This week the State Assembly is taking up Right to Try legislation, Assembly Bill 69, to increase access to treatment options for Wisconsinites who are battling terminal illnesses. The bi-partisan effort, authored by Representatives Pat Snyder and Joel Kleefisch and Senators Terry Moulton and Fred Risser, deserves a yes vote in the Assembly and swift consideration in the State Senate.
Every year, thousands of terminally ill patients are not allowed to access treatment protocols that have passed phase one clinical trials because these treatments have not yet received final approval by the Food and Drug Administration. In many cases, these treatments have already been approved and are being used effectively in other countries. In other cases, patients here in the United States have achieved favorable results while using these treatments as part of a clinical trial, but find themselves cut off from a therapy that works when their clinical trial ends.
Currently, terminally ill patients in Wisconsin only have two options if they want to gain access to an experimental treatment: they can join a clinical trial or apply for a compassionate use approval from the FDA. Neither of these options work well for many terminally ill patients. When operating clinical trials, researchers look for patients who meet very specific criteria. If a patient does not fall within these criteria – and most don’t – they won’t be entered into the trial. And even if they do get accepted into a trial, as previously mentioned, their access to the treatment is cut off when the trial ends.
The odds are even slimmer on compassionate use approvals. A highly bureaucratic, expensive, and drawn out process, only around 1,200 people each year are able to obtain a compassionate use approval. Some of the nation’s leading medical research departments are only able to obtain one or two such approvals each year.
AB 69 doesn’t place any unfunded mandates on government healthcare programs, nor does it create burdensome new regulations or requirements for healthcare providers or insurers. Its authors have also been careful to avoid requiring public or private insurers to cover the cost of these experimental treatments or to mandate that healthcare providers offer them. Importantly, the bill does provide critical liability protections to help allow experimental treatments to move forward for those most in need.
In Right to Try states, providers and patients both enter willingly into a treatment agreement with an understanding of the potential risks. And with the regulatory hurdles cleared away, many terminally ill patients are able to access even very costly experimental drugs with the help of philanthropic donations and other sources of private funding.
Terminally ill patients in Wisconsin deserve to be able to fight for their own lives, and with bi-partisan reforms like Assembly Bill 69, they will have more available options to help them in their battle to extend their lives and improve their quality of life. This bill represents an important step forward in expanding access to potentially life-saving medical interventions for the Wisconsin patients who need it most.
