As a fetus, Charlie endured hearing his mother gasp for life during three heroin overdoses, heard the constant fighting and screaming between his birth mother and my son, endured severe malnutrition second to his parents’ homelessness, felt the poisonous effects of multiple substance abuse, and was the victim of the subsequent, injurious, powerful negative stress hormones pulsing through his mother’s veins.

The Origin Of A New Trauma-related Diagnosis

Addiction and overdose result in deep shame, guilt, and fear for persons suffering from addiction.

Most addicts report a heavy burden of anger and disgust for themselves for their addicted state. Subsequently, they acknowledge an absence of self-worth, which perpetuates hopelessness, low initiative for self-care, and an outward disregard for their lives and health as a way to offset dealing with the deep trauma roots of addiction.

A drug-addicted lifestyle is harder on the soul and body of an addict than on the people who love them, although family and friends suffer inexplicably living with and observing a loved one’s addiction.

However, there is a significant other victim of addiction who is most often never even acknowledged until the damage done to them is permanent. This person receives every spiritual, psychological, and physical impairment that the person in addiction experiences in active addiction and overdoses, but is incapable of processing or recovering from the events.

These lives helplessly experience repetitive, excessive drug use, and very often, overdose, in their body and mind. They can not escape the experiences or the source of those experiences and are unable to tell anyone or ask for protection from the effects of another’s drug abuse.

This is because they are not yet born.

How Excessive Prenatal Exposure To Drugs and Overdose Physiologically Affect A Newborn:

An addict’s excessive drug use is an overt sign of self-rejection. The user may not perceive initially that this is an originating factor of their addiction because there are many other valid facets to addiction.

However, a tragic consequence of addiction-related self-rejection is the destruction of innocence, both of the using individual and of any child growing in the womb of a pregnant addict.

A fetus has every capability to perceive love, affection, and its hopeful birth as it does to receive the innate rejection, disregard, and neglectful abuse occurring in substance abuse overdoses and drug abuse during its womb experience.

What transpires physically to the child through the onslaught of poisonous substances in-utero creates the intrinsic knowledge or perception that it is unwanted, alienable, and dismissible as being worthy of concern and love.

This is how addictive drug use causes any addict to feel. This deep trauma belief is transferred to the unborn through brain synapses, hormones, and the connective spirituality between mother and child.

My own grandson has been born from a severely multi-substance exposed pregnancy. Once home from the NICU, this tiny human being wore the look of the sadness and devastation of his intra-uterine experience in his countenance. I had never seen anything like it. It scared me to the core.

My experience with the result of a loved one’s addiction leads me to educate readers on the tragedies of prenatal opioid and substance abuse.

In my work as a NICU nurse, what always struck me about our “drug babies” was their direct inability to readily accept the human touch. I recognized that although sensory and neurological issues were a major component of that born trait, the inability to want or accept human touch was also resultant of the prenatal rejection occurring through pregnancy drug use and overdose.

They would grimace from touch first, as it appeared to hurt. Watching a new child recoil from another human being’s affection is heartbreaking.

An initial diagnosis of NAS or NOWS is not the separative long-term condition that these children go home with. Most NAS symptoms, some of which initially coincide with PORS symptoms, dissipate after several few weeks.

Most times, these babies were discharged home screaming, red-faced, uncomfortable, and heavily medicated. Their parent(s) would never have the patience and wherewithal to care for them, while still in active addiction or early recovery.

These children begin their fragile lives with both a biological and physical understanding/belief that life is pain, an intrinsic search to end that pain (which becomes a future central focus of existence), an inability to independently stop the physical and emotional pain of rejection (which creates a subhuman existence) and a disconnect from intimacy and self that permanently alters their perspective on self-worth, purpose, and trust for humanity.

Why Medical Intervention is Imperative in PORS and Active Parental Addiction

There are now new trauma classes for foster families accepting children from homes of drug use and other abuses, but few are well versed, if at all, on the subject of prenatal exposure to excessive substance use and overdose-related PTSD or the resultant rejection component in the newborn.

This is because the conditions in this delicate population are not yet medically recognized, documented, and treatable pediatric diagnoses.

It is especially not yet widely recognized that these brand new lives have severe PTSD.

Few professionals have or seek research on this.

Even with today’s recent increased trauma research, both the medical community and society seem to pull a sheet over both the inevitable and unexplainable realities occurring to a human being from prenatal drug exposure.

When medical professionals happen to note both the discord in the addict’s parental dynamics and in how prenatal and postnatal drug addiction (at home) affects those babies conceived in addiction, it is common to see the multitudinous signs and symptoms in a child who is suffering from PORS, dismissed as non-related diagnoses.

CPS can and will not intervene in most cases where a mother does not show up positive for substances at birth or just before. Addicts know to circumvent the system. Who confirms that she is sober a few days prior to the test and several days or weeks after discharge?

For the most part, no one.

An addict traditionally does not get sober during pregnancy just because an innocent life is at stake during or after childbirth.

Overall, there is little intervention from the medical community to acknowledge the delicate situation these children are born into or to actually protect their vulnerable and damaged lives from further damage.

Many times, it seems that this lack of response may stem from willful and/or fearful ignorance to address addiction and an age-old stigma that since an “addict begats an addict,” why intervene?

Few medical providers understand the devastating and insidious nature of the addicted mind. Many do not comprehend the further and continuing damage that occurs to a child who goes home to addiction in a post-exposure crisis medically, emotionally, and physically.

As a result, the formation of special parenting techniques is not addressed through counseling/therapy and things such as specialist referrals are not made or followed through with, compromising the child’s health and safety further.

Persons with an addiction can get better and someday give good care to and parent their child well but, in my experience and opinion as a nurse and observant custodial grandmother, the formative years of the child should not be under the care of addicts (even “functioning” ones) or newly recovered ones.

When an addict is in recovery, they learn that they must focus on themselves and their sobriety first and always to keep themselves in check to stay sober. Decisions must be made that leave out other members of that addict’s family and other life priorities in lieu of the priority of sobriety.

Only time, maturity, and experience weaving the recovery program’s requirements into all aspects of the addict’s life will eventually allow for that addict to be able to properly care for others, and achieve the self-awareness and discipline to do so while maintaining sobriety.

My professional and personal experience so far is the observation of the passive omission of the medical community to take initiative to reach out and engage these parents in any appropriate discussion or intervention of the care of their PORS-affected newborn, or the desperate need for addiction services.

Addressing Latent Effects of PORS and An Addicted Parental Response

A healthy baby whose pregnancy is free of substance abuse requires full-time, attentive, round-the-clock care.

A newborn who is riddled with the physical, mental, and emotional after-effects of prenatal substance abuse requires scrutiny and intervention in every aspect of care and an intimate understanding that their responses to everything around them are woven with distrust, fear, and disconnect.

In most cases, the obvious emotional and physical problems cannot be handled safely or appropriately either by addicts who remain in their addiction or by recovering addicts who are less than 1–2 years stable into their sobriety.

Beginning in the early months after birth, it takes a gentle hand, a calm demeanor, an overly attentive approach, and an excess of undistracted care to settle and restructure these children’s spirit after their womb trauma.

Keep in mind, rejection is a foundational component of their physical, mental, and emotional makeup.

The latent effects of this condition pose further danger to a child as they grow and age as most parents in recovery or in active addiction, will not recognize or understand prevailing and insidious symptoms such as the presence of sensory deprivation/overload, general sensorial problems, neurological delays, night terrors, processing disorders, speech/choking swallowing disorders and other serious maladaptations resulting from prenatal drug use and overdose.

Some of these diagnoses could take months or a few years to become visibly evident, although many are present right after birth.

This places the child in yet another traumatic situation because the uneducated, (uneducated to the problems associated with the diagnosis) addicted or sober parent is again, not traditionally sought out by the baby’s or mother’s medical professionals as an interventional risk or for the teaching of the probable issues to come.

Addicted or recovering parents are prone to getting angry easily (which is a result of their complicated mental and emotional condition in addiction) at the distracting crying, incessant need to eat and be soothed, or the refusal to eat and be held, as well as frequent illnesses.

What commonly happens in the manifestation of symptoms, is the parent(s) will react to the “irrational,” confusing behavior and excessive needs of the child and not to the cause of either. Subsequently, several types of abuse are common to occur, as the baby or older child’s behavior is intrinsically misunderstood.

Parents in active addiction or early recovery will usually misunderstand telltale signs that the baby is in need of a different kind of intense and patient parenting. The parents also do not have the ability in their current state to process or act on the needs of their child.

In one particular NICU environment I was employed in, the staff would read the city’s newspaper weekly on the unit to note which of our discharged babies had died by abuse or neglect. It was that common.

Others ended up in our emergency room completely malnourished and in active severe dehydration. Some made it, some did not.

The medical community as a whole must urgently re-examine the entire and intricate phenom of addiction. We must seriously re-examine sending a drug and overdose-exposed infant home to the people who had damaged them in utero, despite their “cleaned up” appearance and promises, and even despite any recent positive recovery status.

The menace that is relapse is an overshadowing, lurking danger, historically, and must be monitored very closely for a newly sober parent.

Self-coined Prenatal Overdose Rejection Syndrome Diagnosis.

Separate from my extensive nursing experience, I have gathered an immense amount of professional and personal expertise in managing, caring for, and in raising a child born into a heroin and meth addiction.

I noticed the symptoms of PORS in my professional career, but it was not until Charlie, my own grandson, was born from severe addiction that I could pen an actual name for the postnatal (and beyond) symptoms that I was seeing.

I have had legal custody of him since his fifth month of life. Charlie grew in-utero in my home from 28 weeks, was born at 38 weeks, and subsequently endured a month-long NICU stay and then was discharged to my home under the care of his birth mother and my youngest son, his father.

Both Charlie’s parents continue to struggle today with their recovery from heroin and meth, but for all their positive efforts (five years later) neither are in any kind of emotional or physical condition to parent Charlie and will not be for a long time, if ever.

During the pregnancy, in a rescue attempt to get help for her and for Charlie, I insisted that my grandson’s birth mother inform all her doctors and prenatal specialists of her heroin and meth addiction.

However, her specialists were not concerned.

They did not intervene and did not question her or even address her obvious positive drug screens occurring before her 28th week.

Not only was she not flagged as a risk to the baby at and after the birth, but the delivering ob/gyn actually told her that heroin and meth were not known to hurt a baby, so he “should be fine.”

This ridiculous and irresponsible line of thinking and under-education on this doctor’s part is reprehensible and did prove to be tragically wrong. Charlie was born with Gastroschisis, requiring immediate surgery after birth, and was subsequently diagnosed with 12 independent diagnoses.

