Methadone on Methadone

Journal of Opioid Management has a tidy paper about using methadone as an analgesic for patients on methadone maintenance therapy (for heroin addiction).

The data come from a retrospective chart analysis of 53 HIV+ adults on methadone maintenance therapy who were treated in an HIV pain clinic over at least a year. (Note they only included patients who were seen in the clinic for a year, which likely pre-selects 'success' patients.) All patients were in a methadone maintenance program, and had additional analgesic doses of methadone added by the pain clinic (maintenance doses were kept the same). Patient's analgesia methadone was adjusted per routine practice at the clinic. About 44% of patients were being treated for painful peripheral neuropathies.

The mean maintenance dose was 100 mg a day. The mean starting analgesia dose of methadone that the clinic providers prescribed was 60 mg a day (divided per clinic practice tid or qid). At the end of 12 months the mean analgesia dose was ~200 mg a day. Mean pain score at the time of analgesia methadone initiation was 9/10 and was ~5/10 at 1 month and ~4/10 at 12 months (patients were also receiving other analgesics and adjuvants per routine clinic practice). The clinic did routine urine toxicology screens and about a quarter were positive for heroin (13% for heroin alone & 13% for heroin and cocaine) at 12 months (interesting; difficult to interpret without knowing what is expected/routine in MMPs). Side effects were generally acceptable.

This is by far the largest study that I know of about this topic, and while it is uncontrolled data it is still helpful in a few ways.

1. Studies like this are sort of 'proof of principle' studies which underlie the idea that this practice can be done safely and effectively. Of course the patients were receiving other non-opioid analgesics, no controls, etc. etc. However, it suggests that in at least ideal circumstances (a presumably well put together pain clinic with competent providers) adding additional methadone as an analgesic to a patient's maintenance dose can be done safely and is (...at the very least part of a treatment plan that is...) effective.
2. So assuming that's helpful information this sort of data also gives those of us who sometimes do this some useful information about doses etc. This group used starting doses generally ~2/3 of the maintenance dose, and frequently titrated up slowly to doses over double the maintenance dose, seemingly with good outcomes.
3. The authors note that in their experience patients without addiction problems routinely need methadone doses lower than these patients maintenance doses (ie less than 100 mg a day). Many of these MMP patients ended up on 300 mg a day of methadone in this program, giving further support to the widespread clinical observation that patients with addiction problems/histories generally require higher doses than those without.
   

FDA on APAP & Propoxyphene

1.
An FDA advisory committee has recommended restricting acetaminophen on a variety of fronts (WebMD story here). Read the story, which is brief, for the details. Remember this is a committee recommendation, not FDA policy yet. Major points are:

• All this seems to be based in the context of the reality of too-many APAP associated inadvertant overdoses leading to liver failure.
• The committee recommending reducing the 4 gram/day max dose for adults, as well as limiting the maximum one-time dose to 650 mg.
• They also recommended discontinuing all (yes, apparently all) combination products containing APAP. The news article discusses mostly opioid combinations, and it's unclear if non-prescription combination products are targeted as well (e.g. cough/cold remedies, etc.). The basic idea, and probably most of us have seen cases like this, is that patients may inadvertantly overdose on acetaminophen if they are in a lot of pain and take more than prescribed.

Part of me thinks this is reasonable; I've pulled back for a while now on prescribing 4 grams a day of APAP. The suspicious/paranoid part of me worries this is a back-door stragegy to restrict access to opioids.

2.

The FDA has also put a 'black box' warning on propoxyphene products, as opposed to banning them outright as had been considered earlier.

CPR in Older Patients

The New England Journal of Medicine reports an epidemiologic study of in-hospital CPR in older patients (65 years of age and older). The study identified over 430,000 Medicare beneficiaries who underwent in-hospital CPR between 1992-2005 to answer the question of whether survival rates of in-hospital CPR have improved over that time. They also attempt to determine which patient and hospital characteristics might predict survival.

