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A Social Science Perspective on Gifts to Physicians From Industry
Abstract
A conflict of interest exists when a primary ethical or professional interest clashes with financial self-interest, a situation that arises commonly in medical practice. When physicians are remunerated for performing specific tests and procedures, they face a conflict of interest when they also recommend those same tests and procedures. When they are paid for referrals to clinical trials, physicians are in the conflicted position of deciding whether their patients are appropriate for the studies. Performing industry-supported research, physicians face an implicit demand for a positive finding to obtain further financial support. And, when pharmaceutical companies court high-volume prescribers, writing prescriptions becomes an act not only with financial and health consequences for patients, but also with financial consequences for the physician. This last source of conflict of interest is the central focus of this commentary.
... Esimerkiksi klassikkotutkimuksessa 20 lääkäristä 19 uskoi etukäteen, että kaupallinen koulutus ei vaikuttaisi heidän päätöksiinsä, mutta jälkeenpäin osallistujat määräsivät esiteltyjä lääkkeitä selvästi useammin kuin aiemmin ja enemmän kuin koulutukseen osallistumattomat lääkärit (12). Kuvittelemme helposti virheellisesti, että vaikka muut olisivat vaikuttamiselle alttiita, me pystymme torjumaan vaikutukset (13). Vaarallisinta on uskoa olevansa immuuni vaikuttamiselle (11). ...
... Jo aiemmin on osoitettu, että hoitosuositustyöryhmät, joilla on sidonnaisuuksia, ovat taipuvaisia laajentamaan sairauksien määritelmiä ja kiinnittämään vähän huomiota hoitojen haittoihin (15). Laajemmin ilmiötä kutsutaan rahoitusefektiksi: teollisuuden rahoittamien asiantuntijoiden päätelmät ovat usein rahoittajille edullisia (11)(12)(13)(15)(16)(17). ...
... Näistä syistä taloudellisten sidonnaisuuksien katsotaan vaarantavan hoitosuositustyöryhmien kyvyn luotettavaan päätöksentekoon (4)(5)(6)17). Huolena ei ole se, että asiantuntijoiden ajateltaisiin tekevän tietoisesti puolueellisia valintoja, vaan se, että kaikki yhteistyösuhteet vaikuttavat kognitiivisiin toimintoihimme tavoilla, joita on vaikeaa huomata tai estää (13). Taloudellisten eturistiriitojen ongelmaa pidetään yhteiskunnallisesti niin merkittävänä, että New York Times -lehden päätoimittajakunta (14.9.2018) nimitti ongelmaa "lääketieteen saastumiseksi". ...
Hoitosuositukset, systemaattiset vinoumat ja luottamus lääkäreihin Luotettavasti laaditut hoitosuositukset ovat työväline, jolla tarjotun hoidon laatua voidaan tutkitusti parantaa. Hoitosuositusten laatiminen on kuitenkin moniulotteinen prosessi, johon ei ole yhtä yksise-litteisesti oikeaa menetelmää ja joka sisältää näytön tulkinnan lisäksi myös monenlaisia arvovalintoja. Siksi hoitosuositusten laatimisprosessi on altis myös päätöksenteon systemaattisille vinoumille. Koska ne eivät johdu yksilöiden tietoisista valinnoista, niiden tehokkaat ehkäisykeinot ovat rakenteellisia. Kä-sittelemme tässä katsausartikkelissa mekanismeja, joilla päätöksenteko saattaa vinoutua, ja esitämme rakenteellisia ratkaisuja niiden ehkäisemiseksi. Kaksi erityisen merkittävää tekijää, jotka altistavat hoito-suositukset systemaattisille vinoumille, ovat taloudelliset sidonnaisuudet ja ammattikuntaedut. Vinou-mien ehkäisykeinoiksi esitämme puolueettomien asiantuntijoiden käyttöä, metodologisen osaamisen vahvistamista ja moniammatillisia työryhmiä.
... Researchers also studied the impact of industry payments on physicians' prescribing behavior and presented varied findings regarding ethical concerns. Dana and Loewenstein [7] showed that large gifts had more visible commercial influence, but small gifts were also influential. Patwardhan [28] showed that small gifts of $20 were associated with higher prescribing rates. ...
... Some researchers remained unconvinced about the positive relationship between promotions and prescriptions [7,18,31]. Carey et al. [5] offered another perspective, noting that, on average, doctors who received payments prescribed higher quality drugs for their patients. They also found that patients whose prescribers received payments from a pharmaceutical firm tended to have higher expenditures on that firm's drugs. ...
... In the healthcare profession, when physicians gave priority to personal financial gain over patients' welfare then a conflict of interest arises. Physicians accepting gifts and other obligations from industry eventually invoke the principles of reciprocity and thus a conflict of interest arises (Dana & Loewenstein, 2003;Katz et al., 2010). The industry is looking for gaps within the doctors' characters and focuses on the loose points. ...
... In the healthcare profession, when physicians gave priority to personal financial gain over patients' welfare then a conflict of interest arises. Financial and health consequences are bear by patients due to conflict of interest created by the joint venture of pharmaceutical marketing and physicians but physicians also faced financial and career loss (Dana & Loewenstein, 2003). The primary interest of physicians is the health of patients and must dominate the secondary interest which is financial benefits to them. ...
This chapter examined the many marketing techniques employed by pharmaceutical companies to enhance physician prescriptions and, consequently, sales volumes. Thee discussion in the preceding lines led to the conclusion that unethical advertising practices, deceptive marketing tactics, and heavy physician bribery are the main contributors to antibiotic resistance. Physicians have been shown to comply poorly with ethical standards, global standards, and SOPs for clinical practices. It is important to note that individuals are ignorant about medications and the side effects that go along with them. This supports the researcher's conclusion that improper actions by healthcare professionals, industry marketers, and patients are the causes of the emergence and escalation of antibiotic resistance. Because of this, some patients may not respond to current antibiotic therapy, and doctors are increasingly turning to antibiotics as a last resort. Prescription rationality receives very little attention in the healthcare system. The number of medications recommended for each patient and the following dosage of antibiotics varies from patient to patient, but it is typically higher than is necessary. Diagnosing and treating patients rationally, as well as making the most use of available resources and scientific data, is essential. However, the existing clinical practices of doctors and marketers do not practice ethics. It is important to note that institutional ethics are more significant than practice ethics in this context because the former has the power to change the general course of the healthcare system. Good clinical practices give doctors the confidence to carefully identify, examine, and make attempts to address patients' current health-related issues. Physicians claim that they devote all of their energies to helping people, but the reality is quite different.
... In this section, the participants were asked about participating in company-sponsored continual medical education, information from medical representative, frequent visits of medical representative, sales calls made by pharmaceutical companies, free drug samples given by pharmaceutical company, information from promotional drug brochures, different gifts from pharmaceutical company, participating pharmaceutical company-sponsored entertainments/recreational events, sponsorship for travel in conference, subscription of journals with direct mail, invitation to visit a pharmaceutical manufacturing plant, personal relationship to company, product launch meeting, and public relation of pharmaceutical company. The second section explored the influence of product strategy (questions [15][16][17][18][19][20][21][22][23][24] and asked the participants whether product strategy motivate them to prescribe a certain product for a drug company. In this section, the participants were asked about country of pharmaceutical product manufacturer, image of pharmaceutical company, supportive evidence of the efficacy of the medicine given by pharmaceutical company, release of new innovations or combinations of drugs, form of delivery of the medicine, ease to remember brand names, reputation of the source of medicine, quality of medicine, fixed-dose packaging of the product, and full therapy packaging. ...
... They claim to have a proclivity for irrational prescribing, a friendly attitude toward company representatives, a predilection for newer, more expensive treatments, and an inability to spot false medication claims. Furthermore, this effect on physicians' practices and knowledge is dose-dependent: frequent interaction and the acceptance of presents, regardless of the value of the gift, [22] create a need to reciprocate, which influences medical judgment [23]. ...
Background
Exploring the effect of different marketing mix strategies on physicians’ prescribing practices is important due to its positive effect on the management of patients’ diseases and improving the health status of individuals by promoting the use of the most cost-effective and safe treatment for patients.
Aim
This study aimed to assess the perceived influence of the four pharmaceutical marketing mix strategies (product, price, place, and promotion) on physicians’ prescribing practices in Jordan.
