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Journal of Clinical Oncology, Vol 25, No 4 (February 1), 2007: pp. 444-446 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.10.3036
Ethics in Oncology: Consulting for the Investment Industry
From the Vanderbilt University Medical Center, Nashville, TN; American Society of Clinical Oncology, Alexandria, VA; and the Princess Margaret Hospital and University of Toronto, Toronto, Canada for the ASCO Ethics Committee Address reprint requests to Ian F. Tannock, MD, PhD, Department of Medical Oncology and Hematology, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario M5G 2M9, Canada; e-mail: Ian.tannock{at}uhn.on.ca ABSTRACT As Ethics Committee Chair, I am pleased to introduce the first in an ongoing series of ethics vignettes. These columns, which are based on true-to-life situations that arise in oncology research and practice, are intended to identify and explore important ethical issues and provide commentary that is specific to oncology. Please look for them periodically in both the Journal of Clinical Oncology and the Journal of Oncology Practice. The idea for publishing vignettes evolved through the joint efforts of the Ethics Committee and the Board of Directors. Rather than adopt a single set of ethical principles that applies vaguely to any situation and well to none, the Committee and the Board preferred to tackle ethical dilemmas individually, specifically, and directly. Because the Ethics Committee thought the ethical and legal implications of physician interactions with the investment industry were so important and timely, it chose to address this topic in both a position article, which was previously published in the January 20, 2007, issue of the Journal of Clinical Oncology (J Clin Oncol 25:338-340, 2007) and in its first vignette column. The Ethics Committee hopes this column will be the first of several that ASCO members will find helpful as they grapple with the many ethical issues that arise in daily practice in the field of oncology. Because these columns are intended to address the concerns of ASCO members, the Committee welcomes suggestions for future topics at vignettes@asco.org. Martin D. Abeloff, MD, Chair, Ethics Committee An excellent, but disturbing, French film called Caché or Hidden was released last year and won the Critics Prize at the Cannes film festival. In the film, a wealthy Parisian couple receives videos from an unknown (hidden) source that gradually reveal aspects of their life that they would prefer to remain private. In this film, nothing is as it seems on the surface, and the ethical behavior of the couple is called into question. Sometimes oncologists are asked seemingly innocent questions which also contain a hidden agenda, and responding to such questions can create ethical dilemmas for them. The brief vignettes herein provide examples, and illustrate how members of the investment community may seek to obtain information from oncologists who have access to confidential information. VIGNETTE 1 A university-based medical oncologist who is a member of several protocol committees for trials in prostate cancer agrees to participate in a 1-hour conference call with four or five investment analysts for which he will be paid $1,000. After general questions about the current standards of treatment for advanced prostate cancer, he is asked to comment about two molecular targeted agents, A and B, which are being evaluated in clinical trials in which the oncologist is participating. He states that he is not free to comment on the trials. However, he does respond to statements such as "Of course we don't expect you to comment on the trials, but as an educated oncologist what's your sense of where these drugs are going? Which would you bet on, A or B?" The following day, shares of the company that is developing drug A increase by $2 and those of the company developing drug B fall by $5. VIGNETTE 2 An oncologist is appointed to the melanoma program committee for an upcoming American Society of Clinical Oncology (ASCO) meeting. The results of two randomized phase III trials for a new targeted agent are accepted as late-breaking abstracts, and the oncologist is scheduled to be the discussant. Shortly after the abstract grading is over, she is contacted by a member of the investment industry who requests an interview with her about agents that have the same target as the drug being presented at the ASCO meeting. The oncologist agrees to participate in the interview. Although outcome results were not presented in the abstract, there was an adverse effect that occurred frequently and increased with duration of treatment. The oncologist discusses these agents and their adverse effects in general, but does not disclose the information in the abstract. However, when asked whether "the cumulative adverse effect was seen," she replies, "it was seen, but I can't tell you how often or if it was related to the effectiveness of the drug." VIGNETTE 3 A physician in New York contacts a principal investigator (PI) for a trial studying a new drug in patients with lung cancer. The physician begins to ask questions about the trial results (none are public) and asks whether the PI is seeing any hints of activity in his own practice because "he has a patient considering going on the study." The PI becomes suspicious of the line of questioning and informs the physician that he knows of other physicians practicing in his geographic area. The PI queries as to which practice this physician belongs. The physician becomes increasingly evasive and eventually hangs up. VIGNETTE 4 A faculty oncologist is appointed as subchairman for gastrointestinal oncology for the upcoming ASCO annual meeting. Shortly after the abstract grader becomes available, she receives a phone call from a man who claims to be a friend of the state governor. He states that he has colorectal cancer and that his disease has worsened on standard treatment; he has been advised by the governor to call her, as he knows of her international reputation as an expert in this disease. He asks if there are promising new molecular agents that might be used to treat his colorectal cancer, and states that he