A magical mystery tour of NCCAM chelation study sites---part 1

On first learning of the National Center for Complementary and Alternative Medicine’s Trial to Assess Chelation Therapy (TACT) I was optimistic that it would settle the chelation controversy once and for all. But examination of the TACT web pages raises concerns about the quality of the study. The scientific integrity of many of the research sites is questionable. Only 12 of the 110 study sites are located in academic medical centers. Worse, a substantial number appear to be engaged in dubious practices, making pseudoscientific and even fraudulent health claims. This is the first in a series of posts in which I will profile some of the questionable NCCAM study sites involved in TACT.

What is important about a study site? The investigators must be knowledgeable in the scientific underpinnings of the question being studied. Skills in the methodology of clinical research are important. The investigators must be honest, and conflicts of interest must be addressed. As you read my descriptions of the study sites in the posts that follow, keep these points in mind.

Can the overall study quality be any better than that of the individual sites? An argument could be made that because the study is double blinded, it would be shielded from bias that may exist at individual sites. A close reading of the TACT protocol, however, reveals that the blinding is not secure. First of all, the chelation mixture is not stable and therefore must be mixed at the local site. The ascorbic acid which must be injected into the mixture is yellow in color and highly viscous. The work around for this problem is to cover ascorbic acid, chelation mixture and placebo syringes and bags with tinted translucent tape and to add concentrated dextrose solution to the placebo syringe to make it as viscous as the ascorbic acid.

At the very least, the study conditions which I will point out raise serious questions about the validity of the trial.

Good housekeeping and mortality in mechanically ventilated patients

Six simple interventions have been demonstrated to improve outcomes in mechanical ventilation: daily interruptions in sedation, stress ulcer prophylaxis, DVT prophylaxis, elevation of the head of the bed, aggressive glycemic control and spontaneous breathing trials. The first four of these comprise the ventilator bundle. But as basic as they seem their rate of implementation is variable across clinical settings and low overall.

In this report from the American Journal of Medical Quality cases involving mechanical ventilation were reviewed from 38 academic medical centers. Compliance with the six practices was determined and a logistic regression model was used to estimate the effect of each measure on mortality. Compliance rates varied among institutions and were poor in general. Of the six measures, sedation interruption and glycemic control were associated with reductions in mortality.

This is all about the elusive goal of putting evidence into practice. The authors discuss barriers and potential solutions.

Whither primary care?

An article in Medical Economics discusses the primary care crisis and wonders where it’s heading. It cites all the disturbing trends we’re well aware of including increasing demands of an aging population and fewer doctors choosing primary care careers. As interesting as the article itself are the reader comments. One that really got my attention comes from Mark Flodin M.D. of Tallahassee: “You assert that Internists would be better able to manage the more complex medical issues of the elderly than Family Medicine physicians......that's total nonsense.”

That’s a perfect example of the pervasive misconception that Internal Medicine is not really a specialty in its own right. Professional organizations such as the American College of Physicians have, unfortunately, done little to alter that perception.

Background: Internal Medicine’s identity crisis.

BNP and NT-proBNP testing in heart failure

Here’s an update on natriuretic peptide testing in heart failure patients published in CCJM.

Bartlett on avian flu

John G. Bartlett, MD, John Hopkins University School of Medicine, provides perspective on avian flu in this Annals of Internal Medicine review. We don’t know when or even if an H5N1 pandemic may occur or what its impact will be. Bartlett warns that we should assume worst case scenario, and that at present we are woefully unprepared for a pandemic resembling that which occurred in 1918 and 1919.

It’s an alarming trend

Hospitals are selling out to alt med in increasing numbers according to American Hospital Association data. Via Fox News.

A randomized trial of D-dimer testing in suspected pulmonary embolism

This is the first ever randomized controlled study to determine whether a negative D-dimer test can safely obviate additional diagnostic testing in certain patients with suspected PE. The researchers found that in patients with low clinical (pre-test) probability a negative D-dimer excludes PE as effectively as a strategy of nuclear scanning and lower extremity venous ultrasound. Via Annals of Internal Medicine.

Earn continuing education credit while sharing the cosmic consciousness

From the Vancouver Prophets Conference brochure:

The limited linear view of reality in which we abide does not support the nourishing healing consciousness so needed at this time. But, there are visionaries in science who are able to address this linearity in ways that bring it into a complementary and coherent place. These people are offering evidence that immeasurable distances can be spanned instantaneously by a thought, and that past, present, and future may be bridged even within ourselves. We are then learning of the dimensional fields where materialist and metaphysical views join into a universal consciousness, and from this place we begin the realization process and acceptance of personal and planetary healing. This is the place of miracles, and as our minds bridge and break open to greater receptivity we can rest in this place and become whole.

RNs will earn continuing education units for this. ‘Nuff said.

Clarification of off label prescribing and an update on Dr. Gleason

After the lively exchange triggered by my recent post on off label promotion of pharmaceuticals I thought this follow up might be useful. A commenter was concerned by my statement that off label prescribing was legitimate: “Yet, off label prescribing is, by definition, prescription to treat conditions for which there is NO EVIDENCE that such prescription works.” Thus the question is raised---does “evidence based” equate to “FDA approved”?

Not necessarily. I cited metformin for polycystic ovary syndrome, sildenafil for pulmonary hypertension, anticonvulsants and tricyclic antidepressants for neuropathic pain and caspofungin for invasive candidiasis as examples of evidence based treatments, all of which lack FDA approval for those uses. In other words, current examples of legitimate off label prescribing. Another example is the use of vasopressin in cardiac arrest---fully in accordance with ACLS protocols yet off label. And if memory serves, there are past examples in which evidence based prescribing preceded eventual FDA approval for particular indications. Thus, angiotensin converting enzymes were validated and used for heart failure at a time when they were only approved for hypertension.

The flip side is FDA approved (on label) prescribing which is not evidence based. Doxazosin, for example, (Cardura) is FDA approved as monotherapy for hypertension despite strong evidence from ALLHAT that such use is inappropriate. Old farts like me may remember phenformin (Ciba-Geigy’s DBI, the granddaddy of metformin) which remained on label and FDA approved for years despite clear evidence of harm. How many thousands of patients died of lactic acidosis before the FDA finally took action? So much for the FDA as the guardian of evidence based medicine!

That said, I’m sure there are widespread instances of off label prescribing that are non-evidence based and even harmful. One more point about inappropriate prescribing: off label prescribing is to be distinguished from on label prescribing which ignores warnings and contraindications in product labeling. I have blogged about this unfortunately widespread practice here and here.

On to Dr. Gleason. The commenter seems to have misperceived me as defending Dr. Gleason’s promotional activities and questioned my basis for stating that he did nothing clearly illegal. Having no legal expertise of my own, I merely cited experts quoted in the Times article who made that point. If this is a fuzzy area of the law subject to prosecutorial discretion, or zeal, it could be a dangerous precedent of concern to all who speak at CME events.

A discussion forum concerning Dr. Gleason has been set up here for those who wish to keep abreast or weigh in.

Chronic thromboembolic pulmonary hypertension

Reviewed in CMAJ.

Noteworthy: 3.8% of patients who present with acute PE will develop chronic thrombolic pulmonary hypertension (CTPH) within 2 years. Among patients presenting with CTPH only 50% will have a history of PE or DVT. In suspected cases, the workup should begin with V/Q scanning and echocardiography. The prognosis of untreated CTPH is poor. Pulmonary endarterectomy is the treatment of choice.

Be careful what you say about off label prescribing

Do you speak at continuing medical education conferences on drug therapy? Do you ever mention off label use? Be concerned. You may wind up in handcuffs. That’s what happened to Dr. Peter Gleason, a Maryland psychiatrist whose career has been destroyed in an episode characterized by the New York Times as illustrative of the “murky” relationship between drug companies and physicians who help promote their medications. Dr. Gleason frequently spoke about off label use of the Jazz Pharmaceuticals product Xyrem, a drug approved for narcolepsy. Although the extent of Dr. Gleason’s promotional activities are concerning this may be a case of over zealous prosecution. Dr. Gleason stated that he was arrested and charged only after he refused to cooperate with the prosecutor’s investigation of the company. Moreover, according to independent legal experts interviewed by the Times, Gleason’s activities were not clearly illegal. Rather, prosecutors were concerned merely that Dr. Gleason “went too far.”

