The prescription opioid epidemic in a nutshell

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What are your thoughts on a hospital system implementing a hard limit (enforced by pharmacy) of < 90 MED?

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Opana ER: Endo set to profit from an opioid it said was unsafe - CNN

Drugmaker set to profit from an opioid it said was unsafe
By David Heath, Ciara Bri'd Frisbie and Aaron Kessler, CNN

Updated 5:19 AM ET, Mon October 30, 2017


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Story highlights
  • Opana ER was pulled from market after research found addicts more likely to inject it
  • Outbreak of HIV and rare blood disorder were linked to abuse of the drug
  • Drug manufacturer struck deal to cash in on older version it said was unsafe

(CNN)It's not uncommon for drug companies to try to keep generic versions of their best-selling drugs off the market. But this is a story about a drug company that went to extraordinary lengths to do so, calling into question the safety of a drug it had sold for years. When its plan didn't work, the company made an unusual decision.

As the opioid epidemic grew, Endo Pharmaceuticals took the extraordinary step in 2012 of pulling a version of one of its best-selling painkillers off the market, saying that the narcotic was susceptible to abuse.
Endo even unsuccessfully sued the US Food and Drug Administration that year to prevent the approval of any generic version of its drug, called Opana ER. The drugmaker argued that given a chance, drug abusers would crush and snort the generic pills, just as they had with the brand-name drug. Snorting intensifies the high but heightens the chance of overdosing.
It seemed as though a drug maker was taking selfless action to try to curb the growing opioid epidemic. But some industry observers say the story of Opana ER may better illustrate the lengths a drug company would go to in order to protect its profits.
Endo introduced a new formulation of Opana ER before phasing out the old one. Both drugs had the same active ingredient, oxymorphone. Both were extended-release pills for long-lasting effects. Both were called Opana ER.

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170921152007-opana-er-endo-opioid-medium-plus-169.jpg


&lt;img alt="Endo agreed to halt shipments of Opana ER starting September 1." class="media__image" src="//cdn.cnn.com/cnnnext/dam/assets/170921152007-opana-er-endo-opioid-large-169.jpg"&gt;
Endo agreed to halt shipments of Opana ER starting September 1.
The difference was a few inactive ingredients, including a hard coating that made the pills harder to pulverize. Even so, addicts quickly learned how to cook the new painkiller and inject the liquid with a syringe.
Endo contended that the new Opana ER and its hard coating deterred abuse, but this summer, the FDA disagreed. In June, the regulatory agency concluded that the risks of new crush-resistant Opana ER outweighed its benefits and pressured Endo to stop selling it. It was the first time the FDA had taken steps to stop sales of a currently marketed opioid because of the consequences of abuse.
President Trump allude to the drug last week when declaring the opioid epidemic a public health emergency. "We're requiring that a specific opioid, which is truly evil, be taken off the market immediately," he said.
Endo agreed to halt shipments of Opana ER starting September 1. But that's not the end of the drug's story.
Endo still has the patent on the original version of the drug, the one it fought to keep off the market. The FDA's action this summer didn't impact the crushable version Endo stopped selling in 2012.
So on August 8, Endo cut a deal with Impax Laboratories to split the profits of a generic version of its original drug. Endo is now poised to make money from a drug that it said shouldn't be on the market.
'It just doesn't seem right'
Endo's efforts to profit from a drug that it said was susceptible to abuse raises ethical questions, in the opinion of one member of the FDA advisory committee that recently reviewed Opana ER.
"They're the ones who called it dangerous and unsafe," said Suzanne Robotti, who is also the founder of the MedShadow Foundation, a patient advocacy group. "It just doesn't seem right."
Dr. Michael Carome, director of health research for the consumer group Public Citizen, was harsher in his criticism. "The pharmaceutical industry is solely driven by its desire to make profits and boost its bottom line," Carome said. "Here's a situation where the company is talking out of both sides of its mouth, depending on what will make them money."
Endo defended its decision to cut the deal with Impax.
"The FDA is charged with -- and makes -- the sole determination of whether pharmaceutical products are safe and effective," the company told CNN.
"In June 2017, the FDA requested that Endo voluntarily withdraw the formulation of Opana ER that is designed to be crush resistant due to unintended use and misuse. ... In July 2017 the Company, after careful consideration, decided to voluntarily withdraw it from the market. In the case of the prior formulation of Opana ER, the FDA determined that the product should remain on the market."
The FDA declined to comment on why it left the generic version on the market but told CNN it is assessing the abuse patterns for that drug.
History of keeping generics off the market
Endo Pharmaceuticals has a long history of trying to keep generic versions of Opana ER off the market. Because generic drugs are so similar to their brand-name counterparts, a generic drug's maker can piggyback off the FDA approval of the brand-name drug.
Timeline of Opana ER
  • June 22, 2006: FDA approves Opana ER.
  • November 15, 2007: Endo sues Impax Laboratories for patent infringement after Impax says it intends to market a generic version of Opana ER.
  • December 9, 2011: FDA approves a new crush-resistant version of Opana ER.
  • February 2012: Endo begins selling crush-resistant Opana ER and phasing out original Opana ER without yet raising safety concerns with FDA.
  • August 10, 2012: Endo petitions the FDA to keep a generic version of the original Opana ER off the market because of safety concerns.
  • November 30, 2012: Endo sues the FDA to keep generic version off market, demanding a decision by end of the year.
  • January 1, 2013: Impax is scheduled to launch a generic version of Opana ER.
  • May 2013: FDA denies Endo's request to declare original Opana ER unsafe and keep generics off the market.
  • March 14, 2017: FDA advisory committee votes 18 to 8 that the risks of crush-resistant Opana ER no longer outweigh the benefits. Abuse of the reformulated drug appears to have increased and was linked to outbreaks of hepatitis C, a rare blood disorder and HIV.
  • June 8, 2017: FDA asks Endo to take Opana ER off the market.
  • July 6, 2007: Endo agrees to pull Opana ER off the market.
  • August 8, 2017: Endo announces a deal with Impax Laboratories to split profits on generic version of original Opana ER -- the same drug Endo tried to keep off the market for safety reasons.




