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1.  The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors 
Background
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.
Methods
Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.
Results
The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.
Conclusion
The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
doi:10.1186/1472-6963-6-63
PMCID: PMC1524757  PMID: 16734916
2.  Science Across Borders: 5th Annual Natural Health Product Research Conference—March 26–29, 2008, Toronto, Canada 
Canada is experiencing a growing interest in the use of alternative therapies and products particularly natural health products (NHP). In 1997, Canadians spent around C$ 2 billion on NHP. In an attempt to catch with this popularity of NHP use, Canadian researchers and administrators from academia, industry and government jointly established the Natural Health Product Research Society of Canada (NHPRS). Since its formation, NHPRS has been organizing an annual meeting which brings together world renowned researchers and experts in the area of NHP research. For 2008, the annual NHPRS meeting took place in Toronto from the 26th to 29th of March with a focus on ‘Science Across Borders: Global Natural Health Products Research’. The scientific program was spread into three days of plenary lectures and oral presentations. The different sessions containing these talks were on: ethnobotany around the world; chemical analysis of NHP; product standards and quality control; ethnomedicine; novel analytical approaches; systemic research, nutrisciences and molecular medicine; and drug development from NHP. The meeting proved to be a great success in terms of the speakers that were invited and based on the data that was presented which highlighted recent research taking place in the field of NHP not only in Canada but from many parts of the world.
doi:10.1093/ecam/nen059
PMCID: PMC2887334  PMID: 18955362
meeting; natural health products; alternative therapies; ethnobotany; chemical analysis; quality control; drug development
3.  Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops 
Background
With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers.
Methods
A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes.
Results
The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one.
Conclusion
This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.
doi:10.1186/1478-4505-10-29
PMCID: PMC3507868  PMID: 22943625
4.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e357-e363.
Abstract
Objective
To determine the experiences of family physicians in Newfoundland and Labrador with parents’ use of natural health products (NHPs) for their children and to assess physicians’ attitudes toward use of NHPs in children.
Design
A survey using the Dillman approach.
Setting
Newfoundland and Labrador.
Participants
All family physicians in the province.
Main outcome measures
Physician demographic characteristics; whether physicians inquire about the use of NHPs in children; the degree to which they think patients disclose use of NHPs in children; whether they counsel parents about the potential benefits or harms of NHPs; their own opinions about the usefulness of NHPs; whether they recommend NHPs in children and for what reasons; and the particular NHPs they have seen used in children and for what reasons.
Results
A total of 159 (33.1%) family physicians responded; 65.4% were men, 71.7% were Canadian medical graduates, and 46.5% practised in rural areas. Overall, 18.8% of family physicians said they regularly or frequently asked about NHP use; 24.7% counseled patients about potential harms. Only 1.9% of physicians believed NHPs were usually beneficial, but a similarly small number (8.4%) thought they were usually harmful. Most respondents were somewhat neutral; 59.7% said they never recommend NHPs for children, and a further 37.0% said they would only “sometimes” recommend NHPs.
Conclusion
Most physicians believed that NHPs were probably of little benefit but not likely to be harmful. Most NHPs used were vitamins and minerals. Physicians recognized that NHPs were often used by parents for children, but in general they believed NHPs had little effect on their day-to-day medical practices. Thirty-eight (24.7%) of the 154 physicians had at least once recommended an NHP (including vitamins) for their pediatric patients. Physicians believed that parents did not often disclose use of NHPs for their children, but at the same time physicians generally did not actively inquire.
PMCID: PMC3743712  PMID: 23946042
5.  Core Competencies in Natural Health Products for Canadian Pharmacy Students 
Objective
To reach consensus on core competency statements for natural health products (NHPs) for Canadian pharmacy students.
Methods
Four rounds of a modified Delphi method were used to achieve consensus on core competency statements for NHPs. Pharmacy educators from Canada and the United States, and representatives from Canadian pharmacy organizations ranked their agreement using a 5-point Likert scale.
Results
Consensus was achieved on 3 NHP-related core competency statements: (1) to incorporate NHP knowledge when providing pharmaceutical care; (2) to access and critically appraise NHP-related information sources; and (3) to provide appropriate education to patients and other health care providers on the effectiveness, potential adverse effects, and drug interactions of NHPs.
Conclusions
Consensus was reached among leaders in NHP education on 3 NHP-related core competency statements. Implementation of these competencies would ensure that graduating Canadian pharmacists would be able to fulfill their professional responsibilities related to NHPs.
PMCID: PMC2865411  PMID: 20498738
natural health products (NHPs); competencies; Delphi method; complementary and alternative medicine; herbal medicine
6.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e364-e371.
Abstract
Objective
To determine how common it is for parents to give natural health products (NHPs) to their children, which NHPs are being used, why they are being used, and parents’ assessments of the benefits and side effects of NHPs.
Design
Survey.
Setting
Newfoundland and Labrador.
Participants
Parents waiting in their family doctors’ offices.
