s Where is the Outrage? | 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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News Flash

Newsflash Updates for July 2014

Newsflash Updates

Regular weekly updates that supplement the regular monthly homepage edition of i2P. 
Access and click on the title links that are illustrated

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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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Where is the Outrage?

Peter Sayers

articles by this author...

Peter Sayers is vitally concerned about pharmacy professional practice - its innovation, its research and development, and its delivery to create an ongoing revenue stream. Delivery of healthcare is increasingly involved with Information Technology systems. All perspectives in IT must be considered for the impact on pharmacy practice and its viability.

It never ceases to astound me the number of different levels Big Pharma operates on in the orchestration of a clinical trial.
Including the “Short Clinical Trial”, the design of which is created to have the “gold standard” endorsement except that the timeline of the trial is shortened to suit the sponsor of the drug involved.
There is a direct correlation between the length of a clinical trial and the reports of negative side-effects.
Studies cut short have been found to overestimate the study drug's effectiveness and miss dangerous side effects and complications by an average of 30 percent.
This would explain the amazing 85 percent drug study success rate in the hands of Big Pharma according to the Annals of Internal Medicine.

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In some cases, shortened studies don't just make a drug look more effective than it ever could be, but they also turn dangerous and ineffective drugs into “miracle” drugs, according to a study in JAMA.
Studies are often cut short when researchers get "overwhelmingly convincing evidence" of a drug's effectiveness.
If you want to make money with your drug, find an early spike in the data and run with it before the data dives.
Get in, get the result you want, get out fast, and make lots of money by writing up the final report using a Pharma-paid ghost writer to accentuate the positive and eliminate the negative.

How many people really died from Vioxx?
Looking back we see the largest ever rise in US mortality rates occurred in 1999, the very year Vioxx was introduced. Not exactly a smoking-gun until you compare it with the largest ever drop in mortality in 2004, the year Vioxx was withdrawn.
 The net increase was 100,000 deaths per year in 1999 through 2004.

This equates to 500,000 people who died needlessly and Vioxx is the prime suspect in these incidents and that can be styled as murder.

Big Pharma research backing that killer drug was all positive. Merck reported over $11 billion in Vioxx sales during the 5 years the drug was on the market. So far the company has paid nearly $6 billion in litigation settlements and criminal fines over Vioxx. Well, that still leaves quite bit of cash left over to pay greedy executives who were in charge of the company and making criminal decisions. It's all about getting the FDA approval, buying the politicians, making loads of money (even at the expense of human life) and then minimising the penalties and rebuilding the public relations for another run.
 
We see similar strategies enacted through global agriculture companies also petroleum and mining companies.
Just look at the coal seam gas company strategies of today in Australia.
We have virtually no evidence of positive ecological outcomes for the mining of coal seam gas, plenty of evidence of how underground water catchments are polluted and valuable food producing soils totally damaged.
Outrage is building for these industries, but how did they get established in the first instance?
Who paid what to allow these industries to operate without sufficient evidence of guarantees of safety and performance?

And where is the outrage building for the shoddy clinical trials that now pollute the medical evidence databases around the world and are even used to develop new research because of the seeming inability to efficiently retract this corrupt data?
Within the last three weeks a news report from AAP indicates more anomalies in the area of Pharma reporting.

 

“AAP-22nd Jun 2012

SWISS pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side effects, the European Medicines Agency (EMA) says.

Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.

At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.

"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement on Thursday.”

A program that was known to be running with a 19% death rate (deaths compared with reports) should have been sounding alarm bells everywhere!
The fact that it did not illustrates the callous disregard that Pharma has for its patients in any capacity or setting.

In Australia in January 2012, we saw the formation of the Friends of Science in Medicine (FSM) – an organisation dedicated to ensuring that all medical decisions are based on good science.
By far, the majority of members are medical academics, the very people who should take responsibility for tainted or fraudulent evidence – and eradicate it.
Some of these academics have an involvement with Big Pharma and some will have produced tainted evidence (estimated to be around 15% of their number).
We have seen alternate medicine practitioners take a hit for daring to promote their academic courses through evidence-based teaching in a university environment, ultimately involving registration of practitioners
The grounds for complaint are basically the FSM deems them pseudoscience and wants universities to ban such courses.
One would have thought that the science fiction that passes for gold standard evidence would have been the primary target of FSM and once having cleaned up the evidence databases so that it could be relied upon, move on to other objectives.

Pharmacy has also been targeted by FSM with claims that if Pharmacy practiced evidence-based medicine there would be few complementary medicines sold because there is no evidence for them.
Well we might as well extend that argument to dispensing because if pharmacists took a stand and decided not to dispense medicines that had poor or tainted evidence, few prescriptions would be filled.
Further, if medical doctors were forced to prescribe only medicines that had untainted evidence to support their use, few prescriptions would be written.
People in glass houses should definitely not throw stones.
People pontificating on top of ivory towers should definitely get their own act together before trying to ram their flawed points of view into every other science-based health discipline.

