Prabvir Grewal

Publication Bias: The Marketing-based Medicine Tool of Deception

Introduction

Corporate special interests have hijacked medical science research. They

have done this through the bastardization of evidential reasoning, the cornerstone
of the scientific process. There is no exact time or place that one can point to as the
genesis of this problem. However, I contend, it is easy to point out the exact date
when this problem sprouted its legs and began to morph into the into the grotesque
creature it is today. That date was November 14th 1992, the day when “A New
Approach to Teaching the Practice of Medicine” was published in the Journal of the
American Medical Association1. Evidence-based medicine (EBM), touted as a
“paradigm shift”, changed the way in which medical students, residents and
clinicians practised medicine1. The EMB movement sought to de-emphasize clinical
intuition, application of pathophysiological knowledge and clinical expertise as
sufficient grounds for clinical decision making and stressed evidence generated from
well designed comparative clinical trials as the gold standard. From this landmark
paper arose the hierarchical pyramid of evidence, with the golden capstone of
randomized controlled trials (RCTs) asserting ultimate authority over other forms
of evidence. Coinciding with this movement was the budding commercial
availability of the internet, bringing with it for the first time in history access to the
worlds well of knowledge. Online publication of clinical research skyrocketed, and
clinicians become overwhelmed by the deluge of information. The EBM movement
offered a well packaged and easy solution for clinicians to weed through this
information when searching for an answer to a clinical question.

EBM claimed that when evaluating a body of evidence seek out data
generated from RCTs as it is the most scientifically valid and unbiased form of
evidence1. Implicit to this philosophy was the idea that if two studies, with varying
study designs, gave conflicting results place more faith in the outcome of the RCT.
There is no doubt that the EBM movement had noble intentions. It sought to bring
a new air of certainty to clinical medicine, transform the education practices for the
next generation of physicians and to increase the quality of medicine delivered to
patients1. Although it has transformed the educational practices for a generation of
physicians, it has done so to the detriment of the quality of medicine delivered to
patients. Corporate interests have hijacked EBM and have coopted it as a part of
their marketing branch2. Spielmans and Parry have coined this hostile take over as
marketing-based medicine (MBM)2. Through internal documents of the
pharmaceutical industry they make it clear that, at least for the pharmaceutical
industry, the purpose of generating and publishing data from clinical research is to
support, directly or indirectly, the marketing of their products 2.

MBM medicine, disguised as EBM has poisoned the well of medical

knowledge and has created a crisis of legitimacy in the medical community4. This
strategy by industry has worsened the problem of publication bias. Publication bias
is the selective publication of positive trial data and the suppression of negative
data. This issue is the foundational element that has led to the gross distortion of
the medical literature. How can a clinician’s make the best therapeutic decisions for
their patients if the literature doesn’t provide objective information? The question
I will try to address in this paper is how do we address the issue of publication bias
and restore legitimacy to the medical literature? It is of my opinion that publication
bias is the main mechanism driving MBM and thus any discussion of publication
bias will also have to address MBM. I will discuss some of the proposals others have
put forward and then offer some suggestions of my own. Prior to this I will discuss
some of the key elements that may, directly or indirectly, wittingly or unwittingly,
contribute to this issue. I argue that central to this issue is the unethical
interactions between industry, clinical researchers and publishing journals.

The Rise of Industry Sponsored Clinical Trials.

Since the inceptions of the EBM movement in 1992 the generation of medical
knowledge has become increasingly centralized and clinicians have become overly
reliant on and unduly faithful to the outcomes of RCTs. It is around this time we
saw the exodus of clinical research from large academic centers to the marketing
department of the pharmaceutic industry3. To get a grasp of this issue It is
important to understand the incentive structure for clinical researcher as it has,
unfortunately been weaponized by the pharmaceutical industry. The game is cyclic
and very simple. Acquire research funding, generate impactful research, get
published in the most prestigious medical journals and apply for more funding. It is
a simple merit based system. Ideally, those that produce meaningful research tend
to get published in the most prestigious journals and with that comes academic
prowess and advancement in one’s career. Indeed, academic institutions and
universities frequently use the number of publications credited to researcher’s name
as a measure of competency and a criterium during their recruitment process5.
Academic researchers are under immense pressure to publish, the phrase “publish
or perish” initially coined by Archibald Cary Coolidge has become mode of existence
for many academic researchers5. The pharmaceutical industry, has exploited and
weaponized this process to the detriment of the integrity of clinical researchers and
institutions alike.

