“Right to Try” Is a Cruel Farce

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

A technician at pharmaceutical company Aventis Pasteur in this undated file photo. Aventis Pasteur MSD / Getty

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.

Power and Profits

Right to Try is part of a broader effort to attack regulation of the health industry. The Goldwater Institute is also pushing legislation that would allow pharmaceutical sales staff to market and promote drugs for different symptoms than those for which they’re approved. They say their aim is to “restore free speech in medicine.” But the upshot would be more power for the pharmaceutical industry to misinform patients.

Similarly, supporters of Right to Try argue that while drug companies might see some financial benefits, it will allow them to recoup the high cost of research and development while saving lives.

Yet many pharmaceutical companies have shifted away from true R&D toward a model of acquisitions that simply grows their profits and drug portfolio. Some have abandoned in-house undertakings altogether. Meanwhile, funding for federal research has declined, meaning fewer dollars are available for domestic research initiatives. And because of US drug companies’ weight in the international pharmaceutical industry, this shift will likely be replicated globally — critically endangering the development of medications intended to treat rare or orphan diseases.

These developments indicate that the pharmaceutical industry may target chronically ill patients next. After all, there’s no reason Right to Try’s “merciful” rhetoric couldn’t be applied to the chronically ill as well. And the incentives for pharmaceutical companies to exploit this population are just as powerful.

I myself have lived with a chronic illness for the past decade. I see how these companies already control so many aspects of patients’ lives and health. They functionally decide whether we live or die, and if we will leave our loved ones in bankruptcy when the fight is over. The idea that we would cede yet more power and financial leverage to these entities is terrifying.

I know that when I die one day, it will almost assuredly be due to my chronic autoimmune condition. I face this with dignity. I also know that as a small, marginalized constituency, chronically ill people are an easy target for the Right and corporate centrists.

Under the current framework, pharmaceutical companies have a broad degree of latitude in choosing how to develop, market, and administer new treatments. They use the high cost of new drug research as an excuse to protect an exploitative business model. It’s clear that this bargain doesn’t work.

We need to take the power of drug development completely out of the hands of for-profit interest. We should be massively funding public entities like the National Institutes of Health to carry out larger-scale drug development and clinical trials, to be immediately applied for the public good under a Medicare-for-All system.

Even Medicare itself does not go far enough in protecting the rights and health of ill and disabled populations of all ages. When we rally for Medicare for All, we must do so in full solidarity with all terminally ill, chronically ill, and disabled populations. We must do so knowing that Medicare for All is only the first step — but one that will at least begin to limit pharmaceutical companies’ power and profitability.