Distorting Evidence: A South African Example

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One of the cardinal sins of any researcher is to tamper with their data to make them ‘fit’ the results they were wanting. A recent international example is that of Dr Andrew Wakefield, who published articles in the reputable Journal ‘The Lancet’, which apparently showed a causal link between the MMR (measles, mumps, rubella) vaccine and autism. Fortunately his deception was uncovered; he was struck off the roll of the General Medical Council in the UK; and The Lancet retracted his articles. The tragedy is that many people did not have their children vaccinated because of this deception, and a number of these unvaccinated children went on to develop measles and some even died. Others may have to cope with the consequences for years to come.

Hot on the heels of the sin of such deceptive fraud must surely be when other persons’ legitimate research results are misrepresented to promote a product (or medicine) for the purposes of self-gain.

Solal Technologies sells a product called I3Complex™ which it claims to be a ‘Cancer risk-reducing and protection formula for men and women.’ Under the heading ‘Who should use I3Complex™?’ (emphasis added) it is recommended that all people over the age of 40 can use it to reduce the risk of getting cancer. It further recommends that all people with a family history of breast cancer, high risk individuals, and women on hormone replacement therapy should use it as a preventive therapy. It is also claimed that although it should not be used in combination with radiation therapy, it can be used in combination with cancer medication and chemotherapy as part of a cancer treatment protocol. See: http://www.solaltech.com/new/shop/index.php?act=viewProd&productId=136 and http://www.solaltech.com/onepage/I3Complex_One%20Pager.pdf [NB: This webpage has become inaccessible since this article was first published.]  However a copy of it (as fair use) can be found here for your information. (Press browser "back" function to return to article; or right-click and open in a new tab or window.)

The label of the product states that ‘Ideally I3Complex™ should be used preventatively and continuously, for cellular protection.’ (emphasis added) The dose for adults and children over the age of 12 is 2 capsules a day. A month’s supply cost R375.00 on 3 April 2011. See: http://www.solaltech.com/newonepagers/I3Complex.swf

On the full page referred to above (pdf) are two pie charts under the heading ‘Inhibition of growth in estrogen receptor-positive breast cancer cells.’ One chart shows the inhibition by I3C (indole-3-carbinol) to be 90%. I3C is a substance found in cruciferous vegetables such as broccoli and it is one of the main ingredients in Solal's I3Complex™. The other shows the inhibition by tamoxifen to be 60%. Tamoxifen is a medicinal chemotherapeutic agent used in treating breast cancer. It appears from these graphics as if there is a marked 30% difference between these two therapies and that I3C is much more effective than tamoxifen.

The reference is ‘Adapted from Cover, et al, 1999.’

The only article I could find by Carolyn M Cover and her colleagues which tested I3C and tamoxifen was published in the journal Cancer Research, Volume 59, pages 1244-1251 dated March 15 1999. The title is: ‘Indole-3-Carbinol and Tamoxifen Cooperate to Arrest the Cell Cycle of MCF-7 Human Breast Cancer Cells.’ From the title it is clear that the main purpose of the research was about how the two substances worked together, not separately; and it is also clear that the study was not done in living human beings with breast cancer but in ‘MCF-7 Human Breast Cancer Cells’. (MCF-7 stands for 'Michigan Cancer Foundation-7'. Michigan Cancer Foundation obtained the breast cancer cells in 1970 from a 69 year old nun, Sister Catherine Frances, who died that year.)

The main finding of the research was to show that I3C and tamoxifen act in different ways ‘to [together] suppress the growth of human breast cancer cells.’ The authors hypothesised that the combination might represent a possible future therapy for estrogen-responsive breast cancer. However it seems that no further advances in researching this possibility have been published since 1999.

Part of the study involved testing the effect of each substance on its own in order to compare them with the overall effect when they were combined. The effect of I3C on its own was to inhibit DNA synthesis by 90% after 96 hours (4 days), and colony formation (or growth) of the cancer cells by 80% after 8 days. The effect of tamoxifen on its own was to inhibit DNA synthesis by 60% after 96 hours, and colony formation of the cancer cells by 65% after 8 days.

So the seemingly marked 30% difference shown in the pie graphs published by Solal do not in fact reflect ‘[i]nhibition of growth in estrogen receptor-positive breast cancer cells’ as stated by them, but the extent to which DNA synthesis was reduced in the breast cancer cells. (The cells had to be dissolved, the DNA extracted and the amounts of DNA measured, which is not the same as measuring the reduction in the formation of cancer cell colonies. Reduced DNA synthesis does not necessarily correlate linearly with inhibited cell growth.)

The actual inhibition of growth in estrogen receptor-positive breast cancer cell colonies showed a difference of only 15% between the I3C group and the tamoxifen group after 8 days. One wonders what would happen after another 8 or 16 days — would there be any difference at all? And what would happen in real living people?

I am deliberately re-emphasising that this research quoted by Solal was done only in breast cancer cells grown in a laboratory setting, and not in human beings. It is not possible to extrapolate any findings from this study from cells to human beings. There is a difference between 'adapting' findings from a research article but keeping their correct meaning, and 'distorting' those findings in a way that is not in keeping with the published results.

Of further greater concern is whether there is any evidence at all that the specific product ‘I3Complex™’ (or even a generic version of it with exactly the same ingredients and excipients) has been proven to reduce people’s cancer risk; or to prevent cancer; or whether it indeed has any beneficial effects when used in combination with cancer chemotherapy. Surely Solal had a responsibility to initiate or sponsor the research before marketing the product or to at least provide data from human studies using a product with the exact same combination of ingredients? Does the fact that I3Complex™ is ‘trademarked’ mean that there is no other comparable product anywhere in the world? And does that mean it has never been tested in humans? 

As an aside, it is interesting to note that the 'pharmacists who care' — Dischem — are listed at the bottom of the one-pager information sheet referred to above, as selling this Solal product. Are the Dischem pharmacists convinced that this product in fact reduces the risk of cancer or prevents cancer in people using the product? If they are convinced, I wonder what evidence they used. If they are not convinced, I wonder why they are selling the product.

Another thought: could a person who has been taking I3Complex™ but who subsequently develops cancer be awarded damages in terms of the Consumer Protection Act?

This analysis was prepared by Professor Roy Jobson. Professor Jobson is a medical doctor and an Associate Professor of Pharmacology in the Faculty of Pharmacy at Rhodes University. He has previously served as a Council member of the Medicines Control Council (MCC), was the inaugural Chairperson of its Pharmacovigilance Committee, and was also a member of its Clinical Trials and Complementary Medicines Committees. His analysis of this product does not reflect an official viewpoint of any of these institutions.

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15 Responses to Distorting Evidence: A South African Example

  1. Brent Murphy 6 April, 2011 at 11:06 pm #

    Hi Roy and Harris
     
    Roy, you boast about how you are an associate professor in pharmacology, but:
     
    Do you actually have any formal qualifications in pharmacology?
    NO.
     
    Do you have any degree majoring in pharmacology, or even a pharmacy degree for that matter? 
    NO.
     
    I know you are a medical doctor, and have a masters degree in family practice, but how many years of pharmacology did you study?  Less than me I’m sure, as most doctors do (including Harris Steinman). 
     
    And, do you have any clinical experience in the use of complementary medicines? 
    NO.
     
    I am a pharmacist. I studied pharmacology, and I have over 10 years of experience in the clinical use of complementary medicines. It’s what I do every day.
     
    Harris, you hold yourself out to be an expert in allergy medicine, yet you are only registered as a GP.  Is this not fraudulent and misrepresentation – the very thing you accuse others of doing?  And you Harris, like Roy, have no clinical experience in the use of complementary medicines and also have not studied pharmacology as long as I have.
     
    All your criticisms are based on your biased twisted self-serving interpretation of medical literature, with no practical experience in what you are commenting on.  Furthermore, often times you simply ignore the huge mountain of evidence against your argument, as is the case here.
     
    Now onto the issue at hand:
     
    There is ample evidence of the cancer risk-reduction and protective effects of the nutrients contained in I3Complex.  The composition of I3Complex includes indole-3-carbinol, di-indole-methane (which are both broccoli extracts) and curcumin (which is extracted from turmeric spice). You criticise us that the product is expensive, yet the reason for this is because we are determined to ensure that the amounts of each nutrient are contained in adequate quantities to be effective.
     
    I think that your attempts to keep the truth hidden about these cancer-protective nutrients smacks of anti natural medicine vigilantism.
     
