Monthly Archives: August 2015

What’s worth more? A favorable statistical p value or clinical results?

testpostWith the recent talk of p-values and their value in scientific journals it brings to light an important interpretive tool in efficacy of therapies, clinical experience.  P value is the chance of getting a positive response in a scientific study when there is no real effect after all, also known as a false positive.  The smaller this number, the better the certainty that what you are observing is truly an effect of what you are studying.  This number often is given as p .05 meaning that only 5% of the time would you see this happen by chance, the rest of the time it is a true effect of what you are studying.  Put another way, you can say that you are rejecting the “no effect” assumption, and come to the conclusion that drug A has effect B on the body and claim that your results are statistically significant.

This has been the backbone of science forever to determine if what you are seeing is not a fluke.  On closer examination though this value may not be as strong as we first thought.  Don’t get me wrong, it is an awesome way to reduce bias in a study and the best we have to weed this out as long as we don’t play around with this p value after our calculations are done.  What if we applied this 5% theory to a supplement that was being tested for a certain condition.  If we wanted to try 100 supplements for a given condition and only one of these supplements actually did something to improve the condition, we would find 5 supplements that appeared to help (false positives) and one extra that actually did, the one effective supplement in the bunch.  Of the six supplements you came away with thinking worked for the condition, really only one worked.  This means that out of those six conclusions that claim to help the problem, only 1 in truth really does.  You are incorrect 83% of the time in your determination of effective products even though you successfully eliminated 94 ineffective products!  Imagine, a randomized, placebo controlled trial with a p value of 0.05 with this kind of result.

Retractions of published papers also appear to be on the rise and after being involved myself this past year in a scientific study, there really is a lot of pressure felt by the authors to get published in a scientific journal.  It’s almost like a final approval by the cool kids in class and seems to psychologically give a stamp of approval on your work not only to the authors that did the study, but by the public and scientific community that will read or hear about the study.  If you aren’t published, there is almost a sense of failure felt towards the whole project, regardless of how astounding the results are.

This brings us to the world of the front line where these products are actually handed out to the public, the Pharmacy.  Many times I see products written on prescription that work exactly the way they are supposed to but sometimes they fail miserably.   Regardless of how many studies were done on a drug, if a patient paid $100 for it and it didn’t work, they really don’t care how many studies were done or what the p value was; they are out $100 and they now need to fork over more money for another product.  This doesn’t mean the studies that brought this to market were bad, it’s just that they were some of the outliers in the results that didn’t respond to the drug.

When you deal with supplements you often are labeled and dare I say it with  “alternative therapy”, you are always searching for these studies.  They are often small studies but you still look for them.  The same is true for pain compounding.  It is not difficult to be labeled a quack or a charlatan when you try to help someone that doesn’t seem to fit into the regular modern medicine model or wants to try another way first.   Nothing replaces clinical experience in determination of a product’s net worth and if studies are done correctly your results should mimic the studies you originally read.  Keep in mind that this may mean a 70% success rate as determined by the studies.   It is only when you see something work before your own eye(s) that makes you comfortable suggesting it more.  Those products that showed promise in studies and it doesn’t pan out with your patients, these products fall away rather quickly.  When you deal with people that are paying out of pocket for something, you know it is working when they come back for more to spend more money on.  I have had physicians steer away from a product because of one or two bad experiences with it with their own patients.  As always, patient safety is key with any product.  Will this therapy harm this patient based on their existing meds, allergies or medical condition?   Will it cause a dangerous delay in treatment with another more proven product?  These are important questions to as when a patient looks for an alternative medication.

Clinical experience with pain compounding creams has completely change the thinking of a lot of physicians I deal with at the pharmacy level.  Many of these doctors haven’t read even one of the studies I have on the response rate of this type of therapy but when they took a leap of faith with just one patient, then another and another, they realized the value of a therapy they were not taught in school.  When I get in my car and turn the key, a lot goes on to start the car and keep it running.  I haven’t read any studies on car engines but I do it because it seemed to work for others and it works for me for the most part as well.

