Panda Bear quits blogging

Nothing mysterious about it. He explains his reasons. This is a great loss.

Additional blog reactions to Medscape paper on NCCAM’s chelation study

Science Based Medicine

Health Care Renewal

These are similar postings by one of the authors of the Medscape piece, containing an excerpt.

My reaction was here.

Quackademic medicine at Yale

It’s been a good week for the exposure of the fraud, corruption and pervasive conflicts of interest in high places in the world of woo. Just last Tuesday the Medscape Journal of Medicine published an article exposing the bad science and pervasive conflicts of interest behind the National Center for Complementary and Alternative Medicine’s ongoing chelation trial. Today David Colquhoun, blogging at DC’s Improbable Science, wrote about Integrative baloney at Yale in which he exposed, with videos and other examples, some of the wooiest of woo being taught there.

Junkfood Science recently blogged about the program at Yale. Concerning the general problem of medical academic woo she wrote:

Some have questioned if CAM-trained doctors are able to practice as primary care physicians and if we can trust their judgments. The concern that probably most comes to mind is whether these doctors are being taught the scientific process and how to recognize sound evidence from modalities that negate all known laws of science and biological plausibility.

She posted a follow up today. Both bloggers mentioned an astounding statement by Yale professor David L. Katz, MD, MPH, FACPM, FACP, associate professor, adjunct, of Public Health and director of the Prevention Research Center (PRC) at the Yale University School of Medicine. From DC’s post:

Pretty remarble uh? Dr Katz goes through several different trials, all of which come out negative. And what is his conclusion? You guessed.His conclusion is not that the treatments don’t work but that we need a “more fluid concept of evidence”.

That announcement by a prominent medical academic made it official: we are in the era of post-scientific medicine.

DC went on:

It’s equally bizarre to hear Richard Belitsky, Dean of Medical Education at Yale saying he is “very proud” of this betrayal of enlightenment values. If this is what Yale now considers to be education, it might be better to go somewhere else.

But where else is there to go? With quackery spreading like MRSA throughout academic medical centers the list of institutions with true scientific integrity is shrinking fast.

DC cited the Flexner report and made a point I wrote about before:

Flexner would have thought it quite inconceivable that in 2007 medical schools would be offering Continuing Medical Education in homeopathy.

He asked why other academics at Yale aren’t up in arms and suggested, earlier in the post, that it’s about money:

Very few university administrators have the intellectual integrity to turn down money, whatever the level of dishonesty that is required by its acceptance. You can buy a lot of silence for $100m…

…citing NCCAM and massive philanthropic funding of academic woo.

By the way, where’s the AAMC in all this? Aren’t they supposed to be guardians of integrity and professionalism in medical education? Are they asleep at the switch or is money silencing them too?

And a final note--- I got the idea for the term “post-scientific medicine” from the Carlat Psychiatry Blog. Dr. Carlat, writing about AAMC’s new proposal to limit the influence of pharmaceutical companies in medical academia, declared that we are now in the era of “post-deception medicine”. I respectfully disagreed.

On the AAMC’s proposal concerning Pharma gifts, I’ve changed my tune---somewhat

A commenter on my recent post about the AAMC proposal took me to task for not reading the report in the original. Although her reasons for suspecting me were wrong (I twice referred to the AAMC as AAMS, typo’s I’ve since fixed) it turns out she was correct that I hadn’t read the report in the original. I had read some blog reactions and the New York Times article, none of which contained a link to the report.

So I did what I should have done in the first place. I went and read the report. Turns out the proposal isn’t so bad. Not as bad as I thought, anyway. I disagree with the scope and the extent of the restrictions proposed and find it odd, even hypocritical, given all their talk about professionalism and integrity in medical education, that they turn their back on the shameful and pervasive problem of woo. Nevertheless, my characterization of the proposal as “simplistic and extreme” was too strong.

I think it was the NYT article that was simplistic. It implied a total ban on free food. Wrong. According to the AAMC proposal, industry-supplied food is permissible if served at an activity carried out according to ACCME standards and accredited for CME. Some academic medical center Grand Rounds, though perhaps not all, are accredited. So, this proposal will not banish free food from the academic environment. Many activities won’t be affected at all. What it may do is encourage more programs to get their Grand Rounds accredited. That would be a good thing.

