Colleen (from Faith drops) added a comment to the posting of the ASA ruling against the claims of Faith drops. As the comment is far too long, I have added it as a posting.
Colleen (from Faith drops) writes:
To Harris / Geffen / Roy Jobson…. And anyone else
It would appear that everyone is on a mission – I guess we are keeping this site active by swallowing the bait – as before I am even able to respond to one thing they are on to the next…… Allow me to have my say – then by all means, everyone – have at it!!!
Put the truth on your blog – not an extraction of something that is taken totally out of context – at the very least the reading public deserves to be able to make an informed decision based on the full story. That is what we were trying to do on our site….
|Harris writes: The context is simple – Faith drops has NOT given any evidence besides anecdotal evidence to support the claims of FAITH drops. This is the truth. Please Colleen, give us evidence, not a long story around whether the product is legal or not.|
However, I am sure that this will not be posted in its entirety. It’s what these types of blogs do. Sensationalism at its purest.
It would appear that everyone is under the impression that we are misguided or at the very least that we do not know what is going on. That is hardly the case.
We understand exactly what is going on and we are under no illusions about what the Act requires and who is responsible for what.
Having no guidelines for TCAM’s in place in the early days, the act that initially guided us was the Medicines and Related Substances Control Act, Act 101 of 1965 which makes all medicines liable for registration by the Medicines Control Council and contains specific provisions relating to labeling and advertising. This act of course refers specifically to drugs. Alternative / Complementary / Traditional / Herbal Medicines were more recently hived off from allopathic meds and have since been placed in a category of their own, and the initiatives that have been introduced include the development of draft regulations and guidelines for registration and control of these medicines; proposed amendments to the current medicine legislation to provide for Alternative medicines; establishment of an expert committee of the Medicines Control Council to advise the Medicines Control Council on the regulation, registration and control of Alternative medicines; publishing of a government notice requesting the Alternative medicines industry to submit minimal information about their products; and the development of a computer software for submission and processing of future registration applications for Alternative medicines.
|Harris writes: Colleen is simply wrong. Alternative / Complementary / Traditional / Herbal Medicines are all "drugs" according to the definition of a medicine in the Medicines Act and have not been "hived" off at all. The Medicines Act in its entirety still applies to all medicines. Only medicines that have been called up for registration are liable for registration. Medicines are called up according to what they claim to do and not according to what their constituents or ingredients are.The development of a database is a small part of the process. What is required is proof of safety and proof of efficacy in order to register any product. If Colleen has this evidence available, surely she would present it for the product as a whole (not what individual ingredients might do separately but what happens when it is given to people). Readers (and Colleen) may not be aware, that to obtain this evidence in South Africans, MCC permission to conduct a trial would be required. This is exactly why Rath's experimenting on people with AIDS using vitamins was found to be against law by the courts!|
Faith Drops had been in use for more than 15 years when we submitted our product for registration with the MCC. (It would appear by browsing various websites on the net that we are not the only ones to fall “foul” of the law). It was our understanding after receiving the registration document – my apologies the listing document – my apologies yet again – computer database number – that since the document itself referred to the number we had received as a REGISTERY NUMBER – we were indeed registered. (See extract from document below).
Harris writes: If Faith drops has been in use for more than 15 years, it was clearly illegal and contrary to the Medicine Act during all that time for the "Complementary medicines call up" was only gazetted in February 2002. This evidence can be used against Faith drops, oops!
The acknowledgment of receipt states very clearly:
"(i) This document indicates that the Medicines Regulatory Affairs …. has taken receipt of the above-mentioned documents"
(ii) This document does not authorize the use of MCC's name / MRA for trading purposes
It does not state that the product is or was registered. The registry number has nothing to do with registration. It is just a tracking number.
The call to have all alternative / complementary meds registered required that manufacturers / wholesalers submit their product details for registration (which we did), submit information on the product (which we did). The current law does not indicate that it is sixty thousand odd registrations in arrears due to a shortage of manpower…(it would now appear that the situation is worse than anyone can imagine – they are 8 years in arrears… ).
