TABLE OF CONTENTS
Chapter I: INTRODUCTION
1.1 Background of the Study
1.2 An Overview of Pakistani Pharmaceutical Industry
1.3 Statement of the Problem
1.4 Research Hypotheses
1.5 Purpose of the Study
1.5.1 General Purpose
1.5.2 Specific Purpose
1.6 Scope of the Study
1.8 Definition of Key Words & Phrases
Chapter II: REVIEW OF THE LITERATURE
Chapter III: RESEARCH METHODOLOGY
3.1 Data, Sample and Methodology
3.2 Total Population
3.3 Targeted Population
3.4 Sample Size
3.5 Pharmaceutical Sales & Marketing Personnel
3.5.1 Multinational/National Pharmaceutical Personnel
3.6 Doctors Community
3.6.1 General Practitioners (Both Rural & Urban)
3.6.2 MOs & RMOs of Public & Private Hospitals
3.6.3 Consultants of All Specialties
3.7.1 Public Hospitals
3.7.2 Private Hospitals
3.8.1 Retail Pharmacies
3.8.2 Whole Sales Pharmacies
3.9 Government Officials
3.9.1 Federal/Provincial Government Officials
3.10 Patients or their attendants’
3.10.1 Outdoor Patients & their attendants’
3.10.2 Indoor Patients & their attendants’
3.11 Plan of Data Analysis
Chapter IV: DATA ANALYSIS
4.1 Survey Findings
4.1.6 Pharmaceutical Personnel
4.1.8 General Practitioners
4.1.9 RMO / MO
4.1.10 Government & Private Hospitals Officials
4.1.11 Retail Pharmacies
4.1.12 Whole Sales Pharmacies
4.1.13 Outdoor Patients
4.1.14 Indoor Patients
4.1.15 Government Officials (Federal & Provincial)
4.2 Hypotheses Testing
4.2.1 Hypothesis No
4.2.2 Hypothesis No
4.2.3 Hypothesis No
4.2.4 Hypothesis No
4.3 Qualitative Analysis
4.3.1 Tools of Unethical Drug Practices
4.3.2 Drug Promotion to Non-qualified Doctors
4.3.3 Legislation for Unethical Drug Promotion
4.3.4 Eradication of Unethical Drug Promotion
Chapter V: SUMMARY, CONCLUSIONS AND RECOMMENDATIONS
5.1 Summary & Conclusions
5.3 Suggested Areas of Further Research
Appendix – I: Questionnaire
Appendix – II: Cross-Tabulation
Appendix – III: Code of Ethics for Pharmaceutical Marketing
Appendix – IV: The New Pharma Code on Interactions with Healthcare Professionals
CHAPTER ONE INTRODUCTION
1.1 BACKGROUND OF THE STUDY
Unethical marketing practices have become an essential part of the pharmaceutical industry in Pakistan and roots are so strong that it may not be possible to reverse the same (Parmar & Jalees, 2004). However the previous study has a limitation. It was a case study on pharmaceutically industry in Hyderabad. In view of the findings of that study there was a need to carry out the same on larger basis. Thus this research has been undertaken with this objective in mind.
The phenomenon of the unethical drug practices is common worldwide but its severity is deep rooted in developing countries. Unethical drug practices have two dimensions. One is drug related, and other is drug promotion related. Extensive research on drug related unethical practices has been carried out internationally. However, the author was not able to find any empirical study on unethical drug promotion practices except the one that was carried out by (Parmar, Jalees, 2004) in Pakistan. Parmar and Jalees (2004) in their study observed that pharmaceutical industry spends a substantial portion of its budget on market research but do not carry out the research on unethical drug promotion practices. One of the reasons is that the industry itself is indulged in this practice therefore it does not find any need to carry out the research on this issue.
Lack of research on the subject does not mean that unethical drug promotion practices do not exist. The pre-survey and focus groups discussions indicate that unethical pharmaceutical marketing practices have become an acceptable norm of the pharmaceutical diligence, and it is also well supported by more or less all the pharmaceutical groups with the cooperation of government hospitals, private hospitals, doctors and health allied organizations including pharmacies on patients’ interests. All the entities as discussed above appear to be corrupted; therefore, it may not be fair to blame any one of them, including pharmaceutical industry.
Doctors and other entities as discussed above have become greedy; therefore, these are vulnerable to Pharmaceutical industry for unethical drug promotion practices. The Pharmaceutical companies fund nearly all symposiums and educational actions of doctors; therefore, the industry uses the forum to pursue its goals, which at times may not be the same as the purpose and objective of the conferences. Pakistan Medical Journalists Association (PMJA) has published a few articles on this issue. But this has not affected the prevailing unethical drug promotion practices (Zaidi et.al, 1995).
The focus of the subject study was to identify the intensity and trends of unethical drug promotion practices in Pakistan. Ascertaining the contribution of the doctors, health related institutions and the pharmaceutical industry in promoting such practices. Unethical marketing practices have now an integral part of drug promotion. Unethical practices could be classified into two segments. One is related to the medical side of the drug i.e. the trial of the drug both on animals and the human, and registration of indications and patent period in different countries.
