Special Article
The Publication of Sponsored Symposiums in Medical Journals
N Engl J Med 1992; 327:1135-1140October 15, 1992
- Abstract
- Abstract
Background.
An increasing proportion of spending by the pharmaceutical industry has gone to funding symposiums that are published by peer-reviewed medical journals. This study tests the hypothesis that such sponsorship, particularly by a single pharmaceutical company, is associated with a promotional orientation of the symposium and a distortion of the peer-review process.
Methods.
We counted the symposiums published in 58 journals of clinical medicine and surveyed the journal editors regarding their policies for symposium issues. We analyzed the symposium issues that appeared in the 11 journals that published the most symposiums in order to determine the sponsor or sponsors, the topics, whether the titles were misleading, whether brand names were used, and whether the featured drugs were classified by the Food and Drug Administration as innovative or approved.
Results.
The number of symposiums published per year increased steadily from 1966 through 1989. forty-two percent of those analyzed (262 of 625) had a single pharmaceutical company as the sponsor. These symposiums were more likely than those with other sponsors to have misleading titles (P<0.001) and to use brand names (P<0.001), and less likely to be peer-reviewed in the same manner as other articles in the parent journal (P<0.001). Of the 161 symposiums that focused on a single drug, 51 percent concerned unapproved therapies; 14 percent concerned drugs classified as bringing important therapeutic gains.
Conclusions.
Symposiums sponsored by drug companies often have promotional attributes and are not peer-reviewed. Financial relations among symposium participants, sponsors, and journals should be completely disclosed, symposiums should be clearly identified, and journal editors should maintain editorial control over contributions from symposiums. (N Engl J Med 1992;327: 1135–40.)
Media in This Article
Figure 1
Symposiums That Met (Solid Bars) and That Did Not Meet (Hatched Bars) the Gold Standard for Publication, According to Category of Sponsor.Table 1
Characteristics of 625 Symposiums, According to Category of Sponsor.*Article Activity
- Article
AN increasing proportion of marketing expenses of the pharmaceutical industry has gone to funding symposiums, with funding rising from $6 million in 1975 (adjusted for inflation to 1988 dollars) to $86 million in 1988.1 Although the number of sponsored symposiums published in one cardiology journal has increased, the extent of symposium publication within the clinical literature as a whole has not been determined.2 Given that advertising influences prescribing, we hypothesized that industry spending on symposiums had increased because the symposiums serve as a vehicle for marketing the industry's products.3 4 5 6 Anecdotal reports suggest that there is a promotional orientation in some published symposiums.7 , 8 This study analyzes the relation between the type of sponsorship and promotional characteristics, such as the focus on a single drug rather than on a cross section of the latest advances in biomedicine, the featuring of noninnovative ("me-too") drugs that are difficult to sell in a highly competitive market, and the featuring of unapproved drugs that cannot be legally advertised.
Commercial pressure from the pharmaceutical industry could distort the peer-review process of publication in medical journals. Sponsoring companies could bypass this process by selecting the topic of a symposium, selecting and paying the guest editor and speakers, selecting and editing the papers that are published, and paying the journal to obtain editorial control. We examine the published policies of editorial review for symposiums and describe the results of a survey of journal editors and their policies with regard to such publications.
Methods
A symposium was defined as a collection of papers published as a separate issue or as a special section in a regular issue of a medical journal. Special editions, issues with single themes, and collections of abstracts from meetings were not classified as symposiums.
Selection of Journals and Identification of Symposiums
Fifty-eight journals were selected for the study on the basis of their citation rates and clinical readership. We identified the 100 medical journals that had the highest citation rates in 1987 according to SCI Journal Citation Reports, and we used the presence of a drug advertisement in the journal as a proxy for clinical readership.
