s Truth in Medicine – Weighing the Evidence | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists

Editorial

From the desk of the editor

Welcome to the July 2014 homepage edition of i2P (Information to Pharmacists) E-Magazine.
At the commencement of 2014 i2P focused on the need for the entire profession of pharmacy and its associated industry supports to undergo a renewal and regeneration.
We are now half-way through this year and it is quite apparent that pharmacy leaders do not yet have a cohesive and clear sense of direction.
Maybe the new initiative by Woolworths to deliver clinical service through young pharmacists and nurses may sharpen their focus.
If not, community pharmacy can look forward to losing a substantial and profitable market share of the clinical services market.
Who would you blame when that happens?
But I have to admit there is some effort, even though the results are but meagre.
In this edition of i2P we focus on the need for research about community pharmacy, the lack of activity from practicing pharmacists and when some research is delivered, a disconnect appears in its interpretation and implementation.

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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

It started with “tablet” computers deployed on shelves inside the retailer Coles, specifically to provide information to consumers relating to pain management and the sale of strong analgesics.
This development was reported in i2P under the title Coles Pharmacy Expansion and the Arid PGA Landscape”
In that article we reported that qualified information was a missing link that had come out of Coles market research as the reason to why it had not succeeded in dominating the pain market.
Of course, Woolworths was working on the same problem at the same time and had come up with a better solution - real people with good information.

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

Editor's Note: The understanding of a pharmacy's presentation through the research that goes into the design of fixtures and fittings that highlight displays, is a never-ending component of pharmacy marketing.
Over the past decade, Australian pharmacy shop presentations have fallen behind in standards of excellence.
It does not take rocket science - you just have to open your eyes.
Recently, our two major supermarkets, Woolworths and Coles, have entered into the field of drug and condition information provision - right into the heartland of Australian Pharmacy.

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The sure way to drive business away

Gerald Quigley

I attended the Pregnancy, Baby and Children’s Expo in Brisbane recently.
What an eye and ear opening event that was!
Young Mums, mature Mums, partners of all ages, grandparents and friends……...many asking about health issues and seeking reassurances that they were doing the right thing.

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

It should be the scandal of the century.
It potentially affects the health of almost everyone.
Healthcare providers and consumers alike should be up in arms. But apart from coverage in a few credible news sources the problem of ‘Marketing Based Medicine,’ as psychiatrist Dr Peter Parry terms it, hasn’t as yet generated the kind of universal outrage one might expect.

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Community Pharmacy Research - Are You Involved?

Mark Coleman

Government funding is always scarce and restricted.
If you are ever going to be a recipient of government funds you will need to fortify any application with evidence.
From a government perspective, this minimises risk.
I must admit that while I see evidence of research projects being managed by the PGA, I rarely see community pharmacists individually and actively engaged in the type of research that would further their own aims and objectives (and survival).

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

Most of us leave a tremendous impact on pharmacies we work for (as proprietors, managers, contractors or employees)—in ways we’re not even aware of.
But organisational memories are often all too short, and without a central way to record that impact and capture the knowledge and individual contributions, they become lost to time.
It is ironic that technology has provided us with phenomenal tools for communication and connection, but much of it has also sped up our work lives and made knowledge and memory at work much more ephemeral.

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Academics on the payroll: the advertising you don't see

Staff Writer

This article was first published in The Conversation and was written by Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney
In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care.
i2P has republished the article as it supports our own independent and ongoing investigations on how drug companies are involved in marketing-based medicine rather than evidence-based medicine.

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

Editor's Note: This is an early article by Mark Neuenschwander we have republished after the soul-searching surrounding a recent Australian dispensing error involving methotrexate.
Hmm. There’s more than one way you could take that, huh? Like Someday when I get around to it (I’m not sure) I may admit that I was wrong about something. Actually, I’ve been thinking about the concept of admitting wrong. So don’t get your hopes up. No juicy confessions this month except that I wish it were easier for me to admit when I have been wrong or made a mistake.
Brian Goldman, an ER physician from Toronto, is host of the award-winning White Coat, Black Art on CBC Radio and slated to deliver the keynote at The unSUMMIT for Bedside Barcoding in Anaheim this May. His TED lecture, entitled, “Doctors make mistakes. Can we talk about it?” had already been viewed by 386,072 others before I watched it last week.