According to the prominent scholar and eminent physician of the country, Dr Sania Nishtar (2007), the unreliable news of bribery and dishonesty in this pharmaceutical circle have to be given watchful investigation. Health system of Pakistan must have an effect with these corruption practices. These practices can entail together supervisory body and private sector. The process of registration, authorization and pricing criteria, procurement and sales & marketing of drugs are all involve with these types of practices. These all bad practices has their roots for the commercial safety of the pharmaceutical companies, who pay heavy cost and struggle to avoid dealings for the enlistment of their products, accelerate the endorsement procedure, and catch flattering prices of their products.
The astringent method for procuring medicines proffer money-spinning resource for most of the bureaucrats and thus suppliers intend to pay bribes, and paying them through excess in billing and invoicing. In Pakistan, we can find the similar behaviors in almost every public hospital through unreliable data.
Consequently, healthcare prerequisite rely on a system, which proficiently joins fiscal and individual assets to deliver system of check and balance, good management and effective services. Conversely, in our country bad management and dishonesty in health system are symptoms of a wider system trend. These issues need be address and entails consent and right both inside and outside of the health sector system (Nishtar, 2007).
1.2 AN OVERVIEW OF PAKISTANI PHARMACEUTICAL INDUSTRY
There are about 650 leading Nationals and Multinational pharmaceutical companies operating in Pakistan. Of this total 23 are multinationals and rests of companies are local companies. The companies here could be categorized in three groups:
1. Manufacturing plant
2. Importers (bring finished medicines from abroad)
Franchisers are those companies that have all the marketing setup and facilities. These companies obtain the rights of marketing of the drugs of other companies on profit sharing basis. Total current market volume (March 2010) is of Rs.137.7 billion. (IMS, Q3, 2010)
GRAPH – 1
Pakistan Pharmaceutical Market (PKR in Billion)
Abbildung in dieser Leseprobe nicht enthalten
Source: IMS – PKPI Q2 2010 (MAT)
In the year 2009 the industry realized a high degree of fluctuation in the growth rate. One of the major reasons for such a trend was merger and acquisition, and glutting the market by local pharmaceutical industry. However on an average the growth rate in the year 2009-10 was about 15.4% per annum. Comparatively the growth rate in the year 2008-09 was about 12% (IMS, Q2 & Q3, 2010).
A tough competition exists between the multinationals and nationals, day-by-day nationals are taking up the share and in the last six years they have taken around 7% share in value. The gap between multinationals and nationals narrows further during 2009-10 with multinationals losing another 1.7% share to nationals. At present multinationals hold 46.9% share of the market while the nationals have captured 53.1% of the pharmaceutical business. From around 80% share in the pharmaceutical retail market, the MNCs have lost around 29% during the last twenty years as the nationals continue to improve their performance in the market place. Almost an identical trend is observed in units as well, nationals having 54.05% as compared to multinationals 45.95% (IMS, Q1 & Q2, 2010).
GRAPH – 2
Top 10 Pharmaceutical Companies (PKR in Millions)
Abbildung in dieser Leseprobe nicht enthalten
Source: IMS – PKPI Q2 2010 (MAT)
The overall market dynamics are tilted in favour of national companies as they are continuously launching new products at a much faster rate than MNCs, a trend that is becoming increasingly evident. In terms of new product market in value, the sales contribution gap between multinational and national companies has also increased over the last five years. The products launched before 1991 are dominated by the multinationals while after 1991 it is shifting towards the nationals. However, the leading 20 products of the industry are still those products, which are launched by the MNCs between 1970 and 1990 (IMS, Q2 & Q3, 2010).
Of the total markets size of 137.7 billion, the top 20 corporations contribute around 60% of total business, 34% of market concentrated among the top 5 corporations. The rest 40% of the market is distributed amongst 630 corporations in Pakistan. For the purpose of calculation in terms of value, the top 15 corporations make up 54%, top 35 corporations make up 75.09%, and top 75 corporations make up 90.91%, while the remaining corporations are competing for approximately 9% market share (IMS, Q1 & Q2, 2010).
The drugs prices of the national pharmaceutical companies are cheaper, as they have choice of procuring the raw material from those countries where it is available at a cheaper rate. The other reason for the price differential is that the national pharmaceutical industry does not invest in research and development compare to multinationals. Multinational companies invest a huge amount of their net profit in R & D, therefore, when they introduce a new molecule into the market they have already invested billions of dollars for a new product, therefore, the price of the new product keeps high in order to meet the total cost of the drug in a certain time period because after patent period any company can make its Me too or imitation at cheaper rate. So, the national companies have twice leverage to set their prices at the lower level i.e. first they did not invest a single penny on Research & Development and secondly they are having cheaper raw material resources (Ahmed & Jalees, 2008).
