Sunday, August 7, 2011

Self-Tracking, Psychiatric Ethics, and the Changing Patient-Doctor Relationship

A recent New York Times article - "A Dashboard for Your Body" - led me to nose around the web to learn more about developments in what is often called "self-tracking."

It's a fascinating area that is likely to change medical practice, the patient-physician relationship, and even the ways in which we think about ourselves.

Home monitoring devices are already letting clinicians - and perhaps more importantly, family members - keep a virtual eye on the frail elderly and homebound people with chronic illnesses. When our dispersed lives keep family members and close friends from keeping a literal eye on a person in need, devices with internet connectivity allow tracking of vital signs, blood sugar, movement in the living space, eating, and more.

These capacities would have been useful to me, an only child, and my father, in his 80s and legally blind from macular degeneration, during the years he lived in Florida, a thousand miles away. The telephone, and the front desk in the building he lived in, were the tools we had to rely on. Applied wisely, the emerging technologies will make it easier and safer for folks with reduced capacity for self-care to live at home, which is what most prefer.

My search led me to a fascinating article - "The Data-Driven Life" - that describes how some obsessive young technophiles monitor and chart their moods, alertness, uses of time, and much much more. While some of the self-monitoring verges on lunacy, some is potentially transformative.

In medical practice, we do a lot of data collection with our patients (think of the "blood pressure check" or monitoring drug levels). We also spend a lot of time encouraging patients to monitor themselves. The new devices shift the locus of control, power, and knowledge from physicians to patients. In place of coming to the office for a blood pressure check or a blood draw, the new technologies let patients do these themselves. In place of the physician's office notes the patient has his own medical record.

Some years ago a patient of mine with depression (working with her on that was my job) and brittle diabetes, consulted me about problems with her medical team. She had created spread sheets correlating glucose levels, insulin dosage, and other factors. These led her to hypotheses about her regimen. Her team didn't explicitly call her "uppity," but they didn't respond well to her wish to share the driver seat with them. Here my job was to coach her on how to shape a new form of collaboration with her team. Happily, it worked.

Self-tracking may turn out to be especially useful for psychiatry and behavior change. In mental health treatment, patients often relate to clinicians the way our forebears related to oracles. They pose questions like "why did I feel that way?" and "what put that idea into my head?" These are important questions, but seeing the clinician as the all-knowing source of insight is disempowering.

The article on "The Data-Driven Life" identifies implications for future psychiatric practice:
"...a 26-year-old filmmaker named Toli Galanis, [reported] 'I know that immediately after watching a bad movie I am more apt to be negative about my career prospects as a filmmaker'...tracking has made him better able to detect the influence of seemingly trivial circumstances on his mood and decisions.

The idea that our mental life is affected by hidden causes is a mainstay of psychology. Facility in managing the flow of thought and emotion is a sign of happiness and good adjustment. But how is it done? Nearly every therapeutic prescription involves an invitation to notice, to pay attention. Once we have a notion in our sights, we can attack it with an arsenal of tools: cognitive, psychoanalytic, even spiritual. But none of these will tell us if we’ve missed something. You may simply have failed to notice a debilitating habit, a negative correlation, a bad influence."
This next vignette shows how self-tracking can be combined with social support:
"Jon Cousins is a 54-year-old software entrepreneur and former advertising executive who was given a diagnosis in 2007 of bipolar affective disorder. Cousins built a self-tracking system to help manage his feelings, which he called Moodscope; now used by about 1,000 others, Moodscope automatically sends e-mail with mood-tracking scores to a few select friends. 'My life was changed radically,' Cousins told me recently in an e-mail message. 'If I got the odd dip, my friends wanted to know why.' Sometimes, after he records a low score, a friend might simply e-mail: '?' Cousins replies, and that act alone makes him feel better. Moodscope is a blended system in which measurement is supplemented by human sympathy. Self-tracking can sometimes appear narcissistic, but it also allows people to connect with one another in new ways. We leave traces of ourselves with our numbers, like insects putting down a trail of pheromones, and in times of crisis, these signals can lead us to others who share our concerns and care enough to help."
Toli Galanis shows how to use self-tracking as a source of insight to guide self-management. Jon Cousins shows how to use self-tracking to strengthen social support. Developing insight, improving self-management, and strengthening constructive relationships, are central components of virtually every form of psychotherapy. Tools that provide these functions will allow some potential "patients" to be their own therapists, and will enable others to come to therapy having done valuable "pre-work."

