Could the first “piece of Sxxt” be heading for “THE FAN ” ?

Shit-Hits-the-Fan_cartoonTrump’s pick for key health post (CMS) known for punitive Medicaid plan

https://www.theguardian.com/us-news/2016/dec/04/seema-verma-trump-centers-medicare-medicaid-cms

Seema Verma, the president-elect’s choice for Centers for Medicare and Medicaid Services administrator, pushed lockout periods for low-income people

 Seema Verma, president and founder of SVC Inc, gets into an elevator as she arrives at Trump Tower last month.
Seema Verma, president and founder of SVC Inc, gets into an elevator as she arrives at Trump Tower last month. Photograph: Drew Angerer/Getty Images

A close adviser to vice-president-elect Mike Pence, Verma – Trump’s nominee for administrator of the Centers for Medicare and Medicaid Services (CMS) – made her name devising Indiana’s Medicaid plan, one of the most punitive in the country.

Medicaid is a public health program that ensures America’s poor and disabled have health insurance. Obamacare dramatically expanded the program, which now serves more than 73 million people.

The unique requirements Verma and her consultancy firm SVC Inc   http://www.svcinc.org/  designed for Indiana require that the destitute in that state have “skin in the game” by paying “premiums”, even if they were just $1.

In Ohio, a plan designed by Verma’s company and rejected by the current leaders of CMS required people with low incomes to be barred from public health insurance until all “premium” arrears were up to date.

Her plans were “about saving the dollars by any means possible”, said Indiana Representative Charlie Brown, the ranking Democrat on the public health committee.

As a consultant in each state, Verma was the driving force in designing Indiana’s “HIP 2.0” public insurance plan for the poor, and is highly regarded in conservative circles because of its emphasis on personal and fiscal “responsibility”.

Though her plan expanded Medicaid to nearly 400,000 Hoosiers, she has argued that new recipients are “able-bodied” enough to not need “the same set of policy protections” as the “aged, blind, or disabled”. Instead, Verma’s plan forces recipients to pay up to 2% of their income to “premiums”, held in a system similar to tax-free accounts available to commercial plans.

It is a plan meant to mimic the commercial market, as a financial lesson for its recipients. It remains one of the most complex and punitive Medicaid expansions in the country, an outlier in a system of state-run safety nets largely free for the poor.

Further, it is built on the back of the Affordable Care Act, a law that her potential future boss, Congressman Tom Price, explicitly opposes. Trump has nominated Price to be health secretary.

She is often described as a behind-the-scenes Republican operative. Regarded as smart and talented, she is also considered single-minded and conservative. She is a registered Republican, and recently agreed to participate in the “leadership network” of the American Enterprise Institute, a rightwing thinktank.

Her father, Jugal Verma, 77, described her as someone with “passion” for her work, and sympathy for the poor. Each morning on her way to work, he said, she pulled her car to the side of the road to hand the same homeless man cash. “It used to amaze me,” he said.

“She grew up in a Democratic household. I am a staunch Democrat,” said Jugal Verma, discussing his daughter’s work in the deeply conservative Pence administration. “She doesn’t do anything if she doesn’t believe in it.”

Tom Price is poised to be the next US health secretary.
Tom Price is poised to be the next US health secretary. Photograph: Jim Lo Scalzo/EPA

She and Price, if he is confirmed by the Senate, will be charged with helming a more than $1.1tn budget dominated by public health programs for the very poor, disabled and elderly. Medicaid alone covers more than 73 million Americans, nearly one-quarter of the American population. Neither Verma nor a Pence spokesman replied to a request for comment.

Verma’s best known work used a little-known provision of federal health law to push conservative ideas through despite the Obama administration. The strategy made her an influential consultant to Republican state administrations.

In Indiana, for example, some of the most controversial provisions of the state’s law were pushed through using this obscure 1115, or “eleven-fifteen”, waiver. While Obama’s administrator of the Centers for Medicare and Medicaid Services did not approve all of Verma’s plans – a punitive provision developed with Ohio was denied – some were successful. Others are still pending the approval of an agency she may soon run.

“One example of a provision in Indiana, which I think is very severe, burdensome, and in fact does not promote the objectives of the Medicaid program, [is] if someone [can’t pay premiums], they get kicked off the program,” said Andrea Callow, a policy analyst at Families USA, a not-for-profit organization focused on consumer health.

