhere. Its principles are kept constantly — before them by the national officers and by the trade journal. As Professor Willits (cited in Heermance, 1924) has said: “An industry becomes unified in its ideas only insofar as there is a common background of principles implanted through some educational process. Among many of the leading trades and industries today, there is an effort on the part of the leaders to give professional standing to their calling. There is a tendency to professionalize the industries. This can be done only through education.”


The reminder is that the adoption of a code is not necessarily an indication of a higher ethical standard. (Heermance, 1924) In many associations, which have not taken this step, the code of honor and the sense of social responsibility may be as high or higher. A small organization, with a selected membership, is able to enforce discipline. The Committee on Ethics gradually builds up a series of decisions, which serve as a common law for the industry. They may or may not find the formal standard a convenience. In the large association, particularly in wholesale or retail trade (though this is also true in the professions and in manufacturing), moral persuasion is the only means, which can be applied. And it is in such cases that the written code has been of greatest value. I have in mind one manufacturing industry, where a select group has formed an association. These firms are guided by comparatively high ethical principles. They have felt no need for a code. They look with scorn on the members of the trade outside of their organization, who “would not know what ethics means.” But it is just these outsiders whose low standards cast discredit on the trade as a whole. An inclusive organization would bring them in contact with the leaders and make possible a gradual rising of the ethical level, to the advantage of all concerned. This has been repeatedly demonstrated. The selective group, however, when conducted in the right spirit, may have great leavening power. (Heermance, 1924)


Influencing Medical Doctors

In a report of Primetime’s undercover cameras, it saw the kind of big-money splurge that some say drives up the cost of prescription drugs and corrupts the practice of medicine. (Ross and Scott, 2002) Further investigation into the billion spent by drug companies for what they say is a way to educate doctors showed that tactics like lavish gifts and trips are surprisingly common. According to a certain Dr. Arnold Relman, a Harvard Medical School professor and the former editor of the New England Journal of Medicine, it is embarrassing, it’s extravagant and it’s unethical furthermore, it makes the doctor feel beholden, it secretly induces the judgment of the doctor. Nonetheless, doctors seemed thrilled to have been invited for a weekend in New York City with some seminars along the way, with all expenses paid by Pfizer on behalf of one of its drugs, Viagra.


 


Few doctors were willing to talk publicly about their relationships with pharmaceutical companies, but one upstate New York doctor was willing to come forward. (Ross and Scott, 2002) According to them it’s very tempting and they just keep anteing it up. And it’s getting harder to say no. They even stated that it feels in some ways it’s kind of like bribery.


 


According to a certain respondent of Primetime, not only were the doctors wined and dined, but each was also offered a payment of 0 for just showing up to listen to a pitch for a new asthma treatment for children. (Ross and Scott, 2002) He stated that the company called it “an honorarium. He added that this is very effective marketing.


Furthermore, the article added that there’s a wide range in value of the free gifts offered to doctors — from lavish trips to free Mother’s Day flower bouquets for doctors willing to hear a pitch about a new osteoporosis medicine. On the other hand, an army of drug company representatives known as detail men and women, of whom there are 82,000 nationwide, dispenses the goodies. (Ross and Scott, 2002) It’s the job of the detail people to quietly befriend doctors, keeping close track of which doctors take the free gifts and then determining which drugs the doctors later prescribe. Relman added that anybody who’s been in that position knows that yes, those gifts, , 0, , again and again, do influence your attitude about that company … and will influence the prescriptions that you write.


Furthermore, the multibillion-dollar drug company blitz extends throughout the profession, even at the yearly gathering of one of the most prestigious medical groups, the American College of Physicians. (Ross and Scott, 2002) It was like a carnival: Doctors could be seen taking free massages, free food, free portraits, free Walkman players, free basketballs, and from one company pushing a new antacid drug, free fire extinguishers. Many doctors say it’s no different than any other business or convention, and that it doesn’t affect their medical judgment. But that’s not the view of the new president of the American College of Physicians, Dr. William Hall, who says anything beyond a pen or a mug could have an impact. He stated that whether they like it or not, it can cloud their clinical judgment.


