There is no other word for it other than depressing.
The world of pharmacy is falling on its own sword with pharmacist organisations at loggerheads with pharmacy organisations, principally the PGA.
Essentially it is wrong for a minority pharmacy organisation to dominate all others and leave in its wake some very unhappy people.
It is not a pretty sight seeing the juggernaut that is the PGA begin the process of decimation, wasting resources in a negative fashion that ought to have been distributed more equitably.
It is neither smart or strategic to be entering into warfare when leadership would offer the more decent alternative.
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Regular weekly updates that supplement the regular monthly homepage edition of i2P.
Access and click on the title links that are illustrated.
A range of global and local news snippets and links that may be of interest to readers.
Pipeline Extra simply broadens the range of topics that can be concentrated in one delivery of i2P to your desktop.
Over the past year I have written about the need to recognize and remunerate pharmacists appropriately in order that pharmacy can take a necessary step forward in the new Millenium. Following are some points that are worthy of note.
1. In New Zealand, we now have approximately four hundred owners of pharmacies. Within this group, incomes range between $200,000 and $600,000.00. The average income for an employed pharmacist working in community pharmacy is around $65,000.00, and the salaries for young graduates in Auckland, (and Melbourne too I believe) is $24.00 per hour - around $48,000.00 per year. Not much of a reward for 5 years of study and very indicative of the value and respect placed on the employed professional by the employer!!!
A failing in the push for a Senate Inquiry into the 5th Community Pharmacy Agreement is recognition that the Pharmacy Guild is named in the National Health Act as the party the Government must liaise with before making decisions on fees paid to pharmacists for supply and services.
It is not the Society of Hospital Pharmacists, the Pharmaceutical Society, the National Australian Pharmacy Students Association or APESMA - but the Pharmacy Guild.
It is therefore no wonder that the Guild is the party at the negotiating table.
An amendment to the National Health Act would be needed to change this and while there is a Clause that says another organisation can be included if it represents a majority of pharmacists this has never been tested.
Last month I likened the community pharmacy industry to a “Heath Robinson”.
According to Wikipedia, “William Heath Robinson (signed as W. Heath Robinson, 31 May 1872 – 13 September 1944) was an English cartoonist and illustrator, best known for drawings of eccentric machines....
In the UK, the term "Heath Robinson" has entered the language as a description of any unnecessarily complex and implausible contraption...”
This month I’m worried about who’s driving it.
For most business leaders and owners the next decade will provide scope for two strategic options - "hard" or "bad".
A touch of reality is needed.
It will be a daunting prospect for some. For others, who do not recognise or appreciate the unfolding marketplace there will be blissful ignorance and a shortened business life.
Among those who are "hanging on until things turn up for the better", there will be disappointment.
This is not the time to hang in our hang out.
Let me emphasise, the circumstances being confronted at present are neither cyclical nor seasonal. They are structural and accordingly, changes are essential in philosophies, operations and outputs.
The next three years will inevitably be "bad" for those who adopt a "victim mentality" and do little or nothing. Those well-reported "headwinds" will remain and will eventually push the inert (becalmed) "boats" backwards and out of the race.
Rationalisations and consolidations will be in evidence across a wide sweep of industry sectors. Established companies, brands, products and services will disappear from the corporate landscape, replaced by high-energy, and focused new applications, innovations and belief-driven entrepreneurs.
Thus from "bad" will come "good".
Here I am.
Back from another lengthy and self enforced break and reporting in i2P on things and matters with ICT in pharmacy-land and health generally.
It is not that I am lazy.
It is that there hasn’t been much ‘news’ happening worth getting our knickers in a knot.
It is all the same old; same old in e-health playing field and that is rather uninspiring to say the least. So I have taken the view that if there is nothing positive to say it’s best to stay stum.
But now as 2011 is coming to a rattling death perhaps there are some things worth saying, usefully or otherwise.
What is a snapshot of some of the year’s achievements in the e-health community?
Hard to say that the world is on fire with overwhelming success, but a summary of the activities that might interest the i2P reader, in some order of oomph are:
Last month when the controversy surrounding the PGA/Blackmore’s proposed alliance brought out a large number of critics, the PGA found itself in an extremely vulnerable position.
