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.

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.