Premiums are typical of commercial insurance plans – they require beneficiaries to make a monthly payment. But Medicaid recipients typically do not pay premiums because their incomes are so low. The Medicaid expansion carried out under Obamacare allows people to earn a salary of about 138% of the poverty level, about $16,000 for an individual, and remain eligible.

In Indiana, if people on Medicaid earning between $11,000 and $16,000 don’t pay their “premiums”, they can be locked out of the program for up to six months, a provision even commercial insurance does not impose.

“If someone can’t scrape up the money for premiums for two months, they get dis-enrolled, and they get locked out for six months,” said Kallow. “Then say they get cancer, they get hit by a truck, they have an accident. They have absolutely no place to turn for health coverage.”

Kentucky’s 1115 waiver, on which Verma’s company SVC also consulted, proved equally complex and even more controversial. The state asked CMS to allow Kentucky to impose work requirements beginning three months after benefits began, something no state in the country requires as a condition of Medicaid.

“Kentucky’s new expansion proposal has work requirements,” said Kallow, “There’s even sort of unpaid community service, which is very troubling.”

After three months, “able-bodied” adults of working age would need to participate in a “work activity” for at least five hours per week. After one year, that requirement would increase to up to 20 hours per week. If that requirement were not met, the state could end the person’s benefits.

“There seemed to be a paralysis of analysis as it relates to the downtrodden, those who are in the greatest needs,” said Brown.

During a public comment period on Kentucky’s 1115 waiver, 90% of the 1,700 comments received were negative. Analysts also contend that such requirements mean building a new, large bureaucracy just to track whether Medicaid beneficiaries are complying.

“I have no problem with the personal responsibility features to the extent that they improve outcomes,” said Ed Clere, former Republican chair of the Indiana House public health committee. “One of the big questions going forward, both for Indiana and now for the country, will be: is there a link between these personal responsibility features in the way of financial participation and improved healthy outcomes?

“I haven’t seen any evidence.”

However, even critics said portions of the plan designed by Verma improved services. The fact that a voluntary, Obamacare-sponsored Medicaid expansion took place at all in Indiana, a deep red state, had a huge impact in the eyes of many serving poor patients there. Another 19 states still have not expanded Medicaid, even though Obamacare pays for 90% of expansions.

“I have insurance, my child is sick, I take her to the doctor,” said Lauren Lamb, outreach coordinator at a chain of north-west Indiana health clinics, HealthLinc. “I don’t think about it, but when you see people that don’t have that coverage … they worry if their kid is sick, if they can even take them to the doctor.”

The change, Lamb said, comes when patients realize they are eligible for health insurance they can afford.

“You see them, and they leave, and they’ve got tears in their eyes, because they can’t believe how lucky they feel that day. It just sits in your heart.”

Free Event to Answer Insurance related Questions

Free Event to Answer Pain Related Insurance QuestionsFree Event to Answer Insurance Related  Questions

LiveSupportgroup.com is hosting a free event on Monday, the 5th of December at 8:00 PM est, to answer questions and educate the members on insurance for 2017…

The group will have a licensed insurance agent on hand to answer insurance questions ranging on “Everything from policies on Medicare/Medicaid/Obamacare, understanding prescription plans etc.  This also includes private insurance also, and ‘what if you have both’ – cost factors / how to save, etc.”

The agent can also provide a number for people to call in their various states, and it should be known that the cost of getting private help is completely free.

 

According to the group, if anyone has a questions that the specialist does not know, she will personally get back to the group with the answers.

You do have to sign up in order to be able to access the group – and that is free, as well.

Here’s what they shared with us about how to sign up in advance of the Monday event:

  1. To attend, please join livesupportgroup.com on our main website at www.livesupportgroup.com.  We ask for first name, last initial and a current email address, that’s all!  Once you join, please go to your email and confirm your free membership.  Just an FYI – LSG does not allow any 2nd/3rd party advertising to your emails and the site is SSL secured!
  2. Please make sure you sign up as soon as possible so that you can receive your personal link in time for the event. If you join last minute, you may not be able to get the link in time.

Live Support Group is a non-profit corporation which has created an online support group for chronic pain patients that has begun to attract a wide audience. 

Why buy Naloxone.. when you are going to end up in ER anyway ?