Some criticism was well-deserved - other criticism arose from misperception surrounding the proposed alliance, while other criticism evolved surrounding the “evidence” relied on by the alliance to underpin their clinical promotion - was blown out of all proportion, or negatively criticised.
More positively, academic Dr Ken Harvey called for the TGA to manage an evidence database for complementary medicines that have had a full evaluation.
He spoke softly as he lifted my arm while telling me it would stay afloat. It didn't.
In fact, several times during the session, it fell back to my side no matter he said.
While I felt reasonably relaxed after my first visit to a hypnotherapist, I left disappointed.
So does hypnotherapy work and why do some of my skeptical friends support it and, more interestingly, why do they say it is part of acupuncture?
In Australia the Pharmacists’ Support Service (PSS) provides a listening ear and support over the telephone to pharmacists in Victoria, Tasmania, South Australia and the Northern Territory and has plans for expansion to all states of Australia. The medical profession in Australia has a range of state based Doctors’ Health Advisory Services including the AMA Victoria Peer Support Service which provides peer support over the telephone. Victorian is the only state to have a state based health program for doctors; the Victorian Doctors Health Program (VDHP)
Funding from the Cyril Tonkin Fellowship enabled me to undertake a study tour of services which support pharmacists and doctors in the United Kingdom (UK) in March 2011.
The aim of the visit was to find out how these services support the health and well being of pharmacists and doctors, including the services provided and how they are funded.
The support services visited were Pharmacist Support, including participation in a Listening Friends training weekend; the Royal Pharmaceutical Society; the Practitioner Health Programme; the Royal Medical Benevolent Fund; the British Medical Association Doctors for Doctors program and the National Clinical Assessment Service. In addition to obtain background material on the environment for health professionals in the United Kingdom visits were also made to the General Pharmaceutical Council; Manchester University School of Pharmacy and Pharmaceutical Sciences and the Pharmacy Department of the Central Manchester University Hospitals NHS Foundation Trust.
This article is the second in a series reporting on my visit and will detail the services available to doctors and dentists living in London through the Practitioner Health Programme.
The future supply of pharmacists to work in Aboriginal health is healthy if the outcome of a National Australian Pharmacy Students’ Association survey is anything to go by.
While 83% of respondents felt it is important to be taught about Aboriginal and Torres Strait Islander health issues as part of their pharmacy course curriculum, only 60% have access to such education. Furthermore, only half of those respondents feel they are taught enough about this topic.
I’ve been thinking about magnetic resonance imaging, sleeping bags, allergies, and great hospitals.
Well, I went in for an MRI, and the diagnosis was not good: Claustrophobia. But I’m getting ahead myself.
While studying x-rays of my shoulder, my doc ordered an MRI. I told him we were nearing eight on the pain scale and pressed for the earliest appointment.
Seven o’clock the next morning, after being scanned for metal, a rad tech strapped me to the transport board and pushed a button.
Moving into the magnetic abyss, I felt like dead man walking. Except, I couldn’t walk. But I could talk. It took about two seconds to find my authoritative voice:
“I NEED OUT NOW.”
She got the hint, and I was pardoned.
Whether you're managing a team of employees or you're on your own, remember that although what you do and how you do it are important, it's the "why" that provides real motivation to succeed.
An experiment conducted by the University of Pennsylvania's Wharton School of Business demonstrates the power of "why."
At a university call center where employees phone alumni to solicit contributions to scholarship funds, the staff was randomly divided into three groups: The first group read stories written by former call center employees about the benefits of the job (such as improved communication and sales skills). The second group shared accounts from former students about how their scholarships helped them with their education, careers and lives.
The third, a control group, read nothing, just explained the purpose of the call and asked for a contribution.
Straw Man “An argument deliberately put up so that it can be knocked down, usually as a distraction from other arguments which cannot be so easily countered,” - The Macquarie Dictionary.Comments: 2
It appears that pharmacists, in general, are tired of the leadership style imposed by Kos Sclavos, the incumbent president of the Pharmacy Guild of Australia (PGA).
