Sunday, September 30, 2007

Neonatal End-of-Life Ethics

Ethical decisions in the neonatal intensive care unit (NICU) can be very dramatic given the obvious tensions of life and death at such an early age. Our technology for monitoring, our medications for treatment and our surgeries for correcting medical problems in the developed world have opened new doors in sustaining life in the peri-natal period. I was lucky enough to benefit from NICU advances in the 20th and 21st century since my son & daughter were born at 32 weeks, so I am very grateful on many levels. Being in the NICU for my twins for 5 weeks allowed me to observe some very emotionally difficult moments with other families. I was not snooping, the NICU had open bays, and curtains do not muffle tears and sobbing at all.

Those difficult discussions and decisions are well-highlighted in a succinct and enlightening article by Dr. Pedro Weisleder in the Journal of Child Neurology, titled: Dignified Death for Severely Impaired Infants: Beyond the Best-Interest Standard. A case of a 34 week per-term infant who has severe and multiple malformations (microlissencephaly group 5) is presented and the ethical dilemma caused when the neurologist objects to the placement of a VP shunt is discussed. Similar to many cases in adults, the infant is unable to communicate and never expressed prior wishes, so advanced directives and substituted judgment are unhelpful as ethical precedents. Typically the standard for infants is best interest, but as is frequently the downfall of the best interest standard, it is dependent on the values of others, and therefore very prone to bias. So Dr. Weislander highlights how to advocate for ethical treatment based on other conditions, such as the right to avoid futile treatment, and the right to a natural death, and the right to a life worth living. This last one may catch some off guard, as even the term 'a life worth living' has been associated with involuntary euthanasia of disabled people who were deemed living a 'life NOT worth living' (lebensunwertes Leben).

The right to a life worth living separates out being a biological entity to leading a biographical life. The phrase 'leading a biographical life' was new to me, and I think it encompasses many complex things that disability advocates, palliative care providers, and the general public could embrace. It does have a tinge of best interest feel to the idea, but I feel it could even be applied to those in PVS, advanced dementias, or even comas. Adults afflicted with those severely impaired neurological states still lead a biographical life to some degree, but to what acceptable degree is still the difficult question to answer.

This article has echoes in adult palliative care, and is a good summary article for NICU ethics issues. It would have been nice to see some more information on key opposition to these arguments for some balance, alas I am not a journal editor so I will just have to leave that opinion here!

One pediatric/NICU specific issue that I have never heard about are the 'Baby Doe' rules (NYT 1984), which were referenced as a counter-argument to the initial opposition to the VP shunt placement. Apparently states are at risk of losing federal funds (for child abuse programs) if they do not provide all possible care to fix any life-threatening condition. The legislation has provisions for the irreversibly comatose infant, futility (a difficult medical definition at best, a mutually agreed upon legal definition I doubt exists.) and inhumane treatments. Some pediatricians have suggested a change in the rules now over 20 years old.

This has not been an issue taken up by any palliative medicine societies, only a few in the pediatrics community. I imagine as most palliative medicine providers, we are very busy trying to get people to accept good palliative care for dying adults, but there are not many of us with pediatric experience. Although I would strongly encourage you to reach out to your pediatric colleagues, because you would be surprised at how much your consel and guidance could help pediatricians and the children and families they care for.

(I do home visits for our pediatric hospice team, and I am internal medicine trained. If you would like some friendly support and ideas on seeing peds patients, feel free to contact me ctsinclair -- g m a i l d0t c o m )

Picture is of Lindsay, my daughter at 32 weeks and 1 day (not the patient in the article for those HIPAA watchers)

Sunday, September 30, 2007 by Christian Sinclair ·

Thursday, September 27, 2007

Computer-aided decision making; fMRI's

Just one topic today!

Archives of Internal Medicine has an article about medical decision making for patients without surrogates (people without family or friends who are able to make decisions on their behalf). It's mostly about computer-aided decision making support based on patient demographics - something I blogged about before but never thought I'd hear more about (that article shares an author with the current one). This is how the authors describe it:

"For example, a physician faced with the choice of whether to intubate an 80-year-old man with dementia who develops respiratory failure, and lacking evidence of his preferences, would enter variables that may include the patient's age, sex, and diagnoses and the proposed intervention. The treatment indicator would estimate the likelihood that this patient would want the intervention based on analysis of a database of treatment preferences of individuals who share his characteristics. If this analysis indicated that most individuals with the patient's characteristics would prefer to be intubated, intubation would be performed; if it indicated that most would forgo intubation, it would be withheld."

The authors go on to describe further how it would work as well as the ethical & legal implications of such a system. While my initial and continuing reaction to this is that it's nuts, the authors make one very compelling point:

"Given that surrogates predict patients' preferences more accurately than physicians, it follows that a population-based treatment indicator would be more accurate than physicians and other decision makers for incapacitated patients without surrogates."

