45 Congressmen Ask DEA Not to Ban Kratom Next Week

45 Congressmen Ask DEA Not to Ban Kratom Next Week


A large and bipartisan contingent in Congress is asking the Obama administration to delay the sudden ban poised to take effect next week on possessing kratom, a Southeast Asian tree leaf product that supporters describe as a near-miraculous treatment for pain, depression and addiction to opiates and legal narcotics.

Reps. Mark Pocan, D-Wis., and Matt Salmon, R-Ariz., recruited 45 signers in the House of Representatives on Friday afternoon for two letters, which will be sent Monday to Chuck Rosenberg, acting administrator of the Drug Enforcement Administration, and Office of Management and Budget Director Shaun Donovan.

“This significant regulatory action was done without any opportunity for public comment from researchers, consumers and other stakeholders,” the lawmakers say in the letter to Rosenberg. “This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.”

The letter to Donovan asks him to overrule the DEA, which is invoking a rarely used emergency power with just 30 days notice, warning the action “will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions.”

Susan Ash, founder of the American Kratom Association consumer group, which organized a Sept. 13 protest at the White House, says she remains hopeful that the ban won’t go into effect for two compounds in kratom that would essentially ban the plant.

“I feel a lot of hope because the amount of congresspeople who are paying attention to this issue and the media and the public are really weighing in our favor – it’s finally coming to light who the average kratom consumer is,” Ash says.

Those users include recovering heroin, cocaine and alcohol addicts, fibromyalgia patients, and people with arthritis and cancer, according to a sampling of attendees at the White House protest. Some veterans with post-traumatic stress disorder and people with depression say it has helped them, too.

AKA Executive Director Paul Pelosi Jr. says he believes the DEA has been surprised by a deluge of user pleas to keep kratom legal and that “I think everyone’s looking for a way to save face – like, ‘How can we come back from this?'”

Pelosi has tried kratom but does not regularly use it. He says he believes that between 4 million and 5 million Americans may be using kratom – an estimate higher than the hundred thousand or so others offer, which he bases on his understanding of industry sales figures.

“It’s pretty safe. It may be slightly addictive, but there’s no overdose or safety issue, so I think the DEA was unaware people use it in a kava shop, a cafe and that veterans use the leaf naturally,” he says. “It’s not just a couple of teens trying to get high. There’s limited party use for this.”

Indeed, preliminary scientific analysis shows that kratom, despite DEA concern about safety and anecdotal reports about dependence potential, could offer substantial harm reduction — particularly as accidental overdoses of opioids including legal painkillers and illegal drugs like heroin killed more than 28,000 in 2014 alone.

Andrew Kruegel, associate research scientist at Columbia University, says research has shown significant differences between the two about-to-be-banned compounds – mitragynine and 7-hydroxymitragynine – and traditionally abused drugs that act on opioid receptors in the brain.

“Both mitragynine and 7-hydroxymitragynine are partial agonists of the mu opioid receptor, and that is the same target that heroin, morphine and fentanyl bind to,” Kruegel says. “But the key thing from the science side is they activate this receptor in a different way. For one, they are partial agonists, which means they stimulate the receptor to a lower level … no matter how high you go with the dose.”

“In animal studies, both mitragynine and 7-hydroxymitragynine produce almost no respiratory depression,” he adds. “Of course this hasn’t been rigorously studied in humans because there have been no clinical trials, but anecdotal evidence – which is quite substantial – suggests that people aren’t dying of respiratory depression.”

Kruegel says the reason for a lack of respiratory depression, a primary cause of death in heroin and other opioid overdoses, is that the compounds appear to be biased agonists that only trigger one opioid pathway – called the G protein pathway – and not another pathway associated with respiratory depression and constipation.

Kruegel says mitragynine and 7-hydroxymitragynine preliminarily appear “similar in terms of pharmacology” to a drug called Oliceridine that currently is undergoing Food and Drug Administration-approved phase three trials in humans.

Columbia University researchers currently are scrambling to complete research for a paper on kratom’s effects on non-opioid receptors, and are busily boiling leaf matter in alcohol to extract the mitragynine and use chemical reactions to convert it into non-Schedule I analogs.

