Should a Doctor Prescribe Drugs that are Unapproved by the FDA ?

Here’s an interesting clinical dilemma brought to my attention by another physician.

 

She was asked to refill a prescription for a drug called domperidone to help a patient with lactation. Domperidone is not FDA approved in the United States for any indication. However, in Europe and in Canada it is approved as a promotility agent for patients with a condition called gastroparesis, which causes the stomach to empty very slowly and results in chronic nausea and vomiting. As a side effect the drug is also known to increase the production of prolactin, a hormone that stimulates milk production. In the case of this physician's patient, she had adopted a child and found that the medication had effectively enabled her to produce milk and nurse, with seemingly no untoward effects. It’s unclear who had initially prescribed the drug, but various online lactation support forums discuss it as an option  for women who have trouble with lactation.

 

The questions: Is it legal, ethical or good medical practice for a physician in the United States to write a prescription for domperidone for a patient who has been using it for lactation with good results? How about for gastroparesis? Where does one get the drug? Is it even legal to sell the drug in the United States? 

 

I’ve cared for at least two patients who have used domperidone. In both instances it was ordered by prescription from an overseas source by a local gastroenterologist. In these two cases my patients had tried just about everything on the market in the United States for gastroparesis and were still struggling with debilitating symptoms. In one case, my patient had required hospitalizations and ultimately a feeding tube because of intractable vomiting. The drug was ineffective in both patients and it was eventually discontinued. 

 

As I read more about this medication I discovered that the FDA cautions:  

"FDA warned healthcare professionals and breastfeeding women not to use an unapproved drug, domperidone, to increase milk production (lactation). The agency is concerned with the potential public health risks associated with domperidone. FDA took these actions because it has become aware that some women are purchasing this drug from compounding pharmacies and from foreign sources. Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.”

The concern over domperidone is its potential to induce potentially fatal cardiac arrhythmias through QT prolongation (an alteration of electrical activity in the heart). This risk has been recognized in Europe and is currently under study. Nonetheless, at least one expert panel in Canada has endorsed the safety of the drug for use in lactation (though not currently approved for this use in Canada). 

 

As my colleague and I discussed the situation with her patient we both concluded that it would not be prudent to refill this prescription for the purpose of lactation. In fact, it would likely be construed as medical malpractice, in light of the drug’s status with the FDA, should the patient or her baby suffer any toxicity. However, clearly there are gastroenterologists who feel that prescribing this medication in United States for cases of severe gastroparesis is justifiable—and I would concur that in certain situations this might be a compassionate and reasonable option despite the regulatory concerns.   

 

To further extend this discussion—physicians do frequently prescribe drugs that are on the market and FDA approved for off-label use. For example, just yesterday I prescribed gabapentin for hot flashes. One interesting study published in Archives of Internal Medicine in 2006 by Radley, Finkelstein, and Stafford found that 21% of sampled medications were being prescribed for off-label use. 

 

The authors concluded:

"The Food and Drug Administration (FDA) focuses on market entry for prescription drugs rather than regulating physicians' prescribing practices, allowing off-label use of medications for indications beyond those formally evaluated by the manufacturer. Off-label prescribing of medications is legal,1 often thought to be supported by scientific evidence,2 and common in certain clinical settings.3- 4 Although this practice provides a pathway to innovation in clinical practice, it raises key concerns about risks to patients and costs to the health care system.5- 7"

Whereas prescribing approved medications for off-label use falls into the realm of acceptable clinical practice, one has to be very circumspect about prescribing drugs that are not deemed adequately safe or effective to market in the United States for any indication. Unfortunately for those who feel that the FDA is too slow, political, or conservative in its approval process, these are the regulatory constraints under which physicians must practice in the United States.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

What foods are in the Mediterranean Diet ?

The Mediterranean Diet is fresh on my mind, having recently returned from a trip to Turkey.  During my trip I became a particular fan of Turkish vegetables—white beans with tomatoes and onions in olive oil, oven baked green beans or okra, eggplant stuffed with walnuts with a tomato ragout, to name a few. My husband commented that I must be a true fan of olives, as he surveyed my breakfast plate, which was chalk full of several varieties of olives, raw cucumbers, tomatoes, a few arugula leaves, fresh cheese and bread.  During my travels I also enjoyed a variety of grilled fresh fish served with lemon, seaweed salad, pomegranate juice, freshly pressed at the side of road, and roasted chestnuts, also sold by street vendors.