The rate of survival after CPR hasn't changed much in the time period examined with 18.3% of all CPR recipients surviving to hospital discharge (similar to other studies). Lower survival was significantly associated with male gender (OR 0.97), age (with progressive decline in survival as patients age), Deyo-Charlson score of chronic disease burden, admission from a skilled nursing facility (OR 0.60), and race (black OR of 0.70 and other non-white races OR of 0.85).

Non-metropolitan hospitals had better survival rates, perhaps because sicker patients were referred to metropolitan facilities before they required CPR. Neither the number of hospital beds nor teaching hospital status seemed to make a difference in survival.

Overall, there were 2.73 CPR events per every 1000 admissions. This increased slightly over the period of time investigated (a timeframe which also coincides with the introduction of hospital based palliative care in the United States). Over time, the number of hospital deaths that were preceded by CPR increased from 3.9% in 1992 to 5.2% in 2005.

Neither neurologic outcomes nor quality of life data were reported for survivors. I wonder if it's possible to use rough surrogates for these outcomes such as the ICD-9 code for anoxic brain injury and CPT codes for PEG tube and tracheostomy, but that wasn't done. Furthermore, it would helpful to have 6 month or one year mortality data. The study is already chock full of all sorts of data, so perhaps I'm asking for too much or maybe some of this data will be released later.

Over time, fewer patients are being discharged home after CPR with more going to another hospital (long term acute care hospitals, likely), SNFs, or inpatient hospice. As the authors note, rather than necessarily representing poorer outcomes, this likely represents the fact that patients are being discharged quicker and sicker to other places besides home, although they don't report the hospital length of stay for patients in 1992 vs. 2005.

Some thoughts on the various factors examined:

1. Age: The percentage of patients receiving CPR increased from 14.6% in the 65-69 year old group to 22.6% in the 75-79 year old group and then decreased to 7.9% in the nonagenarian group. Survival to discharge in those three groups was 22%, 19%, and 12% respectively. The 12% survival rate in the nonagenarian group seems amazing but likely represents a selection bias, as one could envision the 8% in this group who underwent CPR being the most robust physiologically for their age group.


2. Patients Admitted from Skilled Nursing Facility: While this only represented 2.5% of patients, this is a major risk factor for mortality after CPR. Any patient that returns from a skilled nursing facility to the hospital should have a full exploration of their goals of care, regardless of code status. I wonder how these dismal outcomes compare to being admitted from an intermediate care facility in this population, but alas Medicare doesn't pay for that, so probably doesn't track it.


3. Chronic Disease Burden (using Deyo-Charlson score): Between a score of 0,1, and 2, survival to hospital discharge didn't vary much (around 19% in each group), but then for those with a score greater than 3 it went down to 16.1%. The greater than 3 crowd is probably quite heterogeneous in their survival rate, and it would be curious to parse this out a bit more.


4. Race: In this study, blacks survived to hospital discharge 14.3 % of the time compared to 15.9% of other non-whites and 19.2% of whites. Of hospital deaths amongst black patients, 6.6% were preceded by episode of CPR compared to 3.9% of white patients and this incidence has increased significantly since 1992. In the multivariate analysis, they adjusted for hospital location where blacks were more likely to be admitted and this only improved survival slightly. The authors suggest several possibilities for the lower survival in blacks and other non-whites, including concern about quality of care before, during, and after CPR. They cite research which suggests resuscitation and defibrillation might be delayed in blacks leading to a more malignant rhythm at time of CPR. It's also known that blacks are less likely to elect a DNR order, and they suggest this may play a role. Another disparity factor that was not mentioned in their discussion could be the lower rates of end-of-life discussions occuring between black patients and their healthcare providers (as evidenced by a recent study from JAGS in a nursing facility setting).

The authors lament the lack of improvement in CPR outcomes over time and wonder whether it's because we haven't gotten any better at ACLS in the hospital or if we really have but there's a confounder present that makes it look like we haven't. They ponder whether the nature of acute illness has changed towards illnesses that respond less favorably to CPR. Other confounders could include an increase in age and chronic comorbidity level amongst those receiving CPR, but the change in these over time was not reported.

