Using the instructions from the NEJM I captured this muddy brown cast in a patient with acute on chronic acute kidney injury. I love this new tool.
Muddy brown cast via iPhone 4
The new definition of a rock and a hard place–Updated
The rock would be Amgen with their newest prescribing information for Epogen and Aranesp. The recommendations for dialysis patients can be summarized as:
Specifically, for patients on dialysis, the label advises physicians to initiate ESA therapy when the hemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the hemoglobin approaches or exceeds 11 g/dL. So target a hemoglobin higher than needed to prevent transfusions and no higher than 11 g/dL.
The hard place would be the federal government whose Quality Improvement Plan (QIP) for dialysis units states:
The intent is to control anemia and maintain optimum hemoglobin levels within the range of 10-12 g/dL (grams per deciliter). Anemia management will be assessed by two separate measures:
- CMS will assess the percentage of patients whose hemoglobin levels dipped under 10 g/dL. The program assigns this measure the greatest weight in facility performance calculation, because numbers under 10 g/dL are highly undesirable. (Weight = 50%)
- CMS will assess the percentage of patients whose hemoglobin levels exceeded 12 g/dL. Numbers greater than 12 g/dL could suggest unnecessary or excessive administration of certain drugs. (Weight = 25%)
There is little air to breathe between 10 and 11 g/dL. Something has got to change and my guess is by the end of the year QIP will be suggesting hemoglobins between 9 and 10.
UPDATE: CMS has proposed new rules that remove the lower limit for hemoglobin as a quality measure. Here is some news coverage and here is the PDF.
I think its crazy to remove the lower hemoglobin limit. When CMS introduced the bundled payment system they turned anemia management from a profit center to a cost center for dialysis units. The Quality Incentive Plan was designed to prevent dialysis units from minimizing costs by denying patients adequate treatment. It seems that with the 2013 proposal, a Machiavellian dialysis unit could eliminate anemia management completely and reap financial rewards without penalty.
This can’t be right, at the least CMS should add minimizing transfusions as a quality measure, that would reconcile the prescribing information and the quality goals.
Hat tip to the anonymous first poster.
Using an iPhone for capturing urine microscopy
From the NEJM:
The authors describe their technique:
When microscopy revealed a field of interest, the camera was placed about 0.5 to 1.0 cm over one of the eyepieces, allowing optimization of the image and light intensity by means of the camera’s digital display. The auto-focus and exposure features generally produced a circular image surrounded by a black rim…
Can’t wait to try this.
Hat tip Pediatric Nephrology
Article on aging I want to spend some time looking at
From the American Scientist: Aging: to Treat or Not to Treat?
Patient called me with a blood pressure of 170
He has resistant hypertension that has been well controlled since we added spironolactone. He reported that his systolic blood pressures were between 170 and 205 over the last three hours. In the morning his blood pressure was 120 and for the last week he had been getting blood pressures of 115 to 135, trending toward the lower end of that range.
I told him that I wasn’t worried about the isolated spike in blood pressure. The goal of therapy is to get the average blood pressure down and that chasing individual isolated episodes of hypertension becomes a hopeless game of whack-a-mole.
The treatment of hypertension is like trying to change the climate, not control the weather.
What do you do when they get this phone call? Do you chase after elevated blood pressures with prn clonidine? Is there an evidence based approach to this?
How many cancers have you caused from ordering CT scans
It feels like if a patient coughs they get a CT angiogram to rule-out pulmonary embolism. How many patients would defere that test if they had to sign off on the following chart:
Makes you think twice regarding the CT for stone-profile that some patients get yearly “just to make sure the Urocit-K is working.”
Hat tip to Academic Life in Emergency Medicine blog.
If you are giving a commencement speech be original, don’t steal
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| Arrogant? Stupid? Both? |
Incredible story today comes from the University of Alberta Medical School where the dean, Phil Baker, plagiarized Atul Gawande’s Stanford commencement address from 2010 during U of A’s own graduation ceremony. My favorite part is the students using iPhones to discover the intellectual property theft during the speech:
“A couple of the students recognized the term ‘velluvial matrix,’ which is in Mr. Gawande’s speech,” said class president Brittany Barber. “They Googled it on their phones.
For anyone to think they could rip-off a high profile author in this day and age is the height of arrogance and or stupidity.
Epo, anemia and the lack of placebo controlled trials
By a mistake of communication I was scheduled to give the anemia talk at a recent chronic kidney disease symposium. I would have never selected this topic on my own. I work with Robert Provenzano, one of the Gods of Anemia. Fortunately, this was a happy accident. I loved researching and writing this presentation. The whole experience was an important lesson on the value of working out of your comfort areas.
The anemia saga is well known to all nephrologists and is covered in depth in my presentation but let me recap my version of the story.
Life before Epo was pretty bad. the average dialysis patient received a transfusion more years than not. On the Eve of Epo the transfusion was rate was 16% per quarter!
After the release of Epo, the transfusion rate plummets. It falls by two thirds in a year and continues to fall so that the current rate of 0.3% per quarter is a 98% reduction in transfusions. Revolutionary. And this doesn’t even begin to address the quality of life brought to dialysis patients by higher hemoglobins.