Main outcome measures
Parent and child demographic characteristics; pediatric chronic medical conditions affecting the children; prescribed medications, over-the-counter medications, and NHPs used by the children; why the medications and NHPs were being used, the dose, and parents’ assessments of the effectiveness and side effects; and where parents had heard about the NHPs, whether they had told their physicians that the children were taking the products, and where they had obtained the products.
Results
A total of 202 (53.4%) of the 378 eligible adults who were approached completed the survey. This represented 333 children. Mean (SD) age of the children was 5.1 (3.3) years. Overall, 28.7% of parents reported using nonvitamin NHPs for their children. A total of 137 children (41.1%) had taken NHPs (including vitamins); 61.1% of the NHPs being used were vitamins. The remainder fell under teas (primarily chamomile and green teas), echinacea, fish or omega-3 oils, and a large category of “other” products. These NHPs were most commonly used to improve general health, improve immunity, and prevent colds and infections. Approximately half of the parents (51.7%) believed their children had benefited from taking NHPs, and 4.4% believed their children had experienced adverse side effects. Slightly less than half of the parents (45.0%) had informed their physicians that their children were taking NHPs.
Conclusion
Overall, 45.5% of parents attending physicians’ offices reported using NHPs in their children. If vitamins are not included in the definition of NHPs, this rate drops to 28.7%. Parents most commonly use NHPs to maintain the general health of their children, to prevent colds, and to boost children’s immune systems. About half of the parents believed the NHPs helped, very few had noticed any side effects, and approximately half had informed their physicians that they were giving their children NHPs.
PMCID: PMC3743713  PMID: 23946043
7.  Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality 
BMJ Open  2014;4(3):e003431.
Objectives
To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.
Design
Cross-sectional study of screened patients.
Setting
10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.
Participants
The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.
Primary outcome measures
Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Results
Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.
Conclusions
A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.
doi:10.1136/bmjopen-2013-003431
PMCID: PMC3975764  PMID: 24682573
Complementary Medicine; Toxicology
8.  Roles and Responsibilities of Pharmacists with Respect to Natural Health Products: Key Informant Interviews 
Background
Although many pharmacies sell natural health products (NHPs), there is no clear definition as to the roles and responsibilities (if any) of pharmacists with respect to these products.
Objective
The purpose of this study was to explore pharmacy and stakeholder leaders’ perceptions of pharmacists’ professional NHP roles and responsibilities.
Methods
Semi-structured key informant interviews were conducted with pharmacy leaders (n= 17) and stakeholder (n=18) leaders representing consumers, complementary and alternative medicine practitioners, conventional healthcare practitioners, and industry across Canada.
Results
Overwhelmingly all participants believed a main NHP responsibility for pharmacists was safety monitoring. One challenge identified in the interviews was pharmacists’ general lack of NHP knowledge. Stakeholder leaders did not expect pharmacists to be experts on NHPs, rather that pharmacists should have a basic level of knowledge about NHPs. Many pharmacy leaders appeared to be unfamiliar with current pharmacy policies and guidelines concerning NHPs.
Conclusion
Participants described pharmacists’ professional roles and responsibilities for NHPs as similar to those for over-the-counter drugs. More awareness of existing NHP-related pharmacy policies is needed. Pharmacy owners/managers should provide additional training to ensure front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy.
doi:10.1016/j.sapharm.2009.02.004
PMCID: PMC2923149  PMID: 20188329 CAMSID: cams1316
natural health products; pharmacists; professional roles and responsibilities
9.  The Prevalence of Natural Health Product Use in Patients with Acute Cardiovascular Disease 
PLoS ONE  2011;6(5):e19623.
Background
Natural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown.
Objective
To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.
Methods
Structured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada's definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview.
Results
88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80% male; 41% admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78% of patients) and 75% of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chinese medicines (9%), homeopathic preparations (1%) and other products including amino acids, essential fatty acids and probiotics (35%). In a multivariable model, only older age was associated with increased NHP use (OR 1.5 per age decile [95%CI 1.03 to 2.2]). When compared to the interview, the highest rate of NHP documentation was the pharmacist history (41%). NHP were documented in 22% of patients by the physician and 19% by the nurse.
Conclusions
NHP use is common in patients admitted with acute cardiovascular disease. However, health professionals do not commonly identify NHP as part of the medication profile despite its potential importance. Structured interview appears to be the best method to accurately identify patient use of NHP.
doi:10.1371/journal.pone.0019623
PMCID: PMC3090400  PMID: 21573067
10.  Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey 
Background
There has been a global rise in the use of natural health products (NHPs). Proper regulation of NHPs is pivotal to ensure good quality control standards, enhance consumers' safety and facilitate their integration into modern healthcare systems. There is scarcity of published data on the prevalence of NHPs usage among the general Kuwaiti population. Hence, this study was designed to determine awareness, patterns of use, general attitude and information requirements about NHPs among the public in Kuwait.
