FDA: No Codeine or Tramadol for Children Under 12 — Period

FDA: No Codeine or Tramadol for Children Under 12 — Period
Warnings for children with medical conditions, breastfeeding moms

https://www.medpagetoday.com/pediatrics/generalpediatrics/64673

Use of both codeine to treat pain and coughs and tramadol to treat pain are now both contraindicated in young children under the age of 12, said the FDA in a statement.

Products containing codeine or tramadol will now carry a “Contraindication” for children under the age of 12, which is the FDA’s strongest warning. The agency cited concerns about slowed or difficult breathing or death, especially among younger children and infants in its decision to restrict the use of products containing these two drugs.

“We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies,” said Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research, in a statement.

Throckmorton added in a media briefing that there is no way to know which children are “rapid metabolizers,” because it is genetically determined and varies by racial and ethnic group.

The FDA also added a new “Warning” advising against the use of products with codeine and tramadol in children ages 12 to 18 who are obese or have obstructive sleep apnea or serious lung disease. There is also a strengthened “Warning” advising against the use of these products among breastfeeding mothers, as it may cause serious harm to their infants.

The agency noted that since 2013, prescription products containing codeine have contained a boxed warning and contraindication for children and teens up to age 18 for pain management after removal of tonsils and adenoids. The same will now be true for tramadol-containing products.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for healthcare providers and parents,” said Throckmorton. “However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe.”

The FDA has been evaluating the use of codeine in cold-and-cough medicines in children since 2015 and the risks of using the pain medicine, tramadol, in children ages 17 and younger since September 2015. In 2016, the American Academy of Pediatrics issued a policy statement that advised against the use of codeine in all children.

The agency advised healthcare professionals that single-ingredient codeine and tramadol is only FDA approved for use in adults. Clinicians should advise parents to seek over-the-counter products or other FDA-approved prescription medicines to treat cold and cough in children under the age of 12 years.

At the briefing, Throckmorton described these new “labeling updates” as building on “our understanding of a very serious safety issue based on the very latest evidence.” He added that the FDA plans to hold a public advisory committee later this year to discuss the broader role of prescription cold and cough medicines in children, including those containing codeine.

If an adult inflicts pain on a child.. if found out.. you can expect child protective services/social services to be at their door… it is called CHILD ABUSE…

So now the FDA seemingly mandates that we allow children under 12 to “live in pain” and/or “cough their heads off” because they have seemingly determined that it is best for a child to JUST SUFFER THRU IT…

Again, the bureaucracy in trying to protect a few… tend to make rules/laws/guidelines that cause the overall majority to JUST SUFFER THRU IT.   This is not CHILD ABUSE ?

Prescribers – damned if you do… damned if you don’t

Got a call yesterday from a friend – 63 y/o male.. who has been reluctant to see doctors and more reluctant to take medication(s).

SURPRISE… his blood pressure is high, as is his cholesterol… So the doc wants him to take two different medications..

My friend starts rebelling against taking medication… the doc told him that if “they” reviewed his files and it showed that the doc did not offer treatment for those two conditions… the doc could be charged with MALPRACTICE.

I know that CMS has increased focus on pts getting and taking medications for diabetes, cholesterol, and blood pressure… but this fellow is still employed and has insurance thru his company… outside of CMS’ over sight.

 

Is it time for chronic pain pts to start “rocking the boat”.. when a prescriber tells you that they are cutting your pain meds .. tell them that you are going to cut your meds for hypertension, diabetes and cholesterol in a similar amount as your pain meds… if your pain deserves less treatment.. why not your other medications/conditions ?

CMS has this FIVE STAR RATING in which insurance companies, prescribers, pharmacies are having their feet held to the fire about their pts not being compliant with the medications to treat those specific disease.  If their pts are non-complaint… their reimbursements will GET REDUCED !

They tell you that they are concerned about losing their license… in reality they don’t care about their license.. they care about the income that their license allows them to generate.  Share your “pain” with them !

Man shoots himself in the spine to end agonizing back pain – and is JAILED for possessing a gun

Man shoots himself in the spine to end agonizing back pain – and is JAILED for possessing a gun

  • Paul Davis spent Christmas in Belmarsh prison after trying to paralyse himself
  • The 44-year-old was trying to end agonising pain of a degenerative disc disorder
  • He tried to shoot himself twice but gun, which he bought 20 years ago, jammed
  • Davis, of Sidcup, Kent, originally acquired weapon following his mother’s death
  • Judge quashed his three-year jail sentence, calling his case ‘wholly exceptional’

http://www.dailymail.co.uk/news/article-4135208/Man-shoots-spine-end-agonising-pain.html

A man shot himself in the spine as he struggled to cope with back pain – only to be jailed for three years for possessing a gun.

Paul Davis spent Christmas in London‘s Belmarsh prison after trying to paralyse himself due to the agony caused by a degenerative disc disorder.

The 44-year-old was found on his sofa in April after a second attempt to shoot himself failed as the weapon jammed.

‘The reasons for him shooting himself were extremely unusual and tragic,’ Mr Justice Haddon-Cave told London’s Appeal Court.

Paul Davis spent Christmas in London's Belmarsh prison (pictured) after trying to paralyse himself due to the agony caused by a degenerative disc disorder

Racked with pain due to his degenerative disc disorder, ‘he sought to paralyse himself by shooting himself in the lower back.’