The authors reach one conclusion that will be no surprise to most Pallimed readers:

Of significant concern is our finding that the proportion of patients who died in the hospital after having previously undergone in-hospital CPR has increased during a time of more education and awareness about the limits of CPR in patients with advanced chronic illness and life-threatening acute disease.

As Drew has noted here and here, we still have a long way to go in educating people about CPR and outcomes.

In 1992, the 65-90 year old population was born between 1902 and 1927 whereas in 2005, this cohort was born between 1915 and 1940. There could be a cohort effect going on here, as well, as the earlier cohort was all born well before doctors could routinely save lives with wonder drugs like penicillin, whereas those born in the 1930's were mere babes when the first case report of a penicillin pulling someone back from the brink was published. (Drew pondered the possibility of this type of cohort effect in Ireland as described here.)

Perhaps the advent of hospital based palliative care in the United States has artificially suppressed an increase in non-beneficial CPR in American hospitals? Hard to say- unless you do an analysis of hospitals who had palliative care teams for most of the timeframe vs. those that don't have them to see if the same trends are present (although, once again, one could anticipate many confounders). If not, we can still hope to stem the tide in the future.

Since some elderly patients DO survive CPR with good neurologic outcomes, I'll continue to hope for more research that helps identify those that will benefit most from it so that we can be more selective in our application of resuscitation measures. And it's probably appropriate that a certain percentage of deaths are preceded by unsuccessful CPR, but is 5.2% the right number? Unless we can come up with some new-fangled bedside instant analyzer that tells us prognosis right before we start compressions, it will remain a crapshoot and we can just hope to avoid CPR in those patients where CPR is certain not to meet their goals.

What To Do The Next Time Dad's Heart Stops

Richard Knox is an NPR science reporter who wrote a compelling account of the challenging end-of-life decisions he and his family faced when his father died. I read the first several paragraphs before I looked at the top of the article where it mentions that this piece was originally published in 1989 in the Boston Globe. Twenty years later, the story retains its relevance to the national end-of-life conversation and serves as a nice supplement to the study about CPR outcomes mentioned above.

Richard's father, Albert Knox, was 78 year old who had a history of emphysema (not oxygen dependent) and local prostate cancer for which he'd been undergoing definitive radiotherapy in an attempt to cure it. Richard receives a call one weekend from his stepmother telling him that his father's kidneys and liver are failing and that the doctors suspect his prostate cancer has metastasized but a CT scan isn't available until Monday. Richard tells his stepmother to have the doctors "do whatever is necessary" until they find out what's going on. He then strikes to the heart of the matter:

Behind the emotional turmoil, I make a mental note: In Florida, where death seems as much a part of the environment as mildew, doctors and nurses seem to expect families of terminally ill patients to "let them go" rather than fight. I have no quarrel with that. The issue for us is: What is "terminal"? And when?

Step 1a and 1b in helping a patient and his family with end-of-life decisions should be to develop as much diagnostic and prognostic certainty as you possibly can (easier said than done in many cases). As it turns out, the CT scan doesn't reveal cancer, and Richard concludes that his father still has no "terminal" diagnosis. The physicians eventually conclude that pyridium (which Mr. Knox used for dysuria after prostatectomy) was to blame for his renal and/or hepatic failure. Over the coming weeks, his multisystem organ failure progresses, he develops DIC, respiratory failure, an arrhythmia, coma, ischemic toes, and undergoes successful CPR not once but THREE times.

The course is also complicated by a number of diagnostic, prognostic, and therapeutic dilemmas/misjudgment, all presenting as communication snafus (although Richard seems to give most of the physicians the benefit of the doubt):

• A nephrologist offers "a spot" of dialysis, to which Richard agrees, but then 10 minutes later she calls back and tells him that it would be too risky because of the bleeding risk.
• The hospital's only cardiologist wants Mr. Knox transferred to Orlando for more extensive electrophysiological testing, but then after the admitting physician and Orlando cardiologist reach a consensus that this transfer would be too risky, the local cardiologist childishly dismisses himself from the case (abandoning the patient). He invites himself back onto the case later after a 90 minute conversation with Richard one evening (about God knows what?).
• A neurologist mistakenly concludes that Mr. Knox is in a persistent vegetative state at one point.

