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Black Box Warnings: Time to Reconsider Our Disease=Drug Reflex?

The recent news of a black box warning for psychiatric side effects from the allergy drug Singulair (montelukast) reminded me of a patient I saw ten years ago. She wanted help getting off the hook from a shoplifting charge. The judge didn’t buy it.

It is a frightening thought that medications we prescribe to help people feel better emotionally can do the opposite: Antidepressants, for example, can bring on mania, suicidal or homicidal thoughts or actions and are now known to at least some of the time cause irreversible changes in “brain chemistry”.

It is even worse, in fact horrifying, to consider that psychiatric side effects can occur with medications we think of as allergy treatments (Singulair), antibiotics (Levaquin) or antivirals (Tamiflu), immunosuppressants (methotrexate or steroids), acne treatments (Accutane), Parkinson or restless leg treatments (Requip), blood pressure medications (beta blockers), drugs for smoking cessation (Chantix) and so many others. Not that these types of side effects are all terribly common, but they are common enough to have to be a concern.

It does make you pause. Medical providers have flash card style knowledge memorized: Disease = Drug to prescribe. This knowledge is ingrained, learned reflexes that bypass commonsensical, non-pharmaceutical approaches.

The longer I’m in this business, the more I think we need to consider the options in the space between symptom/diagnosis and prescription. It isn’t as uncharted or infertile as we may think and it is often safer and less loaded with inadvertent liability.

First, do no harm.

Hope is a Contagious Force of Healing

In our last Friends and Family group meeting, which we hold every two weeks to support our Medication Assisted Treatment (Suboxone) program, the word HOPE came up several times.

The first person to use the word apologized, saying it sounded so passive, but another person said it is a very powerful action word.

As the meeting progressed, other people chimed in about the importance of never giving up hope, even though they all had seen and dreaded relapses, any one of which could be fatal.

Wrapping up, we went around the room and everyone said what their takeaway was from the night and what their “homework” would be before the next meeting.

I said I was going to think more about hope and write something about it.

Theologically, the three virtues of Faith, Hope and Charity (Love) are viewed as having God both as their source, infusing them into us, and as their object. In this context, the opposite of Hope, Despair, is viewed as a sin.

Hope has been described as our intellect’s desire for something and our expectation that it will come about. It is a future oriented attitude and frame of mind, an optimistic outlook.

Faith is trust in what is here and now, perhaps something you attain further along your life’s journey than Hope.

With everything we now know of neurobiochemistry, psychoneuroimmunology, placebo effects and natural healing, most of us believe in the power of optimism. We also know that people with addictions struggle with self loathing in all its forms and that any expression of negative expectations from people around them can push them deeper into despair and further into chemical escape. They often have little hope for themselves and no faith in their here and now.

I believe Hope is a powerful emotion that can be contagious, transmitted, shared and multiplied when we claim it for ourselves and publicize it openly. It can be like a blood transfusion or a catalyst in a chemical reaction when we share it with those who have less of it or none at all.

For people who have a hard time believing in themselves and their own future, tangible expressions of hope from people who matter in their lives can change them, just like we all tend to smile when someone else looks happy, if we think of a trivial example. The same contagiousness exists for despair, as history has demonstrated many times from stock market crashes to pandemics to Jonestown.

Our patients’ or loved ones’ lives are on the line. We can’t be neutral; do we choose to carry Hope or Despair? It’s one or the other. The ones we care about can sense it in us and their success or failure may hinge on our innermost expectations.

As Physicians Today, We Must Both Represent the “System” and Disregard it

Healthcare today, in the broadest sense, is not a benevolent giant that wraps its powerful arms around the sick and vulnerable. It is a world of opposing forces such as Government public health ambitions and more or less unfettered market ambitions by hospitals and downright profiteering by some of the middlemen who stand between doctors and patients, such as insurers, Pharmacy Benefits Managers, EMR vendors and other technology companies.

Within healthcare there is also a growing, more or less money-focused sector of paramedicine, promoting “alternative” belief systems, some of which may be right on and showing the future direction for us all and some of which are pure quackery.

I stand by my conviction that physicians must embrace the role of guide for their patients. If we see ourselves only as instruments or tools in the service of the Government, the insurance companies or our healthcare organizations, patients are likely to mistrust our motives when we make diagnoses or recommend treatments.