Method
A quantitative survey study was conducted from May to November 2021 on practising physicians in Jordan. This research utilised a previously validated questionnaire developed by Hailu et al. The convenience sampling technique was used to recruit the study participants. The population of the study was practising physicians from the public and private sectors in Jordan. Any physician who was licensed to practice medicine in Jordan and actively engaged in patient care was considered eligible. The minimum sample size required was 379 participants, which was calculated based on a population size of 35,000 physicians in Jordan. Student t-test/One-way independent-measures ANOVA was used to compare the mean scores (indicating being affected by marketing mix elements between different demographic groups) after performing log transformation to restore the normality of the data. For the binary regression analyses, the dependent variable was the median score for each of the marketing mix elements. For each sub-scale and the overall scale, the median score was used to define the dummy variable used in the binary regression analysis. The study protocol was approved by the Scientific Research Ethics Committee at Isra University (SREC/21/06/005).
Results
A total of 315 physicians participated in the study. Overall, participating physicians showed moderate to high influence from marketing mix elements, with a median score of 141.0 (IQR: 118.0-156.0) out of 185, representing 76.2%. The lowest median score was found for the promotional tools used by pharmaceutical companies, with a median score of 48.5 (IQR: 40.0–56.0) out of 70, representing 69.3%. The highest median score found was for the pricing strategy implemented by pharmaceutical companies, with a median score of 25.0 (IQR: 18.8–28.0) out of 30, representing 83.3%. Working in private sector settings was an important predictor that increased the probability of physicians’ prescribing practices being influenced by marketing mix elements (OR: 1.57; (95%CI: 1.00-2.47)), (p ≤ 0.05).
Conclusion
Physicians in our study were highly affected by marketing mix strategies, specifically price strategy. Policymakers should guarantee a balanced relationship with pharmaceutical companies and physicians. We should make sure that promotion strategies have a positive impact on patients’ health. The government is advised to decrease the taxes on medications to decrease the overall cost for patients.
... 8,9 These payments exist in various forms including fees for professional services (such as consulting and speaking bureaus), gifts, and meals. [8][9][10][11] Payments made to physicians, especially small payments such as meals and gifts, can be an important channel for the industry to build connections with physicians and deliver new information about drugs to physicians. 12 However, pharmaceutical companies may also exert undue influence on physicians through gifts and other financial exchanges, which may distort physician prescribing away from the best interests of patients and lead to suboptimal medical decision making including low-value drug prescriptions. ...
... 12 However, pharmaceutical companies may also exert undue influence on physicians through gifts and other financial exchanges, which may distort physician prescribing away from the best interests of patients and lead to suboptimal medical decision making including low-value drug prescriptions. 10,13 Several studies suggest that industry payments may have led to biased advice of physicians in the form of over-prescription of brand-name drugs. 7,14,15 To address the potential conflict of interest faced by physicians related to the industry payments, the Center for Medicare and ...
Objective:
To evaluate the impact of the Affordable Care Act's Physician Payments Sunshine Act (PPSA), which mandates disclosure of industry payments to physicians, on physician prescribing of branded statins.
Data sources:
Administrative claims data from 2011 to 2015 from three large national commercial insurers provided by the Health Care Cost Institute (HCCI).
Study design:
We adopted a difference-in-differences and event study design, leveraging as the control group physicians in two states, MA and VT, which implemented state laws on disclosure of industry payments prior to the national PPSA. To further address potential confounding caused by differences in prescribing patterns across states, our analytical sample includes physicians practicing in border counties between the treatment (NH, NY, RI) and control (MA, VT) states.
Data collection:
We restricted our sample to physicians who had at least 50 new-fill prescription claims for statins during the five-year study period, with at least one new-fill prescription claim in each year.
Principal findings:
We found that the PPSA led to a 7% (p<0.001) reduction in monthly new prescriptions of brand-name statin over the study period, with little change in generic prescribing. The reduction in branded prescriptions was concentrated among physicians with the highest tercile of drug spending pre-PPSA, with a decrease of 15% (p<0.001) in new branded statin prescriptions. The decline was most prominent after mandated reporting of industry payments began, before the payment data was published.
Conclusions:
The PPSA may have achieved its intended effect of reducing branded prescriptions at least in the short run, particularly among physicians most likely to have engaged in excessive or low-value prescribing of branded drugs.
... According to a commentary summarizing social science research on conflict of interest, research evidence shows that when people have a stake in the outcomes it results in unintentional and/or unconscious self-serving bias, which indirectly affects choices by influencing how people search and weigh the information to make choices. 2 Thus, when left unchecked, conflicts of interest can lead to prescriptions which are unnecessary, less efficacious or more costly than alternatives, while the physician or their family benefits directly or indirectly from such prescriptions. 3 ...
The ethics of physician prescriptions is a matter of globalconcern. While commonalities exist in reasons forunethical prescribing practices such as physicianincentivization by pharmaceutical companies, theunderlying social determinants may be different acrosscountries and socioeconomic strata. This scoping reviewhas collected themes from publications aroundprescription ethics from Pakistan. Four major themeswere identified: 1) Impact – including physical andfinancial harm to patients, deficit in trust anddevelopment of antibiotic resistance, 2) Causes –including personal financial needs, peer pressure,inadequacy of education in ethics and professionalism,lack of evidence for policy-making, and weak regulatoryframework, 3) Type – includes unethical practices likeexcessive, inappropriate/unnecessary, expensive, nonevidence-based, and off-label prescriptions, andprescription of controlled drugs to addicts, and 4)Solution – proposed strategies to curb unethicalprescribing practices included education of communityand undergraduates, trainees and practicing physicians,improvement in policies/laws on drugdispensation/prescriptions, their enforcement andaccountability, as well as making health care accessible. Insummary, this review identifies various socialdeterminants of prescription ethics in the context ofPakistan, a low-middle income country, and highlightslocally applicable measures to prevent unethicalprescribing practices. Keywords: Ethics, prescriptions, incentive-linked,inducement, enticement, incentivization, Pakistan
... Also, two of the systematic reviewers might have financial interests in the outcome of their review and three professors (Bleijenberg, Moss-Morris and Knoop) who were involved in the systematic review, have all built their career on the CBmodel and the reversibility of ME/ CFS through CBT and GET. As noted by Dana and Loewenstein [85], when individuals have a stake in reaching a particular conclusion, they weigh arguments in a biased fashion that favors a specific conclusion. Moreover, as noted by Groopman [86], scientists often ignore what they don't want to see and seek confirmation of what they believe. ...
In this article, we analyzed the systematic review by Kuut et al. into the efficacy of cognitive behavioral therapy (CBT) for my-algic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a disease that predominantly affects women, and the eight trials in it. We found many issues with the studies in the review, but also with the review itself. For example, the systematic review by Kuut et al. included a researcher who was involved in seven of the eight studies in their review, and another one who was involved in five of them. Moreover, at least one of them was involved in every study in the review. On top of that, the three professors who were involved in the systematic review, have all built their career on the CB model and the reversibility of ME/ CFS through CBT and GET and two of the systematic reviewers have a potential financial conflict of interest. Yet they failed to inform the readers about these conflicts of interest. Conducting a review in this manner and not informing the readers, undermines the credibility of a systematic review and its conclusion. Regarding outcome differences between treatment and control group, it's highly likely that the combination of non-blinded trials, subjective outcomes and poorly chosen control groups, alone or together with response shift bias and/or patients filling in questionnaires in a manner to please the investigators, allegiance bias, small study effect bias and other forms of bias, produced the appearance of positive effects, despite the lack of any substantial benefit to the patients, leading to the erroneous inference of efficacy in its absence. That CBT is not an effective treatment is highlighted by the fact that patients remained severely disabled after treatment with it. The absence of objective improvement as shown by the actometer, employment status and objective cognitive measures, confirms the inefficacy of CBT for ME/CFS. The systematic review did not report on safety but research by the Oxford Brookes University shows that CBT, which contains an element of graded exercise therapy, is harmful for many patients. Finally, our reanalysis highlights the fact that researchers should not mark their own homework.
... CoIs can lead to misconduct and illegal or unprofessional behavior, but far more often can influence judgment in subtle ways, and most clinicians and researchers may be unaware of an existing bias in their decision-making 238 . CoIs may threaten the quality of clinical care as well as the integrity of research and education, and may jeopardize public trust in science and medicine, including psychiatry 236,239 . ...