Eventually, after the last resuscitation, the nephrologist recommends a DNR, but the cardiologist intervenes and recommends a "partial code," wanting to do CPR and defibrillation if necessary without intubation (an approach that's rarely successful in this type of circumstance). Richard leans towards the "semicode" approach as it's presented to him. But finally, we get some much needed information that hints at Mr. Knox's "goals of care" (it's almost like this was deliberately not mentioned until towards the end of the story because the doctors never asked about it). Richard describes his father as having "no patience with being a patient" at his age after a lifetime of "fierce independence" and imagines his reaction to the prospect of needing amputations for his gangrenous toes. The patient's wife, Tommie, lends some frank clarity:

"I know you have trouble seeing it from my point of view," Tommie says. "You're young. You have a lot of life ahead of you. But he's 78. He's had a good life and he'd be miserable if he couldn't be the man he was. He wouldn't understand. He wouldn't understand what has happened to him. You have to understand, Dick: I'll take him back in any condition and I'll give him the best care I can. I want him to survive! I love this man! I've loved him for 24 years! But I'm not going to do anything more to help him survive if he's going to be miserable - and Lord, would he be miserable! Is that clear?" It is. I know she's right and I assent. The "Do Not Resuscitate" order stands. But it will take me a couple of days to make my peace with the decision. And of course, the order may be moot. He may surprise us all again and survive.

I'll let you read the touching conclusion. It includes the patient having a period of lucidity. From the story, it's unclear whether any physicians spoke with Mr. Knox himself about the decisions at stake.

In these types of cases, patients cross a blurry line the patient's goals of care are unlikely to be met, regardless of interventions offered. Mr. Knox appeared to wish for a certain quality of life that was not likely to be achieved after a certain point in his case. When that line appears to have been crossed, aggressive, invasive interventions should not be provided. The challenge for providers (and families) is to know where each patient's "line" is and whether it has been permanently crossed. This requires providers to a) discuss early and often what the patient's goals of care are and b) adequately prognosticate what the patient's likely survival will be BUT ALSO what the likely quality of life will be in that survival.

There has been a lot of talk lately about the specter of Medicare "rationing" at the end of life. Most of it is framed in a negative manner (without a realization that Medicare already deliberately rations care intentionally and inadvertantly based on what is and isn't reimbursed). "Bedside rationing" (a physician withholding a beneficial intervention because of the cost to someone else besides the patient) is unethical. However, if you look at cases like this, there's a significant opportunity for providers to unintentionally ration care merely by identifying patient goals and stopping/withholding burdensome, expensive therapies that won't meet those goals. This is appropriate rationing that is patient-centered. That is one of the reasons why palliative care needs to be an integral part of healthcare reform.

In the article's sidebar is a description of the strengths and weaknesses of living wills. Most states' living will forms would have likely been inadequate to help with the decisions at stake in Mr. Knox's case because of the question of whether he was "terminally ill." They rightly suggest that naming a durable power of attorney is a better strategy to ensure your preferences are honored. However, even that strategy has weaknesses (surrogates may accurately predict patients' wishes in only about 2/3 of cases and this strategy still requires providers to communicate well with the DPOA).

Palliative sedation and shortened survival

Annals of Oncology has a paper trying to look at whether palliative sedation is associated with shorter survival. It's a prospective, multi-center, single-country (Italy) study which prospectively matched ~270 cases (cancer patients admitted to hospice units who received palliative sedation) with similar 'controls' (similar cancer patients admitted to the same hospice units during the same period). Controls were matched for gender, age class (less than 65 and greater than 65 years), reason for admission (psychosocial, uncontrolled symptoms, and terminal phase), and Karnofsky performance status (KPS) subdivided into three classes (10–20, 30–40, and 50 or more). Patients who received PS did so based on standard practice by their treating physicians; there was also no standardization of PS treatments.