That is, evidence shows that physicians (and presumably courts) are a relatively poor judge of patient's wishes, and so if we can provide something which is shown to be more accurate than physicians, why not use it even if it is a computer program?

I've been trying to figure out what I don't like about this, and I think it's three-fold. First, I think it's somewhat of a folly to base such things on research asking patients what they'd choose in situation X. It's too artificial; each individual clinical situation is so unique that what people say they'd want in a survey may not accurately reflect what they'd actually want when they're in a similar (but real) situation. You can't pre-plan things: it takes sitting down, talking through the specifics of the situation/options/values/goals and going from there. This is the problem with advance care planning in general (at least insofar as ACP is envisioned as a patient documenting 'when I'm in situation X I want Y'). This gets to my second concern which is that this is a positivistic folly - that we can predict the future and predict people's responses. (On the other hand the authors would say that that's true however they can make a system that is better than physician judgment so why not use that?)

But my major concern is something that the authors themselves bring up - it's an idea that has been squirming around in my head for a while but I've never been able to verbalize it - and that's the idea that the decision making process itself may be just as important as the decision made (they're sort of the same thing). They note:

"One consideration is that patients may have preferences not only about treatments but also about the process of making treatment decisions."

They go on that for some patients what would be of the most importance to them would be, for instance, that the physician made the decision that they thought was in the patient's best interests. The process of decision-making (physician making a judgment about what medical care was in the best interest of the patient) as more important than pre-specifying the decision to be made (in situation X do Y). This reminds me of many of my patients who when I try to bring up planning for specific events (e.g. dying when I'm talking about code status) say "Oh my wife will make the decision at the time" or some variation thereof. For them the process (wife making decision based on immediate clinical situation) is more important than, again, pre-specifying the decision. (There is an element of trust here to be sure, which doesn't apply to some patients.) I've long suspected that the framework we have about these topics ('substituted judgment,' 'patient autonomy') frequently aren't applicable to (or even descriptive of) how decisions are actually made, and that that's not necessarily a bad thing, if the process is right. That's probably the most organized my thoughts about this are going to get tonight; please leave comments if you have any further ones (or if you want to call me nuts).

However I will take this opportunity to break my promise of a single topic and add some more to this post...

Salon has a piece about fMRI and consciousness and the new research that is coming out about how some people in persistent vegetative states show (fMRI) evidence of consciousness (supposedly). I blogged about this here & here. This is a much more cogent and well-informed discussion of the topic than I have been able to provide and I highly recommend it for anyone who frequently works with people in prolonged states of unconsciousness or is interested in the ethics of withdrawing life-prolonging medical care in those situations. It's a must-read. This sort of technology is here to stay, and while neuroscientists are figuring out what this all means, we will be answering more and more questions about it to our patients' families (many pundits opining about the Schiavo case were calling for fMRI testing to see if she was 'really' in a PVS)....

And on a lighter note this piece states that there are probably 'tens of thousands' of patients in the US in PVSs. I was at a conference once honoring the (now late) Dr. Ronald Cranford who took credit for that figure - he said he made it up once in an interview (it was an educated guess but really based on nothing more than his gut sense) and it has now passed into the vernacular, so to speak. If anyone knows actual real data to contradict or support this, let us know.

Image is from the website of some researchers in this area.
Salon is free if you watch a brief ad.
Thanks to my brother Luke Rosielle for letting me know about this.
And while we are indulging in vaguely funny things I was rather astonished tonight when Palladone was briefly referenced on the season premiere of The Office.

Thursday, September 27, 2007 by Drew Rosielle MD ·

Sunday, September 23, 2007

Hematologic malignancies; Lung cancer guidelines; Screening for depression; NSAIDs & opioids

In no particular order:

Internal Medicine Journal has an editorial calling for closer integration of palliative care into the care of people with hematologic malignancies. It's from an Australian perspective although seems to be broadly relevant internationally and speaks to some of the issues I see in my own practice:

"The unique biology of blood cancers has traditionally been seen as one of the key obstacles to the integration of palliative care. It is now understood that it is the varying professional perspectives, rather than the unique biological circumstances of haematology, that makes the difference. There are indeed special considerations for haematology patients, which can include factors such as the high-tech and invasive nature of treatments offered that at times are myeloblative and may involve transient bone marrow failure; the speed of change to a terminal event; the need for blood products and the possibility of catastrophic bleeds. At times there can be a blurring of the distinction between the curative and palliative phase. However, evidence indicates that in most cases there are clear indications that the terminal stage has been reached."

At least in the US - the 'hospice model' doesn't work well for some patients in the terminal phases of hematologic malignancies - especially those that remain ambulatory (and many do) and continue to benefit from blood products, antimicrobials, and even myelosuppressive therapies. However, part of the impetus for palliative care in the US has been to provide 'hospice-like' care to those who (due to prognosis, goals, or - frankly - cost) are not 'hospice-appropriate' and it would seem this is a prime patient population for this.

