Michael S. Wilkes

Pharmaceutical advertisements in leading medical journals: Experts' assessments

Abstract ▪Objective:To assess both the accuracy of scientific data presented in print pharmaceutical advertisements and the compliance of these advertisements with current Food and Drug Administrat...

Medical Scientists and Health News Reporting: A Case of Miscommunication

Most persons, including physicians and scientists, first learn about developments in medicine through the media [1]. Press coverage of medical stories, however, is often inaccurate, superficial, or sensationalized [2-4]. Moreover, some of the most important medical issues are not covered by the press [5]. Low-quality journalism about politics or business can tarnish a reputation, but in medicine, inaccurate reporting can generate false hopes and unwarranted fears. The clinical aftermath of such inaccuracies emphasizes the need for a solution to the problem of misleading journalism. Scientists blame this problem on the press, claiming that reporters are careless about how they present medical research [6-8]. Reporters, in turn, accuse the medical community of obstructing, misguiding, or failing to alert the press [5, 9]. Media critics suggest that the difficulty lies with the audience: People must be more attentive and more skeptical when they interpret news about health [2, 3, 10]. Medical scientists alone cannot correct the deficiencies of medical news coverage, but neither can journalists. In many areas of health news reporting, the underlying problem is an interactive dynamic to which both parties contribute. We examine the roots of the problem and suggest that journalists and scientists share the responsibility for accurate communication to the public. We focus on four problem areas: sensationalism, biases and conflicts of interest, lack of follow-up, and stories that are not covered. In each area, we recommend specific strategies for physicians and scientists who are concerned about coverage of medicine in the media. Problems Sensationalism Too often, journalists pursue medical news as if they are reporting on a hostage crisis. Information is delivered rapidly, but little time is taken to provide a context for the story. Instead, the reporting is sensationalized: The journalist overstates a scientific finding and, as a result, the public is misled about the implications of that finding. This sort of reporting has its roots in newsroom pressures to dramatize stories by sounding alarms [4] or touting cures [5], but scientists and scientific institutions occasionally contribute to sensationalism. Scientists have understandable desires for publicity: It may help them get funding [8], is valued by institutions [11], and increases awareness of their research. The efforts of scientists to attract media attention, however, can result in flawed coverage. For example, press releases are issued that are inaccurate or incomplete [12] and press conferences are held even though the data being discussed are preliminary [13]. Scientific organizations invite the media to their presentations without providing explanations of epidemiologic and statistical concepts or access to scientists who can critique a given research effort. The Hazards of Calcium Channel Blockers In the spring of 1995, news wire services reported that 6 million persons in the United States who were receiving calcium channel blockers for hypertension might be increasing their risk for a heart attack by 60% [14]. Persons who were being treated for hypertension became frightened; in some cases, they stopped taking prescribed medication [15]. Physicians offices were flooded with calls [16]. Was the reaction to the media coverage out of proportion with the findings [17]? Some believed it was and blamed the media for wreaking havoc [14, 18, 19]. However, journalists were not solely responsible for the sensationalism. In fact, journalists had been invited to the presentation by the American Heart Association and had been given a press release on the study [20]. The press release has been described as incomplete [14]. No other written materials were given out, and reporters who covered the story had little access to scientists other than the presenter. Reporters would have benefited from a more thorough written report of the study and access to persons with the ability to criticize the work. Sensationalized Hope Just as the incentive to sound alarms can push the media toward overstatement, journalists desire to offer hope can lead to a false portrayal of new treatments. Many examples of this effect have been seen: An unusual and invasive treatment for Alzheimer disease was widely publicized after a small, unblinded pilot study [13]; fluoxetine hydrochloride (Prozac, Dista Products and Eli Lilly and Company, Indianapolis, Indiana) was hailed as a certain cure for depression when it was introduced [21]; and melatonin recently received excessively positive media treatment as a cure for aging [22, 23]. Journalists who publicize false claims can be faulted for not being skeptical, but the scientists who provide the information must share the blame. Sensational Health Risks