As you'd expect by the design patients were well matched; even though not deliberately matched the two groups ended up having similar Palliative Prognostic Scores, and so should have had grossly similar survival.

They admit that there are a variety of practices which fall under the umbrella of 'PS' and as far as I can tell they included anyone in PS group who received anything which the treating physician labeled as 'PS.' Along those lines, only 25% are described as receiving 'continuous, deep' sedation (ie what historically was described as 'terminal sedation'). There is a confusing array of data presented (some patients receiving mild sedation, others intermittent, some continuous but not deep, a whole variety of meds involved including opioids, etc.).

About 80% of patients received PS for delirium/agitation, with the rest being dyspnea and pain (and 6% for psychological distress only). The survival curves of both groups were identical (median survival in the 10 day range). They did not present separate data for just the 'continuous/deep' sedation group (and their controls). Cessation of artificial nutrition or hydration was not measured.

Their conclusion (from the abstract): "PST does not shorten life when used to relieve refractory symptoms and does not need the doctrine of double effect to justify its use from an ethical point of view."

Some thoughts here.

1. While I may think their conclusion is correct, that's not because this study particularly supports it. Most of the debate about PS has been about 'continuous/deep' sedation/'terminal sedation': essentially deliberately inducing a pharmacologic coma (state of unresponsiveness), with the intention of maintaining that coma until death (usually, although not necessarily, accompanied by cessation of other life-sustaining medical treatments including artificial nutrition and hydration). Only a quarter of these patients, apparently, had this flavor of PS, and we aren't presented with a separate analysis of these patients. Without doing that this is like arguing that light, intermittent sedation doesn't hasten death but that's not really a burning clinical or ethical debate currently.

2. This is a group of patients with a median survival of ~10 days. Even though this is a relatively large study, unless any intervention had a major impact on mortality demonstrating a difference in survival is nearly impossible. If they had given all the PS patients 1gm of pentobarbitol and a bucket of succinylcholine and found that median survival in the 'active' group was 5 minutes vs. 10 days for the controls that'd be one thing but this is not. The real point here is imminently dying patients are imminently dying patients and we're never, ever going to show a mortality difference between PS and non-PS groups of those patients. This sort of study design would be the way to do it - a randomized controlled study trial could not happen for ethical reasons. You could fancy this study up with a more elaborate propensity score matching process, etc. but it'd be essentially be the same study design. It's not going to show any difference however.

3. Is there a real, significant ethical question to be answered about continuous/deep sedation given for intractable symptoms in otherwise imminently dying patients? And is it in fact an important question to even be asking/worrying about - the potential for shortened life? Assuming CDS-PS is used as a last resort (ie nothing else has worked adequately, leaving aside questions about what that might actually mean) it seems the available therapeutic scenarios we have are:

1. Staying the course: patient dies with uncontrolled suffering in ~10 days.
2. CDS-PS without any life-prolonging medical care: patient dies peacefully in 10 days and yes, perhaps it's possible they would have lived 11 days without CDS-PS, or hell maybe we could have made them even live longer like a 12 days or 3 weeks if we mechanically ventilated them, put them on pressors, threw in some CVVH, and even tried a little ECMO.
3. Actively hastening death: applying novel medical interventions with the intention of ending life/shortening life; patient dies in less than 10 days with, well, no more suffering subsequently.
   

My point in throwing about ECMO in #2 there is to point out that in imminently dying patients questions of life-prolongation are really very secondary/unimportant (ideally speaking). If CDS-PS was shown to, let's say, halve survival from 10 days to 5 days, I would hope that no one would care. If they did, I'd ask them why not then string patients along a few more days on the vent then if what is most important is scraping a few more days of organ perfusion out of a dying patient's life?

