Fallout from our Medscape Roundtable on industry support of CME

There’s been quite a bit of feedback in Medscape and the blogs. We’ve had 48 responses so far in the Medscape Physician Connect discussion thread. Consistent with every other poll I’ve seen published, participants overwhelmingly oppose a ban on industry support. 23 comments so far are in opposition to the ban, 4 are in favor and 21 are unclear, neutral or off topic.

There have been at least a couple of blog reactions. Predictably, the Carlat Psychiatry Blog was negative toward my position. But the entry was strangely titled “I’m a physician. I deserve nice things.” My Medscape piece merely demanded evidence to justify restricting doctors’ choices of educational content. What does that have to do with nice things?

Darvon’s days may be numbered

The FDA may be about to yank it after decades of use. According to the CNN report:

The FDA said a review of its adverse-event reporting data base showed 3,028 serious and non-serious reports from 1957 through Sept. 24, 2008, associated with propoxyphene. Of those, 2,136 reports were considered serious and included 1,452 deaths. Many of the serious-event reports included reports of suicides, intentional drug overdoses, heart attacks and unintentional drug overdoses, the FDA said. The agency said some of the serious adverse-event reports also listed more than one type of drug.

That’s nothing compared to the methadone body count, so why pick on little old Darvon? Well, they were under pressure from Public Citizen. They sued to get the FDA’s attention.

More here in a great post from Dr. Wes.

Before the Internet was ready for prime time

---this is what they were saying (1981).




Remember this next time you’re in the Wi-Fi zone at Starbucks catching up on the news.

(Mike Anderson at StL Media says those are Tandy computers).

Hospitalized patients need to know: Who’s on first?

Patients on an inpatient service were asked to name the doctors on their care team. Here are the study results:

Of 2807 patients, 2110 (75%) were not able to name anyone when asked to identify an inpatient physician in charge of their care. For the 697 patients who responded with at least 1 name, only 281 (40%) were able to correctly identify 1 inpatient physician on their team.

This was a busy medicine teaching service with a lot of hand offs staffed by academic attendings, house staff, students and night float personnel. It was not the typical hospitalist model of care. However, there were some non-teaching hospitalists in the mix to accommodate resident work hours, and the lessons learned here apply to many hospitalist programs where shift based work routines result in numerous hand offs.

More from Wachter's World.

Heparin for septic shock???

Activated protein C decreases mortality in patients with sepsis and a high risk of death due to its anticoagulant and anti-inflammatory properties. Why not something cheaper that does the same thing? In this study unfractionated heparin decreased mortality in the most severely ill patients (APACHE II 29-53) with septic shock. It’s not ready for prime time and the findings need more validation. It was not a RCT, but rather a propensity matched retrospective study. Although patients with an admitting diagnosis of acute coronary syndrome or pulmonary embolism were excluded, many patients in the treatment group had their heparin started because of an elevated troponin level or clinical suspicion or VTE.

Editorial comment here.

Recruitment maneuvers in ARDS/ALI---ready for prime time?

Not for routine use according to this systematic review although they may be considered in patients with life threatening hypoxemia.

Background: My previous literature review here.

There’s exceptional blogging about hospital medicine going on

---at The Ether Way. It’ll show up on my blog roll when I get around to updating it.

Should all medical journals be considered “throw-away” journals?

That’s what you might conclude after reading Dr. Marcia Angell’s recent JAMA commentary. (H/T to Retired Doc for alerting me to the article). Angell is concerned about the corrupting influence of the drug industry on research reporting in peer reviewed medical journals. Citing the conflicts of interest that plague present day clinical research, she too is conflicted. She discloses this at the end of the article:

Dr Angell reported receiving royalties from her book The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

In fact, Angell seems to have devoted a great deal of her career over the past decade to criticizing the pharmaceutical industry.

In the first several paragraphs she goes through the usual litany of concerns: conflicts of interest, publication bias, rigged designs and spinning of results. These are valid concerns, but Angell, simplistically putting almost all the blame on industry, wants a government solution:

I have proposed that an Institute for Prescription Drug Trials be established within the NIH to administer clinical trials of prescription drugs, including the premarketing trials that will be submitted to the FDA as a part of new drug applications.

The implied premise, that taking clinical trials out of the hands of the pharmaceutical industry would solve the problems, is faulty. The problems Angell cites permeate non-industry supported research and the government is no exception. Examples abound. I have noted just a few in previous posts: [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14]

But this is over the top:

Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years.