Tragically, however, his condition was now even worse due to his gunshot wound, the court heard.

Davis was on morphine and other heavy pain killers, but ‘on the day in question decided that he could stand the pain no longer’.

‘Remarkably, he decided to shoot himself in the spine to paralyze himself and try to stop that pain,’ said the judge.

‘He fetched the gun, shot himself in the lower back, and then tried to reload for a second shot but the gun jammed.

‘But the injury appears only to have caused more nerve damage and to have exacerbated his condition.’

Davis, of Sidcup, Kent, had acquired the prohibited handgun 20 years earlier – when contemplating suicide following his mum’s death.

The judge who sentenced Davis had reduced the normally automatic five-year term for firearms offences due to his ‘exceptional circumstances’.

But his case reached the Appeal Court as Davis’ barrister, Beth O’Riley, urged the judges to ‘show mercy’ and scrap his sentence.

Mr Justice Haddon-Cave, sitting with Lord Justice Burnett and Mr Justice Warby, noted that Davis was ‘in despair’ at the time.

And he concluded: ‘This is a wholly exceptional and tragic case which calls for mercy.’

The judges quashed the three-year term, substituting a two-year suspended sentence which ensures Davis’s immediate release.

He watched the court session via live video link from jail – walking to his chair using a stick. 

It’s time to end civil asset forfeiture

It's time to end civil asset forfeitureIt’s time to end civil asset forfeiture

http://thehill.com/blogs/pundits-blog/civil-rights/329346-its-time-to-end-civil-asset-forfeiture

By any stretch of the imagination, it hasn’t been a banner couple of weeks for federal agencies that engage in the little-known practice of civil asset forfeiture.

Two separate reports—one by the Department of Justice’s Office of the Inspector General (OIG), and the other by the Treasury Inspector General for Tax Administration (TIGTA)—painted a bleak picture of both departments’ use of the practice, which allows federal law enforcement to seize, keep, and repurpose assets on the suspicion that they’re involved in criminal activity. This process was intended to target bona fide lawbreakers. However, it has become a veritable Godzilla of late, targeting not just proven criminals but individuals who have never been convicted of a crime, let alone even charged with one.

The process has come under withering scrutiny from across the ideological spectrum for years—from the Heritage Foundation to the ACLU—for its increasingly broad scope of practice and limited due process protections for innocent property owners.

 

Such proponents of reining in civil forfeiture have long argued that the practice hasn’t appeared to be in the interest of combating crime, but rather to generate profits. At face value, it’s difficult to argue otherwise. According to an Institute for Justice study, net assets in the DOJ and Treasury forfeiture funds increased by 485 percent between 2001 and 2014, but only 13 percent of DOJ forfeitures between 1997 and 2013 came after a criminal conviction. In other words, forfeiture activity has exploded, but not necessarily against those proven to have committed an actual crime.

These new reports do little to dissuade these concerns, either. According to an analysis of 100 DEA cash seizures that featured no court-issued warrant or presence of narcotics, the OIG found that the DEA could not verify in 56 cases that such seizures advanced or were related to ongoing criminal investigations. Meanwhile, the TIGTA found that the IRS has been freezing accounts under the guise of anti-structuring laws. These statutes were originally intended to combat criminal enterprises involved in money laundering. However, in a whopping 91 percent of sampled cases, the laws were being used to forfeit assets from individuals and businesses found to have obtained their income legally.

While supporters of the status quo are fond of claiming that individuals receive adequate due process in civil forfeiture proceedings before property is taken, a deeper scan of the OIG report reveals a disturbing lack of process at all. Of those DEA cash seizures performed between 2007 and 2016 that resulted in forfeiture, 81 percent were done administratively, which allows agencies to keep assets without judicial involvement whatsoever. These cases amount to little more than a rubber stamp, and are singularly lucrative: the DEA alone confiscated $3.2 billion from such forfeitures over that 10-year period. Orwell himself would shudder. 

As troubling as these revelations are, they aren’t surprising. Such are the fruits of allowing federal bureaucracies to expand their authority on autopilot. By the very nature of its charter, the IRS is already imbued with awesome power to peer into nearly every aspect of a person’s life, and we’ve already seen what that capability has borne. In the recent past, various nonprofit groups have been targeted for inordinate scrutiny by the Lois Lerners of the world—unscrupulous types who will inevitably wield levers of power to dubious ends if given rein to do so. 

The ability to unilaterally seize and keep property—with little recourse to the individual—is no different. The administrative swamp is deep and its reach broad, making it liable to ensnare many people whose sole transgression is being an easy target.

Fortunately, elected officials in Congress are taking renewed interest in the situation, refiling several bills that would greatly circumscribe the ability to forfeit property without appropriately tying it to criminal activity. They should move on the matter quickly. The government’s own watchdogs are confirming with hard facts what many people have suspected about civil forfeiture all along: that it’s being used against people who have done nothing wrong.

All that remains is to end it.

 

Secret Hospital Safety Reports May Become Public Under CMS Proposal

Secret Hospital Safety Reports May Become Public Under CMS Proposal

https://www.managedcaremag.com/news/secret-hospital-safety-reports-may-become-public-under-cms-proposal

Under a new proposal from the Centers for Medicare and Medicaid Services (CMS), the public could soon get to read confidential reports about medical errors and mishaps in the nation’s hospitals that put patients’ health and safety at risk, according to an article posted on the ProPublica website. The CMS wants private health care accreditors to publicly detail problems they find during inspections of hospitals and other medical facilities, as well as the steps being taken to fix them.

