Congress wants a single ALS patient to get a therapy never tested in humans. A family in Iowa believes the Food and Drug Administration will decide whether their only surviving daughter lives or dies, and they’ve been on a monthslong crusade to break through its bureaucracy. And they’re succeeding

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One of the namesakes of the federal “right-to-try” law confirmed Tuesday that he gained access to an experimental treatment thanks to the new law

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“It’s confusing. It’s confusing for even people like me who do this day in and day out,” Alison Bateman-House, a bioethicist at New York University who opposed the federal right-to-try law on the grounds that it would give patients false hope and could potentially lead to patient harm

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The FDA is powerless to stop them. The newly enacted right-to-try law allows drug makers to earn a profit by selling unproven therapies to desperate and dying patients

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Pharma companies don’t have to comply. Large pharmaceutical companies are notoriously risk averse when it comes to expanding access to medications that are still in the testing phase. Many refuse to grant access to investigational drugs outside of clinical trials, and efforts to lobby them to release the medication as part of compassionate use are often rebuffed

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The new law has a catchy name, but it will only make it more difficult to know if medication is effective or safe

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Our Gail Javitt writes, “The reality is that Right to Try is unlikely meaningfully to increase the number of terminally ill patients who can access investigational therapies or improve the outcomes for such patients. Those that claim otherwise, and who cast FDA as the primary obstacle between dying patients and lifesaving medicines, are peddling their own form of ‘snake-oil'”

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