FDA Head Tweets New Warning About Kratom

By Pat Anson, Editor

The head of the Food and Drug Administration is warning again about the marketing of kratom and other dietary supplements to treat opioid addiction – calling them “health fraud scams.”

“FDA believes strongly people addicted to opioids should have access to safe and effective, approved treatments for addiction. Unfortunately, unscrupulous vendors are trying to capitalize on opioid epidemic by illegally marketing products for these purposes,” FDA commissioner Scott Gottlieb, MD, warned on Twitter Friday.

Gottlieb was reacting to a story in The New York Times about the marketing of dietary supplements like “Opiate Detox Pro,” a blend of vitamins and amino acids said to have “amazing benefits” in reducing opioid withdrawal symptoms. 

Similar claims are made about kratom by websites such as HowtoQuitHeroin.com, which was founded by Jorge Fernandez, a recovering heroin addict.

“Kratom works. Kratom helps. It can help you to quit heroin. It can help you to quit Suboxone. It can help you to quit Oxycontin. And believe it or not, it can even help you to quit Methadone as well,” Fernandez claims.

Kratom is not approved by the FDA as a treatment for opioid addiction or any other health condition. But because kratom is classified as a dietary supplement, it’s not held up to the same regulatory standards as pharmaceutical drugs -- as long as vendors don’t make any misleading claims about its health benefits. That’s when the FDA can intervene by seizing kratom products or prohibiting their sale.

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“They’re marketing products as dietary supplements with unproven claims about ability to treat addiction; or as all-natural alternatives to opioids. Health fraud scams like these can pose serious health risks,” Gottlieb tweeted. “FDA will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat opioid use disorder, but which have not been proven safe and effective for these purposes.”

SCOTT GOTTLIEB, MD

SCOTT GOTTLIEB, MD

Although Gottlieb didn’t specifically name kratom as one of those “health fraud scams,” there’s little doubt that’s one of the supplements he was referring to. Last month the FDA issued a public health advisory about kratom, warning that it was addictive and linked to dozens of overdose deaths.

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” Gootlieb said at the time.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In a survey of 6,150 kratom users last year by Pain News Network and the American Kratom Association, most said they used kratom as a treatment for chronic pain, depression or anxiety. But a fair number -- nearly 10 percent -- said the primary reason they used kratom was to treat opioid addiction.

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“It has saved my life. I am a mother of four and have anxiety, depression, acute back pain, and I am an opioid addict. It has kept all these at bay for me,” one woman wrote. “I want to be there for my children, but the sad truth is I know I can't live with these conditions and not find something. It's a sad day when I have to turn to the streets again to have any kind of life.”

“I've had several friends who have died from heroin overdose if they knew about kratom they may still be alive today,” wrote another kratom user.

Last year, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry and lobbying campaign by kratom supporters, saying it would wait for a medical evaluation and scheduling recommendation for kratom from the FDA. Although the FDA has warned the public about using kratom, its full report and recommendations have yet to be released.

Can Kratom Be Patented?

By Jane Babin, Guest Columnist

Discussions surrounding kratom are heating up following the Food and Drug Administration’s public health advisory, and questions have appeared about whether kratom and its constituents are patented or could be. 

The short answer is no.

Patents are important tools for protecting investment in innovation.  Without patent protection, far fewer new drugs would be developed.  An alternative is to keep details of an invention secret to ensure that no one will be able to copy it.  However, this approach isn’t possible in the pharmaceutical industry, where regulations require extensive public disclosure. 

To encourage inventors to share details about their inventions, the U.S. grants a patent right to prevent other people from making the same invention for a limited time, in exchange for publicly disclosing the details about the invention.  The public can read patents and apply their disclosures to other situations, which immediately advances science and technology.  After a patent expires, the invention itself can be made by anyone.

Patents Granted for a Limited Time

U.S. Patents 3,256,149 (“Compositions Compromising an Alkaloid of Mitragyna Speciosa and Methods of Using Same”) and 3,324,111 (“Speciofoline, an Alkaloid from Mitragyna Speciosa”), were both granted to Smith Kline & French Laboratories.

FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and some have suggested a conflict of interest motivated his warning about kratom.

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If there is a conflict, it isn't over these patents, which were issued in the 1960's and have long since expired.  Patents are granted for a limited time.  Currently, patents expire 20 years after filing.  Prior to 1995, a patent term was 17 years from the date of issuance.

Products of Nature are Not Patentable

Prior to their expiration, the two patents gave Smith Kline & French the right to prevent others from making, using, selling, and importing certain alkaloids isolated from kratom, but not the whole plant or leaf. 

