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I don’t recall if I’ve ever mentioned my connection with the Cleveland Clinic Foundation (CCF). I probably have, but just don’t remember it. Long-time readers might recall that I did my general surgery training at Case Western Reserve University at University Hospitals of Cleveland. Indeed, I did my PhD there as well in the Department of Physiology and Biophysics. Up the road less than a mile from UH is the Cleveland Clinic. As it turns out, during my stint in Physiology and Biophysics at CWRU, I happened to do a research rotation in a lab at the CCF, which lasted a few months. OK, so it’s not much of a connection. It was over 20 years ago and only lasted a few months, but it’s something that gives me an obvious and blatant hook to start out this post, particularly given the number of cardiac patients I delivered to the CCF back in the early 1990s when I moonlighted as a flight physician for Metro LifeFlight.

Obvious and clunky introduction aside (hey, they can’t all be brilliant; so I’ll settle for nauseatingly self-deprecating), several of my readers have been sending me a link to a story that appeared in the Wall Street Journal the other day: A Top Hospital Opens Up to Chinese Herbs as Medicines: Evidence is lacking that herbs are effective. I also noticed that our fearless leader Steve Novella blogged about it and was tempted to let it pass, given that I had seemingly lost my window, but then I realized that there’s always something I can add to a post, even after the topic’s been blogged by Steve Novella. Whether that something is of value or not, I leave to the reader. So here we go. Besides, if this article truly indicates a new trend in academic medical centers, it’s—if you’ll excuse the term—quantum leap in the infiltration of quackademic medicine into formerly reputable medical centers. It’s a depressing thing, and it needs to be publicized.

Of course, the Cleveland Clinic has long been a poster child for the evils of quackademic medicine. Indeed, take a look at its Center for Integrative Medicine. Offerings there include acupuncture, chiropractic, something called “holistic psychotherapy,” reiki (of course!), and Chinese herbal therapy. I frequently use the CCF’s woo-ful description of reiki using the “universal life source energy” to heal patients as an example of the utter mystical-religious nonsense that has infiltrated once-proud medical institutions, along with other prime examples carefully curated from selections from other quackademic academic medical centers. So, naturally, it’s not surprising that the CCF would be a “pioneer” (if you can call it that) in bringing traditional Chinese herbal medicine right into the heart of an academic medical center.

The WSJ article isn’t too bad in that it’s not overly credulous and, as the title even proclaims, notes that there isn’t much evidence to support the use of herbal medicine. Of course, herbal medicine is among the most plausible of “complementary and alternative medicine” (CAM) or “integrative medicine” for the simple reason that, for an herb to have a medical effect, there must be a chemical (or chemicals) in it that have pharmacological activity. In other words, there have to be drugs in them thar plants! That’s why pharmaceutical companies and the NIH are so interested in screening natural compounds for chemical properties and pharmaceutical activities that might indicate that they could function as useful drugs. True, much of the low-hanging fruit in terms of naturally occurring chemicals that can make useful drugs has been found and turned into drugs, but there are likely to be lots more where that came from. It just won’t be as easy to identify and characterize them as it was in the past.

As I’ve also described many times and Steve Novella mentioned in his post, the problem with herbal medicines is that they are adulterated drugs (or, as Steve put it, “dirty” drugs). They are not pure. It’s almost impossible to control lot-to-lot consistency with respect to content of active ingredients, given how location, weather, soil conditions, rainfall, and many other factors can affect how the plants from which the medicines are extracted grow and therefore their chemical composition. Let’s just put it this way. It’s much safer and more predictable to administer digoxin to a patient who needs its activity on the heart than it would be for the patient to chew on some foxglove leaves. Given digoxin’s relatively narrow therapeutic window (the difference between the doses needed to produce therapeutic effects and the lowest dose that will cause significant toxicity), that’s critical. There are lots of herbs that can cause significant toxicity, such as Aristolochia, which can cause kidney damage; kava, which can cause liver toxicity; and many others.