Off label use of drugs is legitimate. The mention of off label drug prescribing is commonplace at drug company supported CME events. This prosecution sets a dangerous precedent. There are no clear legal constraints regarding such activities, and this could happen to any speaker at drug company supported educational events.

The myth of the normal coronary angiogram

The most common expression of this myth is the cardiac catheterization report which reads “Conclusion: no significant coronary disease. Plan: cardiac reassurance.” Such reassurance, however, may be false. It is increasingly recognized that patients with angiographically “minimal” coronary disease (usually interpreted as “No significant coronary disease”), or even “normal” coronary arteries, experience coronary events.

In the July 10 issue of Archives of Internal Medicine is a report of pooled data on patients experiencing non-ST segment elevation acute coronary syndromes, 9.1% of which had angiographically “insignificant” or no coronary disease. Long term follow up of such patients revealed a significant rate of recurrent events.

The mechanism of such seemingly discrepant findings is clarified by intravascular ultrasound (IVUS), which has shown that in the initial stages of atherosclerosis the growing plaque presses the adventitia outward rather than the intima inward. Since the lumen is uncompromised the coronary angiogram of such a patient (essentially only a “luminogram”) would appear normal. Nevertheless such a plaque could rupture, producing a coronary event.

A review of advanced coronary imaging, including a nice discussion and images of IVUS, is here.

How safe is warfarin? It depends on the setting

An important paper in Chest reported that levels of anticoagulation are out or range more frequently in community practice than in anticoagulation clinics or clinical trials. This demonstrates once again that drugs are safer in the hands of clinical trialists than in the hands of community physicians. Drug safety is not absolute. It’s all in how they’re used.

The optimal duration of warfarin anticoagulation for venous thromboembolism is controversial, and clinical decisions are often based on the expected annual rate of bleeding. This paper reminds us to be cautious in the interpretation of clinical trial data in estimating this risk.

Playing the quality game

As I recently blogged, the quality and P4P movement is not mature enough for prime time and may be of little more than cosmetic importance. In addition to numerous unintended consequences, some publicly reported “quality” measures (e.g. pneumococcal vaccination) may not even be effective.

Two articles just out in Chest now raise questions about time to first antibiotic dose (TFAD) for pneumonia as a quality indicator. One of these, cited by Kevin and DB, suggests that the incentive could lead to hasty (and inappropriate) antibiotic use. The other paper analyzed records of patients who received antibiotics outside the 4 hour window, thus “failing” the quality screen. The findings suggest that age and comorbidities contributing to an atypical presentation of pneumonia were responsible for the delays. Moreover, these same patient attributes, rather than the delay itself, are causally related to the adverse outcomes associated with delayed administration.

Links between obesity and respiratory disease

Reviewed in CMAJ.

The obvious associations are obstructive sleep apnea and obesity hypoventillation syndrome. Although OSA and OHS overlap there are important distinctions which are reviewed.

Less well appreciated is asthma. Mechanisms for the link may be inflammatory.

Drugs, QT intervals and torsade---the story of methadone

Several years ago a small case series of patients experiencing torsade de pointes (TDP) while taking methadone was published. The doses of methadone were very large (averaging around 400mg) and most of the patients had other risk factors for TDP. Reports such as these prompted in vitro studies confirming methadone’s ability to prolong repolarization by blocking the rapid delayed rectifier potassium current (IKr), the principal mechanism of drug induced TDP.

Despite mounting evidence, the ability of methadone to prolong the QT interval and cause TDP remains under appreciated. Now, a disturbing report in Archives of Internal Medicine places this association decisively in the clinical arena. QTc prolongation was seen in 16.2% of hospitalized patients receiving methadone and none of controls. 3.6% of patients on methadone had TDP. Moreover, QTc prolongation was seen with methadone doses as low as 30mg daily and TDP with doses as low as 40mg. The Center for Education and Research in Therapeutics has now assigned methadone the highest risk rating (category 1).

Thanks to better understanding of molecular mechanisms it is now possible to predict the risk for TDP during the pre-clinical phases of drug development. Drugs with the highest risk of TDP are those which both block IKr and are metabolized by the CYP3A4, 5 and 7 isoforms of cytochrome P-450, as is the case with methadone. These molecular mechanisms and their implications for drug development are reviewed here in Pharmaceutical Discovery and Development. Pre-clinical molecular testing procedures have been codified by an international group of regulatory agencies and experts. Such testing is becoming a standard for mainstream drug development and approval and may reduce the number of post-marketing “arrhythmic surprises.” (In contrast, herbal remedies get a free pass on such molecular testing, another reason not to trust NCCAM funded “research”).

Safety monitoring for risk of TDP has become a daunting task given the ever increasing number of implicated drugs and the difficulty of clinicians in measuring the QT interval. What’s a doctor to do? Linked below are some useful resources.

JAMA review---how to measure the QT, what it means and how to apply it to drug monitoring. Note: although references to specific drugs such as methadone are dated, this is a very helpful general review.

CERT---like the breath mint. It’s the Center for Education and Research in Therapeutics containing a frequently updated list of “QT drugs” and many helpful tools.

Life defining moments with mushrooms

Adventures in neurotheology at Hopkins.

Via Religion News Blog

The American Medical Student Association: consistency after all?

I have occasionally blogged about the inconsistency between AMSA’s Pharmfree campaign (supposedly standing for scientific integrity and evidence based medicine) and their enthusiastic promotion of alternative medicine with its numerous unproven health claims.

One of my posts drew a comment from ba who said “As for integrative medicine, AMSA is not doing enough. The medical schools are still in way too deep with the pharma$ to have credible integrative health programs. So far the integrative medicine programs sound more like mere window dressing and decoys.” That suggests a common thread in the AMSA’s seemingly contradictory positions: the notion that Big Pharma is leading a medical-industrial conspiracy to suppress research in (and the integration of) alternative methods.

Could these positions be part of a broad political agenda? Go to the AMSA’s main page and search such hot button issues as reproductive rights, universal health care and, last but not least, malpractice. Extensive material is posted concerning these issues. After perusing their articles on malpractice I gather they are not in favor of damage caps, think the liability crisis is exaggerated and seek other solutions to rising premiums such as reforming the insurance industry, reducing medical errors and disciplining bad doctors.

Medical students and faculty should be aware that while AMSA purports to be concerned with medical professionalism it is very much a political activist group. At 60,000 members it is the largest medical student organization. Medical students are being groomed to transform the culture of the profession, and in a way that should concern us.

I agree with commenter ba on one point. The integrative medicine programs in most medical schools are not credible. The remedy for this credibility gap is not to decrease reliance on “pharma$”. Instead medical schools need to dispense with magical thinking and be appropriately critical of pseudoscience.

Cephalosporins in penicillin allergic patients

Stay away from first generation cephalosporins, but second and third generation agents appear safer than commonly believed. In a systematic review of PCN allergic patients receiving cephalosporins (originally published in J Fam Pract and abstracted as POEM in CCJM) rash occurred in 2% but anaphylaxis was rare (0.1%-0.0001%). Patients with a history of type I hypersensitivity to PCN should avoid first generation cephalosporins but may be able to safely take second or third generation cephalosporins.

Background: Coombs and Gell classification of hypersensitivity.

Internal Medicine’s identity crisis

An introduction to the specialty of Internal Medicine from the University of Maryland School of Medicine website linked in my June 15 post on the subject has this description: (italics mine) “But the internist always remains the physician (or the diagnostician as internists were called in former times) whose special competence is solving difficult diagnostic problems and personally applying, or obtaining from a colleague, the best treatment available.” It also contains this statement: “Internists have always required special training to acquire their knowledge and skills and have continuously shown a particular interest in the scientific basis of clinical work.”

DB expanded on this view when he described what attracted him to Internal Medicine: (italics mine) “I am driven by both the intellectual challenge and the interpersonal relationships in medicine. I enjoy puzzle solving and relating to individual patients.” Also this: “Internal medicine deals with the most complex patients and most complex situations. Internists handle complex comprehensive care.”

