from the scheduled-for-elimination dept.
FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:
Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.
The FDA continues to discourage the use of kratom, which it is calling an opioid.
The American Kratom Association provided a rebuttal of the FDA statement:
Nine leading scientists in substance addiction and safety wrote to White House Opioid Crisis Team Leader Kellyanne Conway and Acting DEA Administrator Robert W. Patterson requesting they disregard the FDA's latest disinformation campaign against kratom. The scientists warned that "four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain."
[...] David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.
The nine respected scientists pointed out that "kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications." They also pointed out that the FDA's solution – to file a new drug application for kratom – made no sense because "the average time and cost of new drug development is more than 10 years and 2.5 billion dollars."
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Kratom, an herbal drug made of ground-up tree leaves, is "temporarily" joining other natural substances such as cannabis, psilocybin, and peyote on the schedule I list of the Controlled Substances Act. The active ingredients in kratom, the indole alkaloids mitragynine and 7-hydroxymitragynine, are both being added to the list for up to three years, after which they can be added permanently.
Prior to this move, the U.S. has already been seizing shipments of kratom:
In 2014, the FDA issued an import alert that allowed US Customs agents to detain kratom without a physical examination. "We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse," said Melinda Plaisier, the FDA's associate commissioner for regulatory affairs. According to the DEA, between February 2014 and July 2016, nearly 247,000 pounds of kratom were seized.
Advocates say that kratom is a natural treatment for opioid addiction, an application that the Drug Enforcement Agency dismisses. Meanwhile, the heroin/opioid epidemic continues with "unprecedented" events like the recent 174 heroin overdoses in just six days in Cincinnati, Ohio.
Check out the implosion of this kratom subreddit, which is attempting to get 100,000 signatures on the White House petition site:
APATHY WILL GET US NOWHERE. IF THERE WAS EVER A TIME FOR US TO BAND TOGETHER, ITS NOW. stand with me brothers and sisters. hope is not lost.
The blowback against the U.S. Drug Enforcement Administration's decision to ban kratom has caught the attention of a bipartisan group of legislators, but a DEA spokesman has said that "It's not a matter of if. It's simply a matter of when" the DEA bans kratom:
A bipartisan group of nine senators is calling on the Drug Enforcement Administration to delay its "unprecedented" decision to ban kratom, a plant that researchers say holds great potential for mitigating the effects of the opioid epidemic. [...] The Senate letter, spearheaded by Orrin G. Hatch (R-Utah) says: "Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death. The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I.
"Given the long reported history of Kratom use," the letter continues, "coupled with the public's sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders." [...] The DEA cites 600-plus poison-control center calls involving kratom between 2010 and 2015 in its justification for banning the plant, and notes that 15 deaths were linked to the use of the plant between 2014 and 2016. In an interview with The Washington Post, a DEA spokesman later clarified that all but one of those fatalities involved the use of other substances. Earlier this week 51 U.S. representatives similarly called on the DEA and the White House to reconsider or at least delay the ban, which was slated to go into effect as early as Friday. In an interview, DEA spokesman Russell Baer confirmed that the ban was not yet in place. "We have not yet determined a date when we will publish that final order" putting the ban into effect, he said.
There may be a public comment period before the ban takes effect, and the White House is now obligated to respond to the petition about kratom, which has reached over 140,000 signatures.
Previously: DEA Welcomes Kratom to the Schedule I List Beginning September 30
Heroin, Fentanyl? Meh: Carfentanil is the Latest Killer Opioid
Alcohol Industry Bankrolls Fight Against Legal Pot in Battle of the Buzz [Updated]
The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:
It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.
There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
New Jersey Gov. Chris Christie, head of the presidential commission on opioids, warned of the dangers of marijuana in a letter to President Donald Trump earlier this month about the panel's findings, saying the current push for marijuana legalization could further fuel the opioid epidemic.
"There is a lack of sophisticated outcome data on dose, potency, and abuse potential for marijuana. This mirrors the lack of data in the 1990s and early 2000s when opioid prescribing multiplied across health care settings and led to the current epidemic of abuse, misuse and addiction," Christie wrote in the letter, which was released with the commission's final report.
"The Commission urges that the same mistake is not made with the uninformed rush to put another drug legally on the market in the midst of an overdose epidemic."
[...] But some experts say the commission's fixation on marijuana was bizarre and troubling, lending credence to outdated views of marijuana as a gateway drug. And these experts want to nip such thinking in the bud.
They emphasized that they support efforts to curb the nation's opioid epidemic, but not the demonization of marijuana in the process.
"I was surprised to see negative language about marijuana in the opioid report," said Dr. Chinazo Cunningham, a professor of medicine at the Albert Einstein College of Medicine. "Research that examines pain and marijuana shows that marijuana use significantly reduces pain. In addition, the majority of studies examining marijuana and opioids show that marijuana use is associated with less opioid use and less opioid-related deaths."
You had one job.
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