“We obviously can’t have kilograms of kratom around here when the ban goes into effect,” Kruegel says.

If the ban does go into effect, Kruegel says he would like to apply for a special Schedule I license to continue research, but he points out the hoops to jump through are onerous – as marijuana researchers have lamented for years – including installation of a safe that costs about $10,000.

Despite the backlash, the DEA’s knees aren’t buckling, though sympathetic statements one spokesman offered the Washington Post last week gave some advocates hope. “I want the kratom community to know that the DEA does hear them,” spokesman Melvin Patterson told the Post. “Our goal is to make sure this is available to all of them.”

With a week to go before the ban is scheduled to take effect, however, spokeswoman Barbara Carreno says she has received no indication there will be a reversal.

“It’s not that the DEA is unsympathetic to people who have chronic pain or who are addicted to opioids,” she says. “We are people just like everyone else who get in a car accidents and break our femurs and get cancer and have surgery and are in need of pain medicine. … It’s just that science says this is a problem and we need to keep people safe.”

Carreno says “the analysis we did showed there is enough of a public health problem with kratom” to justify it being placed in Schedule I on an emergency basis, a classification that would last two or three years until removal, permanent listing or scheduling in a lower ranking based on additional research.

“I have not been advised it’s being reconsidered, but we have not gotten the congressional letter,” Carreno says.

The DEA said in its notice last month that it believes 15 deaths in the U.S. were associated with kratom. The AKA disputes this and says it hired a toxicologist who reviewed the cases and found that there was no evidence to support the assertion and that most, if not all, of the deaths may have been tied to other drug use.

In addition to the congressional letter, lawyers for the AKA are sending the DEA their own letter on Monday, Ash says, though there are no immediate plans for a lawsuit.

The AKA has received an influx in donations, Ash says, and the Botanical Education Alliance industry group is also working to combat the ban.

Pelosi, son of House Minority Leader Nancy Pelosi, D-Calif., says he’s a volunteer with AKA and that he focuses on the community-organizing aspect of advocacy, rather than lobbying members of Congress. His mother was not among the letter’s signers.

If the ban does take effect, it’s likely to wallop entrepreneurs who have invested hundreds of thousands – or millions – of dollars in the leaf matter, which generally is powderized for use in teas or pills.

Nu Wave Botanicals national sales manager Chris Kratom (a professional rather than legal surname) says he is winding down operations with a business partner. The men operate a warehouse in Utah and two in Texas, he says, and are shipping everything to one of the Texas locations to be cataloged.

Kratom, who primarily wholesales product sourced in Indonesia to other distributors, says he personally has more than $100,000 worth of product that he will be unable to sell. His partner has about $1 million worth of unsold kratom.

That puts the entrepreneurs in a pickle. Two other businesses with similarly large stockpiles are taking the product to Mexico or Canada, where the plant remains legal, Kratom has heard.

But Kratom, whose converts to the product include his Mormon father, currently is leaning toward turning over his supply to the DEA when the ban takes effect. He says he’s in contact with the local DEA office and that it’s his understanding his choices are to incinerate the supply or hand it over.

“I have a family and I don’t have an arrest record. … I’m going to keep it that way,” he says. “We want to work with the DEA so in case the hammer goes down on the 30th we have nothing to raid.”

Kratom says if he gives his product to the DEA he probably can write it off on his taxes and potentially get it back if the DEA decides to delay implementation of the ban. If he took it overseas, he says, he lacks the business connections to sell it and probably would have great difficulty repatriating it if the ban lapses.

“Rumor has it,” he say, “it doesn’t look like they’re actually going to do this on the 30th.”

Though the DEA says publicly it’s standing firm, Ash warns the stakes are high.

“A lot of people say they are scared to death of relapsing without [kratom],” she says. “And if this ban goes through there’s going to be an illicit black market, and who knows what people are going to be putting into this product, so deaths are going to increase by that in itself.”

senior citizen and his wife received flu shots three years ago with a needle at a CVS pharmacy that had been used on another customer, a lawsuit alleges

cvsextracareShocking lawsuit claims flu shot given with needle used on another customer


STATEN ISLAND, N.Y. — A Midland Beach senior citizen and his wife received flu shots three years ago with a needle at a Dongan Hills pharmacy that had been used on another customer, a lawsuit alleges.