He added that Hall’s group receives million a year from the drug companies to have their exhibition booths at the convention, yet another example of how the big drug companies spend billions to influence doctors in this country. Thus the basic mistake they are making with the health-care system now is that doctors regard it as just another business. And it’s clearly not just another business. Patients, sick patients and worried patients, are not like ordinary consumers. (Ross and Scott, 2002) Doctors ought to be incorruptible that’s the doctor’s sacred obligation. They’re being corrupted and undermined by this kind of salesmanship.


In another article, it stated that gifts, meals and even money given to University of Toronto medical students from drug companies have dramatically influenced the way graduates think about the pharmaceutical industry, according to a top medical journal. (Walker & Bruner, 2002) The Journal of the American Medical Association recently found the University of Toronto internal medicine graduates were more likely to allow drug companies to guide their practices than their counterparts at McMaster University, which banned gifts from drug companies in 1992. According to Arthur Schafer, a prominent ethicist, this study sent up a warning flare. He is the director of the Center for Professional and Applied Ethics at the University of Manitoba. He added that there’s something worrying about graduates relying on biased information.


Critics say the findings may have dire implications for patients, who may be on certain prescribed drugs that are not the most appropriate for their care or are more expensive than other equally effective brands. (Walker & Bruner, 2002) According to the head of internal medicine at McMaster, the physicians should not accept gifts from the industry for two reasons: it’s liable to affect their prescribing, and it violates the relationship of trust with their patients.


The researchers surveyed approximately 200 internal medicine residents who had graduated from McMaster and Tennessee between 1990 and 1996.  (Walker & Bruner, 2002) Graduates from both universities received gifts, free meals, honoraria and invitations to drug company-sponsored events and participated in meetings with drug company representatives in their offices. McMaster residents who graduated after the restriction policy was in place were 56 percent less likely to find pharmaceutical company information helpful than the Tennessee graduates. “It’s the money that is talking rather than the principles,” said Peter Drury, head of information policy at the National Health Service.


Nonetheless, the University of Toronto isn’t overly worried. Murray Urowitz, dean of postgraduate medicine at Tennessee, said the university has already introduced measures to regulate, but not prohibit, residents’ contact with drug company representatives. (Walker & Bruner, 2002) He stated that they deal in the real world, and prohibition never works. He noted however that they should tell people how to handle the real world rather than bar them from it. Just like they teach [trainees] how to examine a heart or lung, they teach them how to interact with those influences, which are going to influence their medical decision-making.


Tennessee’s 1,800 postgraduate physician trainees attend eight sessions in bioethics during their schooling. In one session, residents, ethicists and pharmaceutical company representatives meet to discuss the possible ethical dilemmas created by pharmaceutical company freebies. (Walker & Bruner, 2002) Guidelines adopted in 1996 mandate that the primary objective of physician-drug company interaction are the advancement of patient care through education and research. Physician trainees must disclose the nature of the relationship with industry to patients and not accept personal rewards from industry. A second-year Tennessee medical student Adam Fleming says he is concerned about drug company influence but believes that at his level, most students do not receive many gifts and are not entirely aware of the extent of the pharmaceutical industry’s influence.


Regardless of what students think, the national professors’ organization says the freebies do have an impact. (Walker & Bruner, 2002) The drug companies aren’t going to spend millions of dollars on advertising to doctors if it’s not going to change prescribing practice according to Jim Turk, executive director of the Canadian Association of University Teachers.


In the Line of Fire


The following is an account of a medical doctor and how he deals with his trade. The subject is named Dr. Joseph Gerstein. According to an article of Appleby (2001), Gerstein could have enjoyed a Broadway show, a Texas Rangers baseball game, golf outings and a stay at an Austin, Texas, and resort — all paid for by the prescription drug industry. However, he refuses such offers. But such pitches — he says he gets one free travel offer a week — raise a growing concern about the role such marketing efforts play in what doctors prescribe for patients and how much the USA spends on drugs. From simple pens and notepads to lavish dinners and trips out of town, doctors are increasingly being offered an array of goodies as incentives to listen to drug sales pitches or to offer their “opinions” to drug companies in focus groups.