False positives and subjective results can happen this way as well, but when a patient that was previously addicted to hydromorphone prefers a pain cream or an addition of omega-3 with their pain medication, it helps to alleviate thoughts that they are pretending the pain went away.   As one palliative care physician said to me, “If the placebo effect is 30% on drug X, I’ll take that kind of response rate”.  When there are doubts as to the effectiveness of a well-designed trial, clinical experience acts as an effective filter to refine one’s beliefs.

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The Weight Loss Pendulum Swings Towards Carbs Bad, Fat Not So Bad : But before you go eating a stick of butter…

In the last year we have seen a change in what we are eating that is making us unhealthy.  It turns out that after 40 years of being told that eating fat made us fat and we should avoid it as much as possible, there has been an awareness that we have been becoming more obese over that time even though there seems to be a reduction in the amount of fat we consume.  Studies began to come out that seemed to show that this fat in the diet had nothing to do with heart disease.  Although some of these studies appeared to be long-term in nature, the development of heart disease was argued to be longer in its development.  In fact it is now considered possible that a heart attack at 54 years of age can have its genesis when you are in your teens.

So this has led to a growing and popular change in recommendations that increasing fat over carbs in the diet may be the answer to preventing obesity.  Granted, we still realize that trans fat are a mistake in any amount, just now we are told that saturated fat is really not the culprit in making us fat we were led to believe.  Overnight we were switching out margarine for butter, meat, whole milk and eggs.  In my pharmacy this was taken as meaning the more butter the better by a fair number of patients.

But are we communicating the complete truth to everyone with this?  In truth there really is a difference between saturated and polyunsaturated fats.  It has been shown that these two fats result in a completely different response in the body.  Regardless of the size or type of scientific study, we always have two strong sciences to fall back on for our foundation: biochemistry and nutrition.  If we are unclear as to how one dietary study does not mesh with the last one we can at least take a step back and see how the results are caught by the net of these two fields to try and make sense of them.

The study I refer to is a February 18, 2014 double blind study in the Journal Diabetes entitled, Overfeeding Polyunsaturated and Saturated Fat Causes Distinct Effects on Liver and Visceral Fat Accumulation in Humans, showed us that feeding Polyunsaturated Fat does indeed lead to actual muscle growth, the opposite of what we would have thought in the last 40 years.  Feeding saturated fat has the effect of increased visceral fat and liver fat, the type of fat I call the grim reaper because it is so metabolically active in producing inflammatory mediators more than any other fat in the body not to mention elevating immune system response to that area. There is an interesting paper on this from ISRN Inflammation here .  The subjects were broken up into these two groups of saturated and polyunsaturated fat consumption and both groups did gain weight, it’s just that the weight gained by the saturated fat intake group was actual visceral and liver fat and the polyunsaturated fat intake group gained weight as muscle instead.  There is much more to this study including differing genetic responses between the two fats here .

It is interesting to note here that fat creates inflammatory mediators that create more fat and that these mediators created as a result of other types of inflammation also create more fat in the body.   In other words, inflammation causes fat, fat causes inflammation so fat really creates an environment that feeds itself .  This means that once fat takes hold in the visceral tissue in a seemingly healthy individual from inflammatory reasons (ie a person that appears to be of normal body weight on first glance but with a body composition analyzer is much more than 20-25% body fat) it makes it more difficult for that person to lose weight when they physically see they need to lose weight (and at that point they are at 35% or more body fat).  This person is definitely working uphill to lose weight, especially if the existing inflammation is still present.

The reasons for this initial inflammation are a source of great debate in the medical community.  It could be an inflamed Achilles tendon, arthritis, dietary intake, or whatever.  In fact the incidence of obesity in rheumatoid arthritis patients is positively correlated leading to a theory that this inflammation can lead to autoimmune.