Another, important point in price difference is that national companies are not bound to pay certain amount of profit to any other body, whereas, multinational companies are paying certain percentage of profit to their parent companies. Moreover, national companies do not have huge overhead expenses; in contrast, multinational companies allocate huge overhead expenses in different fields at the beginning of every fiscal year for every product in a certain ratio, therefore, the cost of goods (COG) are different in national and multinational companies. In order to maintain all these costs they are bound to set a high price, otherwise bottom line will be very low and business would not be feasible any more.
The connection among pharmaceutical companies, doctors and health officials is also very significant. Commissions may be the reason behind weakness of this sector, to prevent from corruption strict rules and regulations are needed. Heavily regulation is indispensable toward safety and protection of peoples in opposition to inferior and unjustly price of medicines. Another reason for such regulations is to guarantee that industrial strategies fortify the effective economic development and improvement in the pharmaceutical sector. These two intentions at times decline each other’s. If regulators are coercing by pharmaceutical companies, healthiness can be compromised. Charitable campaign and contributions both politically and socially by pharmaceutical companies are instances of these demands offered to doctors for stipulating fastidious medicines and specific brand. These behaviors are very un-ethical as well as illegal in many countries. Most of the companies may make use of underhand procedure to masquerade such bribe (American College of Physicians, 1990, 1995-2002).
In recent years, the problem of illegal and unethical pharmaceutical practices for marketing of medicines has acknowledged an enormous covenant of awareness, indicating from different pharmaceuticals and doctors association who already keep noticing of this problem. Some of them have conceded set of codes and ethical course of action for selling of pharmaceuticals (Ahmed & Jalees, 2008).
There is another kind of practices that reflect corruption happens during clinical trials. Many pharmaceutical companies are paid to doctors to take patients for clinical trials. Many universities have research assessment committees who are engaging in exposure of strategies and actions concerning divergence of interest (Avorn & Hartley, 1982).
Furthermore, there is discussion on whether confession is adequate: must researchers permissible to carry out studies and research for organization wherein they contain finances?
Pakistani pharmaceutical industry also growing at rapid pace over last many years and reached to Rs. 137.7 Billion in 2010 (IMS Q2 2010) in this growth major chunk came from generic drugs manufacturer or generic drugs in Pakistan.
GRAPH – 3
Generic (Copy) Drugs (% Share of Total Market)
Abbildung in dieser Leseprobe nicht enthalten
Source: IMS – PKPI Q2 2010 (MAT)
Above graph shows that market share of generic drugs in Pakistan in continuously increases over the years reach to 53.1% market share and likely to cross 55% market by the end of this year. This can also validated by the number of generic drugs making company in top ten pharmaceutical in Pakistan Getz Pharma, Hilton Pharma, Sami Pharma & Searle are top four generic drugs making companies listed in top 10 pharmaceutical companies in Pakistan.
GRAPH – 4
Research (Branded) Drugs (% Share of Total Market)
Abbildung in dieser Leseprobe nicht enthalten
Source: IMS – PKPI Q2 2010 (MAT)
While looking at the research drugs, market share in Pakistan continuously decreasing compare to the local/ generic drugs making companies in Pakistan more than 53% market share in year 2010 (IMS Q2 2010).
1.3 STATEMENT OF THE PROBLEM
Is unethical drug promotion practice is common in Pakistan? Who initiated unethical drug promotion practice in Pakistan? Who is responsible for the continuation of the same?
1.4 RESEARCH HYPOTHESES
Based on the theoretical framework, focus group and problem statement the following hypotheses statements have been developed:
H1o: The level of unethical drug promotion practices in pharmaceutical industry is high (at least 4) on the scale of (5 to 1)
H1A: The level of unethical drug promotion practices in pharmaceutical industry is less than 4 on the scale of (5 to 1)
H20: The levels of unethical drug promotion practices are high in rural areas.
H2A: The levels of unethical drug promotion practices are not high in rural areas.
H30: There is no significant difference on the opinions of doctor, pharmaceutics companies, hospitals and pharmacies on who initiated unethical drug promotion practices in Pakistan.
H3A: There is significant difference on the opinions of doctor, pharmaceutics companies, hospitals and pharmacies on who initiated unethical drug promotion practices in Pakistan.
H40: The contribution of the pharmaceutical industry in continuation of unethical drug promotion practices is higher than the doctors.
H4A: The contribution of the pharmaceutical industry in continuation of unethical drug promotion practices is not higher than the doctors.
1.5 PURPOSE OF THE STUDY
1.5.1 General Purpose
The overall purpose of the study is to analyze the unethical pharmaceutical drug promotion practices in Pakistan and its impact on common people of the Country.
1.5.2 Special Purpose
Most specifically the study will address the following questions:
1. Is there any relationship between unethical pharmaceutical drug promotion practices & under taken stakeholders i.e. pharmaceutical companies, doctors, hospitals and pharmacies etc?