Psychiatry shares most ethical issues with other branches of medicine, but also faces special challenges. The Code of Ethics of the World Psychiatric Association offers guidance, but many mental health care professionals are unaware of it and the principles it supports. Furthermore, following codes of ethics is not always sufficient to address ethical dilemmas arising from possible clashes among their principles, and from continuing changes in knowledge, culture, attitudes, and socioeconomic context. In this paper, we identify topics that pose difficult ethical challenges in contemporary psychiatry; that may have a significant impact on clinical practice, education and research activities; and that may require revision of the profession's codes of ethics. These include: the relationships between human rights and mental health care, research and training; human rights and mental health legislation; digital psychiatry; early intervention in psychiatry; end-of-life decisions by people with mental health conditions; conflicts of interests in clinical practice, training and research; and the role of people with lived experience and family/informal supporters in shaping the agenda of mental health care, policy, research and training. For each topic, we highlight the ethical concerns, suggest strategies to address them, call attention to the risks that these strategies entail, and highlight the gaps to be narrowed by further research. We conclude that, in order to effectively address current ethical challenges in psychiatry, we need to rethink policies, services, training, attitudes, research methods and codes of ethics, with the concurrent input of a range of stakeholders, open minded discussions, new models of care, and an adequate organizational capacity to roll-out the implementation across routine clinical care contexts, training and research.
... To do all this, the doctor must have a knowledge of the range of marketed products. Cooperation with the industry can lead doctors to have conflicts of interest, with ethical and professional behaviors possibly clashing with financial self-interests (Dana, Loewenstein, 2003). Such conflicts of interest can lead to suboptimal prescription of medicaments and even over-prescribing. ...
Cooperation between the pharmaceutical industry and medical doctors is both necessary and inevitable. As part of the medical community, medical students are likely to have developed specific views as to its benefits and risks. The article is part of a series of articles presenting selected results of nine focus group interviews from three cities (Warsaw, Kraków, and Gdańsk). The study used social constructivism as a theoretical framework, and thematic analysis was performed. In their group discussions, the students drew links between cooperation’s perceived benefits and risks. Despite the associated risks, most medical students perceive benefits obtained from the pharmaceutical industry as attractive. Better education about social, psychological issues (manipulation techniques) and the conflict of interest is needed in medical schools.
... Although FSFW argues that PMI's funding has no effect on its research, 63 evidence shows that financial links can create an 'implicit demand' for researchers' work to benefit the funder, and those in receipt of funds can respond to such pressures unintentionally and subconsciously. 143 Further, although all researchers rely on personal interests and experiences to shape their research, financial COIs, specifically, act as a 'megaphone, amplifying a set of interests that align with the sponsor's'. 144 Despite FSFW claiming a 'confluence' rather than 'conflict' of interest exists (with funder and researchers similarly striving for reduced harm from tobacco), 145 the WHO's FCTC asserts there is an 'irreconcilable conflict' between the tobacco industry's interests and public health. ...
Background
Tobacco corporation Philip Morris International launched the Foundation for a Smoke-Free World (FSFW), a purportedly independent scientific organisation, in 2017. We aimed to systematically investigate FSFW’s activities and outputs, comparing these with previous industry attempts to influence science, as identified in the recently developed typology of corporate influence on science, the Science for Profit Model (SPM).
Design
We prospectively collected data on FSFW over a 4-year period, 2017–2021, and used document analysis to assess whether FSFW’s activities mirror practices tobacco and other industries have historically used to shape science in their own interests. We used the SPM as an analytical framework, working deductively to search for use of the strategies it identifies, and inductively to search for any additional strategies.
Results
Marked similarities between FSFW’s practices and previous corporate attempts to influence science were observed, including: producing tobacco industry-friendly research and opinion; obscuring industry involvement in science; funding third parties which denigrate science and scientists that may threaten industry profitability; and promoting tobacco industry credibility.
Conclusions
Our paper identifies FSFW as a new vehicle for agnogenesis, indicating that, over 70 years since the tobacco industry began to manipulate science, efforts to protect science from its interference remain inadequate. This, combined with growing evidence that other industries are engaging in similar practices, illustrates the urgent need to develop more robust systems to protect scientific integrity.
... Behavioral science provides a powerful i-frame analysis of why people are so vulnerable to misinformation---and should be taken to imply that protecting against these vulnerabilities requires slevel interventions. People are excessively credulous (Gilbert, Tafarodi & Malone, 1993), strongly underestimate the power of conflicts of interests (Dana & Loewenstein, 2003), and are influenced by the many non-epistemic benefits of new information: reducing cognitive dissonance, shoring up personal beliefs systems, creating or cementing identification with 'like-minded' others, providing ammunition in hypothetical or real debates, and many more (Chater & Loewenstein, 2016;Wojtowicz, Chater & Loewenstein, 2022). ...
An influential line of thinking in behavioral science, to which the two authors have long subscribed, is that many of society's most pressing problems can be addressed cheaply and effectively at the level of the individual, without modifying the system in which the individual operates. We now believe this was a mistake, along with, we suspect, many colleagues in both the academic and policy communities. Results from such interventions have been disappointingly modest. But more importantly, they have guided many (though by no means all) behavioral scientists to frame policy problems in individual, not systemic, terms: to adopt what we call the “i-frame,” rather than the “s-frame.” The difference may be more consequential than i-frame advocates have realized, by deflecting attention and support away from s-frame policies. Indeed, highlighting the i-frame is a long-established objective of corporate opponents of concerted systemic action such as regulation and taxation. We illustrate our argument briefly for six policy problems, and in depth with the examples of climate change, obesity, retirement savings, and pollution from plastic waste. We argue that the most important way in which behavioral scientists can contributed to public policy is by employing their skills to develop and implement value-creating system-level change.
... It is well established that distrust in the pharmaceutical industry is associated with lower vaccination rates, for both adults and their children (Attwell et al. 2017). The perceived culpability of healthcare professionals in the opioid epidemic and rising healthcare costs likely contributes to the erosion of trust in healthcare and medicine (Gale 2016;Mazurenko et al. 2020); perceived financial incentives of healthcare professions to work against people's health or best interest is an important component of medical distrust (Dana and Loewenstein 2003;Grande et al. 2012;Schwei et al. 2014;Webb Hooper et al. 2022). Additional research is necessary to elucidate public perception of healthcare's financial "benefit" from the pandemic and how this may have fostered distrust in COVID-19 information and mitigation efforts. ...
Aim
Individual-level COVID-19 vaccination and related preventive health behaviors is politically polarized in the United States. We examined whether the current polarization in COVID-19 health behavior may be explained by differences in trust in healthcare, locus of control, or insurance status.
Subject and methods
Our sample includes 553 US adults recruited on Amazon MTurk. We assessed odds ratios of currently vaccinated, or willing to be vaccinated if unvaccinated using logistic regression. We assessed count of routine changes and positive attitudes toward facemasks using negative binomial regression.
Results
Trust in healthcare was found to be an important determinant of all COVID-19 related health behavior measured in our study. Further, the effects on COVID-related attitudes/behavior from trust in healthcare are large in magnitude. For instance, our results suggest that individuals at or above the upper quartile of trust in healthcare are around 20 percentage points more likely to be vaccinated than those at or below the lower quartile. Further, we find that the effect of trust in healthcare on adherence or endorsement of COVID-19 mitigation strategies is distinct from political affiliation, i.e., the effect on COVID-19 related health behavior is independent of the polarization across political party lines. Locus of control was not associated with adherence/attitude toward COVID-19 mitigation strategies. Insurance status was only found to be positively associated with odds of being vaccinated.
Conclusion
Our study highlights the importance of increasing trust in healthcare as a means to protect public health in the wake of major public health crises.
... Instead, these processes could be considered part of human implicit social cognition, 45 which cannot be curbed by mere awareness or force of will. 45,50 So, while ophthalmologists and optometrists may feel that a meal or other small TOV may not influence their behavior, our data suggest that it might. ...
Importance:
Reported transfers of value (TOV) from pharmaceutical companies have been associated with greater use of branded anti-vascular endothelial growth factor agents by ophthalmologists, but payment under the Medicare Part B buy-and-bill model includes a financial incentive to choose costlier agents, potentially confounding analyses of pharmaceutical TOV and prescribing patterns. How these reported TOV are associated with prescribing patterns for prescription eye drops, not subject to the incentives created by Part B payments, should be considered.