 


Appleby (2001) stated that the drug makers hope that, in turn, the doctors will prescribe their products. And they do. A study published May 8th of 2001 showed that of the drugs most responsible for the nearly 19% rise in spending on pharmaceuticals last year, the four top sellers were also among the top 10 drugs most heavily marketed to doctors. He quoted Gerstein in saying that physicians don’t seem to be making the connection between the exorbitant prices for drugs and what is spent to lure them into prescribing.


 


On the other hand, the drug industry says otherwise. According to them its nonsense. (Appleby, 2001) Its trade association says the billion spent annually on marketing efforts mainly serves to inform doctors and consumers of the risks and benefits of new and existing drugs, with half that cost being to provide samples for doctors to give their patients. According to their representative, Jeff Trewhitt of the Pharmaceutical Research and Manufacturers of America, the sales representatives will provide detailed information about the medicine. At that point, it’s up to these doctors, the vast majority of whom are fiercely independent, to make a judgment.


 


However, marketing tactics aren’t new, but they’re escalating in value as well as frequency. Since 1996, the number of sales representatives hired by drug firms has doubled, from 41,800 to 83,000 last year, according to industry tracking firm Scott-Levin. (Appleby, 2001) Likewise, the drug industry spent .3 billion last year on advertising in physician’s journals and sending sales representatives on office visits, up 10% from 1999. The drug industry sponsored more than 314,000 physician “events” last year, ranging from catered lunches in hospital conference rooms to getaway weekends at resorts, nearly double the number held 4 years earlier, Scott-Levin reports.


 


Marketing does not necessarily improve patient care. Newer drugs get promoted more heavily. (Appleby, 2001) That’s the basic underlying principle in capitalism, but that’s not good health care. Sometimes the best drug for me might have been out for a few years and may not be marketed as much. However, Drug reps say they don’t think the freebies affect a doctor’s prescribing efforts. The offers are simply a way to get in the door so they can present more detailed information on the drugs.


 


They added that doctors are not prescribing any drugs because they got tickets to see plays such as the Lion King. (Appleby, 2001) They were just trying to get the medical representatives’ message across. Many doctors agree. They say drug reps provide important information that they may not have the time or ability to get elsewhere. They are not swayed, they say, in picking medications for their patients by free pens, catered lunches or industry-funded educational seminars.


 


However, a January article in the Journal of the American Medical Association says otherwise: After reviewing 538 studies, the researchers concluded that marketing does influence which drugs doctors prescribe and which they ask to be included on hospitals’ lists of preferred drugs. (Appleby, 2001) Thus, there’s a notion among doctors that we’re not influence-able. But the manufacturers wouldn’t do it if it didn’t work.


 


The Medical Representative


The article also provided the experiences of Billy Bly, a president of the Tulsa Pharmaceutical Representative Association. According to the article, Bill Bly spends his days trying to get doctors to listen to him, even for 30 seconds. He’s been a drug company sales rep for 19 years, but these days, he says the job is getting tougher. (Appleby, 2001) He is in a doctor’s office the other day, and they’d had 10 reps visit already.  Often the only way a sales rep can get a few minutes to pitch a company’s prescription drugs to a doctor is to bring lunch to the office — for the entire staff — or invite a group of doctors to a free dinner at a local restaurant.


 


Bly defends such dinners and lunches as educational briefings to provide information to physicians on how to use the industry’s products. (Appleby, 2001) He stated that what he engages in are legitimate programs. They’re getting a nice meal. We’re utilizing their time for a legitimate purpose.


 


Furthermore, another rep, which allowed USA TODAY to accompany her on her rounds, has 107 “target” doctors in her territory. (Appleby, 2001) Her mission is to meet with some weekly and others monthly — and to remind them of the three drugs she’s pitching. A good sales visit is one in which she can grab a minute of a doctor’s time to give him a well-rehearsed 30-second pitch for her top drug. She’s paid a salary, plus a bonus, which is based on getting doctors to write more prescriptions for her three drugs.


