former FDA commissioner – we only need enough opiates to treat acute pain and cancer pain

A huge step backward on opioids

https://www.cnn.com/2018/01/24/opinions/opioid-health-prison-opinion-collins/index.html

How to fix the opioid crisis 04:51

Michael Collins is the deputy director of Drug Policy Alliance‘s Office of National Affairs, an organization that advocates to end the war on drugs. The views expressed in this commentary are his own.

(CNN)The latest statistics on the overdose crisis — roughly 64,000 deaths in the United States in 2016 — also reveal that fentanyl and other synthetic opioids are now the driving force behind US overdose deaths. Fentanyl is an opioid estimated to be 50 to 100 times more powerful than morphine, and it’s often added to heroin to increase its potency.

Sadly, just as a bipartisan consensus was emerging that a punitive approach to drugs was not the way forward, lawmakers are responding to fentanyl by prioritizing prison over public health and embracing discredited drug war policies proven to make the crisis worse.
Michael Collins

 
In the last two years, 25 states have passed legislation to increase fentanyl-related penalties. At the federal level, there have been several proposals to increase mandatory minimum sentences and even give the death penalty for selling fentanyl. And, in November, Attorney General Jeff Sessions announced a measure to make it easier to prosecute synthetic opioid cases.
Oddly enough, some of the harshest measures have been passed in states that had been making considerable progress in scaling back the drug war and mass incarceration.
In Maryland, in 2016, the governor signed a sweeping package of criminal justice reforms that reduced sentences for drug offenses. Some advocates suggested that the bill’s passage “put Maryland at the forefront of states that are adopting major criminal justice reform.” Yet just one year later the same state passed a bill with a 10-year sentencing enhancement for anyone caught selling fentanyl and its analogues.
Similarly, Kentucky Gov. Matt Bevin signed re-entry and recidivism measures into law in the summer of 2017. He subsequently took to the pages of The Washington Times to tell federal leaders that the “practice of ‘lock ’em up and throw away the key’ in our criminal justice system is an approach whose shot at effectiveness has run its course.” That same summer, Bevin signed a bill that makes the sale of any amount of fentanyl punishable by between five and 10 years in prison.
Other punitive drug war measures as a response to fentanyl have proliferated. A recent report by the Drug Policy Alliance — an organization working to end the war on drugs — noted a rise in drug-induced homicide prosecutions, where individuals are charged with murder or manslaughter when drugs they sell (or even share or give away) lead to an overdose death. Currently, 20 states have such a law. And elsewhere, the rise in fentanyl-related deaths has led lawmakers to pass involuntary commitment laws, where people who use drugs are held against their will in treatment facilities, often in prison-like conditions — and for up to 90 days in some states.
Just as media hysteria drove draconian responses to crack cocaine in the 1980s, there is a similar frenzy around fentanyl today. News stories commonly indulge in hyperbole, with wildly inaccurate tales of police officers overdosing from touching fentanyl, funeral directors unable to handle bodies of fentanyl overdose victims, the arrival of fentanyl-laced marijuana and warnings to wear gloves when handling shopping carts in communities where fentanyl use is prevalent.
It is essential that policymakers, journalists and the public understand a few critical points about this oft-misunderstood crisis.
US and Canadian authorities agree that fentanyl is usually produced and added to heroin outside the United States, so it makes little sense to punish people inside the country for its inclusion. And sellers are often unaware of the composition and potency of the drugs they distribute. An individual may believe he is selling heroin but may be prosecuted for selling heroin and fentanyl and given a stiffer sentence.
People who sell drugs are often drug users. Politicians may intend to target “kingpins” with these proposals, but these laws typically end up targeting people who sell small amounts of drugs simply to fund their addiction. As Maryland public defender Kelly Casper points out, “These aren’t two distinct sets of people. … They want to charge all of these people with drug dealing, when in fact the core of the problem is that they’re users.”
Making matters worse, drug sentences disproportionately affect people of color, even though whites reportedly are more likely to sell drugs, and there is no reason to believe harsh fentanyl penalties will be applied equally.
Most of the heroin on the East Coast and the Midwest now contains traces of fentanyl. If we reduce penalties for heroin only to see them increased for fentanyl, we’ll end up taking two steps forward and three steps back in the fight to end mass incarceration.
Ultimately, the most effective way to turn the tide on the fentanyl crisis is to increase the use of interventions that reduce harm and promote health. Safe consumption spaces would enable people who use drugs to do so under professional supervision, virtually eliminating the possibility of an overdose death. This is especially important because the onset of a fentanyl overdose is often much quicker than a typical overdose.
The speed of a fentanyl overdose is another reason we should expand the availability of naloxone — a drug that reverses overdoses — for drug users. There has been a political push to get naloxone in the hands of law enforcement and paramedics, so-called first responders, but the first people on the scene of an overdose are invariably drug users or their loved ones.
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And drug checking services should be made available so that people can test their drugs for fentanyl. Furthermore, access to methadone and buprenorphine, which are proven to reduce overdose deaths significantly, must be expanded.
Fentanyl is a serious challenge, and as the death count climbs, the pressure is on to “do something.” But that “something” should be a strategy grounded in public health, not approaches that do nothing to decrease deaths and everything to increase the prison population.
If you listen to the video on the website … former FDA Commissioner (David Kessler) PLAINLY STATES that there should be only enough opiates produced to treat ACUTE PAIN AND CANCER PAIN…  I guess although all those with chronic pain or not on Dr Kessler’s radar. Of course, Dr Kessler is – by education – a pediatrician and attorney and was FDA commissioner during President Bust (42) and Bill Clinton’s administration. Before there was a interest in having pain to be considered a “5th vital sign”. And received both of his degrees during the 70’s …mostly during the Nixon and Ford administrations and the war on drugs was being organized and the DEA infrastructure was being built. During the same/similar time that AG Session was getting his law degree…  A couple of “old dinosaurs” bringing their antiquated “70’s ideas” into the 21st Century ?

