Prostate Cancer: Canadian Scientiferousness & Skeptical Action

Last year, I took a look at a product called ProstaCaid, which bills itself as “a comprehensive prostate formula that targets prostate cancer and promotes healthy prostate cells.”  The product caught my eye after its creator tweeted about “Research on new prostate formula that naturally combats #prostatecancer!” but when I checked the data it came up wanting.

Since the company that makes ProstaCaid is in the States, that was about all I could do – I simply wrote the piece and let Google do its work (it’s currently one of the top search results, which is quite gratifying).  But this week, I stumbled upon a similar product from a Canadian company, and decided that a bit more activism was called for.

The product is called Provize (aka Pro-5x), and is manufactured by Nature’s Method in Surrey, B.C.   It’s an extract of Small Flowered Willow Herb that promises, among other things, to prevent prostate cancer.  Let’s start with the research.

Prevents 100% of prostate cancers. If you live in a beaker.

Once Upon a Test Tube in Vancouver

The site touts a study done at Vancouver General Hospital that looks quite impressive, with multi-colored graphs and very scientiferous language.  I’m not trained to sort through the details of what it purports to show, but that’s not really necessary, because only two words on that page are actually important: “in vitro”. It’s test tube research, not a clinical trial, and accordingly the only meaningful thing we can glean from it is whether Small Flowered Willow Herb is a good candidate for further research.  It certainly does not indicate that this product will prevent prostate cancer.  Indeed, to market a product making such a claim on this research alone would be so irresponsible that I naturally assumed there must be better quality research out there, and started looking for it.

Might the Canadian Cancer Society be able to help?  Nope.  Their prevention pages are all about boring stuff like healthy diets and exercise.

Prostate Cancer Canada?  Not there either. Though they helpfully summarize the research on everything from Hormone Therapy and Vitamins to Green Tea and Garlic, Provize and its constituent ingredients go unmentioned.

PubMed? I found twelve studies on the active ingredient, none of which appear to address prostate cancer prevention. It’s perhaps of note that almost all of the studies come out of Eastern Europe, where Small Flowered Willow Herb is a common folk remedy for benign prostate enlargement. That’s benign with a B, not cancerous with a C.

Strangely, the one piece of research I did not find on PubMed was the study on the Provize website.   Puzzled, I called the company to ask for the citation, and was told to contact the owner of the formula, Dr. Paul Hornby, who wrote:

Erik,

This data was never published in a peer reviewed journal…at least, not to my knowledge.

The work was done, as stated on the website, at the Jack Bell Institute, here in Vancouver.
It was commissioned by myself and sponsored in part by an IRAP grant.
The actual laboratory work was carried out by Dr. Emma Gunns, who is an old colleague
of mine. To be honest, i am not sure why we originally did the experiments other
than the opportunity presented at the Bell prostate center.

But to answer your question, the only publication we saw around the work,
was an article in the local newspaper and therefore i cannot direct you
to a scientific citation.

Paul

I Love the Smell of Activism In The Morning

So the research for this product amounts to one unpublished test tube study, yet the company claims that it prevents prostate cancer. This claim actually surprised me coming from a Canadian company, since despite my criticisms of our Natural Health Products Directorate, cancer claims are one area that Health Canada is pretty careful about.  It seemed unlikely they would let this pass, so I checked the database, and indeed, this product does not yet have a Natural Product Number (NPN).  Rather, they’re one of the thousands of products with an Exemption Number (EN-123183).

Prostate Cancer is like a beautiful flower: it can be crushed by Nature's Method

For the uninitiated, the EN system is a particularly reprehensible regulatory kludge whereby Health Canada is allowing natural health products into the market without first establishing that they conform to the (already far too lax) NHPD guidelines — because they’re too swamped to approve all the applications in the queue received.  To justify this massive failure to meet their statutory (and arguably, fiduciary) obligations, they did a cost-benefit analysis that weighed the cost of lost revenues and jobs if they fully implemented their own regulations as written.  Unfortunately, they didn’t weigh consumer protection on the other side of the scale, and it’s not too hard to draw a straight line from there to the unsupported cancer prevention claims of Provize. Clearly it was time for some skeptical action.

