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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All Evidence Must Pass a Test for Integrity

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.

No single source of evidence can be regarded as reliable even if derived from controlled clinical trials and published in a reputable journal.
The reason for this is that there has been no system for validating clinical trials and allowing open comment.  Intellectual fraud is commonplace.
All clinical trials need to be replicated by an independent external body and no published evidence should be regarded as complete without this tick of approval.
A statement regarding replication should appear prominently at the beginning of each published paper to clearly illustrate its status.

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Currently, when a published paper is found to be faulty, it may (or may not) be retracted in a low key fashion (compared to the original high key publishing) and noted in a quiet corner of the retracting journal. Nothing is done to retract other papers that have derived clinical conclusions from the information published in the original journal and is dispersed in other journals creating endless problems in tracking and adjusting faulty information.

Journals should take the initiative and set up a perpetual dedicated page to report on retractions from all sources.

The medical community is slowly waking up to this horrific problem and is beginning to take a fresh look at how evidence is prepared and published.
Some academics have even been jailed for fraud, but the shadowy Pharma companies that create the climate for fraud have still to be made accountable.

Risk management techniques also play a part here.
When I was involved in developing a website that would hold confidential information, I was dismayed to find that certifying authority for a site, did little more than take out an insurance policy to cover the risk of being sued for a large sum of money, should the website be hacked.
Certainly there were basic security checks and an attempt to hack the site by a security certificate provider, but it was only an elementary level of skill involved.
In other words, the insurance policy was the primary method of protection-the ability to sustain one or more major claims.

This same concept has pervaded the development of a drug.

With a pipeline of genuine drugs slowly drying up, drug companies began developing drugs they knew to have risk associated with them. Many companies actually suppressed known adverse problems.
Insurance became the main method of “quality control”.
In other words, an estimate was made of the potential risk (in dollar terms) of being sued for manufacturing and distributing a drug which had limited (or no) efficacy for the condition it was supposed to treat.
Hormone replacement therapy (HRT) is one such treatment that has been discredited (oestrogen is a cancer “promoter”), yet papers are still being published refuting the adverse findings in HRT.
HRT once represented one of the biggest global revenue sources for drug manufacturers and the lure of big dollars once again was shown to be the reason for trying to prop up that market at all costs.
Where is the morality in manufacturing a drug and marketing it in a manner that puts the ability to pay damages claims ahead of efficacy and patient safety.
This is why organisations such as the Friends of Science in Medicine have to be suspect because their membership is substantially medical academics – the same group that actually develop drug evidence that is targeted by Pharma companies to ensure “evidence” is positive for their particular drugs.
A recent survey identified that at least 15% of medical academics have been involved with academic fraud at some level.
For the FSM to claim that complementary medicines are not evidence-based and that controlled trials are the only valid form of acceptable evidence ignores the problem that this “mainstream evidence” is harmful and is involved with numerous and increasing, death rates.
Using safety as a measure of a drug’s effectiveness, complementary medicines outstrip mainstream medicines with ease.
Ignoring the long history of safety and effectiveness coupled with anecdotal evidence through use by many health practitioners, is not a reasonable reason for the FSM to trample over a particular form of evidence base and supplant their own version.
It defies logic that anyone would want to argue that the corrupt mainstream medical base is one that should be imposed on all others – it is not an acceptable alternative and is so discredited it should simply be ignored until it is satisfactorily cleaned up.

It is recommended that pharmacists do not blindly accept “evidence” for any drug unless it has been fully tested for integrity-an element that currently invalidates all published evidence from whatever source.
To assist in this regard the site Retraction Watch should be monitored for flawed evidence. Go to:
http://retractionwatch.wordpress.com/2012/05/22/leading-cancer-vaccines-researcher-retracts-paper-for-figure-discrepancies-flagged-by-watchdog-blog/  

The following is an extract from the Retraction Watch blog:
Leading cancer vaccines researcher retracts paper for figure “discrepancies” flagged by watchdog blog

with 23 comments

Gerold Schuler, a German immunology researcher who shared the 2006 Deutscher Krebspreis — aka the German Cancer Prize — for his work that contributed to cancer vaccines has retracted a paper in International Immunology following concerns raised by a German science watchdog blog.