    I think readers of this blog should make up their own minds if this I3Complex is useful for reducing risk of getting cancer, by reading the original research in medical journals themselves, which I provide the links for here:
     
    Indole-3-Carbinol / Di-indole-methane (broccoli extracts) and cancer – 394 scientific publications and medical trials
    http://www.ncbi.nlm.nih.gov/pubmed?term=indole-3-carbinol%20cancer
     
    Curcumin (turmeric extract) and cancer – 394 scientific publications and medical trials
    http://www.ncbi.nlm.nih.gov/pubmed?term=curcumin%20cancer
     
    Indole-3-Carbinol / Di-indole-methane (broccoli extracts) enhance the effectiveness of Tamoxifen: 30 scientific publications and medical trials
    http://www.ncbi.nlm.nih.gov/pubmed?term=indole-3-carbinol%20tamoxifen
     
    Roy and Harris, instead of unjustly crusading against the healthy nutrients in SOLAL’s products, that actually do good, why not crusade against all the unhealthy environmental chemicals that cause cancer in the first place (and that I3Complex helps get rid of), like dioxins, heterocyclic amines and PCB’s in food and bisphenol-A (BPA) in tinned/canned foods, babies bottles etc. 
     
    You are potentially causing much harm to people’s health by trying to keep truthful information about cancer-protective nutrients hidden from them.  I would love to know what the law would have to say about you trying to prevent people’s right to access these effective and preventive natural medicines.
     
    Regards
     
    Brent
     
     
    ___________________
    Brent Murphy – B.Pharm (Rhodes), MPS
    Pharmacist
    SOLAL Technologies Pty Ltd
    Proud manufacturer of I3Complex

  2. Nathan Geffen 7 April, 2011 at 9:49 am #

     
    Brent
    Most of your response is an ad hominem attack on Roy and Harris.
    The substantive part of your response is based on referring readers to the results of three Pubmed searches. Neither I nor anyone has the time to study the nearly 2,000 articles returned by these searches. However, I browsed several pages of the results and I cannot find any studies of I3C that occurred in humans. Consequently I can't find any clinical trial or even retrospective cohort evidence that I3C reduces the risk of cancer in humans. This was surely Roy's point?
    It is possible that I3C reduces the risk of cancer in humans. But it is unethical to claim that I3C products reduce the risk of cancer until we have compelling evidence from well-conducted large studies in humans. You have not referenced any such studies, so for now I must assume they don't exist.
    Moreover because we do not have clinical trial evidence from humans, even if I3C is effective at reducing the risk of cancer, we do not know the dose or duration for which it must be taken. It even seems to me that we have very little if any good PK data on I3C from studies. I found one PK study conducted in monkeys and dogs (and perhaps there are others), but that's just not good enough. Maybe one day this will change; maybe clinical trials will show great benefit to I3C supplementation. But until then no product claims should be made.
    The main point  made by Roy (which I affirm) is that Solal's adverts claiming that I3C reduces the risk of cancer are irresponsible and based on insufficient evidence. You simply don't address this.
    Finally, I want to make an analogy with your style of argument. I could refer readers to this pubmed search: "zalcitabine HIV". It returns 3045 articles. In contrast to your searches, many of these articles contain compelling clinical trial and cohort evidence in humans showing the efficacy of zalcitabine against HIV. In essence the evidence that zalcitabine is effective against HIV far outstrips the evidence that I3C reduces the risk of cancer. Yet, no decent HIV clinicians would recommend zalcitabine. It has awful side-effects and there are much better drugs. I could make the same argument with adefovir (a drug never approved for HIV treatment). So although a superficially compelling argument for these drugs could be made by referring to pubmed searches, these arguments would be poor. The point is that your style of argument, which consists of referring people to pubmed results without any proper analysis, is not rigorous; you make arguments that don't stand up to scrutiny.

  3. Marcus Low 7 April, 2011 at 9:52 am #

    Brent. Do you honestly believe the references you cite back up your claims?

  4. Harris 7 April, 2011 at 10:08 am #

    Hi Brent,

    You are avoiding the points raised by Roy in his posting (which he wrote without my input).

    1. One does NOT have to have studied pharmacology or pharmacy if one has an excellent understanding of reviewing scientific studies – this is where the proof lies, not in how a pharmacist/doctor decides how they wish to “interpret” the studies.

    2. You have completely avoided responding to Roy’s posting of your flawed interpretation of the study. I reviewed the study that Roy refers to and agree with his interpretation.

    3. You have NOT commented on the fact that the study you quote in support of your products claims was NOT done on humans.

