Last week, I was perusing Twitter, which has become a primary source these days for blog fodder, when I came across this:
Proud to announce @ASCO has endorsed SIO’s Clinical Practice Guidelines for Integrative Therapies During and After Breast Cancer Treatment. A significant milestone for #integrativemedicine and oncology! https://t.co/UhABRnkDFV … … @integrativeonc #breastcancer
— SIO President (@SIOPresident) June 13, 2018
Yes, it was the President of the Society for Integrative Oncology, Linda Balneaves, crowing about how ASCO has endorsed its guidelines for therapies for the “integrative” medical care of patients with breast cancer, something she did on her own Twitter feed as well:
Proud as President of SIO to announce that @ASCO has formally endorsed SIO’s Clinical Practice Guidelines for Integrative Therapies During and After Breast Cancer Treatment. A significant milestone for the field of integrative oncology! https://t.co/BLzI7CyKJO @integrativeonc
— Lynda Balneaves (@LyndaBalneaves) June 12, 2018
ASCO itself had announced this endorsement, too:
We’ve endorsed @Integrativeonc‘s breast cancer treatment practice guideline https://t.co/dnapbGzck2 pic..com/3H4WpjcYyq
— ASCO (@ASCO) June 11, 2018
Elsewhere, even some National Cancer Institute-designated comprehensive cancer centers were touting the news. For instance, here’s the University of Washington with perhaps the worst Tweet of all from a “respectable” cancer center:
Is your oncologist dismissive of Qs about meditation, acupuncture, massage, yoga, etc? You can now tell them @ASCO has endorsed these as evidence-based ways to manage symptoms & side effects of conventional #breastcancer treatment. #IntegrativeOncology https://t.co/x7aquiG3FW
— Fred Hutch (@fredhutch) June 12, 2018
Unfortunately, the Hutch isn’t entirely wrong. ASCO (the American Society of Clinical Oncology) is one of the largest medical professional societies devoted to cancer in the world, if not the largest. Its meeting every year, usually beginning the weekend after Memorial Day, inevitably generates lots of press coverage and news stories about the latest clinical trial results for new cancer therapies. You might recall the flurry of news stories two weeks ago about the TAILORx trial, which clarified the use of the OncoType DX test to determine which patients with the most common subtype of breast cancer can safely forego chemotherapy. ASCO also publishes a number of guidelines for cancer care. Basically, when ASCO endorses a treatment or another organization’s guidelines, it’s a big deal. It’s hugely influential. Now ASCO has endorsed the “integration” of quackery into the treatment of breast cancer patients. To paraphrase David Byrne, “And you may ask yourself, well, how did we get here?”
The SIO clinical guidelines for breast cancer care, round one: Rebranding SBM and integrating quackery
When the first version of the SIO’s Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer was published in December 2014, I commented in detail about it in my usual inimitable fashion. First, I noted that the guidelines were published as a part of a monograph in the Journal of the National Cancer Institute (JNCI). Along with the guidelines, there were multiple other articles designed, among other things, to exaggerate the evidence base for the use of “integrative” therapies in cancer, to promote the “brand” of integrative oncology, and to tout the NCI’s portfolio of “complementary and alternative medicine” (CAM) research through its office with the most inappropriate acronym ever, the Office of Cancer Complementary and Alternative Medicine (OCCAM), whose budget has traditionally been roughly the same size as that of the National Center for Complementary and Alternative Medicine (NCCIH). OCCAM serves the same purpose in cancer research and treatment as NCCIH does for medicine in general: To fund mostly dubious studies on “integrative medicine” and to promote “education” and use of “integrative medicine.” The monograph also taught me that the NCI Community Oncology Research Program (NCORP) has been co-opted such that nearly one-third of NCI-sponsored clinical trials through the NCORP are for “integrative oncology.” Comparing the evidence base for integrative oncology to conventional oncology, it boggles the mind that such a huge chunk of an important resource for testing is diverted in this way.
As a prelude to discussing the updated guidelines, I have to ask: What about the original guidelines themselves?