Its has been made clear to us that if we call the submission of documents IN PREPARATION for review by the MCC for possible registration – a registration – then we are wrong. If we call the submission of documents IN PREPARATION for review by the MCC for possible registration – a listing – then we are still wrong. It would appear now that we need to refer to the non-existent waiting list as a computer database – so before we begin – my apologies to everyone – next time I will be a bit more specific.
Many of us alternative medicine users know that alternative treatments and therapies abound and a LOT of them are indeed quackery – but MANY alternative treatments do indeed cure diseases. However, with both cancer and aids being “patented” diseases, the possibility that alternative methods of treatment for these diseases being accepted by the allopathic world let alone registered with the MCC (or even the FDA for that matter) amount to zero (as Harris so politely put it – but thank you for making my point).
There is no money in “curing” a disease – there is only money in prolonging it….
The internet provides more than enough proof on this subject and it is not one I feel I should cover here.
Harris writes: "There is no money in “curing” a disease – there is only money in prolonging it" is a common phrase used against orthodox medicines in argument of support of CAMs. This is misinformation. Many orthodox treatments cure disease and very rapidly. Many CAMs on the other hand do not, and prolong the suffering of the patient or even make the situation worse if the patient delays seeking treatment.
The complementary medicines call up was very specific that the information requested was not registration but an initial step towards registration. Every manufacturer or seller of CAMs have had all these years to get their ducks in a row in preparation for suppling adequate and acceptable evidence for the registration of their products. If they have not, this is just irresponsible.
I want to make this clear: I insist on evidence that a product works whether it is a conventional medicine or a CAM – for without evidence, it may be nothing more than just a scam. Even scam products use a similar argument that Colleen uses in support of their product! I am not suggesting that Faith drops is a scam, but without evidence, it may be exactly that and no more.
Harris is also very quick to point out that he thinks that
a) we are not registered – when if he cares to read the submission by the ASA it has now been clarified that we are indeed not REGISTERED as has been clearly stated even though the document itself refers to the number as a REGISTERY number (the law does not at this stage have the ability to register anyone – neither are the thousands of alternative med suppliers registered – some perhaps but not all….); and
b) that our drops MUST be a load of rubbish because we refuse to allow him to publish our research, or by the very least we should have offered this information to the ASA or TAC as verification. The ASA quite clearly states that they ARE NOT able to comment on the efficacy of any product – so we have chosen NOT to submit any substantiating documentation which is extremely sensitive being a patented formula, to an organisation that is clearly not equipped to provide comment for or against our product. Similarly, we therefore choose also not to publish this sensitive material on an internet blog site, nor accept the assistance of anyone outside of that organisation. Anyone “browsing” through our research should at the very least be academically capable of doing so and should be qualified to make comments thereon. When the time is appropriate – the documentation will be submitted to the MCC as the current Act requires us to do.
One of the accusations leveled at us by the TAC was that we CLAIMED TO CURE diseases – however, an in-depth investigation of our old site indicated we did not once link the word CURE to any disease. The only contravention we made was to link various diseases to our product and suggest a protocol.
Harris writes: It is irrelevant whether Faith drops cures or treats a disease. The sensitive material or patented formula of the product does not exempt you from providing the evidence. The only reason people do not share patented formulas or sensitive materials is that they fear someone else will steal the information and profit from it — rather than yourselves profiting from it. Please, show the proof! Faith drops do claim to cure cancer in the very name of the website www.cancercure.co.za. Where is the evidence?
The site claims: ". . the answer to AIDS, hepatitis A,B and C, malaria, herpes, TB, most cancer and many more of mankind's worse diseases has been found" but not a single piece of reliable evidence in support of this is provided.
And sorry Colleen, please do not try to fool readers – the website states clearly ". . .aids the immune system to overcome various ailments . . ." "Overcome" surely also = cure!
