






































Bangladesh Journal of Bioethics 2015; 6(2):15-22 

15 

 

Undue influences on drugs and device industries distort healthcare research, and 
practice 

 

Mohammad Arifur Rahman 
1
, Laila Farzana

 2
 

 
1. National Institute of Cardiovascular Diseases, Sher e Bangla Nagar, Dhaka 1207, Bangladesh.                       
Email: drarif79@yahoo.com 
 
2. Holy Family Red Crescent Medical College and Hospital, Dhaka, Bangladesh. 
 
 

ABSTRACT: Background: Expenditure on industry products (mostly drugs and devices) has spiraled over the last 

15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the 

development and marketing of drugs and devices may have given excessive power to these industries to influence 

medical research, policy, and practice. Material and methods: Review of the literature and analysis of the multiple 

pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present 

the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) 

understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, 

(vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer‘s decisions. Results: We 

located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps 

of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of 

these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are 

downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. Conclusion: 

To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, 

understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and Healthcare 

professional education and also exerts direct influences on professional decisions and health consumers. There is an 

urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and 

patient-, population- and society-benefit direction that is free from conflict of interests. 

 

Keywords: undue influence, conflict of interests, evidence-based medicine, healthcare industry, medication, 

pharmaceutical industry. 

INTRODUCTION: A universal characteristic of most healthcare systems in developed countries is the heavy focus on 

pharmacological approaches for treating and preventing chronic disease and the considerable expenditure on high-

tech medical equipment, devices and technologies. This focus is often linked to astonishing financial interests, such 

as the $130 billion a single drug (Lipitor) generated over 14 years
1
 an amount that is higher than the 2010 gross 

domestic product of 129 of the 184 countries in the world 
2 

. Besides traditional drugs, biologics and devices can also 

produce huge revenue. For example, the manufacturers of anti-TNF biological drugs and therapies have created a 

$10 billion annual market 
3,4

 even though these agents are used for indications with rather modest, incremental 

benefits. The market for drug-eluting stents for coronary artery disease is $4_6 billion per year in the United States 

alone 
5
, even though a large share of the indications for which these stents are used (e.g. stable coronary disease) 

has no supporting evidence 
6–9

. This excessive financial capacity and the associated political and lobbying power 

allow the industry to dictate the rules of the healthcare game to serve its interests at several levels. The industry‘s 

interests are often at stark contrast to those of the patients and the society. In this article, we try to analyse the 

multiple complex pathways through which the industry has directly or indirectly infiltrated healthcare systems 

including strategic direction, expenditure, research, medical education and daily clinical practice. 

 

HOW THE INDUSTRY INFLUENCES HEALTHCARE RESEARCH, STRATEGY, EXPENDITURE AND PRACTICE: 

The industry has created means to intervene in all steps of the processes that influence healthcare research, 

strategy, expenditure and practice. These include evidence base production, evidence synthesis, understanding of 

harms issues, cost-effectiveness evaluation, clinical guidelines formation, healthcare professional education and 

direct influences on healthcare professional decisions. 

 

mailto:drarif79@yahoo.com


Bangladesh Journal of Bioethics 2015; 6(2):15-22 

16 

 

Evidence base production: Industry funds and often designs and controls a large portion of the most influential 

medical studies. Trials funded by for profit organizations are on average 4 times more likely than trials sponsored by 

non-for-profit organizations to favour the sponsored drug 
10,11

. Empirical evidence suggests that while methodological 

quality is the same in industry-sponsored and other trials 
10

, industry-sponsored trials are more likely to compare the 

sponsored intervention against an inactive or straw man comparator 
3,10

. An evaluation of over 600 trials registered in 

clinicaltrials.gov shows that with few exceptions, single trials address only products of a single company 
12

. However, 

for most conditions, there exist many possible interventions, including lifestyle changes and products manufactured 

by diverse companies. Finally, for many years now, the public sector has largely abandoned the conduct of 

randomized trials to the industry and thus, not surprisingly, the most cited trials are almost always industry sponsored, 

often exclusively so 
12

. These trials then also guide the conduct of other clinical research. Medical research is 

doomed to navigate only questions posed by the industry and their extensions. There is increasing direct evidence 

about the manipulation of reported results in industry-sponsored trials, which demonstrate favourable results and the 

avoidance of inconvenient findings, as in the case of gabapentin for off-label use 
13

. In addition to these direct biases, 

the industry has a major impact on which research is published in the most influential medical journals through ghost 

authorship 
14,15

, (i.e. raising the status of trial results by listing academically affiliated investigators as first or second 

authors in manuscripts) written by company staff or professional medical writers paid by the companies. It is possible 

that major journals have often undisclosed conflict of interests from publishing industry trials. Journals also have 

conflicts themselves, because such industry trials generate considerable revenue from offprints and can boost the 

journal‘s impact factor by as much as 15% 
6
. 

