FDA Tells Drug and Device Makers to Give Balanced Picture of Risks in Ads, Labels

Abstract

sue with the content of the decision aids, but may become more comfortable with such aids as more of them become available and studies are conducted to assess and compare them, said Arterburn. In the meantime, the International Patient Decision Aid Standards Collaboration is creating a set of criteria that can be used to judge whether decision aids are evidencebased and free of bias or conflict. Although no data are yet available, the Group Health Cooperative has been using decision aids produced by the Foundation for Informed Medical Decision Making (which are reportedly based on systematic reviews of the evidence and focus groups and interviews about patient preferences) and has received some positive anecdotal feedback, Merrikin said. For example, some orthopedic surgeons have commented that patients are better prepared to discuss the options, are more knowledgeable, and ask more sophisticated questions—factors that have helped reduce the amount of time necessary for such discussions. There also is evidence in the literature that patients who go through the shared decision-making process are more likely to adhere to the selected therapy, Braddock said. However, there may be financial disincentives that might discourage physicians from taking time for shared decision making. For example, Braddock said, physicians are reimbursed more for performing procedures than for consultations. Some of the state bills do require reimbursement for shared decision making, however, which may help address this potential barrier. Whether adopting shared decision making will actually cut costs remains to be seen. Patients faced with various options that produce a similar outcome may not necessarily choose the less expensive one. In any case, Braddock and Arterburn said, physicians have an ethical obligation to ensure that their patients are fully informed and given a say in what happens to their bodies. “It’s the right thing to do,” Braddock said.