FDA Weaponizes ‘Opioid’ Label Against Kratom Consumers

https://www.forbes.com/sites/davidkroll/2018/02/09/fda-weaponizes-opioid-label-against-kratom-consumers/#778d17ac4536

The U.S. Food and Drug Administration released a statement on Tuesday afternoon from Commissioner Scott Gottlieb, MD, declaring that kratom, a southeast Asian herbal medicine, contains naturally occurring plant alkaloid chemicals that are predicted by unpublished computer models to be opioids.

The agency has also collected 44 fatal adverse reaction reports where kratom components were present in the bodily fluids of the decedents.

As a result, the agency is heightening its warning to consumers and healthcare professionals, first made in a public health advisory in November, that kratom presents a safety hazard and holds the potential for abuse.

But consumers sing kratom’s praises as a medicinal herb useful for chronic pain, anxiety and depression. Taken primarily as a tea or in capsules containing pulverized dried leaves, kratom is used by some who had been previously dependent on prescription opioids or alcohol. But the FDA states that no scientific studies support these therapeutic uses of kratom. As a result, Dr. Gottlieb’s statement concludes by urging people who are self-medicating with kratom to seek the help of healthcare professionals and prescription opioid-maintenance therapy or non-opioid pain relievers that have passed the FDA approval process.

 

Related: Top Kratom Researcher Discusses Potential Medical Use In Opioid Withdrawal

When the Drug Enforcement Agency announced plans in 2016 to add the two major kratom components to the most-restrictive Schedule I of U.S controlled substances – the classification for drugs with no medical utility and high abuse potential – the general public and members of Congress objected so vigorously that the agency rescinded its plan. In a subsequent comment period, the DEA received 23,000 comments, with 99% voicing positive views on the herb.

 

Along with Tuesday’s FDA warning, the agency also released a 164-page document with case details on 28 deaths where kratom was present, first referred to in the November 2017 advisory. This report joins another from December showing details of eight other deaths. Nick Wing, a Huffington Post senior reporter, dissected these fatal adverse reaction reports and found that in many, kratom and its constituents were likely innocent bystanders. The agency even includes among kratom-associated deaths cases of fatalities by hanging, gunshot and others where kratom was adulterated with the active metabolite of a prescription opioid, O-desmethyltramadol.

My take? If Dr. Gottlieb’s statement were a pharmacology graduate student’s written qualifying exam answer to a question seeking an objective assessment of kratom pharmacology and toxicology, I’d have no choice but to issue a failing grade.

I would tell the student:

  • You failed to read 20 years of published scientific literature on alkaloids present in the kratom plant, Mitragyna speciosa.
  • You failed to demonstrate any mastery of current research on the biochemical pharmacology of opioids.
  • You were overly reliant on unpublished data from a computational model in the absence of direct, experimental confirmation.
  • You made safety conclusions based on confirmation bias and a poor assessment of adverse reaction reports where kratom or its constituents were present.
  • You also made safety conclusions in the absence of considering the impact on public health if kratom were banned.
  • You concluded that the substance has no medical benefit in the absence of a prospective clinical trial for any indication with a well-qualified kratom product or purified kratom alkaloid.

I say this all with great respect for Dr. Gottlieb, a physician and former FORBES contributor, because I also know that the FDA is in a difficult regulatory position: It lacks the flexibility to handle herbal, botanical medicines and other dietary supplements that may be of medical benefit. In fact, herbal medicines in the United States can be sold only as long as no disease treatment or prevention claims are made. The FDA can only remove herbal medicines and other dietary supplements from the market if it can make a case that the product is unsafe.

Kratom’s opioid nature has been known since 1996

There’s no doubt that kratom contains opioid-like chemicals. Why the FDA is trumpeting this now as if it were news seems to be more of a public policy proclamation meant to address opioid denialism among some kratom advocates and stigmatize kratom in the media.

The scientific community has known that kratom contains alkaloid compounds with mild opioid activity since animal experiments first published in 1996 and 1997. These studies showed that the action of the major kratom constituent, mitragynine, could inhibit pain impulses and intestinal movement in a manner that was reversed by the opioid blocker, or antagonist, naloxone. Conclusive evidence of binding by several kratom alkaloids to human opioid receptors was shown experimentally in 2016, but those studies showed kratom-derived opioids behaved very differently from strong opioids like morphine.