Moreover, the report doesn’t ban drug reps from medical campuses. It merely sets standards for drug company presentations and requires oversight by faculty. In other words, drug reps can’t just wander in and, like self appointed faculty, proceed to “teach” students free of any administrative supervision!

My big mistake was that I dropped my guard and violated the cardinal RW rule: always, when possible, go to the primary source! That’s what I get for trusting the New York Times.

One more thing. I had to chuckle at Carlat Psychiatry Blog’s declaration following the announcement of the AAMC proposal: The era of post-deception medicine is finally here. No way. We can’t enter an era of post-deception medicine until we leave the era of post-scientific medicine. Selective outrage?

Cardiovascular risk in retired NFL linemen

They have increased cardiovascular mortality and approximately double the risk of metabolic syndrome as compared to other positions. Via the American Journal of Cardiology.

Cognitive errors in medicine

You don’t have to be a subscriber to the American Journal of Cardiology to read J. Willis Hurst’s editorial on cognitive errors in medicine---the full text is free. I highly recommend it.

The popular approach to limiting cognitive error was recently articulated in Jerome Groopman’s marvelous book How Doctors Think. I call it the negative approach to cognitive error because it emphasizes pitfalls to avoid. Hurst’s essay suggests a more positive approach. It outlines things to do in the systematic collection and processing of clinical data. These approaches are complementary and both ultimately address the same types of error.

Hurst’s approach centers around the medical record as a tool for teaching and learning (thus addressing gaps in the clinician’s knowledge), defining data that need to be collected, analyzing the data and applying the information to the patient’s problems. He advocates the problem oriented medical record (AKA the Weed system) of which he has been a champion for many years.

Most of us would say we use the problem oriented medical record as the ever present SOAP notes and problem lists attest. But a careful reading of Hurst’s essay suggests it’s merely a pretense. The problem oriented record as originally conceived is systematic and rigorous. While it seems cumbersome, Hurst notes that it can be utilized quickly and efficiently once proper habits are developed.

The problem list must designate each item at the level of resolution achieved, from symptoms and laboratory abnormalities at the low end to definitive diagnoses at the highest level. Moreover, diagnoses must reflect the most up to date disease classification and terminology.

That raises an important question. Is it possible to generate and maintain a true problem oriented medical record in today’s environment where the record is hijacked by coders, core measure police and others with competing agendas? Just one example of this problem is the basing of diagnostic terminology on the decades obsolete (created in 1977 and replaced in 1992) ICD-9 classification. In paper based records if you use precise and up to date terminology your patient’s chart is likely to “bounce back” from the coding department and ultimately find itself on the delinquent list. In the electronic world where all diagnoses are inseparably linked to ICD-9 codes the best terms may not be available.

An effective medical record is more than an accurate problem list. Hurst writes (italics mine):

The medical record should reveal the thoughts and actions of the physician in charge. The challenge for the physician is to make the record simultaneously brief and complete. The record should be easily understood by another physician. Each page of the record should be uncluttered, and important information should be displayed prominently so that it can be retrieved easily.

I wonder what Hurst thinks of today’s template generated charting.

There’s much more.

The John Ritter defendants---did they really win?

From Emergency Medicine News:

In the Ritter case, the jury agreed with the defendant physicians and exonerated them of any liability. They were lucky. How lucky? They were able to spend four years with attorneys worrying about their future, including the potential that they would be ordered to pay tens of millions of dollars and be left penniless.

So, they didn't really win. They just lost less.

Read the rest here.

Medscape article blows the lid off of NCCAM’s chelation study

A Medscape article on the National Center for Complementary and Alternative Medicine (NCCAM) sponsored Trial to Asses Chelation Therapy (TACT) declares:

We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.

Orac has already written a wonderful post this morning in which he opines:

As I go to my office and lab this morning, to try to do high quality scientific research based on good science designed to improve our understanding of cancer and hopefully lead to more effective therapies, it galls me to no end to see the equivalent of 15-20 R01 grants going to fund this woo. Worse, it's TACT is not the only example of an unethical and scientifically worthless trial being funded not because the science is compelling but because powerful lobbies and legislators who are true believers in woo applied pressure to the NIH to do them.

