Retraction

Many of you are asking me, “What is with this ‘Retraction’”?  It is there solely because I have been “ordered” to display it so prominently (in order to avoid being prosecuted as a “criminal”), so to save me having to answer so many phone calls, I will tell you what is happening.

It turns out Black Salve is an “unapproved” product.  Unapproved by who you may well ask?  Unapproved by the Medical Monopoly, those who made up the rules without ever consulting “we the people”.  I was never asked for black salve to be “unapproved”.  Who did?  Who made that decision, and why?  What evidence has been reviewed, in order for Black Salve to be considered “unapproved”?  Well, a lot of people out there don’t need for someone to say “this is approved” or “that is approved”.  Doesn’t matter at all to them, they will make up their own minds about these things.  They will do the approving, or not, not someone else.  That’s our right, as human beings created free (to choose) by the Creator.

Some time ago (13.09.11), I received a notice from the HQCC (Health Quality and Complaints Commission- Qld) of a Complaint by a Dr. M of the Gold Coast (his name was kept anonymous, initially), alleging all sorts of practices against me.

My response to this complaint is in Appendix 1.

Then (19.12.11), the HQCC referred this complaint to the TGA (Therapeutic Goods Administration), along with another Complaint, this time an industry-sponsored complaint from the Cosmetic Physicians Society of Australasia Inc., (Dr Gabrielle Caswell – president). The full text of her complaint is provided in Appendix 2, dated 07.11.11.

According to my research, the TGA is not Government-funded. Apparently, it is self-funded, with a bias of relying on work done with and for various drug companies in getting new drugs to market “safely”. You might already suspect a conflict of interest here?

So this TGA Complaints Resolution Panel then assessed the complaint, and submitted to me their opinion that, yes, you have broken the law (as per The Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or the Therapeutic Goods Advertising Code).

What it boiled down to, is that I was accused of saying certain things about black salve, indeed “advertising” black salve, and even making “claims” about black salve, such as “it has benefits…for treatment of cancers, ‘a whole range of cancers’, skin cancers…squamous cell carcinoma, lentigo melanoma…(via) representations conveyed by the photographic images shown in the advertisement”  (These photographic images were in fact a series of photos each showing the progress of treatment of various cancers with black salve over days from start of the application, to the healing up of the tissue).

I was even accused of “advertising (in such a way) as to be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”…. “The advertisement may include restricted or prohibited representations”.

I was required to produce “evidence in support of the claims made in the advertisement”.

So I provided a 24 page response to this matter. In summary, and in the words of my barrister,

“We are instructed that it is clear from our client’s website that the wording in the contents expressly avoids stating that using Black Salve cures or prevents cancer and if you access the FAQ tab on the website (editor: not available now, due to this “judgment” by the TGA of my writings), it is clearly expressed not to make any claims in regarding to curing cancer or any cancer cure.

“We are instructed that the website is providing information of a generic nature about how Black Salve has been used in the past and present by many in Australia and around the world and the results they have obtained and testimonials are provided for information purposes. There are also Disclaimers on the website that clearly state that all who come onto the website should obtain further professional advice to verify the information on the website”.

So, it would appear, that if I tell you a true story of say, Johnny Brown (name changed) who went to his doctor, and got a biopsy of a “suspicious” skin lesion (in this true story, the biopsy report came back as a “malignant melanoma”), then tells me why he came to see me.

“It’s because of what happened to my brother”, he tells me. “I do not want any doctor to cut it out because I saw what my brother went through”. What happened to his brother, he says (and I say this happens literally on a daily basis in clinics all around Australia), is that the dermatologist just looked at the lesion, said “it looks like a basal cell carcinoma”,  the doctor did not do a biopsy, instead he cut what he thought was all of the lesion out and sent it to the lab, only for the sample to be reported as a melanoma, the margins were not clear, and so a second urgent surgery was done with wider margins.

