Imposter syndrome makes medical training more difficult than it should be

In a field filled with history, data, and very smart people, it can be difficult to do anything with confidence. And yet, this is one of the most desirable traits a doctor can have, that and a light hand when it comes to handing out narcotics. However, I have never been a fan of over-confidence. […]

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You might be missing a PCOS diagnosis. Here are 10 reasons why.

Polycystic ovarian syndrome (PCOS) is becoming a significant problem in women’s health. Between 1 in 10 to 20 women have the condition, although more than 50 percent remain undiagnosed. PCOS is the leading cause of female infertility and women who do become pregnant have higher rates of miscarriage, preterm birth, and gestational diabetes. Women with […]

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Why doctors overtreat patients. And how to fix it.

In the late 19th century, Dr. William Halsted, a pioneer of modern surgical techniques, performed ultra-radical mastectomies for women with breast cancer. The procedure, soon named after him, involved the surgeon removing not only the breast itself but also surrounding musculature and the associated lymphatic system. Halsted believed, and taught generations of medical students, that […]

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She became a hospice nurse because of this story

The woman lying on the transport cot in the examination room was terrified. I could see it plainly in her eyes, but there was no time to stop and comfort her. I was a young, recently graduated nurse in a busy urban emergency room, struggling to keep up with its daily array of shootings, stabbings […]

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Being an attending means being a teacher. Take that job seriously.

“Sometimes a simple, almost insignificant gesture on the part of a teacher can have a profound formative effect on the life of a student.” – Paulo Freire Think back to a moment when a teacher or “authority” figure gave you a compliment. We all have them, from kindergarten to high school to college and sometimes […]

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The sad story of how “never events” prevent obese patients from getting new hips

Daytime TV advertising is dominated by two players. Pharmaceutical companies with direct to consumer pitches and the so-called “toxic tort.” How confusing it must be to the average person to see a new drug pushed by one commercial, to be immediately followed by another commercial from a lawyer trying to sue for the known side […]

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You have access to a doctor 24 hours per day. When should you call one?

Patients are entitled to receive medical advice 24 hours a day. If you call your doctor at 3 a.m., you will reach a physician who will advise you. Of course, it may not be your own personal physician as this individual cannot be expected to be available 365 days a year until he retires. Physicians […]

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The sick and the dying can be found in hospitals of any size. Don’t forget that.

I have worked in a lot of hospitals over the past two years. Quite a few of the facilities have been critical access hospitals, which is to say that they are very small, typically having fewer than 25 inpatient beds, and are usually somewhere in the boonies. A number of characteristics allow a hospital to […]

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Research and Reviews in the Fastlane 093

Welcome to the 93rd edition of Research and Reviews in the Fastlane. R&R in the Fastlane is a free resource that harnesses the power of social media to allow some of the best and brightest emergency medicine and critical care clinicians from all over the world tell us what they think is worth reading from the published literature.

This edition contains 6 recommended reads. The R&R Editorial Team includes Jeremy Fried, Nudrat Rashid, Soren Rudolph, Anand Swaminathan and, of course, Chris Nickson. Find more R&R in the Fastlane reviews in the R&R Archive, read more about the R&R project or check out the full list of R&R contributors

This Edition’s R&R Hall of Famer

Airway

Bair AE, Chima R. The Inaccuracy of Using Landmark Techniques for Cricothyroid Membrane Identification: A Comparison of Three Techniques. Acad Emerg Med 2015. PMID 26198864

• This randomized trial of Emergency Physicians use if various techniques to identify landmarks for cricothyrotomy showed that these techniques have limited sensitivity (46-62%), when ultrasound was used as the gold standard. The paper doesn’t speak to procedural success or patient outcomes but given the potential inadequacy of landmark identification, it seems prudent to use ultrasound to mark anatomy in an anticipated difficult airway, should time allow.
• This study of 50 volunteers suggests that three commonly taught methods for finding the cricothyroid membrane (general palpation, four-finger, skin crease) are relatively inaccurate, using ultrasonography as the gold standard. I conclude:1. The landmark techniques are inaccurate for finding the CTM *and that’s okay.* Make your best guess using general palpation and if you feel nothing, use four-finger or skin crease **and then make a long vertical incision.** Once you get through the skin you are very likely to be able to feel the CTM, and even if you still can’t at that point, that’s fine too, cut to air.2. If you have time to prepare (e.g. prior to RSI in a patient predicted to be very difficult laryngoscopy) put the ultrasound probe on the neck and mark the CTM.

• Recommended by Lauren Westafer, Reuben Strayer
  

The Best of the Rest

Emergency MedicineSchechter MT, Sheps SB. Diagnostic testing revisited: pathways through uncertainty. Can Med Assoc J 1985;132(7):755-60. PMID: 3884119

• The authors in this review, describe 4 principles clinicians can use and teach to stop the epidemic of over testing which beleaguers healthcare. Did I mention this was published in 1985? The principles are

1. In the diagnostic context, patients do not have a disease, only a probability of disease.
2. Diagnostic tests are merely revisions of probability.
3. Test interpretation should precede test ordering.
4. In general, if the revisions in probabilities caused by a diagnostic test do not entail a change in subsequent management, use of the test should be reconsidered.

• Full of pearls and examples of how to apply these principles at the bedside, this article is a great read. Also, not to be missed, is the appendix with a MS-BASIC program to calculate post-test probabilities given a positive or negative test result.
• Recommended by Jeremy Fried
• Further information Diagnostic Decision Making in Emergency Medicine (Emergency Medicine Cases)

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Emergency MedicineCapp R et al. Emergency Department With Sepsis and Progress to Septic Shock Between 4 and 48 Hours of Emergency Department Arrival. Crit Care Med. 2015; 43(5): 983-8. PMID: 25668750

• It would be great if we could predict which patients with sepsis will develop septic shock within a short period of time after admission to the hospital. This retrospective chart review attempts to identify factors from the patient’s Emergency Department course which may predict short term decompensation. Although the article has inherent flaws based on its design, it has important findings that can be used to improve patient care. In particular, it points out that non-persistent hypotension is strongly associated with short term decompensation (OR = 6.24)
• Recommended by Anand Swaminathan

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Emergency MedicineCostantino G et al. Syncope risk stratification tools vs clinical judgment: an individual patient data meta-analysis. Am J Med 2014; 127(11): 1126. PMID: 24862309

• Although limited by it’s retrospective nature, this meta-analysis is an interesting contribution to the current state of knowledge on syncope patients presenting to the emergency department, and importantly, demonstrates that clinical judgement outperforms decision tools.The authors identified all prospective studies in which one of the many syncope tools could be derived. They then contacted the primary author of the initial studies to obtain the individual patient data. Six of the thirteen identified authors did so. The decision to admit or discharge the patient was used as a proxy for clinical judgement of high v low risk, and compared to the different decision tools. While there was no difference in specificity between any rule and clinical judgement (all low), the sensitivity of clinical judgement was significantly better than that of the decision tools. A well done article that reminds us there is an important role for clinical judgement in risk stratification of syncope patients.
• Recommended by Jeremy Fried

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TraumaPerez MR et al. Sternal fracture in the age of pan-scan. Injury 2015; 46(7):1324-7. PMID: 25817167

• Not surprisingly, sternal fractures found only on CT aren’t associated with serious underlying injuries. This makes a lot of sense: first, the classic teaching that sternal fractures indicate badness refers to sternal fractures found based on exam or CXR, which are plausibly the worst of the worst. This paper is perhaps most interesting not for this specific finding but for what it represents: classic signs of badness likely don’t portend bad outcomes when found incidentally on advanced imaging.
• Recommended by Seth Trueger

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Intensive CareMalbrain ML et al. Fluid overload, de-resuscitation, and outcomes in critically ill or injured patients: a systematic review with suggestions for clinical practice. Anaesthesiol Intensive Ther 2014; 46(5):361-80. PMID: 25432556

• If the intensive care literature is consistent about one thing, it is that there is nothing positive about positive fluid balance. This paper reviews the literature, offers up a host of relevant definitions – including one for ‘de-resuscitation’ – and suggests how ‘Late Goal Directed Fluid Removal’ might be done. Paul Marik is one of the authors so ‘iatrogenic salt water drowning’ gets a mention. Enjoy!
• Recommended by Chris Nickson

The R&R iconoclastic sneak peek icon key

	The list of contributors		The R&R ARCHIVE
	R&R Hall of famer You simply MUST READ this!		R&R Hot stuff! Everyone’s going to be talking about this
	R&R Landmark paper A paper that made a difference		R&R Game Changer? Might change your clinical practice
	R&R Eureka! Revolutionary idea or concept		R&R Mona Lisa Brilliant writing or explanation
	R&R Boffintastic High quality research		R&R Trash Must read, because it is so wrong!
	R&R WTF! Weird, transcendent or funtabulous!

