Thursday, June 9, 2011

The Cancer Racket

News of a new weapon in the "War of Cancer" raged across the internet last week with the publication of a paper in the New England Journal on vemurafenib, an immune system-targeting drug used in cases of advanced melanoma. Heretofore, prognosis of patients with stage IV melanoma has been dismal, at best. Most die within 6-10 months. Various attempts over the past 15 years to improve survival with the likes of chemotherapy or immune-modulating drugs such as interferon have miserably failed to meet expectations. Paul Chapman's group at Sloan Kettering trumpets the fact that, at 6 months, 84% of participants using vemurafenib were alive compared to 64% who took the chemo agent dacarbazine.

This paper was presented at the American Society of Clinical Oncology and the resultant fanfare would have you believe Jonas Salk himself had announced a cure for the common cold. Here's a sampling of headlines from major media outlets covering the presentation:
'Time to Celebrate'; New Metastatic Melanoma Agent Wows ASCO
---Medscape News
Drugs hailed as a 'major breakthrough' in treating deadly skin cancer
---LA Times
The Biggest Skin Cancer Breakthrough In 30 Years
----Business Insider
Skin cancer 'wonder' drugs that could offer years more life in biggest breakthrough for 30 years
---Daily Mail (UK)

Pretty exhilarating, no? But let's take a look at the actual data. At six months, 84% of patients on vemurafenib were alive compared to 64% on the other standard chemo agent, dacarbazine. Based on this modest 6 month improval, the patients in the dacarbazine group were then switched over to vemurafenib for "ethical" reasons. So there is no data on longer term efficacy or median survival. Since the patients were switched, we'll never know if survival at 12 months, 18 months, or even two years is any different between the two drugs. Isn't that something that would be interesting to know? Furthermore, the results show that less than 50% of patients even responded to vemurafenib. And close to 40% of patients experienced toxic side effects incapacitiating enough to mandate dose modification or even outright temporary cessation of the vemurafenib.

The cost of the drug has not been released but a similar medication, Yervoy, retails for close to $120,000 for a one year course of treatment. Presumably, verumafenib will cost somewhere in this neighborhood.

Now I don't want to belittle the scientific achievement that vemurafenib represents. Being able to manipulate the expression of certain viral and neoplastic proteins at the genetic level is an exciting new frontier. But let's not confuse modest, incremental scientific advancement with real life efficacy. The headlines suggest a quantum leap in medical insight and intervention; which is misleading at best and perilously close to fraudulent misrepresentation at worst.

When it comes to late stage cancer, these pharmaceutical firms and the doctors doing the research have a major financial stake in promoting these newer drugs. Billions of dollars are in play. But this misleading propaganda campaign shamefully exploits a very vulnerable, desparate patient population....

Wednesday, June 8, 2011

So Fast

It sneaks up on you. One day your little girl clambers up for story time before bed and you realize that she just doesn't quite fit in your lap the way she used to. She sort of overflows the confines of the rocking chair and spills across your torso, legs dangling, everything suddenly awkward and cramped. You have to look around her head to see the words on the page. She has to keep shifting to find a comfortable spot. On the one hand you're happy; your child is healthy and growing, becoming a little person. But it still doesn't change the fact that it sort of stings when it happens.

Monday, June 6, 2011

More Checklist Consequences

One of the SCIP protocols involves removing foley catheters post op within 48 hours to reduce hospital acquired urinary tract infections. UTI's acquired during a hospitalization, of course, are a "never event" and hospitals are loath to subject themselves to reimbursement penalties therein. One way to control this is to program the Electronic Medical Record (EMR) for Physician Order Entry (POE) such that all foley catheters are automatically removed by post op day #2 no matter if the surgeon wants it or not. By making foley removal the default pathway, you improve foley removal rates and, presumably, lower rates of acquired UTI's. The doctor is removed from the decision-making process altogether.

My partner operated on someone with an incarcerated hernia not too long ago. The patient was an older guy and he had to perform a limited bowel resection. A foley was placed prior to incision. The guy had a history of severe BPH and it was a struggle to get the catheter in. In his post-op orders he checked the standard box on the POE for Foley care (usually a bag to free gravity).

Unbeknownst to him, the "Foley care" order contained a drop-down box (accessible by clicking a separate tab) mandating that the catheter was to be removed on post-op day #2. In the evening of post op day #2, my partner received a phone call from the nurse---your patient hasn't been able to void since the catheter came out.

"Why is it out? I never wrote that. The guy has a prostate the size of a tennis ball."
"I don't know doctor. But he's having a lot of pain. The lasix you wrote for worked though. The bladder scanner says he's retained 700cc of urine."

And of course the house officer couldn't get the Foley in. Urology had to be consulted, urgently. The guy ended up getting another catheter placed, this time without the benefit of deep anesthesia. According to one of the nurses on that night, it took about 30 minutes of penis stabbing to get it in. But at least the hospital's SCIP data will look good.

Friday, June 3, 2011

The Unintended Consequences of Algorithmic, Bureaucratic Medicine

Whenever someone is scheduled for an operation, the assigned nurse is required to fill out a "pre-op checklist" to ensure that all safety and quality metrics are being adhered to. Before the patient is allowed to be wheeled into the OR we make sure the surgical site is marked, the consents are signed, all necessary equipment is available, etc. One of the most important metrics involves the peri-operative administration of IV antibiotics. SCIP guidelines mandate that the prophylactic antibiotic is given within an hour of incision time to optimize outcomes. This has been drilled into the heads of physicians, health care providers, and ancillary staff to such an extent that it occasionally causes total brain shutdown.