Plants themselves and other substances found in nature have never been patentable, unless they are changed substantially by an inventor.  In the 1960s, isolating a substance from a plant was considered a substantial change to the substance. Today it isn’t. 

Courts have held that substances found in nature, even in impure form, cannot be patented whether they are isolated from a natural source or synthesized in a lab.  If a chemical has the same structure as a natural substance, it is not patentable.

Derivatives are Patentable

Derivatives of natural chemicals can be patented, however.  As good as a natural chemical may be, changing it slightly may make it even better -- or worse.  Scientists tweak a compound's structure to alter its properties, repurpose it, investigate interactions with other molecules, and design around compounds that are unpatentable. 

Patents have been granted for derivatives of kratom alkaloids, particularly derivatives of mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), which potentially may become new drugs that are improved over natural alkaloids. 

Even if they are never commercialized, studying how structural changes affect biological activity can lead scientists to modify other compounds to impart similar properties.  For example, making non-addictive kratom derivatives may show scientists ways opioids could be made non-addictive. 

U.S. patent law recognizes the importance of such inquiry and includes an exception under 35 USC §371(e), allowing scientists to use patented inventions in certain types of research.  Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is needed to take advantage of this exception.

Distinguishing a Patent from a Published Application

Another misconception about patents is that every document that looks like a patent is one.  To obtain a patent, an inventor must first file an application, which doesn't become a patent until the Patent Office is satisfied that it meets all legal requirements. Whether granted or not, the application is usually published, and it looks very much like a granted patent. 

There are two ways to distinguish a U.S. patent from an application:

  1. U.S. Patents have the words "US Patent" at the top of the first page, while applications have "US Patent Application Publication."
  2. Current patents are identified by a 7 digit number.  Published applications numbers have eleven digits beginning with a 4 digit year. For example, 9,458,426 is a US patent, while 2014/0186948 is a published application.

Foreign countries also issue patents and an inventor must obtain a patent in each country where he or she wants to enforce patent rights.  Thus, there may be multiple patents covering the same invention in different countries.  Each country has its own numbering system and may or may not publish applications prior to granting them.  Instead of immediately filing multiple applications in foreign countries, inventors can initially file a single international application with the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT), which can be used as the first step toward patents in many countries.  

Requirements for a Patent and Examination

Applications don't automatically become patents.  They are first examined to see if a patentable invention that meets certain legal criteria is described and claimed.  In addition to claiming patentable subject matter, an invention must be novel, non-obvious, and the application must disclose sufficient description that someone in the field would be able to make and use the invention. 

Examination involves a dialogue between applicant and a patent examiner, often resulting in changes to the claims (the legally enforceable part of a patent).  Some applications are never granted.

US 2010/0209542 is a kratom-related application that is frequently discussed.  It claims a method for treating withdrawal from an addictive substance using a kratom extract.  When this application was first examined, it was rejected because existing literature described kratom itself as being addictive.  The applicant might have overcome this rejection by arguing that kratom is non-addictive or that other addictive substances are used to treat withdrawal.  However, the inventors faced bigger challenges because they didn't actually treat anyone for withdrawal with a kratom extract and described no studies of their own showing the method actually worked. 

Self-treatment using kratom had been reported, but that didn’t help the application because it meant that the applicant was not the first to "invent" the method and the invention was not novel.  Facing an uphill battle, the application was abandoned and never matured into an enforceable patent.

There may be many obstacles on the path to general acceptance of kratom as a beneficial herbal supplement.  Fortunately, patents are not one of them.

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Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California. Jane has worked as a consultant for the American Kratom Association, a pro-kratom consumer group.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Issues New Kratom Warning

By Pat Anson, Editor

The Food and Drug Administration has issued a public health advisory about kratom, an herbal supplement used by millions of Americans to self-treat pain, anxiety, depression and addiction.

In a lengthy statement, FDA Commissioner Scott Gottlieb, MD, said the agency has “significant concerns” about the increasing use of kratom and its potential health risks – especially when it is used to treat opioid addiction.

“At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” Gottlieb wrote.

“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.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules.

Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In his statement, Gottlieb claimed that kratom was addictive and was being used recreationally for its euphoric effects. But he also acknowledged that the herb could have legitimate medical uses.   

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“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” he wrote. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

The evidence is lacking, in large part, because kratom and its active ingredients are natural substances that cannot be patented and have less potential for profit. That discourages pharmaceutical companies from investing in research and clinical studies to prove kratom's safety and efficacy.

"To date, no marketer has sought to properly develop a drug that includes kratom," said Gottlieb. "We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom."

