Doctors would not face liability under HB 1029, but patients would be permitted to try individualized investigational drugs, biological products, or device for treatment of life-threatening or severely debilitating illness. (Photo: Getty Images)
Imagine being a patient diagnosed with a severely debilitating illness, only to learn that there’s nothing readily available on the market your doctor can prescribe to ease your symptoms.
State Rep. Allen Chesser (R-Nash) said what offers hope is technological advances in the medical community that are happening at such an unprecedented rate that may offer that hypothetical patient some measure of relief.
Chesser, a primary sponsor of House Bill 1029, said the measure he’s proposing builds on existing law that’s been in place since 2015, and would give patients the right to try individualized treatments including investigational drugs, biological products, and other devices.
Representative Allen Chesser (R-Nash) explained the benefits of HB 1029 (NCGA Screengrab)
“It’s pretty commonplace for people to get individualized treatments,” explained Chesser. “The medicines that people are taking are genetically engineered for it to fight a particular disease within a certain individual’s body. It uses incredible technology to be that targeted and that individually specific.”
Rep. Chesser told members of the House Health Committee Tuesday that while the science exists to create a very tailored approach for treatment, it’s simply not possible for a sample size to be achieved that would qualify for FDA approval.
Federal approval, he said, requires thousands of patients to be treated with the same exact dose of the same medication for the same exact condition — often an unrealistic burden for some rare illnesses.
“What this does is it allows for people who are diagnosed with terminal or severely debilitated illnesses to be eligible to pursue those treatments on their own accord,” Chesser explained.
“I’m just curious, if an individual who says, ‘I’m going to take this on, I know this is an experimental and it’s not approved by the FDA.’ If they got that information or a suggestion from somebody in the medical field or profession, it’s still saying you take on the absolute responsibility of whether or not you decide to take that medication. Is that correct?” asked Rep. Mary Belk (D-Mecklenburg).
Chesser confirmed that would indeed be the case.
Rep. Carla Cunningham discussed how low-income residents might not be able to afford such experimental treatments with limited resources. (NCGA Screengrab)
Rep. Carla Cunningham (D-Mecklenburg) said experimental drugs are normally not covered by health insurance carriers because of the astronomical cost.
“What would be the limitation for individuals that cannot afford it and they’re under the Medicaid coverage in the state of North Carolina?” inquired Cunningham.
Chesser said there was no intent to create that in this bill.
Wake County Republican Rep. Erin Paré wanted some assurance that the legislation provided sufficient guardrails.
“Is that laid out in the legislation? For example, a physician has to sign off on this. You have to have exhausted every option so far. What are the requirements to be eligible to do this?” Paré asked.
Chesser said such a requirement is established under federal law and supplemented in a state law passed in 2015.
The hypothetical patients would need to have exhausted other treatment options and would need the direct supervision of a physician.
“It’s not a get out of jail free card,” Chesser told his colleague. “It’s not a gateway that we’re trying to create.”
Rep. Reece Pyrtle, Jr. (R-Rockingham) worried about what expertise the attending physician needed to have before advising the patient to move to an experimental treatment.
Rep. Reece Pyrtle, Jr. (R-Rockingham) questioned what expertise the doctor might need to have before pushing an experimental treatment. (NCGA Screengrab)
“Is there anything in this bill that would require the treating physician, although he’s being held harmless by the bill, to have a working knowledge of the experimental treatment that he or she is prescribing?”
Rep. Tim Reeder (R-Pitt), a doctor and co-sponsor on the bill, said there’s nothing specifically in the legislation that requires the physician to have working knowledge of what they’re recommending.
“But I think that inherent in that, if you’re going to recommend a treatment, you’d have to have some knowledge and refer them to the expert who knows about whatever the gene therapy is,” he offered.
Rep. Maria Cervania (D-Wake) said the discussion should be expanded to include whether a patient is paying for said experimental treatment, doing it in exchange for sharing their medical data, or if they are in fact receiving payment to try the new treatment.
Rep. Reeder said the question of inducements would not be covered under the proposal.
“[But] in any experimental study, when you are giving inducements to the participants, there are special requirements to make sure you are not doing nefarious things to patients for money when they are at their wit’s end,” Reeder responded
The House Health Committee did not vote on House Bill 1029 Tuesday. It could be back for a vote by the committee as early as next Tuesday.
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