I’ll take this opportunity to put in my two cents---not that I really have anything to add other than to say “I told you so” not only about this study but also about the under appreciated conflicts of interest in government funded research. When I first read about this study a couple of years ago I smelled a rat and have since written a number of posts, several of which Orac linked to this morning. The Medscape article reinforces some of the points I made in those posts, particularly regarding the dubious credentials and obvious conflicts of interest of many of the study site investigators. Just look at this jaw dropping paragraph from the article:

The TACT includes nearly 100 "chelation site" co-investigators who, in our opinion, are unsuitable to care for human subjects or to report trial data. Most espouse implausible health claims while denigrating proven methods; several have been disciplined, for substandard practices, by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons. Several were members of the ACAM or GLACM IRBs mentioned above. Few appear to have real expertise, required by TACT literature, in treating patients with CAD or in conducting clinical trials. Most continue to promote chelation while the TACT is in progress, contrary to good science, to human studies ethics, and to US Federal Code. The TACT consent form gives no hint of these points.

WOW!! Worse than even I imagined! This stuff belongs in the health pages of the New York Times. (I won’t hold my breath, though. They’re probably too busy exposing the pharmaceutical companies to notice. I hope I’m wrong!). If those ethical issues aren’t egregious enough consider that the study isn’t even securely blinded from the investigators, a concern I raised here and in other posts. The Medscape article describes the problem:

The experimental solutions must be mixed on-site. The 2003 TACT protocol describes a method to preserve blinding and reports that this "has been piloted successfully," presumably in a supervised, academic setting.[5] Nevertheless, the mixing procedure presents simple opportunities for distinguishing between the chelation and placebo solutions. For example, the site coordinator must inject 14 mL of concentrated ascorbate or sham solution into a 500-mL IV bag. The plan calls for the 14-mL solutions to have similar viscosity and to appear similar in color, but a tiny drop applied to the tongue during transfer would instantly identify the ascorbate by its sour taste. Ascorbate goes exclusively with the Na2EDTA solution.

Orac faithfully reported the same concern:

Not only was the protocol itself scientifically implausible, a mix of disodium EDTA and a bunch of supplements, as well as procaine and heparin added for unclear reasons. it is placebo-controlled, but the protocol stipulates that the chelation solution must be mixed on site, allowing ample opportunity for investigators to break blinding, either purposely or even inadvertently.

That may just be the tip of the iceberg concerning TACTs’ design problems. The authors note that the NCCAM was not entirely forthcoming with information in response to their FOIA requests:

Through FOIA requests, we obtained "redacted" copies of the original (2001) and 2003 TACT protocols,[4,5] the roster of the committee that approved the grant application,[39] and the June 2003 consent form.[6] Because the trial had already begun and because our initial FOIA requests were frustrated by delays and incomplete responses, we did not seek further revisions of the protocol or consent form, or other documents that are not available on the NCCAM Web site.

I knew from the get-go this trial was questionable. I didn’t know how bad it really was until I read the Medscape piece. This tops any example you can trot out about the corrupting influence of Big Pharma. What I didn’t cover in my posts was the extent of the pseudoscientific agenda and conflicts of interest that prevailed throughout the planning and implementation of the study. If you think government funding is the answer to Pharma involvement in research this article will give you pause.

Medicare’s no pay policy

---is only part of the DRG revamp rolled out by CMS last year. There’s also the new list of MS-DRGs which replace the old DRGs. And while it may seem like a lot of BS we’ll have to live with it, so we may as well attempt to learn it. An article in ACP Hospitalist offers some tips. Too complicated for me.

Healthy skepticism about practice guidelines

If you didn’t read DB’s rants carefully you might get the idea he was somehow against practice guidelines. That wouldn’t be accurate. There’s a difference between skepticism and cynicism. A Grand Rounds presentation he delivered on the topic at UC Davis puts his rants into perspective. Here are some of my take home messages from the talk:

Guideline developers have conflicts of interest. This is not unique to those supported by drug companies. Virtually all organizations and individuals involved in guideline development---governments, professional societies and individuals interested in their academic careers---have a stake.

Guidelines are not immutable rules and are no substitute for clinical judgment.