“Too late in my opinion”, he says, because the melanoma came back a few months later, with a lesion appearing at the surgical site, but more alarmingly it had now metastasised deep, into the lymph nodes, and despite the best efforts to fix the mess, he died, and so he doesn’t want to risk the same. He had heard about how black salve is considered by those who have had years of experience using it to be a safer option, as practitioners have consistently reported that the salve, unlike surgery, will not spread a potentially lethal cancer, and thus represents a safer (than surgery), genuine “alternative”, and less risky treatment than surgery. He keeps a photographic record of his treatment with the salve, and once the wound had healed sufficiently, goes back to his doctor, had 2 biopsies done over the site, and was given the “all clear”.

It is becoming quite evident, that the Government (at the behest of the medical community, and under the guise of “public safety”) wants to ban black salve, a folk remedy used possibly for centuries in one form or another, and in London cancer hospitals in the mid 1850s, by Dr Frederic Mohs (of Mohs surgery fame), other prominent and famous physicians such as Hoxsey, and which today enjoys popular folk usage in many parts of the world including Australia, and allow the false accusations of the medical establishment, and accuse me as if I am promoting “dangerous” treatments”, and “ripping people off”!

People I know who were “illegally” producing black salve have been intimidated and threatened with legal process (that alone can bankrupt you), multi-million dollar fines, and even imprisonment. I suspect most readers here will see the bigger picture, in which the medical monopoly wants to erase ALL genuine alternative medicine in Australia (and the USA and indeed in many other places), and turn “alternative health professionals” into criminals if they use anything not state-sanctioned. All in the name of “public safety”.

Welcome to the “nanny state”, big brother is watching, and it is getting damned oppressive for anyone who believes, that an individual has the human right and freedom to choose how to be healthy. Do you think you have that right? It is our birthright, as human beings after all.  Well, think again.

As it is, Black salve is not an illegal substance.  It is not illegal to make it, or to possess it, or to use it for one’s better health as one sees fit, and for the health of one’s family.  The waters become muddier when it comes to talking about it, or recommending its use to others, or professionally treating one’s patients with it, whether one uses the patients’ own salve, or one’s own salve for that purpose.  After all, it is easy enough to make, and lots of folk are making it.

SOME CONCLUSIONS

Perhaps the most important human right we have, along with, (and intertwined with the right to choose what to believe, in the religious/spiritual realm, in the political realm), is the right to choose how one addresses one’s own health issues. In fact, it is a matter of being allowed by law to believe whatever you like, even say a flat earth theory, just as long as we do no harm to another.

The laws as they stand in Australia right now, do not permit one to choose, for example, how to treat their skin cancer. Do you really want a risky surgical procedure, or the relative safety (but more painful) treatment with black salve? There are dozens of other health matters too, in which basic rights and freedoms are being denied; even talking about these matters can wind you up in hot water, it seems.

It is way past time for the laws of this country to be changed. Every person in this country who takes even a modicum of responsibility for their own health and the health of their loved ones, has to be concerned right now, because we have become disenfranchised, and even more so as further important, basic human rights and personal freedom to choose the way in which one wants to be healthy, are being eroded. Soon it will be a crime to say “Raw food is good for you”.

And I charge those who have represented the natural health movement over the past decades, with gross negligence, because it has been on their watch that these restrictions have been allowed to pass into law, as the medical monopolists have led blind legislators to script their rules which essentially would exclude and outlaw, any and all alternative practice. Those who currently head up our professional associations also had better wake up, before all we’re left with is garnish around the edges of treatments and cures, with even naturopathic dietary advice being discredited by the medical “nutritionists” and “dieticians”. Want a look at the value of a hospital meal sometime? Time to wake up people.

MY RESPONSE TO THE COMPLAINT

I will now present in summary my response to this blatant attempt to shut down a truly “alternative” treatment for skin cancers.

I pointed out that the “evidence” for the stated safety and effectiveness of black salve for the treatment of skin cancers was not the same sort of evidence that the medical community relies on.  Science uses a model called the Randomised Controlled Trial (RCT) to demonstrate that new drugs (and other medicines and devices) are safe and effective.  I pointed out that the RCT is in fact a hopelessly flawed model, a model that can give us such dangerous drugs as Vioxx, and many others (see Appendix 2).

