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In May, Congress passed and President Trump signed S.204, better known as the Right to Try Act. The law’s key provision allows pharmaceutical companies to sell experimental treatments to terminally ill patients that have yet to be approved by the Federal Drug Administration (FDA). Under the legislation, companies can supply drugs that have only passed Phase I clinical trials. For context, a 2011 study found that of drugs in all categories that made it past that stage, only 9.4 percent to 12 percent ultimately received the green light from the FDA. In other words, roughly 90 percent of the experimental treatments pharmaceutical companies can now sell to terminally ill patients could be, at best, completely ineffective. And patients wouldn’t even know it. By allowing access to Phase I drugs, the law also restricts a patient’s ability to be informed about the treatment’s efficacy. Drugs in Phase I testing are only investigated for safety and dosage — effectiveness and side effects are not examined until Phase II. The bill’s backers justify the new framework by emphasizing their compassion for the terminally ill. They say they’re fighting for a dying patient’s “right to try” an experimental, unproven medication as a final Hail Mary. What right does the government have to stop patients from doing so? Yet as many press outlets have pointed out, the FDA has an “expanded access” or “compassionate use” system in place for just this purpose. The agency reports that it already approves 99 percent of compassionate use applications it receives from terminally ill persons or their medical proxies. Right to Try supersedes this framework. The new law places the decision to sell experimental treatments to terminally ill patients in the hands of the pharmaceutical companies themselves, rather than the FDA or other regulatory bodies. The bill’s primary author, Senator Ron Johnson (R-WI), is not shy about his motivations, writing in an open letter to the FDA commissioner that “the law intends to diminish the FDA’s power over people’s lives.” Johnson goes on to insist that the FDA not respond to the new law by “[writing] new guidance, rules, or regulations that would limit . . . [access to] treatments.” Despite these serious deficiencies, Right to Try passed in the Senate 94-1. All forty-seven Democratic senators voted in favor. The lone nay vote: Vermont senator Bernie Sanders.

How Pharma Benefits While officially authored by Johnson, Right to Try is a pet project of the Goldwater Institute, a libertarian think tank funded by groups like the Koch brothers and ALEC. Johnson is an eager recipient of Koch money and boasts a 100 percent rating from Americans for Prosperity, Charles and David Kochs’ chief political advocacy group. So it’s no surprise that pharmaceutical companies, which already rake in a combined $333 billion annually in the US alone, will see a financial windfall from the legislation. Using terminally ill patients as profitable guinea pigs, pharmaceutical companies can now market drugs that likely don’t work — and that companies may know do not work — and make money off their drug while it is still undergoing the traditional approval process. Not long after the legislation was passed, Brainstorm, a biotech company, admitted it was attempting to use the legislation in just this way. Brainstorm has created an unapproved, and likely ineffective, treatment protocol for ALS called NurOwn. In June, its CEO, Chaim Lebovits, was quoted as saying that with Right to Try, the company might be able to sell its unapproved drug to terminal patients for up to $300,000, allowing the company to turn a “modest profit.” After receiving criticism Lebovits walked back his statement, suggesting that Bloomberg quoted him out of context. But as Adam Feuerstein of Stat News writes, BrainStorm clearly “saw right-to-try as a way to gin up some publicity.” Feuerstein, for his part, has aptly dubbed the law “the right to die poorer.” For terminally ill persons in the aggregate this will do little but choke them out economically — forking over money for experimental treatments could mean being unable to pay for traditional care that might keep them alive longer. Worse, it could allow companies to administer drugs they know will have untenably adverse side-effects, opening the possibility for inhumane testing. All the while, the companies that provide drugs under Right to Try will collect positive PR in addition to profits. If access is up to the drug company itself, it appears that selling someone experimental treatment is a beneficent act. Companies know that it doesn’t matter whether the treatment works. Only the semblance of corporate mercy is necessary. Terminally ill patients are, after all, expected to die.