    Your claim that “394 scientific publications and medical trials http://www.ncbi.nlm.nih.gov/pubmed?term=indole-3-carbinol%20cancer Curcumin (turmeric extract) and cancer” is entirely misleading. It does not include the search terms “humans” and “clinical trial”. If these search terms are included, only 9 results are found. [1] And NONE support, or can be extrapolated to your claims.

    And for your claim of 30 scientific publications and medical trials for Indole-3-Carbinol / Di-indole-methane (broccoli extracts) enhance the effectiveness of Tamoxifen, adding the search terms “humans” and “clinical trial” shows 0 results. [2]

    4. You have NOT commented on the fact that your product’s combination of ingredients has NEVER been tested for safety or efficacy in humans.

    5. You have NOT commented on the fact whether this combination of ingredients are synergistic or antagonistic but that it is simply a best guess.

    6. Clinical experience in the use of complementary medicines does not trump contrary robust evidence from clinical trials.

    7. I am NOT against CAMS. I am against bad or incorrect interpretation. Before I post a product deconstruction, I DO occasionally write to an author to ensure whether my interpretation was correct or whether that author(s) have been misinterpreted. To date I have never had one disagree with my interpretation.

    8. You state: “ … you hold yourself out to be an expert in allergy medicine, yet you are only registered as a GP. Is this not fraudulent and misrepresentation”.

    NO – I have never claimed to be an allergist or an allergologist, or a specialist in allergy. The HPCSA expressly forbids this. The HPCSA allows me to state that I have expertise in allergy (based on, among other, 20 years clinical and research experience in this field, the 5 peer-reviewed allergen reference books I have authored, etc.).

    9. You state: “All your criticisms are based on your biased twisted self-serving interpretation of medical literature”.

    Readers, please note that Natural Medicines Comprehensive Database (NMCD) (“Unbiased, Scientific Clinical Information on Complementary, Alternative, and Integrative Therapies” often contradict Solal’s/Brent’s interpretation. (see below). And these are real experts in CAMS. (http://www.naturaldatabase.com/)

    10. NMCD have NO “Effectiveness” rating for the use of Indole-3-Carbinol for cancer prevention. In fact they state: “There is some preliminary evidence that indole-3-carbinol might promote tumorigenesis* in patients who are in the initiation phase of tumor induction due to carcinogen exposure (7171). However, this potential risk is controversial and has never been documented in humans. Until more is known, it is not possible to determine if there is a real risk to humans or who might be susceptible to this risk.”

    And the similarly for Curcumin: there is NO Effectiveness rating for this substance as an anticancer agent (except for colorectal cancer, which states that it may be “possibly effective”).
    * tumorigenesis = the production or formation of a tumor or tumors.

    11. Users of CAM products have a right to have access to FULL information:
    For example, this more recent 2006 study of Indole-3-Carbinol states:
    “Although most animal studies with Indole-3-Carbinol (I3C) and carcinogen treatment have shown chemopreventive effects (1-10), some experimental models have instead pointed to a tumor-promoting effect of this compound (11-14). In contrast to the reported chemopreventive effects of I3C, the apparent promoting effects of I3C are highly dependent on the species, carcinogen, target organ, and exposure regimens employed (12, 13). Moreover, the I3C doses required for promotion, particularly in liver, are doses that elicit substantial toxicity.”[3]

    The questions raised by this 2006 study has still not been answered.

    A more recent review from reputable Cancer research unit made the following point:
    “Although in vitro studies have contributed significantly to our understanding, quite a number use concentrations orders of magnitude greater than those achievable in humans or toxic to normal tissues (exemplified by toxic concentrations of indole-3-carbinol, epigallocatechin-3-gallate, curcumin, and genistein for breast cells). Such studies may produce results that are physiologically irrelevant, thus hindering predictions of efficacy.” [My emphasis]

    12. Therefore I am not attempting “to keep the truth hidden about these cancer-protective nutrients” but would support them whole-heartedly but only if sufficient good evidence (correctly interpreted), supports the claims.

    Brent wrote:
    “You are potentially causing much harm to people’s health by trying to keep truthful information about cancer-protective nutrients hidden from them. I would love to know what the law would have to say about you trying to prevent people’s right to access these effective and preventive natural medicines.”

    I ask readers to consider whether I am an alarmist, anti-CAM, or simply trying to protect consumers from claims for ingredients or products that do not have sufficient proof of safety and/or efficacy.

