Wisconsin needs ‘right to try.’
During my 32 years as a registered nurse, I have cried tears of joy as a witness to miraculous recoveries. And I have cried tears of sadness as I’ve held the hands of patients as their time on Earth ended. I’ve seen the extraordinary medical capabilities available, and yet I’ve personally experienced the limitations of our current system in providing life-saving treatments with the death of my husband, Mitch Cook.
That is why I am asking state lawmakers to pass the Wisconsin Right to Try Act, so that others like my husband have a fighting chance against terminal illness.
My husband was an avid outdoorsman — fishing, golfing, weather and music were his passions. He was hard-working and spent his life in retail management. One day, Mitch came home from helping a friend paint his home and said, “I dropped the paintbrush three times today.” As a nurse, I knew something was wrong. Our worst fears were confirmed when we were told that Mitch had ALS, also known as Lou Gehrig’s disease.
ALS is a fatal disease with no cure and limited treatment options. The life expectancy of an ALS patient is three to five years.
The same month of Mitch’s diagnosis we learned of a promising treatment being explored by Clive Svendson at Cedars-Sinai in California. The treatment used stem cells and gene therapy to halt the progression of ALS. We were hopeful that Mitch would be able to participate, and waited for approval.
As we waited, Mitch had a feeding tube placed, as he could barely eat and already had lost 50 pounds. His speech was almost gone and he no longer had the use of his right arm. Walking was becoming a challenge without assistance and he required a ventilation machine at night.
Eleven months later we were still waiting, but Mitch could no longer walk or use his arms. He could barely speak and his breathing was worsening daily. Sadly, in his condition he no longer qualified for most of the clinical studies that were happening, including the one we were so hopeful for when Mitch was first diagnosed.
For rapidly fatal diseases such as ALS there are promising therapies that are simply inaccessible. They are stuck in a drug approval process that dates back to 1962. In 2012, Congress directed the Food and Drug Administration to utilize its accelerated approval program for fatal diseases that lack treatments, but the FDA still is resisting this directive.
The Right to Try bill provides necessary legal protections that will allow patients like Mitch to have early access to these treatments, and it applies only to products in the FDA approval pipeline in the very specific case of a terminal illness lacking lifesaving treatments. Without these protections, companies largely are unwilling to make their treatments available; even under the current compassionate use program.
There already are lifesaving treatments approved in Japan, Europe and elsewhere that terminal patients cannot legally obtain in the United States. Those who can afford it are moving to these countries in an effort to save their own lives.
Mitch wanted to try promising treatments, knowing fully there would be risk. He could accept failure, but he could not accept not trying. He wanted the right to try to save his own life.
We are being denied access to the only lifelines we have: therapies showing promising benefits in clinical trials. Unquestionably, we need the FDA to protect public health, but we also deserve an FDA that is reasonable and responsive, especially in the case of fast-moving fatal diseases that lack approved treatments.
Just over two years after his diagnosis, my beloved Mitch died peacefully in my arms. He faced his last days with humor and hope. The same week Mitch died, Svendson got FDA approval to begin clinical trials for the stem cell and gene therapy combination that two years prior we had pinned our hopes and dreams on, 13 years after he developed the treatment.
Desmond Tutu said, “Hope is being able to see that there is light despite all of the darkness.” I am asking Wisconsin lawmakers to please support the Right to Try bill and be the hope that lights our darkness.