The Influence of Disclosure and Ethics Education on Perceptions of Financial Conflicts of Interest

Abstract

This study explored how disclosure of financial conflicts of interest (FCOI) influences naïve or “lay” individuals’ perceptions of the ethicality of researcher conduct. On a between-subjects basis, participants read ten scenarios in which researchers disclosed or failed to disclose relevant financial conflicts of interest. Participants evaluated the extent to which each vignette represented a FCOI, its possible influence on researcher objectivity, and the ethics of the financial relationship. Participants were then asked if they had completed a college-level ethics course. Results indicated that FCOI disclosure significantly influenced participants’ perceptions of the ethicality of the situation, but only marginally affected perceptions of researcher objectivity and had no significant influence on perceptions of the existence of FCOIs. Participants who had previously completed a college-level ethics course appeared more sensitive to the importance of FCOI disclosure than those who lacked such background. This result suggests that formal ethical training may help individuals become more critical consumers of scientific research.

Appendix

Financial conflict of interest scenarios

The first ten scenarios represent those presented to participants in the Disclosure condition; the second ten scenarios represent those presented to participants in the Nondisclosure condition. The bold font was not used in the versions seen by actual participants.

Disclosure scenarios

• 1. Suppose an adjunct research professor at Private U’s prestigious psychiatry department, Dr. U., has received over a million dollars in speaking fees over the past few years from pharmaceutical companies for giving marketing lectures on their drugs. At the same time, Dr. U hosted a popular weekly half-hour public radio program about psychiatric drugs. In an episode titled “Prozac Nation: Revisited,” Dr. U began with the comments, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.” At the end of the show, an announcer says, as he does at the end of every episode, that “Dr. U may have financial relationships with some of the pharmaceutical companies whose products were mentioned on today’s broadcast.” That same week, Dr. U. earned around $20,000 from a particular firm which for years suppressed studies showing that its best-selling antidepressant increased suicidal behavior

• 2. Suppose a nutritionist named Dr. V. at Middle State U. serves as a peer reviewer for a leading journal in her field, the Journal of Obesity Research (JOR). She is also a well-paid consultant for a national chain of weight loss clinics which touts the advantages of calorie-restricted meals that are high in carbohydrates but low in fat. JOR asks Dr. V. to review a large, rigorous study that seems to show the benefits of a low-carb, high fat approach for weight loss and hunger control. She tells the editor that she is not sure she is the best person to review the manuscript, given her affiliation with the weight loss chain, but the editor asks her to review it anyway, since the subject matter pertains to her expertise.

• 3. Suppose that a doctor and research professor at Medical U. named Dr. S. chairs the medical school’s psychiatry department and also serves as the head of the non-profit American Psychiatric Association (APA). The Association publishes the leading academic journals in the field and psychiatry’s standard diagnostic manual. Approximately one-third of the Association’s funding comes from pharmaceutical companies via journal advertisements, fellowships, and by sponsoring industry symposiums and conferences at the Association’s annual meeting. Dr. S. has almost five million dollars of stock holdings in a drug development company working on new psychiatric treatments. The APA website mentions that funding for some events and opportunities is courtesy of industrial sponsors, and that some APA officers may have stock holdings in one or more of these sponsors.

• 4. Suppose a geology professor at U. of T. named Dr. S. serves on the board of a large drilling services firm. For his service on the board, Dr. S. has received half a million dollars over the past 5 years. Dr. S. is then hired by a consortium of energy producers to conduct a study on the safety of hydraulic fracturing, the controversial drilling process known as “fracking.” Dr. S’s study concludes that fracking does not cause water contamination, contrary to various media reports and widespread speculation. The company on whose board Dr. S. serves is a major contributor to the consortium that hired Dr. to do the research. Dr. S. then publishes his study in a leading academic journal. As the journal’s disclosure policy requires, a footnote in the article explains that the study was sponsored by the energy consortium and that the author has been a paid board member of one company in the group.

• 5. Suppose a medical research professor at Atlantic U. named Dr. G. is a paid consultant for a large pharmaceutical company, Acme Drugs Inc. When the Food and Drug Administration (FDA) considers approving a generic version of Acme’s blockbuster blood thinning medication which has been proposed by a rival firm, Dr. G writes the FDA warning that the generic version of the drug may not be as safe as Acme’s brand-name version, emphasizing his academic credentials but also disclosing his affiliation with Acme. Dr. G. engages two medical societies to encourage the FDA to delay approval of the generic medication as well, and Acme pays over five million dollars to the two medical societies. They then also submit letters to the FDA in support of Acme’s efforts, and their letters mention Acme’s much-appreciated and substantial support for their organizations.

