An incorrigible perversion...for men

Last month, linked to Breast Cancer Awareness month, I emphasised a local South African product called Breast Protection Formula™ and its claim that it contains nutrients and plant extracts that help prevent breast cancer. As the US surgeon and breast cancer scientist David Gorski (MD, PhD) stated in commenting on the product:

“No, it does not [prevent breast cancer]. It contains nutrients and plant extracts that can inhibit the growth of breast cancer cell lines in tissue culture. That’s a very different thing.”

The same company, Solal Technologies (Pty) Ltd, also has a cancer prevention product for men: “Prostate Protection Formula™.” This product is described as “the first and only product in South Africa that combines all natural medicines, from herbal and vegetable extracts, scientifically proven to provide protection from … enlarged prostate and to reduce the risk of developing prostate cancer”. They further state that “Prostate Protection Formula™ supplies extracts in the concentrated forms and doses used in clinical trials and is safe”. (Emphases added.)

Prostate Protection Formula™ is recommended by the manufacturer-sellers for all men over 40 years of age who should take two capsules daily for prostate protection and healthy prostate function. (For the rest of their lives?) The dose can be doubled if an enlarged prostate or prostate cancer has already been diagnosed. The formulation is similar in several of its ingredients to Breast Protection Formula™, but is R8 a month cheaper (unless you’re taking the double dose for already diagnosed prostate disease).

Does it work though?
There is no (scientifically proven) evidence that the particular combination of nutrients and plant extracts in the particular concentrations contained in Prostate Protection Formula™ will reduce the risk of developing prostate cancer, or protect against an enlarged prostate. There is no evidence that taking a double dose if the problem already exists will have any beneficial effect. There is no evidence that any clinical trials have been undertaken using this exact product (or a “generic” equivalent) to test whether it works, or if it’s safe.

In considering the individual ingredients (extracts), purportedly supplied in the “doses used in clinical trials”, I have consulted the Natural Medicines Comprehensive Database (NMCD). This is widely regarded as a reliable, reputable and credible source of information — ironically, even by the manufacturer-seller of the Prostate Protection Formula™. There is no evidence in the NMCD that any of the ingredients have any definitive role in preventing (or treating) prostate cancer. It would seem that the clinical trials being referred to by Solal were not clinical trials of prostate cancer prevention (risk reduction) or protection against prostate enlargement.

Each capsule of Breast Protection Formula™ and Prostate Protection Formula™ contains Indole-3-Carbinol (I3C) 50 mg and Di-Indolyl-Methane (DIM) 50 mg respectively. As Dr Gorski points out “I3C is converted to DIM when taken orally” and further ” … it’s rather pointless to be including both of them in the same supplement”. This contrasts with the company’s statement about its formulations: “Formulated by doctors and pharmacists – scientifically-based, providing effective and safe products with the optimal ratios of components” and about its products’ “strength” or potency: “Contains optimal, therapeutic and scientifically-proven doses.” Clearly a more optimal formulation would have been to incorporate only DIM into each capsule and not include I3C at all. Especially if any therapeutic or proven dosage of DIM for reducing the risk of prostate cancer or preventing breast cancer had been demonstrated.

The statement on the company’s website that “unlike many other vitamin and supplement companies in South Africa, SOLAL Technologies is able to provide medical research to back up any claims that is (sic) made” therefore seems questionable. (Emphasis added.)

This statement of Dr Gorski’s about Solal’s Breast Protection Formula™ would in my view apply equally to Prostate Protection Formula™:

“… the product description … is a lesson in leaping from basic science and preclinical observations to producing a product and making claims for it based on early evidence.”

Solal was unable to substantiate (“back up”) its claims for Breast Protection Formula™ when asked to do so by the Advertising Standards Authority (ASA). I have lodged a complaint with the ASA about the claims made for Prostate Protection Formula™. It will be interesting to see if Solal can provide medical research to back up the claims that Prostate Protection Formula™ will protect men from enlargement of the prostate and reduce their risk of developing prostate cancer.

Prostate cancer is the second most common cancer in South African men with 1 in every 23 men being at risk of developing prostate cancer in their lifetime (0-74 years) according to National Cancer Registry (NCR) 2004 statistics. (1 in 34 Asian men; 1 in 48 black men; 1 in 13 coloured men; 1 in 10 white men.) Solal has different statistics according to a “poster” (on page “242” of a 50-page 70Mb “information pack“) that can be accessed from its website. They state that prostate cancer makes up one-third (33%) of all diagnosed cancers in men – presumably referring to South Africans. The NCR (2004) reckons the rate is almost 16% — less than half of Solal’s figure.

Referring to the data provided by the NCR the following discrepancies seem apparent (all errors in calculations are mine):

Solal’s estimate that 1 South African male in 10 000 under the age of 39 is at risk of prostate cancer seems to have been overestimated by about ten-fold;
Solal’s estimate that 1 South African male in 128 between the ages of 40-49 is at risk of prostate cancer seems to have been overestimated about 100 times;
Solal’s estimate that 1 South African male in 9 between the ages of 60-79 is at risk of prostate cancer seems to have been overestimated between 5 to 9 times.

As Solal do not give a source for their statistics, it’s not possible to verify their accuracy — or whether they are in fact derived from data for South African men.

In their poster about this product, Solal states that “an enlarged prostate is a risk factor for developing prostate cancer”. Untrue. The most common cause of an enlarged prostate is “benign prostatic hypertrophy”, which is not a risk factor for prostate cancer.

The Medicines Control Council (MCC) has accepted and acknowledged receipt in terms of the 2002 complementary medicines “call up” of a submission for Prostate Protection Formula™ as “a primary step in the registration process” for this product (Registry number 421755). The MCC would appear however to have not assessed this product at all although the “call up” states that “Council will review the claims of safety, quality and efficacy for all identified products and will determine whether any such claims constitute a public health hazard and act accordingly”. (Emphases added.) One can be fairly confident that had the MCC “reviewed” the ingredients of this product they would have noted that one of the ingredients is a Schedule 3 substance. This means the medicine’s claims may not be advertised to the public (not even on a website) nor may it be sold without a doctor’s prescription.

In summary, four major errors can be shown for the claims made by Solal about prostate problems and its Prostate Protection Formula™:

Unproven efficacy of the product;
Inaccurate rates of prostate cancer;
An incorrect risk factor; and
Advertising and selling in apparent contravention of the Medicines Act.

Note: The brand “Solal Technologies” is owned and licenced by CAVI Brands. The chief executive of Solal Technologies is a director of CAVI Brands, and the chief executive of CAVI Brands is the chairperson of the board of Solal Technologies. The first in the list of the “values” espoused by CAVI Brands is: “Acting with integrity and transparency in everything we do.” I would argue that the promotion of Prostate Protection Formula™ to all men over 40 years without evidence, as well as the errors listed above, is incompatible with “acting with integrity … in everything we do”.

Disclaimers: 1. I am under threat of litigation by Solal Technologies (Pty) Ltd for alleged “defamation and the publication of injurious falsehoods”. I deny these allegations and will not be gagged.

2. I am writing in my personal capacity. My views are not necessarily a reflection of the views of my employer, Rhodes University, or necessarily the views of the Allied Health Professions Council of South Africa, of which I am a council member.