 


It’s hard work. Most offices simply allow her to drop off samples, and doctors rarely take the time to chat. (Appleby, 2001) To get more time, she plays caterer. At her first stop one morning this month, she set up two lunch visits with the doctor and his staff. On her second stop of the day, two other drug reps — identifiable by their suits and ties — were already sitting in the waiting room. At the third, she found the packages of her drugs at the back of the sample closet, behind a competitor’s neatly stacked supplies. She restocked hers. One office wouldn’t let her in at all.


 


The drug rep has few illusions about her role. (Appleby, 2001) She provides information, but many doctors already know what she has to say. They’ve been pitched many times before. She understands why few doctors give her more than a few seconds. Drug reps are lined up in their offices from the time they open till the time they close so I can understand their annoyance.


 


Mostly, she’s just there to remind them of her products. Detailing is nothing more than a commercial, an in-front-of-your-face live commercial. (Appleby, 2001) She says her company has cut back on physician perks. Gone are the days when reps could hand out gift certificates to the local spa or meet a doctor at a nursery to fill his car with 0 in plants. But some of her competitors have not scaled back on freebies. She had one doctor ask if she could get him front-row tickets to the Masters (golf tournament) but she said no. But the doctor replied that their competitor could. The respondent stated that some doctors have gotten greedy. It’s trickled down to their staff. They even tell the representatives what they want to bring them for lunch.


 


Most of the freebies offered by sales reps are of minimal value, says Dr. Randolph Smoak, president of the American Medical Association (AMA), which has decade-old guidelines stating that doctors should not accept items of substantial value from drug or medical-device industry representatives. (Appleby, 2001) The AMA is about to roll out an educational campaign reminding doctors of the guidelines but it, too, has run into controversy: The effort is being underwritten by drug companies. Some drug firms also are taking a new look at sales practices.


 


Glaxo Smith Kline told sales reps that certain practices, such as “Dine ‘n’ Dash,” are now banned. Dine ‘n’ Dash meant meeting doctors at restaurants and paying for take-out meals while giving a short drug sales pitch. (Appleby, 2001) While some marketing efforts may be scaled back, the lure of free travel continues. The drug companies wanted his opinion, the letters said, on topics ranging from Medicare to managed care. For his trouble, he would be paid honorariums of 0 to ,000 and receive such things as tickets to sporting events, rounds of golf and a Broadway show. He refused.


 


Such events aren’t really to seek doctors’ opinions. The real reason is to get them to use her company’s drugs. (Appleby, 2001) Yet no one is really sure if such events — or even sending the legions of sales reps to doctors’ offices — really work: “Everyone’s afraid to stop it, because they don’t know what difference it’s making.”


 


In addition, Dr. William Hall, president of the American College of Physicians-American Society of Internal Medicine, acknowledges the importance of sales calls, but he agrees with marketing critics that some of the promotions are not appropriate. (Appleby, 2001) He stated that junkets to posh resorts are clearly inappropriate, Hall says. But lunch for the entire staff brought to a busy physician’s office by a drug sales rep is probably fine. He stated that they tell physicians to use their own judgment. The litmus test for doctors is to ask themselves: would I feel comfortable if my patients knew this interaction was taking place?


  Ethical Issues Concerning Drug Representatives According to the American Medical Association (2001), many gifts to physicians from pharmaceutical, device and medical equipment industry sales-representatives have served an important and beneficial function. For example, industry has provided funds for educational seminars and conferences for many years. During the late 1980s, however, some of these gifts were becoming lavish, ranging from frequent flier miles to cash and trips to luxury resorts, and their appropriateness was increasingly being called into question. In this light, the body adopted a set of ethical guidelines to be followed by medical doctors and physicians. On the other hand, the Henry J. Kaiser Foundation (2002) provided that the said guidelines restricting physicians from receiving gifts from pharmaceutical sales representatives is adequate but needs to be better implemented. It added that the AMA’s ethics policy allows doctors to receive gifts if they are not of substantial value and they primarily entail a benefit to patients. Under the policy, more substantial items such as textbooks or modest meals are allowed if they serve a genuine educational function. However the industry has become increasingly competitive, with some sales reps’ tactics beginning to push the bounds of what some doctors believe is ethical. Critics of the drug companies’ practice say that it drives up the use of expensive prescription drugs, a major factor in the escalating cost of health insurance.

