Please read the
Vancouver Sun article (below) about Truehope's war against
Health Canada to defend consumer access to Empower Plus a dietary
supplement that helps people with bipolar illness. Truehope survived
several raids by Health Canada and their legal battle has been similar to
yours against the FDA. By winning their legal battle, they scared the
hell out of Health Canada, and thats why C-51 is now coming at them.
Pharma is trying to harmonize Canada to much more restricted Australia, and
they intend to harmonize the USA to Canada and Mexico where supplements are
regulated as drugs.
Its important to realize that due to FDA's Trilateral Cooperation Charter with Canada/ Mexico, via which FDA is harmonizing the food and drug regs as if a North American Union were already in existence, anything that happens in Canada is poses a threat to us here. Please join with me in pushing for Congressional oversight on FDA's Trilateral Cooperation Charter. Please help fund an updated version of Kevin Millers film We Become Silent to call attention to the need for Congressional oversight before its too late.
Keep in mind the global timetable we're dealing with: By January 2009 the EU is going to impose very restrictive "Safe Upper Levels" for vitamins/minerals that will be only slight multiples above RDA. Those numbers will be transposed into Codex which the EU politically dominates. It is via regional harmonization that FDA is trying to usher Codex level restrictions into the USA. Our only chance to defend ourselves is to work very hard to stop regional harmonization.
C-51 Could go to 2nd (of 3) Readings by Monday or Tuesday: To Take Action in Canada & USA See: http://www.ymlp.com/pubarchive_show_message.php?jham+908
Needs Your Donations to Wake People Up To the Need for Congressional
Oversight on FDA's Trilateral Cooperation Charter: IAHF 556 Boundary Bay
Rd., Point Roberts WA 98281 USA or via paypal at http://www.iahf.com/index1.html
Vitamins for bipolar: cure or quackery?
HEALTH I Controversial and (so-called) unproven, a mix of vitamins formulated to calm aggressive pigs has apparently brought relief to thousands of people with bipolar disorder
Saturday, January 05, 2008
CREDIT: Ward Perrin/Vancouver Sun
Monica Carsience, pictured with her husband Stuart, has found relief from her bipolar symptoms and release from pharmaceutical cures with a powerful cocktail of vitamins and minerals.
Monica Carsience says it's the answer to her prayers. David Hardy calls it good pig husbandry. Health Canada suggested it was quackery and spent years trying to shut it down.
A dry cocktail of vitamins and minerals that calms aggressive pigs and seems to have eradicated bipolar disorder symptoms in almost 10,000 North Americans, drives these strongly held views. Views that pit bureaucratic rules against a human need for relief and squeeze the scientists in the middle.
Could pig pills really heal a mental illness, the cure for which has long eluded medicine?
Psychiatric experts familiar with it say the widespread anecdotal success of the pig formula indicates research into mental illness should make a sharp shift away from pharmaceuticals to examine the potential of vitamin and mineral therapy. One goes so far as to say it has the potential to be the most significant breakthrough in mental health since the beginning of time.
Six years ago, the mood disorder came close to destroying the family life Carsience wanted more than anything.
But now, she loves her life in Abbotsford with her husband, Stuart, and their two children. Everyday she takes EMPowerplus, a nutritional supplement she says has so cleared her head she thinks she may finally be able to work as the teacher she was trained to be.
Over 500,000 Canadians suffer from bipolar affective disorder or about 2.2 per cent of the Canadian population, according to a recent study. Most take lithium, a mood stabilizer that is often combined with other drugs such as antidepressants and psychotrophics. They live with the side effects.
Looking back, Carsience thinks she had bipolar disorder long before she was diagnosed. Her manic states actually endeared her to her future husband Stuart.
But immediately after she gave birth to their daughter, Rebecca, she swung into a high the likes of which she'd never experienced. She didn't sleep-- not at all -- and it wasn't because her daughter kept her up. It was adrenalin.
So she'd do laundry, clean, organize, knit, sew, and make arrangements. With a new baby, there was plenty to do. Except sleep. For 10 straight days.
"I'm not a smoker," she said. "But I imagine that maybe it was like someone is having a nic fit. I was really frenetic."
Her husband Stuart didn't get it.
"You can't do this," he told her one night, exasperation framing his words. "You need your rest."
But she couldn't rest.
As well, her entire body felt bruised as if she were a cartoon character who'd been flattened by a steamroller. Only, unlike the cartoon character, Carsience didn't pop back to full recovery.
"I felt crippled up with pain," she said, noting the pain far exceeded what could be explained by the birth. "My muscles were all sore and knotted up and I just felt bruised."
The doctor gave her sleeping pills, but with sleep, came a deep depression.