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

The DEA said at the time that kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers. Gottlieb renewed those claims today and said the FDA was “aware of reports” of 36 deaths associated with kratom. But he did not go into detail about where or when those deaths occurred.

The American Kratom Association (AKA) – a pro-kratom consumer group – has strongly disputed recent autopsy reports linking kratom to sudden deaths in Florida, Georgia and New York, calling them a "rush to judgement."

The AKA filed a dispute resolution petition challenging the "weak scientific basis" of the FDA advisory and asked that it be withdrawn.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities.  AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims," the AKA said in a statement.

In a survey of 6,150 kratom consumers by Pain News Network and the AKA, over 90% said the herb was “very effective” in treating their medical condition, whether it was pain, anxiety, depression or addiction. Many predicted that if kratom were classified as a controlled substance and made illegal, it would only increase the use of alcohol, marijuana, prescription opioids and illegal substances like heroin.

Report Finds ‘Rush to Judgment’ in Kratom Deaths

By Pat Anson, Editor

Medical examiners in New York and Florida made significant errors when they attributed the recent deaths of two young men to the herbal supplement kratom, according to a new analysis commissioned by the American Kratom Association, a pro-kratom consumer group.

At issue are the sudden deaths of Matthew Dana in upstate New York in August and Christopher Waldron in Hillsborough County, Florida in July. Both men were 27.

A medical examiner listed Waldron’s cause of death as “intoxication by Mitragynine,” one of the active ingredients in kratom. The coroner who performed the autopsy on Dana blamed his death on a hemorrhagic pulmonary edema (blood in the lungs) caused by high levels of kratom.

“In both of these cited cases, the conclusions reported by the coroner and medical examiner citing ‘kratom overdose’ and ‘kratom intoxication’ appear to add to the long list of mistaken, inaccurate, and now discredited reports implicating kratom,” wrote Jane Babin, PhD, a molecular biologist and lawyer.

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“These two cases, where it appears there was a rush to judgment to align with a political narrative promoted by the Drug Enforcement Administration on kratom use, undermine the credibility of the search for the actual cause of death for the benefit of the decedent’s family and the public.”

Babin said mitragynine has never been found to cause a pulmonary edema, and the medical examiner erred in not analyzing Dana’s blood for drugs such as anti-anxiety medication or anabolic steroids. Dana was a police sergeant and bodybuilder, who reportedly used steroids as part of his bodybuilding program.

Babin said the medical examiner in Florida also “rushed to judgement” in blaming Waldron’s death on kratom. Two prescription medications used to treat depression and muscle spasms, Citalopram and Cyclobenzaprine, were also found in Waldron’s blood. Labels on both drugs warn they can cause coma or death when taken together. Waldron also had ventricular hypertrophy, an enlarged liver and thyroid disease, which may have contributed to his death, according to Babin’s report.

“What I see here are very troubling indications that these deaths may have been incorrectly attributed to kratom in the face of other causes, including possible anabolic steroid use in one case and contraindicated prescription medication interactions that could kill on their own,” said Karl Ebner, PhD, a toxicologist who reviewed the report.

“These families are owed the best evidence about what happened to their loved ones, not what would appear to be some conclusions that are incompletely supported by the current evidence."

Millions of people use kratom to treat chronic pain, depression, anxiety and addiction. Last year, the DEA attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA said kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers  

The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

"Last year, the DEA tried to demonize kratom. In 2017, the kratom community finds itself in the same situation all over again,” said David Herman, chair of the American Kratom Association (AKA). “This time, we are being told that two deaths were supposedly the result of kratom use.  Let me be very clear about this:  We do not believe that kratom caused these deaths.  That's what the science tells us.

“Given that there are millions of kratom consumers in the U.S., if this botanical was dangerous it would stand to reason that there would be thousands … or even tens of thousands of deaths … and that is absolutely not the case."

The AKA backed another study last year that found kratom has little potential for abuse and dependence. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

Kratom Non-Profit Seeks Missing Financial Records

By Pat Anson, Editor

A widening rift in the kratom community erupted into a virtual earthquake today with the release of a statement by the American Kratom Association that accuses its founder and former chair of financial improprieties.

Susan Ash called the allegations against her “defamation” and suggested she would take legal action against the organization that she created.

Ash founded the American Kratom Association (AKA) in 2014 and played a prominent role in its successful campaign last year to prevent the Drug Enforcement Administration from listing kratom as a controlled substance. She resigned as chair in May after complaints arose about her management of the AKA, a non-profit that has grown considerably in size and funding in the past year.

“I regret to say that even during our biggest successes, I have heard ill-informed and malicious sniping about AKA and me," Ash said at the time. “I am an organizer and a front-line campaigner and that is where I need to be for kratom. I am stepping down from the AKA board effective immediately to concentrate more on those efforts.”