Objective:
To assess the association between prostaglandin analog (PGA) eye drop prescribing and reported nonresearch TOV by makers of branded PGAs to US vision care professionals.
Design, setting, and participants:
This retrospective cohort analysis used a 20% nationally representative sample of 2018 Medicare Part D claims and industry TOV reported to the Open Payments program. Optometrists and ophthalmologists who had more than 10 claims for PGA drops in the 20% sample were analyzed. Analysis took place from June 2021 to February 2022.
Main outcomes and measures:
Multivariable logistic regression assessing the association between membership in strata of reported TOV and branded PGA prescribing rate, controlling for prescriber demographic factors, local area practices, total PGA prescribing volume, and plan formularies involved.
Results:
A total of 20 612 ophthalmologists and 5426 optometrists (7449 [29%] female and 18 589 [71%] male) prescribed PGA eye drops. Of these, 9685 (37%) were reported to have received TOV from manufacturers of branded PGAs in 2018, totaling 65 (147). Multivariable logistic regression showed that the predicted probability of primarily prescribing branded PGAs among prescribers who reported receiving no TOV was 12.9% (95% CI, 12.4%-13.4%). This figure increased to 19.6% (95% CI, 18.8%-20.4%) among prescribers receiving TOV, a 50% increase. There was a dose-response association, such that the top 10% of TOV recipients had a 29.2% probability (95% CI, 26.4%-31.9%) of preferential branded use.
Conclusions and relevance:
While the median reported TOV to a PGA prescriber was relatively low in this study, there was a positive association between amount of reported nonresearch TOV received from PGA makers and the frequency of branded PGA use. This shows that small reported TOV were associated with differences in prescribing. High rates of branded PGA prescribing may pose a cost burden to patients that affects adherence. Clinicians and policy makers should be aware of these associations.
... Physicians' interactions with the pharmaceutical industry have been described in numerous studies worldwide in the last two decades. [1][2][3][4] There is evidence that drug company-physician interactions alter physicians' prescribing behaviour. 5 6 They have been shown to increase prescription of recently marketed drugs with no clear benefit over existing drugs, 7 8 of drugs that are inconsistent with evidence-based guidelines 9 or drugs that are costlier. ...
Objectives
To measure medical students’ exposure to pharmaceutical product promotion and incentives nationwide, and to evaluate students’ attitudes towards the pharmaceutical industry, access to education on promotional strategies and knowledge of institutional policies about drug company-student relationships.
Design
Cross-sectional survey based on a 48-item anonymous questionnaire.
Setting
All 37 French medical schools, from March to April 2019.
Participants
French medical students in their 4th year of study and beyond, having studied exclusively in France.
Main outcome measure
Cumulative frequency of students’ exposure to pharmaceutical product promotion and incentives.
Secondary outcome measures
Exposure within the last 6 months, attitudes regarding interactions with the industry, access to education on pharmaceutical product promotion and incentives and knowledge of institutional policies.
Results
6280 responses were analysed (10.4% out of a total of 60 550 eligible students). 5992 students (96.3% poststratification, 99% CI (96.1% to 96.5%)) had already been exposed to pharmaceutical product promotion and incentives and 4650 (78.1%, 99% CI (77.7% to 78.6%)) within the last 6 months. 5140 students (85.4%, 99% CI (84.8% to 85.8%)) had met a pharmaceutical representative. Regarding attitudes, 2195 students (36.8%, 99% CI (36.0% to 37.5%)) thought receiving a gift could influence their own prescriptions while 3252 (53.6%, 99% CI (53.1% to 54.2%)) thought it could influence their colleagues’ prescriptions. 4533 students (76.0%, 99% CI (75.6% to 76.5%)) reported never having attended any lecture on promotional strategies. Exposure seemed to depend on the year of study and specialty. 5122 (88.1%, 99% CI (87.7% to 88.4%)) did not know whether their faculty had a policy regarding drug company-student interactions.
Conclusion
In France in 2019, medical students’ exposure to pharmaceutical product promotion and incentives remains considerable and starts early during medical training. Education on promotional strategies and institutional policies should be improved to ensure responsible and ethical behaviour in prescribing medications.
... Although these laws and policies may limit payment size or type (e.g., to food and beverage only below a certain dollar threshold), such limitations are not likely to eliminate influence. 2,5 The National Academy of Medicine, an independent organization, has published recommendations for mitigating conflicts of interest in clinical guideline development. 6 The core recommendations are disclosure, divestment of financial investments and cessation of participation in marketing activities or advisory boards, and exclusion of individuals with conflicts of interest, where possible. ...
Background
Randomized clinical trials (RCTs) are considered the gold standard for evaluating the efficacy of healthcare interventions. However, conflicts of interest (COIs) can compromise the scientific integrity in these trials. This study characterized COIs in RCTs on spinal cord stimulation for chronic pain, focusing on the prevalence, disclosure, and monetary value of COIs.
Methods
This cross-sectional study analyzed RCTs published from January 1, 2013 to July 27, 2023. Primary outcomes included the presence, disclosure, and monetary value of COIs, while secondary outcomes assessed the presence of direct/indirect COIs, sponsor access to data, and associations between COIs and select variables, including journal impact factor, publication year, and study outcomes.
Results
Of 38 RCTs, 30 (78.9%) reported COIs. On average, 35.6% of authors per RCT had at least one COI, with a mean of 0.7 COIs per author. The mean annual monetary value of COIs was US$41,157.83 per author per RCT. 29 RCTs (76.3%) had undisclosed COIs, with an average of 24.2% of authors per RCT having undisclosed COIs. Sponsor access to data was reported in 67.6% of RCTs. No associations were observed between the mean percentage of authors with COIs and the monetary value of COIs and select dependent variables (impact factor, publication year, and study outcomes).
Conclusions
A substantial majority of RCTs reported COIs with many authors having undisclosed conflicts, highlighting the need for stringent COI disclosure guidelines to maintain research integrity. Expanding COI registry systems globally and increasing non-industry funding are crucial steps toward enhancing transparency and reducing biases in medical research.
Context: Conflict of interest has always been one of the challenges facing healthcare systems. The pharmaceutical sector is one of the main components of healthcare systems affected by conflicts of interest. Objectives: This systematic review investigated strategies to manage conflicts of interest in the pharmaceutical sector. Methods: In this systematic review, EMBASE, PubMed, Scopus, Web of Science, and Google Scholar were searched using the keywords "conflict of interest" and "pharmaceutical sector" without a time limitation until 2024. The quality of studies was assessed using JBI checklists. Results: A total of 6,217 records were retrieved from the databases, out of which 46 were included in the review. The main strategies for managing conflicts of interest include industry relationship management, empowerment, and transparency and disclosure. These strategies are carried out and supported by two mechanisms: Legislation and self-regulation. Conclusions: Conflicts of interest in the pharmaceutical sector can be addressed through the management of communications, empowerment, education, and, most importantly, transparency in financial and non-financial relationships. These efforts can be supported by government regulations or industry-based self-regulation. Such actions must be implemented and coordinated within the health system.
Objective
To assess the extent and types of financial ties to industry of panel and task force members of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders , fifth edition, text revision (DSM-5-TR), published in 2022.
Design
Cross sectional analysis.
Setting
Open Payments database, USA.
Participants
92 physicians based in the US who served as members of either a panel (n=86) or task force (n=6) on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Services Open Payments database during 2016-19. This period was chosen to include the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the American Psychiatric Association’s disclosure requirements for the fifth revision (DSM-5) of the manual.
Main outcome measures
Type and amount of compensation the panel and task force members of DSM-5-TR received during 2016-19.
Results
After duplicate names had been removed, 168 individuals were identified who served as either panel or task force members of the DSM-5-TR. 92 met the inclusion criteria of being a physician who was based in the US and therefore could be included in Open Payments. Of these 92 individuals, 55 (60%) received payments from industry. Collectively, these panel members received a total of $14.2m (£11.2m; €13m). One third (33.3%) of the task force members had payments reported in Open Payments.
Conclusions
Conflicts of interest among panel members of DSM-5-TR were prevalent. Because of the enormous influence of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be high. A rebuttable presumption should exist for the Diagnostic and Statistical Manual of Mental Disorders to prohibit conflicts of interest among its panel and task force members. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the panels, but they should not have decision making authority on revisions or the inclusion of new disorders.
