Kratom could be illegal before it gets a chance to solve the opioid crisis
White says a way forward for kratom may involve treating it like an over-the-counter medication such as pseudoephedrine, which require patients to consult with a pharmacist about interactions and health issues. For now, though, the FDA maintains that clinical trials should form the basis of any policy that regulates kratom. The agency doesn’t seem to have any ideas on how this should happen, though.
Herman acknowledges that the FDA could play a role in helping to ensure consumer safety, but also asserts that the industry could be self-regulating, governed by a consortium of industry leaders that would hold each other accountable to help keep product quality safe and consistent. Industry self-regulation, of course, has a mixed track record across all sorts of industries. But Herman and the AKA remain clear: They refuse to let the FDA set the agenda for kratom … White also questions the scientific validity of the case reports the FDA cited back in February. In the reports, the agency said kratom was associated with 44 deaths since 2009 — for comparison, opioid overdoses killed over 40,000 Americans in 2016 alone. And just as we don’t have clinical trials showing kratoms safety and efficacy as a therapy, we also don’t have sufficient scientific evidence that shows how dangerous it is and how it interacts with other drugs. “It’s hard to tease out effects when you’re only looking at case reports,” he says. In a lot of those individual cases, we don’t know the doses that were used. Very often they were using [kratom] with other drugs, and we don’t know how those other drugs were either co-factors for harm or whether the other drugs may have been causing the harm and kratom may have been an innocent bystander in the adverse effects that people have.”
Original Article (Inverse):
Kratom Could Be Illegal Before It Gets a Chance to Solve the Opioid Crisis
Artwork Fair Use by: André Karwath