DRUG PROMOTION STRATEGY AND REGULATIONS

Project Report

Submitted in partial fulfillment of the requirements for the degree of M.Sc. in Clinical Research (2008-2010)

To the

Institute of Clinical Research, India (ICRI)

Cranfield University, UK

Submitted By:

1. Dr. Priya Bhasin2. Machut Zimik3. Manoj Kumar Sing4. Mariya Biswas5. Mohd. Shanawaz6. Mohd. Rehmadulla Shah

DECLARATION

We hereby declare that the project work entitled “Drug Promotion Strategy and Regulations”,

submitted to the “Cranfield University”, is a record of an original work done by Learning Group

5 under guidance of Professor Phil Warner (Cranfield University) and Dr. Amit Gupta (Institute

of Clinical Research India).

ACKNOWLEDGEMENT

We, the learning group 5 wishes to thank DR. Reddy, Ranbaxy, Panecea for their support and

guidance.

We would also like to thank Professor Phil Warner and Dr. Amit Gupta for their invaluable

expertise and guidance.

We are also grateful to the following people for contributing their time and expertise in

managing the project:

Project Manager: Dr. Priya Bhasin

Project Members: Machut Zimik, Manoj Kumar Singh, Lucky, Mariya Biswas and Shanawz

Lastly, but most specially, the Learning Group 5 would like to extend our gratitude to everyone

who responded to the survey questionnaire – 100 Health Care Professional, 35 Marketing

Representatives and the Marketing Head of each companies. This project would never have been

completed, if not for their encouragement and support.

SUMMARY

Many people are often unaware of the truth about pharmaceutical companies and prescription drugs whilst they rely on them to a great extend for improving the quality of life and health on a day to day basis. The truth is no drugs are completely safe with side effects taking place as a common phenomena and doctors often know much less about the risk- their main source of information about the drugs being the drug companies themselves. Moreover the new marketed drugs which are considered as “breakthrough” drugs has only a slight fraction of improvement in contrast with products that are already present in the market. The pharmaceutical companies made the public believe that high price of drugs are requisite to support the research and development of drugs, however they actually spend double the amount in marketing rather than on researching drugs and are considerably one of the most profitable industry than any other. In 2002, the USA alone spends almost US$21 billion on drug promotion. In developing countries particularly India pharmaceutical sales representatives are most frequently the only source of medicine information. There are concerns about whether commercial interest or consumer health should given priority.

This report is part of a group project on “drug promotion strategy and regulations” being carried out by Learning Group 5. This phase of group project involved surveying health care professionals, pharmaceutical representatives and marketing head, collecting and analyzing of information on drug promotion and regulations. Research studies were conducted and compiled in a systematic manner to form the basis of this project. This project will examine on drug promotion targeting primarily on four audience; health care professional, sales representative, policies and practices of companies on promotional activities and regulations.

Perception of health care professional on drug promotion

Evidence from research studies have shown that the attitude of doctors on drug promotion vary to a large extend. Some doctors suggest that they should be trained to interact with sales representatives while others discard this idea. Many doctors believe that information on drugs from pharmaceutical companies is useful while most doctors think they are biased. There is a mixed opinion on doctors about direct-to-consumer (DTC) promotion of drugs. At present only USA and New Zealand follows direct-to-consumer (DTC) advertising of drugs and other regulatory authorities are considering whether or not to follow USA pattern of drug promotion model. The truth is promotion tends to influence doctors attitude more then they realize themselves as they report that promotion is the most frequent source of information about new drugs.

The roles and powers of pharmaceutical representatives-educators or marketers

Pharmaceutical Representatives has a direct impact on the growth of a company whose main attributes depends on the power to influence a Health Care Professional on prescribing a drug. Therefore it is the responsibility of a company to provide a comprehensive training to the PRs about products which are in the phase of promotion. The roles and responsibilities of PR should be clearly defined to enable HCPs for appropriate clinical-decision-making. However, research evidence has shown that little is known about PRs’ attitudes for their roles as educators or marketers.

