Differences in the Volume of Pharmaceutical Advertisements between Print General Medical Journals

Background

Pharmaceutical advertisements have been argued to provide revenue that medical journals require but they are intended to alter prescribing behaviour and they are known to include low quality information. We determined whether a difference exists in the current level of pharmaceutical advertising in print general medical journals, and we estimated the revenue generated from print pharmaceutical advertising.

Methods

Six print general medical journals in Canada, the United States, and the United Kingdom were sampled between 2007 and 2012. The number of advertisements and other journal content in selected issues of the Canadian Medical Association Journal (CMAJ), Canadian Family Physician (CFP), Journal of the American Medical Association (JAMA), New England Journal of Medicine (NEJM), British Medical Journal (BMJ), and Lancet were determined. Revenue gained from pharmaceutical advertising was estimated using each journal''s 2013 advertising price list.

Findings

The two Canadian journals sampled (CMAJ, CFP) contained five times more advertisements than the two American journals (JAMA, NEJM), and two British journals (BMJ, Lancet) (p<0.0001). The estimated annual revenue from pharmaceutical advertisements ranged from £0.025 million (for Lancet) to £3.8 million (for JAMA). The cost savings due to revenue from pharmaceutical advertising to each individual subscriber ranged from £0.02 (for Lancet) to £3.56 (for CFP) per issue.

Conclusion

The volume of pharmaceutical advertisements differs between general medical journals, with the two Canadian journals sampled containing the most advertisements. International and temporal variations suggest that there is an opportunity for all general medical journals to reduce the number of pharmaceutical advertisements, explore other sources of revenue, and increase transparency regarding sources of revenue.     

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing

Background

Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.

Methods and Findings

Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.

Conclusions

Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.     

Quality of Pharmaceutical Care in Surgical Patients

Background

Surgical patients are at risk for preventable adverse drug events (ADEs) during hospitalization. Usually, preventable ADEs are measured as an outcome parameter of quality of pharmaceutical care. However, process measures such as QIs are more efficient to assess the quality of care and provide more information about potential quality improvements.

Objective

To assess the quality of pharmaceutical care of medication-related processes in surgical wards with quality indicators, in order to detect targets for quality improvements.

Methods

For this observational cohort study, quality indicators were composed, validated, tested, and applied on a surgical cohort. Three surgical wards of an academic hospital in the Netherlands (Academic Medical Centre, Amsterdam) participated. Consecutive elective surgical patients with a hospital stay longer than 48 hours were included from April until June 2009. To assess the quality of pharmaceutical care, the set of quality indicators was applied to 252 medical records of surgical patients.

Results

Thirty-four quality indicators were composed and tested on acceptability and content- and face-validity. The selected 28 candidate quality indicators were tested for feasibility and ‘sensitivity to change’. This resulted in a final set of 27 quality indicators, of which inter-rater agreements were calculated (kappa 0.92 for eligibility, 0.74 for pass-rate). The quality of pharmaceutical care was assessed in 252 surgical patients. Nearly half of the surgical patients passed the quality indicators for pharmaceutical care (overall pass rate 49.8%). Improvements should be predominantly targeted to medication care related processes in surgical patients with gastro-intestinal problems (domain pass rate 29.4%).

Conclusions

This quality indicator set can be used to measure quality of pharmaceutical care and detect targets for quality improvements. With these results medication safety in surgical patients can be enhanced.     

Citability of Original Research and Reviews in Journals and Their Sponsored Supplements

Background

The contents of pharmaceutical industry sponsored supplements to medical journals are perceived to be less credible than the contents of their parent journals. It is unknown if their contents are cited as often. The objective of this study was to quantify the citability of original research and reviews contained in supplements and compare it with that for the parent journal.

Methodology/Principal Findings

This was a cohort study of 446 articles published in the Journal of Clinical Psychiatry (JCP) and its supplements for calendar years 2000 and 2005. The total citation counts for each article up to October 5, 2009 were retrieved from the ISI Web of Science database. The main outcome measure was the number of citations received by an article since publication. Regular journal articles included 114 from calendar year 2000 and 190 from 2005. Articles from supplements included 90 from 2000 and 52 from 2005. The median citation counts for the 3 years post-publication were 10 (interquartile range [IQR], 4–20), 14 (IQR, 8–20), 13.5 (IQR, 8–23), and 13.5 (IQR, 8–20), for the 2000 parent journal, 2000 supplements, 2005 parent journal, and 2005 supplements, respectively. Citation counts were higher for the articles in the supplements than the parent journal for the cohorts from 2000 (p = .02), and no different for the year 2005 cohorts (p = .88). The 2005 parent journal cohort had higher citation counts than the 2000 cohort (p = .007), in contrast to the supplements where citation counts remained the same (p = .94).