Nearly 90% of U.S. hospitals are directly overseen by health care accreditors, not by the government. Each year, the CMS takes a sample of hospitals and other health care facilities accredited by private organizations and does its own inspections to validate the work of those groups. In 2016, the agency reported that accrediting organizations often missed serious deficiencies found soon afterwards by state inspectors.

In 2014, for example, state officials examined 103 acute-care hospitals that had been reviewed by accreditors during the past 60 days. The officials found 41 serious deficiencies. Of those, 39 were missed by the accrediting organizations. This disparity “raises serious concerns regarding the [accrediting organizations’] ability to appropriately identify and cite health and safety deficiencies” during inspections, CMS officials wrote in their draft regulations, scheduled to be published on April 28.

The new proposal follows steps that the CMS took several years ago to post government inspection reports online for nursing homes and some hospitals, the article notes. ProPublica has created a tool, “Nursing Home Inspect,” to allow people to more easily search through nursing-home deficiency reports. The Association of Health Care Journalists has done the same for hospital violations.

Those government inspection reports do not identify patients or medical staff, but they do offer a description—often detailed—of what went wrong, ProPublica says. This includes medication errors, operations on the wrong patient or the wrong body part, and patient abuse.

But private accrediting organizations, the largest of which is The Joint Commission, have not followed suit, creating a patchwork of disclosures in which some inspections are public and others are not. The proposed rules from the CMS are designed to fix this.

Medical errors are a leading cause of death and injuries in U.S. hospitals. A 1999 report by the Institute of Medicine estimated that up to 98,000 people a year die because of mistakes in hospitals; subsequent reports have said that the number is much higher.

Gabapentin Becomes a Schedule 5 Controlled Substance in Kentucky

Important Notice: Gabapentin Becomes a Schedule 5 Controlled Substance in Kentucky

Amendments to 902 KAR 55:035 were finalized and adopted on March 3, 2017. The regulation may be accessed on the Kentucky Legislative Research Commission website at: http://www.lrc.ky.gov/kar/902/055/035reg.htm

For questions, please call the Drug Enforcement and Professional Practices Branch at 502-564-7985.
Effective July 1, 2017, all gabapentin products will be Schedule 5 controlled substances in Kentucky.
All applicable provisions of KRS Chapter 218A, 902 KAR Chapter 55 and other licensure board regulations will apply to gabapentin. Please review all controlled substance security, storage, record keeping, inventory, prescribing and dispensing requirements. This document is not intended to be an all-inclusive overview.
Authorized practitioners MUST be properly licensed and registered with the DEA to order the dispensing of a controlled substance. Therefore, only DEA registered practitioners may issue prescriptions for gabapentin or order the direct administration or dispensing of gabapentin to a patient.

 

After July 1, 2017, any existing orders for gabapentin (including Rx refills) issued by a practitioner WITHOUT a DEA registration will no longer be valid and MAY NOT be administered or dispensed. Existing orders for gabapentin that were issued by a practitioner WITH a DEA registration will not be affected, except that existing gabapentin prescriptions will expire after 5 refills or 6 months from the date the prescription was issued, whichever comes first. It will not be legal to distribute Gabapentin samples in Kentucky. Please note that Physician Assistants (PAs) are not authorized to prescribe controlled substances in Kentucky.

 

How does moving gabapentin to Schedule 5 affect prescribing practitioners?
• Advance Practice Registered Nurses will no longer be able to prescribe gabapentin unless they have a DEA license.
• Gabapentin dispensed in Kentucky will appear on KASPER reports.
• Prescribers must comply with the legal standards for prescribing controlled substances promulgated by their licensure board.
 • Prescribers may issue written or oral prescriptions for gabapentin.
• Written prescriptions must be issued on a controlled substance Security Prescription Blank or transmitted to a pharmacy using a certified electronic prescribing application.
• Prescriptions for gabapentin may include up to 5 refills and expire 6 months after the date issued.
• Prescriptions for gabapentin may not be pre-signed or post-dated.

 

How does moving gabapentin to Schedule 5 affect dispensing practitioners?
• Only authorized practitioners may directly dispense controlled substances to patients. In Kentucky, no mid-level practitioners are authorized to directly dispense controlled substances.
• Practitioners who directly dispense gabapentin FROM their stock TO a patient, including both administering and dispensing, shall transmit the required dispensing data to the KASPER system in accordance with KRS 218A.202 and 902 KAR 55:110.
• Practitioners must perform an initial gabapentin inventory on or after July 1 but before July 30, 2017.
• Practitioners must include gabapentin in their biennial controlled substance inventory.
• Practitioners must comply with the legal standards for dispensing controlled substances that were promulgated by their licensure board.

 

How does moving gabapentin to Schedule 5 affect pharmacies?
• Pharmacies must perform an initial gabapentin inventory on or after July 1, but before July 30, 2017.
• Pharmacies must include gabapentin in their biennial controlled substance inventory.
• Dispensing data for gabapentin must be transmitted to the KASPER system in accordance with KRS 218A.202 and 902 KAR 55:110.
 • Gabapentin dispensing data will not successfully upload to KASPER if the prescriber does not have a DEA number, so please ensure that your computer system reflects the correct prescriber data.
• Refills on existing gabapentin prescriptions MAY be filled if the prescriber is authorized to prescribe Schedule 5 controlled substances AND the prescriber has a DEA number AND the prescription has
 ot been refilled more than 5 times AND the prescription was written less than 6 months prior.

