There’s a growing range of products that claim astonishing results in aiding general health or treating often- incurable diseases, and highlighting their connections with the faith of the Church. But can they really deliver? Maybe – maybe not. Such products include complementary medicines or dietary supplements and appear to claim success where science has either failed or not yet succeeded. Deirdre Fleming looks at some recent appearances and reflects on whether their astonishing claims can be scientifically verified.
By Deidre Fleming
When Amy was pregnant with her second child, Benjamin, she noticed that a mole on her leg had increased in size. It turned out to be melanoma. That was five years ago and since then, Amy has undergone surgery, chemotherapy and radiotherapy. Not only has Amy received the conventional cancer treatments but friends have also encouraged her to try various alternative therapies.
"Faith drops for instance. So many people have put a lot of pressure on me to use these because ‘it’s this miracle cure.’"
The friends who tried to convince Amy to use Faith drops are described by her as “very religious Catholics.” She observes that "somehow they have the perspective that conventional medicine is the greater evil and that God gave us everything that we needed in nature. My argument was that that’s a New Age ideology."
People struggling with cancer are often swamped with suggestions from well meaning friends about treatments that hold out hope for their recovery. How is one to separate the wheat from the chaff when assessing possible remedies, especially when every treatment carries with it an opportunity cost? With a limited amount of money to spend, which treatment is the most beneficial?
And what is one to think when cancer cures claim to have the support of the Church? In January this year, Zenit, the Catholic Newsagency which specialises in reporting on the Holy See, ran an article on a product called CellAdam which purportedly had a “75 per cent success rate in treating cancer”.
In an interview with Zenit reporter Edward Pentin, Maria Delgarno, public relations officer for the company behind this product and also a member of Focolare, said, "We feel in a lot of ways that Our Lady has really inspired us. We put our work daily under the protection of Our Lady."
According to Zenit, the manufacturers of CellAdam, Biostemworld, were negotiating with a religious order which "has 400 cancer researchers in Italy to carry out human and animal research on the medicine."
Due to commercial sensitivities they wouldn’t name the order, and attempts by The Record to contact them since have elicited no response.
Another product, Avemar, also uses divine intervention as a selling point. According to the alternative medicine magazine, Townsend Letter, the developer of this product, Mate Hidvegi, “being a devout Catholic, prayed to Mary, Mother of God, for guidance and an investor: ‘Ave Maria, if it is your will that this research should be continued, please send an investor.’” The next day, an entrepreneur whom Dr Hidvegi had never met offered him the necessary funding. In thanks, he named his new product “Avemar.”
Its Australian website cites "more than 100 published papers" which review the extract and have been published in "prestigious journals."
It then links to pages of research data on the compound’s anti-tumour, anti-metastatic and immunomodulatory effects, with the obvious implication that this product is a successful cancer treatment. There are two ways for Catholics to respond to such claims: one is to accept them on trust simply because of their invocation of divine assistance.
The other way is to take the advice of Jesus in Matthew 10:16 when He said, "Look, I am sending you out like sheep among wolves; so be cunning as snakes and yet innocent as doves." Or, as CS Lewis put it in Mere Christianity, "Many Christians have the idea that, provided you are ‘good,’ it does not matter being a fool. Christ never meant that we were to remain children in intelligence: on the contrary the fact that you are giving money to a charity does not mean that you need not try to find out whether that charity is a fraud or not."
Obviously the same applies to medical claims. The only trouble is that most of us do not have the ability to assess the reliability of a medical claim. Let’s use these two examples of so-called cancer treatments to give some guidelines about checking the facts.
1. Seek professional advice
According to Professor Gavin Frost, Dean of Medicine at Notre Dame University, Fremantle, if patients are offered a questionable cancer treatment, their first step should be "to seek the advice of their cancer specialist."
By this he means "someone who has undergone probably 15 years of training as a specialist in cancer. Specialist training occurs around six years after you graduate from medical school – and probably longer – and (involves) an additional three to four years." Therefore a chiropractor, naturopath or any other health professional does not qualify unless they have undergone equivalent training.