(This editorial was prompted by a report which is supposedly found at this website but I can't find it. Leave a comment (with link) if you find it.)

Chest has published the ACCP evidence-based guidelines for palliative care for lung cancer patients as well as guidelines for palliative care consultation, quality of life measurement, and bereavement.

The first is mostly a comprehensive, summative review of the literature for symptom control & supportive care of the lung cancer patient. It's quite long & a good one for the teaching file, and very much comes from a 'chest physician' (pulmonologist, thoracic surgeon) perspective. For me its sections on bronchoscopic palliative procedures, hemoptysis management, tracheoesophageal fistula management, effusion management, etc. are the most interesting and worth a read.

The second does the same thing but talks about the role of palliative care consultation, qol stuff, and psychosocial/familial/bereavement aspects of caring for lung cancer patients. It gives the following recommendation grade I-C evidence (meaning there's pretty good data to support it):

"For all patients with advanced lung cancer (and their families), it is recommended that palliative care be integrated into their treatment, including those pursuing curative or life-prolonging therapies. "

Most notable, however, is the column-space this article gives to bereavement - including clinician bereavement. I practically wept when I realized these formal, professional-society based, evidence-based guidelines gave (not insubstantial) space to these matters. There's nothing earth shattering here - it's just the fact that the topic is taken seriously that makes me slightly hopeful for medicine in the 21st century. This is how it starts:

"The grief experience of clinicians is similar to that of loved ones, in quality if not in severity, but the term disenfranchised has been applied to the grief of clinicians because it seems somehow less legitimate than the grief of family and friends. There are additional challenges that involve issues of professional maturity, competence, integrity, and interprofessional friction that may contribute to special difficulties for clinicians. Of particular note is the tendency of clinicians to blame themselves for imagined failures; grief may be more intense if it is believed that the death was preventable."

(Thanks to Dr. Bob Arnold for alerting me to these.)

Annals of Oncology has an interesting look at screening for depression in cancer patients. It's a German study in which a bunch of hospitalized cancer patients were given the Beck Depression Inventory - the authors looked to see how many patients screened positive for depression based on somatic symptoms vs. affective symptoms. The study involved prospectively evaluating ~200 adult cancer patients (mean age 57 years, all hospitalized with newly diagnosed cancers to receive first line chemotherapy) with the BDI. They found that 8% had 'clinically relevant depression' (defined as a score of at least 18 on the BDI) but that most of these this was due to somatic symptoms (fatigue, sleep disturbance, etc.) and not affective symptoms (anhedonia, hopelessness, helplessness, etc.). Using only affective symptoms they suggest only 3% of the population would have 'clinically relevant' depression. Besides the fact that these figures all seem generally low, this study more or less confirms what we already know - the somatic symptoms of cancer interfere with the diagnosis of depression, we have to be quite careful particularly before instituting pharmacologic therapy, and the BDI is an inappropriate diagnostic aid in cancer patients. I realize there is some controversy around this - how much somatic symptoms should be weighed in our diagnosis of depression in cancer. I've always stuck to the affective symptoms only, but would like to hear other perspectives if you've got them - leave a comment.

Supportive Care in Cancer has an article (a randomized trial) of starting an NSAID along with morphine for cancer pain. It's a small Brazilian trial, and involves dipyrone, an NSAID not available in the US. It randomized 34 cancer patients (opioid naive, with a variety of pain syndromes) with baseline pain scores ~7/10 to morphine 10mg q4 hours scheduled plus either scheduled dipyrone or placebo. Patients received this for 48 hours then crossed over (to either placebo or dipyrone) and followed for another 48 hours. Dipyrone patients did better: achieved analgesia faster. In fact, the placebo group had basically no analgesic response until dipyrone was added after 48 hours which, besides the very small N and the fact that I think the cross over time of 48 hours is too short, is the major concern I have with this. The morphine-only-first group didn't respond at all to their morphine (for whatever reason): this indicates to me they weren't getting morphine dosed appropriately - they weren't going through a dose-titration phase - and so at best one could argue that dipyrone is effective when added to fixed-dose morphine. A hypothesis-generating aspect of the study, though, was that those patients who received the NSAID initially, even after it was switched to placebo, had a sustained analgesic reponse from it (they continued to do better than those who were started on dipyrone at 48 hours). I'm often reluctant to use NSAIDs for many cancer patients due to comorbidity and bleeding risk (especially those who are or who will soon be undergoing chemotherapy or procedures): this study raises the possibility that it might benefit patients to give them short-term NSAID therapy along with the opioid.

(Thanks to Dr. Sean Marks who presented this paper at our group's journal club.)

And finally, in line with #2 above, Annals of Internal Medicine's recent clinical update in critical care medicine gives space to end-of-life care (it reviews this article). So hooray.