Here’s the notice:

After publication of our article “Optimizing the exogenous antigen loading of monocyte-derived dendritic cells”, several discrepancies have been brought to our attention. In Figure 1 and Figure 2A, in contrast to what is stated in the figure legends, identical control staining is shown within the various parts of the figures. In Figure 3, the dot-plots with values shown as 10.2 and 10.8 were obtained using the same data file, as were those with 12.9 and 14.1. In Figure 7, the dot-plots with values of 9.8 and 16.2 turned out to be derived from the same data set. The appropriate experiments are being repeated, but in the meantime the authors would like to retract the original manuscript and apologize for these errors.

The paper has been cited 14 times, according to Thomson Scientific’s Web of Knowledge, most recently by a PLoS ONE paper, “A Double-Blind Randomized Phase I Clinical Trial Targeting ALVAC-HIV Vaccine to Human Dendritic Cells.”

The paper’s use of the same controls in a number of images — which has tripped up a number of other authors about whom we’ve written — was noted last year here, here, and here by the Abnormal Science blog. The posts also raise questions about other papers by Schuler’s team.”

The rate of retractions is increasing daily.

I also submit a report prepared to refute evidence cited by Professor Edvard Ernst and cited by the FSM as being the best authority for reference for complementary medicines.
This is done purely to provide balance in what has been previously reported.
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And if more evidence is required for the volume of retractions being generated, please view this extract passed on to me as I began writing this article:

Retracted Publications in the Drug Literature.

Samp JCSchumock GTPickard AS.

Source

Center for Pharmacoeconomic Research, Department of Pharmacy Practice, College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois.

Abstract

Recent studies have suggested an increase in the number of retracted scientific publications. It is unclear how broadly the issue of misleading and fraudulent publications pertains to retractions of drug therapy studies. Therefore, we sought to determine the trends and factors associated with retracted publications in drug therapy literature. A PubMed search was conducted to identify retracted drug therapy articles published from 2000-2011. Articles were grouped according to reason for retraction, which was classified as scientific misconduct or error. Scientific misconduct was further divided into data fabrication, data falsification, questions of data veracity, unethical author conduct, and plagiarism. Error was defined as duplicate publication, scientific mistake, journal error, or unstated reasons. Additional data were extracted from the retracted articles, including type of article, funding source, author information, therapeutic area, and retraction issue. A total of 742 retractions were identified from 2000-2011 in the general biomedical literature, and 102 drug studies met our inclusion criteria. Of these, 73 articles (72%) were retracted for a reason classified as scientific misconduct, whereas 29 articles (28%) were retracted for error. Among the 73 articles classified as scientific misconduct, those classified as unethical author conduct (32 articles [44%]) and data fabrication (24 articles [33%]) constituted the majority. The median time from publication of the original article to retraction was 31 months (range 1-130). Fifty percent of retracted articles did not state a funding source, whereas pharmaceutical manufacturer funding accounted for only 13 articles (13%) analyzed. Many retractions were due to repeat offenses by a small number of authors, with nearly 40% of the retracted studies associated with two individuals. We found that a greater proportion of drug therapy articles were retracted for reasons of misconduct and fraud compared with other biomedical studies. It is important for health care practitioners to monitor the literature for retractions so that recommendations for drug therapy and patient management may be modified accordingly.

© 2012 Pharmacotherapy Publications, Inc.


It is past time where the TGA started to get its house in order and begin to tackle corrupt evidence at its source - and that does not start with complementary medicine.
Creating a database to monitor retractions globally sounds like a good start
Let us see some action occurring with the "big boys" in the drug industry and let the FSM start to rationalise its actions into more productive and realistic activities.
When commonsense prevails and health practitioners have information they can believe in then a measurement of what our health system should promote becomes feasible.

 

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