Yale Law School Files Class Action On Behalf Of US Army Veterans, Tens Of Thousands Of Them

US Army veterans Class ActionYale Law School Files Class Action On Behalf Of US Army Veterans, Tens Of Thousands Of Them

www.disabledveterans.org/2017/04/17/yale-law-school-files-class-action-on-behalf-of-us-army-veterans/

Yale Law School is representing thousands of US Army veterans of the Iraq and Afghanistan wars in a class action lawsuit against Secretary of the US Army.

The lawsuit names the present Secretary of the Army concerning less-than-honorable discharges unlawfully given to soldiers suffering from post-traumatic stress disorder (PTSD). The lower discharges were intended to force mentally ill soldiers out of the military without the retirement, benefits and care to which they were entitled.

The lawsuit implicates unlawful discharges of tens of thousands of veterans who were victimized by unlawful scheme perpetrated by the US Army to reduce the taxpayer burden of the present wars. It involved falsification of administration and mental health diagnosis to force servicemembers out of the military without help or compensation.

Instead of forcing taxpayers to internalize the cost of the wars by way of paying the full price for benefits and health care for veterans affected, the fraud scheme wrongfully placed the burden onto the shoulders of state programs and family coffers.

Said a different way, taxpayers got off the hook for the true cost of the wars (veterans benefits, military retirements) despite continuing to elect officials who place our brave servicemembers in harm’s way to fight wars that never end.

When taxpayers internalize the real cost of war, it is likely the chickenhawks will be forced into a position of accountability. Until then, we will fight covert and overt wars on every continent.

US Army Madigan Fraud

From 2007 to 2012, the US Army engaged in an unlawful scheme that injured soldiers suffering from PTSD. That scheme was implemented in part by medical staff at the Army Medical Command located in Madigan.

There, forensic mental health professionals refused to diagnose at least 40 percent of the soldiers seen with PTSD to save taxpayers money. In a lecture, one Madigan psychiatrist told colleagues that a PTSD diagnosis can cost taxpayers $1.5 million if medically retired.

At Madigan Army Medical Center, soldiers would have their PTSD cases reviewed by forensic mental health professionals to verify the diagnosis before granting retirement. Over 40 percent of the soldiers seen at the facility had their diagnosis changed or reversed entirely.

Soldiers impacted would then receive general or less-then-honorable discharges for behavioral abnormalities linked to PTSD.

US Army Discharge Fraud

Journalist Joshua Kors of The Nation reported the first story about Army soldiers getting screwed by military doctors, and I have broken that process down into ten steps here from an older article I wrote in 2013.

The sequence of events that defrauded many servicemembers went something like this:

  1. Servicemember enlists and is not diagnosed with personality disorder (PD)
  2. Servicemember goes to Iraq after training
  3. Servicemember is injured with traumatic brain injury and/or PTSD
  4. Servicemember seeks treatment from military mental health
  5. Military doctor diagnoses servicemember with pre-existing PD
  6. Servicemember gets pressured into signing personality disorder discharge
  7. Servicemember gets bounced out of the military without proper benefits
  8. Pause and repeat for thousands of servicemembers
  9. Gov saves $12.5 billion in disability and medical payments
  10. No government official is sued for fraud, while veterans’ families suffer

Records indicate that 160,000 veterans may have been impacted when factored into the Madigan scandal, too. Many of those veterans were forced out of the military under these or similar circumstances. Last year, Army finalized its Madigan PTSD probe of the cases but initially chose to withhold the results of its investigation.

The point of fraud here was Army’s violation of the principle of the presumption of soundness. The gist of this presumption follows the “you break it, you buy it” idea. Those who pass through the enlistment and training process are presumed to be fine. All conditions that manifest later while in service are presumed to have occurred in service without some specific contrary evidence.

Instead, Army claimed they missed the defect in an effort to save a buck on the backs of veterans. Shameful.

Kors covered the story of Army soldier Chuck Luther, which looks like the first real exposure of the PTSD scandal. Kors told the story of his investigation into Army’s scandalous policy to Congress in 2010. According to his testimony, Army officials coerced Luther into signing a Personality Disorder discharge after forcing him to endure torture techniques like sleep deprivation and confinement.

During that same Congressional Hearing, Chuck Luther presented his case to the House Committee on Veterans Affairs, wherein he claims he was basically tortured. Army Maj. Gen. Gina Farrisee (Ret) denied the allegation of sleep deprivation and generally deflected questions from former Rep. Bob Filner about her knowledge and involvement.

As far as responsibility, General Farrisee was Deputy Chief of Staff for Personnel in the Army at the time. She was in charge of policy related to personnel management, which likely included discharge policies. However, the full scope of her involvement in the fraudulent policy against servicemembers is unknown.

It is important to note Farrisee went on to head the Department of Veterans Affairs Human Resources during the wait time scandal where few if any employees were terminated despite placing veterans lives at risk.

RELATED: General Reprimanded For Tillman Scandal Now Heads HR At VA

She is still floating around VA playing clean up no doubt.

