EMPowered to Kill

Mentally ill killer tried vitamin therapy, court told


A man with schizophrenia killed his father and gravely injured his mother at their home in North Vancouver, British Columbia. Jordan Ramsay was off his prescribed antipsychotic medication at the time, instead taking an alternative multivitamin preparation called Truehope EMPowerplus™. He believed his parents were aliens and felt compelled to kill them. Ironically, Wendy and Donald Ramsay were in favor of their son's Truehope treatment. But Jordan Ramsay's paternal aunt and grandmother disagreed strongly with this decision:

Leeann Ramsay, the aunt of the accused, believes the family's attempt to control his illness with an alternative therapy rather than his psychiatrist's prescription had a role in his state of mind at the time of the killing.

. . .

...just two days before the murder, a North Vancouver nurse reported, "His mother stated she wanted him on Empower Plus vitamins, and she believed she had permission to reduce his medication."

Leeann Ramsay told CBC News that Jordan's grandmother had serious concerns about the alternative treatment as well.

"My mom had various conversations with them about Jordan weaning off his anti-psychotics and trying this alternative megavitamin therapy, and my mom was very much against it."

Furthermore, Leeann Ramsay wants to launch an investigation into whether EMPowerplus™ played any role in her brother's death, subverting the antipsychiatry paradigm of blaming psychotropic medications for suicides and homicides.

Truehope EMPowerplus™ is no stranger to controversy. In June 2003 Health Canada advised Canadians not to use Empowerplus, and in July 2003 they executed a search warrant to seize imports from the US. The supplement was being marketed to treat bipolar disorder, anxiety, panic attacks, ADHD, schizophrenia, autism, Tourette’s syndrome, fibromyalgia, and OCD without a doctor's supervision and without an approved Drug Identification Number (DIN).

Our main concern deals with the unproven health claims being made about Empowerplus, and the recommendation that patients decrease the dose of, or eliminate altogether, medications prescribed by their doctors. This can result in serious adverse health consequences.

But no matter. The company continues to make false claims. For starters, the current title of the product webpage is still "Depression symptoms reduced or eleminated [sic] by taking EMPowerplus".


But what is EMPowerplus™ exactly? Truehope says it's A Revolutionary Micronutrient Formula...

...proven effective in reducing or eliminating the symptoms of bipolar, anxiety, depression, and ADHD. 16 medical journal publications, plus many individual doctors’ observations, have shown significant reductions in the symptoms of bipolar and other mental disorders.

That's interesting. ONE formulation to treat all of these disorders? Typically, the antidepressants and stimulants used to treat anxiety/depression and ADHD (respectively) are not recommended for bipolar disorder because of the risk of triggering a manic episode. The premise of the Truehope treatment strategy is that a "chemical imbalance" causes all mental illnesses:

The most common explanation for mental disorders is a chemical imbalance in the brain, but how and why these imbalances happen is not yet known. Since a complex web of nutrients, such as zinc, vitamin B6, and vitamin B12, are the building blocks that the brain needs to make the right amounts of important chemicals such as neurotransmitters, it makes sense that a lack of these nutrients could cause the chemical imbalances of mental illnes. [sic]

The thing that I find so fascinating is the simultaneous reliance on a simplistic "chemical imbalance" theory of mental illness and an opposition to traditional pharmaceuticals originally purported to correct those chemical imbalances. This theory has been panned by critics of biological psychiatry and has even fallen out of favor among neuroscientists conducting both basic and clinical research.

However, there is no doubt that vitamin deficiencies can produce neurological and psychiatric disturbances. For instance, a lack of B12 can damage the central nervous system via changes in cytokine and growth factor production (Scalabrino, 2009). Thiamine deficiency is well-known for causing Wernicke's encephalopathy and Korsakoff's syndrome, disorders characterized by severe memory impairments. Previous studies have suggested that vitamins and minerals do have an effect on mood and perhaps even antisocial behavior Kaplan et al., 2007; Bohannon, 2009). The question here is whether broad-spectrum micronutrient treatments (i.e., nutritional supplements) can improve or "cure" bipolar disorder.

