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PubMed2005

Cooperative partnerships or conflict-of-interest? A national survey of interaction between the pharmaceutical industry and medical organizations.

BACKGROUND: There is extensive and varied interaction between the pharmaceutical industry and the medical profession. Most empirical research concerns contact between individual physicians and industry, and reflects North American experience. We sought to clarify the extent and nature of relationships between the pharmaceutical industry and Australian medical organizations. METHODS: We administered questionnaires to 63 medical organizations concerned with clinical practice, continuing medical education or professional accreditation, or the political representation of medical professionals. RESULTS: Survey instruments were received from 29 organizations, giving a response rate of 46%. Seventeen of these organizations (59%) had received support from one or more pharmaceutical company in the past financial year. Support was predominantly for annual conferences, with some support for continuing medical education, research, travel and library purchases. The majority of organizations had an academic journal or newsletter, and 10 (34%) accepted revenue from pharmaceutical advertising. Twenty organizations (72%) had policies or guidelines covering their relationship with industry. Few organizations indicated that they would be unable to continue their activities without pharmaceutical industry support. CONCLUSION: These data indicate a high level of inter-action between the pharmaceutical industry and medical organizations in Australia. While most organizations have policies for guiding their relationship with industry, it is unclear whether these are effective in preventing conflicts of interest and maintaining public trust.

Australia↗
PubMed1989

Ontogeny and regulation of drug metabolism in humans. Phase I: Monooxygenases.

Most data concerning the development and regulation of cytochrome P-450-dependent monooxygenases were obtained in experimental animals, especially rats, by two successive approaches: first, the assay of total liver cytochrome P-450 and of related monooxygenase activities; then, more recently, the immunoquantification of molecular forms of cytochrome P-450, and the estimation of corresponding mRNAs with nucleic acid probes. Results were compared, before and after birth, in untreated animals, and in animals treated by inducers, mainly phenobarbital and polycyclic aromatic hydrocarbons. For evident ethical reasons, fewer data could be obtained in human liver during development. However, the availability of specific antibodies and nucleic acid probes recently allowed some progress in the comparison of the isoenzyme pattern of cytochromes P-450 in fetal and adult human liver.

Aging↗
PubMed1999

Context, confidentiality, and consent in tailored health communications: a cautionary note.

This article highlights key contextual factors that emerge when the evolution of tailored health communications is viewed against the backdrop of dynamic changes in the nation's health care system--including the shift from fee-for-service medicine to managed care and the proliferation of direct-to-consumer and tailored marketing strategies in the pharmaceutical industry. It focuses on contextual variables with potential to significantly mediate the impact of personally tailored health advice--including those related to confidentiality, privacy, and informed consent and to the perceived aims, intents, and sources of tailored health messages. To protect the future of tailored health messages, more research attention must be given to defining these contextual factors and understanding the roles that they play and the ways in which they can be controlled to assure the best outcomes. Such research could point the way towards a set of empirical and ethical "best practices" based on a scientific understanding of how to maximize the benefits, and minimize the potential harms, of the widescale use of tailored health communications.

Confidentiality↗
PubMed1998

Commercial detailing techniques used by pharmaceutical representatives to influence prescribing.

AIM: To determine the use of influence techniques by pharmaceutical representatives in their encounters with medical practitioners. METHOD: We identified six influence techniques from the marketing literature which are thought to be commonly used by sales people. These have been termed the principles of reciprocity, friendship/liking, commitment/consistency, social validation, authority, and scarcity. We examined the use of these techniques by analysing audio-recordings of pharmaceutical representatives' presentations to medical practitioners. RESULTS: Sixteen recordings, detailing 64 medicines, were obtained from seven medical practitioners. Reciprocation was the most commonly observed method of influence. Samples, gifts, printed material, patient information leaflets or invitations were offered in all encounters. Appeals to authority figures, where promotional claims were supported by reference to professors or specialists, specialist groups and specialist hospitals, were recorded. Social validation acts, where reference was made to the peer group were also common. Commitment acts were observed to occur in two ways; the first was as a direct request to use the product detailed and the second was as a series of questions or statements which gradually moved from pre-agreed areas to solicitation of a commitment to prescribe the drug. CONCLUSION: Influence techniques were found to be commonly used by pharmaceutical representatives when they detailed products to medical practitioners. Medical practitioners may not be aware of the potential effect these techniques can have on their prescribing practices. Knowledge of these techniques must be incorporated into educational programmes designed to provide health professionals with critical appraisal skills.