That’s it for this week…

That should keep you busy for a week at least! Thanks to our wonderful group of editors and contributors Leave a comment below if you have any queries, suggestions, or comments about this week’s R&R in the FASTLANE or if you want to tell us what you think is worth reading.

The post Research and Reviews in the Fastlane 093 appeared first on LITFL: Life in the Fast Lane Medical Blog.

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Every patient has an unexpected and special story

As an Air Force family physician and faculty at a family medicine residency, it was my job periodically to lead an inpatient team of young family medicine residents and medical students.  That particular morning seemed like any other — half a dozen new admissions, total census of a dozen or so, and a few new […]

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Strong ethical principles should guide EHR implementation

The U.S. health care system is headed toward a profoundly digital future. Provider organizations around the country are adopting and updating their health information technology (HIT) infrastructures. Many have begun requiring that clinicians gain proficiency in electronic health records (EHRs) in order to provide clinical care. A proliferation of start-ups and HIT companies in health […]

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Parents don’t ask me about screens. But this is what I’d say if they did.

The explosion of tech and screens into the lives of children is outrageously obvious to me as a pediatrician. Besides the fact that most kids and parents seem to be attached to a phone or tablet when I enter the exam room, when I ask questions about how kids spend their days (and nights), screens […]

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How I got 86% off my malpractice insurance. Now, you can too!

I’m a physician entrepreneur. In 1998, I opened my first clinic. My malpractice: $500 per year. Then I tried life as an employed physician. Hated it. So in 2005, I opened my ideal clinic. Best. Job. Ever. My malpractice: $1,230 per year. Want low premiums? Here’s how I did it. A quick tutorial. New malpractice […]

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The dilemma of treating patients, based on their contributions to society

During my third-year internal medicine rotation, I was introduced to and helped care for a patient named Casey (name changed to protect privacy). I identified with Casey because we were the same age, and I felt empathetic toward her situation. Casey was very sick, a direct result of her risky behavior. She was admitted for […]

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Where will you find happiness now?

Mid-November, and Christmas music is already blaring from speakers camouflaged in silver holiday tinsel. Frank Sinatra’s croons reverberate throughout the barren expanse that is Somerset Mall at 8 a.m. “I’m dreaming of a white Christmas…” It’s raining outside. I begin to laugh and try to explain the apparent irony to my grandmother, but my attempt […]

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This is the epic rap video that will change how you feel about dying

You need to watch ZDoggMD’s latest: “Ain’t the way to die.”  This is one of the most powerful videos you’ll see.  Ever. Continue reading ... Your patients are rating you online: How to respond. Manage your online reputation: A social media guide. Find out how.

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It’s inevitable that physicians will evolve into virtualists

If someone was sitting on a veranda somewhere in the Alpha Centauri system, reading about health care in America of planet Earth, one would most likely conclude that the family of viruses known as the common cold are destroying a health system already crippled by a glut of poorly educated physicians practicing their miserable craft […]

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Physicians should monitor their online presence. Here’s how.

A continuing series on physician online reputation.  Created in partnership with The Doctors Company as part of their social media resources for physicians.  It’s important for physicians to monitor their online presence because more patients than ever are researching their doctors on the web, and negative news stories or negative patient reviews can be a part […]

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A background in anthropology comes in handy on the wards

As my third year of clinical rotations comes to an end, I’ve been reflecting on the ways in which I use my training as an anthropologist on the wards. One patient comes to mind, a recent immigrant from South Asia who came into the hospital after an accident where he was bicycling and got hit […]

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ASEA, ORMUS, and Alchemy

An example of Ormus powder. Ormusmanna.com: “Ormus could be the source of all metals. Therefore, we identify the Ormus elements in relationship to the metal they can unfold into (e.g. Ormus copper, Ormus gold, Ormus rhodium, etc.)”

I got an e-mail from a woman who had read my article on ASEA, a multilevel marketing diet supplement that I characterized as an expensive way to buy water.  She had not tried ASEA products but was applying for a position as an accountant with the company, and she chastised me for not doing my due diligence and researching the new science of ORMUS.

First she dismissed science, saying “science as we know it is no longer valid and quantum physics clearly shows this.” Then she claimed there was valid science that would support ASEA’s claims. She had personally done a sea salt cleanse with good results. If ASEA is only salt water, that doesn’t negate its validity, since ORMUS material is from sea salt and when minerals are rearranged they no longer register as the original element. Alchemy is not a myth, and the “quantum non-mainstream sciences” prove it is real. Quantum physics “explains that particles can interact without actually being on contact, this is a form or property of superconductivity.” She thinks ORMUS material is superconductive and constitutes a percentage of the human brain mass, allowing transmission of thoughts to others who tune in to these superconductive energy transmissions.

But wait, there’s more! She went on to tell me about an experiment where a dog’s entire blood volume was replaced by seawater. She shared her belief that the power of the mind can heal all disease, and she explained that she relies on a natural knowing within herself and only uses outside evidence to confirm her beliefs. She has been studying subjects like sacred geometry, Vedic mathematics, the golden ratio, quantum physics, and extraterrestrials.

Orbitally Rearranged Monoatomic Elements

This woman is obviously misguided and misinformed, but what is this ORMUS she’s talking about? I’d never heard of it, so I started with Rational Wiki:

ORMUS, also called ORMEs (Orbitally Rearranged Monoatomic Elements) and m-state materials, is a fictitious group of substances exhibiting many miraculous properties, such as healing powers and superconductivity at room temperature. They were supposedly discovered in 1975 by David Hudson, a cotton farmer from Arizona.

They are precious materials like gold and platinum in an exotic state of matter where they exist as single atoms. They are life-giving elements found in all living beings, and they can supposedly:

• Cure all forms of disease, including cancer and AIDS
• Correct errors in the DNA
• Act as a superconductor
• Emit gamma radiation
• Partially levitate in the Earth’s magnetic field
• Read a person’s mind
• Have a “weigh-ability” different from mass, which probably means an inertial mass different from the gravitational mass
• Be fused into a transparent glass
• Act as a flash powder, causing “explosions of light”
• Make severed cat tails grow back

The “discovery” of ORMUS

The notoriously unreliable Natural News website explains how ORMUS was discovered:

[An Arizona farmer named David Hudson] discovered some material in his soil that he had never seen before. He laid it out to dry in the hot Arizona sun so he could have it analyzed. What happened next was absolutely remarkable: the stuff exploded in a big flash of light and disappeared! But when he dried it without the use of sunlight it didn’t disappear.

A professor at Cornell analyzed it and found gold, silver, iron, and aluminum. These did not dissolve in acids as they should have, and after removal of the elements a staggering 98% of the material was left. Further analysis by a German expert who built special machinery and by a specialist at the University of Iowa revealed that:

• It contained various precious metals
• With heat treatment, precious elements were absent up to 69 seconds but appeared after 70 seconds
• It changed into a white powder or glass depending on temperature
• Elements spontaneously disappeared or morphed into other elements
• It changed weight when exposed to air

He patented 12 elements that he called Orbitally Rearranged Monoatomic Elements or ORMEs, that exist both in a material and an immaterial, energetic form, are superconductors, dissolve in sunlight, and are exempt from gravity. By dissecting animal brains he showed that they contained ORMUS. We can increase the ORMUS content of our brains by taking in food and water with a high ORMUS content.

ORMUS conspiracy theories

The author of the Natural News article goes on to make conspiracy claims. ORMUS makes us more spiritual and corrects our DNA. The ancient Egyptians knew about it, but today knowledge is suppressed by dark and powerful sources that are trying to prevent our true evolution to a higher consciousness. Diseases are both caused and treated with war chemistry; chemotherapy is nothing more than a variation of mustard gas. GMOs make plants sick. In the slaughterhouse, animals are skinned alive.