2. Who is the most responsible for these unethical pharmaceutical drug promotions in Pakistan?
3. How common people are affected by these unethical pharmaceutical drug promotion practices in the Country?
4. Is there any further legislation is required by the government in order to stop these unethical practices?
5. How different stakeholders can play their role in order to stop these unethical practices?
1.6 SCOPE OF THE STUDY
The scope of the study will be limited to all the concerned bodies of the government, pharmaceutical companies, doctor’s community, hospitals, pharmacies and the common people of the Country, which provides the knowledge about the unethical drug promotion practices in Pakistan. Moreover, it will also provide the basis to the government to take some suitable measures to stop these unethical pharmaceutical drug promotion practices from Pakistan and to provide ease to the common people of the Country in order to get better health facilities at nominal cost.
The study is justified on the following grounds:
1. The results of the study can be used by the government and some suitable measures and actions can be taken to improve the legislation in order to stop unethical pharmaceutical drug promotion practices in Pakistan on the basis of the results of the under taken study.
2. The medical facilities can be provide at nominal cost by improving the atmosphere of unethical pharmaceutical drug promotion practices for the common people by taking corrective measures against the responsible stakeholders of the study.
3. To provide the knowledge of actual situation of unethical pharmaceutical drug promotion practices to all the concerned bodies who are directly or indirectly involved in these practices and to realize them that they should fulfill their social responsibilities in order to improve the situation.
4. To give the awareness to the common people of the Country that in the light of study they should play their role in order to rectify the situation.
5. The pharmaceutical ethical committees on local & multinational pharmaceutical companies should implement the new or existing code of conduct with its true spirit after reviewing the results of this study.
6. The concerned bodies’ of government sector should make further effective legislation and to enforce the rules and regulations in order to stop these unethical pharmaceutical drug promotion practices in Pakistan.
7. In the light of result of this study, the Pakistan Medical & Dental Committee (PMDC) and Pakistan Medical Association (PMA) should make some effective code of conduct for the doctors’ community in order to stop these unethical pharmaceutical drug promotion practices in Pakistan.
1.8 DEFINITION OF KEY WORDS & PHRASES
- Unethical Promotion
The promotion of pharmaceutical drugs by avoiding the set of rules & regulations, which are given by the ethical, bodies Worldwide & the local bodies & government.
- Pharmaceutical Drugs
The medicines are being produced and sold by the pharmaceutical companies for human beings.
- Unethical Practices
The unusual and absurd ways of marketing & selling tactics to sell the pharmaceutical drugs.
- MNCs & Local Companies
The Multinational pharmaceutical companies, which operate more than one Country, whereas, the companies, which are only operating in Pakistan.
- Whole Sales & Retail Pharmacies
The medicines shops, which procure the pharmaceutical drugs in bulk quantity from distributors and fulfill the requirement of retail pharmacies, whereas, retail pharmacies are those pharmacies where the consumers purchase pharmaceutical drugs directly.
- Government Officials
The government servants who are employed in those Provincial or Federal governments deportments, which are directly relevant to the pharmaceutical drugs, pharmaceutical companies & the pharmacies.
- Public & Private Hospitals
The public hospitals are owned and run by the federal, Provincial or district governments, whereas, the private hospitals are owned and run by the individual or group of people.
- Indoor & Outdoor Patients
Those patients’ who are admitted in hospitals due to their illnesses are called the indoor patients, whereas, the walk in patients or just come to the doctor and get the prescription and go to home or called outdoor patients.
- Patients & Attendants’
The person who has suffered in any illness is known as patient, whereas, those patients who admitted in hospital and they have been taken care by their relatives’ or friends during the treatment are called their attendants’.
- Consultants, Medical Officers & General Practitioners
The doctors who has done post graduation after their medical graduation are known as Consultants, whereas, those doctors who has started their career as doctor after their medical graduation in any private or government hospital, are called Medical Officers or Resident medical doctors and finally those medical graduates who does open their own clinics in different areas are known as General Practitioners.
CHAPTER TWO REVIEW OF THE LITERATURE
The pre-survey and focus groups discussions indicate that unethical pharmaceutical marketing practices have become an acceptable norm of the pharmaceutical diligence, and it is also well supported by more or less all the pharmaceutical groups with the cooperation of government hospitals, private hospitals, doctors and health allied organizations including pharmacies on patients’ interests.
A report on practices for pharmaceutical companies has published by Lexchin J. (1995) in Consumer International (CI). CI scrutinized that 20 main worldwide medicines companies of the world have developed their own codes of ethics conducts, which are highly biased in their favor.
Pharmaceutical companies exercise immoral and dishonorable marketing devices to persuade doctors to recommend their medicines and also delicately to convince customers to use them. The findings are based on the marketing practice of world top most 20 pharmaceutical companies . The report contends, “Pharmaceutical companies are advancing their medicines through patients set, student and internet chat places to avoid the interdict on promoting excluding doctors” (Lexchin, 1995).
The authors of the report have also the opinions that the subject companies create imprecise declares regarding protection and effectiveness of their medicines. Moreover, the companies also offer enticements to stipulate and uphold medicines including bribes, donations, expensive promotional gift items, free drug samples and conferring contracts. The authors pointed out that several organizations encompass concerned in non-aggressive policies (Lexchin, 1992, 1995).