Few are buying non-prescription naloxone at pharmacies

http://www.mansfieldnewsjournal.com/story/news/local/2016/12/03/few-buying-non-prescription-naloxone-pharmacies/94686092/

Eighteen Richland County pharmacies started selling naloxone without a prescription this year, but few residents apparently are purchasing the opioid overdose-reversal medication.

In fact, at the five local pharmacies willing to discuss the specifics of their naloxone sales, no doses of the drug have been sold over the counter without a prescription.

Pharmacists and public health officials say a combination of a lack of awareness, the stigma surrounding drug addiction, the high cost for consumers without insurance and the preventative nature of the drug account for the lack of sales.

Naloxone, sold under the brand names Narcan and Evzio, blocks the effects of prescription opioids, heroin and fentanyl on the brain and reverses an overdose. It has become the primary tool in fighting the epidemic of opiate overdoses.

Jay Fordyce, a pharmacist with Discount Drug Mart in Shelby, said he believes the lack of sales could be due to a lack of awareness, with the public not realizing they now can walk into a pharmacy and purchase the drug without a prescription.

“I don’t know if people are afraid to come up to the pharmacy and ask for naloxone or what,” he said. “I think people just don’t know about it.”

The Shelby store keeps one box of the drug in stock, containing two nasal pumps.

Chris Peshek, a regional pharmacy supervisor with Discount Drug Mart, said the Discount Drug Mart stores on Briggs Drive in Mansfield and Mansfield Avenue in Shelby have not sold any doses of naloxone since the chain started doing so in April.

He said it could be related to the sense of shame that can surround drug addiction.

“It keeps coming back to that stigma of not wanting to admit you have a problem or not wanting to get help for the problem because you’re afraid that somebody’s going to find out,” he said. “Because of that really strong stigma associated with drug addiction, people don’t want to be seen walking into a drugstore to buy naloxone.”

Three-quarters of the 24  pharmacies in Richland County sell naloxone — four CVS pharmacies, two Discount Drug Mart pharmacies, three Kroger pharmacies, one Meijer pharmacy, five Rite Aid pharmacies and three Walgreens pharmacies.

Map of drug stores selling naloxone

Twelve of the pharmacies are in Mansfield, three are in Ontario, two are in Shelby and one is in Lexington.

CVS, Meijer, Rite Aid and Walgreens declined to share their sales numbers, citing corporate privacy policies.

Similar to Discount Drug Mart’s lack of sales, the three local Kroger pharmacies have not sold any naloxone doses, according to Jennifer Jarrell, a Kroger media relations representative. The Kroger pharmacies on Park Avenue West, Ashland Road and Lexington Avenue, all in Mansfield, have been selling naloxone over the counter since February.

Costs range from $40-$145 a dose

Cost could be another prohibitive factor for buying naloxone at pharmacies.

A two-pack dose sells for about $40 at Meijer and $136 at Walgreens. A single dose of the drug is $45 at Kroger and up to $140 at Rite Aid and $145 at CVS. When it’s bought as a preventative measure, it can be difficult to rationalize spending that much money on it, pharmacists say.

Fordyce has customers come in interested in purchasing naloxone, but no one’s bought any from him yet.

“I guess he decided he didn’t need it that bad,” Fordyce said of a man who came in to buy naloxone but who walked away when he found it it was $75 to $80 per single dose at Discount Drug Mart.

But patients with insurance usually pay a maximum of about $10 out-of-pocket, Peshek said.

Fordyce said the pharmacy bills the insurance of the person buying the drug, not the person who uses it.

“I would encourage people first thing to the call their prescription insurance and ask if they cover (naloxone) and what their co-pay would be,” Fordyce said.

The nature of naloxone’s preventative nature also could be a prohibitive factor. People who can stop an overdose have to prepare in advance to help a loved one who overdoses in the future.

“You have to be thinking way ahead,” Peshek said. “You need it right away, so you’re just going to go to the hospital or ER.”

Fordyce emphasized people who are overdosing still need medical attention, even if they get a dose of naloxone.

The effects of opioids can last between six and 12 hours, but naloxone wears off in 20 to 30 minutes.

“This is just the first step if there’s an overdose,” he said. “You should still call 911 or go to the hospital. Odds are, they’re going to need more (naloxone).”