2. Find out if the drug is listed
Is the drug listed by Australia’s Therapeutic Goods Administration (TGA). "If it’s a complementary medicine and if it’s making a therapeutic claim, then it needs to be on the Australian Register of Therapeutic Goods in order to be supplied to the public," explains an advisor with the TGA. According to her, neither CellAdam nor Avemar is listed.
That does not mean you can’t use them – you can buy them for personal use but it is illegal to sell them to others. "It’s actually really to allow the public to have access to medicines that are not available in Australia – or I guess it’s more about respecting the patient’s right to import. A person can import any therapeutic product that they wish to provided that it’s not included on the Prohibited Imports List that is administered by Customs." So why is Avemar being marketed in Australia by the Queensland company, Medimpex? Surely they have heard of the TGA’s requirements?
3. What is in these products?
Avemar is a fermented wheat germ extract while CellAdam is variously described as a fatty acid complex and a lipopolyamine complex extracted from sunflower and soy.
These products fit into that group of reasonably new, ten-year-old group of foods which claim some pharmaceutical, drug-like properties, the so-called nutraceuticals. And it is also clear that most of the regulatory authorities don’t know what to do with them. Since they are extracts of common (and easily available) foods, one wonders why their price tag is so high.
4. Research the studies
The link to research papers on the Avemar website produces dozens of seemingly scientific references, some of which have certainly been published in technical journals. Intriguing phrases abound, such as "attenuates the growth of sensitive and 5-FdUrd/Ara-C cross-resistant H9 human lymphoma cells through induction of apoptosis."
The most important questions, however, are whether there have been any Phase III clinical trials that are (a) randomised; (b) double-blind and (c) placebo controlled?
Randomised means that the drug is randomly allocated to subjects. ‘Placebo controlled’ means that half of the subjects will receive a harmless sugar pill and half will receive the test drug.
Placebo-controlled studies counter the placebo effect where the patient’s expectations of the drug’s effectiveness can influence his or her reaction to it.
"We know up to 30 per cent of people will be better if you give them an unnamed medication which actually contains no active ingredient," explains Professor Frost.
Double-blind indicates that neither the doctor nor the patient knows whether the drug being administered is the test drug or a placebo.
A Phase III study is a large scale study which has been carried out to determine a drug’s effectiveness compared with whatever the current ‘gold standard’ of treatment is considered to be. This usually involves 300 to 3000 people. To obtain approval from the TGA in Australia for conventional pharmaceuticals, there must be at least two successful Phase III trials demonstrating a drug’s safety and efficiency.
For complementary medicines, however, (into which category both Avemar and CellAdam would fit) the situation is less clear. For example, with traditional medicines, the applicant may only need to provide evidence that the substance has been used traditionally for a specific health-related purpose for at least three generations.
As far as can be ascertained at the time of writing no clinical trials have been carried out on CellAdam
Sifting through the 100 or so published papers on Avemar, however, I found two papers that could be classed as clinical trials, one researching its effect on rheumatoid arthritis and one investigating its effect on high-risk skin melanoma patients (see table). Neither of these was a Phase III or definitive study and both were open-label, ie both the doctors and the patients knew what they were receiving. Therefore, the findings take no account of the conditioning effects which are known to occur in non-blinded studies.
In addition to this, it is important to note that the application of Avemar in the melanoma study involved only 26 subjects and was used as a concurrent therapy together with chemotherapy but it did not replace the chemotherapy.
"There are a couple of questions as a professional I would ask," says Professor Frost.
“Is that difference significant given the small number of people involved? Otherwise, it’s a bit like saying he tossed coins and got three heads; I tossed coins and got two heads. Well, you know, if we’d kept tossing, things might have been very different. Professor Frost also noted that the sample size was small.
“I would like to know how the people were chosen for each group: were they randomly allocated or did they, by design or by chance, choose to place people with a greater likelihood of long term survival into one group rather than the other?