The reason physicians moved away from herbal medicine to pharmaceutical drugs is for predictability. Purified active components have a more predictable action because the amount of drug is tightly controlled and known to a very precise degree, while impurities are kept to a minimum. Moreover, these drugs can be combined with various inactive agents to control how fast they are absorbed into the bloodstream, thus providing another level of control. All of these characteristics make the drugs much more predictable than any drugs still contained in dead plant matter. None of this even takes into account the widespread problem with contamination of herbal remedies with heavy metals, such as lead or even arsenic. It’s such a problem that a particularly obnoxious supporter of quackery has started trying to “distinguish” himself and his supplements from the competition by setting up a lab, measuring heavy metals in his competitors’ products, and then periodically publishing scare stories about “contamination” of various supplements and herbal products. (Yes, I’m referring to Mike Adams.)

So what, exactly, is the CCF doing? Let’s take a look at the patient vignette that begins the WSJ article:

Christina Lunka appeared nervous and excited as she sat in the Chinese herbal therapy center recently opened by the Cleveland Clinic.

The 49-year-old had been to many doctors seeking help for ongoing issues that included joint pain and digestive problems. Now the Kirtland, Ohio, resident was hoping to find relief through herbal remedies.

“Do you have something for inflammation?” Ms. Lunka asked herbalist Galina Roofener during a one-hour consultation.

“Absolutely,” responded Ms. Roofener. “This is for pain, for digestion, for inflammation, all of the above,” she said, handing Ms. Lunka a bottle with capsules of an herbal combination called Xiao Yao San, which translates as free and easy wanderer. The capsules include about eight different herbs, including licorice, mint leaf and white peony root.

This is nonsense. I’d bet a dollar (to steal a cliche) that Roofener has no solid evidence to support any of these claims. It’d be among the safest of bets, particularly given that this isn’t even a single herb she’s talking about. It’s a bunch of herbs all ground together. Even Dr. Josephine Briggs, the director of the National Center for Complementary and Alternative Medicine (NCCAM), whom we’ve discussed many times before, is quoted in this article characterizing the “evidence base for these approaches using modern rigorous methods of randomized trials” as “quite thin,” which is an understatement. Surprisingly (to me at least) she also apparently admitted that, although NCCAM is looking at the basic science of some herbal products, it is currently not funding any efficacy studies involving humans (i.e., randomized clinical trials) of herbal remedies right now. If NCCAM isn’t even funding clinical trials of herbal medicines, they really must not be showing any promise lately. Actually, they aren’t, and haven’t been for quite some time. There are a number of trials now showing that various herbal remedies thought to be very promising don’t actually work, such as ginkgo biloba for memory, saw palmetto for benign prostatic hypertrophy, or black cohosh for menopausal symptoms.

It’s also some good money. Consultations are $100, and follow-up visits are $60. True, many visits to real doctors cost more, but in most cases insurance covers them, minus acopay, with all the paperwork that’s required. This sounds as though it’s pure cash on the barrelhead. Add to that the cost of a month’s supply of herbal remedies ($100), and it sounds as though the CCF could easily turn this clinic into a pretty nice profit center, after a slow start. The practitioner, Galina Roofener, is a graduate of the East West College of Natural Medicine in Sarasota, which is largely a school of acupuncture and traditional Chinese medicine (TCM). It seems a bit confused about what TCM is, though. Under a section of its website entitled What is traditional Chinese medicine? it lists electroacupuncture (who knew they had sources of usable electricity in ancient China?), biopuncture (yes, biopuncture), and homeopathy. Who knew? Maybe Samuel Hahnemann was Chinese.

In any case, Roofener worked at clinic called Asian Therapies Acupuncture Clinic before taking a job at CCF. All that’s there now is a message describing how she sold her practice and moved to Cleveland to work for the CCF. However, the Wayback Machine of Archive.org reveals what the website looked like in 2011. There, I found a number of interesting things. Unfortunately, even many of the Archive.org pages are gone, but the titles live on, titles touting the quackery that is thermography for breast cancer, acupuncture for the flu, and lots of evidence that Roofener used homeopathy, which is not surprising given that she’s a naturopath as well, apparently. (Her LinkedIn page also confirms her use of homeopathy.)