I am sure that I do not need to point out to either Harris of CAMCheck, Geffen of TAC (or anyone else) the information below (or judging by some of Harris’ comments perhaps its imperative that I do), nevertheless I feel it imperative to be transparent so that readers understand the situation more clearly, it is vital that it be included…..
Harris is convinced that our drops’ function is an implausible one – having never read any research on the product to prove or disprove his assumptions.
Harris writes: I have read a great deal of the theory of Faith drops! Really! And simply put, it has no physiological basis based on what we now know of physiology. What Faith drops uses is old theory or studies that showed one particular feature of physiology, later shown to be invalid, but yet continue to use this "faulty" evidence to argue in favour of the product!
Because he has not read it – does not mean that it does not exist. Because we refuse to publish this sensitive material on a blog page also does not constitute proof that we have done no research on our drops – his remarks are implausible……
In fact we feel that the efficacy of our product far outweighs that of the Gold Standard for Cancer and by far outweighs ARV’s for efficacy in reducing the viral load but OUR PRODUCT EXCLUDES the horrendous side effects that ARV’s have.
Harris writes: Agreed, "does not mean it does not exist". But that does not therefore mean that it does either! Show the evidence, please! "we feel that the efficacy of our product far outweighs that of the Gold Standard for Cancer and by far outweighs ARV’s for efficacy in reducing the viral load but OUR PRODUCT EXCLUDES the horrendous side effects that ARV’s have" is a therapeutic claim. Where is the PROOF that your product is better! And by how much exactly? (Is it a percentage? A log scale measurement? Is it statistically significant? Is it clinically significant?) But you have provided NO PROOF! To make these claims requires PROOF! Without proof, this may well be nothing more than a scam!
Taking a basic approach to the proprietary formulation of the FAITH™ Drops, the plants and their compounds (natural agents) are well documented as working within the body on dozens and dozens of illnesses and diseases, and are proven to right imbalances within the immune system. Our drops do not set out to eliminate the very thing it is trying to stimulate….
Harris writes: NO PROOF! To make this claim requires PROOF! You haven't even given one instance of verifiable documentation. Without proof, this may be nothing more than a scam!
With regard to clinical trials, efficacy and safety of MEDS: (The very thing Harris is demanding of complementary /alternative meds in order to authenticate them….)
It is to be noted that Clinical trials for allopathic medicine require toxicity tests to be carried out before clinical trials begin and there are several levels of trials to be conducted before the allopathic meds are signed off for use by the general public – doctors are of course supposed to report any adverse side effects their patients suffer from using the new drugs…… and even then some do not…. Sometimes the side effects from medicines are worse than the sickness it is meant to “cure” or treat, not the least of which are the side effects of chemotherapy, radiation and ARV’s. In our opinion – the so-called “cure” kills the person before it kills the disease.
The WHO have monographs available for use when conducting toxicity tests/trials – but of course not even one plant from our unique flora in South Africa makes an appearance in any one of the four volumes available. Having no guidelines for the development of indigenous herbal meds, did of course create quite a lot of difficulty for us during the development phases of our product. Nevertheless, as the plants have been in use by indigenous people for thousands of years and are still in use today, we felt the efficacy testing and toxicity testing had been sufficiently covered, for both the FDA and the WHO are the two organisations in the world that consider traditional herbal meds to be safe until proven otherwise. Granted – there are people out there taking meds that are not approved and are getting sick but there are just as many if not more people taking the plant formulas available and becoming well.
Harris writes: If you have not done toxicity studies, show us what has been done.
Have you put in place a system to document the side effects of Faith drops? If not, why not? If you haven't, you cannot claim that there are no side effects only that you have not taken the trouble to systematically follow up and document possible side effects.
". . . for both the FDA and the WHO are the two organisations in the world that consider traditional herbal meds to be safe until proven otherwise". Absolute nonsense! Proof please!
Your product has not been in use for thousands of years so that statement has no bearing at all.
