Tuesday, October 31, 2006

How do you prepare pre meds for the woo they’ll be taught in med school?

Teach it in undergrad, of course! Call it Project Head Start. Pre med students, it seems, are taking Boston University’s Chinese Medicine class:

There are also premed students looking for another perspective. Western doctors may generally be skeptical of the field, Kohn says, but she notices more of them are sending patients to classes in yoga and Qigong (posture and breathing exercises).
"You've got a new generation of doctors who've grown up with the idea that some self-practice, self-awareness is really helpful," she says.

Next thing you know, med schools will be adding it to their list of prerequisites, right alongside biology, organic chemistry, etc.

Pulmonary embolism and chronic pulmonary hypertension

A while back I cited a study which showed a 3.8% rate of development of chronic thromboembolic pulmonary hypertension after PE. This was surprisingly high to me. The September issue of Medicine reports this study of patients with PE which looks at outcomes in relation to the degree of pulmonary vascular obstruction. The rate of chronic pulmonary hypertension was much lower, on the order of 1%. The study reported nearly complete resolution of emboli in most patients. I previously linked to this study reporting a high rate of persistence of perfusion defects long term.

Saturday, October 28, 2006

Just got through watching the CBS documentary on the Jeremy Perkins case---

Jeremy was a paranoid schizophrenic. He and his parents were Scientologists. They refused psychiatric help because it was against their beliefs. Jeremy was treated with vitamins and sent to a Scientologist physician who recommended an intravenous treatment to remove toxic metals, possibly chelation therapy. Jeremy’s condition worsened, as did his delusions that his mother was “evil”, and he fatally stabbed her.

The show featured an interview with an official from the anti-psychiatry and Scientology front organization Citizens Commission on Human Rights which maintains that the drug industry has conspired to medicalize non-medical aspects of life by inventing mental illnesses.

Background:

The Lisa McPherson case
CCHR

Friday, October 27, 2006

Sports media bias

If you’re a St. Louis Cardinal fan you know it’s there. Palpable. So thick you could cut it with a knife.

Could you hear the disappointment in the voices of the announcers when the Cards eliminated the Mets? So much for “fair and balanced Fox.”

I’m told one columnist said something like “Detroit in three if the Tigers don’t die laughing.”

Bernie Miklasz of the St. Louis Post Dispatch, relieved that we don’t have to suffer a “subway series”, comments here.

Thursday, October 26, 2006

The Surviving Sepsis Guidelines: guilt by association?

The Surviving Sepsis Guidelines have been under fire for the role of Eli Lilly in their development and promotion. In a recent blog post I argued that much of the criticism of the guidelines is irresponsible because it ignores the evidence and relies solely on the fallacious argument of “guilt by association” or, as one of my commenters put it, “corruption.”

Two of my favorite bloggers who recently weighed in on the controversy took a somewhat more negative view of the guidelines than I. Dr. Roy Poses of Health Care Renewal cites the guidelines as the latest example of “stealth marketing” and concludes with “Maybe with increasing realization how pervasive conflicts of interest fuel deceptive marketing and promotion will come some increased skepticism and a will to address this problem.” I’m all for more skepticism, but what was it that was deceptive about Lilly’s promotion, exactly?

Retired Doc’s response was more scathing. (Retired Doc sees eye to eye with me on many issues, but we may have to agree to disagree on this one!). He’s concerned about how drug companies use EBM for promotional purposes and wonders whether their spin of evidence puts patients’ lives at risk. He cites the NEJM Perspective authors’ concerns that information on the risks of bleeding due to Xigris was suppressed, and feels the jury is still out concerning Xigris.

Let’s examine these questions. Did the guideline authors spin the evidence on Xigris? The guideline section on activated protein C is on page 863 of volume 32, issue 3 of Critical Care Medicine. Looks pretty straightforward to me. Right out of the PROWESS article. Where is the spin here?

