Integrative oncology is but a smokescreen for quacks – Edzard Ernst
Has mindfulness-based stress reduction (MBSR) treatment become the equivalent of a “gateway drug” in cancer patients who go on to access a full range of unproven and disproven cancer treatments? I discuss this possibility in this edition of Quick Thoughts.
Here’s my argument:
- Mindfulness-based stress reduction (MBSR) is widely promoted as a nonpharmacological “wonder drug” changing the brain and improving immune function.
- Belief in the power of MBSR over cancer has replaced discredited beliefs about psychotherapy and support groups bringing the power of the mind to bear in “fighting” cancer.
- MBSR groups are now offered through newly renamed “integrative cancer centers” which offer a full range of unproven and discredited treatments.
- The seeming scientific status of health claims of MBSR lends support to the claims of integrative cancer centers that they have a modern scientific basis for treatments developed on the basis of traditional Chinese medicine.
- Patients’ acceptance of exaggerated claims about the science behind MBSR leads to false confidence in other claims of integrative cancer centers that unproven treatments are actually evidence-based.
- Once engaged at integrative cancer centers, women with advanced breast cancer are particularly likely receive a full range of services, which can consume time and money, but also delay or become alternatives to proven treatments.
- MBSR can thus be a nonpharmacological “gateway drug” into an alternative pathway of cancer care in which unproven treatments are adopted by patients and even come to replace conventional, proven medicine.
Who can remain skeptical about the powers of MBSR?
It is difficult for even educated nonspecialists to evaluate claims of seeming experts that MBSR uniquely changes the brain and improves the immune system.
Studies claiming to correlate changes in brain functioning and structure with practicing MBSR get lots of uncritical media attention. When the studies are given a closer look, they are typically too small to warrant the strength of the claims that they are making, often don’t replicate, and don’t establish that any correlates are specific to MBSR, rather than also found with other experiences. Consumers need to keep in mind that all experiences change the brain, and that finding such correlates usually have unclear significance, even when they can be replicated.
Claims that MBSR influences the immune system come from a body of particularly weak and inconsistent findings with unknown, if any medical significance. I’ll be devoting a future edition of Mind the Brain to a skeptical look at the literature concerning effects of MBSR on the immune functioning of cancer patients. Suffice to say for now, these same claims were until recently made for support and psychotherapy groups. They were discredited not only because of a lack of consistent effects on immune functioning, but a lack of evidence that such groups affect the course or outcome of cancer. Effects of support groups on the immune system had been a presumed mediator, but it is no use pursuing a mediator of an effect if there is no effect to explain.
It is unlikely that endocrinologists or oncologists would be impressed by the findings of these studies of the MBSR or support groups. They would likely be especially skeptical of the plausibility of the medical claims that are being made. The role of the immune system in cancer is poorly understood and complex, but far beyond the simplistic models taken for granted in psychoneuroimunological studies.
The rise and fall of psychotherapy and support groups as a means of mind control over cancer
The claim that psychotherapy and support groups could improve the outcome of cancer garnered excitement and scientific credibility with a small 1989 study in The Lancet by David Speigel. I have critiqued that study thoroughly elsewhere. I showed that the study was not designed nor powered for observing an effect on survival and claims made about its results depend on statistical flaws. Although Spiegel has persisted in his claims, no one could replicate his earlier study, in larger, methodologically superior studies – not even Spiegel. There is a lack of evidence that psychotherapy or support groups can extend the lives or influence the course of cancer.
Perhaps the absence of evidence for an effect of psychotherapy and support groups does not establish the absence of an effect, but the evidence is quite consistent and there is a lack of evidence supporting any plausible mechanism. Large-scale epidemiologic studies suggest that any apparent association between psychological factors and incidence and outcome of cancer is small enough to be within the range to be attributable to uncontrolled confounds and certainly not of clinical significance.
Support groups can be recommended to cancer patients for the opportunity to express their feelings, receive validation and support from others, and be of help to others. They are valued and satisfying experiences for many patients. However, a key difficulty that support groups reduce distress demonstrating in clinical trials is that most patients attending them do not have clinically significant distress . Floor effects are consistently observed, whereby the modest elevations of psychological distress of the bulk of patients recruited to clinical trials preclude there been any demonstration that support groups reduce psychological distress. There has been a move in the psycho-oncology literature to set clinically significant distress one of the entry criteria for enrollment in clinical trials of psychosocial interventions. However, it takes considerable effort to recruit an adequate sample size because many patients who have appropriate levels of psychological distress are already receiving services and not interested in obtaining any more more. Others want to deal on their with what they understand as normal reaction. Setting heightened distress as a requirement for enrolling in a clinical trial of psychological interventions also means that the resulting sample will not be representative of the larger population of cancer patients from which they were drawn.
At the height of enthusiasm for medical benefits of support groups, many cancer patients attended them because they believed that they were getting medical, as well as psychological benefits. Eventually the American Cancer Society had to issue a statement about the lack of evidence of any medical benefits.
The research is clear that support groups can affect quality of life, but the available scientific evidence does not support the idea that support groups or other forms of mental health therapy can by themselves help people with cancer live longer.
Support groups are out of fashion, MBSR is in
MBSR is tremendously popular in non-patient populations. When informed of a cancer diagnosis, patients may view MBSR as a tool with which they already have experience or are familiar. Furthermore, surveys find that cancer patients believe that stress is an important cause of both the onset of cancer and recurrence. Thus, MBSR is readily acceptable as a familiar tool with added benefits in overcoming cancer as a physical disease, not just a psychological threat. The problem is, of course, the lack of evidence for such role of psychological factors, as well as the implausibility of mechanisms by which psychological intervention might conceivably influence disease processes.