You can’t apply all guideline recommendations to patients with multiple complex problems---you must prioritize treatments.

Guidelines can provide impetus for ill conceived performance measures.

There’s much more. Follow the link above and watch the video. It’ll make you think.

What’s so great about CPOE?

My recent criticism of electronic medical records (EMRs) has focused on documentation templates. Now that I’m on a roll with EMR posts I may as well cover the other side of EMRs---computerized physician order entry (CPOE). The push for universal adoption of CPOE is on. Leaders in the patient safety movement tell us it’s a good thing. So what’s so good about it?

For starters let’s look at the description in AHRQ’s glossary:

Physicians (or other providers) directly enter orders into a computer system that can have varying levels of sophistication. Basic CPOE ensures standardized, legible, complete orders, and thus primarily reduces errors due to poor handwriting and ambiguous abbreviations.

It goes on to point out that many systems have decision support built in: suggested doses, allergy alerts and order sets which conform to evidence based practices. More sophisticated systems may integrate patient data such as weight and creatinine clearance.

No one would dispute that these are good ideas. The real rub is how CPOE does in the real world. Do the benefits outweigh the unintended consequences? Bob Wachter, who has written a couple of recent posts on health care technology, seems to think they do. In last Friday’s post he referred readers to AHRQ’s patient safety network where a search on CPOE yields 174 citations. But the top hit is an article on unintended consequences and contains a link to the fabled Pittsburg study showing an increased mortality following the implementation of CPOE. Then there’s this study showing that CPOE actually creates errors. Clearly there’s a trade off between errors intercepted by CPOE (which may or may not have been intercepted “downstream” in traditional paper based systems) and new and unanticipated types of errors introduced by CPOE.

What is the net result in terms of patient safety? To answer that question we need outcome based data. Such data are sparse, but the Pittsburg study is concerning. To be fair, the negative results of that study may reflect learning curve issues more than inherent risks of CPOE itself. On the positive side, Wachter cites this study. But it’s from Brigham and Women's Hospital, raising questions about real world generalizability. Moreover, the significance of the error reduction attributable to CPOE in the study is unclear from the paper. This very recent systematic review demonstrated CPOE’s ability to intercept many errors but failed to show improvement in patient outcomes.

What’s my bottom line as of May 13, 2008? CPOE is a great idea. CPOE has potential. But the boosters of CPOE have a burden of proof which they have yet to satisfy. It has not been proven to help patients. Why is there such a disconnect between theory and real world results? The downside in terms of creating new errors is well documented.

But their’s a less tangible downside. For clinicians, CPOE is a distraction. What do I mean by that? It adds a new burden to our work flow: order processing. Doctors are trained to focus on clinical issues. We need to know what drug to give, when and how much, and what tests to order. We are not trained in how to search the computer for the appropriate orders, how to customize our therapy when the computer’s options are limited, how to be sure that our order entry is properly routed, or how to devise workarounds that are inevitably necessary in such systems. Those issues, formerly in the domain of clerical employees, are now foisted on doctors. They are time consuming and they take away from our clinical focus. The challenge for CPOE development is to create systems that allow doctors to concentrate on the clinical problem at hand, free of questions such as “Where can I find the basal/bolus insulin protocol?” or “Am I sure I entered this right?”

Wachter’s other post puts CPOE in the helpful perspective of the “Technology hype cycle”. New technologies are initially met with unwarranted enthusiasm. Then there follows a back lash when they don’t meet their initial expectations. Finally, gradually, the level of acceptance finds a middle ground in which users appreciate the benefits but realize that the technology isn’t nearly as good as originally hyped. It’s a useful model to keep in mind because it gives us a road map, a kind of sense of where we’ve been and where we hope to end up.

AAMC’s proposed ban on drug company gifts draws controversy

MSNBC ran a point counterpoint on the Association of American Medical Colleges proposed ban on drug company freebies for medical students. Dr. Edward V. Craig, Professor of Clinical Orthopedic Surgery at Cornell Medical School, writing in opposition to the ban, said:

Unfortunately, this proposal ignores all subtlety, is dismissive of the many benefits of industry relationships with medicine, and considers individuals and medical organizations rudderless in their efforts to be steered by a personal and professional moral compass.