and the Tendency To Ignore Negative Studies The negative story about potential health hazards is another sensationalistic tactic. Such stories often acknowledge only the extremes, that is, only two sides of the story: the side of the person who has been harmed and the side of the party that seems to be responsible. For example, news reports about the hazards of breast implants described a battleground on which women who feared that their implants were harming them were pitted against the manufacturers of implants [3]. Little attempt was made to enable the public to understand how scientific studies could shed light on the controversy. Instead, the journalistic drive to present a conflict [21] combined with the journalists need for balance (equal representation of both sides) resulted in superficial reporting. Journalists argue that scientists contribute to sensational stories about health risks when they prevent the public dissemination of information [24]. In the case of breast implants, the existence of secret corporate documents that described potential hazards of implants inspired heightened press coverage and public attention [3]. Similarly, when reports of research fraud in the National Surgical Adjuvant Breast and Bowel Project emerged in 1994 [25], a key aspect of the story was the claim that researchers had failed to be honest with the public and the press [24, 26]. Inaccurate reporting about health risks is furthered by bias in the media and the medical community against negative studies. The media do not mention negative studies [27], perhaps because they seem to be inconsequential. This omission is then compounded because medical journals are less likely to publish studies that have negative results [28] and scientists are less likely to submit them for publication [29]. Recommendations 1. Researchers who present papers at meetings or publish them in journals should be available to the press to clarify and explain their findings. 2. Closed discussion of research may provoke sensationalism that open discussion could prevent. 3. Journals should make efforts to interest the press equally in negative and positive studies. Biases and Conflicts of Interest To avoid inaccurate stories, reporters need to examine the credibility and biases of scientific sources. Such examination is often not done, however, possibly because reporters are misled when the public relations efforts of scientists, institutions, or the pharmaceutical industry turn into blatant boosterism. Scientists or institutions are not wrong to invite the press to cover their research or findings; on the contrary, the media should be stimulated to provide coverage of certain issues. For example, the Centers for Disease Control and Prevention has been criticized for not doing more to interest the media in early reports on the acquired immunodeficiency syndrome (AIDS) [5]. At the same time, however, public relations efforts should be accurate. The Press Release Competition between research institutions for press coverage, combined with similar efforts by drug and device manufacturers, has resulted in medical news reporters being barraged by press kits and other materials from corporate sources, academic institutions, medical journals, and professional organizations [12, 30]. These materials can be misleading and even deceptive [31], sometimes amounting to nothing more than sensationalism [12]. Researchers can prevent inaccuracies by disallowing press conferences held to discuss preliminary data [13] and demanding final review and approval of news releases. Access to Scientists The major sources for a reporters story on a research article or presentation are generally the authors or presenters themselves. Reporters who wish to verify such stories, however, should also speak to persons who can criticize the work. To increase reporters access to critical sources, medical journals could release the names of peer reviewers who are willing to speak with them. When the press is invited to meetings at which peer-reviewed abstracts are presented, sponsoring organizations could also provide reviewers names (if reviewers agree to this practice). Alternatively, journals could provide the names of experts who have published widely in the relevant field. Journals sometimes pair editorials that criticize a study with the study itself, but few studies are currently accompanied by such editorials. Disclosing Conflicts of Interest A journalists audience should be told explicitly whether the journalists source of information could benefit financially from the media attention or whether the source is funded or employed by an institution that will benefit. However, such conflicts of interest are often not apparent to reporters or their audiences. One example comes from a recent article about melatonin [22]. Among sources who were quoted about the anti-aging properties of melatonin was Dr. Russel Reiter, author of a popular book on melatonin [32]. Because of the book, Reiter stood to gain personally from press attention to melatonin, but the article described him only as a scientist. Reporters have become more aware of conflicts of interest bec