 

Evidence synthesis: Systematic reviews that summarize trials addressing the wrong questions (as above) will 

simply reinforce the wrong messages 
17

, unless meta-analysts are astute to diagnose the problems in the generation 

of the evidence, let alone publication and other selection biases. Access to raw data of clinical trials to date has been 

limited, and integration in systematic reviews of the data that are readily available may perpetuate and solidify the 

biases of the primary literature 
18

. Moreover, as systematic reviews and meta-analyses have grown in prestige and 

influence, the industry has also infiltrated this type of research. A systematic review comparing the methodological 

quality of meta-analyses of the same drugs by source of funding (industry-funded verses nonindustry funded) 
19 

concluded that the former type of study is of lower methodological quality and considerably more likely to omit 

reporting bias-relevant details (e.g. descriptions of the excluded patients/studies). Although the estimated treatment 

effects were similar on average, 100% of industry-funded meta-analyses had conclusions recommending the 

experimental drug without reservations compared with 0% of the (independent) Cochrane reviews 
19

. In meta-

analyses of antihypertensive drugs, financial ties to a pharmaceutical company were not associated with favourable 

results, but were linked to four times higher odds to report favourable conclusions 
20

. Furthermore, conflict of interests 

in the original studies included in meta-analyses are usually silenced and unreported 
21

. For example, a recent study 

revealed that only 2 of 29 pharmacological metaanalyses reported the funding sources of the trials and none of them 

reported author–industry ties in the primary trials 
21

. Finally, content experts who co-author systematic reviews and 

meta-analyses may often distort the phrasing of the research questions, the results and the interpretation of these 

reviews in favour of industry products 
22.

 

 

Understanding of harms issues: Licensing for new products or indications requires demonstration of effectiveness 

and absence of major harms. However, the whole process allows plenty of room for serious harms to be 

unrecognized by the time licensing is granted. Many interventions are withdrawn or acquire black boxes years after 

they are licensed and after they have already cost a fortune to the healthcare system 
23

. Recent drug withdrawals 

suggest that financial ties with the pharmaceutical industry can determine the orientation of the authors of trials and 

meta-analyses in drug safety issues. Rosiglitazone, a multibillion selling drug for type 2 diabetes, was approved and 

prescribed to millions of patients worldwide for 10 years despite limited evidence on its benefits and,especially, safety 
24

. Rosiglitazone potentially increases the risk of cardiovascular disease and comorbidities such as weight gain and 

increases blood lipids. It has recently been withdrawn from both the EU and New Zealand markets, and its indications 

have been severely restricted in the United States 
25.

Among the many similar revelations, perhaps the best known 

case is rofecoxib (Vioxx), a blockbuster non steroidal anti-inflammatory drug that nearly doubled the chances of both 

myocardial infarction and stroke 
26

. Data revealed during a litigation case suggested the manufacturer intentionally 

distorted the presentation of trial safety data 
27

 and trained its sale representatives to tactfully avoid physician 

questions on safety 
28.

 



Bangladesh Journal of Bioethics 2015; 6(2):15-22 

17 

 

 

Cost-effectiveness evaluation: Cost-effectiveness of therapies is a major criterion when allocating scarce public 

resources and is directly influenced by commercial pricing strategies. Most published analyses report favourable 

incremental cost-effectiveness ratios, and studies funded by industry are more likely to report ratios below required 

thresholds on cost-effectiveness 
29

. Studies funded by industry are more than twice as likely to report cost-

effectiveness ratios below $20 000 per quality-adjusted life year compared with studies funded by other sources [30]. 

