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in postmyocardial infarction patients.119 They found 70 publications: 5 original research papers, 32 reviews, and 33 letters to the editor. As Table 9.6 shows, researchers with a financial interest in a manufacturer of calcium channel antagonist, or even those with a financial interest in any manufacturer, were significantly more likely to support the safety of calcium channel blockers than researchers without a financial interest. Indeed, this trend held true for researchers with any type of financial interest in any pharmaceutical manufacturer, including receiving honoraria and research funding. The only time there was no association between having a financial interest in any pharmaceutical manufacturer and supporting the safety of calcium channel blockers, was when the researchers' financial interest was to have been employed by or served as a consultant to manufacturers.

Finally, there are data showing that financial interests do alter dissemination of research results. A study of 42 placebo-controlled trials of selective serotonin reuptake inhibitors (SSRI) submitted to Swedish regulators found that, of the 21 studies showing positive effects of the drug over placebo, 19 were published, with the results frequently appearing in more than 1 article. Conversely, of the 21 studies that showed no difference between the experimental SSRI drug and placebo, only 6 were published.120 Whether this is a result of the publication bias against negative studies at major journals or the result of industry withholding negative data was not determined. However, a 1993 survey of 2,167 life science faculty from the 50 universities receiving the most NIH funding found that one-fifth of the faculty had delayed publication for more than 6 months during the past 3 years to allow for patent application or negotiation, to resolve intellectual property rights disputes, to protect their scientific lead over competitors, or to slow the distribution of undesired results. Delays in publication were associated with participation in a research relationship with industry [odds ratio (OR) = 1.34] and with commercialization of one's own research results (OR = 3.15).104,121 More importantly, there have been a number of high-profile cases in which industry has actively and explicitly tried to prevent the dissemination of negative findings about drugs. In the Olivieri case in Toronto, Apotex, the company that funded Dr. Olivieri's research on their drug, tried to prevent her from publishing findings suggesting that the drug was not only not beneficial for patients with iron overload, but may actually be harmful to them.122 Similarly, the manufacturers of Synthroid brand thyroid replacement, Boots Co., funded a study to compare Synthroid with generic thyroid replacement drugs.123 The results showed no difference in patient outcomes. Boots then tried to prevent the

UCSF researchers who conducted the study from publishing the data.

These data suggest that financial interests probably do not have an adverse effect on the conduct of clinical research and may actually be beneficial in terms of study design. Conversely, in terms of data interpretation and dissemination, the data suggest that "money does talk."

How can we protect against this distorting influence of conflicts of interest? In general, there are three types of safeguards for conflicts of interest. First, and most commonly, is for researchers to disclose their financial interest. In addition, the financial interest is managed by instituting data safety and monitoring boards (DSMBs) or independent consent monitors. Finally, when financial interests are too extensive, prohibitions can be implemented.

Disclosure of researchers' financial interests in journal articles is becoming routine and more comprehensive. However, the data about intrainstitutional disclosure and the communication of the disclosed information to the various research oversight groups and committees indicates a flawed system. A recent General Accounting Office (GAO) study of five major research institutions found that the rules regarding disclosure and prohibitions of financial interests varied widely.124 Furthermore, the disclosed information was not well recorded by the institutions and was not readily available to the institutions' IRBs when they considered protocols. Of the 111 cases in which researchers had substantial financial interests, the GAO found that in only 3 did the researchers divest and in no cases were they told to do so by their universities.

There are other data indicating that disclosure may not be an adequate safeguard even if institutions do have conflict of interest (COI) disclosure policies in place, researchers frequently lack knowledge about such policies. For instance, at UCSF and Stanford, 58% of researchers surveyed could not accurately describe the COI policy of their institution.125 In addition, COI policies lack specificity and there are inconsistent standards for disclosure across institutions.126-128

Importantly, while there have been vociferous calls for disclosure of financial interests to research subjects, there have been almost no data on whether patients can understand these data and how they might react.129 Indeed, some highly regarded commentators have worried that disclosure to patients would only reveal the problem without providing them any mechanism to address it, thereby increasing anxiety but not solving the underlying conflict of interest.130

To address problems about conflict of interest, the Board of Directors of American Society of Clinical Oncology (ASCO) voted to revise its conflict of interest policy in 2002.

The new policy requires disclosure of all financial payments or interests from entities "having an investment, licensing, or other commercial interest in the subject matter under consideration," including (1) executive or leadership positions, (2) ownership of stock or equity in companies, (3) consultancy or service on an advisory board, (4) honoraria for speeches, (5) royalty payments on a patent, (6) nonresearch-related travel or gifts, and (7) expert testimony.131 The policy does not view research-related funding, funding to attend investigators' meetings, or funding as part of a grant to present research results at a widely attended open meeting (such as the ASCO annual meeting) as a conflict of interest; therefore, ASCO does not require disclosure of this type of information.

In addition to disclosure, ASCO has also implemented restrictions on researchers' "finder's fees," payments for recruiting goals or recruiting speed, and payments for certain data results. Similarly, ASCO believes that because principal investigators or individuals on the executive committees of large multicenter studies as well as those on data safety and monitoring boards have such extensive decision-making authority over the conduct, analysis, and dissemination of study results, these individuals should have none of the listed financial interests in a commercial sponsor.

There are two important exceptions to these restrictions. Because of the extensive oversight provided through study sections, DSMBs, and other independent review mechanisms, these restrictions do not apply to NIH-supported research studies that might "involve products of specific commercial interests." Furthermore, recognizing the importance of trans-lational research and the reality that the developer of a new technology is probably the best person to conduct the initial research studies, the ASCO policy recognizes that when there is limited worldwide expertise and when "an inventor of a unique technology or treatment being evaluated in a trial," these restrictions might be relaxed. In these cases, there must be a data safety and monitoring board in place to ensure the safety of the research participants.

Ethics is a key area of oncology research, and current ongoing empirical research on many ethical issues—such as how to improve informed consent, the role hope plays in patients' decisions to participate in Phase I studies, and patients perceptions of COI—may well change the answers to these ethical questions.

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