Abstract
To the editor: Our hospital's Institutional Review Committee has the opportunity to evaluate research protocols from various medical specialties. These laboriously designed protocols consider and include seemingly all possible risks. However, an area that seems to be unexplainably neglected is alternative medicines. As Sweet et al. 1 point out in their recent article, the growth in use of herbal medications is extraordinary, while the information on their dangers and appropriate use is just catching up.
In the last 2 meetings of our committee, protocols examining the use of imatinib mesylate (Gleevec) and irinotecan (Camptosar) were reviewed. Imatinib is metabolized mainly by the CYP3A4 isoenzyme. The package insert for imatinib warns about interactions with agents that can induce or inhibit that enzyme, particularly naming St. John's wort. 2 Similarly, St. John's wort has been reported to cause a 50% reduction in the active metabolite (SN-38) of irinotecan. 3 Yet, in neither protocol was there any provision to exclude patients taking alternative medicines or to even inquire about their use.
Over 50% of the general population uses alternative therapies and, for patients with cancer or chronic disease, that percentage may even be higher. 4 Further, whether because of fear of chastisement or desire for control, users of alternative therapies will often not volunteer that information. 5 It is not even safe to assume that a preexisting alternative medicine regimen provides a baseline since the potency of these agents can vary from brand to brand, year to year, and batch to batch. 6
It is therefore incumbent on the developers of protocols to make sure these questions are asked and that appropriate action is taken. In our role as providers of information and with the resources that are available, 1 pharmacists may be uniquely suited to assist in the protocol design. It may even be germane to address these concerns to pharmaceutical manufacturers and the major organizations funding research so that proactive consideration is given. By whatever route accomplished, we must ensure that herbal products get the attention they merit.
If patients being considered for a research protocol are using phytopharmaceuticals, they should be encouraged to stop and, if they refuse to stop, they may need to be excluded as possible subjects. As clinicians and researchers, we need to embrace the benefits and limitations of these compounds so that we do not ignore the effect they can have both on patient safety and study results.