Quackademic medicine versus being “science-based”

Here at the blog, I frequently write about what I like to refer to as “quackademic medicine.” A lot of people think that I coined the term, and I really wish that I had. However, in reality, as far as I’ve been able to ascertain Dr. Robert Donnell coined it around a decade ago to describe the infiltration of quackery and pseudoscience into academic medical centers in research, education, and clinical practice. I merely took the term and ran with it.

Recall that quackademic medicine is a phenomenon that has infiltrated medical academia like kudzu over the last two decades. Basically, ostensibly science-based medical schools and academic medical centers have come to 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—even anthropoosophic medicine—into conventional medicine. As my good bud and former 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. Worse, the taste of the cow pie is spreading beyond medical academia into community hospitals. Meanwhile, in academia, “integrative medicine” docs have become so credulous that they’ll even invite a Yuri Geller-like spoon bender to give a workshop.

I bring the topic of quackademic medicine up once again because last week I was interviewed by Alex Lewontin, a reporter at the Georgetown University student newsmagazine, The Georgetown Voice about quackademic medicine for an article that was published a week ago entitled “An Integrative Education: Georgetown’s Complementary And Alternative Medicine Program Sparks Debate.” Not surprisingly, the article was basically “balanced,” with quotes from me as the skeptic and critic of “integrative medicine” and Hakima Amri and Aviad Haramati, the co-founders of Georgetown’s “complementary and alternative medicine” (CAM) program in 2001. This program was based on based on an NIH grant to develop a curriculum to expose graduate students to the field of complementary and alternative medicine, allegedly in a “critical and evidence based way.” Of course, anyone who’s read SBM on this particular topic knows that the main problem with teaching alternative medicine in medical school or doing research on it is not actually teaching it or doing research on it, but rather teaching it in a credulous manner and wasting resources and potentially endangering patients doing what I like to refer to as “clinical trials of magic.” Also, offering alternative medicine, the way that many academic medical centers do now, before there is solid evidence for its efficacy, is inherently unethical. Sadly, that doesn’t stop medical schools and academic medical centers like Georgetown from doing just that. There’s even an organization for academic medical centers with quackademic medicine programs, the Academic Consortium for Integrative Medicine and Health (ACIMH), which is busily trying to get its residents to learn integrative medicine and co-opting the opioid crisis to promote quackery. It’s also grown from eight founding members to nearly seventy in two decades.

As I contemplated the article that quoted me, I was made aware of a study that shows what I was talking about. It doesn’t have anything to do with Georgetown University, but it has a lot to show about what’s wrong in medical academia today.

Deepak Chopra, medical academia, and clinical trials of woo

I’ve written about Deepak Chopra here on a number of occasions and elsewhere on a number of others. Whether it’s his invocation of “quantum” to justify quackery, his claim of a “conscious universe,” his denial of evolution, or his fanciful invocation of epigenetics and denial that genes can determine our destiny, Chopra’s blather is a perfect example of how New Age mystical mumbo-jumbo can infect medicine and be made to sound sufficiently “science-y” that doctors don’t immediately laugh out loud at it, as I did at Chopra when he criticized Donald Trump for being insufficiently reality-based. Truly, irony meters everywhere exploded.

I first noted Chopra’s insinuation into medical academia over three years ago, when I first became aware of a clinical trial that he was planning to do. Chopra initially described it for the public in SFGate in an article, “Multi-institutional Collaborative Clinical Trial to Examine Health Benefits of Integrative Lifestyle Practices at the Chopra Center for Wellbeing.”