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Dispensing errors – a ripple effect of damage

Kay Dunkley - BPharm, Grad Dip Hosp Pharm, Grad Dip Health Admin, MPS, MSHPA

Most readers will be aware of recent publicity relating to dispensing errors and in particular to deaths caused by methotrexate being incorrectly packed in dose administration aids.
The Pharmacy Board of Australia (PBA), in its Communique of 13 June 2014, described a methotrexate packing error leading to the death of a patient and noted “extra vigilance is required to be exercised by pharmacists with these drugs”.
This same case was reported by A Current Affair (ACA) in its program on Friday 20 June
http://aca.ninemsn.com.au/article/8863098/prescription-drug-warning

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Take a vacation from your vocation

Harvey Mackay

Have you ever had one of those days when all you could think was, “Gosh, do I need a vacation.”
Of course you have – because all work and no play aren’t good for anyone.
A vacation doesn’t have to be two weeks on a tropical island, or even a long weekend at the beach. 
A vacation just means taking a break from your everyday activities. 
A change of pace. 
It doesn’t matter where.
Everyone needs a vacation to rejuvenate mentally and physically. 
But did you also know that you can help boost our economy by taking some days off? 
Call it your personal stimulus package.

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Explainer: what is peer review?

Staff Writer

This article was first published in the Conversation. It caught our eye because "peer review" it is one of the standards for evidence-based medicines that has also been corrupted by global pharma.
The article is republished by i2P as part of its ongoing investigation into scientific fraud and was writtenby Andre Spicer, City University London and Thomas Roulet, University of Oxford
We’ve all heard the phrase “peer review” as giving credence to research and scholarly papers, but what does it actually mean?
How does it work?
Peer review is one of the gold standards of science. It’s a process where scientists (“peers”) evaluate the quality of other scientists' work. By doing this, they aim to ensure the work is rigorous, coherent, uses past research and adds to what we already knew.
Most scientific journals, conferences and grant applications have some sort of peer review system. In most cases it is “double blind” peer review. This means evaluators do not know the author(s), and the author(s) do not know the identity of the evaluators.
The intention behind this system is to ensure evaluation is not biased.
The more prestigious the journal, conference, or grant, the more demanding will be the review process, and the more likely the rejection. This prestige is why these papers tend to be more read and more cited.

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Dentists from the dark side?

Loretta Marron OAM BSc

While dining out with an elderly friend, I noticed that he kept his false tooth plate in his shirt pocket. He had recently had seven amalgam-filled teeth removed, because he believed that their toxins were making him sick; but his new plate was uncomfortable. He had been treated by an 'holistic dentist'. Claiming to offer a "safe and healthier alternative" to conventional dentistry, are they committed to our overall health and wellbeing or are they promoting unjustified fear, unnecessarily extracting teeth and wasting our money?

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Planning for Profit in 2015 – Your key to Business Success

Chris Foster

We are now entering a new financial year and it’s a great time to reflect on last year and highlight those things that went well and those that may have impacted negatively in the pursuit of your goals.
It's also a great to spend some time re-evaluating your personal and business short, medium and long term goals in the light of events over the last year.
The achievement of your goals will in many cases be dependent on setting and aspiring to specific financial targets. It's important that recognise that many of your personal goals will require you to generate sufficient business profits to fund those aspirations

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Attracting and Retaining Great People

Barry Urquhart

Welcome to the new financial year in Australia.
For many in business the past year has been described as a challenging period.
Adjectives are a key feature of the English language.  In the business lexicon their use can be, and often is evocative and stimulate creative images.  But they can also contribute to inexact, emotional perceptions.
Throughout the financial pages of newspapers and business magazines adjectives abound.
References to “hot” money draw attention and comment.  The recent wave of funds from Chinese investors, keen to remove their wealth from the jurisdiction and control of government regulations is creating a potential property bubble in Australia.

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Updating Your Values - Extending Your Culture

Neil Johnston

Pharmacy culture is dormant.
Being comprised of values, unless each value is continually addressed, updated or deleted, entire organisations can stagnate (or entire professions such as the pharmacy profession).
Good values offer a strong sense of security, knowing that if you operate within the boundaries of your values, you will succeed in your endeavours.

