"Right to Try" Is a Cruel Farce

http://www.jacobinmag.com/2018/08/right-to-try-fda-pharmaceutical-companies
Date Written:  2018-08-12
Publisher:  Jacobin
Year Published:  2018
Resource Type:  Article
Cx Number:  CX22931

Drug companies want you to think they're providing glimmers of hope to terminally ill patients. Don't believe them.

Abstract: 
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Excerpt:

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.

Subject Headings

• Pharmaceuticals