Methods
A descriptive cross-sectional survey was performed using a pretested self-administered questionnaire on a sample of 1300 Kuwaiti individuals, selected from six governorates in Kuwait using a multistage stratified clustered sampling. Descriptive and multivariate logistic regression analysis were used in data analysis.
Results
The response rate was 90.2%. NHPs were thought to be herbal remedies by most of participants (63.5%), followed by vitamins/minerals (40.5%), traditional medicines (21.1%), probiotics (14.9%), amino acids and essential fatty acids (7.2%), and homeopathic medicines (5.6%). NHPs usage was reported by 71.4% (95% CI: 68.8-74.0%) of respondents, and mostly associated with females (OR: 1.90; 95% CI: 1.44-2.51). Herbal remedies were the most commonly used (41.3%; 95% CI: 38.5-44.2%). The most common reasons for using NHPs were to promote and maintain health and to prevent illness and build immune system. Family members and/or friends and mass media were the main sources for providing information about NHPs. About 18% of consumers have experienced a side effect due to using a NHP. Attitudes toward NHPs were generally positive; with more than 75% of participants believing that the Ministry of Health in Kuwait should regulate the claims made by the manufacturers of NHPs and it is important to talk to a medical doctor or a pharmacist prior to using NHPs. Most of the respondents showed increased interest to acquire knowledge about different types of information related to NHPs.
Conclusions
The prevalence of use of NHPs among Kuwaiti population is high. The present findings have major public health policy implications for Kuwait. Therefore, there is an apparent need to establish effective health education programs and implement better and more regulated NHPs use policies in Kuwait.
doi:10.1186/1472-6882-14-105
PMCID: PMC3999934  PMID: 24646341
Natural health products; Herbal remedies; Patterns of use; Kuwait
11.  Public Welfare Agenda or Corporate Research Agenda? 
Mens Sana Monographs  2005;3(1):41-80.
As things stand today, whether we like it or not, industry funding is on the upswing. The whole enterprise of medicine in booming, and it makes sense for industry to invest more and more of one's millions into it. The pharmaceutical industry has become the single largest direct funding agency of medical research in countries like Canada, the United Kingdom and the United States.
Since the goals of industry and academia differ, it seems that conflicts of interest are inevitable at times. The crucial decision is whether the public welfare agenda of academia, or the corporate research agenda of industry, should occupy center stage when they conflict.
There is enough evidence to show that funding by industry is very systematic, and results that are supportive of the safety and efficacy of sponsor's products alone get the funds. It is no surprise, therefore, that one finds very few negative drug trials reports published, and whatever are, are likely to be by rival companies to serve their commercial interests.
Renewed and continued funding by industry decides the future prospects of many academic researchers. At the same time there is now evidence that pharmaceutical companies attempt suppression of research findings, may be selective in publishing results, and may delay or stymie publication of unfavourable results. This is a major area of concern for all conscientious researchers and industry watchers.
Industry commonly decides which clinical research/trial gets done, not academia, much though the latter may wish to believe otherwise. It finds willing researchers to carry this out. This can be one area of concern. Another area of pressing concern is when industry decides to both design and control publication of research.
It makes sense for researchers to refuse to allow commercial interests to rule research reporting. Research having been reported, the commercial implications of such reporting is industry's concern. But, doctoring of findings to suit commerce is to be resisted at all costs. In this even pliant researchers need have no fear, for if they indeed publish what will work, the concerned sponsor will benefit in the long run. The only decision academia has to make is refuse to comply with predestined conclusions of sponsors for the ‘thirty pieces of silver’. Instead do genuine research and make sixty for themselves.
The useful rule of thumb is: Keep the critical antenna on, especially with regard to drug trials, and more especially their methodology, and study closely the conflict of interest disclosed, and if possible undisclosed, before you jump on the band wagon to herald the next great wonder drug.
There are three important lessons to be learnt by academia in all academia-industry relationships:
i)Lesson number one: incorporate the right to publish contrary findings in the research contract itself. Which means, it makes great sense for academia to concentrate on the language and contractual provisions of sponsored research, to read the fine print very closely, and protect their research interests in case of conflict.ii)Lesson number two: a number of lawsuits successfully brought up against industry recently reflect earnest attempts by patient welfare bodies and others to remedy the tilt. It will result in a newfound confidence in academia that augurs well for academia industry relationship in the long run. Hence the second lesson for academia: do not get browbeaten by threats of legal actioniii)Lesson number three: Academia should keep itself involved right from inception of the clinical trial through to ultimate publication. And this must be an integral part of the written contract.