So on a cursory read of headlines earlier this week, theoretical concerns exist that a small subset of kratom consumers are using the herb to get an opioid-like high or euphoric sense of well-being.

But from over 200 stories I’ve collected from kratom users over the last two years, consumers using kratom to relieve physical suffering far outweigh the small number of people that might try to use kratom for an opioid-like high. (I’ve tried it myself several times, at a legal kratom bar in North Carolina, and I can assure you that I will still be using prescription opioids following my next surgical procedure.)

Among my correspondents, any addictive potential of the herb appears to be limited to those using concentrated plant extracts, not the crude herb. In fact, using the crude herb is almost self-limiting because its bitter taste precludes ingesting more than 3 to 5 grams at a time; some users report nausea and vomiting when taking too much.

Related: The Benefits Of Kratom, And Risks Of Kratom Extracts, From The People Who Use The Botanical Medicine

While my reader feedback is not a scientific sample – and let me be the first to say that we should be as critical of these reports as I am of the FDA statement – recent work with kratom alkaloids and advances in our understanding of how opioid receptors work may partly account for kratom’s anecdotal reports of utility and relative safety. (At the very least, these reports would lead me to want to conduct a randomized, controlled clinical trial of a well-qualified kratom product in patients with chronic pain, or to compare it head-to-head with prescription medication-assisted therapy for opioid dependence.)

These advances in kratom pharmacology were put forward in a 2016 paper in the Journal of the American Chemical Society by lead authors Andrew Kruegel, PhD, and Madalee Gassaway, PhD, and their colleagues and mentors at Columbia University and Memorial Sloan-Kettering Cancer Center.

First is that when chemicals bind to opioid receptors in the brain, spinal cord and intestines, the maximum response they can exert can be full or partial. Drugs like morphine, fentanyl and heroin all exert a full effect at the mu-subtype of opioid receptors when present at a high enough concentration.

The opioids in kratom appear to only partially stimulate mu opioid receptors. Moreover, they block kappa opioid receptors, albeit at higher concentrations. While not a direct comparison, these kratom alkaloids better resemble the opioid maintenance therapy buprenorphine than the strong opioids most often responsible for overdose deaths, such as heroin and fentanyl.

American Chemical Society

Secondly, it turns out that when a chemical binds to an opioid receptor protein in the brain, the way the signal is transmitted inside neuronal cells can vary between two pathways. One pathway is mediated by a so-called G protein while the other is mediated by a protein called beta-arrestin-2.

Using a series of opioids, the laboratory of Laura Bohn, PhD, at the Scripps Florida research institute has shown that opioids that recruit the beta-arrestin-2 protein cause suppress breathing more so than those biased more toward the G protein pathway when given to mice at equal painkilling doses. A November 2017 paper from her group in the journal Cell is suggestive that bias toward beta-arrestin-2 is somehow linked to fentanyl and opioids like it being more deadly than G protein-biased opioids. These findings are only at the level of animal studies and the obvious next step is to determine if this distinction among opioids occurs in humans.

Why is this gobbledygook relevant to the kratom discussion? Kruegel, Gassaway and colleagues showed that the alkaloids present in kratom are almost entirely biased toward the G protein pathway, with no detectable recruitment of beta-arrestin-2. And two of these, mitragynine and 7-hydroxymitragynine, only partially stimulate the main opioid receptor subtype that’s fully stimulated by drugs like morphine or fentanyl.

So while the term “opioid” carries a stigma in our society because of its association with drugs that cause 65,000 overdose deaths each year, science is beginning to show us that not all opioids are equal, at least in terms of some side effects and relative strength. What’s not yet known is whether this biased signaling could give us opioids that relieve pain with less addictive potential than current prescription opioids.

Kratom suffers from being a potentially useful herbal medicine in the United States

Unfortunately, few financial incentives exist to investigate kratom components as a potential drug, although SmithKline & French Laboratories filed a now-expired patent on the kratom component, speciofoline, in the 1960s. A G-protein-biased opioid called oliceridine made by Trevena just completed Phase 3 clinical trials, but it is only effective intravenously and, if approved, will only be used in hospital and other inpatient settings.

The only paths for kratom in the United States are as a botanical medicine or new dietary ingredient. However, no company has successfully submitted the necessary information to FDA for a specific kratom product to be investigated as a new drug.

As a result, kratom sits in the regulatory no-man’s land of botanical medicines as foods. As long as no direct disease treatment claims are made, retailers can sell all manner or herbal products unless they are proven unsafe by the FDA. It seems that the latest announcement by the agency is an attempt to move in that direction, with the potential goal of prohibiting sales of kratom in the U.S. The herb is already subject to import seizures, and a domestic U.S. cultivation industry, like that for herbs such as echinacea and turmeric, has yet to emerge.

Please note: Forbes discontinued the reader commenting function in December. If you have feedback, please post a reply to @davidkroll on Twitter or on my Facebook post on this article, or send me a Gmail message to tips4davidkroll.

David Kroll, PhD, is a former academic pharmacologist and educator. For more health and pharmaceutical news and commentary, follow him on Facebook, Twitter @DavidKroll or here at Forbes.

Medication Adherence: A $300 Billion Problem

https://www.adhereforhealth.org/medciationadherence/

What is Medication Adherence?

