Setting the record straight on Right to Try

As political support and momentum for Right to Try legislation increases, some opponents are resorting to scare tactics in a desperate attempt to keep Washington bureaucrats firmly in charge of who gets access to potentially life-saving treatments.

Opponents are falsely claiming that terminal patients accessing treatments under Right to Try will be stranded without access to hospice care should they need it.

{mosads}This is simply not true. Eligibility for hospice care is largely set by the Center for Medicaid Services and neither the state nor proposed federal Right to Try laws would change this in the slightest. Eligibility for hospice care will still be determined by the payer for the care, or the non-profit organization providing the services. 

In fact, the only mention of hospice in any of the 50 state Right to Try laws that have been introduced is to ensure patients understand that if they are receiving hospice services but begin to seek curative treatment under Right to Try, their insurance company may determine they cannot also receive hosipice care at the same time. And that makes sense. If a person is seeking curative treatment, then they are not ready for hospice care. Patients can go in and out of hospice care without penalty and this law does nothing to change that. 

This latest ‘alternative fact’ about Right to Try really deflects from the central issue: Should terminally patients have to seek permission from Washington bureaucrats in order to try to save their own lives? 

Right to Try is now law in 33 states and under consideration in the other 17, dozens of patients are being treated under the law, and, based on evidence from overseas, making early access to treatments for terminal patients the rule, rather than the exception, is both possible and desirable.

Right to Try critics seem content to ignore just how arcane the status quo really is. Today, the three leading causes of death in the U.S. are heart disease, cancer, and chronic obstructive pulmonary disease (COPD). They account for more than 1.3 million deaths annually. 

Yet the FDA’s compassionate use program, which is supposed to give patients access to investigational treatments, granted fewer than 1,300 requests in 2015. And even though the FDA did approve almost all of the requests they received, that means, at best, fewer than one-tenth of one percent of terminal patients suffering from one of these diseases is getting early access to a potentially life-saving treatment. This says nothing about how few people with illnesses such as ALS and Alzheimer’s, for which there are currently treatments in the investigational pipeline, are receiving help.

The United States could provide better access to potentially life-saving treatments for terminal patients. Australia has already been doing so for decades and shows how it’s possible. 

The Australian compassionate use program allows a terminal patient’s physician to serve as the approving authority for seeking treatment. They must notify a government agency within four weeks after requesting a treatment from the drug manufacturer or other provider. In other words, compassionate access is the rule, not the exception.

While there is not a good investigational treatment match for every terminal patient in the U.S. and not every terminal patient would seek that course of action, we should be appalled that the right to medical self-defense is given to so few people by the FDA.

Right to Try legislation offers a new path to addressing this problem. Right to Try complements the FDA clinical trial and approval process by ensuring that drugs that people access under Right to Try have been determined safe enough to be given to broader patient populations in clinical trials. If a drug is safe enough for a dying person in a clinical trial, then it’s safe enough for a dying person who cannot qualify for that same trial. 

The federal government should not be the gatekeeper between potentially life-saving medicines and dying Americans. That decision should be made by patients in consultation with their doctors and the company developing the treatment. If all three of them agree that a promising treatment could help someone, the federal government shouldn’t get a veto stamp.

Naomi Lopez Bauman is the director of healthcare policy at the Goldwater Institute.