Prescription Drug Overdose Deaths on the Rise

The Trust for America’s Health, a nonprofit organization, reported that in 2013 over 44,000 Americans died as a result of drug overdose.  Drug overdoses have been rising since 2009, despite federal and state efforts to better monitor and control use of narcotics and other potentially addictive medications.  Over half of these deaths were related to prescription drugs and in fact, in 36 states more people died from a Rx drug overdose than from automobile accidents.  These numbers are staggering, especially when you consider that drugs such as narcotics (Vicodin, Percocet, etc.) do not cure any disease, they only mask a symptom, pain.

Physicians are under increased scrutiny for prescribing these dangerous drugs and are constantly looking for reliable, clinically proven alternatives.  Until recently, options were limited to NSAIDs, such as ibuprofen and naproxen, which can have significant side effects most specifically on the gastrointestinal tract, and medications used to treat other conditions such as SSRIs, anti-epileptics, and SNRIs,  but that may also help pain as well. The efficacy of these options are limited at best and often cause significant side effects without providing adequate pain relief.

 

Evidence Based Options for Patients and Providers

Theramine, a amino acid based treatment for pain, has been shown in multi-center clinical trials to significantly reduce pain in patients with chronic low back pain without any appreciable side effects better than over the counter doses of ibuprofen or naproxen.  Theramine is regulated as a medical food by the FDA and is manufactured in the United States at a cGMP facility using ingredients that are Generally Recognized as Safe. As a medical food, Theramine is subject to much tighter regulatory oversight than dietary supplements, providing patients and providers with piece of mind knowing that the formulations are tested and evaluated for efficacy.  There have been over 40 million individual doses of Theramine administered since 2004, without a single reported GI bleed, adverse cardiac event or stroke reported the most commonly known side effects of NSAIDs.  Theramine is not addictive and can be taken with other medications or medical conditions.  Theramine provides chronic pain patients a safe, effective and proven alternative to other potentially more dangerous pain medications.

The Problem with Prescription Pain Killers

Pain is a big deal. On one level, it’s very useful. It tells us when there’s something wrong, and is pretty efficient at giving us a handy indication when what we’re doing may not be particularly good for us. Those who cannot feel pain [1] suffer from horrendous associated problems, and frequently damage themselves quite badly without being alerted to the fact that they’re doing so by pain. However, unlike a man-made alarm, the body does not come with an ‘off’ switch which one can hit once one’s been made aware of the problem. Chronic pain is a major issue, and one of the most troubling symptoms of a great many medical conditions. It’s a factor which seriously affects people’s lives, and good pain management is recognized as being vital to the all-important quality of life [2] experienced by those needing medical treatment. Having said this, however, it is also being increasingly recognized that the people of North America are becoming dangerously dependent upon prescription painkillers. All too often, we pop a pill when we do not really need to, and plenty of us are relying on prescribed narcotic painkillers when we would undoubtedly be a lot better off with some other method of pain-relief. While there is certainly a place for narcotic painkillers in the management of seriously painful conditions, it needs to be recognized that these drugs do come with a major health warning – and alternatives or avoidance should be the preferred options if at all possible.

Narcotic Painkillers

Opioid painkillers were originally designed for cancer pain and somehow over time have become a first line therapy for many physicians despite the potential for addiction. What may be lesser known, however, are the dangers inherent within these drugs, and the startling scope of America’s dependence upon them. Put simply, opioids such as Vicodin and codeine bind to opioid receptors within the brain, which dulls the brain’s pain response. These receptors are designed to work with the body’s natural opioids – endorphins [3]. Endorphins are released during exercise, and numb pain as well as promoting a feeling of wellbeing, enabling and motivating us to stay on the move and thus potentially to survive for longer. Narcotics fulfil the same role – but in hyper-exaggerated form. Narcotic analgesics swamp our opioid receptors, saturate them to the point where we’re utterly numbed and frequently rather high. They’re very effective as a method of pain relief, but also quite dangerous and are associated with a host of dangerous side effects.