Now, Prenatal Overdose Rejection Syndrome is an additional, undocumented and unrecognized problem I manage in his care and a focal point of intervention in his life.

Symptoms:

Charlie displays a constant need for reassurance of each family member’s role and connection with each other and to secure the idea that he and everyone “go together.” He continually looks for his proper place in the family, as it is clear he feels “out of place,” in general.

He is now almost five years old. Until very recently, he was inconsolable if I was not within sight and behaved as though he believed I was gone for good. This fear of abandonment began at birth. The few months his parents cared for him only cemented his fears as they did not know how and were not focused on meeting his needs…and they had both secretly returned to using just after he came home.

Charlie additionally had sudden, unexplained fevers, frequent illnesses (every 3 weeks almost on the dot) including pneumonia, RSV, strep, and other general maladies. He woke six to seven times a night, screaming inconsolably much of the time.

When a little older, he would hit himself when even gently corrected or if any situation seemed to place him in the spotlight for any reason. These issues are still present but improved now.

Charlie screams and talks angrily in his sleep often, now and seems to have dreams in which he is being threatened or attacked, as evidenced by this sleep speech and cries.

I sincerely believe this has to do with his prenatal and post-birth experiences with substance abuse, overdose, and the irresponsible, incomplete care he received from his parents in the first few months of his life.

For all the physical, neurological, and emotional difficulties (there are many more diagnoses), the most noted after effect of his prenatal exposure and trauma is his noticeable sense of rejection.

I am very careful in my one on one handling of his body when he walks and moves, as any accidental brush, scrape, or slight knock (think of getting a child into a car seat, dressing, or just moving about in general in the home) to his person sends him into a screaming fit, hitting himself.

The expectation of rejection and mistreatment is in his eyes, despite all my expressed care and love for him. I have also seen the same look in the eyes of other special needs children, both in my pediatric career and presently in other children attending therapy appointments at our therapy clinic.

Many things in a human being’s life can cause the rooted belief of unworthiness. It is incomprehensible that a developing fetus can be so poorly treated in the womb that this kind of root would begin before a first breath in the world, but it is an unfortunate reality.

Signs of PORS: (some can be characterized under other diagnoses as well)

If the caregiver/parent/grandparent of a child who suffered prenatal drug abuse and overdoses recognizes some or any of the following signs, immediate PCP’s therapy and developmental delay referrals needs to be made:

• excessive separation anxiety
• frequent night terrors
• social distancing from peers (can be observed as early as 12–18 months)
• delayed or difficult speech and conversation
• frequent, unexplained illnesses
• any purposeful self-injury
• the appearance of being persistently sad, aloof, disengaged or if they appear overexcited, excessively talkative ie: like the Energizer bunny and they are in a noticeable state of stress)
• anything else that appears to be “odd” or out of sorts with their communication methods, thought processes, and reactions to everyday activities and stressors.
• subtle and overt signs of problems processing daily communication and information, discipline, and social expectations. *
• Congenital mobility problems: weaknesses in various parts of the body showing as imbalance, toe-walking, odd gait, frequent falls, weak extremities, etc.

As a fetus, Charlie endured hearing his mother gasp for life during three heroin overdoses, heard the constant fighting and screaming between his birth mother and my son, endured severe malnutrition, felt the effects of multiple substance abuse, and was the victim of the negative stress hormones pulsing through his mother’s veins caused by the distinct chaos of another’s addiction.

Again, I continue to observe that the PORS phenomenon with all its nuances is not considered even when clinicians do work with addicts and their children. The effect of an addict’s life and abuse on the fetus is not addressed head-on.

Medical providers are bound to the search and research of best care and we are trained to unturn every stone for solutions and resolutions. If this is not accomplished, there are dire consequences for a patient who has experienced prenatal exposure to drugs, and especially, severe cases.

This type of unborn life, this type of prenatal rejection, affects the child’s whole physical, mental, emotional and spiritual makeup.

It is a permanent, invisible disfigurement.

Suggesting Further Solutions:

As with any health problem in our world, one effective and necessary solution is education, which is the purpose for my piece on this under-recognized and hugely epidemic medical and social problem.

Active and sober addicts, the parents and caregivers of the affected babies and children, and other involved (and medical) parties affected by Prenatal Overdose Rejection Syndrome need to be educated on the signs and symptoms of this not-yet-diagnosed condition.

Immediate, compassionate and consistent intervention should unequivocally begin at the positive test for pregnancy in an addict. As much as we, the medical community, can do to help that mother obtain permanent sobriety, we should do.

All parties affected by and involved in the care of Prenatal Overdose Rejection Syndrome also need a voice as a way to heal, educate, and be educated to implement treatments and cares and advocate for new research into this devastating issue. This begins by assessing, triaging, monitoring, and providing the utmost, loving and creative care are for these populations, as we are capable of.

This happens through the willful and purposeful engagement of physicians and other medical providers to swiftly address the symptoms of addiction in the parent and those of the child born out of that addiction. Researching and documenting these mental health and physical conditions and presentations is most imperative.

To summarize

Unborn babies in the womb of an active addict are the most at-risk type of patients in society and the medical community due to the inability of this type of patient to advocate for themselves and the inability of the addicted parent (s) to advocate appropriately for either of them.

The lives and health of these babies are severely compromised before birth. They are discarded and rejected prior to life outside the womb through the use and overdosing of substances, whether intentionally or neglectfully done.

Until research on the full psychosocial, psychological, and coinciding physical and emotional prenatal effects of drug use and overdose is addressed thoroughly, and protective measures for the unborn experiencing this abuse are put into effect, many an unborn child in the womb of an active addict will be plagued with a consciousness of intrinsic and lasting rejection before they are even seen or held.

This is unacceptable for our children and grandchildren and for any new human being.

The post Prenatal Overdose Rejection Syndrome appeared first on Medika Life.

These numbers continue to escalate, and the consequences are devastating for individuals, families, and communities. An urgent solution is needed to address this problem, and one potential solution is to make Narcan Nasal Spray (naloxone) available for free. The agent was just approved as an over-the-counter tool, but pricing and access may still be a significant barrier.

Narcan Nasal Spray is a life-saving medication that counteracts the life-threatening effects of opioid overdose. It works by rapidly reversing opioid overdose, blocking the effects of opiates on the brain, and restoring normal breathing in victims. In many cases, it has been a crucial tool in the hands of first responders, medical professionals, and even laypeople who have been trained to administer it.

The urgency of the opioid epidemic cannot be overstated. According to the World Health Organization, more than half a million people died from drug use in 2021, with opioids being responsible for a significant proportion of those deaths. In the United States alone, opioid overdoses claimed the lives of over 100,000 people that same year. The opioid crisis has been declared a public health emergency, with devastating consequences rippling across communities, healthcare systems, and economies.

The pharmaceutical industry must more beyond a business and manufacture to become a beacon of action for the countless lives lost and impacted by the social blight of addiction. 

A pharma-based fund could be established to support the provision of free Narcan Nasal Spray. By pooling resources from pharmaceutical companies, the fund could finance the production and distribution of the medication, making it more accessible to those in need while supporting the manufacture. Emergent BioSolutions. This collaborative effort would demonstrate the industry’s commitment to addressing the opioid crisis and its devastating societal effects.

The post A Life-Saving Proposal: Offer Narcan Nasal Spray For Free appeared first on Medika Life.

Many people living on the streets in Philadelphia’s Kensington neighborhood — the largest open-air drug market on the East Coast — are in full-blown addiction, openly snorting, smoking, or injecting illicit drugs, hunched over crates or on stoops. Syringes litter sidewalks, and the stench of urine fouls the air.

[This story also ran on U.S. News & World Report and is reprinted with permission from KHN.]

The neighborhood’s afflictions date to the early 1970s, when industry left and the drug trade took hold. With each new wave of drugs, the situation grows grimmer. Now, with the arrival of xylazine, a veterinary tranquilizer, new complications are burdening an already overtaxed system.

“It’s all hands on deck,” said Dave Malloy, a longtime Philadelphia social worker who does mobile outreach in Kensington and around the city.

Dealers are using xylazine, which is uncontrolled by the federal government and cheap, to cut fentanyl, a synthetic opioid up to 50 times stronger than heroin. The street name for xylazine is “tranq,” and fentanyl cut with xylazine is “tranq dope.” Mixed with the narcotic, xylazine amplifies and extends the high of fentanyl or heroin.

But it also has dire health effects: It leaves users with unhealing necrotic ulcers, because xylazine restricts blood flow through skin tissue. Also, since xylazine is a sedative rather than a narcotic, overdoses of tranq dope do not respond as well to the usual antidote — naloxone — which reverses the effects of only the latter.

Xylazine has been spreading across the country for at least a decade, according to the Drug Enforcement Administration, starting in the Northeast and then moving south and west. Plus, it has proven to be easy for offshore bad actors to manufacture, sell, and ship in large quantities, eventually getting it into the U.S., where it often circulates by express delivery.

First detected in Philadelphia in 2006, xylazine was found in 90% of street opioid samples in the city by 2021. That year, 44% of all unintentional fentanyl-related overdose deaths involved xylazine, city statistics show. Since testing procedures during postmortems vary widely from state to state, no comprehensive data for xylazine-positive overdose deaths nationally exists, according to the DEA.

Here in Kensington, the results are on display. Emaciated users walk the streets with necrotic wounds on their legs, arms, and hands, sometimes reaching the bone.

Efforts to treat these ulcers are complicated by the narrowing of blood vessels that xylazine causes as well as dehydration and the unhygienic living conditions that many users experience while living homeless, said Silvana Mazzella, associate executive officer of the public health nonprofit Prevention Point Philadelphia, a group that provides services known as harm reduction.

Stephanie Klipp, a nurse who does wound care and is active in harm reduction efforts in Kensington, said she has seen people “literally living with what’s left of their limbs — with what obviously should be amputated.”

Fatal overdoses are rising because of xylazine’s resistance to naloxone. When breathing is suppressed by a sedative, the treatment is CPR and transfer to a hospital to be put on a ventilator. “We have to keep people alive long enough to treat them, and that looks different every day here,” Klipp said.

If a patient reaches the hospital, the focus becomes managing acute withdrawal from tranq dope, which is dicey. Little to no research exists on how xylazine acts in humans.

Melanie Beddis lived with her addiction on and off the streets in Kensington for about five years. She remembers the cycle of detoxing from heroin cold turkey. It was awful, but usually, after about three days of aches, chills, and vomiting, she could “hold down food and possibly sleep.” Tranq dope upped that ante, said Beddis, now director of programs for Savage Sisters Recovery, which offers housing, outreach, and harm reduction in Kensington.

She recalled that when she tried to kick this mix in jail, she couldn’t eat or sleep for about three weeks.