Internal Medicine is thus distinguished by a unique emphasis on scientific underpinnings of medicine and the handling of complex problems. What is the popular notion of Internal Medicine? In search of something “official” I checked the American College of Physicians webpage and was disappointed. They characterize internists merely as "doctors for adults" and elaborate by listing what internists don’t do, such as deliver babies and treat kids. That’s it. For a description of a specialty this definition contains nothing special! The American College of Physicians has thus succeeded in defining Internal Medicine as nothing more than a subdivision of Family Practice, further contributing to Internal Medicine’s identity crisis.

More evidence in favor of inhaled steroids for COPD

This meta-analysis published in the Annals of Family Medicine showed improved outcomes attributable to inhaled steroids, particularly a reduction in frequency of exacerbations. There was a trend toward reduced mortality which failed to reach statistical significance.

Background: I previously posted on this subject here.

Effects of obesity on natriuretic peptides: implications for the evaluation of heart failure

We’ve known for some time that natriuretic peptide levels (BNP and, to a lesser extent, pro-BNP), correlate inversely with body mass index. Obese patients may have deceptively low levels, decreasing the sensitivity for the diagnosis of heart failure.

In this paper from the American Heart Journal (via Medscape) the Breathing Not Properly Multinational Study investigators analyzed BNP levels in various categories of body mass index in order to quantitate the effect of obesity on the test characteristics of BNP in heart failure. The authors conclude that “B-type natriuretic peptide cut-points to maintain 90% sensitivity for a HF diagnosis were 170 pg/mL for lean subjects, 110 pg/mL for overweight/obese subjects, and 54 pg/mL in severely/morbidly obese patients.”

Bugs outpacing drugs

There is an impending shortage of antibiotics to combat emerging resistant infections. The antibiotic pipeline has been regulated to death, so says a commentary from last May in the Washington Times.

Marketing considerations and regulatory costs have exacerbated the antibiotics drought. Until about a decade ago, all major pharmaceutical makers had antibacterial research programs, but they have dramatically trimmed or eliminated these efforts, focusing instead on more lucrative drugs that treat chronic ailments and lifestyle issues. Read the rest.

I previously cited the Infectious Disease Society of America’s warning here.

Exposing absurdity

Retired Doc discusses the corruption of medicine by pseudoscience and links to an article from the Medical Journal of Australia on the absurdity of it all.

Unscientific healing methods may compete in the marketplace of ideas, but does mainstream medicine have to embrace them uncritically? The absurdity lies in the attempt to “integrate” science with quackery and ethical practice with fraud.

FDA supports easier standard for CAM research

In the same San Francisco Chronicle article I linked concerning UCSF’s promotion of herbal tea to boost the immune system is another tidbit concerning lax FDA standards for research on herbal products. Apparently the FDA thinks it’s OK to study unrefined plants without even knowing the active ingredient. The article reports the FDA position thusly:

“The agency is even allowing researchers to experiment with plant materials in clinical drug trials without first identifying their active ingredients. ‘There's a need to adjust our approach if we want to encourage study of these complex mixtures,’ said Shaw Chen, botanical team leader with the FDA's Center for Drug Evaluation and Research. “ Translated: let’s adopt a double standard.

It's all bass akwards in contrast to legitimate drug development which starts with the search for, discovery and characterization of compounds based on anticipated effects on molecular targets. Then come animal studies followed by preliminary safety and dose finding studies on humans, leading, ultimately and tediously to phase III clinical trials.

And the consequences? If an herbal product fails a clinical study the boosters can just say “Since we don’t know the active ingredient how do we know we studied the right component of the plant, or the right species? Were the climate and soil optimal? What about the dose?” Endless questions and more excuses to pour tax dollars into CAM “research.” It’s all quite convenient for the NCCAM which continues to ride the gravy train despite the fact that no significant medical advances have been made in all its years of existence. No breakthroughs. No debunkings.

A recent example is the story of echinacea. NCCAM’s response to disappointing results of one of its own studies was, in effect, let’s try again; maybe we should focus on the roots; or maybe the flowers, or the seeds; maybe we used the wrong echinacea species---and on it goes.

The double standard for research is becoming pervasive. The NCCAM has adopted it for some time. Now the FDA is on board. It’s going to get worse. As I recently posted, a generation of medical students is being indoctrinated.

Background:
Forget the Echinacea (DB’s Med Rants)
NCCAM should be defunded (Quackwatch)

Is UCSF promoting herbal tea and massage to “boost the immune system?”

Evidently, according to the San Francisco Chronicle.

Via the Healthfraud list

Background: About the UCSF Center for Integrative Medicine.

Biphosphonates and jaw osteonecrosis

My post about biphosphonates and osteonecrosis of the jaw (ONJ) drew an interesting comment from Liz, author of a blog devoted to the problem. Concerning my reference to a linked study showing that the major incidence of ONJ is with parenteral biphosphonates in patients with myeloma or metastatic bone disease she states: “That simply isn't true. Oral surgeons and dentists have been seeing patient after patient with jaw necrosis from Fosamax and other bisphosphonate drugs.” Wait a minute. Not so simply, please. According to the systematic review the oncology patients on parenteral therapy represent 94% of published cases despite much heavier use of oral biphosphonates such as Fosamax.

Yes, there are are many “real world” anecdotes about Fosamax, but in order to be convincing Liz should give us a denominator, which I suspect would be huge! Then and only then will we have any idea of the absolute risk for ONJ form oral biphosphonates.

The July phenomenon

As the first day of the new academic year for residency programs draws to a close it’s appropriate to reflect on the July phenomenon. There’s an urban legend that patients check into academic medical center hospitals during the month of July only at their peril. That’s when a new crop of interns, green and fresh out of med school, takes over. But is the notion evidence based? Not according to this paper in SGIM (via Medscape).

Maybe there was something to the idea decades ago. Nowadays house staff are better supervised.

Indoctrination in the eclectic healing arts yields CME credit for doctors

While examining the brochure cognitive dissonance set in: just as my trusty baloney detector was going off I said to myself “Wait---this activity is cosponsored by two reputable medical schools, accredited by the ACCME and approved by the AMA for credit toward the Physicians Recognition Award!” Not only that, there’s no support from Evil Pharma and the faculty list reads like a parade of stars including Andrew Weil, Larry Dossey and Tieraona Low Dog.

While a few scientific trappings are included in the language (“evidence based”, “critical”, “findings”) most of the titles are promotional or, at the very least, non critical. A sampling from the list includes Qi Gong: Enlivening Energy through Ancient Practice; Reiki: Healing Yourself and Others; The Ayurvedic Understanding of Chronic Diseases: Arthritis, IBS and Asthma; Revival of Curanderismo: Mexican Folk Medicine and Rituals and, finally, a sweat lodge ceremony.

Aldosterone receptor antagonists: who, when and how

This review in CCJM covers current and future indications and safety concerns.

Healthy skepticism on the quality movement by a hospitalist thought leader

Background: Recent posts from DB and Retired Doc.

Robert Wachter, one of the originators of the term hospitalist, has a commentary on the quality movement in the June 21 issue of JAMA. He first focuses on accountability for “core measures” promulgated by CMS, JCAHO and others and concludes with speculation on how the quality and information revolutions will change the medical profession.

He suggests, with examples from his own institution (UCSF), that this new accountability has fostered a perfunctory approach to quality with unintended consequences such as patients inappropriately receiving multiple pneumococcal vaccinations or receiving inappropriate antibiotics for heart failure. Worse, this obsession with report cards (“playing for the test” as Wachter terms it) may divert attention away from more important aspects of quality which don’t happen to be the focus of the current report cards. I’ll go a step further and suggest that the quality movement as is now being played out publicly may be of little more than cosmetic importance.

While many of the core measures are of proven effectiveness (e.g. angiotensin converting enzyme inhibition for heart failure and aspirin for acute coronary syndrome) pneumococcal vaccination may be an exception. According to this Cochrane review the pneumococcal vaccine currently approved for adults is not effective in preventing pneumonia or mortality from pneumonia. Although it appears to have some ability to prevent bacteremia the NNTs for bacteremia and mortality from invasive pneumococcal disease are 20,000 and 50,000 respectively! In spite of this fact, pneumococcal vaccination is a major target for public report cards and pay for performance programs.