Buchkowsky and Jewesson reviewed 500 hundred randomly selected clinical

trials published in 5 influential medical journals from 1981-2000 and uncovered
some disturbing findings. Author affiliation with industry sponsored research
increased from 8% during the period of 1981-1984 to 66% by they year 2000, an 8-
fold increase over the study period. During that same period there was a 7.5-fold
increase in the publication of industry sponsorship clinical studies in medical
journals (4% in 1981-1984 to 30% in 1997-200). What is more telling is the steady
decline in the percentage of trial outcomes favouring the study drug in research
funded by non-profit sources and an increase in the percentage of trial outcomes
favoring the study drug in research funded, in part, by industry. There is nothing
inherently wrong with industry sponsorship, but as Spielman’s and Parry have
pointed out the main purpose of generating clinical data for industry is to support
the marketing needs of their products. The goal is to sell their product, not to
increase the wealth of scientific knowledge. In addition, it is important to highlight
some of the qualitative differences between industry and government/non-profit
sponsored research as this can shed light on some concerning issues. The odds of a
positive study outcome, by one estimate, is 8.4 times larger for industry sponsored
trials compared to non-industry published trials6. Positive studies are published
earlier and at twice the rate of studies with negative outcomes and typically have
larger reported effect size than the grey literature7. Citation rates of industry
sponsored trials is significantly greater than non-industry funded research6. The
shift from government to corporate funded research has created a financial conflict
of interest for researchers that needs to be addressed if we wish to bring MBM to a
halt. The exploitation of the academic research incentive structure is one of three
pillars that supports the unethical practise of MBM. The second pillar is the
publishing journals themselves.

The Relationship between Industry Publishing Medical Journals

When faced with a clinical questions physician rely on peer-reviewed journals

for unbiased and reliable answers. There is an unspoken fiduciary relationship
between clinicians and medical journals. Clinicians rely on medical journals for
objective information and place a great deal trust in the editorial staff to provide
them with the best available evidence. In return, clinicians and institutions,
purchase subscriptions to these journals in show of support and to help them
maintain their business. However, these journals are also heavily reliant on
advertisement revenue generated from the biomedical/pharmaceutical industry. In
2003 alone, drug companies spent $448 million on advertisements in medical
journals8. With an estimated return of investment of $5 for every dollar spent,
advertising in medical journals is a cash-cow for the pharmaceutical industry. But
they aren’t the only ones benefiting from this relationship. Publishing is an
expensive business. A sustainable business model for medical journals requires a
steady flow of cash and advertisements are a key source of that revenue. Glassman
et al evaluated 5 journals published by major non-for-profit physician organizations
and found that 4 of the 5 journals generated more than 10% of the yearly revenue
from pharmaceutical advertising (10.4%-31.3%) and four of these journals raised as
much revenue from industry advertisement as they did from membership dues9. So,
this begs the question, if the non-for-profit physician associations generate more
income from pharmaceutical advertisements than they do from membership fees
who are they beholden to? Medical journals also earn considerable revenue from the
sales of reprints where the profit margin can be as high as 70%16. Pharmaceutical
companies are the primary purchaser of reprints17. After gifts and drug samples,
reprints are the most common form of promotional material circulated among
doctors by the pharmaceutical companies17. The revenue generated from
advertisement and purchase of reprints could potentially be a source of publication
bias. These journals are beholden to the pharmaceutical industry which may refuse
to advertise in journals that publish articles critical of the industry or their
products. This was the case when the Annals of Internal Medicine published an
article that critically examined the scientific accuracy of drug advertisements in 10
leading medical journals and found that 62% of the advertisements should have
been revised before publication or should have not been published at all10. Shortly
after the publication of this study the journal lost an estimated $1-1.5 million in
advertising revenue11. At that time an editor of the journal said, “The episode
revealed the true colours of the pharmaceutical industry, which was willing to flex
its considerable muscles when it felt its interests were threatened.” 11 The potential
loss of advertisement revenue for publishing articles contrary to the industries
marketing goals may, consciously or subconsciously, influence the editor’s decision
to selectively publish of articles favorable to their advertisers and supress those
that are critical. Though we do not know the full extent of this undue influence, it
has affected the decision of editorial staff from several medical journals to not
publish articles critical of the industry8. The dependency of medical journals on
pharmaceutical advertisement revenue is the second pillar that supports MBM and
contributes to the issue of publication bias. The third and final pillar propping up
MBM is the pharmaceutical industry itself, which has commercialized scientific
research for financial gains.