Painkiller Addiction

It’s very easy to develop a taste for opioid painkillers. Why wouldn’t you? They keep pain at bay, and they make you feel good. They’re also, unfortunately, highly addictive. Their very nature means that you’re inclined to seek out more and more – and America’s healthcare system doesn’t exactly discourage you from overdoing it. Big pharmaceutical companies do, after all, stand to make a lot of money from plenty of pill-popping patients. North America has the world’s worst rate of prescription painkiller addiction by a long, long way [4]. Places with nationalized healthcare (in which pharmaceutical companies would have nothing to gain from touting their product to the public) are not in any more pain than the people of America, but they’re far less addicted to painkillers. The solution for someone from the USA to the slightest malady invariably involves popping a pill, while those from other countries are put on courses of pills only when necessary, and given alternative pain-relief methods more often. Each system obviously has its pros and cons – but in this particular case the figures concerning painkiller addiction speak for themselves. More overdose deaths in the USA have been caused by prescription narcotics since 2003 than cocaine and heroin put together – partly (if not wholly) because narcotic prescription rates have increased enormously in this time [5].

An Easy Death

A major issue with opioid painkillers is that they’re not only all too easy to get hold of, and highly addictive – they’re also unpredictable killers. While medical science is pretty good at estimating doses according to body weight and so on, the problem of tolerance is always going to rear its ugly head. The body develops a resistance to opioids over time which means that one must take a higher and higher dose in order to achieve the desired effect. And, at any moment, that dose might prove just too high for the body to cope with. Opioids kill in a number of ways. The most common of these is respiratory depression. This can be reversed – but only if the overdose is low and medical aid arrives quickly [6]. If this is not the case, then the overdoser finds themselves unable to adequately fill their lungs and essentially starves of oxygen. It is far better not to risk this, not to get addicted, and to seek alternatives to narcotic analgesics whenever possible!

[1] Gillian Mahoney, “Meet the Child Who Feels No Pain”, ABC, Oct 2013

[2] Nathanial Katz, “The Impact of Pain Management on Quality Of Life”, Journal of Pain and Symptom Management, Jul 2002

[3] PBS, “Role of endorphins discovered, 1975”

[4] Arnold M. Washington, “America’s Painful Love Affair With Painkillers”, Rehabs

[5] National Safety Council, “Opioid painkillers: How they work and why they can be risky”

[6] Ben Wolford, “Respiratory Depression Reversed In Trials With Drug That Fights Opioid Side Effect”, Medical Daily, Aug 2014

 

Safer Options for Pain Management

Pain is complex and there are several treatment options to choose from depending on the type of pain you are experiencing including medications, therapies and mind-body techniques.  The most common treatment consists of analgesics:  narcotic (opioid) and non-narcotic (non-opioid) analgesics.

Narcotics vs NSAIDS
Primary Differences Between Narcotics and NSAIDs

Narcotic analgesics are derived from or related to opium.  Opioids bind to opioid receptors which are present in many regions of the nervous system and are involved in pain signaling and control.  Opioid analgesics relieve pain by acting directly on the central nervous system.  They block incoming pain signals but also work in other parts of the brain, modulating pain receptors in the nervous system, primarily located in the brain and the spinal cord.

Non-opioid analgesics or NSAIDs work by blocking the production of prostaglandins by inhibiting the cyclooxygenase enzyme and therefore decreasing the formation of pain mediators in the peripheral nervous system.   Non-opioids work more directly on injured or inflamed body tissue. In a basic sense, opioids decrease the brain’s awareness of the pain whereas the non-opioids affect some of the chemical changes that normally take place wherever body tissues are injured or inflamed.

Although non-opioids are often preferred for certain types of chronic pain, they have two serious drawbacks.  The first is the ceiling effect; Non-opioids have an upper limit of pain relief that can be achieved.  Once the upper limit is achieved; increasing the dosage will not provide any further pain relief but may exacerbate side effects.  Opioids on the other hand tend not to have a ceiling.  The more you take, the more pain relief you will get.  The second major drawback of non-opioids is the side effects profile.  The side effects of NSAIDS make it impossible for certain patient populations to use NSAIDs such as those with history of peptic ulcer disease, cardiovascular disease and the elderly. In 2014, the American Academy of Neurology determined that the risks of opioids outweigh the benefits for certain chronic pain conditions.