Sunday, September 23, 2007 by Drew Rosielle MD ·

Thursday, September 20, 2007

Vatican & tube feeding; More on Abigail; Nausea review in JAMA

I apologize for the scarcity of posts this last week. It sort of feels like 'school's back in session' here and things have gone nuts. I'm going to quickly post a few things here and hopefully will get to some more on the weekend.

A NY Times blog recently posted about the Vatican's new statement on tube feeding for people in persistent vegetative states:

“A patient in a ‘permanent vegetative state’ is a person with fundamental human dignity and must, therefore, receive ordinary and proportionate care which includes, in principle, the administration of water and food even by artificial means.”

My question is since we're all people with fundamental human dignity shouldn't we all then 'receive...water and food even by artificial means." Even if we're not in a PVS and don't want it? Because if someone in a PVS has to get it then surely we all do? For example - if we have an inoperable malignant bowel obstruction and don't want our dying process prolonged artificially do we have to still (if we are to abide the Vatican's statement) receive TPN? (Assuming we are one of the few percent of patients whose lives are likely to be prolonged by TPN in this case.)

(Thanks to Dr. Paul McIntyre for letting me know about this.)
(NY Times articles are now free, all free, all the way back to 1987!)

BMJ recently published a 'head to head' about whether terminally ill patients should have the right to experimental drugs? (Yes here; no here.) This is prompted by the Abigail ruling which we've blogged about a few times before (posts here): basically it's about a group's attempt to give terminally ill patients the right to experiemental drugs (ones that have passed phase I testing). Note: this is not about allowing them access to the drugs but a right to them. From the 'Pro' position:

"In summary, patients with advanced cancer and limited life expectancy should have the same privilege as all individuals in a free society—that is, to decide their own benefit:risk ratio. It is tragic that regulatory bodies have created a circumstance where people have to live in an aura of hopelessness even though they have the will, the resources, and the ability to expose themselves to the risk of participating in investigational studies and to enjoy the potential for benefit. The solution is legislation or judicial action to permit expanded access to experimental treatments for patients with limited life expectancy."

A couple things about this statement. First, note what they are actually arguing for is to 'permit expanded access' to these treatments. Liberalizing the rules about compassionate use of experimental cancer therapies is, in fact, a much different concept than giving people a
positive right to them which is what the Abigail decision was about. The first statement - about patients deciding their their own risk:benefit ratio - also strikes me as a difficult one to swallow. Why not then let all patients decide on the risk:benefit ratio of all drugs and do away with the FDA, pharmacies, prescription drugs, and physicians altogether? After all, individuals in a free society should be able to read about the drugs themselves and make well informed decisions about using them, right, so why have all these intermediaries? And finally the statement about letting people live with an 'aura of hopelessness' by denying them the right to demand taking substances with unknown benefits/toxicities seems absurd. It is our obligation, as physicians, to provide the best medical care we can for patients - that's rooted in science, likely to help them more than harm them, and takes into account the patient's values and goals. We are not charged with the task of stamping out 'auras of hopelessness' or giving our patients everything they ask for like they're medical consumers...

(Annas' review of the matter in the NEJM is the best thing yet written about this.)

JAMA is continuing their 'perspectives on care at the close of life' series with one on nausea and vomiting. It's a good review of the subject, and focuses particularly on nausea/vomiting in advanced cancer patients. It also gives what is probably the first mention of the widely-used, and controversial, ABHR gel in a major general medical journal:

"The ABHR suppository, a combination preparation of lorazepam (Ativan), diphenhydramine (Benadryl), haloperidol (Haldol), and metoclopramide (Reglan), is often used for home hospice patients, although there are no data to support its benefit. It is well tolerated, but, in our experience, exerts its effect mainly through sedation."

While I'm no proponent of ABHR gel (I'm agnostic about it despite the number of times trusted hospice nurses have sworn to me it is effective), it's unclear to me how something can be both well tolerated and effective mainly through sedation. Anyway, given its widespread use it would be interesting to see an efficacy trial of ABHR but who's going to fund that?

(Thanks to Dr. JP Pinzon for the heads up about the article.)
(The same issue has a follow-up to the perspectives piece about ALS.)

