Wednesday, September 27, 2006

New Orleans wrongful death case on 60 Minutes

Morley Safer interviewed Dr. Anna Pou about the case that made headlines in the Hurricane Katrina aftermath. The Attorney General (AG) for Louisiana has accused Dr. Anna Pou (ENT Oncologist/Surgeon, and Lori L. Budo and Cheri Landry (both nurses) of murdering 4 patients in a long-term acute care hospital a few days after Hurricane Katrina hit NOLA.

The 60 Minutes piece (transcript and video here) is very informative, and takes a innocent until proven guilty approach, which does not seem to be the approach of the AG. No detailed records have been released to the public, let alone the defendant's or their lawyers. The evidence presented thus far has been reports from witnesses and the medical examiner's report. Apparently they were given 'lethal' doses of a benzodiazepine (midazolam, aka Versed) and an opioid (morphine). So basically no new details but this story allows you to imagine the experience in that hospital. The nurses and the doctor seem genuinely distressed and upset over the accusations, understandably. As more info comes out about this case we will make sure to share it with the Palliative Medicine community, as it may come up in conversation in our daily work.

Here are a few blogs that comment on the issue as well:
Kevin MD
Kevin MD #2
Pallimed (old post)
NPR (02/06)
And Rightly So! (includes posts from those who trained with Dr. Pou)

Websites for Dr. Pou and the Nurses Landry and Budo

Wednesday, September 27, 2006 by Christian Sinclair ·

Friday, September 22, 2006

JAMA Trifecta: spirituality, kids, turning off oxygen; I'm going to Montreal

The latest JAMA has 3 articles to note:

1)
A "Clinician's Corner" piece about spirituality and dying . It focuses on a case of conflict surrounding end of life decision making in which a patient believed God would cure him miraculously. The article is mostly a general overview of the topic; it's a good 'teaching file' article but I don't have much more to say about it.

2)
A coda to their recent piece on sudden traumatic death in children .

3)
A commentary on discontinuing oxygen therapy in the dying. It approaches oxygen therapy as any other life-prolonging medical treatment that can be discontinued, and addresses head on concerns with this, including that the decision may be motivated by a desire to stop all barriers to death. I was hoping the the commentary would spend more time attacking and discarding the 'burdensome' idea (that's it's ok to stop 'burdensome' medical interventions at the end of life). The commentary mentions this somewhat but not at length. (I've mentioned this on the blog before--using the rhetoric of 'it's ok to stop burdensome medical interventions at the end of life' implies...sort of...that it's not ok to stop non-burdensome interventions, or that we should continue medical interventions that aren't burdensome, etc. I find this confusing and missing the boat, and instead prefer to talk about what are the goals of care--what are we trying to accomplish and what sort of care, medical or otherwise, is the best way to accomplish it? If the goal is to provide someone with a peaceful, comfortable death then oxygen therapy may or may not be indicated depending on the situation, but the standard is whether or how likely is it to meet some goal-- not whether or not it's burdensome. Of course, a patient may, and many do, decline medical treatments specifically because of the burden it places on them; that is a patient's perogative.)

4)
I'm going to the 16th International Congress on Care of the Terminally Ill in Montreal next week, so I probably won't post until the week after. If you're a Pallimed reader and see me, please say Hi.

Friday, September 22, 2006 by Drew Rosielle MD ·

Wednesday, September 20, 2006

Modafinil for atypical depression

The Journal of Clinical Psychopharmacology has published the results of a controlled trial (sort of) of modafinil for atypical depression in adults. Modafinil is a relatively new agent (it is activating & increases alertness) indicated for narcolepsy but is being used here & there in the cancer population for fatigue as well as by some for opioid-induced fatigue/somnolence (somewhat akin to our use of methylphenidate). As far as I know this practice, while probably effective, doesn't have much of a literature base to support it. This study was a trial of modafinil for atypical depression (characterized by hypersomnolence, hyperphagia, anergia, etc.) in adults. The patients took open-label modafinil for 12 weeks, starting at 100mg QAM, and titrating up every few days in 100mg increments to a max dose of 400mg daily. Essentially there was a substantial and marked response in the patient's depressive symptoms after 12 weeks across the cohort. After 12 weeks responders (which was essentially the whole cohort) were randomized to continuation of modafinil or placebo and they were followed for another 12 weeks. After these 12 weeks, interestingly, there were no discernible differences between the modafinil and placebo groups--both had continued alleviation of their depressive symptoms. There were no major complications in the trial due to modafinil.

