TRUE HOPE FOR MENTAL ILLNESS SUFFERERS

 

 

 

Elissa Meininger
September 20, 2006
NewsWithViews.com

If you or anyone you care about suffers from severe forms of depression, bipolar disorder (manic depression), anxiety disorder (panic attacks), or ADD/ADHD (attention deficit disorder/attention deficit hyperactivity disorder), I have good news for you.

A new nutritional supplement is now available that has been shown to be extremely effective in treating these maladies. This supplement, called EMPowerplus, costs $69 a month for 252 capsules. It is being distributed by a company called Truehope Nutritional Support, Ltd., a non-medical, non-profit research organization dedicated to researching and overcoming disorders of the central nervous system. You can read more about the Truehope story on truehope.com.

Ordinarily I would not single out a specific product to discuss in one of my articles, but the unique features of this particular product, the compelling reasons behind its development, and the political fight the people behind it have had to wage in order to keep it available to the thousands of others who need to take it daily merely to stay alive, is unusually compelling.

Recently, I was sent the 1,847 page transcript of the three-week trial of Truehope�s founders, Anthony Stephan and David Hardy, who have just been found not guilty of criminal charges brought against them by Health Canada (Canada�s FDA) for distributing an �unapproved drug� during the year 2003. So, the rest of this article will include key details of the trial not available elsewhere. Many who are already familiar with the Truehope story believe that the co-founders of Truehope have developed the most significant breakthrough in the treatment of mental illness that has occurred during our lifetime. I am hard pressed not to agree with them.

Truehope�s story began ten years ago, when the wife of Anthony Stephan, a longtime sufferer from bi-polar disorder, committed suicide at age 40. At the time, she and Stephan had ten children, and two of them, Joseph and Autumn, also suffered from bipolar disorder. Concerned for the well-being of his two children, Stephan learned from a friend, David Hardy, of a vitamin/mineral supplement combination that had been used successfully to reduce rage and aggressive behavior in pigs, and he decided to test this formula on his two children. Once he found that it was able to ameliorate all their bipolar symptoms, he and Hardy set up shop and began manufacturing EMPowerplus in the US, distributing it through their Truehope research program in Canada. For people not familiar with the symptoms of severe depression, bipolar disorder and related nervous system diseases, victims often act pretty crazy. They hear voices in their heads, they hallucinate, they fixate on killing other people or themselves, and all too often successfully act on these impulses. They can be very dangerous people to be around. Drug treatments are notoriously ineffective in treating many of these people, and their lives are filled with episodes of being locked up in mental wards with doctors trying one drug combination after another in an effort to find the least lethal group to suppress the demons they live with.

The idea behind the effectiveness of EMPowerplus is that the cause of this abnormal behavior is in fact not a disease at all, but rather a systemic imbalance brought on by massive nutritional deficiencies. Provide the needed nutrients and the person�s behavior returns to normal. Stop taking EMPowerplus and the abnormal behavior returns.

You would think that with this kind of story the world would come clamoring to Truehope�s door, hoping to make this miraculous product as widely available as possible. But this has not been the case. Anyone familiar with the anti-supplement sentiments in the medical community in the U.S., Canada and elsewhere, will know that even though EMPowerplus stands out as a beacon of hope for millions of bipolar sufferers, the product also stands out as a huge target to all those in the medical system who want to maintain the high-priced, drug-drenched status quo.

To put this into perspective, here in the U.S. alone, according to figures posted on the patient-run, Wrong Diagnosis website [Read], 2.3 million adults suffer from bipolar disorder. In addition, according to a 1998 study published in PharmacoEconomics, [Read] the then-gross annual cost of treatment for bipolar disorder was $24 billion, with the average cost per case ranging from $11,720 for a single manic episode to $624,785 for people with nonresponsive/chronic episodes. That�s big business for the medical industry and a massive cost to taxpayers, who often pick up the tab.

But more importantly, the already booming psychiatric drug industry is currently in line to receive the bonanza of a lifetime. Why? Because, in a 2002 Executive Order, President Bush created The New Freedom Commission on Mental Health [Read] [Read]. This commission is charged with establishing a national system to evaluate the mental health of every citizen in America in order to diagnose and prescribe the right mediations needed to control our behavior. An early prototype model called, the �Texas Medication Algorithm Project� or, �TMAP� [Read], developed in Texas while he was governor, was financed by members of the drug industry. Part of its protocol involved matching specific diagnoses to specific, and often the most expensive, new drugs. You can see why a $69-a-month nutritional supplement that actually works, without dangerous side effects, would be as welcome to the drug industry as ants at a picnic. Truehope�s troubles began in earnest in 2002 when Health Canada (Canada�s FDA) became aware of what it was doing. In short order, the agency decided to declare its product a drug, despite the fact that 90% of the health food products sold at that time in Canada were not regulated that way. The ultimatum it gave Truehope and its founders was to either obtain a �Drug Identification Number� (D.I.N.) or stop selling and distributing its products to the thousands of participants in the Truehope program in Canada.