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Evidence-based medicine is broken. Why we need data and technology to fix it

Staff Writer

The following article is reprinted from The Conversation and forms up part of our library collection on evidence-based medicines.
At i2P we also believe that the current model of evidence is so fractured it will never be able to be repaired.
All that can happen is that health professionals should independently test and verify through their own investigations what evidence exists to prescribe a medicine of any potency.
Health professionals that have patients (such as pharmacists) are ideally placed to observe and record the efficacy for medicines.
All else should confine their criticisms to their evidence of the actual evidence published.
If there are holes in it then share that evidence with the rest of the world.
Otherwise, do not be in such a hurry to criticise professions that have good experience and judgement to make a good choice on behalf of their patients, simply because good evidence has not caught up with reality.

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Laropiprant is the Bad One; Niacin is/was/will always be the Good One

Staff Writer

Orthomolecular Medicine News Service, July 25, 2014
Laropiprant is the Bad One; Niacin is/was/will always be the Good One
by W. Todd Penberthy, PhD

(OMNS July 25, 2014) Niacin has been used for over 60 years in tens of thousands of patients with tremendously favorable therapeutic benefit (Carlson 2005).
In the first-person NY Times best seller, "8 Weeks to a Cure for Cholesterol," the author describes his journey from being a walking heart attack time bomb to a becoming a healthy individual.
He hails high-dose niacin as the one treatment that did more to correct his poor lipid profile than any other (Kowalski 2001).

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Culture Drive & Pharmacy Renewal

Neil Johnston

Deep within all of us we have a core set of values and beliefs that create the standards of behaviour that we align with when we set a particular direction in life.
Directions may change many times over a lifetime, but with life experiences and maturity values may increase in number or gain greater depth.
All of this is embraced under one word – “culture”.
When a business is born it will only develop if it has a sound culture, and the values that comprise that culture are initially inherent in the business founder.
A sound business culture equates to a successful business and that success is often expressed in the term “goodwill” which can be eventually translated to a dollar value.

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Pharmacy 2014 - Pharmacy Management Conference

Neil Johnston

The brave new world of health and wellness is not the enemy of Pharmacy, it is its champion.
Australian futurist, Morris Miselowski, one of the world's leading business visionaries, will present the Opening Keynote address on Pharmacy's Future in the new Health and Wellness Landscape at 2.00pm on Wednesday July 30.
Morris believes the key to better health care could already be in your pocket, with doctors soon set to prescribe iPhone apps, instead of pills.
Technology will revolutionise the health industry - a paradigm shift from healthcare to personal wellness.
Health and wellness applications on smartphones are already big news, and are dramatically changing the way we manage our personal health and everyday wellness.

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Generation and Application of Community Pharmacy Research

Neil Johnston

Editor’s Note: We have had a number of articles in this issue relating to pharmacy research.
The PGA has conducted a number of research initiatives over the years, including one recently reported in Pharmacy News that resulted from an analysis of the QCPP Patient Questionnaire.
Pharmacy Guild president, George Tambassis, appears to have authored the article following, and there also appears to be a disconnect between the survey report and its target audience illustrated by one of the respondent comments published.
I have asked Mark Coleman to follow through, elaborate and comment:

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Truth in Medicine – Weighing the Evidence

Neil Johnston

articles by this author...

Neil Johnston is a pharmacist who trained as a management consultant. He was the first consultant to service the pharmacy profession and commenced practice as a full time consultant in 1972, specialising in community pharmacy management, pharmacy systems, preventive medicine and the marketing of professional services. He has owned, or part-owned a total of six pharmacies during his career, and for a decade spent time both as a clinical pharmacist and Chief Pharmacist in the public hospital system. He has been editor of i2P since 2000.

Frequently, I become disillusioned and disheartened by the various “evidence” debates that occur in medicine which are shared with pharmacy when they inevitably concern drugs.
It is very is easy to find authority figures in medicine and public health who will argue that today’s version of drug evidence wisdom is assuredly the correct one - it’s equally easy to find authorities who will say that it is incorrect.
This phenomenon has become known as the “flip-flop” rhythm of science.
The one thing on which they will all agree is that the kind of experimental trial necessary to determine the truth would be excessively expensive and time-consuming, and so will almost assuredly never happen.
Meanwhile, the question of how many people may have died prematurely or suffered unnecessary side effects, because they were taking a medication that their physicians had prescribed for them in good faith (from information generally derived from their most reputable journals), runs into the thousands of patients (or hundreds of thousand in the US).