As I read the original article about the Self-Directed Biological Transformation Initiative (SBTI), one question kept bouncing in my mind: What was the hypothesis? What hypothesis was Chopra testing here? It was a randomized trial, in which study participants were to be recruited for a week-long stay at the Chopra Center at the OMNI La Costa Resort in Carlsbad, CA, where participants were randomized to join either the Ayurveda program or a seven-day stay at the resort without treatment, which served as the control. Chopra’s “Perfect Health” program included a whole bunch of Ayurvedic massage (which can’t be too bad, I would guess), primordial sound meditation, mantra sessions, group sessions, yoga, and, as I speculated at the time, a healthy diet. Participants were to be evaluated four times: at home prior to arriving at the Center, immediately upon arrival, immediately following the treatment program, and one month later in a follow-up assessment. The following markers were tested:

• RNA expression
• Telomerase activity (linked to the aging process)
• A variety of metabolites, peptides, and neurohormones (connected to metabolism, addictions, and mood changes as well as the messaging between brain and body)
• The microbiome (the enormous population of microorganisms on the skin and in the intestinal tract, and their collective genetic material)
• Circulating protease activity
• Mobile cardiac functioning
• Balance of the autonomic nervous system
• Assessments of mental, emotional, and spiritual wellbeing

Chopra described the whole thing here in a YouTube video:

It’s only a couple of minutes. If you can stand to listen to it, you’ll hear Chopra describe the trial’s goal thusly:

The idea is to prove—scientifically—that your biology is a product of the choices that you make, and these choices are made every day, and that we can actually consciously create the experience of a joyful energetic body, a loving compassionate heart, a restful reflective mind, and lightness of being.

Whatever that means. Of course, it’s trivial to show that our health is, at least in part, the product of choices we make. I can choose to exercise—or not. I can choose to eat a healthy diet—or not. I can choose to smoke—or not. You get the idea. Of course, that’s not what Chopra means. He wanted to “prove scientifically” that his program does all sorts of wonderful things that aren’t specified beforehand in concrete, measurable ways. He also did it charging participants to use a facility that he owns.

All these issues aside, somehow Chopra got several collaborators from Harvard, Duke, and different campuses of the University of California to buy into this study and collaborate with him on it. Heck, if you want an example of quackademic nonsense, just consider that Deepak Chopra is Clinical Professor in the Department of Family and Preventive Medicine at the University of California, San Diego. Yes, clinical faculty is basically like adjunct faculty in non-medical departments, but a clinical professor is still faculty and, although not paid by the university, has most of the other privileges that being a professor confers.

So when Chopra publishes anything in the medical literature, it comes under the imprimatur of the University of California, San Diego. So far, I know of two publications from this study.

The results thus far…quackademic magic!

I’ve already discussed the results of the first paper that I knew of published as a result of this study. Granted, my discussion was in the context of a systematic review of gene expression changes supposedly associated with meditation and related practices. (Hint: The evidence catalogued in this systematic review was much less impressive than the authors painted it.)

In brief, healthy women aged 30–60 were recruited to stay at Chopra’s resort and then randomized to a vacation arm or novice meditator arm, for a total of 94 participants who completed the program. A comparison group of regulator meditators was recruited from women aged 30–60 who had already enrolled in the retreat. According to the supplemental data, the sample included women who were non-meditators and lived in California who were randomized to a “vacation” arm or a meditation arm. They did not pay for their stay at the resort. The comparison group of non-randomized women (the “experienced” meditators) was recruited from the pool of those already registered for the retreat and paid for their own expenses. Also, the experienced meditators were not randomized, and they could easily have confounding differences that could affect their results. In any event, although it wasn’t described in the methods of the paper itself, promotional literature described the retreat goal as “to promote an intensive period of learning and psychological change.” The vacation group was hosted at the same resort, but they did not participate in any retreat activities. Subjects reported on well-being immediately after (on day 5), 1 month later, and 10 months later to assess maintenance of benefits.

Unsurprisingly, the study noted improvements in psychological well-being in all groups. Investigators also claimed to have identified gene expression signatures that changed in all three groups consisting of 390 genes. This is code for saying that there wasn’t a detectable difference between the groups in changes in this gene signature, which the authors attribute to the “vacation effect.” They did, however, find differences in another gene signature whose change differed between the vacation and novice meditator arms versus the regular meditator arm. The conclusion:

In summary, our results point to both a significant ‘vacation effect’ that benefitted all groups, and a suppression of stress-related responses and immune function related to acute-phase wound healing and inflammation. We also identified a ‘meditation effect’ within the regular meditator group, characterized by a distinct network of genes with cellular functions that may be relevant to healthy aging, and this network was associated with increased expression of a number of telomere maintenance pathway genes and an increase in measured telomerase enzymatic activity. This study provides a strong distinction between beneficial effects of short-term relaxation typical of a vacation versus acute intensive meditation for regular meditators. Future studies expanding upon these results will be critical for further understanding lifestyle acute adaptations capable of promoting stress reduction and overall health and well-being.