SUSAN ASH

SUSAN ASH

Ash remained as national spokesperson for the AKA, but was suspended after an internal audit of the organization’s financial records.

“The preliminary financial review identified significant discrepancies and missing records in financial documentation for compensation and expense reimbursements paid to Ms. Ash over a significant time period. Several of the expenditures are substantial, and have raised significant questions as to whether they were appropriate for reimbursement from donor funds,” the AKA said in its statement.

“A formal request was made to Ms. Ash to provide receipts and justifications for expenses to allow for the financial review to be completed, but Ms. Ash has been unwilling and/or unable to provide the necessary receipts and records to justify these expenditures.”

The statement also said Ash refused to relinquish control of the AKA’s bank and PayPal accounts. Current AKA chairman Dave Herman told PNN the organization has “no idea how much money" is in those accounts and no longer has access to them.  It has since established new accounts. 

“The statement that the American Kratom Association put out about me today is defamation. That is the only comment I will make about it, as this matter is in the hands of lawyers,” Ash said in a statement on her Facebook page.

Ash worked tirelessly to promote the safe use of kratom, which she used to control her opioid addiction. Millions of others have found the herbal supplement effective in treating chronic pain, depression, anxiety and addiction.

Listing kratom as a Schedule I controlled substance, alongside heroin and LSD, would have made it a felony to possess or distribute. The DEA suspended its plan to list kratom after a very effective public relations and lobbying campaign by Ash and the AKA.

“I've never fought a harder, more public battle -- not just because of the terrible odds against us, but because this one opened up my private life, including my very personal struggles with addiction, to the world,” Ash wrote in a Facebook post last August.

“I wasn't prepared to be the poster child, or to have admirers, or to have haters, but I believed with every fiber of my being that kratom is safe and can change and save lives including my own, so this battle was worth it.”

The AKA’s political success led to an infusion of over $800,000 in donations last year, according to Herman, who says Ash was being paid over $5,000 a month when she resigned as chair.  Until this year she was paid only a small stipend.

Herman said Ash has ignored repeated requests to turn over receipts and other financial records, and has continued to “interfere” with the AKA. He told PNN the board preferred to keep the estrangement with Ash a private matter, but felt it had no choice but to go public.

susan ash at 2016 rally at white house

susan ash at 2016 rally at white house

“I didn’t want to try this in the court of public opinion,” Herman said. “What I want to have happen, with all my heart, is for her to pony up the receipts, go quietly her way and let us go quietly our way with no disparagement of any kind. There’s no desire to do this. I fought hard to not do this. But when you’re given no choice, you got to go.”   

Will New Laws Punish Pain Patients?

By Pat Anson, Editor

Recent efforts by state and federal lawmakers aimed at punishing drug traffickers could wind up sending people to prison simply for seeking pain relief, according to critics.

This week the American Kratom Association (AKA) sent an action alert to members warning that a bill introduced by Sen. Chuck Grassley and Sen. Dianne Feinstein could be a “backdoor way” of banning kratom -- an herbal supplement that millions of people use as an alternative to opioid painkillers.

The “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” – also known as the SITSA Act – would give the Attorney General the power to list as a “Schedule A” substance any unregulated drug that has a chemical structure similar to that of a drug already listed as a controlled substance. A similar measure has been introduced in the House.

The bills are ostensibly aimed at banning chemical cousins or “analogues” of fentanyl, a powerful synthetic opioid blamed for thousands of overdose deaths that is increasingly appearing on the black market.

But kratom supporters fear the SITSA Act could also be used to ban kratom, something the Drug Enforcement Administration tried unsuccessfully to do last year, claiming it was an "opioid substance" with “a high potential for abuse.” Kratom is not an opioid, but it has opioid-like properties that reduce pain or act as a stimulant or depressant – much like a controlled substance.

“So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an ‘analogue’ of the opioid,” said Susan Ash, the AKA’s founder and spokesperson. “After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.”

Ash wants the SITSA Act to be amended to exclude natural botanicals like kratom. In its current form, she says the bill could impose prison sentences of up to 20 years for importers or exporters of kratom, which is made from the leaves of a tree that grows in southeast Asia.

Florida Law Stiffens Penalties for Fentanyl

A new law in Florida is also intended to crackdown on fentanyl dealers, but critics say it could wind up sending unsuspecting pain patients to prison as well.

Signed into law yesterday by Gov. Rick Scott, it requires mandatory minimum sentences for defendants convicted of selling, purchasing or possessing illicit fentanyl.