On the other hand, if we work within the traditional healthcare system, we must strive to understand it well and present fairly the merits of the establishment’s usual approach to our patient’s problem. When our own educated opinion differs from mainstream medicine, it is our professional and ethical duty to tell our patients what we understand about their options and make it clear that this is not at this point in time the typical approach. I have done this for decades, warning patients that low fat diets promote heart disease by often inadvertently increasing intake of refined carbohydrates and telling patients that a Mediterranean diet has been shown to reduce heart attack risk at least as much as statin drug therapy. Medicine has always been an evolving science and to think it won’t continue to change is naive.

But if we disagree with everything conventional medicine does, we need to follow our conviction and move outside the system. If we do, we could be throwing the baby out with the bath water. And we could confuse and jeopardize patients by not informing them plainly enough that we aim to withhold accepted therapy because of our own dogmatism.

Our duty as guides is to walk with our patients in the direction they wish to go and to know more than one way of getting there; some people want the scenic route, others the fastest – some patients want better health with fewer medications and some want every intervention they can get.

It isn’t professional to only offer one approach if you know several. Let the patient choose.

American Primary Care and My Soviet Era Class Trip: Sensing the Inevitable Collapse of a Top Down Bureaucracy

Swedish Healthcare seemed competent but a bit uninspired and rigid to me but my medical school class trip to the Soviet Union showed me a healthcare system and a culture I could never have fully imagined in a country that had the brain power and resources to have already landed space probes on Mars and Venus by the time my classmates and I arrived in Moscow in the cold winter of 1977.

The first time we sat down for breakfast at two big tables in the restaurant of the big Россия hotel near the Red Square, our two male waiters asked if we wanted coffee or tea and people started stating their preferences. The waiters shook their heads and put their hands up in the air. No, they couldn’t split the beverage order, they explained. We had to all decide on one beverage with no substitutions.

The restaurant obviously had both coffee and tea, and as far as I know, they cost about the same. The only thing standing between the tea drinkers and their favorite morning beverage (the coffe crowd won the popular vote) was convention and attitude. I don’t know if this was a policy set by the hotel management or a complete lack of service-mindedness by he staff, but my classmates and I felt as if we, the customers, did not matter.

(Writing this piece, I came across the news item that the Hotel Rossiya, once the biggest hotel in the world, was demolished in 2006.)

From that first morning on, everything I encountered felt dim, dark and repressive. I saw with my own eyes that Sweden’s degree of uniformity was nothing compared to the Soviet Union’s, which some of my classmates, communists and former Viet Cong supporters, had spoken well of before we got there.

During our stay I saw dilapidated hospital wards and surgical suites with antiquated medical instruments in scarce supply, which we couldn’t even all see because of a lack of scrubs and booties. We saw bare-bones ambulances staffed with underpaid specialist physicians, neurologists for stroke victims, for example. I thought being a doctor in the Soviet Union seemed like one of the most depressing things you could end up doing for a living.

I yearned for the freedom and optimism I had seen back in 1971, when as an exchange student I fell in love with America and a girl I met in my high school sociology class.

During my high school year here, I got the impression that almost everybody in America had a personal ambition, like making music, writing a book or starting a business. I saw a service mindedness I had not seen in Sweden, where years later I saw the epitome of that in a restaurant near the Arctic Circle that closed for lunch (for the staff) from 12 to 1 pm every day.

In America I also got the impression that the rules of society were not exactly cut in stone the way there were in Sweden. Due dates seemed a little flexible, rules seemed to have countless exceptions; even spelling of the American language seemed to offer a few individual choices.

Doctors in America were mostly in private practice. I didn’t see much of American healthcare that year, except the afternoon reruns of Marcus Welby, MD that I devoured. It ran from 1969 to 1976 and it solidified my vision of being a primary care doctor in America.

Fast forward twenty years, to 1991, the year the Soviet Union collapsed. The Planned Economy proved itself to be an unsustainable daydream of the social engineers of communism.

That year I had lived in this country for a decade. My work in a Federally Qualified Health Center, part of a safety net that offered subsidized or free care to people without health insurance, had shown me the inequalities and health hazards of “the other half” of American society. I felt proud to be part of such a clinic, providing equal access to everyone.

During the ensuing two decades, the Federal agencies that paid our grants and provided our preferred reimbursement rates started to micromanage what we did and how we structured our work. My original liberated experience of American healthcare turned into a sense that the bureaucrats mistrusted doctors and administrators of FQHCs so deeply that they had to structure our work for us.

