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 DECLARATION

We hereby declare that the project work entitled ³Drug Promotion Strategy and Regulations´,

submitted to the ³Cranfield 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 c # -8 9-8 for their support and

guidance.

We would also like to thank !!: and c#for their invaluable

expertise and guidance.

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

managing the project:

|
 
 : c#-,!

|
 : /082
"80-8-,!4!and
46

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. 



 


 
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 ³breakthrough´ 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 ³drug 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.

!!"
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.
!4!!;!)!
0!
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.

$";!"!)!!
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.

"-40)!;





 
  c
$ 
According to WHO, drug promotion can be defined as ³all 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.

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

,<$=
.
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.

>c 
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.

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

>$!!!
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
 !;!
Focus issues
 Roles and responsibilities
 Training requirement
 Attitude

;!!
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

"-40!
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
>c




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:

$- ! :!!

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=6
15

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

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

ealthcare_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, 1988
3. European Federation of Pharmaceutical Industries and Associations (EFPIA) 2007, EU
4. The Association of the British Pharmaceutical Industry (ABPI) 2008, UK
5. The Pharmaceutical Research and Manufacturers of America (PhRMA) 2008, US
6. Organization of Pharmaceutical Producers of India (OPPI) 2007, India
,<$=?>$c


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.

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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
Brazil Bangladesh Belgium Morocco
Canada China Bosnia Herzegovina South Africa
Central America Hong Kong Croatia Turkey
Representing : India Czech Republic
Costa Rica Indonesia Denmark
El Salvador Japan Finland
Guatemala Korea France
Honduras Malaysia Germany
Nicaragua New Zealand Hungary
Panama Philippines Ireland
Chile Singapore Italy
Colombia Taiwan Netherlands
Dominican Republic Thailand Norway
Ecuador Poland
Mexico Portugal
Peru Republic of Belarus
Uruguay Russia
Venezuela Spain
USA Sweden
Switzerland
United Kingdom

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.

$?>$c



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.

c? 
?  

The definition of 'promotion' is vital. In the context of WHO, µpromotion 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.

³´, 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 µpromotion¶ as any activity undertaken by a pharmaceutical company or with its
authority which promotes the prescription, supply, sale or administration of its medicines.

c= 
 

WHO 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 UK: Advertising Regulatory, MHRA
_ PhRMA Code Activities, Medicines Act
_ OPPI USA: FD&C Act, Lanham Act, DDMAC
Activities
India: Drugs and Magic Remedies Act

c$  
 =

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.

?
@>
 
WHO Ethical Criteria states that ³promotion 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 µnothing 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.
 Significantvariation between the codes and the national regulations and industry codes were
observe in the categorization of gifts and hospitality.

Indicators WHO IFPMA EFPIA ABPI (UK) PhRMA OPPI (IN)

Ethical (Internationa (EU) 2007 2008 (US) 2008 2007
Criteria l) 2006
1988

Ban Have basic Have basic Have basic Have basic No basic Have basic
inducement standard standard standard standard standard standard
to prescribe

Gifts

Ban all kinds No No No No No No

of gifts

Restriction No specific Weak Stringent Stringent Very No specific

on the guidance guidance guidance guidance stringent guidance
nature/purpos guidance
e of gifts

Specific Does not Does not set Does not Set value Set value Does not
restrictions set a a specific set a for only for only set a
on value specific value specific some kinds some kinds specific
value value of gifts of gifts value

Specific Occasionall Occasionally Occasionall Occasionall Occasionall Occasionall

restriction on y or or infrequent y or y or y or y or
frequency infrequent infrequent infrequent infrequent infrequent

Record- None None None Only All gifts None

keeping certain gifts that add up
(expensive more than
gifts) $100 per
year

Public None None None None All gifts None

disclosure that add up
to >$100
per year

Ban of all Strong Strong No If ban If ban Strong

entertainment limitations limitations clarification implicit explicit limitations
on types of on types of on types of
events events events
allowed allowed allowed
c
 ,
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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.

> c 
$  ? 
 > $
$
 2 
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:
ß 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.
ß 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.
ß 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.


 







?  $


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 DTC
Advertising of Prescription Drugs," Vol. 1, 2000/2001, Emmaus PA: Rodale, 2001.
6. Borzo, G., "Consumer Drug Ads Booming: FDA Reviews Restrictions," American Medical
News, 40(6):1, 37, February 10, 1997.