A computer search of the MEDLINE data base for the words "symposia," "symposium," "proceeding," and "congress" in the journal title identified symposiums published by the 58 journals from January 1, 1966, through December 31, 1989. Data from the survey of journal editors were used to supplement the MEDLINE data. Eleven journals that had published 10 or more symposiums from 1980 through 1989 were selected for the content analysis: American Heart Journal, American Journal of Cardiology, American Journal of Medicine, American Journal of Obstetrics and Gynecology, British Journal of Anaesthesia, Cancer, Circulation, Hypertension, Journal of Allergy and Clinical Immunology, Kidney International, and Transplantation Proceedings. At the medical library of the University of California, San Francisco, we found 625 symposiums, 314 of which (50 percent) were identified by the MEDLINE search. (A complete list of the 625 symposiums analyzed is available through the National Auxiliary Publications Service.*) The rate of identification of symposiums through MEDLINE was poor, because the key words used to identify symposiums were not systematically entered by the coders at the National Library of Medicine before 1991 (Kotzin S, National Library of Medicine: personal communication).Data were collected to examine the correlation between the financial support the journals received from the drug industry and the publication of symposiums. The percentage of subscriptions that are paid for and the page ratio of advertisements to editorial copy were used as indicators of financial support.9 To test the hypothesis that smaller journals were more likely to publish symposiums in order to increase revenues, we determined whether journals with low citation rates and small circulations published more symposiums than journals with higher citation rates and larger circulations. Data on the ratio of advertising space to copy, the percentage of paid subscriptions, circulation, and publisher were collected from Business Publication Rates and Data,10 Ulrich's International Periodicals Directory,11 the survey of editors, and the journals themselves.
*See NAPS document no. 04979 for 40 pages of supplementary material. Order from NAPS c/o Microfiche Publications, P.O. Box 3513, Grand Central Station, New York, NY 10163–3513. Remit in advance (in U.S. funds only) $13.75 for the first 20 pages plus $.30 per additional page for photocopies, or $4 for microfiche. Outside the U.S. and Canada add postage of $4.50 for the first 20 pages and $1 for each 10 pages thereafter ($1.50 for microfiche postage).
Characteristics of Symposiums
For each symposium issue studied, data were collected on sponsorship, misleading titles, the symposium topic, the use of brand names, and the editorial-review process. The symposium sponsor was determined to be one of the following: (1) a single pharmaceutical company; (2) more than one such company; (3) one or more pharmaceutical companies plus a nonpharmaceutical organization; (4) another, nonpharmaceutical sponsor or sponsors, including universities, medical societies, government, and foundations; and (5) no sponsor mentioned.
The title of a symposium was considered misleading (1) if it did not refer to drugs (instead mentioning "frontiers," "horizons," or "outcome measures," for example) but the topic of at least half the papers was drugs or (2) if the title referred to drugs generally (such as "new treatments" or "new therapies") but at least half the papers described treatment with a single drug. The authors reached a consensus about the ratings for the titles.
A symposium topic was considered "nondrug" if at least half the articles did not describe studies involving pharmaceuticals (e.g., describing surgical interventions or quality-of-life measures). It was considered "single drug" if at least half the articles focused on a single drug (e.g., a clinical trial repeatedly comparing one drug to other drugs, or a pharmacokinetic study). The topic was considered "multiple drug" if at least half the articles described the results of studies involving more than one drug without featuring any particular one (e.g., a comparison of a variety of drugs with a surgical intervention). A symposium was considered to use brand names if the brand name of a pharmaceutical product appeared at least once in any section other than the Methods section. If the masthead of the symposium issue listed the same editorial staff members as the regular issues of the journal or if the symposium was part of a regular journal issue, the review process was classified as the "same" as that of the journal. By assuming that a symposium issue with a masthead was reviewed in the same way as other articles in the journal, we may have overestimated the number of peer-reviewed symposiums. The review was considered "special" if the process was described, but differed from that of the journal.
When the topic of a symposium was a single drug, we determined the therapeutic class of the drug12 13 14 (with additional data from pharmaceutical companies and the symposium), the drug's date of approval by the Food and Drug Administration12 , 15 (with additional data from pharmaceutical companies), and the therapeutic rating assigned to the drug by the FDA. A therapeutic rating of A denoted important therapeutic gain, B modest therapeutic gain, and C little or no therapeutic gain.12
Survey of Journal Editors
A confidential questionnaire was mailed to the editors of the 58 journals selected for the study. A second mailing yielded a response rate of 81 percent (47 of 58). Thirty-eight respondents were editors of journals that had published symposiums between 1966 and 1989, and nine were editors of journals that had not. The response rates for journals that published symposiums (79 percent) and those that did not (90 percent) did not differ significantly (P = 0.725). The questionnaire also asked the editors' opinions of symposiums, their editorial policies toward them, and the financial arrangements for their publication.