I found them notable for the modalities that the SIO panel charged with developing the guidelines had excluded because they had become “mainstream,” such as cognitive-behavioral therapy, psychoeducation, counseling, and support groups. Of course, these modalities were never considered outside the mainstream, although admittedly some overblown claims have been made for support groups and cognitive-behavioral therapy as being able to improve cancer survival, claims that have not held up to scrutiny. Similarly, prayer and spirituality were also excluded for unclear reasons.
The treatment modalities that remained were subjected to a literature analysis in order to determine whether they can be recommended or not based on existing clinical evidence. The SIO used a scale adapted from the U.S. Preventative Services Task Force to grade the evidence that ranged from A (“Recommends the modality. There is high certainty that the benefit is substantial.”) to H (“Recommends against the service. There is moderate or high certainty that the harms outweigh the benefits.”). Of course there are also I (insufficient evidence) and various gradations between A and H, such that it’s probably worth reposting the table to guide the rest of this discussion:
Tellingly, the only grade A recommendations were for meditation, yoga, and relaxation with imagery for routine use for common conditions, including anxiety and mood disorders (Grade A). There were no grade A recommendations for anything having to do with pain, but only for symptoms with an even heavier subjective component, namely anxiety and mood. Of course, yoga is a form of exercise and therefore nothing out of the realm of conventional medicine, given the number of studies that have shown the benefits of exercise in cancer patients. Similarly, the only grade B recommendations included stress management, yoga, massage, music therapy, energy conservation, and meditation for stress reduction, anxiety, depression, fatigue, and quality of life. Interestingly, again, none of these, with the possible exception of meditation, can be considered in any way “alternative,” thus once again demonstrating how integrative oncology specifically and integrative medicine in general have co-opted treatments that should be considered conventional as somehow “alternative”. As for music therapy, massage, and the like, these represent modalities that I like to point to as examples of what we used to call supportive care that have been “medicalized” by CAM and turned into therapies when in reality they’re just activities and modalities that help patients feel a bit better or help pass the time, no specific effects intended. Oddly, SIO lumped massage together with “healing touch.” Healing touch, of course, is a form of “energy medicine” very much like reiki and thus total quackery. It was also telling that there was no acupuncture use that was rated grade B or above, except for “electroacupuncture” for chemotherapy-induced nausea and vomiting, and, as I’ve discussed before, that evidence is shaky at best.
At the time, I characterized the offerings as giving little or no support for real “alternative” treatments (e.g., homeopathy), although they did give mild support for a few potentially science-based modalities rebranded as CAM/”integrative oncology” and ,tellingly, insisted against evidence on including the quackery (or, if you prefer, the theatrical placebo) known as acupuncture in the guidelines. I wonder if it was because one of the authors of the guidelines, Misha Cohen, is an acupuncturist and practitioner of traditional Chinese medicine (TCM), and Gary Deng is also into TCM.
The SIO clinical guidelines for breast cancer care, round two: A pointless and unnecessary update
About a year ago, for reasons that eluded me then (and were partially why I didn’t do a follow-up post on this topic for SBM), the SIO decided to update its clinical guidelines for breast cancer care. Then, as before, the author list included MDs, some of them respected (e.g., Debu Tripathy). The current SIO President, Lynda Balneaves, was also an author. The author list also contained quacks (e.g., Misha Cohen, TCM practitioner and acupuncturist). It also contained three naturopaths, starting with the first author, Heather Greenlee. Dugald Seely is on the author list again, as well. We’ve met Seely before on multiple occasions. Indeed, he’s quite the flush little naturopathic quack, complete with millions of dollars donated by an anonymous donor to fund “integrative oncology” research at the Ottawa Integrative Cancer Center (OICC). Then there’s Suzanna Zick, who’s even worse than a naturopath. She’s a naturopath at my alma mater, the University of Michigan Medical School. It always depresses me to contemplate that U. of M. actually has a naturopath working for it, but, then, it also has an anthroposophic medicine program. So I guess it’s not a stretch any more for there to be naturopaths there.