For someone looking to complain about the marketing claims of a natural health product, there are at least three potential avenues:

1. Health Canada — provides its own consumer complaints process for regulatory violations

2. The Competition Bureau – provides a complaint process for violations of the Competition Act, which includes misleading advertising and labeling provisions

3. Advertising Standards Canada, the advertising industry’s self-regulating body, provides a complaint process for violations of the Canadian Code of Advertising Standards

Since this was my first time formally complaining about a natural health product, I decided to make the complaint to all three so I could compare the results. I prepared a general overview designed for all three complaints, as follows:

It has come to my attention that Nature’s Method of Surrey, BC is marketing an extract of Small Flowered Willow Herb under the trade name Provize (aka Pro-5x) that it claims prevents prostate cancer. This claim appears to be scientifically unsubstantiated, and in my opinion, the company is engaging in misleading advertising. I base this conclusion on the following points:

1) The research the company puts forth as proof of its prostate cancer prevention claims is a single in vitro study. Such preclinical trials may be useful in directing further research, but it is ethically dubious, and very possibly dangerous, to base treatment advice on such limited evidence.

2) Additionally, this research was not published in a peer reviewed scientific journal, nor to my knowledge in any journal at all. I can find no evidence that it was ever replicated.

3) A search of PubMed for research on the active ingredient in Provize finds 12 studies, none of which provide any evidence of prostate cancer prevention.

4) Neither the Canadian Cancer Society, nor Prostate Cancer Canada, list this product or its active ingredient among known cancer prevention methods.

The following references can substantiate the above:

  • The Nature’s Method website at http://www.naturesmethod.com/ includes the claims and so-called “research”. Screen captures of the most relevant pages for this complaint have been posted to Google Docs at: https://docs.google.com/leaf?id=0B_VMOd3lM6SjNmRhMmIwMjUtMmIxMS00N2Q2LWI3ODEtZGIxOTFkZTY4N2Q5&hl=en in the event the original site is changed after this writing.
  • PubMed search results for the Provize active ingredient: http://www.ncbi.nlm.nih.gov/pubmed?term=Epilobium%20parviflorum
  • Canadian Cancer Society’s prevention page: http://www.cancer.ca/Canada-wide/Prevention.aspx?sc_lang=en
  • Prostate Cancer Canada’s prevention page: http://www.prostatecancer.ca/Prostate-Cancer/About-the-Prostate/Prevention

To this general overview, I added the following information specific to each complaint body:

For the Competition Bureau

I believe the above claims violate Paragraph 74.01(1)(a) and 74.01(1)(b) of the Competition Act, prohibiting the making of misleading and unsupported claims (respectively). Further, I believe their test methodology is inconsistent with that outlined by the Bureau on its website at http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/00520.html, in that the test was not replicated and the controls are unspecified. I respectfully ask the Bureau to investigate, and if appropriate, remediate, these claims.

For Health Canada

Note this product does not have a Natural Product Number but does appear to have an Exemption Number as follows:

EN-123183  SmartCast Inc. dba Provize Laboratories  PROVIZE  Capsule  Valid  2010-08-12

I understand that means that these claims have not yet been evaluated by Health Canada. Clearly, they need to be, and I respectfully ask Health Canada to investigate, and if appropriate, remediate, these claims.

For Advertising Standards Canada

I believe these claims violate Provision 1 of the Code (Accuracy and Clarity), specifically sub-provisions (a) and (e) in that the claims are both inaccurate and unsupported, given the existing state of the research.

Further, I believe these claims violate Provision 8 of the Code (Professional or Scientific Claims ) by implying that the product has a scientific basis that it does not truly possess. I respectfully ask Advertising Standards Canada to investigate, and if appropriate, remediate these claims.

I think it will be interesting, and perhaps instructive, to see what sort of action these organizations take in what appears (to me at least) to be such a clear case.  Watch this space for updates!

Images courtesy of stonebird and deemikay, via Flickr under Creative Commons.

14 Responses to “Prostate Cancer: Canadian Scientiferousness & Skeptical Action”

  1. daijiyobu says:

    Hulk angry, Hulk smash.

    Very interesting.

    -r.c.