Wachter goes on to sound a cautionary note about electronic medical records and computerized physician order entry, reminding us of the Cedars-Sinai debacle, increased mortality in a pediatric population after implementation of CPOE and other examples of adverse consequences. He notes that the success stories of EMR and CPOE come from “institutions that built homegrown computer systems over decades and were staffed with physicians, researchers, and administrators who believed strongly in the value of the systems.”

While Wachter’s skepticism about the current state of the quality and information technology revolution is welcome his predictions concerning the eventual effect on the medical profession are chilling. Citing known practice variations and publicly reported quality breaches he asks “….can there be any doubt that central control of physicians' practice will need to be exercised, especially when there is evidence of substandard performance on publicly reported measures?” Speaking of computer systems which can “ruthlessly enforce rules and standards” he entertains hope that high quality of care can somehow be “electronically ensured.” It all sounds a bit Orwellian to me.

Wachter envisions medical practice becoming increasingly formulaic and rote with diminishing need for the “virtuoso diagnostician” of old. Those arts of medicine that survive the revolution, he suggests, might include procedures, counseling and care coordination. Maybe those clinical and basic science skills I’ve ranted about won’t be so important after all. Get ready for the new breed of physician: the Stepford doctor.

Therapeutic desperation in pulmonary embolism

In a registry of 488 unstable patients reported in Chest who underwent thrombolysis for pulmonary embolism, 8.2% failed treatment, as evidenced by persistent hemodynamic instability and echocardiographically defined right ventricular dysfunction. Those patients were then subjected (not randomly, but at the discretion of their attending physicians) to either surgical thrombectomy or repeat thrombolysis. Outcomes were better in the surgical group (statistically significantly fewer recurrent PEs and a non statistically significant improvement in mortality). 79% of surgically treated patients had an uneventful subsequent hospital course.

The accompanying editorial points out that although high level studies are lacking, this report, adding as it does to the recorded experience in treating such patients, provides some practical lessons. Surgical rescue is feasible. Clinicians should have contingency plans for failed thrombolysis based on resources available at their respective hospitals.

A fully accredited month of navel gazing and woo-woo for 4th year medical students

Sponsored by none other than the American Medical Student Association (AMSA). Founded in 1950 as the student subsidiary of the American Medical Association, the organization severed ties with the AMA in 1967. Although its PharmFree initiative purports to foster professionalism and scientific integrity, AMSA enthusiastically supports unscientific teachings and practices under the rubric of complementary and alternative medicine and receives support from the American Holistic Medical Association.

How do they resolve the inconsistency? By questioning the definition of science, and suggesting an “alternative” scientific standard for CAM. Their general information page on integrative, complementary and alternative medicine contains the statements that for CAM therapies “…the issue of what constitutes a scientific study must be resolved” and “…the type of study necessary and appropriate for CAM therapies needs to be addressed before significant advances will be made in the area of scientific evidence for CAM” and finally “…the type of study necessary to evaluate CAM is unclear.”

In keeping with this fuzzy philosophy of science AMSA is sponsoring HEART---the Humanistic Elective in Alternative medicine, Activism and Reflective Transformation, a nearly month long retreat for 4th year medical students during which students gain credit for a senior elective. Based on a sample schedule from a past retreat the elective will feature studies on the Healing Wheel, Yoga, meditation, naturopathy, Ayruvedic medicine, shamanism, Curanderos and traditional Chinese medicine. What scientific standard will be applied to these modalities during the elective? Perhaps it’s revealed in the slogan at the top of the HEART information page: “It is only with the heart that one can see clearly; what is essential is invisible to the eyes….”

DB weighs in on the definition of Internal Medicine

And well he should. After all he is president of the Society of General Internal Medicine. I share his vision for internal medicine. The curmudgeonly, somewhat tongue in cheek definition I lifted from the pages of Art and Science of Bedside Diagnosis, thought provoking as it is, may push some buttons.

I grew up with the older, somewhat more traditional view of Internal Medicine. My father was a GP who had great respect for internists. He would have become one himself had his training not been interrupted by the Second World War. He would refer his most difficult cases to internists. These were patients in need of special diagnostic sleuthing. In those days internists were often known as diagnosticians. Internists were clearly specialists.

Years later in medical school at Vanderbilt my notion of the internist as specialist-consultant was reinforced as I encountered internal medicine role models who were master clinicians and great teachers. The exemplar of the internist there was Thomas Brittingham. His example helped influence me to choose Internal Medicine.

Early in private practice I first became aware of Internal Medicine’s identity problem. Asked by an acquaintance what kind of doctor I was I replied that I was an internist. She, thinking I meant intern, asked “are you learning anything?” That day I became a “specialist in Internal Medicine.” I never again told anybody I was an internist.

Over the years many factors---the rise of Family Practice as a specialty, the pressures of managed care and the advent of “med-peds”---have further muddied the definition of Internal Medcine. Like DB and Dr. Sapira I believe primary care specialty is a poor characterization of the field.

So what is Internal Medicine? DB says internists provide comprehensive care. That statement is true but it doesn’t define the specialty. Is it a comprehensive care specialty slightly less comprehensive than Family Practice? Another definition I once read characterizes it as the specialty of non-surgical, non-obstetrical diseases of adults. These definitions are lacking. The American Board of Internal Medicine and the American College of Physicians have done a poor job of defining the specialty. Those of us who were trained in the “grand tradition” know what Internal Medicine really is. I only hope DB and other thought leaders in the field can come up with the magic words to define it.

What is Internal Medicine?

I’m trudging through the third edition of Sapira’s Art and Science of Bedside Diagnosis. Full of medical pearls, musings and humor, it’s much more than a reference on physical diagnosis. It’s a book to read at the beach or by the fire. On page 7 I found this definition of Internal Medicine:

"(1) (Obsolete) That nonsurgical medical specialty concerned with clinical diagnosis and scientific therapy. Previously a secondary-care consultant specialty, it underwent crisis by lysis in the late 1960s; (2) (contemporary) a biopolitical consortium of balkanized tertiary nonsurgical subspecialties, which, oxymoronically, claim it to be a primary care specialty."

Hyperkalemia review

This review of hyperkalemia appearing in the Texas Heart Institute Journal focuses on the acute complications of hyperkalemia, the mechanisms of cardiac toxicity and emergency treatment. Modalities of treatment for hyperkalemia can be grouped in three categories in descending order of urgency and rapidity of effect, and ascending order of duration of action. These categories consist of 1) membrane stabilization to directly antagonize the cardiac effects of hyperkalemia (calcium administration), 2) measures to shift potassium into the intracellular space (insulin with or without glucose, beta agonists) and 3) measures to eliminate potassium from the body (ion exchange resins, dialysis).

The authors recommend all three categories of treatment if there are ECG abnormalities or if the serum potassium exceeds 6.5. However, the indications for calcium administration are somewhat controversial. This emedicine review of hyperkalemia recommends calcium if arrhythmia, widening of the QRS or absence of P waves is present, but not if the only electrocardiographic manifestation is peaked T waves.

Calcium is recommended only in extreme situations if the patient is taking digitalis preparations, and only as a slow infusion (over 30 minutes). If digitalis intoxication is the cause of hyperkalemia digoxin-fab fragments (digibind) are indicated.

Antihypertensive agents and diabetes

Antihypertensive drugs have disparate effects on blood glucose regulation. This bench-to-bedside review in Mayo Clinic Proceedings covers physiologic mechanisms and clinical studies which show that thiazide diuretics and beta blockers increase the risk for diabetes while angiotensin converting enzyme inhibitors and angiotensin receptor blockers have the opposite effect.

Despite their diabetogenic effects thiazide diuretics improved cardiovascular outcomes in ALLHAT. However, the duration of follow up in ALLHAT may have been too short to detect adverse consequences of diabetes.

Background: additional commentary and links from DB here and here.