There is no clear formula for what works to aid detoxing from opiates mixed with xylazine.

“We do need a recipe that’s effective,” said Dr. Jeanmarie Perrone, founding director of the Penn Medicine Center for Addiction Medicine and Policy.

Perrone said she treats opioid withdrawal first, and then, if a patient is still uncomfortable, she often uses clonidine, a blood pressure medication that also lessens anxiety. Other doctors have tried gabapentin, an anticonvulsant medication sometimes used for anxiety.

Methadone, a medication for opioid use disorder, which blunts the effects of opioids and can be used for pain management, seems to help people in tranq dope withdrawal, too.

In the hospital, after stabilizing a patient, caring for xylazine wounds may take priority. This can range from cleaning, or debridement, to antibiotic treatment — sometimes intravenously for periods as long as weeks — to amputation.

Philadelphia recently announced it is launching mobile wound care as part of its spending plan for opioid settlement funds, hopeful that this will help the xylazine problem.

The best wound care that specialists on the street can do is clean and bandage ulcers, provide supplies, advise people not to inject into wounds, and recommend treatment in medical settings, said Klipp. But many people are lost in the cycle of addiction and don’t follow through.

While heroin has a six- to eight-hour window before the user needs another hit, tranq dope wanes in just three or four, Malloy estimated. “It’s the main driver why people don’t get the proper medical care,” he said. “They can’t sit long enough in the ER.”

Also, while the resulting ulcers are typically severely painful, doctors are reluctant to give users strong pain meds. “A lot of docs see that as med-seeking rather than what people are going through,” Beddis said.

In the meantime, Jerry Daley, executive director of the local chapter of a grant program run by the Office of National Drug Control Policy, said health officials and law enforcement need to start cracking down on the xylazine supply chain and driving home the message that rogue companies that make xylazine are “literally profiting off of people’s life and limb.”

The post As Opioids Mixed With Animal Tranquilizers Arrive in Kensington, So Do Alarming Health Challenges appeared first on Medika Life.

Opioid addiction and pain relief require massive health professional, patient, payor, policy and product innovator engagement.  The Food and Drug Administration has launched a new Overdose Prevention Framework, targeting unnecessary prescriptions, prolonged prescribing and counterfeit drugs, and supporting new treatments for substance use disorders and physician education.

But how can innovation be part of the public health and policy solution to create a balance between the imperative to monitor and reduce addiction risks?  How can innovation be part of the solution if regulators and payers do not partner with innovators?

Medika Life Editor-in-Chief Gil Bashe talks with serial entrepreneur and investor Jay Schiff, co-founder and CEO of Addinex Technologies, Inc., a young company focusing on one of the nation’s most pressing issues – opioids – to explore the possibilities and opportunities.

Jay is a Wall Street veteran who has invested more than $1 billion in small and mid-sized businesses. He has managed private investment businesses for Merrill Lynch, a $1 billion private equity firm, and a venture-backed finance company. Jay earned his BA in Economics from Cornell University and an MBA in Finance from New York University.

[Medika Life and FINN Partners have no business ties to Addinex Technologies.  This interview focuses on the critical role health innovators serve in exploring new paths to long-standing problems unaddressed.]

Gil Bashe: I understand you have engineered a dispensing system for opioids. Is that correct?

Jay Schiff:  Yes. I read several articles on the opioid epidemic and it struck me as odd that controlled substances like opioids were highly regulated and monitored until they got to the patient. From production to the pharmacy, they are treated as dangerous, with a high potential for abuse, but they were being dispensed with the same level of protection as Tylenol.

The child cap was invented in 1967. That’s more or less where the innovation stopped in terms of keeping the wrong people from accessing medication. And then what do you do with excess meds if you aren’t supposed to flush them down the toilet or throw them in the garbage, given 3.3 billion excess pills prescribed a year?

Bashe: The pill mills were, at first, just distributors filling the demand of the local marketplace of pharmacies. It’s sad how many people misuse opioids, how many people are addicted, and how many people tragically die each year. It’s one of the most significant causes of death in the United States. We can deal with this from a legal standpoint; we can deal with this from a policy standpoint; we can deal with this from an oversight standpoint, governance standpoint – you’ve chosen to deal with this from an engineering standpoint.

Schiff: Some things have been done from a legal and prevention standpoint. Certain states have limitations on initial opioid prescriptions – in New York; you can only get a seven-day supply. New Jersey is five days.

I talked to a doctor about that, and they said that’s not a limitation. If you prescribe a patient two pills every four hours, that’s 12 pills per day. Over seven days, that’s 84 pills: not much of a limitation. The reality is that doctors overprescribe opioids through no fault of their own.

Bashe: But we know that’s because many patients are in pain, and obviously, the doctors don’t want them to be in pain. But they also lack data.

Schiff:  Doctors don’t want their patients to be in pain, but does that mean they should give their patients 30 or even 90 pills? They can’t make an informed decision because that usage and pain level data is unavailable. Believe me. I searched everywhere.

If colleagues are prescribing 30 pills because they think that’s the correct number based on experience, that suddenly becomes the basis by which everyone prescribes.

But it’s not the correct method because we already know that doctors overprescribe after surgery, on average, by 70%, leading to 3.3 billion excess pills out there.

Good data is not available. The CDC put out guidelines in 2016. They’re now going back to the drawing board and coming up with updated guidelines. Again, it’s not based on actual usage data from the hundreds of millions of annual prescriptions; if it is based on some data, it’s just a tiny percentage of the whole picture.

Pain levels are also important. We did a study with Columbia University Medical Center where patients were asked, “What’s your pain level on a scale of zero to 10?” If their pain was a self-reported four or below, our app would automatically send them a message that their doctor would like them to switch to over-the-counter medication. At no time would we limit access, so the patient had no incentive to lie. We barely had any usage at those pain levels.

This feedback is essential because stats have shown that the longer you’re initially on opioids, the more likely you will become dependent on them. We can shorten that duration and therefore minimize the risk of dependency.

Opioids are supposed to be reserved for people suffering from severe pain. Other countries don’t use the same number of opioids as we do here. So, I think that data will help doctors more accurately prescribe and patients understand the risks of taking opioids for moderate pain versus switching to an OTC painkiller.

Bashe: Your dispenser system is password protected. The patient has a unique passcode for each dose they enter to get the medication dispenser as prescribed. How does that help? In other words, what’s to stop a cancer patient from accessing their meds and simply giving them away to other people?

Schiff: In its simplest form, you can think of our dispenser as a speed bump. If the prescription is one pill every four hours, the patient could put the code in, get the dose, set it aside, and wait four hours for each dose. That is a tedious way to collect the medication for diversion. Worst case scenario, they’re back to where they started since there are currently no protections.

Bashe: Let me clarify – you’ve developed a specially engineered pill, tablet, or capsule container, correct?

Schiff: Yes, and we’ve patented it. It’s entirely mechanical, and keeping the price as accessible as possible was essential. It can’t be zero, but we can get it out there to as many people as possible and then collect enough data to enable doctors to determine, “Here is the right amount to prescribe.”

Once we have enough data, a doctor can see, “I have a male patient between the ages of 20 and 30 weighing between 160 and 190 pounds. He’s had surgery to repair a torn ACL, and I want to prescribe him 10 milligrams of oxycodone every 4-6 hours a week.”

We can produce a graph of what similar patients have taken, and based on that information, combined with how similar patients have reported their pain level –  – the doctor can determine how much to prescribe. The doctor can always choose another amount, but they will have access to objective data to decide the right amount for their patient.

Bashe: And the dispenser itself is locked. In other words, the pills are placed in the dispenser and closed at the pharmacy. They are only accessible by way of the timed passcode, which releases a drug based upon the indication of use, according to the physician’s recommendation.

Schiff: Correct. It doesn’t automatically unlock every four hours, for example. The patient gets the unique code for that individual dose in the app, and they can’t get the next dose code until it’s been four hours and it’s time for that dose.

One important distinction for those taking opioids is that those drugs are not ones of adherence. They should be taken as needed, but the goal is to reduce the amount. That’s unlike many other drugs, where you want to keep them on a set schedule.

We can accommodate both, but for opioids, we don’t want to send reminders to take them when they are not necessarily needed. We want patients to use the app to request access when pain levels warrant another dose, and if the time is appropriate per the prescription, it will give them the code.

Bashe: So, this is not just a one-time code for a patient. It’s a one-time dose passcode, assuming pills are left in the dispenser.

Schiff: Yes. Releasing one dose at a time has multiple benefits. It makes overdose more difficult because patients can die if they take too many opioids at once. Tragically, we have a family friend who died after an overdose following major surgery. Also, the individual dose codes keep other people out of your medicine. Even if the interloper figures out a code, they can only access one dose.

Another significant benefit is that the patient must engage with the app to get each dose. This allows the app to provide education and collect information to help with their treatment and future patients. Many app-only solutions suffer from poor engagement with the app, but that is not a problem with our system.

Bashe: And is it purchased by pharmacy chains or drug manufacturers? Who is the customer for your dispensing system?

Schiff: The patient is the customer. We want to get it reimbursed by insurance, but we don’t have that today. It’s something we’re working on. The doctor prescribes and the patient receives it.

Bashe: Often, when we look at growth hormone and the injector, or insulin and the injector, the therapy is generic. Insulin is generic; the injector is the brand, growth hormone is the generic the injector is the prescribed product.  In this case, if someone prescribes a specific opioid, is the opioid generic, and the device itself is prescribed?

Schiff: Yes. It doesn’t go to any pharmacy; it has to be a pharmacy we’ve partnered with. They have to know not just to give a bottle with the pills but to get the pills in our system so we can monitor and dispense when appropriate, along with the disposal mailer.

When the patient is done taking their opioids, we remind them to return the dispenser with excess pills. The pharmacy doesn’t just send our device with the pills in it but also sends a DEA-approved disposal mailer.

After the pain is gone or low enough to use an OTC painkiller, the patient is asked to use the disposal mailer: close it up, drop it into a mailbox, or bring it to the post office. It goes back to a disposal company we have a partnership with, and upon receipt, they scan the mailer and a confirmation of receipt goes back into our app. Our partner then correctly disposes of the excess medication.

In the Columbia University Medical Center study I mentioned earlier, 80% of patients returned the device, representing 84% of excess pills. Compare that success rate with a Johns Hopkins meta-study, for example, where 4% and 9% of pills were correctly disposed of. 

Bashe: So the customer – the patient – receives the medication via Federal Express? “Sign here, please.”  The patient signs for the drug in the device and has to activate it; in other words, after I’ve received the device and registered on the app, I’m now letting Addinex Technologies, and the doctor know the device is in my hands.