Deceptively, Roofener is required by law to invoke the quack Miranda warning as…well, I’ll let the WSJ article explain it to you:

Ms. Roofener’s license doesn’t allow her to claim she treats diseases, a Cleveland Clinic spokeswoman says. She can’t say that Chinese herbs will treat colitis, for instance, but she can say that she can stop diarrhea and pain. She cannot treat arthritis but can alleviate joint pain, the spokeswoman says.

And:

At the Cleveland Clinic’s herbal center, new patients are given a one-hour consultation that may include a battery of questions (How’s your sleep? Body temperature? Ringing in your ears? Headaches?), a physical examination of the tongue, and the traditional Chinese method for pulse-taking (three fingers on each wrist to check different pulses corresponding to various organ systems). They are asked to sign a waiver acknowledging that “herbal supplements are not a substitute for a medical diagnosis.”

Clearly.

Still, in another recent story about Galina Roofener and the herbal clinic at the CCF, Roofener is quotes thusly:

The center doesn’t take walk-ins and primarily sees patients with conditions that Western medicine has, for whatever reason, failed to remedy. “For something like acute pneumonia, Western antibiotics may be faster and more cost-effective,” says Roofener. “But if someone has antibiotic resistance, we can strengthen their immune system.”

Egad! “Strengthen the immune system”? Seriously? That’s one of the top quack claims, regardless of what the quackery is!

Yes, as Steve Novella noted, the CCF is out-and-out admitting in the quack Miranda warning on its consent form for its herbal medicine clinic that the TCM diagnoses Roofener is making and the herbal remedies she is prescribing to treat them are not real medical diagnoses and not real medicine. That’s a staggering admission for an academic medical center to make, that it is offering to its patients medicine that is not real medicine, a system of diagnosis that is not a science-based system of diagnosis. Worse, its physicians are actually referring patients to this clinic, even though they know that there’s no real evidence that it works. For example:

Maged Rizk, a gastroenterologist at Cleveland Clinic who referred Mr. McGeehan, says Chinese herbal medicine is still being critically evaluated. “In the past it wasn’t even considered seriously,” Dr. Rizk says. “At this point there is a thinking, ‘Some of the things we’re doing now aren’t very effective. Should we really be looking at alternatives a little more seriously?’ I think the verdict is still out,” he says.

So, basically, Dr. Rizk seems to be arguing that because current science- and evidence-based treatments for some conditions don’t work as well as we would like we should try treatments with no evidence to support them.

I think I know what’s going on here. I could be wrong, but it sure smells like it. Basically, what we are talking about here are patients with chronic conditions, particularly conditions causing chronic symptoms (there is, for instance, a patient in the story who suffers from chronic nausea), that are not well controlled or well treated with current science- and evidence-based medicine. Understandably, doctors become almost as frustrated as patients when they can’t alleviate their patients’ symptoms. They feel powerless. It’s not surprising that there is a strong temptation to fob the patient off on someone else. It’s also very easy—seductively so—to rationalize a referral to someone like Roofener based on the rationale that maybe she can do something. And if she can’t at least the patient will be someone else’s problem for a while. I know, I know. That’s harsh, but it’s a bit more complicated than that. Few doctors actually want to give up. It’s just that, given an “out” like Roofener’s clinic, it’s not surprising that even good doctors (you have to be good to be on the staff of the CCF) might be tempted to take that out.

Still, we rely on institutions like the CCF to be at the cutting edge of science. We expect that the treatments they offer will be based on the best available science. We do not expect that institutions like the CCF will embrace a prescientific system of medicine that is rooted in what is, in essence, the Asian variant of the humoral theory of medicine in which disease is attributed to imbalances in the five elements rather than the four humors, whose treatments are based on a rationale of somehow channeling or redirecting the flow of a nonexistent “life energy” that has yet to be detected by science and whose medicines are impure mixtures of natural products with nothing resembling what we could consider rigorous evidence of efficacy and safety.

The infiltration of quackademic medicine into medical academia continues apace, to our shame as a profession.

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Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.