Pharmaceutical Industry Representatives Research Articles

Better therapeutic trials in ovarian cancer.

The Ovarian Task Force of the Gynecologic Cancer Steering Committee convened a clinical trials planning meeting on October 28-29, 2011, with the goals to identify key tumor types, associated molecular pathways, and biomarkers for targeted drug intervention; review strategies to improve early-phase screening, therapeutic evaluation, and comparison of new agents; and optimize design of randomized trials in response to an evolving landscape of scientific, regulatory, and funding priorities. The meeting was attended by international clinical and translational investigators, pharmaceutical industry representatives, government regulators, and patient advocates. Panel discussions focused on disease types, early-phase trials, and randomized trials. A manuscript team summarized the discussions and assisted with formulating key recommendations. A more integrated and efficient approach for screening new agents using smaller selective randomized trials in specific disease-type settings was endorsed, together with collaborative funding models between industry and the evolving national clinical trials network, as well as efforts to enhance public awareness and study enrollment through advocacy.

A Situational Analysis of Pharmacovigilance System in Republic of Benin

Background: To date, no investigation has been carried out to systematically assess pharmacovigilance systems including quality control and resistance monitoring of artemisinin based combination therapies (ACTs) and other essential medicines in Benin. Objective: To assess Benin’s pharmacovigilance system, identify the gaps and define elements of strategy which could lead to successful establishment of a functional system in Benin. Methods: Quantitative approach using structure questionnaires was applied to investigate physicians, pharmacists and pharmaceutical industry representatives’ knowledge, attitude and practice regarding Adverse Drug Reactions (ADRs) reporting and the pharmacovigilance system in Benin. Specific questions examining the ADRs related to ACTs were also asked. Questions regarding reasons for non-reporting and important factors in a decision to report were also addressed. The Indicator-based Pharmacovigilance Assessment Tool (IPAT) developed by the USAID-funded Strengthening Pharmaceutical Systems (SPS) program was also used to assess the current landscape with different stakeholders. Collecting data on the IPAT indicators was performed during different interviews of key informants. Reviewing documents from different stakeholders was done as well. Results: All physicians and pharmacists have suspected at least one occurrence of ADR in their practice. 30.77% physicians and 31.11% pharmacists acknowledged that they faced at least one time ADRs suspected to be associated with antimalarial drug treatment (P-value<0.01). However none of the physicians or the pharmacists have ever reported ADRs to the national pharmacovigilance service. Significant difference (Chi2, P<0.05) was found between the proportion of physicians and pharmacists trained in pharmacovigilance (20% versus 1%). The main reasons for not reporting were ‘‘yellow card not available’’ and “not aware about the existence of pharmacovigilance center”. A small percentage (6.97%) of representatives of the pharmaceutical companies in the country monitors the safety of their products and none of them have ever reported ADRs to the health authority (DPM). In return, none of the laboratories have ever received a report related to quality or ADRs related to their drugs on the market from LNCQ or DMP. Use of the IPAT tool led to these respective overall scores for core and supplementary indicators: 10 and 7 demonstrating that there is no functional pharmacovigilance system in place. Using these findings, a SWOT analysis was done. The major shortcoming is the lack of expertise in pharmacovigilance despite the availability of qualified human resource in the country. Several recommendations were also made with respect to critical immediate next steps to be taken to ensure that pharmacovigilance and medicine safety systems are developed and sustained in Benin. Conclusions: This study has helped identify some of the critical challenges and barriers to promoting pharmacovigilance including control of quality and monitoring of ACTs resistance in Benin. There is a need to identify and implement adequate human resources use in order to build capacity and sustain the drug safety system for essential medicines and ACTs in particular. The Ministry of Health should involve all relevant stakeholders including the Faculty of Medicine and researchers to discuss these strategies and develop interventions for the successful implementation of pharmacovigilance in Benin.

Ethical, legal and social implications of rare diseases and orphan drugs in Europe: meeting report of a Brocher symposium

Ethical, legal and social implications of rare diseases and orphan drugs in Europe (Brocher symposium)Geneva, Switzerland 18–19 April 2013As part of the Scientific Program of the Fondation Brocher, a two-day symposium on orphan drugs and rare diseases was held on the shores of Lac Léman in Geneva. Specific focus was on the ethical, legal and social implications of rare diseases and orphan drugs in Europe. The symposium gathered about 30 international stakeholders and experts, representing different scientific disciplines, the pharmaceutical industry and patient representatives.