Schiff: Because it’s a controlled substance, delivery requires a signature.  The patient then goes into the app, puts in their patient ID and the device ID, and if that matches up, the app gives them a unique code for each dose as it becomes available based on their prescription.

.Bashe: So you talked earlier about the challenge of payers. Is this because the device is not on the formulary with the medication? Payers are dealing with this challenge of effective pain management, and they get concerned about misuse, abuse, or addiction, putting them in the spotlight. What’s your specific challenge to the reimbursement?

Schiff: There isn’t a CPT code for a dispenser. It’s much more than a dispenser. We spoke with some of the payers early on in our process, and they expressed interest but wanted us to come back with hard data that shows our device achieves what we know it can. That is why we’ve been doing clinical studies. Columbia is now doing a phase II study and we’re working with two other major medical centers on other studies.

Bashe:  It sounds like your app provides the code like many security or multi-factor authentication systems. You’re emailed a code if you want to access PayPal on a new device. Sometimes they give you a one-time code for sending money as a security measure. It’s basic cyber security.

You’re operating in an area where people can accidentally misuse or intentionally abuse a product. Your work gives us data on what is going on between the patient and access to the pill.

Schiff: Yes, and I would add to that. We’re adapting our system to be able to dispense a drug called suboxone, which is widespread opioid addiction treatment. It comes in a film strip, and nobody could dispense it effectively before us.

For addiction patients, instead of asking them, for example, “What’s the pain level,” we can ask them, “What’s your craving level right now?”

If their craving levels are high the app can contact their doctor to alert them that the patient needs support.  We’ve added a video recording component, as well. It’s optional, but because the only way that doctors can currently confirm that patients who take suboxone or methadone are adhering to their prescription and not diverting it, is that they are required to get a urine analysis once a week or every other week. We can have the patient take a video of every dose that shows they’re taking it each time they say they are so their provider can track it.

It reduces liability for the doctor and keeps patients on track, knowing they’re accountable. Up to 28% of suboxone prescriptions get diverted, and we can help keep those patients on track. It’s hard to break an addiction, and if we can help keep them on medication-assisted treatment, that’s highly valuable.

Bashe: There is a saying that culture crushes innovation. What’s the culture around this topic, in your opinion?

Schiff: Glacial inertia. It’s a very slow process to change anything in this space.  

For example, many people have endorsed using the device for methadone treatment. Patients on methadone must go to a clinic every day and stand in line, sometimes requiring a long trip. It’s time-consuming and stigmatizing. Our system can provide more comfort than take-home methadone is properly used, but current regulations stand in the way.

I’ve been trying to speak with politicians to get their take on it, but it’s not easy. One of the things that we’re exploring is tapping into this vast amount of money coming from the opioid settlements.

Many states and localities plan to use the money to pay for Naloxone. Naloxone is a great drug to reverse overdoses, but there’s only so much money to spend on Narcan. There’s money available in these settlements to try new methods to prevent and treat opioid addiction.

Bashe:  My last question deals with technology and the digital divide. As you said, this dispensing technology is based on an app with a smartphone that connects to the device. Is that correct?

Schiff: It is, and I know where you might be going with your questions. It’s available on any smartphone, Android or iPhone. We’ll also soon be developing a version of our system for text and phone so that you don’t need a smartphone.  You text or call, put your information in, and it gives you back your code. The doctor can ask whatever questions they want to monitor your progress, just like with a smartphone. We want to make it as accessible as possible. We are also offering Spanish language in addition to English.

Bashe: How about seniors?

Schiff: That’s where the phone option comes in. That would make it easier. I will caveat that our study did not involve seniors, and though that’s typical for a study like this, that’s data we should get.

One of the interesting pieces of feedback that we got is that with a child-proof bottle, you have to push and turn it, which can be difficult for an older patient or one with an upper extremity injury or weakness. Our system solves that issue, but you’re right: we have to study this more with older people, people with arthritis, and other disabilities. We’re trying to make it as straightforward as possible, but it will not be perfect immediately. Also, doctors don’t have to prescribe it to patients who can’t easily use it.

Bashe: Yours is an exciting story of innovation. Historically we’ve looked at controlled drug monitoring systems that cast a suspicious eye on the patient. This system is not set up as, “Hey, I know you’re trying to scam the system, so I’ll make it super hard for you to get too drunk.”

This is “How do I make it appropriate to understand when you’re taking the drug and when you no longer need it.”

Schiff: That’s what we’re trying to do. Not everybody feels that way when they see the device, but the feedback was very good from the research, and people appreciated that someone was looking out for them.

Along with medical devices, technology can play a major role in helping health professionals overcome some of the pain medication addiction challenges.  However, the obstacles may not be engineering or generating sufficient clinical data from in-real world patient studies.  Federal regulators and payers need to jump aboard as allies. The barriers facing Jay Schiff and other innovators are similar – obtaining reimbursement coding, securing conversations with health professional associations and finding provider partners to test new ideas.  Along with innovation, collaboration may be among the essentials to success.

The post Policies and Policing Didn’t Stem Opioid Abuse – Can Tech Be A Solution? appeared first on Medika Life.

One of the ways is to indicate that a patient required more pain medication than was administered or to collect any containers that have medication in them and that were to be carefully discarded.

As noted in a professional journal, “Too many of us have known of a colleague with substance use disorder (SUD) whose behaviour resulted in severe consequences to the person or to others. SUD is not specific to our specialty, but doctors are at the top of the occupational risk ranking and the anesthesiologist is at the top of these….”

In fact, “Anesthesiologists experience substance use disorders at a rate reported to be 2.7 times that of other physicians.”

How do we know that any health care personnel working on a unit is or isn’t addicted? Also, how do we know that all of the physicians caring for patients are not cognitively impaired? I knew of one physician who had to be guided by the nurses on the unit whenever he was prescribing a medication.

There was no question that he should have retired, but he had a position of authority and was seen as an expert in his field, and no one wanted to step on his toes. I don’t know what happened to him, but I hope there were no serious mistakes because of his impairment.

Another physician at a nursing home, where he was the medical director, was a known alcoholic, and again the nurses always covered for him. He only left the position when the nursing home was acquired by a large corporation that cut back staff and brought in new management.

A third physician, a surgeon, was known to abuse alcohol and come into the operating room with alcohol on his breath. He was never reported. Once again, neither the nurses nor anyone else ever told anyone.

The Addicted Physician

I once worked at a hospital where a new psychiatrist came to one of the units where a colleague was working. His appearance was somewhat odd. He wore suits that were rumpled and outdated and were too flashy. We chalked it up to his not having done very well in the profession and let it go at that.

Imagine our shock when we discovered that another psychiatrist in the hospital was supervising him because he had previously been an anesthesiologist and was forced to change his specialty to psychiatry. However, the addicted physician found a way to continue his addiction, and it was simple. All he had to do was remove prescription sheets from the back of the pad of his supervisor. The supervisor had left the prescription pad in an unlocked office desk drawer.

How was his deception discovered? Foolishly, the addicted physician took the scripts, using patient names, to a local pharmacy to have them filled. In addition, the scripts were all for quaaludes. The pharmacist found this quite curious and called the director of medicine at the hospital to ask why this psychiatrist was handing in so many prescriptions. It was then that they discovered his ruse, and he was, once again, sent to an addictions rehab hospital. He had already been a patient at two prior addiction rehab facilities.

The cleverness of this deception was thwarted once the state in which he worked required all prescription pads to be printed on special paper and copies sent to a state database by pharmacists. This was not a unique instance, and other states quickly determined they needed to revise prescription pad production and recording databases to prevent misuse. But addiction isn’t the only challenge for medicine.

Setting Standards for Continued Practice

In the past few years, professional literature began discussing when a physician should retire or what types of evaluations should be put in place to maintain a license after a certain age. It doesn’t crop up often, and it is a tough call to make.

The state’s medical licensing board is one place where all physicians can be subjected to a review of their work or where complaints can be lodged. They examine both professional and consumer reports sent to them. If someone wishes to check on a specific physician’s credentials, there’s also a place for that, and it is here on Docinfo.

Unfortunately, another database, the National Practitioner Data Bank (NPBD), is accessible only to specific groups. It was created by federal law to protect consumers, and its site states, “Although these reports are not available to the general public, various entities (e.g., hospitals and other health care entities) may query the NPDB to obtain information on a specific licensee or entity.” I doubt that patients know the database exists or if it contains material on cognitively impaired physicians.

A “graying” of the physician workforce was noted before the 21st century, but there is a reluctance to report or to require evaluation of older physicians. How should this question(s) be resolved? “…the authors issue a call for an expert consensus panel to convene to make recommendations concerning aging physicians with cognitive impairment who are at risk for medical errors.”

We are awaiting such a panel and, in the meantime, let the patient be vigilant and keep good notes on their care and from whom they received it.

The post Are Lives Lost by Cognitively Impaired/Drug-Abusing Physicians? Who Reports Them? appeared first on Medika Life.

Many of those people first received an opioid drug, not from a drug dealer, but from a doctor, prescribing it in good faith to treat pain. The question is: are opiates good for treating pain that is not from cancer. The latest research says, “No.” 

Researchers from Australia randomized two groups of patients who had 1 or more bone fractures that required surgery to receive either oxycodone — what they called a “strong” opioid — or acetaminophen and codeine (aka “Tylenol #3) to treat pain after they were discharged to the hospital. 

They found no significant difference in pain between each group, despite the fact that the oxycodone group had a 6-fold higher opioid dose. The study authors concluded, “These findings suggest that ongoing first-line strong opioid use after discharge from the hospital should not be supported” in those patients who had a surgically managed bone fracture. 

This is an important study. It further strengthens the recommendation that strong opioids such as oxycodone should not be used for noncancer-related pain. In fact, when thinking about a bone fracture, the mechanism of the pain after surgery has nothing to do with the opioid receptors in the body, and they are more likely due to the inflammation after the fracture and the surgery to fix it. 

In fact, the absolute best pain medicine I’ve used to treat the surgical pain of patients recovering from heart surgery — and this was confirmed to me by a physician colleague who had the surgery himself — has been ketorolac, which is an NSAID like ibuprofen. The only thing is, NSAIDs such as ketorolac can cause serious complications like bleeding and kidney failure (which I’ve seen in my practice). 

Still, even though opioids are ubiquitously used for post surgery pain, they really are not good drugs for the pain. This also goes for pain after dental surgery and procedures. As clinicians, we need to use less of them. 

Of course, it is not our fault if we prescribe an opioid for pain in good faith and our patients abuse the medication. At the same time, we need to heed the science about opioids for noncancer pain. The literature increasingly suggests that opioids are not effective and can lead to abuse and complications. Thus, we should prescribe less of these medications as much as possible. 