• 6. Dr. W., a medical doctor working out of a private health clinic, is participating in a large test run by Phillips Pharma which is studying the effectiveness of a new statin drug Phillips is developing. The study involves randomly assigning patients with high blood pressure to either an effective, established treatment or Phillips’ new drug. Dr. W. receives $300 for every one of her patients she enrolls in the trial. Patients are told that they will receive either the standard treatment or a promising new alternative drug, and that Dr. W receives a small financial incentive for every one of her patients who agrees to participate in the study.

• 7. Suppose Dr. P, a polymer scientist at Pacific Coast U. (PCU), develops a new plastic material that appears promising for use in coronary stents. Medical Devices, Inc. (MDI) signs an agreement with Dr. P. and PCU to fund development, testing, and patenting of a stent based on Dr. P’s new material. According to the terms of the agreement, Dr. P., MDI and PCU will share patent royalties equally; Dr. P. also intends to publish the results from tests of the new stent. She plans to disclose her patent rights to academic journals whether or not she is required to do so by journal policy.

• 8. Suppose a large pharmaceutical company, Medic Drugs, develops a new treatment for male pattern baldness. Wishing to establish legitimate, scientific evidence in favor of its product, Medic aims to publish results of its tests on the new product in a respectable, academic journal. It uses staff scientists and researchers to conduct tests and draft the manuscript, then approaches several respected academic dermatologists to be lead authors on the article. One such dermatologist agrees; Medic pays her $10,000 to submit the article to Dermatology Review in her name. She does so, adding to the manuscript a footnote mentioning that she was paid by Medic for her role in the project.

• 9. Suppose a large pharmaceutical company is developing a new drug intended to treat attention deficit disorders and perhaps related cognitive impairments. Having established the drug’s safety, it contacts a prominent research team at Med. U. to design and conduct a study on the drug’s effectiveness. In keeping with established practices, the team proposes a series of studies that would compare the experimental drug with rival medications. However, the pharmaceutical company insists that the tests involve only comparisons between the experimental medication, a placebo, and a relatively ineffective, older drug. The team conducts the study the firm prefers and pays for, and its academic article reporting the positive results of their work explains that the study design was requested by the firm sponsoring the work.

• 10. A respected medical researcher at Western U. is asked to serve on a federal Food and Drug Administration (FDA) panel deciding whether to approve a new cold and flu treatment patented by Allied Drugs, LLC. While the medication was generally very impressive in tests Allied conducted and submitted to the FDA, it also had relatively serious side effects in a small percentage of cases. The researcher, Dr. C., has accepted generous gifts from Allied in the past, including travel expenses to attend an Allied-funded conference in the Bahamas. Such gifts from pharmaceutical companies are common, and Dr. C. discloses his receipt of Allied’s past gifts to the FDA.

Nondisclosure Scenarios

• 1. Suppose an adjunct research professor at Private U’s prestigious psychiatry department, Dr. U., has received over a million dollars in speaking fees over the past few years from pharmaceutical companies for giving marketing lectures on their drugs. At the same time, Dr. U hosted a popular weekly half-hour public radio program about psychiatric drugs. In an episode titled “Prozac Nation: Revisited,” Dr. U began with the comments, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.” However, Dr. U. made no mention of his relationships with pharmaceutical companies in the show. That same week, Dr. U. earned around $20,000 from a particular firm which for years suppressed studies showing that its best-selling antidepressant increased suicidal behavior.

• 2. Suppose a nutritionist named Dr. V. at Middle State U. serves as a peer reviewer for a leading journal in her field, the Journal of Obesity Research (JOR). She is also a well-paid consultant for a national chain of weight loss clinics which touts the advantages of calorie-restricted meals that are high in carbohydrates but low in fat. JOR asks Dr. V. to review a large, rigorous study that seems to show the benefits of a low-carb, high fat approach for weight loss and hunger control. Given her relationships with the weight loss clinics, she could return the article to the journal’s editor for someone else to critically evaluate, but based on her relationship with a chain of weight loss clinics, she decides to review it herself, confident that she can be objective about its merits.

