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picture from www.outcomeresources.com

Oxycontin new formulation – MedAlert:

The study was released 9 months after Purdue announced its reformulation of Oxycontin, a move made to attempt to prevent abuse. The new forumulation makes crushing the pill difficult: instead of turning to a fine powder, it gelitinizes. Despite its release in April, patients have only started to routinely receive this new formulation in the last 6 weeks or so. Since that time, a Medwatch alert has already been released, announcing:

The following events have also been reported, potentially due to the swelling
and hydrogelling property of the tablet: choking, gagging, regurgitation,
tablets stuck in the throat and difficulty swallowing the tablet.

Furthermore, alive on the webchats, patients have discussed lack of efficacy of the new formulation, increased side effects – including GI symptoms and new headaches. As a physician prescribing Oxycontin, I have had patients whose breakthrough opioid demand increased dramatically with the change in formulation, with or without the other stated side effects. My approach has been to convert the long-acting oxycodone to another opioid in each case: to methadone or morphine extended release, based on patient's pain pattern, history of opioid side effects and using principles of opioid conversion.

I wonder whether others of you have had any recent experience with this and how you are addressing the concern.

So far, my experience with these problems has only been related with patients whose Oxycontin requirements were exceptionally high (>1g per day). My concern with what I am starting to see is the risk of undertreatment of pain – the potential assumption that patients who have been on higher doses of Oxycontin for a longer period of time might be labeled as “drug seekers” if they suddenly have an increased need for breakthrough pain medication due to lower efficacy of Oxycontin.

Pain and Palliative Care physicians may be increasingly under the gun to teach our colleagues, make our EDs, oncology and primary care centers aware of this possibility, educate about safe opioid conversion practices, and alert the FDA of observed side effects or change in efficacy through the MedWatch mechanism.

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Driving home tonight, as usual, I was listening to NPR. This time, the voice on the radio was honestly confronting the controversial topic of rationing – specifically, rationing in England. In recent evaluation of palliative care and end-of-life care around the world, England was ranked #1 – and as a result many countries healthcare leaders have visited the UK to learn from them. One of these countries was the United States – and as pointed in in Public Radio International (PRI) – this dialogue between England and the US was stopped after controversy about the “death panels” hit the front pages.

Around that time, Time Magazine published a story putting the pricetag on life – adding to the controversy.

More recently, in April of 2010, PBS hosted a debate on the topic featuring Ira Byock, Physician and Director of Palliative Care at Dartmouth-Hitchock Medical Center, Ken Connor, Lawyer and Chair of the Center for a Just Society, who represented Jeb Bush in Terri Shaivo’s case, and Marie Hillard, Nurse and Director of Bioesthics and Public Policy at the National Catholic Bioethics Center.

PRI has put this story back on the news – and given our place in healthcare, we cannot hide from the controversy as inevitably, in one way or another, we live smack-dab in the middle of it all. Our views on this topic also differ – and so I invite a discussion here.

Note: PRI has created a series about healthcare rationing in England, South Africa, Zambia, and India. Additionally – for all you TweetChatters: @PRITheWorld, @SheriFink and @dhbaron are also hosting another tweetchat on Thursday 1pm EST with the hashtag #rationinghealth.

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Pop Quiz:

1. What is the sensitivity and specificity of a CT scan of the chest for detecting mediastinal involvement in a patient with non-small cell lung cancer?
2. What about a PET scan? 

Palliative medicine practitioners frequently see patients with stage IV lung cancer.  Usually the stage has been fully elucidated prior to the initial palliative care consultation, but not always.  Admittedly, this biased my assumptions about the sensitivity/specificity of these tests and I would have guessed much higher than the actual answers (even though I knew neither was 100% sensitive).

Lung cancer cell dividing.  Source: Wellcome Images

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The trial published earlier this year in NEJM on early palliative care in metastatic non-small lung cancer remains highly publicized after the initial brisk response to the study.  As I review my Google Reader RSS feed that searches for the term "palliative," I still routinely come across references to this study, most which highlight the survival advantage seemingly conferred to the palliative care group.  (See our initial reactions to the study here, here, and here.)

