Trump's Not Protecting Sick People, He's Protecting Pharma Companies
We don't need the "right to try" laws Trump mentioned in his State of the Union.
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Update 5/22/18: The House passed a “right-to-try” bill that was already approved by the Senate; the legislation now heads to President Trump who is expected to quickly sign it into law.
In his State of the Union address last night, President Trump asked Congress to pass a federal “right to try” law, which he says would allow dying patients to get experimental drugs that have not been approved by the FDA. “People who are terminally ill should not have to go from country to country to seek a cure,” Trump said. “It is time for the Congress to give these wonderful Americans the ‘right to try.’”
It should be an easy win for the president, since a pathway for dying people to access experimental drugs already exists and nearly every application is approved by the FDA.
“There is no need for this bill,” says Peter Lurie, former associate commissioner for public health strategy and analysis at the Food and Drug Administration. “This bill is solving a problem that doesn't exist.”
Today, the FDA’s expanded access program says yes to nearly everyone who asks for an experimental drug that they feel there is no other choice but to try, a victory first earned by HIV/AIDS activists in 1992—99.5 percent of requests are approved; only 35 people were turned down between 2010 and 2015.
What stands between a dying person and putting a barely known chemical into their bodies in the hope of reversing fate is not the FDA, which many people assume is the culprit, but rather pharmaceutical companies that are not required to dispense the drugs, no matter what the FDA says.
Pharmaceutical companies are not exactly eager to release data on how many right to try applications they turn down. “We have no idea how many requests go to pharma, no idea how many they deny or approve,” says Alison Bateman-House, a medical ethics professor at NYU and expert on compassionate use trials.
The best information we have is one article in The New England Journal of Medicine which puts the number at 98 denials out of a total of 160 applications in a six-month period—and that’s for a single company. In other words, one pharmaceutical company turned down nearly three times as many applications from dying patients in six months as the FDA did in five years.
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Even so, none of the right to try laws adopted at the state level—thirty-eight so far—force private drug companies to release experimental drugs to dying patients.
What the proposed federal law does do, as state laws before it, is protect any “manufacturer, prescriber, dispenser or other individual entity” from a lawsuit if one of these drugs causes more harm than good. And that’s what these laws are meant to do—protect companies, not patients.
“The right to try laws, including the federal law, take steps to protect from liability doctors and drug companies, but they don't require the drug company to provide the drug,” explains Rebecca Dresser, a biomedical ethics professor at the Washington University School of Law in St. Louis.
While turning down patients for an experimental drug may sound heartless, it may be the more compassionate, if difficult, decision. “There is buried in these right to try laws the assumption that it is highly likely that these products will prove to be effective,” says Lurie.
But the majority of drugs that the FDA approves for compassionate use do not eventually gain approval. In a study that Lurie published with colleagues last year, they found that only 33 percent were approved five years down the road.
That shouldn’t be surprising, since the drugs that the federal right to try law seeks to release have only been through Phase 1 testing, before we know the range of side effects, proper dose, and whether its benefits justify its risks.
“Many patients coming to me for Phase 1 trials ask what's the chance of benefit,” says Mark Ratain, professor of medicine at the University of Chicago and an expert in investigational cancer drugs, believes otherwise. “Unless I have clear evidence to the contrary, I generally respond very low—somewhere between zero and low. There should be no expectation of benefit from an experimental drug. There should be an expectation of toxicity.”
Yet opening the door to weakened requirements (and thus lower price tags) for drug approval is what these right to try laws really hope to accomplish—that, after all, is the not-so-secret goal of the Goldwater Institute, which has often complained about the price of Phase 3 studies and helped sponsor state right to try legislation.
That is also what explains the hypocrisy of Senator Ron Johnson (R-WI) who sponsors the federal right to try legislation, which wants to increase access to unapproved drugs, but opposes Medicaid expansion, which increased access to approved ones.
If the Trump administration and Republican lawmakers are really interested in expanding patients' “right to try,” they would focus first on giving them the “right to try” approved drugs, not unapproved ones that are not likely to work, or worse.
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