The post Oxycodone No Better in Treating Post-Orthopedic Surgical Pain appeared first on Medika Life.

I suffered from a chronic pain issue, but I hid my problem. I feared doctors, and nurses only saw a drug seeker. It was so hard to admit when things got out of hand; that I needed help. I was a drug seeker. But what if, God forbid, my addiction went one step too far? What if it was too late to get help?

My story starts innocently enough but takes a dark turn. Things all started with a typical female gynecologic issue, debilitating menstrual cramps. Every month I suffered the misery of terrible periods. I missed school and work. I tossed and turned in bed, trying to find a comfortable position. I used heating pads, Tylenol, and Ibuprofen.

I would use anything to alleviate the pain.

One day, a friend’s mom recommended a doctor. The office was quite far away, but the doctor had a reputation for being a good listener with a genuine concern for women in pain.

This doctor gave me hope. She suggested birth control pills for cycle suppression but also prescribed something “new” to make me more comfortable. The hope was the new birth control would reduce menstrual cramping while I took the other medication “as needed” for pain.

This new medication was Hydrocodone-Acetaminophen 10/325 mg, a potent opiate.

I went for a follow-up appointment with my regular doctor. The doctor was highly concerned with this new prescription. I was young, healthy, and on a strong dose of opiates for a long period of time.

Honestly, I hadn’t realized this medication came with dangerous addiction potential. The prescribing doctor never mentioned it. My menstrual pain was gone, but now I was facing a new problem.

Pain pill addiction.

Good-bye magic pill

Getting off pain medication triggers horrific withdrawal symptoms. My menstrual cramps paled in comparison to withdrawal pains. These abdominal pains were the worst thing I have ever gone through in my life.

It was agony.

I needed something to make it stop.

Addicts will do anything to get a fix. In our minds, the sky is the limit. We play out every scenario in our minds to get relief. I called everyone I knew who had ever taken this medication. Sadly, finding pain pills was simple. Many people had extra pain medication leftover from surgeries and other medical problems.

Finding more and more pain medication was easy. I learned all the tricks. I spent many hours going to various doctors and emergency rooms to fill the continuous gap in my life.

Hydrocodone made the pain go away.

I continued this pattern for eight years.

I also have a history of depression. Depression is a common compounding problem for addicts, often not correctly diagnosed. Getting high off pain pills filled an emotional hole, as well as the physical one.

A doctor asked the hard questions

I got pregnant with my first pregnancy. My doctor looked at my prescription history and asked if I was taking opiates. No other doctor had ever confronted me with my actual prescription history. They just took me at my word, and I was good at lying.

I wanted to be honest, but I didn’t have the courage to my doctor the truth. I was not ready yet.

I denied narcotic use.

I honestly didn’t have faith in myself to be done with pills after my son was born. I was worried about going through labor and not having good pain relief.

I had many excuses that all made perfect sense at the time.

My doctor saw through my denials. He enrolled me in a pain management program, and I started Suboxone. The pregnancy was a success but soon after I relapsed. After I had my baby, I went through a few more years in and out of the recovery and relapse phase.

After my second child, I finally got tired of prescription chasing. Calling people for pain pills got old. Finding medication was exhausting.

I always had an excuse or a lie. Eventually, the lies catch up to you.

While I had legitimate pain from some nerve damage after my second pregnancy, it was nothing major. I was uncomfortable at times, but I used the MRI showing a small bulge in my spine to get my pain medication.

I no longer had the energy to take care of my boys without a dose of pills. This life was embarrassing and frustrating.

My depression was growing.

A day came when I had enough. A Suboxone clinic opened near my house. I drove by it a few times before I actually made a call.

The clinic’s fees were not sky-high. Finding affordable help is another barrier to addicts. Without health insurance, it is cheaper to buy pills off the street or go to an ER. Cost is also a convenient excuse to avoid the terrifying decision to go get help.

Now it makes sense to me when people say no one can help you until you are ready to help yourself.

The day I called, I made sure to get an appointment for the same day. If I did not go right away, I would make up an excuse to cancel.

I was fighting an intense internal battle. A war between good and evil waged inside my head. Walking into the clinic was the right decision for myself and for my family.

But I tried talking myself out of it.

I did not want to go inside the door. Entry meant something was really going to change in my life. I don’t care for change even though I really needed it. Addiction’s tight grip on your brain is powerful. No matter how much pain it causes, you just can’t pull away.

I held my head up and tried to keep calm. My heart was pounding. My palms were sweating.

I walked through the door, and I have never looked back.

I started appropriate anti-depressant medication. We also began non-narcotic medicines to help with nerve pain.

I am now 3 years sober. I am also happy.

I take the process one day at a time. I am human. Healing takes time. Everyone has baggage. We are all a little damaged. Our scars are part of our unique story.

My faith in God and my family are sources of inspiration to keep walking the right path.

I thank the doctors who confronted me with the truth of my addiction.

You called my bluff. I needed it.

Doctors who express legitimate, sincere interest can help people who are struggling. Addicts will lie and deceive, but they need the trusted help a doctor can give.

If you are a patient struggling with any addiction problems, please know you can reach out. You can get help without being scrutinized. It may not feel like it, but there are people who know what you are going through and want to help.

It is my genuine hope to bring good out of this dark time in my life. For anyone struggling, I hope they see the light shining from my story.

Ask for help.

Come out of the darkness and join the sunshine.

This article was contributed by an anonymous patient at MacArthur Medical Center and edited by Dr. Jeff Livingston. We respect her privacy and value her strength and courage to share her experience.

The post How Suboxone Set Me Free From Opiate Addiction appeared first on Medika Life.

Death is relative unless of course, it affects someone close to you. How we measure deaths and over what period of time matters in how the public perceives these deaths. Here a few figures about deaths related to opioids, and we’ve changed the way they’re presented. Rather than spreading them out over time, we’ve aggregated them. They make for pretty shocking figures.

Opioid-related data demonstrated an almost fourfold increase in overdose deaths from 1999 to 2008, according to a 2018 review published in NCBI.

By 2016, deaths had risen to over 42,000 for that calendar year. Keep in mind these are deaths directly caused by overdose or abuse of the drug. Many deaths aren’t shown as such, so this figure is conservative. People die in drug-related crimes, violence, and suicide, directly linked to their addiction lifestyle. Opioids pulled the trigger, but arent recorded as the primary cause of death.

Opioid overdoses related to illegally manufactured fentanyl (the most powerful of the opioids) represented the greatest contribution to the increasing numbers, accounting for 20,000 of the 42,000 deaths. As a result, on October 16, 2017, the US Government declared the opioid epidemic a public health emergency.

The medical community, and particularly pain medicine practitioners, had been active participants and fully aware of the development of the current state. Prescription drug monitoring programs (PDMPs) and the National All Schedules Prescription Electronic Reporting Act (NASPER) have effectively contributed to the reduction in opioid prescriptions by 8%, but on the ground, these initiatives have not translated into saved lives. In fact, quite the opposite.

Fast forward to 2021. From emerging figures, it becomes evident that we are losing this battle, and spectacularly so. In 2019, nearly 50,000 people in the United States died from opioid-involved overdoses.

From 1999 to 2019, nearly 841,000 Americans died from a drug overdose.³ Over 70% of overdose deaths involved an opioid-like prescription, opioids, heroin, or synthetic opioids (like fentanyl). If you add in figures from 2019 to now, 2021 you can safely assume we are over a million deaths, of which more than 700 000 are related to opioid addiction.

How did we get here?

Opioids and cocaine were widely prescribed in the late 19th century for anything from toothache to diarrhea. No regulation existed and only when street addition became evident was regulation enforced. The Harrison Narcotic Control Act of 1914, passed in response to the sudden emergence of street heroin abuse as well as iatrogenic morphine dependence, influenced both physicians and patients alike to avoid opiates.

It would take nearly eighty years for opioids to come back into vogue as one of the most effective treatments we have to manage pain, particularly extreme and chronic pain. The concept was a simple one. If cancer patients could benefit from opioid use to manage pain, why not extend the benefit to chronic pain sufferers too? The flaw in this concept, evident even to a layman, lies in the fact that the two types of pain differ significantly, cancer pain and chronic, non-cancer pain, and ignores the etiologies of malignant and non-malignant pain

This dangerous conflation disregarded the complex biopsychosocial phenomena that is chronic pain, and despite many cautions to this effect, opioids grew into the primary modality of chronic non-cancer pain treatment we know today in the USA¹.

It can therefore be argued that pressure from within Pharma and the decision to widely ignore the cautionary voices raised across the industry are directly responsible for the opioid scourge that now blights American Healthcare. This is worth noting as we look to assign responsibility for the opioid pandemic.

To explain the depth of complicity, consider this. In 2000 the Federation of State Medical Boards and the Drug Enforcement Agency issued statements promising less regulatory scrutiny over opioid prescribers, thereby assuaging physician reluctance to prescribe more liberal amounts of opioid analgesics.²

Provider abetted addiction in modern-day American Healthcare had just been given the official green light.

How opioids work

All opioids are chemically related and interact with opioid receptors on nerve cells in the body and brain. Opioid pain relievers are generally safe when taken for a short time and as prescribed by a doctor, but because they produce euphoria in addition to pain relief, they can be misused (taken in a different way or in a larger quantity than prescribed, or taken without a doctor’s prescription). Regular use — even as prescribed by a doctor — can lead to dependence and, when misused, opioid pain relievers can lead to addiction, overdose incidents, and deaths.

Exactly how addictive are opioids? That depends on a number of factors and varies from patient to patient. It should take a couple of weeks to become physically dependent on an opioid, but that varies. If you take an opioid for a day or two, it should not be a problem and, generally, you will not become addicted. However, some studies show even the first dose of an opioid can have physiological effects.

There is no exact data and by ingesting an opioid, you are in effect playing a pharmacological version of Russian roulette. If you suffer from cancer-related pain, then you are in a category where the risk is justified by the pain you are experiencing. It is important to understand that you can be physically dependent on a substance but you don’t necessarily have problematic use. A cancer patient with chronic pain may be physically dependent but not addicted.

Opioids are one of the most addictive medications prescribed. Even doctors can become caught up in this dependency cycle, popping a few pills over the course of a few days for sorting out a nagging pain. Ingesting an opioid exposes you to the risk of addiction.

Examining the types of opioids

Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin®), hydrocodone (Vicodin®), codeine, morphine, and many others.