NEJM recently published four letters to the editor regarding the study and yes, almost everyone is focused on the survival result and how to explain the survival advantage.  Points made about the survival result included the following:

•  Could the palliative care wing have received more chemotherapy (not less as I hypothesized), thus resulting in improved survival?  Could the mechanism of improved survival have been that palliative care leads to improved performance status, thus leading to more chemo, thus improved survival? (Authors respond that a preliminary analysis suggests that the number of chemo regimens did not differ between the groups.  They highlight some logistical challenges in measuring PS independently in this study over time. )
• Could the palliative care group have had fewer comorbidities? (Authors acknowledge this possibility but also point out that randomization which resulted in similar pt characteristics between groups should have negated this possibility.)

Only one published letter tried to poke holes in the HQROL conclusion, with the letter writer suggesting that the statistically significant results might not be clinically relevant or perhaps borderline.   In response, the study authors point out that results for the the FACT-L and TOI scores differed enough to be considered clinically significant but did agree that the Lung Cancer Subscale (of the FACT-L) difference was not clinically significant.  This is one of the most challenging aspects of HRQOL research, and those of us who are not researchers need to be aware of meaningful cutoffs.

The letters do nothing to change the evolving significance of this study but should be reviewed by those developing future research to examine similar interventions (perhaps especially the co-morbidity issue). 
 

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Well besides just putting down some rampant speculative numbers here, I suggest if you really want to know the answer,you have to be a CEO or CFO of a hospital or hospice organization, department chair, a palliative care/hospice doctor, spouse of said doctor, or in a few months time you will be to see the results of the AAHPM's brand new survey on palliative medicine and hospice physician compensation.

The deadline was extended until Wednesday December 8th, so if you have procrastinated thus far, you better ask your billing department to collect a few numbers and head on over to the survey.

Here is the link to the AAHPM page with more info about it

Hopefully then the 1,466 of you that land here on Pallimed looking for some salary information will actually have some good info to work with!  (image below taken from keyword search data including the term 'salar*' from Jan 2007 to Dec 2010)

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As our country mourns the death of Elizabeth Edwards who died today, many are recalling her legacy of health care reform and advocacy for hospice.  She was named NHPCO's 2009 Person of the Year. Her writing and her advocacy focused on bringing the humanity back to patients.  I was particularly struck by a blog post she wrote about the death of political commentator and Bush press secretary Tony Snow.  Despite being on opposite sides of the spectrum of American politics, they struck up a friendship as Edwards writes:

"We each chose to reach for something larger than the life and body with which we were saddled when we kept our course after the last diagnoses. We did it because we thought it was important and because (although it is chic to say that one detests politics) we actually loved the give and take it, the struggle to find what you think is right and the imperative to make others understand and agree. But what, in the end, does it tell us about what we each found to be really important? I am guessing it is not school vouchers or the expensing of stock options or class action lawsuits about salacious material in video games."

Any news hound will also realize that it was only yesterday, a day before she died, when it was formally announced that after a recent admission to the hospital, Edwards (with the advice of her doctors) would be forgoing any 'anti-cancer treatments.'  When I first heard the news yesterday about Edwards forgoing anti-cancer treatments, I casually wondered if there would be much discussion about palliative care or hospice.  I will tell you this is something I find hard to stop myself from thinking about given my interest in how hospice, palliative medicine, prognostication and medical decision making is portrayed and communicated in the news and entertainment media.  So my question to all of you is: Is this something you have wondered yourself too?

Now this is much different that wishing or hoping that someone does poorly or dies, that is not what I am talking about at all.  That is plain wrong.

I felt somewhat validated when I saw conversation on a different social media site about how this was a public example of a common challenge seen in hospice and palliative care: late utilization of the hospice benefit.  Someone mentioned we should capitalize on this story to highlight this challenge, which I do not think is appropriate, but I wanted to give a forum for rational discussion about this rarely discussed but (probably) often thought about topic for our community.