In September 2009, Pfizer was fined US$2.9 billion dollars for deceitful marketing practices. This was done because the company was promoting medicines for unapproved uses or “off-label uses”. Pfizer deliberately encouraged doctors to prescribe four medicines to treat symptoms the drugs were not approved by the FDA to treat. The settlement also settles allegations that Pfizer induced doctors to promote these "off-label" uses by paying for their meals and subsidizing their travel. This is the third settlement that Pfizer has signed a “corporate integrity” agreement (Gibbons et al., 1998).
This is just an example of the deceitful and underhanded marketing practices that has occurred. This wrongdoing was done due to the fact that it takes approximately US$1 billion to develop and test a new drug. In recovering their spending, the companies want healthcare professionals to subscribe their drugs as widely as possible (Gibbons et al., 1998).
Another example is that of Johnson & Johnson unlawfully and successfully promoted Propulid off-label for kids regardless of inner objection complaining safety issues. The side effects of this drug include serious cardiac arrhythmias including ventricular tachycardia; ventricular fibrillations have been reported in patients taking Propulid (generic name: Cisapride). This product is no longer available in the United States (Sibbald H., 2004).
Other companies have gotten in trouble over off-sales promotion and withholding of critical information. In 2004, the medicine title Vioxx manufactures by the Merck & Co. pharmaceutical company was inhibited from the market. Merck willingly removed the medicine by reason of serious unease on cardiovascular side effects. Allegedly the company knew that the drug may perhaps raise the probability of heart attacks in cardiac patients from 2000 and has been charges of engineering research outcomes to minimize the threat. In the United States, above 6,000 court cases have been filed by public who suffer from this medicine (Boseley, S., 2006).
Again in 2004, GlaxoSmithKline (GSK) was faced a court case for preservation off-putting data on their medicine Paxil (Paroxetine). GlaxoSmithKline decided to an arrangement to make public regarding results of all clinical trial reviews on its website (Sibbald H., 2004).
The case happened following a secret GSK memorandum disclosed to press acknowledged a clinical trial in 1998 so as to wrap up paroxetine had refusal outcome in the handling of young people. AstraZeneca faced a class action lawsuit alleging that it was misleading in its promotion of its top-selling ulcer treatment Nexium. The lawsuit was brought on behalf of trade union healthcare providers in New York who paid for the drug on behalf of their members. It demanded the return of profits made on Nexium, which had sales of US$3.3bn. It claimed that Nexium is an end to useful than Prilosec, AstraZeneca's older ulcer drug, which is considerably low price as it is no more secluded from opposition by copyrighter (Tomlinson H., 2004).
Gifts that are given by the pharmaceutical industry to healthcare professionals are controversial. Approximately, US$11billion is spent on promotion and marketing each year towards doctors (Gibbons et al., 1998).
A case was inspected against GlaxoSmithKline (GSK) from Italian and German official for supposed corruption of distributing illegal gifts to doctors and other officials, and approximate €228m from 1999 to 2002. After that, GSK has formed marketing ethical codes for his employees, which are compulsory to all new employees to clear an evaluation test. In 2001, a report was public and pointed out 87 employees was terminated or voluntarily departed after violation of these codes (Boseley, S., 2006).
Charges were implicated in opposition to AstraZeneca for unsuitable use of gifts and promotions. In a promotional campaign they invited doctors to attend this seminar/conference free of cost, and they bear their hotel, flights and other charges (Boseley, S., 2006).
Studies were carried out to uncover the impact of relation between physician and medical representatives of pharmaceutical industry. Doctors meeting with pharmaceutical representatives linked with requirements by doctors to put in medicines to the hospital formulary and there was a change in prescribing practice of the doctor (Tomlinson H., 2004).
Overall, residents and physicians have the same attitude towards pharmaceuticals representatives. Physicians believed that they offer precise data regarding the medicines that they promote. They also believe that pharmaceuticals representatives may perhaps offer precise data on recognized or substitute medicines. On the other hand, the majority considers that representative’s precedence the promotion of product over the wellbeing of the patient and use unethical practices to do this (Tomlinson H., 2004).
In the United States, once a medical student comes into school, the pursuance of pharmaceutical companies is significant. Free promotional gift items, medical manuals, journal subscription payments, lunches, and gifts are provided to the medical student. These all are become a component of daily medical practice. The sales representatives from pharmaceutical companies are good-looking, likeable and imminent. From an early stage in the doctors’ career, the pharmaceutical companies have an influence on the medical student (Sibbald H., 2004).
Another study (Zaidi et al., 1995) explores the connection involving in physicians and the pharmaceutical industry. The author while criticizing the pharmaceutical industry observed that the industry is responsible for corrupting the medical profession. The report further indicated that this habit is very widespread in the urbanized countries as well as developing countries.
The author further alleged that the anticipation and requisite of physicians/doctors has increased manifold. The attitude of doctors has changed, and some of the commonly demanded requests are presented below:
- The doctors frequently ask for free travel and hotel accommodation.
- The doctors demands donations for various issues and threaten to not entertain Medical Representatives, if they fail to provide the same.
