Cutting of pain management therapy.. turning a “maker” into a “taker”

I have chronic back pain and hereditary migraines. I had been taking fiornal w/ codeine when I lived in California. During my worst month I was at 120 pills. And I had been managing my pain with that drug for probably 26 years.

 I recently moved to Washington state and the pain management clinic dropped me to 5mg fioricet. This is completely insufficient. I am literally at risk of losing my job because I’m paralyzed with pain.

What can I do?

 

Fiorinal with Codiene has 30 mg of Codeine in each capsule… so using those “fussy math” opiate conversion table… this pt was getting morphine equivalents of 18 mg/day..

The only difference between Fiorinal and Fioricet is that the former has Aspirin in it and the latter has Acetaminophen (Tylenol) in it..

So this pain clinic changed this pt’s medication and basically dropping the (fairly low dose of) Codeine from the pt’s pain management.

Since he is employed and this pain clinic’s decisions – plan of treatment – causes him to lose his job… then that is monetary damages and some law firm may be willing to sue for monetary damages.

Apparently this pt has documentation was to what was working for him and this pain clinic has made a intentional decision to cut the Codeine out of his therapy and could cause the pt to lose his job.

Aspirin Bleeding Risk in Over 75s Higher Than Thought

Aspirin Bleeding Risk in Over 75s Higher Than Thought

http://www.medscape.com/viewarticle/881575

Taking aspirin for secondary prevention of stroke or myocardial infarction (MI) is associated with a higher than expected risk for disabling or fatal bleeding in people aged 75 years and older, a new observational study shows.

The authors suggest that all patients aged 75 years or older prescribed aspirin for secondary prevention should also be given a proton-pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding. 

The study was published online in The Lancet on June 13.

“We knew before that there was an increased risk of bleeding with aspirin in the elderly, but what we didn’t know was how high that risk was and the consequences of those bleeds,” senior author, Peter Rothwell, MD, John Radcliffe Hospital, University of Oxford, United Kingdom, explained to Medscape Medical News.

 “There has been a sense that antiplatelets prevent important ischemic events, such as stroke and MI, and while we knew there is an increased risk of bleeding, this was seen as bit of a nuisance and not equivalent to the ischemic events. But our data shows that actually the bleeding is more likely to be disabling than the strokes in this age group so really needs to be taken more seriously.”

Professor Rothwell notes that many of these bleeds are preventable with PPIs.     

“About half the bleeds in this study were GI bleeds and more than half of disabling or fatal bleeding were GI, and we know from previous studies that PPIs can prevent about 80% of GI bleeding caused by antiplatelet agents.” 

He pointed out that current guidelines advise that patients receiving long-term antiplatelet drugs should be co-prescribed a PPI if they are high risk for bleeding, but they don’t define “high risk.”

“Our data show that pretty much anyone 75 years of age or over should be categorized as high risk,” he said. “I think we could make a reasonable argument for everyone in this age group who is taking long-term antiplatelet therapy for secondary prevention of MI or stroke to be also prescribed a PPI.”

Is Aspirin Necessary Long Term?

But the question has also been raised as to whether long-term aspirin should be prescribed for these patients in the first place.

Commenting for Medscape Medical News on the new study, John Cleland, MD, Imperial College London, United Kingdom, who has long been an aspirin skeptic, suggested that these new data provide further evidence against giving aspirin long term after a stroke or MI.

 “There is no compelling evidence that aspirin continued for greater than 28 days after an event is beneficial,” Dr Cleland said. “The antiplatelet meta-analysis is based on long-term trials that were neutral and done more than 40 years ago before the era of modern medicine. ISIS-2, the only truly positive study, only treated post-MI for 28 days.”

“Doctors should know they are using guesswork rather than evidence-based medicine if they give aspirin for longer than 28 days,” he added. “We need to stop prescribing useless polypharmacy. And PPIs can have risks too, such as increased risk of Clostridium.”

 Responding to this, Professor Rothwell said, “It’s a very difficult question on whether aspirin should be given to older patients long term as all the studies have been done in younger patients. There isn’t much trial information on this age group, so we can’t, hand on heart, say there is a clear-cut benefit long term in the elderly.”   

“But we don’t want to throw the baby out with the bath water,” he added. “I think we need to conform to the guidelines, which recommend that everyone should have an antiplatelet drug after an MI or stroke to reduce recurrent ischemic events, even the elderly. However, we need to do more to prevent bleeding with these drugs.”

 He acknowledged that there is a question about how long aspirin should be given. “We could perhaps do a trial where aspirin is withdrawn after a year or so in those patients without active cardiovascular disease. That is a valid research question.”
 Oxford Vascular Study

For the study, the researchers analyzed bleeding events in 3166 patients (50% age 75 years or older) treated with antiplatelet drugs (mainly aspirin based) after a first transient ischemic attack, ischemic stroke, or MI in the Oxford Vascular Study, a population-based study of the incidence and outcome of all acute vascular events in a population of 92,728 individuals, irrespective of age, registered at nine general practices in Oxfordshire, United Kingdom.

 Patients were started on antiplatelets from 2002 to 2012, with follow-up until 2013. Around 30% were receiving some sort of gastric protection (PPI or histamine-2 antagonist).
 Results showed that 405 patients had first bleeding events (218 gastrointestinal, 45 intracranial, 142 other) during 13,509 patient-years of follow-up. The average annual risk for bleeding was 3.36%; the risk for major bleeding was 1.46%.
 Risk of nonmajor bleeding was unrelated to age, but the annual risk for major bleeding increased steeply above age 70 years, reaching 4.1% at age 85 years or older, with similar patterns for both life-threatening and fatal bleeding. This finding reflects high risks of upper GI and intracranial bleeding at older ages.
 The hazard ratio (HR) for major bleeding in patients aged 75 years or older was 3.10, and the HR for fatal bleeding in this age group was 5.53 (compared to those younger than age 75 years).
 The same was true of major upper GI bleeds (≥75 years: HR, 4.13), and the risk was particularly increased for disabling or fatal GI bleeding (HR, 10.26) in this age group.
 There were 489 nonfatal and 208 fatal ischemic vascular events during follow-up. The ratio of major bleeds to ischemic events increased sharply with age: 0.20 in patients younger than 75 years, 0.32 for those aged 75 to 84 years, and 0.46 for those aged 85 years or older.
 The authors further point out that the risk for major bleeds estimated to be attributable to antiplatelet treatment was similar to the risk for ischemic events estimated to have been prevented in the group 85 years of age or older.  
 They report that in the 75-years-or-older group, major upper GI bleeds were mostly disabling or fatal (45 of 73 patients [62%]) and were more likely to be disabling and fatal than recurrent ischemic strokes (101 of 213 patients [45%]).     
 Disabling or fatal GI bleeds also outnumbered disabling or fatal intracerebral hemorrhage (45 vs 18) in this age group.
 The researchers tried to assess the benefit that routine PPI treatment may have in this population by using data from a meta-analysis of randomized trials of PPIs vs placebo in patients taking antiplatelet drugs (predominantly aspirin), in which PPI use reduced upper gastrointestinal bleeding by 74%.

Using this estimate, they estimate that the number need to treat (NNT) with PPIs to prevent one major upper GI bleed at 5 years’ follow-up is 80 for patients younger than 65 years, 75 for patients aged 65 to 74 years, 23 for patients aged 75 to 84 years, and 21 for patients aged 85 years or older.

 The NNT with PPIs to prevent one disabling or fatal upper GI bleed at 5 years’ follow-up also decreased with age, from 338 for patients younger than 65 years to 25 for patients aged 85 years or older.
 In a comment accompanying the Lancet paper, Hans-Christoph Diener, MD, University Duisburg-Essen, Essen, Germany, says that the benefit–risk association of long-term antiplatelet therapy should be regularly evaluated in patients older than 75 years, as is done with oral anticoagulants in patients with atrial fibrillation. 
 He agrees with the researchers that the study supports the use of PPIs in patients aged 75 years or older receiving antiplatelet therapy.
 Dr Diener points out that PPIs are underused in patients receiving antiplatelet therapy, perhaps because the consequences of upper GI bleeds were underestimated in elderly patients who were treated with aspirin. 
 He also notes that a study published last year suggested a correlation between PPI use and dementia “was reported widely in the media and created a lot of confusion and angst” but was small and underpowered.
 Professor Rothwell noted that PPIs prevent only GI bleeding, and there would still be other bleeds, the most serious of which are intracerebral hemorrhage (ICH). “This is an issue that needs to be considered, and we need to focus on patients’ blood pressure to reduce the ICH risk. But on the whole non-GI bleeding is less preventable.
 “Our recommendation is that all patients 75 years of age or over discharged after a stroke or MI on aspirin should be co-prescribed a PPI, and this should be continued long-term.”  
 At present, patients are often prescribed aspirin at discharge, with hospital physicians thinking the family doctor may follow up with a PPI, but that doesn’t necessarily happen, he said.   
 “Also, while we don’t feel that all patients over 75 currently taking antiplatelet agents should be recalled at this point in order to start a PPI, I do think it is reasonable that when they do go to see their family doctor they are advised to start a PPI,” he said. “Our data show that while the risk of bleeding is highest in the first couple of years it is still significantly elevated over the longer term.”  
 The researchers estimate about half the population older than age 75 is taking aspirin (60% of the US population vs 40% of the UK population in this age group). The current study included patients taking aspirin for secondary prevention after having had a stroke, transient ischemic attack, or MI. Professor Rothwell estimates that these patients make up about two thirds of those taking aspirin, with the other third taking aspirin for primary prevention of cardiovascular disease.
 “I think our results can be applied to the secondary prevention population immediately, but it is not clear whether the primary prevention population taking aspirin also need to be on a PPI, as they do seem to have a lower risk of bleeding.”

 

Lawsuit challenges Kentucky’s ban on using marijuana for medical purposes

 

Lawsuit challenges Kentucky’s ban on using marijuana for medical purposes

http://www.kentucky.com/news/politics-government/article156091284.html

Several Kentuckians who say they get relief from medical marijuana filed a lawsuit Wednesday to challenge the state’s criminal ban on the drug, arguing that cannabis is naturally effective and does not have the addictive dangers of opioid painkillers.

In their suit, filed in Franklin Circuit Court, Dan Seum Jr., 59, and Amy Stalker, 37, both of Jefferson County, and Danny Belcher, 69, of Bath County say that over half of Americans now are permitted by the states where they live to use marijuana for chronic pain and other ailments. But in Kentucky, depending on how much of the drug they possess, marijuana users risk felony or misdemeanor convictions that could put them behind bars.

The plaintiffs are asking the court to decriminalize marijuana possession and trafficking for themselves “insofar as they seek to use cannabis for valid medicinal purposes.” Under Kentucky law, having eight or more ounces of marijuana in one’s possession is considered sufficient evidence of intent to sell it to others.

“It becomes cruel when you have a solution that works and is helping people in other states, but if people use it here, they’re criminals,” Stalker said in a recent interview.

Stalker said she has a long history of health problems due to irritable bowel syndrome and bipolar disorder and the powerful pharmaceutical drugs that were prescribed to her to treat those conditions. In recent years, Stalker said, she has successfully treated herself with a combination of cannabis, amino acids and other natural substances that are gentler to her body.

 

Stalker still carries the medical marijuana patient’s license the state of Colorado issued her four years ago when she lived there and a prescription written by her doctor for the strain called Bubble Hash. However, both pieces of paper became worthless the day she moved back to Kentucky to care for her ailing mother.

“When I’ve talked to legislators in Frankfort about this, their advice was for me to move away again, to go live in a state where it’s legal,” she said. “But I grew up here. I love it here. My family is here. Is that really a choice I should have to make to stay healthy?”

It’s “getting appalling” that Kentucky leaders have consistently ignored their constituents’ pleas to allow marijuana, “especially when the Bourbon Trail is such a fabulous thing to boast about,” Seum said.

Amy Stalker says she had more control over her own health when she lived in Colorado, where marijuana can be legally prescribed as medicine. Stalker now lives in Kentucky, where medical use of marijuana is banned.

jcheves@herald-leader.com

The plaintiffs are represented by Dan Canon, a Louisville civil-rights attorney who was part of the legal team that defeated Kentucky’s ban on same-sex marriage in 2015.

The suit names Gov. Matt Bevin, a Republican, and Attorney General Andy Beshear, a Democrat, as defendants. It claims that Kentucky’s medical marijuana ban violates the plaintiffs’ rights under the Kentucky Constitution to privacy and to be free of the “absolute and arbitrary power” of the state over their “lives, liberty and property.”

“The exercise of the commonwealth’s police powers to criminalize cannabis for medicinal purposes is an unjust result of the broad prohibition against cannabis and has wrought an unjust hardship for Mr. Seum, Ms. Stalker, Mr. Belcher and thousands of other medical cannabis users in Kentucky who were left with the unconscionable choice to either live in permanent pain from their illnesses, risk taking highly addictive and proven deadly opioids or benzodiazepines, or live as criminals for their use of cannabis to treat their illnesses,” the suit claims.

Smoked or ingested, cannabis has been used as medicine for most of recorded history. It was a legal remedy in the United States as recently as the mid-20th century. In 1970, however, as the war on drugs began, the U.S. government classified marijuana as a Schedule 1 controlled substance, the designation intended for drugs — like heroin — that are supposed to have a high potential for addiction and no medical value.

Since 1996, 29 states and the District of Columbia have authorized the medical use of marijuana within their borders, including West Virginia, Ohio and Illinois. While the federal government still considers the drug to be illegal nationwide, Congress voted in May to give the U.S. Justice Department no money to prosecute medical marijuana cases in states where such use has been permitted.

Kentucky is not one of those states. The Kentucky General Assembly — where plaintiff Seum’s father is a longtime Republican state senator — has rejected several medical marijuana bills in recent years. The one it did approve, Senate Bill 124 in 2014, was very narrowly written: It let certain pediatric seizure patients use an oil derived from hemp and marijuana under carefully controlled conditions.

The state officials named as defendants in the suit appear split over the subject. Bevin has said on several occasions that he would support legalization of marijuana for medical use, although not for recreational use.

“The devil is in the details,” Bevin said during a radio interview in February. “I am not against the idea of medical marijuana if prescribed like other drugs, if administered in the same way that we would other pharmaceutical drugs. I think it would be appropriate in many respects. It has absolute medicinal value. But again, that’s a function of (a bill) making its way to me. I don’t get to do that executively, it would have to be a bill.”

In contrast, Beshear said during his 2015 attorney general campaign that he would not consider even limited legalization unless the U.S. Food and Drug Administration authorized cannabis as a medicine.

On Wednesday, spokespeople for the two elected officials said they have not had adequate opportunity to review the lawsuit.

In their suit, the plaintiffs explain the myriad ways that cannabis has helped them.

Seum, for example, was a football coach at Farnsley Middle School in Louisville from 2008 to 2012. Worsening back pain led him to try spinal fusion surgery, followed by an OxyContin prescription. He soon realized, to his horror, that he had become addicted to OxyContin, affecting his cognitive and motor skills and interfering with his coaching job. So he asked his doctor to begin reducing the dosage.

Seum started using cannabis to manage his pain and nausea from OxyContin withdrawal. Since then, several doctors have refused to help Seum with his continuing back problems unless he agreed to stop using marijuana. He has self-medicated with cannabis since 2014.

But possessing the drug is illegal, with penalties that can vary depending on the attitude of local law enforcement. A Jefferson County police officer who caught him with “a tiny fraction of an amount” gave him a $67 citation for the drug; a prosecutor in Grayson County sent him to jail for two days for roughly the same amount.

“It was gonna be four (days) and they made it two, the judge did, and I had to do two days in jail,” Seum said in a recent interview. “I couldn’t have my meds. I had to sleep on a cold, steel rack with four rods in my back. It was terrible, terrible. But there was no getting out of it.”

Belcher served in the Vietnam War during the late 1960s as a combat infantry sergeant. As a result of his combat service, Belcher suffers from post-traumatic stress disorder, alcoholism and a compression fracture in his spine, according to the suit.

The U.S. Department of Veterans Affairs put Belcher on a number of powerful pharmaceutical drugs, including Valium, Librium and Tylenol 3 with codeine. The medicines “left me feeling fuzzy-headed, and they were eating up my insides,” Belcher said recently. By occasionally smoking marijuana at home, he said, an option the VA refused to discuss with him, he has been able to discontinue the use of the prescribed medicines, stop drinking alcohol and manage his health problems.

“It’s not a daily thing. If I need it, I’ve got my pipe,” Belcher said.

