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Bill would allow terminal patients in Nebraska to try unapproved drugs

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Sen. Robert Hilkemann

Sen. Robert Hilkemann 

A bill that would allow terminal patients to try drugs, biological products or devices that are not yet approved by the Federal Drug Administration survived extended debate in the Legislature on Thursday and advanced to a second round of consideration. 

The bill (LB117), introduced by Omaha Sen. Robert Hilkemann, allows access to potentially groundbreaking treatments that could offer hope to patients, Hilkemann said.

The drugs, that have passed the first phase of safety testing, would be for patients who have tried all other conventional treatments, and who, in consultation with their doctors, give written informed consent. 

"'Right to try' (legislation) removes the needless bureaucracy so that those facing the unimaginable suffering can have timely access to medication that could potentially alter their fate," Hilkemann said. 

With the bill, insurance would not be obligated to pay for the treatment and patients would be responsible for related expenses, he said. And manufacturers and doctors would not be liable if the investigational drug does not work. 

"We don't know what type of therapies are on the horizon for Alzheimer's, for (multiple sclerosis), ALS or Lou Gehrig's disease," he said. 

But the bill had its critics. 

While it's important to increase access to experimental drugs for people who are terminally ill, the state would not have authority to do this, said Lincoln Sen. Mike Hilgers. It is in direct conflict with a federal prohibition of general access to experimental drugs, without FDA approval.

Sen. John Kuehn of Heartwell also opposed the bill, saying its goal was to undermine the FDA process of drug approval and create a loophole for exemption. Among the negative aspects is the possibility the bill exposes patients and families to exploitation at their most vulnerable time in health treatment. 

Kuehn said about three-fourths of drugs that pass Phase 1 of the FDA approval process will ultimately fail to be approved because of safety concerns or the inability of the drug, biological product or device to produce the desired result. 

Phase 1 simply shows that the drug won't kill you, Kuehn said. The side effects have not been determined. 

"That's a pretty low bar for safety and for patient protection," he said. 

Hilkemann said Colorado, Iowa, Minnesota, Wyoming, South Dakota and Missouri have passed a "right to try" bill. 

Hilkemann's bill advanced on a 33-12 vote. 

Reach the writer at 402-473-7228 or jyoung@journalstar.com

On Twitter @LJSLegislature.

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