The crowning event was when we all more or less had to earn recognition as “Patient Centered Medical Homes”, which at first sounded like we needed to make our practices Marcus Welby-like. Instead, PCMH was not really about nimbly meeting your patients needs but about creating rigid protocols that in fact made it hard to improvise. This was followed by many other initiatives that to a small or larger degree lacked firm anchoring in the reality of front line medicine and became virtual shackles for medical practices.

This hampering of improvisation in how you meet individual patients needs felt strangely familiar, and brought back memories of that cold December morning in Moscow:

Tea or Coffee, but not both.

Save one same day slot and qualify for easy access recognition, double book freely and fail the access parameter (no “protocol”).

And then when Uncle Sam wanted our “data”, presumably for better central planning some day, we were given grants to computerize our patient records with numerous qualifiers about how to use these computers. “Meaningful Use” broadly sounded like a good idea, except the technology was immature.

One example: Patient information about their medical condition, if generated by the EMR software, often amateurish and rudimentary, gives us Meaningful Use brownie points, but high quality handouts from sources like Up to Date, Harvard or the Mayo Clinic don’t count.

Another Federal shackle: Uncle Sam wants us to deliver comprehensive care, which includes screening for a growing list of clinical and societal issues, like depression, alcohol use, domestic violence, sexual orientation, food insecurity and so forth. If we don’t do all this, we lose brownie points. Consequently, we hesitate fitting infrequent visitors into our clinic schedules, because you can’t possibly do all that in a single visit for a sore throat, so we look better if that patient goes to a walk-in clinic – one ding on the Access parameter instead of numerous dings for all the other ambitious comprehensiveness requirements

I am sorry to report that the well meaning bureaucrats of the Central Planning Office are making American Primary Care feel more and more like the Soviet Union of Lenin and Marx where people mattered as populations, perhaps, but not as individuals. That is not the way Americans think. They don’t want to be told what to drink with their breakfast and they don’t want to be told what the agenda is for their next doctor’s visit.

Collapse or profound disruption seems inevitable.

The Science of Placebo and Nocebo Effects Puts the Doctor-Patient Relationship on Par With the Effectiveness of the Pharmaceuticals We Prescribe

Using a treatment without having any understanding of how it works is often thought of as unscientific and suggesting that a placebo can help a sick patient has until now been viewed as unethical.

The New England Journal of Medicine just published an article about placebo (making you feel better) and nocebo (making you feel worse) effects, two of the most intriguing aspects of the supposedly scientific practice of medicine. These phenomena have long been seen as complicating pharmaceutical research. But today we have a deeper understanding of how placebo and nocebo effects come about, down to the neural pathways. The fact that we understand the mechanisms better has made their use start to gain more legitimacy.

According to the article, placebo effects have been shown to be associated with the release of substances such as endogenous opioids, endocannabinoids, dopamine, oxytocin and vasopressin. We even have some understanding of which substances mediate which type of response. For example, placebo treatment of Parkinson’s disease raise dopamine levels and “increased pain perception through verbal suggestion, a nocebo effect, has been shown to be mediated by the neuropeptide cholecystokinin”.

In my own clinical experience (40 years last summer) and writing, the understanding of the impact of exactly how a treatment option is presented is a recurring observation and theme. See for example “Negative Expectations”, “Patients are the Real Healers”, “Patient Centered and Evidenced Based Medicine – Can We Really Have Both?” and “Getting it Right”.

As the NEJM article points out, many double blind clinical trials of medications for pain and psychiatric disorders show similar effectiveness of placebo and active substance. Another interesting statistic is that up to 19% of adults and 26% of elderly patients report side effects from placebos. The article, in linking placebo and nocebo effects to patients’ relationship with and trust in their physician suggests that a patient who stops a medication may not or not only be doing this because of perceived side effects but perhaps deep down due to mistrust in their physician.

Similarly, “patients with common colds who perceive their clinicians as empathetic report symptoms that are less severe and of shorter duration than those of patients who do not perceive their clinicians as empathetic; patients who perceive their clinicians as empathetic also have reduced levels of objective measures of inflammation such as interleukin-8 and neutrophil counts”.

As we present patients with treatment options, we need to give more thought to the risk-benefit of the traditionally all-important notion of informed consent.

I, for instance, have tended to present statistics in a counterproductive way. Instead of saying 5% of people get a particular side effect, the article hints that maybe we should say that 95% don’t get it while at the same time explaining the potential benefit of the treatment.

