Health Professionals “Make Their Choice”: Pharmaceutical Industry Leaders’ Understandings of Conflict of Interest

Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders’ understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We contrast this with participants’ unanimous belief that the antidote to conflicts of interest with health professionals were “informed consumers.” It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry’s routine and accepted practices for disclosing and managing employees’ conflicts of interest could, paradoxically, serve as an excellent model for healthcare.     

An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group

The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled, a feat that continues to become both faster and cheaper to perform. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group (I‐PWG) offered some ‘Points‐to‐Consider’ on this topic within the context of the drug development process from those who are affiliated to pharmaceutical companies. Today many of these points remain applicable to the discussion but will be expanded upon in this updated viewpoint from the I‐PWG. The exploratory nature of pharmacogenomic work in the pharmaceutical industry is discussed to provide context for why these results typically are not best suited for return. Operational challenges unique to this industry which cause barriers to returning this information are also explained.     

Individual adaptation of industry LCA practice: Results from two case studies in the Swedish forest products industry

Goal, Scope and Background The mere existence of life cycle assessment (LCA) methodology and general acceptance of the life cycle philosophy is not enough to make their use widespread in industry. To gain a better understanding of factors shaping LCA studies and life cycle related practice, field studies of the development of LCA practice in two companies were carried out. Methods In order to obtain a deeper understanding of LCA practice, the number of ‘variables’ was minimized and two similar companies were chosen for study: Stora Enso and SCA. Both companies are part of the Swedish forest products industry, are large multinational enterprises and have been working with LCA since the early 1990s. Both interviews and document studies were used to collect data regarding LCA work from its introduction until 2003. Results and Discussion We found fundamental differences in LCA practice between two similar companies in regard to LCA studies per se (the number of studies undertaken and methodological preferences) and also in regard to the organisation of and approach to LCA work. By testing various theoretical explanations of these divergent LCA practices, we identified the actions of individuals and their understanding of the situation as important factors shaping LCA practice. Conclusions Although sector-wide recommendations on LCA practice are common in the LCA community, this study indicates that companies use LCA differently despite similar structural conditions such as company size or sector affiliation. Recommendations and Perspectives Since the understanding and actions of individuals are important in shaping LCA practice, people working with LCA in industry probably have greater scope for action than they recognise and than sector recommendations may imply when it comes to organising and carrying out their work. Thus, those working with life cycle issues, even in different sectors, can learn much from each other about ways of organising and benefiting from LCA work.     

基因工程药物研制过程中相关问题探讨

以DNA重组技术为核心的现代生物技术是国际上优先发展的高技术领域之一。以基因工程技术为核心的生物药物已形成一个高新技术产业。利益驱使很多科研单位和企业投入大量资金到基因工程药物的开发中来。在基因工程制药选题立项时应首先考虑产品市场风险、研制过程中的技术风险和国家政策法规的修改所带来的风险;其次,在药学研究、临床前药理药效研究、临床研究、资料申报的具体过程中,要根据产品的具体特性确定好实验方案、工作计划和合作单位,并按药品注册管理办法的要求作好每一阶段的具体工作。就基因工程药物研究过程中的实际问题阐述了一些经验,希望对业内同仁有所帮助。     

Return migration and economic turmoil: experiences of repatriated Chinese professionals in Shanghai, China

From 2007, the economic turmoil in the USA has had a dramatic impact on immigrant populations living within the nation’s borders. One such group is Chinese migrants who came to the USA as students in the 1980s and 1990s. This paper focuses on a segment of this population—medical professionals—who obtained graduate degrees in the USA and subsequently stayed on to work in pharmaceutical or health industries in Philadelphia’s metropolitan area. As a result of the economic crises in the USA and also the burgeoning market in China, pharmaceutical companies have begun to repatriate some of these Chinese professionals. This paper will examine reflections on the return experience to Shanghai, which has developed rapidly to become the most commercialized modern city in China as a result of the market reform initiated in 1979. I argue that neoliberal ideology in the USA not only forces these Chinese immigrants back to China, but also challenges their concepts of identity and citizenship, including cultural citizenship. This paper also examines the ways in which processes of change are affected by global capitalism and neoliberalism.     

