Monday, 6 March 2017

A Closer Look at the Right to Try Act for the Terminally Ill

There are hundreds of different investigational drugs that are in various phases of clinical trials all over the world. Until they’ve been cleared to be marketed to the public, they are only available in very limited clinical trials. While there are risks associated with the use of these medications, they could potentially save or extend the lives of terminally ill patients. With this is mind, many states have begun passing Right to Try laws for terminally ill patients. What do these laws entail and how could they change lives?

A guest post by Megan Ray Nichols

What is the Right to Try Act?

While the exact wording of the act varies from state to state, the essence of the Right to Try Act is that it allows terminally ill patients to access experimental medications that have passed Phase I of their clinical trials.

Clinical trials come in 4 phases. Phase 1 is for healthy volunteers to help researchers determine the best dosage for the drug, while Phases 2 and 3 are used determine the drug’s efficacy and side effects. Phase 4 wraps it all up with long term studies after the drug has been marketed to the public. In normal cases, terminally ill patients would not be able to access a new investigational drug until it reached Phase 4. Right to Try Acts enable these patients to access these new medications while they are still in phases 2 and 3.

Why the Support For Right to Try Acts?
With the danger that untested medications present, why is there such support for these acts in states around the country? The personal accounts of patients and family members almost speak for themselves. In one story, a woman’s mother was diagnosed with Stage 4 cancer and given just a few months to live. At the time, her home state did not have a Right to Try law on the books, so she was forced to travel to another state to try an experimental drug to treat her cancer.

Instead of living for just 6 months after her diagnosis, she was able to live for another 12 years, thanks to an experimental treatment. In her own state, she likely would not have survived long enough for the treatment to become available to the public.

State Vs. Federal Powers
Right now, if a patient has exhausted all FDA approved options for treatment they can apply to the FDA for access to experimental drugs under what is known as ‘compassionate use.’ The Right to Try laws are being explored because many supporters believe that the compassionate use applications take too long to be processed by a big government agency.

Since these laws are being passed by each individual state, the question becomes whether or not the state laws are able to supersede the regulations already being followed by the FDA. Most laws include language that specifies the patient’s right to access the drugs.

Another possible solution in the works is to revamp compassionate use though the FDA so the application process is faster and more accessible to terminally ill patients who might not have enough time to wait for the traditional application process.

Physician Opinions on Right to Try Acts

With more and more states introducing these laws, are physicians willing to sign their name to an order for an experimental drug for their patient?

When it comes down to it, it really depends on the physicians. Some believe that the Right to Try laws can actually harm patients by providing them with drugs that haven’t had their efficacy proven, potentially leading to patient injury or death.

There are also questions about insurance and who is responsible for paying for this experimental treatment. Some insurance companies may offer reimbursement for experimental procedures but they are not under any current obligation to do so.

31 states currently have some form of Right to Try law currently on the books, increasing options for terminally ill patients.

While Right to Try laws might not be the perfect solution, they offer a ray of hope to terminal patients who might have run out of options. Sometimes all you need is that little glimmer of hope.

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