Egidio Rasile was told he and his spouse needed to have blood work performed because of the needle’s multiple use in the CVS Pharmacy at 1361 Hylan Blvd., alleges a civil complaint.

Rasile has sued CVS in state Supreme Court, St. George, and seeks unspecified monetary damages.

The complaint, filed last week, alleges he suffered “serious and permanent personal injuries and was required to seek medical treatment.”

The injuries are not specified.

Advance reports indicate Rasile is in his mid-80s.

According to the complaint, Rasile received the flu shot in the pharmacy on Sept. 14, 2013.

Three days later, on Sept. 17, the pharmacy contacted him.

He was advised “the needle used for him and his wife, Josephine Rasile, was used on another customer, and that blood work was necessary,” said the complaint.

The complaint provides no further details on the incident.

Rasile alleges CVS negligently administered the flu vaccine and failed to properly train staff.

The pharmacy also used “unsterilized and unsanitized needles, equipment and tools” and “improper equipment and tools” to administer the vaccination, alleges the complaint.

John M. O’Dowd Jr., Rasile’s lawyer, did not immediately return telephone messages seeking comment on the suit.

Mike DeAngelis, a CVS corporate spokesman, said the company had not been served with suit papers and was unable to comment on the allegations.

However, DeAngelis did say CVS has “stringent processes and procedures in place to ensure that vaccinations are administered safely and accurately.”

DEA official could not explain how the civil forfeitures had happened despite a policy against it

stagecoachWashington County got money from civil forfeitures after all


FORT EDWARD — In the past four years, Washington County has participated in seizing $515,581 from people who were not charged with a crime.

The program, called civil forfeiture, allows law enforcement to seize cash from people who are believed to be using the money illegally, even though there isn’t enough evidence to charge the person with a crime.

The procedure has been highly criticized after some high-profile cases in which law enforcement wrongly seized cash that had been earned legally. New Mexico banned the practice in 2015.

In Washington County, Hartford Supervisor Dana Haff began refusing this year to approve the monthly receipt of forfeiture money unless he was assured that it came only from criminal cases.

Washington County gets a share of the cash seized by the Capital Region Drug Enforcement task force, which generally seizes money that is believed to be used to buy and sell drugs. But task forces throughout the country have been under scrutiny in recent years for seizing cash from people who were never arrested. Those cases, called civil forfeiture, have been questioned by many politicians and activists.

Sheriff Jeff Murphy assured Haff that the office has never, during Murphy’s tenure, accepted money that was not tied to a criminal case. A spokeswoman for the Drug Enforcement Agency, which runs the task force that seizes cash for forfeiture cases, also said the DEA never engages in civil forfeitures.

But The Post-Star filed a Freedom of Information request with the federal government to get the details on every forfeiture for which some cash was shared with Washington County, from 2011 to 2014.

The Freedom of Information request showed that the county benefited financially from three civil forfeitures — in 2012, 2013 and 2014. Murphy did not return calls seeking comment on the news, and a DEA official could not explain how the civil forfeitures had happened despite a policy against it.

In total, Washington County received money from 34 forfeitures cases from 2011 to 2014. Washington County gets to keep only a tiny percentage of the total forfeited amount. In the three civil cases, out of the more than $500,000 seized, the county got to keep $5,242.21.

Haff was incensed by the information.

“This runs counter to what I was led to believe,” he said.

He is adamantly opposed to civil forfeiture, saying that every time law enforcement seizes property from someone, they should also charge that person with a crime.

“I don’t care if it’s one dollar, it’s not right,” he said. “I think it’s against the 4th, 5th and 8th Amendments. Charge ’em and let ’em have their day in court.”

Board of Supervisors Chairman and Argyle Supervisor Bob Henke defended the idea of civil forfeiture, which he used during his career as a state environmental conservation officer, mainly in cases of hunters shooting or trapping animals out of season. Civil forfeiture isn’t inherently wrong, he said, and can be used when it’s not clear who committed the crime.