Advertising↗
PubMedDate not supplied

Independent clinical trials: a commentary.

The so-called norms of good clinical practice have been incorporated into the Italian regulatory legislation governing clinical trials sponsored by pharmaceutical companies, but there are no legislative provisions governing independent clinical trials: ie those not sponsored by the industry. The pharmaceutical industry has recently increased considerably its commitment to sponsored trials by establishing a series of economic relationships with individual researchers and hospital or university institutions. It has also set up and strengthened a series of bodies and service companies with the aim of making the clinical trials "machine" more efficient. Such developments have aroused alarm in the medical literature because of the risk that they may have negative effects on the freedom of research and research results. At the same time, there is also the risk that independent clinical trials will be greatly penalized by having to compete with sponsored trials in terms of patient enrollment, and because they are currently having to face a series of difficulties connected with the lack or scarcity of economic resources provided by the State or non-profit organizations, with problems relating to patient insurance and to the availability of the necessary drugs. However, the objective of independent trials is to improve the medical art by answering specific diagnostic and therapeutic questions, whereas that of industry-sponsored trials is to generate money, directly or indirectly, by means of the registration of new drugs. It is therefore now necessary to ensure better surveillance of the influence of pharmaceutical companies over the trials they sponsor (as a minimum by ensuring the transparency of a series of potential conflicts of interest between them and clinical researchers) and, simultaneously, protect independent trials from coming to an inglorious end by means of specific support initiatives such as those proposed in this article.

Clinical Trials as Topic↗
PubMed2004

Patient and physician attitudes to using medications with religiously forbidden ingredients.

BACKGROUND: Over 1000 medications contain pork- and/or beef-derived gelatin and stearic acid as inert ingredients. Use of these medications in patients with religious beliefs against consumption of these ingredients might constitute an ethical conflict. OBJECTIVE: To assess patients' and physicians' attitudes about using medications with religiously prohibited ingredients derived from pork and/or beef. METHODS: In this pilot study, 100 patients and 100 physicians completed a survey designed to assess their knowledge and opinion on using medications that might contain inert ingredients derived from animals whose consumption offends followers of certain religions. RESULTS: Of the 100 patients surveyed, most (84%) reported that they were not aware that several medications contained ingredients derived from pork and/or beef. About 63% of the patients wanted their physicians, and 35% of the patients wanted their non-physician healthcare providers (pharmacists, nurses), to inform them when using such medications. Thirteen percent of the patients shared religious reasons for not consuming pork and/or beef products. Approximately 70% of physicians were unaware that several medications contain ingredients that might be against their patients' religion, and most (70%) thought that it was important to inform their patients if such drugs were prescribed. CONCLUSIONS: This pilot study suggests that both patients and physicians think that patients should be informed whenever medications that contain pork- and/or beef-derived products are prescribed. The use of medications with these ingredients is an ethical issue. Informing patients about this issue promotes respect for their religious beliefs and may promote therapeutic alliance; therefore, this might have public health implications and needs further research.

Adult↗
PubMed2000

Antibiotic resistance. An impending crisis.

The global emergence of antimicrobial resistance has become a pre-eminent concern in medicine and public health. Antimicrobial resistance is of particular concern because the problem is widespread, the causative factors are uncontrolled, and national strategies to address the problem are lacking. The persisting burden of infectious diseases makes elimination of antibiotic use unethical, but dramatic overuse and misuse of antimicrobial agents around the world must be reduced to extend the useful lifetimes of these drugs. Population genetic models suggest that resistance emerges rapidly under the selective pressure of antibiotics, but decays slowly once that pressure is removed. Hence, measures to prevent the emergence of resistance must be implemented urgently. A multiplicity of factors drive antibiotic resistance, and solutions require the collaboration of governmental agencies, the pharmaceutical companies, healthcare providers, and consumers. Leadership in the form of a national steering committee on antimicrobial resistance is needed in the Kingdom of Saudi Arabia to guide collective action to control the threat of antibiotic resistance.

Anti-Bacterial Agents↗
PubMedDate not supplied

A proposed ethical framework for prescription drug benefit allocation policy.

OBJECTIVES: To present an ethical framework that could aid prescription drug benefit design and to propose that such a framework could be organized around a benefit allocation hierarchy. SUMMARY: Four hierarchical levels of allocation are proposed, as follows: (1) drug categories and subcategories, (2) individual drugs within covered drug categories, (3) specific indications of covered drugs, and (4) special features of drug use, such as quantities covered for specific indications. Rationales for decision making should address the distinct ethical issues apparent at each level. CONCLUSION: Ethical issues associated with designing and managing a pharmacy benefit can be identified by using a hierarchical prescription drug allocation scheme. Articulating these issues is an important first step toward arriving at a fully developed framework that will serve to produce rationales acceptable to typical stakeholders in prescription drug benefits.