Back at the doctor's office, the doctor didn't recognize the mood swings for what they were. She thought she had postpartum depression and prescribed Prozac. A year later, the little family moved from Regina to Abbotsford and Carsience let her prescription run out.
"That is when I realized I was really really depressed. It didn't matter how nice the day was. It didn't matter how great my life was, I couldn't shake it."
Carsience found a GP in Abbotsford, who referred her to a psychiatrist, who diagnosed her with fibromyalgia and Type Two bipolar disorder, the milder form of the disorder. She was never psychotic or suicidal, but she swung regularly from manic to depressed.
The psychiatrist prescribed various seratonin reuptake inhibitors or SRIs and lithium. But the cure wasn't much better than the condition.
"I became numb. I had no feelings. I became fat. My weight soared to 200 pounds from 150 pounds. What feelings I could feel were completely unreliable."
Stuart used to advise her on what emotion fit the situation.
She celebrated her child's milestones by scrapbooking, but she would have to intellectualize her feelings.
"I knew that this was exciting, but I couldn't feel excited."
Meanwhile, the fibromyalgia got so bad she couldn't do up her buttons or open baby food jars. Sometimes, it was all she could do to lay in front of the fireplace with the heat at her back to get some relief. She'd lay out toys around her for Rebecca to play with and they'd just stay there. For hours.
Stuart, meanwhile, spent more and more time at work.
"I couldn't deal with it," he said now. "I didn't want to deal with her in that state. I was travelling a lot and it was easy for me to get away and I did."
But he wanted another child. So did Monica, but lithium can kill a fetus and they weren't prepared to risk that. Carsience tried going off lithium under supervision, but she relapsed right away into depression. She endured for a couple of months, hoping to get pregnant. But she couldn't take it.
"I needed the relief of feeling nothing and being numb."
One day, she was reading the Bible, James 5: 14-16, which says if you are sick you should call the church elders to pray over you and annoint you with oil.
"I'm like; 'I'm really sick. I've got this problem with depression and mania and this problem with fibromyalgia and I've had a digestive problem for a decade.' I felt like I was 80-years-old and I was getting close to 30."
She went to the church, and the elders prayed over her.
A RAY OF HOPE
Meanwhile, a family drama was unfolding in southern Alberta that would have a huge impact on Carsience and her family.
Autumn Stringam was a young Alberta woman with bipolar disorder who had also spiraled out of control with the birth of her first child. Experts now say pregnancy and birth can trigger bipolar disorder. Now the subject of a hot selling autobiography, called A Promise of Hope, The Astonishing True Story of a Woman with Bipolar Disorder and the Miraculous Treatment That Cured Her, Stringam tells the story of her own descent into psychosis, paranoia and extreme mood swings and how her dad and his friend, David Hardy, rescued her.
Stringam's mother committed suicide after living with bipolar disorder for years. She left 10 children behind. Stringam's grandfather also suffered with the disorder and took his life. Then Stringam and her brother Joseph got sick.
Her dad, Anthony Stephan, studied documents on the problem at the library and on the Internet and he met with numerous psychiatrists.
"I was in a situation where I was left with nothing," he recalls. "I was trying to find an answer in a hurry because my family was coming unglued before my eyes."
Then he met David Hardy, a biologist by training whose company supplied farmers with custom-made pig and cattle feed.
Stephan managed buildings, including one that Hardy's church owned. As they toured the building talking about ceiling tiles and carpet replacement, something about Hardy allowed Stephan tell him how bad it was getting at home with Joe. He weighed more than 200 pounds and frequently exploded with rage. Stephan's children were afraid of their brother.
Hardy was quiet for a minute and then he started thinking out loud.
"I don't know a lot about mental disorders," he told Stephan. "But I can tell you one thing. I spent 20 years working in the agriculture industry formulating feed stock.
"We used to see a thing called ear-and-tail-biting syndrome. The pigs would go into an explosive rage and tear off their ear or tail or rip off part of the rear flank. We had to separate them or they would kill each other."
Hardy developed a special feed enriched with vitamins and minerals specifically for ear-and-tail-biting syndrome and it pretty well always solved the problem. Maybe, he said, the same could work for humans.
Stephan felt a light go on in his dark world. All the psychiatrists he'd consulted had said his children had no hope of getting better. The best they could do was take drugs to suppress the symptoms, but the drugs would create their own set of unpleasant side effects. Stephan feared he'd have to put Joe in an institution.
The two men went off to the health food store and bought all the ingredients Hardy's pig formula contains. Returning to Stephan's kitchen, they began experimenting, using Joe as their guinea pig.
The first few blends showed about 15-per-cent improvement, but gradually they came upon a recipe that completely eliminated Joe's aggression in 30 days. It contained 14 vitamins, 16 minerals, three amino acids, and three botanicals. Except for ginko biloba, all are found in common foods.
They tried it on Autumn.