US Army Veteran PTSD Lawsuit

That leads me back to the PTSD class action. It appears the US Army veterans have signed up with Yale Law School to sue the Army for its misdeeds.

While the lawsuit may not be a winner (it is very hard to sue the military), the discovery phase of the lawsuit should reveal a great deal of information about the scheme and what the US Army did to the bad actors.

But let’s be honest here.

We know the majority of those involved in the fraud scheme were probably promoted so long as they stayed out of the public view.

I hope these men and women win. What do you think?

Source: http://wtnh.com/2017/04/17/army-veterans-filing-nationwide-class-action-lawsuit/

 

When Equal Isn’t Really Equal

When Equal Isn’t Really Equal

nationalpainreport.com/when-equal-isnt-really-equal-8833382.html

By Steven R. Ariens, P.D. R.Ph.
 
We are now starting the second year of the CDC opiate dosing guidelines being in place. We have seen these so called “guidelines” that do not carry the weight of law being adopted by many healthcare organizations as their standard of care and best practices.

Steve Ariens

Many have pointed out the poor quality of studies/data that the CDC committee used to develop these guidelines and ignored other and often better studies/data that contradicted what was used.

Many healthcare entities are slicing and dicing the guidelines, implementing certain sections and ignoring/discarding other whole sections.

The one section of the guidelines that EVERYONE seems to include in their policies and procedures is the daily Morphine mgs Equivalent limits.

 

If one looks at these opiate conversion tables you will find warning like these:

http://clincalc.com/opioids/

Equianalgesic conversions used in this calculator are based on the American Pain Society guidelines and critical review papers regarding equianalgesic dosing.4,5,6,7 When possible, chronic-dosing studies have been used, including bidirectional and dose-dependent conversions.

There is an overall lack of data regarding most equianalgesic conversions, and there is a significant degree of interpatient variability. For this reason, reasonable clinical judgment, breakthrough (rescue) opioid regimens, and dose titration are of paramount importance.

reasonable clinical judgment, breakthrough (rescue) opioid regimens, and dose titration are of paramount importance

As a clinician, it is important to note that there are significant limitations to equianalgesic conversions and tables. While these equianalgesic tables are current the “best” solution, their limitations should be emphasized:

Single-dose studies: Early studies determining equianalgesia were based on single doses, not chronic administration. Due to drug accumulation, half-life, tolerance, and active metabolites, subsequent chronic administration studies often vary greatly from the original single-dose data.

Bidirectional conversions: When converting between certain opioids, the direction of conversion (eg, morphine to hydromorphone versus hydromorphone to morphine) will produce a different conversion ratio. These bidirectional differences are not captured in a traditional equianalgesic table.5,7

Dose-dependent conversions: The conversion ratio of certain opioids can be dependent on the dose of the original opioid. In the case of converting morphine to methadone, methadone has a relative potency of 4:1 at lower morphine doses, but becomes much more potent (12:1) in patients converting from very high morphine doses.5,7

Cross-tolerance: Many references recommend a cross-tolerance reduction between 25-50% when converting between unlike opioids.9 In patients with very high opioid requirements, the difference between 25% and 50% can be a very significant discrepancy.

Equianalgesic Discrepancies: There are significant discrepancies in equianalgesic dosing tables, with even FDA-approved drug labels not demonstrating agreement. These discrepancies are a factor of both references using old data (single-dose studies) and an overall paucity of data in chronic dosing studies.

Patient-specific factors: No equianalgesic table is able to take into account patient-specific factors — primarily hepatic function, renal function, and age. Opioid metabolism and excretion do differ among the opioids; therefore, alterations in drug disposition will alter the relative potencies of different opioids.

To put it in “layman’s terms”.. These opiate conversion tables are made up of “fuzzy math” with the exception of Methadone conversion, which is “FUZZIER MATH”.

The second variable that is ignored by the CDC guidelines is the variable of a pt’s Cytochrome P450 enzyme system. Which 20%-30% of the population has “defective” metabolism of opiates. Requiring higher and/or more frequent dosing to achieve adequate pain management.  http://www.medscape.com/viewarticle/771480

There are more than 57 genes in the CYP450 liver enzyme system that are used by the body to metabolize different medications but only three are primarily involved with opiate metabolism – except Methadone.

So we have two major variables that can dramatically affect the pt’s overall pain management and they are not on anyone’s “radar”.  So many healthcare professionals and healthcare entities just blindly following guidelines that were set up by a committee that intentionally or unintentionally set up guidelines that does not take a individual pt’s variable needs into consideration.

Steve Ariens is a pharmacy advocate, blogger, and National Public Relations Director for The Pharmacy Alliance.

The Likely Cause of Addiction Has Been Discovered, and It Is Not What You Think

The Likely Cause of Addiction Has Been Discovered, and It Is Not What You Think

http://www.huffingtonpost.com/johann-hari/the-real-cause-of-addicti_b_6506936.html

VIDEO ON LINK ABOVE

It is now one hundred years since drugs were first banned — and all through this long century of waging war on drugs, we have been told a story about addiction by our teachers and by our governments. This story is so deeply ingrained in our minds that we take it for granted. It seems obvious. It seems manifestly true. Until I set off three and a half years ago on a 30,000-mile journey for my new book, Chasing The Scream: The First And Last Days of the War on Drugs, to figure out what is really driving the drug war, I believed it too. But what I learned on the road is that almost everything we have been told about addiction is wrong — and there is a very different story waiting for us, if only we are ready to hear it.