Thursday, September 20, 2007 by Drew Rosielle MD ·

Friday, September 14, 2007

Spirituality Neglected in Palliative Care; The Good Works of AAHPM

1) Spirituality Neglected in Palliative Care

Howard Spiro, MD at the Yale Journal for Humanities in Medicine recently chided a Hastings Center report (Feb 2007) as an example where:

"...there was, as sadly usual, little consideration that what practicing physicians know provides a penumbra around the process of dying, and that is our inherited culture of religion and spirituality."
I am not quite clear as to the meaning of this sentence. As I read it, Dr. Spiro highlights that when doctors talk about end-of-life issues, they frequently ignore the spiritual/religious side of the equation. This was clarified by a later statement:
"...the problem with exhortations about end-of-life care, that they too often ignore the spiritual baggage that we all bring with us. "
What I found surprising about this was the amount to which palliative care aims to highlight the spiritual/religious side of a person in considering them as a whole person. A great example is the recent JAMA article by Sulmasy, Spiritual Issues in the Care of Dying Patients. Maybe it is not solely the role of the physician, given most of us work closely with chaplains, but most training for palliative care practitioners usually encourages basic spiritual assessments and helpful ways to discuss spiritual issues in patient care. It may be that Dr. Spiro was talking about medicine in general and not palliative medicine, but I find the claims to be unsupported by my experience with many practitioners in this field. Despite this critique, he has written a book titled "The Power of Hope," which from reading the synopsis, seems to suggest an approach to patients in line with a palliative care philosophy. By the way if you have not read the Yale Journal for Humanities in Medicine, check out some of the other offerings.

Also on the spiritulaity note, another study was done studing the effect of spirituality and religion on acute myocardial infarctions. The study essentially found no significant conclusion as far as effect., but there are some interesting points to discuss. I am getting ready to leave for Yosemite to climb Half Dome (not up the face), so I will write some commentary on this article, sometime next week.

2) A couple of notes about the AAHPM:

A) The AAHPM has opened up the call for submissions for the Case Conference. Now many of you reading this may be thinking., "I thought there were only two calls?" Well this is a niche call but an important one that our field should support. Basically this call is for clinical cases to be presented by trainees across all disciplines (MD, DO, SW, RN, PharmD, Chap, etc). It gives our junior members a chance to present at a national meeting, hopefully encouraging them to become leaders in our field and continue the great work that has been done before them. The reason this late call was created was to allow those in one-year training programs (that usually start July 1) a chance to present in the year they were training. Without this call in the autumn, trainees would miss the opportunity to submit and present a case.

Now in the past, these sessions have been sparsely attended. Maybe it was slotted against a heavyweight presenter, or probably because no one was sure what it was really about because the title may have made you think, 'Oh that's for trainees, not me.' But the cases have been good, really good, and the people who have gone have given great feedback. And you get time for great discussions and to test the trainees and make them show that they know their stuff.

So if you have never gone before, then plan on going to this 'hidden gem' of the AAHPM.

If you have gone or presented before, please feel free to leave a comment to let others know I am not making this up. If you know someone in training in any discipline, make sure they submit a case, so we can make sure the cases are the cream of the crop.

The call is open until October 24, 2007.

Disclaimer: I am heading up the session and selecting the cases with other faculty.

B) The AAHPM has a call for tools and instruments for use in fellowship programs. Laura Morrison, my good friend in Texas, is heading this up. So if you have anything to help other fellowship programs, please submit it to her.

C) A program just started with the AAHPM and the National Palliative Care Research Center (led by Dr. R. Sean Morrison) to fund junior faculty and pilot research projects for one or two years. If you have the facilities and means to get one of these off the ground, please submit a proposal to them. The deadline is November 1, 2007, so get cracking!

3) And a quick blogosphere side note...

Death Maiden posted a link to a site about figuring out the time of death if you were not present. As a interested scholar in prognostication this is the flip side of prognosis. Taking data in front of you and figuring out the past not the future. It is basically temperature based. Not sure it would be of much help to palliative care folks but it may help a home nurse out in the field some day or be useful fodder for a presentation for someone.

Photo from user Wylie Maercklein

Friday, September 14, 2007 by Christian Sinclair ·

Tuesday, September 11, 2007

The media looks at the other side of the (opioid) coin; International Pain, Part 2

Most television news is forgettable for one reason or another. A recent broadcast on MSN (is that television? looks & sounds like it, but it's on my computer screen. I can't tell the difference). The title of the 2-minute report, "Pros, cons of narcotics" is not promising, but 'narcotic' is not used again; remarkably, 'opioid' replaces it. The intro acknowledges that most reporting on prescription pain drugs is about crime or abuse, but opioids actually benefit "a lot" of people. Hydrocodone is the featured opioid. One of the people featured has persistent pain from a back injury. Opioids (and other drugs) alleviate the pain enough for him to get through the day (the point: opioids aren't just for cancer pain). The final words of the piece: " . . . no one doubts the value of hydrocodone and other opioids for critical pain relief." This is a wildly optimistic and misleading statement, but it is a tiny, tiny hint of a step toward rebalancing reportage and normalizing the use of opioids for pain.

Yesterday Christian blogged on an article in the New york Times on the horrific state of end-of-life pain management in the poorest countries. The second of the two-article series, in today's Times, highlights the situation in India. In a bow to the adage "Better to light a single candle than to curse the darkness," Dr. M.R. Rajagopal has established a hospice, Pallium India, and trained other doctors in the use of morphine in tiny Kerala State . His program is an anomaly in this huge, rapidly advancing but still poor and largely rural country. The opium poppy is an important cash crop, but almost exclusively for export. Some cancer centers do not stock morphine. Government regulations are arcane and suffocating. Another bright spot: the Health Minister recently got Parliament to approve the national cancer plan's palliative care budget.