The FDA approved oxymorphone as a painkiller in 1959, but the pill form was voluntarily taken off the market in 1982. Endo decided 15 years later to revive the drug as an extended-release pill. In 2006, the FDA approved Opana ER.
The extended-release pill comes in higher doses that are slowly released in the body for up to 12 hours. Opana ER is more potent than its two competitors, morphine and oxycodone, and was intended for use for moderate to severe pain for patients who needed 24-hour relief.
In 2007, Impax sought FDA approval to sell a generic version of Opana ER, but Endo immediately sued for patent infringement. The drugmakers settled in 2010, with Impax agreeing to wait until 2013 to launch its generic.
But as that date drew near, Endo tried again to keep Impax from selling a generic version of Opana ER.
That's when Endo decided to pull the original formulation of Opana ER off the market, saying the drug was susceptible to abuse. Endo petitioned and later sued the FDA to force the agency to declare formally that the original formulation was withdrawn for safety reasons. Doing so would keep generic drugmakers from piggybacking off the drug's FDA approval.
Endo filed the FDA lawsuit only about a month before Impax was scheduled to sell the generic drug. The drugmaker urgently sought a decision by the end of the year. But the FDA persuaded the court to dismiss the lawsuit, telling it "Endo's self-inflicted December 31 deadline is a thinly-veiled attempt to maintain its market-share and block generic competition from Impax."
Opana ER was one of Endo's best-selling brand-name drugs. In 2012, net sales of the narcotic amounted to nearly $300 million, or 10% of Endo's total revenues.
Endo justified withdrawing the original version of Opana ER by telling the FDA that it saw misuse of Opana ER soar after Purdue Pharma introduced a crush-resistant version of its top-selling Oxycontin in 2010. The company cited research showing that abuse of Opana ER rose 111% from August 2010 through March 2012.
Endo said it introduced a crush-resistant version of Opana ER "in recognition of increased reports of the potential for abuse and misuse" of the original formulation.
However, the FDA says Endo never told it about these safety concerns until months after it began selling the crush-resistant pill and phasing out the original one.
Even when Endo announced the FDA's approval of crush-resistant Opana ER in December 2011, the company said, "It has not been established that this new formulation of Opana ER is less subject to misuse, abuse, diversion, overdose, or addiction."


&lt;img alt="Emergency declaration is key to curbing opioid epidemic, experts say " class="media__image" src="//cdn.cnn.com/cnnnext/dam/assets/160401170746-oxycodone-frontiers-large-169.jpg"&gt;
Emergency declaration is key to curbing opioid epidemic, experts say

In the lawsuit, the FDA asked why Endo continued to sell original Opana ER if it thought the drug was unsafe.
Allowed to join the lawsuit, Impax put it more bluntly: "Contrary to its insincere concern about public safety, Endo distributed the allegedly 'dangerous' Opana ER for years, and then apparently continued distributing it for up to nine months even after obtaining approval to market (crush-resistent) Opana ER."
In 2013, the FDA ruled on Endo's petition, saying that Opana ER "was not withdrawn from sale for reasons of safety and effectiveness." The ruling was based on the company's failure to present sufficient evidence that the crush-resistant version of Opana ER was less likely to be abused than the crushable version. The decision allowed Impax to sell a generic version of Opana ER.
Last year, the Federal Trade Commission sued Endo and Impax, alleging that their 2010 agreement to delay the launch of a cheaper generic until 2013 violated federal consumer laws.
The FTC alleged that Endo paid Impax more than $110 million for the delay. The federal lawsuit also alleged that Endo launched its crush-resistant pill "to protect and extend its Opana ER franchise in the face of potential generic entry."
Endo settled the FTC lawsuit in January, promising not to cut any deals intended to keep generic drugs off the market. Impax is still contesting an administrative complaint from the FTC on the same allegations.
Abuse of new drug goes up
Meanwhile, the FDA decided to take a closer look at Opana ER. Over time, data from drug rehabilitation centers showed that as users learned to inject the reformulated drug, the rate of overall abuse actually increased.
Opana ER is not the only opioid being abused, but medical researchers were linking its misuse to outbreaks of hepatitis C as well as a rare but deadly blood disorder affecting at least 30 people in Tennessee and North Carolina and an HIV epidemic affecting more than 200 people in southern Indiana.
Opana can be bought illegally for a hefty price on the street, where the drug is sometimes called "biscuits," "O bomb" and "stop signs." Because it is so potent, addicts often split the dose with others. The high is over quickly, so addicts shoot up several times a day. This year, an FDA advisory committee said these factors may have encouraged needle sharing and the spread of disease.


&lt;img alt="Drug addiction: There is help " class="media__image" src="//cdn.cnn.com/cnnnext/dam/assets/170525020402-opioid-overdoses-large-169.jpg"&gt;
Drug addiction: There is help

Vice President Mike Pence, then governor of Indiana, reluctantly gave in to calls in 2015 for a needle exchange -- replacing used needles with sterile ones -- to stop the spread of HIV in his state linked to Opana ER abuse.
In March of this year, an FDA advisory committee held two days of hearings on crush-resistant Opana ER. The group concluded by a vote of 18-8 that the risks of the newer version of the drug outweighed its benefits.
But before pulling the drug, the Pennsylvania-based drugmaker went into negotiations with Impax to settle ongoing litigation. The deal announced in August was to split the profits on generic extended-release oxymorphone for the next 11 years, starting January 1, 2018.
Endo told CNN that the deal "allows Endo to be fairly compensated for Impax's license to use Endo's valuable intellectual property in offering the product for use as intended."
Last year, Impax made $72.7 million from sales of the generic drug. Endo's sales of Opana ER amounted to about $159 million last year.
Follow CNN Health on Facebook and Twitter
See the latest news and share your comments with CNN Health on Facebook and Twitter.

During a recent conference call with investors, Paul Bisaro, president and chief executive officer of Impax, said, "I think our challenge will be to make sure that patients and caregivers understand that if their patients are on oxymorphone extended-release product because they prefer that, that that product remains available."
Asked by CNN about the safety of the generic, Impax issued a statement: "Patient safety is very important to us. We believe that our product is an effective therapy for patients with chronic pain when used as directed by a physician and in accordance with the label/package instructions."
The future of oxymorphone is not entirely certain, however. In March, the FDA advisory committee was shown data that generic extended-release oxymorphone had the highest rate of abuse of all opioid pills, even among users who are snorting or injecting the drugs. The FDA told CNN it is reviewing the safety of all oxymorphone drugs.
Big Pharma is the major culprit in the opioid epidemic... it continues...
 
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Mirror mirror on the wall...
 

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Mirror mirror on the wall...

Physiatry, Greek for ‘the art of healing,’ is a specialty that began in 1937 at the Mayo Clinic to train physicians to handle the complex neurological, psychological and musculoskeletal issues involved with rehabilitating a patient from combat and disease injuries. Physiatrists diagnose and manage injury, with the goal of maximizing function for the individual patient. This specialty addresses acute and chronic musculoskeletal disorders and pain, neurological conditions involving central and peripheral nervous systems, and rehabilitation of impairments associated with disabilities in adults and children.
 
Best to lead by example though. If IM and FP see their patients being managed by “specialists “ with high MED... why can’t they write for that amount?

Based on that graph, it looks like the message might be getting to primary care (or, they are punting high MED patients to specialty practice)
 
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We prescribe way too much.

Hopefully that is past tense. The “ under treatment of pain” dogma was still in full effect during that 5 year period.