This left Truehope in an impossible situation. To obtain a D.I.N., the product would have to go through years of expensive testing, which, for a nutritional product, is virtually impossible to do. Aside from the prohibitive cost of testing a non-patentable product where any hope of recouping the expense is non-existent, Truehope was faced with the added problem of having to test each active ingredient separately from all of the others. In testing synthetic patentable drugs, the one active ingredient usually found in such products is the one selected for testing. However, nutritional supplements usually contain many more active ingredients than are found in patentable drugs, and EMPowerplus had 24. So, there was no practical way to comply with the testing criteria.

Worse yet, if Stephan stopped providing the product to his customers, he knew that within days, these people would revert back to their previous bizarre and potentially lethal behavior. Aside from wanting to protect his own children from killing themselves as their mother had done, he was faced simultaneously with the ethical issue of what to do about the thousands of others he knew would be in the same boat.

So, instead of proceeding with testing, Stephan and Hardy began what was to become a tedious, time consuming, and largely fruitless effort to gain an audience with officials at Health Canada and the Canadian Minister of Health, hoping to obtain a Ministerial Exemption or some other agreement that would allow them to continue distributing their product. For well over a year and a half, their requests for an audience were largely ignored. Then, when hundreds of testimonials and letters of support eventually began pouring in, Health Canada responded officially by setting up a 1-800 crisis line on which callers were advised to stop taking the product and to seek drug therapy and psychiatric help. This �help,� of course, had already proven to be as worthless as no help at all, and a nightmare that some people would choose to avoid by committing suicide rather than having to re-live it.

During the time that Truehope continued to develop and promote its product, Health Canada tried many ways to shut Truehope down, including raiding Truehope�s corporate offices and seizing corporate and patient records, as well as closing down a study financed by the Province of Alberta at the University of Calvary. Eventually, by the time Health Canada started seizing the product at the border as it came from the American manufacturing plant into Canada, the Canadian Mental Health Association jumped in to arrange �personal exemptions� for desperate patients, and even reported several deaths to Health Canada because of the stoppage.

Despite extraordinary difficulties, Truehope continued to seek scientific validation showing that the product worked and that every one of the 3,000 people taking the product in 2003 were being carefully monitored. A number of doctors had already signed on and were conducting clinical tests on their own patients, with a phenomenal 80% rate of success. Other supporters lobbied Parliament in the hope of passing C-420, a bill that bill-backers called the Canadian DSHEA bill. (In the U.S., DSHEA -- the Dietary Supplement Health and Education Act of 1994 -- established by law that dietary supplements and herbs were food and thus should be regulated as food, and not regulated as unapproved drugs as the FDA had done in America before DSHEA was passed.)

One highlight of the Truehope story is the fact that some important support came from a most unlikely source -- Harvard Medical School psychiatrist Charles Popper, M.D.. Popper is the type of psychiatrist who you could call a �doctor�s doctor,� in that he is a specialist in helping fellow psychiatrists tweak drug protocols for difficult child and adolescent cases. In short, he�s a psychiatric drug expert.

Popper emerged as one of the star witnesses for the defense, testifying to the absolute truth of Truehope�s claim that EMPowerplus can restore normal behavior to seriously ill patients. In short, Popper explained to the court how most medical doctors have no idea how nutritional supplements work and are not prepared by their medical school training to use them effectively. He also pointed out that after working with Stephan and Hardy, he learned a great deal more about the many problems people experience when they withdraw from psychotropic drugs that are only now starting to be noted in medical journals.

Dr. Popper described in detail the lengths to which he went to avoid even meeting with Stephan and Hardy, and how he didn�t believe a word they said after a colleague arm-twisted him into attending a meeting conveniently arranged with them in his own hospital. He further testified as to how he was originally so negative to the idea of being associated with such a product that he hid the bottle of EMPowerplus he had been given, hoping even the cleaning lady would not find it and possibly ask him about it. And, the most interesting part of his transformation came when he finally decided to let a colleague try the bottle on his own son, only to find out that the claims Stephan and Hardy had made that EMPowerplus could restore normal behavior within a few days were actually true.

