Ethics of Publication, Abuse of Process - Control of Information:

Ethics of Publication, Abuse of Process - Control of Information:

Background:

Appropriate dialogues in law, public policy and science require specialists and informed audiences. However, the identification of specialists, termed "experts" in law and government, is comparatively difficult. It requires competent and current technical experts within government. Because of the complexities of today’s technical fields, it also requires investigations to determine the amount of activity and the participants in the areas of interest. This can be done by locating formal publications ("peer reviewed publications") and identifying their primary authors.

It is also feasible by retrieving other information which connects current ‘experts’ with research work, technical achievements, books, seminars, symposia or scientific jurisprudence("expert witnesses"). Creating a list of suitable candidates is the first step in assembling working teams for development of public policies in any field. Meritorious individuals who are somehow unable to publish their work remain invisible and unavailable to the selection process.

The second step is to select the participants for a ‘dialogue’ which, in government, normally takes the form of a committee or an equivalent structure. Accordingly, lists of credible technical candidates for positions on committees and for development of public policies will include only ‘visible’ experts as reflected by publications or equivalent written material. Non-technical participants are also generally appointed but they are selected according to political expedience. Their selection is based on recommendations from within government circles. Their role can be important but they rarely contribute technical or scientific input.

All experts cannot be easily identified by this process. There are other factors. Some experts in technical areas are not ‘visible’ through publications because their area may be so specialized that there is no large "audience" or "market" for their writings.Thus, there are few or in some cases no appropriate publication vehicle. In other instances, their expertise is pertinent to "technology" as opposed to science and their knowledge is mostly of a proprietary nature. Thus, such material is not published in scientific journals. It may, however, appear in patent literature. Such experts can be evaluated through patent authorship or possibly through reports released in connection with past projects or cases. Participation in projects can be an alternate criterion. This situation often applies to civil engineers involved in public work projects.

Biotechnology and Medical Technology Sectors - Problem Areas:

Pharmaceutical research and medical technology areas share these problems. Additional complications such as the multiplicity of relevant journals make the identification, selection and evaluation of experts even more difficult in these commercially lucrative areas. In recent years, these sectors have become a multi-disciplinary focus of great complexity. More disturbingly, like many aspects of medical practice, some parts have also become ‘corrupt’ with individuals of influence devoid of qualifications or interest. Some appear to the public or are presented as ‘leaders’ by the organizations that employ their services. Most are in positions where they derive pecuniary, professional or career benefits from the activity. Some participate in decisions where there is scope for conflict of interest. Many are unconnected with fields for which they claim expertise.

Typical examples of such individuals include highly visible public figures and bureaucrats long disconnected from current activities. Many are lucky opportunists, commercial promoters, salesmen, mediocre researchers or outdated medical practitioners. They may presently hold key administrative or academic positions which they achieved through time or by accident. Others arrived and remained in these positions through aggressive guile or unethical processes which damaged the careers of colleagues. Past inertia and disarray within the organizations they serve sometimes played a role in strengthening their hold.

Historically, governments have had a markedly elevated fraction of such individuals. Most have gravitated to key management positions by default or disinterest on the part of more qualified and better motivated potential competitors. Canada and the UK are examples where this phenomenon has reached crippling proportions amongst the scientific, technical and health sectors.

Some of these individuals are physicians. Though unconnected with concepts, designs, developments or evaluation of medical technology product, they are often accepted as experts on the strength of their clinical background. Whereas this approach was acceptable in the early part of the century, the degree of specialization now necessary for even modest contributions in the development of medical products is such that it is inaccessible to all but clinicians with supplemental qualifications in pharmacology, engineering, manufacturing and many other fields, some of which require lifetime commitment.

Emerging Trends in Medical Technology:

Medical products do not depend solely on clinical knowledge. Furthermore, this rapidly evolving field is not a monolithic area, nor is it yet recognized as a discipline in its own. It is a complex confluence of technical, scientific and medical information. Many classes of experts converge and overlap to produce the body of knowledge pertinent to this field. Medical products are developed by large multi-disciplinary teams of individuals each of whom contribute their expertise. An extremely small number of such individuals have presently reached the level of professional maturity to claim an adequate ‘foothold’ on the field. Experts of this kind tend to be concentrated in the U.S. west coast. A few are in government or in senior industrial management positions after many years of specialized work. Some of their work may be published. Other information forms a conglomeration of interesting and pertinent material which may be extremely important in their field of expertise but which is not suitable for publication.

