Bill would give terminally ill access to early-stage drugs



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INDIANAPOLIS (AP) — Terminally ill patients could get access to drugs that have passed the first stage of federal approval under legislation being considered by Indiana lawmakers.

The "right to try" legislation would allow the use of medicines that have cleared basic safety tests to ensure they aren't toxic so long as the patient's doctor and the drug manufacturer approve.

Michigan, Colorado, Missouri and Louisiana have passed similar legislation, and Arizona put a measure in place through a voter referendum. Nearly two dozen other states are considering similar measures, The Indianapolis Star reported (http://indy.st/1F6ILAs ).

"This isn't to help drug companies. This is all patient-driven, because we have heard stories of people who are dying and there's drugs out there that could possibly save them and they're not allowed to take them and they're like, 'What have I got to lose?'" said Rep. Wes Culver, R-Goshen, sponsor of the Indiana bill.

Some medical professionals fear the bill might offer patients false hope.

"I think these are mostly coming out of the illusory thinking that meaningful benefit is likely," said Dr. Paul Helft, an oncologist and director of the Charles Warren Fairbanks Center for Medical Ethics at IU Health. "These come out of the sense there's nothing to lose, you're going to die anyway. But there are things that you could lose: You might die faster or might spend time getting sick from the side effects of the drug."

Culver said his bill was inspired by the lack of approved medicines to treat Ebola.

Frank Burroughs, whose daughter, Abigail, died of head and neck cancer at age 21 in 2001, said he wishes his daughter had had access to early-stage medications.

Burroughs said his daughter learned late in her illness about a drug that was doing well in trials. It targeted the same type of cancer Abigail had, but in the colon, not the neck, so she wasn't eligible to participate.

"What this is saying is that there are promising drugs that you can identify as drugs that need much earlier approval," said Burroughs, who has since founded the Abigail Alliance for Better Access to Developmental Drugs.

The organization is working to persuade Congress and the Food and Drug Administration to speed up approval of promising drugs.

Supporters of right-to-try legislation note that only about 3 percent of those with conditions that qualify for clinical trials are accepted.

But IU's Helft said right-to-try legislation could discourage people from trying to get in a clinical trial.

"I have no problem with patients enrolling in early-phase trials to get drugs, because those trials are done in a systematic way so we actually get to learn something and they're done with informed consent," he said. "If patients have relatively unfettered access to drugs, that could interfere with future trial participation ... it would be much easier to go out and get the drug rather than participating in a clinical trial."

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Information from: The Indianapolis Star, http://www.indystar.com

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The Associated Press

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