The whole thing turned on “evidence”. The TGA wants so-called “scientific” evidence. That is the problem, however, right there. This type of evidence is not at all reliable. We have a different, superior type of evidence, which of course the TGA doesn’t accept. And why not? Because this type of evidence has been rejected by the Medical Monopoly precisely because it is superior, and vindicates alternative medical models.

This is the evidence re the safety and effectiveness of black salve to cure all types of skin cancers.  We have multi-centred, clinical evidence from black salve practitioners around the world, (naturopaths, herbalists, medical doctors, and hundreds of thousands of lay folk, if not more), and all this from different times in history, all showing consistent models (everyone agrees on safety and effectiveness), and this evidence is verified by medical pre- and post-treatment histopathology reports every day of the week.

You have a biopsy, it is melanoma. You treat the melanoma with the black salve, 5 successive applications over a 9 day period. The lesion heals up, you go back and get another biopsy. The biopsy says “no evidence of malignant melanoma in these samples”.

For most folk, that is all the “evidence” needed.  And this happens whenever one bothers to go and get these medical reports. A lot of folk don’t bother, they know when a lesion has “gone”, because it doesn’t come back.  Pretty simple, really.  Does one really need anything more than that?

The old saying is true, "If the effect is clinically important, you do not need statistical analysis (i.e. ‘scientific trials’) to decide if it is valuable or not".  Hence the value of clinical, anecdotal and case history evidence.

But the real issue here, is, freedom not only of speech, to be able to freely say what one believes without fear of penalty (fines, imprisonment), but the freedom, the basic human right to be able to treat oneself with natural products, as one chooses for themselves, indeed choose how to be healthy. If one wishes to use the black salve as preferred treatment for skin cancers, then one has that right.  But this freedom is being eroded by agencies like the TGA, the “attack dog” of the Medical Monopoly.

So what do you think? Please email us with your thoughts, this issue is of public importance, indeed the whole future of individual freedoms and basic human rights is under threat. The issue of black salve as a cure for skin cancers is like a “Custer’s last stand”. We must stand up to these agents of the Medical Monopoly, and let them know we will not be bullied or intimidated by their nonsense. We have the right to choose our own treatments and path of health. And we’re prepared to pay for it, and that lightens the load on the public purse. So we put our money where our mouth is, unlike the majority who pass this responsibility onto the medical system, “hey doc I’m sick, fix me”.

Appendix 1

My Response to Dr B Complaint
“REPLY 03/10/2011

a. “…Adrian Jones is portraying himself as a legitimate ‘physician’…”

According to the Macquarie Dictionary, a physician is “one who is skilled in the art of healing”. That is what a naturopath is. And yes, I am “legitimate”. However, as a member of ATMS, I am not permitted to use the term “doctor”, and I do not use that term about myself.

b. “He is unqualified as a medical professional…”

Correct. But so what? I am a professional naturopath. I don’t claim to be a “medical” professional. However, I am a professional alternative medicine practitioner.

c. “..(he is) promoting dangerous, unproven treatments…”

Someone who is unfamiliar with the history and usage of black salve might suggest this. However, this assertion is untrue. Using black salve is no more “dangerous” than any medical procedure, indeed many consider it less dangerous. It is claimed by many practitioners to be much, much safer than surgery for skin cancers. Why? Because according to the literature it has never killed anyone.

Can one say that about even as simple procedure as an appendectomy? Or indeed an excision of say, a melanoma? Doctors don’t guarantee the safety or outcomes of such surgery, how could they? It could certainly be argued that in countless cases currently in Australia, that surgery for melanoma or SCC has been done, only for the cancer to turn up within 18 months, disseminated or deep, throughout the lymphatic system, or in the lungs or some other organ.

So, many folk suggest that on the evidence, surgery appears to be a much more dangerous treatment (especially for SCCs and melanoma), given the potential for cell lines to be traversed and (hence, sometimes) spread the cancer into the blood stream or lymph, leading to fatality.  Not so with black salve, according to the experts. (So just who might be seen to be “promoting dangerous procedures”)?

d. “…at the same time (he is) discouraging people from seeking advice from properly qualified medical doctors”.