Tight white coat syndrome

Are doctors the next targets of the fat police? The medical profession gets a gentle scolding in this Medscape video editorial---we’re too fat. Obese physicians suffer a credibility gap says Dr. Michael Dansinger. We become less effective in helping patients because it’s a case of “do what I say and not what I do.” I can see it now---physical fitness tests incorporated into future certification exams.

Metabolic risks of schizophrenia and antipsychotic medications

Complex interactions exist between mental illness, antipsychotic medication and cardiovascular risk factors. The purported causal relationship between atypical antipsychotics and diabetes has been particularly newsworthy.

Evidence points to multiple causal factors. Schizophrenic patients have an underappreciated risk of cardiovascular disease which tends to be under treated. Antipsychotic drugs seem to be associated with increased risk of diabetes (and its associated dyslipidemias) and the risk varies among agents. Multiple mechanisms are involved including increased appetite and weight gain, effects on histaminic and cholinergic receptors and direct effects on the pancreas.

Recent evidence suggests that the use of antipsychotic agents for behavioral problems associated with dementia is associated with adverse cardiovascular outcomes.

The benefits of medications may outweigh the metabolic risks in many patients. In such cases a thorough baseline assessment of cardiovascular risk factors coupled with close monitoring during treatment is essential.

The topic is thoroughly covered in this review from Clinical Diabetes.

Is Fosamax the next Vioxx?

The lawyers are interested. The problem is osteonecrosis of the jaw, and class action status is being sought. Although fosamax is a major target, according to this systematic review in the Annals of Internal Medicine the major problem with biphosphonates and osteonecrosis is in patients receiving intravenous biphosphonates for myeloma and metastatic bone disease.

DIC review

February 21 Thrombosis Journal.

Just out in NEJM: old news about pulmonary embolism (PIOPED II)

Despite popular opinion CT pulmonary angiography has not emerged as the diagnostic modality of choice for PE. Finally, 16 years after PIOPED was reported in JAMA and 9 months after I posted the PIOPED II findings here PIOPED II is reported in NEJM.

Detailed findings, discussed in my earlier post, will not be repeated here. Suffice it to say that although CT is a useful addition to the diagnostic armamentarium it does not emerge as a clear cut stand alone modality of choice. Just as with V/Q scanning, the predictive power of CT is poor when test results are discordant with pre-test probability. A Bayesian approach using an integrated clinical algorithm is still the best method. There is a 17% false negative rate with CT. Fortunately small peripheral emboli, of questionable clinical significance, account for the majority of these false negatives. This is inferior to nuclear scanning which, if normal (as distinguished from “low probability”), demonstrated 100% sensitivity in PIOPED. Put another way, no patient in PIOPED with a normal perfusion scan had PE. Editorial comment in the same NEJM issue is here.

Questions raised by firing of CMAJ editors

Heated discussion continues about the Canadian Medical Association Journal (CMAJ) since my post May 20. The bitter dispute between the journal owners and the editors raises fundamental questions.

What should a medical journal strive to be?
As pointed out in this BMJ editorial from several years ago a journal’s niche could occupy any point on a broad spectrum, “from being like Brain, a forbidding, research based journal, to Cosmopolitan, a magazine full of froth and colour.” But such a niche needs specific definition. Confusion results when a journal tries to be too many things. Therein lies part of the problem at CMAJ. The journal should define what it intends to be---a scholarly research journal, a medical news magazine or a political rag. It can’t be all those. Who, for example, would think of publishing peer reviewed research in Medical Economics?

What is the appropriate role of an editor?
Perhaps that depends on the type of journal in question. If the journal purports to be a scholarly scientific publication the editor should be objective, neutral and “disinterested.” There should be no social or political agenda and no personal bent that might bias the selection or editing of articles. Dr. John Hoey, though, seems to have other ideas. In the May 11 NEJM piece in which he recounts his firing from CMAJ he writes that “the defining characteristic of an editor is quixotic idealism….” Quixotic idealism? Well, whatever that means it sounds anything but objective or neutral. Concerning the attributes of an editor he writes that “An eager propensity to poke a stick into something or somebody is also useful.” Useful, perhaps, for The American Spectator.

What is editorial independence and are there limits?
Dr. Hoey’s absolute notion of editorial independence amounts to a lack of editorial accountability. But editorial independence must be balanced against accountability. In a May 23 piece in CMAJ the interim editors write “Editorial independence should not confer immunity from accountability.” In that same article the authors note that the World Association of Medical Editors (WAME), which Hoey cites in defense of his views, has reconsidered the concept of editorial independence. Indeed, in its May 15 2006 revision, the section titled "Editorial Independence" has been retitled "The Relationship Between Journal Editors-in-Chief and Owners."

Is Hoey’s concept of absolute independence realistic? As pointed out in a recent Lancet editorial on this matter “The CMA might legitimately argue that they should not be saddled indefinitely with an editor whose policies and perspectives were not in keeping with its own views. The publisher of The Economist might not hire the editor of The Nation, and vice versa. So what is the voice that should be reflected in a journal owned by a medical association?” Consider the American Medical Association and its lobbying efforts for tort reform. Suppose the editor of JAMA, the AMA’s general medical journal, wrote and selected articles predominantly in opposition to tort reform. Would it be appropriate for the AMA to intervene? It would in such political issues where the membership had a stake, as opposed to purely scientific questions in which detached neutrality is essential. The only way to avoid such a conflict is to avoid mixing political commentary and science in the same journal.

What are the risks of political influence in a scholarly scientific journal?
Science influenced by any sort of agenda is biased and corrupt. I have given examples in the pages of this blog here, here and here. Orac gives an example here. Scientific discourse differs so fundamentally from political debate that the two are hardly compatible. The former involves objective discussion between disinterested parties while the latter involves impassioned contests between those with competing interests, with participants bolstering their positions according to their own biases. But as I posted on May 20, Hoey seems to have no problem mixing scientific inquiry with politics.

Should there be a demarcation between scientific reporting and other content such as journalism and political commentary?
Although the essential importance of demarcation should be self evident, not all agree. Another Lancet editorial on the firing said “To distinguish between a journal's responsibility to publish peer-reviewed research and investigative journalism is false.” But all sorts of problems emerge when the distinction is not clear. As the same Lancet editorial points out, “According to the CMAJ, the journal's publisher ordered a news article containing a survey of women's experiences of trying to obtain the Plan B morning-after pill (levonorgestrel) to be withheld, after receiving a complaint from the Canadian Pharmacists Association. The CMA's withdrawal request was justified on the grounds that the survey of women's experiences constituted scientific research, rather than journalism, and the editorial team should therefore have sought ethical counsel and peer review of the article.” Jerome P. Kassirer and others in this CMAJ editorial disagreed with “Contrary to the claims of the CMA that the Plan B article could be construed as a scientific study and was subject to all the requirements of such an investigation, in the opinion of the Committee, the report (both as it was intended to be published and as it eventually appeared) does not meet the definition of 'research' as understood in medical science.” Though the informal survey of women seeking emergency contraception was not research these comments indicate that the point was in dispute. The distinction was blurred, and one of the essential points of contention between the publisher and the editors was whether it did in fact constitute research. Perhaps a clear distinction would have averted the crisis.

Are there solutions?
Political debate, medical journalism and rigorous scientific reporting, each of which has an important role, are best played out in separate venues. This not only avoids confusing the different forms of writing but also minimizes conflicts of interest by keeping politics and personal bias at arm's length from scientific inquiry. Structures are already in place to accomplish this. Most professional societies have companion publications which serve separate purposes. I’ll draw an example from my own specialty organization, the Society of Hospital Medicine, which has just launched its scientific journal, The Journal of Hospital Medicine. It is a pristine, scientifically rigorous publication devoid of politics, self-promotion or items of personal or economic interest to hospitalists. The Society’s companion tabloid style publication, The Hospitalist, contains all those things. That’s just fine, because it makes no pretense at being a scholarly scientific journal.

Heparin for ischemic stroke: still not evidence based

This study looked at low molecular weight heparin in various subsets of patients with atrial fibrillation, published in Stroke. Outcomes were not improved.