What to make of the 2nd 12 weeks? Either there was a major placebo response across the cohort to modafinil, which really didn't do much in and of itself; or modafinil can induce a lasting remission from atypical depression with just 12 weeks of therapy. I'm not sure of another good explanation to this. What seems to be needed is a true randomized placebo controlled trial using placebo from the outset, although for unclear reasons the authors recommend a long term randomized discontinuation trial which would seem to muddy the water too much. I've avoided modafinil in my fatigued/asthenic/sleepy patients who I thought were depressed (opting instead for methylphenidate) but this trial will probably change that a little: I'll give it a try in my depressed patients as well, even if it is "just" a placebo-effect. Leave comments if you've been using this with your patients for depression, opioid-induced sedation, or cancer-related fatigue--I'm curious about people's experiences with it.

Wednesday, September 20, 2006 by Drew Rosielle MD ·

Tuesday, September 19, 2006

We are now an official subspecialty in the US!

In case you haven't heard AAHPM has made the following announcement:

ABMS Recognizes Hospice and Palliative Medicine

We received word today from Paul Sloan, ABHPM Trustee, who was present this morning at the American Board of Medical Specialties (ABMS) Assembly meeting, that ABMS has voted unanimously to establish a subspecialty in Hospice and Pallative Medicine.

Ten boards co-sponsored the motion:
The American Board of Internal Medicine
The American Board of Anesthesiology
The American Board of Family Medicine
The American Board of Physical Medicine and Rehabilitation
The American Board of Psychiatry and Neurology
The American Board of Surgery
The American Board of Pediatrics
The American Board of Emergency Medicine
The American Board of Radiology
The American Board of Obstetrics and Gynecology

We expect to receive an official announcement later this week from ABMS that we will forward to you.

American Academy of Hospice and Palliative Medicine

Tuesday, September 19, 2006 by Drew Rosielle MD ·

Wednesday, September 13, 2006

Parenteral nutrition saves lives?

The Journal of Parenteral and Enteral Nutrition has a provocative article showing a mortality benefit of parenteral nutrition in advanced cancer. Reading this study is like taking a trip through bizarro world (more on this in a second). This was a randomized trial of 150 patients with advanced cancer (mostly rectal, esophageal, and gastric) and 'malnutrition' (BMI less than 20 or a 5% loss of body mass in 3 months). All were undergoing anti-cancer therapies (chemo, radiation) at a cancer center in Germany. They were randomized (details of the randomization are not disclosed) to either supplemental parenteral nutrition (PN) (through a central venous line) or oral nutritional supplementation (calorie shakes). Mean age was ~58 years and BMI 23. The idea was that the PN patients would get 30% of their daily nutritional needs via the PN and the rest via regular oral diet (50-60%) and calorie shakes (10-20%). The non-PN patients would get their daily needs via calorie shakes (20-40%) and the rest via regular oral diet. Total calorie and protein intake, on average, was the same between the groups during the study (albeit from different sources). Patients were followed for a mean of 11 months. The study's primary aim was purportedly the effect of PN on quality of life and body composition (there doesn't seem to be a set time frame for the primary outcome...e.g. at 6 months? 12 months? etc.).

What they found was that the PN group had higher BMI's, albumin, and quality of life scores. Remarkably they found that the PN group's median survival was 12.5 months vs. 9 months in the non-PN group (this difference was statistically significant).

Let me repeat that: they found that PN prolonged life by about 3 months in this group of patients with advanced, incurable malignancies.