“I know veterans who are drugged out of their minds on 25 or 30 pills for all sorts of stuff, approved by the VA. They drug the daylights out of us Vietnam vets because they don’t know what else to do with us,” Belcher said. “And then I’ve got friends in the states where (marijuana) is legal, and they’re getting the relief that they need. These aren’t a bunch of stoners using it recreationally. They use it when they’re in pain, and that’s it, and it works for them.”

Dr. Andrew Kolodny: wants all opiates taken off the market ?

The FDA Is Going After an Opioid Painkiller for the First Time

www.motherjones.com/politics/2017/06/the-fda-is-going-after-an-opioid-painkiller-for-the-first-time/

Last Thursday, for the first time in history, the Food and Drug Administration asked a pharmaceutical company to take an opioid painkiller off the market. The agency found that the benefits of the medication, Opana ER, were outweighed by its risks: It is frequently snorted and injected, and linked to HIV outbreaks, the spread of hepatitis C, and a blood clotting disorder called thrombotic microangiopathy.

“We are facing an opioid epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Dr. Scott Gottlieb in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” said Gottlieb.

The FDA’s request may indicate that the commissioner, accused of cozy relationships with pharmaceutical companies, is taking a tough stance on painkiller prescribing, which has laid the foundation for today’s soaring overdose epidemic. “I am pleased, but not because I think that this one move by itself will have much impact,” says Dr. Andrew Kolodny, who researches opioid policy at Brandeis University and directs Physicians for Responsible Opioid Prescribing.

“I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell.”

Opana ER (for extended release) was created by Endo Pharmaceuticals and approved by the FDA in 2006. After finding that drug users crushed and snorted the drug, taking in 12 hours worth of medication instantaneously, Endo introduced a reformulated version in 2012, which had a hard shell that Endo claimed made the drug more difficult to abuse. This decision may have been motivated by more than just public safety—as NPR noted, Endo faced loss of patent protection without a reformulation. But the FDA found that the reformulation made abuse more likely than the former version: instead of snorting it, users took to injecting it—leading to a cluster of thrombotic microangiopathy deaths in Tennessee in 2012 and Indiana’s HIV outbreak in 2014 and 2015.

The FDA’s decision doesn’t necessarily indicate that Opana ER is more abusable than other opioid painkillers still on the market, but rather that it is riskier than the previous (now generic) version. In fact, Opana ER is chemically similar to a number of other painkillers, notes Kolodny. High dosage painkiller pills in particular are easily abused: Without tolerance to opioids, experimenting with one 80-milligram OxyContin pill or Subsys prescription fentanyl spray could cause an overdose. Critics worry that even “abuse-deterrent” versions of painkillers, which typically are harder to crush or dissolve and are marketed as a safe alternative to other opioids, are still abusable. “Abuse-deterrent formulations are no less addictive and no less effective and they are mostly going to take our eye off the ball,” says Dr. Caleb Alexander, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. If you are dealing with opioid addiction, you can look into Residential Addiction Care Facilities for help.

Whether or not Endo will comply remains to be seen; the company is “evaluating the full range of potential options as we determine the appropriate path forward,” according to a prepared statement. Since last Thursday’s announcement, its stock price has plummeted by nearly 20 percent. If Endo doesn’t pull its product, the FDA “intends to take steps to formally require its removal by withdrawing approval,” according to a press release.

He stated, because it is his pharmacy he can do what he wants !

This pharmacist told my  nurse I could pick up my pain medication  a day earlier,which is today 6-14-17 that he insisted telling me I cannot pick it up for 2 days ,He stated because it is his store he can do what he wants ! he lied to her of our talk . His family are very old in this town and well known . so of course folks will believe him , he has always been a spoiled brat , age now of 48 , yes that is beside the point .Others have had similar complaints of Jody’s professionalism .

This is another good example of why pts need to audio/video recording of all interactions with healthcare providers – or in this case a healthcare denier – 

IMO.. if a healthcare provider will intentionally throw a pt into cold turkey withdrawal… there is little reason to believe that they are not also capable of lying to cover their ass about what happened or was said/promised.

In today’s environment… the healthcare provider will probably pull the “addict card” to support and defend the lie they are putting forth as to what happened… and the pt won’t stand a chance of prevailing.

While this Pharmacist is correct that “it is his pharmacy“… but his license and the license to operate a pharmacy belongs to the state and the state can take both of them away, if it is found that the way that he operates could harm the health and safety of the general public

 

Is this what happens when addiction is treated as a chronic disease ?

The case for prescription heroin

Vancouver gives heroin to drug users suffering from addiction — and it works.

https://www.vox.com/policy-and-politics/2017/6/12/15301458/canada-prescription-heroin-opioid-addiction

VANCOUVER, British Columbia — The Providence Crosstown Clinic is decorated with posters espousing the sort of medical advice you might expect at any other doctor’s office: Cover your cough, wash your hands, don’t use antibiotics to treat the flu, and ask staff if you need any help.

In the main treatment room, a familiar smell of rubbing alcohol lingers in the air — the kind of scent I associate with getting a vaccine shot. At Crosstown, the smell is the remnants of the medicine that 130 to 150 patients inject themselves with multiple times a day at the clinic.

Except the injection here isn’t a vaccine. It’s medical-grade heroin.

A clinic where patients use heroin may sound shocking and irresponsible, particularly now, as a deadly and devastating opioid epidemic ravages North America. But this approach is meant to treat the victims of that epidemic.

The idea is this: If some people are going to use heroin no matter what, it’s better to give them a safe source of the stuff and a safe place to inject it, rather than letting them pick it up on the street — laced with who knows what — and possibly overdose without medical supervision. Patients can not only avoid death by overdose but otherwise go about their lives without stealing or committing other crimes to obtain heroin.

And it isn’t some wild-eyed theory; the scientific research almost unanimously backs it up, and Crosstown’s own experience shows it can make a difference in drug users’ lives.

“People are forced into the illicit stream of opioids because they can’t get legal access to meet their opioid needs,” said Scott MacDonald, Crosstown’s head physician. “So they will access whatever is available and least expensive.”

Crosstown represents an international move toward providing a full spectrum of care for people who are addicted to drugs. It isn’t a first-line defense against opioid addiction, and it’s not going to solve the crisis by itself. But for a fraction of opioid users suffering from addiction (maybe about 10 to 15 percent), other treatments won’t produce good results, almost certainly leading users to relapse — and possibly overdose and die.

To combat this cycle, Crosstown offers these opioid users medical-grade heroin (called “diacetylmorphine”). Under supervision, nurses are at the ready with the overdose antidote naloxone and oxygen tanks in case of an emergency. These patients are the people for whom other treatments have failed. It’s a last resort. And it works.

Since 2011, the clinic has seen about 200 patients. None of them, MacDonald said, have died under the clinic’s supervision. In fact, as far as he can tell, no one has died at any prescription heroin facility due to an overdose — not in Canada, Switzerland, Germany, or the Netherlands.

“So relatively safe,” I said.

“Yes,” MacDonald said. “Well, not even relatively. It’s safe.”

Heroin-assisted treatment has been used in the UK since 1926. But it’s gained more international attention in the past couple of decades thanks to Switzerland’s embrace of it in the 1990s. Twenty-one clinics there (and a prison program) now deploy the treatment. Due to the opioid epidemic, the approach is now getting more attention in the US — MacDonald even testified in front of Congress last year.

But Crosstown is still the only clinic of its kind in North America. And despite its success, the concept of a full spectrum of addiction care, including heroin-assisted treatment, isn’t even close to reality in the US — which is experiencing its deadliest drug overdose crisis in history and which, report after report has found, often doesn’t offer even the bare minimum of addiction care. A clinic like Crosstown, though, provides a beacon for how the country can move forward as it tackles its opioid epidemic.

Crosstown’s lifesaving work

A line of about a dozen patients quietly formed at the door to the injection room at Crosstown. One of them approached MacDonald as I stood to the side. “Thank you for saving my life,” he said.

As MacDonald and I shuffled through patients to his office, I asked him how often this sort of thing happens. “Daily,” he said.

Crosstown is run like a standard doctor’s office. Outside the injection room, clients patiently sit in waiting rooms, chatting about their families, getting and keeping a job, and, of course, their drug treatment. It’s a typical clinical setting, aside from the people injecting heroin just a few steps away.