Statistical Analysis
The median values for continuous variables were compared by the Kruskal—Wallis test, because the distributions were not normal. Dichotomous variables and proportions were compared by chi-square analysis.
Results
Extent of Symposium Publication
The number of symposiums published per year by the 58 journals selected for the study increased from 71 for the period from 1966 to 1971 to 307 for the period from 1984 to 1989. Ten journals did not publish any symposiums during the study period, 21 journals stopped publishing symposiums, and 3 journals began publishing symposiums in 1990. (The Appendix contains a list of the 58 journals surveyed and the number of symposiums published by each.)
Characteristics of Journals That Published Symposiums
There were no significant differences with respect to circulation, citation rate, publisher, percentage of paid subscriptions, or ratio of advertisement to editorial copy between journals that published symposiums and those that did not. Two hundred eighty-three of the symposiums (45 percent) were published in three journals (American Heart Journal, American Journal of Cardiology, and American Journal of Medicine) that are owned by two large publishing companies.
Reasons for Publishing Symposiums
Twenty of the 38 survey respondents who published symposiums answered a question about the percentage of the journal's net revenue that was derived from this type of publication. Six stated that more than 6 percent of their revenue was derived in this manner, eight gave a figure of 1 to 5 percent, and six stated that their journal derived no revenue from publishing symposiums. Seven of the 30 editors (23 percent) who answered a question about why they published symposiums stated that financial gain for the journal was the main reason. Two editors reported that their journals charged $400 to $1,500 per page to publish symposiums, and another reported charging a flat fee of $100,000. The journals charged an average of $15 per reprint, and reprint requests for symposiums ranged from 100 to 200,000 (average, 25,000). Additional reasons given for publishing symposiums were to disseminate information (63 percent of respondents), to stimulate reader interest (40 percent), and to allow discussion of a topic in depth (10 percent).
Content Analysis of Symposiums
The descriptive characteristics of the 625 symposiums analyzed are shown in Table 1Table 1
Characteristics of 625 Symposiums, According to Category of Sponsor.*. Forty-two percent had a single pharmaceutical sponsor, 26 percent had a single drug as the topic, 15 percent used brand names, and 11 percent had misleading titles, such as "Anxiety: Quest for Improved Therapy" for a symposium describing only a brand-name form of buspirone.16 (A complete list of the symposiums with misleading titles is available through the National Auxiliary Publications Service.*) Sponsorship by a single pharmaceutical company was associated with single-drug topics, misleading titles, and the use of brand names.The types of drugs most frequently featured in the 161 single-topic symposiums were cardiovascular medications (86 symposiums), antiinfective agents (18), nonsteroidal antiinflammatory drugs (12), and immunosuppressant agents (11). The date of FDA approval and the drug's therapeutic rating could not be determined for three and five symposiums, respectively. Eighty-one of 158 symposiums that focused on a single drug (51 percent) featured products that had not received FDA approval. Twenty-nine percent of the single-topic symposiums featured drugs that had not received FDA ratings. Of the rated drugs, 14 percent were assigned a rating of A (presenting an important therapeutic gain), 47 percent a rating of B (a moderate therapeutic gain), and 40 percent a rating of C (little or no therapeutic gain). The proportion of all FDA-approved drugs that received an A rating before 1990 was 13 percent, whereas 37 percent were B-rated and 50 percent were C-rated. Fifty-nine percent of the C-rated drugs were featured in symposiums before they were approved, as compared with 33 percent of the B-rated drugs and 27 percent of the A-rated drugs (P = 0.014).
Editorial Review of Articles in Symposium Issues
For 44 percent of the symposiums analyzed (275 of 625), the review process followed for the symposium articles was not specified. Forty-six percent (286 of 625) were subjected to the same type of peer review as the regular articles published in the journal, and 10 percent (64 of 625) received some type of "special" review. Published policies for special review varied among the symposiums, ranging from review by a publication committee, to review by the guest editor only, to review provided by the sponsoring company. Regardless of the type of review, 94 percent of theeditors (34 of 36) replied that they retained the right to reject a manuscript. Eight editors reported that their special review procedures were distorted by a variety of pressures from symposium organizers.
