MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Samueli Institute

I recently received this unexpected and surprising email:

Dear Friend,

I wanted to point out an article that published last month in the New England Journal of Medicine Catalyst that gets to the root of why we are not solving the nation’s current epidemics of chronic pain, obesity, opioids, suicide, and cardiovascular disease.

My co-authors included Dr. Eric Schoomaker, the former surgeon general of the Army; Dr. Tracy Gaudet, who leads cultural transformation at the Veterans Health Administration; and Dr. James Marzolf, the chief health and data analyst in Dr. Gaudet’s office.

In the article Finding the Cause of the Crises: Opioids, Pain, Suicide, Obesity, and Other “Epidemics”, we show how our nation’s response to our current epidemics are tackling the wrong problems.

For example, take the opioid epidemic. The response has been to restrict opioids and focus on other drugs. This narrow approach is compounding the problem. The root cause is that we don’t manage chronic pain appropriately. We need a major roll out of non-pharmacological approaches for pain.

Instead of treating pain with a pill, we need to pay attention to the whole person in mind, body, and spirit. When we do this, we may find that non-drug approaches to treating the person are more appropriate, and treat not only the pain, but the suffering that often accompanies it.

The article describes how systems like the Military and Veterans Health Administration are doing this with transformative approaches that embrace whole person, integrative health.

The good news is that the answers are out there. The entire nation can do this, and we can start now.

Be well.

Dr. Wayne Jonas

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In case you don’t know who my ‘friend’ Wayne is (I did mention him before here and here, for instance), here is a concise summary of his background. As you doubtlessly do know, the NEJM is a (perhaps even the most) respected medical journal. I therefore tried to find the article there and was amazed not to find it. Then I realised that Wayne said it was published not in the NEJM but in the ‘New England Journal of Medicine Catalyst’, a very different proposition.

The New England Journal of Medicine Catalyst brings health care executives, clinical leaders, and clinicians together to share innovative ideas and practical applications for enhancing the value of health care delivery. From a network of top thought leaders, experts, and advisors, our digital publication, quarterly events, and qualified Insights Council provide real-life examples and actionable solutions to help organizations address urgent challenges affecting health care.

But what about the paper that Wayne so warmly recommends? It turns out to be little more than a promotional stunt for integrative medicine. Here is an excerpt from it:

It is often a surprise to people that two of the largest health care systems in the country are trying to radically redesign what they do to provide more whole-person and integrative care. These two systems are run by the Department of Defense (DoD) and the Veterans Health Administration (VHA) and collectively care for over 20 million people. The nation can learn from their efforts.

The need for reform emerged after the turn of this century when leaders in the DoD and VHA began to hold informal meetings under the title “From Healthcare to Health.” Over the course of those meetings, the participants recognized the failure of their health care systems to get at the underlying causes of chronic disease. In 2009, they secured the support of the Chairman of the Joint Chiefs of Staff to change overall military doctrine and guidance to a radically holistic approach called “Total Force Fitness,” which subsequently led to health and community innovations. An example of these redesign innovations was the Defense and Veterans’ Pain Management Task Force and Report and the resulting strategy that preceded the National Academy of Medicine’s report on pain in America.

Other innovations included the Healthy Base Initiative and the Performance Triad, the latter of which focuses on the importance of asking all patients about their sleep, nutrition, and physical activity. All services — Army, Navy, Air Force, Coast Guard, and Special Forces — continue to shift to whole-person models that seek to implement behavioral and complementary approaches. For example, >6000 providers have been trained in and routinely use Battlefield Acupuncture for pain.

The transformation currently underway in the VHA, which goes under the name “Whole Health,” is also an offshoot of that leadership dialogue from 20 years ago. In the Whole Health approach, the emphasis is to empower and equip people to take charge of their health and well-being. In this approach, trained peers help veterans explore their sense of mission and purpose, and well-being programs focus on skill-building and support for self-care. These elements, in addition to person-centered, holistic clinical care, create the Whole Health delivery system. VHA facilities are shifting from a system designed around points of clinical care (in which the primary focus is on disease management) to one that is based in a partnership across time (in which the primary focus is on whole health). Clinical encounters are essential but not sufficient. This health system is designed to focus not only on treatment, but also on self-empowerment, self-healing, and self-care.

