A point-counterpoint on commerce in medicine

In an earlier post about the CME Thought Police I briefly mentioned Tom Stossel’s piece on the proposed ban on commercial support of CME and larger issues regarding the interface between commerce and medicine. Stossel cites an inquisition against commercial influence in medicine. He appeals to a nuanced and careful analysis of risks and benefits of commerce and believes that guidelines for ethics and policy should be based on careful examination of evidence rather than extreme philosophical bent. To conclude that commercial interests are invariably conflicted with medicine’s professional ideals is simplistic, he said.

Read Stossel’s commentary, then go read a rebuttal by Howard Brody and an accompanying comment thread. I’ll have a thing or two to say about those in a future post.

Activated protein C from bench to bedside

Early this year the Surviving Sepsis Campaign downgraded its recommendation for activated protein C based on new evidence. I blogged it here. At about that time the journal Critical Care published a supplement containing a series of basic science and clinical topics on the use of apC and how it fits in with the overall management of sepsis.

Toxicology for the hospitalist

This review from Chest belongs in your list of references. You’ll find out how the latest evidence applies to questions such as these:

What tests are indicated when?

What is the role of the gaps (osmolar, anion and oxygen saturation) in establishing a diagnosis?

What is the role of GI decontamination?

When does the Rumack-Matthew nomogram fail to identify patients with acetaminophen toxicity in need of treatment with N-acetylcysteine?

What are the indications for hemodialysis?

Pacemaker ECG interpretation

A guide from the November 2001 issue of the American Journal of Emergency Medicine.

Medical management after acute coronary syndrome

----with a focus on post discharge antiplatelet agents.

Eli Lilly and the Surviving Sepsis Guidelines

Recent blistering attacks on the Surviving Sepsis Guidelines have made a large appeal to public distrust of the pharmaceutical industry (specifically Eli Lilly) with little regard for the actual evidence. I originally made that point here and here. Critics implied that the guidelines were little more than marketing for Lilly’s activated protein C (Xigris). They were proven wrong when the guideline authors remained true to the evidence by downgrading their recommendation for Xigris in the 2008 update.

A commentary just out in the journal Critical Care made those same points:

Some have argued that the campaign is simply advanced marketing for activated protein C. That Eli Lilly are interested in promoting education in the field of sepsis because they have a product to treat sepsis is unquestionably true. But the multiple checks and balances outlined above prevent any direct influence in the guidelines content. While the consensus process included a number of proponents of activated protein C, it also included some of activated protein C's more vocal critics. If Eli Lilly's primary objective is to cast their drug in a favourable commercial light, they have shown questionable judgment in supporting the SSC, as the current recommendation for activated protein C use in sepsis is a weak one.

You mean those free gifts don’t work after all?

Critics of pharmaceutical industry detailing like to accuse doctors of taking "bribes" in the form of small gifts in return for prescribing non-evidence based medications. Their premise: "The drug companies wouldn’t spend all that money on small gifts if it didn’t work." Well, if you believe the converse of that statement, as #1 Dinosaur does, it doesn’t work:

I have no doubt in the world that the recent withdrawal of pens and mugs from the drug reps' goodie bags is nothing more than the result of a consultant's report that the return on that investment is not worth it.

Maybe. The lobby opposing all forms of interaction between industry and the medical profession has focused on the giving of small gifts because it’s the easiest target for ridicule. What the Dinosaur refers to, the latest move by the industry trade organization (Pharma) to stop the gifts, may just take some of the wind out of their sails.

And that tired canard that accepting gifts is taking money out of our patients’ pockets because it drives up drug prices can now be put to the test, right?

You can access the new Pharma code here.

Bill Maher’s prescription for health care reform

One hundred cc of get up off your ass STAT!

Best hospitals?

U.S. News and World Report’s best hospitals list is out. Ironically, all but 4 of the 19 hospitals (Cedars-Sinai, Hopkins, Wash U. and University of Pittsburgh) also made the Academic Woo Aggregator.

To all Wal-Mart haters

DB’s recent posts on these topics give me an excuse to write about Wal-Mart. Disclosure (aside from the fact that I have a little Wal-Mart stock): I live about 5 miles from Wal-Mart corporate headquarters. The quality of life and the professional opportunities in my community are attributable in no small part to Wal-Mart. Wal-Mart and Mr. Sam (as the locals called him) helped transform a few sleepy towns into a small metropolitan area with an ever-expanding list of amenities. Yes, I’m conflicted.