Sponsorship, Authorship, and Accountability

As editors of general medical journals, we recognize that the publication of clinical-research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical-trials data have been gathered and are presented in an objective and dispassionate manner. This discourse is vital to the scientific practice of medicine because it shapes treatment decisions made by physicians and drives public and private health care policy. We are concerned that the current intellectual environment in which some clinical research is conceived, study participants are recruited, and the data analyzed and reported (or not reported) may threaten this precious objectivity. Clinical trials are powerful tools; like all powerful tools, they must be used with care. They allow investigators to test biologic hypotheses in living patients, and they have the potential to change the standards of care. The secondary economic impact of such changes can be substantial. Well-done trials, published in high-profile journals, may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor. But powerful tools must be used carefully. Patients participate in clinical trials largely for altruistic reasonsthat is, to advance the standard of care. In the light of that truth, the use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool. Until recently, academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The intellectual and working home of these investigators, the academic medical center, has been at the hub of this enterprise, and many institutions have developed complex infrastructures devoted to the design and conduct of clinical trials (1, 2). The academic enterprise has been a critical part of the process that led to the introduction of many new treatments into medical practice and contributed to the quality, intellectual rigor, and impact of such clinical trials. But, as economic pressures mount, this may be a thing of the past. Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis. As trials have become more sophisticated and the margin of untreated disease harder to reach, there has been a great increase in the size of the trials and consequently the costs of developing new drugs. It is estimated that the average cost of bringing a new drug to market in the United States is about

Financiación, autoría y responsabilidad

500 million (3). The pharmaceutical industry has recognized the need to control costs and has discovered that private nonacademic research groupsthat is, contract research organizations (CROs)can do the job for less money and with fewer hassles than academic investigators. Over the past few years, CROs have received the lions share of clinical-trial revenues. For example, in 2000 in the United States, CROs received 60% of the research grants from pharmaceutical companies, as compared with only 40% for academic trialists (1). As CROs and academic medical centers compete head to head for the opportunity to enroll patients in clinical trials, corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally (4). Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavorable to the sponsors product. Such issues are not theoretical. There have been a number of recent public examples of such problems, and we suspect that many more go unreported (5, 6). As editors, we strongly oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor. Such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. Because of our concern, we have recently revised and strengthened the section on publication ethics in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, a document developed by the International Committee of Medical Journal Editors (ICMJE) and widely used by individual journals as the basis for editorial policy. The revised section follows this editorial. (The entire Uniform Requirements document is undergoing revision; the revised version should be available at the beginning of 2002.) As part of the reporting requirements, we will routinely require authors to disclose details of their own and the sponsors role in the study. Many of us will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish. We believe that a sponsor should have the right to review a manuscript for a defined period (for example, 30 to 60 days) before publication to allow for the filing of additional patent protection, if required. When the sponsor employs some of the authors, these authors contributions and perspective should be reflected in the final paper, as are those of the other authors, but the sponsor must impose no impediment, direct or indirect, on the publication of the studys full results, including data perceived to be detrimental to the product. Although we most commonly associate this behavior with pharmaceutical sponsors, research sponsored by government or other agencies may also fall victim to this form of censorship, especially if the results of such studies appear to contradict current policy. Authorship means both accountability and independence. A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication. We encourage investigators to use the revised ICMJE requirements on publication ethics to guide the negotiation of research contracts. Those contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publishthe hallmarks of scholarly independence and, ultimately, academic freedom. By enforcing adherence to these revised requirements, we can as editors assure our readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names. The authors can then stand behind the published results, and so can we. The section on publication ethics from the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication follows below. The full revised Uniform Requirements will be published later. Conflict of Interest Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the authors institution), reviewer, or editor has financial or personal relationships with other persons or organizations that inappropriately influence (bias) his or her actions. The potential of such relationships to create bias varies from negligible to extremely great; the existence of such relationships does not necessarily represent true conflict of interest, therefore. (Relationships that do not bias judgment are sometimes known as dual commitments, competing interests, or competing loyalties.) The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and science itself. Conflicts can occur for other reasons, however, such as personal and family relationships, academic competition, and intellectual passion All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest. Disclosure of these relationships is particularly important in connection with editorials and review articles, because bias can be more difficult to detect in those publications than in reports of original research. Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Editors should publish this information if they believe it will be important to readers in judging the manuscript. Potential Conflicts of Interest Related to Individual Authors Commitments When authors submit a manuscript, whether an article or a letter, they are responsible for disclosing all financial and personal relationships between

Sponsorship, authorship, and accountability.

