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'Right to try' helps evade the FDA logjam

June 11, 2015

Originally written by Steven Greenhut for the San Diego Union Tribune

Ironically, the association has yet to remove its opposition to bills to let terminally ill patients opt for experimental treatments that have yet to receive federal approval.

The doctors’ lobby is not opposed to a “right to die,” but is opposed to a so-called “right to try.” The group’s spokesperson said it is likely to accept the experimental-treatment bill once some technical amendments are made, but the contradiction (also evident in the California Nurses Association’s similar positions) showcases the odd and often contradictory world of Capitol politics.

I’ve expressed concern about assisted suicide — not because adults shouldn’t have the right to make up their own minds on such matters, but because of the potential for coercion. In a health-care system where cost-related decisions are overpowering, will there be pressure by insurers and government officials to promote this cheaper, quicker “death” option? But it’s an issue in which it’s easy to understand both sides.

It’s hard to understand any reasonable opposition to AB 159 by Assemblyman Ian Calderon, D-Whittier, or similar SB 149 in the Senate. They are designed to let patients — under the care of a doctor — try experimental drugs rather than wait for a federal approval process that might outlast their remaining time on Earth. “This is just a human element bill,” Calderon told me, which explains why the bills have been moving ahead with bipartisan support.

Similar new laws in 22 other states “provide patients with improved access to investigational treatments and highlight the broader issue at hand: the lengthiness of the FDA approval process delays potentially life-saving drugs from reaching the market in a timely manner,”according to a statement from Calderon’s office.

Defenders of the current system say the FDA approves 99 percent of requests by patients for experimental drugs and even has an emergency process. But supporters of “right to try,” such as Starlee Coleman, a policy advisor with the libertarian-oriented Goldwater Institute in Phoenix, say such approvals still take a maddeningly long time. The Calderon bill is based on Goldwater’s model legislation.

“Critics of the FDA process have raised concerns that the expanded access application is too cumbersome for physicians and patients to complete” and that “it currently requires an application that takes doctors 100 hours to fill out,” according to the Assembly analysis. The FDA promises more streamlining, but Coleman’s point is a fair one: “Dying people ought not have to ask the government (for permission) to try to save their own lives.”

The Pharmaceutical Research and Manufacturers Association (PhRMA)doesn’t formally oppose the bill, but has expressed concern to the Assembly “that investigational drugs be used within the boundaries of carefully constructed and monitored clinical trials to ensure patient safety, and to glean key understandings about the safety, efficacy, and uses of investigational drugs.”

Some argue it gives false hope to patients. Perhaps, but who can blame terminally ill people who want to spend their days hoping for a cure rather than for a federal agency to get around to approving their application?

The modern FDA process evolved in the wake of the thalidomide horror in the late 1950s, involving the sedative used to treat morning sickness in pregnant women. The FDA delayed its approval as it investigated some side effects — and in the meantime learned the drug led to severe birth defects, explained a 2010 article in the Journal of American Physicians and Surgeons.

This stopped a broader tragedy, but reinforced a conservative predisposition. “(W)hen it comes to approving new drugs, waiting may well be the best course of action,” according to the article. But such inaction has had unintended side effects, with statisticians arguing over how many deaths — and how much suffering — has been caused by ensuing delays in the release of useful drugs.

Whatever one’s view of the FDA, this much seems logical: If the California Legislature is ready to allow terminally ill people to take drugs that hasten their death, it is right to let them take experimental drugs that might save their life.

 

 

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