could access almost any drug because of his connections. He is knowledgeable about experimental agents, several of which are being evaluated in phase III trials that have been submitted for presentation at the ASCO meeting. The oncologist becomes suspicious when he probes for specific information about comparisons between treatments that were evaluated in some of these trials. VIGNETTE 5 Dr Smith has been informed that an international trial that he has led for patients with advanced breast cancer has been accepted for oral presentation at the upcoming ASCO meeting. He receives an e-mail from Dr Brown, whom he remembers vaguely as a classmate in medical school, stating that he happens to be visiting family in town the following week and that it would be great to get together for dinner and to talk about old times. Dr Smith agrees, and initially enjoys sharing dinner and a few glasses of wine. He becomes more uncomfortable, however, as his colleague is rather evasive about his current career and constantly turns the conversation to developments in breast cancer—ostensibly because a close friend is suffering with the disease. DISCUSSION In these vignettes, each modified from real experience, the oncologist has access to confidential information and is being contacted by people who wish to obtain that information. In the first two vignettes, the oncologists know that they are speaking with representatives of the investment community, and unless they are very naïve, must know that the goal of the conversations is to obtain information that will be useful in guiding investments for their clients. Variants of this scenario are very common—many oncologists involved in drug development trials have been contacted in this way. Investment in companies that own proprietary rights to potential new anticancer agents can lead to immense profits (or losses) and investment advisors use multiple methods to obtain information to guide them. Many of these methods are open—oncologists are asked to provide advice to consultants about which drugs they believe are likely to be successful and are paid well for their time.1,2,3 Most often, oncologists targeted in this way are involved in clinical trials; they may have confidential information about how patients have performed on such trials, or in some cases may know the results of the trial itself. In that situation it can be a major challenge not to disclose confidential information, albeit inadvertently. The people seeking such information are usually trained in interview techniques, and like detectives investigating a crime, can gain much from nuances of voice, even if the oncologist refuses to disclose specific information.3 Or, as in the second scenario, the oncologist may have felt that she did not disclose information relating to efficacy, but her admission that the abstract indicated cumulative toxicity in the trials that they described could provide sufficient hints to guide the investment industry. Thus, oncologists can become unwitting participants in insider trading. We suggest that oncologists who are involved (or have been involved recently) in clinical trials of new agents, and certainly those who have confidential information as members of an ASCO program committee, should not agree to discussions with members of the investment industry—whether they are paid or not. This would apply not only to clinical trials relating to the drugs that are ostensibly the topic of the interview, but, given the subtlety with which information can be extracted, to those for any investigational anticancer agents. ASCO strongly discourages its members against engaging in these relationships, citing potential legal and ethical repercussions, and requires physicians who choose to consult with the investment industry to disclose.4 We urge physicians not to interpret ASCO's disclosure requirement as an endorsement of these relationships and to refrain from participation altogether. The other vignettes describe more subversive situations, and represent an increasing trend to obtain confidential information by deceit. In one of them the contact pretends to be a patient, in another, a physician caring for a patient, while the last is a physician who makes use of shared past experiences to create the guise of renewing friendship. There is no question that they describe unethical conduct on the part of those seeking information, but how can oncologists guard themselves against these situations, and maintain their own ethical behavior? Academic exchange is critical to the advancement of science, and communication between doctors is an important part of clinical practice. Many oncologists do receive genuine enquires about treatment from friends and relatives of patients and from other physicians. Also, it would be churlish to refuse contact with past colleagues, many of whom may have elected to work in the pharmaceutical industry. There are no simple answers to these questions, but these examples illustrate the need for caution and a degree of healthy suspicion that things are not always as they seem. We do not need to be paranoid, but we do need to be cautious. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The authors indicated no potential conflicts of interest. Author Contributions Conception and design: Jordan Berlin, Ian F. Tannock Provision of study materials or patients: Jordan Berlin, Ian F. Tannock Manuscript writing: Jordan Berlin, Suanna Bruinooge, Ian F. Tannock Final approval of manuscript: Jordan Berlin, Suanna Bruinooge, Ian F. Tannock NOTES Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. REFERENCES
1. Topol EJ, Blumenthal D: Physicians and the investment industry. JAMA 293:2654-2657, 2005 2. Steinbrook R: Wall Street and clinical trials. N Engl J Med 353:1091-1093, 2005 3. Timmerman L, Heath D: Drug researchers leak secrets to Wall Street. The Seattle Times, August 7, 2005 4. American Society of Clinical Oncology: Interactions with the investment industry: Practical and ethical implications. J Clin Oncol 25: 10.1200/JCO.2006.08.9052 Submitted December 7, 2006; accepted December 7, 2006.
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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