I'll leave with a quote from Edwards:

"Hospice and palliative care professionals support and care for people at a time when hope can be hard to find.  The professionals of NHPCO know more than I will ever know about providing that care; I know more than I wish I knew about receiving it and I am happy to share my perspective with them.”

NOTE: Eleanor Clift writes about hospice and Elizabeth Edwards here.

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Two posts have recently received a little more attention and I wanted to bring them back to everyone's attention if you had not seen the discussions.

The first is a post called "Holiday Heart"  from August 2010 written by Holly Yang.  Anon posted this comment which i thought might get better attention if it got bumped up to a post:

My hospital began LVAD-DT procedures recently. Our inpatient Palliative Medicine Department has been invited by the CV surgeons to participate in their pre-op inter-disciplinary patient evaluation process.

Our discussions re the old adage of "Hope for the Best; Prepare for the Worst", a phrase I never like to use, seems to be now changed in a nuanced way in the process of goals of care discussions with these patients. They have already experienced years of frustrating medical care and are very aware of their limited treatment options. Thus, some are hanging on to a thin thread of hope of this procedure as their last and saving option.

I wish to ask about how do others approach the subjects of hopes, wishes, goals, fears, scenario planning and related topics in the context of the person facing an LVAD procedure? I appreciate any comments.

Any suggestions for our fellow Pallimed reader? Feel free to comment on the original post.

Also a few anonymous commenters have taken to my "Good Luck on Boards" post to start a conversation about board prep and the test. If you needed a space to discuss this it is available, but please do not disclose anything about the questions or answers directly. and keep the comments constructive.

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I know many palliative care practitioners were cheering the news that the world's least effective opioid propoxyphene (Darvocet (w/ APAP) /Darvon)  (similar efficacy to acetaminophen) is being pulled off the market by the FDA.  Along with meperdine (Demerol) I am not sure if a medicine exists that produces as much disdain as propoxyphene amongst palliative care clinicians.

But let's look a little closer as to why this happened.  The FDA cites the increasing cardiotoxicity and risk of heart arrythmias in a post-market study conducted by Xanodyne.  It is a little difficult to find out more exact information since the study is not published but lets do a little Scooby Doo-like sleuthing.

• Propoxyphene is a synthetic derivative of methadone.
• Methadone causes QT prolongation of questionable clinical significance in palliative care patients.
• QT prolongation is a risk factor for ventricular arrhythmias.

Searching beyond just the press releases and news articles I found this FDA memo from Dr. Sharon Hertz *(Deputy Division Director Division of Anesthesia and Analgesia Products) noting that Xanodyne was asked to do a Thorough QT study. Never heard of that before? Well all new drugs since 2005 have had to pass through one before being approved. Given this increased risk of QT prolongation and the fear of resulting ventricular arrhythmias, the risk of the drug started to overwhelm the very minimal benefit it offered.
Interestingly the FDA has no evidence of QT Prolongation Adverse Event related deaths with Propoxyphene. Here is a quote from the memo: (emphasis mine)

At the 2009 advisory committee meeting, FDA staff shared postmarket data that have been suggestive, but inconclusive, about the risk for propoxyphene-related cardiac toxicity when used at therapeutic doses. No cases of torsades de pointes (TdP) causally associated with propoxyphene have been reported despite extensive use for many years. In an analysis of serious adverse events reported to the Adverse Event Reporting System (AERS) covering the period from marketing to February 2, 2005 (approximately 33 years), there were 91 U.S. deaths associated with Darvocet, the most commonly dispensed formulation of propoxyphene.  Most of the reports identified opioid drug overdoses in individuals with profiles of drug dependency, in which there was coingestion of multiple medications, or in those attempting suicide.