“It isn’t necessarily indicative it was not criminal,” he said. “If you find a car full of heroin and cash, you’re not necessarily going to have a bad guy to arrest. But you’re not going to just leave it there.”

Henke is concerned by cases in other parts of the state, however, in which police seized cash after routine traffic stops, despite finding no evidence of drugs or other criminal acts.

“In a case where there’s a criminal act, I have no problem with forfeiture,” Henke said. “I think each case bears looking at individually.”

The Post-Star has filed a new Freedom of Information request with the DEA to get court documents on each civil forfeiture.

The Freedom of Information request already fulfilled by the DEA also showed that very few of Washington County’s forfeitures came from criminal forfeiture.

The vast majority were administrative forfeitures, a lesser-known program that allows law enforcement to quickly get approval to keep cash and other property that was seized. The approval comes within weeks, long before the owner faces his or her charges in court.

Owners cannot use a public defender to argue against the forfeiture of their cash. They must hire their own attorney, because property does not have the same rights as a person. Among the many legal rights that do not apply is the right to representation.

According to the federal government, any forfeiture of funds less than $500,000 in a criminal case should be seized as an administrative forfeiture.

If the person is later acquitted or a district attorney decides not to prosecute, the person can go back to court to try to get their property back. But the person must still prove that the property was obtained through “legitimate means,” according to the DEA.

35 AG’s seeking $$$ from pharmas because they have a profitable product ?

pilingon1Virginia Attorney General joins lawsuit to make opioid treatment drug more available



Yesterday it was Minnesota’s AG Is our “FREE MARKET PLACE” under attack by the bureaucracy ?

Today it is Virginia… along with a total of 35 states and DC … at some time.. it is going to become unprofitable to produce a medication/product or line of products and then what are those people who have a medical necessity going to do ? Does this really have something to do with the profits of the company making this company or that the company used existing laws to extend the “profit life” of a product… or that the people using this product is according to our court system in 1917… are CRIMINALS… and the legal profession has a problem with the legal treatment of criminals using controls ?


RICHMOND, Va. (WRIC) — Virginia Attorney General Mark Herring and 35 other attorney generals throughout the country filed an antitrust lawsuit in federal court against the makers of Suboxone.

Suboxone is a prescription drug used to treat opioid addiction.

In the suit, the attorney generals claimed that the companies engaged in a “product hopping scheme,” where small changes were made to the product to block generic competitors and cause purchasers to pay artificially high prices for an important addiction treatment medicine.

Reckitt Benckiser Pharmaceuticals and Indivior are accused of conspiring with MonoSol Rx to switch Suboxone from its tablet version to a film that dissolves in the mouth, with the goal of delaying generic alternatives to maintain monopolistic profits.

The companies are accused of violating state and federal antitrust laws.

Herring said he is participating in the lawsuit because he thinks it will aid in resolving the opioid abuse epidemic.

“For many Virginians struggling with an addiction to heroin and other opioids, Suboxone can be an important part of a treatment plan that allows them to manage their substance abuse disorder,” Herring said. “After extensive investigation, my colleagues and I have reason to believe that these monopoly practices violated the law and made this important medication more expensive and more difficult to obtain.”

Suboxone is a brand-name prescription o buprenorphine and naloxone that is used to treat heroin addiction and other opioid addicitons by easing addiction cravings. No generic alternative for Suboxone film currently exists.

The attorneys general allege that consumers and purchasers have paid artificially high monopoly prices since late 2009 when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion.

The lawsuit, filed in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of violating the federal Sherman Act and state antitrust laws. In the suit, the attorneys general ask the court to stop the companies from engaging in anticompetitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.

Thirty-four additional states and the District of Columbia have joined the lawsuit including Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, and Wisconsin.

The “worse” for chronic pain pts… may still be over the horizon ?

Could Pharmacy Schools Go the Way of Law Schools?


