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Terminally Ill People Want More Access to Experimental Treatments. Here's Why Doctors Are Pushing Back

From TIME - February 5, 2018

Doctors and medical ethicists are criticizing a bill supported by President Donald Trump that would allow people with fatal illnesses to have access to drugs not yet approved by federal authorities.

Right to Try is a policy that Trump mentioned during his State of the Union Address on Jan. 30. People who are terminally ill should not have to go from country to country to seek a cureI want to give them a chance right here at home, he said. It is time for the Congress to give these wonderful Americans the right to try.'

Right-to-try laws have passed in some 38 states. While no one wants to argue against giving potentially beneficial drugs to people who need them, not everyone in the medical community is convinced a national right-to-try policywhich has been introduced in the Housewill ultimately make life better for patients. The bill for the federal law was passed by Senate in August by unanimous consent.

For a drug to be approved for use in the United States, it must undergo several rounds of clinical testing, a process that can take several years. The U.S. Food and Drug Administration (FDA)the agency that oversees that approval processdoes already have a system in place, often referred to as compassionate use, for getting unapproved drugs to people who are out of other options. Physicians can submit an Emergency Investigational New Drug (EIND) application to the agency if their patient has no other treatment options. With FDA permission and drug company willingness, a patient can try that treatment.

One of the biggest concerns with the federal right-to-try bill is that the FDA would be cut out of the loop. The bill would allow patients and their doctors to bypass the FDA process and work solely with drug companies for access to unapproved drugs that have undergone at least basic safety testing. The federal bill would also prevent doctors and drug companies from being held liable should something go wrong, and bar the FDA from using data on negative outcomes from right-to-try cases to impact the approval of a drug unless that data is critical to assessing the drugs safety.

The proposed legislation is a thinly veiled attempt to dismantle the FDA, which could take us back a hundred years or more, says Dr. Steffanie Strathdee, the associate dean of global health science at the University of California, San Diego (UCSD) who requested an EIND for her husband in recent years. Dying patients and their families are vulnerable; we could become victims to the likes of snake oil salesmen offering treatments that could kill rather than cure. Treatments that work need to be monitored so their success can push forward randomized clinical trials that will decide if they work on a broader scale. And we need to know when treatments dont work, so that the deaths of these patients are not in vain and that their failures arent repeated.

A letter drafted and circulated by medical experts, which currently has more than 300 signatures from ethicists and physicians, argues that weakening the oversight of the FDA through the right-to-try law could ultimately be dangerous. The signed letter will be sent to the House Committee on Energy and Commerce on Monday. Expanded access can be improved, but the right to try approach is misguided and would likely do more harm than good, the letter reads. This legislation sells vulnerable patients and families false hope at the expense of weakening the FDAs critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products.

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