Treatment of pain with the use of medical foods gives patients a safer option for pain management by approaching pain from a new perspective.  Medical foods treat the nutritional deficiencies that are found in patients with acute and chronic pain.  By restoring an optimal balance between the chemicals in the body, substances called neurotransmitters, that are responsible for transmitting and dampening pain signals, one can better manage pain.

Research has found low levels of the amino acids gluatamate, tryptophan, arginine, serine, and histidine in patients with chronic and acute pain.  The perception of pain can be modified by providing amino acids and nutrient precursors to the key neurotransmitters involved in the pain process. Amino acids are able to cross the blood brain barrier and are necessary to produce the appropriate neurotransmitters needed to reduce pain signals and lower inflammation. Increasing the intake of amino acids and nutrients lead to an increase in neurotransmitter levels [1].

The theory that the body’s need for amino acids and nutrients are modified by a disease has been long recognized and is supported by studies that reflect changes in plasma, urinary and tissue levels of nutrients with modified intakes of these nutrients [2].   There are various reasons for depletion of nutrient levels including diet, metabolic demands and genetics.  The required amount for each patient varies depending on the duration and severity of pain. Addressing the increased demand for amino acids and nutrients is a key component for improving clinical outcomes.

Two double-blind clinical trials compared Theramine, a medical food specially designed to address the increased amino acid and nutrient requirements of pain syndromes, to low dose naproxen and ibuprofen.  In both studies, Theramine showed statistically greater pain relief than either naproxen or ibuprofen.  This was measured by patient report and a reduction in the inflammatory markers C-reactive protein (CRP) and interleukin-6 (IL-6) [3, 4].  Treatment with amino acid precursors was associated with substantial improvement in chronic back pain and a reduction in inflammation.

Pain Reduction with TheramineThe improvement in pain directly correlated with increased amino acid precursors to neurotransmitters in the blood.

Theramine is designed using Targeted Cellular Technology (TCT), which facilitates the uptake and utilization of the neurotransmitters precursors that are used in the modulation of pain.  TCT allows for the production of neurotransmitters from ingestion of smaller amounts of amino acids to elicit the same response as larger amounts, making daily dosing more feasible and reducing the potential for tolerance.

At least 100 million adult Americans suffers from chronic pain, a safe and effective treatment option such as medical foods that do not treat symptoms alone but addresses the distinctive nutritional needs of adults who have different or altered physiologic requirements due to pain is vitally needed.

To date, Theramine has been in clinical use for over 10 years with no report of GI bleed or adverse side effects and the clinical trials of Theramine clearly support the theory that the nutritional management of pain syndromes is a safe and effective treatment for pain.

Alternatives to Opioid Pain Medications for Injured Workers

Workplace injuries affect approximately 4.1 million Americans annually (1) .  More than half of these injured individuals will have to miss work and receive long-term medical care.  Worker’s compensation plans provide partial wages during the time of injury and recovery period in addition to covering the cost of medical care.  The recent trend among physicians treating work related injuries has been the practice of prescribing high and sometimes dangerous doses of opioid pain medications for extended periods of time.  Data from 2005-2008 in 17 states showed an average number of 1,599 cases requiring narcotics for non-surgical cases, with more than seven work days missed due to injury(2).  Additionally, in an average of 6% of these cases, the narcotics were prescribed for long-term periods of time.  These drugs may include but are not limited to hydrocodone, fentanyl, methadone, and oxycodone.  Approximately 50-90% of injured workers will receive narcotics for chronic pain conditions (3).  Opioid pain medications can have deadly side effects and the increased availability and dosages of these medications can be detrimental to an injured worker and prolong the time it takes to return to work.

