BACKGROUND

The abuse of and addiction to opioids such as heroin, morphine, and prescription pain relievers is a serious global problem that affects the health, social, and economic welfare of all societies.  It is estimated that between 26.4 million and 36 million people abuse opioids worldwide, with an estimated 2.1 million people in the United States suffering from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 addicted to heroin.  The consequences of this abuse have been devastating and are on the rise.  For example, the number of unintentional overdose deaths from prescription pain relievers has soared in the United States, more than quadrupling since 1999.  There is also growing evidence to suggest a relationship between increased non-medical use of opioid analgesics and heroin abuse in the United States.

The total number of opioid pain relievers prescribed in the United States has skyrocketed in the past 25 years (see graph above),  The number of prescriptions for opioids (like hydrocodone and oxycodone products) have escalated from around 76 million in 1991 to nearly 207 million in 2013, with the United States their biggest consumer globally, accounting for almost 100 percent of the world total for hydrocodone (e.g., Vicodin) and 81 percent for oxycodone (e.g., Percocet).

In terms of abuse and mortality, opioids account for the greatest proportion of the prescription drug abuse problem.  Deaths related to prescription opioids began rising in the early part of the 21st century.  By 2002, death certificates listed opioid analgesic poisoning as a cause of death more commonly than heroin or cocaine.

It is estimated that more than 100 million people suffer from chronic pain in this country. and for some of them, opioid therapy may be appropriate. The bulk of American patients who need relief from persistent, moderate-to-severe non-cancer pain have back pain conditions (approximately 38 million) or osteoarthritis (approximately 17 million).  Even if a small percentage of this group develops substance use disorders (a subset of those already vulnerable to developing tolerance and/or clinically manageable physical dependence), a large number of people could be affected.  

Scientists debate the appropriateness of chronic opioid use for these conditions in light of the fact that long-term studies demonstrating that the benefits outweigh the risks have not been conducted. In June 2012, NIH and FDA held a joint meeting on this topic, and now FDA is requiring companies who manufacture long-acting and extended-release opioid formulations to conduct post-marketing research on their safety.

Recently Johns Hopkins medical center published an evidenced based approach to prescriptions drugs and Katz et.al, have identified the so called stakeholders in the management of risk in prescribing opioids.

OUR APPROACH

1. Use the same process (identify pain syndrome, discuss risks and benefits) every time we      prescribe opioids for chronic pain. This is done monthly for most patients and bimonthly for “trusted” patients.

2. Perform imaging studies including CT and MRI as well as electrophysiological studies such as EMG, NCV and SSEP to confirm pathology and ongoing nature of cause for pain.

3. Assess risks for misuse by the use of the SOAPP system.

4. Use a pain management treatment contract/agreement. 

5. Identify an appropriate formulary for our practice. (We avoid for instance the use of OxyContin and long acting delivery systems because of the relative risk of these drugs).

6. Integrate urine toxicology screens into our prescribing patterns

OUR PHILOSOPHY

Our practice is based on compassionate medicine and our goal is to provide neurological care and chronic pain management using the highest ethical standards of care. Our guidelines balance the need to care for our patients with the need to “protect the public trust” and to follow the Hippocratic oath of “DO NO HARM”. 

We realize the benefit of short term relief of pain and the need to balance it with the long term harmful effects of opiate use. (The physiologic consequences of opioid use are adverse, occur quickly, and can be permanent. Decreased brain gray matter, release of calcitonin gene-related peptide, dynorphin, and pro-inflammatory peptides, and activation of excitatory glutamate receptors are all associated with opioid exposure).

We therefore attempt to use the minimal amount and dosage of opiate drug needed to manage unbearable pain and combine its use with anti-inflammatory drugs, physical therapy and injections.

Many patients come to us on massive doses of opiates prescribed by general practitioners of other pain management clinics. We need to then re-educate them as to our philosophy of practice which often causes anxiety that we will “cold turkey” them off all medications. Nothing could be further from the truth. The doctor patient relationship demands compassion above all other concerns, however we will be certainly titrating them down off the massive doses they come to us on, if we feel there is an inappropriate prescription of opiates by other prescribers. We approach this carefully by combining the appropriate use of opiate dosage with judicious use of injections and therapy as well as other anti-spasm and anti-inflammatory medications.

We engage in strategies to identify risk patients in order to protect the public trust by the use of the State prescription on line “Inspect” reports as well as the urine toxicology screens. These identify aberrant behaviors as well as “doctor shoppers” and have protected our legitimate patients who seek pain relief. The SOAPP forms are to be filled out at every visit and identify risk behaviors. We therefore stratify risk at 4 levels based on the risk of diversion, aberrant behavior and use of concurrent illegal drugs. These risk assessments protect our licensure as well as the public trust.