This radical redesign is built on decades of VHA work enhancing its integrative approaches with innovations such as Patient-Aligned Care Teams, Primary Care Mental Health Integration, peer-to-peer support, group access to mental health services, and the increasing use of complementary medicine approaches. These changes laid the groundwork for the kind of radical redesign now underway in the VHA and that is needed in all national health care delivery systems.

In 2011, the VHA established an Office of Patient Centered Care and Cultural Transformation to further redefine health care delivery and to oversee this unique approach. Whole Health has begun rapid deployment across the entire VHA system, starting with 18 VHA medical centers in 2018 and with a planned expansion to all VHA medical centers by the end of 2022. System-wide implementation will require an estimated $556 million over 5 years.

When fully implemented, operating costs for this shift are projected to represent 1% of the VHA annual budget. This implementation will involve hiring almost 6,400 new staff, the majority for positions that did not previously exist in the VHA, including health coaches and peer health partners, nutritionists, acupuncturists, and yoga instructors. Whole Health is building access through group visits, peer-to-peer support, and the development of Personal Health Plans for every veteran — something everyone in the country could use. In addition, new payment codes have been created, allowing providers to capture and cover their time and efforts using relative value units (RVUs) and to track productivity.

Will Whole Health help to cure what ails health care? Current models suggest that it will. With improvement in health outcomes, there will be a reduction in the need for existing clinical and biomedical services. These models predict increased access and more proactive population health management. With the addition of these new Whole Health services, we project a 24.5% increase in access when fully deployed — without the addition of a single hospital bed or medical specialist. In addition, Whole Health exceeds cost neutrality and is conservatively estimated to return $2.19 for every dollar invested over 6 years.

These returns reflect net cost avoidance and are derived from reductions in the need and demand for existing clinical health services — exactly what the nation needs in order to reduce chronic disease crises and contain costs. The per capita savings or cost avoidance is modest, averaging $535 per veteran annually over the 6-year period. Cumulatively, however, this totals over $6.2 billion in cost avoidance. Given that the Whole Health approach will improve the health of veterans, many of whom are dealing with complex issues such as chronic pain, mental health conditions, and opioid use at a cost of about $1 per day per veteran, it is a financially sound, cost-effective change from the current health care paradigm.

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So, does this change my mind about integrative medicine?

I’m afraid not! And Wayne fails to provide the slightest evidence that his concepts amount to more than wishful thinking (note how he first mentions predictions of cost savings and, in the next paragraph, pretends they are a reality). I simply do not believe that adding a few unproven therapies to our routine healthcare and wrapping the mixture into politically correct platitudes will improve anything. This cannot work from a theoretical standpoint and, crucially, there is no empirical evidence that it does improve anything else but the income stream of charlatans.

If healthcare needs reform, then let’s reform it! Adding cow pie to apple pie is not a solution, it merely spoils what we have already. I am saying this now since 17 years when I published my first comment on integrative medicine. It was entitled Integrative medicine: not a carte blanche for untested nonsense. I do still think that it sums up the issue succinctly.

A few days ago, the German TV ‘FACT’ broadcast a film (it is in German, the bit on homeopathy starts at ~min 20) about a young woman who had her breast cancer first operated but then decided to forfeit subsequent conventional treatments. Instead she chose homeopathy which she received from Dr Jens Wurster at the ‘Clinica Sta Croce‘ in Lucano/Switzerland.

Elsewhere Dr Wurster stated this: Contrary to chemotherapy and radiation, we offer a therapy with homeopathy that supports the patient’s immune system. The basic approach of orthodox medicine is to consider the tumor as a local disease and to treat it aggressively, what leads to a weakening of the immune system. However, when analyzing all studies on cured cancer cases it becomes evident that the immune system is always the decisive factor. When the immune system is enabled to recognize tumor cells, it will also be able to combat them… When homeopathic treatment is successful in rebuilding the immune system and reestablishing the basic regulation of the organism then tumors can disappear again. I’ve treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases.