Would be interested to see 2012-2017 data to see if there has been a correction.
 
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It's time for pain medicine to make amends. Let's do the DEA and CA Medical Board a favor and critique these 3 charlatans. Forest needs to
do prison time like Hurwitz. I suspect that there are going to be a lot of pro bono experts for the prosecution.

12 Myths About Opioid Pain Medication
December 08, 2017


By Ryle Holder, PharmD, Scott Guess, PharmD, and Forest Tennant, MD, Dr. P.H.

Myth #1: Above 100mg of morphine equivalence, opioid pain medications are ineffective. NONSENSE! They have no ceiling in most patients and may remain effective at dosages in the thousands.

Myth #2: All pain patients who take over 100mg of morphine equivalence are diverting or selling part of their prescription allotment. NONSENSE! Most patients who have a bad enough pain problem to need this much opioid don't usually want to part with it.

Myth #3: All patients who use the "Holy Trinity" of an opioid, benzodiazepine, and muscle relaxant are either selling their drugs or will shortly overdose. NONSENSE!

The original "Holy Trinity" was a simultaneous ingestion of a combination of the short-acting drugs hydrocodone (Norco), alprazolam (Xanax), and carisoprodol (Soma). A different, long-acting drug from either of the 3 classes (opioid, benzodiazepine, muscle-relaxant) markedly lowers the risk. So does taking the drugs separately.

Many severe, centralized pain patients have to take a drug from the 3 classes and do it safely and effectively. In other words, they take the drugs "as prescribed."

Additionally the “Holy Trinity,” originally called the “Houston Cocktail,” is a term coined by law enforcement. Addicts tend to use monosyllabic terms to refer to their poison of choice; “Holy Trinity” has too many syllables.

bigstock-+woman+Checking-The-Label-486812.jpg

Myth #4: Centralized, intractable pain doesn't exist. NONSENSE! Much research documents that pain from an injury or disease may cause glial cell activation and neuroinflammation, which may destroy brain and spinal cord tissue. Multiple, high dose drugs may be needed to prevent tissue damage and control the immense pain that this condition may produce. As inflammation develops, the overall stress on all organ systems increases dramatically, occasionally to a life-threatening level.

Myth #5: The risk of an opioid dosage over 100mg of morphine equivalence is too great to prescribe opioids above this level. NONSENSE! If a severe, chronic pain patient can't find control with opioid dosages below 100mg or with other measures, the benefit of the high dose far outweighs the risks.

Myth #6: Overdoses occur even if opioids and other drugs are taken as prescribed. NONSENSE! If this even happens, it is extremely rare. Overdose victims often take alcohol, marijuana and other drugs in combination, but opioids and the prescribing doctors are always blamed.

Myth #7: There are no "proven" benefits to long-term opioid therapy. NONSENSE! Simply talk to someone who has taken them for 10-20 years. Never has there been, nor will there ever be, a double-blind, placebo-controlled study to provide "evidence." Opioids are a last resort when all else fails. Opioids in doses >100mg have improved quality of life and prevented death in some instances.

Myth #8: Chronic, severe or intractable pain is just a nuisance that doesn't warrant the risk of opioids. NONSENSE! Severe pain has profound detrimental effects on the cardiovascular, immune, endocrine (hormone) and neurologic systems. Pain must be controlled or pain patients may die of stroke, heart attack, adrenal failure or infections due to a suppressed immune system.

Myth #9: Genetics has no effect on the need for a high opioid dosage. NONSENSE! Bigger and heavier people need a higher dose of medications (just add 1 drop of food coloring to a 1 gallon bucket and then a 5 gallon bucket and observe). It is well documented that some genetic variations impede opioid metabolism to the active form of the drug, or increase the speed the body excretes the opioid. Both metabolic variations will require a higher dosage.

Myth #10: All pain patients can get by on standard opioid dosages under 100mg. NONSENSE! There are persons who are outliers with all disease conditions such as heart failure, diabetes and asthma. Same with pain. A few unfortunate individuals will always require high dosages. Remember our friend the bell curve? What if YOU were on the extreme end?

Myth #11: All patients started on opioids some time ago can just suddenly stop opioids. NONSENSE! Once a person is on high dose opioids they don't dare suddenly stop, because sudden withdrawal may cause hypertension, tachycardia, adrenal failure, and sudden heart stoppage. Some patients who have stopped too suddenly have committed suicide because they had no way to control pain. Montana reports that 38% of all suicides in the state are pain patients, many of them undertreated.

Myth #12: There are plenty of alternatives to opioids. NONSENSE! Common pain problems are generally mild to moderate and respond to a variety of non-opioid treatments. Unfortunately, there are some severe, intractable pain patients who can only control their pain with opioids.

bigstock-Tell-Us-Your-Story-card-with-c-78557009.jpg

Forest Tennant is a pioneer in pain management who operates a pain clinic for intractable pain patients in West Covina, CA. His clinic was recently raided by DEA agents.

Ryle Holder is a Georgia pharmacist and patient of Dr. Tennant. Scott Guess operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management.

This column was distributed by Families for Intractable Pain Relief, a project of the Tennant Foundation.

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone.
 
It's time for pain medicine to make amends. Let's do the DEA and CA Medical Board a favor and critique these 3 charlatans. Forest needs to
do prison time like Hurwitz. I suspect that there are going to be a lot of pro bono experts for the prosecution.

12 Myths About Opioid Pain Medication
December 08, 2017


By Ryle Holder, PharmD, Scott Guess, PharmD, and Forest Tennant, MD, Dr. P.H.

Myth #1: Above 100mg of morphine equivalence, opioid pain medications are ineffective. NONSENSE! They have no ceiling in most patients and may remain effective at dosages in the thousands.

Myth #2: All pain patients who take over 100mg of morphine equivalence are diverting or selling part of their prescription allotment. NONSENSE! Most patients who have a bad enough pain problem to need this much opioid don't usually want to part with it.

Myth #3: All patients who use the "Holy Trinity" of an opioid, benzodiazepine, and muscle relaxant are either selling their drugs or will shortly overdose. NONSENSE!

The original "Holy Trinity" was a simultaneous ingestion of a combination of the short-acting drugs hydrocodone (Norco), alprazolam (Xanax), and carisoprodol (Soma). A different, long-acting drug from either of the 3 classes (opioid, benzodiazepine, muscle-relaxant) markedly lowers the risk. So does taking the drugs separately.

Many severe, centralized pain patients have to take a drug from the 3 classes and do it safely and effectively. In other words, they take the drugs "as prescribed."