Anyone caught with as little as four grams of fentanyl would face a minimum of three years in prison. Sentences escalate depending on the amount of fentanyl seized and murder charges could be filed if someone dies of a fentanyl overdose.

Dealers often mix fentanyl with heroin or sell it in counterfeit pills disguised to look like oxycodone or other prescription painkillers. Many users have no idea they’re buying fentanyl, which is 50 to 100 times more potent than morphine.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times. "You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl.”

DEA PHOTO

DEA PHOTO

Florida has been down this path before. According to an investigative series by Reason.com, mandatory minimum sentences in Florida for oxycodone and hydrocodone trafficking resulted in 2,300 people being sent to prison, most of them low-level drug users or patients who went to the black market seeking pain relief. 

“The signing of this bill by Gov. Scott is another example of using get tough drug policies for political gain,” said Tony Papa, Manager of Media and Artist Relations for the Drug Policy Alliance. “This is not going to stop the sale of heroin in Florida. It's another prosecutorial tool that will be used for bargaining by district attorneys in drug cases.  Under this new law many individuals will be subject to the death penalty for a 10 dollar bag of dope. It's totally insane!”

Wisconsin to Involuntarily Commit “Drug Dependents”

A bill that recently sailed through the Wisconsin legislature with little opposition would allow for the involuntary commitment of someone who is drug dependent. The bill’s sponsor, Assemblyman John Nygren, has a daughter who has struggled with heroin addiction and served time in jail.

Current Wisconsin law allows for the involuntary commitment of alcoholics if three adults sign a petition alleging that a person lacks self-control over their use of alcohol and whose health is substantially impaired. 

The new bill adds “drug dependence” to the list of reasons someone can by committed. Dependence is defined as a person’s use of one or more drugs that is beyond their ability to control and that substantially impairs their health or social functioning.

The bill is one of nearly a dozen anti-opioid measures sponsored by Nygren that Gov. Scott Walker asked to be approved in a special legislative session. It now heads to his office for consideration.

New Efforts to Ban Kratom in Florida and New York

By Pat Anson, Editor

Federal efforts to ban kratom may be on the back burner – for now --- but that isn’t stopping lawmakers in Florida and New York from introducing bills that would make the sale of kratom illegal in those states.

Millions of Americans use the herbal supplement to alleviate symptoms of anxiety, depression, addiction and chronic pain.

Florida State Rep. Kristin Jacobs (D) has reintroduced legislation that would add mitragynine and 7-hydroxymitragynine – the two active ingredients in kratom – to the state’s list of controlled substances.  Selling, manufacturing or importing kratom in Florida would be a criminal misdemeanor if the bill becomes law.

Similar legislation has been reintroduced in New York by Assemblywoman Aileen Gunther (D), which would make the sale and distribution of kratom punishable with a fine of $2,000. After a third offense, retailers caught selling kratom would also lose their licenses to sell lottery tickets, alcohol and tobacco – a far bigger financial penalty.

A request for an interview with Gunther went unanswered.

“This would be the nail in the kratom coffin for New York wouldn't it?” said Fred Kaeser, the former Director of Health for New York City’s public schools.

Kaeser started using kratom a few months ago and found that it relieved his chronic back pain and reduced his need of opioid pain medication.

“So I find something that helps me to minimize my opioid consumption for my severe chronic pain, and this bill will now force me to reconsider resuming that opioid consumption. Truly amazing isn't it? Let's ban the very substance that helps you to limit your opioid intake,” said Kaeser in an email.

“Why ban something that has very limited empirical research behind it? Yet what research that does exist on kratom suggests promise as a real alternative to opioids. Why not advocate for more research to determine the true risk-benefit of this plant rather than a bill that shuts down that potential promise altogether?”

Kratom or its active ingredients are already illegal in six states (Alabama, Arkansas, Indiana, Tennessee, Vermont and Wisconsin), and came close to being banned nationwide last year.

The Drug Enforcement Administration announced plans in August for the emergency scheduling of kratom as a Schedule I Controlled Substance, the same classification given to heroin, LSD and marijuana. The DEA called kratom “an imminent hazard to public safety” and cited anecdotal reports that the herb was linked to several deaths.  

The emergency scheduling was withdrawn after an unprecedented lobbying campaign by kratom users, retailers and some members of Congress.  Over 23,000 comments were made on a federal website – the vast majority of them supporting the continued classification of kratom as a dietary supplement. The DEA said it would reevaluate its decision and ask the Food and Drug Administration to conduct a full scientific and medical review of kratom.  

Three previous attempts to ban the herb in Florida have failed, but Rep. Jacobs is not giving up. She calls kratom a “scourge on society” and said the American Kratom Association was spreading lies about the herb’s medical value.