Both articles in this series cited a major barrier to increased morphine use for end-of-life pain: the belief that "morphine inevitably addicts and kills." The author states that these notions have "long faded in the West." Would that it were so. These beliefs are still strongly held by lay people and clinicians alike. Yes, they have "faded," but they are still present and still interfering with appropriate care.

Both NYT articles also highlighted legal and regulatory issues, and mentioned the Pain and Policy Studies Group at the University of Wisconsin, Madison. PPSG is working with individual countries, including India, and the WHO to make opioid analgesics more accessible. In July the PPSG issued it's latest federal and state-by-state report cards on legal and regulatory barriers to balanced prescribing of opioids. Last week I mentioned the new Washington State opioid dosing guidelines as being a barrier to adequate pain management. Yet our most restrictive laws and regulations would be a major improvement in many of the poorest countries of the world.

Before someone out there blasts me for defending the status quo in this country or for saying "Buck up, you don't have it so bad," I'm doing nothing of the sort. We have a long way to go in this country to heal our attitudes and laws, to start treating patients in pain with compassion and good medicine rather than suspicion and disdain. We also need to be sensitive, as human beings, to the dramatic disparities in health care that exist on many levels. This is one of them.

Tuesday, September 11, 2007 by Thomas Quinn, APRN ·

Monday, September 10, 2007

International Pain Crisis; Surgeons Hip to Palliative Care

1) The NY Times highlights the difficulties in controlling pain (especially at the end-of-life) around the world. We have posted here at Pallimed before about international palliative care efforts and discrepancies (one, two, three, four posts). The article is well done with enough of the human side but still imparting the facts that show how poorly we as a international community are handling this. Some of the main fears about opioids (opiophobia) in the US seem to be amplified around the globe. If you take a cursory jaunt through the medical blogosphere you will find many physicians and pharmacists lamenting drug-seekers, pill-poppers, and addicts that come into their clinics, pharmacies and ER's. But this constant howl of the frustration of the dealing with this small population unknowingly reinforces the stereotype that these medications make addicts. The public hears this, the trainees hear this, and pain gets undertreated, unless it is 'cancer pain' (see previous post & comments about this fallacy).

The key stat in the article from the International Narcotics Control Board:

6 countries
(US, Canada, France, Germany, UK, Australia)
consume 79% of the world's morphine.

80% of the world's population
(poor/middle income countries)
get around 6%

Now some will look at the imbalance and conclude those 6 countries use too much, i.e., "A-ha! It is because of all those people who are coming into my ER and asking for hydrocodone." Alas, it is not that simple. Many international countries have laws that may allow for opioids to be utilized, but there are restrictions to location or amount, or these are laws in writing only but not in practice.

The article even paints a line between suffering in pain and utilizing suicide to avoid further suffering, which I think most people would say is inexcusable. Especially inexcusable because of lack of access to cheap, effective medications, often the same argument made for treating HIV, or preventable infections (vaccines). I am really impressed that they also highlight pediatric issues, since not many people in industrialized countries experience/think about children in pain or dying.

Although all kudos aside for the article, they do misuse the word narcotics when they intend to say opioids. I have said it before and I will say it again, 'Narcotics' is a primarily a law enforcement term, 'opioids' are a class of medications. Opioids can be enforced as narcotic medications, but not all narcotics are opioids (i.e. cocaine, which as a narcotic does not make you sleepy).

There is an accompanying article about Japan and pain meds and a slide show that is quite moving as well.

Thanks to Pam H for the tip!

The City of Hope surgeons Podnos and Wagman have a great article about palliative care and surgeons in the recent Annals of Surgical Oncology (free pdf!). While most people in palliative care do not have surgical backgrounds, the ABMS and the American Board of Surgery recognize surgeons can be good palliative care doctors. This article reviews the frequency with which surgeons are already good palliativists, and builds on that. As an internist by training, I confess to being biased in considering how surgeons view medical problems, as evidenced by the mantra, "a chance to cut is a chance to cure." This article is written by surgeons and for surgeons which is the best way to make change occur. I was also introduced the Palliative Surgery Outcomes Score:

# of non-hospitalized days without symptoms /
number of hospitalized days (up to 180)

This score is relatively simple to conceptualize, but how to measure it accurately is more difficult. (Did you have 45 or 47 days of nausea in the last 180 days?) Obviously it would have to be kept prospectively for any accuracy. Since the article is free, feel free to pass it around the next time you get invited to the Surgery or Trauma ICU, and see what kind of response you get.

Monday, September 10, 2007 by Christian Sinclair ·

Saturday, September 8, 2007

Implantable devices; Statistics; Korean-Americans & dying; & More...

