To people with incurable illnesses, Donald Trump must seem like their saviour. On Wednesday, he the Right to Try Act, which will give terminally ill people greater access to experimental medical treatments. That might sound good 鈥� but experimental means they haven鈥檛 been fully tested to make sure they are safe, or even that they work.
People in the US with serious illnesses who want to try experimental medicines , but only with the permission of their doctor, the US Food and Drug Administration and the company testing the treatment. Around 1000 apply each year to the FDA, and it approves 99 per cent of the requests.
Now, people can apply for untested fixes without the FDA鈥檚 say-so. 鈥淔ederal law now protects the right of dying patients to obtain and use cutting-edge medicines without asking first for government permission,鈥� said Victor Riches, president of the Goldwater Institute, . The institute has led a nationwide campaign to get the law passed.
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Untested treatments
Beguiling as that may sound, we know untested treatments can cause harm. Take thalidomide, which was given to pregnant women during the 1950s without proper testing, leading to severe birth defects.
Since then, almost all countries have set up strong regulatory regimes to prevent something similar happening again. In the US, policing this is the job of the FDA. But backers of the new law see the FDA as an obstacle to access and free choice.
Yet what campaigners for the right to try don鈥檛 talk about is what happens when untested treatments go wrong. There is a clear risk of people being charged exorbitant sums for treatments that don鈥檛 work, and uncertainty over whether people will qualify for compensation if a treatment fails or causes serious harm.
This issue has arisen in recent months following the proliferation of clinics offering potentially untested treatments based on stem cells, especially in Florida and California. Some people have been blinded by treatments in which they received injections of their own fatty tissue into their eyes. Since the turn of the year, the FDA has stepped up efforts to curb the activities of stem cell clinics, and in early May sought permanent injunctions through the US Department of Justice to stop two major clinics from operating.
FDA weakened
The FDA鈥檚 powers to crack down on purveyors of untested treatments may be weakened by Trump鈥檚 new law. Scott Gottlieb, head of the FDA, voiced concerns about the draft act . Key among them was a fear that the act would weaken the FDA鈥檚 ability to prosecute companies or clinics violating the rules and ethical norms that govern its existing scheme allowing access to experimental treatments.
All of this could see people denied legal redress and the backing of the FDA when things go wrong. 鈥淭he impact of the bill will be to undermine patient welfare by undermining FDA regulation,鈥� says Sean Morrison of the University of Texas Southwestern Medical Center, who monitors the growth of stem cell clinics. 鈥淚t provides a path around FDA regulation, and there are lots of snake-oil salesmen out there just waiting for the opportunity to sell fraudulent therapies to desperate patients.鈥�
Read more: How 鈥榮tem cell鈥� clinics became a Wild West for dodgy treatments