Health Policy↗
PubMed2003

Factors associated with failure to publish large randomized trials presented at an oncology meeting.

CONTEXT: Large clinical trials are the criterion standard for making treatment decisions, and nonpublication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions. OBJECTIVES: To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing nonsignificant results, and identify factors associated with time to publication. DESIGN: Survey of 510 abstracts from large (sample size, > or =200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (P< or =.05 for the primary outcome measure) or nonsignificant (P>.05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1, 2001; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication. MAIN OUTCOME MEASURES: Publication rate at 5 years; time from presentation to full publication. RESULTS: Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with nonsignificant results (P<.001). Studies with oral or plenary presentation were published sooner than those not presented (P =.002), and studies with pharmaceutical sponsorship were published sooner than studies with cooperative group sponsorship or studies for which sponsorship was not specified (P =.02). These factors remained significant in a multivariable model. The most frequent reason cited by authors for not publishing was lack of time, funds, or other resources. CONCLUSIONS: A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Nonpublication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards.

Bias↗
PubMed1998

Disease management: the example of amyotrophic lateral sclerosis.

Disease management is defined as any medical or pharmaceutical intervention designed to improve both outcomes for the patient and overall cost-effectiveness of the health plan. Disease management focuses on the patient throughout the entire course of the disease, involving both health providers and third-party payers. It requires structured management of change, inter- and intra-professional communication and access to information, identification of pertinent economic and clinical outcomes, and the establishment of guidelines, computerized systems and quality assurance. The concept of disease management remains controversial, primarily because its effectiveness is untested. Furthermore, if only economic outcomes are considered, ethical problems such as the selection of populations (for example, the exclusion from health care of people deemed 'too old') will emerge. As a model of neurodegenerative disease, amyotrophic lateral sclerosis (ALS) is a suitable condition for disease management. Many possible targets for disease management initiatives in ALS can be defined, including training, communication, education, guidelines for diagnosis, follow-up, clinical trials and treatments. Medico-economic studies need to be improved if accreditation is planned. Much remains to be done to improve the therapy and disease management of ALS. However, the identification of optimal treatment will improve care of ALS patients, particularly in less affluent countries.

Amyotrophic Lateral Sclerosis↗
PubMed2006

There is no such thing as free pizza.

For many years, it has been standard practice in the United States to allow pharmaceutical representatives to provide drug samples, pens, note pads, visual aids, t-shirts, etc., and pay for attendee meals in conjunction with teaching conferences for hospital physicians. The "gifts" typically aren't as luxurious in the clinical laboratory, but even so, is any vendor freebie too much?

Conflict of Interest↗
PubMed2006

Stem cells: a regenerative pharmaceutical.

Stem cells (SC), found in both adult and fetal tissues, are self-renewing elements that can generate the various cell types in the body. There are 3 classes of SC: totipotent, multipotent, and pluripotent. The SC with a significant developmental potential are the embryonic stem (ES) cells, which are derived from the early stages of mammalian embryo. SC possess regenerative properties and this offers unprecedented opportunities for developing medical therapies for debilitating diseases. Hematopoietic SC have been used successfully in bone marrow transplants for over 40 years. Pluripotent SC offer renewable source of replacement of cells and tissues to treat a myriad of diseases. However there are limiting factors. Adult SC are rare and cannot multiply as the ES. Pluripotent SC have great therapeutic potential, but face technical challenges. A serious concern is the ethical issue since they are derived from human embryos or fetal tissue. Quite often SC have been targets of mutations and risk carcinogenesis. Various markers have been identified based on the uniqueness of SC receptors and in vivo tracking studies using nanocolloids and radioactive tracers have been performed. Though 111In-oxine has been used to image SC transplants, PET with a high spatial resolution would be ideal. Currently 2 agents are being studied, 18F-FDG and 64Cu-Pyruvaldehyde bi(N4-methylthiosemicarbazone). The following few pages bring forth the various limitations and summarize progress made in SC utilization so as to create awareness of SC research in ISORBE community and to foster strategy that ISORBE community can disseminate information and exchange knowledge on radio labeled SC.

Humans↗
PubMed2006

Interactions of doctors with the pharmaceutical industry.