When it’s their turn, patients will line up, go into the injection room, get the drug prescribed to them, and inject it. The room is surrounded by mirrors that make it impossible to hide from your own image — and, helpfully for staff, make it hard for patients to do anything without getting caught, like smuggle drugs out of the room.

When they’re done, the patients move on with their days — to the kind of school, work, and family that just about any other person can expect to have.

The clinic has been open since 2011, residing in a downtown building that used to be a bank (as the old-timey vault in Crosstown’s basement shows). Although the concept of heroin-assisted treatment has been around for decades, the recent opioid crisis has led Canada — and particularly British Columbia — to step up the work, with Prime Minister Justin Trudeau enacting rules in 2016 to potentially expand the treatment.

Scott MacDonald, head physician at the Crosstown Clinic in Vancouver, Canada.

In 2015, the latest year with data, drug overdoses killed more than 52,000 people in the US, and more than 33,000 of those deaths were linked to opioids. The total drug overdoses dwarf car crashes (more than 38,000 deaths in 2015), gun deaths (more than 36,000 that year), and even HIV/AIDS at its peak (more than 43,000 in 1995).

Canada and particularly Vancouver haven’t been spared. As I heard repeatedly while visiting the city in April, there were nearly 1,000 drug overdose deaths in British Columbia in 2016 — an unprecedented death toll in a province of around 4.7 million people. Vancouver’s city officials say the clinic is part of their comprehensive approach to the growing drug crisis.

“For people who are in care with us, we’ve not had a single opioid overdose death,” MacDonald said. “We’re like a bubble immune to this — at least, knock on wood, today.”

Even within the context of the opioid epidemic, recent events had made approaches like Crosstown’s more urgent. City officials estimate that more than 80 percent of the heroin bought in the streets is now contaminated with deadlier, more potent opioids like fentanyl and its analogs. On the street, someone might unknowingly shoot up these drugs, which their tolerance can’t handle, and overdose. But in a clinical setting like Crosstown, doctors and nurses can ensure the heroin they supply is not laced with these chemicals.

As Maryland-based drug policy experts Bryce Pardo and Peter Reuter wrote in a recent editorial in the Baltimore Sun, “Heroin-assisted therapy addresses the immediate overdose threat posed by fentanyl — something naloxone attempts to do after the fact. Prescribed heroin use in a clinical and supervised setting ensures that users are not consuming fentanyl and that staff are on hand should something go wrong.”

Vancouver offers a glimpse at how this would work in North America. And so far, it’s working very well.

A patient’s lifelong struggle — until now

One Crosstown patient, John Pinkney, can trace his drug use back to the age of 6, when he was first prescribed Ritalin. By his 20s, he was using heroin and other street drugs. Now in his late 50s, he says his life is in a much better place. He has a part-time job. He brags about owning a television and furniture — the kinds of things others might take for granted, but were hard-fought for someone struggling with drug addiction.

“I have a two-bedroom apartment,” Pinkney said. “I have things. I got my TV and my pet and living room furniture and bedroom furniture. You know, it’s like I got my life back.”

None of this, he said, would be possible for him without the Crosstown Clinic.

Pinkney laughed nervously as he retold his story. He was an orphan, passed around from home to home until at around 8 years old he ended up with “a middle-class, government family” in Edmonton, Canada. His mom was abusive — chasing him around the house, beating him, and at one point even threatening him with a knife.

Around age 14, Pinkney ran away from home — “too much violence,” he said — and was cut off from his Ritalin prescription. Despite attempts to buy it off the street, the lack of a steady prescription, he said, made him feel like he was “missing something.” In his 20s, he filled that void with illicit substances like heroin.

John Pinkney, a patient at the Crosstown Clinic.

He eventually ended up in prison for several years, following a series of robberies for money to buy drugs.

Pinkney heard of the Crosstown program a few years ago from his brother-in-law, who is also a heroin user. Pinkney — along with his wife, who also used heroin — decided to check it out. It changed his life.

“Within the first month and a half, I was able to go back to school,” Pinkney said. “Just by the mere fact of coming here, I didn’t have to worry about where my money was going. I didn’t have to go spend all my money on drugs.”

This proved a massive change for Pinkney. Previously, he estimates he and his wife were spending $500 a day on drugs. To pay for that, his wife “worked the street,” and he, for some time, stole and scavenged trash cans and dumpsters (“binning”) for things to sell. When they became patients at Crosstown — which is covered by government-provided insurance — they both were able to stop doing illegal or unsafe work to buy drugs.

Pinkney now feels like his life is on track. He works a part-time job as a security guard at an apartment building, and he gets disability insurance. He also regularly talks to media about his experience, fashioning himself as an advocate for heroin-assisted treatment. Last year, he injected his prescription heroin in front of thousands of live viewers for the New York Times.

 

Above all, though, Pinkney is proud that his life is fairly normal now. That doesn’t mean the treatment is easy. He comes to the clinic three times a day for heroin — in the morning, in the afternoon, and at night. This is typical for more frequent heroin users and standard for the clinic. The drug’s effects wear off quickly, so patients need to go back to it multiple times a day to avoid withdrawal.

Yet even two or three visits a day may not be enough for some, so the clinic offers some patients a dose of methadone, an opioid often used in medication-assisted treatment, in their evening session so they can get through the night before their morning session.

For Pinkney, this busy schedule isn’t too much of a burden. And even if it were, the alternative — going back to hustling for drugs that might be laced with more lethal chemicals — is worse.

“When you look at the social consequences of that, it’s far superior going at this route than going the other route,” he said.

Before starting heroin-assisted treatment, Pinkney tried Alcoholics Anonymous and Narcotics Anonymous. He tried Christian-based treatment centers. Even methadone didn’t work for him. So he continued using heroin, even while on methadone.

After decades of struggles, Crosstown gave him a much-needed way out.

The research shows heroin-assisted treatment works

The idea of treating opioid addiction with opioids isn’t new. For years, doctors have prescribed the opioids methadone and buprenorphine to get users off more dangerous opioids like heroin and traditional painkillers. When taken as prescribed, methadone and buprenorphine eliminate someone’s cravings for opioids and withdrawal symptoms — to help avoid relapse — without producing the kind of euphoric high that heroin or more traditional painkillers can.

These drugs, used in medication-assisted treatment, are largely considered the best form of care for opioid addiction. The research on this point is, frankly, indisputable, with public health groups like the Centers for Disease Control and Prevention, the National Institute on Drug Abuse, and the World Health Organization all acknowledging methadone and buprenorphine’s medical value.

Medication-assisted treatments don’t work for everyone, though; up to 40 percent of opioid users don’t respond well to methadone or buprenorphine. Pinkney complained of bone aches on methadone, while MacDonald noted that some patients feel symptoms such as nausea, headaches, and fatigue. For others, even high doses of these drugs are simply ineffective.

“When treating any medical condition, no one substance will work for everybody,” MacDonald said. “Methadone and Suboxone [buprenorphine] are great treatments. They work for many people. But what are we going to offer those folks [they are] not working for, continue using illicit opioids, [and] are forced into crime in order to get the medication that they need?”

For some of these patients, heroin-assisted treatment can help.

Researchers credit Switzerland’s program with reductions in drug-related crimes and improvements in social functioning, such as stabilized housing and employment. Canadian studies also deemed heroin maintenance effective for treating heavy heroin users. A review of the research — which included randomized controlled trials from Switzerland, the Netherlands, Spain, Germany, Canada, and the UK — reached similar conclusions, noting sharp drops in street heroin use among people in treatment.

One of the Canadian studies, the results of a randomized controlled trial published in the New England Journal of Medicine, put the promise of heroin maintenance treatment this way:

In this trial, both diacetylmorphine [heroin] treatment and optimized methadone maintenance treatment resulted in high retention and response rates. Methadone, provided according to best-practice guidelines, should remain the treatment of choice for the majority of patients. However, there will continue to be a subgroup of patients who will not benefit even from optimized methadone maintenance. Prescribed, supervised use of diacetylmorphine appears to be a safe and effective adjunctive treatment for this severely affected population of patients who would otherwise remain outside the health care system.

As the study notes, the treatment is typically available as a kind of second, third, or last resort — for patients who just haven’t had success with other kinds of care.

“There are some people who are going to — no matter what — just continue to inject,” David Juurlink, a doctor who studies the opioid epidemic at the University of Toronto, told me. “These are people who are literally waiting to die if they don’t have access to a supervised consumption facility.”