Additionally the “Holy Trinity,” originally called the “Houston Cocktail,” is a term coined by law enforcement. Addicts tend to use monosyllabic terms to refer to their poison of choice; “Holy Trinity” has too many syllables.

bigstock-+woman+Checking-The-Label-486812.jpg

Myth #4: Centralized, intractable pain doesn't exist. NONSENSE! Much research documents that pain from an injury or disease may cause glial cell activation and neuroinflammation, which may destroy brain and spinal cord tissue. Multiple, high dose drugs may be needed to prevent tissue damage and control the immense pain that this condition may produce. As inflammation develops, the overall stress on all organ systems increases dramatically, occasionally to a life-threatening level.

Myth #5: The risk of an opioid dosage over 100mg of morphine equivalence is too great to prescribe opioids above this level. NONSENSE! If a severe, chronic pain patient can't find control with opioid dosages below 100mg or with other measures, the benefit of the high dose far outweighs the risks.

Myth #6: Overdoses occur even if opioids and other drugs are taken as prescribed. NONSENSE! If this even happens, it is extremely rare. Overdose victims often take alcohol, marijuana and other drugs in combination, but opioids and the prescribing doctors are always blamed.

Myth #7: There are no "proven" benefits to long-term opioid therapy. NONSENSE! Simply talk to someone who has taken them for 10-20 years. Never has there been, nor will there ever be, a double-blind, placebo-controlled study to provide "evidence." Opioids are a last resort when all else fails. Opioids in doses >100mg have improved quality of life and prevented death in some instances.

Myth #8: Chronic, severe or intractable pain is just a nuisance that doesn't warrant the risk of opioids. NONSENSE! Severe pain has profound detrimental effects on the cardiovascular, immune, endocrine (hormone) and neurologic systems. Pain must be controlled or pain patients may die of stroke, heart attack, adrenal failure or infections due to a suppressed immune system.

Myth #9: Genetics has no effect on the need for a high opioid dosage. NONSENSE! Bigger and heavier people need a higher dose of medications (just add 1 drop of food coloring to a 1 gallon bucket and then a 5 gallon bucket and observe). It is well documented that some genetic variations impede opioid metabolism to the active form of the drug, or increase the speed the body excretes the opioid. Both metabolic variations will require a higher dosage.

Myth #10: All pain patients can get by on standard opioid dosages under 100mg. NONSENSE! There are persons who are outliers with all disease conditions such as heart failure, diabetes and asthma. Same with pain. A few unfortunate individuals will always require high dosages. Remember our friend the bell curve? What if YOU were on the extreme end?

Myth #11: All patients started on opioids some time ago can just suddenly stop opioids. NONSENSE! Once a person is on high dose opioids they don't dare suddenly stop, because sudden withdrawal may cause hypertension, tachycardia, adrenal failure, and sudden heart stoppage. Some patients who have stopped too suddenly have committed suicide because they had no way to control pain. Montana reports that 38% of all suicides in the state are pain patients, many of them undertreated.

Myth #12: There are plenty of alternatives to opioids. NONSENSE! Common pain problems are generally mild to moderate and respond to a variety of non-opioid treatments. Unfortunately, there are some severe, intractable pain patients who can only control their pain with opioids.

bigstock-Tell-Us-Your-Story-card-with-c-78557009.jpg

Forest Tennant is a pioneer in pain management who operates a pain clinic for intractable pain patients in West Covina, CA. His clinic was recently raided by DEA agents.

Ryle Holder is a Georgia pharmacist and patient of Dr. Tennant. Scott Guess operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management.

This column was distributed by Families for Intractable Pain Relief, a project of the Tennant Foundation.

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

Blood boils....love the comments. Insightful.
 
The way out of the overdose epidemic with thanks to Andrew Kolodny, where
this tread began many years ago.

1. Prevent new cases of addiction: for us applying CDC guidelines.
2. Treat the addicted: for us getting and using our x-waivers.
3. Reduce the supply: again apply CDC for legacy patients and
moving forward keeping the opioid naive, naive.

The graph below is what happened in France in the 1990s when they were dealing
with a heroin/HIV/Hep C epidemic. They encouraged PCPs to Rx buprenorphine,
removed the cap and dropped the counseling requirement. 80% reduction in 5yrs.
 

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What would it take to get the Laser Spine Institute to stop marketing. It's almost every single day I hear about the "one inch incision". I'm bloody sick of it!
 
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What would it take to get the Laser Spine Institute to stop marketing. It's almost every single day I hear about the "one inch incision". I'm bloody sick of it!

What procedures do they offer that the patient can go home same day? One level fusion/laminectomy/ foraminotomy, percutaneous discectomy, MILD? Where I am finishing up my anesthesiology residency, we have 7-8 operating rooms doing nothing but spine surgery. Any alternative to flaying the back open, doing multilevel surgery, and dumping them to pain clinics after revision would be preferable.
 
Dream Land
"Children of the most privileged group in the wealthiest county in the history of the world were getting hooked and dying in almost epidemic number from substances meant to, of all things, numb pain.
"What pain?" a South Carolina cop asked rhetorically one afternoon as we toured the fine neighborhoods of south Charlotte where he arrested kids for pills and heroin."
 
Original Investigation
March 6, 2018
Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis PainThe SPACE Randomized Clinical Trial
Erin E. Krebs, MD, MPH1,2; Amy Gravely, MA1; Sean Nugent, BA1; Agnes C. Jensen, MPH1; Beth DeRonne, PharmD1; Elizabeth S. Goldsmith, MD, MS1,3; Kurt Kroenke, MD4,5,6; Matthew J. Bair4,5,6; Siamak Noorbaloochi, PhD1,2
Author Affiliations
JAMA. 2018;319(9):872-882. doi:10.1001/jama.2018.0899



FullText
Key Points
Question For patients with moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use, does opioid medication compared with nonopioid medication result in better pain-related function?

Findings In this randomized clinical trial that included 240 patients, the use of opioid vs nonopioid medication therapy did not result in significantly better pain-related function over 12 months (3.4 vs 3.3 points on an 11-point scale at 12 months, respectively).

Meaning This study does not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.

Abstract
Importance Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.

Objective To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.

Design, Setting, and Participants Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.

Interventions Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.

Main Outcomes and Measures The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).

Results Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).

Conclusions and Relevance Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.
 
Portenoy 1994. Opiates for CNCP. Guidelines:

  1. (1) Opioid therapy should be considered only after all other reasonable attempts at analgesia have failed.

  2. (2) The use of opioid therapy in an individual with a history of substance abuse is clinically complex and should be approached with great care. The inclusion of an individual experienced in addictions evaluation and treatment is recommended in such instances.

  3. (3) A single practitioner should take primary responsibility for treatment.

  4. (4) Patients should give informed consent before starting therapy; points to be covered include recognition of the low risk of true addiction as an outcome, potential for cognitive impairment with the drug alone and in combination with sedative/hypnotics, likelihood that physical dependence will occur (abstinence syndrome possible with acute discontinuation), and understanding by female patients that children born when the mother is on opioid therapy will likely be physically dependent at birth.