Upon reading the introduction to the 2017 update to the SIO guidelines, I also couldn’t help but note that what the SIO apparently means by “recommendation” is not what most doctors producing evidence-based guidelines mean by the word:
Of note, it is important to define the use of the term recommendation in these clinical practice guidelines. In many settings, a clinical guideline recommendation suggests that it should be used as the standard of care and is favorable or equal compared with all other options based on best clinical evidence for benefit/risk ratio. Here, in the setting of integrative oncology, we use the term recommendation to conclude that the therapy should be considered as a viable but not singular option for the management of a specific symptom or side effect. Few studies have conducted a head-to-head comparison of a given integrative therapy against a conventional treatment, and most integrative therapies are used in conjunction with standard therapy and have been studied in this manner. Moreover, combination-based approaches and the interactions of the numerous permutations of integrative and conventional treatments have not been formally investigated, such that recommendations must account for this limitation of our knowledge. Despite these limitations to evaluating the use of integrative therapies in the oncology setting, there is a body of well conducted trials of specific therapies for specific conditions that provides sufficient evidence to warrant recommendations on the therapies as viable options for treating specific conditions.
Ah, “integrative medicine,” where even “recommendation” doesn’t mean what it does in real medicine. I couldn’t help but be reminded of the famous quote by Humpty Dumpty in Lewis Carroll’s Through the Looking Glass, “When I use a word, it means just what I choose it to mean—neither more nor less.” In clinical guidelines in real medicine, though, “recommendation” means just that: a recommendation to use the treatment in question, graded, of course, according to the strength of the evidence. Yet here in the world of integrative medicine, “recommendation” means something…squishier. One can’t help but make the analogy that integrative medicine’s evidence standard is squishier than that of real medicine. Of course, the answer to that question of whether the new studies included in the 2017 update to the SIO clinical guidelines added much of anything to the 2014 clinical guidelines was, as I suspected, no, at least as far as I could tell.
I can’t help but mention that, by embracing the newer SIO guidelines, ASCO has also put its imprimatur on language like this:
Acupuncture involves the stimulation of specific points, (ie, acupoints) by penetrating the skin with thin, solid, metallic needles.[154, 155] A variation of acupuncture includes electroacupuncture, in which a small electric current is passed along acupuncture needles to provide a stronger stimulus than acupuncture alone, with distinct effects suggested by functional magnetic resonance imaging.[156, 157] Acupuncture has been practiced in Asia for thousands of years as a component of traditional medicine systems (eg, traditional forms of Chinese, Japanese, and Korean medicine) and is thought to stimulate the flow of a form of energy called qi (chee) throughout the body. Traditional Chinese acupuncture, which is commonly used in North America, requires needle manipulation to produce a de qi sensation (a soreness, fullness, heaviness, or local area distension[157, 158]), along with a period of rest with the needles in place. It is posited that this removes energetic blockages, thus reestablishing homeostasis. The mechanisms for acupuncture’s effects are not well understood but are thought to function in part through modulation of specific neuronal/cortical pathways.
Neither SIO nor ASCO appear to be aware of how much revisionist history (or, as I like to call it, retconning) is contained in the passage above about acupuncture. The claim here was that acupuncture has been practiced “thousands of years,” most commonly for at least a couple of thousands of years. Yet two thousand years ago the technology to produce thin needles of the sort used by acupuncturists today didn’t exist. In fact, it’s unclear when acupuncture in something resembling its current form evolved, but it appeared to have evolved from bloodletting. Harriet Hall once related the story of Dugald Christie, a Scottish surgeon who served as a missionary doctor in northeastern China from 1883 to 1913, and his experiences observing traditional Chinese medicine (TCM), including acupuncture. Let’s just say that acupuncture practiced 100 years ago was rather brutal. In fact, acupuncture began as nothing more than a Chinese version of bloodletting, very much like “Western” bloodletting and has been called “astrology with needles.” In reality, acupuncture and TCM achieved their current form under Chairman Mao Zedong, who promoted their use when he couldn’t supply enough scientifically-trained doctors for his people and exported to the world, something China is still doing. It’s a history that’s been retconned, and the SIO panel just repeated that retconned revisionist history. No wonder there are so many forms of acupuncture.
