Empowerplus: The Lure of a Miracle Pill for Mental Illness - Diagnosed with Schizophrenia

Written by HealthyPlace.com Staff Writer

Serious disorders like these should not be self-medicated or self-diagnosed, Health Canada said in a statement.

Tara Madigan, a spokeswoman for Health Canada, said it is Truehope's responsibility to provide Health Canada with data that would support the therapeutic claims being promoted for the drug.

Dr. Kaplan's studies were exploratory in nature and involved only a small number of subjects, she said. Fourteen subjects were enrolled in, but only 11 completed, the six-month trial in 2001. Another 2002 study involved case reports on the use of Empower on two children, eight and 12 years of age.

Even the researchers acknowledge there were many weaknesses in the design of the two studies, said Ms. Madigan.

For one thing, there was no placebo control.

Another potential source of bias is from the psychiatrists themselves. "As in any open-label study, unblinded assessments can result in exaggerated results," she said.

Vitamin toxicity is also a serious consideration. As well, there is the problem of how the supplement interacts with medications, she said.

Mr. Hardy insists there are no health risks associated with the supplement.

"You don't have to be a rocket scientist to know that every product in the blend has been in use at least for 40 years," he said.

As for patients who go off their meds, mentally ill people who take pharmaceutical drugs have a chemical imbalance, he maintains. There may be disturbances when the brain is normalized by using the supplement, he said. "The best success happens when people slowly transition from their medications."

Still, there are many questions about how Truehope runs its operations.

Mr. Hardy says he and Mr. Stephan "don't make a dime" from the supplement.

However, if a customer takes 18 pills a day, it costs about $165 a month to buy Empowerplus. If the company has 3,000 customers in Canada alone, it's making almost $500,000 a month.

Mr. Stephan insists that figure is incorrect, because so many customers get their supplements for free.

It's more like $300,000 and a lot of the money goes to pay the 55 "support" workers who operate the phones.

Many have themselves suffered from mental illnesses. The fact that they have no medical credentials concerns people like Mr. Ross.

"People have the right to try whatever they want," he said. "But they should work with their doctors."

Mr. Hardy says Truehope customers can get more personal time with a "support" worker than a busy doctor. And, adds Mr.Stephan, people who have had mental problems "know what works and what doesn't work.

"All we're here to do is tell you how the program operates."

Empowerplus doesn't work for everyone, said Mr. Stephan. Anything could tip the balance of a mentally ill person -- not taking enough of the supplement, an illness or stress.

"But they come back for more. Because they felt better on the nutrients," he said.

Dr. E. Fuller Torrey, a well-known research psychiatrist who is executive director of the Stanley Medical Research Institute in Bethesda, Maryland, says his institute is considering doing a "careful" double-blind study of the supplement.

The product still needs U.S. Food and Drug Administration approval in order for that to happen, however.

"Our belief is that there is sufficient anecdotal information that warrants careful study," he said.

"It tells you that it's worth looking at, one way or another."

But anecdotal studies don't wash in the greater scheme of things he said. He wouldn't recommend this kind of treatment to a patient.

"No. Wait for there to be hard data," he said. "Any time a patient goes off their mediations, they are likely to have a relapse."

He's also concerned about the fact that Truehope claims to be effective for a wide variety of disorders.

"In the more than 30 years I have been studying mental illnesses, there have always been some people who have made a good living treating people with schizophrenia with various vitamin mixtures," said Dr. Torrey.

"If it works, use it. But the amount of hard research in this area is very, very small."

Much more proof is needed, says Dr. Jacques Bradwejn, psychiatrist-in-chief of the Royal Ottawa Hospital.

"It's the whole question of showing efficacy through standards of research that include clinical trials," he said.

That means the supplement needs to go through a test against a placebo.

Yes, the rules are strict and will take years to follow, but "the same approach needs to be taken for any products that have claims (of medical effectiveness) attached to them," he said.

As well, the manufacturers need to prove their mix is standardized and pure, he said.

In the past, some herbal remedies have run into problems with doses that fluctuate or background chemicals that creep in unnoticed and do harm.

Mr. Hardy and Mr. Stephan have questions of their own: Why not let more studies go ahead? "We feel we're onto something, and it has to be looked into," said Mr. Stephan.

"If they think it's a scam, then let's prove it."

Source: The Ottawa Citizen

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