Brand names (generic names)

• Abstral (fentanyl),
• Actiq (fentanyl),
• Avinza (morphine sulfate extended-release capsules),
• Butrans (buprenorphine transdermal system),
• Demerol (meperidine [also known as isonipecaine or pethidine]),
• Dilaudid (hydromorphone [also known as dihydromorphinone])
• Dolophine (methadone hydrochloride tablets)
• Duragesic (fentanyl transdermal system)
• Fentora (fentanyl)
• Hysingla (hydrocodone)
• Methadose (methadone)
• Morphabond (morphine)
• Nucynta ER (tapentadol extended-release oral tablets)
• Onsolis (fentanyl)
• Oramorph (morphine)
• Oxaydo (oxycodone)
• Roxanol-T (morphine)
• Sublimaze (fentanyl)
• Xtampza ER (oxycodone)
• Zohydro ER (hydrocodone)

Street Names

Captain Cody, Cody, Schoolboy, Doors & Fours, Pancakes & Syrup, Loads, M, Miss Emma, Monkey, White Stuff, Demmies, Pain killer, Apache, China girl, Dance fever, Goodfella, Murder 8, Tango and Cash, China white, Friend, Jackpot, TNT, Oxy 80, Oxycat, Hillbilly heroin, Percs, Perks, Juice, Dillies.

Opioids listed by strength

Opioids are not all created equally and are available in varying strengths, with carfentanil and fentanyl widely recognized as the most potent. This list, provided with thanks by the Dana Point Rehab Campus lists the typical opioids by strength.

1. Carfentanil — Carfentanil is an extremely dangerous opioid that is 10,000 times more potent than morphine and 100 times more potent than fentanyl. Carfentanil is used to tranquilize elephants and other large animals and is not intended for use in humans. Drug dealers may mix carfentanil into their drug supplies to provide their customers with a more potent, addictive high.

2. Fentanyl — Fentanyl is 50 to 100 times more potent than morphine and has been the main contributor to the rise in overdose deaths in recent years. The majority of fentanyl-related deaths involve synthetic fentanyl that is manufactured overseas and mixed with other illicit drugs including heroin, cocaine, and methamphetamine.

It is sold under brand names including Sublimaze, Duragesic, and Actiq. It also has many street names including China Death, TNT, Murder 8, Jackpot, Goodfella, Dance Fever, Apache, and China Girl.

3. Buprenorphine (Butrans) — Buprenorphine is an FDA-approved medication for the treatment of opioid use disorder. It is about 25 to 100 times more potent than morphine, but it does not provide a euphoric high like other opioids. Buprenorphine is used in drug detox to relieve and reduce opioid withdrawal symptoms.

4. Oxymorphone — Oxymorphone is sold under brand names such as Opana and Numorphone. It is an extended-release opioid that has many street names including O Bomb, Stop Signs, Biscuits, and Blues. Oxymorphone is used to relieve moderate to severe pain in patients who are unable to reduce or control pain with other medications. Oxymorphone is 3 times stronger than morphine when taken in tablet form, and 10 times stronger than morphine when received as an intravenous injection.

5. Hydromorphone — Hydromorphone is used to relieve moderate to severe pain and is about two to eight times more potent than morphine, reports the DEA. It is available as an injection, tablet, liquid, and rectal suppository.

6. Heroin — Heroin is an illicit drug classified as a Schedule I substance with a high potential for abuse. Heroin is usually two to five times stronger than morphine and commonly mixed with other potent substances such as fentanyl or carfentanil. In 2018, heroin was involved in 14,996 overdose deaths in the U.S.

7. Methadone (Dolophine, Methadose) — Methadone is another FDA-approved medication for the treatment of opioid addiction and is about three times stronger than morphine. Methadone is often used for long-term maintenance in people in recovery from opioid addiction, and can only be dispensed at an outpatient clinic under direct medical supervision.

8. OxyContin — OxyContin is a brand name for Oxycodone, a well-known extended-release opioid. Oxycodone is prescribed to treat moderate to severe pain and is about 50% stronger than morphine. The CDC reports that oxycodone is one of the most common drugs involved in prescription opioid overdose deaths. In 2018, prescription opioids like oxycodone contributed to 14,975 overdose deaths in the U.S.

It is usually sold as a tablet that is meant to last an entire day, which is often bypassed by drug abusers to quicken the release time. Street names include O.C., Oxy, Oxycet, Oxycotton, and Hillbilly Heroin.

9. Percocet — This drug is a combination of oxycodone and acetaminophen. It comes in tablet, liquid oral solution, and capsule form. Some of the street names for the drug include Percs and Hillbilly Heroin since it also contains oxycodone.

10. Hydrocodone — The next in the list of opioids strongest to weakest is hydrocodone, which is sold under many different brand names such as Norco, Vicodin, and Zohydro. It is usually sold as a way to manage pain after surgery, chronic pain, or pain from an injury. It comes in both syrup and tablet form. Street names for hydrocodone include names such as Watson-387 and Vike.

Hydrocodone has about the same strength as morphine and is commonly combined with other pain relievers such as ibuprofen and acetaminophen.

11. Morphine — The drug that was known as the “soldier’s disease” due to addictions it caused during war times, is the next in our list of opiates. Brand names include MS Contin and Duramorph among others. It is often used as a pain-management solution for cancer patients. It is available in tablet, capsule, suppository, and injectable form. It has street names such as White Stuff, Monkey, and Miss Emma.

12. Tramadol (Ultram) — Tramadol is used to relieve moderate to moderately severe pain and has about one-tenth the potency of morphine. This drug is the only opioid categorized as a Schedule IV substance on the Controlled Substances Act.

13. Demerol (Meperidine) — The brand name opioid, Demerol, is most frequently used to treat moderate to severe pain, and is about 7 to 10 times less potent than morphine. It may also be used as anesthesia due to its potency. The drug comes in a variety of forms including an injectable solution, tablet, and liquid oral solution. Common street names include Pain Killer and Demmies.

Though meperidine is less potent than many other opioids, it is classified as a Schedule II narcotic along with oxycodone and fentanyl.

14. Codeine — This opioid is a relatively short-acting opiate. It is commonly prescribed along with aspirin and acetaminophen. Tablet, capsule, and liquid forms of the drug are sold. Some of the names that Codeine goes by when sold illegally include Purple Drank, Lean, Cody, and Sizzurp.

Overcoming opioid addiction

It will probably come as no surprise that pharma has been beavering away to create treatments it can sell you to counter opioid addition. Ironic and possibly the most glaring indictment of an industry bereft of ethics or patient-focused motives. Weaning a patient off opioids is a lengthy, expensive and demanding process, for both provider and patient and is often met with failure.

Methadone, when administered properly, is included in treatment with counseling and is always provided in a clinical setting. It helps to block the effects of opioids and to reduce cravings.

The medicine buprenorphine also helps opioid cravings without giving the same high as other opioid drugs. Prescribed by many physicians, this is typically a daily dose placed under the tongue and can also be delivered as a once-a-month injection or through thin tubes placed under the skin every six months.

These medicines both activate opioid receptors in the body that suppress cravings, and are effective and similar in safety and side effects, and typically used for maintenance treatment. They can be used as a taper agent as well but some patients relapse. Patients who are highly motivated and have good social support have a tendency to do better.

Naltrexone

This medicine is very different and doesn’t activate the opioid receptor the way that buprenorphine and methadone do, but instead blocks the euphoric/sedative effects of opioids. Your system must be completely free of all opioids before beginning naltrexone. It can be taken orally or as a once-a-month injection.

References

1. Opioid treatment of chronic nonmalignant pain. Stein C Anesth Analg. 1997 Apr; 84(4):912–4. [PubMed] [Ref list]
2. Pain management, controlled substances, and state medical board policy: a decade of change. Joranson DE, Gilson AM, Dahl JL, Haddox JD J Pain Symptom Manage. 2002 Feb; 23(2):138–47. [PubMed] [Ref list]
3. America’s Drug Overdose Epidemic. [CDC]

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It hasn’t been tested, at least not in meaningful ways that would allow traditional medicine to give it the green light. Additionally, current pressure in the public sphere from groups of Kratom supporters reeks of ulterior motives and their strategies look remarkably similar to those used by the anti-vaccination campaigners. 

So what is the truth? Is the drug a godsend, as users would have you believe? Is it a dangerous narcotic that needs to be banned, or is it perhaps something more important? A medicine, waiting to be formally recognized. I asked a few users from within the Kratom community to share their stories. I’ve received many but wanted to share the two below as they highlight the two different benefits of the drug claimed by its supporters, namely pain relief and release from opioid addiction. 

To be clear, I am not an advocate for Kratom, not as it currently distributed. I do however believe the drug offers a real window of hope to many suffering from chronic pain and it is my firm belief that action needs to be taken to both protect users and to ensure. availability of a clean and safe, clinically trialed product. I’ll discuss the routes to this below. 

Let’s hear from Keith first, a Kratom fan and potentially, a life long devotee. He has been using the product for a while and his story is reflective of many Kratom users. Here. unedited, is his response to my request for information. 

Hi Robert. I am a 48 year old Catholic School Teacher in NYC the last 24 years. Had terrible DDD and didn’t want to use any Rx drugs. Found Kratom in 2011. Got my pain down so much I put a full gym in my house. Down 120lbs. Healthiest I’ve ever been. Kratom has been a God send. I saw what opioids did to my dad and swore never to take them. Found it in a simple Google search and now I’ve been on network news 3x (NBC, CBS, PIX11) and have contributed to many interviews and podcasts. I have to say, your statement that it’s deadly is misleading. Sure, theres some bad apples out there, but I am getting pure, lab tested, cGMP Kratom. Never abused it. I drink 2 cups of tea a day with a few grams of it in each. My entire family (wife is a Doctor. Mom an RN) support Kratom after seeing the amazing results. Energy, focus, motivation…All fantastic. Zero side effects. Zero WD. Have to have a good honest source with labs. I look forward to a productive conversation\debate.

Next up is Kendell. Kendell was addicted to opioids and experienced life threatening symptoms from Tramadol use. This is his experience with Kratom, verbatim from his response. 

I’m responding to your request for kratom input. I can’t speak to other advocates, but me personally, I use kratom for 3 things. TO manage chronic pain from scoliosis, to keep me away from medications of the opioid class, specifically tramadol, and to manage the mild depression that goes along with my tramadol withdrawal. I’ve been using it for a total of a year this december, so I’m new compared to most other kratom users. One of your reporters wrote a very negative article on kratom claiming it to be a legal narcotic that people can buy at gas statations, he’s right, it can be bought at gas stations, but it’s no more a narcotic than coffee is. Others will probably send you good scientific proof of this, so all I can do is share my own personal kratom story. Read here at kratomherald.com/real-life-kr…. We don’t ordinarily respond so passionate to reporters but this article was particularly unpleasant, with a host of assumptions, mainly that all kratom users are drug addicts looking for a legal high or to get around the regulations on opioid pain meds. Kratom is a partial bias gProtein agonist at the mu opioid receptor, so yes it does bind at the same site as opioids, but it binds differently. Most opioids are full agonists, and cause a huge release of dopamine into the nucleus acumbuns, leading to addiction. Kratom’s alkaloids don’t affect this area of the brain, and one of them, mitragynine, reverses the downregulation of opioid receptors caused by chronic opioid use, and also reduces the upregulation of cAmp, cyclic adenasine monophosphate, which happens when you use opioids for a long time. We fight for kratom’s legality because we don’t see any other choice, but we aren’t ordinarily so harsh with reporters unless they treat kratom advocates rather badly, as this one did.

