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© 2002 American Society for Clinical Oncology
The "Cure" for Cancer: Can the Media Report the Hope Without the Hype?University of Chicago, Chicago, IL AT ONE TIME, giving experimental agents to patients with advanced cancer was kept something of a secret. During the earliest days of government-sponsored cancer clinical trial research, beginning in the 1940s, the use of experimental agents on cancer wards occurred far away from the limelight and with minimal information passed from physician-researcher to patient-subject.1-3 It is said that our oncologist peers of the past did not talk in any detail about the disease of cancer with their patients, nor did they talk (in any organized or documented way) about the experimental agents they injected into their patients. Although far from an acceptable situation by today’s standards, some of the reasons for these past actions can be understood given both the degree of trust patients placed in the medical profession and the accepted doctor-patient communication norms of the time. As a result of the then-current social and cultural milieu, oncologists were constrained from more open communication about cancer and available treatments with patients (and their families). In addition to these social constraints, some oncologists were specifically not allowed to publish, or even talk about, their experiences with experimental agents by the third parties who sponsored their research, ie, the federal government.2,3 While lasting only a relatively brief period, the dawn of clinical medical oncology involved the use of experimental agents that were of interest to (and sponsored by) the federal government, not in regard to their therapeutic potential per se, but in the desire to understand better the toxicities that might be incurred from chemical and nuclear warfare.3 In fact, many of the reports that documented the early uses of these experimental anticancer agents were initially classified as top secret by the federal government, making them unavailable and hidden to the general public and the medical community.2,3 These reports included the first clinical experiences with the very agents on which the foundation of subsequent antineoplastic drug development and treatment would be built, eg, the nitrogen mustards.4,5 Thus, under sponsorship of the federal government, it was under essentially clandestine conditions that many physicians involved in caring for patients with cancer first administered these early experimental agents. Times have changed and secrets are no longer allowed. As a result of the erosion of public trust in the medical profession and the recognition of the need for informed consent, as well as the important role of patient autonomy in medical decision-making, the norms of doctor-patient communication have been profoundly altered. The current environment is one that dictates full and open disclosure not only of a cancer diagnosis, but also of all available treatment options (including the use of experimental agents), and even the statistical likelihood of survival and death from cancer. Tell-all cancer patient narratives are omnipresent from celebrity exposés, television talk shows, and wonderfully erudite and poetic expressions on the meaning of cancer as an illness in our time. More so, with regard to experimental agents, the first reports of a promising therapy now make the front pages of the daily newspapers before they have even been given to a single human subject with cancer—let alone before they have been published within the realm of peer review. Indeed, curing cancer in mice has become headline news. Or so reporter Gina Kolata stated in the lead sentence of her front page article of the May 3, 1998, issue of the New York Times: "Within a year, if all goes well, the first cancer patient will be injected with two new drugs that can eradicate any type of cancer, with no obvious side effects and no drug resistance—in mice" (italics added).6 With the clever irony of those last two words, she apparently quells any false hope or unrealistic optimism that a desperate patient or family member might have regarding expectations of his or her own survival from advanced cancer. Clearly, Kolata is seeking to grab the public’s attention and tell the now well-known story of Judah Folkman and his quest for angiogenesis inhibition. Coming from one of the bastions of the print media, Kolata’s story is designed not only to inform the public and sell newspapers, but also perhaps even to shape the future. Before rushing to judge the media for either unjustified overexuberance or calculated underreporting, we should recognize that—just as was the case for the oncologists of an earlier time—reporters like Kolata operate within a specific social environment where their words and stories are the embodiment of our current age. One might argue that she is simply telling a story that the public now wants, even demands, to hear. As evidenced by the hyperbolic quotes Kolata attributes to Nobel Prize winner James Watson and then-director of the National Cancer Institute Richard Klausner about the promise and importance of Folkman’s angiogenesis inhibitors, it is apparently a story that the medical community strongly supports. We oncologists of the current day also operate within this environment. In fact, the available data would suggest that those investigators who publish their research in high-profile medical journals welcome and enjoy the media coverage of their research and believe the media is accurate in its coverage.7 To this end, we see our cancer physician peers giving experimental agents for the first time to individuals with advanced cancer, not in the back rooms of the cancer wards without informed consent, but under the glare of spotlights, with cameras rolling and with subsequent appearance of patient and doctor on the evening news. Elsewhere, mounds of information regarding clinical trials of experimental agents are readily accessible, not just in the print media but also with the click of a computer mouse. Literally, reams of media documents can now be pored over by patients and families and then brought to the attention of well-intentioned, but only partially informed, oncologists. Some of this media information pertains to available, well-designed trials and is presented in an unbiased and objective