By Brandon Moseley
Alabama Political Reporter
U.S. Rep. Mo Brooks, who represents Alabama’s 5th Congressional District, delivered a House floor speech Thursday calling for a vote on Senate Bill S. 204, the Right to Try Act, which would give terminally ill patients the right to try experimental treatments that have not yet completed the Food and Drug Administration’s lengthy and complex approval process.
That process can take years if not decades.
Brooks was motivated by the story of Steve Mayfield, a respected high school football coach at Central High School in Lauderdale County, Ala., who, in March 2017, died after a lengthy fight with Lou Gehrig’s disease, also known as ALS. A federal bureaucracy denied him the right to try potentially life-saving experimental treatments.
“Roughly four years ago Steve Mayfield was a respected high school football coach at Central High School in Lauderdale County, Alabama, who, in October 2014, was diagnosed with ALS. Steve Mayfield bravely fought his terminal disease and kept a smile on his face throughout his lengthy three-year battle and ordeal,” said Brooks.
“In a land of freedom and liberty, Steve Mayfield would have had two choices,” Brooks continued. “On the one hand, he could abide by Food and Drug Administration regulations and recommendations . . . and die. On the other hand, Steve Mayfield could try experimental treatments that gave some hope of beating ALS and extending Steve Mayfield’s life. Unfortunately, when it comes to terminal illnesses in America, there is no freedom or liberty. Steve Mayfield not only had to fight ALS, he also had to fight the Food and Drug Administration before he could try experimental but potentially life-saving treatments.”
“Sadly, Steve Mayfield lost both fights,” Rep. Brooks said. “Steve Mayfield was barred by the federal government from trying possibly life-saving treatments and, not long ago, passed away. Steve Mayfield’s son, Brooks Mayfield, of Florence, Alabama, was with his father when he passed away.”
“I call on the House to have a floor vote on Senate Bill S. 204, the Right to Try Act, which passed the Senate last year, that restores the right of terminally ill patients to try experimental treatments that may save their lives,” Brooks said. “Brooks Mayfield’s father might be alive today if the Right to Try Act had been the law of the land. Mr. Speaker, we must remember who we are as Americans. Our ancestors fought the Revolutionary War over liberty and freedom, yet, today in America, patients who are 100 percent certain to die are denied the freedom, the liberty, the right to decide for themselves whether to try experimental treatments that may save their lives. Every day in America, terminally ill patients and their families are told there are no options but death. By way of background, fewer than 3 percent of terminally ill patients in America have access to investigational treatments through clinical trials. While the Food and Drug Administration grants compassionate use waivers, meant to allow terminal patients access to experimental drugs, only about 1,500 waivers were granted in 2016.”
“Given the stark contrasts between life and death, between freedom and federal dictates, between hope and hopelessness, the House should take up and pass the Right to Try Act, thereby giving a chance for life to terminally ill patients and their families,” Brooks said. “The United States Senate overwhelmingly passed Right to Try legislation last year. It is time for the House to do the same, thereby restoring freedom, liberty and hope, and giving terminally ill patients across America a better chance to live.”
According to a policy report by the Goldwater Institute, an estimated 97 percent of the sickest patients are ineligible for or otherwise lack access to clinical trials.
The Right to Try Act would require, “The federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs, biological products, and medical devices that are: (1) intended to treat a patient who has been diagnosed with a terminal illness, and (2) authorized by state law. The federal government must allow unrestricted possession and use of such treatments by patients certified by a physician as having exhausted all other treatment options. A manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment. The outcome of manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment. The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.” (Summary of HR878 Congress.gov.)
Many critics of the health care system have suggested that if drug manufacturers and doctors were granted immunity from liability across the board, particularly from class action lawsuits, then costs of medical care would drop substantially.
Brooks is presently battling prostate cancer himself.