The time to repeat cliches about the exciting future of the academia-industry connect is past. A concerted effort to lay a strong foundation of the relationship on practical ethical grounds has become mandatory.
doi:10.4103/0973-1229.27878
PMCID: PMC3369180  PMID: 22679348
Public Welfare or Corporate Research Agenda; The Olivieri Case; Doctoring of Research Findings; Selective publishing; Delay and Under reporting; Complete Disclosure; Multi-centred Trials; Ghost writing; Duplicate Publication; Access to Data; Control over Publication; Negative Drug Trials; The Porcupine Dance; Law Suits Against Industry; Design and Control of Publication; Connection between Funding and Positive Findings
12.  Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products: a study of focus groups 
Background
Natural health products (NHPs) such as herbs, vitamins and homeopathic medicines, are currently available for sale in most Canadian pharmacies. However, most pharmacists report that they have limited knowledge about these products which have been regulated in Canada as a specific sub-category of drugs. In this paper, consumers' and practicing pharmacists' perceptions of pharmacists' professional responsibilities with respect to NHPs are examined.
Methods
A total of 16 focus groups were conducted with consumers (n = 50) and pharmacists (n = 47) from four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax).
Results
In this paper, we illustrate the ways in which pharmacists' professional responsibilities are impacted by changing consumer needs. Many consumers in the study utilized a wide range of information resources that may or may not have included pharmacists. Nevertheless, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and felt that pharmacists should be able to manage drug-NHPs interactions as well as identify and evaluate the variety of information available to help consumers make informed decisions.
Conclusion
This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.
doi:10.1186/1472-6882-8-40
PMCID: PMC2483265  PMID: 18625059
13.  Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them? 
Background
In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product.
Discussion
Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations.
Summary
Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated.
doi:10.1186/1472-6963-11-64
PMCID: PMC3073891  PMID: 21435247
14.  Legal and ethical considerations in processing patient‐identifiable data without patient consent: lessons learnt from developing a disease register 
Journal of Medical Ethics  2007;33(5):302-307.
The legal requirements and justifications for collecting patient‐identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population‐based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient‐identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient‐identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient‐identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.
doi:10.1136/jme.2006.016907
PMCID: PMC2598125  PMID: 17470509
15.  Canada and access to medicines in developing countries: intellectual property rights first 
Canadian reports have recommended that health as a human right must be Canada’s overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada’s commitment to this goal. Specifically it examines cases where improved access has been in conflict with increased intellectual property rights. The 6 cases are: Canada’s position when 39 pharmaceutical companies took South Africa to court in 1998 over its legislation to allow parallel importation of patented medicines and to regulate the price of medications; the stance that Canada took in the negotiations around the Doha Declaration in 2001; the passage of Canada’s Access to Medicines Regime in 2004 and subsequent attempts to amend the legislation in 2011 and 2012; Canada’s involvement in the final declaration at the United Nations High-Level meeting on non-communicable diseases in 2012; Canada’s views about the terms in the Anti-Counterfeiting Trade Agreement as expressed in 2009; and Canada’s 2013 position on the extension of the exemption for least developed countries from having to comply with the terms of the Trade Related Aspects of Intellectual Property Rights Agreement. In the first case Canada was neutral but in the remaining 5 cases Canada prioritized intellectual property rights over access. This position is consistent with how Canada has acted around domestic issues involving intellectual property rights for pharmaceutical products. Canada has supported strengthened rights despite the fact that their touted benefits have not been realized either domestically or in developing countries. As a result Canada has failed in its humanitarian duty to protect the human right to health in the form of safe and low cost medicines for the people in developing countries.
doi:10.1186/1744-8603-9-42
PMCID: PMC3844468  PMID: 24007595
Access; Anti-Counterfeiting Trade Agreement; Canada; Canada’s Access to Medicines Regime; Doha Declaration; Intellectual property rights; Least developed countries; Non-communicable diseases; TRIPS
16.  Transnational Tobacco Company Interests in Smokeless Tobacco in Europe: Analysis of Internal Industry Documents and Contemporary Industry Materials 
PLoS Medicine  2013;10(9):e1001506.
In light lobbying by transnational tobacco companies to remove the European Union ban on the sale of snus (a smokeless tobacco product), Silvy Peeters and Anna Gilmore explore the motivation behind tobacco companies' interests in smokeless tobacco products in Europe.
Please see later in the article for the Editors' Summary
Background
European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction.
Methods and Results
Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy.
Conclusions
There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from cancer, heart disease, and other tobacco-related diseases. In recent years, to reduce this growing loss of life, international and national bodies have drawn up various tobacco control conventions and directives. For example, the European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies aimed at reducing tobacco consumption. The 2001 EU Tobacco Products Directive also bans the sale of snus, a form of smokeless tobacco (SLT), in all EU countries except Sweden. Snus, which originated in Sweden in the early 19th century, is a moist tobacco product that is placed under the upper lip. Although snus is considerably less harmful than smoking, the sale of snus was banned in the EU in 1992 because of fears that it might cause cancer and was being marketed to young people. When Sweden joined the EU in 1994, exemption from the ban was made a condition of the membership treaty.
Why Was This Study Done?