Right now we have a growing surplus of Pharmacists and the average “new grad” is coming out of school with abt $150,000.  Has had been stated before… the majority of Boards of Pharmacy are stacked with non-practicing corporate Pharmacists… so as their chain employer pushes for more authority granted to technicians.. they will either have to agree – as board members… or end up being replaced.. since the board position are generally appointed by the Governor of the state.  Contributions to re-election campaigns can get political favors like the preferred appts to the board of pharmacy. Technicians will have to probably have to rely highly on the pharmacy computer system as to what to do or not do … in regards to filling or not filling prescriptions for pts.  Their education will be at a “lower level” and they will not have – or be able to develop or use – clinical experience to assist the pt. The pharmacy computer will be the final word as it is programmed according to the corporate guidelines… as to what the tech is allowed to do. Throw on top of that dictatorial edicts of the Prescription Benefit Managers (United Health, CVS Health, Express) being the major players as of now.

A recent report by the Clayton Christensen Institute observed the following about the law education climate:

Facing dramatic declines in enrollment, revenue, and student quality at the same time that cost structure continues to rise and public support has waned, law schools are in crises. A key driver of the crises is shrinking employment opportunities for recent graduates, which stem in part from the disruption of the traditional business for provision of legal services. Although this root problem will soon choke off the financial viability of many schools, most law schools remain unable or unwilling to address this existential problem in more than a marginal way, as they instead prefer to maintain the status quo and hope that the job market soon improves.1

Now, I know it’s not politically correct to raise concerns about pharmacy education, but as I read the report on law schools, I couldn’t help but think a similar report could easily be generated about our industry. I’ve heard from faculty in many schools that the quality of applicants seems to be declining, as is the number of applicants. I heard of one school hiring a high-level marketing expert to try to increase its applicant pool to address the problem.
Could there be a bigger issue in pharmacy that increasing applicants won’t correct, at least in the short run? Let me suggest 2.
The current reimbursement model doesn’t pay well for the provision of clinical services that student pharmacists are being trained to do. Not many employers can afford to hire these graduates for these new roles because they aren’t receiving reimbursement for such services. At the same time, the reimbursement for providing dispensing services is also being cut. This is forcing employers to automate as much as possible and find ways to use technicians in greater numbers.
Yes, Board of Pharmacy laws and regulations limit that role now, but will the move by the Pharmacy Technician Certification Board to require formal education for pharmacy technicians by 2020 lead to efforts to use technicians for the dispensing role, thereby putting further pressure on the pharmacist job market? I know that isn’t what most individuals want to think, but the “tech-check-tech” movement suggests it’s as safe as “pharmacist-check-tech” systems. If all pharmacy techs are program graduates, they’ll also put pressure to become recognized and given advanced responsibilities, just as pharmacists have been working to gain their own advanced roles.

Does this suggest pharmacy education needs to change to prepare a different kind of graduate for new roles? I think so. Will we need as many schools to train these new graduates? I don’t think so. It looks to me like we’ll see a major disruption in both pharmacy practice and education over the next 5 years. When that happens, what will happen to those trained and practicing under the old model?
1. Pistone MR, et al. Disrupting law school: how disruptive innovation will revolutionize the legal world. Clayton Christensen Institute website. christenseninstitute.org/publications/disrupting-law-school/. Accessed September 9, 2016. 
– See more at: http://www.pharmacytimes.com/contributor/fred-eckel-rph-ms/2016/09/could-pharmacy-schools-go-the-way-of-law-schools#sthash.md9bnOBK.dpuf

Is our “FREE MARKET PLACE” under attack by the bureaucracy ?

Minnesota Attorney General Lori SwansonMinn. AG sues drug companies over opioid treatment



When “do no harm” flips from pt focused to physician’s livelihood ?

When treating chronic pain, don’t compromise your principles


One of the most difficult things I deal with as a physician is patients’ demands for pain medications. I treat patients with cystic fibrosis, a genetic disease present at birth with no cure, and its issues are indeed complex. There are legitimate causes for misery from the chronic coughing, abdominal pain, and joint pain recognized as common symptoms of the disease.

But the associated issues of depression, stress with family, and money make giving out narcotics problematic. There is also intense pressure on a physician in the CF community, as there is in many other practices, to retain your patients. Having a patient leave you for another provider is painful, and feelings of failure and a sense of letting somebody down pervade.