This assertion is untrue. I do encourage a correct diagnosis where it might be necessary, from medical folk. However, it is also true that the majority of folk who come to see me do so because they either do not trust the medical “system” as such, either with diagnostic procedures (eg biopsy), or with treatment (surgery etc). This single fact might explain why there are as many naturopaths as there are.

As a naturopathic professional, however, I prefer a patient arrives with a medical diagnosis, especially if something is considered “serious”. I do not diagnose skin cancer, biopsy is the most reliable (although not perfect) diagnostic tool.

Here is an excerpt from my e-book on this point:-
“Conscientious professionals ought to consider it important at least to recommend to their patients to do two things in regards to any treatment one might wish to pursue, whether they choose the medical, or an alternative treatment:-
1. Get a medical diagnosis in writing
2. After treatment, get a follow up check-up, and get it in writing”.

So, what is this person implying with the phrase used here, “properly qualified”? That a naturopath is not “properly trained”? That would be incorrect, if not defamatory.

e. “…She saw Deirdre Parkinson ND who then apparently referred her to a ‘cancer specialist’, Adrian Jones ND”.

I rang Deirdre Parkinson to ask her if she would have used that term. She denies it. So whose words are these? Besides, I cannot be held responsible for what other folk might or might not say about me. Mrs Parkinson is not part of my business. If the word “specialist” is a problem, then tough titties; it’s what I am, someone who has special knowledge and experience using black salve. Again, according to the dictionary, a specialist is “one who devotes himself to one subject, or one particular branch of a subject or pursuit”. However, I never refer to myself as a “cancer specialist”.

f. “…(Adrian) told her that she had a BCC on her lip…”

That is just a lie. As I stated above, and were one to read the documents on my website as part confirmation, I have always made it clear that it is just not possible to simply diagnose a skin cancer (let alone a particular type of skin cancer, given histological variations observable only pathologically, even within the given major groups), merely by observation. In fact, nor can a GP, or a dermatologist for that matter. That’s why biopsies are recommended.

I am always clear with that, because I hate it when folk come and tell me their doctor says, “that looks nasty, we need to get it out..” without a prior biopsy. And that happens all too frequently, unfortunately. It is too late sometimes after the event; incomplete excision (say of a melanoma or SCC) can and does in some instances actually cause fatal metastases. But unfortunately this practise continues.

So if this complainant really wanted to do some good, he should be complaining about these negligent medical practises of excising an undiagnosed lesion, which can cause the death of innocent folk.

g. “Black salve has been shown to cause serious burns…”

That is an incorrect assertion; it quite simply does not. The black salve has been around at least 150 years in one form or another (in the mid 1850s it was being used by cancer surgeons in several hospitals in the UK and USA where for some doctors it was the preferred modality; Mohs surgery originally included the use of black salve to the wound as part of the procedure also). This assertion is rubbish; when the salve is made correctly (and it’s a folk remedy, it is easy enough to make), it does not have the capacity to “burn” at all. That is not its mode of action.

h. (re my e-book “How Black Salve is being used to treat Skin Cancer in the 21st century”) “….which generally claims to be able to treat cancers…”

This is an untrue statement. The e-book simply tells exactly what the title says, it is an objective, historical and factual account of how folk are using, and have used, black salve to treat skin cancers. The author does not make any “claims” at all.

i. “…and paints orthodox treatments as corrupt and ineffective”.

That is untrue as well. This is classic eisogesis (reading something into a text that is not intended), or drawing a conclusion that is incorrect). The inherent limitations, dangers and risks of the “orthodox” skin cancer treatments are discussed, however. Any fair-minded person would concede these things need to be impartially reviewed. As for corruption, I think it is a matter of opinion as to whether any system (including the medical) is free of corruption. My own belief is, however, (and my brother is a doctor, and I have several friends who are doctors etc), there are thankfully many good folk in the orthodox system, (take me to a hospital if I get smashed up on the road). However, I believe it is medical negligence for a doctor to excise any cancer without a prior, proper diagnosis (eg a biopsy), and we see it happening all too often, and is all-too-often fatal.

j. “These naturopaths, especially Adrian Jones are promoting unproven, disproven, and dangerous treatments for various conditions including cancers……..They are a danger to patients with cancer…..(they are) being ripped off”.

