information from previous randomized clinical outcome studies can be used to assess cost-effectiveness. For example, data from the Framingham heart study have been used to look at genetic markers that increase the risk of heart disease and the costs of preventing heart disease in various ways (Shiffman et al., 2012).
Patients tend to differ from patient advocates, said Mary Lou Smith, cofounder of the Research Advocacy Network. Patients are more focused on themselves, their treatment, their families, and their future, whereas advocates look at a broader picture with the needs of a composite patient in mind. Smith is a two-time breast cancer survivor and spoke as a patient, not as an advocate.
Patients want to know what the best treatments are for them. They want to know whether they will benefit from a treatment, suffer the effects of toxicity, or both. If a genomic test will provide that information, the question becomes whether a physician will order the test, whether the physician will understand the test results, and whether the physician will use the test correctly, said Smith.
Patients need time with their physicians to discuss options, but physicians do not have incentives to make this time. They are pressured by their administrators to be productive, and chemotherapy is profitable for hospitals, which can distort incentives throughout the system, said Smith.
Research is needed on how information from genomic tests is used by patients, said Smith. For example, studies conducted by the Research Advocacy Network indicate that benefit matters more than toxicity to patients when making treatment decisions. The greater the benefit, the more likely a patient is to choose treatment. The higher the toxicity, the less likely a patient will choose a treatment, although the nature, duration, and severity of the side effects are also factors. “It’s not a simple process,” she said.
One important application of genomic testing will be to identify patients who will not benefit from particular treatments. Such testing, Smith said, could produce both tremendous cost savings and great improvements in quality of life.
Smith also commented on informed consent. “I don’t think anyone in this room actually believes those 27-page documents inform patients,” she said. Even easy-to-read consent forms do not necessarily increase retention or understanding. “We need to start from square one and say, What does a patient really need to make an informed decision? And what is an informed decision?” Smith noted that she is a lawyer but still did not read the consent form given to her when she entered into a clinical trial. “I knew the