2015年度中国医药市场发展蓝皮书——产业经济部分 （ Ⅰ ）

从产业经济角度,包括医药工业总产值、医药工业销售收入、医药工业盈利水平、医药流通行业销售规模、医药商业效益水平、     

2014 年热门生物技术公司的研发动态

FierceBiotech 网站报道了2014 年最热门的16 家生物技术公司,其涉足生物制药、体外诊断以及医疗器械研发等热门医疗领域,其中多家公司与包括葛兰素史克、罗氏、拜耳、默克等公司在内的制药巨头展开合作,值得医疗行业的投资者关注。对这16 家热门生物技术公司的研发重点、主打产品的适应证/ 用途、合作伙伴、并购交易信息进行归纳总结,旨在为新一代生物技术药物的深入研发提供参考。     

Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator? Affair

Background

The present study aimed to describe exposure and attitudes of French medical residents towards pharmaceutical industry. The study was performed shortly after the Mediator affair which revealed several serious conflicts of interest inside the French health system.

Methods and Findings

A cross-sectional study was implemented among residents from 6 French medical faculties. Independent education in pharmacology, attitudes towards the practices of pharmaceutical sales representatives, opinions concerning the pharmaceutical industry, quality of information provided by the pharmaceutical industry, and opinions about pharmaceutical company sponsorship were investigated through a web-based questionnaire. We also assessed potential changes in resident attitudes following the Mediator affair. The mean value of exposure to drug companies was 1.9 times per month. Global opinions towards drug company information were negative for 42.7% of the residents and positive for only 8.2%. Surprisingly, 81.6% of residents claimed that they had not changed their practices regarding drug information since the Mediator affair. Multivariate analyses found that residents in anesthesiology were less likely to be exposed than others (OR = 0.17 CI95% [0.05–0.61]), exposure was significantly higher at the beginning of residence (p<0.001) and residents who had a more positive opinion were more frequently exposed to drug companies (OR = 2.12 CI95% [1.07–4.22]).

Conclusions

Resident exposure to drug companies is around 1 contact every 2 weeks. Global opinion towards drug information provided by pharmaceutical companies was negative for around 1 out of 2 residents. In contrast, residents tend to consider the influences of the Mediator affair on their practice as relatively low. This survey enabled us to identify profiles of residents who are obviously less exposed to pharmaceutical industry. Current regulatory provisions are not sufficient, indicating that further efforts are necessary to develop a culture of disclosure of conflict of interest and of transparency in residents.     

The Pricing of Breakthrough Drugs: Theory and Policy Implications

Pharmaceutical sales exceed $850 billion a year, of which 84% are accounted for by brand drugs. Drug prices are the focus of an ongoing heated debate. While some argue that pharmaceutical companies exploit monopolistic power granted by patent protection to set prices that are “too high”, others claim that these prices are necessary to motivate the high R&D investments required in the pharmaceutical industry. This paper employs a recently documented utility function of health and wealth to derive the theoretically optimal pricing of monopolistic breakthrough drugs. This model provides a framework for a quantitative discussion of drug price regulation. We show that mild price regulation can substantially increase consumer surplus and the number of patients who purchase the drug, while having only a marginal effect on the revenues of the pharmaceutical company.     

Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review

Background

The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians'' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.

Methods and Findings

We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students'' exposure to the drug industry, as well as students'' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students'' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%–100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%–69%) were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%–71%) were more likely than preclinical students (29%–62%) to report that promotional information helps educate about new drugs.

Conclusions

Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism about negative implications of these interactions. These results support future research into the association between exposure and attitudes, as well as any modifiable factors that contribute to attitudinal changes during medical education. Please see later in the article for the Editors'' Summary     

Professional societies and industry support: what is the quid pro quo?

Professional medical societies have become increasingly dependent on pharmaceutical, device, and biotechnology companies for ongoing support of their programs, but the internal influence of this financial largesse on medical societies' practices is well hidden. Many examples exist in which societies' educational products, including clinical practice guidelines and professional publications, have been tainted by involvement by industry-paid individuals. These examples show that professional judgments of organizations can be affected in ways that are not in the best interests of our patients. Society leaders should develop policies that leave critical decisions, especially those that affect patient care, in the hands of members without financial ties to industry. Society leaders should not accept funds designated for specific industry-recommended projects unless such programs are already part of their planned agenda. These leaders, who typically serve for only a year or two, should delve into arrangements that salaried society executives make with industry, and insure that no promises are made that compromise an organization's professional goals. Professional societies should also find ways of reducing the vast, embarrassing industry involvement at their national meetings, especially the vulgar circus-like displays and the drug company-sponsored symposia. We must reduce commercialism and restore professionalism to our medical meetings.     

Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.

The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada.     

Regulación de la expresión sexual de los mayores ingresados en residencias: la visión de los profesionales

Introduction

The purpose of this study is to determine the opinion of professionals working in residential aged care facilities on the regulation of sexuality in these settings.

Materials and methods

Fifty-three professionals from five residential aged care facilities located in the metropolitan area of Barcelona answered several questions regarding the advisability of establishing measures for the regulation of sexuality in RACFs, the elements that could contribute to this, and the aspects that such regulations should consider.

Results

Around 50% of the participants recognized the advisability of having some type of measures for sexuality regulation in residential aged care facilities. According to their responses this should be developed taking into account professional opinions, but also the points of view of the residents and their relatives. The most frequently mentioned regulations were those that ensured that any kind of sexually charged situation occurred in a private environment. The development of strategies are suggested to distinguish those people with dementia that are competent to consent to sexual acts from those who are not.

Conclusions

The opinion of professionals working in RACFs regarding the advisability of establishing measures for sexuality regulation seems to be considerably divided. Thus, whilst around 50% of them recognize their potential usefulness, the other half consider them unnecessary or even counterproductive for the sexual freedom of residents. Associating regulation with prohibition and sexuality with sexual activity was not uncommon among the responses of the participants.     

Physicians and the pharmaceutical industry: a dysfunctional relationship

The pharmaceutical industry is one of the largest and most profitable industries in the world, and in the United States, the industry has a particularly privileged economic position. Yet the cost of drugs in the United States is higher than anywhere else, due largely to the fact that the industry is focusing increasingly on marketing rather than on the development of meaningful new medications: available evidence does not support claims of great expense for the development of new drugs. Because of its vast resources, the pharmaceutical industry has assumed an increasing influence in medicine, which, given the differences in values and priorities between medicine and the drug companies, is a cause for concern. The pharmaceutical industry has acted to maximize its profits in ways that frequently conflict with medicine's need for truth and full disclosure. Indeed, the industry has arguably worked to compromise physicians' judgments, as well as academic standards. As a result, despite government regulation there have been unnecessary adverse effects from drugs. The experience with butorphanol (Stadol) exemplifies problems in the current system and the harm that can result. Changes are suggested to make the pharmaceutical industry more responsive to the needs of patients and physicians.     

Theme B: Biomedical signal and image processing

This paper presents an overview of the main actions and projects of the theme B ‘Biomedical Signal and Image Processing’ of the GdR Stic-Santé. Several scientific meetings have been organized during the 2011–2012 period. They are always devoted to advanced signal and image processing that could bring innovative solutions to relevant medical applications. The theme has strong relationships with other GdRs and also organizes meetings in close coordination with these GdRs. It also supports two working groups with well-identified research projects. Prospects includes reinforcing communication and cooperation with the other GdRs, involving labs from other countries, and attracting private companies that could also share their needs in terms of developments for which the theme participants could offer solutions. The whole motivation is to enhance the fit between academic research, needs from the medical community and impact for medical research and applications.     

22nd International Conference on Medical Physics 2016, Bangkok,Thailand; Medical physics propelling global health

As medical technology evolves and patient needs increase, the need for well-trained and highly professional medical physicists (MPs) becomes even more urgent. The roles and responsibilities of MPs in various departments within the hospital are diverse and demanding. It is obvious that training, continuing education and professional development of MPs have become essential.One of the ways for an MP to advance his or her knowledge is to participate in conferences and congresses. Last year, the 22nd International Conference of Medical Physics (ICMP 2016) took place in Bangkok, Thailand. The event attracted 584 delegates with most of the participants coming from Asia. It attracted also delegates from 42 countries. The largest delegations were from Thailand, Japan and South Korea. ICMP 2016 included 367 oral presentations and e-posters, most of these being in the fields of Radiation Therapy, Medical Imaging and Radiation Safety. All abstracts were published as an e-book of Abstracts in a supplement to the official IOMP Journal. Many companies had exhibition stands at ICMP2016, thus allowing the participants to see the latest developments in the medical physics-related industry. The conference included 42 mini-symposia, part of the first “IOMP School” activity, covering various topics of importance for the profession and this special issue follows from the success of the conference.     