If we truly absorb this new story, we will have to change a lot more than the drug war. We will have to change ourselves.

I learned it from an extraordinary mixture of people I met on my travels. From the surviving friends of Billie Holiday, who helped me to learn how the founder of the war on drugs stalked and helped to kill her. From a Jewish doctor who was smuggled out of the Budapest ghetto as a baby, only to unlock the secrets of addiction as a grown man. From a transsexual crack dealer in Brooklyn who was conceived when his mother, a crack-addict, was raped by his father, an NYPD officer. From a man who was kept at the bottom of a well for two years by a torturing dictatorship, only to emerge to be elected President of Uruguay and to begin the last days of the war on drugs.

I had a quite personal reason to set out for these answers. One of my earliest memories as a kid is trying to wake up one of my relatives, and not being able to. Ever since then, I have been turning over the essential mystery of addiction in my mind — what causes some people to become fixated on a drug or a behavior until they can’t stop? How do we help those people to come back to us? As I got older, another of my close relatives developed a cocaine addiction, and I fell into a relationship with a heroin addict. I guess addiction felt like home to me.

If you had asked me what causes drug addiction at the start, I would have looked at you as if you were an idiot, and said: “Drugs. Duh.” It’s not difficult to grasp. I thought I had seen it in my own life. We can all explain it. Imagine if you and I and the next twenty people to pass us on the street take a really potent drug for twenty days. There are strong chemical hooks in these drugs, so if we stopped on day twenty-one, our bodies would need the chemical. We would have a ferocious craving. We would be addicted. That’s what addiction means.

One of the ways this theory was first established is through rat experiments — ones that were injected into the American psyche in the 1980s, in a famous advert by the Partnership for a Drug-Free America. You may remember it. The experiment is simple. Put a rat in a cage, alone, with two water bottles. One is just water. The other is water laced with heroin or cocaine. Almost every time you run this experiment, the rat will become obsessed with the drugged water, and keep coming back for more and more, until it kills itself.

The advert explains: “Only one drug is so addictive, nine out of ten laboratory rats will use it. And use it. And use it. Until dead. It’s called cocaine. And it can do the same thing to you.”

But in the 1970s, a professor of Psychology in Vancouver called Bruce Alexander noticed something odd about this experiment. The rat is put in the cage all alone. It has nothing to do but take the drugs. What would happen, he wondered, if we tried this differently? So Professor Alexander built Rat Park. It is a lush cage where the rats would have colored balls and the best rat-food and tunnels to scamper down and plenty of friends: everything a rat about town could want. What, Alexander wanted to know, will happen then?

In Rat Park, all the rats obviously tried both water bottles, because they didn’t know what was in them. But what happened next was startling.

The rats with good lives didn’t like the drugged water. They mostly shunned it, consuming less than a quarter of the drugs the isolated rats used. None of them died. While all the rats who were alone and unhappy became heavy users, none of the rats who had a happy environment did.

At first, I thought this was merely a quirk of rats, until I discovered that there was — at the same time as the Rat Park experiment — a helpful human equivalent taking place. It was called the Vietnam War. Time magazine reported using heroin was “as common as chewing gum” among U.S. soldiers, and there is solid evidence to back this up: some 20 percent of U.S. soldiers had become addicted to heroin there, according to a study published in the Archives of General Psychiatry. Many people were understandably terrified; they believed a huge number of addicts were about to head home when the war ended.

But in fact some 95 percent of the addicted soldiers — according to the same study — simply stopped. Very few had rehab. They shifted from a terrifying cage back to a pleasant one, so didn’t want the drug any more.

Professor Alexander argues this discovery is a profound challenge both to the right-wing view that addiction is a moral failing caused by too much hedonistic partying, and the liberal view that addiction is a disease taking place in a chemically hijacked brain. In fact, he argues, addiction is an adaptation. It’s not you. It’s your cage.

After the first phase of Rat Park, Professor Alexander then took this test further. He reran the early experiments, where the rats were left alone, and became compulsive users of the drug. He let them use for fifty-seven days — if anything can hook you, it’s that. Then he took them out of isolation, and placed them in Rat Park. He wanted to know, if you fall into that state of addiction, is your brain hijacked, so you can’t recover? Do the drugs take you over? What happened is — again — striking. The rats seemed to have a few twitches of withdrawal, but they soon stopped their heavy use, and went back to having a normal life. The good cage saved them. (The full references to all the studies I am discussing are in the book.)

When I first learned about this, I was puzzled. How can this be? This new theory is such a radical assault on what we have been told that it felt like it could not be true. But the more scientists I interviewed, and the more I looked at their studies, the more I discovered things that don’t seem to make sense — unless you take account of this new approach.

Here’s one example of an experiment that is happening all around you, and may well happen to you one day. If you get run over today and you break your hip, you will probably be given diamorphine, the medical name for heroin. In the hospital around you, there will be plenty of people also given heroin for long periods, for pain relief. The heroin you will get from the doctor will have a much higher purity and potency than the heroin being used by street-addicts, who have to buy from criminals who adulterate it. So if the old theory of addiction is right — it’s the drugs that cause it; they make your body need them — then it’s obvious what should happen. Loads of people should leave the hospital and try to score smack on the streets to meet their habit.