I was elated to hear that a new study published in the New England Journal of Medicine in April of this year  validated the health benefits of the Mediterranean diet. The study randomized 7447 women and men with risk factors for cardiovascular disease to receive either a Mediterranean diet enriched with olive oil, a Mediterranean diet enriched with nuts, or a standard low fat diet for the control group. Participants assigned to the two Mediterranean diet arms were found to have a significantly reduced risk of adverse cardiovascular outcomes (heart attack, stroke, death from cardiovascular causes) compared with the control group. The study was terminated after a mean follow up time of 4.8 years.

 Are you wondering how your diet matches up with the “Mediterranean Diet” as defined by the recent study? I was after I read these results.

Here are the criteria with answers qualifying for the Mediterranean Diet shown in bold.

1. Do you use olive oil as main culinary fat?     Yes

2. How much olive oil do you consume in a given day (including oil used for frying, salads, out of house meals, etc.)?     4 or more tablespoons

3. How many vegetable servings do you consume per day? (1 serving = 200g - consider side dishes as 1/2 serving)     2 or more (at least 1 portion raw or as salad)

4. How many fruit units (including natural fruit juices) do you consume per day?     3 or more

5. How many servings of red meat, hamburger, or meat products (ham, sausage, etc.) do you consume per day? (1 serving = 100-150 g)     Less than 1

6. How many servings of butter, margarine, or cream do you consume per day? (1 serving = 12 g)     Less than 1

7. How many sweet/carbonated beverages do you drink per day?     Less than 1

8. How much wine do you drink per week?     7 or more glasses

9. How many servings of legumes do you consume per week? (1 serving = 150 g)     3 or more

10. How many servings of fish or shellfish do you consume per week?  (1 serving: 100-150 g fish, or 4-5 units or 200 g shellfish)     3 or more

11. How many times per week do you consume commercial sweets or pastries (not homemade), such as cakes, cookies, biscuits, or custard?     Less than 3

12. How many servings of nuts (including peanuts) do you consume per week? (1 serving = 30 g)     3 or more

13. Do you preferentially consume chicken, turkey or rabbit meat instead of veal, pork, hamburger or sausage?     Yes

14. How many times per week do you consume vegetables, pasta, rice, or other dishes seasoned with sofrito (sauce made with tomato and onion, leek, or garlic, simmered with olive oil)?      2 or more

*From Table in S1 in Supplement to: Estruch R, Ros E, Salas-Salvadó J, et al. Primary prevention of cardiovasculardisease with a Mediterranean diet. N Engl J Med 2013.

Taking a closer look at the details of the study as described in the NEJM supplement, it seems to me that the particular factors of those listed above that really differentiated the Mediterranean groups from the control group were: the quantity of olive oil ingested, the increase in nuts consumed, and, somewhat less significantly, the amount of seafood consumed, legumes consumed, and sofrito sauce consumed.

In this study the particular kinds of nuts prescribed were walnuts, hazelnuts and almonds. However, there may be health benefits with other nuts as well. Here is some useful nutritional information from University of Michigan Health System (my alma mater) about nuts.

Personally, this study has changed my health practices. While I was already doing well with some of its components, since reading the specifics of the Mediterranean Diet prescribed and found to be associated with reduced cardiovascular risk I’ve made greater attempts to incorporate legumes, nuts, and fish into my diet.

 

 

Alternative, Holistic and Integrative Medicine: Definitions and Safety Considerations

Recently a patient of mine brought in a bottle given to her by her acupuncturist. She had turned to acupuncture with my encouragement after traditional medicine fell short at addressing her chronic pain. Indeed, there is data to support the efficacy of acupuncture in the management of chronic pain . I was encouraged to hear that this treatment, often labeled as “alternative,” seemed to be helping her substantially. 

However, my patient’s questions had to do with the ingredients of the herbal medication she was given  to help with weight loss and phlegm-- a potpourri of botanicals translated from Chinese to English. She asked for my assessment and blessing, reminding me that I was a self-proclaimed “holistic” doctor. Quickly I scanned the product’s label. It contained, among other things, Raphanus Semen, something I immediately felt that I personally would not care to ingest. Despite my initial concern, I promised to research the herbal supplement to the best of my ability.  Later, I discovered that Raphanus Semen was radish seed, which at least seemed less disgusting than what I had imagined.