Countering promotional activities of drugs-policies and practices

By definition the main objectives of drug promotion is to accelerate the sales of products. Pharmaceuticals Company adopts a drug promotion strategy that is aimed at both health care professionals and the public. However, due to the competitive nature of drug promotion by different companies their remains a concern regarding the ethical implementation of their practice. A study has shown that two-third of the world has either no regulation on drug promotion or does not implement the regulations they have (1). Pharmaceuticals Company should maintain a sense of responsibilities towards drug promotion; directed not only in generating their sales but also provide appropriate information that the consumer will need. Studies have suggested that guidelines and regulations on drug promotion are ineffective. Despite a regulatory system being enforced on post marketing surveillance, it has not shown any success of proper implementation. Conflicts of interests seem apparent among the drug companies which often lack enough policies to be dealt with.

Regulatory framework-an international perspective

INTRODUCTION

According to WHO, drug promotion can be defined as “all informational and persuasive activities by manufacturer and distributers to induce/influence the sale and use of medicinal drugs” (2). The rational use of drugs depends exclusively on the activities of drug promotion. The methods applied in drug promotion takes a varying form with new product lines often plugging a common place. Off-label drug prescription is a common practice in which drugs are commonly marketed even though it has never been proven of being effective. The truth about pharmaceutical companies is that, they actually spend more on marketing prescription drugs then researching drugs. There is a considerable evidence of seeing more insidious and conspicuous forms of promotion which indicates that these methods don’t seem to be promoting a drug product at all. It is no secret that drug companies are often fuelled by profits just like any other corporations whose main aim is to raise consumer demand and eventually adopts unethical drug promotion. There is varying number of promotional strategies that pharmaceutical companies deploy for description medicines which are often misleading the consumers. Evidence from experience has shown that the pharmaceutical industry remains guilty of inappropriately involving in unethical promotion that will hinder with clinical-decision making by encouraging irrational use and over-prescription of medicines. This approach remains a concern for the consumers because it not only increases the cost of healthcare but also endanger consumer to unnecessary health risk.

Since 1980, there has been development of variety of mechanisms to regulate drug promotion by wide range of actors including WHO, national government and industry association. The spending on drug promotion for prescription drugs by drug manufacturers directed to consumers has increased to tenfold since 1994 (3). The influence of drug promotion on consumers and physicians are apparent from several research studies (4-6). Direct-to-consumer advertising (DTCA) has been on the rise since the early 1980s’ when Merck’s Pneumovas for pneumonia vaccine first printed its ad in reader’s digest in 1981. The spending on DTCA through TV and radio has now increased dramatically from $220 million in 1997 to more than $2.8 billion in 2002 after the FDA first drafted guidance for DTCA in 1997. To catch up with the competitive edge of drug industry there is a change in marketing mix being constantly updated by pharmaceutical manufacturers aimed at responding to new changes in regulations and market behavior.

This project will also provide a briefing on the recent activities regarding regulation and promotion of medicines whilst providing overture about what we observed from our findings. The major focus of this project therefore, is to understand the know-how about policies and practices of 5 major pharmaceutical companies operating in India and specifically reviewing their promotional activities with regards to self-regulatory code of the company, industrial associations and the national regulations. With conflict-of-interest apparent among the pharmaceutical companies it is essential to pay attention to the regulatory framework of different countries and justify the variations persisting in their promotional practices.

AIM:

The aim of this project is to interpret the current scenario on drug promotion and determine the appropriate practices to be implemented.

OBJECTIVES:

This project primarily focuses on wide range of different topics on drug promotion

1) Determine the perception of health care professionals on drug promotion.2) Understand the roles and responsibilities of medical representatives on drug promotion.3) Determine the drug promotional activities of pharmaceutical companies and identify the

variations in promotional practices among them.4) Highlight the regulatory frameworks on drug promotion through international perspective.5) Annotate on the control of drug promotion by identifying the right practice-both regulations and

pharmaceuticals promotional activities.

METHODOLOGY

This project report was carried out to analyze the marketing practices of drugs by pharmaceutical companies and understand its impact on consumers along with reviewing the regulatory codes on drug promotion of different countries.