    The South African Constitution states: Chapter 1 – The South African Constitution and Bill of Rights states under Section 12: Freedom and security of the person: This includes the following rights: “the right not to be subjected to medical or scientific experiments.”[3] (In clinical trials, patients give fully informed consent to a detailed exposition of the aim and risks of the study.)

    [1]
    Correct PubMed search: http://www.ncbi.nlm.nih.gov/pubmed?term=”indole-3-carbinol“[Supplementary Concept] OR “indole-3-carbinol”[All Fields] OR “indole 3 carbinol”[All Fields] AND (“neoplasms”[MeSH Terms] OR “neoplasms”[All Fields] OR “cancer”[All Fields]) AND (“humans”[MeSH Terms] AND Clinical Trial[ptyp])

    [2]
    Correct PubMed search: http://www.ncbi.nlm.nih.gov/pubmed?term=((“indole-3-carbinol”[Supplementary Concept] OR “indole-3-carbinol”[All Fields] OR “indole 3 carbinol”[All Fields]) AND (“tamoxifen”[MeSH Terms] OR “tamoxifen”[All Fields])) AND (“humans”[MeSH Terms] AND Clinical Trial[ptyp])

    [3]
    Reed GA, Arneson DW, Putnam WC, Smith HJ, Gray JC, Sullivan DK, Mayo MS, Crowell JA, Hurwitz A. Single-dose and multiple-dose administration of indole-3-carbinol to women: pharmacokinetics based on 3,3′-diindolylmethane. Cancer Epidemiol Biomarkers Prev. 2006 Dec;15(12):2477-81. http://cebp.aacrjournals.org/content/15/12/2477.full

    [4]
    http://books.google.co.za/books?id=BZQ9LqUHDWYC&pg=PA429&lpg=PA429&dq=south+africa+constitution+have+medical+or+scientific+experiments+done+on+people&source=bl&ots=r7ABj3IJf9&sig=uucWci0ojUf8UJwgPozThqmMHs0&hl=en&ei=HOecTZDWBIiucJeKrdsF&sa=X&oi=book_result&ct=result&resnum=2&ved=0CCIQ6AEwAQ#v=onepage&q&f=false

  5. Michael Meadon 7 April, 2011 at 1:41 pm #

    Brent, three points. 
    1) I see no reason why a "formal qualification in pharmacology" is required to understand clinical research. A medical statistician, for example, is arguably more qualified to assess such studies than you are. 
    2) Your implicit claim that only those people with clinical CAM experience is qualified to judge CAM is silly. Think of the analogy: it's insisting the only people qualified to criticize adulterers are those who have committed adultery themselves. Critics of CAM cannot ethically have any CAM experience because they believe CAM is ineffective. 
    3) We can all do Pubmed searches. If you're really intent on changing minds, give us your <i>best</i> evidence: the handful of large, high-quality, randomized, double-blinded, placebo-controlled clinical trails that support your views. (<i>In vitro<i/> studies like Cover et. al. obviously do not count). 

  6. Brent Murphy 7 April, 2011 at 3:01 pm #

    Hi Michael
    I understand and accept you viewpoints 1 & 2 as having some merit. 
    However please understand that medicine (including complementary medicine) is as much of an art as a science; and you can only gain the art of treating patients, if you actually treat them.  You cant do this from behind a computer screen all day. We (our pharmacists and medical practitioners) see the day to day sucesses and results of CAM.  I also dont accept the analogy of CAM being some sort of evil (like adultery).  It is a discipline of medicine the expertise and understanding of which comes mainly through practice.
    Re you point 3:  I will compile the info and post shortly.
    Regards
    Brent

  7. Harris 7 April, 2011 at 3:34 pm #

    Interesting point Brent makes.

    Sounds like a rational and decent argument except I am reminded about the history of bloodletting, performed by doctors from antiquity up to the late 19th century. There was great resistance to changing this practice following blinded studies which showed that patients were actually worse off  – which contradicted doctors opinion that ". . . medicine is as much of an art as a science; and you can only gain the art of treating patients, if you actually treat them."