Quite frankly, this letter appears to be but another example of rather thinly disguised, age old (and weary), gratuitous “naturopath-bashing”, and represents nothing more than the personal opinions of this nameless third party (editor’s note: at the time the complainant, Busby, was not identified to me). He claims to have read the literature on my website, but he appears not to have done his homework sufficiently for one prepared to make all these false allegations and assertions.

Summary

The whole thing here is, black salve will always be a folk remedy, and people will continue making it and using it, that’s how it is. And they can get into trouble sometimes if they are not able to draw on the specialty expertise and clinical experience of someone like myself who is called upon to guide. If doctors bothered to study and understand the usage of black salve, things might be different.

The fact is, a significant proportion of our population will not go to a doctor if they can possibly avoid it, or they’ve been to doctors and get no satisfaction, so they consciously choose “alternative health providers” in these instances. And they probably keep on going precisely because they do get satisfaction. That’s what I hear a lot. Thank God for freedom of choice.

Sincerely
Adrian Jones ND”

Appendix 2

Showing some of the fundamental weaknesses of the so-called ‘gold standard’ of scientific evidence, the “scientific trial”. From a paper compiled by Adrian Jones in 2001, but submitted here as forming part of my defence.

A “Scientific Trials” (RCTs)
The Randomised, Controlled - Blinded, Placebo Controlled, Crossover, Peer Reviewed - Trials (RCTs1).
1 See Wikipedia under “Randomised Controlled Trials”, for more detail.

This method of trialling has been touted as the very best vehicle (the “gold standard”) to assess the value of evidence in treatment protocols and medicine effectiveness. The methodology is currently used to trial the safety of pharmaceutical drugs, as well as compare the effectiveness of different treatments for various conditions.

Perhaps even more pertinently, this vehicle (the RCT) is being used also to drive what is currently being called ‘evidence-based medicine’ into the 21st century, and is most recently been further defined by the CONSORT statement of 2010.

The RCT has several levels and processes of organisation from beginning with deciding which criteria will be followed (ie the design), selection of participants, etc to the end which sees results offered for peer review, and often culminates in the development of a new drug or method of treatment. RCTs are meant to tell the public about efficacy (does it work? Is it better than a sugar pill? How well does it work, compared to existing treatments etc), and safety (What are the side effects, what are the contraindications, does it kill etc.

Glossary of terms

Randomised
If a trial is ‘randomised’, it selects participants randomly within the trial to be in either the trial group or the control group (e.g. as in a placebo-controlled study), and is supposed to reduce selection bias; it “balances known and unknown prognostic factors”.
Blinded
Blinding is supposed to prevent study participants, personnel, or outcome assessors from knowing which intervention was received. According to the most recent guidelines as per the CONSORT Statement (2010), the trial must nominate just whom is blinded, and how.
Placebo controlled
A placebo is a (pill, treatment etc) that is not the therapeutic agent being trialled, but a ‘sugar pill’.
Crossover
Over a period of time, each study participant does, or does not receive an intervention in a random sequence.
There are designs other than ‘crossover’, such as the most popular ‘parallel group’ (78% of RCTs, compared to just 16% being ‘crossover’). In parallel group design, each participant is randomly assigned to a group, and that whole group do receive, or do not receive, the intervention.
Peer Reviewed
A “peer review” is when individuals with recognised qualifications within the same field as the study or trial , are invited to “review” the trial results. These people can be paid or unpaid.

RCTs

The question discussed in this paper is, How effective is this method? In other words, how valuable or reliable is the “evidence” obtained under the protocols provided by the RCT?