- Group of doctors have formed companies. The doctors do not manufacture the medicine in this company, but they have obtained the marketing rights from the other companies. Subsequently these doctors heavily prescribe their products.
- The liaison between doctors and chemists has increased tremendously. In this kind of relationship the doctors prescribe those medicine that carry heavy discounts, which are then shared by the doctor and chemist as per pre agreed arrangement.
- It is a common practice of doctors asking cash for each recommendation of medicines.
- Demand for renewal of hospitals and clinics.
Zaidi, et al., (1995) observed that in the 13th national psychiatric conference held at Abbottabad in September, nine papers were read by different doctors; however, most of the papers were not on the subject issue but were mainly focused on their experience of administrating specific drugs to the patients. Incidentally, some of the foreign guests thought that the conference was not on psychiatric issue but it was more on the specific drug promotion activity. Two inferences could be drawn from this incidence. One, the doctors are so much involved in the unethical drug practices that they did not realized what was the objective of the conference. Second is that the doctors did not spend considerable time for developing the appropriate paper for the conference.
Zaidi, et al., (1995) in the same report pointed out about an incidence of the 17th International Gastroenterology conference held at Rawalpindi. In this conference about a dozen of local doctors’ presentations were on a particular drug that belonged to the pharmaceutical company that was sponsoring the event. The foreign delegates became so frustrated with the proceeding that they left the conference by stating that their purpose of the visit was to gain insight and share their views on the issue “gastroenterology”. However, the conference appears to be one directional with objective of promoting the drugs of the sponsoring company.
Zaidi et al. (1995) also pointed out that unethical drug practices was originally initiated by multinationals as they were in the position to afford this unethical practices due to huge resources at their possession. Subsequently, the local national companies also followed the suit, and now it has become the norm of the industry.
In Nepal, a study conceded Giri, BR., Shankar, PR., (2005) also observed that doctors recommend such drugs that are keenly promoted by representative. The authors observed that the pharmaceutical companies use conferences and seminars for entertaining doctors, unethical demand of traveling, and lodging etc.
According to Fisher et al., 1993, “It is immoral for research journals that issue information on psycho-Pharmacology to recognize medicine company money for everything. Similarly, it is unethical that the American Psychiatric Association permits Medicines Company financially supported symposia as part of its yearly meetings” (Fisher, Bryant & Kent, 1993).
According to the WHO Ethical Criteria for Medicinal Promotion, the nastiest immoderation of deceptive and unprincipled promotion of drug keep on in developing countries, where parameters for pharmaceutical industry are very weak (American College of Physicians, 1990).
Promotion can be defined as “the information whose intention is to promote or market a product and for itself it has an inbuilt unfairness in favor of the product in the finest doable way. Worldwide, an enormous disparity in the funds obtainable for promotional against existence of self-governing information (Lexchin, 1995).
Another study of Lexchin pointed out that the Companies which prop up tranquilizers and antidepressant medicines through similes of women are nonentity to flout the agreed product tagging, but they probably to give a well-acknowledged setback of unsuitable stipulation of psychotropic medicines to women (Lexchin, 1992).
The Lexchin further concluded in the study that most of the countries rely a lot on overseas multinational pharmaceutical companies, through exports and local production. Promotional actions must focus to parameters according to the company’s origin country. “Promotional materials and labeling should be required to be acceptable in both countries, i.e. to adhere to the higher of the two standards. This would put more of an onus on governments in industrialized countries to prevent messages with negative health consequences from being provided overseas by multinational companies with head offices in their country” (Lexchin, 1992).
Arun Phatak studies concluded that pharmaceutical industry is already profit taking and intends at giving utmost profit to share owners. The pharmaceutical industry is not worried about their consumers, or else the market would not be swamped by illogical formulations . In United States, it obtains $9.4 million to build up a fresh medicine and catch its approval. The only approach to give back this is through forceful promotion . An expected 20% of drug companies’ funds are used up on marketing of drugs; and of this amount, 20% is used up on retaining and instructing medical representatives, 30% for publicity media, and 50% for unusual schemes which involves dinner meeting for doctors and other medical staff, printing & publication of books and other materials (Phatak, 1998).
Arun further concluded here can be no doubt of getting a handsome profit in this industry. The obnoxious is taking advantage by deceitful ways:
- Imperfect and insufficient product information provided by medical representatives. However, it is the solitary resource of information related to drugs for most of the practitioners.
- Support for educational actions can be suitable if it is exclusive of filaments and the event’s planners is the only decision making authority of each and every portion of the event: Donations should be given to the institutions, and the charges of speaker should be pay back by the proficient, not by the pharmaceutical company.
- Funding should be handed to institutions and certified bodies not to individual persons.
- The practitioners must worry about fake information and advertisements in the media for drug injurious to the health. They prohibit on advertisements of alcohol, child milk substitutes and feeding bottles are examples of this concern. Medicine companies also publicize their drugs in research journals and publications. It has to be making sure that incorrect information and messages are not given, and ridiculous medicines are not promoted through advertisements.