Let me explain. For most elective surgeries (i.e. hernias, lap choles) I give a single dose of antibiotics just before I cut. For elective colon surgery, the antibiotics are continued for 24 hours post-op. This is accepted standard of care. You don't want to give antibiotics inapprpriately or continue them indefinitely.

But what about a patient with gangrenous cholecystitis or acute appendicitis? What if, in my clinical judgment, I want to start the patient on antibiotics right away (i.e. several hours before anticipated incision time) and then continue them for greater than 24 hours post-op, depending on what the clinical status warrants? I should be able to do that right?

Well, you'd be surprised. You see, at two different, unaffiliated hospitals I cover, the surgeons have seen that decision-making capability removed from their power. If a young patient comes in with acute appendicitis and I feel that it would be prudent to continue the Zosyn an extra couple of days, an automatic stop order is triggered in the department of pharmacy and the antibiotic is stopped after 24 hours, no matter what. Unless the surgeon specifically writes "please do not stop this antibiotic after 24 hours; it is being administered for therapeutic purposes, not prophylaxis", the antibiotic will not be sent to the patient's floor for administration. As a result, patients end up being treated sub-optimally, and potentially harmed, due to an over-emphasis on "protocol" and "quality care metrics".

Similarly, the 60 minute timeline for preoperative antibiotic administration can be problematic. I have had patints come into the ER with appendicitis or cholecystitis and, in my pre-op orders, write for Zosyn or whatever, to be started ASAP, no matter what time the operation is scheduled. Not too long ago, I admitted a gallbladder over the phone at 2am. I gave the nurse admitting orders which included one for a broad spectrum antibiotic.

When I saw the patient in the morning, I added her on to the OR schedule. By the time a room opened up, it was about 1030AM. The OR nurse asked me if I wanted to give an antibiotic for the case. I told her that the patient was already on antibiotics as part of her admit orders for treatment. The nurse shook her hand. It had never been given; the floor nurse held it so that it wasn't administered until 60 minutes before the scheduled OR time, just like the algorithm dictates--- despite the fact it had been ordered nearly 8 hours prior to the case, not for peri-op prophylaxis, but for treatment of an established pathology. And there it was, the cefotetan, hanging on her IV stand. Now nothing bad happened but here you have a situation where health care providers are so terrified of violating Quality Assurance Protocol that they end up withholding necessary treatment. It's just astounding.

As surgeons, we have bitched and moaned. You would think that these issues would be quickly rectified. But no. It is the responsibility of the surgeon to write qualifying statements for therapeutic antibiotics because the default mode is to override a licensed physician's clinical judgment. This is what I'm talking about when I say that blind allegiance to a top-down, systems analysis-driven algorithm can turn everyone involved in health care into a bunch of mindless drones.

Errata- In a previous iteration of this post, I mistakenly substituted NSQIP for SCIP. I mix them up all the time. The above version is now correct.

Thursday, June 2, 2011

Macho Man!

The very driven Maggie Mahar has a sweet takedown of little old me over at her Healthbeat blog. Please go check it out pronto. I've read through it a couple times, in addition to the attached comments, and I must say I honestly feel thoroughly Tressel-ized. I learned quite a few interesting facts about myself of which I was heretofore previously unaware. According to Ms Mahar I am pretty much an asshole who manifests a "macho" attitude toward patient care. I exhibit paternalistic and faintly misogynistic chracteristics. I have no compassion, in fact I have "contempt", for the poor and uneducated patients of America. I'm also not very eloquent, an assertion I wouldn't ordinarily object to, but it certainly isn't because I haven't been "a regular contributor to the New Yorker". Adam Gopnik is horrible. And I can't stand Hilton Als and Sasha Frere-Jones. Tom Junod at Esquire writes circles around everyone at the New Yorker. But anyway.

The bottom line is this. I agree with Atul Gawande on some things and disagree (vehemently) on others. We can have a back and forth debate like gentlemen. But that wasn't the point of my previous blogpost. The point was to draw attention to the fact that the commencement address was lame and uninspiring and completely inappropriate, given the context. I mean, this was a medical school graduation speech! The graduating students had just spent the past 12 years grinding through a very rigorous and exhausting phase in their lives. And now they are to embark upon a life of selfless labor, dedicated to the well being of their future patients. To use that moment as an opportunity to give a wonkish health care policy speech is entirely self-serving and, well, boring.

In fact, Dr Gawande was in the area last weekend when my little sister got married. I saved the transciption of his wedding toast:

"Jen and Brandon, congratulations on your recent betrothal. I know it's exciting and all but please beware of indulging your romantic fantasies too much. The truth is, we Americans don't do so well at the institution of marriage. Over half will end in divorce. Domestic violence is on the rise. Children can be emotionally scarred by the fallout from broken homes. I would advise you to throw away your Shelley and Lord Byron, your Shakespearean sonnets, your anachronistic Valentine's Day traditions. Such mindlessness is old school and inappropriate in the modern age of love and marriage. Instead, I would encourage you two to engage one another in more actionable displays of a solid married life. Instead of random weekend getaways, consider a more robust, algorithmic approach to love. Those warm fuzzy feelings you get from time to time are completely unpredictable. Do not trust them. It is a cowboy mentality to lose yourself in a sappy loving brain goo. You have to collaborate in a pro-active, value added fashion. My wedding gift to you is a special Love Checklist that I have released to you, free of charge, prior to its intended publication date in the fall. Please review it and implement its tenets and re-purpose its structure for your own needs. Thank you. Again, my heartfelt congratulations."

/cue electric slide.