Does Angell think simplistic readers’ acceptance of this alarmist statement will rally support for more government control? Complete government control of the performance of clinical trials and their publication is not likely to happen soon and, for the reasons I stated, would not solve the problem.

What then are practicing doctors to do? Angell’s statement above suggests that in the current environment the practice of evidence based medicine and science based medicine are impossible. Nonsense. EBM is premised on the fact that all research reports have weaknesses and are to be viewed with skepticism. SBM, recognizing that EBM lacks the tools to examine all claims, goes a step further by evaluating reports in light of prior research and scientific plausibility. In short, doctors have the tools to critically appraise the medical literature. It’s hard to believe Dr. Angell wants to abandon EBM altogether. More likely she would revise EBM’s evidence pyramid to look something like this: (Click image to zoom).

Before you use the D dimer to rule out VTE

---do a clinical assessment first, using a tool such as the Wells score:

From the paper in Chest:

In the patients with an unlikely probability of PE (n = 477), VTE was confirmed in 1.1% of the patients with a normal d-dimer concentration (95% CI, 0.4 to 2.4%). In those patients with a likely clinical probability of PE (n = 86), VTE was confirmed in 9.3% of the patients with a normal d-dimer concentration (95% CI, 4.8 to 17.3%). The difference in VTE incidence between patients with unlikely and likely clinical probabilities of PE was significant (p less than 0.001).

A regimen for MRSA decolonization

The use of topical mupirocin as monotherapy for decolonization of hospitalized patients has been disappointing. Here is a paper detailing the effectiveness of a multi-agent topical and systemic regimen.

The indications for decolonization are not well defined but this regimen can be considered for patients who have repeated presentations with MRSA infection.

Clinical trial enrollment suspended

---amidst concerns about ethics breeches, conflicts of interest, safety, and investigator qualifications. The latest Pharma funded study, you’re thinking. No, it’s funded by a branch of the NIH. It’s none other than the Trial to Asses Chelation Therapy (TACT). The NIH is keeping mum about this---no announcement has been issued. In fact, the guvment’s official web site says the study is still recruiting participants!

Although I smelled the rat and started agitating about this over two years ago I’ve been a little remiss in keeping up with recent developments and missed this Science Based Medicine post last fall concerning the suspended enrollment. What finally tipped me off was an article from the International Journal of Clinical Practice posted January 22 in Medscape. It reads, in part:

A comprehensive review of the TACT trial by Atwood et al.[2] calls into question the safety of the study and highlights deficiencies in the NIH application process, economy with detailing the adverse effect potential, inappropriate political pressure to undertake the study and failure to provide complete data on conflicts of interest, especially investigator financial gain. The authors concluded in May 2008:

"... TACT is unethical, dangerous, pointless and wasteful. It should be abandoned."

That review, a powerful expose of the corruption associated with the trial, was published in the Medscape Journal of Medicine and may have had something to do with the suspension of enrollment.

Among the allegations swirling around TACT is that it violates provisions of the Declaration of Helsinki. I can think of a number principles being violated, one of which is that:

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

That principle, that research be based on “generally accepted scientific principles,” proscribes (or ought to) many forms of woo based research currently being supported by NCCAM, the Consortium of Academic Health Centers for Integrative Medicine and the Bravewell Collaborative.

Narcotic use associated with delayed diagnosis and more severe C diff.

Via Hospitalist News.

If some one makes malicious or blatantly false statements about you on Rate MDs

---there’s not much you can do according to this Medical Economics article.

Here’s a sampling from the article:

"WORST DOCTOR AND STAFF I HAVE EVER EXPERIENCED!! DO NOT SEE THIS HORRIBLE DOCTOR!!"

"I feel like I was just another number at the office."

Incidence and predictors of post-thrombotic syndrome

Via Annals of Internal Medicine:

At all study intervals, about 30% of patients had mild (score, 5 to 9), 10% had moderate (score, 10 to 14), and 3% had severe (score greater than14 or ulcer) postthrombotic syndrome. Greater postthrombotic severity category at the 1-month visit strongly predicted higher mean postthrombotic scores throughout 24 months of follow-up (1.97, 5.03, and 7.00 increase in Villalta score for mild, moderate, and severe 1-month severity categories, respectively, vs. none; P less than 0.001). Additional predictors of higher scores over time were venous thrombosis of the common femoral or iliac vein (2.23 increase in score vs. distal [calf] venous thrombosis; P less than 0.001), higher body mass index (0.14 increase in score per kg/m2; P less than 0.001), previous ipsilateral venous thrombosis (1.78 increase in score; P = 0.001), older age (0.30 increase in score per 10-year age increase; P = 0.011), and female sex (0.79 increase in score; P = 0.020).