In the meantime, pharmacists should simply trust their own clinical judgement and experience and take on board only the evidence that THEY deem competent, and simply get on with the job.

Return to home

Submitted by Joseph Conway on Wed, 04/07/2012 - 14:58.

Really you can't say that Vioxx killed 100,000 people a year from 1999 to 2004 - That is outrageous! You can't make causal inferences from ecological epidemiological observations.
As a pharmacist, I have trust that the TGA and PBAC do a fine job keeping Drug Companies honest and provide for me a barometer of what constitutes sufficient evidence. I am aware that Drug companies take their obligations very seriously. I have a lot more faith in clinical trials than in the variety of CAM's often from companies with names making them sound scientific - Bio[Insert name here]...

Submitted by Mark Coleman on Sun, 08/07/2012 - 15:27.

Dear Joseph,
While you may believe that the TGA and the PBAC do a fine job in keeping drug companies honest, the fact is that both those agencies approved Vioxx for use in Australia.
Admittedly,a lot of the evidence that was needed to make a proper assessment was suppressed by Merck, but under no circumstances can I agree with your view that drug companies take their obligations very seriously.
I simply point you to the range of major fines imposed on the largest Pharma companies in the world (see http://www.i2p.com.au/article/largest-health-care-fraud-settlement-us-hi...).
The design of Pharma developed clinical trials and their manipulation at multi-levels would never underpin my faith in their quality and accuracy.
Peter Sayers' frustration is that most health professionals seem to ignore the enormity of the problem and the human issue of loved ones dying in favour of increasing drug company sales.
If you were found to knowingly withhold information about a patient's treatment that could have prevented their death I would hope that your humanity simply takes over to prevent the occurrence from ever happening again.
Pharma companies are deliberately damaging or killing patients for all the reasons that are being published in i2P.
All health professionals, including pharmacists, should hold all Pharma's accountable for their bad behaviour and scrutinise all available evidence before allowing any drug to appear on pharmacy shelves.

Submitted by Joseph Conway on Tue, 10/07/2012 - 21:00.

"...because if pharmacists took a stand and decided not to dispense medicines that had poor or tainted evidence, few prescriptions would be filled."

I basically was talking about this point. How does a pharmacist decide whether a particular product has sufficient evidence? I think that it's impossible (For multiple trials and drugs). I know of a Biostatistician who says that it can take days to properly examine a clinical trial to check for statistical flaws alone. Also, there are issues relating to methodology and bias. As professionals, we have to rely on someone to do this work for us. If the TGA are just accepting applications from Pharma with just the Pharma data , then I do worry about the system as claims are not triangulated until Adverse events are reported and effects of a drug become widely known in the years after listing. It just takes one "bad apple" to ruin it for everybody. I think that it's important for people to have faith in Big Pharma and there is a challenge to all authorities to maintain the faith of the public in modern medicine. If people reject newer prescription drugs then, it would be a loss to pharmacy too as the newly listed drugs of today become the generics of tomorrow.
P.S. I am biased as I work in Oncology clinical trials and I think that there have been wonderful advances in that area. I hope to work for Big Pharma some day...

Submitted by Peter Kennedy on Mon, 02/07/2012 - 14:54.

"How many people really died from Vioxx?
Looking back we see the largest ever rise in US mortality rates occurred in 1999, the very year Vioxx was introduced. Not exactly a smoking-gun until you compare it with the largest ever drop in mortality in 2004, the year Vioxx was withdrawn.
The net increase was 100,000 deaths per year in 1999 through 2004.

This equates to 500,000 people who died needlessly and Vioxx is the prime suspect in these incidents and that can be styled as murder."

So should we believe your preposterous claim?, or the US Centers for Disease Control, which stated (see http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5605a1.htm )
"The number of unintentional poisoning deaths increased from 12,186 in 1999 to 20,950 in 2004. ...Previous studies, using multiple cause-of-death data, have indicated that the trend described in this report can be attributed primarily to increasing numbers of deaths associated with prescription opioid analgesics (e.g., oxycodone) and secondarily to increasing numbers of overdoses of cocaine and prescription psychotherapeutic drugs (e.g., sedatives)"

Submitted by Mark Coleman on Sun, 08/07/2012 - 15:02.

Dear Peter,
I understand your statistics on unintentional poisoning deaths, but these deaths correspond to a period when known adverse effects of Vioxx were deliberately suppressed by Merck.
What was entered on the death certificates is another matter-was it unintentional poisoning or death by heart failure or other unreported adverse drug effect.
There was a major spike in the death rate at the time Vioxx was introduced to the market, that disappeared when Vioxx left the market.
Peter Sayers is simply highlighting the enormity of the death rate.While he implies that in his mind Vioxx is highly suspect, he does not claim this as formal evidence.
He is simply outraged that health professionals in Australia and the US remained blind to the fact that deaths did occur and the human side of what passes for evidence these days is simply ignored.
In November 2011 Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales.
No matter how you construe Peter Sayers' comments you cannot under any circumstances condone the method of developing "evidence" used by Merck or any other Pharma company that is little more than promotional material that bears no relation to evidence.

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