Opioid pain medications are the most commonly prescribed medication in the United States(4).  They work to decrease the perception of pain and increase pain threshold.  While these drugs are helpful to decrease overall pain of various injuries and conditions, they are highly addictive and only address a portion of the pain process.  Common side effects may be mild such as constipation and fatigue, however, they have also been linked to more severe side effects including sleep apnea, decreased hormone production, and increased falls and broken bones among the elderly population(4).  Additionally patients taking opioid pain medications for long periods of time can become addicted and experience serious symptoms of withdrawal which include nausea, shaking, chills, and sweating when finishing a course of these medications (5).  Lately there has also been in an increase in drug overdose leading to death.  In a study that observed 10,000 patients who were prescribed opioids for 90 days, 51% experienced at least one overdose, and six individuals died as a result of overdose 6.  In 2008 the number of deaths resulting from overdose reached nearly 15,000 individuals(1).

Increased availability and access to opioid pain medications is one of the main problems leading to addiction and overdose among injured workers.  Some physicians are prescribing these medications to treat acute and long-term pain disorders such as arthritis and musculoskeletal pain.  Oftentimes high doses are prescribed and the dosage continues to increase over time as tolerance to the effects of the medications increases.  Instead of treating the underlying physiological conditions causing the painful condition, opioid pain medications are prescribed to help manage and mask the pain associated with a work related injury. They are prescribed for many reasons, however, a few of the most common are pressure from patients to prescribe a strong medication that will lead to decreased pain, as well as pressure from insurance companies to prescribe the most cost-effective generic pain medications. Patients may experience temporary pain relief while on these medications, however chronic pain may persist long after the injury has healed.

Prescribing high dose opioid pain medications for work related injuries often leads to other injuries and physiologic impairments.  In many cases, patients remain out of work for much longer than individuals who are not prescribed opioids, as they often develop new health conditions and require more medications.  In the study conducted by the Danish Health Interview Survey in 2000 observing 10,434 individuals, patients who were not prescribed opioid pain medications to treat their injuries recovered four times more often than individuals prescribed opioid pain medications(7).  Additionally, in this study patients taking opioid pain medications were shown to have a lower quality of life and higher death risk than those patients managing pain without opioids.

Some patients who are prescribed opioid pain medications, especially long-term, may develop other serious conditions such as obesity, mood disorders, and depression.  An injured worker who is taking medication for a pain condition may not be able to exercise regularly and weight gain is fairly common.  Opioid pain medications can also have an effect on overall mood and quality of life.  If an individual takes these medications long-term it can be very hard to stop taking them.  The patient can experience large amounts of anxiety and depression when decreasing the dosage or attempting to discontinue the medication all together.  Research has found that of the 1.9 million workers claims that were filed between 2007-2008, those who previously had or developed a co-morbidity as a result of injury such as depression, obesity, or hypertension, experienced more costly treatments and often longer treatment plans all together(8).

Work related injuries will continue to be an issue for insurers and employers.  The overprescribing of opioid pain medications in this country must be addressed by physicians, insurance companies, and drug manufacturers.   The conversion of acute pain to chronic pain associated with a work related injury can be managed in a more efficient way that will allow an injured worker to return to work as soon as they are healed without the burden of addiction or other opioid pain medication related side effects.  Theramine can be used as a complimentary or standalone therapy among this vulnerable population and can provide treating physicians with the ability to prescribe the lowest effective dose of an opioid pain medication while addressing the underlying pathology of the pain process.

Theramine is a prescription only medication regulated by the FDA as a medical food. Medical foods are prescription only medications which address the underlying pathology of pain associated with the work related injury or illness.  Theramine is clinically proven to correct amino acid deficiencies associated with chronic pain syndromes, and improve the overall perception of pain(9).  Theramine is designed to manage the increased nutritional requirements associated with acute or chronic pain conditions.  Theramine is a proprietary amino acid formulation that, by providing neurotransmitter precursors, helps stimulate production of neurotransmitters that are often deficient in pain conditions.  The ingredients in Theramine are Generally Recognized as Safe by the FDA, and are specially formulated utilizing a proprietary Targeted Cellular Technology to facilitate the uptake and metabolizing of milligram quantities of amino acids and other nutrients.  There have been no reported adverse side effects associated with the clinical application of over 50 million individual doses of Theramine. The most common side effects associated with amino acid therapies are headache, dry mouth, and upset stomach and are often short term, and can be decreased with increased fluid intake.  Theramine can be administered in conjunction with the lowest effective doses of an opiate or NSAID pain medication without loss of efficacy(10).  Treating work related injuries with Theramine may prove to be one possible medication solution to control pain and help decrease the quantity and dosages of opioid pain medications administered in the United States.