I should not be naive: there are of course plenty of people for whom the thought of potentially 'hastened death' (really it's 'not-prolonged death') via deliberating sedating patients or using meds with sedating side effects is troubling. Research like this can be reassuring which is a good thing. I'm arguing however is that what is 'really' needed is not reassurance that these practices probably don't influence survival but engaging with clinicians who have these concerns about the fundamental issue: that it's ok not to prolong dying, that a peaceful, comfortable death should be the preeminent treatment goal when someone is dying and we don't need to twist ourselves into ethical knots about it.

4. The real ethical question about CDS-PS is whether it is an appropriate option for patients who aren't imminently dying (and I'm not going to define exactly what I mean by that), including for patients who have intractable psychological and existential suffering. In these cases, CDS-PS is almost certainly life-shortening and the question is is that acceptable? How much 'life-shortening?' How much suffering? This is a question that can't be answered by research.

Hat tip to Lyle for his thoughtful comments about this post.

Palliative Care Grand Round July

Tim Cousounis at Palliative Care Success has posted the July edition of Palliative Care Grand Rounds. Go check it out and some of Tim's other posts for some insightful views on the future of palliative care organizations.

Pall-Pourri: Some reviews; Death in ALFs

1)
CA has a nice review, directed at oncologists, about discussing prognosis with cancer patients, with a particular focus on end of life care planning/hospice decisions/etc. Has a lot of practical language examples. Good one for the teaching file.

2)
Gerontologist has a qualitative study about hospice in the assisted living setting. It involves semi-structured interviews with ALF staff members and caregivers about death & hospice in ALFs. It thoughtfully discusses some of the barriers, particularly given that ALFs are designed for stable, somewhat independent individuals which does not describe most hospice patients, at least in the final weeks of life. I thought this section was quite notable:

Rather, if an ALF was committed to providing EOL care to a particular resident, the staff went far above and beyond the usual level of care provided to other residents or described in their policies. The ALFs provided much complex care such as assistance with all activities of daily living, increased monitoring of symptoms, rapid and frequent changes in medications, skin care, mouth care, and emotional support. Two factors, the length of time the resident had lived in the ALF and whether they were well liked by the staff, were consistently associated with whether the ALF would support the resident’s staying in the ALF as levels of care need increased. The more ALF staff knew the resident and liked them, the more likely they were to bend rules or go “ above and beyond ” in trying to facilitate dying in the ALF.

Which is admirable, and the right thing to do of course for those patients. However this is the problem: ideally one should not need to rely upon the good graces/dedication/love of your ALF staff in order to be able to stay in you ALF home until death. The way ALFs are structured/staffed now however this is the case and it puts many patients in a position of having to leave home to die. Of course many 'home-home' dwelling patients need to do that as well, and it's not the fault of ALFs that this is the case; they weren't designed for this. Anyway - the paper discusses all of this in detail.

3)
Chest has a review about pain management in ICUs, specifically in end of life settings. It's actually a much broader overview of death in the ICU, cultural issues, caregiver issues, etc. Not too specific about pain management itself, but worth a read for the larger issues it discusses. E.g.:

Although the relief of suffering for patients in the critical care setting is of prime importance, suffering experienced by their family members and those engaged in caregiving also deserve attention. Of 906 critical care nurses surveyed about their experiences with ICU patients at end of life, 78% thought that dying ICU patients frequently (31%) or sometimes (47%) received inadequate pain medicine. Nurses who understood the principle of double effect (98% of 906 surveyed) agreed that administering analgesics to decrease patient pain, even though there might be an unintended consequence of hastening death, is an ethical way to treat a dying patient. Yet other nurses have identified lack of adequate pain relief for their patients as one obstacle to providing good end-of-life care,and they believe that effective symptom control is a prerequisite for a dignified death. When nurses provide care that does not relieve their patient's suffering or when they follow orders for pain medication even when the medications prescribed do not control the patient's pain, they are at high risk for suffering moral distress. ICU nurses can be prepared with the knowledge and skills to make decisions about patients' analgesic needs and be provided guidelines or protocols that will assist them in making analgesic treatment decisions. If they are provided the time necessary to titrate analgesics according to the patient's response by being relieved of some of their other responsibilities during this period, their contributions to patient comfort may increase while their vicarious suffering decreases.