  2. Jeff Orchard says:

    Well done. I can’t wait to hear the results.

  3. Mozglubov says:

    I know Canada is not nearly as litigious as the States, but I’m still surprised that companies making these sorts of claims aren’t open to class action lawsuits from anyone using their product who actually does develop prostate cancer (or whatever it is the particular product claims to prevent).

  4. Nice work, Erik. Looking forward to hearing more on this!

  5. Savage says:

    The part that would be relevant to NHPD would be the Canada’s Food and Drugs Act. This product could be violating 3(1) of Food and Drugs Act which states: “3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.”
    http://laws-lois.justice.gc.ca/eng/acts/F-27/page-2.html

    Cancer is a certainly a disease that is refereed to in Scheduled A.
    http://laws-lois.justice.gc.ca/eng/acts/F-27/page-17.html#h-18

  6. I took a look at the graphs on the Nature’s Path website. As you said, the studies were in vitro and in no way applicable to humans. One thing that did pop up to me was that in graphing cell viability against willow herb concentration, there was no difference between the response by ‘normal’ cell than the ‘cancerous’ cell. The viability of all cells was decreased.

    If the study were applicable to humans, it would mean that we would die in order to kill the cancer. Effective, but not very useful.

  7. Epinephrine says:

    Any luck?

    Curious as to how well this is working, as I’ve made a few complaints that have gone nowhere on other issues.

    • Erik Davis says:

      So far, I’ve seen acknowledgment letters from all three. The only one that has gotten back to me with anything substantive was the Ad Standards Bureau, which indicated it was outside their jurisdiction since prostate cancer products are covered by the Food & Drug Act. I’ve asked for clarification of that position.

  8. Randy O. says:

    The reason Prostacade may work is contained in today’s Johns:

    “Experts now estimate that up to 90 percent of cancers of the prostate may have a dietary link.
    -New evidence that the progression of prostate cancer may actually be slowed by dietary changes. One study published in the Journal of Urology found that tumor cells from men taking flaxseed in combination with a lowfat diet appeared to be growing more slowly and dying more quickly than those of the control group.
    -Two types of foods that should be included plentifully in the diet of anyone at risk for prostate problems — or experiencing them.”
    Prostate cancer is unique and ultimately the future treatments for prostate cancer will be different that what people like the skeptic here can understand. As I mentioned in my reply (which you have not posted), I have had prostate cancer and opted for immediate standard treatment. But I have embarked on a deeper study of the state of knowledge relative to prostate cancer.

    You do a disservice to people when you don’t fully understand what you are addressing.
    I don’t take Prostacade, but I believe there is important information in the studies related to dietary control for certain cancers…possibly prostate cancer and breast cancer.

    • Erik Davis says:

      Randy, your comment was posted yesterday, but it was for a different article.

      I’m not sure what connection you’re trying to draw between Prostacaid and the above quote. ProstaCaid is not flax based, nor is it a lowfat diet. And again, my only complaint about it is that the marketing is incommensurate with the research. You cannot base cancer treatments on test tube results — especially for prostate cancer, where conventional treatments have a 96% 5 year survival rate.

      Honestly, with those kind of numbers, I’d argue any alt-med treatment is Russian Roulette — and especially one that hasn’t gone through any phased clinical trials.

  9. Mike F says:

    Obviously there are people out there who don’t quite understand why clinical trials are necessary to establish the efficacy of any treatment. Two excellent sources of information are the National Cancer Institute at http://www.cancer.gov/clinicaltrials as well as MedlinePlus at http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

  10. Paul Buhler says:

    Erik,

    since you had received the acknowledgements regarding your concerns about Provize from Health Canada and the Competion Bureau, has there been any further action on their part to deal with the situation?

Trackbacks/Pingbacks


  • Erik Davis

    Erik is a technology professional based in Toronto, focused on the intersection of the internet and the traditional media and telecommunications sectors. A reluctant blogger, he was inspired by the great work Skeptic North has done to combat misinformation and shoddy science reporting in the Canadian media, and in the public at large. Erik has a particular interest in critical reasoning, and in understanding why there’s so little of it in the public discourse. You can follow Erik's occasional 140 character musings @erikjdavis