ORMUS-based medicine

He recommends that we expose ourselves to as much ORMUS as possible by:

• Growing food with diluted ocean water or sea salt
• Taking supplements like Mountain Manna or Liquid Chi [You can look these up. The first is homeopathic, and both claim to have miraculous health results.]
• Eating natural products grown with love
• Gazing into the sun with eyes closed and palms outstretched
• Breathing in as much forest air and sea air as possible

He says ORMUS is life energy, and we need it to counterbalance

the death energy we are exposed to daily through our food, our drinking water, our ‘medicines’, electromagnetic fields and radioactivity due to the use of depleted uranium by a flourishing war industry. This negative energy keeps us sick and dumb.

Many amazing claims are made for health benefits of ORMUS. Here are just a few:

• Enhanced immune system functioning
• Increased rate of healing
• Slowing and reversing the aging process
• Boosting strength and athletic conditioning
• Mood enhancing and antidepressant
• Improved sleep
• Heightened energy and awareness
• Increases electrolytes
• Improves vision
• Increases absorption of nutrients
• Maintains healthy blood sugar level
• Promotes healthy cellular pH balance

Another website makes specific disease claims for AIDS, Alzheimer’s, cancer, diabetes, emphysema, heart disease, MS, and several others.

Citing Hal Putoff

The Natural News article says Hudson consulted “one of the pioneers of quantum physics, Hal Putoff.” Putoff’s PhD is in electrical engineering and he is a parapsychologist. His name will be instantly recognized by many in the skeptic community as half of the gullible Targ/Putoff team that was fooled by Uri Geller into believing he had psychic powers. Putoff was a Scientologist who reached the top OT VII level and claimed he had developed remote viewing abilities.

Hudson’s errors

Rational Wiki says most of the time Hudson is “babbling incoherently and not even wrong or teaching a disfigured version of high school chemistry.” They provide a non-exhaustive list of his errors,  showing his misunderstanding and distortion of basic chemical and physical principles.

The research

There is a lot of metaphysical mumbo-jumbo about ORMUS on the Internet, including claims that it is the philosopher’s stone long sought by alchemists, that it is the secret alchemy of Mary Magdalene, that the word Ormus was originally another name for the Zoroastrian deity Ahura Mazda. There are even instructions for making your own ORMUS at home.

But there is some scientific research. Here’s a list of scientific papers about ORMUS. In my opinion they don’t even begin to support the claims that have been made.

The dog experiments

Rene Quinton did experiments on abandoned dogs in 1897. In one experiment he completely removed a dog’s blood and replaced it with diluted seawater. The dog developed an infection and fever, but recovered and by the eighth day had become exaggeratedly exuberant and ran about wildly. Five years later the dog was still alive and well.

Based on this experiment, some people have suggested sea water could be used as a substitute for blood transfusions, which would be a great boon for Jehovah’s Witnesses if it worked.

Frankly, I don’t believe the story. There is a huge body of established scientific knowledge that would have to be overthrown before we could accept that an animal’s entire blood volume could be replaced with saline without resulting in death. Extraordinary claims require extraordinary evidence, and this century-old report doesn’t even meet the standards of ordinary peer-reviewed published evidence.

A tribute to the unlimited inventiveness of the human imagination

You are probably rolling on the floor laughing at this point. Indeed, there is an entry for David Hudson in the Encyclopedia of American Loons that describes the ORMUS people as belonging to the more extreme fringes of the lunacy movement. It says they serve as an illustration of how far into idiot land it is possible to fall without being committed to an institution.

ORMUS is a tribute to the unlimited inventiveness of the human imagination and the human capacity for self-deception, and it is great as humorous entertainment, but there is no reason to think it has anything to do with reality or science. If the claims were true, it would be Nobel Prize-worthy. Science doesn’t recognize ORMUS, and it won’t unless the proponents can come up with credible evidence. I’m not holding my breath.

 

 

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What, exactly, does a “real doctor” look like?

A guest column by the American College of Physicians, exclusive to KevinMD.com. In the spring of 2009, I represented the American College of Physicians (ACP) at a meeting in Washington of health policy experts discussing payment reform. When I arrived at the cocktail reception the night before the meeting, a well-known medical leader not known to be […]

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How motivational interviewing can relieve patients’ suffering

The acronym “MI” has traditionally meant myocardial infarct, or heart attack. Recently it’s taken on a new, more salubrious meaning: motivational interviewing. A growing number of docs are practicing this technique, which amounts to listening to patients to help them recognize their internal sources of behavior. Boston’s NPR affiliate, WBUR, describes typical MI interventions in […]

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Physician success stories don’t make it to the newspaper

Jim almost convinced me.  The burning in his chest, after all, could have just been gastroesophageal reflux.  He assured me that the sensation was nothing new; that he got it from time to time after a large meal and took Tums.  I couldn’t, however, ignore that it seemed to worsen with activity.  The pain was […]

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Your cancer doctor can’t judge what life means to you

Let me be clear. I have spent a career, my adult life, 80 hours a week, 131,000 hours, fighting the dread disease: every method, every drug, every machine, every medical technique, every sinew of my being, to control or cure malignancy. A synopsis of my existence will say, “fought cancer.” Nonetheless, let us take a […]

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Bastions of quackademic medicine: Georgetown University

The cover of Georgetown Medicine Spring/Summer 2015 issue. This image will drive Mark Crislip crazy, as it features yet another acupuncturist not using gloves while sticking needles into people. Dr. Gorski loves watching Dr. Crislip’s reactions to such photos.

We frequently discuss a disturbing phenomenon known as quackademic medicine. Basically, quackademic medicine is a phenomenon that has taken hold over the last two decades in medical academia in which once ostensibly science-based medical schools and academic medical centers embrace quackery. This embrace was once called “complementary and alternative medicine” (CAM) but among quackademics the preferred term is now “integrative medicine.” Of course, when looked at objectively, integrative medicine is far more a brand than a specialty. Specifically, it’s a combination of rebranding some science-based modalities, such as nutrition and exercise, as somehow being “alternative” or “integrative” with the integration of outright quackery, such as reiki and “energy healing,” acupuncture, and naturopathy, into conventional medicine. As my good bud and fellow Science-Based Medicine (SBM) blogger Mark Crislip put it, mixing cow pie with apple pie does not make the cow pie better, but we seem to be “integrating” the cow pie of quackery with the apple pie of science-based medicine thinking that somehow it will improve the smell, taste, and texture of the cow pie.

I remember how, when I first discovered how prevalent outright pseudoscience and quackery had become in medical academia (which was before I became one of the founding SBM bloggers), I was in denial. I couldn’t believe it. Then I tracked this phenomenon with something I called the Academic Woo Aggregator. It turned out to be a hopeless endeavor because, as I soon discovered, the phenomenon was so pervasive that it was really hard to keep the Aggregator up to date. Since then, I’ve generally only focused on particularly egregious examples, naming names when institutions like my alma mater embrace anthroposophic medicine; “respectable” journals publish “integrative medicine” guidelines for breast cancer patients; cancer organizations include “integrative oncology” in their professional meetings; NCI-designated comprehensive cancer centers promote reiki to pediatric cancer patients or offer high dose unproven vitamin C treatment to patients; or respected academic institutions embrace traditional Chinese medicine (TCM) and the quackery that is function medicine. You get the idea. It’s depressing just how far medical academia has fallen in terms of being “open-minded” to the point of brains falling out when it comes to medical pseudoscience.

From time to time, I’ve briefly thought about reviving the academic woo aggregator, but quickly inevitably ended up giving up trying to come up with lists of the worst of the worst. There are just too many now, and keeping such an aggregator up to date would be too much work, as I discovered when I wrote my Nature Reviews Cancer article on integrative oncology last year. However, I do believe in featuring specific institutions when something comes up that draws my attention to them, and this just happened last week with Georgetown University. Basically, a reader at my not-so-super-secret other blog pointed out the Spring/Summer issue of Georgetown Medicine Magazine. It’s an issue devoted to integrative medicine at Georgetown and it is horrifying to anyone who believes that medicine should be science-based. Not surprisingly, t was a Georgetown alumnus who was so shocked when he received this issue in the mail that his embarrassment knew no bounds for having come from that institution. Worse, from the tone of the articles in this issue, Georgetown is proud of its integrative medicine program, to the point where it is touting it as a strength and featuring it on the cover of its magazine. Just look at its cover, which features a picture of a woman preparing to get an acupuncture needle stuck somewhere along with the title of the issue, Caring for the whole person with integrative medicine. Yes, it’s the “holistic” trope that drives me crazy because you don’t have to embrace quackery to be a holistic physician.