During his extremely illuminating testimony as a prominent medical expert coming to terms with a new idea that was contrary to his medical specialty, Dr. Popper was eager to endorse David Hardy, in particular, as the most informed nutritional expert he�d ever met, including those at Harvard Medical School. When the judge asked Popper, under oath, if he would use Empowerplus on himself, should he be diagnosed as having bipolar disorder, he answered, �Yes.�

Another compelling eyewitness to the virtues of EMPowerplus was Autumn Stringam, Stephan�s daughter, whose riveting testimony should, in my view, be required reading for medical regulators as well as drug company executives all over the world, not to mention the rest of us, too. It is a testament to the depths of the suffering people endure, when, just by chance, they develop a malfunction in their system and end up suffering from some devastating mental illness. Autumn�s testimony vividly illustrated how their intense suffering is then compounded by the endless, hit-or-miss prescribing of toxic drugs in an often fruitless effort to merely suppress symptoms.

Among other things, Autumn testified that as she drifted into psychosis after her first baby was born, she started hearing voices, she experienced her own uncontrolled slapping of her body and face, and she began making elaborate plans to kill herself or cause harm to her new-born baby. Autumn described how, as her behavior deteriorated during one hospital stay, she was put on 13 different drugs and became so toxic and bloated, she could no longer bend her fingers. In another drug episode, when she was put on lithium, she gained 30 pounds in 28 days.

However, it was Autumn�s description of her outpatient experience with a drug cocktail of Haldol, Rivotril, Ativan, Epival, and Cogentin, that thoroughly shocked me. The purpose of this cocktail was to sedate her so she could �function� in the outside world. Yet, as a result, she ended up so sedated that she could not even sit upright. Instead, she would fall to the floor, and as she described it, she would then drool on the carpet until somebody picked her up, and placed her upright again in her chair.

Then, the next event Autumn testified about in this bizarre, drug-induced �suppression of her bad behavior� was that, suddenly, this particular combination of drugs stopped working altogether, and once again she became manic and out-of-control.

Despite this ongoing out-of-control behavior, when she and her doctor learned that her brother had been helped with the new nutritional supplement protocol her father had developed, her doctor tried to discourage her from trying the protocol, saying that he was sure he could find the right chemical cocktail for her within the next two years.

Undaunted, within days of starting the vitamin/mineral supplements, Autumn was able to taper off taking the drugs she was on and her behavior returned to normal. As she testified in court, she took her last drug on March 28, 1996, and since then has had three more children and is now a normally-functioning human being.

The testimony during the trial also showed that at the same time the people at Truehope were saving lives and making every effort to make it legal to distribute EMPowerplus without a DIN number, valuable Canadian legislative activity that had dragged on from 1999 finally came to fruition. The goal to create a new system of regulation called �The Natural Health Products Directorate� finally became the law of the land in January 2004, thus providing EMPowerplus with an appropriate regulatory means to be able to comply with the law. By May, 2005, EMPowerplus was granted a Natural Health Products Number, which means it meets or exceeds Health Canada�s standards of manufacture. In addition, a new Minister of Health came into power in 2004. This new Minister finally granted an exemption under special terms which now allows Stephan and Hardy to distribute and monitor the product in Canada through Truehope.

However, despite the fact that Stephan and Hardy had finally been blessed with regulatory approval, the unrelenting regulators at Health Canada went on to charge them with six breaches of the Canadian Food and Drugs Act and Food and Drug Regulations for their continued illegal distribution of EMPowerplus without a DIN number between January 1st and December 31st of 2003. By the time this case finally ended up in court in March of 2006, five of the six original criminal charges were dropped and Health Canada officials said they would not seek possible imprisonment and ask only for the maximum $500 fine should the defendants be found guilty.

Many revealing statements were made during the trial, but to me, perhaps the most upsetting of all was one made by a Health Canada official who testified that the agency was well aware that if the product were withdrawn, people could literally die due to lack of access to the nutrients it offered. However, according to his testimony, it was the agency�s position that this eventuality, should the product be made unavailable due to the agency�s regulatory actions, was not the agency�s concern. On July 28, 2006, the judge handed down a 30-page ruling [Read] that spelled out the fact that Truehope and its officials were caught between a rock and a hard place, and were entitled to the defense of necessity as justification for violating the law. They knew that if they had followed the law, people would die and they would be criminally liable for those deaths. Consequently, according the judge, they are legally obligated to continue to sell EMPowerplus in Canada.

Now that the March trial has been decided, Anthony Stephan and David Hardy are seeking an official Judicial Review [Read] of what they believe are Health Canada�s abusive and illegal actions throughout the entire affair. Shipments of EMPowerplus are still being seized sporadically at the border and Health Canada has just announced it will appeal the ruling.

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In the meantime, Autumn has published a book entitled, �These Painted Wings,� which is a touching and detailed memoir of her years growing up with a mentally ill mother, how her mother�s suicide affected the family, and how her father, against all odds, created a miracle so that she and others would not have to suffer the same fate. The book also covers the years of development of EMPowerplus, the politics in Parliament, the actions of Health Canada, and it ends with Autumn�s impressions of the trial.

� 2006 Elissa Meininger - All Rights Reserved