Medication adherence occurs when a patient takes their medications according to the prescribed dosage, time, frequency, and direction.  A breakdown in any one of these elements has the potential to result in unanticipated side effects and complications. Studies show that:

  • Half of all patients do not take their medications as prescribed;[1]
  • More than 1 in 5 new prescriptions go unfilled;[2]
  • Adherence is lowest among patients with chronic illnesses.[3]
RxUnfilled-100.jpg
CHRONICIllnessBPM-100.jpg

What Are the Effects of Poor Medication Adherence?

Poor medication adherence, or non-adherence, limits effective management and control of chronic illnesses. Non-adherence increases the likelihood of preventable disease progression, increased hospitalizations, avoidable doctor and emergency room visits, and other problems arising from poor health, which can significantly increase costs.

  • At least 125,000 Americans die annually due to poor medication adherence.

  • As adherence declines, emergency room visits increase by 17% and hospital stays rise 10% among patients with diabetes, asthma, or gastric acid disorder.[5]
  • Poor medication adherence results in 33% to 69% of medication-related hospital admissions in the United States, at a cost of roughly $100 billion per year.[6]
  • NEHI estimates that total potential savings from adherence and related disease management could be $290 billion annually — 13% of health spending.[7]

What Can Be Done?

A growing body of evidence suggests that medication adherence programs have the potential to reduce health spending and, in the process, generate significant savings for taxpayers.  Policies to promote medication adherence have the potential to improve health and significantly reduce health spending.

The Council for Affordable Health Coverage (CAHC) has launched Prescriptions for a Healthy America: Partnership for Advancing Medication Adherence (the Partnership) in collaboration with several patient, pharmacy, provider, pharmaceutical, and employer organizations to identify specific legislative and regulatory solutions that can be brought to the attention of Congress and the Administration.  

Key Campaign Deliverables

The Partnership will develop policy recommendations and engage in a robust advocacy campaign to advance medication adherence strategies and interventions that lower costs and improve health.  Working with Congress and the Administration, we will aggressively pursue legislative and regulatory solutions to the challenges of medication adherence.  In addition, the Partnership will:

  • Hold monthly membership meetings to discuss policy issues, strategy and advocacy;
  • Conduct briefings with industry, policy and government experts and leaders;
  • Conduct advocacy in support of Partnership-backed solutions; and
  • Foster public interest in adherence through a proactive and aggressive media campaign

TWICE AS MANY PEOPLE DIE BECAUSE THEY DON”T TAKE THEIR MEDICATION THAN OD ON OPIATES

They claim that 64,000 die from DRUG OD’s and often the DEA is out to make some healthcare professional for a person that takes more medication than was directed. If logic would prevail.. who is responsible for those pts who fail to take their medication as prescribed and DIES ? But there seems to be very little logic within the various bureaucracies

Film on Chronic Pain Nearing Release

www.nationalpainreport.com/film-on-chronic-pain-nearing-release-8835451.html

Many of our readers have recommended that more needs to be done to educate people about the chronic pain issue.

An ambitious effort is nearing completion. It is a documentary called Pandemic of Denial that has been in production for several years and is being reading for release this year.

Tina Petrova, a Canadian whose non-profit is designed to educate about chronic pain, is an award-winning filmmaker who suffers from chronic pain. She and her production partner Eugene Weis have recorded literally hundreds of hours of interviews—has virtually completed editing and is now seeking Broadcast and Distribution Partners in Canada and the U.S.

They hope to release the film this year. Recently, Petrova gave the National Pain Report some thoughts about why they decided to embark on this 4-year long project.


National Pain Report: “What impact do you hope the documentary will have?

Tina Petrova: “Navigating through the health care system in both the US and Canada can be very frustrating, upsetting and protracted. Only if you are one of the lucky ones– and I emphasize lucky– to actually have a “Pain Specialist “ treating you, can one even begin to make sense of chronic pain as a disease, and all that this entails. In both Canada and the US, we are sadly under educated when it comes to chronic pain as a lifelong disease in its own right.

A 10-year old Toronto boy shares his battle with chronic pain in Pandemic of Denial, a documentary expected to be released this year.

“If, by making this feature film and taking an in depth look into the challenging lives of pain patients and their families we can educate, decipher, inform and help others navigate the complexity of our worlds- then we have accomplished what we set out to do as story tellers and filmmakers.

“Chronic Pain ends hopes and dreams and even lives at times – due to suicide and medical complications from managing it. 1 in 4 North Americans are reported to be living in daily chronic pain- More than cancer, heart disease and diabetes, combined. It is no small disease. – hence our title: Pandemic of Denial.”

National Pain Report: “You suffer from chronic pain—and it explains some of why you tackled this big and important topic. What else inspired you?”

Tina Petrova: “In my experience, many pain patients you speak with, will share that they had to self diagnose. It was their fervent searches on the internet that led them to understand that they had strange sounding diseases like CRPS and Arachnoiditis.  It was these very patients that printed out information to bring to their primary care physicians and ask that the appropriate tests be done to determine a correct diagnoses and appropriate follow up treatment plan.