Table 2Table 2
Types of Editorial Review in 625 Published Symposiums, According to Category of Sponsor.* shows that the rigor of the review process varied with symposium sponsorship. The type of review also depended on the journal that published the symposium (P<0.001). Ninety percent or more of the symposiums published in the American Journal of Obstetrics and Gynecology, the British Journal of Anaesthesia, Cancer, Circulation, and Kidney International were subjected to peer review of the same type as regular journal articles. In contrast, for more than 70 percent of the symposiums published in the American Heart Journal, the American Journal of Cardiology, and the American Journal of Medicine, no review policy was stated.Seventy-five percent of the symposiums that did not have a stated review policy were sponsored by single pharmaceutical companies (P<0.001). Table 3Table 3
Characteristics of Symposiums According to Type of Review.* shows that a focus on a single drug, the use of misleading titles, and the use of brand names were also associated with the lack of a review process.*See NAPS document no. 04979 for 40 pages of supplementary material. Order from NAPS c/o Microfiche Publications, P.O. Box 3513, Grand Central Station, New York, NY 10163–3513. Remit in advance (in U.S. funds only) $13.75 for the first 20 pages plus $.30 per additional page for photocopies, or $4 for microfiche. Outside the U.S. and Canada add postage of $4.50 for the first 20 pages and $1 for each 10 pages thereafter ($1.50 for microfiche postage).
The Gold Standard for Symposium Publication
We defined an ideal or "gold standard" for the publication of a symposium to mean that the symposium did not have a misleading title, did not mention brand names, and was peer-reviewed in the same manner as the parent journal. There was an association between the type of sponsorship and whether or not a symposium met this gold standard (Fig. 1Figure 1
Symposiums That Met (Solid Bars) and That Did Not Meet (Hatched Bars) the Gold Standard for Publication, According to Category of Sponsor.). Thirteen percent of the symposiums sponsored by single pharmaceutical companies (34 of 262) met the standard, as compared with 74 percent of those with nonpharmaceutical sponsors (66 of 89).Discussion
Our data suggest that industry-sponsored symposiums are promotional in nature and that journals often abandon the peer-review process when they publish symposiums. Published criteria for the acceptance of symposiums support our findings that the standards for review vary among journals.17 18 19 20 21 22 Financial pressures on journals appear to contribute to the increasing publication of symposiums.
Symposiums may be used to bring noninnovative and unapproved drugs to the attention of prescribing physicians. It has been argued that in so doing, they educate readers about important advances in medicine. However, the majority of symposiums sponsored by single pharmaceutical companies focused on single drug products, and the percentage of A-rated drugs featured in symposiums was no higher than the percentage of all FDA-approved drugs with such a rating. The featuring of unapproved and noninnovative drugs suggests that manufacturers of these drugs are seeking preapproval promotion to allow them to get a jump on the market, increase product recognition, or enhance investor interest.23 The FDA has warned some pharmaceutical companies about their use of symposiums to promote unapproved uses of their products.3 , 24
One possible consequence of the publication of symposiums that appear in the form of peer-reviewed scientific literature is that they can be used to influence the prescribing practices of physicians. The inaccuracies of drug advertisements have been well publicized, and prescribers usually approach an advertisement with skepticism.4 5 6 , 24 25 26 27 28 29 Our findings suggest that symposiums should also be approached with skepticism. A lack of peer review such as we found with symposiums is associated with publications of poorer quality.30 Symposiums may be given more credence than they deserve, because they often resemble regular journal issues and may be presented as educational material. Courses of continuing medical education, which are sometimes published as symposiums, have been found to have content that is biased in relation to the funding source.31
The acceptance of symposium publications could distort the medical literature and ultimately alter physicians' prescribing practices and patient care. Physicians might be persuaded by promotional symposiums to prescribe drugs that are inappropriate, expensive, or both. The increasing amount of money that the pharmaceutical industry devotes to symposiums could contribute to rising drug prices. We offer the following recommendations to reduce the promotional nature of symposium publications.
Recommendations
For the FDA
We encourage the FDA to continue to develop and enforce guidelines for industry-sponsored symposiums.32 , 33 The definitions of promotional and educational material need to be clarified. The FDA's definition of "independent" material should include an absence of financial ties between each participant and the sponsoring company, a broad topic for the symposium, and an avoidance of discussions of unapproved drugs. A list of all sponsors and the amount contributed by each should be made public.