Other knowledge, in particular that related to product development and performance, is closer to technology and there is minimal opportunity for publication. Some of these areas have experts as well but they are difficult to identify as they tend to be employees of large firms involved in the commerce of such products. Production of pharmaceutical, pharmacology of specialized chemical entities, the engineering of pharmaceutical and medical device production, bioengineering and design of medical devices fit this category. Surprisingly, this expertise is not germane to the medical disciplines and very few medical practitioners have the depth of knowledge required to provide information, policy or formal expert opinion on areas of this kind, in spite of their being the primary users of the technology. Their position is similar to that of the airplane pilot as opposed to the aeronautical engineers and the technicians responsible for the design and fabrication of his aircraft.

Publications and How Experts are Selected and Evaluated:

Through tradition and established jurisprudence, governments and courts tend to measure the suitability of experts according to classical, ‘political’ and frequently outdated scientific and medical criteria. Thus, reliance on peer-reviewed journals is overwhelming. Much of this tradition is comprised under the term "Daubert" criteria for expert testimony. Accordingly, the suitability of proposed experts is a function of their visibility to the scientific and medical community and the general acceptability of their opinions to the mainstream disciplines. This further narrows the selection of experts to a very small number of individuals.

Technology experts are generally excluded; they are more difficult to assess by these criteria and there is little jurisprudence with respect to their evaluation. Highly qualified experts of this kind and where their opinions are essential to understanding the fine structure of the issues at hand are frequently excluded in spite of the central role that such individuals play in the design, testing and distribution of commercial products.

Publications as Commercial and Policy Promotion Vehicles:

Paradoxically, publications also play a major role in the evolution and the success of commercial products in the medical technology sectors. Policies can also be promoted in the same way. This is particularly true for medical products and medical technologies targeting large populations. In this context, scientific and medical journals are the visible part of what is presented to the public as the advancing frontiers of knowledge. As such, they constitute powerful promotional material.

Professionals and the public alike assume that such publications are forthright and are subjected to rigorous evaluation with respect to content and accuracy. This is not necessarily true. Historically, there have been numerous aberrations which document failure of the process. Many such instances have led to large scale mortality. Others proved profitable for their promoters but later emerged as costly morbidity episodes which became the financial burden of the public health insurance programs.

Similarly, publications are often perceived as ‘disclosures’ of information generally believed to be uninfluenced by parties likely to derive material or professional gains from the publications. This is also a fallacy and recent policy changes by major journals have attempted to address this issue but with limited success. All of these issues have been termed matters of ‘honesty’ and belong within the area of ‘publication ethics’. Some relate to basic professional ethical matters such as professional codes of conduct as they affect human clinical trials and securities promotion.

The Publication Process Revisited:

Publications play a role in shaping public opinions, commercial activity and professional views of science and medicine. It is thus interesting to examine mechanisms whereby manuscripts are selected for publication and ultimately become visible to professionals. It is even more interesting to study how meritorious manuscripts and valuable information can be systematically excluded from publication and thus kept out of public view.

Overt abuses of editorial mandate, unethical manuscript review practices and conflicts of interest amongst editors and editorial boards afflict most fields at some point in time. Instances where influential authors failed to disclose major personal advantages from the promotion of certain products and technologies are also known. Such aberrations have been noted in connection with journals on fertility control, vascular surgery as well as plastic and reconstructive surgery circa 1965-1989. Most of the abuses have taken place in the clinical sector and involved clinicians, frequently in positions of influence as medical directors of health care centers and university department chairmen.

Control of ‘Uninvited’ Information:

There are other mechanisms to control public and professional perception of commercial products or medico-surgical procedures. Some involve the restriction of information pertinent to adverse reactions or other unfavorable information. Public perception of "medical technology" is strongly influenced by public media and trade magazines, In turn, the public believes that professional thinking is shaped by specialized journals. This not true for most scientific areas, least of all for the health sectors.

The general ‘review’ type and ‘newspaper’ style technical publications directed at professionals are much more influential because of their wide readership. They are also more appealing because compartmentalization of disciplines and daily time commitments prevent mature professionals from reading extensively. All of these publication vehicles are part of the more visible information pathways. All are subject to complex editorial policies and sometimes are afflicted by illogical content selection mechanisms. They are frequently roots of the problem.