Last Monday DB quoted Sam Walton:

Outstanding leaders go out of their way to boost the self-esteem of their personnel. If people believe in themselves, it’s amazing what they can accomplish. - Sam Walton

There are many Mr. Sam stories circulating around which attest to the fact that he believed in people. Here’s one:

Back in the late 80s, when I was a teenager, I worked at a restaurant on the MO-AR stateline called the Stephenson's Cider Mill. At the time, this was one of very few restaurants in the area. Mr. Sam and his family visited many times.

On a busy Friday night, I was elected to be the "bun girl", which meant I would have a basket of hot rolls and would hand them out to customers that wanted one. In a hurry to get hot rolls to our customers, I left one of the dining rooms and started running quickly to the other dining room. (I knew I wasn't supposed to be running in the hall, do teenagers ever listen?) Mr. Sam was coming around the corner at the same time and I ran right into him, almost knocking myself down. Hot rolls flew everywhere! He helped me pick them up, shook my hand and said keep up the good work! He was a wonderful person!

On Wednesday DB praised the Wal-Mart $4 generic drug program and quoted from a Wal-Mart hating web site:

Rep. Pennartz, for her part, expressed concerns for independent pharmacists across the country, who would face serious difficulties matching Wal-Mart’s low price. Independent businesses are certainly struggling to keep up with Wal-Mart’s pricing, but Pennartz’s concerns reveal a larger point: Wal-Mart’s $4 generics are aren’t an answer to America’s health care problems, they’re a way for Wal-Mart to make more money. Whether that means luring in Medicaid recipients who need cheaper drugs, getting employees to use the company pharmacies for their prescriptions or driving out competing pharmacies, Wal-Mart is only looking out for one thing: itself.

Catch the logic: The company benefits from the program, so it doesn’t matter that it helps patients.

So, Wal-Mart haters of the world, lighten up and watch this vid. It’s pretty funny.

Wrong side surgery

Reading CEO Paul Levy’s post about the recent episode of wrong side surgery at his institution and Bob Wachter’s reaction I’m left wondering. This evokes all kinds of questions and reactions, a few of which I want to share here. Lest I come across as insensitive or cynical I first want to say that judging from Levy’s post and the comments of some of the people who work with him, it’s clear the folks at Beth Israel Deaconess Medical Center (BIDMC) take safety very seriously. I can only imagine what they and the patient must be going through.

Wachter deals with two dimensions of safety, starting with the notion that our obsession with “throughput” (Wachter also refers to it as “production pressure”) may threaten patient safety. The OR crew at BIDMC was having a hectic day, full of distractions. But today’s culture of production pressure makes every day hectic. Some see throughput itself as a safety goal because of its ultimate impact on ER crowding. That goal may come into conflict with other safety and quality concerns as I observed in Wednesday’s post on early goal directed therapy in which I quoted a rant from an academic leader in emergency medicine (italics mine):

The crowded ED is a blatant patient safety issue, much more so than medication reviews by pharmacists, medication reconciliation, time-outs, or two patient
IDs.

A time out, omitted in this case, would have averted the error. Wachter goes on to address the issue of blame surrounding the failure to observe the time out. While boosters of today’s patient safety movement purport to deemphasize blame their efforts have had the opposite effect as I noted here, here and here. Wachter asks whether this is a situation where we should go beyond our systems approach and actually assign blame. Not if it’s a case of human error, he concludes, but perhaps so if individuals are found to have flouted established safety measures. We don’t have enough information about this case to make the call.

What surgical procedure was actually done? We aren’t told, but given that it was characterized as wrong side we know it involved a structure of bilateral symmetry. And, from White Coat Notes (linked from Levy’s post) we learn that it was not an organ removal and did not result in permanent harm. Was it a biopsy, an arthroscopic procedure or carpal tunnel release?

Whatever it was the hospital is apparently not threatened with huge financial loss. Levy’s candor, laudable as it is, must be viewed in that context. After the OR staff disclosed the error to the patient Levy emailed the entire hospital staff, the Boston Globe and other media about the incident! But what if the patient had renal cell carcinoma and had the wrong kidney removed, sentencing him/her to long term hemodialysis? Would Levy have responded in the same way? I doubt it. If he shared such an incident with the media Beth Israel’s attorneys would have concerns and the malpractice carrier would arguably be within its rights to refuse coverage. One of Levy's commenters said:

Because the team of doctors are working so hard for everything to be perfect, they need assistance from a protocol ambassador that will check final review before any procedure starts. The ambassador will then give the green light to go ahead with the procedure. This would eliminate a number of errors.

Not a bad idea. The ambassador, an outsider not in a hurry and not distracted by other details of the case, would have added a layer of safety and likely have averted the error. So I was a little disappointed in Levy’s response:

I have to respectfully disagree.In my view, you have the right sentiment, but the wrong cure. Nobody should need to be appointed to go in to the OR to make sure a time out is done. That is the responsibility of the surgeon, first, and everybody else, too. That happens in the overwhelming majority of cases. It did not here. The goal is to make sure it does. But, if you take away the responsibility from those who should own it, you don't ever get to the result that is needed.

