Natural Mental Health Treatment Pioneer Memorial

David Hardy passed away last week after suffering a stroke. You may not have heard of him, but you may be one of the many thousands of people who have been helped by the products of his research, EmPowerPlus and Daily Essential Nutrients (DEN). These pioneering products have been instrumental in the  treatment of mental health problems with multiple micronutrients (minerals and vitamins) for the past two decades. Independent clinical research on these products has been led by Bonnie J. Kaplan, PhD, Professor Emeritus, Cumming School of Medicine, The Child Development Centre at the University of Calgary (Alberta, Canada) for over ten years. This research — which is not paid for by the manufacturers and hasn’t had a government grant for many years — has been conducted in Canada, the US and New Zealand.

Although David was not a medical doctor or a scientist, he developed the original product, a broad-spectrum micronutrient formula, not through traditional animal studies, but using the knowledge gleaned from his career in the livestock feed industry. I remember David telling me how adding nutritional substances to livestock feed was observed to calm the animals when they were agitated and stressed (such as when being shipped by truck or train) and stopped them from fighting and injuring each other. He formed Truehope Nutritional Support Ltd. 20 years ago with his partner Tony Stephan to manufacture and distribute EmPowerPlus directly rather than go over-the-counter at pharmacies and mass merchandiser outlets.  The direct marketing served several purposes.  It kept the price down by avoiding the “Middle-Man” and it enabled the company to provide free direct customer support via 800 number direct to staff (and later over the internet). The company was reviled by the pharmaceutical industry who convinced Health Canada (the equivalent of the Food and Drug Administration in the USA) to shut down the business and seize all their product. Although not financially in the same league as the deep pockets of Big Pharma and the government, the company fought the battle through the courts, and emerged victorious after several expensive and strenuous years of litigation.  Not only was TrueHope victorious, but the judge decreed that Health Canada had to issue a public apology (which was probably a first).

Not long ago, David left TrueHope to start Hardy Nutritionals and developed his own nutritional supplements for mental health.  Tony Stephan still operates TrueHope and continues to manufacture and distribute EmPowerPlus. The whole story is inspiring in so many ways.  In her memorial to David, Dr. Kaplan reminisced: “I personally will never forget the afternoon in September 1996 when David, Tony, and Autumn (Tony’s daughter) came to my home to talk about their experiences and observations, and to see if I could study what they knew to be true — that extra micronutrients can bring some people back to complete mental wellness. The honesty and integrity of all 3 of them were clear, and the visit ultimately resulted in my changing career directions — something I have never regretted, because what topic is more important in psychology or psychiatry than helping people make the symptoms go away?”

I got involved when a patient (who had read about EmPowerPlus online) asked me if it would be appropriate for her.  To tell the truth, I couldn’t recommend it at that time, as it didn’t have the traditional research-based evidence behind it. But a year or maybe two later, I kept my eye on the product and TrueHope had gleaned a few papers on small studies that had been done, and I decided that it was harmless enough to recommend to my patients. Little did I know how effective  and safe it would be — and I started using it as a first-line treatment for some patients with particular diagnoses. In 2006, Dr. Kaplan organized an international meeting in Colorado for people like me who had been treating patients and had positive results.  She wanted to encourage formal research.  She set me up as the only test site in the US, and our clinical trial was funded through a grant from the Provincial government of Alberta, Canada. A later trial was launched in New Zealand headed by Dr. Julia Rucklidge, how has since given a widely-admired TED Talk.

It was a rigorous double-blind placebo-controlled test, just the same as if we were a pharmaceutical company.  We had to get the approval of the FDA and meet a lot of requirements, including hiring an external Institutional Review Board (an ethics watchdog).  None of these were required the way a pharmaceutical drug must pass testing before being allowed on the market.  EmPowerPlus had been on the market several years. But the proof would prove valuable in getting this natural, safe treatment accepted into the mainstream. Unfortunately, the treatment is not eligible for insurance coverage, which has limited it to those who are able to afford paying for it out of pocket.  But to that end, David and Tony put programs in place to help those who couldn’t afford EmPowerPlus with discounted (or in some cases free) pills. Hardy Nutritionals continues helping patients, thanks to David’s family.  Son Jared Hardy stated that the company would “… carry on the marvelous work he undertook in a way that would make our father proud.” Dr. Kaplan established  a charitable fund — actually one in Canada and one in the US — in 2015.  There is more research to be done, and Dr. Kaplan said: “This work will not be supported by large pharmaceutical companies that fund drug research for profit, and it should not be funded by commercial interests like Truehope, Hardy Nutritionals, or Q Sciences. In this way, we can ensure that research findings are not influenced by any profit motive. That is why it is especially important that this work be funded by private contributors.” If anyone is moved to contribute to this charitable fund — tax-exempt, of course — “to honor and extend the influence of David’s life and work” please contact Dr. Kaplan at kaplan@ucalgary.ca