1)      http://www.workers-comp-news.com/injury_stats.php

2)      http://www.wcrinet.org/studies/public/books/WCRI_2012_Annual_Report.pdf

3)      http://ehstoday.com/health/workers-compensation/injured-workers-opiate-addiction-0209/

4)      http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?pagewanted=all

5)      http://www.opiates.com/opiate-withdrawal.html

6)      http://www.crcotp.com/crcotp_featured/even-when-prescribed-opioids-can-cause-addiction-and-overdose.php

7)      A Population-based Cohort Study on Chronic Pain:The Role of Opioids Per Sjøgren, MD, DMSC,* Morten Grønbæk, PhD, Vera Peuckmann, PhD,  and Ola Ekh-+olm, PhDw, Lippincott Williams & Wilkins, 2010.

8)      http://coventrywcs.com/web/groups/public/@cvty_workerscomp_coventrywcs/documents/webcontent/c054910.pdf

9)      Shell WE, Silver D, Charuvastra E, Pavlik S, Bullias D; “Theramine and Ibuprofen for the treatment of chronic low back pain double blind clinical trial”, 2010 Targeted Medical Pharma Inc.

10)   Shell WE et al.; “Theramine and Naproxen for the treatment of low back pain, a double bind clinical trial”; Americal Journal of Therapeutics April,2012.

Pain Management in Lyme Disease

Lyme disease is spread through the bite of infected blacklegged ticks, also known as deer ticks.  Ticks can attach to any part of the human body, but tend to reach areas that are difficult to see such as the groin, armpits, or scalp.  Ticks must be attached for 36 hours or more before the Lyme disease bacterium, Borrelia burgdorferi, can be transmitted.

There are four stages in the progression of Lyme disease.  The first stage, known as the early localized stage, takes place between 3-30 days after the tick bite.  The infected person can experience fatigue, chills, fever, headache, muscle and joint aches, and swollen lymph nodes.  One of the most prominent signs of this stage is the Erythema migrans rash, also known as the bull’s-eye rash for its unique shape.  This rash occurs in 60% of infected individuals. (CDC)

The second stage is known as the early disseminated stage and it occurs days to a week after the tick bite if the bite is not treated within the early localized stage.  During this stage, a person starts to experience more noticeable and serious symptoms.  These symptoms include Facial or Bell’s palsy, additional erythema migrans rashes, and stiffness due to meningitis.  At this point, patients begin to feel shooting pains that can interfere with sleep as well as pain and swelling in the large joints.

If the disease is not treated, 60% of patients enter into the late disseminated stage which happens months to years post-tick bite.  These individuals typically develop arthritis with severe pain and swelling in the joints.  It is typically found in the larger joints, for example the knees.  Arthritis caused by Lyme disease exhibits itself differently than other causes of arthritis.  Lyme arthritis is similar to osteoarthritis because of stiffness due to painful swollen joints.  This happens because Lyme bacteria invade the joints and cause inflammation to the tissue that lines the joints, and eventually, if untreated, can cause the cartilage within the joints to become damaged.[1]

The final stage is the lingering symptoms after treatment.  About 10-20% of patients experience symptoms after the patient has taken antibiotics.  This is called Post-treatment Lyme disease syndrome (PTLDS).  Some evidence shows this is due to an autoimmune response, in which the immune system is continuing to respond after the infection has been cleared, causing damage to be done to a body’s tissues.  Symptoms of PTLDS can include muscle and joint pain, cognitive defects, sleep disturbance, and fatigue. (CDC)

The quicker a doctor is able to diagnose Lyme disease, the quicker they can treat it.  Patients can be prescribed antibiotics in order to rid their system of the bacteria.  Most patients who are prescribed the antibiotic during the early stages usually recover quickly and completely.

With the antibiotics working to take care of the bacteria, what is taking care of the pain associated with Lyme disease?  A patient can still be experiencing pain while taking these antibiotics, which progressively becomes worse throughout all the stages Lyme disease.  Patients who experience pain in association with Lyme disease are less likely to be active, sleep well, or eat properly due to pain.