And so we enter bizarro world. The first question anyone should ask here is why is this study which shows there is a therapy that can prolong life by 3 months (when your expected survival is 10 months that's pretty darn good) published in the (with all due respect) obscure JPEN and not Journal of Clinical Oncology or the NEJM for that matter? This, if true, would be a super-big deal. Second, and this is why reading this study was weird, is that they bury this finding after multiple tables of subgroup analyses about total body weight etc. etc. as if anyone cares (maybe the eds & readers of JPEN care but the rest of the world doesn't). It's as if the authors aren't really excited about their finding.

So what's going on? I don't know. The article doesn't disclose several things one would like to see (the nature of the randomization, etc.) and you sort of get a sense that this isn't the most rigorous research ever conducted (alternatively the editors of JPEN may not have cared about this stuff). Also, if one is to believe these findings it would imply that it's not that the patients were benefitted by increased calorie/protein intake but by the fact that the nutrition was delievered via an IV as protein/calorie intake was the same between groups. All this being said, these people took 150 sick people, ostensibly randomized them, and found out that one group lived ~25% longer than the other, and that's a finding that needs to be investigated. I would really like Pallimed readers to check this article out and leave comments if you have any further insight into this.

Wednesday, September 13, 2006 by Drew Rosielle MD ·

Sunday, September 10, 2006

Detecting awareness in a gravely brain injured woman

Science has published research findings suggesting awareness in a woman in a persistent vegetative state (these findings were published as 'Brevia,' essentially an announcement of findings, not as a full peer-reviewed research article). The 23 year old woman, in a PVS due to a traumatic brain injury, was studied 5 months after her injury using functional MRI. Essentially the fMRI findings suggested that the woman's brain was responding 'appropriately' (as in how an uninjured brain would respond) to verbal cues and commands--some part of her brain heard the commands and processed them appropriately. The story has been making the rounds on the news, and while I haven't checked out the so-called pro-life blogosphere I imagine the findings are being used to all sorts of ill-ends including and not limited to revisiting the death of Terri Schiavo. I found this NY Times article quite reasonable, and it also made the revealing point that this woman 11 months post-injury recovered a little and is now in a minimally conscious state.

Some things to keep in mind about this event. 1) What has happened, while probably rare, is also perfectly consistent with the known natural history of the PVS. PVS following traumatic brain injury (as opposed to anoxic brain injury) has a better prognosis: people make some sort of recovery more often than in anoxic PVS and it takes longer before one's PVS is considered permanent (meaning <<1% chance of recovery). Even anoxic PVS's of 5 months duration have been known to have some recovery. It seems that the researchers caught fMRI evidence of some form of consciousness before it was clinically evident: there should be nothing surprising about this. 2) Could fMRI be used as a way of predicting those likely to make some recovery? Sure, of course, but no one has any clue if this will pan out or not yet. 3) These findings represent a growing refinement in medicine's understanding of prolonged states of impaired consciousness and we should be prepared for more, much more, of this in the coming years. The PVS, the MCS, etc., are clinical, bedside diagnoses and describe a final common pathway from a multitude of neurologic insults but there are probably many subtypes of each with their own etiologies, natural histories, (and maybe at some point therapies), etc., and things are going to change. Helping families make decisions about appropriate medical care for loved ones in these conditions is already complicated, and will probably get more complicated at least for a while as new information comes out. 4) The fact remains that for many of us the distinction between the prolonged states of impaired consciousness is meaningless & when people say "I don't want to be kept alive artificially if I'm like that," by "like that" they mean profoundly disabled and unable to have meaningful communication with loved ones. This includes the PVS, the MCS, profound dementia, etc., and the prospect of going from a pain- & suffering-free PVS to a potentially suffering- & pain-full MCS doesn't seem like a good deal. Not everyone of course would agree with this, but I'd wager most people reading this blog and most North Americans would agree with this. (A distinction between the two which is more likely to have meaning to at least some people is the difference in their prognoses as one's chance of a decent neurologic/cognitive recovery in a PVS is tiny vs. not quite as tiny in an MCS.) 5) These are findings in a single person and no one knows how frequently, if ever, this will be replicated let alone what the long-term implications will be. 6) These findings have zero implications either medically/scientifically or morally/ethically for the highly controversial public PVS cases including Terri Schiavo.