OBJECTIVE: To assess the opinions and practice patterns of obstetrician-gynaecologists on acceptance and use of free drug samples and other incentive items from pharmaceutical representatives. METHODS: A questionnaire was mailed in March 2003 to 397 members of the American College of Obstetricians and Gynecologists who participate in the Collaborative Ambulatory Research Network. RESULTS: The response rate was 55%. Most respondents thought it proper to accept drug samples (92%), an informational lunch (77%), an anatomical model (75%) or a well-paid consultantship (53%) from pharmaceutical representatives. A third (33%) of the respondents thought that their own decision to prescribe a drug would probably be influenced by accepting drug samples. Respondents were more likely to think the average doctor's prescribing would be influenced by acceptance of the items than theirs would be (p<0.002). Respondents who distributed drug samples to patients indicated doing so because of patients' financial need (94%) and for their convenience (76%) and less so as a result of knowledge of the efficacy of the sample product (63%). A third (34%) of respondents agreed that interactions with industry should be more strictly regulated. CONCLUSION: Obstetrician-gynaecologists largely indicated that they would act in accordance with what they think is proper regarding accepting incentive items from pharmaceutical representatives. Although accepting free drug samples was considered to be appropriate more often than any other item, samples were most commonly judged to be influential on prescribing practices. The widely accepted practice of receiving and distributing free drug samples needs to be examined more carefully.

Advertising↗
PubMed2001

[The roles of pharmacists on prior review of clinical trials].

A prior review system for clinical trials was introduced into The University of Tokyo Hospital in March 1999, for the purpose of supporting the Institutional Review Board (IRB). In this study, we investigated the effect of this system on IRB, and evaluated roles of pharmacists involved in utilizing this prior review system. An average period from the acceptance of regular application of each protocol to the approval of IRB was 1.7 months, and the period was significantly shorter than that before the introduction of this system (2.3 months). On the other hand, the number of instructions given to applicants increased to be 2.8 times before the introduction of this system, suggesting the improvement of the quality of this prior review system. In the prior review, the number of instructions pointed out from pharmacists concerning pharmacokinetics, pharmacodynamics, drug-interactions, adverse reactions, and the other matters related to investigational drugs was greater than that from doctors or nurses. According to the results of the surveys for doctors, nurses, and other clerical employees, pharmacists were indicated to review from a pharmaceutical point of view and their review was found to be very important. In conclusion, the prior review system was considered to be useful for the rational practice of clinical trials and pharmacists were recognized to be indispensable as reviewers on the prior review.

Clinical Trials as Topic↗
PubMed2000

[Duplicate publication a way of embellishing research results. Unethical misuse which threatens the validity of systematic reviews and meta-analysis].

Studies showing favourable results tend to be published more than once. This practice of duplicate publication is, however, dishonest and unethical on the part of scientists and pharmaceutical companies. Inclusion into a meta-analysis of the results from multiple papers derived from one and the same controlled study gives an inflated picture of the efficacy of the treatment. If manufacturers and researchers not only made all their study data public but also registered trials prospectively these pitfalls could be avoided.

Clinical Trials as Topic↗
PubMed1992

Policy recommendations for pharmaceutical representative-resident interactions.

Based on our review of existing written policies regarding pharmaceutical representative-resident interactions, we believe that residencies should develop more comprehensive policies. We present six topic areas that programs should address in formulating policies: 1) policy tone, 2) traffic control, 3) samples, 4) gifts, 5) screening of educational and promotional materials and events, and 6) honoraria, research funding, and other monetary exchanges.

Data Collection↗
PubMed1992

P & T Committee response to evolving technologies: preparing for the launch of high-tech, high-cost products. Roundtable discussion.

P & T Committees are entering an exciting era in which the introduction of biotechnology-derived pharmaceuticals is providing life-saving opportunities for conditions for which there was little or no hope for a cure. The P & T Committee at Thomas Jefferson University Hospital has anticipated the challenge that these novel therapeutics present, and has already positioned itself for the pending approval of the first therapeutic human monoclonal antibody. Nebacumab (HA-1A, formerly known as Centoxin; by Centocor) will be used for the treatment of gram-negative sepsis. Although this antiendotoxin has a good side effect profile, its use also carries a high price tag. This will raise several difficult ethical issues once the product is introduced. In this exclusive Hospital Formulary roundtable, members of Thomas Jefferson's P & T Committee and Technology Assessment Subcommittee provide their insights for responsibly managing a high-tech, high-cost product such as nebacumab.

Antibodies, Monoclonal↗
PubMed1994

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.

Canada↗