This patient interaction brought to light two topics worth discussing:

1.       What is meant by “Holistic Medicine?”

2.       How does one assess the safety of complementary and alternative therapy, and more specifically, of botanicals and natural supplements?

I am fairly certain that “holistic” does not carry the same meaning to me as it does to many Americans.  In my view holism in medicine implies having a whole person view.  That is, seeing each patient, not just as a constellation of physical symptoms to diagnose and treat, but also within their psychosocial context.   After all, a person’s unique psychology and cultural background determine how he or she reacts to physical illness, diagnosis, medical advice, and treatment prescribed.  A doctor who makes attempt to understand these parts of his or her patients is apt to be more successful at treating them. However, most Americans tend to think of a “holistic doctor” as one who is well-versed in alternative therapies and who bucks standardized approaches endorsed by the medical establishment, including the pharmaceutical industry and the FDA.   This is not true of my practice, though I am aware of the existence of bias and limitation within the scientific process.

As of late, the term “Holistic Medicine” has actually become antiquated and has been replaced by the contemporary field of “Integrative Medicine.” As defined by the wise Dr. Andrew Weil, one of its best known proponents:

“Integrative Medicine is healing-oriented medicine that takes account of the whole person (body, mind, and spirit), including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative.”

By this description I am an advocate of Integrative Medicine, though, the key point here is “use of all appropriate therapies.”  The unfortunate truth is that many physicians who profess to practice Integrative Medicine treat multiple diagnoses that are not at all well-established by science, for example, “adrenal fatigue.” In addition, many advocate use of products that lack sufficient evidence for safety and efficacy, for example DHEA or bio-identical hormones, and disavow standard FDA approved drugs for unclear reasons.  This business too can be a money-making operation, as some of these physicians do not bill health insurance for their services, run a multitude of diagnostic lab tests of uncertain significance, and may even sell their non-approved “natural” products for significant profit.

Which complementary and alternative therapies are safe and reasonable to try? There are a number of resources that can help to guide both doctors and patients, such as NIH’s National Center for Complementary and Alternative Therapy page on Herbs at a Glance. Unlike prescription drugs, the manufacturers of medicinal herbs and botanicals are not required to prove the safety and efficacy of their products prior to marketing them.  In addition to the definite possibility that these substances might be ineffective, there are two major safety considerations--their potential for causing drug interactions and the risk of product contamination. If you are researching for negative reports on a particular substance you may find the NIH's index "How Safe is this Product or Practice?" to be useful. 

In the case of my patient, she is on a fairly long list of medications for several serious health conditions.  For example, she has a history of pulmonary embolus and also has an inherited condition that makes her prone to clotting. For this she takes a blood thinner. Her other drugs include strong pain medications and several psychotropic drugs with narrow therapeutic indices. My immediate concern was for the possibility of botanical-drug interactions, which might increase or decrease levels of her prescription drugs and cause toxicity or adverse medical events.

It turns out that my research was unable to shed light on any reliable information whatsoever about Raphanus Semen, nor the remaining six ingredients of the herbal medication that she showed me. I was left to shrug my shoulders and advise her, in this case, “probably not a good idea.”  On the other hand, I support the use of acupuncture for chronic pain and have been known to advise melatonin for sleep, probiotics for various digestive ails, and even strontium for osteoporosis.

 

 

 

 

Have you planned your retirement from driving?

When should drivers retire from driving? This question is always difficult to answer.  In our suburban car culture driving allows seniors to maintain their independence and prevents social isolation. However, at what point does it become unsafe for the elderly to drive and what are the risks?

One month ago my fit and about 80-year-old in-laws were involved in a serious car accident. A young man crashed into the passenger side back corner of their car on the highway as he shifted from right to left lane behind them causing them to lose control, and sending them head on into the concrete median of the highway.  He drove away, his car and him unscathed, but my in-laws were not so lucky.  Their car was totaled and they were taken to Grady Hospital in Atlanta. My father-in-law, who suffered a lumbar fracture and contusions, was released after three days. My mother-in-law had more serious injuries—she fractured all of her ribs on the left, her sternum, and subluxed her cervical spine to a dangerous degree requiring emergent decompression and fusion or the cervical spine to prevent spinal cord injury. She stayed in the hospital for one week, and then came to our home to convalesce for another three weeks, requiring physical therapy, home oxygen, a home health aide and multiple assistive devices to help with her activities of daily living. Fortunately, she has done very well, and recently has flown home to Michigan where she will continue to do physical therapy to try to regain her former functional ability, which was fantastic (just before the accident she was giving dinner parties and had planted pansies in my back yard).  My father in law was also in great shape—an avid gardener and retired physician. He maintains his medical license and stays current by reading the New England Journal of Medicine.