The approach is not without detractors. The International Task Force on Strategic Drug Policy, for one, argues that programs like Vancouver’s “promote the false notion that there are safe or responsible ways to use drugs.” The group argues that this kind of program — and other harm reduction strategies — weakens the social stigma against drugs, leading more people to try and use these dangerous substances.

But the danger here isn’t whether someone is using drugs; most Americans, after all, use caffeine or alcohol regularly throughout their lives with few problems. Drug use transforms into addiction, according to the definition provided by the Diagnostic and Statistical Manual of Mental Disorders, when using drugs begins hurting someone’s function — by, for example, leading them to steal or commit other crimes to obtain heroin, or, in the worst case scenario, death.

The Providence Crosstown Clinic in Vancouver.
The Providence Crosstown Clinic in Vancouver.
German Lopez and Javier Zarracina/Vox

Heroin-assisted treatment relieves this problem: It gives patients a safe place to get their heroin without resorting to bad behaviors.

Still, experts and those involved in Crosstown emphasize it’s not a first-line treatment. For instance, MacDonald said Health Canada, which covers the care provided at Crosstown for some patients, requires a laundry list of qualifications for coverage: 18 years or older, at least five years of opioid use, regular illicit opioid use in the past year, current use of illicit opioids, physical or psychological complications as a result of opioid use, and previous attempts to get drug treatment, particularly medication-assisted treatment like methadone or buprenorphine.

So even if this treatment method spreads throughout North America, it’s never going to be a matter of just walking into the clinic and getting some heroin — as can happen at “medical” marijuana dispensaries in the US today.

Also, clinics like Crosstown aren’t just about supplying heroin; they offer a chance to link drug users to other forms of aid, including social workers, other health care and treatments, and, potentially, a plan to wean people off opioids altogether — although some patients will use heroin for years or life.

“With time, a third to half the people step down to oral options, like methadone, or to abstinence,” MacDonald said. “But we don’t arbitrarily say, ‘Okay, you’ve been with us for six months. It’s time to reduce your dose.’ There’s a study out of Belgium — they have injectable treatment there — that shows if you just arbitrarily stop people, they will go back to using illicit opioids.”

The US fails to provide full addiction care

In the US, more than 20 million Americans suffer from some form of drug addiction — about 8 percent of the adolescent and adult population. According to the surgeon general, “That number is similar to the number of people who suffer from diabetes, and more than 1.5 times the annual prevalence of all cancers combined (14 million).”

But there’s still so much we don’t know about how addiction works. We don’t even know why it afflicts some people but not others, and why some treatments work for certain individuals but not large segments of the population.

In this environment, experts argue, it’s best to provide a spectrum of options that can help all sorts of different patients with various kinds of individualized problems.

“It’s just like any other chronic disease,” Keith Ahamad, a clinical researcher at the University of British Columbia, told me. “We need a stepwise approach to managing patients. If you’re not able to engage and stabilize patients on less intensive treatment, then, like you do for other chronic conditions, you step them up to more intensive treatment modalities.”

Yet while Canada considers expanding heroin-assisted treatment, the US isn’t able to meet the medical needs of as many as 90 percent of patients with drug use disorders, based on the surgeon general’s 2016 addiction report, due to the high costs and low supply of adequate addiction care.

The treatment that does exist in America is often ineffective. Much of the focus in the US is on abstinence, which is potentially dangerous for opioids. If someone quits heroin cold turkey, they’re going to quickly lose the tolerance they developed over years of use. So if they relapse (which is expected in addiction medicine), they may overdose after they try the quantities of heroin they were used to before.

Dr. Scott MacDonald and patient John Pinkney at the Providence Crosstown Clinic in Vancouver.
Dr. Scott MacDonald and patient John Pinkney at the Providence Crosstown Clinic in Vancouver.
German Lopez and Javier Zarracina/Vox

But groups like the Drug Free America Foundation (which did not respond to multiple requests for comment) say that abstinence is necessary, arguing that anything short of it is simply masking and even enabling dangerous drug use. Addiction experts disagree with this view, but it’s prevalent in the US — sometimes with deadly results.

In 2013, Judge Frank Gulotta Jr. in New York ordered an opioid user arrested for drugs, Robert Lepolszki, off methadone treatment. In January 2014, Lepolszki died of a drug overdose at 28 years old — a direct result, Lepolszki’s parents say, of failing to get the medicine he needed. In his defense, Gulotta has continued to argue that methadone programs “are crutches — they are substitutes for drugs and drug cravings without enabling the participant to actually rid him or herself of the addiction.”

In the case of Lepolszki, methadone seemed key to saving his life. While this is one case, the idea that using methadone, buprenorphine, or other opioids for treatment is simply “replacing one drug with another” — without any consideration for the broader context of how the replacement drug is used — is a standard misconception in America.

Meanwhile, Vancouver’s government is moving forward with the full spectrum of care, including Crosstown. Chris Van Veen, the lead urban health planner for Vancouver, told me, “Unfortunately with addiction, there’s no silver bullet. Any treatment that we have doesn’t have very high success rates. Traditional abstinence treatments have incredibly low success rates.” That, he said, is why it’s important to let people “have access to as many treatment options as possible.”

This won’t stop all drug overdose deaths. British Columbia is still suffering from a very bad opioid crisis, even though it already does many of the things that experts think the US health care system should do in response to drug addiction — from heroin-assisted treatment to medication-assisted therapy to other kinds of prevention and rehabilitation. But adopting an approach like Vancouver’s would, experts say, at least help greatly reduce the death toll.

How one US city is trying to move forward

As the opioid epidemic surges, some US lawmakers are seriously looking at approaches like Vancouver’s.

Ithaca, New York, Mayor Svante Myrick is pushing for supervised injection facilities and considering heroin-assisted treatment as part of his comprehensive plan to deal with the opioid epidemic.

Several years ago, Myrick put together a 50-person committee to study how to solve the opioid crisis. He gave them just one condition: “We got a large drug problem. We’re not going to arrest our way out of it. So don’t come back and say we need more SWAT teams and police officers.” As part of the 25 proposals the committee put forward, the committee recommended building a supervised injection facility and studying heroin-assisted treatment.

So Myrick and Ithaca’s former police chief, John Barber, went to the Crosstown Clinic and a supervised injection facility, Insite, in Vancouver. Myrick was impressed, finding “that by providing the heroin, you cut down on street crime.”

But Myrick hasn’t been able to get a supervised injection facility — much less a heroin-assisted treatment clinic — off the ground. He blames that on hesitation from state lawmakers, who would need to change the law to let his plans move forward.

“We’re enacting the other 23 parts of our plan,” he said, listing more after-school programs and medication-assisted treatment among the other pieces. “But we’re really in limbo right now until we can get the votes out of the New York state legislature.”

After decades of a war on drugs fought mostly through the criminal justice system, getting US lawmakers to open up to alternative approaches — or even just widely accepted approaches like methadone and buprenorphine — is going to take a lot of time and patience.

“They still think it’s a way to condone drug use or encourage it. Which is madness,” Myrick said. “Anywhere you study it, it does the exact opposite: You get fewer deaths, fewer diseases, fewer people using.”

Jeff Sessions: A mental throwback to the 70’s & 80’s “war on drugs mindset” ?

Jeff Sessions Wants To Unleash The DEA On States That Have Legalized Medical Marijuana

Jeff Sessions Wants To Unleash The DEA On States That Have Legalized Medical Marijuana

https://www.civilized.life/articles/jeff-sessions-medical-marijuana-dea/

Attorney General Jeff Sessions wants permission to crack down on medical marijuana across the United States. Last month, Trump’s top law enforcer wrote a letter to Congress asking them to remove the only thing stopping him from prosecuting state-legalized medical marijuana industries and patients.

The letter – which was first reported on by Tom Angell of MassRoots – specifically asks Congress not to renew the Rohrabacher-Farr amendment – a federal budget rider that prevents the Department of Justice and the DEA from using any money to enforce cannabis prohibition in states that have legalized medical marijuana. Right now, that rider is the only thing keeping the attorney general from cracking down on everyone involved in the industry – from state-legalized growers, to dispensary workers to patients. But Sessions wants that leash taken off the DEA.

