I hate to admit it, but I’ve known about this story since Friday night, when I received a couple of e-mails about it. I had meant to mention it here either over the weekend or on Monday, but I’m a bit like Dug the Dog in the movie Up. Think of it this way: Squirrel!
Yes, I’m easily distracted. I shouldn’t have been, but I was this time.
I do, however, usually get back to business, and this is nasty business. In fact, it’s a type of business of the sort that completely enrages me and the sort of thing I’ve blogged about many times in the past, namely the use of legal thuggery by promoters of dubious health claims to try to shut up critics through lawsuits where they can’t win on the evidence. I’ve learned from a couple of sources, including the ever-inimitable Andy Lewis of Quackometer fame, that a skeptic named Kevin Charleston is being sued by a South African company, Solal Technologies for having called it out publicly for its pseudoscientific claims. In fact, it’s instructive to see exactly what Solal states in its lawsuit:
In the article published on the CAMcheck and Quackdown websites aforesaid, the Defendant says of the Plaintiff that it is “… a company that actively promotes pseudoscience …” (“The statement”).
Solal then claims:
The statement is wrongful and defamatory per se of the Plaintiff, and made with the intention of defaming the Plaintiff and injuring its reputation.
Particularly galling to Solal Technologies, apparently, is the subtitle of the CAMCheck website, “A South African Consumers Guide to scams, pseudo-science, and voodoo-science.” The folks who maintain this particular website sound like skeptics after my own heart.
Now, whenever I hear of legal thuggery of this sort, my first reaction is to look into a few of the health claims that resulted in the criticism in the first place. If, as is almost always the case, the claims are without adequate basis in science, I then gleefully pile on, because frivolous lawsuits designed to shut down criticism of quackery gall me. Given that it’s Breast Cancer Awareness Month, naturally, I can’t resist gravitating to breast cancer- and breast health-related claims, which led me to Solal’s Breast Protection Formula, which is billed as containing nutrients and plant extracts that help prevent breast cancer. Looking over the product description on Solal’s website is a lesson in leaping from basic science and preclinical observations to producing a product and making claims for it based on early evidence.
So what’s in the Breast Protection Formula, and what does Solal Technologies claim that it can do? Let’s take a look:
Contains nutrients and plant extracts that help prevent breast cancer: Calcium-d-Glucarate and Broccoli extracts (I3C and DIM) help the body excrete cancerous toxins and hormonal waste by-products. EGCG from green tea helps protect DNA from mutations; selenium, co-enzyme Q10 and vitamin D3 protect and boost immune function and help prevent cancer growth. Breast Protection Formula™ also contains other nutrients that support the liver’s detoxification of environmental and hormonal carcinogens
Oh, dear. The sellers of this particular supplement just couldn’t resist, could they? They just had to use the all-purpose quack catch-all claim, “boosts the immune system” and then add to it the other favorite quack catch-all claim, “supports detoxification,” whatever that means. Of course, Solal doesn’t tell us exactly how this supplement supposedly “boosts immune function,” what “toxins” it helps the liver eliminate, or how it “supports the liver’s detoxification of environmental and hormonal carcinogens,” but that’s no surprise. The claims are so vague as to be virtually meaningless and appear designed to bypass South Africa’s consumer protection laws the way the Quack Miranda Warning is designed to bypass American consumer protection laws.
As a breast cancer scientist and surgeon, I recognized immediately before I even read the rest of the product’s
propaganda information sheet main ingredients of this supplement are I3C (indole-3-carbinol), DIM (diindolemethane), and EGCG (Epigallo Catechin Gallate), although there are several other “active” components that supposedly protect against breast cancer. I recognize this because I happen to know an investigator who studies I3C and DIM as potential cancer preventative agents, and EGCG is the main ingredient in green tea that is thought to have potentially protective effects against cancer. And if you do a PubMed search on I3C and breast cancer, it doesn’t take long to find a bunch of articles that suggest that I3C might have anticancer effects. Ditto a PubMed search for diindolemethane and breast cancer. So Solal Technologies has a point, right?
If you examine the PubMed searches, what you will find is that virtually all of the studies that come up are preclinical. They’re either cell culture studies in which investigators put the extract on cells and measured various markers of apoptosis or cell growth and found indications that these compounds inhibit the growth of breast cancer cell lines, or they are animal studies. There are a handful of human studies, but they are pretty much all biomarker studies like this one, which is a biomarker study that looked at surrogate markers for breast cancer risk over the short term and do not show that taking these compounds long term as a supplement actually measurably decreases the risk of breast cancer in normal, otherwise healthy women. Interestingly, I3C is converted to DIM when taken orally. Solal Technologies even points that out in its literature on Breast Protection Formula. What Solal doesn’t point out is that if DIM is a metabolite of I3C and is active, then it’s rather pointless to be including both of them in the same supplement, but it probably seems more impressive. Instead, Solal Technologies throws a lot of impressive sounding science-y jargon at readers:
Indole-3-Carbinol (I3C) and its metabolite diindolemethane (DIM) are constituents of cruciferous vegetables. When I3C comes into contact with stomach acid it is converted into diindolemethane and indolylcarbazole. Researchers are interested in I3C and DIM for cancer prevention, particularly breast, cervical, endometrial and colorectal cancer. I3C and DIM has a variety of effects on the liver metabolism of toxins. Researchers believe the I3C and DIM are particularly protective against hormone dependant cancers such as breast cancer. I3C and DIM effects on the metabolism of both 16-alpha-hydroxyestrone and 2-alpha-hydroxyestrone. The 16-alpha hydroxyestrone metabolite has both genotoxic and tumorigenic effects and is thought to increase the risk of cervical and breast cancers. I3C and DIM shifts metabolism of estradiol from 16-alpha-hydroxyestrone to the weaker 2-alpha-hydroxyestrone metabolite, possibly producing a protective effect against hormone-mediated cancers. I3C also induces cytochrome P450 2B1,2B2,3A1,and 3A2,as well as phase II enzymes including glutathione S-transferase (GST), quinone reductase, and uridine diphosphate glucuronide transferase. The phase II enzyme induction seems to have a detoxifying effect by increasing water solubility and increasing excretion of carcinogenic toxins. There is some evidence that I3C might have other protective effects including antioxidant properties and might also cause cancer cell apoptosis and cell cycle arrest.