We choose medications based on evidenced based medicine principles. The use of opioids is usually accompanied by muscles relaxants (flexeril, zanaflex, and baclofen) especially for axial spine pain where muscles spasm is a large component of the pain syndrome. For neuropathic pain due to diabetes and other causes we use such agents as Neurontin and Lyrica. For the pain of central causes such as Multiple Sclerosis, RSD or post stroke pain we are challenged by the refractory nature of such pain.

Many times we identify anxiety as a co-morbidity in pain syndromes. Patients often mis-identify depression and anxiety disorders as pain. Unfortunately, many of our patients cannot afford the luxury of psychological care and come to us with multiple life complaints of which chronic physical pain is only one component. We have a responsibility to accurately define the cause of pain and treat the appropriate causes. This is why we perform imaging and electrical studies, as well as blood studies. We routinely find diagnoses that were missed by other referring physicians (in a study in 2013 we found a 15% rate of misdiagnosis of patients referred to our clinic.) 

Many patients come to us with a diagnosis of fibromyalgia of which prior sexual and other abuse has a high degree of correlation. Merely treating the pain symptoms surely does not get to the heart of the cause yet because of the socio-economic realities of our population we seem to be the only access to healthcare (be it because of limited funds to travel to clinics or other medical reasons) yet we have to address these issues. Furthermore, we have found missed diagnoses such as neuropathy, discogenic disease, polyarthritis and Lupus, sarcoid in many patients who have been “written off” as fibromyalgics. The FDA treatment for fibromyalgia allows for 3 approved drugs none of which are opiates. This is a big challenge for those patients who cannot tolerate Lyrica, Savella, or Cymbalta because of side effects.

Migraine is another disease we treat that proves a big challenge. The use of opiates is not recommended for the treatment of migraine disorders. Yet many patients are referred to us after the primary care physician throws up his hands after having tried the usual pharmacy of medications approved for migraine. Again the psychological co-morbidities and triggers are usually uncovered after listening to the patient carefully and often can be avoided. Yet we have a persistent core of patients who come to us opiate dependent. We advocate the weaning off these medications and the judicious use of BoTox injections and deep tissue massage therapy in combination with new FDA approved drugs.

The use of injections (from local nerve blocks to epidurals, pain pumps and dorsal column stimulators) is an integral part of our pain management program. 

We believe that a combined approach making use of all these parameters significantly manages moderate to severe pain in our population of patients.

Chronic headache is a common and costly neurological disorder. Estimates suggest that about 11 percent of adult populations in Western countries are affected by migraine.
Prevalence is highest during the peak productive years—between the ages of 25 and 55, accounting for the significant economic impact of the condition.

Despite the significant impact of migraine on the individual and society, diagnosis and management remain challenging. Studies indicate that between 56 percent and 91 percent of chronic headache sufferers seek treatment from healthcare providers, yet only one-third report having received a diagnosis of a specific headache condition. 

For the majority of patients presenting for neurological evaluation of headaches, effective headache prophylaxis is the key to improved outcomes. Preventative treatments, however, are generally underutilized. One study found that approximately 90 percent of migraineurs have moderate to severe pain, but most “treat their headaches with acute treatments
to the exclusion of preventive drugs.” 

Indications for preventive therapy include frequent or very severe headaches, excessive acute medication use, severe disability, and patient preference. However, evidence suggests that most patients do not pursue effective prophylactic treatment. As of 2015, the Migraine Research Foundation says only 4% of migraine sufferers who seek medical care consult headache and pain specialists. Depression, anxiety, and sleep disturbances are common
for those with chronic migraine.

Many effective prophylactic medications are associated with significant adverse events (AEs) and often take a few months to notice clinical improvement. In addition, some patients prefer to avoid daily medication and patient compliance can be an issue.

Most preventive medications for migraine, such as many beta-adrenergic blockers, antidepressants, and anticonvulsants, have not been rigorously studied for the treatment of chronic migraine (CM).

Discovered by serendipity, onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis after randomized and rigorous studies. We usually
perform BoNTA injections every three months, and pain relief typically begins in less than two weeks. Recent clinical trials demonstrate that BoNTA is effective in the treatment
of chronic migraine, leading to approval by the US Food and Drug administration of BoNTA for CM prophylaxis. There are many other reports of BoNTA use in other headache disorders, such as tension-headache, episodic migraine, cluster headache and nummular headache.