1247 Como editores de publicaciones médicas somos conscientes de que la publicación de los resultados de investigaciones clínicas en revistas científicas con impacto constituye un factor determinante en la elección del tratamiento médico a utilizar. En el debate público sobre los resultados de seguridad y eficacia de un estudio se asume tácitamente que la recogida y tratamiento de los datos se ha realizado de forma objetiva e imparcial. El respeto de este principio es vital para la praxis científica de la medicina: la publicación de resultados influye tanto en la elección del tratamiento por parte del médico como en la política sanitaria, bien sea pública o privada. Nos preocupa especialmente que la objetividad, indispensable y valiosa, se vea amenazada por el marco intelectual en el que se conciben parte de las investigaciones clínicas actuales, por los criterios de inclusión de los participantes en los estudios y por la forma en que los datos son analizados y comunicados (o no comunicados). Todos reconocemos que los estudios clínicos son herramientas poderosas y que, por ello, merecen ser tratados con cautela. Los estudios clínicos permiten a los investigadores comprobar en pacientes la validez de tesis biológicas, con el potencial de llevar a modificaciones del tratamiento convencional. El impacto económico de dichas modificaciones puede ser importante. Los estudios bien realizados, publicados en revistas científicas de gran alcance, son frecuentemente utilizados para la comercialización de medicamentos e instrumental médico que resulta en beneficios sustanciales para el promotor del estudio. Por otro lado, los pacientes, en general, participan en estos estudios por razones altruistas, es decir, colaboran sin ánimo de lucro en la mejora de los tratamientos existentes. Según este hecho, la utilización de estudios clínicos con fines fundamentalmente económicos defrauda el fin propio de la investigación clínica y supone una desviación en el uso originalmente esperado de estas herramientas. Hasta hace poco tiempo, los investigadores académicos independientes tenían un papel fundamental en el diseño y desarrollo de los estudios clínicos y en la interpretación de los datos. El ámbito de trabajo de estos investigadores, el centro médico académico, era el eje de esta actividad, de forma que muchas instituciones han desarrollado infraestructuras complejas dedicadas al diseño y desarrollo de ensayos clínicos. La iniciativa académica ha sido protagonista indiscutible en la introducción de nuevos tratamientos y, sin lugar a dudas, ha contribuido a la calidad, rigor intelectual e impacto de los ensayos clínicos. No obstante, debido a la creciente presión económica, esta realidad puede formar parte ya del pasado. El objetivo último de una parte importante de los estudios clínicos actuales es facilitar la aprobación del uso de uno u otro medicamento o de este o aquel material médico. No se trata, pues, de probar la validez de una hipótesis científica innovadora. Como consecuencia del aumento de la sofisticación en el diseño y desarrollo de los ensayos clínicos y del estrechamiento del margen para introducir un nuevo producto en el mercado se ha producido un incremento en el tamaño de los estudios y, en consecuencia, un incremento en los costes del desarrollo de nuevos medicamentos. Se estima que el coste medio de la introducción de un medicamento en el mercado es de alrededor de 500 millones de dólares americanos. La industria farmacéutica se ha visto en la necesidad de reducir gastos y ha descubierto que los grupos u organizaciones privadas de investigación (CRO, acrónimo del inglés Contract Research Organisations, organizaciones no académicas) pueden desarrollar el trabajo por menos dinero y que, además, ponen menos trabas que los investigadores académicos. Durante los últimos años, las CRO han recibido buena ED I TO R I A L E S

Editor's pick.