As seen in billboard and TV advertising campaigns, providing care for cancer is a lucrative and competitive business even among non-for-profit cancer centers. There is seldom evidence for the claims made in advertising campaigns that particular cancer center gets better outcomes. But advertisements typically back up the claims with carefully chosen emotional patient testimonials about the outcomes they received.
Reputations for providing better care than rival centers attracts not only patient volume, but donor contributions. Most large cancer centers have fund raising departments , which routinely document the wealth of patients and the extent of effort that would be justified in obtaining a donation. I once worked at cancer center that had a large yacht bequeathed to it, which was kept and used to entertain potential donors of known wealth. There was also a fund for female oncologists to buy expensive fashionable clothes in order to make a pitch for funds at charitable events.
Cancer centers have established fees with hefty administrative costs by which donors can attach their name to the bench in the waiting area for tens of thousands of dollars or millions for naming a whole cancer center.
Effective marketing requires the cancer centers advertise that they treat the whole person, not just the tumor. Wealthy donors often specify that particular amenities be available. For instance, at the cancer center where I worked, a donor had insisted that friendly greeters welcome arriving cancer patients, just had been done for her at a world-renowned spa where she went for recuperation.
A name change: from complementary and alternative medicine to integrative medicine centers
Such amenities and services requested by donors become available for all patients and can improve their treatment experiences. But in the past decade, many cancer centers found competitive advantage in offering a full range of unproven and disproven alternative treatments. Sometimes donors specifically requested that such services be established. The availability of complementary alternative medicine (CAM) became a selling point. But then, a name change was required. As the pseudonymous cancer surgeon blogger Orac noted:
It was not long before the problem with the term CAM became apparent. It had the word “complementary” in it. The implication of that word, of course, is that what they were doing was still somehow not real medicine. It was complementary to real medicine, the icing on the cake, if you will. Real medicine could do without it, and having that implication in the very name that their evolving specialty had taken on was offensive to the quacks.
So they changed it.
Thus was born “integrative medicine.”
Breast Cancer Integrative Oncology Care and Its Costs
A recent article in Integrative Cancer Therapies documented the cost of integrative cancer care and contained some surprising revelations:
Standish LJ, Dowd F, Sweet E, Dale L, Weaver M, Osborne B, Andersen MR. Breast Cancer Integrative Oncology Care and Its Costs. Integrative Cancer Therapies. 2016 May 26:1534735416649034.
More and more people diagnosed with cancer are choosing to supplement their conventional oncology treatment with complementary care provided by licensed complementary and alternative medicine (CAM) providers, including doctors of osteopathy, doctors of traditional Chinese medicine (TCM), and oncology board certified naturopathic oncologists (Fellows of the American Board of Naturopathic Oncology or FABNOs; http://www.fabno.org/), some of whom are co-licensed as acupuncturists. This growing field of medicine is increasingly being referred to as integrative oncology (IO). ND, FABNO consultations and some procedures are reimbursed by medical insurance companies in some states in the United States.
The article reported results of a study of 324 women who
Sought care at 1 of 6 naturopathic oncology clinics in Washington State were asked to enroll in a prospective 5 year observational outcomes study.
More than 72 oral or topical, nutritional, botanical, fungal and bacterial-based medicines were prescribed to the cohort during their first year of IO care. Trametes versicolor was prescribed to 63% of the women. Mind-body therapy was recommended to 45% of patients, and 49% received acupuncture. Also, 26% were prescribed injectable therapy, including mistletoe, vitamin B complex (12%), IV ascorbate (12%), IV artesunate (7%), and IV nutrition and hydration (4%). Costs ranged from $1594/year for early-stage breast cancer to $6200/year for stage 4 breast cancer patients. Of the total amount billed for IO care for 1 year for breast cancer patients, 21% was out-of-pocket.
A comprehensive protocol for stage 4 breast cancer includes IV nutrients and botanicals plus oral and topical natural medicine and costs approximately $32 000/year.
The article describes these services as all “evidence-based” but if they were evidence-based, they would be conventional, not complementary and alternative medicine.
Is MBSR the gateway drug to quack treatments?
Confrontation with a diagnosis of cancer, particularly when it is advanced and life-threatening, often leads to a search for information that inevitably includes unproven treatments. Patient’s susceptibility to misleading information is increased by the offering of unproven treatments and their labeling as “evidence-based” by prestigious cancer centers associated with medical schools lends credibility to unwarranted claims.
Almost half of the patients going to integrative medicine centers receive mind-body therapies, and undoubtedly MBSR figures prominently. MBSR is familiar, widely promoted as evidence-based, and use of it is consistent with patient believes about the role of stress in cancer. The acceptance of unwarranted claims of MBSR can be a step on the path of accepting claims of unproven and quack treatments as being evidence-based. In that sense, MBSR is the gateway drug for cancer patients to quack treatment.
What is our responsibility to patients?
There are always ethical issues with exaggerating the effectiveness of treatments or their evidence base for particular claims. But with vulnerable and often desperate cancer patients, ethical responsibilities become more pronounced. It’s incumbent on promoters of MBSR as a cure for all that ails should be clear about something: that effects of MBSR on the immune system and the course and outcome of cancer are not established. Further, there is no plausible biological mechanisms by which such effects would occur. Just as acknowledgment is now being done for support groups, it should be done for MBSR, particularly because of its likely place as a step on the way to unproven and quack treatments.