The article also suggests describing the severe or significant side effects a medication can cause and then mentioning that other, milder side effects can occur, but because of the nocebo effect, the mere mention of these has been shown to increase the statistical probability that patients may have them. Giving the option of hearing all the non-critical reported side effects has been called “contextualized informed consent” and “authorized concealment”.

I can’t help reflecting on how focused we are in medicine on the subject matter and how little we speak about the delivery of subject information. The business world seems to talk more about how to sell something than how to produce it. I think as physicians or scientists we look down on that, thinking that a cup of coffee is a cup of coffee, so why are all these people devoting their lives to how to sell that cup of coffee?

So we need to get off our high horses and take a look at how we present information about what we “sell”, because what we try and hope to sell may have greater impact on our “customers” future health than which brand of coffee they choose to drink.

Medicine is Child’s Play: Where’s Waldo, Spot the Difference and Whack-a-Mole

I started writing a post a few days ago about the challenge of quickly finding what you’re looking for in a medical record. As I came back to my draft this morning, it struck me how much this felt like some of the games my children played when they were young. This got me thinking…

Where’s Waldo: Finding what’s important in the medical record

I did a peer review once of an office note about an elderly man with a low grade fever. The past medical history was all there, several prior laboratory and imaging tests were imported and there was a long narrative section that blended active medical problems and ongoing specialist relationships. There was also a lengthy Review of Systems under its own heading.

In what would probably have printed out over ten pages long, the final diagnosis was “Urinary tract infection” and the man was prescribed antibiotics.

This final diagnosis seemed to come out of left field. I didn’t recall reading anything about urinary symptoms, urinalysis, an abdominal exam or pain on percussion over the back.

I had to read the note again twice. Finally I found mention of increased urinary dribbling in the sentence that stated that the patient was seeing a urologist for his enlarged prostate. There was a same day urinalysis mixed in with almost a dozen other, previously done lab tests for things that in no way had any bearing on body temperature. And the physical exam was exhaustive, including items that in no way could relate to why an elderly man might have a fever.

My task as a reviewer included answering the question whether the Chief Complaint, Review of Systems, Physical Exam, tests ordered, Assessment and Plan were all consistent. I gave the note a passing grade with a scathing comment about how hard it was to follow my colleague’s line of thinking in diagnosing the patient’s problem because of all he irrelevant data that was included.

After reviewing this one office note, my brain was exhausted. I had not expected chart review to be so much more like “Where’s Waldo” than “Who Dunnit”.

Spot the Difference: How to monitor trends and find the abnormal among the normal

I’ve said it before, much of what we do in medicine is triaging. We run down symptom checklists and we run our fingers over lymph nodes; we scan lab reports and run our eyes over dozens of moles on people’s backs; we look at growth charts for consistency and medication lists for inconsistencies. Our job is to find the abnormal among everything that is normal. Sometimes an apparent abnormality is a persistent and normal “baseline” for one particular patient. To do the best job possible with this, we shouldn’t have to rely on memory alone. We need our EMRs to display information in a way that makes our job easier and reduces the risk of errors. The ability to quickly generate graphs or flowsheets for lab results is crucial because of the volume of tests we have to review, or triage, actually.

We still use warfarin, even though the $400/month never anticoagulants don’t require blood test monitoring and dose adjustments because of interfering medications or foods. Not all EMRs display historical INR values and dose changes well; I have some colleagues who will look at only one INR value and change their patient’s warfarin dose. Sometimes their typical increase or decrease will create the same overcorrected result again and again because the EMR doesn’t provide the same overview as the old paper flowsheets.

Whack-a-Mole: Just when you think you’ve solved one problem, another pops up

This is the most clinical and most deeply frustrating child’s game we have to play in medicine. One leg ulcer heals, and another one develops. One COPD or heart failure exacerbation successfully treated and the patient gets sick again. One cancer seems beaten and another tumor develops.

The other games we find ourselves playing are annoying obstacles created by health care workers or systems. But Whack-a-Mole is the modus operandi of the many human diseases we battle. And unlike the other two “games”, this is one we must accept and not take personally when we don’t win. And because this is a game with sometimes devastating consequences, I take absolutely no pleasure in the child’s play version, although I did enjoy playing both Where’s Waldo and What’s the Difference when my children were young.