Although the guideline authors appropriately emphasize that Xigris is to be used in patients assessed to be at high risk of death, some might criticize their failure to be more explicit in how the APACHE II score and the number of failing organs should determine candidacy for the drug. The results of ADDRESS later suggested restricting Xigris to patients with two or more failing organs or an APACHE II score above 25, but those results were not announced until 7 months following the guideline publication and were not published until 18 months after the guidelines. That fact didn’t stop the NEJM Perspective authors from trying to hold the guideline authors accountable. They state: “Although the results of the ADDRESS study were reported at the October 2004 ESICM meeting, no mention of the study was included in a supplement to the Surviving Sepsis Campaign Guidelines published the following month in Critical Care Medicine.”

But, digging deeper, the ESICM meeting in question was held October 10-13 2004. The November supplement to Critical Care Medicine was certainly already posted and printed during the month of October and probably in press by the time the ADDRESS results were announced. The Perspective authors left out those little details. Now who’s being deceptive?

Was the risk of bleeding suppressed? The body of the report mentions bleeding risk and refers the reader to an appendix which explicitly states this risk and cites product labeling containing the actual data on bleeding from clinical trials. I’m still looking for the smoking gun.

What about the evidence favoring activated protein C in severe sepsis? Critics of the guidelines talk around this issue but seem to come short of any direct criticism. Retired Doc correctly notes that the jury is still out. That’s often the case, to one degree or another, in clinical research, but at any given time we have to go by the best evidence we have. Is PROWESS so hopelessly flawed that we should throw it out? Nothing in the subsequent analysis or research on this topic suggests that we should. The NEJM Perspective authors acknowledge that the Surviving Sepsis Guidelines are supported by randomized controlled trials but make this astounding statement: “Although such trials represent the gold standard of medical evidence, overreliance on them in the construction of guidelines has a tendency to favor new drugs and devices, which typically undergo at least one such trial in order to obtain government approval.” Overreliance on randomized controlled trials? Do the authors want to turn evidence based medicine upside down?

I should mention the XPRESS study comparing outcomes in patients receiving Xigris with and without heparin in DVT prophylactic doses, showing a mortality rate comparable to the treatment arm of PROWESS. Although presented last January at the Society of Critical Care Medicine meeting the NEJM perspective authors did not mention it. The results indicate that DVT prophylaxis using low molecular weight or unfractionated heparin need not be withheld during treatment with activated protein C.

Most of the critics of drug company marketing, up until now, have complained that doctors are influenced to prescribe counter to the best evidence. The NEJM Perspective authors have taken the novel tack of complaining that a drug company promotes in line with evidence. The drug companies can’t seem to win for loosing!

Imaging studies in acute pancreatitis

Who, when and how, from CCJM.

Wednesday, October 25, 2006

Authors’ conflicts of interest----selective outrage

Allan Detsky, guest editorialist in the October 24 issue of CMAJ, writes about conflicts of interest in writing guidelines. Financial conflicts of interest due to drug company ties are generally mentioned while other types of conflicts are ignored, Detsky notes. Underappreciated conflicts include a personal stake (reputation, academic career) as well as incentives to promote one’s specialty.

If conflicts of interest invalidate the development of guidelines perhaps we should question how the American College of Gastroenterology writes guidelines pertaining to endoscopy or whether the American College of Cardiology should write guidelines for coronary interventions. Such conflicts, though less tangible, are no less powerful than those involving drug company money. The journals tend to ignore them, as Detsky notes in this example: “A recent review article in the New England Journal of Medicine promoted positron-emission tomography (PET) scans for cancer assessment; of the 2 coauthors, 1 was a radiologist (who, I assume, reads PET scans). The article contained a statement that ‘No potential conflict of interest relevant to this article was reported.’ Really?”

Political agendas create powerful conflicts of interest as I have noted here, here and here. I first wrote about the “other” conflicts of interest over a year ago here.

In Detsky’s concluding paragraph he states “Although these other influences may be even more difficult to document and quantify than financial ties, they are no less important.”

Thanks to DB for pointing me to the editorial.

Wachter on the state of the hospitalist movement

I’m always interested in what Robert Wachter, hospitalist thought leader, has to say on the state of the field. He was recently interviewed by Internal Medicine World Report. Points of interest:

Rise of hospitalists and decline of primary care: true, true and unrelated in Wachter’s opinion. Not sure I agree.

