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Drug Safety

David A. Fox, MD  |  Issue: July 2008  |  July 1, 2008

8. Full disclosure, and an emphasis on ethics: Potential conflicts of interest are an ever-growing concern of the ACR, and the issues surrounding drug safety provide an excellent example of why this is important. In the development of treatment guidelines, Hotlines, white papers, and activities of officers, board members, and committee members, disclosure of potential conflicts of interest is strictly enforced. Sometimes such conflicts exclude participation by specific individuals, even if they are otherwise well qualified. Industry funding and influence is not permitted for any ACR advocacy activities. Our relationship with our Industry Roundtable partners provides us—in my view—with an opportunity to make inroads into the practices of ghostwriting, data manipulation, and other undesirable activities that can cloud our understanding of drug safety issues. Our legal counsel tells us that, to his knowledge, no other professional society is as vigilant on conflict of interest issues as the ACR, and we intend to stay ahead of the curve as ethical standards continue to evolve.

9. Development of an ACR patient data registry: If the need for better real-world data is the most important reason for a drug safety problem, then the development of an ACR registry is likely to be the boldest and most effective step that we can take. Most ACR members don’t know it yet, but intense planning is underway—through a task force led by Jim O’Dell, MD—to develop a plan for an ACR patient data registry that would allow all ACR members to participate. Creation of better drug safety and toxicity data is only one potential benefit of such a registry—others include providing a pathway for meeting recertification requirements, quality improvement, quality measure reporting, and clinical research. Many questions still need to be addressed before the ACR board can authorize full implementation of this project, and ACR members will be kept updated as this initiative unfolds.

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Is the ACR doing enough about drug safety? Probably not yet, but this issue is certainly getting plenty of attention. As we move forward, we can be confident that all of our initiatives in this area are not only for the benefit of our members, but also for the benefit of our patients. In this effort—and indeed in everything that the ACR does—aligning the interests of our members and our patients will be essential to our future success.

Dr. Fox is president of the ACR. Contact him via e-mail at [email protected].

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Filed under:Drug UpdatesPresident's Perspective Tagged with:DrugsFDASafety

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