Commonly prescribed pain medications are opioids and NSAIDs.  Both, although common, can be very dangerous.  According to a report released by the National Institute on Drug Abuse, there can be consequences when choosing to use an opioid.  Opioids are easy to abuse because of their addictive qualities.  Regular or long term use of opioids can lead to physical dependence and addiction. Once a patient stops using opioids, they can experience withdrawal symptoms such as restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps, and involuntary leg movements.  An overdose can cause severe respiratory depression and death. [2]

NSAIDs, although effective in treating pain and inflammation, are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs which can lead to costly hospitalizations or death.  A study on the effects of NSAID induced side effects in the elderly reflected the average direct costs of GI side effects per patient-day on NSAIDs were 3.5 times higher than those of a patient-day not on NSAIDs. Seventy percent of the cost was attributed to GI events resulting from NSAID treatment.[3]  Treatment of GI problems alone caused by the use of NSAIDs is estimated to add over 40% to the cost of arthritis care.[4]

Stephen Harrod Buhner’s book “Healing Lyme Disease Coinfections” discusses an alternative to these common pain medications called Theramine®. Theramine is a medical food specifically designed for the dietary management of pain syndromes. This specialized natural product, provides the specific amino acids and nutrients required by the brain and nervous system to effectively reduce pain and inflammation. Theramine is non-addictive and is not associated with adverse GI or cardiovascular side effects.  It is used in clinical practice to reduce inflammation and improve pain perception by addressing the increased nutritional requirements of pain syndromes.  In two double blind, multi-center clinical studies comparing Theramine and an NSAID, Theramine was shown to be more effective at treating pain and inflammation than either naproxen or ibuprofen. Lyme disease can alter the metabolic requirements of the body, leading to specific amino acid and nutrient deficiencies. Effectively managing the increased demand for these essential physiologic components should be an integral part of any pain management protocol.

 


[1] American Academy of Orthopaedic Surgeons. “Effective treatment of Lyme-disease-related arthritis depends on proper diagnosis.” ScienceDaily. ScienceDaily, 2 February 2011.

<www.sciencedaily.com/releases/2011/02/110202132605.htm>.

[2] “Prescription Drugs: Abuse and Addiction” NIDA. October 2011. National Institute on Drug Abuse.

[3] Br J Clin Pharmacol. 2001 August; 52(2): 185–192. Cost of prescribed NSAID-related gastrointestinal adverse events in elderly patients

[4] Bloom, BS. Direct medical costs of disease and gastrointestinal side effects during treatment for arthritis. Am J Med. 1988; 84(2A): 20-24

The Cost of Pain

Pain and the treatment of pain affect every sector of our society with at least 100 million adult Americans reportedly suffering  from common chronic pain conditions, a conservative estimate because it does not include acute pain of children.[1]  The proliferation of pain in the United States has resulted in a sharp increase over the past decade in the overuse of narcotics. The prescribing of narcotics has become a popular option for the treatment of chronic pain associated with back injuries, headaches, arthritis, and fibromyalgia.

Chronic pain takes an enormous personal toll on millions of patients and their families, and leads to increased health care costs. Patients with chronic pain have more hospital admissions, longer hospital stays, and unnecessary trips to the emergency department. Such inefficient and even wasteful treatment for pain is contributing to the rapid rise in health care costs in the United States.

The prevalence of pain has a tremendous impact on business.  A recent report by the Institute of Medicine indicated that the annual value of lost productivity in 2010 dollars ranged between $297.4 billion to $335.5 billion. The value of lost productivity is based on three estimates: days of work missed (ranging from $11.6 to $12.7 billion); hours of work lost (from $95.2 to $96.5 billion); and lower wages (from $190.6 billion to $226.3 billion)[2]. This billion dollar annualized price tag will likely climb as the U.S. population ages.

The cost of pain also includes the cost of treating side effects. The most commonly prescribed drug for pain is Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).  Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 (IMS 2012).  Although effective in treating pain and inflammation, NSAIDs are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs which can lead to costly hospitalizations or death.