There are many different methods by which industry-sponsored cost effectiveness analyses can achieve more 

favorable results, including but not limited to biased assumptions about the intervention, its comparators (e.g. 

underestimating the sensitivity/ specificity of the standard Pap test for analyses of HPV vaccines or HPV DNA tests 

for cervical cancer prevention) 
31

 or other parameters that need to be modeled (e.g. extent of indirect effects for 

vaccines) 
32

. 

 

Clinical practice guidelines: Clinical practice guidelines are supposed to be based on best evidence. They are 

endorsed by recognized authorities, and to a large extent, they define daily medical practice. Integrity, objectivity and 

independence are of paramount importance for a correct translation of the evidence into clinical guidelines. These 

three crucial attributes are difficult to safeguard. Most (56%) scientists involved in the 17 most authoritative US 

cardiovascular clinical practice guidelines released between 2004 and 2008 received research grants, honoraria for 

speeches in drug-promoting events, stocks (shares) or consultancy fees by pharmaceutical and related industries 
33

 

Over 80% of the committee chairs had such conflict of interests. Over 50% of guideline panel members in the United 

States and Canada have conflict of interests while the respective figure for guidelines sponsored by nongovernment 

sources approaches 70% 
34

. Overall, between 56 and 87% of clinical practice guidelines, authors have been found to 

have at least a conflict of interest (consultancies, research support, equity/stock ownership) 
35

. There is substantial 

margin for the members of these committees to input their subjective views through ‗expert opinion‘ (evidence level 

C), which represented nearly half of all major US cardiovascular clinical care guidelines published between 1984 and 

2008 
36

. Even higher levels of interaction were noted between the authors of 44 clinical guidelines and the 

pharmaceutical industry in a previous publication 
37

. Given that the boundary between industry and academia has 

become so vague, it is hardly surprising that clinical practice guidelines often are heavily focused on new costly 

interventions and only loosely follow the available evidence. For example, current guidelines still advocate tight 

pharmacological glycaemic control for patients with type 2 diabetes, despite the best available evidence suggesting 

that there is no major benefit for patients 
38

 and possibly even deterioration of quality of life 
39

. Declarations of the 

conflict of interests of expert panels and researchers are thought to guarantee transparency and integrity in the 

evidence base and clinical recommendation generation process. Nevertheless, there appears to be a gap between 

the intended purpose and practice as financial conflict of interests are severely under-reported in drug trial meta-

analyses and panel guidelines 
34

 and practitioners very rarely discount for such conflicts when evaluating the 

evidence base 
40

. Besides clinical guidelines formation, narrative review and editorials by key opinion leaders also 

have a major impact on clinical practice decisions and the medical community in general 
41,42

. An example of the 

influence of the conflict of interests of key opinion leaders is that although evidence does not support that brand-

name drugs are superior to generic drugs 4
3
, editorials often counsel against the interchangeability of generic drugs 

43
. 

 

Healthcare professional education: Intense exposure to pharmaceutical marketing commences during 

undergraduate medical education for future prescribers. A study showed that third-year medical students are exposed 

to one industry-sponsored gift or activity per week and almost (93%) all have been asked or required to attend at 

least one industry-sponsored lunch 
44

. The large majority (67 –92%) of medical students acknowledge that education 

from industry sources is biased and that pharmaceutical industry pressures increase over the course of medical 

school 
45

. This exposure brainwashes medical students‘ attitudes towards the marketed products 
46

. In the USA, 60% 

of medical school chairs have some form of personal relationship with industry (e.g. consultant, a member of a 

scientific advisory board, a paid speaker, an officer, founder or member of the board of directors) 
47

.
 
Continuing 

medical education (CME) is an essential part of the development for practicing health professionals. In the United 

States, industry support for CME increased from $301 million per year in 1998 to $1_2 billion per year in 2007 

accounting for approximately 60% of the total accredited CME costs (including advertising/exhibit payments) 
48

. 

Although there are signs of a reversing trend (due to regulatory restrictions and the economic trends), industry funded 

CME still accounted for approximately half of all CME by 2010 
48

. Industry sponsors have substantial influence over 



Bangladesh Journal of Bioethics 2015; 6(2):15-22 

18 

 

the content of education programmes, which often involve heftily paid prominent medical figures presenting 

information about the company‘s latest products, often using slides provided by the company 
49

. Sponsored CME 

leads to increases in prescription rates by the attendant physicians of the promoted medication 
50

. In the UK, most 

hospital educational ‗grand rounds‘ and many other medical education meetings are sponsored by the industry, with 

lunches provided in return for sales and marketing opportunities. In primary care, many staff events are sponsored by 

the pharmaceutical industry in return for a lunch and ‗educational‘ opportunities on pharmaceutical products. 