Basically, there’s not much new in these guidelines. Relatively uncontroversial modalities like meditation, music therapy, stress management, and yoga are given the highest recommendations. However, acupuncture and its bastard offspring electroacupuncture (which really has no basis in TCM, given that there was no electricity hundreds or thousands of years ago to hook needles up to) consistently get B or C recommendations for several indications, despite acupuncture being nothing more than a theatrical placebo that hasn’t convincingly been shown to work for any clinical indication. That includes acupressure.
As is the case with most systematic reviews of integrative medicine, there are some head scratchers. For instance there’s this level C recommendation, meaning that they can be considered:
Acupuncture,[49-51, 91, 92] healing touch,[93, 94] and stress management[36-38, 95, 96] can be considered for improving mood disturbance and depressive symptoms.
Acupuncture,[119-124] healing touch, hypnosis,[125, 126] and music therapy[31, 34] can be considered for the management of pain.
Healing touch is the rankest quackery. It’s energy medicine that postulates that practitioners can manipulate human life energy fields. It’s such a silly form of quackery that even a 12-year-old girl could disprove it.
Basically, these guidelines, now endorsed by ASCO, were even more unnecessary and pointless than the first set of guidelines published in 2014. It’s not as though clinical studies have advanced knowledge enough to justify a new set of guidelines, and these guidelines suffer from the same issue that integrative medicine itself suffers from, mixing cow pie with apple pie as though they were equivalent.
The SIO clinical guidelines for breast cancer care, round two: Enter ASCO
So now we arrive at ASCO’s contribution to this sad saga. This time around, several of the authors are the same, but there are some additions. For instance, Dr. Lorenzo Cohen of the University of Texas-M.D. Anderson Cancer Center is senior author. I’ve discussed him before here on SBM a few times. Suffice to say that he is a heavy hitter in the world of “integrative oncology” and co-authored the introduction to the original JNCI monograph that contained the first iteration of the SIO breast cancer guidelines. He’s also edited a book on “integrative oncology” that was favorably reviewed in the New England Journal of Medicine by one of his friends. He’s also popped up as a strong advocate for integrative oncology in various news stories. He also co-authored an article using the Delphi method to try to define just what “integrative oncology” is. (He and his co-authors came up with a vague, pretty much useless definition.) Finally, relative to ASCO, Dr. Cohen was one of the main speakers for a session on integrative oncology at the ASCO meeting in 2014 where he argued that stress and mental state contribute to cancer development and progression and that reversing those “bad” mental states can contribute to the improved survival of cancer patients, citing a raft of dubious science to do it. (That was the first time I noticed that ASCO was starting to delve into woo.) Overall, I got the impression that Dr. Cohen believes in the central dogma of alternative medicine, namely that wishing makes it so.
As for the rest of the co-authors, naturopath Heather Greenlee is back. Another co-author, Judith Fouladbakhsh, is on the board of trustees of SIO and is an advanced practice nurse who developed the CAM Healthcare Model©. Overall, there are a lot fewer quacks on this author list (one naturopath versus three, for instance) than there were on the SIO guidelines author list, which in its own way is pretty depressing because it suggests that critical thinking skills are lacking in the very highest levels of academic oncology, so much so that these august authors concluded:
The ASCO Expert Panel determined that the recommendations in the SIO guideline—published in 2017—are clear, thorough, and based on the most relevant scientific evidence. ASCO endorsed the guideline with a few added discussion points.
Basically, ASCO updated the SIO literature review (yet again). You can read ASCO’s discussion and endorsement of recommendations for yourself. ASCO’s treatment suffers from the same problems as the original SIO recommendations did. As a result, I’m not going to go into incredible detail, but I am going to touch on some highlights (or lowlights if you prefer) of the ASCO discussion. One section in particular struck me, specifically the part on the results of the ASCO updated literature review, where it was noted that 26 publications considered potentially relevant to the updated analysis were reviewed by Heather Greenlee, and nine given to the panel for further discussion.