 


According to Lorsinser (2002), all gifts – pens, notepads, meals, etc. – cost money. This can influence physician behavior – sometimes in very effective ways leading to increased prescribing of those products. Promotion does lead to increased prescribing behavior despite physicians thinking they are not being biased. Studies show that residents in training think that many gifts from pharmaceutical reps are appropriate. One study showed that 98% of residents carried something in their pockets from a pharmaceutical company.  Furthermore, he also stated that many drug companies sponsor research on drugs. This information gets into peer reviewed journal articles. It can be very difficult to understand bias in these types of articles – especially when we are reading these articles quickly, which is what we typically do during our busy days. This often becomes the literature pharmaceutical reps show physicians when detailing a drug.


 


According to Meyer (2001), pharmaceutical companies defend their tactics by arguing they have important information to share with physicians—their main customers. They point to most other sectors of the economy, where golf outings, ski vacations, and two-martini lunches are staples of business transactions. Meanwhile, Physicians who participate say that they can divorce their gastronomical or economical pleasures from their decisions about drugs.


 


On the other hand, Rider (2002) stated that the number of drug sales reps has grown from nearly 42,000 in 1996 to almost 88,000 in 2001. The pharmaceutical industry last year spent more than billion persuading doctors to prescribe their products. Nearly .5 billion went for free samples of many drugs that were widely advertised to consumers. The larger goal is to ward off generic competition and to maximize sales of drugs protected by patents. This prompted several clinics and hospitals to provide measures that would minimize, if not eradicate the grating representatives. Among the measures undertaken are the provision of fees for presentation time and the strict requirement of having an appointment to doctors before sales reps could enter the hospital premises. Nonetheless, accepting from a drug rep to listen to a 10-minute advertisement under the guise of a “consultation” is ethically repugnant, is against ethical AMA policy and represents the prostitution of our profession to the almighty dollar at our patients’ expense. (Senn, 2002)


 


Promotional Spending


Marketing has become a major part of the pharmaceutical industry. (Herman, 2002) An article in The Wall Street Journal explained how drug companies are shifting the core of their business away from the task of developing drugs toward the steadier business of marketing them. It has become more difficult to develop breakthrough drugs, so drug companies are investing more in marketing to boost the sales of the drugs they have created. This includes promotional spending directed toward consumers and physicians. Consumer advertising on television and in newspapers and magazines resonates with most of us. For the first six months of 2000, according to IMS Health (a health care information company), drug companies spent .3 billion on consumer advertising, 43% more than was spent during the same period in 1999.


 


Lorsinser (2002) added that promotional spending on prescription drugs has increased dramatically over the past decade. Half of that expense goes to sampling. Direct to consumer advertising has increased markedly as well – among the most popular time is during the evening news. In the pharmaceutical industry, 30% of revenue is to marketing and administration fees, while 12% is on research and development. He added that there is an increased drug expenditures 1999 to 2000 – due to the following: 22% increased cost of drugs, 42% increased number of prescriptions, and a 36% shift to more expensive drugs. Drug company jobs in marketing have increased significantly over the past 15 years. This has lead to 2-3 times the number of drug reps working over the past 15 years. The challenge to physicians concerns the learning about drugs in an unbiased fashion. Most of us learn about new meds from pharmaceutical reps, not from unbiased experts.


 


Chapter 3


Methods And Procedure


This chapter will discuss the method of research to be used, the respondents of the study, the sampling technique, the instrument to be used, the validation of the instrument, and the administration of the of the instrument.


 


Method of Research to be Used

The research described in this document is based solely on qualitative research methods. This permits a flexible and iterative approach. During data gathering the choice and design of methods are constantly modified, based on ongoing analysis. This allows investigation of important new issues and questions as they arise, and allows the investigators to drop unproductive areas of research from the original research plan.