Furthermore, most of these publications are strongly dependent on advertisement or funding from commercial source. Their editorial boards are comprised mostly established clinicians and commercial promoters who depend on product sales, university grants and clinical investigation contracts. Publications of a promotional nature are widespread in these media; they are often masked as "scientific news" or "clinical study papers". Predictably, adverse information on products and procedures is extremely difficult to publish via such routes.

This is largely a consequence of control by editorial boards. Even in the absence of conflicts of interest within the publication screening process, there are still enormous obstacles to the release of ‘negative’ information. This is primarily through perceived fear of losing valuable commercial support.

Abuses of the Law as a Control Mechanism for Information:

Control can be even more direct and invidious through threats of litigation-related tangles with third parties involved in the promotion and marketing of medical products. Such overt and implicit threats have been widely used to suppress publication of unfavorable information or the printing of articles that are discordant with ongoing promotional campaigns.

The use of law suits structured along the aims of Strategic Litigation Against Public Participation (SLAPP) is still prevalent against authors whose views are unfavorable to commercial or government activity. This form of suit is very effective as a means of silencing or suppressing published views in medical and scientific journals.

Lawsuits of various kinds, including the many variations on the theme of libel, are still fashionable as information control weapons because scientific and medical publishers rarely have sufficient resources to defend suits by promoters of policies, products and technologies that have failed and attract unfavorable press. Journals avoid the issue by rejecting embarrassing manuscripts in areas where there is set government policies or profitable commercial activity by strong, aggressive and financially solvent manufacturers. Similar problems extend to the public media.

One need not explicitly reject manuscripts. There are more subtle ways of denying "uninvited" works. One of the most effective is to delay the review process and eventually "lose" the manuscripts. This is less dramatic and much more difficult to document. It is also widespread. Fortunately, many authors are fluent with the game. When delays become inordinately long, they look for alternate publication routes.

Why Reviewers Reject Manuscripts:

There are many reasons to reject "unwelcome" publications. One of the most frequent is fear of embarrassing a granting agency, an influential colleagues or an institutions known to be associated with faulty treatments, practices or technologies. Pecuniary issues are more often secondary considerations. Except for plastic surgery areas, frank or grossly visible corruption of the editorial process is rare. Peer review mechanisms are more effective as control methods as it is easier to influence reviewers. At any rate, manuscripts of potentially embarrassing papers tend to be widely circulated and generally find their way into government and commercial circles well before they are published. Numerous examples of this kind have been noted in connection with adverse reactions from faulty drugs, surgical implants and ophthalmic products.

Subject examples of illegitimate publication "control" include early manuscript censorship incidents involving DES, the Dalkon Shield, the Björk-Shiley Heart Valve, the Sparks Mandril Artery, the irradiation of the thymus gland in children, the Azar 91Z Intraocular Lens, the Becker Tissue Expander, the Angelchick anti-reflux implant, the Intra-Gastric Balloon, Pitanguay curettage (liposuction), pre-emptive mastectomy deemed of value for breast cancer prevention ("Wood-Mayo Doctrine"), Gonadotropin for acne, the Ashley breast prosthesis, Novobiocin antibiotics, the microbiological aetiology of digestive tract ulcers, Proplast joint implants, corneal damage from contact lenses, risks of donor plasmapheresis, long term use of triazolam, the Copper-7 IUD, pediatric use of Ionescu Cardiac Bioprostheses and Ivalon (polyvinyl formal foam) implants.

Other reasons have to do with avoidance of controversy because it is a destabilizing factor for even a large, well-financed scientific publisher. The operation of a journal requires stability and editors of prominent journals are habitually chosen because of their ability to stabilize organizations through negotiation, compromise and arbitration. Most editors represent mainstream views and generally function in insecure politico-professional climates, more often universities. They are therefore vulnerable to pressures of all types. Personal pecuniary issues, commercial consulting contracts, intra and extramural institutional feuds as well as university funding problems and interprofessional quarrels further complicate matters.