manner. Yet much of this information is full-blown advertising or, more insidiously, advertising in the disguise of medical reporting. Indeed, as seen in a relatively recent Newsweek magazine insert,8 direct marketing to patients regarding specific cancer clinical trials is occurring now, even in the mainline print media. (It might be important for the oncology research community to note that such overt advertising may not be acceptable to many of the institutional review boards that are responsible for enforcing human subjects protections and who are required to review, and approve, any advertisements before they are deployed.9,10 But what of it? What is the impact of the media onslaught of cancer clinical trial information, reports, and advertising on patients and their families? What is the impact on the day-to-day practice of oncology, including on the involved cancer physicians, nurses, and others? Is it harmful? Is it, like the snake oils of the past, stepping beyond acceptable ethical boundaries to the point of creating false hopes and inducing desperately ill patients into behavior that they otherwise would not undertake—behavior that stands only to benefit the interests of those other than cancer patients themselves? Or is it helpful? Is it facilitating cancer research by accelerating needed clinical trial accrual and thus contributing to improving the care of future cancer patients and taking us all one step closer to "winning the war on cancer"? In the absence of objective evidence describing harms or benefits, the answers to these questions are the subject of conjecture, opinion, and editorialization. With specific regard to the clinical trials of at least one of the high-profile angiogenesis inhibitors that was the subject of Kolata’s New York Times article, Rebecca Pentz et al11 attempt to provide such evidence in this issue of the Journal of Clinical Oncology. In this study, 100 individuals who had been specifically referred to M.D. Anderson’s phase I trial of endostatin were surveyed about several issues, including their sources of clinical trial information, their understanding of the phase I trial’s research purpose, and their reasons for trial participation. As in previous survey studies of patients with advanced cancer participating in phase I trials,12,13 most respondents incorrectly stated the research purpose of the trial as seeking a therapeutic outcome. The vast majority of subjects also seemed to have unrealistic expectations of clinical anticancer benefit from trial participation, with relatively reduced concerns about toxicities and side effects. Also in keeping with previous research,14 more than three quarters of the surveyed subjects stated that they had already made a decision to participate in the trial before they had even been asked to participate. With regard to the role of media reporting and its influence on patients, nearly half of the subjects first heard about endostatin from the print media. Of those who had heard about the trial from these sources, only half spoke directly to their physician about it. Only one third stated that they had heard about the trial from their doctor. In perhaps what might be the most ominous and telling result, three patients described first hearing about endostatin from their stockbrokers. The investigators also analyzed media reports from three newspapers known for their medical reporting. From both this analysis and survey subjects’ own interpretations, the investigators found that the general tone of the media reports about the trial was predominantly a positive one. Given these findings, it seems that approximately half of all interviewed subjects made a decision to enroll in the endostatin trial, and found their way to M.D. Anderson, without significant involvement of their primary cancer physician. For many in the oncology community, it might seem somewhat concerning (and even disappointing) that such a significant proportion of patients did not entrust their physicians to help them in their decisions to receive an experimental agent. But such behavior may not have been of much harm. While it seems that an almost burdensome number of subjects arrived at M.D. Anderson over a relatively short period of time, they also seem to have been appropriate candidates for the trial. They were neither so ill as to have been ineligible for the trial, nor were they individuals who seem to have forgone any available standard anticancer treatments. There is even evidence for actual benefit from the media reporting given that those subjects who identified the media as the primary source of information about the trial were better informed, at least with regard to being able to state the research purpose of the trial as a dose-finding and/or toxicity study. In fact, within this selected population, there was no evidence that actually communicating with a trial investigator about endostatin was associated with an increased ability to state the research purpose of the trial. Thus, from these data alone, one could conclude that no harm came from media reports about endostatin and that there may have been some benefit with regard to both increasing accrual rates and promoting a better understanding of the purposes of the phase I trial. However, final conclusions about the harms and benefits of the media reporting on the endostatin trials should not come from relatively simple analyses of the tone of newsprint articles or survey results of a group of prospective clinical trial participants alone. Final conclusions should come only after a more comprehensive analysis of the harms and benefits of media reporting in relation to all those involved in the testing and development of endostatin. As expected for phase I trials, and as is the case with virtually all previously published phase I trials, the clinical anticancer benefits for the patients with advanced cancer who actually participated in both the M.D. Anderson and Dana Farber endostatin trials seem to have been minimal to none.15,16 On the other hand, the potential benefits to some of those involved in, or having knowledge of, the sponsorship of the trial seem to have been significant, at least on initial release of the Kolata article. As noted by Mike Pazella in his commentary on the market effects of Kolata’s article on Wall Street, the media’s coverage resulted in "an almost riot."17 Within 24 hours of