“According to recent published articles, doctors receive on average 7 hours of learning about chronic pain as a disease at medical school, while veterinarians receive some 70 hours for their animal counterparts. Note that specific bodily systems are covered in depth, such as managing and correcting pain from heart attack, pain from gall stone attack etc.- I am referring to chronic intractable pain as its own disease.

“I myself was shuffled from general practitioner to specialist after specialist- it took me 8 years of suffering undiagnosed to finally meet the pain physician who is treating me now. Hallelujah!  Only 8 years. Sadly, that seems to be the norm when I reach out and dialogue with the chronic pain  community.

“I want adequate and better pain care for myself as I age- I watched my mother suffer horrendously the last 2 decades of her life with chronic pain conditions and her sister, my auntie languish in hospice for back pain not dissimilar to my own, the last 18 mos. of her life. I also wish that for others. If not me telling this story, then who ? I decided not to wait for Deus ex Machina (God to drop down from the sky) and just do it.”

National Pain Report: “You delve into the research—or lack of it—in chronic pain.”

Tina Petrova: “Sadly the field of research into pain and the brain has been severely underfunded the last several decades. Opioids have long been held the gold standard in treating severe intractable pain, end of life pain, post cancer and surgical pain – among other pain conditions. Since opioid medications were developed and came into widespread use, there have been very little significant developments made in the field of pain care medicine and treatment.

“As a result, we have large numbers of pain patients who have been under professional supervised medical care, some for decades on stable doses of opioids, that due to a hostile regulatory environment for doctors, are having those very medications being either titrated down to minute doses or being taken off their medications completely.

“While I can appreciate that overdose deaths are a deadly and disturbing trend that need to be addressed head on, I also believe that being undertreated for intractable pain is just a serious an issue.

“I have been witness to multiple suicides in our national pain community resultant of being undertreated for pain these last 2 years. It is their stories that we bring into focus in our documentary- those of abandoned pain patients, undertreated pediatric pain, and the persecution of doctors for attempting to uphold their Hippocratic oath by agreeing to continue to treat pain aggressively where indicated, even when faced with loss of license or even incarceration.”

National Pain Report: “What happens with the documentary now?”

Tina Petrova: “We began the film in 2014 with a limited amount of startup funding. Due to angel investors and donated services we were able to film multiple interviews at a myriad of locations this past year from California to the Mid -West to Canada to India.

“We are now in great shape with compelling stories and stunning cinematography – to seek TV Broadcasters and Distribution to move our film to the next level of production. Our primary focus will be entering into film festivals around the world later this year 2018 and organizing community screenings both across North America and beyond.

“As filmmakers and storytellers. we hope to reach as many people as possible and begin the overdue and badly needed conversation of what is CHRONIC PAIN, how best to approach treating it and how to encourage better funding for a cure.

“We hope to exhibit the film to medical schools, front line staff such as ER and social workers and pain groups that support and encourage education of the myriad of diseases that fall under the chronic pain rubric. We are also compiling a list of interested parties who would like to co- host screenings in their local communities.”

Editor’s Note: If you want to follow this project on Facebook, you can do it here.

If you’d like to talk with Tina and her team directly, she’s offered her email: pandemicofdenial@gmail.com

Insulin quality questions have diabetes experts scrambling

https://m.chron.com/news/medical/article/Insulin-quality-questions-have-diabetes-experts-12558865.php

TRENTON, N.J. (AP) — Preliminary research suggesting that some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself.

 

The study author, a pharmacist, bought vials of insulin at a number of pharmacies and found that on average the vials had less than half of what was listed on the label and none met a minimum standard.

The study tested just 18 vials of insulin — far too few to be definitive — and questions have been raised about the methods used to test the insulin. Insulin makers, patient advocate groups and diabetes experts say if the findings were accurate, diabetes patients would be getting sick.

 

But given potentially serious implications for millions of diabetics, many of these groups are now trying to reassure patients in the wake of the research. All say that patients should continue to taking their insulin as prescribed.

The groups are discussing how to quickly mount a major study that would ease fears by involving multiple research labs, different testing methods and many more samples of various insulin types.

Scientists warn Trump administration that banning kratom will result in more opioid deaths

http://www.washingtonexaminer.com/scientists-warn-trump-administration-that-banning-kratom-will-result-in-more-opioid-deaths/article/2648561

A group of scientists who have studied kratom are warning the Trump administration that banning the drug would worsen the opioid epidemic, following a declaration from the Food and Drug Administration that kratom has “opioid properties” and is associated with 44 deaths.

The drug, a Southeast Asian tree leaf, is legal under federal law, but FDA officials have recommended it be categorized as a Schedule 1 drug, which would effectively mean that scientists would be unable to study its effects. People who take the drug, which can be sipped in a tea or taken as a pill, say that is has helped them beat off cravings for opioids and has alleviated chronic pain and depression.

The scientists pleaded against a kratom ban in a letter sent to Robert Patterson, acting administrator of the Drug Enforcement Administration, and Kellyanne Conway, counselor to the president who is overseeing the administration’s efforts on the opioid crisis.

They raised doubts about the deaths determined to be associated with kratom and drew attention to surveys that have indicated that kratom was being used as “a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom.” For these users, they wrote, a ban would result in “relapse to opioid use with the potential consequence of overdose death.” Instead, they wrote, the government should be encouraging research on the product to assess its safety and effectiveness.