Diagnostic approach to muscle disease

A comprehensive review in Seminars in Neurology.

All you need to know about homeopathy

---and other forms of woo.

Low tidal volume ventilation for ALI and ARDS---read the fine print

The care of patients with ALI/ARDS was revolutionized several years ago with publication of the ARDSnet trial of low tidal volume ventilation (LTVV). Recently investigators reporting in Critical Care Medicine looked at an underappreciated complication of LTTV: breath stacking. Breath stacking refers to patient triggering of machine breaths in rapid succession. When two or more breaths occur in sufficiently close proximity they behave as a single breath with higher tidal volume.

The low tidal volumes recommended following publication of the ARDSnet trial are insufficient to satisfy the dyspnea of many mechanically ventilated patients, leading to more frequent inspiratory efforts and, consequently, breath stacking. The resulting high tidal volume (which is easily determined as the area under the curve of the flow-time graph) counters the beneficial effects of the LTTV strategy.

According to the Critical Care Medicine paper breath stacking occurs frequently, is often unrecognized and is more frequent with lower set tidal volumes. Although breath stacking can be mitigated by increasing the tidal volume or via sedation (both of which are allowed for in the ARDSnet protocol) breath stacking in this patient series was frequent despite deep sedation.

An editorial in the same issue of the journal suggested that slavish adherence to the protocol may have served as a substitute for clinical judgment, leading to failure to recognize and address the unintended consequences. There’s a larger lesson to be learned here regarding the application of EBM.

Background:

Practical aspects of LTVV via NEJM.


ARDSnet resource page containing the LTVV protocol, determination of dosing body weight for tidal volume, the PEEP scale and more.

Ventilator graphics made easy.

(±)-1-(Isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)- tartrate, 5mg IV STAT!

That’s how you’d be writing for IV metoprolol if a proposal from a few years ago had taken hold. It made sense. Many eschew brand names because they’re too commercial. But all too often forgotten is the fact that official (i.e. generic) drug names are also chosen by the companies during development. Who knows, they may contain subliminal messages. Then there’s the issue of sound alike generic names that lead to medication errors. Why not play it safe and use scientific nomenclature?

DM 2 update

Since publication of guidelines for type 2 diabetes a number of negative trials and cardiovascular safety issues have surfaced. A new evidence synthesis was needed, and authors of a review published in the January 1 issue of American Family Physician took a stab at it. AFP is no longer open access so I can’t link to the full article, but this Medscape CME activity provides a summary. (The CME content is non-industry supported).

Problems with VA’s EMR

A tip of the Dr. RW hat goes to Retired Doc (glad he’s back from his blogging hiatus, by the way) for reporting this story:

The top Republican on the House Veterans Affairs Committee
demanded Wednesday that the VA explain how it allowed software glitches to put the medical care of patients at its health centers nationwide at risk.

Reading between the lines of this report it appears there were two issues, one of which, patient data showing up under the wrong name, was indeed a glitch. The other issue, inappropriate medication stop times, may be more complex and illustrative of a more pervasive problem in how we use EMRs.

Disclaimer: I have never used the VA EMR but I have received electronically generated records from the VA and talked to some users. The print outs have a lot of electronic clutter. Frustrated users describe multiple mouse clicks for simple tasks. I can easily imagine the resulting user fatigue making it difficult to follow order trails. A more general problem with hospital EMRs that feature CPOE is that secretaries and nurses are disengaged from their traditional roles in order processing. Consequently an important safety net is removed. That’s a problem with the culture around implementation of the EMR rather than the EMR itself.

Specifying the duration of medications by directly entering start and stop dates is counterintuitive to how we did it in the paper days not to mention distracting to the traditional clinical train of thought. In the paper environment I could order a tapering course of steroids by writing “Solumedrol 80mg IV Q 6 hours x 4 doses then 40mg IV Q 6 hours x 4 doses then 20mg IV Q 6 hours x 4 doses then D/C.” Although it was clear to me and others exactly what I wanted clinically the order processing was, for me, a black box---not what I was trained to do. The secretary and nurses, knowing my clinical intent, took care of all the entry and processing stuff, and all the checking and double checking to make sure it happened as intended. Not fail safe, but worked well. All those layers of safety are gone in the electronic environment, where entry and processing are in the doctor’s lap. So I can imagine a gazillion ways infusion times got messed up in the VA system by virtue of design, not necessarily a glitch.