A study on the effects of NSAID induced side effects in the elderly reflected the average direct costs of GI side effects per patient-day on NSAIDs were 3.5 times higher than those of a patient-day not on NSAIDs. Seventy percent of the cost was attributed to GI events resulting from NSAID treatment. [3]

NSAIDs Image

Treatment of GI problems alone caused by the use of NSAIDs is estimated to add over 40% to the cost of arthritis care[4]

From the perspective of the healthcare system, minor GI side-effects and prophylactic gastroprotection against NSAID-related side-effects may consume even more healthcare resources than severe events because of their high prevalence.

Opioid use has resulted in increased hospitalizations, increased spending on opioid addiction and increased workplace costs.  The cost of the average lost time claim with long acting opioids is 900% higher than those without the use of opioids. U.S. emergency room visits have also increased.  The number of cases in which an opioid other than heroin was cited as a reason for an emergency room treatment in  2004 was 299,498 and in 2011 was 885,348, an almost 300% increase.[5]

While many assume that increase spending and use of pharmaceuticals for pain has had a positive effect on the overall mitigation of pain, there is little scientific data on the relationship between spending on pharmaceutical agents and pain resolution.  Simply treating the symptoms of pain have not proven to be effective nor cost saving in the long run. However, it is increasingly clear that there may be a positive relationship between the use of non-pharmaceutical interventions with or without the use of pharmaceutical and the resolution of pain.

#medicalfoods #NSAIDs #opiods #sideeffects


[1] IMS Health Data, California Workers’ Compensation Institute

[2] Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC

[3] Br J Clin Pharmacol. 2001 August; 52(2): 185–192. Cost of prescribed NSAID-related gastrointestinal adverse events in elderly patients

[4] Bloom, BS. Direct medical costs of disease and gastrointestinal side effects during treatment for arthritis. Am J Med. 1988; 84(2A): 20-24

[5] IMS Health Data, California Workers’ Compensation Institute

Pain Management without Harmful Side Effects

The reduction and management of pain can involve many approaches: prescription medicines, over the counter medicines, medical foods, cognitive behavioral therapy, physical exercise, surgery, nutritional modification, pain education, massage, biofeedback, music, guided imagery, laughter, distraction, acupuncture, and nerve stimulation.  Two or more approaches combined can have a synergistic or additive effect that is greater than the sum of the parts.  One approach, medical foods, has medicinal value that is just beginning to be understood and can be used as a stand-alone therapy or adjacent treatment for chronic pain.

Due to its’ additive effect and low side-effect profile, Theramine®, a medical foods, can be used with high-risk patients over the age of 65 as an alternative to NSAIDs or narcotics.  Adding Theramine to a pain treatment protocol can lead to a reduction in previously prescribed narcotics and minimize the use of NSAIDs or both.  The ingredients in Theramine are Generally Recognized As Safe (GRAS) by the FDA, have no risk of addiction or adverse GI or cardiovascular side effects.  Reducing the burden of adverse side effects while improving clinical outcomes is critical for the overall patient care and a return to activities of daily living.

Two studies comparing Theramine to a low dose NSAIDs in adults 18 years of age and above found Theramine to be more effective than either naproxen or ibuprofen alone for inflammatory pain.  When Theramine was given in combination with the low dose of either product the results were even more beneficial.  Incorporating the use of Theramine into a clinical pain management protocol, allows physicians the flexibility to use less of a narcotic or NSAID pain reliever and potentially eliminate their use all together.

The two studies comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicates significant reduction in back pain with the administration of Theramine alone, and as an adjunct therapy to a low dose NSAID, while administration of a low dose NSAID had no appreciable effect on pain. The use of Theramine as either a standalone or adjunct therapy can significantly improve pain perception.

Theramine is encapsulated with a patented technology that promotes the rapid cellular uptake and conversion of milligram amounts of amino acids and nutrients into the specific neurotransmitters responsible for modulating pain and inflammation.  This patented technology allows Theramine to be effective without losing efficacy over time.