How many hospitalists are needed? 30,000 to 50,000, perhaps, more than previously estimated.

What makes the difference between a good program and a bad one? Communication---with families and primary care docs.

Tuesday, October 24, 2006

NCCAM chelation study site tour---Part VII

The Marino Center for Progressive Health in Cambridge, Massachusetts is one of the NCCAM chelation therapy study sites. The clinic features the usual array of alternative methods including acupuncture, chelation and chiropractic. Their IV therapy program offers intravenous therapy for multiple ailments including the common cold. One of the major components of the IV program is magnesium therapy. According to the web site magnesium “plays a critical role in a vast array of acute and chronic diseases” and “studies strongly suggest that when it comes to magnesium, most of us may be running on less than a full tank.”

At the Magaziner Center for Wellness, another chelation study site in Cherry Hill, New Jersey, patients are offered a variety of alternative treatments including hyperbaric oxygen therapy for neurologic diseases. The Center promotes this vast array of herbal products for everything from faulty immune systems to stress.

The Gables Natural Medicines Center and Day Spa is another NCCAM study site located in Mayville, New York, offering chelation and naturopathic medicine.

The Rhinebeck Health Center in Rhinebeck New York, another study site, advocates chelation therapy and a variety of other CAM modalities. The site contains a number of articles, one of which advances the theory that mercury containing vaccines help cause autism, and defends the work of the Geiers in this area.

Background: part VI here; part V here.

Monday, October 23, 2006

The Surviving Sepsis Campaign guidelines: evidence based or not???

An exhaustive review on sepsis in the October 19 issue of the New England Journal of Medicine (NEJM) covers nomenclature, pathophysiology and treatment, including a discussion of the Surviving Sepsis Campaign guidelines. But in what could be viewed as a strange attempt on the part of the Journal to appear “fair and balanced” the same issue’s Perspective piece entitled Surviving Sepsis---Practice Guidelines, Marketing Campaigns, and Eli Lilly dismisses the guidelines as little more than a marketing strategy disguised as evidence based medicine. The authors base their criticism entirely on the role of Eli Lilly in the development and promotion of the guidelines, which endorse its drug Xigris (activated protein C) for restricted indications in patients with severe sepsis. (When I wrote about this controversy 5 months ago I took the more moderate position that the Eli Lilly ties deserved exposure and these guidelines, like any guidelines should be viewed with healthy skepticism. I also took the position that any responsible criticism of the guidelines should appeal to the primary sources of evidence and not be based solely on arguments concerning industry affiliation).

Guidelines, though useful, are imperfect. This can have unintended consequences when they are promulgated by agencies like IHI and JCAHO or become the focus of pay-for-performance initiatives. Even greater harm can result when they are hijacked by the trial lawyers and their hired guns under the rubric of “standard of care.”

Although the authors correctly point this out their criticism of the sepsis guidelines is misdirected and at times defies logic. Proper criticism of the guidelines should be based on the measuring stick of evidence. Portions of the Surviving Sepsis Guidelines indeed depart from high level evidence. The Perspective piece authors, however, don’t seem to care about evidence and disregard the fact that the only examples of the guidelines’ departure from evidence are unrelated to influence by Eli Lilly.

So let’s look at how each recommendation in the guidelines stacks up:

Early goal directed therapy----supported by high level evidence.
Diagnostic studies to ascertain source and microbiology---supported by low level evidence.*
Antibiotic therapy---supported by low level evidence.*
Source control---supported by low level evidence.*
Fluid therapy recommendations---supported by low level evidence.
Vasopressor recommendations---supported by low level evidence.
Inotropic agents---supported by low level evidence (high level evidence if used as part of early goal directed therapy).
Corticosteroids---conflicting evidence; use is controversial.
Activated protein C---supported by high level evidence.
Low tidal volumes for patients requiring mechanical ventilation---supported by high level evidence.
Sedation protocols and avoidance of neuromuscular blocking agents in mechanically ventilated patients---supported by high level evidence.
Intensive glycemic control---not supported.
Renal replacement therapy recommendations---supported by high level evidence.
Non-recommendation of bicarbonate therapy for most cases of hypoxic lactic acidosis---supported.
DVT prophylaxis---supported by high level evidence.
Stress ulcer prophylaxis---supported by high level evidence.