1. Surprisingly, there has not been an RCT study or document to indicate the validity of its own methodologies. So it falls short of the standards explicit in its own methodology!!
“Has the RCT itself, as a model, been subjected to an RCT?”. To my knowledge, no, it hasn’t.
That should be enough. That is the fatal blow, right there. To go on, and present more evidence of the failure of this vehicle to provide truthful, useful and reliable information, is like the barrister who gives all sorts of reasons as to why his client is a no-show in court, and then adds “he’s also dead, your Honour!”. That should have been explanation enough, without anything else at all.
So we don’t really know if it is reliable standard at all, let alone a “gold standard”, it hasn’t been through a trial yet!!

2. But there is more. A lot more, your Honour!
Do the statistics gathered from such a study actually apply to a particular human being, or simply to some statistical phantom, who might be some sort of Mr Average? Humans are far more individual than some perceived statistical “average” to which an arbitrary set of statistics can be applied.

Can the “confounding variables”, the unknown impact of genetics, age, nutritional status, lifestyle, stress, happiness, meaning of life, attitudes, time of day, season, religiosity, confidence in doctor's opinions etc. etc. be controlled in any blinded placebo crossover study? No they can not. Not sufficiently.

3. Why use a vehicle which arbitrarily excludes so many variables? Would you use a ruler as a measure if it expanded and contracted with temperature, sunlight, or time of day?
To illustrate, a 1994 Finnish Study of 29,000 males conducted over a 6 year period was designed to study the effects of supplementation with beta-carotene (a pro-vitamin, a precursor to vitamin A) in male smokers.

There was a “surprise” result; the trial showed “no significant protection against lung cancer” (see Appendix 1). A surprise, because at that time there were about 150 other studies from around the world that showed that beta-carotene did have a significant and beneficial effect on protecting against lung cancer!

This demonstrates how variables can confound trial outcomes data. And we can put this down simply to flawed human behaviour. This type of sloppy science is still being done today, (see Appendix 2).

4. Can a study of say 30 or 100 or even 1000 individuals be extrapolated with any real meaning to a population of say 1,000,000 or 100,000,000? Biochemical individuality is as variant as physical uniqueness; but whilst height and skin and hair color are rather obvious physical variations, biochemical differences are not as obvious. So you need to ask the right questions, and if you don’t, the trials will be terribly skewed, indeed flawed.

5. The fact that a patient knows he / she is part of an experiment can also affect any so-called objective result. Very few studies are in fact blind, as patients will
usually know of the effects and side effects of a drug during the course of the trial. Many drugs have toxic side effects.  For example, tamoxifen is a drug touted as able to "reduce breast cancer".   What is not stated so readily, is that tamoxifen does not reduce overall patient mortality. Why is that? Because apparently tamoxifen also doubles the risk of uterine cancer, and trebles the risk of strokes!!

So selective reporting bias allows, indeed promotes the use of a drug as a prophylactic for breast cancer, even though it is toxic and promotes other life-threatening side effects!! The longer one takes a drug, the higher the risk of side effects / which are often toxic. Most blinded studies are of a finite duration, e.g. 3 weeks, 6 mo, or 5 yrs etc.

How can such short-term results be extrapolated over a course of 20 or 40 years with any degree of scientific certainty (as against probability, predictions, or guesses?).  This is a pertinent question. How many drug trials for example, initially show a drug as “safe”, only to find out a few years later that it is killing people? For instance, Vioxx, the best-selling drug for arthritis, went through initial safety trials, only to be withdrawn from the US market some years later in 2004 because it was causing a 500% increased episodes of heart attacks and strokes. Some evidence suggests up to 60,000 people have died by Vioxx; this is the figure in print, but I have been unable to verify the data. This figure is also quoted by www.mercola.com.

We could give literally dozens of examples, here are just a few, for example, Seroquel for schizophrenia, Bextra a pain killer, Rezulin for diabetes, Baycol for cholesterol, Phenylpropanolamine a decongestant.

The “revolving door” is a term used to describe the frequent movement of executives between the FDA and pharmaceutical companies, as has been pointed out by many observers.