Truehope lists 17 published studies on the effectiveness of EMPowerplus™ in treating bipolar, ADHD, autism, and OCD. However, none of these studies is a randomized controlled trial that compares placebo to EMPowerplus™ in a double-blind fashion. Thus, it cannot be established that any improvements are due to the supplement, rather than to expectation or placebo effects.

In one study, Gately and Kaplan (2009) presented results from 358 self-identified bipolar individuals (120 men, 238 women)¹ who purchased EMPowerplus™ from the Truehope website and subsequently filled out a symptom reporting checklist using the company's Self-Monitoring Form.² The diagnosis of bipolar disorder was not confirmed by a mental health professional. We don't know how many have bipolar I vs. bipolar II vs. cyclothymia. Here's a description of how the sample was selected:

There were 682 participants who reported having been diagnosed with bipolar disorder: 378 with no other disorders, 17 with both depression and bipolar disorder,³ and 287 with bipolar disorder as well as additional diagnoses such as ADHD, OCD, anxiety-panic, or schizophrenia. The conservative selection of just the 395 reporting bipolar disorder but no additional disorder except for the 17 also reporting depression was an attempt to reduce the heterogeneity of the sample.

Although physician confirmation of diagnosis was not available, 81% of the sample were taking psychiatric medications at the time they commenced taking the micronutrients, indicating that a physician considered their mood symptoms to be sufficiently severe to warrant medication.

If you're going to ultimately claim that a treatment reduces the symptom severity of an illness, you'd better confirm the clinical diagnosis of that illness (and the presence or absence of any co-morbidities). Of the 358 participants in the primary sample, only 136 were taking a mood stabilizer (e.g., lithium or divalproex sodium), the first-line treatment for bipolar. 145 were taking antidepressants, 75 were on antipsychotics, and 57 on anxiolytics. In addition, reliance on a totally self-selected sample of people who wanted to try an alternative micronutrient treatment is suspect.

Dr. John Grohol made similar points about deficiencies in study design and outcome reporting in a post at PsychCentral:

Some of the published research comes from researchers who have used the company’s own data collection routines through a “Self-Monitoring Form” that’s filled out by customers of the product (a form whose psychometric properties we know nothing of). The majority of customers stop filling out the form after two weeks, however (Rucklidge et al., 2010), suggesting they’ve either stopped using the product or stopped enjoying any positive effects from it.

In the aforementioned study, 120 families (out 709) agreed to monitor symptoms of their children who were taking EMPowerplus over 6 months’ time. Naturally, the researchers found a positive effect for the supplement — a 46% decrease in mean bipolar symptom severity scores at LOCF and a 40% decrease in ADHD symptoms.

But what’s that LOCF thing? Well, it’s a technique called Last Observation Carried Forward that researchers use that carries forward drop-out scores as though they had completed the entire study (in this case, observation of scores over 6 months’ time). In this study, only 49 percent of the participants kept providing the researchers data at 6 months — meaning the majority of them dropped out of the study before the 6 months were up!

LOCF is generally frowned upon in good research unless there’s a very good rationale for its use. Why? Because research conducted on the effects of LOCF shows that this method gives a biased estimate of the treatment effect while underestimating the variability of the result. In other words, it stacks the deck to demonstrate a treatment’s effectiveness — even when the treatment might not be effective. It’s a research slight of hand.

Retention in the Gately and Kaplan study at the 3 month time point was actually quite high (349 out of 358), but this had dropped to 242 at 6 months. What happened to the other 107 participants? Did they feel worse (i.e., depressed) and decide to stop the supplement, or did they just get tired of filling out the checklist? OR did they get worse in an objective sense (i.e., hypo/manic) and decide they were cured?