*Although diagnostic studies, antibiotic therapy and source control recommendations are based on “weak” evidence the guideline authors unequivocally recommend these measures. The ethical problems in demanding high level evidence for these modalities are obvious.

From the synopsis above it is readily apparent that any evidence based criticism of the Surviving Sepsis Guidelines would have to question intensive glucose control and the use of corticosteroids. The Perspective authors were conspicuously silent about these, the two weakest recommendations in the document. Why? Because they can’t blame it on the drug companies! Cheap, generic, plain ole insulin and hydrocortisone, the only non-evidence based drugs supported by the guidelines, are of no financial interest to the drug companies.

Gotta ask this question: is this ad hominem attack on the sepsis guidelines anything more than gratuitous bashing of the drug companies?

Friday, October 20, 2006

Harry Potter would be right at home in today’s medical schools

Orac, dangit, you beat me to it.

Homeopathy: Holmes, Hogwarts, and the Prince of Wales. This piece in the FASEB Journal isn’t just about homeopathy. It takes on many forms of pseudoscience currently promoted by NIH, NHS and U.S. medical schools. It concludes: Hogwarts is certainly on the move! If the trend persists, perhaps MIT or Cal Tech will march in step with the medical schools and offer prizes for integrative alchemy or alternative engineering.

Wednesday, October 18, 2006

More evidence of under-utilization of VTE prophylaxis

Presented at the American Heart Association’s 7th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.

Via Internal Medicine News and World Report.

Tuesday, October 17, 2006

A boost for open access

Five major UK research funders now require open access publishing of all their supported research. We can expect more and more studies to be published in open access journals. Read the rest from Biomed Central.

Wednesday, October 11, 2006

Biphosphonates and osteonecrosis

Two brief items appeared in September’s Internal Medicine World Report.

General update on the problem.
New guidelines with focus on prevention of osteonecrosis

Monday, October 09, 2006

Avoiding ambulance diversion: how does it work in the real world?

Recent blog discussions [1] [2] [3] [4] [5] about ambulance diversion have been generally critical of the Institute of Medicine’s unrealistic mandate for hospitals to avoid diversion and patient “boarding” by improving the efficiency of patient flow.

St. Louis area hospitals, feeling the crunch, offer a picture of what can realistically be achieved by the most aggressive bed management conceivable, as reported in today’s Post Dispatch. It’s an impressive effort---arguably the best hospitals could be expected to make. These folks are organized, and they’re trying everything in the book, from more efficient room cleaning to electronic tracking systems. The results? Although diversion lessened it still occurs at a rate of one to two hours per day in spite of some patient boarding.

When there’s no room there’s no room, and there’s only so much you can do.

Saturday, October 07, 2006

More criticism of the Institute of Medicine

A recent commenter on ER crowding and the IOM said----

“The IOM is basically a government agency whose aim seems to be to find fault with and criticize health care professionals without having to find the means to properly fund their mandates. They make headlines and take the public's attention away from the real issues of healthcare economics. Our various professional organizations are afraid to refute their findings because we don't want to sound like we're whining. Yet we had better do so or all we're going to see is continued finger pointing and no real change.” I certainly agree with that. If the professional organizations won’t do it maybe the bloggers will!

As long as we’re picking on the IOM, NEJM recently reported on the IOM’s assessment of pay for performance. As we know, P4P is merely “playing for the test” and has little if any impact on real quality. Not to my surprise I found the IOM recommendations a little naïve. You can listen to the interview here or access a free transcript here.

The interview raises a few questions. They want to expand the P4P concept to reward not just quality, but also efficiency and “patient centered” care. Well, we already have a very powerful negative efficiency incentive----that hidden provider tax known as DRG. We also began a massive experiment in efficiency incentives almost a decade ago known as managed care.