How many other drugs demonstrate the rather gross limitations of “scientifically” based safety trials? What about Avandia which reportedly has killed tens of thousands of people, and just recently (October 2010) it is being withdrawn from European markets.

It should not surprise us that despite all the development trials etc., the real truthfulness as to the safety of a drug, or indeed any product, will inevitably come out, eventually. This highlights the value of the element of time to human health. Especially when we consider that a ‘drug’ by definition is a highly toxic, synthetic (non-naturally occurring, hence able to be patented) substance, that will always cause some degree of toxicity when introduced to the internal animal / human environment, and this will tend to accumulate pollution over time.

However, given the high money stakes, we note potential profits from the release of a new patented drug can run in the $billions, and the “revolving door4” between regulatory authorities (eg the FDA) and pharmaceutical companies, it should come as no surprise at all that in the USA there might be a culture of corruption when it comes to the management and reporting of the scientific trials.

So we can’t say that scientific trials prove anything much, least of all provide unbiased, truthful information about these drugs, so as to protect a nation’s citizens against exploitation by profit-driven pharmaceutical companies.  And the “regulators” such as the US FDA and our TGA, the supposed industry watchdogs, are looking more and more like lap-dogs for the pharmaceutical industry anyway.

Statistics are “slippery little suckers” indeed; to mix the metaphor, a statistician and his statistics is like a master violinist with his violin, both equally quite adept at playing any tune he likes. We also note, that whilst it is true that statistics don't lie, it is also true that liars use statistics.

What about the cost of an RCT?

The longer a trial goes on, potentially the greater will be the costs. This is quite clearly a limiting factor when it comes to just how long a trial is run for. Some trials cost tens, even hundreds of millions of dollars. This is a major problem, too, given the need for toxicity studies over longer time periods than typically the study lasts for. Cutting corners here and future patients can end up dead.

What if the doctor believes statistically that the patient is better off with a particular treatment program, but the patient feels that it is of little clinical significance, especially if there are major side effects?

The old saying is also true, "If the effect is clinically important, you do not need statistical analysis to decide if it is valuable or not (only for just how valuable)". Hence the value of clinical, anecdotal and case history evidence.

What about peer review?

The late David F. Horrobin, founder in 1972 of Medical Hypotheses (the only journal devoted to discussing ideas in medicine) suggested that peer review provides “no safeguards whatsoever”, and they are so biased and useless as to be a major cause for concern, if we are expecting any relevant objectivity from such “reviews”.  See Trends in Pharmacological Sciences (22:2, Feb 2001).

One could write a whole book on the ethics or rather lack of them, when it comes to some pharmaceutical companies and their drug research results – see Appendix 1. One thinks of people like the recently discredited Dr Scott S Reuben who pled insanity (!) as a defence when found to be manipulating data, trying to hide serious short-comings in his drug trial.

The recent history of pharmaceutical companies benefitting the researchers (“vested interest”) where truth and the health of patients is the casualty, is illustrated by the 25/29 authors of the trials of the diabetes drug Avandia who themselves had financial ties with GlaxoSmithKline, (GSK) who owns Eli Lilly (the manufacturers). Another looming problem is the unethical Monsanto research and false reporting of their GM crops, and the blatant lies underlying their “scientific trials”.

The value of “peer review” has been seriously questioned recently even within the US Supreme Court. Conclusions suggest that “incentives”, offered or inferred, devalue the process of peer review to the point of non-meaning. It has to do with incentives offered to do a review being seen as an incentive (by the reviewee and the critics) to write just what the trial managers want to hear, if at all they can. This will ensure certain benefits down the track, yes? Good all round for business.

In other words, time to re-evaluate the “peer review” part of the RCT process as well.

B. Who funds most of the RCTs anyway? (or “who pays the piper”).

Pro-industry findings in industry-funded RCTs
Many RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986-2002 articles comparing industry-sponsored and non-industry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.[63]

A 2004 study of 1999-2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs "are more likely to be associated with statistically significant pro-industry findings."[64] One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.[64]

So how should "evidence-based medicine" proceed?