 “Placing kratom into Schedule I of the [Controlled Substances Act] will … have a profound and pervasive chilling effect on this needed additional research,” they wrote.

The latest available federal data show that 42,249 people died from an opioid overdose in 2016, whether from heroin, fentanyl, or prescription painkillers. Of the deaths, 3,373 were caused by methadone, a medication often prescribed to treat people with addictions to opioids.

FDA Commissioner Scott Gottlieb has said that his agency was concerned about reports that people had been using kratom to wean themselves off opioids, saying “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.” He has warned in the past that kratom can cause seizures and liver damage.

The DEA has not said whether it intends to take action given the latest analyses and recommendations by the FDA and does not have a specific deadline. The agency said in October 2016, during the Obama administration, that it would hold off on banning kratom as a Schedule I substance such as heroin, marijuana or LSD, as it waited for additional public comment as well as FDA recommendations.

Secrecy rules at Georgia medical board

 

http://investigations.blog.ajc.com/2018/02/07/secrecy-rules-at-the-georgia-composite-medical-board/

 

Shoddy care by doctors. Sexual misconduct. Malpractice cases that led to $1 million settlements. Violations involving prescription drugs. Those are among the serious allegations made against Georgia doctors last year in formal complaints.

But the public will never know the details of how the Georgia Composite Medical Board handled the vast majority of these complaints. That’s because almost everything the medical board does related to doctor discipline is kept top secret.

The board’s secrecy came to light again recently in the case of Dr. Paul Harnetty. The board had investigated the former Georgia doctor, a criminal case revealed, but he was never publicly disciplined. Harnetty was convicted last month of sexually assaulting patients in a Wyoming. The AJC investigated the doctor’s Georgia history in a story published Sunday. 

If the Georgia board issued Harnetty a private order, or dismissed the case, that would be the usual order of business, judging by the board’s latest data.

 The board got 1,787 new complaints in the 2017 fiscal year that it determined were within its jurisdiction, according to the board’s annual report for the 2017 fiscal year, which runs from July 2016 through June 2017.

During that year, the board issued only 36 disciplinary actions, the report says. Among them, one doctor had his license revoked, and two had their licenses suspended. The most common public actions the board took were 23 public reprimands, according to the report.

The medical board staff did not respond to the AJC’s request for more information about confidential letters and orders and the disciplinary actions summarized in its annual report.

Dr. Paul Harnetty

The board dismissed a lot of cases, and it will never have to justify why. In fact, Georgia law bars the board from discussing any case, even a case in which it has imposed public discipline.

The board’s meeting minutes reveal that the doctor-dominated board takes many more private actions than public ones.

In just one month last year, for example, the board accepted two “private consent orders” and amended another one. The only information the board provided about those doctors was the case number. No names. No description of the case. No public information at all.

At the same meeting, the board also accepted one of its committee’s recommendations to “require a private consent order as a condition of licensing” a pain clinic. The owner of the clinic had been interviewed by the committee, the minutes show. Pain clinics need special licenses because their focus on treating pain generally leads to lots of prescriptions for highly-addictive opioid pain pills.

The same month — May of 2017 — the board closed 14 cases with “Letters of Concern,” according to the meeting minutes. What were the concerns? That’s something the public simply has no right to know. It’s between the doctor and the board.

Not every state handles so much of its doctor discipline privately. Georgia is among 21 states where the law allows secret actions in physician discipline, according to a 2016 AJC national investigation.

When Dr. Paul Ruble surrendered his license last April, the medical board didn’t reveal that he was on his way to federal prison after a 2015 indictment in a pill mill case.

The Georgia board also usually provides no details if a doctor gives up a license. The AJC found some 30 cases in Georgia where physicians who were facing criminal charges involving controlled substances, or who were facing sanctions in other states, surrendered their licenses without the medical board noting any reason.

If the doctor instead keeps practicing after being arrested, the board often remains silent,  routinely letting a case play out in court before taking any action against a doctor’s license.

The AJC investigated the board’s handling of doctors who improperly prescribe opioids in a series published in December. The AJC also studied improper prescribing in all 50 states in its 2017 national investigation, Healers or Dealers?

The AJC discovered in its 2016 Doctors & Sex Abuse national investigation that the Georgia board has handled even serious allegations in private.  The board placed Dr. Jacob Ward on probation after he pleaded guilty in a criminal sexual misconduct case. But that criminal case revealed a back story. Two other patients had made similar charges against Ward four years earlier and the board did nothing other than write a “personal and confidential” letter to the doctor expressing its “concern regarding exams and patients of the opposite sex.”

The Georgia Composite Medical Board is a 16-member board made up of 13 physicians, two consumer members and one nonvoting Physician Assistant member. All voting members are appointed by the Governor and confirmed by the State Senate.

Could this explain why CDC stats are all F-upped ?

Death investigation highlights problematic coroner system in state

https://www.columbiamissourian.com/news/state_news/death-investigation-highlights-problematic-coroner-system-in-state/article_e1e4b5f0-0b98-11e8-897b-7fa32d65f210.html

FAYETTE — Missouri’s coroners don’t have many requirements to get the job. Some do not even attend training sessions, according to the coroners’ professional association.

