Important Article from Health Canada

Thank you to Dr. Wilson Lit for brining this article to our attention and sharing it with us! You can find the original article here.
Reports of adverse reactions in patients with serious mental health conditions suspected in association with use of prescription medications and EMPowerPlus

Information Update
2007-17
February 28, 2007
Information Update

OTTAWA – Health Canada is updating Canadians about adverse reaction reports it has received concerning the use of EMPowerplus, a vitamin mineral supplement, for serious medical conditions.

Health Canada has received nine case reports of serious adverse reactions associated with the use of EMPowerplus. Most of the adverse reactions relate to worsening of psychiatric symptoms in those patients with serious underlying mental health problems, such as bipolar disorder and depression. The worsening of these symptoms could be related to taking the product and discontinuing prescription medications or taking the product in conjunction with prescribed medications. As a result, Health Canada is advising consumers with these serious conditions that there is a potential risk to health associated with the use of the product EMPowerplus.

Health Canada is concerned about the health risk posed by this product’s promotion, including unauthorized health claims, and medical advice being provided by non-medically qualified staff of Truehope Nutritional Support Ltd. to patients with serious medical conditions to discontinue their prescribed medications. This may result in serious adverse health consequences.

It is important to discuss the treatment of serious medical conditions with a medically qualified practitioner.

A Health Canada public advisory and an information bulletin were previously issued in 2003, concerning the use of EMPowerplus for the treatment of serious medical conditions. With the receipt of the adverse reactions, Health Canada remains concerned about the health risks associated with the use of this product.

Consumers requiring more information about this Health Canada Information Update can contact Health Canada’s public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction with this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca

Advertisements

One thought on “Important Article from Health Canada

  1. True Hope is the non for profit organization that makes EMPowerplus. Here you can read the Judge ruling regarding the product and Health Canada. I’m shocked!

    Health Canada v. Truehope court case
    Here are a few excerpts from the written ruling by the Honorable Judge G. M. Meagher on the 2006 Health Canada v. Truehope court case:

    case background
    ‘Health Canada insisted that the Defendants [Truehope]…stop selling and distributing EMPowerplus to the thousands of participants in the Truehope program in Canada.’

    ‘Since the Defendants made claims that EMPowerplus was useful for the treatment of depression and bi-polar disorder, Health Canada took the position that this brought the micronutrient treatment within the definition of a “drug” within the meaning of the Food and Drugs Act, even though the product was clearly a vitamin/mineral micronutrient treatment.’

    ‘Health Canada advised the Defendants that they could not sell or distribute the micronutrient treatment in Canada without a Drug Identification Number or “D.I.N.”. However…it would not be possible for the Defendants to obtain…a D.I.N. for EMPowerplus, and Health Canada was well aware of this fact.’

    ‘Fearing for the health, safety and well-being of their participants in the Truehope support program, the Defendants continued to take orders for the micronutrient treatment, transmit the orders to their manufacturer in the United States, and distribute the micronutrient treatment in Canada.’

    evidence from expert witnesses
    ‘the significant results of treating depression and bi-polar disorder with vitamin/mineral micronutrient treatment rather than conventional pharmaceuticals attracted interest from…experts in the field of treatment of depression and bi-polar disorder in Canada and the United States.’

    ‘Dr. Charles Popper, a psychiatrist at Harvard University, who also teaches psychiatry to other psychiatrists, testified that…if the micronutrient treatment [EMPowerplus] became unavailable, symptoms associated with depression and bi-polar disorder…would return.’

    ‘Dr. Popper has most impressive qualifications. Although he was initially extremely skeptical with regards to the micronutrient treatment, by the time of trial approximately 100 to 150 of his patients were using the micronutrient treatment… In addition to his patients, Dr. Popper testified to having consulted on 300 to 500 additional patients on the micronutrient treatment.’

