Far too many Americans have experienced the terrible frustration of watching a loved one endure the final stages of a terminal disease, without access to potentially live-extending experimental medication because the Food and Drug Administration has yet to grant approval.
The U.S. House of Representatives is finally considering legislation which could address that dilemma. The bill would “authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes.” Similar legislation was passed by the Senate last August, and has been endorsed by President Trump, who noted his support in his State of the Union address. Vice President Pence also has publicly approved the concept.
The bill is modeled off a federal policy known as “Compassionate Use,” but contains several key changes meant to make it faster and easier for patients to obtain experimental therapies.
The Right To Try advocacy group notes that “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…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…While millions of Americans will be diagnosed with or die of terminal illnesses each year, compassionate use exceptions are only granted to about 1,200 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.”
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The Goldwater Institute notes: “For patients suffering from terminal illnesses, the FDA is the arbiter of life and death. These patients… face little chance of recovery… The FDA, however, often stands between the patients and the treatments that may alleviate their symptoms or provide a cure… Sadly, over half a million cancer patients and thousands of patients with other terminal illnesses die each year as the bureaucratic wheels at the FDA slowly turn. Patients should be free to exercise a basic freedom – attempting to preserve one’s own life. The burdens imposed on a terminal patient who fights to save his or her own life are a violation of personal liberty. Such people should have the option of accessing investigational drugs which have passed basic safety tests, provided there is a doctor’s recommendation, informed consent, and the willingness of the manufacturer of the medication to make such drugs available.”
There is a glaring lack of logic in the practice of withholding experimental medications that may hold the only source of hope for patients facing death. There is also a serious legal and constitutional issue, as well. There is no obvious right or grant of power to Washington to intervene in the decision of qualified physician to attempt every possible measure to save or extend the life of a terminally ill patient.
FDA photo