But getting back to the main topic at hand, keep in mind that just because we now realize that increased carbs, particularly increased refined carbs in our diet can lead to obesity and that it isn’t necessarily ALL about the fat intake in our diet making us obese; this is not a free ticket to throwing ½ a stick of butter into your popcorn and getting healthy from it.  Whoa there big fella.  Can’t we just go back to our knowledge of biochemistry and nutrition and remind ourselves that when we deviate from the word “moderation” and “physically active” and we try to tie in long term health benefits with a huge change from what we know to work, no processed food, low sugar and refined carbs and moving (every day) it becomes less complicated.  Hopefully Canada’s Food Guide will improve its recommendations to give Canadians a better list of how we should eat (separating fruits and veggies, completely eliminating trans fat, not making milk mandatory).  Combining this with regular exercise to reduce inflammation seems to be the common denominator we keep trying to re-invent , and it seems to be over and over again .

Keep in mind that fat carries with it a large number of calories.  The danger is switching to a diet that is a higher percentage of fat and lower in carbs than it used to be without discriminating what type of fat you are eating.

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Stone’s Withdraws Sugary Beverages – One Year Later


September 11, 2014 was a busy day at Stone’s Drug Store in Baddeck.  The week that followed was a similar pace.  After months of contemplation the trigger was pulled to remove the sale of all sugary beverages from the pharmacy on the second Thursday in September.  Before opening on that day I removed all of the pop, juice, chocolate milk, and sports drinks from the floor and coolers and put it in our counseling room for what I thought would be a normal day.  Perhaps there would be a few questions or even complaints about this but that would be all.


In response to an editorial by a group close to the beverage industry that this type of move is ineffective in changing overall health,  I responded with


Turned out there was a lot of attention grabbed by this move, not just by local and national media, but also from a Scientist at the Propel Centre for Population Health Impact named Leia Minaker.  The Propel Centre is a research centre located at the University of Waterloo that aims for overall better health and cancer prevention.  Leia’s proposal was to undertake a natural experiment whereby the effects of a local retailer restricting the purchasing of (in this experiment) carbonated beverages in a small town might have effects like less purchasing of carbonated beverages or perhaps lead to switching of purchasing behavior of these products among stores in the village by its residents.


This study would not have been possible were it not for the amazing cooperation of the two other main retailers in the Village of Baddeck, the Coop (the local grocery store) and Needs (the local convenience store).  Along with our sales data Leia collected the sales data of these other two businesses for their carbonated beverages for a period of 88 weeks prior to the September 11 date and a total of 128 weeks of data was collected to give a before and after snapshot of sales.  The data showed that we at Stone’s sold just 6% of the carbonated sales in Baddeck.  With this in mind it is even more amazing to see that after controlling for summer peak sales, weekly carbonated beverage sales declined by 11.4% as a whole in Baddeck in the post intervention period.  In a separate statistical analysis, it was determined that after controlling for model specified seasonality, the sales decreased by 21.4%.  Not bad for a little store that sold only 6% of the carbonated beverages overall in Baddeck!  Another unexpected finding beyond this was that buying patterns did not appear to shift to the other retail outlets in the village


So congratulations to Leia, to Stone’s and to the residents of the Baddeck area for getting the message we drove out relentlessly about what sugary beverages do to you.


Leia and her team are now embarking on a longer term look at this data.  Part of this involves trying to determine the overall buying patterns of the Village before and after we stopped selling the beverages.  Natural studies can be rare opportunities for this type of evaluation and they certainly want to use as much data as possible in finding the effects of the sugary drink withdrawal.


Common questions asked of me during this time:


Was this something meant to inspire other retailers to do the same thing?   Not really, but that would be nice.  It was done for the sole purpose of showing my customers that if I stressed on a daily basis how bad a product is and how it so quietly sneaks into your diet and causes long-term health problems for you then I couldn’t sell it anymore.


You still sell bars and chips.  Isn’t this a nanny state move to grab headlines in the news?  “Haters gonna hate” I always say.  The point shows how much we think drinking juice is good for you, how sports drinks are important to increase athletic performance, how chocolate milk is as healthy as white milk and how pop is ok to have daily because of the sheer presence of these pop companies in sporting event advertising and sponsorship – when this is the exact opposite of the truth in all cases.