“For example, if one group was bedbound and given the apparently active ingredient then they’re not the same group as the people who walked to the surgery to get it. There are all these things we would look at in research methodology to see if you’re comparing like with like before they make sweeping statements like 44 months (overall survival) in one group and 66 in the other. Is that a real difference? I don’t know. The results for the treatment group fit within the confidence interval of the control group which means that it is possible that some of the people in the control group – those without the Avemar – might have done just as well."
Furthermore, the rheumatoid arthritis study using Avemar was carried out by the manufacturer of the drug and has not yet been confirmed by a study independent of the manufacturer. The melanoma study does not disclose who the study’s sponsors are. Add to this the fact that both clinical studies have emanated from Eastern Europe (Hungary and Russia), an area of the globe not renowned for regulatory robustness, making the picture more cloudy. Further independent studies carried out in places such as Europe, Australia, Japan or the US, for example, would assist potential users to reach conclusions.
According to the Therapeutic Goods Advertising Code 2007, advertisements (including labels) for therapeutic goods must not contain, expressly or by implication, a representation regarding the treatment, cure or prevention of neoplastic (cancerous) diseases.
The only exception to this is the claim usually found on sunscreen lotions regarding the prevention of skin cancer by the use of 15+ sunscreens.
As mentioned above, Avemar’s Australian website links to dozens of research papers describing Avemar’s trials in cancer treatment. The website also uses in its head tags – words used by internet search engines to find sites – a host of words related to cancer treatment.
"I’d have to have it investigated," we were informed by Neil Branch from the Federal Health Department when we queried the legality of this.
"If they’re in breach of law I’d have to take legal advice on that and also speak to the investigations unit of the TGA and the Advertising Standards Council."
According to the TGA advisor, "if they’re saying it’s supposed to help with health and wellbeing, that’s not really making a therapeutic claim; that’s not saying it’s treating cancer, etc so there is a grey area in terms of how they’re making the claim. It depends on how good they are at sidestepping the Advertising Act."
6. Check the price
One can reasonably assume that if one is being charged a seemingly high amount for a fermented wheat germ extract – not usually considered technically challenging from a manufacturing perspective (for example, Vegemite) then the product may be untrustworthy in other areas as well. Medimpex’s website advertises Avemar at $239 for a pack of 30 x 17g, which amounts to $469 per kg. Celladam is even more expensive: US$65.50 for 15ml, which comes to $4,367 per kg – not your everyday sunflower oil.
The Catechism of the Catholic Church’s exhortation that "recourse to so-called traditional cures does not justify … the exploitation of another’s credulity" (2117) would probably apply equally to complementary medicines and pharmaceutical quackery in general.
It is one thing to exploit another’s gullibility but an order of magnitude worse to exploit those who are already weakened by illness. Fortunately, Zenit issued a disclaimer a few days after the original CellAdam report by journalist Edward Pentin, saying that Zenit "cannot and does not officially endorse the treatment" and that the writer "had been impressed by the faith and sincerity of the company’s Catholic directors."
The lesson is that those impressed by apparently remarkable medical cures should always be cautious, prudent and wary. While the reports may be correct, they also might not.
Chaucer’s corrupt 14th century Pardoner makes money by preying on the poor with his fake relics, which included pigs’ bones.
“And in a glas he hadde pigges bones.
But with thise relikes, whan that he fond
A povre person dwellynge upon lond,
Upon a day he gat hym moore moneye
Than that the person gat in monthes tweye;
And thus, with feyned flaterye and japes,
He made the person and the peple his apes.”
In fact, it is surprising that there are not a great number of unscrupulous businesses exploiting the ready-made Catholic market of around one billion souls. Having fallen into the modern myth that faith and reason are incompatible, purveyors of snake oil assume that the corollary of this is, "If Christians believe in miracles, why not miracle cures?" But, of course, when we hope for miracles, we should not expect them to come with a price tag.
Deirdre Fleming is a former Science educator currently undertaking postgraduate studies in Public Health at Curtin University in Perth.