Autumn had been warned never to go off her meds. She was on a five-drug cocktail that may have improved things a little, but she was so unstable she was on suicide watch and not allowed to be alone with her son. She was also psychotic and wouldn't shower alone or naked because she feared demons would escape from her belly. Paranoid, she believed her husband was trying to kill her.
When Autumn was released from her third hospital stay into her father's care, Stephan insisted she try the formula.
She resisted and so did her husband, Dana, who had seen what going off her meds would do. There was no reason to think taking pig pills was a rational idea, she said. Dana whole-heartedly agreed.
"I knew things weren't great," recalled Dana. "But we were in the best care. We had the best psychiatrist in Edmonton. He was the specialist for bipolar. He told us specifically 'don't rock the boat. Give us a couple of years to work with her and find a balance.'"
But Stephan kept at it and Autumn finally agreed.
A MIRACULOUS RESULT
He gave her the first dose on Sunday. On Tuesday, she stopped hallucinating and on Friday, she had a shower. On her own, without clothing.
As the days went by, Autumn became more herself and Dana started to think his father-in-law might be on to something.
"I still had tons of hesitation, tons of reservation while at the same time seeing it's looking better," he said. "The better she did the more you want her to keep getting better, but you're scared this is just going to be a temporary thing and it's all going to fall apart."
After 40 days, she showed no symptoms of the disorder. They put away her meds and she dutifully ingested the 32 pill pigs each day.
Stephan and Hardy packaged up their formula, called it EMPower Plus and formed a company named Truehope to sell it to other needy folks. They didn't realize Health Canada would try to stop them.
Autumn has been symptom-free for 12 years. She's had three more children and enjoys a mental clarity the drugs never gave her.
"There was such an incredible sense of keeping my thoughts," she said, enjoying a drink in a Vancouver coffee shop.
"Both [drugs and formula] might do something to even out moods, but one leaves you feeling like yourself and the other makes you feel like you've got your head in a glass box."
It wasn't an instantaneous fix. The worst time was going through withdrawl from the medications. She said she would never recommend anyone stop their meds cold turkey. But most people seem able to replace the drugs with the formula gradually.
Carsience didn't read the autobiography. Instead, a friend knocked on the door with a news clipping headlined "Miracle cure for bipolar" about Truehope and EMPower Plus.
At about $200 per month at first, her husband worried about the cost, but if it meant they could have another child, he said he'd find a way.
Her doctor looked into it, too. He'd never heard of it and the scientific literature was pretty scant.
Bonnie Kaplan, a research psychologist at the University of Calgary, had conducted some preliminary trials. She found 80 per cent of her first 12 subjects experienced a significant reduction in symptoms. Half were off their prescriptions in six weeks.
But these were open trials where everyone knew what they were taking. The potential of subjects to experience the placebo effect was high, but it was reduced somewhat by the experiences of many who went off the supplement briefly and relapsed.
Next, Kaplan wanted to conduct a controlled double-blind study.
She received grant money from the Alberta government but Health Canada shut her down before she got started because it claimed she hadn't been authorized by them for a clinical trial.
Charles Popper, a prominent child and adolescent psycho-pharmacologist at Harvard Medical School, heard about Kaplan's work at a seminar she gave. It struck him as unlikely and far-fetched.
"This made no sense to me at all," he said on the phone from Boston. "In fact, it took some work to get me in the room."
Still when a bottle of the formula was pressed into his hand as he left, he took it and wound up observing the effects of the supplement on the son of colleagues who was having terrible tantrums.
"The results of the treatment were dumbfounding," says Popper who later published an article about the supplement in Journal of Child and Adolescent Psychopharmacology. "There was a far more rapid and complete improvement in symptoms than conventional medicine ever produces."
Popper was still pretty doubtful and tried it on a few other patients who were resistant to conventional drugs.
Over six months, 22 patients used the formula and 19 experienced a positive response. Of the 15 who were on medication, 11 were able to gradually withdraw from the drugs and remain stable on the supplement alone.
"I saw more reason to be encouraged and gradually treated more of my patients using this approach."
Health Canada did not share Popper's enthusiasm. It which raided Truehope's office in the summer of 2003 and blocked the import of the supplement from the U.S. after a man with schizophrenia, who had no previous criminal record, was charged with assault, mischief and criminal harassment while off his prescription and on the vitamins.
No officials with the federal government would be interviewed, but its public relations department sent an e-mail outlining its position.
Since Truehope offered hope of recovery, Health Canada deemed it a drug, not a natural supplement. As such, it is subject to the rigorous tests all drugs must undergo to ensure they're safe before being sold.
"Health Canada's responsibility," the e-mail states, "is to ensure that drugs sold in Canada are safe and effective. To do that, we require drug manufacturers to provide us with scientific evidence that the drug is safe and effective at meeting its stated claims of effectiveness of treatment.