Integrating pseudoscience into the medical curriculum

Longtime readers might remember that I’ve discussed Georgetown before because it was a “pioneer” (if you can call it that) in “integrating” quackery into the medical school curriculum. Having received a grant from the then-National Center for Complementary and Alternative Medicine (NCCAM), renamed in December the National Center for Complementary and Integrative Health (NCCIH), to integrate CAM into its core curriculum, Georgetown proceeded to do just that. Here’s an example, a blast from the past if you will, quoted from an 2003 Georgetown brochure (retrieved again, thanks to Archive.org):

“One of the reasons CAM is usually offered as an elective is that there’s just no time or room in U.S. medical schools to fit in one more massive subject,” says Michael Lumpkin, Ph.D., professor and chair of the department of physiology and biophysics at Georgetown. “When the course is an elective, a self-selected group – maybe 10 or 20 students in a class of 180 medical students – will take it,” Lumpkin says. “What we’ve tried at Georgetown is rather than create all new courses, we take relevant CAM issues and modalities and weave them seamlessly into existing courses.

The “seamless” weaving of CAM into existing classes includes, for instance, a presentation by an acupuncturist on the “anatomy of acupuncture” in the gross anatomy course for first-year students. The same lecturer explores acupuncture’s application in pain relief in the neuroscience course…

Haramati and Lumpkin say Georgetown’s program is distinct from CAM initiatives in other medical schools in two ways: The school is integrating CAM education into existing course work across all four years of each student’s medical education, and the initiative includes a mind-body class to help students use techniques to manage their own health and improve self-care.

Teaching acupuncture points during gross anatomy? You can hear the cringing of advocates of science-based medicine everywhere, given that acupuncture points do not exist except in the minds of acupuncturists, as there are no anatomic correlates to them. So what’s been going on since then? Jane Varner Malhotra tells us in Georgetown’s Evolving Study in Complementary and Alternative Therapies. Here’s what happened after Georgetown got the $1.7 million grant in 2001:

Haramati recalls some uncertainty around the method for how to actually make it happen. “We were walking a path where the advocates were saying, ‘You’ve got to do more,’ while skeptics were saying, ‘What are you doing teaching nonsense?’” he recalls. “And we were going down the path saying, ‘We’re going to look at this objectively.’”

Objectively. You keep using that word. I do not think it means what you think it means. An objective analysis of acupuncture would not support “integrating” the teaching of acupuncture points into gross anatomy and neurology class. Once again, acupuncture points do not exist except in the minds of acupuncturists, and even then I’m not so sure.

The article also does the requisite rebranding of natural products pharmacology as somehow being “CAM,” when it’s not. There’s a pharmacologist named Hakima Amri, featured smiling with her arms crossed in one of those stereotypical poses that magazines like this like to use in their photos bragging how she had realized that in her research she was “using top-notch technology in the biomedical sciences,” such as PCR, animal studies, cell culture, all “to study a plant extract” (Ginkgo biloba). None of this, of course, is CAM.

And Georgetown credulously teaches homeopathy, The One Quackery to Rule Them All:

Amri enjoys seeing students open their minds to new concepts. Learning disciplines like homeopathy may require students to radically disregard their previous understandings about receptors and responses in toxicology, for example. “I tell students that for the next few hours, put aside all they have learned in biochemistry, pharmacology and cell biology—empty their brains—because homeopathy is a completely different concept. Then I see big eyes on their faces!” laughs Amri.

Yes, Georgetown is telling its medical students, forget all that boring old reductionist “Western” science you’ve learned all these years. Open your mind to the sympathetic magic that is homeopathy. Never mind that it has no basis in science and its precepts violate multiple well-established laws of physics and chemistry. Personally, I don’t mind a medical school teaching homeopathy, but only so that doctors know what it is and how utterly pseudoscientific it is. (Most doctors still think it’s just herbal medicine.) However, clearly that’s not what Georgetown is doing. How a pharmacologist can teach homeopathy as anything but as an example of the most abject pseudoscience is beyond me, but that’s what Amri sure appears to be doing, her claim that “we are teaching them [medical students] how to evaluate the science of the therapy, critically analyze it and learn about these medical systems in the most open-minded way” not withstanding. She seems to be all about the open-mindedness and not so much about critical thinking, as does the entire Georgetown CAM curriculum.

And its faculty are proud of Georgetown’s role in promoting quackademic medicine:

Since the early years of complementary medicine research and education at Georgetown, the university has held a critical place on the national scene. Hosting multiple cross-disciplinary dialogues, Georgetown has convened chiropractors and conventional doctors, acupuncturists and anesthesiologists to advance the science-based study of integrative medicine.

And:

Over the past 15 years, the way CAM has been taught at Georgetown has evolved, but the goals have remained constant: to train students to objectively and rigorously assess the safety and efficacy of various modalities, and explain the mechanistic basis for therapies like acupuncture, massage, herbs and supplements, and mind-body interactions.

If Georgetown teaches homeopathy as anything other than an example of pseudoscience and integrates acupuncture into its gross anatomy, physiology, and neuroscience curricula, it’s doing nothing of the sort. Let’s take a look at the sort of research into the “mechanisms” of acupuncture that Georgetown is so proud of.

Torturing rats in the name of acupuncture pseudoscience

In another article in the issue Where’s the Evidence? Probing the Underlying Mechanisms of Acupuncture, a recently published study by a member of the Georgetown faculty is featured as a great example of how Georgetown is doing what it claims with respect to evidence for CAM. First, though, we learn that a nurse anesthetist and licensed acupuncturist Ladan Eshkevari, Ph.D., teaches sessions on acupuncture in the second year physiology class. There, she teaches TCM medicine pulse analysis. Now, certainly every physician should know how to assess a pulse, but that’s not what’s going on here. What’s going on here is the teaching of an ancient, prescientific method of assessing pulses:

The professor of nursing, pharmacology and physiology shows the students three different pulse points on each hand used in TCM to diagnose the health of specific anatomical organs. The best practitioners employ over 70 different ways to describe the subtle variations in the human pulse, she explains, as the students touch their own wrists. Is the pulse skipping, surging, floating, faint? Determining the right descriptor can be a challenge, Eshkevari adds, but the richness of the options reveals the complexity and nuance of the ancient practice.

“In traditional Chinese medicine, organs are viewed by their energy function, not their anatomic function,” Eshkevari continues, showing visual maps of the body linking heart and small intestine, lung and large intestine. She explains that with holistic medicine, everything is connected, versus the more typical American, allopathic medical practice of dividing the body into compartments and developing specialties.

One notes that these “subtle variations” are in general not reproducibly detected from practitioner to practitioner and have little or no evidence to show that they reliably link to specific organs. The same is true of tongue diagnosis in TCM, in which different organs are mapped to different parts of the tongue, such that examining the tongue can lead to diagnoses of abnormalities of specific organs. It’s utter nonsense, of course, no more than a TCM version of reflexology, which does the same thing, only mapping organs and body parts to the soles of the feet and palms of the hand. Yet at Georgetown, TCM reflexology is taught as fact.

Let’s take a look at the study that is featured in a large chunk of this article:

Eshkevari turned to rats to help her find answers. Using a successful stress model developed by a fellow researcher at Georgetown, she exposed three of four groups of animals to one hour a day in a container with a layer of ice water on the bottom. After two weeks, the rats measured high stress hormone levels that would not come down to baseline. They had chronic stress.

Won’t someone think of the poor lab rats?

Ladan Eshkevari, Ph.D. in her laboratory. Truly, I need to have a picture of myself taken with such a kick-ass “I’m a scientist, ma-an!” pose in my laboratory. Sadly, I don’t have as much stuff on my lab bench and shelves, which mean I must not be as much of a true scientist as Eshkevari, but I could add Erlenmeyer flasks with colored solutions in the background for an even more “science-y” feel.