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At the centre of this experience is the science of epidemiology, and, in particular, a kind of study known as a prospective or cohort study.
The Nurses’ Health Study is among the most renowned - it is conducted in the US and is ongoing.
In these studies, the investigators monitor disease rates and lifestyle factors (diet, physical activity, prescription drug use, exposure to pollutants, etc.) in or between large populations (the 122,000 nurses of the Nurses’ study, for example).
They then try to infer conclusions — i.e., hypotheses — about what caused the disease variations observed.
Because these studies can generate an enormous number of speculations about the causes or prevention of chronic diseases, they provide the fodder for much of the health news that appears in the media — from the potential benefits of fish oil, fruits and vegetables to the supposed dangers of sedentary lives, trans-fats and electromagnetic fields.
Because these studies often provide the only available evidence outside the laboratory on critical issues of our well-being, they have come to play a significant role in generating public-health recommendations as well.

Critics of these hypotheses exist on the other side of the debate within the “flip-flop” rhythm – all necessary to examine all issues, but some arguments are developed to deliberately cause doubt and confusion
Prospective studies are a stronger form of anecdotal evidence, basically one step further along the knowledge trail.
If the basic hypothesis is wrong then patients will be irreparably damaged as happened with HRT drugs and drugs such as Vioxx, although the latter two resulted by exacerbation through distorted clinical information that will be commented on in detail, in a separate article.

The dangerous game being played here is in the presumption of preventive medicine. The goal of this thinking is to tell those of us who are otherwise in fine health how to remain healthy longer.
But this advice comes with the expectation that any prescription given — whether diet or drug or a change in lifestyle — will indeed prevent disease rather than be the agent of our disability or untimely death.
With that presumption, how unambiguous does the evidence have to be before any advice is offered?
Pharmacists are often caught up in this “grey” area and despite being able to furnish details of desirable and safe outcomes, they are still criticised for recommending substances, such as complementary medicines, that are deemed to have insufficient “evidence” to support their sale.

The catch with observational studies like the Nurses’ Health Study, no matter how well designed and how many tens of thousands of subjects they might include, is that they have a fundamental limitation.
They can distinguish associations between two events — that women who take H.R.T. have less heart disease, for instance, than women who don’t.
But they cannot inherently determine causation — the conclusion that one event causes the other; that H.R.T. protects against heart disease.
As a result, observational studies can only provide what researchers call hypothesis-generating evidence — what a lawyer would call circumstantial evidence.

But it is nonetheless a form of evidence.
A previous i2P article comparing forms of criminal evidence to medical evidence, noted that all forms of evidence are admissible in a court of law – just a different “weighting” being applied by a judge for each form of evidence.
This has evolved from a standard where only “gold standard” evidence was solely admissible, to today’s multiform evidence – surely an argument that would similarly fit comfortably into the medical world?
The argument developed in this article was that the “judge” in the medical world becomes the experienced and qualified clinician who, after weighing the evidence (and fully informing the patient) makes a recommendation on the patient’s behalf.

It is then left up to the patient to take responsibility for their condition by accepting or rejecting the considered advice.

Testing these hypotheses in any definitive way requires a randomised-controlled trial — an experiment, not an observational study — and these clinical trials typically provide the flop to the flip-flop rhythm of medical wisdom.
They are also accorded the highest “weighting” when compared to other evidence formats.
Problem is this form of evidence is not always available, mainly due to cost.
Wealthy global pharma companies are able to exploit advantage because of this fact.

Until August 1998, the faith that H.R.T. prevented heart disease was based primarily on observational evidence, from the Nurses’ Health Study most prominently.
Since then, the conventional wisdom has been based on clinical trials

No one questions the value of epidemiologic studies when they’re used to identify the unexpected side effects of prescription drugs or to study the progression of diseases or their distribution between and within populations.
Just because randomised trials do not exist for a medicine does not mean that efficacy does not exist – only that randomised controlled trials have not been performed as yet.

Epidemiologic studies have also been invaluable for identifying predictors of disease — risk factors — and this information can then guide clinicians in weighing the risks and benefits of putting a particular patient on a particular drug.

The studies have repeatedly confirmed that high blood pressure is associated with an increased risk of heart disease and that obesity is associated with an increased risk of most of our common chronic diseases, but they have not told us what it is that raises blood pressure or causes obesity.
Indeed, if you ask the more sceptical epidemiologists in the field what diet and lifestyle factors have been convincingly established as causes of common chronic diseases based on observational studies without clinical trials, you’ll get a very short list: smoking as a cause of lung cancer and cardiovascular disease, sun exposure for skin cancer, sexual activity to spread the papilloma virus that causes cervical cancer and perhaps alcohol for a few different cancers as well.