What is really interesting about this memo is section 1.2.1.1 on page 20, where they discuss QT studies of other opiate agonists. 6 lines of the report are redacted and in the whole 20 pages there is not one mention of methadone despite nearly all other opioids being mentioned. Redaction? Should we call Wikileaks founder Julian Assange?

So in the end I am not sure if propoxyphene being removed is really about cardiotoxicity and QT, minimal effectiveness, abuse and overdose potential or a combination of all of the above.

Well all this may be a whole lot of nothing but my real concern is that methadone may be a drug in the crosshairs of the FDA soon. It already has four strikes against it:
1) documented QT prolongation
2) stigma of heroin treatment programs
3) accelerating percent of all deaths related to opioids
4) methadone could be considered an orphan drug

And evidence of  methadone being a very useful medication is possibly not strong enough to overcome these issues. So while we can cheer propoxyphene disappearing we should also be cautious and gather better evidence for the medications we wish to keep in our arsenal to ensure good pain control for years to come.


Beaver, W. (1984). Analgesic Efficacy of Dextropropoxyphene and Dextropropoxyphene-containing Combinations: a Review Human and Experimental Toxicology, 3 (1 suppl), 191-220 DOI: 10.1177/096032718400300118


Collins, S., Edwards, J., Moore, R.,  McQuay, H. (1998). Single-dose dextropropoxyphene in post-operative pain: a quantitative systematic review European Journal of Clinical Pharmacology, 54 (2), 107-112 DOI: 10.1007/s002280050430


Ripamonti, C., Bianchi, M., Bruera, E. (2004). Methadone: An Orphan Drug? Journal of Palliative Medicine, 7 (1), 73-74 DOI: 10.1089/109662104322737278

** Yes the Deputy Direcotr in charge of pain medicine at the FDA is Dr. Hertz. Ha!

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After 5+ years of doing this, and much deliberation, I am stepping aside from being the editor of Pallimed.  If you hadn't already noticed, Christian, Pallimed's co-editor, has really been the energy behind the success of the blog for well over a year now, and I am grateful he has agreed to continue to lead the blog.  Thanks, friend.  I plan on remaining a contributor.

For those of you who know me - don't worry - everything is fine.  Between my kids getting older and staying up later, and a whole set of new (& welcome, & engaging) challenges & projects with my move to Minnesota, I have needed to closely examine my priorities and for now stepping away from the blog makes the most sense. 

Thanks to all the readers and supporters of the blog for your generosity and wisdom over the years.  See you in the comments.

--Drew.

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With health care reform and Medicare budget cutting being the latest buzz in Washington DC, we need to be very proactive in making sure palliative care (including hospice) gets 1) included in a fair and professional manner  and 2) not let other people narrowly define us and misinform the public who we are or what we do.

But this is going to take some work, you must not just read this email/post and say, "Yeah! People need to make sure Palliative care is represented" and then wait for other people to do it for you.  So go to GeriPal and read Eric Widera's latest post on Accountable Care Organizations and how to advocate for palliative care issues to be represented.  After you are done commenting tell 4 other people about it and then follow-up to make sure they commented.

For some background on this, Eric and I had a conference call with Diane Meier, Alex Smith and Phil Rodgers. Some of the very enlightening things from Diane from her time in Washington was that all of these comments are read and carbon copied ones tend to not get as much value as the original well-crafted ones.  You are not just sending your words into some bureaucratic abyss.

Diane also shared that there will be many, many more of these opportunities to comment to all sorts of different committees and agencies so we should be prepared for a sustained response.  Knowledge of when and how to comment is not always reliable, so Geripal and Pallimed are working on someway to help our readers stay informed. Any ideas you have please share with us as we plan to have a more comprehensive solution in 2011 and will be looking for some input and volunteers to assist.

Some things that we brainstormed:

• Website to direct people where/how/why to comment along with ways to share what you wrote so others could learn, critique, and support each other. 
• Entertaining slides/videos/podcasts that help to explain the alphabet soup of the agencies receiving our comments
• A way to report success to encourage people to continue to writing/advocating