Note that in the accompanying photo, Eshkevari is shown in the same pose as everyone else, arms crossed, with the exceptions that the smile is missing and she’s wearing a lab coat standing in front of an impressive lab bench full of chemicals and instruments, the better to paint the picture of her in the mind of the reader as a Very Serious Scientist. At least the photographer restrained himself from filling up Erlenmyer flasks and beakers with multicolored solutions, which is the ultimate photographic cliche in stories of this sort. I also note that the Georgetown magazine story seems to be part of a PR offensive to promote this study, complete with a press release and breathlessly credulous descriptions of the story in the media with titles like Rats help scientists get closer to solving the mystery of acupuncture.

In any case, these stories follow a template. Basically, every study is represented as “the strongest evidence yet” that the “ancient Chinese therapy” (which, remember, really isn’t particularly ancient, at least not the way it’s practiced) is more than placebo and that a definitive mechanism has been found for this magic to work. In this particular case, notice how it’s claimed that acupuncture does the same thing as actual drugs used to treat stress and pain. So it must be real! In every case, if you go and look at the actual study, there’s way less there then is being sold. This case is no different, as I saw when I looked up the actual study, Effects of Acupuncture, RU-486 on the Hypothalamic-Pituitary-Adrenal Axis in Chronically Stressed Adult Male Rats.

The first thing I noticed about this study is that it uses a common bait-and-switch favored by acupuncturists, in which they do something called “electroacupuncture” (EA). Basically, EA is acupuncture plus electricity. Acupuncture needles are stuck in the subject at the various acupuncture points and hooked up to an electrical source, after which as weak electrical current is applied. Whenever I see this bait-and-switch, the first question that comes to my mind is: Those ancient Chinese must have been really brilliant to have discovered how to use electricity thousands of years ago! Obviously, attaching electrodes to acupuncture needles is a modern twist on acupuncture, which is why all the language about this “ancient Chinese therapy” is so grating. Indeed, the Georgetown Medicine article claims that acupuncture dates back 4,000 years, which is further than I’ve ever heard anyone claim. One wonders how Bronze Age craftsmen made such exquisitely thin needles. In any case, EA is not ancient at all, nor is it acupuncture. Really, it’s just transcutaneous electrical nerve stimulation (TENS) grafted onto acupuncture to produce a mutant Frankenstein monster of a therapy that has little to do with either. When I see a study like this, my usual reaction is a big, “Meh.” This doesn’t demonstrate that acupuncture works. If it demonstrates anything at all (which is questionable) it demonstrates that passing an electrical current through the skin has physiological effects.

Does this study demonstrate anything? Let’s take a look. There were two experiments. In the first, the investigators divided the the rats into four groups. Three of these groups were stressed and were divided into groups receiving electroacupuncture; sham acupuncture (delivered to an area that is not an acupuncture point); and a third group that did not receive acupuncture. A fourth group of animals served as controls; they received no acupuncture and were not subjected to the stress stimulus. The stressed animals were placed in 1 cm deep icewater for one hour daily for 14 days, after which they were returned to their cages. On day 5 experimental treatments were begun, which consisted of acupuncture or sham acupuncture 30 minutes after the cold exposure. (Poor rats.) The acupuncture point used was St36, which in humans is on the leg, one finger width lateral from the anterior boarder of the tibia and four finger breadths below the patella. Its action and effects are said to include:

• Tonify deficient Qi a/or Blood.
• Tonify Wei Qi and Qi overall – low immunity, chronic illness, poor digestion, general weakness, particularly with moxibustion, very important acupuncture point for building and maintaining overall health.
• All issues involving the Stomach a/or the Spleen – abdominal/epigastric pain, borborygmus, bloating, nausea, vomiting, GERD, hiccups, diarrhea, constipation, etc.
• Clear disorders along the course of the channel – breast problems, lower leg pain.
• Earth as the mother of Metal – will support Lung function in cases of asthma, wheezing, dyspnea.
• Psychological/Emotional disorders – PMS, depression, nervousness, insomnia.

Whatever.

Here it is, the acupuncture point St36 that everyone’s been talking about. Of course, a rat’s leg bends differently than humans; so I have a hard time seeing how this was mapped from humans.

The nonacupuncture point used as “sham” for sham electroacupunture (sham-EA) was on the back 2 cm lateral to the tail region. The needles were then attached to an electroacupuncture machine via electrodes and were stimulated for 20 minutes at a frequency of 10 Hz with 2 mA output. Ten of the 14 rats in both the sham-EA and the EA St36 groups continued to receive EA for the 14 days that they were exposed to the cold stress. However, after 10 days, 4 of the animals in each of the sham-EA and EA St36 groups stopped receiving the EA treatments, whereas exposure to cold stress was continued for the remaining 4 days, to determine whether the effects of the sham-EA and/or EA St36 were long lasting.

In a second experiment, rats were assigned to five groups: Group 1 (no treatment and no RU-486); group 2 (no treatment but started RU-486 at day 10); group 3 (daily cold stress and start RU-486 at day 10); group 4 (sham EA + RU-486 + cold stress); and group 5 (EA + RU-486 + cold stress). The mice were also tested in other stress tests, including the forced swim tests and open field test. In this case, RU-486 was not used for its properties that allow it to work as a “morning after” pill, but rather for its ability to block the glucocorticoid receptor, the hypothesis being that however EA “works” it does so through glucocorticoid (steroids), a hormone signaling axis known as the hypothalamic pituitary adrenal (HPA) axis, which mediates stress.

The first thing I noticed was that levels of ACTH (which stimulates cortisol production) and cortisol were not impressively different, particularly ACTH (Figure 1; the paper is open-access if you want to check for yourself). Indeed, the differences in ACTH are so modest that my reaction was a yawn. Cortisol showed more difference, but a most unimpressive difference between EA and sham-EA. In the second experiment, there were a whole lot of graphs that didn’t show much difference in anything. The best that the authors could say is that RU-486 didn’t affect EA or sham-EA, but that ACTH didn’t go up in the St36 group. It was reported that stress behaviors were less in stressed EA St36 animals, but looking at the graphs sure didn’t impress me. Basically, the authors conclude that application of EA St36 after initiation of chronic stress prevents the stress-induced increases in the hormones evaluated, adding that “this action may be specific to EA St36 vs the sham points used, as sham-EA does not prevent the rise in stress hormones as effectively.” One notes that sham did have an effect. The effect, if real, was very modest.

There were a lot of other problems, as well. For instance, it’s important to note that the controls chosen were not exactly…robust. There was no group of rats in which the needle was inserted but no current was applied, nor was there another non-St36 control. (Choosing one “incorrect” acupuncture point to apply “sham” acupuncture to might be (barely) justifiable in human trials because of how hard it is to get enough subjects, but in an animal trial there is no excuse. How do the investigators know they weren’t just lucky picking their control? Also, there is no mention of blinding. Zero. Zilch. Since humans were evaluating behavior in the second experiment, it was critical that the observer doing the evaluations of how the rats reacted to the swim test and open field test were blinded to the experimental group from which the rats came. This appears not to have done. Finally, as noted on PubPeer, a website for post-publication peer review, Figures 6B and 6C appear to be the same figure even though they are said to represent different experiments.

The kindest description of the conclusions of this study is that it shows that running electrical current through the leg, as opposed to running current through the skin of the back, might decrease stress by decreasing the effect of stress hormones. It does not show that acupuncture works. A more realistic description of these results is that they don’t show much of anything that is scientifically interesting. One even wonders if, for instance, there is a simpler explanation, namely that having a needle stuck in the leg and having current run through it hurts less than having a needle stuck in the back and having current run through it. There’s no way of knowing because we can’t ask the rat. Alternatively, I also note that St36 is rather close to the sciatic nerve, whereas the acupuncture point on the flank used for the sham-EA control is nowhere near a major nerve.

Basically, this is a poorly done study with small numbers that doesn’t even test acupuncture but electricity. If this is the “evidence” for acupuncture that Georgetown touts, it’s thin gruel indeed. Yet it was published in a respectable journal, Endocrinology. Clearly, Endocrinology needs a better class of peer reviewers, as peer review utterly failed in this case.

Unfortunately, this doesn’t stop Eshkevari from wanting to “translate” these results to the clinic:

The next stage for her research will be human trials—an expensive and complicated endeavor but one she is determined to explore.

“This is where I’m now stuck,” she explains. “I’m trying to get grant funding to do research on humans to see if these discoveries translate.”

Eshkevari remains hopeful that, with rising interest from both the public and scientific communities, this next critical step will find support.

