Don’t give the terminally ill false hope

With right-to-try laws, interest groups and politicians seek to circumvent the FDA at grave risk to public health

November 17, 2015 2:00AM ET

Over the past 18 months, state legislators and governors in 24 states, from Oregon to Texas to Virginia, have passed right-to-try laws, which claim to provide terminal patients with access to medications that have not yet been federally approved. Thirteen other states are considering bills, including New York, and a ballot initiative was approved by Arizona voters on Nov. 4. California’s Jerry Brown became the first and only governor to veto a right-to-try bill last month.

The success of these laws has hinged on an outpouring of support for terminal patients, often children, whose parents desperately want access to drugs not yet approved by the Food and Drug Administration. Emotional campaigns have captured thousands of Facebook and Twitter followers, and pulled at the heartstrings of state legislators across the country. But the bills do nothing to guarantee drug access, let alone save lives. They do, however, pose a danger to new, potentially lifesaving pharmaceuticals in development.

The push to sidestep the FDA’s approval process began in earnest in 2008 when Abigail Alliance, a nonprofit founded by Frank Burroughs and named for his daughter, who died of cancer in 2001, partnered with the conservative Washington Legal Foundation to argue in court that patients had a constitutional right to receive unapproved drugs. The Supreme Court declined to hear the case.

Social media gave the cause momentum in March 2014, when Tennessee mother Aimee Hardy posted a plea on Facebook for her son, Josh, who was sick with an adenovirus that was attacking his immune system. Chimerix, a company developing a drug called brincidofovir to treat the virus denied the family’s initial request. #SaveJosh, for lack of a better term, went viral; Chimerix executives even receiveddeath threats. Less than a week later, Chimerix negotiated a new trial with the FDA, one that could enroll Hardy. But the tone of the #SaveJosh campaign, which reduced the complicated issues of drug testing and approval to a simple, impassioned plea for one boy’s life, stuck.

Colorado became the first state to approve right-to-try when Gov. John Hickenloopersigned a bill into law in May last year. During the campaign, state Sen. Irene Aguilar, a doctor and co-sponsor of the measure, nicknamed it the Dallas Buyer’s Club bill, after a 2013 movie that (not completely accurately) chronicles activist Ron Woodroof, who smuggled unapproved AIDS drugs into the U.S. in the 1980s.

When Republican Utah state Rep. Gage Froerer introduced a right-to-try bill in January, he said, “It gives hope. It gives the opportunity for patients and doctors to make decisions based upon what’s best for their patients.”

Politicians readily gain the favor of their constituents when they champion legislation that shows their compassion, particularly when the bill is intended to do something as uncontroversial as save lives.

However, hope may be all right-to-try laws provide. Based on model legislation drafted by the libertarian Goldwater Institute, the laws have several restrictions that make their passage all but meaningless for requesting patients. Drug companies are not required to comply with requests; insurance companies, which don’t cover experimental drug costs, aren’t either, leaving many terminal patients without the resources to pay. The bills are restricted to terminal patients who may be too sick for any drug, however effective, to reverse their diagnosis.

What’s more, experimental treatment could prevent terminal patients from enrolling in hospice care, an end-of-life service that Medicaid will cover only when patients stop curative treatment.

As long as social media campaigns perpetuate ‘shallow notions of truth’ and as long as legislators are drawn to their irresistible rhetoric, the passage of right-to-try laws will continue.

Right-to-try laws state that patients can access drugs as soon as phase I trials —small and short-term studies that shed only the most preliminary light on a drug’s safety — are completed. “About one out of a hundred phase I drugs make it to approval,” bioethicist Arthur Caplan said. “There’s no tracking, there’s no reporting” built into the laws, so the use and efficacy of treatments can’t inform their further development. And there’s no evidence that the Colorado law, which has been in effect the longest, has provided even one terminal patient with an experimental drug.

Right-to-try advocates, who tend to be critical of Big Government in general, don’t acknowledge the FDA’s current compassionate-use program, which provides preapproval drugs to patients. Or they have branded it too cumbersome — an irony, in light of the agency’s nimble response to the #SaveJosh campaign. Last year the FDA experienced a 92 percent increase in compassionate-use requests. In February 2015, under pressure from right-to-try advocates, the agency made the application process quicker and easier.

But the greatest danger posed by state legislators, seduced by what Caplan called the “irresistible rhetoric” of right-to-try laws, is to general public health. The future of a drug, and the thousands of lives it may ultimately save, is secondary to the concerns of the laws’ proponents, who are desperate for any hope, even if that hope is false. Right-to-try laws seek to circumvent the FDA’s testing protocol: A terminal patient may not qualify for the drug because of underlying conditions, and there’s no scientific tracking of efficacy. Yet drug manufacturers, bioethicists and FDA officials fear that any death or adverse effect from a drug obtained under right-to-try laws will lead to lengthy investigations, delayed or altered future trials, or public concern for a drug’s safety — and could suspend or halt the approval process altogether.

When Richard Plotkin, a vice chair of the Max Cure Foundation, appeared on “Fox and Friends” last year, he recounted a conversation he had with Kevin Moch, then the chief executive of Chimerix. Plotkin offered Moch the $50,000 it would cost to get Josh Hardy the drug he needed. “He then told me it isn’t about money,” Plotkinsaid. “[Moch] told me it’s all about ethics.”

Moch meant that his company and other drug manufacturers are ethically obligated to develop drugs that are scientifically proven safe and effective and that government and society are ethically obligated to provide all patients, not just those with compelling social media campaigns or the ear of the governor, with lifesaving drugs. But as long as social media campaigns perpetuate what writer Vinson Cunningham has called “shallow notions of truth (achievable by dialogic cut and paste) and egalitarianism” and as long as legislators are drawn to their irresistible rhetoric, the passage of right-to-try laws will continue, with negligible benefit for desperate patients and the potential to harm future public health.

Ann Neumann is author of “The Good Death: An Exploration of Dying in America,” to be published by Beacon Press in February, 2016. She is a visiting scholar at The Center for Religion and Media at New York University and a contributing nonfiction editor at Guernica magazine.

The views expressed in this article are the author's own and do not necessarily reflect Al Jazeera America's editorial policy.

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