Legislature passed bill unanimously

Ohio Gov. John Kasich signed House Bill 4 into law in July 2015 to allow pharmacists to dispense naloxone without a prescription to at-risk opioid users and those who can intervene during overdoses, such as family members, friends or roommates. The bill had passed both the Ohio House and Senate unanimously.

“For friends and family members, pharmacies play a unique role,” said Cameron McNamee, director of policy and communications for the State of Ohio Board of Pharmacy. “If you have an active opioid user in your family and they feel like they’re not ready to get help yet, getting naloxone from a pharmacy is one of the best things you can do to get a little bit of peace of mind.”

Previously, pharmacies could not sell the drug without a prescription from a doctor.

Nearly 1,400 pharmacies, or 65 percent of all Ohio retail pharmacies, in 84 of Ohio’s 88 counties sell naloxone without a prescription as of the end of November.

Holmes, Morgan, Noble and Vinton counties do not have any pharmacies selling naloxone.

Not many other alternatives

Currently, the only other way to receive naloxone is from first responders or high-risk agencies, such as hospitals or mental health agencies.

Richland Public Health started providing naloxone kits to first responders and their high-risk contacts in February with funding from the Ohio Department of Health.

The kits, known as Project DAWN kits, come with two pocket masks, two atomizers, two two-milliliter syringes and two milligrams of naloxone.

Project DAWN, which stands for “deaths avoided with naloxone,” is an Ohio community-based overdose education and naloxone distribution program.

The first site was created in Portsmouth in 2012.

First responders administer naloxone if they believe someone has overdosed or if they observe symptoms such as blue or gray skin, sweating, unresponsiveness, absent or shallow breathing, absent or shallow pulse or pinpoint pupils, said Keith Evans, public health nursing supervisor with Richland Public Health.

It can be administered via intravenous (through the veins), intraosseous (into the bone marrow) or intranasal (in the nose) methods, Evans said.

Richland Public Health has provided 30 to 40 kits to first responders since January.

But the organization started discussions with the Ohio Department of Health in October to receive shipments of naloxone kits available to the public.

“Like any disease, if you get rid of that disease, then you can start the healing process,” Evans said. “Easier said than done to eliminate the product from the community.”

There are more than 50 Project DAWN naloxone distribution and training sites across Ohio, where members of the public can receive naloxone kits and training on how to administer the drug, but there are none in Richland County.

“When I see things like that where the county has a drug problem and then I also see that same county doesn’t have a Project DAWN, it always kind of makes me scratch my head,” Peshek said.

55 overdose deaths in 2016

So far in 2016, there have been 55 drug overdose deaths in Richland County, according to the Richland County Opiate Board’s Keith Porch, who is assistant police chief with the Mansfield Police Department.

Richland County has seen an increase in the number of overdose deaths since 2012, when there were seven overdose deaths.

In 2013, there were 22 deaths, in 2014, there were 25 deaths and in 2015, there were 42 deaths.

ejmills@mansfieldnewsjournal.com

419-521-7205

Oregonian Turns To Heroin For Pain Relief After Opioid Prescription Cut

Oregonian Turns To Heroin For Pain Relief After Opioid Prescription Cut

http://www.opb.org/news/article/oregon-heroin-opioid-prescription-addiction-treatment/

John lives in his truck and takes heroin to deal with his chronic pain. “It’s a really upsetting story and one thing that’s so upsetting about it, is that it’s actually quite common,” said neurologis Dr. Eve Klein.  
John lives in his truck and takes heroin to deal with his chronic pain. “It’s a really upsetting story and one thing that’s so upsetting about it, is that it’s actually quite common,” said neurologis Dr. Eve Klein.

 

 

Every year more than 500 Oregonians overdose and die on painkillers. As a result, Oregon doctors are reducing prescriptions dramatically. In this three-part series, OPB’s Kristian Foden-Vencil looks at new approaches to the state’s opioid epidemic. Read more: Part 1 | Part 2 | Part 3

John is a carpenter, OPB is only using his first name for reasons that’ll become clear in this story.

John grew up in southern Oregon and for 20 years had a successful business installing kitchens. Then, in 2005, he was in a car crash. “I mean, fractured my neck, fractured my back. I had to have my right shoulder replaced,” he said.

John was prescribed opioids to deal with the pain.

