HEALTH CARE/Joan Retsinas

‘Promises Promises’: Right to Try Legislation

“Promises Promises … I’m so sick of promises.” Thus sings Burt Bacharach; thus sings the electorate. Our president spouts forth feel-good rhetoric. He will make America great, make our enemies quake, restore Big Steel and Big Coal, dump Obamacare for something wonderful and – notably – drain the Washington swamp.

Thus far, the promises have fallen short. Health insurance is zooming back to the future (to pre-condition exclusions, Model T policies, a higher census of the uninsured). The tariff that will not bring back steel will hurt other industries; coal is not rebounding. He has dismissed so many State Department experts that the chance for diplomacy dims.

As for Washington’s swamp, his appointees have excelled in self-serving spending: think Tom Price, Ben Carson, Steven Mnuchin. And he and his family have melded Trump Inc with the USA.

The latest feel-good salvo: the Right-to-Try Act. Just imagine: millions of very sick Americans, waiting on the banks of the River Styx, are reaching out to lifeboats – but the bureaucratically sclerotic Food and Drug Administration bars them. This Administration will get rid of those FDA oarsmen, leaving terminally ill patients free to board the lifeboats.

This bill pushes the right (literally and figuratively) buttons. It promises freedom-of-choice to consumers — a freedom the Administration has not granted to women seeking abortions, indeed to women seeking contraceptives. The bill castigates the FDA as an agent of bungling Washington. It is decidedly pro-life, arguing against those restrictive clinical trial rules that doom some patients to placebos, or nothing.

The zeal-to-try began in 2001, when Abigail Burroughs could not get Erbitux, still in clinical trials, still barred by the FDA. Her father subsequently established the Abigail Alliance for Better Access to Developmental Drugs (abigail-alliance.org), which sued the FDA. In 2007 the court ultimately ruled for the FDA. The key points: access would subject patients to “potentially toxic drugs with no proven benefit.”

The zeal-to-try persisted. Thirty-eight states, starting with Colorado, have passed “right to try” laws.

Why not a federal right-to-try law?

First, the FDA already has a route for terminally ill patients to try some drugs. In 2009 the FDA launched the Expanded Access Program. The FDA approves 99% of requests; parties know within 24 hours of the FDA’s decision. (Crucially, the FDA may alter the regimen, based on confidential information from the trials.)

The FDA allows access to drugs in Clinical Phase III, or, in some cases, Phase II, trials. The proposed federal “right-to-try” bill would lower the bar, to drugs that have passed only Phase One clinical trials, which test for safety and side effects, not efficacy. Roughly 10% of drugs that pass phase 1 clinical trials eventually gain FDA approval.

“Right-to-try legislation” opens the door to drugs that are “potentially toxic with no proven benefits.” Imagine the entrepreneurial floodgates swing open, as some companies market their maybe-effective, maybe-harmful drugs, with the proviso, in written text and spoken warnings, that these might not work, that “caveat emptor” stands behind the drugs.

Second, the pharmaceutical companies have, for the most part, been the ones barring those lifeboats. (A “right-to-try” law would not force manufacturers to release their drugs.) The companies – the usual bogeys - want to market safe, effective drugs.

The companies have not overtly opposed “right to try” bills. After all, the public generally abhors pharmaceutical companies, blaming them for high prices. Companies that publicly opposed the bills would emerge as not only greedy, but cruel. Yet savvy companies know that letting desperate people try not-yet-proven drugs risks the disasters that would be devastating humanely and financially.

Third, even states have tied restrictions to their laws; i.e., insurers can refuse to pay for hospice care for patients taking these drugs, and insurers can refuse to pay treatment of complications. Again, caveat emptor.

Caveat emptor, however, stands behind a free consumer culture. Taking away the FDA overseer aka “nanny” leaves desperate patients free to make their own decisions – a hallmark of conservatism, a hallmark of libertarianism. Why not let patients try anything that they – or the touters of the drug – think might help? In the end, a few patients might benefit – and the ones who suffer won’t be around to speak up. The feel-good promises behind this bill are empty.

Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email retsinas@verizon.net.

From The Progressive Populist, May 1, 2018


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