Both must keep the patient’s interests at heart
The drug industry, the medical profession and the patient have a unique relationship. The industry makes products which it cannot sell to the patient (consumer) directly. On the other hand, the medical profession cannot treat the patient without drugs produced by the industry. Thus the industry and medical profession are interdependent with a common aim. One should be able to evaluate them according to the principles of beneficence, non-maleficence, patient autonomy and justice. The industry must provide drugs to the patient, not manufacture drugs that have harmful effects. It must make reasonable profits and to help in the research of newer drugs.
The primary objective of this joint effort is to alleviate pain and suffering. The secondary objective is to be rewarded for this effort. The drug industry expects a profit and the physician expects a suitable reward. There is nothing improper in these objectives.
As in all partnerships there can be conflict between the partners. One major area of conflict is the industry’s tendency to influence doctors. The KeFauver Committee hearing on drugs states that “the incidence of disease cannot be manipulated and so increased sales volume must depend at least in part on the use of drugs unrelated to their utility or need or in other words improperly prescribed. Human traits can be manipulated and exploited and this is a fertile ground for anyone who wishes to increase profits.”
Drug promotion and advertisement is a major part of the drug industry’s budget. In 1988, the top 16 companies in the United States spent about $85 million in this area, up from $6 million in 1974. Companies are estimated to spend anywhere between six and 15 percent of their gross income on drug promotion. No business enterprise would spend shareholders’ money unless it was sure of getting something in return. If advertising does not influence, a lot of people are wasting a lot of money and time.
The word ‘advertise’ is derived from the Latin word ‘advertere’ which means ‘to turn towards’. Advertising is generally regarded as a legitimate means of fostering the competition that drives a free market economic system. The moral justification is that consumers benefit. Businesses that satisfy consumers will prosper at the expense of those that do not. Consumers are presumed to benefit from advertising because it is presumed to broaden their choice and maximise their chances of getting the most value for their money. Yet advertisements by their very nature simplify and contain an element of potential deception. Virtually any advertisement is capable of misleading, though it can be made less misleading by the addition of detailed disclaimers.
Drug advertisements which include product information are circulated to health professionals through journals, medical representatives and the mail. Persuasive advertising highlights the product’s beneficiary properties. “X :the drug of choice for enteric fever” Certain facts can also be manipulated, focusing on the good effects without mentioning the bad effects. “The typhoid bacterium resistant to many antibiotics except X… “ Finally, advertisements can also intimidate to get the doctor to prescribe: “The top 100 doctors prescribe X for enteric fever: Do you belong to this group?”
This process of simplification, highlighting and concealing enables companies to withhold essential information on indications and contraindications and to sell a drug differently in different parts of the world.
The main promotional thrust of the pharmaceutical industry is through its medical representatives (rep). There is one rep for every four-five doctors. The meeting with a doctor and the rep leave little to chance. Reps profoundly affect the way a doctor prescribes. They have been aptly described as “stealth bombers” of medicine. Their bottom line is “prescribe my drug”. These are invariably polite and reasonably knowledgeable. Before meeting a doctor they study the doctor’s prescribing habits on the basis of information gathered from local pharmacists and a preview of patients’ prescriptions. They also get to know something about the doctor’s likes and hobbies, family life and social interests and generally cultivate them. It has been estimated that it takes between one and two years before a practitioner can be prevailed upon to change practice.
Some reps categorise doctors according to whether they are ‘conservative’ or ‘risk takers. ‘ Conservative doctors will not try out a new product unless it has proven itself. Risk takers are willing to try out new products; reps will try and obtain a commitment to use new products on a few patients. Conservatives will start using new products only when used by opinion formers or local consultants, also called ‘educationally influential physicians’: hospital consultants in major hospitals whose prescriptions are imitated by other practitioners.
Reps try to persuade doctors into trying their products by using reason. If it fails, then they try to manipulate by offering of gifts, or by intimidating them or by appealing to their professional pride. If all fails, then they appeal to the doctor’s mercy “If you do not give me business I will not get my salary.”
As the major source of information to a majority of doctors and pharmacists, medical reps have a role in helping practitioners to know about the drugs available in the market and their costs. It is the practitioner’s duty to use reps while taking care not to be unduly influenced by their sales pitch.
Gifts act as regulators of human relationships. By offering a gift a person is really offering a friendship. Accepting a gift is accepting the initiation or reinforcement of a relationship and triggers off an obligatory response. The recipient generally assures grateful conduct and reciprocation of the gift. While giving can be an act of generosity, it also serves the self interest of the giver.
Gifts may be personal when given to an individual or impersonal when given for a cause. A donation to the AIDS fund of the hospital may be impersonal; a donation to the hospital director is personal.
The physician accepting gifts has three major ethical dilemmas. Gifts cost money and the cost is ultimately passed on to the patients. Secondly, gifts may erode the concept that the medical professional best serves his patient’s interest. Thirdly, they establish a relationship between the donor and recipient.
It may be improper for individuals to accept, from a pharmaceutical company, monetary gifts, loans or expensive items of equipment for their personal use. No exception can, however, be taken to grants of money or equipment by a firm to an institution, hospital, health care centre or university department when they are donated for the specific purpose of research.
To the best of my knowledge, there are no specific guidelines laid down and expounded by the Medical Council of India. Hence it may be. useful to refer to those laid down by the General Medical Council of the U. K.
The term hospitality has been used very frequently. Hospitality means friendly and generous entertainment of guests.
Should a physician accept gifts like paper pads or ball pens? Most people would consider this practice acceptable. The grey areas come when it concerns larger gifts. Holidays and sponsorships for attending conferences are unacceptable.
Drug companies are also involved in holding seminars, conducting research and sponsoring programs of professional societies and institutions. Though this does not affect physicians directly, there is always a fear that office bearers of the society may be influenced. Sometimes the topics for seminars are chosen in such a way that a drug can be promoted. Drug companies may influence the speakers. Sometimes they provide a useful CME for the physicians but most often these symposia tend to promote a particular drug.
In our country the Drug Controller requires a multicentric trial to be conducted before it accepts a drug, even if the drugs have already been established in the West. Many GPs nowadays get carried away by the importance placed on research. This research involves getting GPs to try the new drug on their patients. But what if a newly started drug is found beneficial to the patient but becomes unaffordable after the trial is over? Hence it is essential that researchers discuss the drug protocols, the way the results will be handled and the control of data that is generated by the study.
We must be constantly vigilant that we keep the interest of the patient at heart and not be led astray by drug companies.