In other words, a relaxing vacation will do you good. As for the supposed difference in gene expression signatures between novice and regular meditator groups, even if real (and reproducibility of such gene expression signatures is a huge pitfall of studies like these) it doesn’t really tell us anything, given that the regular meditators could easily have confounding factors at play based on behaviors and diet different from the vacation and novice meditator groups. Basically, this study was pretty unremarkable.

So was this other study, published in the open access journal published by Nature Publishing Group, Scientific Reports. (I can’t help but note that this particular journal is often misrepresented by quacks as being Nature.) One notes that this study emphasizes that the “Perfect Health” program at Chopra’s retreat is based on Panchakarma, an Ayurvedic medicine intervention sometimes called the “fivefold” detoxification treatment. It involves massage, herbal medicines and promises:

Panchakarma will remove the excess doshas and correct imbalances in them as well as eliminate the harmful ama out of your system through the body’s own organs and channels of elimination (colon, sweat glands, lungs, bladder, urinary tract, stomach, intestines, etc). Panchakarma purifies the tissues at a very deep level. It involves daily massages and oil baths, herbal enemas, nasal administrations. It is a very pleasurable experience. Ayurveda recommends Panchakarma as a seasonal treatment for maintaining mental and physical hygiene and balance.

Well, there you go.

In this study, meditation was not really examined. The only comparison made was between the “Perfect Health” (PH) group, which undertook the Ayurvedic Panchakarma detoxification program coupled with meditation, and the vacation controls:

Based on principles of Panchakarma, Ayurvedic Medicine’s principle cleansing and rejuvenation protocols, PH incorporates various treatment modalities such as a vegetarian diet, Ayurvedic herbs using the Zrii Purify™ herbal program per manufacturer’s instructions, meditation, yoga, specialized Ayurvedic oil massage, heat therapies, and lectures on self-care and well-being (see Supplementary Methods S1 for detailed herb, oil, and prebiotic fiber cleanse protocol). The PH program employs a palliation approach, which combines gentle reduction and tonification therapy, and is focused on Purvakarma (preparatory techniques of Panchakarma) procedures and 2 of the 5 main Pradhankarma techniques of elimination, namely Virechana and Nasya. Gentle Virechana is accomplished using the purgative herbs of the Zrii Purify™ herbal program. All study participants were housed onsite at the resort. The study was approved by the University of California, San Diego Human Subjects Research Protections Program Investigational Review Board and performed in accordance with institutional guidelines for research with human subjects. The SBTI study was registered at ClinicalTrials.gov as NCT02481544

It’s interesting to note what the cleanse consisted of. It’s more than just eating a vegetarian diet. For instance, there’s an AM “detox” involving potassium glycinate, a supplement containing Manjishtha (Rubia cordifolia) root, Guduchi (Tinospora cordifolia) root, Kutki (Picrorhiza kurroa) root, Punarnava (Boerhavia diffusa) root, Neem (Azadirachta indica) leaf, Musta (Cyperus rotundus) root, Gokshura (Tribulus terristris) aerial parts, Bhumyamalaki (Phyllanthus niruri) whole plant; another supplement containing dandelion root, burdock root, milk thistle seed, artichoke leaf, parsley leaf, mullein leaf, uva ursi leaf; and a third supplement containing Alpha-lipoic acid, calcium D-glucarate, N-acetyl cysteine, inositol. The PM cleanse involves magnesium oxide and a supplement with cascara sagrada bark, chitrak (Plumbago zeylanica) root, marshmallow root, slippery elm bark, prune fruit, fennel seed, peppermint leaf, and ginger root.