And what is meant by “patient centered care”? It sounds great, but I thought all medical care was basically patient centered. It must mean something extra special----so what is it, exactly? Those folks at the IOM must be mighty smart if they can measure something as nebulous and subjective as patient centeredness. For phase two of their initiative they might consider measuring compassion, honesty, and empathy.

Although those are pretty lofty goals they’re going to start with the basics: reward providers “just for reporting data, at least initially.”


Friday, October 06, 2006

Bloggers respond on ER overcrowding

In response to my post on ER overcrowding DB notes that the Institute of Medicine (IOM) is unrealistic on many issues and points out the relationship of ER overcrowding to under compensation of general ambulatory care. Increasing utilization of the ER as a “clinic” by patients without access to primary physicians overtaxes emergency care. Worse, some ER patients require hospital admission largely due to the shortage of clinic doctors and inordinate wait times which preclude expeditious out patient work ups.

Today Grunt Doc offered a dissenting view and said (referring to DB, Kevin and myself): “The linked commenters in the first paragraph give a 'suck-it-up ED' subtext that rankles. We're doing that.” I guess I pushed the wrong button here, but no such subtext was intended. I was being critical of the IOM, not emergency departments. I have no doubt they’re doing the best they can.

He made this comment over at DB’s blog: “I think there’s a lot of arrogance in absolving the hospital of any responsibility to ease ED overcrowding. Overcrowding isn’t a result of ED inefficiencies, it’s a lack of hospital ownership of the patients admitted to the hospital through their own ED.” Wait a minute---nobody’s blaming the ER here. This isn’t “us against them.” The emergency department is part of the hospital. Their problems are the hospital’s problems, and vice versa. If the ER is overtaxed the entire hospital feels the strain due to extensive overlap and sharing of resources.

What’s Grunt Doc’s solution? Hallway beds. Fine. It seems to work at his institution. I’m not exactly sure what the hallway protocol entails, but I suppose it means that if all regular beds are occupied (hospital “full”) you put the patients where ever there’s physical space, initiate care and hold them there until a regular bed opens up. To me that’s a form of boarding, but you do what you have to do. There’s nothing written in stone in my mind that such boarding has to take place in the ER unless the patient needs cardiac monitoring.

But hallway boarding has its problems too. If the hospital has reached the capacity of its licensed beds (presumably the case if its wards are really full) might those hallway admissions run afoul of the law? In many cases it’s about more than licensed beds and physical space----it’s about staffing. That’s a patient safety issue. There’s plenty of evidence that higher patient to nurse ratios are associated with increased mortality. In this study, for example, 30 day mortality rose 7% for each patient added per nurse.

I’ll say it again. My whole point was directed at the IOM. They say hospitals wouldn’t have to divert or “board” if they’d just be more efficient. That is simplistic. Hospital administrators, physicians and case managers have been working their fannies off to make hospitals more efficient under draconian negative cost incentives (AKA DRGs) that have been in place for 23 years. That is not the answer to ER crowding.

Related criticisms of IOM:

The hyping of medical errors.

The promotion of pseudoscience.

Thursday, October 05, 2006

Wish I’d said that

A commenter (Okulus) over at Kevin MD’s link to my post on the Institute of Medicine’s recommendations concerning ER overcrowding wrote:

Now the IOM will become the deserving target of the AHA. Given the abstracted and unrealistic ideas that seem to come with great regularity from the IOM, perhaps it is time government funds were spent elsewhere.
It seems wasteful to fund the production of so-called analysis that produces such wasteful and stupid results.

So right.



Wednesday, October 04, 2006

Speaking of ER delays and overcrowding---

In view of all that’s been written lately on the hazards of ER delays, this Perspective piece in NEJM is timely. The author, Arthur Kellermann, M.D., M.P.H., reports findings and recommendations from an Institute of Medicine (IOM) committee on emergency care. Due to increased utilization and shrinking resources, according to the article, ER care has reached a point of crisis. It points out that EMTALA, intended to improve ER access has in fact diminished it by giving emergency rooms an unfunded mandate.