But here’s the strange thing: It virtually never happens. As the Canadian doctor Gabor Mate was the first to explain to me, medical users just stop, despite months of use. The same drug, used for the same length of time, turns street-users into desperate addicts and leaves medical patients unaffected.

If you still believe — as I used to — that addiction is caused by chemical hooks, this makes no sense. But if you believe Bruce Alexander’s theory, the picture falls into place. The street-addict is like the rats in the first cage, isolated, alone, with only one source of solace to turn to. The medical patient is like the rats in the second cage. She is going home to a life where she is surrounded by the people she loves. The drug is the same, but the environment is different.

This gives us an insight that goes much deeper than the need to understand addicts. Professor Peter Cohen argues that human beings have a deep need to bond and form connections. It’s how we get our satisfaction. If we can’t connect with each other, we will connect with anything we can find — the whirr of a roulette wheel or the prick of a syringe. He says we should stop talking about ‘addiction’ altogether, and instead call it ‘bonding.’ A heroin addict has bonded with heroin because she couldn’t bond as fully with anything else.

So the opposite of addiction is not sobriety. It is human connection.

When I learned all this, I found it slowly persuading me, but I still couldn’t shake off a nagging doubt. Are these scientists saying chemical hooks make no difference? It was explained to me — you can become addicted to gambling, and nobody thinks you inject a pack of cards into your veins. You can have all the addiction, and none of the chemical hooks. I went to a Gamblers’ Anonymous meeting in Las Vegas (with the permission of everyone present, who knew I was there to observe) and they were as plainly addicted as the cocaine and heroin addicts I have known in my life. Yet there are no chemical hooks on a craps table.

But still, surely, I asked, there is some role for the chemicals? It turns out there is an experiment which gives us the answer to this in quite precise terms, which I learned about in Richard DeGrandpre’s book The Cult of Pharmacology.

Everyone agrees cigarette smoking is one of the most addictive processes around. The chemical hooks in tobacco come from a drug inside it called nicotine. So when nicotine patches were developed in the early 1990s, there was a huge surge of optimism — cigarette smokers could get all of their chemical hooks, without the other filthy (and deadly) effects of cigarette smoking. They would be freed.

But the Office of the Surgeon General has found that just 17.7 percent of cigarette smokers are able to stop using nicotine patches. That’s not nothing. If the chemicals drive 17.7 percent of addiction, as this shows, that’s still millions of lives ruined globally. But what it reveals again is that the story we have been taught about The Cause of Addiction lying with chemical hooks is, in fact, real, but only a minor part of a much bigger picture.

This has huge implications for the one-hundred-year-old war on drugs. This massive war — which, as I saw, kills people from the malls of Mexico to the streets of Liverpool — is based on the claim that we need to physically eradicate a whole array of chemicals because they hijack people’s brains and cause addiction. But if drugs aren’t the driver of addiction — if, in fact, it is disconnection that drives addiction — then this makes no sense.

Ironically, the war on drugs actually increases all those larger drivers of addiction. For example, I went to a prison in Arizona — ‘Tent City’ — where inmates are detained in tiny stone isolation cages (‘The Hole’) for weeks and weeks on end to punish them for drug use. It is as close to a human recreation of the cages that guaranteed deadly addiction in rats as I can imagine. And when those prisoners get out, they will be unemployable because of their criminal record — guaranteeing they with be cut off even more. I watched this playing out in the human stories I met across the world.

There is an alternative. You can build a system that is designed to help drug addicts to reconnect with the world — and so leave behind their addictions.

This isn’t theoretical. It is happening. I have seen it. Nearly fifteen years ago, Portugal had one of the worst drug problems in Europe, with 1 percent of the population addicted to heroin. They had tried a drug war, and the problem just kept getting worse. So they decided to do something radically different. They resolved to decriminalize all drugs, and transfer all the money they used to spend on arresting and jailing drug addicts, and spend it instead on reconnecting them — to their own feelings, and to the wider society. The most crucial step is to get them secure housing, and subsidized jobs so they have a purpose in life, and something to get out of bed for. I watched as they are helped, in warm and welcoming clinics, to learn how to reconnect with their feelings, after years of trauma and stunning them into silence with drugs.

One example I learned about was a group of addicts who were given a loan to set up a removals firm. Suddenly, they were a group, all bonded to each other, and to the society, and responsible for each other’s care.

The results of all this are now in. An independent study by the British Journal of Criminology found that since total decriminalization, addiction has fallen, and injecting drug use is down by 50 percent. I’ll repeat that: injecting drug use is down by 50 percent. Decriminalization has been such a manifest success that very few people in Portugal want to go back to the old system. The main campaigner against the decriminalization back in 2000 was Joao Figueira, the country’s top drug cop. He offered all the dire warnings that we would expect from the Daily Mail or Fox News. But when we sat together in Lisbon, he told me that everything he predicted had not come to pass — and he now hopes the whole world will follow Portugal’s example.

This isn’t only relevant to the addicts I love. It is relevant to all of us, because it forces us to think differently about ourselves. Human beings are bonding animals. We need to connect and love. The wisest sentence of the twentieth century was E.M. Forster’s — “only connect.” But we have created an environment and a culture that cut us off from connection, or offer only the parody of it offered by the Internet. The rise of addiction is a symptom of a deeper sickness in the way we live — constantly directing our gaze towards the next shiny object we should buy, rather than the human beings all around us.

