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The Bridge device, which requires a prescription, "sends
gentle electrical impulses . . . to the brain to reduce
withdrawal symptoms," its website says. (Photo from site)
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By Sam Adams
The Mountain EagleThe Letcher County Fiscal Court has reversed itself — at least for now — on whether it will give $125,000 of its opioid settlement money to a Christian-based drug-rehab center for an experimental electrical-stimulation therapy.
The court voted 4 to 1 with one abstention to table the contract with Isaiah House, a Willisburg-based nonprofit, until County Attorney Jamie Hatton can negotiate it. Hatton said the contract, brought to the court by Ted Adams of Letcher, does not allow the county to back out in case the treatment doesn’t work. “There’s nothing in there about termination for cause,” Hatton said.
Three of the five magistrates who had voted to give the money for the treatment expressed reservations this week, echoing Hatton that the contract needs to be negotiated, and saying the treatment is unproven, and at $5,000 per patient would allow only 25 patients to participate.
Adams was livid that the court did not approve the contract, saying the court voted to give the money before the NSS-2 Bridge device was approved by the federal Food and Drug Administration, and now wants to back out after it has been approved. “ It doesn’t make any sense,” he said.
The device, marketed by Innovative Health Solutions Inc. of Versailles, Ind., was approved under an FDA program called “the de novo premarket review,” which the FDA describes as “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”
Devices approved under that program are assessed to be low- to moderate-risk to patients, but it does not include an assessment of whether the devices have a therapeutic effect. A test included only 73 patients, 64 of whom self-reported decreased distress during opioid withdrawal after getting the device. Critics say the device has not undergone a randomized test to account for a placebo effect. While the company charges $600 per device, Isaiah House is asking the county for $5,000 per patient.
Adams said he could “bring in all the churches” where people have seen results of the device, but some magistrates said they would prefer that he brought in someone from Isaiah House and people who have used the device.
“The only thing is, I would like to talk to some people it helped,” District 5 Magistrate Benny McCall said. “I have talked to some people who said it didn’t do much for them, but I’d like to talk to some who say it has.”
District 1 Magistrate Jack Banks also questioned whether the device is worth the money the court would have to pay, saying it would only possibly help 25 people and that’s not guaranteed. Adams, however, criticized other programs the county has agreed to help fund, including the Harm Reduction Program run by the Kentucky River District Health Department. He said the court gave $50,000 to “buy needles for people to kill themselves.”
District 3 Magistrate Deb Collier responded, saying the needle exchange can’t be criticized because it prevents people who are addicted to drugs from passing deadly diseases such as AIDS and hepatitis to others by sharing needles.
Judge/Executive Terry Adams suggested the county wait to see how other patients in other counties that have agreed pay Isaiah House have progressed, but Ted Adams stopped him. “How many people are going to have die?” he said.
That also drew a response from Collier and from Banks, who said the court is watched about how it spends the opioid money and has a responsibility to spend it well. Banks said people are watching, and “if we spend $125,000 on this and it doesn’t work, how does that look on us?”
“How does it look to give $125,000 to CANE Kitchen?” Ted Adams asked.
Banks said CANE Kitchen is part of a rehab program that helps people get back to work, but Adams said that’s part of his ministry, too.
Collier, McCall, Banks, and Judge Adams voted to table the issue until Hatton can negotiate. Ted Adams left immediately when the vote was taken.
from KENTUCKY HEALTH NEWS https://ift.tt/tcKCQ7W Letcher County backs off its plan to spend $125,000 in opioid-settlement money on an experimental therapy by Isaiah HouseHealthy Care
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