One troubling (but not unexpected) aspect of the symptom reporting data is the variability of days that were reported: 15% of the 358 participants reported between 60-90 days of the 180 days, 22% between 91-120 days, 21% between 121-150 days, and 42% reported 150 of the 180 days. A related concern is the failure to include specific symptoms or adverse reactions. The words "hypomanic" and "manic" and "psychotic" do not appear in the text. Furthermore, individuals in those states often lack insight into their mental status and may even feel better than ever (in the case of hypomania).

The table below shows that many participants decreased their dose of psychotropic medication or went off their drugs entirely (just like Jordan Ramsay). In fact, this is generally encouraged by the non-medically trained sales staff, called "Truehope Assistants".

- click on image for a larger view -

Sandra Kiume, blogger at Channel N, made these observations about the dangerous lack of medical monitoring:

When you attempt to purchase the product you are forced to sign a terms of agreement that includes:

“Some of the medications I’m currently taking or have taken (if any) may require that I take extra care when starting the EMPowerplus nutrient program and I agree to follow the guidelines of the program as suggested by my Truehope Assistant.”

A Truehope Assistant is essentially a sales rep for the company. They are not mental health professionals. However, based on your checking a box when you order that states “I am taking or have recently taken medication for sleep or a mood disorder,” they advise you to discontinue taking all psych medications before taking Truehope. Why? If it were really a safe nutritional supplement, there wouldn’t be any interaction, and if it’s not, they don’t say what’s in their proprietary formula so we don’t know what’s in it that might pose a risk. Either way, advising people to discontinue medication – without a professional assessment or medical supervision – is a dangerous ploy. To me, this what’s most disturbing about Truehope, even more than their marketing techniques and lack of rigorous research.

In calls to the Truehope sales team, Dr. Terry Polevoy used scripted scenarios to solicit advice about various ailments. It makes for interesting reading (pdf) and listening (mp3). In one scenario, the caller presents with a recent diagnosis of bipolar disorder, and inquires about the product:

. . .

Caller: and if I start the Empower and I still feel good do I stop my lithium, or…?

Truehope: Ok generally what will happen is that after you start on the Empower it gets into your body and it starts to repair that chemical imbalance a little bit at a time. And each time it repairs a little bit your body’s going to go through an adverse drug reaction and you’re going to need just a little bit less medication. And that will continue happening until you wean off all your medication

Caller: I see so there’s really no risk if I stop taking the lithium.

Truehope: Um, we never recommend that you stop your medication before Empower has a chance to get into your system and before your body’s ready. And we always recommend just very slight gradual reduction over a period of anywhere between a month, two months and some people even longer than that.to come off the medication.

And this is done without medical supervision. Later in the conversation, the Truehope Assistant recommends inositol, which can trigger manic episodes (see Levine et al., 1996) at the suggested dose of 6000 mg/day (Red Bull contains 50 mg, to compare):

Truehope: We also, just for your information, we also carry a product called inositol powder and what that is it’s one specific component of the B complex family and what it does is it gives a gentle calming effect over the body. We found it extremely beneficial in helping with anxiety, irritability, withdrawal from coming off of medication, as well as many people have told me they actually find it a lot of help when they are first starting off on Empower just cause it gives them a little bit of a benefit there when they first start off.

Nonetheless, many satisfied customers have provided testimonials on the supplement's effectiveness and how it has improved their lives. These appear not only on the company's website but on numerous blog posts covering the product. The positive comments even appear on the Gately and Kaplan (2009) paper, which is open access and can be read by all.

But testimonials are not the same as double-blind, placebo controlled studies. EMPowerplus™ believers and skeptics alike might ask if there are any ongoing clinical trials. Well there was one registered in the ClinicalTrials.gov database, but Study NCT00109577 has been terminated.

Footnotes

¹ Already we can see this sample is not representative of the general population with bipolar disorder, because women are overrepresented. Bipolar is equally prevalent in men and women, but in this study women outnumber the men 2:1. Also, these participants had the financial means to purchase their own supply of EMPowerplus™ ($150 for one month). This likely rules out many individuals who are unable to work because of the severity of their illness.