Understanding the distinction in evidence-based medicine between observational studies and randomised controlled trials, or the more recent type of “active comparator” studies or “active control” trials and the importance thereof – what we cant understand is that when a treatment exists that is clearly better than doing nothing for the subject – it is refused to the patient and the Gold Standard methods are forced onto them – KNOWING that they do not work!!!
These processes still leave me in doubt as to the trials done on chemotherapy and radiation – for these “Gold Standards” have been proven not to work and if I even begin to comment on the safety of ARV’s it will take up an entire page for that subject alone. But, suffice it to say that of the approximately 12 ARV’s researched – the side effects listed for these drugs boggle the mind. When you study these drugs it will astound the readers to note that each and every single one of them affected the white blood cells to more or lesser degrees than the next…. If the drugs are meant to help people with depressed immune systems they should not be damaging it further. I can provide research on this subject if anyone cares to challenge – the internet is FULL of it as well.
Harris writes: This is not true. This paragraph wants you the reader to believe that out of the millions of doctors, that practical all are working together in favour of orthodox medicine except for the few "enlightened ones". And yes, some treatments don't work very well, but they are the "best" available considering the use of products that do not work at all! Again, clever words, but still no proof that FAITH drops works or is safe. I am not comparing FAITH drops against other treatments – I am comparing it against itself and its claims!
The main reason medicines list so many side effects is that it protects the manufacturers from being sued.
We despair that toxic ARV drugs are being promoted worldwide as "life savers" and "cures" for a disease – immune deficiencies / AIDS – which they obviously cannot cure, even though these same toxic drugs are particularly harmful to the immune system, thereby further aggravating the conditions – immune deficiencies / AIDS – for which they are being promoted. The pharmaceutical multinationals invest millions of Rand in organizations promoting ARVs – despite their inability to cure.
Harris writes: This is typical arguments in favour of products like Faith drops. ARV drugs are NOT being promoted as "cures". ARV drugs have EVIDENCE that they are "life savers" (compared to nothing or other products) – but not in every individual. ARV drugs are known to have toxic side effects, that is why only health professionals can prescribe them, in order to monitor potential side effects. And herbal products can be just as toxic. For example, comfrey kills the liver! There is NO PROOF that Faith drops can prolong life or that the product is safe! If there is, where is it?
BUT most important of all is that hardly any of the patients taking ARV pills receives the product information that is mandated by law, because in many doctor’s offices and hospitals, ARV pills are deliberately removed from the manufacturer’s box containing the warnings, long before the patients receive the pills. In addition, most of these drugs do not prevent opportunistic infections from creeping in………….. Not much of a cure or treatment in my books! SO to comment on Mr. Jobson’s remarks:
“BTW: Virtually every legitimate medicine puts the body into a position where it is able to heal itself. The most dramatic modern example of this must surely be the antiretrovirals which assist the body in healing itself despite being unable to cure AIDS”.
Is Mr. Jobson intimating by his statement that “legitimate medicines” (and by that I take it he means REGISTERED) by some magical process by having been registered suddenly aid the body in healing??
Harris writes: Colleen, what Prof Jobson was saying was simply that to be registered, that an independent panel checked the evidence in support of the claims that the product works, either by curing or assisting in prolonging life, and that the product was relatively safe or that the side effects can be managed or the risk of taking the drug is acceptable compared to not taking it. Registration is PROOF that someone examined evidence in support of the claims. If the evidence is poor, absent or not sufficient, the product is NOT registered. So Prof Jobson is NOT stating that registration is the magical process which suddenly aids the body to heal, but that someone with expertise EXAMINED the evidence and found it of a high standard to support the claims! Where is Faith drops evidence?
It is also true that many conventional medicines assist the body in healing itself, and we have the evidence to show that.