When I did my training, our patients' families and friends were often seen as intruders on the therapeutic process. In subsequent decades psychiatry and psychology wised up and learned to work with patients in the context of their social environment - using it when it was constructive and trying to change it when it was not. I foresee a time in the not-too-distant future when we'll be working with their iPads as well!

Thursday, August 4, 2011

Rethinking the Value of Medical Services

by Brian Klepper and David KibbeOne of American politics’ most disingenuous conceits is that health care must cost what we currently pay. Another is that the only way to make it cost less is to deny care. It has been in industry executives’ financial interests to perpetuate these myths, but most will acknowledge privately that the way we value and pay for medical services is a deep root of

Tuesday, August 2, 2011

How a Well-Intended FDA Policy on Colchicine is Harming Patients

The road to hell is paved with good intentions.

The FDA has reaffirmed the truth of this aphorism with its policy about Colchicine. Here's the story:

I recently spoke with a friend who has a family member suffering from Familial Mediterranean Fever (FMF), an auto-inflammatory disorder, most commonly seen in eastern Mediterranean populations. The condition is characterized by recurrent painful inflammation of the abdomen, chest and joints, accompanied by fever. FMF is associated with mutation of a gene on chromosome 16 involved with regulating Pyrin, a protein that is part of the inflammatory response. There is no specific test for the disease. Diagnosis is made on the basis of symptoms, family history, and ruling out other conditions.

Since the 1960s, Colchicine, a plant extract first used for treatment of gout two thousand years ago, has been used for treating FMF. As an ancient treatment widely used prior to formation of the FDA, Colchicine did not require FDA approval as a new drug.

In 2009, the FDA granted approval to URL Pharma for Colcrys, its version of Colchicine, based on randomized controlled trials the company conducted. Because Colchicine had never been subjected to the FDA approval process, Colcrys was, in a technical sense, a "new" drug approved for a "new" indication - treatment of gout and FMF - despite the centuries of prior use.

Here's where the well-intended harm comes in. The FDA is allowed to give market exclusivity to a new drug for new indications, as an incentive for pharmaceutical companies to conduct tests and seek FDA approval. In September 2010 the FDA did just that - it ordered all other manufacturers to cease production and marketing of their versions of Colchicine.

Generic Colchicine cost ten cents per dose. Colcrys costs close to five dollars. The company defends the price increase as (a) necessary to support its research and (b) offset for vulnerable patients by a support program for circumstances of hardship.

The FMF community, however, has documented that FMF patients respond differently to different preparations of Colchicine. Apart from the financial impact of a fifty-fold price increase, many who were stable on a previously available form of the drug relapsed on Colcrys.

That's what happened to my friend's family member - a series of severe fevers and inflammatory reactions, leading to emergency room visits and hospitalization.

An editorial in the New England Journal of Medicine argued that URL Pharma's research added no significant benefit to public health of the kind that would justify the reward of market exclusivity. (See here for a vigorous response from URL Pharma.) But apart from the financial hardship market exclusivity creates for patientr and insurers, banning the alternative forms of Colchicine injures patients who respond to those forms and not to Colcrys.

My friend is resourceful, and was able to find "contraband" Colchicine. When it was administered, it did the job for his family member.

Encouraging research and true innovation is a social good. But so is preventing recurrences of FMF! A policy that does not allow exceptions to prevent avoidable harms is an unethical policy. Given that alternative forms of Colchicine are no longer manufactured and sold in the U.S., the FDA should make provision for importation from abroad for patients like my friend's family member.

(See here for an excellent article on FMF and the impact of the FDA policy by Dr. Janine Jagger, an epidemiologist who suffers from the condition.)

Monday, August 1, 2011

The Debt Deal: There Will Be Blood on the Floor on November 23rd

The debt deal is finally done. But it really isn’t an agreement on what cuts will be made, just the process that will be used to make them.The real work is left to the Congressional appropriators for the first $917 billion and for a super-committee of Congress for the second $1.2 trillion to $1.5 trillion in ten-year cuts.That second tranche is where health care will make its contribution. The