If your medical school is being over run by drug reps or if they are creating a distraction in the learning environment, you as an administrator or faculty member should take action. But the AAMC proposal is simplistic and extreme.

The larger problem in medical education is the need to teach students to think critically. Although that would address not only the slanted information in drug company promotions but also the woo students are exposed to it’s not being done effectively. Instead, students are being asked to check their brains at the door to the classroom. If you have doubts on whether med students are embracing pseudoscience on a large scale check out the complementary and alternative medicine pages of the American Medical Student Association web site.

Via Kevin M.D.

How well do eICUs work?

The ones that are profiled in a recent issue of ACP Hospitalist seem to be working pretty well. Do they all work that well? It depends entirely on the quality of relationships between the personnel at both sites.

Electrocardiographic T wave inversion

Various forms are discussed in this review from the American Journal of Emergency Medicine.

Diagnosis: Fabry’s disease

Case description and literature review in Nature Clinical Practice Cardiovascular Medicine.

Precipitating causes of heart failure exacerbation

The OPTIMIZE-HF data base provided us with a wealth of information on heart failure. A report from that data base which focused on precipitating causes of exacerbations was recently published in the Archives of Internal Medicine.

In heart failure one can think about underlying causes and precipitating causes. While a good deal of evidence supported the importance of the former, there was little, up until now, on the importance of the latter even though expert opinion (as well as my mentors going all the way back to med school and residency) held that we should think about both. This paper, by showing that a majority of heart failure episodes had an identifiable precipitant, adds credence to that teaching. Precipitating causes matter.

DB of Med Rants provided a nice summary of the findings. I’ll just make a few observations I found interesting:

Patients with no identifiable precipitating cause had a modestly lower mortality. That’s counter-intuitive. You’d think the folks who decompensated for “no reason” would be those with the least hemodynamic reserve who are approaching “end stage”.

The distribution of length of stay was not a bell curve. The median length of stay was 4 days whereas the mean was 6.4. That tells me there were some outliers with very long stays. It matches real world experience.

Finally, I was a bit surprised that pulmonary embolism was not on the list of precipitating causes. That may reflect how hard investigators looked for PE rather than its actual occurrence. Recall that in COPD exacerbation, when you look for PE you find it in 25%. I’d like to see a similar study in hear failure.

So you want to be a doctor?

In Reasons Not to Become a Doctor Tara Weiss writes that physicians’ professional rewards are shrinking, and that is contributing to a growing shortage of doctors. She quotes three authors from the recruiting firm of Merritt and Hawkins:

This is not just a question of career choice---consumers will be affected greatly by this shortage. If you think there’s a long wait for an appointment now, it could be nothing compared with 15 years down the road. The three co-authors of Will the Last Physician in America Please Turn Off the Lights, all from the physician staffing firm of Merritt, Hawkins and Associates, say the wait will jump to three to four months to see a doctor for a non-emergency, and a routine doctor’s visit will cost two to three times what it does now—whether you are insured or not, they say.

I have a lot of respect for Merritt and Hawkins. They are uniquely in touch with physicians’ attitudes and working conditions. But you don’t need data from Merritt and Hawkins to know that what Weiss says is true. The shortage of doctors, particularly primary care, touches all of us.

Although all doctors realize the increasing frustrations of the profession, medical blog reactions have been somewhat more optimistic:

Kevin M.D.

DB’s Med Rants

JaneMarie MD

The Blog that Ate Manhattan

My take? I can’t see myself doing anything else. I love medicine. It is said that one of my medical school mentors was quite wealthy and worked for the university, at his own insistence, for a dollar a year. He’d say to his students “You should love medicine so much that if you were independently wealthy you would be willing to pay for the privilege of being a doctor.” I sometimes feel that way!

Nobody goes into medicine primarily to get rich. Perhaps a few consider it just a job. Most appreciate the professional rewards. For me the issue is not the profession of medicine; it’s the baggage. I love medicine but I hate the baggage. The baggage is growing and choking off the professional rewards. For many doctors, even the ones in the profession for the “right” reasons, the baggage has become unbearable.

Wanna be a doctor? Think long and hard, and count the emotional cost.