I am traveling for the next week so I'm going to quickly clear out my backlog before I go. I probably won't post again until the middle of the month.

Journal of Medical Ethics has a few articles about implantable cardioverter-defribrillators. First is a discussion arguing that ICD's are neither regular 'medical devices' or treatments, nor are they parts of one's body (as would be a transplanted kidney) but are instead in a unique category: an integral device.

"We submit that a better model is to consider ICDs as integral devices, representing a middle ground between medical device and part of the body. By defining the technology in this way, it is possible to escape the restrictions of the treatment/non-treatment dichotomy, which is not apt to cover ICDs. An integral device, though not organic, is part of the patient. We suggest that where technology has been integrated into the physical being, a patient should retain stronger autonomy than he does with external mechanical devices. Interfering with it unilaterally should not be justified on grounds of benevolent paternalism. Nonetheless, an integral device is not truly a part of the body. Thus, deactivation should be permitted in some circumstances. Furthermore, a patient should have the right to demand that his ICD be disabled, even against medical advice, just as he would have the right to refuse external defibrillation in advance."

A lot of the argument focuses on the idea that a 'regular' medical treatment (like a drug or external device) can be unilaterally discontinued by a physician even against patient's wishes (based on 'benevolent paternalism') and that this is inappropriate for an ICD. Insofar as I agree that a physician shouldn't wrestle a patient to the ground to deactivate their ICD against their wishes this seems reasonable. However the the absurdly low probability of that ever happening makes me suspect that the need to have a new 'ethical category' of treatment just to accomodate it. Medical care/decisions don't happen that way and when they do they are obvious breaches of proper conduct and decision making (i.e. we don't need to make new categories to illuminate why it is improper).

There is a general editorial supporting the rights of patients & physicians to turn off ICDs, which is more in the ICDs=regular medical therapy camp.

Last there's a Swedish study about patient participation in decision making about receiving an ICD: there was no decision-making - the patients were told they needed one so they assented. Discussions about prognosis, magnitude of expected benefit, etc. were absent.

Journal of the American Geriatrics Society has a few notable papers.

First is a look at symptoms of dying long-term care patients. It's based on after-death surveys of family members and caregivers (not the most reliable sources of symptom information to be sure) and found pain, dyspnea, problems with cleanliness were all major symptom concerns, and not well treated.

Next is a trial looking at maintenance therapy (with drugs or psychotherapy) for depressed elderly patients who had already responded to short term drug & psychotherapy (16 weeks). These patients were randomized to receive paroxetine, psychotherapy, both, or neither for a year. Briefly, those who received drug therapy did better - health related quality of life was maintained than those who didn't receive drug therapy suggesting it makes sense to keep this popualtion on SSRI's for a least a year.

Finally there's a qualitative study about Korean-American's knowledge of/attitudes towards end of life care, which involved focus group discussions with elderly Korean-Americans and their caregivers (mostly adult children). Filial piety, family (not patient)-as-decision-maker, communication about end of life care/wishes, misconceptions about hospice care, etc. are all discussed. A good read.

Gerontologist has a well-written book review about a couple books on dying in America.

& if you're wondering what the 'Statistics' reference is in this post's title, it was to the recent JAMA article about medical resident's understanding of medical statistics. It is generally poor, and I had composed many-a-wise sentence about this & EBM & what journal editors should do to make sure statistics used in medical papers are presented in ways that clinicians can use, etc. However Christian let me know that Blogger corrupted my post, destroying most of my text, rendering it unintelligible. Sorry about this; I'm traveling and not up to re-composing anything so we'll leave it at that.

Saturday, September 8, 2007 by Drew Rosielle MD ·

Wednesday, September 5, 2007

When is cancer pain not cancer pain?

This question is generated by two recent articles, the new Washington State opioid-prescribing guidelines, and a statement attributed to Kathy Foley in her presentation at the NIH conference on pain and addictions in March: “Distinctions that we make about cancer pain and noncancer pain are rather arbitrary. Opiate receptors don’t know if a patient has cancer or doesn’t have cancer.” (Seen in a hard copy-only publication called PainReporter underwritten by Alpharma)

It has been common in the past to distinguish cancer (or “malignant”) pain from “benign” (as if there were such a thing) chronic pain. That paradigm, always suspect, is now becoming obsolete as a growing number of people survive cancer but with a significant burden of pain. Burton et al provide an excellent overview of the problem of pain in cancer survivors, pointing out both prevention and treatment strategies, including borrowing from the noncancer pain experience.