Pallimed's 4th Anniversary

Christian gently reminded me, albeit a few weeks late, that we missed our 4th anniversary (June 8th). So I thought that I'd note it anyway.

I continue to be amazed by the reception of the blog, and the support, humor, and wisdom of our readers (& their comments) over the years. So thank you, keep telling your friends and colleagues about the blog, and keep letting us know how we're doing (with both positive and 'constructive' feedback). You know how to find us.

Last year's highlights (via Christian's datacloud in the sky):

• We had a steady growth in visits of about 70%: ~72,000 in 2008-2009 vs. 42,000 in 2007-08. We had a similar increase in our pageviews: 115,000 vs 69,000 in 2007-08.
• Growth in subscribers: we had 675 total subscribers in June 2008 and 2146 in June
  2009 including over 450 on Twitter. (Some are inevitably duplicates but some
  are new audiences we never reached before.)
• We had 542 comments since last June
• Expanding the family of blogs into Arts & Cases: Amy & Amber have clearly hit a nerve in particular with their Arts blogging.
• AAHPM gave us an award, which they haven't retracted despite the fact that Christian, Tom, and I unceremoniously stormed the podium prior to Russ Portenoy finishing introducing us. And he called Tom a 'young man' - making it a double smile day for Tom.
• Christian, a man of many plans, got the blog integrated with Twitter & Facebook, Twittered AAHPM (along with many others), tried to start some sort of Twitter FDA revolution, and got interviewed in the NYT and almost got the blog mentioned by name in it.
  
• And we invited Lyle to join and have patted ourselves on the back every day since for doing it - glad you're here Lyle.

So a good year. Thanks for reading and hope the next year is as good.

CAPC FDA opioid petition

Sorry about the extra post, but....

The Center to Advance Palliative Care (CAPC) is circulating a petition (originating from the American Pain Foundation) to urge the FDA to protect the rights of people with pain regarding access to opioids, as the REMS process unfolds.

The text of their press release/call to action:

As you are probably aware by now, the U.S. Food & Drug Administration (FDA) is currently working with makers of long-acting opioids to develop a plan to reduce opioid diversion/illicit use. This plan is known as Risk Evaluation and Mitigation Strategies, or REMS. The FDA is currently accepting comments from the general public until June 30, 2009 surrounding this issue. You should know that some of the comments the FDA has received have called for an outright ban or moratorium on certain opioid pain medications.

CAPC is distributing a petition created by the American Pain Foundation in order to help facilitate your response to the FDA. Please sign this petition TODAY to help make sure that patients in pain continue to have access to effective pain care, including prescribed opioid medications. Your voice and the voices of other pain advocates are needed to remind decision makers that the lives and livelihoods lost to pain are worth no less than victims of drug misuse or abuse. The FDA needs to hear how vital access to these medications is to people with pain and what tragic results could occur if they were denied access to these medications or if additional barriers were created making access more difficult for people who are legitimately prescribed these medications.

Petition here.
CAPC page about FDA action/REMS here.

Lancet editorial on euthanasia & choice

Lancet has an editorial about euthanasia (by a palliative doc and UK Member of Parliament**) and the shift in the UK debate about euthanasia from 'relief of suffering' to 'patient choice/control.'

It begins provocatively:

“I have never seen such a clear cut case for euthanasia” were the general practitioner's words when he referred to me a young man with a fungating malignant spinal tumour. The patient's distress was palpable and compounded by neuropathic pain. But, most of all, he hated losing control through creeping paraplegia and through his increasing dependence on his young wife, who was struggling to cope with their two children and 7-week-old baby. He asked me to end it for him, and his request persisted for several weeks. He would have passed all the tests about mental competence that euthanasia campaigners suggest and appeared to fulfil all the criteria in legislation from other countries: he was terminally ill with a short predicted prognosis, suffering unbearably, persistent in his competent request, fully informed, and had no psychiatric condition.