“After about four years I was on 160 milligrams of oxycontin … and then it was 56 milligrams of oxycodone and that went on for maybe four years.”

Today, he’s a mess. He lives in his pick-up truck and is in constant pain.

Without pain killers he said, he misses work. Which is why he was alarmed recently when his doctor — following new state guidelines — started reducing his dosage.

“The first thing he did was cut me back by a full one-third,” he said. “It became an argument with him. Two months later, he cuts me back by another full third,” he said.

John concedes he was using too many opioids — but points out it was all legal and under a doctor’s supervision. He said tapering off the drugs left him with terrible pain in his neck and back.

“Your body becomes so jittery and moving around. And just, I mean there’s no place of comfort,” he said. “I mean it’s torture.”

John said he stuck with the low doses for seven weeks, then decided to visit Old Town Portland to buy heroin.

He was incarcerated for cocaine use in the 1980s, which is how he knew where to go for illegal drugs. He said he turned to heroin because he had to have something to deal with his chronic pain.

He didn’t want to inject it, so his solution was to cook the heroin in tin-foil with a lighter — like he’d seen others do — then inhale the fumes.

“But most of the drug just goes up in smoke. So the next time I went to this dealer, I said, ‘Well, how do you do it?’ And he said, ‘Well, I snort it.’ And I said, ‘Well this is black tar, how do you snort it?’ And he said, ‘Oh! You cook it and you put it in a needle except you take the needle off and you shoot it up your nose and snort it,’” explained John.
 
John said he understands the need to crack down on opioids. He knows more than 28,000 Americans overdose and die abusing the drugs every year. But, he said, acupuncture and physical therapy just don’t give him much relief.

“It’s a really upsetting story and one thing that’s so upsetting about it is that it’s actually quite common,” said Dr. Eve Klein, a neurologist working on pain management. She said when somebody’s been on opioids so long, tapering often doesn’t work. She hasn’t met John but thinks he should probably go to a methadone clinic.

“And then once he’s on something like methadone and he’s stable and he’s out of that rat race of needing heroin every six hours. Then he can start looking into things like, ‘OK, what am I going to do about pain management now?,’” she said.

Congress just passed a bill to reduce opioid addiction. Democratic Oregon Sen. Ron Wyden voted for it, but said it’s only a “half measure.” He’s said more legal options for dealing with pain are needed, “If all you do is restrict choices to medication, the addiction does not vanish magically. You’ve got to have prevention and treatment.”

Meanwhile, John lives in his truck and seeks relief where he can. He’s terrified of the traffic stop that could land him in jail.

 

A Portland pain management program that doesn’t use opioids is showing success, according to a new report.

The Quest Center started working with FamilyCare 18 months ago — one of the state’s largest Coordinated Care Organizations.

Instead of opioids, the center helps patients deal with pain using acupuncture, massage, meditation and other alternative treatments.

Dr. David Eisen said a six month study showed 80 percent of patients reported less pain on average. “Seventy five percent reported an increase[d] ability to do normal work. And that’s huge,” she said. “Washing yourself, cleaning your house, being able to lift, bend and stoop. If people can resume activities of daily living, their life becomes much better.”

An average of 78 Americans die every day from opioid abuse — at least half get the drugs from a prescription.

 

Start collecting your documentation

paulaIn SEVEN WEEKS we will have a NEW PRESIDENT along with a whole new Cabinet members and other new people in very important positions, many who have the ability to have positive or negative influence/impact on the chronic pain community.

Hopefully, this new administration will take a different approach of enforcing the Americans with Disability Act and denial of care and those on Medicare/Medicaid/Medicare Advantage program that they will recognize similar denial and sub-par treatment of chronic pain pts.

Here is where you can file a complaint of ADA violations https://www.ada.gov/filing_complaint.htm

Here is the website of Center Medicare/Medicaid Services (www.cms.gov) 800-MEDICARE

Health and Human Services has a on line complaint form http://www.hhs.gov/civil-rights/filing-a-complaint/complaint-process/index.html

Everyone needs to get motivated to file complaints/violations of existing laws/rules/regulations, once these new bureaucrats are in place. The bureaucrats are routinely told that there are some 100 + million chronic pain pts… when they only get a few dozen complaints… they will – most likely – ask “where is the problem” ??

There can’t be much of a problem… if only a few dozen people are being compromised enough to take action… THERE REALLY IS NO PROBLEM !!!