Some county coroners are concerned cases are being mishandled, deaths are going under-investigated, and too few autopsies are being ordered. They say most of the state’s laws are antiquated, some not having seen a governor’s signature since the 1940s.

At just 27 years old, Jayke Minor died in his home in Fayette in 2011. His girlfriend found him and by the time paramedics got there, it was too late. Six and a half years later, his dad still doesn’t know why his son died.

“I’m never going to have the answers I need to know what happened to Jayke,” Jay Minor said.

Jayke Minor had a history of drug use, according to his father and police, but officers said there was no evidence of drug use on the scene. Even so, Howard County Coroner Frank Flaspohler decided the death was an accidental drug overdose.

“That’s what he listed it as. With no evidence,” Jay Minor said. “He didn’t do an autopsy. He didn’t contact me to ask for one.”

Flaspohler said Jayke Minor’s history of drug use factored heavily into his decision that evening.

“Talked to the two policemen on scene. They said nope, there’s nothing suspicious. There was some history there,” Flaspohler said.

But two years later, a toxicology report from the Missouri State Highway Patrol brought everything in the original determination into question.

“When we got the toxicology report back, it started falling apart,” Jay Minor said. “It came back negative for anything but marijuana. And you don’t die from marijuana.”

Another year passed, and Flaspohler changed his report to indicate Jayke Minor died from a heart issue, with the manner of death listed as “natural.”

But now, all evidence that could help get a definitive answer is gone: Jayke Minor was cremated, the blood samples were destroyed per lab protocol, and there was no autopsy.

Six years ago, Flaspohler said, only autopsies involved in criminal cases would be paid for by the county, with few exceptions.

Fixing inconsistencies

Other coroners call the case flawed, and are pushing for legislation to improve training for the career.

Flaspohler is being accused of mishandling the case by fellow coroners for a number of reasons, from the wrong name being on his coroner’s report to obvious discrepancies KOMU 8 News identified between his report and police reports, including the location and temperature of the body.

Saline County Coroner Willie Harlow, who sits on the board of the Missouri Coroners’ and Medical Examiners’ Association, said he is frustrated with the case, calling it flawed and directly blaming Flaspohler.

“He made a quick decision that (Minor) was a drug user, so he died of a drug overdose. And at that moment in time, Frank Flaspohler was done with that case,” Harlow said.

Harlow supports a bill in the Missouri House that would collect a fee on death certificates that would fund better training for coroners. Currently, there are only age and residency restrictions to become a coroner in the state. Even though coroners may have no experience with medicine, the training requirement is just 20 hours a year, a requirement not everyone is completing. House Bill 2079, introduced by Rep. Dan Houx, R-Warrensburg, would prohibit coroners who are not up-to-date on training from being able to sign death certificates.

“There are many coroners who do not attend training of any kind, yet there is nothing that our association can do about that,” Harlow said.

There are also few requirements dictating how a coroner must handle a death investigation. According to coroners, children under 1 year old who die must be autopsied, but there are few set standards after that.

“There really needs to be a standard guideline for coroners to follow to tell them, ‘This is when you should be doing autopsies, and this is when you should be ordering toxicology,’” said Kathleen Little, executive director of the Missouri Coroners’ and Medical Examiners’ Association.

Jay Minor and his girlfriend, Debby Ferguson, have spent years asking anyone who will listen for help. They recently launched a letter-writing campaign to reach every coroner and medical examiner in the state, as well as lawmakers.

“Our goal is that no other parent has to go through this and wonder what happened to their child,” Jay Minor said.

Some states, like Kansas, require coroners to be doctors, according to the Centers for Disease Control and Prevention. Other states require a death investigator certification; Little said the association may push for that in Missouri.

When it comes to the Minor investigation, Flaspohler said it has made him think about changes.

“I will tell you, it took way too long. I totally agree with that,” Flaspohler said. “I’ve had 1,000 calls, never had one that took this long.”

He said he is now tracking his cases using a new computer system and is making sure records are done faster. He said he does attend training, including additional, optional training, and he is in favor of upping the training requirements for coroners across the state.

Flaspohler also said a recent coroner’s inquest related to a teen’s suicide death related to bullying has made him look at things differently.

“I’ve actually spent the last year dealing with this inquest and saying we need to look at the schools and say we can do better. So, I can look at me and say, I can do better. We can find a better way. We can get more training. We can get a better computer program,” Flaspohler said.

SD: bill to limit opiates for acute pain – DIED IN COMMITTEE TODAY

South Dakota lawmaker looks to rein in opioid painkiller prescriptions

http://www.argusleader.com/story/news/politics/2018/02/06/south-dakota-lawmaker-looks-reign-opioid-painkiller-prescriptions/306626002/

PIERRE — Doctors would only be able to prescribe seven days’ worth of opioid painkillers to children or patients taking the drugs for the first time under a bill up for consideration Wednesday in the Statehouse.

Under Senate Bill 176, physicians would be required to consider and discuss with patients alternatives to the painkillers before prescribing opioids for pain management. They would also be required to discuss with patients the risks associated with opioids and proper methods of disposing of the drugs.