The cleanse itself involves:

A. Upon Rising: Take 4 AM Detox Capsules with 8 oz. of water at least 15 minutes prior to breakfast and at least 15 minutes before taking the Fiber-Herb Blend.
B. Breakfast: Take 1 scoop of Fiber Blend with 8 oz. of water, 1 Tbsp. Detox Oil, and a sensible meal
C. Freshly prepared Ayurvedic breakfast meal provided.
D. Lunch: Ayurvedic meal provided.
E. Dinner: Take 1 scoop of Fiber Blend with 8 oz. of water, 1 Tbsp. Detox Oil, and Ayurvedic meal on your own.
F. Bedtime: Take 2 capsules PM Cleanse with 8 oz. of water before going to bed and at least 15 minutes after taking Fiber Blend.
G. Drinks

1. Plenty of water every day – about six 8-oz. glasses.
2. Hot water with sliced fresh ginger frequently throughout the day.
3. Herbal, non-caffeinated teas.
4. Vegetable juice.
5. Avoid alcohol, soda and caffeine.

H. Yoga: Two 1-hour yoga classes per day.
I. Meditation: Two to three 20-minute mantra-based silent meditation practices per day.
J. Massage: Hour-long Ayurvedic massage treatment and external oleation per day.
K. Heat therapies: Choice of dry or wet sauna and Ushma Svedana (steam tent) treatment.
L. Lectures: Practical morning and afternoon lectures on well-being, food and self-care.

Avoid alcohol and caffeine? This is not the sort of vacation I’d be interested in.

In any case, the researchers drew fasting blood samples from each participant at the beginning and the end of the six day program metabolomics analysis. To their credit, all metabolomic analyses were done blind to treatment arm, and 186 metabolites were measured using the AbsoluteIDQ® p180 kit and liquid chromatography-mass spectroscopy (LC-MS) or Flow Injection Analysis method (FIA-MS/MS). The authors did observe a change in several metabolites in the PH group, including significant reductions in 12 phosphatidylcholines and significant changes in an additional 57 metabolites classified as amino acids, biogenic amines, acylcarnitines, glycerophospholipids and sphingolipids were observed in the PH compared to the control group. To be honest, it’s not that important that you understand what all of these are, other than that phosphatidylcholines are membrane phospholipids that consist of a glycerol core with a choline head group and two fatty acid residue and that eggs are a primary source of phospholipids. What’s so clear that even the authors have to admit it is that it is almost certain that the changes in the levels of these metabolites almost certainly are a result of the diet and supplements. The authors note, for instance, that lower serum phosphatidylcholine and sphingolipid levels have been reported in vegans and vegetarians compared to meat eaters; so it is not at all surprising that they would see the same thing. It’s also been noted that certain phosphatidylcholines have been found to be inversely related to risk of type II diabetes, although the authors could make no comment on whether the profile changes they observed are associated with decreased risk of any disease.

None of that stopped them from speculating wildly, though:

Many dietary constituents serve as substrates that are metabolized by the gut microbiota into products that can alter host physiology. The significant alterations in plasma metabolites following PH are consistent with previous studies that reported that the gut microbiota and host metabolism are altered rapidly following a dietary shift23,24,25. The absence of meat and minimal dairy products in the PH diet are consistent with the alterations in plasma metabolites observed and may suggest that diet may have an impact on the plasma analytes reported here. The timeframe of these changes is consistent with reports comparing human subjects, using a cross over design, consuming an omnivorous or vegetarian diet. The gut microbiota composition displayed marked change after just 1 day with additional changes occurring over the following 6 days post-intervention.

One notes that no data are presented to demonstrate that the gut microbiota changed in the PH group, although, given how the “cleanse” almost certainly induced a bit of diarrhea (or at least loose stools) and a diet without meat can change the gut microbiota, it would be surprising if there were no change. Even so, no health benefit was really demonstrated. Again, as I characterize this study earlier, it was just a big fishing expedition that didn’t really provide much in the way of interesting hypotheses to pursue. Also, given the non-random assignment of the “expert meditators” one can’t help but wonder if they skewed the experimental group based on other confounders.

Which brings us to the study I became aware of a couple of weeks ago.