In February 2015, the American Headache Society updated its acute migraine guidelines, providing a new analysis on the strength of the evidence. “Some of the newer drugs in combination work. We have evidence, for example, for the new DHE inhaled product, for the sumatriptan patch, and for new formulations of non-steroidals,” said study author Stephen Silberstein, MD, FACP of Jefferson University Hospitals, in Philadelphia.

Unmet Need to Treat Chronic Migraine and Cardiovascular Disease. Numerous studies have described a relationship between chronic migraine and stroke, and there is emerging
evidence that migraine is also associated with cardiovascular disease, according to a 2015 study. 

Until now, only an acute class of drugs (triptans) have been specifically designed and approved for migraine. However, monoclonal CGRP (calcitonin gene-related peptide)
antibodies represent a new class of biologics designed for migraine prevention. “While many potential migraine drug targets have emerged over the past 30 years, none have been
more thoroughly investigated and appear more promising than CGRP and its receptor,” according to Dr. Dodick. “The preliminary efficacy and safety findings from these studies are very encouraging.” Confirmation will await the completion of two other Phase II studies with two other antibodies and future Phase III studies.

There are many ways in which technology has made our lives more convenient. When was the last time you called a travel agent, or got lost in a city, or not known where the nearest pizza establishment was? On some level, this convenience, ubiquity, and ease-of-use has created an expectation that the internet can answer all questions. But the truth is that while the information super-highway has transformed the world in profound and lasting ways, there are still tasks that it is not well suited to. One of those tasks is diagnosing disease. I know how tempting it can be when something goes wrong to browse on over to WebMD or any of the other dozens of sites that offer symptom checking services, but a recent Harvard Medical School review shows that these sites often get it wrong. According to the review, only 34 percent of symptom checkers had the correct diagnosis listed first. And here’s the thing. Depending on the symptom and the individual case, if relied upon this information could lead at best to wasting precious time and at worst to actual catastrophe. This is not to suggest that as physicians we always get the diagnosis right. Far from it. But would you go to a doctor who only got it right a mere 34% of the time? The popularity of these sites probably comes from a combination of factors. They are immediately available, they leverage the instant gratification that we’ve become accustomed to from technology, and many Americans simply do not have access to proper medical care. I’m a big proponent of patients educating themselves about their conditions and using all of the tools at their disposable, including the internet, to better understand their disease. But at the crucial phase when you know something is wrong, but you’re not sure what it is, avail yourself of our services. As medical professionals, we have spent a lot of time and effort honing our diagnostic skills and those of us who are good at what we do excel at the art of diagnosis in ways that an algorithm will never be able to replicate.

It’s not often that a true paradigm shift occurs in a well-established field such as Neurology, but two recent research trends seem to be building towards a very exciting one. The first relates to the microbiome, that ecosystem of friendly bacteria that live in our gut and help us to digest food. For a decade or more, this has been an active area of interest with regards to diet and obesity, but lately, there’s been some research on the effects of the microbiome on the brain. The most striking of these studies has to do with Autism. It seems that people with this disorder have a higher proportion of digestive ailments than the rest of us and consistently different microbiomes. In a recent study, when autistic mice were fed B. Fragilis, a species of friendly bacteria commonly found in the gut, their symptoms improved dramatically. In another study, 12 healthy women were given probiotic yogurt twice a day for 4 weeks and then had their brains scanned while they were shown images of different emotional facial expressions. This group was compared against 13 healthy women who did not eat the yogurt. The yogurt-consumers had significantly calmer brain reactions to the facial expressions. All of this new evidence suggests a much more direct connection between the gut and the brain than was previously supposed. The exact mechanism of this connection is still unknown, but a very recent study on Parkinson’s disease implicates the Vagus nerve as one potential conduit.

The second trend has to do with the elusive connection between the brain and the immune system. Intuitively, it has always made sense that the nervous system and the immune system somehow communicate with one another, but until last month, no one had any evidence that they did. In a stunning discovery, researchers at the University of Virginia School of Medicine uncovered an unknown system of lymphatic vessels in the brain. That we could have overlooked this system for so long is a marvel in and of itself. But this discovery is quite literally the missing link that will open a whole new world of understanding. This avenue may even lead in our lifetimes to new treatments for intractable neurological diseases. A few years ago, if you had told me that there was a direct connection between the gut and the brain, I would have probably smiled and filed the comment away under unsubstantiated alternative mumbo-jumbo. I would have had a similar reaction to talk of a connection between the immune system and the nervous system. But in 2015, we have solid scientific evidence to support both claims. And it’s a very exciting time to be a neurologist.

Ask a physician about the Placebo effect and depending on his or her poker face, they might betray a little discomfort. This is because the Placebo effect and its counterpart the Nocebo effect(when an otherwise inert intervention causes harm), lie at the very threshold of our knowledge as medical professionals.