His example of ARV’s is in our opinion not valid. The drug industry is using an army of lobbyists, including celebrities and even politicians, some of whom may not be aware of the scientific facts: none of these drugs has ever been shown to cure either HIV or AIDS and they are not allowed to be sold as a cure. Moreover, these toxic drugs are known to attack the immune system of patients and eventually destroy it. Some of the symptoms listed on the information sheets show the following: Neutropenia ; lymphopenia; Hemic and Lymphatic System: Adenopathy, bruising, eosinophilia, granulocytosis, leukopenia, pancytopenia, purpura, spleen disorder, and prolonged prothrombin time; hematologic toxicity including severe anemia, particularly in patients with advanced human immunodeficiency virus (HIV) disease; bleeding dermal, haemolytic anemia, microhemorrhages, splenomegaly, thrombocytopenia leading to death. I could continue as the list is endless however I feel I have made a point regarding the statement made by Mr. Jobson. For those of us not familiar with the terms used above an example would be:
Leucopenia = Decrease of all white blood cells
Neutropenia = Decrease of neutrophils, a subtype of white blood cells
Pancytopenia = Low levels of all blood cells (i.e. red blood cells (erythrocytes), white blood cells (leukocytes) and platelets) due to toxic effects of ARVs on blood cell formation in the bone marrow
Thrombocytopenia = Low levels of platelets (blood cells required for coagulation) due to toxic effects of ARVs on blood cell formation in the bone marrow
Do these drugs sound like the type of drug that helps the body to heal itself??? I think not!! I am sorry but any drug that causes at the very LEAST Mitochondria toxicity is certainly NOT something that assists the body in healing itself – my apologies for being rude –but in our books that is a total load of nonsense.
For those of us not scientifically educated a brief explanation here about Mitochondria Toxicity or MT might be in order:
Mitochondria have an enzyme that helps them multiply. This enzyme is called polymerase gamma, or “pol gamma.” It is very similar to HIV’s reverse transcriptase enzyme. Unfortunately, this means that the drugs we use to inhibit reverse transcriptase can also inhibit pol gamma. When this happens, fewer new mitochondria are produced. The nucleoside analog reverse transcriptase inhibitors (AZT, 3TC, ddI, d4T, and abacavir) all inhibit pol gamma to some degree. MT is more likely to occur the longer you take these drugs. Different medications build up in different parts of the body. This could explain how MT caused by different drugs can lead to side effects in different parts of the body. We know that MT can cause muscle weakness in people taking AZT. It is probably the cause of “fatty liver” (hepatic steatosis) and high levels of lactic acid that can be caused by all of the nukes. Unfortunately, there is very little research on how much mitochondrial damage each ARV causes to different parts of the body. We also don’t know which combinations of drugs cause the most MT. Researchers know how to measure the number of mitochondria in different cells, compared to normal. However, they don’t know many mitochondria a cell can lose before there are problems.
So much for clinical trials!
Harris writes: This is nonsense. Clinical trials documented these side effects – that is why we know that they occur! The point of clinical trials is simply to show that without a product, e.g., ARVs, that the body will completely fail, e.g. death occurs, but taking the product will keep that individual alive or cured (depending on the disease and the medicine), and to help make the decision to whether the side effects were acceptable compared to the outcome of not taking the treatment. Eeveryone knows that the side effects for ARV's may be terrible, but compared to not using them and then having almost a 100% chance of dying, that these side effects are a small price to pay.
Alternative medicine users know that the realistic situation is that the “Gold Standard” method of treating cancer for example is the cut, burn or poison method (surgery, radiation therapy or chemotherapy) and in our opinion these methods fail to address a person’s health needs and heal cancer to any great extent- yet, information on these so-called “Gold Standard” methods abound, even though it is proven that the success rate for these methods are as low as 3%. Information on alternative therapies is stringently excluded even to patients that have been sent home to die…….
All one has to do is a bit of investigation on the net and one will discover the truth. In fact, I quote from Tim O’Shea’s book “The Cancer Patient” …..”How can that be true of the main cancer treatment in the U.S.? Fact is no solid scientific studies or clinical trials prove chemotherapy's effectiveness, except in a small percentage of very rare types of cancer. For solid tumours of adults, the vast majority of cancer or anything that has metastasized, chemotherapy just doesn't work”….
