One of the cardinal sins of any researcher is to tamper with their data to make them ‘fit’ the results they were wanting. A recent international example is that of Dr Andrew Wakefield, who published articles in the reputable Journal ‘The Lancet’, which apparently showed a causal link between the MMR (measles, mumps, rubella) vaccine and autism. Fortunately his deception was uncovered; he was struck off the roll of the General Medical Council in the UK; and The Lancet retracted his articles. The tragedy is that many people did not have their children vaccinated because of this deception, and a number of these unvaccinated children went on to develop measles and some even died. Others may have to cope with the consequences for years to come.
Hot on the heels of the sin of such deceptive fraud must surely be when other persons’ legitimate research results are misrepresented to promote a product (or medicine) for the purposes of self-gain.
Solal Technologies sells a product called I3Complex™ which it claims to be a ‘Cancer risk-reducing and protection formula for men and women.’ Under the heading ‘Who should use I3Complex™?’ (emphasis added) it is recommended that all people over the age of 40 can use it to reduce the risk of getting cancer. It further recommends that all people with a family history of breast cancer, high risk individuals, and women on hormone replacement therapy should use it as a preventive therapy. It is also claimed that although it should not be used in combination with radiation therapy, it can be used in combination with cancer medication and chemotherapy as part of a cancer treatment protocol. See: http://www.solaltech.com/new/shop/index.php?act=viewProd&productId=136 and http://www.solaltech.com/onepage/I3Complex_One%20Pager.pdf [NB: This webpage has become inaccessible since this article was first published.] However a copy of it (as fair use) can be found here for your information. (Press browser "back" function to return to article; or right-click and open in a new tab or window.)
The label of the product states that ‘Ideally I3Complex™ should be used preventatively and continuously, for cellular protection.’ (emphasis added) The dose for adults and children over the age of 12 is 2 capsules a day. A month’s supply cost R375.00 on 3 April 2011. See: http://www.solaltech.com/newonepagers/I3Complex.swf
On the full page referred to above (pdf) are two pie charts under the heading ‘Inhibition of growth in estrogen receptor-positive breast cancer cells.’ One chart shows the inhibition by I3C (indole-3-carbinol) to be 90%. I3C is a substance found in cruciferous vegetables such as broccoli and it is one of the main ingredients in Solal's I3Complex™. The other shows the inhibition by tamoxifen to be 60%. Tamoxifen is a medicinal chemotherapeutic agent used in treating breast cancer. It appears from these graphics as if there is a marked 30% difference between these two therapies and that I3C is much more effective than tamoxifen.
The reference is ‘Adapted from Cover, et al, 1999.’
The only article I could find by Carolyn M Cover and her colleagues which tested I3C and tamoxifen was published in the journal Cancer Research, Volume 59, pages 1244-1251 dated March 15 1999. The title is: ‘Indole-3-Carbinol and Tamoxifen Cooperate to Arrest the Cell Cycle of MCF-7 Human Breast Cancer Cells.’ From the title it is clear that the main purpose of the research was about how the two substances worked together, not separately; and it is also clear that the study was not done in living human beings with breast cancer but in ‘MCF-7 Human Breast Cancer Cells’. (MCF-7 stands for 'Michigan Cancer Foundation-7'. Michigan Cancer Foundation obtained the breast cancer cells in 1970 from a 69 year old nun, Sister Catherine Frances, who died that year.)
The main finding of the research was to show that I3C and tamoxifen act in different ways ‘to [together] suppress the growth of human breast cancer cells.’ The authors hypothesised that the combination might represent a possible future therapy for estrogen-responsive breast cancer. However it seems that no further advances in researching this possibility have been published since 1999.
Part of the study involved testing the effect of each substance on its own in order to compare them with the overall effect when they were combined. The effect of I3C on its own was to inhibit DNA synthesis by 90% after 96 hours (4 days), and colony formation (or growth) of the cancer cells by 80% after 8 days. The effect of tamoxifen on its own was to inhibit DNA synthesis by 60% after 96 hours, and colony formation of the cancer cells by 65% after 8 days.
So the seemingly marked 30% difference shown in the pie graphs published by Solal do not in fact reflect ‘[i]nhibition of growth in estrogen receptor-positive breast cancer cells’ as stated by them, but the extent to which DNA synthesis was reduced in the breast cancer cells. (The cells had to be dissolved, the DNA extracted and the amounts of DNA measured, which is not the same as measuring the reduction in the formation of cancer cell colonies. Reduced DNA synthesis does not necessarily correlate linearly with inhibited cell growth.)
The actual inhibition of growth in estrogen receptor-positive breast cancer cell colonies showed a difference of only 15% between the I3C group and the tamoxifen group after 8 days. One wonders what would happen after another 8 or 16 days — would there be any difference at all? And what would happen in real living people?
I am deliberately re-emphasising that this research quoted by Solal was done only in breast cancer cells grown in a laboratory setting, and not in human beings. It is not possible to extrapolate any findings from this study from cells to human beings. There is a difference between 'adapting' findings from a research article but keeping their correct meaning, and 'distorting' those findings in a way that is not in keeping with the published results.
Of further greater concern is whether there is any evidence at all that the specific product ‘I3Complex™’ (or even a generic version of it with exactly the same ingredients and excipients) has been proven to reduce people’s cancer risk; or to prevent cancer; or whether it indeed has any beneficial effects when used in combination with cancer chemotherapy. Surely Solal had a responsibility to initiate or sponsor the research before marketing the product or to at least provide data from human studies using a product with the exact same combination of ingredients? Does the fact that I3Complex™ is ‘trademarked’ mean that there is no other comparable product anywhere in the world? And does that mean it has never been tested in humans?
As an aside, it is interesting to note that the 'pharmacists who care' — Dischem — are listed at the bottom of the one-pager information sheet referred to above, as selling this Solal product. Are the Dischem pharmacists convinced that this product in fact reduces the risk of cancer or prevents cancer in people using the product? If they are convinced, I wonder what evidence they used. If they are not convinced, I wonder why they are selling the product.
Another thought: could a person who has been taking I3Complex™ but who subsequently develops cancer be awarded damages in terms of the Consumer Protection Act?
This analysis was prepared by Professor Roy Jobson. Professor Jobson is a medical doctor and an Associate Professor of Pharmacology in the Faculty of Pharmacy at Rhodes University. He has previously served as a Council member of the Medicines Control Council (MCC), was the inaugural Chairperson of its Pharmacovigilance Committee, and was also a member of its Clinical Trials and Complementary Medicines Committees. His analysis of this product does not reflect an official viewpoint of any of these institutions.