While criticism of PGA leadership style and policy has been building for some time, opposition solidified recently with formation of the Pharmacy Coalition for Health Reform – a body that boasts over 20,000 pharmacists among its membership.
Recently, i2P was sent a media release from APESMA, the pharmacist trade union.
It was embargoed until Saturday December 10, which was a point at the beginning of the i2P update cycle.
The release contained a link to an email that is alleged to have emanated from NAPSA – the National Australian Pharmacy Students' Association.
Because it was politically sensitive to that organisation and because it also contained a number of normally private contact details for their members, i2P decided to withhold the information unless it became public knowledge through other media sources - and that has happened..
The email provided the basis for published claims that the PGA was engaged in a bullying process with NAPSA to force their disengagement with the newly-formed PCHR- the Pharmacist Coalition for Health Reform, and it is hard to avoid this view when an examination of the pressures exerted by the PGA are examined in broad daylight.
Because it is near the end of the year, I thought it appropriate to highlight one of our earlier articles published in July 2010, because it gave a foretaste of things to come -
“The New Competitors- Wholesalers, Manufacturers, Pharmacists and Nurses”
The gist of the article was that because global pharma companies would be unable to sustain the “blockbuster” business model and that there would be only modest growth in future drug developments, an unstoppable chain reaction would begin to occur where global pharma would create a new disruptive business model that would remove wholesaler discounts and begin a process of different segments of the health services “scavenging” from each other.
Once upon a time pharmacy was a small, typically one-person show that focussed on patients (as distinct from customers).
It was considered very bad form if a patient presented with a problem and ;
(i) they were not immediately attended to by a qualified pharmacist and;
(ii) they left the pharmacy holding a product in their hands that had not been personally compounded by the pharmacist.
Most patients asked for “their pharmacist” by name and entered into an obvious and valued pharmacist/patient relationship. The care was obvious and not substituted with branded medicines or had the patient interviews delegated to pharmacy assistants or technicians.
In other words the human relationships were respectful and this respect extended between pharmacists as a collegiate relationship.
I started the New Year by researching retail environments that could be adapted to pharmacy and deliver pharmacy 2012 marketing requirements, with emphasis on "professional".
When I got to the Apple retail environment, it simply jumped off the page.
This could be the most important article you read this year.
Few would realise that the title to this article is actually the slogan for Apple Retail Stores, and is in fact the base philosophy behind one of the most successful forms of retail enterprise experienced in the 21st century.
The story of the Apple retail experience has a direct translation across to the malaise that is currently being felt by most Australian pharmacists, so a brief history of the Apple company may help to illuminate a realigned direction for community pharmacy that would capitalise on its strengths and help get off the discount treadmill.
Recently I noticed an article published in "The Conversation" authored by John Dwyer Emeritus Professor at University of New South Wales. The article opens with:
"It’s difficult enough to counter the massive amount of misleading information provided to consumers through the media and online. But the task becomes much harder when tertiary institutes give an undeserved imprimatur to pseudo disciplines by offering them as courses. Central Queensland University (CQU) is the latest to do so, announcing it will offer a Bachelor of Science degree (Chiropractic) from 2012. I’m one of thirty-four doctors, scientists and clinical academics who, in an attempt to protect health-care consumers from the dangers associated with unscientific clinical practices, have today written to the science deans at CQU urging them, as fellow academics, to reconsider this decision.
We want the deans to acknowledge the importance of our universities remaining champions of rigorous academic standards and remind them of the primacy of the evidence base for scientific conclusions and health-care practices." Read more at this link
Coming up to speed after the festive break, I have been astounded at the number of community pharmacy prescription out-of-stocks, both short-term and long-term, that are mounting by the day.
This has a number of financial impacts on a community pharmacy and one assumes that the PGA has a strategy to lessen these impacts - but where is it?
No business can stay in business without customers.
How customers are treated and sadly, mistreated, determines how long the doors stay open. Poor quality service has probably doomed as many businesses as poor quality products.
Enter the "guru of customer service," John Tschohl.