Postgraduate education departments foster strong relationships with sales representatives, and educational meetings 

and conferences are nearly always industry financed 
51

. 

 

Direct influences on healthcare professional decisions: Direct marketing pressures by sales representatives are 

substantial, for example, a US cardiologist meets with sales representatives nine times a month on average 
52

. In 

2004, over a third of the $57 billion that pharmaceutical companies spent on promotional activities went on visiting 

doctors to promote new drugs and establish relationships with health professionals in community or academic 

settings 
53

. Regular interactions with sales representatives increases the chances to add the drug company to a 

hospital‘s formulary by over 300%, and the combination of the physician receiving honoraria leads to even greater 

increases 
54

.The culture of industry-offered ‗gifts‘ or equipment, educational textbooks, sponsorship or luxury travel 
55 

and free meals has been common across the entire spectrum of health practitioners. In many countries, most 

industries have a trade association representing their profit-orientated members, for example, the UK Association of 

the British Pharmaceutical Industry (ABPI) with 150 members, which has set up the Prescription Medicines Code of 

Practice authority to administer the pharma-ceutical industries‘ own code of practice. However, there has been a 

recent exodus of ABPI members, with even fewer companies choosing to follow even this largely voluntary code [56]. 

Surveyed patients consider the financial ties between practitioners and drug companies unacceptable and a 

compromise to their quality of care 
57

; however, patients are rarely aware of their doctor‘s ties with the industry, which 

may have biased their care plan. 

 

Direct-to-consumer advertising: In the United States, where such marketing practices are permitted by law, direct-

to-consumer advertising (DTCA) is a major force of rising pharmaceutical costs 
58

. Industry spending on DTCA for 

pharmaceuticals alone increased from $11 billion to $30 billion within the 1996–2005 decade 
59

, about the same 

period of time when the total costs of prescription drugs were rising at a rate higher than 30% a year 
60

. Besides 

inflated costs for patients and healthcare providers [58], DTCA is linked to concerns over the aptitude of the lay public 

to understand risks and benefits through a 30-s TV or a one page magazine advertisement. DTCA typically 

commences one year after release of a new drug 
59

, which is a very short time frame for many unwanted side effects 

to become apparent. The US Senate has previously considered legislation prohibiting such advertising for at least two 

years 
61.

 

 

CONCLUSIONS: Given that many of the problems discussed above are closely linked to financial interests, we would 

argue that there is an urgent need to better deal with conflict of interests in medicine and healthcare. The Institute of 

Medicine has published a comprehensive set of recommendations on how to deal with conflict of interests in 

medicine so that the undue industry influences we describe above are eliminated 
62.

 These recommendations cover 

general policy measures, medical research, undergraduate and continuous medical education, medical practice, as 

well as clinical guideline formation. The evidence we presented highlights the case for tighter regulation on how the 

healthcare industry designs, conducts, disseminates and publicizes their research, markets their products and 

interacts with medical students, health professionals and researchers. Currently, industry expenditure influences and 

determines medical practice and attitudes at various levels at the expense of patients‘ health, healthcare budgets and 

medicine‘s integrity. There are positive signs of action taken in both United States and Europe, for example, the 

Sunshine Act in the United States that requires drug companies to declare all payments and hospitality or gifts they 

give to doctors. In Denmark, companies have been required to declare their payments to doctors since 2008, in 

Scotland, doctors have to declare such transactions themselves, and France is currently preparing such legislation. 

The New England Journal of Medicine banned cost-effectiveness evaluations sponsored by product manufacturers 

almost two decades ago. These are some indicative steps towards redefining the mission of medicine towards a more 

objective and patient-, population- and society-benefit direction that is free from conflict of interests. 

 

CONFLICT OF INTERESTS: None of the authors have any conflict of interest to declare. 



Bangladesh Journal of Bioethics 2015; 6(2):15-22 

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