"Health Canada has identified risks associated with the use of Empowerplus -- the safety and efficacy of Empowerplus has not been shown. Health Canada is concerned that individuals using Empowerplus could be putting their health at risk."
AFOUL OF HEALTH CANADA
In July, 2004, EMPower Plus was charged with six counts of violating Section 31 of the Food and Drug Act, including the import for sale, sale, and the advertisement of a drug.
Then, just before the case went to trial, all counts were dropped, except for the charge of selling without a drug identification number or DIN. Despite repeated attempts, no Health Canada official would explain why the other charges were dropped.
The Alberta Provincial Court in July 2006, found the company not guilty and said "the defendants were overwhelmingly compelled to disobey the DIN regulation in order to protect the health, safety and well-being of the users of the supplement and the support program."
In fact, the judge said, the defendants could have been prosecuted if they had stopped providing the supplement.
Hardy and Stephan say they're victims of an abuse of power by Health Canada.
But Barbara Mintzes, an epidemiologist at the University of B.C. and a member of Theraputics Initiatives, which evaluates the scientific claims of pharmaceuticals, says Health Canada should interfere when a company promises a cure without backing it up with good science.
"There are a lot of charlatans out there and you want to protect people with serious diseases."
Mintzes said it sounds to her like EMPower Plus should go through the proper testing of the drug.
"If it is shown to be effective, it would be an enormous advance, but I want to see the evidence," she said, agreeing with Health Canada that suggesting people can stop taking their medications can be dangerous.
Kaplan has since been authorized by Health Canada to conduct a double-blind study in two sites, Calgary and San Diego for which recruitment is currently underway.
Popper says he agrees study is essential. Seeing a treatment approach appear to work in a clinical setting is very different from seeing it work in controlled trials, he says.
"If I see a patient for whom it works, I don't know if it works in one in a thousand, one in 20 or seven out of 10."
There's a good chance, he said, there will come a time when vitamins and minerals are viewed as effective treatments for a whole range of medical disorders.
"If these findings turn out to have merit -- and at present time that is a real if -- then this would be expected to attract a lot of research attention toward the mechanisms of disease physiology," he said.
"What that would mean is basically we would look at the diseases from a different point of view. We would think of them in terms of how vitamins and minerals play on the biochemical processes involved. And we'd look at treatment differently for the same reason."
There is logic to it, Popper said. Lithium is a mineral and it is the first line of treatment for bipolar disorder.
Dr. Estelle Goldstein, a psychiatrist and psychopharmacologist in San Diego who treats some of her patients with the formula and is participating in Kaplan's double-blind study, said that while the formula does suggest a shift in the way science looks at mental illness, she still accepts that bipolar is a chemical imbalance. But the micronutrients would correct the imbalance differently.
For example, a seratonin reuptake inhibitor drug prevents the existing seratonin in the brain from being reabsorbed into the cells thereby making it more available for therapy.
A natural formula would instead be a catalyst to producing more seratonin. The result would be similar except the drugs tend to have more side effects.
Neither Goldstein nor Popper observed side effects on patients who have not been on drug therapy before taking the supplement. On those transitioning from drugs, the side effects have been minor; a little stomach discomfort or high energy, which can be alleviated by slowing down the transition. The worst side effects occurred when patients stopped taking their prescriptions cold turkey.
NO MORE DRUGS, NO MORE SYMPTOMS
Monica Carsience started the formula in September six years ago and gradually reduced her prescription medications so that by November that year she was off them.
By December, she had no more bipolar symptoms and within six months, the fibromyalgia was gone.
Her son, Joshua, was born while she was taking the initial higher dose of EMPowerplus and was born so strong he could hold his head up at two days. Her daughter's weak muscle tone grew strong after Carsience started giving her the formula. It allowed Rebecca to stop physiotherapy and take up gymnastics.
Her doctor, Dr. Richard Welsh, said in a phone message that since Carsience began taking EMPowerplus, she's had no recurrences of bipolar or hypomanic symptoms.
It took a while to fully transition from drugs to supplement, but even in that first month on the formula, Carsience says she felt different.
"I just leapt out of bed each morning," she recalls. "I used to roll out in pain."
She dug up her front yard and planted a garden overjoyed at her energy. It wasn't manic, she insists. She just did a couple of hours a day when the baby slept. She calls it her Truehope garden.
Her emotions matched the context, too. And she had more emotion than she thought.
"I thought I was a patient person, but I learned that I was just medicated," she said with a laugh.
Stuart said it was a tough transition for both of them, but that now they are much more connected.
"I think it's really been a life saver, a marriage saver," he said. "It brought stability to her, it brought stability to the relationship and it brought me back to her."
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