“I believe it would be unwise for Congress to restrict the discretion of the Department to fund particular prosecutions, particularly in the midst of an historic drug epidemic and potentially long-term uptick in violent crime,” Sessions wrote. “The Department must be in a position to use all laws available to combat the transnational drug organizations and dangerous drug traffickers who threaten American lives.”

Sessions’ War on Facts

There are two glaring problems with Attorney General Sessions’ arguments. First off, he is perversely trying to link America’s opioid epidemic to cannabis use, even though studies have consistently found that cannabis does not lead people to abuse harder drugs like heroin. In fact, recent scientific studies suggest that medical marijuana could actually help wean addicts off of opioids. So blaming the epidemic on marijuana is like blaming starvation on food.

Cracking down on medical marijuana would force more patients across the country to use the prescription pills that do lead to opioid addiction. So instead of fixing this public health crisis, Sessions’ plan would likely fan the flames of an epidemic that claimed the lives of over 55,000 Americans last year.

The second problem is that the connection that Sessions is trying to make between marijuana legalization and violent crime is also contrary to fact. A 2014 study published by PLOS One found that marijuana legalization “may be correlated with a reduction in homicide and assault rates” in legal states. More recently, a study published in January 2016 in the Journal of Drug Issues found that “There is no evidence of negative spillover effects from medical marijuana laws (MMLs) on violent or property crime. Instead, we find significant drops in rates of violent crime associated with state MMLs.”

So if Sessions is serious about needing to put the DOJ in a “position to use all laws available to combat” international drug trafficking, why doesn’t he consider cannabis legalization? Allowing states to determine their own marijuana laws is healthier for the American people as well as the economy since the disastrous War on Drugs, which has wasted billions of taxpayer dollars, crammed more convicts into America’s overcrowded prisons and yet hasn’t curbed illicit drug use.

Will Congress Unleash the DEA?

Congress has not issued a response to Sessions’ letter, so we don’t know if they will give in to his request. But at least some members are speaking out against the attorney general.

“Mr. Sessions stands athwart an overwhelming majority of Americans and even, sadly, against veterans and other suffering Americans who we now know conclusively are helped dramatically by medical marijuana,” a spokesman for Congressman Dana Rohrabacher (R-California) told The Washington Post. Rep. Rohrabacher, incidentally, is the same Rohrabacher whose name appears on the budget rider protecting medical marijuana. He’s also the first sitting congressperson to step out of the cannabis closet, so Sessions will face fierce opposition from him on the issue.

And the American people will also be a major obstacle in the way of Sessions’ dream of renewing the War on Drugs. Nearly 80 percent of North Americans support legalizing marijuana in some form, according to Civilized’s 2017 Cannabis Culture Poll,. That means only one in five Americans oppose reforming the country’s cannabis laws.

So when it comes to America’s marijuana policy, Jeff Sessions is basically a talking fossil from the prohibition era. 

Mexican Cartels: Find a need and fulfill it… make GOBS of TAX FREE MONEY !!!

Mexican drug cartels could be behind deadly fake Percocet pills

http://www.11alive.com/news/mexican-drug-cartels-could-be-behind-deadly-fake-percocet-pills/448080815

Federal agents believe Mexican drug cartels could be linked to a deadly wave of fake Percocet pills moving through Georgia.

The Georgia Department of Public Health said that at least five people are suspected to have died and dozens more have been hospitalized after overdosing from the pills in central Georgia.

Last week, the GBI’s crime lab said that initial tests indicated that the fake yellow pills that read “Percocet” are a mixture of two synthetic opioids. One of the drugs is consistent with fentanyl analogue.

The Drug Enforcement Agency said the fake pills are a problem on the national level now entering Georgia. The DEA is investigating possible ties to Mexico.

“There is a concerted effort by these cartels to press fentanyl into pills illicitly and sell them,” said DEA Special Agent Dan Salder.

The DEA is working with local law enforcement in central Georgia to gather details about the recent overdoses in hopes of finding the original source.

“So I don’t think we know definitely as of yet, but I would say anytime that you’re seeing an explosion of a particular drug, it is coming from these cartels that impact us here in Georgia,” Salder said.

The fifth death in central Georgia possibly triggered by fake Percocet happened Sunday. A 34-year-old man who was found unconscious Friday died two days later.

Georgia Poison Control recently noticed the trend of overdoses all with similar symptoms. Doctors at their offices said the patients’ outcome depends on how quickly they get help.

“These synthetic — who knows what — causes people to stop breathing, so the longer that you’re without oxygen and supportive care possibly could mean a more severe outcome for the patient,” said Dr. Stephanie Hon of Georgia Poison Control.

Hon said that three suspected overdoses happened over the weekend — which was down from the previous week.

“Not as heavy as last week, so I don’t know if things are kind of quieting down or calming down, but about three of the unconfirmed suspected cases that meet our definition for the cluster,” she said.

While the cluster of overdoses possibly caused by fake pills is in central Georgia, the DEA believes it could spread to Atlanta.

“I think a fair assessment would be that it is just a matter of time, Salder said. “Obviously we are close to central and middle Georgia. Most oftentimes, drugs transit through here in Atlanta and go to our smaller counties.”

The DEA reports there is a large market for selling fentanyl-laced pills. A single kilo of the drug can sell for anywhere between $4,000 to $7,000, with a million one-milligram pills being made from the kilo.

US officials are starting to treat opioid companies like Big Tobacco — and suing them

US officials are starting to treat opioid companies like Big Tobacco — and suing them

http://www.msn.com/en-us/money/companies/us-officials-are-starting-to-treat-opioid-companies-like-big-tobacco-%e2%80%94-and-suing-them/ar-BBCfoAG

You can expect more lawsuits against opioid companies in 2017.

It is impossible to talk about the causes of the opioid epidemic without pointing to the manufacturers and distributors that marketed and proliferated these dangerous pills. Yet over the past several years, these multibillion-dollar companies have avoided much in the way of serious accountability.

Until — maybe — now.

This year, multiple lawsuits have been launched against opioid manufacturers and distributors. With the opioid crisis now having resulted in more than 300,000 deadly opioid overdoses since 1999 (greater than the population of Cincinnati), there’s a push to hold accountable the people and companies behind the products that spawned the epidemic.

The latest high-profile lawsuit came from Ohio, which sued five opioid manufacturers and their subsidiaries. The state’s Republican attorney general, Mike DeWine, said that these companies knowingly misled patients and physicians about the drugs’ risks.

“They knew they were wrong, but they did it anyway — and they continue to do it,” DeWine said in a statement. “Despite all evidence to the contrary about the addictive nature of these pain medications, they are doing precious little to take responsibility for their actions and to tell the public the truth.”

DeWine even compared opioid manufacturers to tobacco companies, arguing in the lawsuit that opioid manufacturers are “borrowing a page from Big Tobacco’s playbook.”

Previously, the Cherokee Nation also made headlines when it announced it was suing opioid distributors and pharmacies, including CVS, Walgreens, and Walmart, for their involvement in supplying the pills to the Cherokee population. At the center of their claim: data that shows 845 million milligrams of opioids were distributed in the 14 counties that make up the Cherokee Nation — which, if you assume an average pill size of 20 milligrams, amounts to 360 pills for each prescription opioid user in the Cherokee Nation.

© Provided by Vox.com

These lawsuits get to the two major legal arguments that different jurisdictions are raising against opioid makers and distributors:

1. Starting in the mid-1990s, opioid manufacturers unleashed a misleading marketing push underplaying the risks of prescription opioids and exaggerating the drugs’ proven benefits. This, the lawsuits argue, adds up to false advertising with deadly consequences — by encouraging doctors to overprescribe the pills and getting patients to think the pills were safe and effective.

2. Opioid distributors supplied a ton of these pills, even when they should have known they were going to people who were misusing the drugs. This is backed by data that shows that in some counties and states, there were more prescribed bottles of painkillers than there were people — a sign that something was going very wrong. Federal and some state laws require distributors to keep an eye on the supply chain to ensure their products aren’t falling in the wrong hands. Letting these drugs proliferate, the lawsuits say, violates those laws.

Opioid manufacturers and distributors, of course, ferociously deny these allegations. While some suits have been settled, and some executives have even been criminally convicted for their involvement in the epidemic in the past, opioid companies vigorously reject the argument that they have carelessly fueled the current drug crisis. And so far, what the companies have paid by and large amounts to peanuts compared with the profits they’ve taken in from the drugs.