    I am not equating Brent nor Solal to individuals who sell AIDS cures, but it is unfortunate that their argument is the same: see: http://www.camcheck.co.za/faith-drops-in-response/

  8. Michael Meadon 7 April, 2011 at 3:44 pm #

    Brent…. You (and the other commenters here) are far more qualified on this topic than I am, but I have to disagree with your suggestion that medical practitioners must (or even should be allowed to) substitute "clinical experience" for robust scientific evidence.
    I think it was Goldacre who said " 'in my experience' is the most dangerous phrase in medicine", and it's reasonably clear he's right. Medical history is full of smart people who used ineffective or even downright counterproductive treatments – blood letting, homeopathy, etc. – that they thought worked because of their own "clinical experience". Such medical experiences are just anecdotal evidence: numerous variables (placebo effect, regression to the mean, contamination due to prior belief, etc.) cannot be controlled in such settings, and proper inferences can thus not be drawn. For why this is the case, see my (long, but I think quite good) article on the status of anecdotal evidence: http://ionian-enchantment.blogspot.com/2010/06/anecdotes-as-evidence.html

  9. Brent Murphy 7 April, 2011 at 5:31 pm #

    Hi Michael

    I read your article. It presents a logical argument and I agree with much of it. However the confounding variables that you refer to, that make anecdotes (clinical experience in this case) untrustable and not data, are the very reason medicine is as much an art as a science.

    I will explain by means of an example (not quite the Jessica Alba example you describe, but I will try):
    A doctors see a long-standing patient of his, a slightly overweight man, with high blood pressure and elevated cholesterol. Hard scientific evidence says the patient should be put onto a blood-pressure lowering and anti-cholesterol medication. However, the doctor, being an empathetic man, notices a glint of sadness in his patient’s eye, gently puts his hand on his patient’s shoulder and asks him what else is wrong (don’t worry, this story is this is not going the way of brokeback mountain). Because of the doctors compassion the patient breaks down in tears and explains that he is not sleeping at night because of marital problems. He has also been drinking to relieve the stress. Now the doctor, through his experience and through recent not-so-robust, but nonetheless plausible evidence, has noted that lack of sleep causes weight gain and insulin resistance (check pubmed). Insulin resistance causes metabolic syndrome and elevated cholesterol and high blood pressure, all aggravated by alcohol consumption. The doctor decides, instead of giving anti-cholesterol and blood pressure medicines (which is most strongly supported by scientific data to bring down cholesterol and blood pressure), rather, based on his experience (and scientific studies, although not as “robust” as some would like, even though they are clinical and done on humans), to put the patient on melatonin for sleep; chromium, alpha lipoic acid, and d-chiroinositol, and maybe metformin for insulin resistance. HE also puts the patient on kudzu extract for weak evidence suggest is good for preventing alcohol cravings (see pubmed). As a result the patient sleeps longer and therefore becomes insulin responsive, loses weight, drinks less and his blood pressure and cholesterol normalises. Had the doctor treated the blood pressure and cholesterol only he would have been treating the symptoms not the underlying cause: insomnia and insulin resistance. If the doctor had not seen the glint sadness in his patient’s eyes, the wrong therapy would have been chosen.

    The confounding variables in this case, ie deficiency of sleep, stress, insulin resistance, alcohol use, overweight, high blood pressure, elevated cholesterol, a nagging wife, are not reasons NOT to rely clinical experience (and instead scientific evidence only);
    but rather the opposite: theses confounding variables, individual variability, that science can never anticipate or account for, that are very reasons that one MUST rely on clinical experience as an equally important part of medicine; something not possible from behind a computer screen.

    To summarise the above, I would argue that medicine is as much an art as it is a science, mainly because of individual variability (confounding variables) and complexity (of doctor and patient) – unlike the laws of physics and chemistry which are static and known.

    As Sir William Osler, father of modern medicine said: “If there were no individual variability, medicine would have been science not an art”

    This from British Medical Journal, Feb 2001: “The practice of clinical medicine as an art and as a science”
    http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1071282

    Some quotes from above BMJ link:

    “I want to suggest that the art and science of medicine are inseparable, part of a common culture. Knowing is an art; science requires personal participation in knowledge.”

    “The controlled, randomized clinical trial has been a powerful instrument in furthering medical knowledge, and, of course, a physician should know its results. But it is often not enough in recommending treatment for a particular patient. The double-blind, randomized, controlled trial (RCT) is an experiment, but experiment may be unnecessary, inappropriate, impossible, or inadequate.9 A dramatic intervention such as penicillin in meningococcal meningitis does not need a RCT to demonstrate its efficacy. An RCT would be inappropriate if the effect of random allocation reduces the effectiveness of the intervention (when active participation of the subject is required, which in turn depends on the subject’s beliefs and preferences).”