Jane Ballantyne has a thoughtful article (which is therefore sure to generate controversy) on the need to re-think treatment of chronic cancer-related pain, now that cancer is becoming a chronic condition with the potential for long-term survival for an increasing number of patients. She reviews the history of cancer pain treatment with opioids, recalling the difficulty pain management advocates had 20+ years ago trying to convince clinicians and patients alike that use of opioids is an important and low-risk intervention for severe pain. (The sometimes non-so-subtle message sometimes became “they’re going to die anyway, so why worry about addiction?”) Well, maybe now we do need to worry, says Ballantyne, who advocates using the same risk-reduction practices with cancer survivors as are suggested for people with chronic noncancer pain. Strikes me as very reasonable. I take issue with a point she makes a couple of times: that chronic exposure to opioids produces “inevitable” changes in the brain which have been associated with addictive behaviors. She is undoubtedly better versed in that science than I am, but I don’t see the same inevitability that she does. Certainly the changes in the brain, if universal, are insufficient to “cause” addiction, which is manifested by a collection of behaviors which are relatively rare.

Ballantyne and other responsible commentators point out that no one knows the incidence of addiction among people with chronic pain of any etiology (because no one has done that study and published estimates are often based on pain clinic populations, hardly a representative sample of the universe of people with persistent pain), that the risk is low for an individual without multiple risk factors, and that simple exposure to an opioid does not “cause” addiction.

I should point out that Ballantyne distiguishes between a palliative care model for patients with progressive and especially end-stage disease, and those with pain but a prolonged prognosis. She expresses concern that a shifting pradigm for cancer pain management has the potential to victimize patients with end-stage disease who may need aggressive pain treatment with opioids.

By the way, this entire issue of Current Pain & Headache Reports is devoted to cancer pain.

The Washington State Guidelines have generated controversy for suggesting a ceiling of 120 mg of morphine per day for people with chronic noncancer-related pain. A referral to a pain specialist (undefined definition, but only 11 listed for the entire state) is recommended for patients needing more than 120 mg/day. Long-term cancer survivors (undefined) with chronic pain would be included under the treatment guidelines. The American Pain Society has cited concern about the care of patients with cancer-related pain under these guidelines.

A related topic (sort of—some people will relate them too closely) is the treatment of pain in end-stage disease in patients who have addictive illness. At this year’s AAHPM Ron Crossno gave a presentation about this. Among other things, he said something like: “If you haven’t seen any patients who are abusing some substance, it’s because you’re not paying attention.” Steve Passik and colleagues have a couple of articles (here and here) and Passik & Russ Portenoy have a book chapter on this topic (2nd edition of Principles and Practice of Palliative Care and Supportive Oncology; I don't think it carried over to the 3rd ed.).

Wednesday, September 5, 2007 by Thomas Quinn, APRN ·

Monday, September 3, 2007

Hypercalemia of malignancy; Palliative care for prisoners

Happy Labor Day.

Supportive Care in Cancer has an article about the natural history of hypercalcemia of malignancy in the age of bisphosphonates. The patients were 260 consecutive patients presenting to a cancer center in France with solid tumors, no prior history of hypercalemia, and who received bisphosphonate therapy. Median corrected calcium levels were 2.83 mmol/L (~11.32 mg/dL) and half the patients had either head & neck or breast cancer. Median survival was 60 days across the cohort. The authors looked at patient characteristics associated with worse prognosis and the following ones survived multivariate analysis: corrected calcium over 2.83, hypoalbuminemia (<3.5 g/dL), squamous-cell histology, bone mets, and liver mets. Of note, women lived twice as long as men (94 vs 45 days), and one wonders if this was due to a preponderance of breast cancer in these patients, although this sex difference didn't survive multivariate analysis and survival based on underlying prognosis was not broken out.

This is an interesting article for a couple of reasons. Various sources have quoted for years that prognosis in the setting of hypercalemia of malignancy is dismal, but the last time I did a literature review on this it seemed that most of the studies (and there are only a few) were old (1980's, early 1990's), had relatively small N's, and were done prior to the use of bisphosphonates. So this recent data (which is, to be sure, from a single institution, although it does have a decent N for this type of study) is an important addition and, unfortunately, demonstrates that prognosis remains dismal for these patients, despite the availability of bisphosphonates.

2) JAMA continues their 'perspectives on care at the close of life' series with one on palliative care for prison inmates. It's a general overview, and well written. This is a topic I really have known nothing about and found it quite interesting. There are many differences in care between the civilian and prison worlds although, as the following he said/she said suggests, some things are exactly the same:

"DR V:
Mr L gets MS Contin, I believe 90 mg every 8 hours. He can have Vicodin at pill call for breakthrough pain. . . . When I ask him about pain, he says it's fine. I have no reason to doubt him.

MR L: [The pain] gets pretty out of hand sometimes. . . . If you can catch the right nurse or the right doctor, they can situate you where they can help you some. If you were to gauge my pain on a scale of 1 to 10 right now, it would be about 8.5. I’ve learned to deal with that kind of pain. I don't want to be totally out of pain because then I won't know what I'm really going through."

Monday, September 3, 2007 by Drew Rosielle MD ·