SCOPE

The overall focus of our project can be summarized as below:

Health Care Professionals

Focus issues

Views on medical representatives in particular and drug promotion in general Training of health care professionals to interact with medical representatives Information provided by medical representatives about pharmaceutical products Offers

Medical Representatives

Focus issues

Roles and responsibilities

Training requirement Attitude

Promotional activities of the pharmaceutical companies

Companies: Ranbaxy, Dr. Reddy,

Focus issues

Drug promotion strategy Channels of drug promotion Competition among the pharmaceutical companies Effectiveness of drug promotion Shortcomings Ethical Criteria

Regulatory frameworks

Codes: WHO Ethical Criteria (1988), IFPMA 2006, OPPI 2007 (India), ABPI 2008 (UK), EFPIA (EU) 2007, PhRMA (US) 2008

Focus issues

Objectives of the codes Applicability of the codes Scope of the codes Definition of promotion in the codes Medical Representatives Gifts and hospitality Advertisement Distribution of free samples Product information

METHODS

REGULATIONS

The main sources for reviewing both the national and international industry codes and the WHO ethical criteria were extracted from the websites of respective codes as given below:

Country Applicable codes Websites

International WHO ethical criteria http://apps.who.int/medicinedocs/en/d/Js16520e/

International IFPMA http://www.ifpma.org/EthicalPromotion

EU EFPIA http://www.efpia.org/content/Default.asp?PageID=615

UK ABPI http://www.pmcpa.org.uk/?q=getcopiesofcode

USA PhRMA http://www.phrma.org/code_on_interactions_with_healthcare_professionals

India OPPI, IFPMA http://www.indiaoppi.com

http://www.ifpma.org/EthicalPromotion

The primary objectives of ethical criteria for the promotion of drugs are to encourage and support the improvement of health through the implementation of rational use of pharmaceutical products. Promotion of irrational prescription drugs are considered unethical in any form of activities. Many countries have their own regulations for the promotion of prescription drugs in which the strength of the regulations varies from one country to another. It is therefore important to determine the ethical code of drug promotion so as to bring about changes to overcome the unethical practices of pharmaceutical marketing. The following codes will be analyzed for this study:

1. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) 2006, International

2. WHO Ethical Criteria, 19883. European Federation of Pharmaceutical Industries and Associations (EFPIA) 2007, EU4. The Association of the British Pharmaceutical Industry (ABPI) 2008, UK5. The Pharmaceutical Research and Manufacturers of America (PhRMA) 2008, US6. Organization of Pharmaceutical Producers of India (OPPI) 2007, India

OBJECTIVE OF THE CODES

1. IFPMA/OPPI

The international pharmaceutical industry is committed to the improvement of the health of the mankind through research and development of new medicines and production and marketing of pharmaceutical products of reliable quality, in accordance with internationally defined standards of good practice.

2. WHO Main objective of ethical criteria for medicinal drug promotion is to support and encourage the improvement of health care through the rational use of medicinal drugs.

3. EFPIA The objectives of EFPIA codes of practice are to ensure the highest possible standards in the promotion and advertising of medicines.

4. ABPI The objectives of ABPI codes of practice are to ensure that the promotion of medicines to health professionals and to administrative staff is carried out within a robust framework to support high quality patient care.

The objectives of each code specify different aspects of promotional practices which are rarely put into practice. In the current scenario of pharmaceutical marketing many new drugs are produce with mere molecular manipulation to match with the competitive edge of the industry and drugs with the same level of effect are sold at higher prices. The ethical criteria of drug promotion also start from the validity of the medicine itself. The existence of many codes also makes it difficult to follow internationally defined standards of good practice as suggested in IFPMA.

5. PhRMA PhRMA considers ethical relationship with healthcare professionals as their critical mission to help patients by developing and marketing new medicines. They focus primarily on the interaction with healthcare professionals that relate to the marketing of products.

APPLICABILITY OF THE CODES

IFPMA confined mainly to its member organizations and affiliates in the industry.

The countries listed in the table are a member of IFPMA

Americas Asia Pacific Europe Middle East and Africa

Argentina Australia Austria Israel

BrazilCanadaCentral AmericaRepresenting :Costa RicaEl SalvadorGuatemalaHondurasNicaraguaPanamaChileColombiaDominican RepublicEcuadorMexicoPeruUruguayVenezuelaUSA

BangladeshChinaHong KongIndiaIndonesiaJapanKoreaMalaysiaNew ZealandPhilippinesSingaporeTaiwanThailand

BelgiumBosnia HerzegovinaCroatiaCzech RepublicDenmarkFinlandFranceGermanyHungaryIrelandItalyNetherlandsNorwayPolandPortugalRepublic of BelarusRussiaSpainSwedenSwitzerlandUnited Kingdom

MoroccoSouth AfricaTurkey

WHO expanded to people in all walks of life:  governments; the pharmaceutical industry (manufacturers and distributors); the promotion industry (advertising agencies; market research organization’s and the like); health personnel involved in the prescription, dispensing, supply and distribution of drugs; universities and other teaching institutions; professional associations; patients and consumer groups; and the professional and general media (including publishers and editors of medical journals and related publications). EFPIA is the representative body of pharmaceutical industry in Europe and its code applies to its members which consist of thirty pharmaceutical producing countries in Europe along with over forty leading pharmaceutical companies.