Conclusions/Significance

Articles published in JCP supplements are robustly cited and thus can be influential in guiding clinical and research practice, as well as shaping critical thinking. Because they are printed under the sponsorship of commercial interests, they may be perceived as less than objective. A reasonable step to help improve this perception would be to ensure that supplements are peer-reviewed in the same way as regular articles in the parent journal.     

Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue - cohort study

Background

Transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials'' influence on journal impact factors and revenue.

Methods and Findings

We sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996–1997 and 2005–2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005–2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005–2006.

Conclusions

Publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals'' revenue and impact. Please see later in the article for the Editors'' Summary     

Fifty-Year Fate and Impact of General Medical Journals

Background

Influential medical journals shape medical science and practice and their prestige is usually appraised by citation impact metrics, such as the journal impact factor. However, how permanent are medical journals and how stable is their impact over time?

Methods and Results

We evaluated what happened to general medical journals that were publishing papers half a century ago, in 1959. Data were retrieved from ISI Web of Science for citations and PubMed (Journals function) for journal history. Of 27 eligible journals publishing in 1959, 4 have stopped circulation (including two of the most prestigious journals in 1959) and another 7 changed name between 1959 and 2009. Only 6 of these 27 journals have been published continuously with their initial name since they started circulation. The citation impact of papers published in 1959 gives a very different picture from the current journal impact factor; the correlation between the two is non-significant and very close to zero. Only 13 of the 5,223 papers published in 1959 received at least 5 citations in 2009.

Conclusions

Journals are more permanent entities than single papers, but they are also subject to major change and their relative prominence can change markedly over time.     

High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey

Introduction

International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported.

Method

Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industry-initiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.

Results

With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation.

Conclusion

Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country''s compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.     

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

Objective

To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.

Materials and Methods

Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.

Results

Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.

Discussion

Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.     

Increased Prevalence of Diabetes in Argentina Is Due to Easier Health Care Access Rather than to an Actual Increase in Prevalence

Introduction

According to the Argentine National Risk Factor Survey (ANRFS), between 2005 and 2009, self-reported Diabetes increased in Argentina from 8.4% to 9.6%, accompanied by a raise in the prevalence of obesity and low physical activity. In the same period, it also increased blood sugar checks from 69.3% to 75.7%. Since surveillance data in Argentina rely on self-reports, the estimated prevalence of diabetes may be affected by an increase in the proportion of subjects with access to preventive services. We evaluated the independent effect of a recent blood sugar check, on the increase in self-reported diagnoses of diabetes between 2005 and 2009.

Materials and Methods

A secondary analysis of data from the 2005 and 2009 ANRFS was performed. Diabetes was defined as having been diagnosed Diabetes or high blood sugar by a health professional, obesity was calculated as BMI≥30 kg/m², based on self-reported height and weight and physical activity was measured using the International Physical Activity Questionnaire. We used logistic regression models to explore the relationship between prevalence of self-reported diabetes and recent blood sugar check as the main predictor.

Results

The prevalence of diabetes rose from 8.4% to 9.6%; obesity from 14.5% to 18% and low physical activity from 46.2% to 55%, between 2005 and 2009. Among those who recently checked their blood sugar no differences were found in the prevalence of diabetes: 13% in 2005 vs. 13.2% in 2009. Findings of the multivariable analysis showed that obesity and low physical activity were significantly associated with self reported diabetes in the adjusted model (OR = 1.80 for obesity, and OR = 1.12 for low physical activity but the strongest predictor was recent blood sugar check (OR = 4.75).

Discussion

An increased prevalence of self-reported diabetes between 2005 and 2009 might indicate an improvement in the access to preventive services rather than a positive increase in the prevalence of diabetes.     

Trends in the Incidence of Lower Extremity Amputations in People with and without Diabetes over a Five-Year Period in the Republic of Ireland

Aims

To describe trends in the incidence of non-traumatic amputations among people with and without diabetes and estimate the relative risk of an individual with diabetes undergoing a lower extremity amputation compared to an individual without diabetes in the Republic of Ireland.