Harris writes: Readers should NOT accept the Internet as a source of good evidence! All information on the Internet, including this blog, could be a source of very bad misinformation, lies, or cherry-picking of evidence. Readers are urged to examine information very carefully and to compare with other reputable sources before believing a written piece. For example, Colleen makes the point that ARVs are ineffective against AIDS – and many sites support this view (without "hard" evidence but clever argument). Contrast this with many other reputable sites that supply "hard" evidence of the success of ARVs. Furthermore, common sense that South Africans with AIDS and taking ARVs are living, and speaking out, and those not taking these drugs are dying, will guide the reader in making appropriate conclusions.
Indeed, we are in support of the plans to put more stringent methods in place to protect the public – but we do suggest it not be at the expense of the man on the street, nor should these methods be at the expense of a person’s right to choose how they wish to address their health.
Once procedures are in place and standards / guidelines have been set and are firmly in place then these stringent methods can be more easily applied to transgressors. In the interim those that are genuinely attempting to offer hope and health to people, should not be penalized when the failure of registration by the relevant body to process the necessary paperwork at an acceptable rate, causes a persons rights to be diminished.…………
Harris writes: Colleen writes " . . these stringent methods can be more easily applied to transgressors."
Faith drops, with NO PROOF, could indeed be one these transgressors! You haven't even given one instance of verifiable documentation. Without proof, this may be nothing more than a scam!
FAITH™ Drops and the developer of the drops take an alternative approach to “treating” dis-ease within the body, by looking at the person as a whole and “treating” the cause of the problem. So, whilst we are trying to “treat” the cause – many others are treating the symptoms. Whilst they continue to treat the symptoms only – they do not “cure” the dis-ease, and the vicious circle continues…….
I guess money does speak loudly after all…… big pharma has a hold on everything…..
Harris writes: Again this is the same argument spun in favour of alternative therapies but without foundation. Any orthodox doctor who does not look at the person as a whole and only treating the cause of the problem, is a bad doctor. Doctors are taught to look at the patient as a whole. There is no proof that Faith drops (or other alternative treatments) treats the patient as a whole any different than that of orthodox treatments.
And not only does big pharma have money — the CAMs industry is now estimated at R5 billion a year . . . Not bad for so many products that have not been proven to work or to be safe.
We have had our say – we do not intend to conduct a trial by correspondence – so we will not be making any further comments on this blog regarding this subject other than if the FULL transcript is not published.
We do however intend to direct people from our site to this blog page to read our comments……
Harris writes: This is the full "transcript" of what was posted. I have chosen to make it into a whole new posting.
Although some of Colleen's arguments may be true, they too often use "logical fallacies" (http://www.camcheck.co.za/20-common-logical-falacies/) in support of diverting attention from the simple and basic fact repeated throughout my response: there is NO evidence that Faith drops works or is safe.
Readers may wish to know that the Consumer Protection Act, to be promulgated soon, will allow consumers to take action against products such as Faith drops if they do not work.
The question must asked why there is a disclaimer on the Faith drops website if Colleen is so sure that the product works and is safe. The disclaimer basically states that the company will not take any responsibility if anything goes wrong. It is also strange that the disclaimer focuses on the FDA and the USA rather than the South African law regulating medicines. South Africa, unlike the USA, does not have a category of products called dietary supplements. So it is completely misleading to call a product for sale in SA a dietary supplement. The whole debate about "structure/function" claims does not apply in South Africa. It should be noted that Advocate René Doms who is also a qualified pharmacist has stated that: (the following is edited slightly from the original, but does not change the meaning)
"Adding a disclaimer or qualifying language that effectively characterizes the claim as baseless because neither the disclaimer nor the qualifying language can rectify the false message conveyed by the unsubstantiated claim. In such a situation adding a disclaimer or qualifying language does not provide additional information to help the consumer understand but merely contradicts the claim."
"Where a person has set in motion forces that result in creating an impression that a product has value in the treatment of disease, (s)he cannot avoid the legal consequences of such action by a disclaimer. . ."
Faith drops claims can be seen at www.faithdrops.co.za