To me, it would be unethical to carry out a human study based on such poor quality and equivocal preclinical evidence. Unfortunately, it would not surprise me if Eshkevari succeeds in getting funding to do one. Such is the pernicious effect of quackademic medicine on clinical trial ethics. Eshkevari argues that doctors didn’t know how inhalational anesthesia worked when it was first discovered but used it anyway, the implication being that we should not be uncomfortable using acupuncture because we don’t yet understand its mechanism of action. Does anyone see the flaw in that reasoning? It’s obvious. That inhalational anesthesia worked was indisputable. In contrast, there is no good evidence that acupuncture works better than placebo. This brings up another problematic attitude in the mindset of quackademics:

“Western, allopathic physicians and nurse practitioners want to be able to point to the evidence, and see the research published in peer-reviewed journals,” says Eshkevari. “This helps us comfortably recommend complementary medicine to our patients. Finding the evidence—I think that’s the biggest step.”

In other words, rather than finding out if acupuncture works, quackademics like Eshkevari assume that it does work and then go chasing mechanisms. It is, as Harriet Hall so aptly described it, Tooth Fairy science.

Faith healing in the chemotherapy suite

I frequently call homeopathy The One Quackery To Rule Them All. However, there is a definite challenger for that title, which can be looked at a different way as well; i.e., as Saruman trying to usurp Sauron on his dark throne. I’m referring, of course, to “energy medicine.” Whatever form energy medicine takes, it’s based on prescientific vitalism of a variety that posits the existence of a “life energy” that can be manipulated or infused into the patient for healing effect.

The two most common forms of energy medicine in quackademia are therapeutic touch and reiki. Therapeutic touch (TT) s a misnomer in that it doesn’t usually involve actual touching (which negates the potential pleasure of a good massage or back rub), but rather the placing of hands close to the body. It rests on the concept that there is a human “energy field” that TT practitioners can manipulate to make patients feel better. It’s a concept so ludicrous that even an 11 year old girl could show that TT practitioners cannot detect a human energy field any better than random chance alone would allow them to guess. Unfortunately, TT is almost ubiquitous in nursing programs and hospitals. The second is reiki. The main differences between the two are that (1) reiki involves more elaborate hand gestures and (2) reiki posits the existence of an external source of life energy (the “universal source”) into which the reiki practitioner can tap to direct the healing energy into the patient. Reiki is, in essence, faith healing based on Eastern mysticism rather than Christian religion. Unfortunately, reiki is commonly offered in many medical centers, academic or community, and even in NCI-designated comprehensive cancer centers.

Including Georgetown’s, apparently, as shown in the Georgetown Medicine article, A Patient’s Experience With Energy Healing:

For a long time Denise von Hengst had a secret she kept from friends and physicians alike. As she was undergoing treatment at Georgetown Lombardi Comprehensive Cancer Center for a particularly aggressive type of breast cancer—triple positive, HER2 positive—she was also regularly receiving Reiki, an ancient form of Japanese healing, to mitigate the debilitating anxiety and fear that accompanied her cancer diagnosis.

“At first I told no one about the Reiki,” says von Hengst. “Fear of the ‘woo-woo’ factor. People might think I’m nuts.”

No, a patient like Denise von Hengst is not “nuts,” although, it must be noted, she discovered reiki before coming to Georgetown for her cancer and ultimately became a reiki master. However, Georgetown Lombardi Comprehensive Cancer Center is unethical and irresponsible for offering, in essence, magic to its patients as therapy. If I were not a physician and didn’t know anything about reiki, if an NCI-designated comprehensive cancer center offered it I’d think it must be evidence-based. That’s how most patients perceive it. The failure is on Georgetown’s part for offering reiki as though it were anything more than prescientific vitalistic superstition and claiming that it has a scientific basis, not on the part of patients like von Hengst, who trust that doctors are offering science-based therapy. In this case, Georgetown reinforced von Hengst’s initial attraction to reiki by giving it the appearance of scientific validity.

To its credit, the article does acknowledge the “skepticism” that doctors have about reiki:

However, skepticism remains, not only in the general population, but also within the medical field. Recently, several clinical trials have emerged attempting to prove, or disprove, the effectiveness of Reiki. Many of these studies have been criticized for the trial. design, number of participants and reporting mechanisms. Results of the trials are often inconclusive.

Note that Bayes theorem tells us that “inconclusive” results plus incredibly implausible mechanism equal negative trial. These are negative trials. None of that matters, though, because the article quickly shifts gears to use anecdotal evidence and appeals to authority and popularity:

Yet as the anecdotal proof mounts and Reiki’s popularity increases, prestigious medical centers around the country are taking note and offering the treatment to patients at their facilities. Reiki can be found at hospitals and medical centers such as Boston Children’s Hospital, Dana Farber Cancer Institute, Stanford Health Care, Memorial Sloan Kettering Cancer Center, Duke University Health System and Cleveland Clinic, to name a few. Many academic medical centers such as Georgetown incorporate complementary therapies into their teaching curricula.

And all of these hospitals have failed to uphold a science-based standard of care. Sadly, they are not alone. Far from it. Worse, they are training the next generation of doctors to embrace pseudoscience.

Integrating quackery: The future of medicine?

Perhaps the most disturbing part of this issue of Georgetown Medicine is an article entitled Putting Integrative Medicine Into Practice. Basically, it’s a profile of medical students and recent Georgetown graduates doing exactly what the title says. It also includes a profile of an acupuncturist named Rebecca Berkson, who works at a Georgetown-affiliated facility the Kaplan Center for Integrative Medicine in McLean, Virginia. In the name of Georgetown, she provides “acupuncture, its associated techniques including moxabustion and cupping, and Chinese herbal medicine.” Cupping, remember, claims to remove unnamed “toxins” from the skin thusly:

It’s a treatment almost as ridiculous as TT, and it’s being offered at Georgetown as though it has validity.

There’s also a medical student from the Howard University class of 2015 named Brian Nwannunu. He graduated from Georgetown’s CAM master’s degree program. Now he’s a believer:

My plan is to go into orthopedic surgery. For my patients experiencing back pain, I will work with CAM practitioners such as acupuncturists and chiropractors in addition to offering allopathic medicine. After my own experience with a low-back injury during a workout, I went to a chiropractor for a few weeks and felt tremendously better.

And:

I took a holistic medicine and pediatrics course last summer, and people were speaking quietly about homeopathy. I find it interesting to see how many practitioners approach complementary medicine like it’s voodoo. But that is changing. As holistic medicine becomes more prevalent, more students are talking about it, and we’re being taught to be aware and accepting.

Pardon me while I pound my head against the nearest wall.

Then there’s Megan Blunda, who graduated from Georgetown in 2011 and is now a family practice doctor:

I worked with Steve Schwartz, M.D., in the Introduction to Osteopathic Manipulative Medicine elective at Georgetown. I have carried the skills I learned in that course to my career as a family physician in Seattle. Over the last year and a half, I have been training in the art of cranial osteopathy. Through work with a mentor and an intensive 40-hour course, I have learned the skills to perform basic treatments for patients with headaches, neck pain and back pain. The ability to actually make a patient’s pain better, instead of masking it with medications, is incredibly fulfilling.

That’s right. Here’s a Georgetown graduate who is practicing cranial osteopathy, also known as craniosacral therapy, which is what Mark Crislip likes to call a “SCAM of infinite jest“—and for very good reason. Worse, Blunda is proud of this, claiming that her integration of such treatments into her practice allows her to “provide higher quality and more personalized care.”

Unless checked, this is the future of medicine. Indeed, this entire issue makes the case that makes the case that integrating quackery into medicine, bringing the Hogwarts School of Witchcraft and Wizardry to life as medical schools is the future of medicine. Unfortunately, strive as we might against it, I’m having a hard time disagreeing. Proponents of “integrating” witchcraft like reiki, acupuncture, homeopathy, and craniosacral therapy into medicine will say that’s not at all like Hogwarts. They have a point, but not in the way they thing. In marked contrast to the magic gaining traction in the current world of quackademic medicine, in J.K. Rowling’s fictional world of Hogwarts, magic could be studied rigorously and actually worked. Would that this Brave New World of integrative medicine could say the same thing.

via Medicine Joint Channels

The evolving story of the harms of anti-inflammatory drugs

Owing to summer vacation, today’s post updates a 2011 post and a 2013 post with some new information.

