The Koch-backed right-to-try law has been a bust, but still threatens our health

Michael Hiltzik
The Los Angeles Times
Originally posted September 17, 2019

The federal right-to-try law, signed by President Trump in May 2018 as a sop to right-wing interests, including the Koch brothers network, always was a cruel sham perpetrated on sufferers of intractably fatal diseases.

As we’ve reported, the law was promoted as a compassionate path to experimental treatments for those patients — but in fact was a cynical ploy aimed at emasculating the Food and Drug Administration in a way that would undermine public health and harm all patients.

Now that a year has passed since the law’s enactment, the assessments of how it has functioned are beginning to flow in. As NYU bioethicist Arthur Caplan observed to Ed Silverman’s Pharmalot blog, “the right to try remains a bust.”

His judgment is seconded by the veteran pseudoscience debunker David Gorski, who writes: “Right-to-try has been a spectacular failure thus far at getting terminally ill patients access to experimental drugs.”

That should come as no surprise, Gorski adds, because “right-to-try was never about helping terminally ill patients. ... It was always about ideology more than anything else. It was always about weakening the FDA’s ability to regulate drug approval.”

The info is here.

When Patients Request Unproven Treatments

Casey Humbyrd and Matthew Wynia
medscape.com
Originally posted March 25, 2019

Here is an excerpt:

Ethicists have made a variety of arguments about these injections. The primary arguments against them have focused on the perils of physicians becoming sellers of "snake oil," promising outlandish benefits and charging huge sums for treatments that might not work. The conflict of interest inherent in making money by providing an unproven therapy is a legitimate ethical concern. These treatments are very expensive and, as they are unproven, are rarely covered by insurance. As a result, some patients have turned to crowdfunding sites to pay for these questionable treatments.

But the profit motive may not be the most important ethical issue at stake. If it were removed, hypothetically, and physicians provided the injections at cost, would that make this practice more acceptable?

No. We believe that physicians who offer these injections are skipping the most important step in the ethical adoption of any new treatment modality: research that clarifies the benefits and risks. The costs of omitting that important step are much more than just monetary.

For the sake of argument, let's assume that stem cells are tremendously successful and that they heal arthritic joints, making them as good as new. By selling these injections to those who can pay before the treatment is backed by research, physicians are ensuring unavailability to patients who can't pay, because insurance won't cover unproven treatments.

The info is here.

The So-Called Right to Try Law Gives Patients False Hope

Claudia Wallis
Scientific American
Originally posted in the September 2018 issue

There's no question about it: the new law sounds just great. President Donald Trump, who knows a thing or two about marketing, gushed about its name when he signed the “Right to Try” bill into law on May 30. He was surrounded by patients with incurable diseases, including a second grader with Duchenne muscular dystrophy, who got up from his small wheelchair to hug the president. The law aims to give such patients easier access to experimental drugs by bypassing the Food and Drug Administration.

The crowd-pleasing name and concept are why 40 states had already passed similar laws, although they were largely symbolic until the federal government got onboard. The laws vary but generally say that dying patients may seek from drugmakers any medicine that has passed a phase I trial—a minimal test of safety. “We're going to be saving tremendous numbers of lives,” Trump said. “The current FDA approval process can take many, many years. For countless patients, time is not what they have.”

But the new law won't do what the president claims. Instead it gives false hope to the most vulnerable patients. “This is a right to ask, not a right to try,” says Alison Bateman-House, a medical ethicist at New York University and an expert on the compassionate use of experimental drugs.

The info is here.

The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward

Alison Bateman-House and Christopher T. Robertson
JAMA Intern Med. Published online January 22, 2018.

In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is not going to live more than four weeks [anyway.]”  Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box). As of December 2017, the US House of Representatives was considering the bill.

The article is here.