Anyone with a smidgen of knowledge about healthcare understood that the right-to-try legislation signed by President Trump on Wednesday was a scam, perpetrated by the Koch brothers and their henchmen.
Masquerading as a “compassionate” measure aimed at providing victims of terminal diseases with a last bit of hope that an experimental treatment might save them, it really was aimed at undermining the authority of the Food and Drug Administration to make sure our drugs are safe and effective.
Among those who bought into this pretense out of sheer ignorance was Trump, who claimed the measure would save “hundreds of thousands” lives, which was just fantasy.
Now, the measure’s chief sponsor has pulled open the curtain, so that even laypeople can understand how horrible this law is. He’s Sen. Ron Johnson, R-Wisc. In a letter Thursday to FDA Commissioner Scott Gottlieb, who was critical of the law, Johnson wrote:
“This law intends to diminish the FDA’s power over people’s lives, not increase it.”
Apparently under the misbegotten impression that he was doing the public a favor, Johnson proceeded to underscore some of the more egregious provisions of his own bill. Among them is a prohibition against the FDA’s using clinical results from these last-chance treatments as the drugs continue through its regulatory process.
Put simply, if a drug is found not to work or even to be harmful in right-to-try cases — findings the FDA normally considers of paramount importance in judging a drug’s fitness for approval — the FDA can’t use those findings in the approval process.
The bill carves out cases in which right-to-try treatments raise questions about safety, but it takes that judgment out of the FDA’s hands and gives it to the secretary of Health and Human Services. That’s a major blow to FDA authority.
The measure also absolves drug companies and healthcare providers from liability for administering the drug, though it leaves doctors (though not manufacturers) still liable in cases of “reckless or willful misconduct, gross negligence, or an intentional tort.” In the words of David Gorski of Wayne State University, a veteran quack-hunter, the measure “leaves doctors out to twist in the wind but still protects manufacturers.” Gorski calls the version of the bill that Trump signed “the very worst version of the sham known as ‘right-to-try.’”
As we’ve reported, the right-to-try law was cooked up by the far-right Goldwater Institute, which has ties to the Koch network, as a means of undercutting the FDA. (The Goldwater Institute also is the perpetrator of campus free-speech legislation that similarly functions as a wolf in sheep’s clothing, concealing a right-wing agenda behind a cloak of “free speech” liberalism.)
FDA Commissioner Gottlieb drew Johnson’s ire by suggesting, just prior to the bill’s passage, that his agency would have to promulgate guidance and regulations to balance the measure’s broadening of access to experimental drugs with “appropriate patient protections.”
Johnson made clear that he has no use for any additional patient protections. His bill, he wrote, “is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations.”
In other words, patients so desperate for a last chance that they’ll try anything are on their own. As for other Americans who might have an interest in seeing that the FDA maintains its jurisdiction over drugs and drug makers, they’re on their own too.
What Johnson and the other Koch mouthpieces don’t like to acknowledge is that the FDA already has a program to give desperately ill — that is, terminal — patients access to experimental treatments. It monitors those treatments to make sure they’re administered properly and the results are public. Even with those rules, the agency has almost never turned down an application for access.