  5. (5) After drug selection, doses should be given around the clock; several weeks should be agreed on as the period of initial dose titration, and although improvement in function should be continually stressed, all should agree to at least partial analgesia as the appropriate goal of therapy.

  6. (6) Failure to achieve at least partial analgesia at relatively low initial doses in the nontolerant patient raises questions about the potential treatability of the pain syndrome with opioids.

  7. (7) Emphasis should be given to capitalizing on improved analgesia by gains in physical and social function; opioid therapy should be considered complementary to other analgesic and rehabilitative approaches.

  8. (8) In addition to the daily dose determined initially, patients should be permitted to escalate dose transiently on days of increased pain; two methods are acceptable: (a) prescription of an additional four to six “rescue doses” to be taken as needed during the month; or (b) instruction that one or two extra doses may be taken on any day, but must be followed by an equal reduction of dose on subsequent days.

  9. (9) Initially, patients must be seen and drugs prescribed at least monthly. When stable, less frequent visits may be acceptable.

  10. (10) Exacerbations of pain not effectively treated by transient, small increases in dose are best managed in the hospital, where dose escalation, if appropriate, can be observed closely and return-to-baseline doses can be accomplished in a controlled environ- ment.

  11. (11) Evidence of drug hoarding, acquisition of drugs from other physicians, uncontrolled dose escalation, or other aberrant behav- iors must be carefully assessed. In some cases, tapering and discontinuation of opioid therapy will be necessary. Other patients may appropriately continue therapy within rigid guidelines. Consideration should be given to consultation with an addiction medicine specialist.

  12. (12) At each visit, assessment should specifically address: (a) comfort (degree of analgesia);
    (b) opioid-related side-effects;
    (c) functional status (physical and psychosocial); and (d) existence of aberrant drug-related behaviors.

  13. (13) Use of self-report instruments may be helpful but should not be required.

  14. (14) Documentation is essential and the medical record should specifically address comfort, function, side-effects, and the occur- rence of aberrant behaviors repeatedly during the course of therapy.
 
Portenoy 1994. Opiates for CNCP. Guidelines:

  1. (1) Opioid therapy should be considered only after all other reasonable attempts at analgesia have failed.

  2. (2) The use of opioid therapy in an individual with a history of substance abuse is clinically complex and should be approached with great care. The inclusion of an individual experienced in addictions evaluation and treatment is recommended in such instances.

  3. (3) A single practitioner should take primary responsibility for treatment.

  4. (4) Patients should give informed consent before starting therapy; points to be covered include recognition of the low risk of true addiction as an outcome, potential for cognitive impairment with the drug alone and in combination with sedative/hypnotics, likelihood that physical dependence will occur (abstinence syndrome possible with acute discontinuation), and understanding by female patients that children born when the mother is on opioid therapy will likely be physically dependent at birth.

  5. (5) After drug selection, doses should be given around the clock; several weeks should be agreed on as the period of initial dose titration, and although improvement in function should be continually stressed, all should agree to at least partial analgesia as the appropriate goal of therapy.

  6. (6) Failure to achieve at least partial analgesia at relatively low initial doses in the nontolerant patient raises questions about the potential treatability of the pain syndrome with opioids.

  7. (7) Emphasis should be given to capitalizing on improved analgesia by gains in physical and social function; opioid therapy should be considered complementary to other analgesic and rehabilitative approaches.

  8. (8) In addition to the daily dose determined initially, patients should be permitted to escalate dose transiently on days of increased pain; two methods are acceptable: (a) prescription of an additional four to six “rescue doses” to be taken as needed during the month; or (b) instruction that one or two extra doses may be taken on any day, but must be followed by an equal reduction of dose on subsequent days.

  9. (9) Initially, patients must be seen and drugs prescribed at least monthly. When stable, less frequent visits may be acceptable.

  10. (10) Exacerbations of pain not effectively treated by transient, small increases in dose are best managed in the hospital, where dose escalation, if appropriate, can be observed closely and return-to-baseline doses can be accomplished in a controlled environ- ment.

  11. (11) Evidence of drug hoarding, acquisition of drugs from other physicians, uncontrolled dose escalation, or other aberrant behav- iors must be carefully assessed. In some cases, tapering and discontinuation of opioid therapy will be necessary. Other patients may appropriately continue therapy within rigid guidelines. Consideration should be given to consultation with an addiction medicine specialist.

  12. (12) At each visit, assessment should specifically address: (a) comfort (degree of analgesia);
    (b) opioid-related side-effects;
    (c) functional status (physical and psychosocial); and (d) existence of aberrant drug-related behaviors.

  13. (13) Use of self-report instruments may be helpful but should not be required.

  14. (14) Documentation is essential and the medical record should specifically address comfort, function, side-effects, and the occur- rence of aberrant behaviors repeatedly during the course of therapy.

Ah..."Opioids for Chronic Pain"...the dream of the 1990's...
 
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Fox News: Opioids: Facts and Fallacies

Greg Gutfeld: Opioids -- Facts and fallacies

“According to a recent article written by CDC officials in the American Journal of Public Health, death certificate data does not always differentiate between illegally and legally obtained drugs, so a fatal overdose involving illicitly manufactured fentanyl could have been counted as a legal opioid prescription death."
 
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Cash only
Seeing up to 100 patients per day (avg 65/day), per doc
Employing ex-cops instead of nurses
Sending patients discharged for failed drug screens to another doctor in system to ensure continued prescribing
Pre-signed script pads sitting around office
Giving narcs to employees without exam
Giving patients the "option" of not seeing a physician, still charging cash for opiate Rx
Multiple docs facing up to 200-300 years in prison

Everything not to do. Bad. Bad. Bad.


"FOR IMMEDIATE RELEASE
Tuesday, February 20, 2018

U.S. Attorney announces 69-count indictment charging owners, managers and physicians associated with Hope Clinic
United States Attorney Mike Stuart announced the unsealing of a 69-count indictment charging a total of 12 individuals with operating a “pill mill.” The indictment charges the owners, managers and physicians associated with HOPE Clinic, which operated as a purported pain management clinic in Beckley, Beaver and Charleston, West Virginia, as well as Wytheville, Virginia, and a related company, with conspiring to distribute oxycodone and other Schedule II controlled substances, not for legitimate medical purposes and outside the usual course of professional practice, from November 2010 to June 2015.