Sunday, September 10, 2006 by Drew Rosielle MD ·

Thursday, September 7, 2006

Dialysis and hospice

There's an interesting article in the Clinical Journal of the American Society of Nephrology about hospice use by dialysis patients in the US. It relies on data collected nationally for all U.S. dialysis patients (USRDS & CMMS data) and looks at hospice use amongst dialysis patients who died in 2001 & 2002. It provides a helpful snapshot of end of life circumstances in this population. Hospice use was relatively rare: 14% of deaths overall. 22% of patients died after withdrawal of dialysis; of these 42% used hospice services**. Not surprisingly hospice use was associated with older age, white race, and lower Medicare costs in the last weeks and months of life. What was most interesting to me however was the broad geographic disparity in hospice use: the extremes were 56% of patients dying after dialysis withdrawal in Iowa used hospice compared to 17% in Maine. This disparity was not associated with state hospice density (number of hospices per population) which suggests it is not a disparity in access to hospice but in physician practice regarding hospice referral. I'm not going to speculate as to why some regions did 'better' than others; this extreme variation in practice however is a quality red flag suggesting major problems.

(For those that are interested August's Journal of Palliative Medicine has a comprehensive review of end stage renal disease and palliative care.)

**About 3% of the patients died on hospice without dialysis withdrawal indicating that this practice, while rare, does occur. The authors suggest it's so rare because people don't realize that patients can get hospice care while still receiving dialysis if their terminal diagnosis in non-renal. In my experience this is not the case--the issue is that for dialysis patients who are dying of something else, when the time comes that people are considering hospice care, they are usually so ill that continuing dialysis is impractical--the patient is bedbound or too unstable medically to be transported to and from dialysis centers. Continuing dialysis in these moribund patients just becomes a non-issue.

Thursday, September 7, 2006 by Drew Rosielle MD ·

Tuesday, September 5, 2006

Discussing prognosis; Treatment limitation in the ED; Chemoembolization for liver CA

A couple of things

1)
The Journal of Clinical Oncology has twin articles on discussing prognosis with cancer patients ( one focusing on when the patient wants to know; the other on when the patient expresses a reluctance to know ).

They are well written with refreshingly straight-forward language such as:

"One of his colleagues prides himself on being a realist, "I tell patients the truth because they need to know, whether they want to hear it or not." Another colleague feels he must give hope, "I go into cheerleader mode." Neither alternative seems optimal to Dr B—the nurses tell him that the realist tone is a little brutal, and that the cheerleader is more than a little clueless."

They are both quite practical, problem-focused, and directed straight at practicing oncologists, although the principles and techniques discussed are appropriate for almost all prognostic discussions. There is a lot of wisdom in these articles and I would strongly recommend adding them, along with Christian's article, to your teaching files for residents, fellows, colleagues, etc.

2)
Academic Emergency Medicine has a seminar on " withdrawal of treatment" in the emergency department. Should I point out that by 'withdrawal of treatment' they mean 'withdrawal of life-prolonging treatment?' It tries to make an argument that the ED is an appropriate place to consider treatment limitation but then makes the whole 'withdrawal of treatment is morally superior to withholding treatment' argument (treat now; ask questions, and if needed withdraw, later) which I find problematic (as much as I sympathize with the ED staff who are faced with crashing chronically ill patients all the time).


3)
The Journal of Vascular and Interventional Radiology has a position statement from the Society of Interventional Radiology about chemoembolization (free full text) for liver tumors--for the most part it critically appraises the literature supporting its use for a variety of cancer. Many of us I'm sure take care of patients for whom chemoembolization is the only antineoplastic treatment available to them, and at least at my institution the palliative care team has a relatively close relationship with the interventional radiologists as they are often a patient's "last stop" prior to "full" palliative care (yes yes I hate the phrase "full palliative care" too but I can't for the life of me think of another way of writing this now). This position statement, while informative, unfortunately doesn't mention palliative care or difficult decision-making involving patients with far advanced illness who are not infrequently referred to radiologists. It is my dream that one day all (appropriate) position statements will contain such language....