Transnational tobacco companies (TTCs) have been investing in European snus manufacturers since 2002 and more recently in pure nicotine products, and it has been suggested that, faced with declining cigarette markets in Europe and elsewhere, TTCs are preparing for a “post-cigarette era”. Since 2008, TTCs have been lobbying EU member states and the European Commission to remove the ban on snus sales, arguing that public health would be improved if governments allowed potentially reduced-harm products like snus onto the market. At the end of 2012, however, the European Commission proposed that the ban on snus sales should be continued. Here, to help inform this controversial policy debate, the researchers explore the interest of TTCs in SLT and pure nicotine in Europe from the 1970s to the present by examining internal tobacco documents and compare these interests with public claims of support for harm reduction made by TTCs.
What Did the Researchers Do and Find?
By searching the Legacy Tobacco Documents Library (internal tobacco industry documents released following US litigation cases), the researchers identified 416 documents that detail the historical interest of TTCs in SLT and pure nicotine and their efforts to enter European markets, and to influence national and EU public-health policy. The researchers analyzed these documents using a “hermeneutic” approach—methodical reading and re-reading of the documents to identify themes and sub-themes. Finally, they used TTC investor presentations and other documents to confirm these themes and to provide recent data on TTC investment in SLT. British American Tobacco (BAT) explored the opportunities for marketing SLT products in Europe from 1971 onwards. This exploration was driven by regulatory threats and health concerns, both of which were likely to impact tobacco sales, and by the potential to create a new form of tobacco use among people no longer interested in taking up smoking. TTCs did not begin to invest in SLT, however, until 2002, a time when EU cigarette sale volumes started to decline, smoke-free legislation was being introduced, and tobacco harm reduction first became a major public-health issue. All the TTCs have now invested in snus even though snus test markets appear to have failed and even though there is little evidence in corporate materials that snus is central to the business strategy of TTCs.
What Do These Findings Mean?
These findings suggest that BAT's early interest in SLT in Europe was driven by business concerns and was based on the potential for creating an alternative form of tobacco use among people—particularly young people—who would no longer take up smoking because of health concerns. They also suggest that TTC investments in snus were defensive—by buying up snus manufacturers and more recently nicotine producers, TTCs have eliminated competition between cigarettes and lower-risk products, thereby helping to maintain the current market balance in favor of cigarettes while ensuring the long-term future of TTCs should cigarette sales decline further. Although these findings are limited by the possibility that some relevant documents may have been omitted from this analysis, they nevertheless raise the concern that, if TTC investment in SLT continues, competition between cigarettes and SLT will reduce the potential for harm reduction to benefit public health. Legalization of snus sales in the European Union may therefore have considerably less benefit than envisaged.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001506.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control, an international treaty for tobacco control; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
Details of European Union legislation on the manufacture, presentation, and sale of tobacco products is available (in several languages)
Wikipedia has pages on tobacco harm reduction and on snus (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and their tactics to influence tobacco regulation
doi:10.1371/journal.pmed.1001506
PMCID: PMC3769209  PMID: 24058299
17.  Why should i comply? Sellers' accounts for (non-)compliance with legal age limits for alcohol sales 
Background
Availability is an important predictor of early and excessive alcohol consumption by adolescents. Many countries have implemented age limits to prevent underage purchases of alcohol. However, shop-floor compliance with these age limits appears to be problematic. This study addresses the issue of non-compliance with age limits. Which measures do vendors take to avoid underage alcohol sales, and what do they report as important reasons to comply or not with age limits for alcohol sales?
Methods
Open-ended telephone interviews were conducted with store managers selling alcohol (N = 106). Prior to the interviews, all outlets were visited by an underage mystery shopper in order to measure compliance with the legal age limits on alcohol sales. The interview results are compared against actual compliance rates.
Results
Several measures have been taken to prevent underage sales, but the compliance level is low. Furthermore, open coding resulted in 19 themes, representing both valid and invalid arguments, that vendors mentioned as relevant to their decisions of whether to comply with the law. Compliance with age limits is dependent on the knowledge of the rules and the ability and motivation to follow the rules. The ability aspect in particular seems to be problematic, but in many cases, the motivation to actively comply with the age limits is lacking.
Conclusions
To enhance compliance, it is important to raise the awareness of the importance of age limits and to connect possible violations of the regulations to negative consequences.
doi:10.1186/1747-597X-7-5
PMCID: PMC3299589  PMID: 22269016
compliance; age limits; alcohol sales; availability; adolescents; vendors
18.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
19.  New Canadian natural health product regulations: a qualitative study of how CAM practitioners perceive they will be impacted 
Background
New Canadian policy to regulate natural health products (NHPs), such as herbs and vitamins were implemented on January 1st, 2004. We explored complementary and alternative medicine (CAM) practitioners' perceptions of how the new regulations may affect their practices and relationships with patients/consumers.
Methods
This was an applied ethnographic study. Data were collected in fall 2004 via qualitative interviews with 37 Canadian leaders of four CAM groups that use natural products as a core part of their practises: naturopathic medicine, traditional Chinese medicine (TCM), homeopathic medicine and Western herbalism. All interviews were transcribed verbatim and coded independently by a minimum of two investigators using content analysis.