Anti-inflammatory drugs are among the most well-loved products in the modern medicine cabinet. They can provide good pain control, reduce inflammation, and eliminate fever. We give non-steroidal anti-inflammatory drugs (NSAIDs) in infancy, continuing through childhood and then adulthood for the aches and pains of modern living. It’s the later stages of life where NSAIDs are used most frequently, usually in the treatment of joint disease like osteoarthritis, which eventually affects pretty much everyone. Over 17 million Americans use NSAIDs on a daily basis, and this number will grow as the population ages. While they’re widely used, they also have a long list of side effects. Not only can they cause stomach ulcers and bleeding by damaging the lining of the gastrointestinal tract, cardiovascular risks are also significant.

It was the arrival (and withdrawal) of the drugs Bextra (valdecoxib) and Vioxx (rofecoxib) that led to a much better understanding of the potential for these drugs to increase the risks of heart attacks and strokes. And it’s now well-documented that these effects are not limited to the “COX-2″ drugs – almost all NSAIDs, including the old standbys we have used for years, raise the risk of heart attacks and strokes.

Natural origins

ASA (acetylsalicylic acid, better known as aspirin) is the prototypical NSAID. ASA traces its origins back to willow bark, a natural source of the chemical salicylate. All NSAIDs work the same way, interrupting the production of inflammatory and pain-related hormones called prostaglandins. Since ASA’s introduction in 1897, more than two dozen chemically-related drugs have been developed. They’re now among the most commonly used drugs used worldwide. If you believe the marketing, you may think there are vast differences between the NSAIDs in terms of efficacy and safety. But the evidence show that NSAIDs are similarly effective at the population level, though individual response, and toxicities, can vary between drugs. Currently available NSAIDs differ in their side effect profile based on the way they work at a molecular level. The discovery of different forms of what are called “cyclooxygenase” enzymes led to interest in developing drugs that targeted COX-2 (at sites of inflammation) rather than COX-1 enzymes. COX-1 enzymes regulate normal cellular processes including protecting the lining of the stomach and blood clotting. Inhibit COX-2 rather than COX-1, the thinking went, and you could get the anti-inflammatory action of traditional NSAIDs without serious gastrointestinal side effects. Traditional NSAIDs (e.g., Advil) are considered “unselective” NSAIDS. To minimize GI side effects, manufacturer’s developed more “selective” NSAIDs that preferentially inhibited COX-2. “COX-2″ drugs like Celebrex (celecoxib) provide comparable pain relief to a traditional NSAID, like Naprosyn (naproxen) but with a lesser risk of causing stomach ulcers and bleeds. However, as the Vioxx debacle demonstrated, COX-2 inhibitors had a significant prothrombic (i.e., blood clotting) effect – with devastating cardiac consequences (e.g., heart attack and stroke).

The risks of NSAIDs

Prescription drugs can cause harm. They can even hospitalize. While we may think nothing of popping a few Advil now and then, NSAIDs have been linked to about 30% of drug-related hospital admissions, and it’s estimated that 12,000-16,000 Americans die annually as a result of gastrointestinal bleeding caused by NSAIDs.

Stomach bleeding and ulcers are an expected side effect of the way NSAIDs work – their effect on prostaglandins. The lining of the gut is weakened, and stomach and duodenal ulcers result. Even very low doses of ASA have been documented to have measurable effects on the mucosal lining of the gastrointestinal tract. The risks of gastrointestinal toxicity are significantly increased in the elderly, in those on high doses of NSAIDs, and when combined with other drugs (e.g., steroids) that suppress normal stomach protection.

The cardiovascular risks of NSAIDs became well documented following the worldwide withdrawal of Vioxx and international examinations of the cardiovascular risks of the entire category of drugs. Data have now emerged to convincingly establish that most NSAIDs (except ASA in low doses) are associated with an increased risk of cardiovascular events. Vioxx alone is estimated to have caused as many as 140,000 heart attacks over the five years it was sold in the US. Chronic (routine) consumption of NSAID drugs is linked to small but real increases in heart attacks and stroke. These effects may be a consequence of interference with the beneficial effects of concurrent low dose ASA, direct negative cardiovascular effects, and worsening of fluid balance, leading to heart failure.

When it comes to cardiovascular risks, not all NSAIDs are the same, and the US Food and Drug Administration (FDA) has met regularly to review emerging data since the Vioxx/Bextra withdrawal. The FDA also asked Pfizer to examine celecoxib’s safety compared with ibuprofen and naproxen in what became known as the PRECISION trial (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen) that launched in 2005. As of 2015 there are over 24,000 participants enrolled, however the rate of cardiovascular events has been lower than expected, limiting any conclusions about the differences in cardiovascular harms. The trial wasn’t expected to conclude until the end of 2015 [PDF], and that date has since been revised to 2016.

The most recent FDA meeting was in 2014. It resulted in an FDA announcement earlier this month that strengthened their warning on the use on non-aspirin NSAIDs and the risk of heart attack and stroke. If you’re interested in the details of the FDA’s review, there is a nice open-access summary in Drug Safety, but here are a few highlights of some of the data examined:

• A 2011 network meta-analysis examined traditional NSAIDs, like naproxen, ibuprofen, and diclofenac, as well as the COX-2 selective NSAIDs, like celecoxib and rofecoxib. It concluded “Although uncertainty remains little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug.”
• A 2011 Danish observational study examined NSAID use in those with cardiovascular disease and concluded that even short-term use of NSAIDS raises the risk of heart attack and death. It recommended against short- and long-term use of NSAIDs in this group.
• A 2013 network meta-analysis of trials concluded that the cardiovascular risks of diclofenac and high-dose ibuprofen are comparable to the COX-2 drugs, and noted that naproxen is associated with less risk than other NSAIDs.

Given the latest data, the FDA has now announced the following for over-the-counter and prescription NSAIDs (excluding ASA):

• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
• The risk appears greater at higher doses.
• It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
• NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
• In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
• Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
• There is an increased risk of heart failure with NSAID use.

So for the individual consumer, when do the risks outweigh the benefits of NSAIDs? Ultimately this comes down to an individual consideration of reasons for use, risk factors, and expected benefits. When used for treating short-term conditions, the increase in risk for those without cardiovascular disease appears to be very low. While the data seems pretty convincing that naproxen is associated with less cardiovascular risk, the FDA did not make a definitive statement to this effect. In those with a low risk of cardiovascular disease, there doesn’t appear to be much difference between ibuprofen and naproxen when taken occasionally. In those that need to take an NSAID for a longer period, naproxen (versus the other NSAIDs) looks like a safer choice from a cardiovascular perspective.

Topical NSAIDs: The evidence

Over the past two decades, evidence has emerged to demonstrate that topical versions (e.g., over-the counter gels) of NSAIDs are well absorbed through the skin and reach therapeutic levels in synovial fluid, muscle, and fascia. Given the cardiovascular harms of NSAIDs seem to be dose-related, do topical versions provide comparable benefits with less harm? A 2012 Cochrane Review provides the most recent summary of the evidence for chronic pain, concluding that there is good evidence that topical NSAIDs (like diclofenac) provide similar pain relief to oral NSAIDs (for knee and hand osteoarthritis) with reduced gastrointestinal side effects. The reviewers note that there is a lack of long-term safety data for topical NSAIDs, and consequently there is a lack of evidence on the associated cardiovascular risks. (This is owing to their relative rarity compared with gastrointestinal side effects.) A 2010 Cochrane review also reports positive findings about the use of these products in the treatment of acute pain conditions. Forty-seven trials were included in their analysis that considered topical NSAIDs for strains, sprains, and overuse-type injuries. Compared to placebo, topical NSAIDs were evaluated to be more effective, with fewer side effects. Given the systemic absorption of NSAIDS like diclofenac is lower with topical versions, the toxicity we associate with oral NSAIDs should be lessened, too. There’s little evidence to demonstrate that topical NSAIDs are effective for some types of pain, like back pain, headache, or neuropathic pain. But based on what’s now known about the cardiovascular toxicity of NSAIDs, it’s likely that topical products provide a superior risk/benefit perspective over the oral NSAIDs (at least for some pain/joint conditions).

What about Tylenol?

