In 2010, after experiencing weakness in my legs and hands, I found myself at Emory University Hospital sitting across from one of the foremost neurologists in the world. My wife and I sat in disbelief as our world was turned upside down. The doctor explained to us that I had ALS, or Lou Gehrig’s disease. The chilling words — “There is no known cause, and no known cure” — continue to reverberate through my head.
I was 38. I was facing a future without hope, until I had a chance to exercise my “right to try,” thanks to Emory University and their partnership with Neuralstem Inc.
A groundbreaking safety study was taking place at Emory involving the injection of neural stem cells directly into the grey matter of ALS patients’ spinal cords. I was told it was only to prove it was safe, that it was very risky, and that it most likely wouldn’t help me. I gave my informed consent to participate.
Then the most unexpected thing happened. It helped.
Weeks after invasive surgery, I put down my cane and regained strength throughout my body. Empirical data showed that while I was not cured, they could document me regaining strength. You can only imagine the depth of my family’s joy and happiness, all because we had the “right to try.”
The Goldwater Institute has crafted “Right to Try” legislation that four states are in the midst of passing and eight others are considering. “Right to Try” allows a patient access to investigational medications that have passed basic safety tests without interference by the government when certain conditions are met:
1.) Patient has been diagnosed with a terminal disease;
2.) Patient has considered all available treatment options;
3.) Patient’s doctor has recommended the investigational drug, device or biological product represents the patient’s best chance at survival;
4.) Patients or their guardians have provided informed consent;
5.) The sponsoring company chooses to make the investigational drug available to patients outside the clinical trial.
I am making it my personal mission to introduce “Right to Try” to the Georgia General Assembly as part of next year’s legislative session. Everyone deserves hope and the opportunity to “try.” Can anything be more inhumane than forcing people to endure a fatal plane crash because the onboard parachutes weren’t approved by a federal agency?
This scenario plays out in medicine daily. I appreciate that the FDA is the gold standard in drug safety; however, if you or a loved one were facing mortality, would you be willing to settle for a silver standard?
The research and results of the safety and potential efficacy of this research has gone global. A small glimmer of hope, a commodity previously nonexistent in the ALS community, has been ignited. I regularly receive emails requesting help from people throughout the world.
The desperation is not unique. According to the Goldwater Institute, “More than 500,000 Americans died last year of cancer alone, and thousands more of other terminal illness. Promising treatments exist that could save their lives, but it takes a decade and a billion dollars for a drug to reach full FDA approval. Only 3 percent of the sickest Americans qualify for clinical trials, and the FDA protocol for approving drugs has not changed in 50 years.”
Through my advocacy efforts, I have learned that only an average of 27 new drugs are approved by the FDA on an annual basis. They could be for acne, arthritis or anemia. Typically, very few of them are for diseases that have no cure, such as ALS or virulent forms of cancer. This leads sufferers to risky and potentially fraudulent “treatments” that may cost tens to hundreds of thousands of dollars..
If you believe as I do, that patients in Georgia deserve the right to try, then please reach out to state legislators and tell them to introduce and pass “Right to Try” legislation next session. Trying will not be enough. That right should be reserved for people dying without hope.
Ted Harada, a former manager for FedEx and DHL, is on the Board of Directors of the Georgia ALS Association. He lives in McDonough.