Who do you think you are controlling what I can or cannot buy?  Well, first of all it’s my store.  Second of all you can go for a 30 second walk and still purchase these sugary beverages if you need them.


What about all of the other unhealthy things you sell in the drug store?  This criticism ranged from homeopathic products, to vitamins and supplements, to weight loss programs, whatever was the last headline in the newspaper that was useless or dangerous.  As a pharmacist my number one thought process is to prevent harm as well as providing an effective product.   Any pharmacist will tell you of countless customers who take a product different from the one they spent the last five minutes recommending.  In that situation we realize they are buying that other product so we just want to make sure their choice will not result in harm, even if that product is homeopathic.  Some of the customer’s choices are unchangeable and part of their beliefs for whatever reason.   Often it is a part of a process of that patient determining on their own what works for them and what doesn’t.

And what of the hydromorphone capsules I sell and see addiction develop, the chemotherapy pills when they work sometimes and other times they lead to more suffering and therapeutic failure (try explaining the concept of a successful randomized controlled trial with this patient’s family), taking statins and have a heart attack, take NSAIDS and end up with a GI bleed, take a benzodiazepine for anxiety and get addicted?  Everyone has their story of something that went wrong in medicine.  I can’t remove everything from the store that has risk so I chose to remove the biggest offender.


So what about the bars – are you removing them also?  I’ll admit this was one I didn’t really have an answer for right away but I thought why not get rid of all of this.  As I described in the last question I needed to strike a balance between what I thought was completely crazy and acceptable in slightest moderation.  I believe that the sugary drinks put us in the hospital long-term and shorten our lives.  If everyone ate the bars like they consumed the sugary beverages then they would be gone also.


Have you noticed a change in your sales since you made this move?

Getting rid of these coolers and freeing floor space from pop led to a rearrangement of some of the merchandise in the pharmacy.  The organic food and gluten free section definitely was one of the first to expand.  So sales grew in this area that is largely driven by large consumer demand and we basically carry what they ask for.  The main areas that expanded beyond this were related to the nutraceuticals and compounding.  The unexpected exposure gained when the sugary drinks were dropped drew the attention of those who were interested in controlling their health and prevention on their own and for many this meant non-prescription means through evidence bases supplements and food that was free of pesticides and herbicides and were GMO free.  These are definitely consumer demand driven products and nutraceuticals require a fair bit of education beyond the Pharmacy degree education I received.  Compounding had led me to this area.  It turned out all of these “beyond ordinary” pharmacy services caught the eye of these preventative medicine patients out there, so this is where we saw the expansion.


What has been the overall reception from the public?

Overall the public’s response has been great and even a year later people come into the pharmacy that never set foot in here to congratulate us.  On social media where one’s backbone grows and anonymity is popular there were some comments that were less than complimentary but overall it seemed most people got it when it came to understanding the reason for this and the real message behind it.


Is it really that unsafe for someone to consume pop or juice?

I use the analogy of a person holding out their hands together to catch marbles that are falling.  At first they find it easy to catch the marbles but after a while their hands begin to fill with more and more marbles and they eventually let one drop.  This represents the tipping point where something happens to your health and the marbles are the insults over a lifetime, like heavy metal exposure, pesticides, herbicides, fertilizers, stress, processed food, and sugar.  Perhaps a little bit here and there doesn’t seem to matter, especially early on, but they all add up together.  With the growing mountain of evidence of what sugary beverages can do in even low consumption – it really is that unsafe!


Also a special thanks to Dr. Yoni Freedhoff, a family doctor and assistant professor at the University of Ottawa and author of The Diet Fix for sharing this with a guest blog on his ever popular Weighty Matters blog and for the Village of Baddeck and its surrounding area for making this study so successful.


Graham MacKenzie Ph.C.

Stone’s Pharmacy

Baddeck N.S.

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