Quality of life: Caregiver-delivered reflexology during treatment of advanced breast cancer was compared with attention control in an RCT among 256 patient–caregiver dyads. Patients in the reflexology arm experienced reductions in average symptom severity and interference over 11 weeks. There were no significant differences between study arms in functioning, social support, quality of relationship, or satisfaction with life at weeks 5 and 11.17
One notes that this trial was not blinded and basically showed that a nice placebo foot massage made patients feel a bit better. Another study cited was a worthless single-blind study of two forms of acupressure versus waitlist control. In any case, the ASCO panel concluded that the studies they found “support, and in some cases may strengthen, current recommendations.” Given how poor most of the cited studies are, this is thin gruel indeed.
In the end, ASCO basically agreed with the SIO guidelines with three caveats. For chemotherapy-induced nausea and vomiting, ASCO basically walked back the SIO recommendation for acupuncture, at least a bit:
Induced Nausea and Vomiting
These treatment modalities received a grade B recommendation in the SIO guideline, which supports the addition of either one to a standard antiemetic regimen to improve chemotherapy-induced nausea and vomiting. This varies from the 2017 ASCO antiemetic guideline, which concluded that the evidence for complementary therapies, including acupressure and acupuncture, remains insufficient for a recommendation.7 The ASCO Expert Panel noted that the two guidelines address different patient populations—the ASCO antiemetic guideline applies to all cancer types, whereas the SIO guideline focuses only on patients with breast cancer—and also discussed the low risk of adverse events from acupressure and electroacupuncture. Nevertheless, the ASCO Expert Panel favored a grade C recommendation for these therapies. As noted in the SIO guideline, several of the cited trials were conducted before current pharmacologic antiemetic regimens became available. Furthermore, trials to date have tended to be small; two of the three cited acupressure trials20-22 and one of the two cited electroacupuncture trials23,24 enrolled fewer than 40 patients.
Grade C is the weakest of the positive recommendations: “Recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences (there is at least moderate certainty that the net benefit is small—offer/provide this modality for selected patients, depending on individual circumstances).”
There were two other quibbles by ASCO. First, it wanted to highlight SIO’s grade C recommendation for ginseng for fatigue by pointing out that the efficacy and safety of ginseng extracts can vary by type of ginseng and extraction method. The panel was also concerned that some preparations of ginseng can have estrogenic properties and that it might not be the greatest idea to use them in estrogen receptor-positive breast cancer. The second is that subcutaneously injected mistletoe extract, for which the SIO gave a grade C recommendation for improving quality of life, is not FDA-approved. ASCO was also concerned that ingestion of high doses of mistletoe berry or leaf is “known to cause serious adverse reactions.”
In other words, ASCO fully endorsed the SIO guidelines with only minor quibbles.
The emerging narrative
I know what ASCO (and the SIO) would probably say in response to this. They’d think it unfair of me to characterize them as having endorsed quackery because most of what is “recommended” (to use the SIO term) in the guidelines is fairly unremarkable: exercise, lifestyle interventions, and the like, the sort of modalities that “integrative medicine” has been co-opting and rebranding as somehow “alternative or integrative” for at least a couple of decades now. While that is largely true, I argue that they don’t get a pass on recommending acupuncture, and they certainly don’t get a pass for recommending healing touch (which is “energy medicine” mystical quackery) just because they “only” gave it these modalities a grade C (or in one case, a grade B, later downgraded to grade C) recommendation. It’s as if the SIO couldn’t bear not recommending acupuncture or healing touch and bent over backwards to make sure the two modalities got at least their weakest level of recommendation.
Through it all, the utter lack of evidence found in the SIO review for so many modalities is glossed over. Here’s the table from ASCO itself:
Then there’s the narrative. Look at how the press release about the guidelines from the Fred Hutchinson Cancer Center at the University of Washington spins it:
The first time Elizabeth Johnson told her oncologist she wanted to start folding integrative therapies into her breast cancer treatment regimen as a way to alleviate side effects, he told her “Sure, you can try, but it’s not going to help.”