Results
Three key findings emerged from the data: 1) all CAM leaders were concerned with issues of their own access to NHPs; 2) all the CAM leaders, except for the homeopathic leaders, specifically indicated a desire to have a restricted schedule of NHPs; and 3) only naturopathic leaders were concerned the NHP regulations could potentially endanger patients if they self-medicate incorrectly.
Conclusion
Naturopaths, TCM practitioners, homeopaths, and Western herbalists were all concerned about how the new NHP regulations will affect their access to the products they need to practice effectively. Additional research will need to focus on what impacts actually occur as the regulations are implemented more fully.
doi:10.1186/1472-6882-6-18
PMCID: PMC1481533  PMID: 16686960
20.  The Ethics of Dietary Supplements and Natural Health Products in Pharmacy Practice: A Systematic Documentary Analysis 
Aims and Objectives
Many natural health products (NHPs) and dietary supplements (DS) are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence-based information about them. This study was designed to identify how the pharmacist’s role with respect to NHPs/DS is portrayed in the literature.
Method
A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and NHPs/DS. Of the 786 articles identified, 665 were broad-coded and 259 were subjected to in-depth qualitative content analysis for emergent themes.
Key Findings
Overwhelmingly, support for the sale of NHPs/DS in pharmacies is strong. Additionally, a role for pharmacists in NHP/DS counselling is underscored. But another recurrent theme is that pharmacists are ill-equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling NHPs/DS and to highlight the existence of an ethical conflict stemming from the profit-motive associated with NHP/DS sales.
Conclusion
This analysis raises concerns about the ethics of NHPs/DS being sold in pharmacies, and about pharmacists being expected to counsel about products of which they have little knowledge.
PMCID: PMC2918535  PMID: 20218027 CAMSID: cams1317
21.  Guidelines, Editors, Pharma And The Biological Paradigm Shift 
Mens Sana Monographs  2007;5(1):27-30.
Private investment in biomedical research has increased over the last few decades. At most places it has been welcomed as the next best thing to technology itself. Much of the intellectual talent from academic institutions is getting absorbed in lucrative positions in industry. Applied research finds willing collaborators in venture capital funded industry, so a symbiotic growth is ensured for both.
There are significant costs involved too. As academia interacts with industry, major areas of conflict of interest especially applicable to biomedical research have arisen. They are related to disputes over patents and royalty, hostile encounters between academia and industry, as also between public and private enterprise, legal tangles, research misconduct of various types, antagonistic press and patient-advocate lobbies and a general atmosphere in which commercial interest get precedence over patient welfare.
Pharma image stinks because of a number of errors of omission and commission. A recent example is suppression of negative findings about Bayer's Trasylol (Aprotinin) and the marketing maneuvers of Eli Lilly's Xigris (rhAPC). Whenever there is a conflict between patient vulnerability and profit motives, pharma often tends to tilt towards the latter. Moreover there are documents that bring to light how companies frequently cross the line between patient welfare and profit seeking behaviour.
A voluntary moratorium over pharma spending to pamper drug prescribers is necessary. A code of conduct adopted recently by OPPI in India to limit pharma company expenses over junkets and trinkets is a welcome step.
Clinical practice guidelines (CPG) are considered important as they guide the diagnostic/therapeutic regimen of a large number of medical professionals and hospitals and provide recommendations on drugs, their dosages and criteria for selection. Along with clinical trials, they are another area of growing influence by the pharmaceutical industry. For example, in a relatively recent survey of 2002, it was found that about 60% of 192 authors of clinical practice guidelines reported they had financial connections with the companies whose drugs were under consideration. There is a strong case for making CPGs based not just on effectivity but cost effectivity. The various ramifications of this need to be spelt out. Work of bodies like the Appraisal of Guidelines Research and Evaluation (AGREE) Collaboration and Guidelines Advisory Committee (GAC) are also worth a close look.
Even the actions of Foundations that work for disease amelioration have come under scrutiny. The process of setting up ‘Best Practices’ Guidelines for interactions between the pharmaceutical industry and clinicians has already begun and can have important consequences for patient care. Similarly, Good Publication Practice (GPP) for pharmaceutical companies have also been set up aimed at improving the behaviour of drug companies while reporting drug trials
The rapidly increasing trend toward influence and control by industry has become a concern for many. It is of such importance that the Association of American Medical Colleges has issued two relatively new documents - one, in 2001, on how to deal with individual conflicts of interest; and the other, in 2002, on how to deal with institutional conflicts of interest in the conduct of clinical research. Academic Medical Centers (AMCs), as also medical education and research institutions at other places, have to adopt means that minimize their conflicts of interest.
