Sarah Karlin-Smith, Politico, August 3, 2017
The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights.
The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The powerful pharmaceutical lobby, which had quietly opposed an earlier version, kept an unusually low profile. The industry has been focused on fighting off any efforts to go after drug pricing, which President Donald Trump has said he would tackle. […]
The legislation would allow patients with serious diseases — anything from a late-stage cancer to multiple sclerosis — to request access to experimental drugs directly from drug companies without having to go through the FDA, which has its own compassionate use program that approves 99 percent of requests.
But the right-to-try bill doesn’t require drugmakers to make the experimental treatments available. In the 37 states that have similar laws on the books, Goldwater can point to only one doctor who says he has utilized a state right-to-try law for a patient — and that medicine was being made available to certain patients by the FDA anyway.
That’s led some critics to call it “right-to-ask” — and it may give desperately ill people false hopes. […]
And if the experimental drugs do become widely used outside the standard clinical trial system, it could undermine some of the rigorous science needed to know whether medicines are safe and effective. Many drugs that start the clinical trial process flop. Some are harmful.
“You have a situation where patients think they want to take a risk and don’t necessarily understand what risk they are taking,” said Diana Zuckerman, president of the National Center for Health Research, which lobbied against the bill.
And while the revised bill would require annual reports on whether the drugs used by these patients helped — or potentially harmed — them, patient safety experts are concerned it may not be enough. […]
Read the original article here.