Platelets and vascular events

This bench to bedside review in Mayo Clinic Proceedings covers clinical trials of platelet antagonists and discusses the biologic mechanisms. Open access to the full text of this article is available 6 months after publication date.

Kudos to Medpundit

I knew there was another reason to miss Medpundit. She was, on occasion, willing to challenge the PC orthodoxy in medicine. In researching my post on the CMAJ mess I overlooked this.

Straight to the guts of the issue, she said: “Well, it is the Canadian Medical Association's journal, so they're well within their rights to tell the editors to tone down the politics, aren't they? It happens all the time to political writers and editors. It isn't as if the Association asked the editors of the CMAJ to suppress scientific research papers. Political proselytizing, like religious proselytizing, doesn't belong in a scientific journal. And if the editors want to make the journal political, then they should realize they have to play by the same rules as every other political editor.”

Wish I’d said it.

Are state medical boards becoming draconian?

Perhaps so, opines Chris Rangel. State boards, suffering from an image of being too lax, are under public pressure to police the medical profession more aggressively. And, according to Dr. Rangel, at least in the state of Texas, an increasing frequency of complaints to medical boards, often frivolous, may be an unintended consequence of successful tort reform in that state. He writes that physicians in Texas fear the board is getting out of control and notes the case of one doctor who was “fined $500, ordered to take classes on documentation, publicly reprimanded, and all for forgetting to time and date an addendum note in a chart.” (Though I have no hard data I’ve heard of instances of this sort of thing).

Rangel writes that board investigators tend to take the attitude that the doctor is guilty until proven innocent. If that’s not already true one influential consumer activist group wants the standard to move in that direction. The Public Citizen Health Research Group wants “A reasonable statutory framework for disciplining doctors (preponderance of the evidence rather than beyond reasonable doubt or clear and convincing evidence).” And just how “reasonable” is preponderance of evidence as a standard for disciplinary hearings? I had that standard of explained to me by a plaintiff attorney when I was on jury duty a few years ago. He asked prospective jurors to imagine preponderance as analogous to “one thousand and one grains of sand” balanced on the scales of justice against “one thousand grains of sand.” Wow. Two grains of sand shy of guilty until proven innocent.

Related post here.

Just the FACTTs (Fluid and Catheter Treatment Trial)

Just in: For patients with ALI and ARDS, pull the PA catheter and keep ‘em dry. These long awaited results have been posted on line ahead of print in NEJM along with related editorials here and here.

We’ve long suspected the dry strategy was better. However up to now the jury was still out on the PA cath.

I’ve previously commented on the PA catheter and the wet-dry debate.

Medical webcast: physician-Pharma relationships

My latest find is Internal Medicine Grand Rounds (traditional Grand Rounds that is) at the University of Nebraska.

Noteworthy:

Dr. Martin Tobin spoke on April 14. We know Dr. Tobin as a leader in pulmonary and critical care medicine and the originator of the “Tobin index” for liberation from mechanical ventilators (frequency to tidal volume ratio) but on this occasion he spoke on “Patients, Pharma, Physicians.” This defense of the No Free Lunch position is eloquent but listen closely for the specious arguments and generalizations. (E.g., promotion influences prescribing; is this always bad? Industry-profession relationships deserve rigorous scrutiny, but should all industry supported publications and CME be rejected out of hand? Though individuals may be unduly influenced is it fair to characterize doctors as puppets?).

An interesting tidbit from Tobin’s presentation was the extent of Eli Lilly’s involvement in the Surviving Sepsis Campaign guidelines and the closely related IHI sepsis bundle. The commercial interest in these lofty initiatives deserves exposure (here’s the inside story on ties between Surviving Sepsis and a Lilly supported public relations campaign). Some take the cynical position that these guidelines are hopelessly tainted by industry influence. I take the moderate position of skepticism which looks to the primary sources of evidence while acknowledging value in the documents.

Despite flaws in the arguments there’s enough good material in the webcast to make for worthwhile viewing. Tobin presents foundational issues with a clarity that will help sharpen one’s perspective on the ethics of physician-Pharma relationships no matter which side of the debate one adheres to.


Background: Additional medical webcasts have been cited by me as well as Clinical Cases and Images. You can find more by entering your favorite medical subject into a Yahoo search under the video tab. Over time more and more institutions are posting video archives of their grand rounds.

Most physicians don’t know a long QT when they see one

Not even cardiologists, according to this study from last year in Heart Rhythm. There are many pitfalls. Sometimes the T wave is not well demarcated, and in many cases is fused with the U wave (an arrhythmogenic situation in and of itself which may have the same significance as a long QT). Many times the computer doesn’t correctly make the call.

This is concerning, because proper recognition can be life saving. It’s a basic skill we should all master. As a primary care physician or emergency physician you may be the first person to see the electrocardiogram of a patient with LQTS.

Essentials of blood banking

Here’s what takes place when you order blood products. From CMAJ.

Fired CMAJ editor rants in NEJM

Politics versus science, editorial independence versus accountability

Dr. John Hoey wants editorial independence. Maybe he should start a blog. In the May 11 on line edition of the New England Journal of Medicine (NEJM) he recounts his dismissal as editor of the Canadian Medical Association Journal (CMAJ) and the related shake up that resulted in additional dismissals and resignations, virtually decimating the journal’s editorial staff.

Although a confidentiality agreement prevents both sides from divulging details there were known to be repeated clashes between the editors and the owners of the Journal, the Canadian Medical Association (CMA). By most accounts it’s about not only editorial independence but also politics and the mixing of scientific content with journalism.

It all came to a head with the Journal’s publication of articles in March and December of 2005 about how Canadian pharmacists question and counsel women seeking behind the counter access to levonorgestrel (Plan B). The articles were highly critical of the Canadian Pharmacists Association (CPA) which, apparently getting wind of the December story before publication from one of the reporters, complained to the CMA and responded in the journal thusly.

The March editorial asserted that counseling by pharmacists makes women “fair game for unwanted questioning and unsought advice — at their own expense” and characterized involvement by pharmacists as a “lingering paternalism.” The response from George Murray, president of CMA, made these points: “Imagine the outrage if the Canadian Pharmacists Association (CPhA) were to suggest that doctors should not ask a woman her name if she is asking for EC, or that they not be paid for the service they provide. Further, for CMAJ to suggest that the information a pharmacist collects is not kept confidential is irresponsible. Any information provided is private, secure and confidential, which would not be the case if the product was available in a convenience store or supermarket.” And this: “CMAJ's position flies in the face of the medical professions' recognition of the importance of collaborative, interprofessional practice where physicians and other health care providers have a clearly identified and valued role.”

But there are larger questions. First, is political content appropriate for a scholarly medical journal? I would disagree strongly with Dr. Hoey and argue that it is not. Such politicization occurs in the form of opinion pieces under the guise of “scientific journalism” or in less transparent forms of editorial mischief such as publication bias or the acceptance of tainted articles. How does this pollute science? For example after example read Steve Milloy’s Junk Science Judo. On page 46 he writes: “When faced with alarming ‘news’ about a new health threat (especially one that might benefit some third party), keep the slow, steady ho-hum scientific method in mind. Boring? Sure. Tedious? You betcha. Slow and deliberative? Be grateful.” It’s dangerous to mix science with public debate. Sure, science can and should inform such debate, but it should never be the other way around, and the lines of demarcation should be clear. Political discourse should not influence science. The doing and the reporting of science should be pure, pristine and sterile. Once scientific results are released from scholarly journals public debate can then be played out in other more appropriate venues.

I like the way Milloy characterizes the process of science. Tedious. Boring. Ho-hum. But Hoey takes a different view. In the May 11 NEJM piece he writes “The ability of an editor to edit depends to an important degree on the editor's own outlook and self-assurance (often mistakenly interpreted as arrogance).” (My translaton: The ability of an editor to edit depends to an important degree on the editor’s own agenda). He goes on with “An eager propensity to poke a stick into something or somebody is also useful. It is a characteristic so widespread, at least among the editors I have known, members of the ICMJE and others, that it may be essential. But the defining characteristic of an editor is quixotic idealism, a characteristic that makes publishers nervous.” Hmmm. An eloquent defense of the eternal right of journal editors to function as loose cannons.