United States Attorney Mike Stuart was joined in the announcement by Special Agent in Charge Maureen Dixon, U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), Philadelphia Regional Office and Assistant Special Agent in Charge Sherri Arp, Internal Revenue Service Criminal Investigations (IRS CI), Washington, D.C. Field Office. “I commend the work of my team, under the leadership of AUSAs Monica Coleman and Meredith Thomas and the critical work of our law enforcement partners,” said United States Attorney Mike Stuart. Stuart commended the investigation conducted by agents with:

  • U.S. Department of Health and Human Services, OIG
  • Internal Revenue Service, Criminal Investigations
  • Food and Drug Administration – Office of Criminal Investigations (OCI)
  • Federal Bureau of Investigation
  • Drug Enforcement Administration
  • West Virginia State Police
  • Metropolitan Drug Enforcement Network Team (MDENT)
  • Beckley Police Department
  • Kentucky State Police
  • Harrison County (KY) Sheriff’s Department
  • Appalachia HIDTA
The charges announced today aggressively target medical professionals involved in the unlawful distribution of opioids and other dangerous controlled substances. “As of today, there are 69 counts. 10 doctors in total. Clinics from Beckley to Beaver, and Charleston to Wytheville. Lots and lots of pills, and even more misery,” said United States Attorney Mike Stuart. Stuart continued, “Home-grown drug dealers hidden behind the veil of a doctor’s lab coat, a medical degree and a prescription pad are every bit as bad as the heroin dealers from Detroit who bring their poisons to West Virginia. Today’s 69-count indictment is the continuation of our efforts to hold accountable those who prey on the good citizens of West Virginia.”

The following individuals are charged in the indictment: James H. Blume, Jr., D.O, Mark T. Radcliffe, Joshua Radcliffe, Michael T. Moran, M.D., Sanjay Mehta, D.O., Brian Gullett, D.O., Vernon Stanley, M.D., Mark Clarkson, D.O., William Easley, D.O., Paul W. Burke, M.D., Roswell Tempest Lowry, M.D., and Teresa Emerson, LNP. “We are committed to protecting all those in government health programs,” said Maureen R. Dixon, Special Agent in Charge of the Office of Inspector General for the U.S. Department of Health and Human Services. “Working side by side with our law enforcement partners we will aggressively investigate charges of medical providers needlessly prescribing deadly opioids.”

In addition to the conspiracy charge, the indictment charges defendants Blume and Mark Radcliffe with maintaining drug-involved premises in Beckley, Beaver and Charleston, and includes 62 counts charging several physicians with distribution of controlled substances not for legitimate medical purposes and outside the usual course of professional practice. The indictment also charges Sanjay Mehta, D.O., a former physician at the Beckley and Beaver HOPE Clinic locations, with two counts of distribution of controlled substances causing death, and charges 10 of the defendants with conspiracy to launder drug proceeds by paying bonuses to HOPE Clinic physicians and employees of Patients, Physicians, and Pharmacists Fighting Diversion, Inc. (PPPFD), to encourage continued prescribing of Schedule II narcotics to customers.

According to the indictment, defendant James H. Blume, Jr., D.O., the owner of the HOPE Clinic, entered into a Physician Practice Management Agreement with defendant Mark T. Radcliffe, owner of PPPFD, to be the practice manager of the HOPE Clinic. The indictment alleges that together Blume and Radcliffe operated HOPE Clinic as a cash-based business that prescribed oxycodone and other Schedule II controlled substances to customers, while refusing to accept insurance, charging in-state customers at least $275 for an initial appointment, and at least $160 for each subsequent appointment. Out of state customers paid as much as $330 for initial visits and at least $185 for subsequent visits. The indictment alleges that HOPE Clinic practitioners prescribed thousands of oxycodone-based pills to individual customers and some HOPE Clinic locations, including Beaver and Charleston, averaged 65 or more customers a day during a 10-hour workday with only one practitioner working. In addition, the indictment alleges that Blume and Mark T. Radcliffe contracted the services of physicians without any knowledge of pain management who consistently conducted cursory, incomplete, or no medical examinations of Clinic customers and provided large amounts of Schedule II prescription medications to customers that they knew, and had reasonable cause to believe, were drug addicts. The indictment further alleges that Mark T. Radcliffe and his son, Joshua Radcliffe, neither of whom had any formal medical education or training, instructed medical practitioners at HOPE Clinic to provide customers with prescriptions for Schedule II controlled substances, sometimes in direct contrast with the practitioners’ clinical opinions.

"Those who facilitate the abuse of controlled dangerous substances are negatively impacting our entire community and will be held accountable,” said Kimberly Lappin, Special Agent in Charge, IRS Criminal Investigation, Washington D.C. Field Office. “Today’s indictment is a reminder that IRS-CI will remain vigilant in our financial investigations and will continue to work with our law enforcement partners to combat this type of conduct.”

If convicted on all charges as alleged in the indictment, Dr. Blume and Mark Radcliffe face up to 100 years; Joshua Radcliffe faces up to 20 years; Teresa Emerson faces up to 20 years; Michael Moran faces up to 60 years; Sanjay Mehta faces a forty year mandatory minimum sentence up to life imprisonment; Vernon Stanley faces up to 240 years; Brian Gullett faces up to 340 years; Mark Clarkson faces up to 80 years; William Earley faces up to 200 years; Paul Burke faces up to 180 years; and Roswell Tempest Lowry faces up to 120 years. In a related case, John Pellegrini faces up to 20 years imprisonment for his role in a conspiracy to commit money laundering.

This case is part of an ongoing effort led by the United States Attorney’s Office for the Southern District of West Virginia to combat the illicit sale and misuse of prescription drugs and heroin. The U.S. Attorney’s Office, joined by federal, state and local law enforcement agencies, is committed to aggressively pursuing and shutting down pill trafficking, eliminating open air drug markets, and curtailing the spread of opiate painkillers and heroin in communities across the Southern District. "





Here's the actual indictment:

https://www.justice.gov/usao-sdwv/press-release/file/1036381/download
 
here is a good read as to some of the standards of care and what the government expects. the doc was writing for 60 Norco, 60 Xanax, and 60 soma, the holy trinity. but clearly Gov doesn't think that docs can get off scott free writing under 90 MED... the alcohol part is also very revealing.

https://www.deadiversion.usdoj.gov/fed_regs/actions/2018/fr0430.pdf
 
Where did we go wrong?

This was on BBC this week:

Sweet Sweet Codeine - BBC World News

Nigeria and black market Codeine cough syrup.

the Nigerian gov banned Codeine cough syrup < 24 hours after this report came out.


How many degrees stronger are oxy 30s and heroin the US addict gets, I ask...

And... What has the US gov done??

(FYI oxy 30s are 15 times stronger than Codeine 30 mg...)
 
but clearly Gov doesn't think that docs can get off scott free writing under 90 MED...

Because pill mills are still illegal and they can obviously still run a pill mill under 90 MED. That doesn't mean that any legitimate doctor is at risk of having their license suspended just for writing under 90 MED....

