Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Sunday, March 27, 2016

Caveat Emptor

"Vivimind is available in Canada only because of a lax regulatory framework that has allowed an ineffective prescription drug to be rebranded and marketed as a natural health product."
Scott Gavura, Science-Based Pharmacy blogRelated image
"This product [Neurochem Inc.'s Vivimind, as a natural-health product] is not intended to treat, prevent or reduce the risk of any specific diseases."
Health Canada 

"[An effective Alzheimer's treatment] is perhaps the greatest unmet need facing modern medicine."
Extracted from a Canadian co-authored journal paper in Lancet Neurology

"It's an urgent public-health problem e have to address very quickly."
"I remember looking at a paper in Science -- a vaccine against amyloid in a mouse model ... and lo and behold the pathology just melted away, disappeared. It was very exciting."
Dr. Howard Feldman, Alzheimer's researcher,  University of British Columbia

"For the clinical trialists in the world ... the past ten years have been frustrating."
"If it doesn't work, you waste money and the patient's time."
Dr. Serge Gauthier, University of Montreal
Related image

A great deal of money was wasted by Montreal resident Francesco Bellini, by his pharmaceutical company Neurochem Inc. He was convinced he had a winning formula in a pharmacological product he was advancing with the name of Alzhemed, as a promising drug to treat the dread disease Alzheimer's. It had gone through the discovery stage and was in advanced Phase 3 trials. He had invested $100-million in the product, certain it would make him a billionaire. And then, phhht! A failure.

Dr. Gauthier found in his research, that two thousand trials involving about 900 hoped-for dementia drugs were registered in the past two decades. None of them succeeded. Of the total less than 200 products are still listing in their development stages. Of all research pharmaceutical products only 3.8 in the discovery stage and 1.2 percent in advanced Phase 3 trials are for dementia. Yet Alzheimer's and other dementia diseases are on the rise.

Millions of lives worldwide are devastated by that diagnosis and the agonizing failure of the human brain leading to death. Alzheimer's is the sole major cause of death in industrialized countries still without a disease-modifying treatment, in spite of the billions that have been invested in attempts to research an effective treatment. Scant little research is being done, however, in contrast to 31 percent of research dedicated to cancer treatments.

One strategy in particular looked so promising that researchers failed to look at the potential that might exist in other areas and tended to focus primarily on it. Proteins known as beta-amyloid and tau in Alzheimer's-afflicted brains spread abnormally, affecting neuron transmission and killing off cells. The assumption was that reducing amyloid plaque would result in an improvement in the condition of demented patients.

What has happened is that drugs shown to be effective in reducing amyloid plaque in animals have not succeeded in bringing that hoped-for improvement to humans experiencing symptoms of Alzheimer's. Moreover, pharmaceutical companies have traditionally been so eager to get their product to market in hopes of reaping huge profits they have gambled erroneously on drugs which, in the end, fail.

The drug Alzhemed which failed in 2007 clinical trials, disappointing Mr. Bellini, was given approval from Health Canada as a natural-health product in 2010, with a change in name to Vivimend, effectively giving it a bill of health as it were, as a natural health remedy for Alzheimer's. With natural-health products there is no need to prove effectiveness. Vivimend is a synthetic drug that mimics the active ingredient homotaurine, found in some seaweed.
warning signs.ENG

1. Memory loss that affects day-to-day function

2. Difficulty performing familiar tasks

3. Problems with language

4. Disorientation of time and place

5. Poor or decreased judgment

6. Problems with abstract thinking

7. Misplacing things

8. Changes in mood and behaviour

9. Changes in personality

10. Loss of initiative

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