The exchange highlights a fundamental question. In response to an incident such as this should we look for someone to blame or should we look to improve system design? Design is the first principle of today’s patient safety movement. Adding a final check point in the form of a protocol ambassador is a design enhancement. It adds a safety net; it doesn’t remove responsibility from anyone.

Some might ask how many more safety nets we need in a system already designed with redundancies. A review of wrong site surgery in the Annals of Surgery (reproduced in Medscape) suggests that the time outs and check points now in place are not enough; wrong site surgery still occurs at an alarming rate. Suggestions for design improvement were made in the discussion at the end of the article: Withhold instruments from the surgeon until the time out is done; hold a briefing among OR personnel before entering the OR (in addition to the last minute time out in the OR); require documentation of the time out in the op note.

Donald Berwick, safety expert and leader of the Institute for Healthcare Improvement (IHI) addressed this issue in his talk at SMH 2008. Berwick is a big advocate for system design. He believes asking individual doctors to be more vigilant and take more “ownership” of patient safety is 180 degrees wrong. Doctors in general are conscientious and work at top speed, he said. If the surgeon at BIDMC is an exception to this rule it will be revealed in the root cause analysis and can be addressed appropriately.

Why haven’t we done a better job of implementing early goal directed therapy?

Last December the journal Critical Care ran a supplement on the treatment of sepsis focusing on activated protein C. One article I found useful was a general overview of sepsis management. It gave an insightful analysis on putting best evidence into practice. That seems to be a particularly difficult task when it comes to early goal directed therapy (EGDT).

With the exception of timely and appropriate antibiotic therapy EGDT is the most robust of the measures advocated in the Surviving Sepsis Campaign. Despite that fact, as well as the fact that it’s been several years since publication of Rivers’s classic paper validating EGDT, implementation is not as widespread as it should be. Even after all these years we seem to be in the talking stage of implementation. Why?

Barriers to implementation are both institutional and cultural. I mentioned the institutional barriers before. Briefly, when it’s not a “core measure” that will show up on public report cards it’s difficult to convince a hospital to commit resources. (Unfortunately, hospital administrators probably don’t realize that EGDT shortens ICU stay and can save money). Should EGDT become a publicly reported core measure? I doubt it. Think of the unintended consequences---hasty and ill advised central lines, transfusions and inotropes come to mind.

A significant cultural barrier may exist in the emergency department, where EGDT, or at least its initial phase, is supposed to be carried out. But with the current concerns over ED crowding the big push nowadays is “throughput.” Just read emergency medicine professor Richard Bukata’s rant on ED crowding in a recent piece from Emergency Medicine News:

The philosophy is to sacrifice the ED and its patients for the sake of the rest of the hospital. Until recently, the perceived consequence of this decision was to reinforce the general beliefs of the community that EDs are associated with long waits and a litany of other indignities.

ED staff become frustrated and exasperated because it seems they are powerless to change the situation. The concept that excess patients are, in reality, a hospital challenge rather than simply an ED challenge has been a tough sell when you look at the typically impotent actions taken to address the problem.

and…

…why aren't regulatory agencies interested in the problem? It is obviously dangerous to be working in an environment that is substantially over capacity. It is obviously a problem when ED patients wait hours to see a doctor. It is obviously a problem when the rate of patients leaving the ED without being seen is five percent to 10 percent. With the mantra of patient safety on everyone's lips, how can these obvious problems be overlooked? It would be one thing if there were truly nothing that could be done, but this is fundamentally untrue. There are myriad solutions that have been demonstrated to facilitate turnaround times in the ED. It requires the hospital leadership (both medical staff and administration) to have the stomach to make some hard and not-so-hard
choices.

Why not offer incentives? If the CEO's annual bonus were linked to ED patient throughput, it is guaranteed that most hospitals would see their problem solved. This may sound like an inflammatory statement, but truly, the only one who can fix the ED problem is the CEO. It is a top-down initiative. Driven by money or fear, it can be fixed. Money has already been suggested; make it a criterion for the bonus, and watch what happens. But what about fear? For all practical purposes, the most feared entity in the hospital world is the Joint Commission, and its ability to shut down a hospital gives it unprecedented clout. So why hasn't the Joint Commission taken on the hospitals, given its passion for patient safety and multiple initiatives in this matter? The crowded ED is a blatant patient safety issue, much more so than medication reviews by pharmacists, medication reconciliation, time-outs, or two patient IDs.