Our new President will be sworn in Jan 20,2017… which is a FRIDAY… you want change… you want to make a impact… flood their emails, faxes, Facebook, Twitter accounts and start filing complaints with the above agencies on Monday  Jan 23, 2017… as the new administration comes to power.

If the vast majority of chronic painers chose to do little/nothing at this point in time… the likelihood of things improving for the chronic pain community will be between SLIM and NONE !

 

 

 

One good thing: with Ken Mc Kim.. HEART OF GOLD

Mayor defends plan for tax-funded heroin injection center

$750 life-saving drug recreated by high school students for $2

Martin Shkreli’s $750 life-saving drug recreated by high school students for $2

http://www.ctvnews.ca/health/martin-shkreli-s-750-life-saving-drug-recreated-by-high-school-students-for-2-1.3185163#_gus&_gucid=&_gup=GSEmail&_gsc=u38DMmS

Remember Martin Shkreli? He’s the so-called “pharma bro” who was dubbed “the world’s most hated man,” and a symbol of corporate greed, when he hiked the price of a life-saving drug from US$13.50 to $750 per tablet after his company Turing Pharmaceuticals acquired rights to the drug in 2015.

Now, the former CEO and hedge fund manager is responding to claims that he’s been “shown up” by a group of high school students in Australia. The Sydney Grammar School students managed to recreate the active ingredient in the anti-parasitic drug Daraprim for a fraction of the price Shkreli’s company charges.

The teenagers produced 3.7 grams of the key ingredient, pyrimethamine, in their high school chemistry lab for only AU$20, which works out to AU$2 per pill. Daraprim is used to treat infections such as malaria and toxoplasmosis, particularly in patients with weakened immune systems, such as those living with HIV, undergoing chemotherapy or pregnant women. The drug is listed on the World Health Organization’s list of essential medicines.

According to the Sydney Morning Herald, the students began working on the project as part of an after-school program under the guidance of Alice Williamson, a chemist at the University of Sydney, and the school’s Open Source Malaria Consortium, which is an online research-sharing platform. They were tasked with using publicly available ingredients to treat malaria.

A couple of the students involved in the experiment told the Australian newspaper that the controversy surrounding Shkreli and the drug made the project more engaging.

“Working on a real-world problem definitely made us more enthusiastic,” Austin Zhang, 17, said.

Another member of the team, 17-year-old James Wood agreed.

“The background to this made it seem more important,” Wood said.

Williamson said the Sydney Grammar School students were also outraged by the Shkreli scandal, which motivated them to focus on synthesizing the important drug. The teenagers said they participated in the year-long venture to highlight Turing Pharmaceutical’s inflated price of US$750 per Daraprim tablet. In most countries, the drug is sold for approximately $1 to $2 per tablet.

The teenagers said their goal isn’t to sell the drug, but to inspire other manufacturers to use their inexpensive method. The details of the student’s experiment have been published online.

The students’ story has attracted international attention, which prompted countless social media users to heckle Shkreli about it online.

So how has the man who once spent US$2 million on the lone copy of a Wu-Tang Clan album responded to the students’ project? Shkreli took to Twitter on Wednesday to dismiss the significance of the achievement and laugh off the mocking comments directed at him.

Will FACTS matter to the DEA about KRATOM scheduling ?

American Kratom Association: Major New Analysis Shows No Basis For DEA To Restrict Herb Kratom

Expert Finds Potential for Abuse May Be As Low As Such Unrestricted Substances as “Nutmeg and St. John’s Wort”

http://www.prnewswire.com/news-releases/american-kratom-association-major-new-analysis-shows-no-basis-for-dea-to-restrict-herb-kratom-300371521.html

WASHINGTON, Dec. 1, 2016 /PRNewswire-USNewswire/ — A long-awaited analysis by one of the world’s leading experts on drug abuse and addiction concludes that there is “insufficient evidence” for the U.S. Drug Enforcement Administration (DEA) to ban or otherwise restrict the coffee-like herb kratom under the Controlled Substances Act.  According to the comprehensive analysis, kratom has little potential for abuse and dependence – as low or lower than such widely used and unscheduled substances as “nutmeg, hops, St. John’s Wort, chamomile, guarana, and kola nut.”  