It would never have occurred to me to caution my in-laws not to drive, either as a physician or as a concerned family member, given their excellent physical and cognitive functioning.  However, the accident did cause me to reflect upon the issue of driving and safety for seniors.  There are two components of driving risk for the elderly:   the risk that a senior driver could present to another person on the road, and that which an elderly driver poses to his or herself. 

It turns out that with the aging process, changes in the architecture and mechanics of bones makes them more prone to fracture. Not only are bones more osteoporotic, but also the rib cage changes shape making it more susceptible to injury by frontal force.  Loss of muscle mass and subcutaneous fat increase the likelihood of serious injury.  My mother-in-law, the front passenger, restrained by a seat belt and cushioned by the airbag of her Hyundai Sonata, certainly was a victim of these physiological changes. 

According to the National Highway Traffic SafetyAdministration the elderly (persons 65 and older) make up 16% of traffic fatalities.  As we all know the elderly are a growing percent of our population. What will happen to travel patterns as our population ages? 

A study by the AARP in 2012 looked at the impact of the baby boom on travel and recommended research into strategies aimed to address the specific transportation needs of the senior population.

Debra Whitman, AARP Executive Vice President for Policy, quoted in the Huffington Post report on this study, said: “people who live past age 70 will outlive their driving years by seven to 10 years on average. The challenge will come when the generation that is turning the suburbs gray hangs up the keys.”

Often family members come to physicians asking for help with telling their loved one not to drive. I remember one patient who was 90 and had dementia and severe cardiovascular disease. I recommended to his family that he quit driving after he had several fender benders in town. However, I would have liked for him to stop before the fender benders. There are a variety of resources on line to help guide seniors and their family members on decision making about driving in the elderly.   In the case of my in-laws my feeling is that they, and many other octogenarians in similar shape should safely be able to drive. However, given their increased risk of serious injury, perhaps car design needs to evolve to better meet the safety needs of the elderly driver and passenger.

What is your plan for driving and transportation as you grow older? Have you given it thought? Are you confident that you will know when it’s time to turn over the keys? Just as middle-aged adults think about retirement, long-term care insurance, estate planning and advanced directives, they should also think about their plan for transportation as they grow older.  In turn there is a social need to address how to maintain safe and efficient transportation for our seniors, which enables our healthy octogenarians to maintain independent living for as long as possible.

Here are some helpful resources:

Older Drivers (National Institute on Aging)

Senior Driving (AAA)

Patient and Caregiver Educational Materials (AMA)

Physician’s Guide to Assessing and Counseling Older Drivers (AMA)

 

 

 

 

 

Generic Drugs: Bioequivalent and Interchangeable?

Use of generic drugs has the potential to reduce annual consumer spending on prescriptions by billions.  A study published in the New England Journal of Medicine and discussed in the New York Times Economix blog in 2012 looked at Medicare Part D expenditures and correlated them with drug prescribing patterns. The regions of the United States with the highest Medicare expenditures were those where more name brand drugs were prescribed.  But, are generic drugs as safe and effective as name brand drugs?

Generic medications become available after brand name drugs go off patent (usually 10 to 14 years after coming to market). The pharmaceutical industry maintains that the high cost of brand name drugs relates to the research and development required to innovate and bring new products to market.   Advertising and promotion are also, no doubt, a major factor.  

A generic drug is a drug that has been determined to be the bioequivalent of a brand name drug in terms of its active ingredient.   Standards for proving bioequivalence are defined by the FDA and are similar to standards used in Canada, Japan and Europe.  Here’s what the FDA website says about bioequivalence:

“One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.”

The following graph illustrates the bioavailability of two drugs, Drug A and Drug B. The statistics may be difficult to understand, but to be determined bioequivalent the 90% confidence interval of the ratios of the mean bioavailability, or “area under the curve” (AUC), of the two drugs and their peak concentrations (Cmax) must be in the ranges of 80 to 125%.  In more concrete terms, analyses of numerous studies of bioequivalence have shown that differences in blood concentrations of the active ingredients of branded versus generic drugs are generally less than 4 percent.