In many ways, the entire edifice of modern medicine rests on the Placebo effect. When a pharmaceutical company develops a drug, one of the most important hurdles they must jump is demonstrating that it outperforms a placebo in clinical trials. The theory is that if the drug really works, it will perform better than a placebo, or a fake drug. The problem is that the fake drugs often work. Indeed, placebos have been shown to be remarkably effective at treating a variety of illnesses. Moreover, as pharmaceutical companies well know, subtle differences such as the color or shape of a pill can have a dramatic impact on clinical results. And yet if we admit that the Placebo effect is real and can actually heal people, are we not also devaluing our own interventions? What distinguishes us at that point from a snake oil salesman?

The answer must be science. Science is what distinguishes us from the quackery of the unscrupulous. So we must shine the light of science on the phenomena known as the Placebo and Nocebo effects to better understand their mechanisms of action. Happily, there has been a shift in thinking on this subject over the last decade or so and scientists are finally making strides to better understand the mechanisms of action that underlie these peculiar phenomena.

As it happens, some of the most interesting research on Placebo and Nocebo is being done around the experience of pain. One of the many benefits of the Placebo effect is that it can reduce pain. Recent studies have shown that Naloxone, a drug that interferes with opioid receptors, also has the potential to block the analgesic placebo effect. These studies suggest that the analgesic placebo effect leads to a release of endogenous opioids in the spine which produce relief. Other studies have shown that people who have a propensity for more profound placebo analgesia also have more marked responses to opioids, pointing to a possible genetic component for the Placebo effect. But beyond the molecular mechanisms, we are also learning that expectations play a role. When patients participating in a clinical trial are unwittingly given the placebo pill, they are given the exact same warnings about potential side effects as those taking the real drug. Unfortunately, the Nocebo effect ensures that many of them will actually suffer from these negative side effects, despite the fact that the substance they are taking is totally inert.

We are clearly just beginning to scratch the surface of these fascinating phenomena. But as physicians, we need to be more sensitive to them in our practices. We must harness the Placebo and mitigate against the Nocebo effects in the service of our patients. Finally, we must approach both our patients and our profession with a greater degree of humility.

You hear it all the time. Regular exercise is an essential component of maintaining a healthy lifestyle. Why is it so hard for us to get off the couch and make it happen? And if I eat a healthy diet, do I really need to worry about exercise? The reason it seems so hard has to do with our modern lifestyle. As a society, we are overworked and underpaid. And the stresses of making ends meet, raising a family, and getting ahead in the workplace are such that exercise is often relegated to unfulfilled New Year’s resolutions. While eating well is certainly necessary for maintaining a healthy lifestyle it is insufficient.

A recent Finnish study of identical twins demonstrates just how profound the effects of exercise can be on both body and mind. As a result of the fact that it was a twin study, researchers from University of Jyvaskyla were able to eliminate one of the ordinary confounding variables, namely genetics, from their investigation. Moreover, they were able to narrow their focus on twins whose exercise habits had only diverged since they left their childhood homes. It was a small study, but these unique characteristics make the results very interesting. The researchers found that the twins who exercised had higher endurance capacities, lower body fat, and more grey matter in their brains. Additionally, the twins who did not exercise showed signs of insulin resistance which is a precursor for Diabetes.   

The Finnish study, along with much of the published scientific research to date on exercise suggests that regular exercise is essential to our health. So make time for it. Get to the gym. Take a long walk with a loved one. Get the bicycles out of the garage and go on a family outing. Make it a part of your routine. Both your body and your mind will thank you for it. 

"What should I eat?" seems like a simple question, but in reality it is quite complex. On the one hand, we are living in an age of abundance. Never in human history has the quantity, quality, and variety of food that we now enjoy been available to so many people. On the other hand, diet-related disorders like Obesity, Diabetes, and Cardiovascular Disease are reaching epidemic proportions. To make matters worse, the conventional wisdom of our top health authorities seems to be in flux on many of the key questions related to diet.

A big part of the problem comes from the food industry whose profit motive has had a profoundly negative impact on our health, the state of scientific research, and government policy for many decades now. To make matters worse, the diet industry continues to sell miracle weight loss plans that make mutually exclusive claims and all purport to be based on the best science available. Low Fat, No-Carb, Slow Carb, Paleo, the list goes on and on. But even if you cut through the web of profit-driven propaganda, what we are learning about nutrition is that it is far more complicated than we ever imagined.