“They have a story,” Jacobs told the Florida Politics blog. “Just like Hitler believed if you tell a lie over and over again, it becomes the truth.

“The Kratom Association stands to lose a lot of money if they aren’t able to continue profiting off the misery of addicts.”

In 2015, the Florida Department of Law Enforcement released a report stating that “no pervasive health issues” have been attributed to kratom and the herb “does not constitute a significant risk to the safety or welfare of Florida residents.”

A survey of over 6,400 kratom users by Pain News Network and the American Kratom Assocation found that 98 percent did not consider kratom a harmful or dangerous substance. Three out of four also said they did not get "high" from using kratom.

Surge in Fake Painkillers as Opioid Prescribing Drops

By Pat Anson, Editor

A decline in the abuse and diversion of prescription pain medication is being offset by a “massive surge” in the use of heroin and counterfeit painkillers, according to a comprehensive new report by the U.S. Drug Enforcement Administration.

The DEA’s 2016 National Drug Threat Assessment paints a stark picture of the illicit drug trade in prescription medication, fentanyl, heroin, marijuana, methamphetamine and cocaine.  Interestingly, the 194-page report doesn’t even mention kratom, the herbal supplement the DEA attempted to ban in August before postponing its decision after a public outcry.

"Sadly, this report reconfirms that opioids such as heroin and fentanyl - and diverted prescription pain pills - are killing people in this country at a horrifying rate," said DEA Acting Administrator Chuck Rosenberg. "We face a public health crisis of historic proportions. Countering it requires a comprehensive approach that includes law enforcement, education, and treatment." 

The diversion of prescription opioids has fallen dramatically, according to the DEA report, from 19.5 million dosage units in 2011 to 9.1 million in 2015. Less than one percent of the opioids legally prescribed are being diverted to the black market.

The agency says the prescribing and abuse of opioid medication is also dropping, along with the number of admissions to treatment centers for painkiller addiction.

“With the slightly declining abuse levels of CPDs (controlled prescription drugs), data indicates there is an increase in heroin use, as some CPD abusers have begun using heroin as a cheaper alternative to the high price of illicit CPDs or when they are unable to obtain prescription drugs,” the report states.

The increased use of heroin coincided with federal and state efforts to reduce the prescribing of opioids. So did the appearance of counterfeit pain medication made with illicit fentanyl – a synthetic opioid that is 50 to 100 times more potent than morphine.  

“In 2015, there was a marked surge in the availability of illicit fentanyl pressed into counterfeit prescription opioids, such as oxycodone. In many cases, the shape, colorings, and markings were consistent with authentic prescription medications and the presence of fentanyl was only detected after laboratory analysis,” the DEA said. “The rise of fentanyl in counterfeit pill form exacerbates the fentanyl epidemic. Prescription pill abuse has fewer stigmas and can attract new, inexperienced drug users, creating more fentanyl-dependent individuals.”

As Pain News Network has reported, the number of fentanyl related deaths has surged around the country. In Massachusetts – where there has been a marked effort to reduce opioid prescribing -- three out of four opioid overdoses are now being linked to illicit fentanyl.

In Ohio’s Cuyahoga County, the problem is even worse. The medical examiner there estimates 770 people will die from either fentanyl or heroin overdoses by the end of the year, ten times the number of overdose deaths from prescription opioids.

The DEA predicts the problem will only grow worse.

“Fentanyl will remain an extremely dangerous public safety threat while the current production of non-pharmaceutical fentanyl continues,” the agency warns. “In 2015 traffickers expanded the historical fentanyl markets as evidenced by a massive surge in the production of counterfeit tablets containing the drug, and manipulating it to appear as black tar heroin. The fentanyl market will continue to expand in the future as new fentanyl products attract additional users.”

Those who do manage to get their hands on prescription painkillers for recreational use are mostly getting them from friends or relatives. Less than 25% of the painkillers that are used non-medically are obtained directly from doctors.

Over two-thirds of the painkillers that are abused are bought, stolen or obtained for free from friends and relatives.

Despite the shifting nature of the opioid epidemic, government efforts to stop it continue to focus on punishing doctors who overprescribe and reducing patient access to opioids.

“I have several chronic pain conditions that I was managing with a doctor’s care and Norco,” one reader recently emailed Pain News Network. “The DEA closed his office out of the blue. I was left with no doctor, no medical records, and the responsibility of weaning myself off what meds I had left on my own. 

SOURCE OF PAINKILLERS USED NONMEDICALLY

SOURCE: DEA

“My life is in shambles and I live in constant pain with no mercy. How much medical proof of real pain does it take? They just run me around to see different doctors. All the money and time wasted. I can't imagine living the rest of my life like this.”