Prerequisites for the pharmaceutical industry to develop and commercialise helminths and helminth-derived product therapy

During the past 10 years, immunologists, epidemiologists and parasitologists have made many new exciting discoveries in the field of helminth-mediated immune regulation. In addition, many animal experiments have shown that certain helminths or products derived from helminths can protect mice from developing allergic or autoimmune disease. Some clinical trials utilising Trichuris suis or Necator americanus for the treatment of allergic disorders and inflammatory bowel disease have been conducted. The outcomes of these trials suggest that they may be used to treat these disorders. However, to date no helminth therapy is routinely being applied to patients and no helminth-derived product therapy has been developed. In order to bring new drugs to the market and shoulder the enormous costs involved in developing such therapies, pharmaceutical companies need to be involved. However, currently the resources from the pharmaceutical industry devoted to this concept are relatively small and there are good reasons why the industry may have been reluctant to invest in developing these types of therapies. In this review article, the hurdles that must be overcome before the pharmaceutical industry might invest in these novel therapies are outlined.     

Should direct-to-consumer personalized genomic medicine remain unregulated?: a rebuttal of the defenses

Direct-to-consumer personalized genomic medicine has recently grown into a small industry that sells mail-order DNA sample kits and then provides disease risk assessments, typically based upon results from genome-trait association studies. The companies selling these services have been largely exempted from FDA regulation in the United States. Testing kit companies and their supporters have defended the industry's unregulated status using two arguments. First, defenders have argued that mere absence of harm is all that must be proved for mail-order tests to be acceptable. Second, defenders of mail-order testing have argued that there is an individual right to the tests' information. This article rebuts these arguments. The article demonstrates that the direct-to-consumer market has resulted in the sidelining of clinical utility (medical value to patients), leading to the development of certain mail-order tests that do not promote customers' interests and to defenders' downplaying of a potentially damaging empirical study of mail-order genomic testing's effects on consumers. The article also shows that the notion of an individual right to these tests rests on a flawed reading of the key service provided by mail-order companies, which is the provision of medical interpretations, not simply genetic information. Absent these two justifications, there is no reason to exempt direct-to-consumer personalized genomic medicine from stringent federal oversight.     

Content analysis of oncology-related pharmaceutical advertising in a peer-reviewed medical journal

Background

The oncology market represents one of the largest pharmaceutical markets in any medical field, and printed advertising in medical journals is an important channel by which pharmaceutical companies communicate with healthcare professionals. The aim of the present study was to analyze the volume and content of and trends and changes in oncology-related advertising intended for healthcare professionals in a peer-reviewed medical journal. Information that could be included in advertisements to promote drug development and improve treatment strategies for cancer patients is discussed on the basis of the results of the analysis.

Methods/Principal Findings

Overall, 6,720 advertisements covering 13,039 pages in a leading oncology medical journal published (by the American Society of Clinical Oncology) between January 2005 and December 2009 were analyzed. The advertisements targeting pharmaceuticals and clinical trials, in particular, were reviewed. A total of 6,720 advertisements covering 13,039 pages were included in the analysis. For the years 2005–2009, the percentages of total journal pages dedicated to advertising were 24.0%, 45.7%, 49.8%, 46.8%, and 49.8%, respectively. Package insert information and efficacy and safety explanations appeared in more than 80% of advertisements intended for pharmaceutical promotion. From 2005 to 2009, the overall quantity of drug advertisements decreased by approximately 13%, whereas advertisements calling for the enrollment of patients into registration trials increased by approximately 11%.

Conclusion/Significance

Throughout the study period, oncology-related pharmaceutical advertisements occupied a considerable number of pages relative to other journal content. The proportion of advertisements on ongoing clinical trials increased progressively throughout the study period.     

医药 CRO 专题报告——蓝海市场，强者恒强

随着全球制药企业研发投资成本加大、研发周期变长、研发成功率降低,作为社会分工专业化的产物,CRO 企业凭借其低成本、高效率、 多服务的特点,快速发展,且服务范畴已涵盖药物研发的整个过程,成为医药研发产业链中不可缺少的环节。报告采用文献调研、数据库检索、 数据统计与分析等定性定量研究方法,从发展概况、发展策略、竞争格局、企业布局等角度对国内外医药 CRO 领域进行多角度、多层次的 分析,旨在为相关企业确定产品研发思路、制定市场策略提供线索和参考。