He earned that moniker from USA Today, Time and Entrepreneur magazines. After 31 years focused solely on customer service, he is president of Service Quality Institute, which has representatives in 40 countries.
He's authored hundreds of articles and six best-selling books. And he is willing to share his wisdom with my readers. I don't often devote so much of my column to one resource, but John is the best of the best.
I was thumbing through my January copy of the AJP when I noticed a small column covering a conversation with Nicola Roxon, the ex-Minister for Health and Ageing.
She, along with other commentators on the same page, was basically encouraging pharmacists to “jump in” to reform health.
The encouraged pathway was through fee for service arrangements, some of which are covered under the 5CPA.
“Staff in almost one fifth of pharmacies could be wasting more than five hours per week, the equivalent of one month's working time a year, trying to source out-of-stock medicines.”
So claims a report published in the UK newsletter Chemist & Druggist this month.
The report goes on to claim:
With all the change and distress that is apparent in all ranks of pharmacy at the moment, do you have the urge to lash out at someone or some organisation or just something?
All pharmacists want to evolve their version of an ethical practice, balancing some commercialism with professional core business – whether they own a pharmacy or not.
Multiple groupings of pharmacists have formed up around each special interest and this has created a range of competitive groups, some more aggressive than others, to compete for absolute dominance of pharmacy – and endeavour to create a single voice.
When something does not make sense I always find there is a political objective involved.
And underlying the politics always is the motivation of greed.
Make no mistake about it, Australian pharmacy is about to enter a period of manipulation never before experienced, and it involves supply chain manipulation by government and by Big Pharma.
It is globally orchestrated and tactics vary slightly country to country and the victims of this strategy are very ill patients and the pharmacies behind them desperately trying to bridge supply to keep them alive.
APESMA today proposed a new Terms of Reference for a Senate Inquiry into pharmacy which focuses on new potential benefits to the pharmacy profession including providing a role for pharmacists in medicare locals and GP clinics and new measures to reform the health care system.
Mr Walton said despite incorrect and mischievous claims by the Pharmacy Guild there was nothing in the Senate Inquiry before the Senate that would cause the current Community Pharmacy Agreement to cease.
More than 850 delegates will be in Hobart this week for Medicines Management 2011, the 37th SHPA National Conference.
At Medicines Management 2011, the 37th SHPA National Conference, SHPA will celebrate 50 years as a national organisation and 70 years since its inception.
In 1941, 25 pioneer pharmacists from public hospitals in Victoria first conceived SHPA, and in 1961 SHPA moved formally to become a national organisation and held its first national conference in Adelaide.
Medicines Management 2011, the 37th SHPA National Conference opened today in Hobart. With over 800 delegates, 80 presented papers and 200 posters, this year’s conference is yet another example of the enthusiasm and dedication of pharmacists in hospitals and other parts of the healthcare system to share their work and learn from their peers.
During Medicines Management 2011, the 37th SHPA National Conference, held in Hobart last weekend, the SHPA Australian Clinical Pharmacy Award for 2011 was awarded to Mr Greg Roberts, Clinical Research Pharmacist at the Repatriation General Hospital in Adelaide.
SHPA believes that consumer interests should be at the centre of health delivery and the health reform agenda. SHPA members have a strong ethos of working collaboratively within interdisciplinary healthcare teams and across the continuum of care.
Editor's Note: Nano-particles have been adopted by various manufacturers of consumer products because they improve absorption of their active ingredients and the cosmetic appearance of the product.
Early researchers in this field warned that conditions similar to mesothelioma may result through exposure to nano-particles and that more research is required before endangering the general public.
Very few manufacturers identify that their products contain nano-particles, but recent studies have confirmed the potential for an association with cancer.
Certainly, the least that needs to occur is a warning label, particularly as some sunscreen preparations contain zinc oxide.
It is ironical that the Australian Cancer Council promote the message of "slip, slop and slap" yet allows for another form of potential cancer exposure through the "back door" involving nano-particles in sunscreen products, including the zinc oxide identified in the following study.
Guild Clinical is pleased to announce the course dates for Apply First Aid 2012.