I was in college when this happened and it’s a little hard to imagine how exciting that must have been. The introduction of Epo launched a million observational trials that all pointed in the same direction:
Where you found higher hemoglobins you found better patient outcomes.
It almost didn’t matter what outcome you were interested in: hospitalizations, mortality, regression of left ventricular hypertrophy, quality of life, fatigue score. It didn’t matter, everything was better with higher hemoglobins. I suspect the community was seduced by the observational results but for what ever reason the amount of randomized controlled trial data that emerged was laughably small. By 2007, Epo was eating up 1.8 billion Medicare dollars. It should have been the best studied drug and instead it was among the least studied.
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| I tried to find Henry Paulson’s signature but had to settle for George Bush’s. |
Here is the table from K/DOQI anemia recommendations where they summarized all of the RCT data from the birth of Epo through May 2006 (apparently it omits a single 2005 study).
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| 8 Epo vs Epo studies and 3 placebo controlled trials, 1 placebo controlled trials in pediatrics |
The paucity of placebo controlled trials is shocking. No one demonstrated that higher hemoglobin targets had a mortality benefit or regressed LVH compared to placebo. This would not be so problematic if the Epo vs Epo studies had been positive, but those too were negative trials. So we are in the awkward position, a quarter century after the introduction of EPO we cannot conclusively state that the drug does any more than reduce transfusions and improve quality of life. All the mortality reductions, cardiovascular disease protection amount to observational-backed hype (one small rct (N=38) study did show a reduction in LVH).
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| Favorite slide from the deck |
Part of me is outraged but another part understands how difficult it would be randomize dialysis patients to placebo. I couldn’t, in good faith, expose trial subjects to the transfusions, fatigue and weakness that being randomized to the placebo-arm would entail. It fails my personal “Grandma test” (i.e. Would you feel comfortable enrolling your grandma in a placebo controlled trial of Epo? No). I understand that and forgive the dialysis researchers; however I am a little disturbed to witness how in the pre-dialysis CKD population the same pattern of relying on observational data. In CKD these is no transfusion epidemic that needed to be derailed, there is no profound fatigue turning patients to zombies. We had an opportunity to do the right studies to figure out if this expensive Nectar of Thousand Oaks really helped. The paucity of placebo controlled and randomized controlled trials in pre-dialysis patients is embarrassing.
Reading this editorial by Marc Pfeffer crystalized this critical mistake. I spent a fair proportion of the presentation laying out how statins evolved from being used in only the sickest patients to larger and larger populations and how at each step placebo controlled trials were used to prove efficacy. Not every step was a win, statins for heart failure failed, but the key is that cardiologists know that statins don’t improve heart failure because they tested it with two (1, 2) placebo-controlled trials.
Why is nephrology lacking the randomized controlled trials that have defined the huge advancement in cardiovascular disease over the last 25 years?
- It isn’t due to the severity of illness, the first placebo controlled trial of ACEi in heart failure used a cohort with 40% mortality at 6 months.
- It isn’t timing, ACEi for heart failure was developed and proven at the same time as the introduction of Epo.
I don’t know the why but I have a couple of theories. One is the richness of the retrospective data in nephrology, brought to us by the USRDS, blinds us to the importance of prospective data. This could explain why are repeatedly burned by observational studies, see: kT/V, vitamin D, and binders.
The other theory is that, unlike statins and ACEi where there are many vendors producing drugs in the class of interest, there is a total monopoly in the field of ESA. You want to increase the hemoglobin you need to buy Epogen. No generic, no competing ESA. In the ACEi market, having enalepril as the drug studied in the CONSENSUS and SOLVD trials paid huge dividends to Merck. Having in-class competition lead to commercial support of critical research. Amgen had no need for this because the US Patent Office gave them a monopoly. A monopoly that seems to last forever. Why is it that every other drug from the late 80’s is generic: omeprazole, captopril, enalepril, benazepril, metformin, simvastatin, etc. Even drugs from the 90’s are now generic: losartan, lansoprazole.
Epogen stands alone without generic competition. And unfortunately, largely without placebo controlled trials to back-up mountains of hype.
The most difficult decision: Palliative care
I was peripherally involved in a patient with end-stage heart failure. We were consulted for hyponatremia. The patient had a sodium on 120 which we helped increase to 130. During our involvement, the family was wrestling with choosing palliative care. The patient was frail with advanced dementia.
The patient ultimately died in the hospital before being made comfort care. The family was relieved that he passed. I was struck by the question, that if the family was so relieved that he passed why was it so difficult to decide on palliative care.
In all the intensity of care conversations I have been involved in, I can’t remember the principal asking the family to imagine how they would feel if that got a call from the hospital that their loved one had passed. And then add, that if the feeling is one of relief, that hospice, or DNR, or palliative care, is probably the right decision.
I need to get this font
Inspired by the title credits from Dr. Strangelove: Strangelove typeface
Here are screen captures of the title credit sequence:
