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Right-to-Try Laws Do Not Live Up to Their Promise
So-called “right-to-try” laws have done little to give terminally ill people access to investigational drugs or devices, according to the Annals of Internal Medicine.
Right-to-try laws permit terminally ill patients to request access to investigational drugs or devices not yet approved by the FDA. The laws aim to nullify the FDA’s power to approve or reject agreements between the physician requesting the product on behalf of a patient and the entity developing the product. The aim of the laws is to increase the number of patients accessing investigational products; however, the Annals of Internal Medicine says there are no reports of patients gaining access to such products through this approach.
The lack of improvement in access to investigational medical products can be attributed to a number of factors. Variances in how terminal illness in defined is one reason why access to investigational products remains inequitable. In addition, the use of terminal illness as a necessity for access means that patients who have exhausted all other treatment options and are not imminently facing death, such as those with multiple sclerosis and chronic pain, are ignored.
With minimal oversight, there is significant potential for abuse with right-to-try laws. These laws do not set qualifications for either the health care provider making the attestation of terminal illness or the physician recommending the experimental treatments. As a result, patients cannot be assured of adequate assessment of their condition or benefit from the experimental treatment. Furthermore, patients and their families who are desperately ill may even be preyed upon through the use of interventions without scientific evidence.
Patients are permitted to request any medical product that has completed phase I testing, according to right-to try laws. As such, informed consent becomes a complicated aspect of these laws. Patients are told they will be given a description involving the best and worst outcomes of using the investigational drug as well as the most likely outcomes, despite the fact that the interventions have not been tested for efficacy.
As of early September 2015, 24 states have right-to-try laws and many other states are considering similar bills. Despite the continued progress and hope, concerns remain surrounding access, oversight, abuse, and therapeutic misconception.
Source: Annals of Internal Medicine; September 29, 2015.