SCOPE OF THE CODES

The IFPMA code states that promotional activities within the scope of the code include direct to-consumer advertising (DTCA), where this is permitted under local laws. However, in many Third World countries there is no regulatory law for promotion of medicines through DTCA. What will be the responsibility of the industry and who will monitor them? Such code becomes ineffectual as evident in several clauses of the IFPMA code.

 DEFINITIONS OF PROMOTION

The definition of 'promotion' is vital. In the context of WHO, ‘promotion refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.'

For some reason the IFPMA code did not feel the need to provide such a definition. It states: 'Promotional materials for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only to legal requirements but also to high ethical standards and to be in good taste.' This definition is not clearly understood.

OPPI guideline stated more specific terms of promotion, defining it as: 'Promotional material on pharmaceutical products: printed literature (package inserts, data sheets, detail/visual aids, flip-charts, leave-behinds, mailings and advertisements); audio-visuals; sponsored symposia/conferences/guest lectures; gift items; information through medical representative training.'

However, OPPI has ignored advertising through the electronic media, gifts, literature or display materials given to wholesalers and chemists, the sponsoring of individuals to attend meetings/conferences, etc.

“Promotion”, as used in the EFPIA Code, includes any activity undertaken, organized or sponsored by a Member Company, or with its authority, which promotes the prescription, supply, sale, administration, recommendation or consumption of its medicinal product(s). ABPI also defined ‘promotion’ as any activity undertaken by a pharmaceutical company or with its authority which promotes the prescription, supply, sale or administration of its medicines.

ADVERTISEMENTSWHO has defined 11 specific criteria for advertisements, OPPI mentions four criteria and IFPMA mentions three criteria.IFPMA categorizes advertisements as

all advertisements full advertisements

IFPMA code states that contraindications, side-effects and precautions must be mentioned only in 'full advertisements. IFPMA code is more strictly followed in developed countries like USA and UK for advertisements.

According to ABPI advertisement for prescription drugs must not appear anywhere where the general public will see them; therefore drug advertisement can generally only be placed in medical journals and magazines. There are also guidelines as to what constitutes an advertisement, for example, a review article placed in a specialist nurse or physician magazine may be rules as an advertorial if it is deemed too promotional. There are also limits on the number of pages per publication that can be dedicated towards the promotion of one product.

PhRMA ensures that direct-to-consumer (DTC) advertisement comply with the regulations of the Food and Drug Administration (FDA). In general, FDA requires all DTC information:

To be accurate and not misleading

To make claims only when supported by substantiated evidence To reflect balance between risks and benefits To be consistent with the FDA-approved labeling

The table below shows the pharmaceutical advertising controls:

Examples Self regulatory Regulatory Legal Global IFPMA Code WHO ethical criteria 1988

Company Codes Regional EFPIA Code EU Directive 2001/83 (as amended by

2004/27)National ABPI Code

PhRMA Code OPPI

UK: Advertising Regulatory, MHRA Activities, Medicines ActUSA: FD&C Act, Lanham Act, DDMAC ActivitiesIndia: Drugs and Magic Remedies Act

MEDICAL REPRESENTATIVES IFPMA mentions that medical representatives must be trained with sufficient medical and technical knowledge. They should also collect information from professionals about the use of a product.WHO states that training should be-

Updated Continuous Training should include ethical codes.

MR’s should not offer inducements to prescribers and dispensers, and prescribers and dispensers should not solicit such inducements.