Hoey seems to have a double standard concerning politics in medical journals. Apparently it’s OK for the editors but not for the journal owners. That untenable position is articulated in this paragraph from the May 11 article: “The notion that politically sensitive topics can be expunged from a medical journal is folly. It is also irresponsible. Physicians and their patients must have faith that professional journals facilitate a discourse unencumbered by the economic and political interests of their owners.”

Scholarly medical journals should, of course, avoid all political agendas, no matter whose. The problem can take various forms. An editor may have a political bent which the journal owners dislike, perhaps the case at CMAJ. Equally dangerous is an editorial agenda in lockstep with that of the owners, apparently the case at the Journal of American Physicians and Surgeons (JPANDS). Orac recently touched on this problem in connection with a controversial JPANDS paper purporting to demonstrate a link between mercury containing vaccines and autism. (Note that the Association of American Physicians and Surgeons opposes mandatory vaccination). The JPANDS example may be extreme but it’s nevertheless illustrative of what can happen when a medical journal cozys up to political interests. Such political affiliation has cost JPANDS a great deal in credibility as illustrated by this article by Terry Krepel (caution: ad hominem attacks here). Ironically, Hoey’s defenders seem to invoke the credibility argument in defense of more political content.

The debate about mixing journalism and politics with scholarly reporting of science was played out a few years ago in the British Medical Journal (BMJ) when that journal decided to emulate Cosmopolitan. The announcement from the pages of the January 5 2002 issue read: “The BMJ might be on a long march from being like Brain, a forbidding, research based journal, to Cosmopolitan, a magazine full of froth and colour. The trick is deciding how fast to go. Most current BMJ readers would be appalled by a BMJ that was like either Brain or Cosmopolitan, but some--- those who regret what they see as a constant "dumbing down" in our culture--- would like a journal more like Brain, while others longing for more accessibility and readability want something closer to Cosmopolitan. Today the BMJ introduces a few changes that take us closer to Cosmopolitan.” If readers wanted a dumbing down, BMJ did not disappoint. (Its heavy content of pseudoscientific fluff has earned it a venerable place on Quackwatch’s list of non-recommended periodicals).

Of course no discussion of medical politics and editorial mischief would be complete without mention of the George Lundberg incident at the Journal of the American Medical Association (JAMA). Briefly, an 8 year old study on whether oral sex is generally perceived as “sex” was suddenly selected for publication just in time to influence public debate on allegations surrounding President Clinton. Not surprisingly, Hoey and others, in the February 23 1999 issue of CMAJ weighed in with: “General medical journals are not just a repository of science….” and statements such as “policy makers, among others, crave the contributions of ‘science’” (it’s rather telling here that the authors put the word science in quotation marks). It goes on with “Moreover, it is naïve to think that scientific inquiry is conducted on a rarefied plane free of values and political perspectives in the first place.”

Wow. Let’s parse that statement. First, what is meant by “values?” Basic values such as scientific integrity and honesty, as well as ethical dealings with research subjects, are essential. But I would submit that “political perspectives” have no place in scientific inquiry. (Imagine the howls of indignation if that same statement was made by a Big Pharma leader with the phrase “money interests” substituted for “political perspectives).”

Finally, what about editorial independence? A reasonable view would be that journal owners should hire the editors and then let them do their job unencumbered. But just what is the job of an editor? Most would agree that it is to critically review submitted manuscripts and impartially select those that withstand rigorous scrutiny in order to ensure high scientific quality. Yes, journal owners must let editors do their job. But what is a journal to do when editors fail that job and create a conflict of interest by straying into the political arena? Nothing, apparently, according to Dr. Hoey. Dr. Hoey seems to be asking for more than editorial independence. He wants complete freedom from accountability.

Background: An expose by Michael Fumento on the tainting of science by politics as played out in medical journals.

How far do you have to jog to burn off that Big Mac?

Try the on line calculators at calories per hour.

The Medical Algorithms Project

Since I last checked a few years ago this resource has become a gem. It’s a vast and easy to navigate collection of reference material—more than just algorithms. Primary sources are thoroughly cited. Some of the material is dated. Nevertheless there’s enough good stuff here to include it in my favorites. It’s free but requires registration.

Playing with Google calculator

1 light year in angstroms

1 ml in bushels

9th root of 4

360 joules in BTUs

Wait times in Canada spur new industry: medical travel agencies

The Canadian Institute for Health Information has released its first survey on health care wait times, reported here in CMAJ. The wait for hip and knee replacement was reported to be around 3 months---quite a long time, but shorter than I had previously heard.

Meanwhile, companies such as Timely Medical Alternatives are responding to Canadians’ frustration with waiting lists by booking more rapid treatment in nearby U.S. hospitals. Another company, MedSolution.com, is sending patients to India and France because of lower costs in comparison to the U.S. (Reported here in the same issue of CMAJ).

Any med students listening in?

At least one, over at Medskool, who offers this take on basic science in medical school.

JAMA reprints CDC distortion on chelation deaths

This week’s JAMA republished the March 3 MMWR piece on chelation associated deaths being investigated by the CDC. This was spun by the CDC as a case of medication error due to “look alike, sound alike” medications and JAMA makes no effort to correct the distortion. Here’s my take from last March.

Medical school basic science---a follow up

Somehow I can’t quite let this go. Dr. Rangel’s post and my reply on the question of how much basic science should be taught in medical school sparked several discussion threads on other blogs.

Noteworthy:


Orac weighed in with a lengthy post of his own. One of his commenters referenced my statement about hydrophobic and hydrophilic amino acids and illustrated the self-correcting nature of the blogosphere with---

Pedantically, however, this:"some [amino acids] are hydrophobic and comprise membrane lipid bilayers" is wrong. Lipid bilayer membranes comprise phospholipids. Hydrophobic amino acid sidechains are exposed in integral membrane proteins, allowing the protein to embed within the phospholipid bilayer. Mea culpa. Sloppy terminology on my part. The principal components of cell membranes are phospholipids. Various proteins, the exposed amino acids of which tend to be hydrophobic, may traverse or be embedded in the lipid bilayer. Post revised.


Reflecting on the article about compromised basic science education in Australia’s medical schools Orac observes similar trends in the U.S.---

None of this was news to me, or, I daresay, to most surgeons. When I quiz third year medical students about anatomy in the operating room, even very basic anatomy, far more frequently than I like, I'm amazed at how little some of them know or, with the exception of students going into surgical specialties, seem to care. I've never seen a student quite as clueless as the ones described in the Australian article, but it's nonetheless clear to me that the deemphasis of anatomy and basic science in medical education is not a phenomenon confined to Australia. Indeed, the above article only echoes and amplifies complaints that I've heard for a long time right here in the good old U.S.A.


Though not in academic medicine and therefore unable to directly observe such trends I’ve suspected this sort of thing for some time. Constant tinkering with curricula and the increasing encroachment of pseudoscience in med school courses has been a long time concern of mine.


DB links to the discussion and wonders if we need a new Flexner report. As I said before Abraham Flexner may be turning over in his grave over the current state of medical education. I agree medical education needs another housecleaning. I only hope the next Flexner doesn’t have this vision for medical training proposed a few years ago in BMJ: “….gone will be the days of freestanding courses in biochemistry, physiology and anatomy” and “There will be no exams in anatomy, physiology, or biochemistry, and no one will need to learn by rote the entire Krebs cycle or the names of all those little holes in the skull.”

Is the hospitalist movement a product of intelligent design?

A letter to the Annals of Internal Medicine seems to suggest it is. Dr. Ashok Daftary writes “Academic medicine is the carpenter that fashioned the coffin of internal medicine. Instead of re-engineering internal medicine to accommodate change it cannibalized the discipline reducing its worth, creating the hospitalist and ambulatory care internist.”