Clinical Trials and Industry Sponsorship

The zeal of the EBM movement has shifted clinical decision making away
from clinical expertise and pathophysiological reasoning to the reliance on data
generated from RCTs. This has unwittingly centralized evidential authority that
has subsequently been exploited by the pharmaceutical industry for their
marketing needs. As Spielman’s and Parry point out, data generated from
sponsored clinical trials belongs to the sponsor and the purpose of the data is to
support marketing goals of their product and not primarily to expand the existing
knowledge base, as you would expect to be the goals of medical research2. MBM, at
least when it comes to pharmaceutical interventions, is the main driving factor of
publication bias. If publication of clinical results only serves to advance marketing
goals, then why would industry publish trials with negative outcomes? Indeed, the
rate of publishing negative outcomes is far lower in industry sponsored research
than non-industry sponsored research12. Recently Turner et al obtained reviews
from the Food and Drug Administration (FDA) for studies of 12 antidepressants
agents, identified matching publications in literature and then compared the
published outcomes and reported effects sizes with those retrieved from the FDA
dataset13. Of the published studies 94% of the trial outcomes were positive13. By
contrast, the FDA analysis showed that only 51% had positive outcomes13. They also
found that one third of the studies that the FDA considered as negative or
questionable were published in a way that conveyed positive outcomes. Spinning
negative or dubious results is a common and unethical strategy used by the
industry2. In addition, Turner et al noted that the published studies had inflated
effects sizes that overexaggerated the true therapeutic value of the drugs. If the
hypothetical resident from the landmark EBM article had done her literature
search today to determine if antidepressants were an effective treatment for her
patient’s depression she would have come to a confident, but an erroneous
conclusion.

The pharmaceutical industry controls an immense quantity of data which

they have claimed as proprietary18. Due to the inhibitory financial cost of
conducting clinical trials, it is difficult for non-industry sources to fund clinical
research. The pharmaceutical industry provides twice as much funding for clinical
trials than non-for-profit agencies, a gap that has been widening over the years21.
As for the industry funding that does make its way to academic researcher it often
comes with strings attached that can allow sponsors to prepare drafts, edit drafts,
delayed publication and prevent researchers from gaining access to data. In one
study, authors found that nearly 60% of clinical trials published in three large
psychiatric journals reported receiving funding from the pharmaceutical industry14.
That a majority of clinical trials are being funded by industry, that often hides data
from academic researchers and uses research as primarily a marketing tactic calls
into question the efficacy of many medications that are prescribed to patients today.
In my view this is a highly unethical process that may be doing more harm than
good to patients. Clearly there is a significant financial conflict of interest when it
comes to industry sponsorship of clinical trials. The same entities that sell a product
should not be responsible for generating data that validates its efficacy. These three
pillars that support MBM through selective publication of clinical trials must be
fully addressed if we wish to resolve the concerning and unethical practise of
publication bias. Many have made suggestions that address the pillars
independently, but none to my knowledge have synthesized a formulation to
address all three.

