Have you heard of the Right-To-Try laws? I learned about them Wednesday from a speaker from Phoenix’s Goldwater Institute.
The formal definition: Right-To-Try laws are state laws that were created to let terminally ill patients try experimental drugs or devices that have completed initial testing, but have not been approved by the Food and Drug Administration (FDA).
Arizona’s Right-To-Try initiative was voted into law on Nov. 4, 2014.
Imagine if you or a loved one received a diagnosis of a typically-fatal disease. The doctor gives you the routine treatment options available. However, he mentions a drug that’s in a testing phase that has shown a remarkable cure rate. You think, “Oh, a light at the end of this tunnel?” No. Because you aren’t allowed to take that drug because the FDA has not yet approved it.
The federal government takes nearly 15 years to approve drugs and treatments other countries are already using to save and improve lives.
Only a small percentage of patients are approved for clinical trials. An additional 1,000 U.S. patients get compassionate use exceptions that they and their doctors must fight for – and sometimes the approval comes too late for the patient.
We need to educate ourselves on issues like this because this is just one symptom of us losing our rights as American citizens. Some of our so-called representatives at the federal level are not representing us.
The federal government has heard all of the arguments for these laws for over 10 years, but has ignored them. This is why the Goldwater Institute took it to the state level. Half the states have passed them, more are on the way.
It’s time Americans stop assuming they still have a choice in everything involving their bodies. You don’t … not when the federal government, insurance and drug companies withhold treatment and basically decide whether you can live or die. Not when our government representatives won’t fight for your rights on so many other topics, like whether you can choose to die when you are suffering from a fatal illness.
TO LEARN MORE
500 E. Coronado Road
Phoenix, Arizona 85004
I am providing facts on the laws from righttotry.org below, so our readers can learn more. I encourage you to share what you learn with others and make a clear and loud protest to our federal representatives.
Q: WHAT IS THE RIGHT TO TRY ACT?
A: Right To Try is legislation that allows terminally ill patients to access investigational treatments that have passed basic safety testing (Phase I) with the FDA, but are not yet available on pharmacy shelves.
Q: WHY WAS RIGHT TO TRY DEVELOPED?
A: Over 1 million Americans die from a terminal illness every year. Many spend years searching for a potential cure, or struggle in vain to get accepted into a clinical trial. Unfortunately, FDA red tape and government regulations restrict access to promising new treatments, and for those who do get access, it’s often too late.
Q: IS RIGHT-TO-TRY LAW IN MY STATE?
A: Right To Try has been signed into law in 24 states, including Arizona.
Q: I HAVE A TERMINAL ILLNESS AND LIVE IN A RIGHT TO TRY STATE. WHAT ARE MY NEXT STEPS?
A: You and your doctor should discuss best treatment options for your condition. If those options include a qualifying investigational drug your doctor believes is your best hope, he/she can initiate contact with that drug manufacturer’s compassionate use program director to discuss your options for access.
Q: SOME CRITICS SAY RIGHT TO TRY IS JUST “FEEL GOOD” LEGISLATION THAT WON’T ACTUALLY HELP ANYONE. IS THIS TRUE?
A: No. Right-To-Try laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be available on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.
Q: IF PATIENTS CAN ACCESS INVESTIGATIONAL TREATMENTS BY PARTICIPATING IN CLINICAL RESEARCH TRIALS, WHY DO WE NEED RIGHT TO TRY?
A: Fewer than 3 percent of terminally ill patients gain access to investigational treatments through clinical trials. Right To Try was designed to help the other 97 percent.
Q: THE FDA HAS AN EXPANDED ACCESS PROGRAM THAT ALLOWS PATIENTS QUICKER ACCESS TO INVESTIGATIONAL TREATMENTS. HOW IS RIGHT TO TRY DIFFERENT?
A: While millions of Americans will be diagnosed with or die of terminal illnesses each year, compassionate use exceptions are granted only to about 1,000 patients a year. Many patients run out of time before they can qualify for the exemption or complete the process. Right-To-Try laws help patients get immediate access to the medical treatments they need before it’s too late.
Q: ARE TREATMENTS AVAILABLE UNDER RIGHT TO TRY SAFE?
A: Yes. These are no different than the treatments currently available to the 3 percent of patients who are lucky enough to be accepted into clinical trials.
Q: HOW DO PATIENTS PAY FOR TREATMENTS UNDER RIGHT TO TRY?
A: Under Right To Try, patients will be responsible if there are costs for their investigational treatments. Fortunately, many drug manufacturers offer investigational treatments to patients in need for free or at cost. Associations for major illnesses and other charitable foundations also help patients afford treatments.
Q: DO STATES HAVE THE POWER TO ENACT RIGHT-TO-TRY LAWS?
A: Yes. FDA regulations cannot preempt state laws that preserve constitutionally protected rights, such as the fundamental right to life and medical self-preservation. The U.S. Supreme Court has never addressed Right To Try specifically, but it has held that states have great latitude in regulating health and safety, including medical standards, which are primarily and historically a matter of local concern.