The recent TV programme showed a doctor at this establishment confirming that homeopathy alone can cure cancer. Dr Wurster (who currently seems to be a star amongst European homeopaths) is seen lecturing at the 2017 World Congress of Homeopathic Physicians in Leipzig and stating that a ‘particularly rigorous study’ conducted by conventional scientists (the senior author is Harald Walach!, hardly a conventional scientist in my book) proved homeopathy to be effective for cancer. Specifically, he stated that this study showed that ‘homeopathy offers a great advantage in terms of quality of life even for patients suffering from advanced cancers’.

This study did, of course, interest me. So, I located it and had a look. Here is the abstract:

BACKGROUND:

Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.

METHODS:

We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS).

RESULTS:

HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 – SD 8.9) to t1 (32.1 – SD 8.9) and declined again after a year (31.6 – SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study.

CONCLUSION:

In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.

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Even the abstract makes several points very clear, and the full text confirms further embarrassing details:

  • The patients in this study received homeopathy in addition to standard care (the patient shown in the film only had homeopathy until it was too late, and she subsequently died, aged 33).
  • The study compared A+B with B alone (A=homeopathy, B= standard care). It is hardly surprising that the additional attention of A leads to an improvement in quality of life. It is arguably even unethical to conduct a clinical trial to demonstrate such an obvious outcome.
  • The authors of this paper caution that it is not possible to conclude that a causal relationship between homeopathy and the outcome exists.
  • This is true not just because of the small sample size, but also because of the fact that the two groups had not been allocated randomly and therefore are bound to differ in a whole host of variables that have not or cannot be measured.
  • Harald Walach, the senior author of this paper, held a position which was funded by Heel, Baden-Baden, one of Germany’s largest manufacturer of homeopathics.
  • The H.W.& J.Hector Foundation, Germany, and the Samueli Institute, provided the funding for this study.

In the film, one of the co-authors of this paper, the oncologist HH Bartsch from Freiburg, states that Dr Wurster’s interpretation of this study is ‘dishonest’.

I am inclined to agree.

The aim of this three-armed, parallel, randomized exploratory study was to determine, if two types of acupuncture (auricular acupuncture [AA] and traditional Chinese acupuncture [TCA]) were feasible and more effective than usual care (UC) alone for TBI–related headache. The subjects were previously deployed Service members (18–69 years old) with mild-to-moderate TBI and headaches. The interventions explored were UC alone or with the addition of AA or TCA. The primary outcome was the Headache Impact Test (HIT). Secondary outcomes were the Numerical Rating Scale (NRS), Pittsburgh Sleep Quality Index, Post-Traumatic Stress Checklist, Symptom Checklist-90-R, Medical Outcome Study Quality of Life (QoL), Beck Depression Inventory, State-Trait Anxiety Inventory, the Automated Neuropsychological Assessment Metrics, and expectancy of outcome and acupuncture efficacy.

Mean HIT scores decreased in the AA and TCA groups but increased slightly in the UC-only group from baseline to week 6 [AA, −10.2% (−6.4 points); TCA, −4.6% (−2.9 points); UC, +0.8% (+0.6 points)]. Both acupuncture groups had sizable decreases in NRS (Pain Best), compared to UC (TCA versus UC: P = 0.0008, d = 1.70; AA versus UC: P = 0.0127, d = 1.6). No statistically significant results were found for any other secondary outcome measures.

The authors concluded that both AA and TCA improved headache-related QoL more than UC did in Service members with TBI.

The stated aim of this study (to determine whether AA or TCA both with UC are more effective than UC alone) does not make sense and should therefore never have passed ethics review, in my view. The RCT followed a design which essentially is the much-lamented ‘A+B versus B’ protocol (except that a further groups ‘C+B’ was added). The nature of such designs is that there is no control for placebo effects, the extra time and attention, etc. Therefore, such studies cannot fail but generate positive results, even if the tested intervention is a placebo. In such trials, it is impossible to attribute any outcome to the experimental treatment. This means that the positive results are known before the first patient has been enrolled; hence they are an unethical waste of resources which can only serve one purpose: to mislead us. It also means that the conclusions drawn above are not correct.