- The medicine companies convince doctors to recommend specific medicines by giving gifts or payments. In Pakistan, where poverty stripe of people is 40%, the payments and gifts connection infringe the moral values of loyalty and non-maleficence. Medicines companies like LOCOST, who do not involve in unprincipled marketing and promotional activities of their medicines, are capable to offer valuable and standard medicines under common names at half price as compare to market rates (Phatak, 1998).
Daniella, & Michael studied the interaction between medicine companies’ representatives and physician in training sitting. According to them contact with medicine companies’ representatives were widespread among locals. Most of the trainees experienced that the connections were suitable while other think that their own prescribing could be predisposed by gifts or relations, but were more possible to deem that others' prescribing could be inclined. Occupant prescribing was linked with pharmaceutical representative appointments and the accessibility of medicines samples. A range of rules and instructive interferences come into view to sway local mind-sets toward relations with pharmaceutical companies, though information on the durable possessions of these interferences is inadequate. In general, locals reported deficient exercises in this area (Daniella & Michael, 2005).
Finally they concluded that the drug industry has a noteworthy existence for the period of placement training, has added on the whole receiving of trainees, and come into views to control prescribing activities. Training sessions can promote from policies and curriculum that educate residents about industry manipulate and traditions in which to gravely assess information that they are provided.
Komesaroff and Kerridge (2002) evaluate numerous issues regarding the connection between medical practitioners and the drug industry, highlighting that planning between doctors and drug companies have to be transparent and obvious. They recognize the key sources for concern and inspect ways in which unusual phases of the medical profession are missing susceptible to sleaze. Furthermore they recommended the points, which are as follows:
- Drug companies and medical practitioners serve each other interests that occasionally overlie and clash.
- There is sturdy proof that relations between drug industry and medical practitioners manipulate the last actions in relation to clinical decision-making as well as carry out of research.
- Present the jeopardy of concession relationships with patients and the honesty of the research process, physicians must work out in their communication with pharmaceutical industry.
- The basic philosophy for the behavior of physicians with respect to drug companies must directness and lucidity.
- Evidently uttered measures should be constructed to deal with precise problems such as traveling expenses, delivery of gifts, funding of conferences and seminars and enduring education activities.
According to Bodenheimer (2000) and Mathieu (1999) Doctors and the drug companies carve up a number of common interests. For example, both are anxious with heartening effectual and accountable utilization of accessible medicines in handling and care, their usage monitoring, and pioneering research . But both parties have different importance and having different center of attention. Doctors are concerned mainly in patient health care and scientific advance, while companies are interested first and foremost in financial benefits . The resemblances and dissimilarities between participants and their interests generate both a requirement for dialogue and the possible for differences . The contribution for medical knowledge and practice done by drug industry has been considerable. The cost of development of a fresh medicine is between US$300 to $600 million, nearly all is provided by pharmaceutical industry. Clinical research is also luxurious: last year, in the United States, about US$6 billion was used up on clinical research, out of which 70% came directly from drug industry. The total amount used for research and development is still much superior. In spite of these clear mutual benefits and interests of cooperation, both the medical profession and the community have expressed concerns of an ethical nature. There are three main concerns:
1. The probability of connection between physicians and medicine companies may dole out commercial purposes of industry and greedy interests of clinicians more willingly than lawful thinking, research and educational objectives, thus compromising the main moral compulsion of doctors to patients, dividing the faithfulness of physicians and discouragement the fundamental belief on which clinical relations depend.
2. The hazard that medicines promotion will unsuitably pressurize physician’s decisions.
3. The risk that industry participation in research and development of new drugs will lead to deformations in scientific confirmation and stop self-governing appraisal of information.
Parmar and Jalees, 2004, developed the distinctions between ethical and unethical drug promotions practices based on the focus group discussions. “The acceptable norms of promoting drugs through doctors are visiting them, giving a presentation on the merits and demerits of the drugs. Explicitly, pointing out the side effects of drugs, giving nominal quantity of drugs sample. These gifts and give away must not be highly expensive and restricted to items such as dairies, calendar, year planner, etc.” (Parmar & Jalees, 2004).
“The drugs thus prescribed to the patients on the merits of drugs with focus on the well being of the patient will fall in the category of ethical drug promotion practices.”
“Comparatively, unethical drug promotion practices are prescribing drugs to the patients based on the monetary considerations, and ignoring the well being of the patients. The commonly used monetary rewards for unethical promotion of the drugs are discussed below” (Parmar and Jalees, 2004).
(i) Monetary Reward
The crudest type of immoral medicine promotion is financial return. In this type, the cash payment is associated with the quantity of the medicine prescriptions by the physicians. The rewards are given on quarterly or monthly basis.
(ii) Visits With in Country
In this category, the drug companies manage seminars and conferences for the physicians in those cities where doctors are not domiciled. The purpose of such arrangement may be to keep informed physicians on the current advances in the industry, but the actual intention is to offer effusive paid medicines. The drug companies manage the travelling expenses, accommodation expenses in posh hotels. This paid medicine may possibly for the physicians their families. Doctors travel to other cities for personal reasons. The pharmaceutical firms entertain the doctors by arranging the air traveling with lodging & boarding expenses of the doctors’ personal visits.