Reaching the golden milestone. The 2013 ERS Dublin summit: preparing the road to Rome

The Milliarium Aureum (or golden milestone) was a monument erected by the Emperor Caesar Augustus near the Temple of Saturn in the central forum of ancient Rome, Italy. All roads were considered to begin from this monument and all distances in the Roman Empire were measured relative to that point. To travel a road and to reach a milestone, one often needs a roadmap. At the first Annual Presidential Summit in Leuven, Belgium, in 2011, the European Respiratory Society (ERS) reflected on what must be done to prevent the rise of respiratory diseases in the future and produced the European Respiratory Roadmap [1, 2]. This roadmap has served as a guide to subsequent summits as they address the varying and complex issues of policy as it relates to respiratory medicine. The summits have developed into key advocacy events where the leadership of the ERS interacts with a wide range of decision makers in Europe relevant to respiratory medicine. Last year’s summit in Tallinn, Estonia, focused on the austerity of the times we live in and the rise of health inequalities in Europe [3]. Next year with the opening of the Italian Presidency of the European Union, the summit will travel the road from basic science to translational research and will arrive in Rome [4]. The objective of this year’s 2013 Presidential Summit in Dublin, Ireland, was to identify priority research topics that should be addressed at European level. All stakeholders were involved: medical professionals, patients, pharmaceutical industry representatives, research funders and research policymakers. The …

P327: A situational analysis of pharmacovigilance in republic of benin based on the Artemisinin-based Combination Therapies (ACTs)

To assess Benin’s pharmacovigilance system, identify the gaps and define strategy which could lead to its functional establishment, structure questionnaires was applied to investigate physicians, pharmacists and pharmaceutical industry representatives’ knowledge, attitude and practice regarding Adverse Drug Reactions (ADRs) reporting.

Medical school gift restriction policies and physician prescribing of newly marketed psychotropic medications: difference-in-differences analysis

Objective To examine the effect of attending a medical school with an active policy on restricting gifts from representatives of pharmaceutical and device industries on subsequent prescribing behavior.Design Difference-in-differences approach.Setting...

721 – European psychiatric trainees and their interactions with the pharmaceutical industry: results from the efpt-prirs study

The influence of pharmaceutical industry (PI) on clinical practice and research in psychiatry has been considered a serious problem. Strict rules and guidelines were developed to regulate the interactions between doctors and PI. However, there is an ongoing debate whether these were thoroughly implemented in practice and internalized by physicians. The objective of our study was to assess the attitudes and behaviors of trainees in psychiatry and child & adolescent psychiatry toward PI across Europe. Methodologically, a validated questionnaire with additional items was administered to1444 trainees in 20 European countries. The minimum response rate was set at 60%. We found a high variation across countries in number of interactions between trainees and PI representatives; Portugal and Turkey had the highest number of interactions. The majority (59.76%) agreed that interactions with PI representatives have an impact on physicians’ prescribing behavior; whereas only 29.26% and 19.79% agreed interactions with PI representatives and gifts from PI have impact on their own prescribing behavior, respectively. Most of the gifts were considered appropriate by the majority, except tickets to vacation spot and social dinner at a restaurant. Of the sample, 70.76% think they have not been given sufficient training regarding how to interact with PI representatives. Only less than 20% indicated they have guidelines at institutional or national level. In conclusion, there is substantial interaction between trainees and PI across countries. The majority feel inadequately trained regarding professional interaction with PI, and believes they are immune to the influence of PI.

'No more whispers' - 30 years of HIV/AIDS and 10 years of HIV treatment in South Africa.