In preparing the report for the American Kratom Association (AKA), Dr. Jack Henningfield, Ph.D., vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, concludes: “Kratom has a low potential for abuse and a low dependence liability and there is insufficient evidence of personal harm, adverse health effects or detriment to the public health to warrant control under the [Controlled Substances Act] . . . Appropriate regulation of kratom under the [Food, Drug, and Cosmetic Act] is the most effective way to protect the public health by ensuring appropriate access and oversight and to sustain the overall very low adverse personal and public health effects associated with kratom consumption.”

Dr. Henningfield previously served as chief of the Clinical Pharmacology Research Branch of the National Institutes of Health’s National Institute on Drug Abuse (NIDA), and is currently an adjunct professor of Behavioral Biology in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. 

A DEA comment period on kratom closes at 12:59 p.m. EST tonight.  AKA has filed its comment letter (http://bit.ly/akacomments), including the Henningfield analysis (http://bit.ly/Henningfieldreport), in the DEA public docket. 

The AKA comment letter to the DEA notes: “[K]ratom does not meet the criteria for permanent scheduling under the CSA – under schedule I or any other schedule – and DEA cannot satisfy the legal requirements for use of the emergency scheduling provision of the CSA to temporarily schedule kratom.  Scheduling kratom under the CSA would divert government resources from more critical initiatives, have a significant negative impact on a substantial number of small businesses and consumers who choose to use kratom products safely and responsibly, yet yield no positive impact on the public health.”

The letter continues: “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.  Kratom’s profile also resembles that of various botanical dietary supplements such as chamomile, lavender, St. John’s Wort, kava, and hops. “

Commenting on the Henningfield analysis, Susan Ash, founder, American Kratom Association, said: “Kratom is a natural botanical product consumed by millions of Americans daily.  Like caffeine, when used responsibly, kratom is enjoyable, safe, rarely associated with any serious adverse effects, and not prone to abuse.  Kratom simply does not pose an imminent threat to the public health.  Rather, kratom is more reasonably characterized as a dietary supplement, and could be ably regulated as such by FDA.  Through that regulatory framework, manufacturers and distributors of kratom could be held accountable for the safety and labeling of their products, while ensuring continued access to Americans who consume them.  We believe such an approach would represent a much more efficient use of governmental resources than the scheduling process could provide.”

The AKA comment concludes that singling out kratom for scheduling would be inconsistent with federal handling of other supplements:  “For example, the botanical substances St. John’s Wort, Valerian, and Kava Kava are known to have reinforcing effects and to act as sedatives, and have been the subject of hundreds or thousands of calls to Poison Control Centers.  Yet, these substances have not been scheduled, but have been regulated as dietary supplements.  The same is true for guarana and kola nut, which also have certain characteristics of a drug of abuse.  Yohimbine, the primary component of yohimbe extract, is an indole-containing alkaloid that is structurally similar to [the active ingredient in kratom], yet yohimbe is available in the U.S. as a dietary supplement …None of these botanical substances is scheduled, despite sharing some characteristics with controlled substances; rather, all of them are adequately regulated by FDA through existing authority.  Kratom, with a comparable or lower potential for abuse than these substances, would likewise be best regulated” by the FDA.

In the United States, there have been few reported serious side effects associated with kratom use and no reported deaths directly attributable to the substance.  There have been no deaths, serious adverse effects, or emergency department visits reported for children.  The relative safety of kratom is consistent with several key clinical and pharmacologic properties of the substance, including its low toxicity, extremely low bioavailability (absorption into the body), and its blocking of opioid receptors that limit the possible euphoric effect and substantially reduces the risk of respiratory depression.   

Dr. Henningfield and his PinneyAssociates colleagues conducted a comprehensive review of publicly available data on the same eight factors indicative of control that the DEA and FDA will weigh in deciding if and where to control kratom:

(1)   Its actual or relative potential for abuse.

(2)   Scientific evidence of its pharmacological effect, if known.

(3)   The state of current scientific knowledge regarding the drug or other substance.

(4)   Its history and current pattern of abuse.

(5)   The scope, duration, and significance of abuse.

(6)   What, if any, risk there is to the public health.

(7)   Its psychic or physiological dependence liability.

(8)   Whether the substance is an immediate precursor of a substance already controlled through the CSA.