the New York Times article, Entremed, the industry sponsor of endostatin, achieved stock values that were nearly seven times their value before the article’s release. Thus individuals other than prospective trial participants, eg, Entremed’s shareholders, potentially benefited from the media attention devoted to endostatin. Although presumably protected by confidentiality laws and practices, a relatively empiric question arises: How many individuals achieved significant financial benefits from the media attention? A crude and rhetorical calculus that might help address questions about the ethics of media reporting on endostatin would be to suggest that if the number of individuals who achieved significant financial benefits as a result of the media reporting was, or is, greater than the number of subjects who actually benefited from trial participation, then perhaps certain ethical boundaries have been breached. If in the future endostatin proves to be of significant clinical benefit to actual patients with cancer, then obviously this calculus should be reset. In the end, any harm from the media reporting on new experimental agents cannot be fully measured simply by an analysis of the words on the newsprint (or virtual) page. From an ethical perspective, such potential harm should be measured by both the original intent of, and fallout from, the reports themselves. The discipline of journalism has always prided itself on recognizing the importance of distinguishing its role in reporting events from its potential role in actually shaping events. Such a distinction is of particular importance in the setting where large third parties are involved and where those third parties’ interests stand to benefit from media attention, ie, free advertising. With specific regard to medical reporting, and when desperately ill patients are at least part of the media’s intended audience, it is likely that fewer problems would arise if the media could be more cognizant of the possible fallout from their stories and also remain truly sensitive to cancer patients’ needs for information.18 There is no denying that our oncologist peers of the past injected experimental agents into relatively unknowing cancer patients.3 Although reluctantly, they also acceded to the questionable demands of the government sponsors of their research. At least one well-known research ethicist has even argued that these past investigators should be retrospectively judged as having committed research abuses.3 However, given the social constraints of the time, as well as the subsequent and undeniably successful growth of antineoplastic drug therapy, history has more commonly judged those involved in this early research kindly.3 Despite the vastly increased human subjects protections present in today’s research environment, it is an interesting paradox that the verdict remains out as to how history may judge all those with conflicting interests in the current process of experimental agent administration and development. To answer the specific question, Can the media report the hope without the hype? Well, they should. Their ability to do so would be increased if the oncology research community recognized its own potential role in contributing to the kind of hype that can never be lived up to. When we contribute to the hype, knowingly or ignorantly, we then fail to stand firm in protecting the primary interests of our patients. In so doing, we put ourselves at risk of further losing our patients’ trust in our abilities both to care for them and to improve the future care of patients with cancer. REFERENCES 1. Gilman A: The initial clinical trial of nitrogen mustard. Am J Surg 105: 574-578, 1963[CrossRef][Medline] 2. Jacobson LO: From atom to eve. Perspect Biol Med 24: 195-216, 1981[Medline] 3. Advisory Committee on Human Radiation Experiments: The Final Report of the President’s Advisory Committee on the Human Radiation Experiments. New York, NY, Oxford University Press, 1996
4. Goodman LS, Wintrobe MM, Dameshek W, et al: Clinical experiences with the use of methyl-bis (beta-chloroethyl) amine hydrochloride and tris (beta-chloroethyl) amine hydrochloride (nitrogen mustards) in the therapy of Hodgkin’s disease, lymphosarcoma, leukemia, and certain allied and miscellaneous disorders. JAMA 132: 126-132, 1946
5. Jacobson LO, Spurr CVL, Barron ES, et al: Nitrogen mustard therapy: Studies on the effect of methyl-bis (beta-chloroethyl) amine hydrochloride on neoplastic and allied disorders of the hematopoietic system. JAMA 132: 263-271, 1946 6. Kolata G: Hope in the lab. New York Times, May 3, 1998, p 1
7. Wilkes MS, Knutz RL: Medical researchers and the media: Attitudes toward public dissemination of research. JAMA 268: 999-1003, 1992 8. Advertising insert. Cancer Clinical Trials: Your First Decision Counts. Newsweek, May 6, 2002 9. Hochhauser M: "Therapeutic misconception" and "recruiting doublespeak" in the informed consent process. IRB 24: 11-12, 2002[Medline] 10. Hochhauser M: DTC clinical trial advertising. Appl Clin Trials 11: 1, 2002 (letter)[CrossRef]
11. Pentz RD, Flamm AL, Sugarman J, et al: Study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol 20: 3785-3791, 2002 12. Daugherty CK, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I clinical trials. J Clin Oncol 13: 1062-1072, 1995[Abstract] 13. Daugherty CK, Banik DM, Janish L, et al: Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB 22: 6-14, 2000[Medline] 14. Gordon EJ, Daugherty CK: Referral and decision making among advanced cancer patients participating in phase I trials at a single institution. J Clin Med Ethics 12: 31-38, 2001
15. Herbst RS, Hess KR, Tran HT, et al: Phase I study of recombinant human endostatin in patients with advanced solid tumors. J Clin Oncol 20: 3792-3803, 2002
16. Eder JP Jr, Supko JG, Clark JW, et al: Phase I clinical trial of recombinant human endostatin administered as a short intravenous infusion repeated daily. J Clin Oncol 20: 3772-3784, 2002 17. Pazella M: Time article sparks howling headlines, hysteria on Wall Street. Cancer and Genetics Report, May 18, 1998, p 11 18. Passalacqua R, Campione F, Caminiti C, et al: Patients’ opinions, feelings, and attitudes after a campaign to promote Di Bella therapy. Lancet 353: 1310-1314, 1999[CrossRef][Medline]
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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