1held in Durban in June. The conference brought together clinical scientists, basic scientists, educators and learners, law and human rights experts, practitioners (doctors, nurses, community carers), community workers, NGOs, members of civil society and lay members of so-called key populations (e.g. sex workers), pharmaceutical industry representatives, people from the world of work, politicians and policy makers. June 2011 marked the 30th anniversary of the recognition of the pandemic, then manifesting in New York as outbreaks among the gay population of Kaposi’s sarcoma and pneumocystis pneumonia in ostensibly healthy young men. A year later the Centers for Disease Control coined the term ‘acquired immune deficiency syndrome’ – AIDS. A soaring death rate led to a scramble to identify the cause. Assigning credit for the discovery of HIV was controversial, but it is agreed that Robert Gallo, a ‘retrovirologist’ at the National Cancer Institute, Maryland, Luc Montagnier and their research groups contributed significantly. Montagnier’s group first isolated HIV, while Gallo’s group demonstrated that the virus causes AIDS and generated much of the science that made the discovery possible, including a technique previously developed by Gallo’s laboratory for growing T cells in the lab. 2 There have since been breathtaking scientific advances, and understanding of the virus’s structure, mode of replication and targeting of the immune system have led to the development of drug therapy to restore immunity, although not yet to cure infection, and tools and methods to limit transmission. South Africa has proved particularly vulnerable. While having 0.7% of the world population we carry 17% of the global HIV burden, and 1 out of every 100 South Africans has tuberculosis. The Durban conference celebrated the enormous continuing contributions by South African professional and lay health communities. Our scientists and practitioners have played pivotal roles in the field, many reported in this journal and its sister, the South African Journal of HIV Medicine. The dark days of denialism have ended and reduction of a vicious epidemic is envisioned on the back of the National Department of Health’s Strategic Priority Framework for the New HIV/STI and TB National Strategic Plan and New Primary Healthcare Revitalisation Programme. The health system’s robust new approach encompasses a massive HIV counselling and testing (test one – test all) campaign, antiretroviral (ARV) treatment and expansion of medical male circumcision. 3

Effect of Drug Sample Removal on Prescribing in a Family Practice Clinic

Little is known about the impact of recent restrictions on pharmaceutical industry detailing and sampling on prescribing behavior, particularly within smaller, independent practices. The objective of this study was to evaluate the effect of a policy prohibiting prescription drug samples and pharmaceutical industry interaction on prescribing patterns in a rural family practice clinic in central Oregon. Segmented linear regression models were used to evaluate trends in prescribing using locally obtained pharmacy claims. Oregon Medicaid pharmacy claims were used to control for secular prescribing changes. Total and class-specific monthly trends in branded, promoted, and average prescription drug costs were analyzed 18 months before and after policy implementation. Aggregate trends of brand name drug use did not change significantly after policy implementation. In aggregate, use of promoted agents decreased by 1.43% while nonpromoted branded agents increased by 3.04%. Branded drugs prescribed for respiratory disease declined significantly by 11.34% compared with a control group of prescribers. Relative to the control group, prescriptions of promoted cholesterol-lowering drugs and antidepressants were reduced by approximately 9.98% and 11.34%, respectively. The trend in average cost per prescription for lipid-lowering drugs was significantly reduced by $0.70 per prescription per month. Overall, average prescription drug costs increased by $5.18 immediately after policy implementation. Restriction of pharmaceutical industry representatives and samples from a rural family practice clinic produced modest reductions in branded drug use that varied by class. Although aggregate average costs increased, prescriptions for branded and promoted lipid-lowering agents and antidepressants were reduced.

Psychiatric Resident and Faculty Views on and Interactions With the Pharmaceutical Industry

Sales visits, or detailing, by pharmaceutical industry representatives at academic institutions has been increasingly criticized. The authors surveyed psychiatric residents and faculty members on their views and interactions with representatives of the pharmaceutical industry. In 2007, a 46-item online survey measuring attitudes toward and interactions with pharmaceutical industry representatives was sent to 49 faculty psychiatrists and 40 psychiatric trainees (residents and fellows) at a Northwest academic medical center. Sixty-five percent (N=58) of surveys were completed. Two-thirds of respondents did not agree that pharmaceutical representatives have an important teaching role. Only 24% of faculty and 18% of trainees agreed that pharmaceutical representatives provide useful and accurate information on new drugs. Forty-one percent of faculty and 53% of trainees agreed that pharmaceutical representatives should be restricted from making presentations on campus. Trainees were less likely than faculty to agree that they would maintain contact with representatives if no gifts or food were distributed. Nevertheless, most respondents endorsed that pharmaceutical companies supported important conferences, and more than 90% had attended an industry-sponsored event in the previous year. In open-ended questioning, respondents revealed worries that bans would undermine the ability to secure national speakers and to support other activities that residents valued. Faculty and psychiatric residents and fellows do not view pharmaceutical representatives as having an important teaching role and mistrust the information they offer but believe that loss of industry financial support does adversely affect educational and other highly valued activities. They favor greater policy restrictions but do not support an outright ban on pharmaceutical support.

RETIRED: Pre-conceptional Vitamin/Folic Acid Supplementation 2007: The Use of Folic Acid in Combination With a Multivitamin Supplement for the Prevention of Neural Tube Defects and Other Congenital Anomalies

This document has been archived because it contains outdated information. It should not be consulted for clinical use, but for historical research only. Please visit the journal website for the most recent guidelines.