He also told her that the second, the third, and fourth time she asked.
“He’s no longer my oncologist,” said Johnson, a 28-year-old homemaker from Minnesota who’s a year out from diagnosis but still in treatment. “He was great in many ways but not a good fit for me. It’s really important for me to have an oncologist who has a reasonably open mind. All he knew about and apparently all he cared to learn about was chemotherapy.”
Breast cancer patients like Johnson can now tell their doctors that integrative therapies like acupuncture, meditation, massage and yoga have been endorsed by the world’s leading professional organization of cancer doctors, the American Society of Clinical Oncology, as evidence-based ways to manage symptoms and side effects of conventional breast cancer treatment.
The endorsement, published today in the Journal of Clinical Oncology, came from an expert panel that reviewed a set of clinical practice guidelines for integrative therapies put out by the 15-year-old professional organization, the Society for Integrative Oncology, or SIO.
Co-chaired by ASCO senior statesman Dr. Gary Lyman of Fred Hutchinson Cancer Research Center, the panel did not embrace each and every one of the practices recommended in the SIO’s guidelines.
But they did send a clear signal to breast cancer patients and their care teams: It’s OK to integrate.
It gets worse. The press release takes a contemptuous swipe at “skeptics,” with a section entitled “Serving patients, not skeptics.” Indeed, it’s downright insulting and built on a huge straw man. Before the straw men, however, come the “do it for the patients” line, with Lyman saying that oncologists “who scoff at these therapies should still respect their patients’ requests, record the use of any integrative therapy in their charts and encourage them to share results, particularly if they experience side effects.” No serious medical skeptic—and that includes every physician who writes for SBM—says otherwise, but Lyman makes it a point to portray us as being contemptuous of patients and their beliefs.
Then Heather Greenlee chimes in:
Naysayers tend to lump anything alternative into one big bucket, she said, while ASCO and SIO are trying to tease these therapies apart to determine which ones work and which ones don’t.
“We’re reporting on therapies that have clear biological mechanisms, where we have clinical trials showing whether they are effective or not, and whether they are safe,” she said. “We need to conduct more trials and we need to publish more guidelines. We need to get the information out there for patients and clinicians to use.”
I can’t help but burn that strawman with a bit of fire of irony. After all, it’s the promoters of “integrative medicine” who try to lump all the potentially science-based treatments, such as diet, exercise, and lifestyle interventions, with the quackery like acupuncture, energy medicine, and, yes, the vast majority naturopathy. (Again, Greenlee is a naturopath, and I’d love to know if she is willing to call homeopathy, which is an integral part of naturopathic training, quackery.) No, it is the skeptics who separate out the various parts of “integrative medicine” and examine the evidence for each of them individually. That’s why it’s not so much the SIO’s recommendations for music therapy, yoga, and exercise that bother me. It’s the conflation of these patient support measures and potentially science-based interventions with quackery based on mystical pseudoscience like acupuncture and healing touch. It’s the embrace of methods that are negatively correlated with the use of effective medicine for cancer, like chemotherapy. It’s the increasing number of NCI-CCCs embracing quackery. As for “biological mechanisms,” perhaps Greenlee can tell us how qi works or how healing touch can channel “life energy” to heal patients.
In the end, you and I both know how this spin will play out. Promoters of quackery will trumpet ASCO’s endorsement of the SIO guidelines for breast cancer with a narrative like the Hutch’s other press release, “Mozart, meditation and a yoga mat: Oncologists welcome integrative therapies for breast cancer.” Those who advocate the integration of quackery into medicine will point to the ASCO endorsement as legitimizing many of their favorite dubious or quack treatments, and, unfortunately, that’s just what ASCO did. Even Greenlee and Lyman are touting this endorsement as a major “milestone” for integrative oncology, and, sadly, I can’t argue with that. I’m sure John Weeks will be adding it to his other “milestones” to his other milestones on the path to integrating quackery with medicine. In fact, I’m surprised I couldn’t find him already crowing about this. It’s only been less than a week since this new pebble in the quackademic avalanche has fallen.