ABOUT AKA

The America Kratom Association, a consumer-based non-profit organization, is here to set the record straight, giving voice to those suffering and protecting our rights to possess and consume kratom. AKA represents tens of thousands of Americans, each of whom have a unique story to tell about the virtues of kratom and its positive effects on their lives. www.americankratom.org

 

Americans may have faced widespread privacy violations by the DEA… consequences to those in the DEA ?

DEA Paid Millions To Volunteers Searching Americans’ Luggage, Mail

Investigators told Congress on Wednesday that agency paid out almost a quarter of a billion dollars over five years, but can’t say exactly what it got back or how many people had their privacy breached.

https://www.buzzfeed.com/paulmcleod/dea-paid-millions-to-volunteers-searching-americans-luggage?

WASHINGTON — Americans may have faced widespread privacy violations as outsourced government spies rooted through their luggage or mail looking for evidence to give to the Drug Enforcement Administration in exchange for cash rewards, a House committee heard Wednesday.

For a federal agency to snoop through the belongings of private citizens could be a Fourth Amendment breach. But the Justice Department says that the DEA allowed for exactly that behavior by recruiting and paying millions of dollars to “voluntary” sources working at Amtrak, airlines and parcel companies.

“If you incentivize an Amtrak employee or an airplane employee or a cargo company employee [to seize shipments of money for a reward], how many boxes are they opening? How many passenger manifests are they providing? How many people are getting pulled out of line to find the person or persons where a seizure results in a reward?” Department of Justice Inspector General Michael Horowitz told the House Oversight and Government Reform Committee.

Department of Justice investigators spent two and a half years investigating the DEA’s confidential source program and released their findings in September. They uncovered a system rife with problems.

In one case, a DEA source working for a package company would rummage through private mail in the hopes of finding bundles of cash he could turn in for reward money.

In other cases, TSA employees working the X-ray machines at travel screening points would tip off the DEA about suspicious packages for cash, rather than report to their own superiors.

It was all part of a program of what the DEA terms “limited use” confidential sources. In theory, these were tipsters who voluntarily handed information over to the DEA.

But in practice, federal investigators found that these sources had become a de facto arm of the agency. The informants did repeat business, were well-compensated, and took direction from the DEA on what information to pass on.

In some cases they made more money from the DEA than they did from their day jobs. Investigators found that one airline employee made $600,000 in four years while a parcel company employee was paid over $1 million across five years.

And yet, the DEA did not keep full records of what they got from the program. While successes were logged, false searches and bad information was not.

The use of the program was widespread in the DEA. According to the federal investigation report, the DEA handed out $237 million to about 10,000 confidential sources over the five years, from 2011 to 2015. This includes $27 million to 477 “limited use” informants.

Yet, the DEA cannot conclusively say what it got in return.

“They did not keep records on what the overall success rate was. We don’t know, for example, whether they were batting 1.000 or batting .050. That’s a concern,” Horowitz told the Oversight Committee.

In some cases, DEA agents extended health insurance benefits for federal employees to their sources. Investigators said they did not know whether the DEA was legally allowed to do so.

In response to grilling from members of Congress on Tuesday, DEA Chief of inspections Rob Patterson told the House Oversight Committee that the agency is enacting a long list of reforms to fix the system.

Patterson said one problem was that the essentially everyone in a position of leadership in the DEA’s inspection division was working in temporary roles. He said those positions have since been staffed permanently.

The DEA no longer makes payments to government or quasi-government employees, Patterson said. He added they have enacted new reviews on the limited use informant program, and are working to improve their data recording system.

Horowitz said that under former DEA head Michele Leonhart’s tenure the DEA was hostile to investigators and continually threw up roadblocks. (Leonhart resigned in 2015 in the wake of revelations that DEA agents were sleeping with their sources and providing them six-figure payments of taxpayer money).

Horowitz said that in the 18 months since her departure, however, there has been a complete turnaround and that the DEA has cooperated with their audits completely.

Members of Congress on Tuesday were frequently frustrated by the lack of information available.

“Are there any metrics on convictions, drug seizures? Like, what did we get for $237 million?” asked Oversight Committee chairman Jason Chaffetz.

But Patterson was only able to say that the DEA is working to be able to answer those questions in the future.

“We are working on properly staffing and reviewing a number of these issues at the headquarters level, making sure that the data getting into our system is proper,” he said.