    ‘Dr. Charles Popper…testified that if the micronutrient treatment became unavailable there would be aggressive behaviour, assaults, hospitalizations, incarcerations and suicides. He testified that his patients would have to be returned to medications which lack stability and had negative side-effects. Overall, Dr. Popper testified that he would not be able to manage his practice at the level to which it had grown and he would have to refer patients away from his practice.’

    ‘The expert evidence before the Court with regards to the objective harm that could occur included the observations of Dr. Bonnie Kaplan, a psychologist from the University of Calgary, who observed the rapid return of symptoms once the micronutrient treatment was discontinued’.

    ‘The expert evidence of Mr. Dales, consultant, with regards to the classification of substances and the approval process under the Food and Drugs Act and Regulations was that the process for the approval of a new drug through the Therapeutic Products Directorate of Health Canada, was a process which would take several years and cost millions of dollars. In the end, Mr. Dales evidence was that it would have been impossible to obtain a D.I.N. for this vitamin/mineral micronutrient treatment because of the nature of the product as a health food product with multiple ingredients going through a therapeutic drug testing regime which typically tested products with only one or two ingredients.’

    evidence from other witnesses
    ‘the evidence of numerous witnesses called by the Defendants [Truehope] on the effects of the micronutrient treatment [EMPowerplus] on their lives or on the lives of their family members…was compelling and persuasive.’

    ‘If an individual stopped taking, or was denied access to the micronutrient treatment, that person would revert within a matter of days to an earlier state of depression or bi-polar behaviour characterized by aggressiveness, mood swings, and violence to one’s self or to others with a very real risk of personal injury and, in some cases, death.’

    ‘the evidence of Sabine Colson, Autumn Stringam, Debra Oxby and Sheila Stanley [was] based on their personal experiences or observations of close family members regarding how depression and bi-polar behaviour rapidly returned when the micronutrient treatment was not taken.’

    ‘Ms. Colson described self-inflicted injuries, being involuntarily committed, and becoming useless to the point where she had formulated a plan to kill herself before she lost her mental health again.’

    ‘Ms. Oxby described the harm as having to hear her son beg her to kill him several times a day and watching her son deteriorate as he lost his mental health, his friends, his self- esteem, his dignity and his will to live.’

    ‘Ms. Stanley expressed similar concerns with regards to her daughter and her husband.’

    ‘Ms. Stringam described her severe incapacitation prior to the micronutrient treatment and was fearful and concerned that without the micronutrient treatment she would not be able to care for her children and her family and that she could not go out in public for fear of her behaviour. She feared being medicated and consumed with drugs, and becoming suicidal and hospitalized.’

    ‘Ron LaJeunesse, the Alberta head of the Canadian Mental Health Association, was very knowledgeable of the risks facing persons with mental illnesses. He expressed grave concern for the conduct of Health Canada in preventing the micronutrient treatment from coming into this country. He testified that death was a consequence of bi-polar disorder and that he was concerned that there would be suicides if individuals could not get access to the micronutrient treatment.’

    ‘Dr. Lunney, a Member of Parliament, attempted to intervene on behalf of the Defendants to obtain a meeting with the Minister [of Health].’

    court ruling
    ‘The Defendants [Truehope] are not guilty’

    Necessity. ‘The Defendants were overwhelmingly compelled to disobey the D.I.N. regulation in order to protect the health, safety and well-being of the users of the micronutrient treatment [EMPowerplus] and the support program.’

    ‘…thousands of individuals who had found relief from mental illness through the micronutrient treatment [EMPowerplus] without the negative side effects of conventional medications were relying upon them [Truehope] to continue to sell and distribute their product and to maintain the Truehope program.’

    ‘…the Defendants were under a duty or duties described in [Section] 216 and 217 of the Criminal Code of Canada to continue to provide the vitamin/mineral micronutrient treatment and to maintain the support program or possibly face the consequences of being charged with criminal negligence.’

    Due diligence. ‘The Defendants took all reasonable care that could have been expected of a reasonable person in the circumstances to comply with the requirements of Health Canada under the Food and Drugs Act and Regulations.’

    http://www.truehope.com/truehope_bipolar_disorder_court.aspx

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s