Right for Patients?
“Right to Try” legislation may have compassion at its heart, but it does not do enough to ensure patient protection.
Ellen Sigal |
“Right to Try” is a newly passed piece of US legislation that allows terminally ill patients to request access outside of clinical trials to experimental therapies that have completed Phase I testing, but have not been approved by the FDA. In the US, the main advocate for the law was the Goldwater Institute – a libertarian think tank that created the legal template used by many states.
Prior to this bill being passed, hundreds of patient advocacy organizations pushed back against it – and although the bill was signed into law in May 2018, we along with others remain concerned about the impact on patients (1). You may be thinking: but surely, if there is no hope for a patient, is an experimental treatment not worth trying? I think we can all agree that terminally ill patients should have access to promising experimental therapies when they have exhausted all other options. The concerns, however, centered around the need to ensure that patients were not harmed by potentially lethal side effects, as well as the importance of maintaining FDA oversight.
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