(iii) Foreign Visits
Drug companies organize overseas visits of the physicians. Like in country travelling, these visits are managed in the setting of conferences and seminar, but again actual aim is to offer paid medicines.
(iv) Gifts & Give away
a) Medical Equipments: Drug companies offer medical instruments like stethoscope, thermometers, surgical kits and other expensive medical equipments.
b) Personal Use Items: Drug companies provide personal use items such as mobile, laptop, air-conditioned, and even cars.
(v) Chamber Decoration
In this category, the drug companies refurnish the physician’s clinics, as well as provide air-conditioners, furniture, display boards, computers etc.
(vi) Home Decoration
The arrangements for the home display is alike to the physician’s clinics decorations as mentioned above.
One author has suggested in the study (Brennan et.al, 2006), that doctors record their attachment with medical companies . Actually , data given to the people who are most expected to be debilitated looks most rational. Drug companies promote their medicines to doctors, patients, and facilities for health care in turn to boost sales and reinforce sales revenues. Literature shows many marketing models, which deal with the control distressing: What are the conditions at which companies and peoples select medicine for their use (Aaker & Williams; 1998, Bar-On & Parker; 2000, Curcura, 1999; Gonul et al., 2001; Mintzes, 1998, 2002; Tutor2u, 2004; Wolfe, 2002).
In many research papers, we can easily find literature regarding the control of Medicine Company fully funded gifts and paid education for medical students, practicing expenses of experience and naïve doctors (Avorn et al., 1982; Curcura, 1999; Gonul et al., 2001; Stolberg & Gerth, 2000; Wazana, 2000).
Pharmaceutical companies used approximate more than 11 billion USD per year for their marketing and promotion budget, between 5 to 8 billion USD set off to promotion of medicines through their sales staff (Greene, 1999, 2000), and for doctors a projected 8-13 thousand USD per year used up (Gibbons et al., 1998; Greene, 1999, 2000; Wazana, 2000; Westfall, McCabe, & Nicholas, 1997, 1998). Medical students, experience and naïve doctors fully confessed that listeners in seminars and conferences latently fewer incase of lack of lunch and gifts (Steiman, Shlipak & McPhee, 2001; Wazana, 2000).
According to an article published in New York Times, which shows the explication of investigation by Federal Department. It engages different pharmaceutical manufacturers for example Schering-Plough, Bristol-Myers Squibb, Johnson and Johnson, and Wyeth (Coleman, J., Katz, E., Menzel, H., 1968)
In the course of an assessment of interrogation with doctors and managements of drug manufacturers, the government has acknowledged unsuitable, incongruence and unlawful promotional campaigns. It comprises of financial payback and appreciating medical doctors to invoice intermediary payers for medicines delivered to physicians with no cost (Harris, 2004).
In recent years, different medicines companies have pled blameworthy to elicit accuse connecting the promotion of their medicines and even paid some fines. In 2001 TAP Company paid 875 million USD, while in 2003 Astra Zeneca paid 355 million USD. Beside this a multinational Pharmaceutical company Pfizer settled to pay 430 million USD against fines. These all are beseech culpable to unlawful allegation of dishonesty for heartening doctors to tab government against free medicines, which these companies delivered to doctors (Harris, 2004).
A question has been lifted due to these problems related to unprincipled influence those programs which could cover doctors’ stipulated observations (Avorn et al., 1982; Curcura, 1999; Gonul et al., 2001; Wazana, 2000, Wolfe, 2002). A number of investigation claimed that students and residents of at medical universities considerably undervalue the control medicine organization fully funded education has on their prescribing practices (Steinman et al., 2001; Wazana, 2000; Waud, 1992).
A research shows that 46% of doctors stated that medical company sales and marketing persons be fairly significant in pressurizing their set down practices (Avorn et al., 1982). Other researchers claimed that 61 percent of residents at medical universities affirmed that marketing and promotions by pharmaceutical companies did not weight their own selection of medicines, on the other hand the remaining 16 percent understood other doctors to be also uninfluenced (Steinman et al., 2000).
In 2002, survey conducted by the journal Medical Economics found that 71% of doctor’s respondents did not consider that accepting gifts, trips or hospitality weaken their objectivity (Murray, 2002). Murray reports, “Indeed, many physicians found the suggestion that they may be influenced insulting” (Murray, 2002).
For the treatment of hypertension “Chew & Colleagues” researched in year 2000, if the sample was obtainable in the office to hand out a patient, over 90% of doctors would distribute a sample that different from their chosen medicine options. According to Industry estimate in 2000, 7.2 billion USD values of free medical samples were distributed in 2000 (IMS Health, 2002).
Westfall et al. (1997) found that 96% of physicians and their staff had taken drug samples for personal and family utilization in last year. The authors projected that the value of these drugs is about USD 10,000. Westfall, et al. further states: “The use of whatever medication is available on the sample shelf (usually the more expensive of several options) is contrary to the development of good prescribing habits that will be necessary for success in practice”.