As the new year approaches, critically ill Americans are desperately hoping that Washington finally enacts comprehensive “Right to try” legislation.
The Right to try concept allows terminally ill people access to experimental drugs not approved by the Food and Drug Administration, if recommended by a physician. According to the New York Times “Instead of relying on the F.D.A. to move quickly, the “right to try” laws seek to speed up access by eliminating the F.D.A. from the process entirely. Once a doctor and patient decide that an experimental drug is the right choice, the laws let them apply to the drug company directly.”
According to Regulation Tracker “Since early 2014, more than 20 states have introduced so-called “Right to Try” bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as “Compassionate Use,” but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.”
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 the life of a terminally ill patient.
According to the Washington Post, “Opponents of the approach call it an ill-advised effort that circumvents federal law, undermines the drug development process and threatens to harm more people than it helps by providing access to medications that haven’t been proven safe and effective.”
The Goldwater Institute notes: “For patients suffering from terminal illnesses, the FDA is the arbiter of life and death. These patients, suffering from diseases ranging from ALS to Zellweger Syndrome, 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. To access these treatments, patients must either go through a lengthy FDA exemption process or wait for the treatments to receive FDA approval, which can take a decade or more and cost hundreds of millions of dollars. 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.
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“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.
“States should enact “Right to Try” measures to protect the fundamental right of people to try to save their own lives. Designed by the Goldwater Institute, this initiative would allow terminal patients access to investigational drugs that have completed basic safety testing, thereby dramatically reducing paperwork, wait times and bureaucracy, and, most importantly, potentially saving lives…
“The FDA is concerned that allowing wider access to investigational medications outside the clinical trial setting will create a lack of test subjects who are willing to join a clinical trial, because in clinical trials some patients receive placebos or already approved medications instead of the investigational drug. The agency argues that freer access to such medications would discourage enrollment in the double blind clinical trials and ultimately harm scientific understanding of the medications. Therefore, the FDA puts protection of the clinical-trial process above the lives of terminally ill patients.
“Beyond the lack of humanity inherent in this policy, there are additional flaws to the FDA’s position. Experimental medications designed to treat terminal illnesses are only a subset of the drugs undergoing clinical trials.The FDA’s position makes the assumption that the current clinical trial process, complete with the double blind studies, is the only sound way to test new medications. However, many scholars and even the former Director of the FDA, Andrew von Eschenbach, have urged alternatives to the current clinical trial process. Nevertheless, the agency continues to place its outdated processes above all other concerns.”
As Washington hesitates, state governments are acting. 23 states have enacted various forms of Right to try laws, and another 13 are considering similar bills.