“Mind-body” practices and “spiritual awakening”

The first study looked at a bunch of genomic signatures in the various groups being studied. The second study did not. Rather, it looked at how the members of the various experimental groups felt. Naturally, it wasn’t published in a journal like Translational Psychiatry, which is fairly well respected and has a decent impact factor. Instead, it was published—where else?—in the Journal of Alternative and Complementary Medicine (JACM). Yes, that’s the same journal edited by our old friend John Weeks. The title of the paper ought to tell you all you need to know: “Change in Sense of Nondual Awareness and Spiritual Awakening in Response to a Multidimensional Well-Being Program.” It is truly a masterpiece of quackademic medicine woo, although it does suffer for not once invoking the word “quantum.”

This study looks at the same three groups. In this case, they were asked to fill out questionnaires three times, once at home before the program, once immediately after finishing the program, and once a month later at home. Three of the instruments were fairly unremarkable, such as the 20-item self-report screening tool for depressive symptoms was developed by the National Institute of Mental Health, an eight-item scale that is part of the National Institute of Health research initiative, the Patient-Reported Outcomes Measurement System (PROMIS), and the Delaney Spirituality Scale. The scale that really drew my attention, though, was the Nondual Embodiment Thematic Inventory (NETI), which, unlike the other three scales, was the primary outcome of this study. Here’s how it’s described:

Although there are a number of standardized questionnaires that assess spiritual and transpersonal constructs,31–33 few specifically address nondual awareness. For this study, the NETI, a 20-item questionnaire that was developed by John Astin and David A. Butlein, was used. Butlein and a team of experts in nonduality attempt to evaluate qualities of the nondual experience and spiritual awakening.34–37 The NETI yields a single total score that can range from 20 to 100 and attempts to differentiate between individuals with transpersonal ideas from individuals who live the transpersonal at the deepest levels possible.34 The qualities that the scale assesses include compassion, resilience, propensity to surrender, interest in truth, defensiveness, capacity to tolerate cognitive dissonance and/or emotional discomfort, gratitude, frequency of nondual experience, anxiety level, motivational paradigm, authenticity, level of disidentification from the mind, and humility34 (Appendix).

You should look at the scale, as it’s really rather odd. Here are a couple of the questions:

6. Understanding that there is ultimately no separation between what I call my “self” and the whole of existence. Please choose only one of the following:

1. Never
2. Rarely
3. Sometimes
4. Most of the time
5. All of the time

And:

9. Conscious awareness of my nonseparation from (essential oneness with) a transcendent reality, source, higher power, spirit, god, etc. Please choose only one of the following:

1. Never
2. Rarely
3. Sometimes
4. Most of the time
5. All of the time

And:

20. A sense of the flawlessness and beauty of everything and everyone, just as they are. Please choose only one of the following:

1. Never
2. Rarely
3. Sometimes
4. Most of the time
5. All of the time

Of note, this scale, as far as I can tell, has never been validated for anything, much less “nondual” awareness, which, I gather, is woo-babble for being “at one with the universe,” or some such thing. In any case, the authors report that the NETI score increased in the PH group compared to controls. Specifically, in the PH group, it increased from 63.8 to 74.4; in the control group, it increased from 62.8 to 67.8. The authors also noted that both groups showed similar decreases in depressed mood and anxiety; so basically the PH program did no better than a one week vacation for general mental health. They also noted that the NETI score correlated with the Delaney Spirituality Scale.

Interestingly, there was a difference in the dropout rate between the two groups. Out of 65 in the PH group who underwent the program, only 33 (51%) completed the immediate post-intervention follow-up questionnaire and only 20 (31%) completed the one month follow-up. This is in contrast to the control group, where, out of 54 participants, 36 (67%) completed the questionnaire immediately following the intervention, and 25 (46%) completed it one month later. These are both high rates of dropout, and it’s odd that the intervention group would have the higher rate of dropout. Basically, it’s a huge problem with the study when the dropout rate is that high.

So what does this study mean? Hell if I know! It shows no positive results using the two validated instruments and only shows a result using the made-up instrument which, we are assured, correlates with spirituality, even though it wasn’t designed to assess spirituality. I’m just glad that NIH money didn’t go to fund this study for a change.