Methods

All adults who underwent a nontraumatic amputation during 2005 to 2009 were identified using HIPE (Hospital In-patient Enquiry) data. Participants were classified as having diabetes or not having diabetes. Incidence rates were calculated using the number of discharges for diabetes and non-diabetes related lower extremity amputations as the numerator and estimates of the resident population with and without diabetes as the denominator. Age-adjusted incidence rates were used for trend analysis.

Results

Total diabetes-related amputation rates increased non-significantly during the study period; 144.2 in 2005 to 175.7 in 2009 per 100,000 people with diabetes (p = 0.11). Total non-diabetes related amputation rates dropped non-significantly from 12.0 in 2005 to 9.2 in 2009 per 100,000 people without diabetes (p = 0.16). An individual with diabetes was 22.3 (95% CI 19.1–26.1) times more likely to undergo a nontraumatic amputation than an individual without diabetes in 2005 and this did not change significantly by 2009.

Discussion

This study provides the first national estimate of lower extremity amputation rates in the Republic of Ireland. Diabetes-related amputation rates have remained steady despite an increase in people with diabetes. These estimates provide a base-line and will allow follow-up over time.     

Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials

Objective

In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world’s largest clinical trial registry.

Materials and Methods

We considered two trial result artifacts: (1) existence of a trial result journal article that is formally linked to a registered trial or (2) the deposition of a trial’s basic summary results within the registry.

Results

The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2%) had no structured trial-article link present. A total of 2367 trials (26.6%) deposited basic summary results within the registry. Of those , 969 trials (10.9%) were classified as trials with extended results and 1398 trials (15.7%) were classified as trials with only required basic results. The majority of the trials (54.8%) had no evidence of results, based on either linked result articles or basic summary results (silent trials), while a minimal number (9.2%) report results through both registry deposition and publication.

Discussion

Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the “trialome”). Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased.

Conclusion

Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.     

Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

Background

Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments.Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs.

Methods and Findings

We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall.We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes.The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs.

Conclusions

In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors'' Summary     

The clinical characteristics and direct medical cost of influenza in hospitalized children: a five-year retrospective study in suzhou, china

Background

There have been few studies on children hospitalized with influenza published from mainland China. We performed a retrospective review of medical charts to describe the epidemiology, clinical features and direct medical cost of laboratory-proven influenza hospitalized children in Suzhou, China.

Methods

Retrospective study on children with documented influenza infection hospitalized at Suzhou Children Hospital during 2005–2009 was conducted using a structured chart review instrument.

Results

A total of 480 children were positive by immuno-fluorescent assay for influenza during 2005–2009. The hospitalizations for influenza occurred in 8–12 months of the year, most commonly in the winter with a second late summer peak (August-September). Influenza A accounted for 86.3%, and of these 286 (59.6%) were male, and 87.2% were <5 years of age. The median length of hospital stay was 7 days. Fever was the most common symptom, occurring in 398 (82.9%) children. There were 394 (82.1%) children with pneumonia and 70.2% of these hospitalized children had radiographic evidence of a pulmonary infiltrate. One hundred and twelve children (23.3%) required oxygen treatments and 13 (2.7%) were transferred to the ICU. Multivariable logistic regression showed that compared with the ≤6 months children, those aged >60 months old had shorter hospital stay (OR = 0.45); children with oxygen treatment tended to have longer hospital stays than those without oxygen treatment (OR = 2.14). The mean cost of each influenza-related hospitalization was US$ 624 (US$ 1323 for children referred to ICU and US$ 617 for those cared for on the wards). High risk children had higher total cost than low-risk patients.

Conclusion

Compared to other countries, in Suzhou, children hospitalized with influenza have longer hospital stay and higher percentage of pneumonia. The direct medical cost is high relative to family income. Effective strategies of influenza immunization of young children in China may be beneficial in addressing this disease burden.     

Sugar Sweetened Beverages and Weight Gain over 4 Years in a Thai National Cohort – A Prospective Analysis

Introduction

Sugar sweetened beverages (SSBs) are implicated in the rising prevalence of obesity and diet-related chronic diseases worldwide. However, little is known about their contribution to weight gain in Asian populations. This study aimed to investigate weight change associated with SSB consumption between 2005 and 2009 in a large national cohort of Thai university students.

