Column: Right-to-try laws are hazardous to your health--and now they’re backed by the Koch brothers
Falling victim to a terminal disease is one of the ultimate human tragedies in its own terms. But congressional conservatives, egged on by libertarian ideologues and the Koch brothers, are working hard to burden these people with another layer of victimization in their last weeks or months of life.
They’re doing so by pushing what has aptly been termed “a cruel sham”: a federal “right-to-try” law. State versions of such laws, which have been enacted in 38 states, purport to offer a last ounce of hope to the terminally ill, by allowing them to try drugs that have not fully been tested for safety and efficacy.
On the surface, right-to-try laws look like humanitarian relief from regulatory barriers for last-gasp treatments. Under the surface, however, they’re insidious. They don’t offer patients any legal or financial safeguards, they don’t improve access to drugs, and their real goal — here’s where the Koch brothers come in — is to weaken drug regulations in a way that will hurt every American.
The purpose of state-level right-to-try laws was never really to help terminally ill patients. It was...a first big step toward weakening the FDA.
After years of unsuccessful attempts to get a right-to-try law through Congress, the push is on again. It’s being spearheaded by Vice President Mike Pence, who signed a state right-to-try law as governor of Indiana. Just last week, Pence tweeted that a federal right-to-try law is “about restoring hope and giving patients with life threatening diseases a fighting chance.”
What it’s really about, however, is advancing the agenda of the Kochs and other libertarians to hollow out the authority of the Food and Drug Administration to protect the nation’s pharmaceutical users from unsafe and ineffective nostrums.
The chief sponsor of state-level right-to-try laws long has been the Phoenix-based Goldwater Institute, which bills its mission as working “to help all Americans live freer, happier lives” — this is, free from government regulation. Earlier this month, the Koch-associated right-wing groups Freedom Partners and Americans for Prosperity jumped into the fray with a congressional lobbying campaign, a series of digital ads and other social media campaigning.
Don’t be misled. “The purpose of state-level right-to-try laws was never really to help terminally ill patients,” observes medical myth-buster David Gorski. “It was to put pressure on lawmakers to pass a federal right-to-try law as a first big step towards weakening the FDA.” The 38 state right-to-try laws are preempted by federal law, so they can’t overturn the FDA’s authority — only Congress can do that. The only governor known to have vetoed a right-to-try law placed on his desk is California Gov. Jerry Brown, in 2015. The federal version is sponsored chiefly by Sen. Ron Johnson (R-Wis.) who has lately been seen retailing a fabricated attack on Medicaid.
Let’s look under the hood of the typical right-to-try law to see how terminal patients are harmed rather than helped.
Right-to-try laws are drafted to eliminate that oversight. Typically, they allow patients with irreversible terminal illnesses to try any drug that has passed its phase 1 clinical trials under FDA rules.
What’s wrong with that? Phase 1 is a very coarse screen for safety and efficacy, aimed at testing a drug for major side effects among generally small populations, sometimes fewer than 30 subjects. As Alison Bateman-House and Christopher T. Robertson of NYU reported Monday in the Journal of the American Medical Association, “most of the drugs that succeed in phase 1 trials turn out to be too unsafe or ineffective for clinical use.” Two-thirds fail in phase 2, and even more at phase 3, the last trial hurdle before a drug receives FDA approval for marketing.
What’s even worse is that right-to-try laws dissolve away any semblance of legal, financial or medical protection for the patients and their families, not to mention fairness in the administration of healthcare. They don’t require insurers to cover the costs.
Under the FDA’s expanded access rules, the treatments must be monitored by institutional review boards and doctors are still subject to malpractice lawsuits if they do something wrong. Not under right-to-try laws; the patients are entirely on their own.
The federal law being pushed by Pence and his apparent handlers in the Koch shop features a couple of even worse provisions. One absolves drug companies of any liability for a drug administered under right-to-try. The other prohibits the FDA from considering the results of any such treatment in its review of the drug itself. In other words, Gorski notes, “even if a patient death is clearly due to use of an experimental drug under right-to-try, that death cannot be considered by theFDA in deciding whether to approve the drug…. This is profoundly anti-patient.”
To his credit, Scott Gottlieb, the new FDA commissioner, has been pushing back on the federal right-to-try bill despite intensive lobbying by Pence. Last October he asked for several changes in the Senate draft, including a narrowing of the patients who would be covered by its provisions. He urged the Senate to remove language limiting the FDA’s oversight of right-to-try treatments. And he spoke up for the expanded access program as the right way to go. But he seemed almost resigned to some version of right-to-try becoming federal law.
Virtually from the inception of the FDA’s jurisdiction over the safety and efficacy of drugs marketed to U.S. patients, the drug industry and other anti-regulatory forces have been trying to back it off. Right-to-try may be their best bet for doing so because it masquerades as humanitarianism. It’s nothing of the kind.