Purposed Solutions

An effective solution for addressing publication bias must address the three
pillars that support the MBM apparatus. It must address the pressure of publishing
for academic researchers, the financial conflict of interest in medical journals and
decoupling industry marketing aims from clinical research. Several proposals exist
in the literature that address different elements of this issue. What ties these
various viewpoints together is the call for transparency, increasing accessibility of
research data and attempting to minimize the influence of industry on clinical
research. Speilmans and Parry outline several changes to increase transparency of
clinical research. They suggest that editors and peer reviewers, should check online
clinical trial registry entries to verify whether the data in a published clinical trial
matched the results and protocol in the registry2. One tactic used by the
pharmaceutical industry to spin negative trial outcomes is to publish positive
secondary outcomes as if they were the primary endpoints of interest for the
study.2,13 In theory this tactic would hold pharmaceutical companies accountable
and limit deceptive publishing practises. They also call for public access to
regulatory agency reports, trial protocols and results to increase transparency of
clinical research2. Regulatory agency reports present an honest and unbiased
analysis of clinical data that is free from spin. These outcomes can be directly
compared to the primary endpoints outlined by the trial protocols and allows
readers and independent researcher to hold the pharmaceutical companies
accountable.

Richard Smith, the former editor of the British Medical Journal, who has
called medical journals an “extension of the marketing arm of pharmaceutical
companies”, believes medical journals should cease publishing clinical trials
altogether16. Similar to Spielman’s and Parry, he calls for greater transparency of
clinical trial data. He suggests that protocols and clinical trial data should be
publicly available and accessible through a regulated website. All three authors
suggest that the data generated from clinical trials should viewed as a common
public good, instead of proprietary information of the pharmaceutical companies.
This would go a long way for rebuilding the public trust in the pharmaceutical
industry and allow for a true free market system to flourish. He also recommends
that medical journals should stop publishing trials and instead concentrate on
critically describing them. Although this sounds like a promising idea, it is far to
easy to exploit. It is not hard to imagine pharmaceutical companies contracting out
analyst to generate favorable critiques of their trial data and then have them
submitted for publication. In addition, he calls for an increase in public funding of
trials, particularly of large head-to-head trials, to evaluate the efficacy of all
existing treatments16.

Sismondo considers industry sponsorship of clinical trials as form of

systematic bias that needs to be eliminated completely18. He argues that this bias is
introduce at several stages from research design to the publication process. Some of
these biases include ghost-management of the entire research projects and the
inappropriate social ties between sponsors and researchers in academic institutes.
He claims that existing proposition such as stronger disclosure requirements,
rigorous trial reporting standard and trial registries have done very little to curb
problem of biased trial reporting18. He argues that because the bias is not the result
of a simple methodological problem, a more radical solution is required: the
complete separation of the pharmaceutical industry and published research18. This
would mark a distinct departure from current research practises, but would
eliminate many of the financial conflicts of interest associated with industry
sponsored research.

There is no shortage of individuals who are aware of the financial conflict of

interest with medical journals publishing industry-sponsored trials while taking in
million of dollars in advertising revenue form the same industry. Many potential
solutions put forth share several common themes. They call for increasing
transparency of the editorial staff’s financial ties with industry, public disclosure of
advertising revenue and a shift away from biomedical industry advertisements.
Fugh-Berman et al, who critically evaluated the advertising practises of medical
journals, have made several suggestions for journals to wean themselves off
industry advertisements. They suggest that medical journals should change their
restrictive policy of categorically refusing advertising space for companies that are
not in a healthcare-related business and open themselves up to other commercial
advertising interest8. The goal here is to diversify and expand the pool of potential
advertiser so they are not reliant on a single industry to generate revenue. This
would reduce the conflict of interest that arises from publishing industry sponsored
clinical trials while receiving advertisement revenue from the same industry.
Although this sounds promising there are several drawbacks. Because the readers
of these journals are a small niche of potential consumers it may be difficult to find
advertisers that are willing to pay the exorbitant advertising fees. Print is a dying
industry and it doesn’t make much sense in the digital age to advertise in this
fashion, especially for consumer products intended for broader audiences. In
addition, the move away from industry advertisers will reduce the number of
reprints purchased, which represents a significant source of revenue for medical
journals17.