As editors of general medical journals, we recognize that the publication of clinical-research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical-

Reviews and Notes: How To Break Bad News: A Guide for Health Care Professionals

In 1994, the US Congress passed a law severely curtailing the powers of the Food and Drug Administration to regulate herbs and other alternative health products or dietary supplements. The law was in part a response to manufacturers, who urged deregulation to foster growth of their industry. (The manufacturers were no fools: the industry has tripled in economic terms since the law was passed.) But Congress was also responding to the passions of consumers who use alternative products on a regular basis. Many of these consumers have doctors.

Pharmaceutical advertisements in leading medical journals: Experts’ assessments

How to Break Bad News: A Guide for Health Care Professionals Robert Buckman. 223 pages. Baltimore: Johns Hopkins University Press; 1992.

Treating the developmentally disabled

15.95. In a recent exercise at our medical school, expert physicians from different specialties demonstrated for medical students the process of giving a patient bad news. Each clinician gave the same patient (a trained actress) the news that she had breast cancer. Students commented afterward that none of the physicians really listened to the patient, none gave her the chance to share her concerns, and none directly responded to her questions. These same observations are heard whenever patients talk about their physicians. As physicians we are too often guilty of not listening to our patients and of not knowing how to discuss bad news. Everyone has a general feeling about what constitutes bad news. Further, most of us have been in situations in which we have needed to tell others news that will negatively and drastically alter their view of the future. Fewer physicians, however, have developed an ability to relate this news with compassion, empathy, and a facility to handle various responses from the patient. Medical textbooks and books on doctor-patient relationships acknowledge the importance of giving patients bad news, but none address the issues with practical suggestions, case scenarios, or detailed explanations. This short, easy-to-read book fills this void and has a great potential to improve the way clinicians understand the process of breaking bad news. The book features clear writing, believable examples, and practical suggestions. Topics such as basic communication skills and a simple six-step protocol for breaking bad news fill the books six chapters. The chapter entitled The Patients Reaction is particularly enlightening; it details the basis of specific patient reactions to bad news and offers concrete suggestions for how to deal with these reactions. One problem with the book is the redundancy between chapters. Several chapters would be more effective if they were less rambling. Despite these flaws, clinicians of every specialty and skill level will benefit from How to Break Bad News. Further, it should be required reading for all medical students and residents who plan to take care of people.

[Sponsorship, authorship and accountability].

OBJECTIVEnTo assess both the accuracy of scientific data presented in print pharmaceutical advertisements and the compliance of these advertisements with current Food and Drug Administration (FDA) standards.nnnDESIGNnCross-sectional survey.nnnMEASUREMENTSnEach full-page pharmaceutical advertisement (n = 109) appearing in 10 leading medical journals, along with all available references cited in the advertisement (82% of the references cited were available) were sent to three reviewers: two physicians in the relevant clinical area who were experienced in peer review and one academic clinical pharmacist. Reviewers, 95% of whom responded, were asked to evaluate the advertisements using criteria based on FDA guidelines, to judge the educational value and overall quality of the advertisements, and to make a recommendation regarding publication.nnnRESULTSnIn 30% of cases, two or more reviewers disagreed with the advertisers claim that the drug was the drug of choice. Reviewers felt that information on efficacy was balanced with that on side effects and contraindications in 49% of advertisements but was not balanced in 40%. Reviewers agreed with advertisements claims that the drug was safe in 86% of the cases but judged that headlines in 32% of the advertisements containing headlines misled the reader about efficacy. In 44% of cases, reviewers felt that the advertisement would lead to improper prescribing if a physician had no other information about the drug other than that contained in the advertisement. Fifty-seven percent of advertisements were judged by two or more reviewers to have little or no educational value. Overall, reviewers would not have recommended publication of 28% of the advertisements and would have required major revisions in 34% before publication.nnnCONCLUSIONnIn the opinion of the reviewers, many advertisements contained deficiencies in areas in which the FDA has established explicit standards of quality. New strategies are needed to ensure that advertisements comply with standards intended to promote proper use of the products and to protect the consumer.