That was 1991. In 2001, he telephoned me to say that his beautiful wife had been diagnosed with pancreatic cancer. She died some months later, and he has brought up their children alone, aware that the law in Britain had saved them from being orphaned. Yet the media campaign for legalising what is euphemistically called “assisted dying” rarely shows this side of the coin.

The rest of the editorial discusses a renewed focus within the UK debate on choice/control. It's an issue we've discussed before on the blog, and in some ways reflects, at least in my opinion, a focusing of the debate onto the issues that most drive requests for/interest in assisted death (assisted suicide and euthanasia) where it is practiced: it is not actually used as a last resort option in patients suffering intractably (at least physically). Palliative/terminal sedation (let's leave aside debate about what term to actually use) is used in these scenarios (generally speaking - even in the Netherlands where both TS and AD are practiced it seems TS is generally used to treat active/current intractable physical symptoms like pain, dyspnea, restlessness). Assisted death, generally, is sought by those who wish to control the circumstances of their death, and are worried about future indignity, loss of meaning, and symptoms.

So actually framing the debate this way seems to me to be, at the very least, honest, and for it or against it I think it is appropriate to at least have the discussion about assisted death in the context that in real life it is not generally used for the relief of active (somatic) suffering but for more existential reasons around loss, control, etc. To rephrase: the actual debate about it should less be about whether it is necessary to have access to euthanasia as a way to 'treat' intractable suffering and more about patients' rights to have medically-assisted deliberate hastening of death for (the complex of interrelated concerns around control/loss/dignity that I'll paraphrase as) 'existential' reasons.

While absolutely acknowledging that this is indeed why most patients seek assisted death, the author is concerned this shift in the rhetoric/justification for euthanasia/assisted death is tied with a (what she states is at least for some an intentional) de-linking of assisted death from terminal illness itself. And, apparently, this is happening. She discusses some draft proposals being tossed around in the Scottish Parliament:

Her consultation document, intended as a prelude to a bill in the Scottish Parliament, proposes to legalise euthanasia not only for people who are terminally ill but also for others “enjoying otherwise satisfactory health but with degenerative, irreversible conditions”, for “patients who unexpectedly become incapacitated to a degree they find intolerable”, and to people “who are not terminally ill, suffering from a degenerative condition, or unexpectedly incapacitated but who find their life to be intolerable”. These wide-ranging proposals seem a natural consequence of the shift in emphasis of the pro-euthanasia campaign from the relief of pain and other symptomatic distress in the dying to an agenda based on personal choice and control.

I have written on the blog before that I'm essentially against the legalization of 'assisted death' practices (physician assisted suicide and euthanasia) as for me I do not think that loss of meaning/choice/control are sufficient reasons to have medical assistance with dying. I understand why people (at least a substantial minority if not a majority of Americans) are for the legalization of assisted suicide. One of the leading proponents of its legalization once told me that we can say all we want about the effectiveness of palliative care and, if needed, palliative/terminal sedation, but many patients just don't trust us to be there for them. I also think about what my patients go through sometimes and ask myself 'Yikes, would I really go through that myself?'

For me, thouth, it's about the role of medicine in these scenarios - is this loss of meaning (or however you want to describe the existential issues at play here) and desire for control the domain of medicine or not? Something which should be 'treated' medically? I basically come down on the side of 'No.' Acknowledging that I do treat this 'medically' all the time of course, with antidepressants for 'depression' even at times when I suspect it's not this organic brain disease called 'depression' but Something Else; or with benzodiazepines for 'anxiety,' etc. This is perhaps hypocritical, and makes me wonder if I've decided that it's not that it shouldn't be medicalized, but that it shouldn't be medicalized 'in that way' so to speak.

Regardless of this, I do think it's possible to have this debate and not de-link assisted death with terminal illness. I accept that this delinking is happening but don't think it is inevitable....

These issues aren't going away, and am interested in what others have to say about this.

**Sounds like a good combo to me and something we should try stateside. Hmmmm...Diane Meier?