In case you’re wondering about that nasty reporter, guilty as charged. You can read the article he is referring to here. 

That feedback was not what I had expected, given the drug’s bad reputation and FDA advice. It wasn’t the end of it though. My DM’s on Twitter soon filled with similar stories and this has led me to a few conclusions I will share below. First off though, let’s have a closer look at some of those ingredients Kendell was referring to. It’s important, as these alkaloids are at the very heart of the Kratom controversy.

The two primary alkaloids of Kratom that are in contention are Mitragynine and 7-Hydroxymitragynine. We’ll start by examining each of these ingredients individually.

Mitragynine

According to a ScienceDirect article (reproduced in part below), Kratom is a psychoactive compound (drug) found in the leaves of M. speciosa. It can be consumed in fresh, dried (leaf or powder), or concentrated liquid extract form. The use of M. speciosa as a narcotic is not new; however, the extraction and refinement of the alkaloids from the plant into Kratom is relatively neoteric (new).

This is an important point and lies at the heart of regulation. There is a world of difference between chewing on a leaf and extracting and refining the active ingredients. It is very likely that this practice has led directly to regulation and bans imposed globally (see countries listed below).

A common route of administration is by chewing the fresh leaves at a dosage of normally 10 to 30 leaves per day. Kratom can be ingested as crushed dried leaves by taking the powder, drinking as a tea, or by smoking the leaves or the extract. Mitragynine is the major alkaloid (up to 66% in the extract) in kratom and is the principal compound responsible for analgesic activity due to its potent opioid agonist property

Recently, 7-hydroxymitragynine, a minor constituent (2%) of M. speciosa, was isolated and demonstrated potent antinociceptive activity in mice. It is now considered to be a major contributory factor for the analgesic properties of M. speciosa due to its selectivity for μ- and κ-opioid receptors. The presence of an hydroxyl group at C-7 increases the potency of 7-hydroxymitragynine to be 13- and 46-fold higher than morphine and mitragynine, respectively. This clearly indicates that this is one of the main pharmacological markers of kratom products’ quality and potency.

In addition to analgesic activity, mitragynine is also a key component for the anti-inflammatory properties of kratom by suppressing prostaglandin E2 (PGE-2) production in the cyclooxygenase 2 (COX-2) pathway [73].

This all sounds very promising but is there a downside, According to the research documents, yes.

Mitragynine has been shown to demonstrate a wide range of adverse effects. Opioid-like adverse effects have been observed and include constipation, dry mouth, and loss of appetite. There have also been reports of patients suffering from intrahepatic cholestasis after two weeks of kratom use and seizure and coma which might result from opioid agonist action of the major components in kratom.

Studies in mice showing serious conditions after administration, for example, elevated blood pressure and hepatic enzymes after a single dose, impaired cognition and behavior from long-term use, and acute lethally hepatotoxic and mild nephrotoxic effects after high dose administration. Kratom extracts and mitragynine have also been shown to possess cytotoxicity to some human cancer cell lines namely SH-SY5Y cells (neuronal cells).

In conclusion, the author cites the following;

A study looking at ‘kratom dependence syndrome’ has suggested that as it is a short-acting μ-opioid receptor agonist, therapeutic agents such as dihydrocodeine and lofexidine are effective in aiding detoxification. Further studies on kratom toxicology and other natural NPS are crucial to understanding the harms associated with this material due to their increasing popularity.

7-Hydroxymitragynine

7-Hydroxymitragynine is a potent opioid analgesic alkaloid isolated from the Thai medicinal herb Mitragyna speciosa. The following is again courtesy of ScienceDirect and the link will take you to the article, parts of which I have highlighted below.

In clinical studies conducted on mice, Subcutaneous (s.c.) administration of 7-hydroxymitragynine produced a potent antinociceptive effect mainly through activation of μ-opioid receptors. Tolerance to the antinociceptive effect of 7-hydroxymitragynine developed as occurs to morphine. Cross-tolerance to morphine was evident in mice rendered tolerant to 7-hydroxymitragynine and vice versa. Naloxone-induced withdrawal signs were elicited equally in mice chronically treated with 7-hydroxymitragynine or morphine.

7-Hydroxymitragynine exhibited a potent antinociceptive effect based on activation of μ-opioid receptors and its morphine-like pharmacological character, but 7-hydroxymitragynine is structurally different from morphine. These interesting characters of 7-hydroxymitragynine promote further investigation of it as a novel lead compound for opioid studies.

Important research by a mouse does not a man maketh. How these ingredients react in humans still needs to be established and clinical trials are already underway, but are very limited and have no doubt been affected by the Covid pandemic. 

The Alkaloid Takeaway

Clearly, we are dealing with two very promising and potentially lethal (If abused) compounds here, a fact which has no doubt prompted the countries listed below to act against Kratom. Remember the extract comment earlier. We aren’t simply dealing with a leaf you chew anymore. We’ve now extracted the useful bits in concentrations that are untried and untested. These are potent concentrates in quantities previously not available through simply chewing a leaf. 

Further study is definitely warranted, given the initial research and user feedback, but this raises a particularly interesting question, one which should be at the forefront of most people’s minds.

Where is big pharma? Why do they apparently express very little interest in the plant or its compounds? Make no mistake, combatting pain is big money. The only market more lucrative, and arguably one they have created themselves, is dealing with opioid addiction, one of the biggest challenges American healthcare faces in the coming decade. There are two possible answers to this question.

The first is simply this. They may have already evaluated the compounds and not seen the financial viability in further development, given the clinical risk profile associated with (perhaps unfairly so) both ingredients. The second is that they may simply view any opioid-related products as tainted, given their current market saturation and the associated negative press surrounding opioids. Simply put, if the drug works, pharma is all over it.

The conspiratorialist that lives on my shoulder would also like to raise a third possible scenario. Existing treatments for opioid addiction, developed at huge cost and generating massive income for big Pharma may have seriously affected decisions to explore a cheaper alternative. Pharmaceutical companies don’t down-sell. It is simply not in their makeup. 

Next, let’s examine global regulation and then look at the nutrition and health sectors’ role in Kratom distribution in the US.

Global Regulation and Bans

This is a definitive list of countries across the globe that have either ruled Kratom to be a regulated medicinal drug (available from your doctor on prescription) or classified it along with other illegal substances, such as heroin and cocaine, meaning possession of the drug is illegal. The information below was sourced from this webpage.

European countries

Belarus, Bulgaria, Croatia, Denmark, Estonia, Finland, France, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Moldova, Norway, Poland, Portugal, Romania, Russia, Slovenia, Switzerland, Turkey, United Kingdom,

Worldwide

Ironically, Indonesia. It is the world’s largest producer of Kratom but use and possession are illegal. Shipping it off to users globally is however encouraged. China and Hong Kong, Japan, Malaysia, Myanmar, Singapore, South Korea, Taiwan, Thailand, Vietnam, Middle East (all countries), Israel, Australia, New Zealand, Egypt, and Argentina all regulate Kratom. 

USA (States)

Alabama, Arkansas, Indiana, Mississippi, Vermont, and Wisconsin have called for a ban on sales. It’s is freely available in most other States or can be ordered online. 

That makes a total of 45 countries (excluding American states) globally that either ban or regulate Kratom as medicine or a controlled substance. Many of these countries have only recently (within the last decade) applied bans or stricter regulation, indicating a growing awareness globally of the dangers of Kratom’s two psychotropic substances in unregulated use. The fact the plant is now sold as an extract has undoubtedly also impacted this decision-making process. 

The Business Side of Kratom

In 2016, Kratom exports from the region of West Kalimantan, Indonesia conservatively reached $130 million in annual profits. Most of these exports were to the USA and in the subsequent years till 2020, profits and volumes have risen annually, but not for much longer. 

A law was passed in late 2019 in Indonesia banning the further production of Kratom. Farmers have been given a five-year “window of grace” to switch over to another crop, but you can be sure production will be ramped up in that period. Make hay will the sun shines. 

The world will soon be facing a Kratom supply problem. This is great news for countries with the right climate and lax legislation. As shrinking demand drives up Kratom prices, the supply chain will be rubbing its hands in glee, in anticipation of the financial windfall to follow. To sell your product though, you require a legal marketplace to peddle your wares, and America’s lax regulatory system allows the perfect climate for exploitation.

To clarify, Kratom is currently sold and marketed by the natural products sector. A sector Medika views as a real danger to public health. These are the same companies and individuals that encourage the sale of Covid cures, bleach-based treatments and that make a plethora of ridiculous claims about the products they sell. 

They are unscrupulous, driven by profit, and a complete lack of ethical responsibility to the users who buy their snake oils. They are also largely unregulated. 

If anything, every effort should be made to ensure Kratom distances itself from this market. The accompanying reputation of dishonesty and deception the natural products market brings with it will do nothing to further Kratoms case to be recognized as a real medicine with legitimate benefits. 

Enter the AKA (American Kratom Association). This not for profit is essentially a group of lobbyists petitioning anyone and everyone for the right to legally choose to use Kratom. Their pitch is essentially this. Fund us and we will ensure that you retain the right to have access to your drug. 

Again I take issue with the tactics being employed by the AKA. Confusing freedom of choice and the safety of the patient is misleading and a clear effort at diversion. Diversion from what though? Could the AKA simply be a tool of the natural products industry to secure future sales? This is simply my suspicious nature at this point smelling smoke, but further investigation is, in my opinion, warranted. If I am wrong, I’ll be the first to hold up my hands.

There are supposedly over 25 million Americans who currently use Kratom if the figures the AKA give out are to be seen as reliable. This figure is an indicator of the size of the market in America and any product with this potential reach is worth its weight in gold to the retailers selling it. 

The looming issue around supply will only serve to drive up prices and poses a further potential risk. The development of synthetic versions of the two key ingredients to ensure availability and dilution of existing formulations to stretch existing stock. 

As there is currently a lack of regulation there is little to stop manufacturers from lacing or watering down formulations with a myriad of potentially life-threatening cocktails. That’s 25 million potential fatalities waiting for us, not so far down the road. 

The AKA’s efforts to ensure self-regulation and quality control, impossible and unenforceable within the natural health sector, in my opinion, may simply be an attempt to avoid regulation from a higher authority. Yeah, I know. Cynical, but sadly a very real possibility. 