    “Good physicians use their personal judgment to affirm what they think to be true in a particular situation. Their knowledge is not purely subjective, for they cannot believe just anything, and their judgment is made responsibly and with universal intent—that is, they take it that anyone in the same position should concur. It is practical wisdom. Medical practice demands such judgments on a daily basis. The good doctor is able to reflect on diverse evidence and to apply it in a particular context. No computer could replace him or her, for the judgment cannot be reached by logic alone. Here medical practice as art and science merge.”

    “None of these processes of decision, described by McDonald, are logical or scientific in the usual sense of the words, nor are any based on evidence. Some could be, but for many, this is impossible even in principle.”

    “All data, regardless of their completeness or accuracy, are interpreted by the clinician to make sense of them and apply them to clinical practice. Experts take into account messy details, such as context, cost, convenience, and the values of the patient. “Doctor factors” such as emotions, bias, prejudice, risk-aversion, tolerance of uncertainty, and personal knowledge of the patient also influence clinical judgment. The practice of clinical medicine with its daily judgments is both science and art. It is impossible to make explicit all aspects of professional competence. Evidence-based decision models may be powerful, but they are like computer-generated symphonies in the style of Mozart—correct but lifeless. The art of caring for patients, then, should fluorish not merely in the theoretic or abstract gray zones where scientific evidence is incomplete or conflicting but also in the recognition that what is black and white in the abstract often becomes gray in practice, as clinicians seek to meet their patients’ needs. In the practice of clinical medicine, the art is not merely part of the “medical humanities” but is integral to medicine as an applied science.”

    All the best

    Brent

  10. Roy 8 April, 2011 at 10:12 am #

    Hi Brent,

    Thank you for your kind words. Are you saying that Rhodes University erred in appointing me Associate Professor of Pharmacology in the Faculty of Pharmacy? Do you know the basis on which they appointed me?

    You have yet to explain why / how you confused "inhibition of DNA synthesis" with "inhibition of cell colony formation (growth)" in the information you adapted from Cover et. al.

    You have not provided any evidence that your product I3Complex(TM) — as a whole — will actually deliver on its claims to reduce the risks of cancer or to prevent cancer.

    The link you provided in your last posting to Michael — to the Feb 2001 "British Medical Journal" (an article by John Saunders) is in fact a link to "Western Journal of Medicine" — which is part of the BMJ publishing group (but is not the BMJ). A similar error to confusing (reduced) DNA synthesis with (inhibition of) cell colony formation?

    Saunders also questions "fashions" in diagnosis and treatment and calls them "bad science" and "bad medicine". I wonder if he would include "anti-aging medicine" and diagnoses such as "adrenal fatigue"?

    The most quoted definition of evidence-based medicine is that of David Sackett (BMJ 1996): "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research." See http://www.bmj.com/content/312/7023/71.full

    Applying this definition to I3Complex(TM) "as a whole" — there is no "current best evidence" nor is there any "available external clinical evidence from systematic research" for its use. If I am mistaken, I would be most interested to read the research, and assess the methodology and the data for myself. I promise if it is confidential to keep it to myself. I'm particularly interested in the evidence for the statements that "all" people over the age of 40 "should" be taking the product, and that "all" people with a family history of breast cancer, high risk individuals, and women on hormone replacement therapy should use it as  preventive therapy.

    I do not see the relevance of your "art of medicine" description to this situation. You are selling an OTC product via Dischem, "leading" pharmacies, health stores, and on-line — where you have no knowledge of the patient and their particular individual circumstances. There is neither art nor evidence in this.

  11. Michael Meadon 8 April, 2011 at 11:53 am #

    Brent,

    Roy makes some excellent points – I hope you’ll address them. And you’ve still not provided those links to clinical trails. (I don’t want to soon too demanding, but please don’t send us masses of studies. Just the handful of large, randomized, double-blinded etc. etc. clinical trails in humans. Or even better, a systematic review or meta-analysis).

    I’m not seeing how your story undermines or alters any of the points I made. Getting the extra information is exactly what any doctor should be doing, and I have no doubt that bed side manner is an art. The problem isn’t taking as many individual factors of his patient into account as possible, it’s whether the medications he ends up prescribing are evidence-based. The only way to determine whether, say, kudzu extract really does work for alchohol is to do controlled experiments. No matter how many times the doctor prescribes kudzu and it seems to work, it won’t ever be evidence of efficacy. (Because it could be the placebo effect or regression to the mean or some of the other medications working in combination or or or).