Tuesday, September 5, 2006 by Drew Rosielle MD ·

Sunday, September 3, 2006

Schiavo story and the 16 year old with cancer in Virginia

Hello everybody!

I am sure many of the loyal Pallimed readers out there have noticed that Drew has been doing all the posting for a while. Not to worry I am okay, no bodily harm or anything. Just pretty sidetracked with the kids versus work thing! Kind of like Drew.

Anyway, there have been a lot of things I wanted to comment on, but I though I would start off with an article featured on the front page of the NYTimes on August 16th.

Headline: Husband Takes Schiavo Fight Back to Politicians

The even handed article basically talks about the grass roots effort of Michael Schiavo starting a PAC (Political Action Cmte) called TerriPAC to fundraise for politicians opposing politicians who tried to create barriers to the withdrawal of artificial nutrition for Terri Schiavo last year. Apparently Mr. Schiavo was even involved in the highly publicized Lamont-Lieberman Democratic primary race in CT supporting Mr. Lamont because Sen Lieberman had endorsed the emergency federal bill to reinsert the feeding tube.


The basic reason for accepting a donation from TerriPAC is that Mr. Schiavo is:
"...the human face of government intrusion,"

said Angie Paccione, a candidate for representative in Colorado.


The article goes on to discuss the Terri Schindler-Schiavo Foundation, founded by Terri's parents, the Schindler's. The goal of the Foundation is to

"protect the rights of the disabled, elderly, and vulnerable citizens against care rationing euthanasia and medical killing."
Well what does this have to do with the 16 year old boy in Virginia? Well if you were not watching the 24 hr news networks when this made the rounds, I will give you a brief summary. A 16 year old boy with Hodgkins Lymphoma had been through one round of chemotherapy with severe symptoms. He had a relapse of his cancer and the oncologists suggested another round of chemo. Citing the severe side effects of the first round of chemo 'that almost killed' him, the boy and his parents opted for a 'alternative' treatment of diet and herbal therapy called the Hoxsey Method at a alternative medicine center in Tijuana, Mexico. (American Cancer Society info, Wikipedia, Quackwatch info)

The oncologists and social workers reported the parents for neglect and the boy was ordered to have chemotherapy against his and his parents requests. Well eventually through appeals and this issue making its way through the media, the boy won the right to follow his alternative treatments but under the guidance of an oncologist in Mississippi with experience in alternative treatments and with the possibility of radiation treatment.

So what do these two seemingly unrelated issues have to do with each other. Well this all is about the issues of surrogate decision makers which is one of the central tenets of providing effective palliative care. Because many patients who may receive palliative care may not always be able to express their wishes, medical staff rely on the patients previously expressed verbal and written wishes as expressed by themselves or via the surrogate decision maker. Because hospice and the palliative care field have fought so long for the right to withdrawal any medical treatment even when involving a surrogate decision maker, I would be interested in the palliative care field's take on the alternative treatment case when it is also a case of right to refuse treatment, but now involving a 16 year old boy.

Would palliative care practioners have differing views is the 16 year old boy did not want any treatment any more and wanted to be allowed to die without further symptoms?

Would palliative care practioners feel the same way about refusing blood for a child of Jehovah's Witness parents?

I struggled while contemplating these issues because I have a high respect for the issue of surrogate decision maker, but also a profound respect for the science and research of mainstream medicine that alternative treatments lack.

My wife (a pediatric emergency medicine physician) and I talked about these issues for a long time without any real great answers, but I thought I would stoke the fires a little and see if there were any pearls of wisdom from the palliative care community.

Sunday, September 3, 2006 by Christian Sinclair ·