REVIVA First Aid Training provides industry specific, highly interactive training perfect for pharmacists, graduates and pharmacy assistants.
No more forgetting to take your medicine! NPS has introduced a range of new features to its award-winning Medicines List iPhone app that allow people to schedule in reminders to prompt them to take their medicine.
As part of the upgrade, people can also record whether they took their medicine on time — and if not, why not, which is useful information to share when they next see their doctor.
The Australian Self-Medication Industry (ASMI) today welcomed the announcement of a series of significant reforms to the Therapeutic Goods Administration (TGA) and the regulation of non-prescription products.
The measures will impact areas including product advertising and promotion, regulation of complementary medicines, and the transparency of TGA decision-making.
A Queensland University of Technology (QUT) PhD student has developed a potential breakthrough test for predicting the likelihood of the spread or return of breast cancer.
"While in recent years there have been fantastic advances in the treatment of breast cancer there has been no way of predicting its progress," said Helen McCosker, a PhD student at the Institute of Health and Biomedical Innovation (IHBI).
In our July edition of i2P, Kay Dunkley wrote an excellent article relating to social media and its use by health professionals. In that article Kay noted:
The Medical Journal of Australia recently published an excellent article on the topic of social media and the medical profession. It was this article that prompted me to write this opinion piece and I recommend that it should be read by all health professionals who are users of social media. I believe that many of the issues raised for medical practitioners are equally applicable to pharmacists and other health professionals. That article can be found at http://www.mja.com.au/publicissues/194_12_200611/man10874_fm.html
Now the PSA have weighed in with an official version for pharmacists.
Dynamic warm-ups included range of motion activities like high-knee raises, leg swings and run-throughs or change of direction tasks.
Mr Zois said the study proved that, from a power point of view, static stretching was worse than no warm up at all.
i2P news and articles will continue to be published weekly over the Christmas/New Year period, but not quite so "in-depth".
You are invited to explore the recent archives of i2P when you begin to plan for the coming year.
We also encourage you to post comments at the foot of each published item.
i2P knows that the coming year will be more challenging than in previous years.
It will be a year of sorting out priorities - those within the industry wishing to needlessly fight to prop up inappropriate structures will be seen to waste time and resources.
They will be judged harshly by participants at the "coalface"- the silent majority.
i2P hopes that all of its subscribers have a peaceful and safe festive season.
The following news item from Orthomolecular.org adds one more dimension to the debate on nutritional supplements. It seems that safety is definitely not an issue where nutritional supplements are used.Comments: 3
Editor's Note: In Australia, criteria for generating a medication review includes a patient currently taking five or more regular medicines or taking more than 12 doses of medicine per day.
Patient falls are a major reason for patients being admitted to a hospital and quite commonly, patients are further damaged through falls while they are already in a hospital.
The system currently requires a referral by a GP to an accredited pharmacist, which is a slow and cumbersome (sometimes very unrewarding) process.
Editor"s Note: Global Pharma has an unusual and pervasive influence on politicians, regulators and statutory bodies around the globe.
I’ve always had a philosophy of recognising that when things do not go as they are supposed to, first look at the surrounding politics and then follow the money trail.
In the US the main regulator for drug registration and marketing is the Food and Drug Administration (FDA) which has come under greater scrutiny by industry commentators because of seemingly corrupt and improper decisions increasingly made in favour of drug manufacturers.
This month we have selected a media story that appeared in Pharmacy News on the 3 November 2011, and it is story of the continuing saga of direct distribution by Pfizer.
The bigger story underneath is - what is the Pharmacy Guild of Australia doing to represent its members in this ongoing dispute?
i2P has covered the direct distribution saga since its inception here in Australia.
The problem seems to be worsening rather than improving, so we have asked Mark Coleman to comment.
His comments appear below the media item that follows.
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).
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.
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.
Kay Dunkley - BPharm, Grad Dip Hosp Pharm, Grad Dip Health Admin, MPS, MSHPA: Support services for pharmacists and doctors in the United Kingdom – Part 2 Practitioner Health Programme | open full screen