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and Australia later this year, but The other two probes were treatments through clinical trials, laws are an opportunity to
some fear the measures won’t go announced in August before and argues that the rest should be victimise patients and be
far enough.“Until we see details the new rules were unveiled. allowed to take drugs that immune to the consequences,”
of the new TGA regulations, it’s But critics say the FDA have passed initial safety tests. adds Morrison.
impossible to decide how effective underestimates the scale of It says that more than a million At present, federal law upheld
they will be,”says John Rasko of action needed.“It’s not just a Americans die each year because by the FDA trumps state law,
the Royal Prince Alfred Hospital in couple of bad centres,”says of FDA red tape that can delay full but there are currently bills under
Sydney, and the main author of a Turner.“They say they’ll pick ones approval by as much as 15 years. consideration to introduce right
global investigation of stem cell at greatest risk, but it may mean to try across the US. Given the
clinics in 2016. that only the most outrageous “There’s a long list of combined impacts of right-to-try
In the US, experts fear that businesses get targeted while stem cell clinics making laws and a lack of resources,
the FDA lacks the resources to the rest carry on as normal.” claims that are scientifically there are fears that however
meet the challenge posed by A further obstacle is that people impossible” well-intentioned, the FDA
investigating hundreds of clinics. themselves – encouraged by the crackdown will falter.
At a press briefing in November, right-to-try laws promoted by “For those who do get access, “They need more inspectors,
FDA commissioner Scott Gottlieb libertarian organisations such it’s often too late,” says its website. to send out more warning letters,
implied there are only a few as the Goldwater Institute in But supporters of an FDA and the thing that would make
unscrupulous actors, and these Arizona – see the FDA as an clampdown on dubious stem most difference would be
could be targeted as a priority. enemy of free choice. cell treatments say that widening criminal charges, proof of fraud
So far, the FDA has only openly The institute says on its access plays into the hands of and that people were harmed,”
investigated three clinics. The website that less than 3 per cent clinics offering unregulated says Turner.“Convicting
most recent warning notice was of terminally ill US patients therapies. “People don’t someone of fraud would have
made public earlier this month. get access to experimental understand that the right-to-try the biggest impact.” ■

20 January 2018 | NewScientist | 23