² From the Methods:

...people wanting to take [EMPowerplus™] for amelioration of psychiatric or neurologic symptoms are encouraged to use a checklist to monitor their progress, usually using symptoms specified in the DSM-IV. The Self-Monitoring Form which forms the basis of the current analyses consists of 16 DSM-specified mood symptoms (e.g. loss of interest in hobbies or activities; an excessively high or elated mood). Clients were asked to rate each symptom from 0 (not at all) to 3 (very much), for a maximum score of 48. Use of the Self-Monitoring Form is voluntary, and not all of the company’s clients choose to use it.

³ The diagnosis of bipolar disorder requires both depressive and hypo/manic symptoms, so saying you have both depression and bipolar is redundant.

⁴ aka the Synergy Group of Canada. The founders said, "We have named this work “TRUEHOPE” because we believe true hope can only be found in the healing sustenance God offers. No man, company, or scientist can ever replicate or replace that which our Creator provides."


References

Bohannon J (2009). Psychology. The theory? Diet causes violence. The lab? Prison. Science, 325 (5948), 1614-6. PMID: 19779166

Gately D, Kaplan BJ (2009). Database Analysis of Adults with Bipolar Disorder Consuming a Micronutrient Formula. Clinical Medicine: Psychiatry, 2, 3-16. Link

Kaplan BJ, Crawford SG, Field CJ, & Simpson JS (2007). Vitamins, minerals, and mood. Psychological bulletin, 133 (5), 747-60. PMID: 17723028

Levine J, Witztum E, Greenberg BD, Barak Y. (1996). Inositol-induced mania? Am J Psychiatry 153:839.

Rucklidge JJ, Gately D, Kaplan BJ. (2010). Database analysis of children and adolescents with bipolar disorder consuming a micronutrient formula. BMC Psychiatry 10:74.

Scalabrino G. (2009). The multi-faceted basis of vitamin B12 (cobalamin) neurotrophism in adult central nervous system: Lessons learned from its deficiency. Prog Neurobiol. 88:203-20.


Additional Reading - from CIRCARE (Citizens For Responsible Care and Research Inc.):

EmpowerPlus Research I

EmpowerPlus Research II

EmpowerPlus Research VII


Pig Pills, Inc.

Dr. Terry Polevoy has waged a tireless campaign against Empowerplus. His voluminous research on Truehope Nutritional Support Ltd.⁴ is available at these sites:

Truehope Empowerplus loses lawsuit against Health Canada

Canadian Quackery Watch - Truehope's Empowerplus and other miracles

He also has an ebook: Pig Pills, Inc., The Anatomy of an Academic and Alternative Health Fraud:

It's the unlikely story of a "cure" for psychiatric disorders by "inventors" who were neither doctors nor research scientists. They were, however, seasoned sales people with dubious tragic stories to help them focus their pitch on others in need...

Their pitch was based on the absurd notion that young piglets on their way to becoming ham for your dinner table could be cured of a condition that is know as Ear and Tail Biting Syndrome. They claimed that pigs of course could be healed by just throwing them a haphazard mixture of vitamins, minerals, and herbs - the pig pills. Yes, pig pills! Then in an amazing leap of faith, these two fellows from rural Alberta, Canada, with connections to nutraceutical conglomerates in Utah, came up with the idea that their pig pill formula could help wipe out the scourges of otherwise incurable mental illness in humans.

Appendix

Four Explanatory Models for how vitamins and minerals may influence mood states (Kaplan et al. 2007, in the highly regarded Psychological Bulletin):

1. Unstable Mood May Be the Manifestation of Inborn Errors of Metabolism
2. Unstable Mood May Be the Manifestation of Deficient Methylation Processes
3. Unstable Mood May Be the Result of the Alteration of Gene Expression by Nutrient Deficiency
4. Mood Disorders May Be Long-Latency Deficiency Diseases

"The four models described above are entirely compatible ideas that provide overlapping views of how brain metabolic pathways may become deficient and result in mood symptoms."