Methods

Questionnaire data were collected from a large Thai cohort (the Thai Health-Risk Transition: a National Cohort Study). The analysis was based on responses from 59 283 of the 60 569 (98%) cohort members who had valid SSB consumption and weight variables in 2005 and 2009. The relationship between SSB consumption in 2005 and self-reported weight change was analysed using multiple linear regression models controlled for socio-demographic, activity and (non-validated) dietary factors shown to influence weight.

Results

Higher frequency of SSB consumption in 2005 was significantly associated with greater weight gain between 2005 and 2009 in all age groups and in both sexes (p<0.0001); persons who consumed SSBs at least once a day in 2005 gained 0.5 kg more than those who consumed SSBs less than once a month. The estimated weight gain for the average person in the sample was 1.9 kg (95% C I 1.95–1.96). The difference in weight gain between those who increased their consumption frequency (<once a month to > once per day) between 2005 and 2009 compared to those who maintained it was 0.3 kgs, while persons who reduced their consumption frequency (once a day to > once a month) gained 0.2 kgs less than those whose consumption remained unchanged.

Conclusion

SSB consumption is independently associated with weight gain in the Thai population. Research and health promotion in Thailand and other economically transitioning countries should focus on reducing their contribution to population weight gain and to diet-related chronic diseases.     

Can We Depend on Investigators to Identify and Register Randomized Controlled Trials?

Purpose

To reduce publication bias, systematic reviewers are advised to search conference abstracts to identify randomized controlled trials (RCTs) conducted in humans and not published in full. We assessed the information provided by authors to aid identification of RCTs for reviews.

Methods

We handsearched the Association for Research in Vision and Ophthalmology (ARVO) meeting abstracts for 2004 to 2009 to identify reports of RCTs. We compared our classification with that of authors (requested by ARVO 2004–2006), and authors’ report of trial registration (required by ARVO 2007–2009).

Results

Authors identified their study as a clinical trial for 169/191 (88%; 95% CI, 84–93) RCTs we identified for 2004, 174/212 (82%; 95% CI, 77–87) for 2005 and 162/215 (75%; 95% CI, 70–81) for 2006. Authors provided registration information for 107/172 (62%; 95% CI, 55–69) RCTs for 2007, 103/153 (67%; 95% CI, 60–75) for 2008, and 126/171 (74%; 95% CI, 67–80) for 2009. Most RCT authors providing a trial register name specified ClinicalTrials.gov (276/312; 88%; 95% CI, 85–92) and provided a valid ClinicalTrials.gov registration number (261/276; 95%; 95% CI, 92–97). Based on information provided by authors, trial registration information would be accessible for 48% (83/172) (95% CI, 41–56) of all ARVO abstracts describing RCTs in 2007, 63% (96/153) (95% CI, 55–70) in 2008, and 70% in 2009 (118/171) (95% CI, 62–76).

Conclusions

Authors of abstracts describing RCTs frequently did not classify them as clinical trials nor comply with reporting trial registration information, as required by the conference organizers. Systematic reviewers cannot rely on authors to identify relevant unpublished trials or report trial registration, if present.     

Quality of pharmaceutical industry press releases based on original research

Background

Press releases are a popular vehicle to disseminate health information to the lay media. While the quality of press releases issued by scientific conferences and medical journals has been questioned, no efforts to assess pharmaceutical industry press releases have been made. Therefore, we sought to systematically examine pharmaceutical company press releases about original research for measures of quality.

Methodolgy/Principal Findings

Press releases issued by the ten top selling, international pharmaceutical companies in the year 2005 were selected for evaluation. A total of 1028 electronic press releases were issued and 235 were based on original research. More than half (59%) reported results presented at a scientific meeting. Twenty-one percent of releases were not explicit about the source of original data. While harms or adverse events were commonly cited (76%), study limitations were rarely noted (6%). Almost one-third (29%) of releases did not quantify study results. Studies presented in abstract form were subsequently published within at least 20 months in 53% of cases.

Conclusions

Pharmaceutical company press releases frequently report basic study details. However, readers should be cautioned by the preliminary nature of the data and lack of identified limitations. Methods to improve the reporting and interpretation of drug company press releases are desirable to prevent misleading media coverage.