    So, yes. Medicine is an art as well as a science. But the “art” bit does not license ignoring the “science” bit. Except in extreme circumstances, no doctor should prescribe any treatment for which there isn’t robust experimental data in humans. (When a patient is at death’s door it is of course permissible to try experimental treatments. But there should at least be some evidence of efficacy. Trying, say, homeopathy at this point is as unethical as it is treating a non-terminal patient with homeopathy).

  12. Pieter Botha 26 April, 2011 at 2:24 pm #

    Hi Prof Jobson, Harris, Michael, Marcus, Brent, Nathan
    I am a pharmacist and the General Manager for a small "pharmaceutical / complementary medicines" manufacturer in Gauteng. I found your debate, insight and comments refreshing and relevant to the changing industry. It does however set off all the alarm bells, where will this end. We as well as our clients employ a pharmacist as their Responsible Pharmacist, the current team boast M. Pharms in pharmacology, pharmaceutical practise, and pharmaceutics (all from Potch). We concentrate more on the actual manufacturing as opposed to marketing, R&D and development of new "complementary" products, but invariably find ourselves in the complementary mess defending our profession against excellent marketers and sellers . Legislation has become very difficult to understand. There seems to be two distinctly different schools of thought but no clear regulations pertaining to the "manufacturers" of these so called complementary medicines. Would the industry not be clearer if the manufacturers of these products are regulated and saddled with the responsibility of ensuring ethical, regulatory, legal, etc compliance. I have the time of my life dodging magic bullets and miracle cures, and am becomming ever unpopular when I turn down manufacturing opportunities as these have a direct impact on our growth (only to find out that someone else is either importing a similar product or even manufacturing the product that we said no to). We are a fully BBBEE certified company that has been around for 10 years, awaiting our inspection report from MCC (we were inspected at the end of January), but are unable to focus on any long term goals as the industry has been changing since 1998 with the SAMDRA Act. and yet there seems to be no clear end in sight. How will we ever be competitive if our industry has no clear rules and regulations that prevents rogue manufacturers and marketers from filling up the shelves with their magic bullets that could never meet worldwide standards for safety, efficacy and quality.  
    Kind regards,
    Pieter  

  13. Roy 27 April, 2011 at 12:48 pm #

    @Pieter
    It is good to hear that there are pharmacists trying to ensure that consumers receive well manufactured quality products.
    I hope your inspection report from the MCC arrives soon.
    It seems that Regulations for Complementary medicines are to be published soon. I'd recommend that you (and any interested readers) submit appropriate comments during the comment period — especially if you think the Regulations are too lax. Hopefully the end is in sight for rogue manufacturers and marketers! (And that safety and efficacy will also be addressed.)

  14. Sick and Tired 25 July, 2012 at 6:48 pm #

    As someone on the other end (and not remotely scientifically oriented or qualified with regard to your discussions), ie the patient, I have found this very interesting. Both my sister and her husband have had consultations with Solal Practitioners and have been recommended certain Solal products. My family, concerned for my health, has tried to push me in the direction of Solal, stating that a third opinion would be “interesting” and “wouldn’t hurt”. However, even before I read any of this, I personally was concerned that Doctors are pushing their own products and therefore worried about the efficacy of their claims and their supplements.

    On the other hand I dread the moment that Vitamins and other therapies or complimentary health products are controlled by the government. There are good and bad intonations were this to become the norm. On the one hand people (manufacturers) would have to comply with certain standards. However, this would negatively impact on the price of goods because the government would indirectly benefit from this legislation.

    As a sufferer of RA, AS, Hypothyroidism, high blood pressure, high cholesterol, chronic depression and a slew of other complaints and ailments, I am more confused than ever!

Trackbacks/Pingbacks

  1. Is an “anti-aging pill” possible? | CAMcheck - 18 April, 2011

    […] It would seem that Solal most likely did not access the original article in the journal Nature about the effects of resveratrol on worms and fruit flies respectively and ended up quoting the incorrect figures for fruit flies. Not that this really makes a difference to whether or not it has an effect in humans — that is still undetermined, although Solal claims it does. The issue is that once again Solal have made a mistake in its interpretation of scientific data. See also the article on this website on distorting evidence. […]

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