It is not as if the RCT model doesn’t work at all. It does work really well, a lot of the time. But a lot of the time also there are failures, based in part at least on the foregoing considerations (see also Appendix 3).

‘Evidence-based’ medicine cannot rely any more on the RCT model, if it is seeking credibility above the standards the 20th century delivered, or failed to deliver, a credibility it must be said that is largely in tatters6 as it is in 2010.

Given the problems seemingly endemic in scientific research, mostly to do with vested interest and the profits at stake when trial data outcomes prove favourable (to the new drug, or treatment etc), indeed it appears doubtful that the RCT should ever have enjoyed the kudos it has.

Moving forward into the 21st century, we need to look outside the old model, and look at the relative values (strengths and weaknesses) of data available from other less developed, less sophisticated models, such as observational studies, biochemical studies, epidemiological studies, anecdotal references, and case studies.

A comparative study has been done between “observational studies” and RCTs, and published in the NEJM7. The conclusions? “We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials” (see Appendix 5).

^ a b Benson K, Hartz AJ (2000). "A comparison of observational studies and randomized, controlled trials". N Engl J Med 342 (25): 1878–86. doi:10.1056/NEJM200006223422506. PMID 10861324. http://content.nejm.org/cgi/content/full/342/25/1878.
See Appendix 4, Dr David Graham’s comments on the culture at the FDA.
So, this study is suggestive of at least similar value when comparing observational trials and RCTs. But all have levels of value, and perhaps a new, more “wholistic”, maybe even a synergistic trial model could be developed that would incorporate the strong points of the RCT, as well as features from the other less developed models as noted above.

So the next time someone says to you, “But there isn’t any ‘scientific evidence’ for (this or that alternative treatment)”, you can say, “So what? Just what reliable value is there in an RCT?”.

What should we now consider about the FDA and the TGA?
(Note to reader: it is not my intention to disparage the many good, honest and upright folk who work in “the system”, and there is nothing personal intended. One is just attempting to understand why it is that people’s human rights to determine their own best treatments, and to be presented with genuine alternatives to what is sometimes no more than what the medical system offers today, these rights and opportunities are being eroded daily. “Father, forgive them, for they know not what they do”.

Citizens in the US, Canada and Australia as well as some European countries, have grave public concerns regarding the coziness existing between the “regulators” and the pharmaceutical companies they are meant to be regulating.

The insights of Dr David Graham, the Vioxx whistleblower, lifted the lid (and not for the first time it must be added) on just how mutually dependent the FDA and the pharmaceutical industry have become, in which we see the “revolving door” phenomenon that inevitably promotes nepotism, greed and down-right graft has been alleged and documented.
Inaction, caused by ignorance, inadequate testing and checking industry data, inaccurate or biased reporting, even downright lying, on the part of individual regulators within the bodies such as the FDA and the TGA, all cost the public their health, quite literally sometimes even costing people their lives.

And that is serious enough. But this will continue unchecked, for as long as the culture within the Regulators is one of “We work (co-operatively) for the pharmaceutical industry” instead of one that is interested in safeguarding the health of the public who should) employ them.

Who does the FDA work for again? “We The People”. The public pay their salaries. Not the drug companies, they are the ones from which “we the people” require protection; and these august bodies are supposed to be our protectors8.

Given their behaviour as well as admissions, they seem to have forgotten their charter. They have become maverick, seemingly not accountable to anyone any more. They need to start protecting we the people from sloppy and biased “scientific trials” from which arise treatments and medications that currently are poisoning and killing our citizens.

An unbiased accounting, of course, should consider the “evidence” presented by any alternative, non-drug company product. Instead, the FDA all too readily criticize and lambaste such evidence as not having any “proof”, meaning it has not specifically itself undergone any RCTs.

But why ignore this body of evidence altogether? It might be a folk medicine with a long history of positive anecdotal testimony, or have had multi-centred clinical observational studies, have enjoyed altogether unbiased peer reviews, and repeatable trialling, with histo-pathology reports of the  “before and after” confirmatory data.

Appendix 3

  2010 - 2015 © Adrian Jones Naturopath   Global Star Services