Both medical associations and research journal editors are getting concerned with individual and institutional conflicts of interest in the conduct of clinical research and documents are now available which address these issues. The 2001 ICMJE revision calls for full disclosure of the sponsor's role in research, as well as assurance that the investigators are independent of the sponsor, are fully accountable for the design and conduct of the trial, have independent access to all trial data and control all editorial and publication decisions. However the findings of a 2002 study suggest that academic institutions routinely participate in clinical research that does not adhere to ICMJE standards of accountability, access to data and control of publication.
There is an inevitable slant to produce not necessarily useful but marketable products which ensure the profitability of industry and research grants outflow to academia. Industry supports new, not traditional, therapies, irrespective of what is effective. Whatever traditional therapy is supported is most probably because the company concerned has a product with a big stake there, which has remained a ‘gold standard’ or which that player thinks has still some ‘juice’ left.
Industry sponsorship is mainly for potential medications, not for trying to determine whether there may be non-pharmacological interventions that may be equally good, if not better. In the paradigm shift towards biological psychiatry, the role of industry sponsorship is not overt but probably more pervasive than many have realised, or the right thinking may consider good, for the health of the branch in the long run.
An issue of major concern is protection of the interests of research subjects. Patients agree to become research subjects not only for personal medical benefit but, as an extension, to benefit the rest of the patient population and also advance medical research.
We all accept that industry profits have to be made, and investment in research and development by the pharma industry is massive. However, we must also accept there is a fundamental difference between marketing strategies for other entities and those for drugs.
The ultimate barometer is patient welfare and no drug that compromises it can stand the test of time. So, how does it make even commercial sense in the long term to market substandard products? The greatest mistake long-term players in industry may make is try to adopt the shady techniques of the upstart new entrant. Secrecy of marketing/sales tactics, of the process of manufacture, of other strategies and plans of business expansion, of strategies to tackle competition are fine business tactics. But it is critical that secrecy as a tactic not extend to reporting of research findings, especially those contrary to one's product.
Pharma has no option but to make a quality product, do comprehensive adverse reaction profiles, and market it only if it passes both tests.
Why does pharma adopt questionable tactics? The reasons are essentially two:
What with all the constraints, a drug comes to the pharmacy after huge investments. There are crippling overheads and infrastructure costs to be recovered. And there are massive profit margins to be maintained. If these were to be dependent only on genuine drug discoveries, that would be taking too great a risk.Industry players have to strike the right balance between profit making and credibility. In profit making, the marketing champions play their role. In credibility ratings, researchers and paid spokes-persons play their role. All is hunky dory till marketing is based on credibility. When there is nothing available to make for credibility, something is projected as one and marketing carried out, in the calculated hope that profits can accrue, since profit making must continue endlessly. That is what makes pharma adopt even questionable means to make profits.
Essentially, there are four types of drugs. First, drugs that work and have minimal side-effects; second, drugs which work but have serious side-effects; third, drugs that do not work and have minimal side-effects; and fourth, drugs which work minimally but have serious side-effects. It is the second and fourth types that create major hassles for industry. Often, industry may try to project the fourth type as the second to escape censure.
The major cat and mouse game being played by conscientious researchers is in exposing the third and fourth for what they are and not allowing industry to palm them off as the first and second type respectively. The other major game is in preventing the second type from being projected as the first. The third type are essentially harmless, so they attract censure all right and some merriment at the antics to market them. But they escape anything more than a light rap on the knuckles, except when they are projected as the first type.
What is necessary for industry captains and long-term players is to realise:
Their major propelling force can only be producing the first type. 2. They accept the second type only till they can lay their hands on the first. 3. The third type can be occasionally played around with to shore up profits, but never by projecting them as the first type. 4. The fourth type are the laggards, real threat to credibility and therefore do not deserve any market hype or promotion.
In finding out why most pharma indulges in questionable tactics, we are lead to some interesting solutions to prevent such tactics with the least amount of hassles for all concerned, even as both profits and credibility are kept intact.
doi:10.4103/0973-1229.32176
PMCID: PMC3192391  PMID: 22058616
Academia; Pharmaceutical Industry; Clinical Practice Guidelines; Best Practice Guidelines; Academic Medical Centers; Medical Associations; Research Journals; Clinical Research; Public Welfare; Pharma Image; Corporate Welfare; Biological Psychiatry; Law Suits Against Industry
22.  Consumers of natural health products: natural-born pharmacovigilantes? 
Background
Natural health products (NHPs), such as herbal medicines and vitamins, are widely available over-the-counter and are often purchased by consumers without advice from a healthcare provider. This study examined how consumers respond when they believe they have experienced NHP-related adverse drug reactions (ADRs) in order to determine how to improve current safety monitoring strategies.
Methods
Qualitative semi-structured interviews were conducted with twelve consumers who had experienced a self-identified NHP-related ADR. Key emergent themes were identified and coded using content analysis techniques.