The restriction wouldn’t apply to patients receiving hospice or end-of-life care or those with chronic pain that cannot be treated without the painkillers.

More: Avoiding opioids: Avera, law enforcement aim to prevent crisis in S.D.

Supporters said the bill could help rein in opioid addiction and diversion in the state. Meanwhile, opponents said the bill would prevent physicians from making individual choices based on patients’ needs.

Sen. Arthur Rusch, R-Vermillion, brought the bill in an effort to curb opioid addiction in the state. He pointed to National Conference of State Legislature data which showed first-time patients were less likely to develop addictions when prescribed smaller amounts of the drugs.

 

“I read a lot about the issue and it just seemed to be the right thing to do,” Rusch said. 

More: Senate panel votes to drug test Legislature, splitting with peers

Doctor Bob VanDemark Jr., president of the South Dakota Medical Association, said the proposal is well-intended but doesn’t take into account the distinct situations physicians face in weighing opioid prescriptions.

“It’s such a complex issue, and it’s really hard to legislate one prescription program for everybody,” he said. 

The Senate Health and Human Services Committee is set to take up the bill Wednesday morning.

John Stossel: The war on drugs is just like Prohibition. And it won’t work either

FILE -- In this Aug. 9, 2016, photo, a bag of 4-fluoroisobutyrylfentanyl, which was seized in a drug raid, is displayed at the Drug Enforcement Administration (DEA) Special Testing and Research Laboratory in Sterling, Va.

http://www.foxnews.com/opinion/2018/02/07/john-stossel-war-on-drugs-is-just-like-prohibition-and-it-wont-work-either.html

Ross Ulbricht was a quiet nerd — an Eagle Scout who never cursed.

Then he became a libertarian, and he decided, “I want to use economic theory as a means to abolish the use of coercion.”

By coercion, Ulbricht meant force.

He viewed laws against drugs as coercion — government force that stops people from living the way they want.

So he created a website called Silk Road. Silk Road let people buy and sell contraband — mostly drugs — using bitcoin. The site became successful quickly. It soon carried a billion dollars in transactions.

Because Silk Road didn’t use dollars, it was also private, said Ulbricht. “The State is unable to get its thieving murderous mitts on it.”

But he was wrong. Ulbricht slipped up, using his real name in an internet forum, and the FBI found him and jailed him.

A jury, looking at his former website, convicted him of things like “conspiracy to traffic narcotics.” He was clearly guilty of that.

But then Judge Katherine Forrest said that because “Silk Road was a black market of unprecedented scope” she would sentence Ulbricht to “double life plus 40 years, without parole.”

That’s a longer sentence than many murderers get.

My former Fox colleague Bill O’Reilly applauded it.

“We all agree here,” he told his TV panel. “Life in prison without parole! Any other wiseguys want to do it, that’s what you are gonna get.”

Give me a break. Locking some people up forever will not stop sales of drugs.

Americans should have learned that from our last attempt — Prohibition.

Making popular things illegal rarely diminishes their use. People still buy the banned items, but now they buy them from criminals. Violence increases. Sellers, instead of resolving disputes in courts, settle them with violence.

The illegal activity doesn’t go away. It just becomes more dangerous.

What we saw during alcohol prohibition, we now see in the drug market.

What did government accomplish by closing Silk Road? Nothing lasting. Other illegal sites opened. Today, they offer more contraband than Silk Road ever did. Silk Road had 12,000 listings. Now several sites carry more than 100,000 listings.

“So I guess they weren’t scared by Ross’s life sentence, as the judge said,” says his mother, sarcastically.

But law enforcement still brags about brief successes. “The dark net is not a place to hide!” crowed Attorney General Jeff Sessions after one bust. “We will use every tool we have to stop criminals from exploiting vulnerable people.”

“Our critics will say we shutter one site, another site emerges, and they may be right,” says Andrew McCabe, who recently stepped down as Deputy Director of the FBI. “But that is the nature of criminal work. It never goes away.”

Never. Ever.

But the criminality would go away if we just legalized drugs. Today, there are no shootouts over alcohol sales.

But what about sketchier products — like hackers selling people’s credit card information?

“Silk Road had some rules at least, like nothing that harmed or defrauded,” says Ulbricht’s mother. “No child pornography was allowed.”

Also, the drugs were high quality. The FBI made more than 100 purchases from Silk Road and concluded that the drugs had “high purity levels.”

Still, I find it hard to sympathize with Ulbricht because police now also have charged him with hiring a hit man to kill someone.

Ross’s mom believes that threat was faked, possibly by law enforcement agents themselves.

No one was actually killed, and the government didn’t charge Ulbricht with murder-for-hire in the trial that jailed him for life.

A typical sentence for murder-for-hire when no murder occurs is about 10 years. But Ulbricht got much more than that. Was the sentence for damage Ulbricht allegedly did, or because the State resents its inability to control this sort of online trade?

“He was a libertarian,” says his mother. “Believed in free markets and volunteerism. He’s not a dangerous person.”

No American is safer because Ross Ulbricht is in jail for life. He is just one more casualty of our futile war against drugs.