“The Four Horsemen of the Medical Apocalypse”: It’s All About Inflammation

“Although there may never be such a single path, mounting evidence suggests a common underlying cause of major degenerative diseases. The four horsemen of the medical apocalypse — coronary artery disease, diabetes, cancer, and Alzheimer’s — may be riding the same steed: inflammation.” – Harvard Health Letter, 2006

It has been said that it takes 17 years for new scientific information to change medical practice. So, it’s been 14 years since Harvard posted the article titled “Inflammation: A unifying theory of disease”.

Note the dramatic allegory, “The four horsemen of the medical apocalypse”. The chronic diseases listed plus obesity and probably also depression, which is now costing more in disability payments than back pain and other musculoskeletal conditions combined, are driving our healthcare expenses into the stratosphere and our population into a quagmire of suffering and death from diseases that seem to actually be preventable and in many cases reversible.

What is inflammation?

A cut or scrape heals through the process of inflammation, which is a good thing. But too much inflammation can make that process go overboard and a thick, raised keloid scar forms.

Pounding your heels on a concrete factory floor day after day can cause mechanical stress on the plantar fascia, the tendon-like band that helps maintain the arch of your foot. Through the process of inflammation, part of that fascia undergoes thickening and eventually calcification, and a heel spur forms.

A ruptured disc in your lower back can cause acute pressure on the nerves that supply feeling and control muscle activity in your leg – sciatica. In response to this pressure, the injured nerve swells through the process of inflammation and becomes even more squeezed than it was from the initial injury.

Chronic disc problems can cause calcification, just like with heel spurs, at the corners of each vertebra and sharp bone spurs can form in your back.

Autoimmune diseases like arthritis, psoriasis and colitis involve similar processes in our bodies. Misguided efforts to repair minimal or imaginary (on the part of the immune system) damage or fight off “foreign” invasion cause changes to our bodies like bone spurs or destruction, rashes or peeling skin and diarrhea or ulcer formation, and profound alterations in mood and cognitive ability.

Inflammation can also occur inside our blood vessels. It is now well known that foods and chemicals can increase or decrease inflammation, which helps determine whether blood borne fats start building up in the walls of our blood vessels.

More and more evidence also implicates inflammation as a contributor to obesity , which in turn can promote more inflammation.

The new movement of Functional Medicine is studying and promoting non-pharmaceutical approaches to these inflammation mediated medical conditions. Calling their philosophy “The medicine of why”, they reject the idea that the best way to fight inflammatory diseases is by suppressing the immune system. Instead they focus on avoiding triggers, correcting deficiencies and reversing the modern day imbalance between helpful and excessive immune responses. I have written about this before, here.

The frighteningly simple theory is now more and more anchored in science, down to the specific chemical reactions at work in our bodies and the dietary phytochemicals involved. What we eat, drink, inhale or otherwise expose ourselves to can cause or prevent disease and can determine whether our genetic risks manifest in disease or not. This exploding field is called epigenetics.

How do we fight inflammation?

Here are some very simple fundamentals about what everyone can do to reduce their risk of the inflammation mediated diseases Harvard called the medical apocalypse:

Pro-inflammatory foods to avoid:

Sugar and high fructose corn syrup as well as “refined carbohydrates”, which means anything made from flour (bread, pasta, crackers, boxed breakfast cereals and many snack foods).

Artificial trans fats or partially hydrogenated oils (now phased out from our food supply).

So called “tropical” oils like palm and coconut oil.

Processed meats.

Excessive alcohol.

Also, although not foods, inhaled substances like cigarette smoke can cause inflammation and at the same time decrease normal immune defense responses.

Anti-inflammatory foods to choose:

Healthy Omega-3 fats like olive oil, fatty fish like salmon, avocado and tree nuts.

Berries, cherries, grapes and tomatoes.

Vegetables like broccoli, Brussels sprouts and kale.

Turmeric, cocoa and green tea.

(More details here:

Of course, there is more, but imagine if everyone took these simple steps – olive oil consumption alone reduces heart attack risk by 25%, for example. (I just said that in my previous post, too – sorry for repeating myself here).

I am still puzzling about why we aren’t thinking and talking much more about this. Unfortunately, it seems this is not going to revolutionize medical practice in a mere 17 years.

Osler said “Listen to your patient, he is telling you the diagnosis”. Duvefelt says “Listen to your patient, he is telling you what kind of doctor he needs you to be”.

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