Orentlicher and Hehir II suggest that medical journals should sell

advertisement space only to non-health-related companies. They propose that
medical journals focus on selling advertisement to consumer-oriented companies
especially luxury item. Common to both approaches is reducing the reliance on
industry sponsorship which in theory will free-up editors to publish articles critical
of the industry, balancing the perspective of therapeutic interventions available in
the medical literature. Although this sounds like a simple solution, it may be more
theoretical than practical for most medical journals. It is hard to imagine how
advertisements for luxury yachts or vacation getaways can make up the revenue
lost from pharmaceutical industry advertisements. Lexchin and Light call for a
systematic investigation into the influence of commercial interest in medical
journals. They demand for a considerable change in, and transparency of,
publishing practises11. Some of their suggestions include; journals publishing
information about their sources of income, for editors to disclose their own relevant
conflicts of interest to readers, editorial staff, managers and owner and perhaps
consider not allowing editors to have any direct financial ties (stock ownership,
speaker’s fees, advisory board participation) to any healthcare business that
advertises in the journal they edit11. This call for transparency may shed light on
the degree of industry influence on publishing journals, but it does very little to
shift the advertisement revenues away from industry. They also recommend that
editors consider publishing earlier version of manuscripts online together with
reviewer’s and editors’ comments, so readers can see how the tone of the content of
articles is changed. They believe this information could help detect the origin of any
bias on the behalf of the editors or peer reviewers.

The marketing divisions of the pharmaceutical industry understand that the

appearance of credibility and independence of their research is vital for selling their
products2. One method of establishing ostensible independence is by having their
published research authored by clinical researchers in academia. Academics are
more than willing to accept the generous offer of authorship as it bolsters their CVs
and elevates their academic status. This unholy alliance has resulted in the
expansion of ghost management and ghost writing that has veiled industry-
sponsored research in a cloak of independence. Although there isn’t anything
inherently wrong with academic researchers working alongside industry, the issue
becomes problematic when all aspects of the research and publication process is
controlled by industry and the publishing author only serves as the figurehead for
publication.

Sismondo has offered some suggestion to address this issue. As many of the
publishing firms contracted by industry deal directly with the publishing journals
themselves, Sismondo suggest that journals should take a strong stance and refuse
to deal directly with publication planners. In addition, journals could adopt a “film
credit model” of authorship, in which authors rigidly and closely specify their roles
in the research process. Of course, violations of these rules should be met with swift
penalties to discourage academic researchers for taking part in such dishonest
activities. He also calls for universities and academic health centers to prohibit
contracts that allow for sponsor to draft, edit or facilitate publications as well as
prohibiting sponsors from keeping raw data from the academic researchers. Angell
takes a more aggressive approach and insists academic institutes adopt stronger
conflict of interest guideline and certain financial ties be inhibited altogether. She
focuses on the social interactions between academic researchers and industry. She
states that although most researchers would insist that they can remain objective
and not be influenced by industry, close collaboration with industry creates a sense
of good will on part of the researchers and may influence their judgment20. She
takes a strict stance on the degree of social interaction between industry and
researchers and suggests academic institutes place firm restrictions on researchers
receiving sponsored trips, gifts, symposiums, consulting fees and honorariums20.
Although limiting social interaction with industry may improve the objectivity of
the academic researchers, it fails to address some of the more pressing issues such
as such as the overreliance on industry for research funding, ghost writing and
concerns relating to the ownership of data generated from sponsored studies.