Clearly safety concerns surrounding ED crowding may, in the minds of some, be in conflict with other quality and safety goals including the implementation of EGDT. The notion that some patients, even after being designated for admission, should remain in the department for an extended time to receive ongoing treatment may be foreign to some ED types. In Rivers’s original study the entire six hours of EGDT were delivered by the ED (the intensivists in the ICU were blinded to the type of ED treatment patients received). Such an arrangement would be impractical in many departments and undoubtedly evoke howls of protest from ED personnel.

Although the review cites evidence of poor ED adherence to sepsis guidelines (one example here) this paper reports successful ED implementation. In most institutions collaboration across hospital departments works best. Initial rapid screening can be done in the ED. If the patient is eligible for EGDT a sepsis page is sent. A sepsis team presents and initiates therapy. The protocol continues in the department until an ICU bed is available.

Lipid lowering drugs underutilized

This survey from the American Journal of Cardiology looked at factors associated with more evidence based prescribing.

TTP and related disorders

Reviewed in CCJM.

Background:

Thrombotic microangiopathies.

Platelets on the Web (from OUHSC).

Obesity can be costly

---to you or someone on your behalf, despite a shortened life span, according to a study of obesity related health care expenses.

Internet meltdown ahead?

Is this a real concern or just another Y2K scare?

Thoughts on the 4 hour rule and other core measures

Bob Wachter’s post on the 4 hour pneumonia rule lists these lessons to apply to future quality measure development:

First, results from studies of patients with known diagnoses should be extrapolated cautiously, if at all, to patients who lack a diagnosis.

Second, or some measures, “bands” of performance (i.e., 80-100% adherence) may make more sense than “all-or-nothing” expectations.

Third, representative end users of quality measures (in this case, ED docs and hospitalists) should participate in measure development.

Fourth, quality measurement and reporting programs should build in mechanisms to reassess measures over time. In this case, CMS and the Joint Commission are to be praised for listening to the chorus of criticism: in response, the measure has been revised from a 4-hour to a 6-hour standard. Even though a 6-hour TFAD rule is still not evidence-based, it should cause less harm.

Finally, biases, both financial and intellectual, that may influence quality measure development should be minimized. The TFAD measure was proposed and endorsed by many of the same people who conducted the foundational studies. None of us can be completely unbiased when evaluating our own research results.

These are important lessons for developers of quality measures. But I think there may be an even larger lesson for us “end users.” One of Wachter’s observations is telling:

As I’ve discussed previously, the biggest surprise of the last decade in the quality field has been this: public reporting alone (even without pay-for-performance) leads to huge changes in the behavior of providers and healthcare organizations… even though there is virtually no evidence that patients are reading or acting on the reports.In other words, shame and pride are powerful forces for change.

The lesson? Shame and pride are about me, us, our institutions. Shame and pride motivate us to play for the test. It’s called performance. I would submit that real quality is something different. Real quality is not about us or our public reports; it’s about the patient. Yes, shame and pride get results, but are they may not be the results we want.

The 4 hour pneumonia rule is just one example of the conflict between what performs well and what really works for patients. Last year I commented on the disappointing results for heart failure core measures:

The rush by hospitals to get a good report card may have diverted attention from other life saving therapies such as devices and aldosterone receptor antagonists.The first quality measure was the provision of discharge instructions on medications, diet and other aspects of heart failure care. In one study on which this recommendation was based the instructions included a full hour of one-on-one verbal counseling. The intervention was associated with improved outcomes. The “core quality” measure, in contrast, required only that written instructions be given to the patient. It’s one thing to hand patients a ream of paper as they are rushed out the door and quite another to provide detailed counseling. Nominal compliance may earn the hospital a perfect report card while doing little of substance to help patients.

DB weighed in here.

The four hour antibiotic rule for pneumonia is a sentinel event

---in patient safety policy. Bob Wachter, a leader in the field, said so and I agree. Like every sentinel event it deserves a root cause analysis, which Wachter and his colleagues provided in an article in the current issue of Annals of Internal Medicine.

Via Kevin MD

Neurotoxicity of cefepime

All beta lactam antibiotics can cause neurotoxicity, chief among them penicillin and imepenem. A paper showing increased mortality associated with cefepime use suggested neurotoxicity, including encephalopathy and non-convulsive status epilepticus, may be responsible for the increased mortality. Now comes this report suggesting severe neurotoxicity of cefepime in patients with renal failure. I have access only to the abstract, but a review citing this report suggested that cefepime was not renally adjusted and some patients were massively overdosed.

Neuro exam tips

---focusing on the cranial nerve and cerebellar exam. From Today’s Hospitalist.