Treating pain and relieving suffering are an inherent part of what is expected of us as healers. The Hippocratic oath was written in 400 BCE, and is one of the most enduring and momentous codes of ethics ever written. The Yale University version of the Hippocratic Oath explicitly mentions relieving pain and suffering in the third sentence. As gatekeepers of medicine, it is within our power to both give and refuse potent medicines.

My perspective on pain medications is similar to that of many of my colleagues in mid-career. I attended medical school in the 1990s, when the whisper that physicians weren’t treating pain turned into a thunderous roar. Pain became the fifth vital sign, no longer a symptom but something as important to a patient’s life as their heart rate and blood pressure.

Unfortunately, somewhere along the way something bad happened. Really bad. The country got hooked on pain medications. We turned into a nation of pill poppers, and when that got too expensive for people, heroin came back. The stories of drugs ruining people’s lives began to show up not only in arrest reports, but also in obituaries. There was simply too much access to these drugs, and the country was clearly suffering. Many addictions could be traced back to a single prescription for a narcotic for a tooth removal or after a minor surgical procedure.

With the drug overdoses piling up, the medical establishment began to take notice. The pendulum had swung too far to the side of easy narcotic prescriptions. At the same time, data began emerging that opiates were not an effective treatment of chronic pain. We were doing more harm than good with these drugs, and the medical societies began to act. In 2016 the CDC came out with new guidelines highlighting the importance of attempting to limit the use of narcotics for chronic pain.

But making a change in practice patterns overnight is never easy. It is a process. The CDC guidelines were not a recommendation to switch from using one antibiotic to another for a pneumonia, or to use this blood pressure medicine instead of that one because of side effects. These changes got very deep into issues of relieving suffering.

Recently I had struggled with the help versus harm conflict of prescribing opiates these issues. A few of my patients began asking for opiates for their chronic pain, and asking insistently. As usual, their situations were complex. They had real reasons for pain, but mixed up with them were depression, a chronic illness, and sometimes a history of drug abuse. I tried to steer them to non-opiate pain relievers, as well as yoga, exercise, and counseling to help treat them. They looked at me like I had asked them to grow a third eye.

I was confused about my role as healer. Pain has been described as the physical sensation of discomfort, while suffering is the story we tell ourselves about the experience. There was no doubt my patients were suffering, but I wasn’t convinced pain medication was the answer.

I took my concerns to a seminar on the psychological aspects of cystic fibrosis. When it came time for the question-and-answer session, I was ready.

“What should I do when my patients ask me for pain medications, and they aren’t indicated, and I think they’re going to do more harm than good? I’m afraid to lose them to another center, or have them get their meds off the street. Wouldn’t it be better just to treat them in a controlled setting?”

The speaker looked me in the eye. “Michael,” he said, “you simply cannot compromise your principles for fear that somebody is going to reject you or buy illegal drugs off the street.”

He elaborated, but that first statement was all I needed. They were the right words at the right time, and put everything into perspective for me: Decide if you think the medicine is going to do more good than harm. If you don’t think it is, then you simply do not prescribe it. You cannot sacrifice your ethics for fear of rejection, and what that patient decides to do from there is not your responsibility.

Since then, I’ve had patients hate me and leave me. I know most of the time they are going to another provider and getting what they want, or, worse, going to the street to get what they want. Hopefully, sometimes they focus on other ways to ease their chronic pain. And sometimes I’m sure I’m wrong, and with luck, they do find the right practitioner to give them what they need — I’m not a pain doctor.

The elephant in the room is that we don’t have a great answer for the millions of Americans who suffer from chronic pain. It doesn’t seem as if opiates are our answer. I still do prescribe opioids occasionally, but try to keep it short term, constantly evaluating if the patients are more functional or less functional on their medications. But I’ve gotten away from the mindset of prescribing for chronic pain, and psychologically I’m back in line with being able to say no. And with that, I feel like I’m back in line with another part of the Hippocratic Oath: to abstain from doing harm.

Michael J. Stephen is an pulmonary physician and adult program director, cystic fibrosis program, Drexel University College of Medicine. Philadelphia, PA.