The Centers for Disease Control and Prevention says 52 Americans die every day from overdoses of prescription opioids, although the accuracy of its estimates has been questioned. Some deaths caused by heroin and illicit fentanyl are wrongly reported as prescription drug overdoses. Other deaths may have been counted twice.

Over 22,000 Comments on DEA’s Kratom Ban

By Pat Anson, Editor

Over 22,000 public comments – a record number on any issue -- have been posted on a government website taking comments on a threatened federal ban on the herbal supplement kratom. The final number is likely to be even higher once all the comments are recorded.

The vast majority of commenters oppose plans by the Drug Enforcement Administration for the emergency scheduling of two ingredients in kratom as Schedule I controlled substances, a move that would make the sale and possession of the herb a felony.

Thursday, December 1 was the last day that public comments were accepted at Regulations.gov on the kratom ban. The number of kratom comments is over five times the number who commented on the controversial opioid prescribing guidelines released by the Centers for Disease Control and Prevention earlier this year.

“I think the quality of the comments and the quantity of the comments show that kratom really does have potential and that the three to five million people that are consuming kratom would suffer greatly if it becomes a Schedule I controlled substance,” Susan Ash, founder of the American Kratom Association, told Pain News Network.

Ash started using kratom several years ago to help fight opioid addiction. Many others use it to treat their chronic pain, anxiety and depression.

“If Kratom is banned by the DEA my quality of life will decrease tremendously,” wrote a 62-year old veteran who started using kratom four years ago as an alternative to anti-anxiety medication. “My life was out of control with benzodiazepines. With kratom, I can live a somewhat anxiety-free life and not have all the negative side effects that come with benzodiazepines.”

“The VA prescribes lots of pain medication that’s very addictive. I have since gone off the medication and switched to kratom,” wrote Brandon Lang, another military veteran.  “The effect as far as pain relief is comparable, but the addictive nature and the ‘high’ is nearly nonexistent. I feel much better knowing pain relief is available and affordable. I am now free and clear of narcotics.”

“Kratom is nowhere near as dangerous as alcohol, tobacco, acetaminophen, aspirin, and countless other things which are widely available. It makes absolutely no sense to ban kratom,” said John Miller.

“I am a former addict and know others who suffer from addiction including alcoholism,” wrote Chris Simmons. “In my experience kratom significantly reduces cravings while allowing people to go about their day as normally as possible. Please keep this legal.”

One of the comments opposing the ban came from a retired deputy chief of the Los Angeles Police Department.

“Kratom has been used safely by millions of people in the U.S., just like marijuana was used safely prior to its prohibition. And, just like marijuana, kratom has many medicinal benefits that scheduling would deny to those who benefit from its use. Its prohibition would only drive thousands more to opiate use,” wrote Stephen Downing, who has called for the legalization of many illicit drugs.

“There is no evidence to support prohibition of this plant. Putting it on the Controlled Substances Schedule will serve no useful purpose other than the continued survival of a massive and harmful out-of-control government bureaucracy.”

Only a small minority of commenters support a ban on kratom.

“Adding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, leading to serious unintended consequences as our nation struggles with the crisis of opioid addiction,” wrote Daniel Fabricant, PhD, a former FDA official who is now CEO and Executive Director of the Natural Products Association (NPA), a trade association that represents the food and dietary supplement industry.

“NPA strongly urges DEA and FDA to take appropriate legal action to ensure that American consumers are protected from an unknown and unregulated botanical ingredient whose use could have widespread and unintended negative consequences for public health and safety.”

Fabricant’s comments to the DEA rely primarily on anecdotal reports that kratom might be harmful or have a narcotic effect.  Although kratom leaves have been used for centuries as a natural remedy in southeast Asia, it is relatively new in the United States, and there have been few clinical studies on its safety and efficacy.

In a new analysis of existing studies funded by the American Kratom Association, Jack Henningfield, PhD, said kratom was no more dangerous than many other herbal supplements, such as St. John’s Wort, lavender, kava and hops. 

"For both abuse potential and dependence liability, kratom's profile is comparable to or lower than that of unscheduled substances such as caffeine, nicotine-containing smoking cessation products, dextromethorphan, and many antihistamines, antidepressants, and other substances sold directly to consumers,” said Henningfield, who is a former chief of research at the National Institute on Drug Abuse and is currently an adjunct professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. 

What happens now with the threatened ban is not clear. The DEA has asked for a new analysis of kratom from the Food and Drug Administration, which initially recommended that the herb be made a controlled substance. The new analysis has yet to be released publicly.