Experience of VA Psychiatrists With Pharmaceutical Detailing of Antipsychotic Medications

Experience of VA Psychiatrists With Pharmaceutical Detailing of Antipsychotic Medications

The UK Department of Health intends to reopen negotiations with pharmaceutical industry representatives regarding the Pharmaceutical Price Regulation Scheme

The UK Department of Health intends to reopen negotiations with pharmaceutical industry representatives regarding the Pharmaceutical Price Regulation Scheme

Adding or Switching Antipsychotic Medications in Treatment-Refractory Schizophrenia

This study compared patients with schizophrenia whose antipsychotic medications were switched to manage treatment-resistant positive psychotic symptoms with those for whom another antipsychotic was added. Psychiatrists' characteristics and perceptions of effectiveness of the medication change on clinical outcomes were also reported. Psychiatrists participating in a nationally representative mailed survey (N=209) reported on the clinical features, management, and response to the change in antipsychotic medication (added versus switched) of one adult patient with treatment-refractory schizophrenia under their care for at least one year. Thirty-three percent of patients were treated with an added antipsychotic medication. Compared with patients whose antipsychotic medications were switched, those with an added antipsychotic medication were more likely to be female, to have received care from the same psychiatrist for more than two years, and to have been recently prescribed an antidepressant. Compared with psychiatrists who switched antipsychotic prescriptions, those who added an antipsychotic reported that the change was less likely to reduce positive symptoms, improve functioning, and prevent hospitalization. Psychiatrists who added rather than switched antipsychotics reported more frequent attendance at educational programs sponsored by a pharmaceutical company. Consistent with other lines of research and practice guideline recommendations, psychiatrists perceive antipsychotic polypharmacy to be a generally ineffective strategy for treatment-resistant positive psychotic symptoms. In light of these findings, efforts to identify and implement more effective evidence-based pharmacologic approaches should be undertaken.

Adding or Switching Antipsychotic Medications in Treatment-Refractory Schizophrenia

Adding or Switching Antipsychotic Medications in Treatment-Refractory Schizophrenia

GREEN CHEMISTRY AGS, pharma initiative awards first grant

The Pharmaceutical Roundtable of the Green Chemistry Institute, a division of the American Chemical Society, has awarded its first research grant as part of a broad effort to advance green chemistry and engineering practices in the global pharmaceutical industry. The $130,000 grant goes to chemistry professor Jianliang Xiao of the University of Liverpool, in England, whose group will seek to develop a cleaner, more efficient method of reducing amides to amines, an important transformation in drug synthesis. Together with major pharmaceutical firms, the Green Chemistry Institute established the Pharmaceutical Roundtable in 2005. Made up of pharmaceutical industry representatives, the group spent its first year singling out seven common reactions and processes that need cost and environmental improvements, including the amide reduction, and drawing up a wish list of five reactions that chemists would like to add to their research arsenals (C&EN, July 24, 2006, page 36). Last fall, the roundtable called for ...

Promotional methods used by representatives of drug companies: A prospective survey in general practice

Objective. To examine the extent and composition of pharmaceutical industry representatives’ marketing techniques with a particular focus on drug sampling in relation to drug age. Design. A group of 47 GPs prospectively collected data on drug promotional activities during a six-month period, and a sub-sample of 10 GPs furthermore recorded the representatives’ marketing techniques in detail. Setting. Primary healthcare. Subjects. General practitioners in the County of Funen, Denmark. Main outcome measures. Promotional visits and corresponding marketing techniques. Results. The 47 GPs recorded 1050 visits corresponding to a median of 19 (range 3 to 63) per GP in the six months. The majority of drugs promoted (52%) were marketed more than five years ago. There was a statistically significant decline in the proportion of visits where drug samples were offered with drug age, but the decline was small OR 0.97 (95% CI 0.95;0.98) per year. Leaflets (68%), suggestions on how to improve therapy for a specific patient registered with the practice (53%), drug samples (48%), and gifts (36%) were the most frequently used marketing techniques. Conclusion. Drug-industry representatives use a variety of promotional methods. The tendency to hand out drug samples was statistically significantly associated with drug age, but the decline was small.