OPPI states that Adequate training should include information on basic medical sciences such as anatomy,

physiology, microbiology and pharmacology. Sufficient medical knowledge should be given regarding aetiopathology and clinical

aspects of the disease for which the product is used. The representatives should be properly trained to impart information in an accurate and

scientific manner. There is no reference to the appropriate conduct of a medical representative (MR)

PhRMA Representatives must be given adequate training and have sufficient scientific knowledge

to enable them to provide appropriate information about the medicines which they promote.

They must maintain a high standard of ethical conduct and comply with the Code at all times. Companies must prepare briefing material for representatives on the technical aspects of the medicine and how the product should be promoted.

They must not use inducements or subterfuge to gain an appointment, and should ensure that the frequency and duration of calls do not cause inconvenience.

Payment of a fee for an appointment – even to a charity – is not permitted.

ABPI Clause 15 of ABPI mentions that representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines they promote. Representatives must not make claims or comparisons which are in any way inaccurate, misleading, disparaging, in poor taste etc, or which are outside the terms of marketing authorization for the medicines or inconsistent with the summary of product characteristics.

GIFTS & HOSPITALITY

WHO Ethical Criteria states that “promotion in form of financial or material benefits should not be offered to or sought by HCPs to influence them in the prescription of drugs”. This statement does not explicitly prohibit the provision of gifts, however by not spelling this out specifically, the WHO Code could be interpreted to mean that ‘nothing should be given’ as if all gifts are inducement. OPPI and PhRMA also included similar statement that nothing should be offered as an inducement to prescribe medicine.

Restriction on the nature/purpose of gifts is strictly followed in US law where as the IFPMA Code remains quite weak in this issue. OPPI also fails to specify these cultural celebrations. The IFPMA and the EFPIA leave it up to the national associations to define the specific value of gifts that are permitted. However, PhRMA sets a maximum of $100 for educational items only.

Both codes and legislation are weak on the issues of ban on stand-alone entertainment. None of the legislation bans all forms of entertainment. Even EFPIA Code seems unclear on this issue. However, ABPI seems to be banning all entertainment as they considered such activities as unprofessional.

Significant variation between the codes and the national regulations and industry codes were observe in the categorization of gifts and hospitality.

Indicators WHO Ethical

IFPMA (Internationa

EFPIA (EU) 2007

ABPI (UK) 2008

PhRMA (US) 2008

OPPI (IN) 2007

Criteria 1988

l) 2006

Ban inducement to prescribe

Have basic standard

Have basic standard

Have basic standard

Have basic standard

No basic standard

Have basic standard

Gifts

Ban all kinds of gifts

No No No No No No

Restriction on the nature/purpose of gifts

No specific guidance

Weak guidance

Stringent guidance

Stringent guidance

Very stringent guidance

No specific guidance

Specific restrictions on value

Does not set a specific value

Does not set a specific value

Does not set a specific value

Set value for only some kinds of gifts

Set value for only some kinds of gifts

Does not set a specific value

Specific restriction on frequency

Occasionally or infrequent

Occasionally or infrequent

Occasionally or infrequent

Occasionally or infrequent

Occasionally or infrequent

Occasionally or infrequent

Record-keeping

None None None Only certain gifts (expensive gifts)

All gifts that add up more than $100 per year

None

Public disclosure

None None None None All gifts that add up to >$100 per year

None

Ban of all entertainment

Strong limitations on types of events allowed

Strong limitations on types of events allowed

No clarification

If ban implicit

If ban explicit

Strong limitations on types of events allowed

DISTRIBUTION OF FREE SAMPLES

So far the OPPI remains silent with respect to the distribution of free samples. The IFPMA states that samples may be given to prescribing professionals to familiarize them with the products, enable them to gain experience with the products in their practice, or on request.

On the other hand WHO guidelines appear to be more lenient, considering that free samples may be used by the weaker sections of society.

Depending on the national and community laws and regulations EFPIA allows a limited number of samples of a particular medicinal product to be supplied to HCPs who are qualified to prescribe that medicinal product. However, samples must not be given as an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products. ABPI also lays similar provisions on distribution of samples which may be provided only to HCPs qualified to prescribe that particular medicines.

THE INDIAN SCENARIO OF REGULATING PHARMACEUTICAL MARKETING

India has only one relevant clause of its own that relates to the promotion of prescription drugs; Clause 4 of the Magic Remedies (Objectionable Advertisement) Act, 1954 on misleading of advertisements. There has been a constant debate on the guidelines of pharmaceutical marketing across the globe, more so in India. The drug industry sets their own standard of drug promotion and interprets their own rules. Many issues are not clear and needs to be addressed and amended. Due to certain reasons, fortunately no major cases of unethical promotion have been reported in the Indian media as compared with the western countries. The reason though could be because many such unethical promotional activities haven’t come to light.