Once a generic drug is deemed to be bioequivalent by these statistical standards it is not required to go through the same extensive clinical safety and efficacy trials, as a newly innovated brand name drug applying for its initial patent.

What are some pitfalls of using generics? The inactive ingredients in generics compared with branded drugs are not required to be the same. Therefore allergies to these fillers and inactive compounds can be an issue. Also, special consideration should be taken when changing from a branded drug to a generic drug, or when changing between generics, if the drug has a narrow therapeutic index. Some drugs with narrow therapeutic indices include thyroid medications, anti-epileptics and warfarin.

Here are some examples of issues that come up with generics:

The adhesive contained in a fentanyl transdermal patch differs depending on whether the patch is generic or brand name. Some of my patients have developed allergies to the adhesive in the brand name patch (as opposed to the generic,) others complain that the generics don’t stick as well.

Along the lines of narrow therapeutic index—I can recall two separate instances in which a patient was changed to a new warfarin generic drug product. In each case the patient’s PT and INR (coagulation test) had been stable for months, but after the change their levels of anti-coagulation became too high. This took some detailed history-taking to figure out. One review of the literature suggested that generic warfarin and Coumadin products are equally effective and safe and uphold the FDA’s criteria for bioequivalence, yet the authors still suggested that patients limit switches amongst warfarin products and brand and monitor anti-coagulation after making changes.

If a product is deemed bioequivalent then it is also deemed “interchangeable” and pharmacists are not required to inform physicians when they change a patient from brand to generic, or when they change from one generic to another.

Another patient, who reports a high level of drug sensitivity, noticed that a particular generic of nortriptyline used for chronic insomnia was more effective for him than others.

Thyroid medication is known to vary amongst the generics and Synthroid brand in terms of clinical effects. While the FDA has deemed these various products to be bioequivalent and interchangeable many endocrinologists disagree.  In attempt to address this issue in 2004 a  Joint Statement was issued by the major endocrinology professional societies making recommendations on the topic.

The most recent controversy regarding generics has to do with biological drugs, or “biologics.” Because of the inherent complexity of these innovator drugs, which are derived from living cells, the concept of “biosimilar” has replaced bioequivalent for the generic products being developed.  As reported last week in the New York Times, the pharmaceutical industry is currently engaged intense lobbying to prevent biosimilar generic biologics from coming to market as competition to the numerous, ultra-expensive biologics whose patents will be expiring in the near future. 

The science behind the FDA approval process for generic drugs is rigorous. My advice, it can be smart to try a generic. There is no evidence that these products are of lower quality, or less effective than name brand products—though they are not required to go through clinical efficacy trials. However, be wary of minor fluctuations in the clinical effects of your medications when switching between name brand and generic, and amongst different generics, and be aware that your pharmacist may change your generic from one manufacturer to another without your knowledge (the pill should look different). 

What is your experience with generic medications versus name brand products?

 

 

 

A Lesson on Mental Illness Care: Connecting Two Tragedies

For the past month I’ve been trying to formulate a blog that could capture my thoughts about mental illness and the prevention of violence. At this point my ideas are still not crystallized, but perhaps writing this will help. A few days before Christmas I received a phone call from a former patient’s mother.  She called while I was at the mall with my family doing some last minute shopping—I had taken the day off work.   My patient, who I will call “Mark,” and his family had left the state of Georgia and my care approximately 6 months prior.  Fighting to contain her grief Mark’s mother told me that her son, who was just 25 years old, had taken his own life.

It came as a shock, though admittedly during the brief time that I doctored Mark I had been very concerned about his well-being.  His mother said that she wanted me to know because I had worked so hard to help her son. As I listened to the story of the months leading up to his suicide I was flooded with questions:  Could I have prevented this? How did he kill himself? Had he found another physician after he moved? Had he been seeing a psychiatrist, as I had recommended?

I had only cared for Mark for three or four months. When we first met, early in 2012, his mother and he were desperate.  She called me one evening after clinic hours. I was at my son’s saxophone lesson and stepped outside to take the call. She found my medical practice and phone number on Google. She thought I might be able to help. He’d had a tough childhood. His sister was severely disabled. Then, he suffered a traumatic life event in college. Mark, though obviously very intelligent, had dropped out, unable to function.  While he was my patient Mark confided that he was desperate to be independent and get back to normal functioning, but felt crippled by his health.  He was a very likable young man who I connected with.