As Harriet Hall noted last year, while acetaminophen (paracetamol) is widely used for the treatment of pain, the evidence for its efficacy is modest. As long as it is given in appropriate doses, however, there’s no evidence that suggests that Tylenol is associated with the cardiovascular risks of NSAIDs. However, it seems reasonable to continue to use acetaminophen before trying NSAIDs for conditions that require pain relief but not anti-inflammatory effects.

Conclusion: NSAIDs are convenient, effective, and safe, but not harmless

While NSAIDS may be conveniently purchased in large quantities from your neighbourhood drug store, don’t let the ease of access imply these products are harmless, especially if used inappropriately. Everyone that takes an NSAID raises their risk of cardiovascular and gastrointestinal harm to some extent. Consequently, the safest strategy is to take the lowest effective dose for the shortest duration of time. Those with pre-existing cardiac conditions or risk factors should check with their primary care provider before taking NSAIDs, to determine if non-NSAID alternatives may offer a better balance of benefit vs. risk.

While the evidence comparing NSAIDs is still somewhat murky, naproxen seems safest amongst the non-prescription oral NSAIDs. Topical NSAIDs also appear to be useful alternatives to regular oral NSAID use. Among the prescription NSAIDs, it’s somewhat of a mystery that oral diclofenac remains licensed and in use as a prescription drug despite the evidence that it causes heart attacks and strokes in rates similar to that of Vioxx.

The lesson in the NSAID–cardiovascular story is the impact and need for good evidence. All drugs, even those with life-changing benefits, may have serious albeit rare unintended consequences. The evolving safety evidence on NSAIDs is a constant reminder of the challenge of balancing risks and benefits in the absence of good evidence.

Photo via flickr user An Nguyen used under a CC licence.

 

 

via Medicine Joint Channels

Galvanic Skin Response Pseudoscience

Selling snake oil is all about marketing, which means that a good snake oil product needs to have a great angle or a hook. Popular snake oil hooks include being “natural,” the product of ancient wisdom, or “holistic.”

Perhaps my favorite snake oil marketing ploy, however, is claiming the product represents the latest cutting-edge technology. This invariably leads to humorous sciencey technobabble. There are also recurrent themes to this technobabble, which often involve “energy,” vibrations and frequencies, or scientific concepts poorly understood by the public, such as magnetism and (of course) quantum effects. Historically, even radioactivity was marketed as a cure-all.

One category of technical pseudoscientific snake oil measures some physiological property of the body and then claims that this measurement can be used for diagnosis and determining optimal treatment. For example, machines might measure brain waves, heart rate variability, thermal energy or (the subject of today’s article) the galvanic skin response.

These are all noisy systems – they are highly variable and produce a lot of random results that can be used to give the impression that something meaningful is being measured. Systems that rely on these measurements to make highly specific determinations are no different than phrenology or reading tea leaves, but they look scientific.

The galvanic skin response

I was recently asked to look into a product called Zyto technology. This is an electronic device that you place your palm on top of so that it can read your “galvanic skin response” (GSR) to specific stimuli. It then uses your responses to prescribe a specific treatment.

The GSR is actually an older term for what is now called electrodermal activity (EDA), which is simply the electrical conductance of your skin (Harriet Hall has written about such devices before). Skin conductance is primarily affected by sweat, as salty water is an excellent conductor. So essentially the machine is measuring how sweaty your palms are.

Sweatiness, in turn, can be affected by a number of variables, one of which is your current level of psychological “arousal.” Arousal is a deliberately non-specific term, because many types of arousal can increase your autonomic activity which causes sweating. Arousal can be anger, fear, anxiety, being startled, excited, or under mental stress. You cannot tell which simply by measuring EDA.

The EDA is one measure that is used in the polygraph test, which is famously unreliable precisely because you cannot infer the source of the stress that is being measured. Is it due to the stress of lying, or the stress of being interrogated?

Environmental conditions, such as ambient temperature, can also affect the autonomic response.

There is also a great deal of individual variability. Different people have very different levels of autonomic activity in response to different stimuli. These highly variable responses can then further vary based upon mood, environment, medication, and underlying conditions.

Such a noisy and highly variable system is problematic for measuring a specific property (such as stress) although it can be of some use in highly controlled situations, such as rigorous scientific studies. The only real clinical application of measuring EDA is for measuring autonomic function itself (in order to diagnose an autonomic disorder). Otherwise it is simply too variable to be of much clinical use.

This variability, however, makes it perfect as a target for pseudoscience.

Zyto Technology

I always love reading that part of a snake oil website that is labeled, “how it works.” In this case the Zyto website has a detailed description. They begin:

ZYTO Scan technology uses Virtual Stimulus Items, or VSIs, which are computer-generated digital signatures that represent specific physical stimuli.

The nonsense begins right up front. They are claiming that they have somehow divined the “digital signatures” of specific toxins, foods, and nutritional supplements. I would love to see the study that established the specific “digital signature” of Gingko biloba.

There is, of course, no basic scientific principle by which you could determine the specific type of electrical stimulation that represents bananas, for example. The very idea is not scientific. If these signatures were determined empirically, imagine how much work that would take. Where are the thousands of studies necessary to create these “VSIs?”

They further claim that:

The body is able to respond to the virtual stimulus in less than one second.

This is demonstrably wrong – EDA requires a few seconds on average. There is nothing they could do to get the body’s autonomic response to be quicker than it is.

After the Zyto hand cradle measures the EDA in response to their virtual stimulus:

The ZYTO software analyzes the data for patterns of coherence. Coherence is a state where two or more things exist without conflict. By tracking the body’s Galvanic Skin Responses, ZYTO technology can calculate shifts in coherence to VSIs. In other words, the shift patterns indicate whether VSIs exist in coherence or conflict with the body.

The concept of coherence or conflict of the EDA (or GSR as they call it) is utter nonsense with no basis in established science. This is the pure magical thinking that ultimately lies at the heart of such devices. This is the “phrenology” component. The device assigns either a positive or negative result to each stimulus then compiles the results.

The ZYTO software then creates a detailed report that translates the analyzed data and your biological preferences in an easy-to-read graphical interface. Essentially, the report presents the body’s responses ranked in order of priority, which can then be used to facilitate better decision making about your health and wellness.

Zyto: Carefully not giving you medical advice (or useful information)

They are careful not to prescribe a specific treatment, just to inform your health decisions. The user gets a result like the picture above. I could determine if you require calcium and magnesium supplements much more accurately by simply measuring the calcium and magnesium levels in your blood, but I guess that’s too old-school.

This is a remarkable chain of claims made for Zyto technology. In order to be true then there would have to be virtual digital signatures for things like food and toxins, the EDA would have to be somehow quicker with their device than normal physiology, and there would need to be some physiological basis for “coherence and conflict” in the EDA which is currently completely unknown to science

Further, think of how extensively each device would need to be calibrated in order for any results to be meaningful. The EDA varies from person to person, with environment, and with current mood. Extensive calibration and standardization would be necessary for the results to be anything other than pure noise. Even the manner in which a user places their hand on the device could affect the results.

In fact, they admit on their website:

Because ZYTO technology interfaces with the body’s fastest moving component, energy, biosurveys can collect a significant amount of information in a short amount of time. Since energy moves and fluctuates so quickly, you are likely to see differences if you repeat a biosurvey and compare individual data points.

In other words – there is no reliability to the results, by their own admission. They make no further comment about this. I guess they think by admitting this, users will expect the variability and not worry about it.

Just to add one more layer of pseudoscience, the write:

Although no meridian points are directly measured, many Virtual Stimulus Items in the software that represent meridians, individual acupuncture points, and even EAV points (Electro-Acupuncture according to Voll) can be measured.

Conclusion: Zyto is Sciencey and pseudoscientific, not science

Measuring GSR or EDA in order to infer some biological property or state is highly problematic, even for careful and rigorous researchers. It is, however, the perfect target for snake oil pseudoscience.

Measuring EDA gives the impression of advanced technology and of measuring something real, at least to the uninformed. It is also a set up for confirmation bias and other cognitive biases that are likely to convince the user that it is working.

For the non-expert who is confronted with similar claims, it is helpful to recognize the red flags. It is highly unlikely that any one approach to diagnosis could provide such a wide variety of specific information. Also, think about all the specific information that would be necessary for such a device to work. Finally, you can ask yourself if the technology is being used by mainstream physicians and at universities. If not, then why not?

When it doubt, of course, you can always search Science-Based Medicine.

 

 

via Medicine Joint Channels