Politicians, decision-makers, and public servants may be influenced by lobbyist gifts, which they receive or have the prospect to receive, resulting in detrimental effects on the fulfillment of their official duties. This paper provides an overview of how gifts given by lobbyists lead to influence by reviewing experimental evidence on various mechanisms that cause bias and distortions in attitudes, beliefs, judgments, decisions, and behavior. Additionally, it outlines factors that inhibit self-deception processes and discusses policy implications.
Based on the distinction drawn by R. A. Duff between attacks and endangerments as two different kind of wrongs, this paper advocates a view of the crime of conflict of interest in the public sector as implicit endangerment against government decisions. This view is supported by different empirical studies, which demonstrate that, in scenarios of conflict of interest, although agents do not act with a deliberate purpose of benefiting themselves, their decisions tend to privilege their private interests. In addition, it is argued that, according to the perspective defended, the scope of the offense should include interests and acts of a non-economic nature. It should be clarified that the purpose of this paper is to contribute to the development of a normative theory of negotiations incompatible with public office which determines how this crime should be regulated, regardless of the specific way in which each legislation defines such behavior.
The literature on corporate political activity (CPA) generally views nonmarket actions aimed at influencing political actors (e.g., lobbying or campaign contributions) as related but separate activities from market actions. This study demonstrates how firms’ core market actions (e.g., market entry or geographic expansion) can function as CPA. We theorize two mechanisms through which firms leverage market actions as CPA: “pork” (i.e., ones that primarily benefit a politician’s constituents) and “perk” (i.e., ones that directly benefit the politician). We document these mechanisms through an empirical analysis of data from the U.S. airline industry in 1990–2019. Specifically, we find that airlines increase the supply of flights from the airports in the home district of the chair of the Transportation Committee in the U.S. House of Representatives (pork). We also find that the airlines increase the supply of nonstop flights to Washington, DC. from the Chair’s district (perk). We use counterfactual estimation methods and exogenous turnovers in committee leadership to provide causal evidence. Moreover, the observed increase in flight supplies is negatively associated with formal policy changes in Congress, and with text mining techniques, we find that this effect is stronger for bills related to aviation safety and security. We contribute to the literature on CPA by demonstrating a blurred boundary between market and nonmarket actions, which helps explain firms’ competitive actions that cannot be explained by market considerations alone.
Supplemental Material: The online appendix is available at https://doi.org/10.1287/orsc.2022.17026 .
Objective:
Post-stroke depression is a depressive mood disorder that follows a cerebrovascular accident and is a burden on stroke patients. Its management is included in clinical practice guidelines focused on stroke, and the recommended treatment is selective serotonin reuptake inhibitors in conjunction with psychotherapy. Clinical practice guidelines are recommendations used to standardize best medical practice, but there is no current evaluation of guidelines containing post stroke depression recommendations. Thus, the objective is to appraise the selected guidelines manner of development and quality.
Materials and methods:
A systematic literature review across three databases and a manual google search was performed to collect guidelines that included recommendations on the management of post-stroke depression. 1236 guidelines were screened, and 27 were considered for inclusion. Considered guidelines were manually reviewed by the authors, and ultimately, 7 met inclusion criteria. The appraisal of guidelines for research and evaluation was used to evaluate these guidelines' recommendations around post-stroke depression.
Results:
Three guidelines met the threshold considered "High", with all of them having five or more quality domains eclipse the cutoff score of 70%. Across all guidelines, the highest scoring domains were "Scope and Purpose", "Clarity of Presentation", and "Editorial Independence" with scores of 76.98%, 73.81%, and 91.36% respectively. The lowest scoring domains were "Applicability", "Rigor of Development", and "Stakeholder Involvement" with respective scores of 58.73%, 54.02%, and 43.90%.
Conclusions:
The domains "Applicability", "Rigor of Development," and "Stakeholder Involvement" were the lowest scoring domains. These specific domains represent areas in which future guidelines could be more developed.
India is a low-middle income country with a population of 1.4 billion and home to one quarter of the world's children. Exclusive breastfeeding until 6 months and continued breastfeeding until at least 2 years as per global recommendations are common practice. The Indian government and associated organisations have strived to protect breastfeeding, which is important in a country with high under-5 mortality, malnutrition and stunting. Allergic disease is under-recognised in India, but despite the absence of a dedicated allergy medical specialty, awareness of allergy is increasing among healthcare practitioners and in the general population. In high-income countries, over diagnosis of allergy has become recognised as an issue in recent years. Allergy healthcare professionals have also attracted criticism for close relationships with the formula industry, which appear to have contributed to excessive use of specialised formula products and undermining of breastfeeding. Specialised formula has been used unnecessarily for preventing allergy, based on fraudulent and selectively reported science; and for managing normal infant symptoms which are mislabelled as milk allergy. This forms part of a broader formula industry corporate strategy to widen the boundaries of illness in order to expand sales and markets. In India, allergic disease management is hindered by limited understanding of the disease entity among practitioners, low access to diagnostics, limited healthcare resources, high exposure to air pollution and a large, diverse population. Data specific to India on allergic disease prevalence and interpreting allergy diagnostics are incomplete. The knowledge gaps mean allergy management in India is often extrapolated from guidance developed in high-income countries with low breastfeeding rates. As the allergy specialty develops in India, local guidance and practice will need to recognise the threat that current allergy practice poses to India's normative infant feeding culture, and ensure that breastfeeding continues to be supported at all levels.
K E Y W O R D S breastfeeding, milk allergy, over diagnosis, paediatrics
Objectives:
There has been growing concern about doctors' conflicts of interests (COIs) but it is unclear what processes and tools exist to enable the consistent declaration and management of such interests. This study mapped existing policies across a variety of organisations and settings to better understand the degree of variation and identify opportunities for improvement.
Design:
Thematic analysis.
Setting and participants:
We studied the COI policies of 31 UK and international organisations which set or influence professional standards or engage doctors in healthcare commissioning and provision settings.
Main outcome measures:
Organisational policy similarities and differences.
Results:
Most policies (29/31) referred to the need for individuals to apply judgement when deciding whether an interest is a conflict, with just over half (18/31) advocating a low threshold. Policies differed on the perception of frequency of COI, the timings of declarations, the type of interests that needed to be declared, and how COI and policy breaches should be managed. Just 14/31 policies stated a duty to report concerns in relation to COI. Only 18/31 policies advised COI would be published, while three stated that any disclosures would remain confidential.
Conclusions:
The analysis of organisational policies revealed wide variation in what interests should be declared, when and how. This variation suggests that the current system may not be adequate to maintain a high level of professional integrity in all settings and that there is a need for better standardisation that reduces the risk of errors while addressing the needs of doctors, organisations and the public.
Trotz ihrer weiten Verbreitung sind Wirkungen von Geschenken durch Lobbyisten an politische Entscheidungsträger untererforscht. Dieser Beitrag gibt einen Überblick über experimentelle Evidenz zu mannigfaltigen verhaltensökonomischen Mechanismen, die ursächlich eine Verzerrung von Einstellungen, Annahmen sowie letztlich Verhalten und Entscheidungen von Politikern durch Geschenke seitens Lobbyisten hervorrufen, ermöglichen oder erleichtern können. Zudem werden Faktoren dargestellt, die Selbsttäuschungsprozesse erschweren sowie Implikationen für die Eindämmung der Beeinflussbarkeit diskutiert.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Learning medical professionalism is a challenging, evolving, and life-long endeavor. Professionalism in Medicine: A Case-Based Guide for Medical Students helps begin this process by engaging students and their teachers in reflection on cases that resonate with the experiences of life in medicine. Through the book's seventy-two cases, commentaries, videos, and literature-based reviews, students explore the many challenging areas of medical professionalism. Readers will appreciate the provocative professionalism dilemmas encountered by students from the pre-clinical years and clinical rotations and by physicians of various specialities. Each case is followed by two commentaries by writers who are involved in health care decisions related to that case, and who represent a wide variety of perspectives. Authors represent 46 medical schools and other institutions and include physicians, medical students, medical ethicists, lawyers, psychologists, nurses, social workers, pharmacists, health care administrators, and patient advocates.