One area of research that is both very important and poorly understood is the so-called “Microbiome”. Did you know that there are literally trillions of microscopic organisms that live in and around your body? Before you panic, understand that most of these organisms are actually good for you. These “good” micro-organisms have evolved alongside us in symbiosis and are in fact essential to the normal functioning of our bodies and digestion. But how exactly this system works, what role it plays in health and disease, and how the needs of individual Microbiomes differ from one another are all very new areas of research. We simply don’t have the answers yet. 

With all of those important caveats out of the way, there are some steps you can take to improve the quality of your diet. These are our tips for healthier eating:

1) Learn to cook.

Yes, it’s easier to eat out, but if you care about your health, cook most of your meals at home and only dine out once or twice a week. You’ll have the added benefit of saving some money.

2) Eliminate sodas(including diet sodas!) and juices from your diet.

Switch over to good old-fashioned water and for some variety brew a nice pot of green tea.

3) Make vegetables the centerpiece.

If most of your calories are coming from veggies, you will be well on your way to good nutrition.

4) Reduce the amount of processed foods in your diet.

A processed snack here and there is not the end of the world, but you should try to keep your calories from processed foods at under 10% of your total diet.

5) Replace red meat with leaner substitutes and reduce your intake of dairy

If you follow 3, you shouldn’t be having much of this to begin with, but if you must, make the meat lean and try to keep dairy at under 5% of your total calories consumed.

How would you react if I told you that there is something you could do to improve your memory, lose weight, and reduce your chances of getting ill? Sounds like snake oil, right? But it’s absolutely true. Getting the proper amount of sleep does all of these things and more. Unfortunately, we have a host of negative cultural associations with sleep. We think of people who sleep a lot as lazy or indulgent. We reserve respect for those who pull all-nighters, because they were able to power through their slothful desire for slumber. But the science of sleep teaches us that catching z’s has a profound impact on our health and wellbeing.

Healthy sleep is divided into 4 main stages. Stages 1-3 are called “Non-rapid eye movement” and the 4th stage is called “Rapid Eye Movement”, or REM for short. Sleep progresses through these stages in 90-120 minute cycles throughout the night. As the night progresses, the REM stages get longer and this is when we dream. The amount of sleep that we need is totally variable from individual to individual, but generally speaking adults require anywhere from 7-9 hours of sleep every night.

Are you a student who has been studying through the night in an effort to ace your exams? While your dedication is admirable, you may actually be making things harder on yourself than they have to be. Recent studies suggest that sleep deprivation has a profoundly negative impact on memory performance. While the exact mechanisms are still being researched, the association between sleep and memory formation is now firmly established. Struggling to lose weight? If you aren’t getting enough sleep, the hormones that regulate hunger and satiation may very well be out of balance. People who are sleep deprived tend to have more Ghrelin (the hunger hormone) and less Leptin (the satisfaction hormone) than those who are fully rested. Have you been getting sick a lot lately? A growing body of evidence suggests that there is a correlation between sleep deprivation and reduced immune function. Not only does this make your body more friendly to nasty microbes, but it may also make you more susceptible to certain forms of cancer.

Sleep is not an indulgence. It is not lazy. Sleep is something that we all need and meeting our sleep needs ought to be a priority that we take seriously.

New Year’s Eve is a wonderful time to celebrate. It marks the transition from one year to the next and as such it earns our attention with resolutions, countdowns, and for some of us the consumption of copious amounts of alcohol. Here are our top five tips for responsible drinking this New Year’s Eve.

1. Party with at least one person who cares about your well-being.

You’re a social butterfly and meeting new people is one of your favorite things to do. But when you throw alcohol into the mix, it’s always good to be around someone you trust. Use a buddy system to ensure that you are safe this New Year’s.  

2. Know your body and its limits.

It seems obvious, but it’s easy to lose track of how many units of alcohol you have consumed on a night like New Year’s Eve. Being aware of how many you’ve had and having the discipline to stop before you hit your limit will ensure a healthy start to the new year.

3. Stay hydrated.

Alcohol is a diuretic. This means that its natural effect on your body is to cause dehydration. Every unit of alcohol you consume(1 beer, 1 glass of wine, 1 shot of hard liquor) should be accompanied by a full glass of water. Keep that balance and you will be much less likely to experience a hangover the next morning.  

4. Don’t drive.

You know that friend who just earned their 10 year AA chip? Have them take you home. Better yet, if at all possible, party somewhere within walking distance of your home. New Year’s Eve is the most dangerous time of the year to be on the road.   

5. Sleep it off.

It may feel like you had a good night's sleep, but if you got drunk, chances are you did not. Excessive alcohol consumption actually interrupts sleep patterns and reduces the quality of sleep. Take a nap. Your body will thank you later.