Still, more lawsuits are likely coming. According to the lawyers I’ve talked to who have worked and advised on these cases, a growing number of jurisdictions are showing interest in such legal challenges. The ultimate hope is this could all lead to some sort of massive settlement — one that would finally quash the practices that helped lead to the deadliest drug overdose crisis in American history.

The case against opioid makers: false advertising

Ohio’s central claim against opioid manufacturers is that these companies knew — or at least should have known — that their products weren’t safe or effective, yet they advertised their products as safe and effective anyway. The state’s lawsuit goes after five opioid manufacturers and their subsidiaries: Purdue Pharma, Endo, Teva Pharmaceutical Industries (and subsidiary Cephalon), Johnson & Johnson (and subsidiary Janssen Pharmaceuticals), and Allergan.

The lawsuit cites several examples of misleading marketing: An Endo-sponsored website, PainKnowledge.com, in 2009 claimed that “[p]eople who take opioids as prescribed usually do not become addicted.” Janssen approved and distributed a patient education guide in 2009 that attempted to counter the “myth” that opioids are addictive, claiming that “[m]any studies show that opioids are rarely addictive when used properly for the management of chronic pain.” Purdue sponsored a publication from the American Pain Foundation, which is heavily funded by opioid companies, claiming that the risk of addiction is less than 1 percent among children prescribed opioids — suggesting pain is undertreated and opioids are necessary.

This is only a small sampling. In total, DeWine claims opioid companies spent “millions of dollars on promotional activities and materials that falsely deny or trivialize the risks of opioids while overstating the benefits of using them for chronic pain.”

Contrary to opioid companies’ claims, there has been evidence for literally centuries that opioids are highly addictive. Some of their marketing, in fact, explicitly tried to debunk this well-known fact: They characterized the understanding that opioids are addictive and potentially deadly as “opiophobia.” They latched onto a five-sentence letter to a medical journal that, with nearly no proof, claimed addiction among opioid patients is rare. (One author of the letter later said he was “mortified” at what drugmakers had done.) And they directly communicated with doctors — through videos, pamphlets, and other marketing — to foster the idea that new opioids on the market were safe and effective.

The current epidemic is proof of what we already knew: As opioid companies saw their profits increase, so too did drug overdose deaths and treatment admissions.

As opioid painkiller sales increased, more people got addicted — and died.© Provided by Vox.com As opioid painkiller sales increased, more people got addicted — and died.
Annual Review of Public Health

It’s not just the addiction claims, though. Opioid companies also misled doctors and the public about the effectiveness of their drugs.

As an extensive Los Angeles Times investigation found, Purdue’s opioid OxyContin was marketed for its supposed ability to provide 12 hours of pain relief. But as Harriet Ryan, Lisa Girion, and Scott Glover reported, “Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.”

This was critical to Purdue’s competitive advantage: If it really didn’t provide 12-hour relief, then it wasn’t more effective than other similar painkillers on the market. In the face of the evidence, though, Purdue stood by its claim for years. And it told doctors that if patients weren’t seeing the promised results, then the problem was that doses were too low.

These efforts, it seems, were in the name of profit. One sales memo uncovered by the Times was literally titled “$$$$$$$$$$$$$ It’s Bonus Time in the Neighborhood!”

This is alarming for public health: As the Centers for Disease Control and Prevention warned, higher doses significantly increase the risk of overdose and addiction.

The Los Angeles Times investigation found, “More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.”

Opioid makers’ claims that their drugs are an effective treatment for chronic pain are similarly faulty. There’s simply no good scientific evidence that opioid painkillers can actually treat long-term chronic pain as patients grow tolerant of opioids’ effects — but there’s plenty of evidence that prolonged use can result in very bad complications, including a higher risk of addiction, overdose, and death. (Again, this has all been known for at least decades. Opium, morphine, and heroin have been around for a long time.)

Yet opioid makers were highly influential in perpetuating the claim that their drugs can treat chronic pain. Several public health experts explained the recent history of opioid marketing in the Annual Review of Public Health, detailing Purdue Pharma’s involvement after it put OxyContin on the market in the mid-1990s:

Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers].

By encouraging long-term prescriptions for chronic pain, opioid companies fueled the epidemic. As a CDC study found, the risk of dependency, which can turn into addiction, dramatically increases the longer one uses opioids.

This is the kind of marketing that led Ohio to file a lawsuit. A similar challenge from Mississippi is going through the courts right now. Local jurisdictions in California, Illinois, and New York state have filed similar challenges. Kentucky previously settled with Purdue (for $24 million) and Janssen (for nearly $16 million) in cases alleging misleading marketing.

In 2007, Purdue Pharma and three of its top executives paid more than $630 million in federal fines for their misleading marketing. The three executives were also criminally convicted, each sentenced to three years of probation and 400 hours of community service.

As the opioid epidemic has continued, however, more and more lawsuits are expected to come.

I reached out to the companies named in Ohio’s lawsuit. Only Purdue gave a comment on the record: “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions. OxyContin accounts for less than 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone — all important components for combating the opioid crisis.”

The case against opioid distributors: allowing diversion

Beyond the false advertising charges, there’s a separate legal argument, dubbed the “diversion theory” by some of its proponents. This argument has so far been leveled against companies that distribute opioids, particularly in a recent lawsuit by the Cherokee Nation against big names like the McKesson Corporation, Cardinal Health, AmerisourceBergen, CVS, Walgreens, and Walmart.

Under federal and some state laws, opioid distributors have a legal obligation to stop controlled substances from going to illicit purposes and misuse. The diversion theory argues that these distributors clearly did not do that: As the opioid epidemic spiraled out of control, and as some counties and states had more prescriptions than people, it should have become perfectly clear that something was going wrong — yet, the claim goes, distributors continued to let the drugs proliferate.

Mike Canty, an attorney at the New York–based firm Labaton Sucharow who’s advising states and other jurisdictions on opioid-related legal challenges, drew a comparison between opioid distributors and credit card companies.

“[Credit card companies say], ‘Someone tried to make a very large purchase on your account in another state and we flagged it as suspicious and stopped it from going through.’ That’s what distributors should be doing,” Canty said. “For example, there’s a small town with 500 residents, and the local pharmacies order a million pills from the distributors. That should set off an alarm bell from a compliance standpoint or a quality control standpoint, where the distributors say, ‘Wait a minute, what’s going on here? We need to investigate this order. And until it passes muster, we won’t ship.’”

The Cherokee Nation has some fairly alarming numbers behind its claim, suggesting there were literally hundreds of pills on average for each opioid user in the Cherokee Nation.

This is a national problem. The CDC, for example, put out 2012 data that found there were more painkiller prescriptions than people in several states.

Some states have more painkiller prescriptions than people.© Provided by Vox.com Some states have more painkiller prescriptions than people.

Centers for Disease Control and Prevention

West Virginia’s case is particularly striking. It is the state hardest hit by the epidemic, suffering the highest rate of opioid overdose deaths in 2015. A previous investigation by the Charleston Gazette-Mail in West Virginia found that from 2007 to 2012, drug firms poured a total of 780 million painkillers into the state — which has a total population of about 1.8 million. Some of the numbers were even more absurd at the local level: The small town of Kermit has a population of 392, but a single pharmacy there received 9 million hydrocodone pills over two years from out-of-state drug companies.

“When you have 140 prescriptions being written for every 100 people, you know that people have failed to meet their obligations,” Serena Hallowell, who’s also with Labaton Sucharow, said. “And they’re not just ethical obligations, which I would say they have too. They’re obligations under state and federal law and their own industry guidelines as well.”

The Cherokee Nation’s lawsuit is the first to really push against all of these opioid distributors at once. But other jurisdictions have pursued legal challenges as well; West Virginia, for one, settled with Cardinal Health and AmerisourceBergen for $36 million in payouts (although the companies denied wrongdoing), and several counties in the state are pursuing new legal challenges.

Meanwhile, some distributors have already been dealt penalties for their negligence. Just this year, for example, McKesson agreed to pay a $150 million settlement to the Department of Justice for failing to report suspicious orders of pharmaceutical drugs, particularly opioids, and stopped sales of at least some distribution centers in multiple states. And that came after McKesson paid a more than $13 million fine for similar violations in 2008.

CVS, Walgreens, and Cardinal Health paid fines, sometimes multiple times, for similar violations in the past several years.