The writer George Monbiot has called this “the age of loneliness.” We have created human societies where it is easier for people to become cut off from all human connections than ever before. Bruce Alexander — the creator of Rat Park — told me that for too long, we have talked exclusively about individual recovery from addiction. We need now to talk about social recovery — how we all recover, together, from the sickness of isolation that is sinking on us like a thick fog.

But this new evidence isn’t just a challenge to us politically. It doesn’t just force us to change our minds. It forces us to change our hearts.

Loving an addict is really hard. When I looked at the addicts I love, it was always tempting to follow the tough love advice doled out by reality shows like Intervention — tell the addict to shape up, or cut them off. Their message is that an addict who won’t stop should be shunned. It’s the logic of the drug war, imported into our private lives. But in fact, I learned, that will only deepen their addiction — and you may lose them altogether. I came home determined to tie the addicts in my life closer to me than ever — to let them know I love them unconditionally, whether they stop, or whether they can’t.

When I returned from my long journey, I looked at my ex-boyfriend, in withdrawal, trembling on my spare bed, and I thought about him differently. For a century now, we have been singing war songs about addicts. It occurred to me as I wiped his brow, we should have been singing love songs to them all along.

The full story of Johann Hari’s journey — told through the stories of the people he met — can be read in Chasing The Scream: The First and Last Days of the War on Drugs, published by Bloomsbury. The book has been praised by everyone from Elton John to Glenn Greenwald to Naomi Klein. You can buy it at all good bookstores and read more at www.chasingthescream.com.

Medicinal Cannabis Treatments Coming, Experts Say

Medicinal Cannabis Treatments Coming, Experts Say

Larger-scale research, better regulation needed

https://www.medpagetoday.com/PrimaryCare/AlternativeMedicine/64606

WASHINGTON — Medicinal cannabis industry officials and scholars here touted potential breakthroughs to treat health problems and questioned why cannabidiol (CBD) is not mandatory for athletes to address traumatic brain injury (TBI). Others, meanwhile, cautioned the field needs much more research and regulation.

“The whole concept of cannabis as medicine is very new,” Stuart Titus, PhD, told MedPage Today during an interview at the Americans for Safe Access (ASA) annual meeting on medical cannabis last week. “Everything is at such a ground-floor state.”

Medical professionals including Titus, a former physiotherapist working with athletes, cited cannabis medicines being developed (including these by Axim Biotech) for heath problems including:

  • Chronic pain
  • Cancer-induced pain and nausea
  • Irritable bowel syndrome and irritable bowel disease
  • Psoriasis and dermatitis
  • Multiple sclerosis

“It is the herbal medicine, it should be the paradigm,” Ethan Russo, MD, a neurologist and pharmacology researcher said.

Medicinal development is stalling, he noted: “The problem is those guys,” he said of federal and state politicians, “who make the rules, those rapacious bastards who are ruining our lives.”

Cannabis is not undergoing the randomized controlled trials needed in academic settings, said Christina Marrongelli, PharmD, an independent industry consultant and former University of Mississippi researcher in natural products.

“It’s not like a bunch of [pharmaceutical companies] are waiting to get in. This is a harder thing to develop,” she said. Marrongelli suggested advocates encourage more companies to test the plant.

“How do you take a tree and make it into an FDA approved drug?” she wrote later in an email to MedPage Today. “Development of a botanical drug substance is an enormous task to begin with.” Ultimately, she said, large trials must confirm dosages and efficacy in specific conditions.

Better regulation is also needed, said Nic Easley, CEO of Comprehensive Cannabis Consulting. Regulations vary too much between states, he noted, and between states and the federal government. “It’s medicine, but (without regulation) to some it’s really dangerous,” he said. “We’re fighting over a dandelion and it’s ridiculous.”

CBD has shown enough promise to treat TBI in young athletes, said Titus, president of Medical Marijuana Inc. (which sells CBD products); he asserted that all high school and college athletes should use botanical hemp oil that includes CBD and other compounds from the hemp-cannabis plant.

“Hopefully at some point this will be mandated for the NFL [National Football League]” and other levels of football, he added, a position already advocated by former NFL player Eugene Monroe and Dallas Cowboys owner Jerry Jones.

Titus cited studies including UCLA research published in 2014 showing cannabis consumption (in this case tetrahydrocannabinol, or THC) was “associated with decreased mortality in adult patients sustaining TBI”; he also cited pre-clinical and animal studies he said positively tested cannabis as a neuroprotectant — including protection against chronic traumatic encephalopathy.

 

Two recent review articles — a systematic review of clinical literature on neuroprotection and one of preclinical cannabis work — also suggested cannabis may have neuroprotective properties to treat TBI.

But: “While studies have demonstrated neuroprotective properties of marijuana (and other cannabinoid analogs) in animal models,” the authors of the systematic review wrote, “more studies are needed to ascertain the potential benefits (if any exist) of cannabinoids in humans with TBI.”

CBD has also yielded positive results controlling epileptic seizures in children, Titus said, citing two other recent studies showing botanical CBD was effective . “You’d normally expect better results with the pharmaceutical version (of treatment),” he said. But: “This CBD hemp-cannabis botanical has a pretty profound effect,” perhaps because of the entourage effect.

“We are in the very early stage with informational studies,” Titus cautioned. “But the best therapy at the moment seems to be on the botanical side.”