Vivimind, Evidence, and Ethics

I’m constantly amazed by what the sellers of “natural” health products get away with. The pharmaceutical industry, rightly, is subject to considerable scrutiny. But if you’re selling something labelled as “natural,” no one seems to give a second thought to actually examining your claims to be able to work wonders on the human body.

Well, almost no one. Check out this nice posting by Scott Gavura, at the Science-Based Pharmacy blog: Vivimind: Forget About It

You’ve seen the billboards for Vivimind across Canada. Remember them? Targeting an aging population of boomers, Vivimind is touted as a “scientifically proven” natural health product that “protects memory function”. The website goes to great lengths to promote that Vivimind is both “scientific” and “evidence based”. So let’s take a look at what sort of science supports the claims for Vivimind….

First, Scott gives us a bit of history:

Vivimind was once a promising prescription drug. It was called Alzhemed, and was hoped to be a breakthrough treatment for Alzheimer’s disease. Alzheimer’s disease is a neurodegenerative process, where amyloid plaques form in the brain, leading to dementia. It was proposed that Alzhemed might reduce the deposits of plaque, slowing progression of the disease.

So, what does science have to say about Vivimind?

Two major phase 3 trials were subsequently launched to test if Alzhemed could be an effective treatment for Alzheimer’s disease. Unfortunately, the results showed that patients taking Alzhemed did no better than patients taking a placebo. The FDA concluded that the results could not support a claim of clinical efficacy – that is, the manufacturer could not claim the drug worked. A European trial of Alzhemed was subsequently discontinued before the results were reported.

Case closed for Alzhemed? Not quite. After the failure of the phase 3 trial, where Alzhemed was shown to be ineffective, the manufacturer announced its intention to bring the product to market – but not as a treatment for Alzheimer’s. Nope – they were going after a bigger market – people with age associated memory impairment. And forget about all that pesky evidence and data the FDA wanted. Since approval of Alzhemed as a prescription drug to treat Alzheimer’s disease seemed out of the question, the manufacturer, Neurochem, decided to market it as a natural health product. The company changed its name to Bellus Health, and renamed the product Vivimind.

It didn’t work on Alzheimer’s, and there are no published studies on whether it works on more minor forms of memory impairment.

So, basically, Vivimind is a product that failed as a prescription drug, and is now marketed — without any evidence that it works — to people who don’t know any better. Sound ethical to you?

Now, it may not be that Bellus Health is flogging a product they know doesn’t work. Maybe that’s an uncharitable assumption on my part. But what are the other options? That they don’t care about evidence? Or that they’re deluded about the evidence? Ask yourself: is any of those possible scenarios comforting, when a company is selling you pills?

3 comments so far

  1. jpbauer on

    Hello Professor Chris MacDonald

    In some of these reports, it is written that the proposed drug performs no better than a placebo, but is it not true that the proposed drug has some positive medicinal/health effect?

    Of course, who would purchase an item in the first place which is identified on its label as a fake substance or quasi-placebo type drug. So as I see it, the dilemma is this: does Big Brother make illegal the sale of substances that have no harmful side effects but do not outperform placebos, or does it allow the marketing, distribution and sale to occur, but requires better warnings on the product labels to enable purchasers to make informed choices.

    Thanks for your excellent blog articles – they raise excellent issues and points which need to be explored and looked at in the context of our daily lives and experiences.

    Best regards,

    jpbauer

  2. Chris MacDonald on

    jbauer:

    Thanks for the comment.

    But I think, yes, we do want government protecting us from companies that try to sell us things that don’t work — even if that just means “don’t work better than placebo.” Placebo = fake. When something doesn’t work better than placebo, that means it basically IS a placebo, and its ingredients are useless. Any time someone swallows a pill in the belief that it will help them, it can end up doing so to at least some extent, just through the power of suggestion. That’s the placebo affect: it doesn’t happen for everyone, and it wears off. People have a right to know whether they’re buying a something that could actually help them in the long run, or not.

    Chris.

  3. Suresh Kumar G on

    Hi,
    This appears to be another case of caveat emptor. Are there no legislations preventing the sale of such useless items? Or are natural products immune to such legislation? Anyway, this appears to be a suitable case study.
    Suresh.


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