An alternative and in my view more accurate conclusion would be this one: both AA and TCA had probably no effect; the improved headache-related QoL was due to the additional attention and expectation in the two experimental groups and is unrelated to the interventions tested in this study.

In our new book, MORE HARM THAN GOOD, we discuss that such trials are deceptive to the point of being unethical. Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

As with any gift, one ought to ask what precisely it is for. If someone made a donation to research aimed at showing that climate change is a hoax, that white supremacy is justified, or that Brexit is going to give Brits their country back, I doubt that it would be a commendable thing. My point is that research must always be aimed at finding the truth and discovering facts. Research that is guided by creed, belief or misinformation is bound to be counter-productive, and a donation to such activities is likely to be detrimental.

Back to the Samuelis! The story goes that Susan once had a cold, took a homeopathic remedy, and subsequently the cold went away. Ever since, the two Samuelis have been supporters not just of homeopathy but all sorts of other alternative therapies. I have previously called this strikingly common phenomenon an ‘epiphany‘. And the Samuelis’ latest gift is clearly aimed at promoting alternative medicine in the US. We only need to look at what their other major donation in this area has achieved, and we can guess what is now going to happen at UCI. David Gorski has eloquently written about the UCI donation, and I will therefore not repeat the whole, sad story.

Instead I want to briefly comment on what, in my view, should happen, if a wealthy benefactor donates a large sum of money to medical research. How can one maximise the effects of such a donation? Which areas of research should one consider? I think the concept of prior probability can be put to good use in such a situation. If I were the donor, I would convene a panel of recognised experts and let them advise me where there are the greatest chances of generating important breakthroughs. If one followed this path, alternative medicine would not appear anywhere near the top preferences, I dare to predict.

But often, like in the case of the Samuelis, the donors have concrete ideas about the area of research they want to invest in. So, what could be done with a large sum in the field of alternative medicine? I believe that plenty of good could come it. All one needs to do is to make absolutely sure that a few safeguards are in place:

  • believers in alternative medicine must be kept out of any decisions processes;
  • people with a solid background in science and a track-record in critical thinking must be put in charge;
  • the influence of the donor on the direction of the research must be minimised as much as possible;
  • a research agenda must be defined that is meaningful and productive (this could include research into the risks of alternative therapies, the ethical standards in alternative medicine, the fallacious thinking of promoters of alternative medicine, the educational deficits of alternative practitioners, the wide-spread misinformation of the public about alternative medicine, etc., etc.)

Under all circumstances, one needs to avoid that the many pseudo-scientists who populate the field of alternative or integrative medicine get appointed. This, I fear, will not be an easy task. They will say that one needs experts who know all about the subtleties of acupuncture, homeopathy, energy-healing etc. But such notions are merely smoke-screens aimed at getting the believers into key positions. My advice is to vet all candidates using my concept of the ‘trustworthiness index’.

How can I be so sure? Because I have been there, and I have seen it all. I have researched this area for 25 years and published more about it than any of the untrustworthy believers. During this time I trained about 90 co-workers, and I have witnessed one thing over and over again: someone who starts out as a believer, will hardly ever become a decent scientist and therefore never produce any worthwhile research; but a good scientist will always be able to acquire the necessary knowledge in this or that alternative therapy to conduct rigorous and meaningful research.

So, how should the UCI spend the $ 200 million? Apparently the bulk of the money will be to appoint 15 faculty chairs across medicine, nursing, pharmacy and population health disciplines. They envisage that these posts will go to people with expertise in integrative medicine. This sounds extremely ominous to me. If this project is to be successful, these posts should go to scientists who are sceptical about alternative medicine and their main remit should be to rigorously test hypotheses. Remember: testing a hypothesis means trying everything to show that it is wrong. Only when all attempts to do so have failed can one assume that perhaps the hypothesis was correct.