Does the Angiotensin-converting enzyme (ACE) gene insertion/deletion polymorphism modify the response to ACE inhibitor therapy? – A systematic review

BackgroundPharmacogenetic testing to individualize ACE inhibitor therapy remains controversial. We conducted a systematic review to assess the effect modification of the insertion/deletion (I/D) polymorphism of the ACE gene on any outcome in patients treated with ACE inhibitors for cardiovascular and/or renal disease.MethodsOur systematic review involved searching six electronic databases, then contacting the investigators (and pharmaceutical industry representatives) responsible for the creation of these databases. Two reviewers independently selected relevant randomized, placebo-controlled trials and abstracted from each study details on characteristics and quality.ResultsEleven studies met our inclusion criteria. Despite repeated efforts to contact authors, only four of the eleven studies provided sufficient data to quantify the effect modification by genotypes. We observed a trend towards better response to ACE inhibitors in Caucasian DD carriers compared to II carriers, in terms of blood pressure, proteinuria, glomerular filtration rate, ACE activity and progression to end-stage renal failure. Pooling of the results was inappropriate, due to heterogeneity in ethnicity, clinical domains and outcomes.ConclusionLack of sufficient genetic data from the reviewed studies precluded drawing any convincing conclusions. Better reporting of genetic data are needed to confirm our preliminary observations concerning better response to ACE inhibitors among Caucasian DD carriers as compared to II carriers.

Differences in prescribing between GPs. Impact of the cooperation with pharmacists and impact of visits from pharmaceutical industry representatives

Community pharmacists, pharmaceutical industry and differences in prescribing between GPs. To explore the role of the pharmacists and pharmaceutical industry representatives. A cross-sectional survey was undertaken of 1434 GPs in The Netherlands in 2001. Prescribing indicators based on general practice guidelines were used to assess the quality of prescribing. Three constructs, based on survey questions, were used as possible determinants for the quality of prescribing: cooperation with the pharmacist; quality of the Pharmacotherapeutic audit meeting (PTAM); and the GP's attitude towards the pharmacist's role. Data were collected about the frequency of visits by pharmaceutical industry representatives. Responses from 324 solo GPs were analysed using multiple linear regression. Response rate: 71%. For the 324 solo GPs the average score for the 20 prescribing indicators was 64% (SD 3.7). For the non-solo GPs this score was 65% (SD 3.8, P < 0.05). The differences between solo and group practices were: the number of visits from pharmaceutical industry representatives (5.7 versus 3.8 visits per month), full time GPs (93% versus 50%), the number of patients per GP (2151, SD 693 versus 1506, SD 742), and the presence of a GP trainer (21 versus 38%). Of the solo GPs, 4.6% are female, compared with 26% of the GPs in non-solo practices. The quality of prescribing in solo practices was not correlated with the GP's attitude towards the pharmacist's role, the way in which GPs cooperated with pharmacists or the quality of the PTAM. More frequent visits from pharmaceutical industry representatives was associated with a lower quality of prescribing. There was a negative correlation between quality of prescribing by solo GPs and frequency of visits by pharmaceutical industry representatives. In day-to-day practice, no measurable effects of the cooperation between solo GP and pharmacist on the quality of prescribing were observed.

What residents don't know about physician-pharmaceutical industry interactions.

Little is known about the knowledge and skills internal medicine residents need to interact appropriately with pharmaceutical industry representatives. The authors conducted a needs assessment of current knowledge and preferences for potential components of a new educational initiative among residents. In 2001, a two-page questionnaire using a five-point ordinal scale was mailed to all internal medicine residents and faculty at one institution. Analysis included use of Wilcoxon two-sample test. Response rates were 97% (85/88) for residents and 79% (86/109) for faculty. Residents and faculty's knowledge about formal position statements or literature on the impact of marketing strategies on prescribing patterns, drug marketing costs, or how pharmaceutical representatives are trained to interact with physicians was very limited. Most responders felt residents should learn to critically interpret promotional materials, recognize potential for conflict of interest, and consider how patients perceive the physician-pharmaceutical industry relationship. More faculty than residents valued including position statements (66% versus 39%, p <.001) and literature exploring the impact of marketing on prescribing patterns (70% versus 41%, p <.001) in education. Only one-half or fewer favored small-group discussions, lecture series, critical-reading skills seminars, or panel discussions. Internal medicine residents and faculty reported low levels of knowledge about physician-pharmaceutical industry relationships. Some consensus about educational components existed, but optimal educational formats remain uncertain. A six-hour curriculum to address this complex, emotionally charged topic was developed, implemented, and evaluated.