Internationally, efforts promoting greater transparency and improved management strategies for conflicts of interest (COI) have gained traction in healthcare settings. This particularly pertains to the development and use of clinical practice guidelines (CPG). Mounting evidence indicates that pharmaceutical industry payments to GPG authors and developers influence clinical recommendations, including drug selection, often to benefit commercial interests and at the expense of patients. To prevent undue influence of COI and develop trustworthy CPG, authors and developing organizations should establish strict COI management policies, including full disclosure. Such policies should include details about the monetary values and funding sources of all payments and gifts from pharmaceutical companies. Authors and developers should refuse any payments or gifts while drafting CPG. CPG developers should establish clear and comprehensive COI definitions and create monitoring committees that implement COI policies, promote external review, and track COI declared by CPG authors using existing payment databases.
Financial relationships between physicians and pharmaceutical and medical device companies (Industry) represent a conflict of interest (COI). A medical COI exists when any outside interest competes with the physician’s primary professional responsibility to place the patient first. Fraud and manifest bias represent one end of the COI spectrum. Subtler COI are more widespread and often problematic. Many scholars have advocated for the disclosure of Industry relationships to mitigate bias and preserve the benefits of collaboration. The Physician Payment Sunshine Act established the “Open Payments” database (OPD), in which companies are legally required to report all payments to U.S. physicians. Recent scholarly work using the OPD has identified that physicians routinely underdisclose Industry-related financial relationships. In this chapter we will discuss financial COI between neurologists and Industry. We review pertinent ethical issues and discuss potential solutions to enable neurologists to best work with Industry without compromising professional integrity.
The spread of misinformation and disinformation related to science and technology has impeded public and policy efforts to mitigate threats such as COVID-19 and anthropogenic climate change. In the digital age, such so-called fake science can propagate faster and capture the public imagination to a greater extent than accurate science. Therefore, ensuring the most reliable science reaches and is accepted by audiences now entails understanding the origins of fake science so that effective measures can be operationalized to recognize misinformation and inhibit its spread. In this chapter, we review the potential weaknesses of science publishing and assessment as an origin of misinformation; the interplay between science, the media, and society; and the limitations of literacy as an inoculation against misinformation; and we offer guidance on the most effective ways to frame science to engage non-expert audiences. We conclude by offering avenues for future science communication research.
David Sackett, the father of evidence-based medicine once said, “Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough”. This quote represents the delicate balance of evidence and opinion in the practice of evidence-based medicine (EBM) and evidence-based surgery (EBS). Doctors and surgeons alike are constantly dealing with an ever-changing environment, as well as individual patients who require individualized care. Therefore, while evidence from high-quality clinical trials should be considered, some evidence may not be applicable for an individual patient or situation. It is times like these, where a surgeon may need to seek out an expert opinion, either in person or within the literature. Currently, expert opinion is at the bottom of the hierarchy of evidence, yet it remains to be an integral part of the practice of EBS. Due to the importance of expert opinion in the practice of EBS, surgeons and surgeon-researchers need to understand what makes a reliable and trustworthy source. This chapter will outline, for the reader, the value and limitations of expert opinion, where expert opinion fits into surgery, and if it applies to the readers’ practice. Lastly, the reader will be given a set of questions that can be used to appraise the article, and the author of that article to ensure that the opinions stated can be trusted.KeywordsExpert opinionReliabilityDecision-makingOpinion in surgeryOpinion in medicine
Ethics has been a subject of medicine since the beginning of humankind for both physicians and patients. Ethical and morality theories of biomedical ethics should be a part of pain medicine. Beauchamp and Childress in their Principles of Biomedical Ethics , have described four principles essential for biomedical ethics: respect for autonomy, non maleficence, beneficence, and justice. Manchikanti et al. described the ethical issues of interventional pain management in the following terms: overuse, abuse, waste, and fraud; inappropriate application of EBM; and organizational issues related to multiple societies. The secondary interest of practice profit may play a large role in interventional pain management. Chronic pain patients face many difficulties including lack of relief exacerbated by iatrogenic or traumatic injuries. The ethical dictum of non maleficence, or do no harm, is strongly tested under these conditions.
Resumo Este artigo busca investigar conflitos de interesses envolvendo a apresentação de ensaios clínicos em congressos brasileiros de cinco especialidades médicas, ocorridos entre 2004 e 2018. Foram estudados 407 resumos em 22 anais. Após aplicar critérios de seleção, obteve-se um corpus de 77 ensaios. Detectou-se maior frequência de conflitos de interesses envolvendo ensaios com drogas para as quais não havia genéricos/similares ( p =0,000), sendo que em 48% daqueles em conflito de interesses não houve declaração. Os resultados favoráveis à droga-teste ocorreram em 90,9% do total de ensaios, mas em 48,6% deles não foi reportado valor de p . As categorias terapêuticas mais testadas foram imunossupressores e imunomoduladores, antidiabéticos e antineoplásicos, que, juntas, representaram 68,9% do total de drogas envolvidas. Os resultados apontam conflitos de interesses ocultos, supervalorização de resultados positivos de drogas-testes, nem sempre com evidências suficientes, e concentração de produção em drogas de alto custo.
This article seeks to investigate conflicts of interest involving the presentation of clinical trials in Brazilian congresses of five medical specialties between 2004 and 2018. A total of 407 abstracts in 22 annals were studied. After applying selection criteria, we reached a corpus of 77 essays. A higher frequency of conflicts of interest was found involving essays with drugs for which no generic/similar option was available (p=0.000), and 48% of those with a conflict of interest declared nothing. Favorable results to the test drug occurred in 90.9% of the total of essays, but 48.6% of them lacked the p-value. The most tested therapeutic categories were immunosuppressors and immunomodulators, antidiabetic, and antineoplastic, which, together, amounted to 68.9% of the total of the involved drugs. The results pointed to hidden conflicts of interest, overvaluing of positive results of test drugs, not always with sufficient evidence, and focus of production on high-cost drugs.
Resumen Este artículo analiza los conflictos de intereses en ensayos clínicos presentados en congresos brasileños de cinco especialidades médicas, realizados entre 2004 y 2018. Se analizaron 407 resúmenes de 22 anales. Tras aplicados los criterios de selección se obtuvo un corpus de 77 ensayos. Hubo una mayor frecuencia de conflictos de intereses en ensayos con medicamentos para los que no había medicaciones genéricas/similares ( p =0,000), y el 48% con conflictos no hubo su declaración. Los resultados favorables para droga prueba están en el 90,9% del total de ensayos, pero el 48,6% de ellos no informó el valor de p . Las categorías terapéuticas más probadas fueron inmunosupresores e inmunomoduladores, antidiabéticos y antineoplásicos, que juntas compusieron el 68,9% del total de fármacos. Los resultados apuntan a conflictos de intereses ocultos, sobreestimación de los resultados positivos de las drogas prueba, no siempre con evidencia suficiente, y concentración de la producción en medicamentos de alto costo.
Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care clinicians and the industry is necessary for the design and manufacture of these medical products. However, health care clinicians must recognize that their duties and the interests of the industry may at times diverge. Relationships with the industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care clinicians as targets of their efforts, and some of the interactions that occur between the industry and health care clinicians have the potential to alter decision making in ways that may not necessarily benefit patients. Health care clinicians have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. At a minimum, health care clinicians should be aware of the techniques used to attempt to alter their behavior and guard against them.
Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care providers and industry is necessary in the design, testing, and manufacture of these medical products. However, health care providers must recognize that their duties and the interests of industry may, at times, diverge. Relationships with industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care providers as a target of their efforts, and some of the interactions that occur between industry and health care providers have the potential to alter decision making in ways that may not necessarily benefit patients. Health care providers have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. Health care providers should be aware of the techniques used to attempt to alter their behavior and guard against them.
Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial. Moral corruption is all too familiar within churches and other ostensibly beneficent institutions, and it happens within medicine and the pharmaceutical industries. Corrupt behavior reduces trust, costs money, causes injustice, and arouses anger. Yet it persists, despite all efforts since the beginnings of societies. People who act corruptly may lack conscience and empathy in the same way as those with some personality disorders. Finding ways to prevent corruption from contaminating beneficent organizations is therefore likely to be frustratingly difficult. Transparency and accountability may go some way, but the determined corruptor is unlikely to feel constrained by moral and reporting requirements of this kind. Punishment and redress are complicated issues, unlikely to satisfy victims and society at large. Both perhaps should deal in the same currency-material or social-in which the corrupt dealing took place.