For Pharmaceutical Companies
Pharmaceutical sponsors should continue to support and publish symposiums that do not have a promotional orientation. No suggestions of speakers, topics, or data selection should accompany the funding. Pharmaceutical companies should sponsor symposiums jointly because our data suggest that joint sponsorship reduces promotional characteristics. When pharmaceutical companies sponsor a symposium, the sponsorship should be acknowledged in all brochures describing the symposium, in announcements at the symposium, and in all subsequent publications.
For Journals and Journal Editors
If journal editors publish symposiums, they should insist that the papers be subjected to review of the same quality as articles in the regular issues of the journal. Journals should publish their review practices in each symposium issue and should maintain strict control over the selection of the topics and of the guest editor. Journal editors should reserve the right to reject any paper. If the participants include speakers associated with the sponsoring company, the journal editor should nominate an extra speaker, not associated with the sponsor, to give an overview of the conference. Journal editors should refuse to publish symposiums that are sponsored by a single pharmaceutical company or that have misleading titles, feature single products, or use brand names. If journals do publish industry-sponsored symposiums, each article should contain a complete statement disclosing all financial ties, past and present, among the authors, the guest editors, and the sponsoring company.
Each paper included in a symposium issue should be clearly identified as such. Each page of a symposium issue and each reprint should name the symposium sponsor, and the symposium title should be followed by a subtitle saying "symposium proceeding." In addition, symposium issues should be distinguished from the regular journal issues with a different cover.
If articles from symposiums are referenced in journal articles, they should be listed separately or preceded by a prefix that clearly indicates their source. A similar style should be used in MEDLINE and other reference data bases.
For Universities
We advise universities cosponsoring symposiums with drug companies to maintain complete control over the selection of the topic, the speakers, and any articles to be published. Universities should encourage the funding of symposiums by multiple sponsors to avoid a promotional bias.
For Speakers at Symposiums
We suggest that before participating in a symposium, potential speakers investigate the source of funding and the degree of editorial control, and that they avoid participating in symposiums with a promotional orientation. Speakers should also avoid symposiums that are solely sponsored by a company that funds their research. Those who do choose to speak at industry-sponsored symposiums should not feel obligated to gratify their hosts by promoting their products. Such speakers should disclose their connections with the sponsor during their talks.
Professional organizations should discuss industry-sponsored symposium publications in their ethics guidelines. The American College of Physicians and the Pharmaceutical Manufacturers Association have recently issued guidelines for the acceptance of gifts and other marketing practices,34 but the guidelines fail to address the problem of industry-sponsored publications. The American Medical Association has recently established a policy with regard to the publication of collections of articles that can serve as a model for symposium publications.35
For Readers
We urge readers to approach symposium issues that are sponsored by a single pharmaceutical company with skepticism and to evaluate each article for any promotional content. Readers should determine what peer-review process has been followed for an article or reprint before they consider the conclusions. Prescribing physicians should ask representatives of the pharmaceutical company about the sponsorship and review the criteria used to prepare any reprints they distribute.
In conclusion, pharmaceutical companies, journals, and the FDA should work together to eliminate promotional aspects of symposiums and ensure that the papers included are peer-reviewed.
Supported in part by the American Association of Retired Persons, Washington, D.C., and by a Career Development Award (2KT0072) from the California Tobacco-Related Disease Research Program.
We are indebted to Andrew Herxheimer, Michael Cunningham, and Elliot Rapaport for their assistance with this project; to Kenneth Feather, Robin Fox, Stanton Glantz, Jere Goyan, Philip Lee, Stuart Nightingale, William Parmley, Jane Smith, Richard Smith, and Ann Witt for their careful review of the manuscript; and to the participants in the writing seminar of the Institute for Health Policy Studies.
Source Information
From the Institute for Health Policy Studies, School of Medicine (L.A.B., A.G., D.R.), and the Division of Clinical Pharmacy, School of Pharmacy (L.A.B.), University of California, San Francisco; and the Journal of the American Medical Association, San Francisco (D.R.). Address reprint requests to Dr. Bero at the Institute for Health Policy Studies, School of Medicine, University of California, San Francisco, 1388 Sutter St., 11th Fl., San Francisco, CA 94109.
Appendix
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