All of which is a highly convoluted say of saying that maybe I3C and DIM do something, but the evidence is all preclinical, cell culture and animal studies. It’s not ready for prime-time yet, and it’s certainly not ready to be sold as a supplement with the promise that it will decrease a woman’s risk of breast cancer. As Professor Roy Jobson points out, none of this stops Solal Technologies from recommending Breast Protection Formula for women who:
- Have breast cancer in the family, or
- drink more than one alcoholic beverage daily, or occasionally binge drink, or
- are taking oral contraceptives, or have done so within the past five years, or
- are on HRT (hormone replacement therapy), or
- eat tinned or canned foods, or
- are overweight.
Jobson also points out, and I agree, that there is no evidence that this particular witches’ brew of plant extracts and nutrients has any effect whatsoever on a woman’s breast cancer risk. Hilariously (and simultaneously sadly), when asked to support its claims with evidence, Solal Technologies argued that it is sufficient to show that some ingredients used in isolation may have an effect. That’s right: May have an effect. None of this stops Solal Technologies from claiming quite confidently and unequivocally that its product “contains nutrients and plant extracts that help prevent breast cancer.”
No, it does not. 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.
Perusing Solal Technologies’ list of products, I was struck at the sheer range of nonsensical claims the company makes for them. For instance, it markets a product called Craving Control that claims to “reduces addictive cravings for cigarettes, alcohol, recreational medicine and food.” It contains mainly tyrosine, 5-HT, and other nutrients, and the rationale Solal uses to argue for its effectiveness is very much like that used for Breast Protection Formula, only even more tenuously related to reality. Then there’s a product called Stress Damage Control, which claims to “prevent excessive cortisol and adrenaline production when exposed to long term stress” and to “protect the brain and heart from the dangerous physical damage and consequences that stress causes, such as raised blood pressure and heart attack.” The product contains a “proprietary formulation of:
Rosavin and salidroside (extracted from Rhodiola rosea), ashwaganda standardised extract, beta-sitosterol, alpha lipoic acid, thiamine pyrophosphate.” Evidence that it works to do what Solal Technologies claims it can do? None is presented. The list goes on and on, including claims that its products can treat HIV. For instance, its Bitter Melon is claimed to “inhibit the progression of some forms of cancer” and to be “beneficial for the treatment of (AIDS).” If you are at all familiar with South Africa, you’ll know that AIDS quackery has been a particularly vexing problem there, particularly with the influence of HIV/AIDS denialist Peter Duesberg and Matthias Rath’s selling of supplements to treat HIV.
Prof Roy Jobson and I, and others, have examined many of Solal’s claims and products and have found that much of the evidence is inappropriate, often distorted, applicable only to animal models, not reproducible, extrapolated from a specific study population to inappropriate populations, conflicts with many other superior studies. Indeed, their evidence often even flies in the face of consensus reports or evidence from internationally recognised credible experts. I can supply an example for each of these. It is no wonder that the ASA have ruled against many of the claims being made for their products.
In other words, Solal often stands alone in the interpretation of the evidence that they apply in support for their claims. Astonishingly Solal’s claims are often even contradicted by NMCD (Natural Medicines Comprehensive Database, a highly regarded review system for authoritative assessment of natural/complementary medicines. Solal confuse an association with a cause. They extrapolate from small studies in Japanese children to the population in general. They apply pseudoscientific arguments. They use methods contrary to the principles of evidence based medicine which are utilised throughout the world by all credible scientific universities and research establishments including all reputable South African centres of higher learning.
In other words, Solal Technologies is very much like the most dubious supplement manufacturers we have in the United States.
It’s also very much like them in its propensity for trying to silence its critics through abuse of the legal system rather than through evidence. For example, it is demanding R350,000 from Charleston. Fortunately, Charleston has help. The Treatment Action Campaign (TAC) will be supporting him. As Andy Lewis points out, the TAC is a formidable ally that has a history of having helped to ensure that the the people of South Africa continue to have access to proven anti-retroviral treatments “despite appalling opposition from quacks both inside and outside of the government.”
If I’ve pointed it out once, I’ve pointed it out a thousand times. Quacks do not like to be criticized. When they are criticized, particularly on the basis of evidence and science, their first reaction is not to try to refute that criticism with evidence of their own. Rather, it is to attack and smear the person criticizing them. If that fails to silence critics, then the next step on their part is frequently to sue. They are bullies who rely on their superior resources to intimidate and silence. That is why Kevin Charleston is to be commended and supported in his fight against Solal Technologies.