"it was clear in the undercover recordings that this Respondent was not engaging in a thorough physical examination or asking probing, sincere questions regarding symptoms present in the two undercover investigators that would warrant pain medicine"

The undercover cop also admitted to running out of pills early, trading pills with the neighbor, and using Xanax so that he wouldn't drink as much moonshine. The doctor didn't care about any of that. The doctor was discussing how much these pills would be worth on the street. The PDMP showed that the patient was doctor shopping for Xanax, which was also ignored. Sounds legit.....
 
Last edited:
You agree with what I wrote.

My point - don’t think by just writing for <90 MED the govt won’t come after you. The govt expects certain standards of care that are well pointed out in the site.
 
One Opioid Crisis or Many? | American Council on Science and Health


Two insights emerge:

  1. There were major variations but no trends in opioid OD death rates and opioid prescription rates from State to State in 2016.
  2. Opioid OD death rates had no apparent relationship to opioid prescription rates from State to State. Any effect of medical prescribing on OD deaths was literally “lost in the noise” of other factors.

"These State to State outcomes suggest that the US is dealing with not one National opioid crisis but many local crises. In 2016, medical prescribing contributed almost nothing to these crises."
 
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I agree we have multiple opioid crises. However, the start of the crisis is the opioid overprescribing.

As I have stated many times, decreasing opioid prescribing won’t decrease the number of current addicted legacy patients, but it may reduce the opioid addiction rate for the virgin patients out there. I guess it may save the life of one of overprescribed patients...
 

First, Marijuana. Are Magic Mushrooms Next in Oregon?
Barbara Feder Ostrov, Kaiser Health News

In Oregon and Denver, where marijuana is legal for recreational use, activists are now pushing toward a psychedelic frontier: “magic mushrooms.”

Groups in both states are sponsoring ballot measures that would eliminate criminal penalties for possession of the mushrooms whose active ingredient, psilocybin, can cause hallucinations, euphoria and changes in perception. They point to research showing that psilocybin might be helpful for people suffering from depression or anxiety.

“We don’t want individuals to lose their freedom over something that’s natural and has health benefits,” said Kevin Matthews, the campaign director of Denver for Psilocybin, the group working to decriminalize magic mushrooms in Colorado’s capital.

The recent failure of a nationally publicized campaign to decriminalize hallucinogenic mushrooms in California may not portend well for the psilocybin advocates in Oregon and Denver — though their initiatives are more limited than California’s.

The proposal in the Golden State would have decriminalized sales and transportation of magic mushrooms, not just possession. The proposed Denver measure would apply only to that city, while in Oregon mushroom use would be allowed only with the approval of a physician and under the supervision of a registered therapist.

None of the proposed initiatives envisions fully legalizing psilocybin mushrooms, which would allow the government to regulate and tax sales in a similar fashion to medical and recreational marijuana.

In Oregon, advocates face a steep climb to qualify their measure for the ballot, because such statewide initiatives typically require hiring paid signature gatherers, said William Lunch, a political analyst for Oregon Public Broadcasting and a former political science professor at Oregon State University.

Still, familiarity with recreational marijuana may have “softened up” voters and opponents of drug decriminalization, he said. Oregon legalized marijuana for recreational use in 2015, Colorado in 2012.

The Oregon and Denver activists, echoing Lunch, say they hope voters who already accepted pot would now feel comfortable decriminalizing personal use of magic mushrooms as well.

Taking mushrooms can lead to nausea, panic attacks and, rarely, paranoia and psychosis. But they generally are considered safer and less addictive than other illegal street drugs.

Even so, Paul Hutson, professor of pharmacy at the University of Wisconsin who has conducted psilocybin research, says he is wary of the drive for decriminalization. Psilocybin isn’t safe for some people — particularly those with paranoia or psychosis, he said.

“I reject the idea that this is a natural progression from medical marijuana,” Hutson said, noting that the safety of pot is much better established. Mushrooms, he added, “are very, very potent medicines that are affecting your mind. In the proper setting, they’re safe, but in an uncontrolled fashion, I have grave concerns.”

Even psilocybin advocates share Hutson’s concerns. “It is such a powerful compound. People should take it very seriously when experimenting,” Matthews said.

These efforts to legitimize hallucinogenic mushrooms come at a time of renewed interest in the potential mental health benefits of psychedelics, including mushrooms, LSD and MDMA (known as ecstasy). Two small studies published in 2016 by researchers from Johns Hopkins University and New York University found that a single large dose of psilocybin, combined with psychotherapy, helped relieve depression and anxiety in cancer patients.

A British company backed by Silicon Valley investor Peter Thiel plans clinical studies in eight European countries to test the use of psilocybin for depression. Other research has examined the effectiveness of psilocybin in treating alcohol and tobacco addiction.

In California, the campaign to decriminalize psilocybin was always a long shot — even though the famously liberal state legalized possession of recreational marijuana in November 2016 and sales starting this year.

California ballot measures typically require nearly 366,000 signatures to qualify, and supporters usually have to spend between $1 million and $2 million to pay signature gatherers. A Monterey County couple leading the decriminalization campaign managed to collect more than 90,000 signatures for their proposal with the help of volunteers, but they halted their efforts late last month.

The initiative would have exempted Californians 21 and over from criminal penalties for possessing, selling, transporting or cultivating psilocybin mushrooms.

Possessing them is generally a misdemeanor under California law, but selling them is a felony. State statistics on psilocybin offenses are scarce, but few people are jailed for such crimes, according to an analysis by the California attorney general’s office.

“It’s not a reckless community,” said Kitty Merchant of Marina, Calif., who spearheaded the California psilocybin campaign alongside her husband, Kevin Saunders. “It’s experimentation with your mind and your thoughts. There’s a safeness to it. And there’s an intelligence to it.”

Merchant said she and Saunders, both medical marijuana advocates, spent about $20,000 of their own money on the campaign.

In Denver, Matthews and his pro-psilocybin colleagues want voters to pass a city ordinance eliminating criminal penalties for possessing, using or growing magic mushrooms. City officials have cleared the measure for signature gathering. Supporters need 5,000 signatures to get it on the ballot in November. Matthews said he has already lined up dozens of volunteer signature gatherers.

He said he has used mushrooms to help alleviate depression and other mental health problems. A big part of the decriminalization campaign, he said, is promoting responsible use.

Denver, a progressive city in a state that was the first to legalize recreational marijuana, “is a good testing place for this initiative nationwide,” Matthews said. Just getting it on the ballot, whether or not it passes, would be “a huge victory,” he added.

In Oregon, activists are proposing a measure for the 2020 ballot that would decriminalize psilocybin statewide for adults 21 and over who get approval from their doctors and agree to participate in a “psilocybin service.” The service would include a preparatory meeting with a therapist, one session of supervised mushroom use and a follow-up visit. Patients would be under the care of state-certified “Psilocybin Service Facilitators.”

Tom Eckert, a Portland, Ore.-based therapist who leads the psilocybin decriminalization campaign with his wife, Sheri, said the proposed limitations on psilocybin use are important.