One expert in the field of epidemiology has stated, “Epidemiologic studies, like diagnostic tests, are probabilistic statements.”
“They don’t tell us what the truth is”, he says, “but they allow both physicians and patients to ‘estimate the truth’ so they can make informed decisions.”

The randomized-controlled trials needed to ascertain reliable knowledge about long-term risks and benefits of a drug, lifestyle factor or aspect of our diet are inordinately expensive and time consuming.
By randomly assigning research subjects into an intervention group (who take a particular pill or eat a particular diet) or a placebo group, these trials “control” for all other possible variables, both known and unknown, that might effect the outcome: the relative health or wealth of the subjects, for instance.
This is why randomized trials, particularly those known as placebo-controlled, double-blind trials, are typically considered the gold standard for establishing reliable knowledge about whether a drug, surgical intervention or diet is really safe and effective.

But clinical trials also have limitations beyond their exorbitant costs and the years or decades it takes them to provide meaningful results. They can rarely be used, for instance, to study suspected harmful effects. Randomly subjecting thousands of individuals to second-hand tobacco smoke, pollutants or potentially noxious trans fats presents obvious ethical dilemmas. And even when these trials are done to study the benefits of a particular intervention, it’s rarely clear how the results apply to the public at large or to any specific patient.
Clinical trials invariably enrol subjects who are relatively healthy, who are motivated to volunteer and will show up regularly for treatments and checkups.
As a result, randomized trials are very good for showing that a drug does what the pharmaceutical company says it does, but not very good for telling you how big the benefit really is and what are the harms in typical people (because they don’t enrol  typical people).

These limitations mean that the job of establishing the long-term and relatively rare risks of drug therapies has fallen to observational studies, as has the job of determining the risks and benefits of virtually all factors of diet and lifestyle that might be related to chronic diseases. The former (risks) has been a fruitful field of research; many side effects of drugs have been discovered by these observational studies. The latter (benefits) is the primary point of contention.

While the tools of epidemiology — comparisons of populations with and without a disease — have proved effective over the centuries in establishing that a disease like cholera is caused by contaminated water, as the British physician John Snow demonstrated in the 1850s, it’s a much more complicated endeavour when those same tools are employed to elucidate the more subtle causes of chronic disease.

And when you add other evidence confounding factors such as patient compliance and the “prescriber effect” also the “ghost writing” of research reports (see separate article), you begin to wonder what you are able to believe in because every system of evidence is so imprecise, even deliberately distorted (as in the case of “ghost writing”).
What do we really mean when we make a statement to practice evidence-based medicine?
It seems to me that while we can try, the elusive precision of a scientific method just seems to be out of reach with each new level of understanding that occurs.
Evidence-based medicine is really just a work in progress.

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Submitted by Gerald Quigley on Sun, 04/12/2011 - 15:35.

Really interesting reading Neil, and it's rather sad now that pharmacists are "bullied" into hiding behind the "evidence based" curtain instead of taking some responsibility on behalf of the patient and seeking to help them access the best solution to their health concerns. I know many patients who are perfectly happy to buy their natural medicines from a grocer (read "supermarket") because their local pharmacist has such strong opinions on particular supplements which, in his or her view, are not not supported by "evidence" in spite of thousands of years of safe use. We have backed ouselves into a corner from which the academics may never let us escape. Just because there's no evidence, doesn't mean something doesn't work. In summary, evidence follows money, and the recent Pradaxa hysteria in the press supports my own "evidence".

Submitted by Lesley Braun on Sat, 03/12/2011 - 09:54.

Congratulations Neal on an excellent discussion about evidence - its strengths and limitations

As a senior researcher conducting studies with various models and writing systematic reviews, the limitations of randomised trials, observational studies and epidemiological evidence is apparent

Determining causality - 'this' definitely caused 'that'- is often elusive because of multiple confounders - known and unknown. Statistical models can compensate for some of this but sometimes they can also give different results using the same data set, depending on what model is used.

Determining whether a factor was causative or consequential is another problem - in other words, what came first? and if you have worked that bit out, does it matter clinically? The Womens health study has multiple confounders and causative/consequential arguments abound

We dont enrol typical people into RCTs - there is a very strict inclusion/exclusion criteria and there is definitely a therapeutic effect just by giving people more attention than in the real world where people are left on their own and compliance can be patchy

Clinical experience and individualisation are still essential as is looking beyond the bell-shaped curve.

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