Synthesis for a Comprehensive Approach

Independently, the proposals above offer reasonable solutions to each of the

three pillars propping up MSM and facilitating the problematic issue of publication
bias. However, a more comprehensive approach, that integrates these suggestions,
needs to be taken to address the issue completely. Transparency and honesty are
foundational to the resolution of this issue. First and foremost, medical journals,
that have not already done so, should follow in the footsteps of the International
Committee of Medical Journal Editors(ICMJE) and refuse to publish the outcomes
of clinical trials that have not been registered with the Clinicaltrials.gov registry,
managed by the United States National Library of Medicine (USNLM)27. Second,
prior to publishing, editors of medical journals should be mandated to identify the
relevant study in the ClinicalTrials.gov database and assesses for the consistency of
reporting with the trial submitted for publication. Those trials that have altered
their reporting on primary endpoints or have failed to accurately report serious
adverse effects should be rejected for publication22.The reasons for rejection should
be outlined on the publishing journals website to discourage the authors from
seeking publication in other journal that do not adhere to these stringent standards.
This strategy will keep industry sponsored research honest and reduce the amount
of spin they can place on negative outcomes. The ICMJE should offer an insignia to
members of their organization to place on the cover of their publications to assure
readers that the medical journal is part of their campaign for increasing
transparency. What I am purposing is similar to what has been suggested by
Spielmans and Parry, the only difference being the introduction of the ICMJE
insignia that will make it visually apparent to the readers that the published
clinical trials in the journal have been vetted appropriately.

Similar to what was purposed by Sismodo publications should require

submitting authors to outline their specific role in the research process and clarify
the role of any of contracted research organizations (CROs) or publishing firms that
were involved in the study. The only disagreement I have with Sismodo is his
suggestion for medical journals not to deal with publishing firms directly. It seems
the use of publishing firms is common practise in the industry and asking journals
not to deal with them directly may not be reasonable. Instead, I purpose that during
the review process the editors of medical journals should require the submitting
authors to clarify if a CRO or a publishing firm was involved in any aspect of the
research or publishing process. If these manuscripts are accepted for publication,
the publishing journal should codify these publications with a specific page color or
badge placed under the title of the article to let readers know that these agencies
were involved in the research or publication process. This would alert the readers
that the research of the publication was not fully conducted by the author. These
codes should have a universal standard across all biomedical publication. codifying
the articles will allow readers to identify research that could be potentially biased
by corporate interest. In addition, it would make it easier for readers to distinguish
between authors that have conducted the research themselves and those that had
industry do most of the work for them. This will also leave a mark on the authors of
the publication and hopefully discourage them from taking credit for research that
they had not primarily conducted themselves.

Unlike Smith I do not call for the outright ban of journals publishing clinical
trials. I believe the method that I have laid out above will maximize transparency
and honesty of publications and bring to the awareness of the readers which
publications have been sponsored by industry, involved CROs and/or publishing
firms. In agreement with Speilmans, Parry and Smith I also think raw data from
clinical trials should be made public for independent analysis. The USNLM should
require all registrants of Clinicaltrials.gov to also submit raw data in a
standardized format no later than two weeks after the completion of the study. This
data should be organized and kept in an online national archive that is easily
accessible to the public. The USNLM, on the same website, should also publish the
independent analysis of clinical trials conducted by the FDA. Medical journals
should be mandated to provide a link to the raw data at the tail end of each
published article, so readers can access the data and FDA reports directly. If these
conditions are met, it will resolve many of the concerns outlined by Spielmans,
Parry, Smith and Sismodo, without having to go the extreme step of completely
separating industry from clinical research. I think my approach is more feasible as
it allows industry to continue funding expensive research endeavors and authors
from academic institutes to continue receiving research funding from industry. At
the same time this approach will hold the industry accountable for negative trial
data, increase transparency of ghost management and possibly discourage authors
from using their academic credibility as a veil of independence for industry. In
addition, this will allow researchers to continue bolstering their resume with
publications while letting consumers of these publications know the degree of the
authors involvement in the research process. This creates a self-regulating system
whereby an academic researcher would have to weigh the benefit of publication
with potential loss of credibility.
 Industry advertisement in medical journals is a difficult web to unweave. I
am in full agreement with Lexchin and Light who suggestion that; journals should
publish information about their sources of income, for editors to disclose their own
relevant conflicts of interest to readers, editorial staff, managers and owner and
perhaps consider not allowing editors to have any direct financial ties to any
healthcare business that advertises in the journal they edit. I think this is a step
towards the right direction, but is insufficient as it does not fully address the
reliance of medical journals on industry advertisement revenue. Orentlicher and
Hehir II have suggested that medical journals should only sell advertising space to
non-medical commercial interest, while Fugh-Berman et al have taken a more
conservative approach and suggested that medical journals should at least make
available advertisement space for non-medical commercial interest. As I have
mentioned above the pharmaceutical industry makes a sizeable return on
investment(ROI) for advertising in medical journals and thus could afford to pay the
exorbitant fees. I highly doubt that luxury products would make a similar ROI and
be able to afford the hefty price tag for advertising in these journals. I think the
medical journal publications are in the same unfortunate situation as many
newspapers and magazines. More people are going online for information and less
are relying on print. Publishing is an expensive process and because of this shift to
online platforms many median companies have ceased printing hardcopies of their
products and have moved online23. The upside of moving to online is that it is far
less costly to publish articles and thus medical journals would not require as much
advertisement revenue to keep their business operational. This can allow these
journals to expand their pool of potential advertisers, especially if they make
publications free and open to the public. Decreasing their reliance on industry
advertisements may free up the journals to publish articles critical of the industry.
Indeed, this has been tried and successfully implemented by the Public Library of
Science (PLOS) a non-profit publisher which declared that it would no be a part of
“the cycle of dependency that has formed between journals and the pharmaceutical
industry”24. This publishing firm has made a valiant effort to separate itself from
industry. The online journal does not accept any advertisements for drugs or
devices, does not benefit from exclusive reprint sales to drug companies and decline
to publish studies aimed purely at increasing a drug’s market share24. PLOS is a
perfect example of how my approach could be implemented effectively.