Similar challenges could, in theory, be tried against opioid manufacturers as well. The Drug Enforcement Administration, for one, previously pursued one of the nation’s largest opioid makers, Mallinckrodt Pharmaceuticals, for the proliferation of its pills in Florida since 1999. But as the Washington Post found, the investigations went nowhere. In the end, the company agreed to pay, without admitting wrongdoing, just $35 million to settle the case with the federal government — far from the billions in dollars the DEA reportedly hoped for, and a tiny fraction of the $3.4 billion in revenue the company reported in fiscal year 2016.

I contacted the opioid distributors named in the Cherokee Nation’s suit for comment. AmerisourceBergen, Cardinal Health, and CVS said they are committed to stopping the misuse of their products, and that they will work closely with federal regulators to do so. Cardinal Health went further, arguing that it “is confident that the facts and the law are on our side, and we intend to vigorously defend ourselves against the plaintiff’s mischaracterization of those facts and misunderstanding of the law.”

One goal of the lawsuits: a tobacco-style settlement agreement

Although opioid manufacturers and distributors have already paid out some fairly high penalties and damages for their actions, the reality is that the total costs for the legal challenges so far don’t amount to much for these massive opioid companies. Hundreds of millions of dollars is obviously a lot of money for most people. But for companies that make billions of dollars a year, it’s not much.

Take Purdue Pharma. In 2007, it paid a penalty more than $630 million. But thanks to OxyContin, the company has reaped $31 billion in revenue since the mid-1990s. That fine adds up to just 2 percent of what the company has made in revenue, which isn’t much of a deterrent for Purdue. Indeed, Ohio’s lawsuit alleges that Purdue continued its misleading marketing after 2007 — citing, as one example, a 2011 pamphlet in which Purdue argued that signs of addiction are actually a form of “pseudoaddiction” that suggests someone needs more, not fewer, opioid painkillers to treat pain.

The crisis also likely demands far higher damages than a few hundred million dollars. A 2016 study, for instance, estimated the total economic burden of prescription opioid overdose, misuse, and addiction at $78.5 billion a year, about a third of which is due to higher health care and drug treatment costs. Many jurisdictions can’t afford to pay for these new expenses — and may need a big lawsuit settlement or legal damages to pay.

Richard Fields, an attorney with the Cherokee Nation case, put the cost for his clients in the hundreds of millions of dollars. “That’s an extraordinary sum for a sovereign nation of 350,000 people,” he said. “The suit is [in part] an effort to recover for what we think is a very direct harm caused by these companies.”

“But,” he added, “the hope is too that if enough attorneys general around the country bring these suits, they can do what the [federal government] hasn’t been able to do on its own.”

In the long term, one hope of the different lawsuits is that they’ll eventually snowball, leading to an outcome similar to what happened with tobacco companies in the ’90s.

A cigarette.© Provided by Vox.com A cigarette.

In 1998, big tobacco companies agreed to the Master Settlement Agreement with 46 states. This massive agreement forced tobacco companies to pay tens of billions in upfront and then annual payments, and it put major restrictions on the sale and marketing of tobacco products.

The parallels between the tobacco and opioid companies are clear: Both knew they were selling a dangerous product, yet they misled the public about it — leading people to get addicted and die. (And now that opioid companies are facing pressure at home, they are borrowing a page from big tobacco companies and taking their product internationally with the exact same kind of messaging, with claims that opioids are good for chronic pain and not very addictive.)

But there are some big differences that could make it much harder to get a tobacco-style settlement for opioids. The big one is that, unlike cigarettes at the time of the Master Settlement Agreement, opioids are already regulated by the Food and Drug Administration. This could effectively let opioid manufacturers and distributors punt responsibility to the FDA, since it, after all, approved these drugs for medical use. Jodi Avergun, a former chief of staff at the DEA and now a defense lawyer, told Reuters that this is a “fundamental weakness” of the current lawsuits.

There are other issues, like the involvement of the rest of the health care system in the opioid crisis, from medical boards to doctors to patients themselves. That all of this involved so many different actors could insulate opioid companies from carrying too much of the legal consequences. That’s especially true since some of these other actors have copped to serious negligence — the West Virginia Board of Pharmacy, for one, admitted that it didn’t enforce a law for reporting suspicious orders of narcotics for years.

“With tobacco, it really is an interaction between an industry and the consumer,” Keith Humphreys, a drug policy expert at Stanford University, told me. “In this case, there was supposed to be this intervening body that also failed. That doesn’t mean the pharmaceutical companies should get off, but … plenty of other people enabled it.”

Still, this is something that many levels of government are taking seriously. While they couldn’t offer details, the lawyers involved in some of these cases said they have been approached by several states. Fields in particular said to expect dozens more lawsuits just this year.

“Both Democrat and Republican attorneys general have expressed an interest in this,” Canty said. “They are serious about the epidemic. They are educated on the epidemic. They understand the magnitude of the problem and want be proactive in addressing it.”

I have been saying for WEEKS that the bureaucrats were viewing the end of the annual tobacco settlement payments money and that they had become FISCALLY ADDICTED to that money and had to start looking for another industry to go after to SUE and hopefully find a NEW SOURCE of revenue to feed that ADDICTION.

To a certain extent, bureaucrats cannot control their GREED… just think about it… there is a “sin tax” on Alcohol and Tobacco taxes, plus there is a sales tax on these products when they are sold.  Everyone in the retail/legal manufacturing/distribution of these products end up paying taxes on the profits they made on these products. Along with the property tax, employment taxes etc..etc.. that the bureaucracy extracts out of each business and individuals.

The bureaucrats make a product legal and tax the crap out of all those involved with the product and now they want to extract more monies out of the very entities involved in a particular industry… they did it with Tobacco … now they seem to be going after opiate manufacturers. Since hundred of millions of people have a medical necessity for many/most/all of these products… guess who is going to end up paying for any settlement out of this “GREED LAWSUIT ” ?

Even Moderate Drinking Changes Brain: Study

Even Moderate Drinking Changes Brain: Study

http://www.newsmax.com/Health/Health-News/moderate-drinking-changes-brain/2017/06/07/id/794639/?ns_mail_uid=38004974&ns_mail_job=1735839_06112017&s=al&dkt_nbr=fds1dvix

Drinking even moderate amounts of alcohol is linked to changes in brain structure and an increased risk of worsening brain function, scientists said on Tuesday.

In a 30-year study that looked at the brains of 550 middle-aged heavy drinkers, moderate drinkers and teetotallers, the researchers found people drank more alcohol had a greater risk of hippocampal atrophy – a form of brain damage that affects memory and spatial navigation.

 People who drank more than 30 units a week on average had the highest risk, but even those who drank moderately – between 14 and 21 units a week – were far more likely than abstainers to have hippocampal atrophy, the scientists said.

“And we found no support for a protective effect of light consumption on brain structure,” they added.

The research team – from the University of Oxford and University College London – said their results supported a recent lowering of drinking limit guidelines in Britain, but posed questions about limits recommended in the United States.

U.S. guidelines suggest that up to 24.5 units of alcohol a week is safe for men, but the study found increased risk of brain structure changes at just 14 to 21 units a week.

 A unit is defined as 10 milliliters (ml) of pure alcohol. There are roughly two in a large beer, nine in a bottle of wine and one in a 25 ml spirit shot.

Killian Welch, a Royal Edinburgh Hospital neuropsychiatrist who was not directly involved in the study, said the results, published in the BMJ British Medical Journal, underlined “the argument that drinking habits many regard as normal have adverse consequences for health”.

“We all use rationalizations to justify persistence with behaviors not in our long term interest. With (these results) justification of ‘moderate’ drinking on the grounds of brain health becomes a little harder,” he said.

 The study analyzed data on weekly alcohol intake and cognitive performance measured repeatedly over 30 years between 1985 and 2015 for 550 healthy men and women with an average age of 43 at the start of the study. Brain function tests were carried out at regular intervals, and at the end of the study participants were given a MRI brain scan.

After adjusting for several important potential confounders such as gender, education, social class, physical and social activity, smoking, stroke risk and medical history, the scientists found that higher alcohol consumption was associated with increased risk of brain function decline.

 Drinking more was also linked to poorer “white matter integrity” – a factor they described as critical when it comes to cognitive functioning.

The researchers noted that with an observational study like this, no firm conclusions can be drawn about cause and effect. They added, however, that the findings could have important public health implications for a large sector of the population.