He described multiple symptoms—head pressure, mental fogginess, intense pain and burning all over his body coursing from his center outward and down his extremities, nausea, heartburn, post-nasal drip, an intensely dry mouth, insatiable thirst, difficulty swallowing, loss of appetite, change in his bowel habits, weight loss and muscle wasting.   Mark felt that he was dying from a medical condition that remained undiagnosed. As he explained it, his trouble had started while was under the care of a psychiatrist. He attributed some of his symptoms to a medication, a serotonin re-uptake inhibitor, Effexor, which he felt had permanently changed him.

He asked if I could test him for permanent damage caused by traces of the drug that might remain in his blood stream months after his last dose. He had left his psychiatrist’s care wanting another opinion and a thorough evaluation of these physical symptoms that were relentless and incapacitating.  

I embarked on a very thorough medical evaluation—including a plethora of blood tests, an MRI of his brain, a neurology and an allergy and immunology consultation.  I knew all the while that the root problem was very likely his underlying psychiatric condition. Mark acknowledged ongoing depressed mood and severe long-standing anxiety, but was primarily concerned about his physical health. I asked to speak with his psychiatrist, but his preference was that I evaluate his condition independently, and he refused.  When questioned about thoughts of self-harm or harming others Mark stated, “I could never do that to my mother.”

After frequent lengthy office visits and phone calls over a period of several months I was not able to arrive at a unifying medical diagnosis that explained my patient’s condition. I was, however, increasingly concerned about his psychological health and referred him to another psychiatrist. I had become aware of underlying paranoid overtones in his affect, which I felt were delusional. He had been concerned about a pharmacy contaminating his prescriptions with a substance that made him ill. He asked me if I knew what the substance was (I had never heard of it), and asked me to investigate it. He expressed suspicion about various commercial labs and preferred that I send his lab specimens to a smaller lab that he had researched and chosen. He felt this lab would do a more accurate job with his lab testing. He asked me my opinion on his future career—he said he was very interested in the military, and asked if I thought that might be a good direction for him.  Inwardly I cringed at the thought, and tried to steer him toward a more flexible career choice, and one that would not involve use of firearms.

After several months of working closely with Mark his mother informed me that the family would be moving out of state.  Although the timing was not ideal, his father could not turn down the job opportunity and Mark could not stay on his own. Despite my referrals he had never established with a new psychiatrist.  In a last ditch attempt to get him some help, I made a phone call to a psychiatrist who I knew and trusted. The psychiatrist agreed to see Mark several times prior to his move—it was the best we could think of.

 I felt that I needed to clearly articulate my clinical impression to Mark’s mother prior to their departure, which was that my patient was suffering from a psychiatric condition that caused a disorder of thinking in the form of paranoia and delusions.   I mentioned schizophrenia. Mark’s mother acknowledged that this diagnosis had been previously suggested, but that she and Mark wanted another opinion. 

At the time of his last visit Mark brought in a fairly organized list of the symptoms he was suffering from and how they impacted his ability to function. He wanted me to write a letter attesting to the fact that he was unable to work or go to school because of his condition. I agreed to write a letter describing his condition, which was difficult given the fact that there was no psychiatrist involved and his diagnosis appeared to be primarily psychiatric—I explained this to Mark and had a direct conversation with him about my clinical impression.

The visits to my psychiatrist referral never occurred. My patient moved later that summer and I had no further contact until the phone call in December. The news about my patient’s tragic suicide came one week after the shooting at Newtown, where, as we all know, another young man with significant psychiatric illness inexplicably sacrificed not only his life, but the lives of 26 children and teachers. I immediately wondered if my patient had shot himself, but somehow during our brief phone conversation, I could not bring myself to ask his mom how he died—it seemed irrelevant to her grief at the time. These two events cast a shadow over my holiday season.  

I continue to try to make reason of these two tragedies, hoping to arrive at a pithy lesson by connecting the two that I can bring to clinical practice to avoid future heartbreak. What makes it so difficult to get patients with psychiatric illness the help that they need? In this case it was not problems of access, but the underlying disease process itself made my patient resistant to care.  

 I am still searching for broader answers, but perhaps I will start with a call back to my patient’s mother to find out more details. In the meantime, I remain highly skeptical that improved mental health care alone, without restricting access to firearms will be enough to curb gun violence in our country.