“Psilocybin is generally safe, but it puts you in a vulnerable state of mind,” he said. “If you do it in the wrong setting, things can go sideways.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

May 16 2018
 
First, Marijuana. Are Magic Mushrooms Next in Oregon?
Barbara Feder Ostrov, Kaiser Health News

In Oregon and Denver, where marijuana is legal for recreational use, activists are now pushing toward a psychedelic frontier: “magic mushrooms.”

Groups in both states are sponsoring ballot measures that would eliminate criminal penalties for possession of the mushrooms whose active ingredient, psilocybin, can cause hallucinations, euphoria and changes in perception. They point to research showing that psilocybin might be helpful for people suffering from depression or anxiety.

“We don’t want individuals to lose their freedom over something that’s natural and has health benefits,” said Kevin Matthews, the campaign director of Denver for Psilocybin, the group working to decriminalize magic mushrooms in Colorado’s capital.

The recent failure of a nationally publicized campaign to decriminalize hallucinogenic mushrooms in California may not portend well for the psilocybin advocates in Oregon and Denver — though their initiatives are more limited than California’s.

The proposal in the Golden State would have decriminalized sales and transportation of magic mushrooms, not just possession. The proposed Denver measure would apply only to that city, while in Oregon mushroom use would be allowed only with the approval of a physician and under the supervision of a registered therapist.

None of the proposed initiatives envisions fully legalizing psilocybin mushrooms, which would allow the government to regulate and tax sales in a similar fashion to medical and recreational marijuana.

In Oregon, advocates face a steep climb to qualify their measure for the ballot, because such statewide initiatives typically require hiring paid signature gatherers, said William Lunch, a political analyst for Oregon Public Broadcasting and a former political science professor at Oregon State University.

Still, familiarity with recreational marijuana may have “softened up” voters and opponents of drug decriminalization, he said. Oregon legalized marijuana for recreational use in 2015, Colorado in 2012.

The Oregon and Denver activists, echoing Lunch, say they hope voters who already accepted pot would now feel comfortable decriminalizing personal use of magic mushrooms as well.

Taking mushrooms can lead to nausea, panic attacks and, rarely, paranoia and psychosis. But they generally are considered safer and less addictive than other illegal street drugs.

Even so, Paul Hutson, professor of pharmacy at the University of Wisconsin who has conducted psilocybin research, says he is wary of the drive for decriminalization. Psilocybin isn’t safe for some people — particularly those with paranoia or psychosis, he said.

“I reject the idea that this is a natural progression from medical marijuana,” Hutson said, noting that the safety of pot is much better established. Mushrooms, he added, “are very, very potent medicines that are affecting your mind. In the proper setting, they’re safe, but in an uncontrolled fashion, I have grave concerns.”

Even psilocybin advocates share Hutson’s concerns. “It is such a powerful compound. People should take it very seriously when experimenting,” Matthews said.

These efforts to legitimize hallucinogenic mushrooms come at a time of renewed interest in the potential mental health benefits of psychedelics, including mushrooms, LSD and MDMA (known as ecstasy). Two small studies published in 2016 by researchers from Johns Hopkins University and New York University found that a single large dose of psilocybin, combined with psychotherapy, helped relieve depression and anxiety in cancer patients.

A British company backed by Silicon Valley investor Peter Thiel plans clinical studies in eight European countries to test the use of psilocybin for depression. Other research has examined the effectiveness of psilocybin in treating alcohol and tobacco addiction.

In California, the campaign to decriminalize psilocybin was always a long shot — even though the famously liberal state legalized possession of recreational marijuana in November 2016 and sales starting this year.

California ballot measures typically require nearly 366,000 signatures to qualify, and supporters usually have to spend between $1 million and $2 million to pay signature gatherers. A Monterey County couple leading the decriminalization campaign managed to collect more than 90,000 signatures for their proposal with the help of volunteers, but they halted their efforts late last month.

The initiative would have exempted Californians 21 and over from criminal penalties for possessing, selling, transporting or cultivating psilocybin mushrooms.

Possessing them is generally a misdemeanor under California law, but selling them is a felony. State statistics on psilocybin offenses are scarce, but few people are jailed for such crimes, according to an analysis by the California attorney general’s office.

“It’s not a reckless community,” said Kitty Merchant of Marina, Calif., who spearheaded the California psilocybin campaign alongside her husband, Kevin Saunders. “It’s experimentation with your mind and your thoughts. There’s a safeness to it. And there’s an intelligence to it.”

Merchant said she and Saunders, both medical marijuana advocates, spent about $20,000 of their own money on the campaign.

In Denver, Matthews and his pro-psilocybin colleagues want voters to pass a city ordinance eliminating criminal penalties for possessing, using or growing magic mushrooms. City officials have cleared the measure for signature gathering. Supporters need 5,000 signatures to get it on the ballot in November. Matthews said he has already lined up dozens of volunteer signature gatherers.

He said he has used mushrooms to help alleviate depression and other mental health problems. A big part of the decriminalization campaign, he said, is promoting responsible use.

Denver, a progressive city in a state that was the first to legalize recreational marijuana, “is a good testing place for this initiative nationwide,” Matthews said. Just getting it on the ballot, whether or not it passes, would be “a huge victory,” he added.

In Oregon, activists are proposing a measure for the 2020 ballot that would decriminalize psilocybin statewide for adults 21 and over who get approval from their doctors and agree to participate in a “psilocybin service.” The service would include a preparatory meeting with a therapist, one session of supervised mushroom use and a follow-up visit. Patients would be under the care of state-certified “Psilocybin Service Facilitators.”

Tom Eckert, a Portland, Ore.-based therapist who leads the psilocybin decriminalization campaign with his wife, Sheri, said the proposed limitations on psilocybin use are important.

“Psilocybin is generally safe, but it puts you in a vulnerable state of mind,” he said. “If you do it in the wrong setting, things can go sideways.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

May 16 2018


Milk of the poppy is next. Then we could focus on health and fitness. Freedom from needing rx for any drug. Survival of the fittest.
 
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Opinion | Drug policies without compassion are doomed to fail

"And that’s because prescriptions aren’t the problem. Sure, the epidemic might have had its roots in prescription painkillers. But the fact remains that the vast majority of people who use prescription opioids under medical supervision do not become addicted. The real danger is illicit opioids, such as heroin and fentanyl. That doesn’t mean we should do away with drug monitoring, but we need to stop thinking about the crisis as solely a supply problem."
 
like all articles that defend writing whatever the patient wants, this article misses the epidemiologic point - exposing more people to opioids/narcotics from the start increases risk of overdose.


stop exposing people to narcotics, less chance in the future of causing addicted people. the ones already exposed are kind of doomed - they are the ones that benefit from treatment.
 
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