What is missing from all of the approaches outlined by the authors above is
the failure to recognize the importance of prestige and credibility for all three key
players; the pharmaceutical industry, the publishing journal and the publishing
authors (clinical researchers). The changes that I and others have purposed can be
catalyzed if the proper social pressures are applied. According to the 2016 GALLUP
the pharmaceutical industry is the second worse publicly rated U.S business
sector25. Public trust in the medical profession has also seen a decline. A large
international survey conducted by the Robert Wood Johnson foundation and the
National Institute of Mental Health found that in 1966 73% of Americans said they
had great confidence in the leader of the medical profession. In 2012 only 34% of
Americans shared the same sentiment26. In the same study the authors found that
only 23% of the public have a great deal of confidence in the U.S health care
system26. What is clear is that there is a growing mistrust in both the medical
community and the pharmaceutical industry. I doubt that the public is aware of the
rampant issue of MBM and publication bias, although, judging form the public
opinion polls they would not be surprised to hear this information. We can’t ask the
industry to change, we must make them want to change. The key stakeholder to
target would be the medical journals, academic authors and clinicians. The
campaign, implemented through social media and online publications, would bring
to public awareness the insidious relationship between industry and clinical
research. It’s primary aim would be to expose the issues I have highlighted above
and target the credibility of clinical researchers and publishing journals. The
campaign would arm citizens with credible publications, that dispute the
therapeutic claims of pharmaceutic drugs, and would ask them to present these
publications to their physicians and demand an explanation as to why they are
being prescribed medications with questionable efficacy. Ideally this would be to
create unrest in the medical community and have them question the reliability of
the medical journals that have published biased industry studies. This tactic is not
to dissimilar with the ongoing “fake news” campaign in the United States that is
demanding greater objectivity of media organizations. The social milieu is ripe for
what I would call a “fake medicine” campaign that would demand greater
objectivity in clinical research. This in turn would place the needed pressure on
medical journals to change their publishing practises or risk losing their credibility
and subscribers. Although this strategy sounds nefarious, it could result in a rapid
shift in publishing practises and bring to the forefront the need for more
transparency in, and public funding of, clinical research. Publication bias and MBM
as been discussed in literature and policies have been proposed, but have not been
implemented to the extent needed to curb the issue. If we truly want this issue to be
resolved, we must devise a political strategy in conjunction with effective policy
proposals and use social pressure to catalyze the changes we desire.
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