Context
Controversy exists over the fact that physicians have regular contact
with the pharmaceutical industry and its sales representatives, who spend
a large sum of money each year promoting to them by way of gifts, free meals,
travel subsidies, sponsored teachings, and symposia.Objective
To identify the extent of and attitudes toward the relationship between
physicians and the pharmaceutical industry and its representatives and its
impact on the knowledge, attitudes, and behavior of physicians.Data Sources
A MEDLINE search was conducted for English-language articles published
from 1994 to present, with review of reference lists from retrieved articles;
in addition, an Internet database was searched and 5 key informants were interviewed.Study Selection
A total of 538 studies that provided data on any of the study questions
were targeted for retrieval, 29 of which were included in the analysis.Data Extraction
Data were extracted by 1 author. Articles using an analytic design were
considered to be of higher methodological quality.Data Synthesis
Physician interactions with pharmaceutical representatives were generally
endorsed, began in medical school, and continued at a rate of about 4 times
per month. Meetings with pharmaceutical representatives were associated with
requests by physicians for adding the drugs to the hospital formulary and
changes in prescribing practice. Drug company–sponsored continuing medical
education (CME) preferentially highlighted the sponsor's drug(s) compared
with other CME programs. Attending sponsored CME events and accepting funding
for travel or lodging for educational symposia were associated with increased
prescription rates of the sponsor's medication. Attending presentations given
by pharmaceutical representative speakers was also associated with nonrational
prescribing.Conclusion
The present extent of physician-industry interactions appears to affect
prescribing and professional behavior and should be further addressed at the
level of policy and education.
There are few issues in medicine that bring clinicians into heated discussion
as rapidly as the interaction between the pharmaceutical industry and the
medical profession.1- 4
More than 5 billion of which goes to sales representatives.5- 6 It has been estimated that 13,000 is spent per year on each physician.7- 8
The attitudes about this expensive interaction are divided and contradictory.
One study9 found that 85% of medical students
believe it is improper for politicians to accept a gift, whereas only 46%
found it improper for themselves to accept a gift of similar value from a
pharmaceutical company. Most medical associations have published guidelines
to address this controversy. Perhaps the intensity of the discussion is related
to the potential consequences were it confirmed that gifts influence prescription
of medication that results in increasing cost or negative health outcomes.
This article addresses the question by way of a critical examination
of the evidence. Two review articles10- 11
have addressed the factors affecting drug prescribing, but only 1 has focused
on the impact of the physician-industry interaction on the behavior of physicians.12 This article critically examines the literature and
highlights articles with rigorous study methods.
To determine the effect of three types of interaction between physicians and the pharmaceutical industry--company-funded clinical trials, company-sponsored continuing medical education (CME) and information for physicians supplied by pharmaceutical detailers--on orientation and quality of clinical trials, content of CME courses and physicians' prescribing behaviour.
MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection.
A total of 227 papers from the MEDLINE and HEALTH searches and about 2000 items from the author's library were initially reviewed. The following selection criteria were used: studies conducted in Australia, Canada, New Zealand, Britain and the United States; studies conducted after 1977; quantitative surveys containing details of the survey methods; studies on the orientation and quality of company-funded clinical trials and on the content of CME courses giving explicit criteria used in the evaluation; and reports on the outcome of interactions stating how the outcomes were assessed. Thirty-six studies met these criteria.
Information was extracted on five topics: physicians' attitudes toward drug industry interactions, frequency with which physicians participate in the interactions, orientation and quality of company-funded clinical trials, content of company-sponsored CME courses and changes in physicians' prescribing behaviour as a result of an interaction.
Although most physicians participate only occasionally in company-sponsored clinical trials, most see detailers and attend company-sponsored CME courses. However, physicians do not have a very high opinion of the information from detailers or of company-sponsored CME events. Many doctors regard pharmaceutical companies as an important source of funding for clinical trials, but they also have concerns about accepting money from this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction.
Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices.
To the Editor.—
The article entitled "Doctors, Drug Companies, and Gifts"1 is surprising for its naïveté, yet is profoundly disturbing for its characterization of both physicians and drug companies. Drug companies spend their money to gain our attention, rather than our gratitude. Were we to live in a land where there was only one drug company, and it was controlled by the state, this would not be necessary. The authors state that three problems concern them. First, gifts cost patients money. Second, acceptance may erode common perception and threaten physician-patient relationships by altering prescribing habits. Finally, that obligation ensues that engenders relationships at patients' expense.The advertising business is such a pervasive force in our economy that it would be foolish to believe that the pharmaceutical industry alone would be immune. Television already directs advertisements at consumers, bypassing physicians. And numerous allied health professionals, including pharmacists, have a significant influence
OBJECTIVE: To compare physicians’ and their patients’ attitudes toward pharmaceutical gifts.
DESIGN: Survey of physicians and their patients.
SETTING: Two tertiary-care medical centers, one military and one civilian.
PARTICIPANTS: Two hundred sixty-eight of 392 consecutively surveyed physicians, 100 of 103 randomly selected patients at the military center, and 96 patients in a convenience sample at the civilian center completed the survey.
MEASUREMENTS: Participants rated 10 pharmaceutical gifts on whether they were appropriate for physicians to accept and whether they were likely to influence prescribing. Patients found gifts less appropriate and more influential than did their physicians. About half of the patients were aware of such gifts; of those unaware, 24% responded that this knowledge altered their perception of the medical profession. Asked whether they thought their own physician accepted gifts, 27% said yes, 20% no, and 53% were unsure. For patients, feeling that gifts were inappropriate was best predicted by a belief that gifts might influence prescribing, while for physicians, the best predictor was knowledge of guidelines.
CONCLUSIONS: Patients feel pharmaceutical gifts are more influential and less appropriate than do their physicians. Physicians may want to consider this in deciding whether to accept particular gifts. Broader dissemination of guidelines may be one means of changing physician behavior. At the same time, future guidelines should further consider the potentially different viewpoints of patients and physicians.
Previous experimental research has found that self-Serving biases are a major cause of negotiation impasses. In this study we show that a simple intervention can mitigate such biases and promote efficient settlement of disputes.
Two equity models were evaluated by fitting them to subjects' judgments of the fairness of payment distributions to “self” and “other” under hypothetical work situations. Neither the E. Walster, G. W. Walster, and E. Berscheid (Equity: Theory and Research, Boston: Allyn and Bacon, 1978) equity formulation nor Harris' (Journal of Experimental Social Psychology, 1976, 12, 194–209) linear model adequately accounted for the fairness judgments regardless of whether self worked more or less than other. Subjects also were asked to indicate their most preferred payment distributions and these preferences were significantly different from the fairness judgments. Results suggested that fairness judgments were influenced by a bias in the direction of overpayment to self.
When court trials (or arbitration) are the mechanisms for resolving bargaining impasses, the costs and risks associated with third-party intervention should motivate settlement (Henry Farber and Harry Katz, 1979). However, empirical evidence suggests that impasses and inefficient settlements are common in the legal system and in contract negotiations. For example, one study of asbestos suits found that only 37 cents of every dollar spent by both sides end up in the plaintiffs' hands (James Kakalik et al., 1983).
The authors explore the role that choice of comparison groups plays in explaining impasse in teacher contract negotiations. They hypothesize that the negotiators select 'comparable' districts in a biased fashion such that teachers' salaries in districts that unions view as comparable are higher than teachers' salaries in districts that school boards view as comparable. The authors also predict that strike activity is positively related to the difference in the salary levels of the unions' and boards' lists of comparables. They test these predictions using a unique combination of subjective survey and field data on teacher contract negotiations in Pennsylvania. Both hypotheses are supported by the data. Copyright 1996, the President and Fellows of Harvard College and the Massachusetts Institute of Technology.
We examined the impact on physician prescribing patterns of pharmaceutical firms offering all-expenses-paid trips to popular sunbelt vacation sites to attend symposia sponsored by a pharmaceutical company. The impact was assessed by tracking the pharmacy inventory usage reports for two drugs before and after the symposia. Both drugs were available only as intravenous preparations and could be used only on hospitalized patients. The usage patterns were tracked for 22 months preceding each symposium and for 17 months after each symposium. Ten physicians invited to each symposium were interviewed about the likelihood that such an enticement would affect their prescribing patterns. A significant increase in the prescribing pattern of both drugs occurred following the symposia. The usage of drug A increased from a mean of 81 +/- 44 units before the symposium to a mean of 272 +/- 117 after the symposium (p less than 0.001). The usage of drug B changed from 34 +/- 30 units before the symposium to 87 +/- 24 units (p less than 0.001) after the symposium. These changed prescribing patterns were also significantly different from the national usage patterns of the two drugs by hospitals with more than 500 beds and major medical centers over the same period of time. These alterations in prescribing patterns occurred even though the majority of physicians who attended the symposia believed that such enticements would not alter their prescribing patterns.