In summary, popular or professional scientific publications do not always reflect the real world. More often they lag by many years the discovery of adverse reactions. Mostly, they tend to reinforce existing views and beliefs. The publication review processes facilitate that. The peer review process is an imperfect tool for the selection of manuscripts intended for dissemination of new knowledge, in particular adverse reaction information with potential to affect large populations, alter prevailing clinical practices and buck existing commercial trends. Overt and covert government participation in the process further distorts reality and generally magnifies the problems. Thus "the scientist’s "Duty to Publish" and "The Public’s Right to Know" are more often utopian hopes as opposed to practical realities even in matters of public health.

The Limits of the Process:

The mechanism of publication as it exists today is better suited for reinforcement of established views and the promotion of superficially attractive, non-controversial ideas that fetter professional aspirations and dreams. This is particularly strong in environmental health, nuclear industrial development, cosmetic and plastic surgery, cancer abatement and family planning areas. These are all sectors of direct interest to governments, industry, as well as private promoters and medical practitioners but which have not been associated with visible scientific developments for many years. Conversely, all have also have been objects of much adverse publicity, in particular with respect to government promotion and fraudulent investigational activities regarding widely used but poorly tested technologies.

The peer review process does not look favorably on manuscripts that bring sobering reality after the implementation of catastrophic government policies. It does not like to dash false optimism brought about by prime publications by authors who achieve notoriety and public accolades. This seems true even if the celebrated studies conveniently neglected to follow-up on adverse effects. It is particularly ill-suited to adjudicate works that challenge long established views, in particular if some of these views have become enshrined in public policies and ministerial pronouncements.

The review process is even less forthright when manuscripts bring embarrassment to ministers, congressmen, and well-monied promoters. Most of all it fears giving visibility to any self -evident truth with an unpalatable but predictable conclusion. Especially avoided are articles showing that earlier studies were sloppy, biased or fraudulent and that governments, ministers, as well as large segments of elite professional groups were fooled by coarse commercial promoters or self aggrandizing bureaucrats. Other unwanted revelations include paper trails showing how other authors with important manuscripts were refused publication by privileged groups of unqualified and profit-motivated individuals placed by luck and circumstances in decisive peer review roles.

Current Trends in Canada:

The recent publication debacles in Canada’s Departments of Fisheries, Defence, Environment and Health are more symptoms than disease. Publication control is part of a well organized ‘culture of coverup’. In earlier times, clumsy coverup mechanisms were developed within Federal departments headed by celebrated ‘accident-prone’ ministers. The coverups were poorly done and sometimes provided humorous material for media ‘field-days’ in the sixties. Journalists of the time were not easily fooled by rank amateurs eager to please unpopular political figures .

Later efforts were more sophisticated and such processes were successful to some degree. Evidently, they were condoned by several successions of senior public servants. They became addictive to beleaguered ministers and bureaucrats in the turbulent seventies. In the eighties, it evolved into more ominous secretive departmental programs complete with ‘enforcers’, staff ‘counselling’ specialists and full-time Media Relation Officers working as crisis management teams. There are now full directorates with clerical staff as well as mandates and capacity to embellish, distort, fabricate and distribute ‘information’ deemed favorable to the Minister’s or the current government’s image. Predictably, further expansion is presently underway and major resources have been allocated to make use of Internet™-based promotional services.

Canada has a long and worsening record of information manipulation. Its Access to Information system is dysfunctional. Courts are impeded by Department of Justice solicitors who intervene on behalf of other departments to protect ‘sensitive information’. Destruction of records and fabrication of data are commonplace activities as revealed in ongoing public enquiries on defence, intelligence and public health issues. It is at its worst in government departments involved in health, food, manpower, communications, defence, technology and transport policy sectors. Large "media information" offices are maintained to further hide information of importance to the public and promote costly and unnecessary programs.

In 1998, directories listed more than 1600 government "media relations officers" in Ottawa alone. Their activities are coordinated by additional "spin specialists" termed policy advisors" attached to most federal departments. In ncontrast, Ottawa then had only about 400 media people, mostly journalists and broadcasters with a small fraction of contract researchers.

Incidents of gross and illegitimate information control continue to take place in many technical areas with importance for the public. They partly explain current controversies of the nineties on inconsistent government policy, gross violations of Access to Information (Freedom of Information) legislation, friction with the media and coverup efforts affecting environmental health, defence procurement, food production, industrial expansion, communications, health care and scientific research. Public health and other areas associated with large cash flow or with marked impact on socio-medical and economic matters have been notoriously subject to information manipulation.

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