As I read the article everything seemed reasonable until I got to the discussion of ambulance diversion and emergency department boarding. Briefly, when no inpatient beds are available for hospital admission the emergency department may commence care of the patients and keep (“board”) them in the department until an inpatient bed becomes available. In extreme situations ambulances are diverted to other area hospitals. These practices have become quite common due to overcrowding. But now the IOM is recommending these practices cease, except in disaster conditions. That’s all well and good, but what’s the hospital to do when there’s no room in the inn? Dr. Kellermann writes that the IOM decrees “Hospitals can achieve this goal by adopting operations-management techniques and related strategies to enhance efficiency and improve patient flow.” Huh? Isn't that what hospitals have been struggling to do for their very survival ever since DRGs were enacted in 1983? This is supposed to solve the problem of ER overcrowding, suddenly? It strikes me as naïve. The full IOM report is here.

If you’re experiencing STEMI-----

Do not pass go, do not collect $200.00 and do not stop in the ER. Go straight to the CCU or cath lab. That’s the message of an observational study published in the October issue of Heart. Patients with ST segment elevation MI who were shipped directly to the CCU or cath lab were admitted earlier (by 48 min) and had a lower mortality than those who were admitted via the ER.

Mortality for ER patients was 8.6% for ER patients and 4.9% for those directly transported to the cath lab or CCU. By my math that means that the benefits of direct transport are RRR 43%, ARR 3.7%, NNT 27. In terms of relative risk, mortality rose by 0.9% per minute of delay, translating into 54% per hour.

This is one more piece of evidence that ER delays are lethal (see this recent post citing evidence that, across the board wait time is associated with 20% mortality per hour for all patients admitted) and that by some folks’ definition there are lots of emergency department homicides out there.

So how do you know if you’re having a STEMI (as opposed to NSTEMI or non cardiac chest pain)? Well, you don’t, initially. But the paramedics can tell from their pre-hospital ECG.

That raises another point. If you experience chest pain DO NOT come to the ER in a private car. Call an ambulance. Transport by private car was the first mistake in the Illinois heart attack death recently ruled a homicide.

Sunday, October 01, 2006

Abraham Flexner’s legacy---NEJM authors miss the point

The New England Journal of Medicine (NEJM) launched a series of articles on medical education with this piece on the legacy of Abraham Flexner. The 1910 Flexner Report, a comprehensive and highly critical evaluation of medical schools in the United States and Canada, helped spur a revolution in medical education, setting a blueprint for the twentieth century.

The authors, discussing how medical schools today might measure up in Flexner’s view, cite poor training in procedural skills, compromised teaching due to competing research and economic agendas and a lack of attention to professionalism and ethics. These are valid concerns. But conspicuously absent form the discussion was mention of a major problem plaguing medical training today about which we were warned in the Flexner Report: the rampant teaching and promotion of quackery and pseudoscience in medical school. Almost a year ago I pointed out that medical schools had backslidden from the recommendations of the Flexner Report as evidenced by their promotion of homeopathy, Reiki, Ayurvedic medicine and innumerable other unscientific claims.

As I reviewed the Flexner Report in its entirety this weekend I caught myself wondering whether the NEJM authors even read it at all. Flexner’s concern for the sanctity of science, practically an obsession, is evident throughout. If the authors read the report they must have skipped chapter 10 which warns strongly against what medical educators today call “integrative medicine.” The chapter is titled “The Medical Sects”, in reference to groups of teachers and practitioners who advocated for various non-scientific claims, referred to by Flexner as “dogmas.” Chapter 10 opens questioning the integration of dogma with science thusly: “Is it essential that we should now conclude a treaty of peace, by which the reduced number of medical schools should be pro-rated as to recognize dissenters on an equitable basis? The proposition raises at once as to whether in this era of scientific medicine, sectarian medicine is logically defensible; as to whether, while it exists, separate standards, fixed by the conditions under which it can survive, are justifiable.” Flexner’s emphatic answer, bolstered by eloquent arguments in the succeeding pages, is no.

Medical schools are showing increasing disregard for the principles of science. If the NEJM in its forthcoming series of reviews on medical education ignores this pernicious trend it will have done the profession a great disservice.

Orac exposes the “pharma shill” gambit

It’s a favorite fallacy for the alt-med crowd. It’s been used on me a time or two.