SOCIAL SCIENTISTS describe the "norm of reciprocity," or the obligation to help those who have helped you, as one of the fundamental principles that guides human interactions. It is not surprising, therefore, that pharmaceutical companies rely on this principle of human nature by giving gifts to physicians in hopes that they will prescribe their firms' products in return.
In the context of medicine, however, many feel that the act of accepting a gift has far-reaching ethical consequences that put the "gift" at too great a price.
The recent Senate hearings that investigated the use of gifts and other extravagant marketing practices of the pharmaceutical industry were conducted primarily out of concern that these expensive promotional schemes were raising the prices of drugs while offering no benefit to consumers.
The concern has been repeated often in the medical literature. John Nelson, MD, immediate past president of the Utah Medical Association and
To determine the nature, frequency and effects of internal medicine housestaff and faculty contacts with pharmaceutical representatives (PRs).
The authors surveyed internal medicine faculty at seven midwest teaching hospitals and housestaff from two of the teaching programs. The survey asked about type and frequency of contacts with PRs and behavior that might be related to these contacts. T-tests and logistic regression were used to estimate the relationship between reported physician contacts and behavioral changes.
Two hundred forty faculty (78%) and 131 house officers (75%) responded to the survey.
Faculty and housestaff averaged 1.5 brief contacts per month with PRs. Housestaff averaged more than one meal/month at pharmaceutical company expense. Twenty-five percent of faculty and 32% of residents reported changing their practices at least once based on PR contact. Independent predictors of faculty change in practice were brief or extended conversations and free meals. Predictors of faculty requests for formulary addition were brief conversations and receipt of honoraria or research support. Only brief conversations independently predicted housestaff changes in practice.
Academic housestaff and faculty have frequent PR contact; such contact is related to changes in behavior. The potential for influence of PRs in academic medical centers should be recognized, and their activities should be evaluated accordingly.
We surveyed faculty and residents from seven hospitals affiliated with three academic internal medicine training programs about their perceptions of the informational and service benefits vs the risks of ethical compromise involved in interactions with pharmaceutical sales representatives. Questionnaires were returned by 467 (81%) of 575 physicians surveyed. Residents and faculty generally had somewhat negative attitudes toward the educational and informational value of detailing activities at their institutions but indicated that representatives supported important conferences and speakers. Residents were more likely than faculty to perceive contacts with sales representatives as potentially influencing physician decision making. Sixty-seven percent of faculty and 77% of residents indicated that physicians could be compromised by accepting gifts. More than half of the physicians who suggested that such compromise was possible indicated that acceptance of gifts worth more than +100 from drug companies would be likely to compromise a physician's independence and objectivity. A majority of both faculty and house staff favored eliminating presentations by pharmaceutical representatives at their hospitals. Only 10% thought they had had sufficient training during medical school and residency regarding professional interaction with sales representatives.
A survey of a national sample of family physicians was undertaken to investigate several aspects of attitudes and prescribing patterns related to generic drugs. Questionnaires were returned by 317 of 501 eligible respondents for a response rate of 63.3 percent. Of the respondents, 62.5 percent said they had enough confidence in generic drugs to prescribe them in their practices, but only 26.9 percent said they actually prescribed mostly generics. Respondents were also asked to indicate the relative importance of several potential sources of information on new drugs and to test their ability to recognize a list of generic and trade name drugs. Several associations were identified between physicians' sources of drug information and generic drug recognition, attitudes, and prescription patterns. The habit of prescribing mostly generic drugs, for example, was found to be more common among family physicians who were residency trained, who relied least on drug company representatives, and who were regular readers of the New England Journal of Medicine. The ability to recognize all ten generic names was found to be highest among these same groups of physicians and also among those who relied least on journal advertisements and those who were regular readers of The Medical Letter.
To evaluate the educational effect on residents of a grand rounds given by a pharmaceutical company employee.
Using a retrospective cohort study design, the authors questioned 75 housestaff at a university hospital three months after a February 1990 grand rounds on Lyme disease to determine whether the residents' beliefs about the drug of choice for this disease differed between attendees and non-attendees. Odds ratios, 95% confidence intervals, and logistic regression were used for the analysis of results.
The 22 housestaff who had attended the grand rounds were more likely to choose appropriately the cephalosporin manufactured by the speaker's company over other drugs for patients with Lyme disease presenting with second-degree heart block (adjusted odds ratio of 8.4; 95% CI 2.1-38.9). However, they also chose it inappropriately for first-degree heart block (adjusted odds ratio of 7.8; 95% CI 1.6-45.5). None of the attendees, compared with 11 (21%) of the non-attendees, named an oral antibiotic for both of two milder presentations, even though oral therapy would be more appropriate (p = .027).
The results suggest that grand rounds effectively change residents' beliefs, but a sponsoring company's drug may be favored. Information assimilated in this way may not be well supported by the scientific literature and could result in a choice of treatment that is more expensive than other acceptable treatments.
To evaluate the influence of primary care physicians' attitudes toward and use of information provided by pharmaceutical representatives on prescribing costs in ambulatory practice.
A mailed questionnaire collected information about physician demographic and practice characteristics and attitudes toward and use of information provided by pharmaceutical representatives.
Kentucky physicians practicing primary care adult medicine (family medicine, general practice, general medicine; n = 1603).
Relative cost of prescribing, based on physician responses to treatment choices for ambulatory clinical scenarios in primary care. A multivariable regression model assessed predictive relationships between independent variables and prescription costs.
Four hundred forty-six returned questionnaires were suitable for analysis. No significant differences were noted in age, gender, days worked per week, or years since graduation between responders and a sample of nonresponders. A significant positive correlation was found between physician cost of prescribing and perceived credibility, availability, applicability, and use of information provided by pharmaceutical representatives (P < .01, Pearson's Product-Moment Correlation Coefficient). Physicians in academic or hospital-based practice settings had significantly lower prescribing costs than physicians in nonacademic and nonhospital practices (P = .001, analysis of variance). Frequency of use of information provided by pharmaceutical representatives (P = .01, multiple linear regression) and the group practice setting (P = .02, multiple linear regression) remained significant, independent positive predictors of cost in the multivariable regression model.
Frequency of use of information provided by pharmaceutical representatives and the group practice, nonacademic and nonhospital setting may be associated with increased primary care physician prescribing costs.
Little is known about the factors that influence housestaff attitudes toward pharmaceutical industry promotions or, how such attitudes correlate with physician behaviors. We studied these attitudes and practices among internal medicine housestaff.
Confidential surveys about attitudes and behaviors toward industry gifts were distributed to 1st- and 2nd-year residents at a university-based internal medicine residency program.
Ninety percent of the residents (105 of 117) completed the survey. A majority of respondents considered seven of nine types of promotions appropriate. Residents judged the appropriateness of promotions on the basis of their cost (median percentage of items considered appropriate 100% for inexpensive items vs. 60% for expensive ones) more than on the basis of their educational value (80% for educational items vs.75% for noneducational ones; P < .001 for comparison of appropriateness based on cost vs. educational value). Behaviors were often inconsistent with attitudes; every resident who considered conference lunches (n = 13) and pens (n = 18) inappropriate had accepted these gifts. Most respondents (61%)stated that industry promotions and contacts did not influence their own prescribing, but only 16% believed other physicians were similarly unaffected (P< .0001). Nonetheless, more than two thirds of residents agreed that it is appropriate for a medical institution to have rules on industry interactions with residents and faculty.
Residents hold generally positive attitudes toward gifts from industry, believe they are not influenced by them, and report behaviors that are often inconsistent with their attitudes. Thoughtful education and policy programs may help residents learn to critically appraise these gifts.
The authors review studies conducted by themselves and coauthors that document a 'self-serving' bias in judgments of fairness and demonstrate that the bias is an important cause of impasse in negotiations. They discuss experimental evidence showing that (1) the bias causes impasse; (2) it is possible to reduce impasses by debiasing bargainers; and (3) the bias results from selective evaluation of information. The authors also review results from a field study of negotiations between teachers' unions and school boards in Pennsylvania that both document the fairness bias in a naturalistic setting and demonstrates its impact on strikes. Copyright 1997 by American Economic Association.
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