I intend to reach out to the AKA to discuss these issues in more depth in a later article. 

What’s the Value of the Kratom Industry in the US 

Great question, but I am not certain anyone has reliable figures. How could they? Product quality differs wildly as does presentation. Kratom takes the form of anything from vapes to powders, teas, and tablets, and with a user who requires the product on a daily basis in varying strengths, the numbers are huge. 

The actual active ingredients or alkaloids in the product are often not measured or represented correctly and as there is no testing of products made available to the public, it’s pretty much a question of going on what the label says. Labels sadly are often misleading. Particularly when you’re dealing with the unregulated natural products industry. Fancy packaging isn’t an indicator of quality or content. No matter what the marketing blurb says. 

Protecting current users

If there are in fact 25 million Americans using Kratom then the issue truly is pressing. Finding a way forward that protects both the users and assures them continued access to Kratom matters. Particularly to those individuals that rely on Kratom to combat chronic pain. 

Banning the drug is short-sighted and counterproductive to its acceptance as medicine if that is where it truly belongs and mounting evidence suggests that to be the case. 

Make a claim, substantiated or not, relating to the use of Kratom and its ability to relieve pain or assist users to kick an opioid addiction and you’ve just moved the product into the realm of medicine. Let’s be completely clear about this point. There is no getting around it. Kratom is a medicine that hasn’t as yet been labeled as such. 

You can dress it up any way you like, it will always come back to this one simple fact. What Kratom purports to do and what you claim as users, makes Kratom a medical drug, a medicine. 

If it’s to be sold OTC or under the supervision of licensed doctors remains to be seen. My gut feel tells me that it is going to require medical supervision, particularly for patients looking to escape the vicious cycle of opioid addiction. 

Dosing and safe levels need to be established. Interactions with other medications need to be listed and monitored. Long-term usage brings its own risks and with it, the need to monitor for symptoms that would indicate problems. For all of the above, you require the hand of a trained medical professional. Not an online Quack with a degree in bullshit and shelves of herbal products waiting to be sold.. 

These individuals are neither properly trained nor do they have the best interests of the patient at heart. Admittedly, neither does every doctor, and it is the duty of the patient to recognize poor care and seek an alternate care provider. 

How do we get Kratom reclassified?

Human trials are an essential part of any medication’s journey to acceptance by the FDA. There aren’t any short cuts. Not unless your name is Covid and you’re threatening the globe. Kratom may be controversial but it’s definitely not in that league so it’s going to be subject to lengthy scrutiny. 

What may very well benefit the drug is its widespread usage in the US. We have, in effect, got real live clinical trials underway and some of these subjects have years of exposure to the product in varying degrees. 

The whole scope of usage is covered. From the occasional mild dose to daily cocktails that would send an elephant into a coma, we have data at our fingertips. Data that could easily be harvested and would reveal the drug’s true risk profile. 

Additionally, testing of users for blood toxicity and related safety concerns centered around the liver and high blood pressure would be easy to determine. As would dependency. 

It is our intention, through our MOBILIZE Health platform to enable a start to the collection of this data. We will, over the coming days, reach out to research groups involved currently in assessing Kratom’s alkaloids. 

Hopefully, harvesting data, data which current users are all too keen to share, will help this novel drug find a safe path onto the shelves of pharmacies across the country. 

In doing so, this will also ensure the safety of current and future generations of Kratom users. Feel free to register a free account and add your comments below to join in the conversation. We value your opinions.

The post Kratom, the Undiluted Truth. Is it a Dangerous Drug or a Godsend? appeared first on Medika Life.

If you would like your local retailers to stop selling this drug to your children and other vulnerable members of the community, there is a link at the end of this article to report the drug and actions you can take to have the product removed from shelves.

What is Kratom?

According to a very detailed analysis of the plant on Wikipedia, Mitragyna speciosa (commonly known as kratom) is a tropical evergreen tree in the coffee family native to Southeast Asia. It is indigenous to Thailand, Indonesia, Malaysia, Myanmar, and Papua New Guinea, where it has been used in herbal medicine since at least the nineteenth century. Kratom has opioid properties and some stimulant-like effects.

As of 2018, the efficacy and safety of kratom are unclear, and the drug was unapproved as a therapeutic agent due to the poor quality of the research. FDA and other investigations suggest that any applications for licensing would fail, based on the drug’s current safety profile and reported interactions with other medications and substances, reactions that are often fatal.

In 2019, the Food and Drug Administration (FDA) stated that there is no evidence that kratom is safe or effective for treating any condition. Some people take it for managing chronic pain, for treating opioid withdrawal symptoms (no shred of clinical evidence exists to support this), as a herbal cure-all sold on various websites as a treatment for pretty much everything, from the common cold to cancers, or for recreational purposes.

The onset of effects typically begins within five to ten minutes and lasts for two to five hours. It’s worth noting that most opioid users end up taking both opioids and Kratom (or cycling), clear evidence that Kratom is useless as a treatment against opioid addiction.

Common and more serious side effects include;

• nausea
• itching
• sweating
• dry mouth
• constipation
• increased urination
• loss of appetite
• seizures
• hallucinations
• respiratory depression (decreased breathing),
• seizure
• addiction
• psychosis

Other serious side effects may include high heart rate and blood pressure, trouble sleeping, and, rarely, liver toxicity. When use is stopped, withdrawal symptoms often occur. Deaths have occurred with kratom both by itself and mixed with other substances. Serious toxicity is relatively rare and generally appears at high doses or when kratom is used with other substances.

Kratom is a controlled substance in 16 countries and, in 2014, the FDA banned importing and manufacturing of kratom as a dietary supplement. As of 2018, there is growing international concern about a possible threat to public health from kratom use. In some jurisdictions, its sale and importation have been restricted, and several public health authorities have raised alerts.

The real danger posed by Kratom

Availability is a key problem. Your child can stop in to shop at a gas station and buy the product off the shelf. A fact verified today by my colleague in Texas. It also doesn’t show up on regular drug tests, so many deaths associated with Kratom go unlisted.

If in some weird alternate universe Kratom is shown to possess any real medical benefits (none have been discovered or scientifically validated as yet) it would still require a lengthy regulation process for certification by the FDA. This process exists to protect consumers against products exactly like Kratom. In 2013, the US Drug Enforcement Agency (DEA) issued a warning about Kratom, stating that there was no proven medical use for the drug.

To be 100% clear on this. Kratom is considered highly dangerous by the FDA and many other countries’ drug licensing authorities. It can lead to death, dependency, and a host of other nasty conditions. It is a psychedelic, so please don’t feed me bullshit about pain management. Get stoned enough and your pain tends to magically evaporate for the duration of the high. The effects reduce with each usage, leading to increased dosages and almost guaranteed addition.

Kratom also won’t cure any diseases or conditions, no matter what the quacks and con-artists selling Kratom promise you.

New drugs often enjoy a honeymoon period with the public, a window where they can be freely distributed simply because legislation has not yet been enforced to protect the public. Cocaine was legally sold across the counter not so many years ago. The system isn’t perfect and it is slow to react. Sadly, death and addition are an all too common byproduct of this window.

There is a reason doctors don’t (or shouldn’t) keep their patients permanently stoned up the yazoo and there is a reason America has a MASSIVE problem with opioid addiction. Psychotropic and psychedelic drugs aren’t the answer for management of chronic pain. In fact, they aren’t a medical solution for just about anything.

If you’re a late-stage cancer patient or other, bedridden and on death’s door, that is a different issue. Don’t confuse chronic pain with end of life scenarios.

On overdose and related interactions

There have been multiple reports of deaths in people who had ingested kratom, but most have involved other substances. A 2019 paper analyzing data from the National Poison Data System found that between 2011–2017 there were 11 deaths associated with kratom exposure. Nine of the 11 deaths reported in this study involved kratom plus other drugs and medicines, such as diphenhydramine (an antihistamine), alcohol, caffeine, benzodiazepines, fentanyl, and cocaine. Two deaths were reported following exposure from kratom alone with no other reported substances.

In 2017, the FDA identified at least 44 deaths related to kratom, with at least one case investigated as possible use of pure kratom. The FDA reports note that many of the kratom-associated deaths appeared to have resulted from adulterated products or taking kratom with other potent substances, including illicit drugs, opioids, benzodiazepines, alcohol, gabapentin, and over-the-counter medications, such as cough syrup.

Also, there have been some reports of kratom packaged as dietary supplements or dietary ingredients that were laced with other compounds that caused deaths. The FDA also seized various Kratom products that were contaminated with Salmonella. Still think your local retailer should be selling this?

Figures above provided by the National Institute on Drug Abuse

The FDA and Kratom in the US

According to a 2019 statement on the FDA website the FDA stated the following regarding Kratom.

The U.S. Food and Drug Administration is warning consumers not to use Mitragyna speciosa, commonly known as kratom, a plant which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.

There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. FDA is actively evaluating all available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.

To date, they have taken the following actions against the product’s import into the US.

• In September 2014, U.S. Marshals, at the FDA’s request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
• In January 2016, U.S. Marshals, at the FDA’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro.
• In August 2016, U.S. Marshals, at the FDA’s request, seized more than 100 cases of products labeled as containing kratom and worth more than $150,000. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy.

The FDA has issued warnings to companies. The companies receiving warning letters use websites and social media to illegally market kratom products, making unproven claims about the ability of the kratom drug products they distribute to cure, treat, or prevent disease. Examples of claims being made by these companies include:

• “Kratom acts as a μ-opioid receptor-like morphine.”
• “In fact many people use kratom to overcome opiate addiction.”
• “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
• “Usage: It is for the management of chronic pain, as well as recreationally.”
• “Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue…Kratom has been reported to have taken the place of brand name drugs like Hydrocodone or Oxycodone for individuals, all the way to weaning people off of Heroin.”
• “Some researchers have even claimed that kratom can protect you against cancer!”
• “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat . . . Chronic Pain, Migraines, Opiate Addiction, ADHD/ADD, Anxiety, Depression, Arthritis, Insomnia, and much more!”

Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.

There are a lot of advisories issued by the FDA on this drug, you can find an extensive list in the footer of the article linked to above.

Reporting This Drug

You can use this link provided by Medwatch to report the drug and any adverse interactions you, or someone you know, may experience.

MedWatch Online Voluntary Reporting Form

What can you do about retailers making these products freely available in your town or city? If they are large chains, reach out with a formal letter to their head office, notifying them of the dangers of Kratom, and copy in your local government and press. For smaller private retailers, try dropping off or sharing information on the dangers of the product and if they show disregard for your children’s safety and others within their community, consider boycotting the stores.

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