• 3. Suppose that a doctor and research professor at Medical U. named Dr. S. chairs the medical school’s psychiatry department and also serves as the head of the non-profit American Psychiatric Association. The Association publishes the leading academic journals in the field and psychiatry’s standard diagnostic manual. Approximately one-third of the Association’s funding comes from pharmaceutical companies via journal advertisements, fellowships, and by sponsoring industry symposiums and conferences at the Association’s annual meeting. Dr. S. has almost five million dollars of stock holdings in a drug development company working on new psychiatric treatments. The APA website makes no mention that funding for some events and opportunities is courtesy of industrial sponsors, and that some APA officers may have stock holdings in one or more of these sponsors.

• 4. Suppose a geology professor at U. of T. named Dr. S. serves on the board of a large drilling services firm. For his service on the board, Dr. S. has received half a million dollars over the past 5 years. Dr. S. is then hired by a consortium of energy producers to conduct a study on the safety of hydraulic fracturing, the controversial drilling process known as “fracking.” Dr. S’s study concludes that fracking does not cause water contamination, contrary to various media reports and widespread speculation. The company whose board Dr. S. serves on is a major contributor to the consortium that hired Dr. to do the research. Dr. S. publishes his study in a leading academic journal, but his publication does not mention the study’s energy production sponsors.

• 5. Suppose a medical research professor at Atlantic U. named Dr. G. is a paid consultant for a large pharmaceutical company, Acme Drugs Inc. When the Food and Drug Administration (FDA) considers approving a generic version of Acme’s blockbuster blood thinning medication which has been proposed by a rival firm, Dr. G writes the FDA warning that the generic version of the drug may not be as safe as Acme’s brand-name version, emphasizing his academic credentials but not disclosing his affiliation with Acme. Dr. G. engages two medical societies to encourage the FDA to delay approval of the generic medication as well. Acme pays over five million dollars to the two medical societies, and they also submit letters to the FDA in support of Acme’s efforts.

• 6. Dr. W., a medical doctor working out of a private health clinic, is participating in a large test run by Phillips Pharma studying the effectiveness of a new statin drug Phillips is developing. The study involves randomly assigning patients with high blood pressure to either an effective, established treatment or Phillips’ new drug. Dr. W. receives $300 for every one of her patients she enrolls in the trial. Patients are told that they will receive either the standard treatment or a promising new alternative drug, but are not told of Dr. W’s personal financial incentive to enroll them in the study.

• 7. Suppose Dr. P, a polymer scientist at Pacific Coast U. (PCU), develops a new plastic material that appears promising for use in coronary stents. Medical Devices, Inc. (MDI) signs an agreement with Dr. P. and PCU to fund development, testing, and patenting of a stent based on Dr. P’s new material. According to the terms of the agreement, Dr. P., MDI and PCU will share patent royalties equally; Dr. P. also intends to publish the results from tests of the new stent. She does not intend to disclose her patent rights to academic journals when submitting manuscripts for publication.

• 8. Suppose a large pharmaceutical company, Medic Drugs, develops a new treatment for male pattern baldness. Wishing to establish legitimate, scientific evidence in favor of its product, Medic aims to publish results of its tests on the new product in a respectable, academic journal. It uses staff scientists and researchers to conduct tests and draft the manuscript, then approaches several respected academic dermatologists to be lead authors on the article. One such dermatologist agrees; Medic pays her $10,000 to submit the article to Dermatology Review in her name. The dermatologist does not disclose to the journal that she did not conduct the study or draft the manuscript, and neither does she disclose that Medic is paying her to lend her name as lead author.

• 9. Suppose a large pharmaceutical company is developing a new drug intended to treat attention deficit disorders and perhaps related cognitive impairments. Having established the drug’s safety, it contacts a prominent research team at Med. U. to design and conduct a study on the drug’s effectiveness. In keeping with established practices, the team proposes a series of studies that would compare the experimental drug with rival medications. However, the pharmaceutical company insists that the tests involve only comparisons between the experimental medication, a placebo, and a relatively ineffective, older drug. The team conducts the study the firm prefers and pays for, but its academic article reporting the positive results of their research does not disclose why they designed their study as they did.

• 10. A respected medical researcher at Western U. is asked to serve on a federal Food and Drug Administration (FDA) panel deciding whether to approve a new cold and flu treatment patented by Allied Drugs, LLC. While the medication was impressive in tests Allied conducted and submitted to the FDA, it also had relatively serious side effects in a small percentage of cases. The researcher, Dr. C., has accepted generous gifts from Allied in the past, including travel expenses to attend an Allied-funded conference in the Bahamas. Since such gifts from pharmaceutical companies are common, Dr. C. sees no need to disclose them to the FDA.