The problem with Georgetown and all too many academic medical centers

While it wasn’t Georgetown faculty who did this study and collaborated with Deepak Chopra, Georgetown is indeed a major center of quackademic medicine, as I described last time when I listed all the nonsense that it offers. What stood out to me about Georgetown was, in fact, the very program founded by Amri and Haramati, not so much because it taught CAM. That’s unfortunately very common these days. Rather, it was how the CAM was taught. Specifically CAM was—if you’ll excuse the term—”integrated” into the medical school curriculum from day one. I frequently cite the example of how at Georgetown an acupuncturist would teach a session of gross anatomy to point out where acupuncture meridians are. Never mind that no one has ever convincingly demonstrated an association between meridians and any anatomic structure. Similarly, an acupuncturist would teach a session of neuroanatomy and neurobiology to describe how acupuncture modulates pain. Never mind that it’s never been convincingly demonstrated that acupuncture is anything more than a theatrical placebo.

Yet in the article for which I was interviewed:

The CAM faculty doesn’t see it that way, however. “As scientists and academicians, as long as we have the evidence, and our statements are evidence-based, then that’s what we’re going to teach our students,” Amri said. “I want [our critics] to show me what they have read that is really a good study, and shows negative effects. If there are negative effects, I want to know also. I want to show that to the students. We are not teaching the students to become advocates of the field. That’s not our focus. Our focus is to teach them how to separate the good from the bad.”

I can’t help but contrast Amri’s statement above with her statement three years ago for Georgetown Medicine:

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.

Well, yes. Accepting homeopathy does rather require one to empty one’s brain of science.

In fairness, Amri states again that she is evidence-based and that her goal is to prepare students to separate the wheat from the chaff. Still, her expressed glee at teaching homeopathy and seeing students’ reaction to it rather belies her claim to be all about the science.

Her partner in woo is no better:

Haramati, a self-described skeptic, sees this as in line with Georgetown’s Jesuit philosophy. When he started the program, he met with university President DeGioia, and warned him that there could be pushback. “I told him, ‘We are going to explore areas with objectivity, and with rigor, and isn’t that the Jesuit way?’”

And:

The Department of Defense, in response to the opioid epidemic, has been investigating acupuncture, mindfulness, and other integrative treatments to help veterans with chronic pain. “This is the military,” Haramati said. “They’re not exactly San Francisco hippies.” The CAM program itself uses the same scientific standards as any other program in the Medical Center. “We’re not going to be teaching students about crystals. We are careful about what subjects we bring to the table. There is something called ‘biological plausibility,’ where we start with practices that are common and which there is an evidence base for.”

Actually, as we’ve documented many times before, the military is not what I’d call the greatest example to point to for scientific rigor in medicine. The Veterans Health Administration is actively pushing naturopathy, auricular acupuncture (which is incredibly bizarre quackery), and a whole boatload of other “integrative” quackery while the military itself is promoting pure quackery. As for biological plausibility, all I can say is: “Biological plausibility. You keep using that term. I do not think it means what you think it means.” Why do I say that? Because, as I documented before, Georgetown offers “energy medicine” in the form of reiki in the chemotherapy suite. As I say so often, reiki is nothing more than faith healing based on a religion other than Christianity; it has about as close to zero biological plausibility as you can imagine. Georgetown also offers cupping, which is also pure quackery with close to zero biological plausibility. Ditto the cranial osteopathy that it teaches, whose biological plausibility is nonexistent because the anatomic structures and physiologic processes that it claims to utilize do not exist and do not work the way claimed. There’s a reason Mark Crislip once called craniosacral therapy a “sCAM of infinite jest.” I’d love to hear Drs. Amri and Haramati explain to me the biological plausibility of these modalities. I really would. I’d also like to know why Georgetown has a reiki master as one of its “mind-body facilitators.”

Doctors running integrative medicine programs like the one at Georgetown like to claim that they are evidence-based, that they are all about the science, that they don’t do anything that doesn’t have scientific support. They are deluding themselves. Meanwhile, they continue to get away with it because patients like it and because the vast majority of their colleagues are shruggies. It’s the reason why real scientists will willingly team up with New Age mystics like Deepak Chopra undertake quackademic “research.”