Results
Consumers were generally not comfortable enough with their conventional health care providers to discuss their NHP-related ADRs. Consumers reported being more comfortable discussing NHP-related ADRs with personnel from health food stores, friends or family with whom they had developed trusted relationships. No one reported their suspected ADR to Health Canada and most did not know this was possible.
Conclusion
Consumers generally did not report their suspected NHP-related ADRs to healthcare providers or to Health Canada. Passive reporting systems for collecting information on NHP-related ADRs cannot be effective if consumers who experience NHP-related ADRs do not report their experiences. Healthcare providers, health food store personnel, manufacturers and other stakeholders also need to take responsibility for reporting ADRs in order to improve current pharmacovigilance of NHPs.
doi:10.1186/1472-6882-10-8
PMCID: PMC2847952  PMID: 20184759
23.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Background
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
Conclusions
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001076.
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
doi:10.1371/journal.pmed.1001076
PMCID: PMC3160341  PMID: 21886485
24.  Beyond "medical tourism": Canadian companies marketing medical travel 
Background
Despite having access to medically necessary care available through publicly funded provincial health care systems, some Canadians travel for treatment provided at international medical facilities as well as for-profit clinics found in several Canadian provinces. Canadians travel abroad for orthopaedic surgery, bariatric surgery, ophthalmologic surgery, stem cell injections, “Liberation therapy” for multiple sclerosis, and additional interventions. Both responding to public interest in medical travel and playing an important part in promoting the notion of a global marketplace for health services, many Canadian companies market medical travel.
Methods
Research began with the goal of locating all medical tourism companies based in Canada. Various strategies were used to find such businesses. During the search process it became apparent that many Canadian business promoting medical travel are not medical tourism companies. To the contrary, numerous types of businesses promote medical travel. Once businesses promoting medical travel were identified, content analysis was used to extract information from company websites. Company websites were analyzed to establish: 1) where in Canada these businesses are located; 2) the destination countries and health care facilities that they market; 3) the medical procedures they promote; 4) core marketing messages; and 5) whether businesses market air travel, hotel accommodations, and holiday tours in addition to medical procedures.
Results
Searches conducted from 2006 to 2011 resulted in identification of thirty-five Canadian businesses currently marketing various kinds of medical travel. The research project began with what seemed to be the straightforward goal of establishing how many medical tourism companies are based in Canada. Refinement of categories resulted in the identification of eighteen businesses fitting the category of what most researchers would identify as medical tourism companies. Seven other businesses market regional, cross-border health services available in the United States and intranational travel to clinics in Canada. In contrast to medical tourism companies, they do not market holiday tours in addition to medical care. Two companies occupy a narrow market niche and promote testing for CCSVI and “Liberation therapy” for multiple sclerosis. Three additional companies offer bariatric surgery and cosmetic surgery at facilities in Mexico. Four businesses offer health insurance products intended to cover the cost of obtaining privately financed health care in the U.S. These businesses also help their clients arrange treatment beyond Canada’s borders. Finally, one medical travel company based in Canada markets health services primarily to U.S. citizens.
Conclusions
This article uses content analysis of websites of Canadian companies marketing medical travel to provide insight into Canada’s medical travel industry. The article reveals a complex marketplace with different types of companies taking distinct approaches to marketing medical travel.
doi:10.1186/1744-8603-8-16
PMCID: PMC3503750  PMID: 22703873
Medical tourism; Canada; Transnational healthcare; Globalization; Websites
25.  Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach 
Background
Over 30% of individuals use natural health products (NHPs) for osteoarthritis-related pain. The Deficit Model for the Public Understanding of Science suggests that if individuals are given more information (especially about scientific evidence) they will make better health-related decisions. In contrast, the Contextual Model argues that scientific evidence is one of many factors that explain how consumers make health-related decisions. The primary objective was to investigate how the level of scientific evidence supporting the efficacy of NHPs impacts consumer decision-making in the self-selection of NHPs by individuals with osteoarthritis.
Methods
The means-end chain approach to product evaluation was used to compare laddering interviews with two groups of community-dwelling Canadian seniors who had used NHPs to treat their osteoarthritis. Group 1 (n=13) had used only NHPs (glucosamine and/or chondroitin) with “high” scientific evidence of efficacy. Group 2 (n=12) had used NHPs (methylsulfonylmethane (MSM) and/or bromelain) with little or no scientific evidence supporting efficacy. Content analysis and generation of hierarchical value maps facilitated the identification of similarities and differences between the two groups.
Results
The dominant decision-making chains for participants in the two scientific evidence categories were similar. Scientific evidence was an important decision-making factor but not as important as the advice from health care providers, friends and family. Most participants learned about scientific evidence via indirect sources from health care providers and the media.
Conclusions
The Contextual Model of the public understanding of science helps to explain why our participants believed scientific evidence is not the most important factor in their decision to use NHPs to help manage their osteoarthritis.
doi:10.1186/1472-6882-12-198
PMCID: PMC3517436  PMID: 23107559
Natural health products; Decision-making; Means ends chain analysis; Osteoarthritis

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