Two multicenter double blind trials have established the safety and efficacy of Theramine in the treatment of chronic back pain. Pain fell by 63% with administration of Theramine and an NSAID as measured by the Roland- Morris Index (Figure 1), and by 62% as measured by The Oswestry Disability Index.

Pain Scale Graph

Traditional pain medication will always have its place in therapeutic treatment and, if used properly, is very effective.  However, physicians, insurance companies, employers and patients are requesting safer, more effective alternatives to treat pain without harmful and costly side effects. The rapidly increasing population of patients 65 years of age and older is a major concern for both physicians and insurance companies as the pain-related costs to overall U.S. health care expenses are likely to rise proportionally as well. The economic impact of pain is certain, as are the physical, emotional, and social impact for millions of people. Reducing the burden of treating chronic pain is a societal necessity, a medical challenge, and an economic requirement.

#medicalfoods #NSAIDs #theramine

The Rising Healthcare Costs of Pharmaceuticals

Prescription drug use and abuse in the United States, continues to rise at an alarming rate as consumers continue to rely on pharmaceuticals for managing disease symptoms. A recent Mayo Clinic study reports that nearly 70% of all Americans have used at least one prescription drug and more than half receive at least two prescriptions, a percentage that has grown over the last decade. A startling 13% of Americans are on painkilling opiods. Increased prescription writing for pharmaceuticals unfortunately results in more side effects, polypharmacy, fatal overdoses and frequent abuse. According the Centers for Disease Control and Prevention (CDC) The overall impact on healthcare expenditures on prescription drugs reached $259 billion in 2010, and accounted for 12 percent of the total personal health care expenditures and is expected to double over the next decade.

This dramatic increase in prescription drug use can be attributed to a number of factors. For example,  as the average lifespan of people increases so to does the incidence of chronic disease, many of which are conditions requiring more treatments and drugs for longer periods of time; patients expect that they will always receive a prescription when they go to a physician’s office which encourages doctors to overprescribe; hospitals and emergency rooms with little time for alternative treatments, want to help patients by giving them prescriptions to treat them expediently for pain, sleep and other issues; and since women on average visit a doctor more frequently than men do, women are often prescribed a narcotic or anti-anxiety drug more often than most men.

generic pills and bottleIncreased prescribing of drugs unfortunately results in more side effects and even fatal overdoses. According to the CDC, from 1999 to 2010, the number of fatal overdoses has increased fivefold among women and tripled among men. When abuse of prescriptions is considered, the problem can be described as epidemic.  Data from the National Survey on Drug Use and Health (NSDUH) show that nearly one-third of people aged 12 and over whom used drugs for the first time in 2009 began by using a prescription drug non-medically.

These escalations continue to put stress on America’s health care system.  Many studies point to the economic impact associated with the increased use of pharmaceuticals. In a recent study released by the Worker’s Compensation Research Institute, the average cost of treating an injured worker without an opiate is $13,000, compared to an average cost of $117,000 for a patient prescribed a long-acting opiate like OxyContin.  According to the Express Scripts 2012 Workers’ Compensation Drug Trend Report for each dollar spent on abused drugs, an additional $41 is used for associated medical treatment.

It’s no secret that more Americans want medical alternatives without the harmful side effects associated with certain pharmaceuticals.  Consumer demands have shifted away from traditional pharmaceuticals to natural alternatives such as plant based pharmaceuticals and more recently medical foods.  In fact, seventy-one percent of sleep-deprived Americans would rather use other means than pharmaceutical drugs to help them sleep, according to a 2013 Harris interactive Rx Sleep Survey.

In one pharmacoeconomic analysis published in the Journal of Pharmacy Research, it was determined that the actual cost of using the non-opiate pain medication, Theramine®, a prescription medical food with minimal side effects is considerably lower when compared to the total impact of NSAIDs.  Medical foods, once a novelty, are becoming mainstream for a variety of diseases. Since drugs and medical foods work along different pathways in the body, medical foods are often recommended as a complementary or adjunct medication to a reduced dosage of a drug, thereby minimizing the potential of harmful side effects associated with traditional, high dose medications. Medical foods offer an important alternative to traditional pharmaceuticals ultimately improving patient outcomes and reducing healthcare care costs.