It appears likely that a final decision on kratom will be left to the incoming Trump administration, and there are conflicting signs where that may lead. Trump’s nominee as Attorney General, Alabama Sen. Jeff Sessions, has been a longtime critic of marijuana legalization. If confirmed by the Senate, Sessions will oversee the DEA.

Trump’s nominee as Secretary of Health and Humans Services, Georgia Rep. Tom Price, will oversee both the CDC and FDA if he is confirmed. Price is a noted Tea Party member and longtime critic of Obamacare, who wants a more free market approach to healthcare that allows patients to make their own decisions. 

Susan Ash is hopeful that these dueling interests will decide that kratom is best left alone as a dietary supplement. 

“I’m nearly 100% confident that they are not going to emergency schedule this again,” she told PNN. “I truly believe that science is going to be on our side. How long it is going to take for that science is my concern.”

Medical Use of Kratom ‘Too Large to Be Ignored’

By Pat Anson, Editor

A threatened ban on kratom would stifle scientific understanding of the herb and its value in treating pain, addiction and other medical problems, according to a commentary published in the Journal of the American Osteopathic Association.

"There's no question kratom compounds have complex and potential useful pharmacologic activities and they produce chemically different actions from opioids," said Walter Prozialeck, PhD, chairman of the Department of Pharmacology at Midwestern University Chicago College of Osteopathic Medicine.

“In my opinion, the therapeutic potential of kratom is too large to be ignored. Well-controlled clinical trials on kratom or the many active compounds in kratom are needed to address this issue.”

In August, the U.S. Drug Enforcement Administration issued an emergency order saying it would classify two of kratom’s active ingredients -- mitragynine and 7-hydroxymitragynine -- as Schedule I controlled substances.

Such an order would have effectively banned the sale and possession of an herbal supplement that millions of people use to treat pain, anxiety, depression and addiction. It would also make it harder for researchers to conduct clinical trials of kratom.

The DEA postponed its decision only after a backlash from kratom supporters and some members of Congress. The agency said it would seek new guidance from the FDA and allow public comment on the proposed ban until December 1. Over 7,000 people have commented so far at Regulations.gov.

In its emergency order, the DEA said kratom posed an “imminent hazard to public safety” and referred to its chemical compounds as “opioid substances.” But Prozialeck says kratom behaves differently than opioids, because it doesn't produce euphoria or depress respiration.

“At the molecular level, mitragynines are struc­turally quite different from traditional opioids such as morphine. Moreover, recent studies indicate that even though the mitragynines can interact with opioid receptors, their molecular actions are different from those of opioids,” he wrote. “Based on all of the evidence, it is clear that kratom and its mitragy­nine constituents are not opioids and that they should not be classified as such.”

Prozialeck also disputes the notion that kratom is linked to several deaths, saying other drugs or health problems could have been involved. While he thinks banning the herb would be a mistake, Prozialeck believes some regulation is needed to prevent kratom products from being adulterated or contaminated with other substances.

"After evaluating the literature, I can reach no other conclusion than, in pure herbal form, when taken at moderate doses of less than 10 to 15 g (grams), pure leaf kratom appears to be relatively benign in the vast majority of users. Without reported evidence, however, it would not be appropriate for phy­sicians to recommend kratom for their patients,” he concludes.

That’s a sentiment that Dr. Anita Gupta agrees with.  She says several of her patients have successfully used kratom for pain relief, but until more research is conducted on the herb’s safety and efficacy, Gupta won’t recommend it to other patients.

“What I hear from patients is that they’re getting good benefit from it. But we have to wonder if kratom itself has pharmacological benefit or if it’s a placebo effect,” said Gupta, an osteopathic anesthesiologist and pharmacist who also serves on an FDA advisory board.

“I would encourage more oversight of kratom. There should be more regulation of kratom substances. That could come from the FDA or DEA, to make sure patients are safe and there’s no harmful interaction. To say that it’s only a dietary supplement, I don’t know if that’s the right classification, because we’re using it for clinical conditions and diseases. I think we need more oversight and more research should be conducted,” Gupta told PNN.

It’s a Catch-22 for kratom supporters. If research confirms its therapeutic value, that could result in kratom being classified as a Schedule II or III controlled substance, on the same level as other medications that have a potential for abuse. Kratom would still be legal to obtain, but only with a prescription.

In a survey of over 6,000 kratom users by Pain News Network and the American Kratom Association, over 98 percent said they wanted kratom to remain available as a dietary supplement without a prescription.  Seven out of 10 also said pharmaceutical companies should not be allowed to produce and market kratom products.