At present prescription drug promotion in India is governed by three major documents:

The Drugs and Cosmetics Act, 1940

It is defined as an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. It has last been amended in 1995.

The Drugs and Cosmetics Rules, 1945

It describe the essential information to be provided regarding labeling of drugs. The product monograph should comprise the full prescribing information necessary to enable a physician to use the drug properly. It should include description, actions, indications, dosage precaution, drug interactions, warnings and adverse reactions.

The OPPI Code of Conduct, 2007

This code sets out the guidelines to be followed for promotion of prescription drugs by the pharmaceutical industry. It is based on the IFPMA code and incorporates local region (India) specific guidelines. It sets out certain principles basic to the ethical promotion of pharmaceuticals

in the country. Though it is widely followed, it is not legally binding and the final responsibility for implementation lies with the pharmaceutical marketing organizations themselves.

The Medical Council of India (MCI) started 2010 with a long awaited bang. On 1/1/10, MCI put out a statement asking the country's doctors to stop receiving gifts or favors from any pharmaceutical companies and said they must desist from endorsing products. 

As per the MCI, All medical practitioners shall not receive any gift, national/international travel facility, paid vacations (for self or family), from any pharmaceutical or allied healthcare industry and their sales people or representatives. The punishments range from censure (for accepting gifts valued between Rs.1,000 and Rs.5,000) to removal from the Indian or State Medical Registry for more than one year (for accepting gifts worth more than Rs.100,000). 

Now the MCI wants the government to regulate the Pharmaceutical companies. Authorities said the health ministry is discussing with all stake-holders and a fair outcome will come out.

CONCLUSION

Research and policy questions to be addressed include the development of effective methods of educating doctors about drug promotion, the impact of guidelines on promotional gifts, and the development of effective guidelines for managing conflicts of interest in research. The effects of different regulatory frameworks also urgently need to be compared.

While there are government agencies charged with monitoring the marketing of medicines, typically this is one of many briefs for these agencies and is often only in a reactive fashion. In other words such monitoring as does occur, occurs only in response to complaints, and even then is often very slow and cumbersome.

RECOMMENDATION

Drug promotion strongly influences prescribing behavior, but doctors underestimate this influence. Company funding of doctors, of educational events and of research are important elements in this influence.

Several key factors to control unethical promotion of prescription drugs can be made effective through government regulation, training of students (both before and after graduation), media

exposure of abusive promotion, and free and abundant provision of reliable non‐commercial therapeutic information to professionals and the public.

Independent monitoring bodies should be established to police marketing codes of practice with real penalties. Government and national medicines agencies should take pro-active stances in monitoring promotional activities since self-regulatory are often misleading or inaccurate in their promotional practices.

Increased attention should be paid to the education of the consumers of pharmaceutical advertising, in particular those with prescribing powers. Attempts should be made to introduce a more effective general consumer’s awareness program.

Need improvement on current industry codes particularly the clause on gifts because it is

difficult to define different kinds of gifts. Gifts should be ban as the evidence has shown that it

influences the prescribing behavior of the doctors.

REFERENCES

1. Rhein RW. Law enforcement and the Internet superhighwaymen. Scrip Magazine. 1996. Dec: 18-22

2. World Health Organization. Ethical criteria for medicinal drug promotion. Geneva, 1988:5.

3. Henry J. Kaiser Family Foundation, Prescription Drug Trends: A Chartbook, Menlo Park, CA,July 2000.4. Alperstein, N. and M. Peyrot, "Consumer Awareness of Prescription Drug Advertising," Journal of Advertising Research, July/August 1993, vol. 33, #4 pp. 50-5. Prevention Magazine, "International Survey on Wellness and Consumer Reaction to DTCAdvertising of Prescription Drugs," Vol. 1, 2000/2001, Emmaus PA: Rodale, 2001.

6. Borzo, G., "Consumer Drug Ads Booming: FDA Reviews Restrictions," American MedicalNews, 40(6):1, 37, February 10, 1997.