My experience tells me that experts in integrative medicine are quite simply intellectually and emotionally incapable of making serious attempts showing that their beliefs are wrong. If the UCI does, in fact, appoint people with expertise in integrative medicine, it is, I fear, unavoidable that we will see:

  • research that fails to address relevant questions;
  • research that is of low quality;
  • promotion masquerading as research;
  • more and more misleading findings of the type we regularly discuss on this blog;
  • a further boost of the fallacious concept of integrative medicine;
  • a watering down of evidence-based medicine;
  • irreversible damage to the reputation of the UCI.

In a nutshell, instead of making progress, we will take decisive steps back towards the dark ages.

The ‘Samueli Institute’ might be known to many readers of this blog; it is a wealthy institution that is almost entirely dedicated to promoting the more implausible fringe of alternative medicine. The official aim is “to create a flourishing society through the scientific exploration of wellness and whole-person healing“. Much of its activity seems to be focused on military medical research. Its co-workers include Harald Walach who recently was awarded a rare distinction for his relentless efforts in introducing esoteric pseudo-science into academia.

Now researchers from the Californian branch of the Samueli Institute have published an articles whic, in my view, is another landmark in nonsense.

Jain and colleagues conducted a randomized controlled trial to determine whether Healing Touch with Guided Imagery [HT+GI] reduced post-traumatic stress disorder (PTSD) compared to treatment as usual (TAU) in “returning combat-exposed active duty military with significant PTSD symptoms“. HT is a popular form of para-normal healing where the therapist channels “energy” into the patient’s body; GI is a self-hypnotic from of relaxation-therapy. While the latter approach might be seen as plausible and, at least to some degree, evidence-based, the former cannot.

123 soldiers were randomized to 6 sessions of HT+GI, while the control group had no such therapies. All patients also received standard conventional therapies, and the treatment period was three weeks. The results showed significant reductions in PTSD symptoms as well as depression for HT+GI compared to controls. HT+GI also showed significant improvements in mental quality of life and cynicism.

The authors concluded that HT+GI resulted in a clinically significant reduction in PTSD and related symptoms, and that further investigations of biofield therapies for mitigating PTSD in military populations are warranted.

The Samueli Institute claims to “support science grounded in observation, investigation, and analysis, and [to have] the courage to ask challenging questions within a framework of systematic, high-quality, research methods and the peer-review process“. I do not think that the above-named paper lives up to these standards.

As discussed in some detail in a previous post, this type of study-design is next to useless for determining whether any intervention does any good at all: A+B is always more than B alone! Moreover, if we test HT+GI as a package, how can we conclude about the effectiveness of one of the two interventions? Thus this trial tells us next to nothing about the effectiveness of HT, nor about the effectiveness of HT+GI.

Previously, I have argued that conducting a trial for which the result is already clear before the first patient has been recruited, is not ethical. Samueli Institute, however, claims that it “acts with the highest respect for the public it serves by ensuring transparency, responsible management and ethical practices from discovery to policy and application“. Am I the only one who senses a contradiction here?

Perhaps other research in this area might be more informative? Even the most superficial Medline-search brings to light a flurry of articles on HT and other biofield therapies that are relevant.

Several trials have indeed produces promissing evidence suggesting positive effects of such treatments on anxiety and other symptoms. But the data are far from uniform, and most investigations are wide open to bias. The more rigorous studies seem to suggest that these interventions are not effective beyond placebo. Our review demonstrated that “the evidence is insufficient” to suggest that reiki, another biofield therapy, is an effective treatment for any condition.

Another study showed that tactile touch led to significantly lower levels of anxiety. Conventional massage may even be better than HT, according to some trials. The conclusion from this body of evidence is, I think, fairly obvious: touch can be helpful (most clinicians knew that anyway) but this has nothing to do with energy, biofields, healing energy or any of the other implausible assumptions these treatments are based on.

I therefore disagree with the authors’ conclusion that “further investigation into biofield therapies… is warranted“. If we really want to help patients, let’s find out more about the benefits of touch and let’s not mislead the public about some mystical energies and implausible quackery. And if we truly want to improve heath care, as the Samueli Institute claims, let’s use our limited resources for research which meaningfully contributes to our knowledge.

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