Although Retired Doc, DB and Kevin have this issue well covered I’ll weigh in as a representative of the hospitalist movement. I have to agree with DB that the movement was nobody’s grand scheme—it arose out of economic pressure as I pointed out earlier this year:

"Finally, to remind readers of the historical perspective, the hospitalist movement is a bit like the blogosphere, arising not by anyone’s personal agenda but almost as if out of thin air. About a decade ago changing practice patterns in pockets of California with heavy managed care penetration captured the attention of Robert Wachter and Lee Goldman who published this prescient article in NEJM in which the term “hospitalist” was coined. Economic pressures were the initial driving force. As the movement gained momentum it came to be driven more and more by its original detractors, the family docs who, for a variety of reasons, chose to eliminate their hospital practices."

I’ll be the first to admit that the movement is too self promoting at times, but as DB aptly put it, it was “not a nefarious plan or conspiracy.”

CPAP and BiPAP in acute pulmonary edema---evidence based and ready for prime time

ER and critical care docs I’ve worked around seem to have figured this out some time ago, and now we have high level evidence to support the use of these modalities in acute cardiogenic pulmonary edema (ACPE). The meta-analysis just published in Critical Care provided robust evidence that non invasive (usually via face mask) continuous positive airway pressure (CPAP) and non invasive continuous positive pressure ventilation (NPPV, more popularly known as BiPAP), when combined with standard medical therapy (SMT) reduce mortality and the need for intubation when compared to SMT alone.

Absolute risk reductions were striking, with numbers needed to treat (NNT) for CPAP of 4.5 in preventing need for intubation and 8 to save one life. For NPPV the NNTs were 5.6 and 14 respectively. All of those results were statistically significant except for the effect of NPPV on mortality, in which the confidence interval overlapped zero. A few studies in the analysis compared the two modalities, showing a non statistically significant trend in favor of NPPV.

The authors conclude that these modalities, which already had a class IIa recommendation in the 2005 guidelines for management of acute heart failure from the European Society of Cardiology, are first line interventions and should be considered “mandatory.”

Refining our approach to pulmonary embolism

From the February 27 issue of Archives of Internal Medicine come three studies and an editorial on this subject.

A prediction rule using history, physical exam and arterial oxygen saturation identified PE patients at low risk. Echocardiographic assessment of right ventricular function was not required. This is appealing because the safety of initial out patient treatment of PE is not clear. The authors caution that validation of the rule in additional studies is necessary before it can be recommended as a clinical tool to select patients for out patient treatment.

In this study of emergency room patients with prior history of venous thromboembolism a negative D-dimer test (VIDAS D-Dimer Exclusion) seemed to safely exclude a recurrent event. The relatively low number of patients with prior thrombosis who have a negative D-dimer limits the applicability of this approach.

Multimodal bedside testing was as good as V/Q scanning in ruling out PE in this study. A negative clinical score combined with a negative D-dimer safely excluded PE. If these two modalities were discordant, bedside determination of alveolar dead space fraction excluded some additional patients.

It was all nicely synthesized in this accompanying editorial.

What’s the best level of PEEP for ARDS?

The struggle to make a dent in the mortality of acute respiratory distress syndrome (ARDS) has frustrated clinicians and researchers for decades. It is perhaps for this reason that there has been much tinkering with a vast array of technological advances and novel modalities, most of which have not been supported by high level clinical studies. Among the latest approaches to fail the rigorous test of evidence based medicine was the use of high “recruitment” levels of positive end expiratory pressure (PEEP). This was discussed in my recent post about ARDS.

As a follow up I should mention the paper by Gattonini and colleagues in the April 27 issue of NEJM (also recently cited by Pulmonary Roundtable). Gattonini has done pioneering work to help advance understanding of the pathophysiology of ARDS. The investigators demonstrated a method of CT imaging to determine the amount of recruitable lung in patients with ARDS. Not surprisingly patients were heterogeneous in the amount of recruitable lung present. A significant number of patients had little recruitable lung. Such patients might be harmed by high levels of PEEP. For those patients with larger degrees of recruitable lung, this study does not tell us how much PEEP is optimal.

An accompanying editorial discusses physiologic rationale and contains illustrations (with a video clip in the on line version) of ex vivo rat lung ventilation with and without PEEP, demonstrating dramatically how PEEP restores homogeneity of aeration by recruiting atelectatic areas. Striking as this illustration is the editorial writer reminds us that the ARDSnet study found no benefit of high level PEEP compared with conventional PEEP.

So what approach should we use? The best guide is still the ARDSnet PEEP scale.

A contrarian view of the drug companies

Dr. Jerald Kreisman, associate clinical professor of psychiatry at St. Louis University, in Defending the Drugmakers writes “Over the past several years, the pharmaceutical industry has replaced managed care as the Bad Boys of Health Care. Public opinion, government oversight, and litigation pressures have obliged the industry to adopt a litany of mea culpa declarations.” Indeed “Big Pharma” has become analogous to big oil, big money and everything else that’s big and bad. Alongside that physicians, many of whom interact with drug company representatives, are portrayed as the mindless minions of an industry-led conspiracy to harm patients. Notwithstanding the patent absurdity of this characterization the drum beat is getting louder and louder.

Doctors are not devoid of critical thinking skills. Moreover, there’s no convincing evidence that physician-industry interactions result in net harm to patients’ health. Immediately comes the shrill cry “What about Vioxx?” Yes, the promotion of Vioxx has been linked to harm. What is not known is how this balances against the effects of promotion of clearly beneficial yet underutilized therapies such as DVT prophylaxis and beta blockers and ACE inhibitors for heart failure.

Finally, haven’t we heard about enough of the tired old argument that doctors succumb to drug company deception because of their dependence on free trinkets such as pens and note pads? Where’s the evidence for that argument? (I’ve done without for seven years and couldn’t care less about ‘em). I’m much more concerned that continued industry bashing will lead to an erosion of support for CME and the ultimate end of resources like Medscape and emedicine.

What’s evidence based in ARDS?

A review in Cleveland Clinic Journal of Medicine summarizes the latest findings on several modalities. Low tidal volume ventilation (6 ml/kg ideal body weight) is well established. High “recruitment levels” of positive end expiratory pressure (PEEP) are theoretically appealing but do not improve outcomes. Prone positioning, high frequency ventilation, and nitric oxide have failed to live up to initial promise. Conspicuously absent from this article was the mention of corticosteroids for late phase (greater than 7 days) ARDS, recently studied in the ARDSnet Late Steroid Rescue Study. This study has been completed and, after publication date of the CCJM article, was published in NEJM with the conclusion that late phase corticosteroid therapy for ARDS is not beneficial.

Timing of hip fracture surgery

In this observational study of 129,522 patients admitted with femoral neck fracture, surgery delay of more than one day was associated with increased mortality with an odds ratio of 1.27 (1.23-1.32) after adjustment for comorbidity.

Hospitalists are often called on to optimize medical management of hip fracture patients prior to surgery. Physiologic disturbances and laboratory abnormalities must be addressed as fully as possible, but these and other recent data suggest that the time window is short and that lengthy preparation has diminishing returns.

Something new in COPD

Inhaled corticosteroids decrease mortality, as reported here in Thorax.

ICD-9 coding

I have always rebelled against ICD-9 codes. The terminology is archaic and often clinically irrelevant. As a physician I have more important things to keep track of. Nevertheless ICD-9 is part of the game I’m forced to play.

Fortunately, for those inevitable occasions when you have to sign off on medical equipment and the coder isn’t handy there’s help on line. Kevin once showed us how to Google for ICD-9 codes and pointed us to this resource. Wikipedia has this user friendly index and an overview of the International Classification of Disease. The classification system is horribly out of date. ICD-9, still in use, was published in 1977. ICD-10, conceived in 1983, completed in 1992 and probably already out of date, has not yet been implemented in the U.S.

The new C. diff marches across Canada

It’s not unique to Quebec anymore. It’s turned up in 7 provinces according to this CMAJ report. I previously mentioned it here.

Is rock-and-roll stardom hazardous to your health?

I know of no systematic studies but here’s a collection of anecdotes---dead rock stars. Read and be amazed. The causes of some of the deaths are in dispute. For example, did Karen Carpenter really have anorexia nervosa? The Pathology Guy thinks not. Maybe she had right ventricular cardiomyopathy, Brugada syndrome, LQTS or some such.

Via The Pathology Guy.