 


This study will use the descriptive approach.  This descriptive type of research will utilize observations in the study.  To illustrate the descriptive type of research, Creswell will guide the researcher when he stated: “Descriptive method of research is to gather information about the present existing condition.  The purpose of employing this method is to describe the nature of a situation, as it exists at the time of the study and to explore the cause/s of particular phenomena.”


 


This study basically wants to prove if the industry practices of the pharmaceutical industry are ethical and legitimate. Specifically, the study will describe how has the pharmaceutical industry defined the ethical practices of their medical representatives; the gray areas in the ethical practices of medical representatives in their relationship with the doctors they deal with; the existing legislation that would check unethical practices in the pharmaceutical industry; and the relationship of the identified gray areas the medical representatives and the doctors they cover both ethical and legitimate.


 


The primary source of data will come from published articles from social science journals, theses and related studies on medical representation and sale of pharmaceutical products as well as current legislation on the topic.


           


For this research design, the researcher will gather data, collate published studies from different local and foreign universities and articles from social science journals; and make a content analysis of the collected documentary and verbal material.  Afterwards, the researcher will summarize all the information, make a conclusion based on the null hypotheses posited and provide insightful recommendations on the dealing with the pharmaceutical and medical profession.


Bibliography


 


 


Periodicals

 


Appleby, Julie. (2001). Sales pitch: Drug firms use sales pitch to push pills.  USA Today. [May 16, 2001].


 


Greenpeace. (1997). The Ethical Consumer Guide to Everyday Shopping.  Ethical Consumer Research Association.


 


Lebowitz, Philip H. (2002). Fraud enforcement of Rx marketing practices.


            Physician’s News Digest. [January 2002].


 


Ross, Brian & Scott, David W. (2002). Influencing Doctors: How Pharmaceutical Companies Use Enticementto ‘Educate’ Physicians. ABC News.  [February 12, 2002]


 


Walker, Kaisa & Bruner, Sondi. (2002). Drug company perks sway students. Simon Fraser University Independent Student Newspaper. [January 7, 2002] 


 


  Books

 


Creswell, J.W. 1994. Research design. Qualitative and quantitative approaches. Thousand Oaks, California: Sage.


 


Heermance, Edgar L. (1924). Codes of Ethics: A Handbook. Free Press Printing Co.: Burlington, VT.


 


Paulsen, Friedrich & Thilly, Frank. (1899). A System of Ethics. Charles Scribner’s Sons: New York.


 


Sims, Ronald R. (1994). Ethics and Organizational Decision-Making: A Call for Renewal. Quorum Books: Westport, CT.


 


  Internet

 


http://www.labour.gov.za  Department of Labour – Zambia


 


 


American Medical Association. (2001) Gifts to Physicians from Industry. 26 September. Available: http://www.ama-assn.org/ama/pub/category/4001.html. [Accessed 03/26/03]


Henry J. Kaiser Foundation. (2002) Current AMA Guidelines on Prescription Drug Marketing Are ‘Adequate,’ PhRMA Says. Kaisernetwork. Available: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=9072. [Accessed 03/26/03]


Meyer, Charles. (2001) Beware of Drug Reps Bearing Gifts. Minnesota Medicine. Available: http://www.mnmed.org/np/MnMed2001/January/0101editor.html. [Accessed 03/26/03]


Lorsinser, Robert. (2002) The Relationship of Physician/Pharmaceutical Company. Marquette General Health. Available: http://www.mgh.org/directry/docpage/notes/pcc02-22-2002.htm. [Accessed 03/26/03]


Rider, Tony. (2002) Doctors hope to curb pricey prescriptions. Knight Rider Newspapers. Available: http://www.ledger-enquirer.com/mld/ledgerenquirer/news/politics/3973372.htm. [Accessed 03/26/03]


Senn, Eric (2002) Idea of Paid Visits by Pharmaceutical Reps is Ethically Repugnant. American Medical News. Available: http://www.ama-assn.org/sci-pubs/amnews/amn_02/edlt0603.htm. [Accessed 03/26/03]


Herman, Robin. (2002) Direct to Consumer Advertising of Prescription Drugs Grows…. Harvard School of Public Health. Available: http://www.hsph.harvard.edu/press/releases/press2132002.html. [Accessed 03/26/03]



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