Background:

Alteration of business records, falsification of data and submission of deceitful publications for the purpose of profit or for altering the outcome of a trial, as well as more serious offenses such as intimidation or corruption of jurors, witnesses and government officials, are perceived as criminal acts in most countries. More elaborate schemes involving threats, multiple participants, secretive planning and systematic distortion of information to achieve similar ends are variations on the themes of commercial fraud and conspiracy. If government agencies are involved in such activities, infringement of public service regulations take place. When information tampering affects public health and gives rise to morbidity, such activities may become criminal acts.

Events surrounding disclosure of breast implant morbidity and the revelation of improprieties from promoters of the products in the late-eighties fall into some of the above categories. Many clearly infringe on existing codes of conduct and contravene principles of law. Such occurrences are not limited to breast implants and cosmetic surgery products. They are encountered in other health care areas in increasing numbers and are causes of much apprehension within the scientific and medical community.

Why Information is Vital:

An informed dialogue is essential in law, government, science and technology. When contentious issues arise in connection with faulty products, the absence of timely information is a decisive impediment to a rational resolution of problems posed by such products. Conversely, inaccurate and deceitful information disseminated for promotion may mask risks of the product and delay corrective action. This may contribute to morbidity which otherwise would not occur.

Information is essential in many processes on which society depends. Scientific, medical, financial and technical information affects nearly every aspect of society ranging from strategic government decisions to a patient’s choice to accept or refuse a medical procedure. History demonstrates that information can be manipulated, hidden, promoted, altered or fabricated for many purposes. The intent may be to hide past events which would lead to embarrassment or loss of credibility. Overemphasis of certain information can be used to rally public opinion and force public policies; this is often encountered in times of war. False information can also be used to influence stock market trends and allow undue gains from insider trading. Scientific and technical information can be distorted to serve political, commercial and personal agendas. Promotion of medical products and awarding of grants to researchers are typical examples.

The promotion and release of faulty health care products that culminate in morbidity frequently lead to litigation. Recriminations against government agencies tasked with protecting the public from such occurrences often take place. Litigation against public agencies almost always follows.

Aberrations in the Information System:

Information is a commodity. In health care sectors it is indispensable for decision making, in particular for issues in public health. Information systems are rarely ever complete or comprehensive. Gaps and defects are inevitable. Deliberate distortion of information is encountered in some situations leading to pathological conditions which corrupt or diminish the value of information. The defects can result from natural occurrences such as insufficient work, incomplete data bases or inaccurate but nevertheless honest observations. However, serious problems can develop through deliberate or fraudulent processes. Selective suppression of information, insertion of 'fabricated' data, promotional material masked as scientific publications and deliberately distorted disclosures are examples of aberrant practices.

An informed dialogue cannot take place where there is coercion within the information gathering process and where suppression of information takes place. Instances of gross abuse of process in information gathering range from frank intimidation through threats of physical harm to some of the most sophisticated legalistic suits ever structured in North America. The trend in information suppression which started in the eighties continues unabated. Abuses surrounding information on breast prostheses issues are case examples which became publicly visible recently. Defective information and suppression involving pharmaceuticals, vaccines, blood derivatives and consumer products present similar problems with potentially far more serious repercussions affecting larger populations of users.

In the light of present knowledge and according to information derived from manufacturers and an inner circle of proponents including consulting surgeons and physicians, adverse events from breast implants are rare and random occurrences. Studies on explanted devices and correlation of information with users of implants reveal otherwise. They confirm that complications are widespread and their severity increases with dwell time. The nature of the complications are severe and they appear inevitable if sufficient time is given. Thus, they are not 'probable occurrences'. They are certainties.

Examinations of randomly sampled prostheses removed from users reveal major manufacturing defects, gross design inadequacies and time-dependent changes in constituent materials. These observations were noted almost from the outset in the early-seventies but the information was not widely disseminated. Some of the information was retained within corporate files under confidential classifications and surfaced much later incidental to product litigation. Government agencies worldwide with responsibility for health care products compiled adverse reaction reports and complaints surrounding the use of these implants. Individual adverse reaction reports, mostly of an anecdotal nature, appeared sparingly at different times amidst rumours of strong objections with evidence of interference with the publication process.

In the final analysis, it is clear that only a small fraction of the unfavourable information appears in the public domain. This information is offset by a flood of favourable, primarily promotional information and lobby activity by proponents. In such an environment, governments are deprived of essential decision-making information. Consumers have no reliable basis to decide on matters that can affect their health. Physicians are not given appropriate tools to diagnose diseases caused by the faulty products. Governments are unable to develop sound policies on reimbursement of medical services involving potentially harmful products and technologies. Consequently adverse events needing medical treatments become part of the public burden on health care. Concurrently, commercial agencies and assorted lobbies flood the public media and the trade journals with advertisements and further promote the use of the technologies expecting gains and rising profits.

Sources of Defective Information:

Unfavourable information offsets promotion. Promotional information is the prerogative of proponents. Commercial agencies or financially-involved professionals provide the bulk of it, usually in exchange for gains or stipends. Superficially unconnected researchers and promoters also provide much of this information frequently disguised as medical news. Very large costly studies conducted by prestigious centres invariably receive major funding from proponents. Predictably, the results of their studies are supportive, devoid of disparaging information and often promotional. Unfavourable information is not commercially valuable. Thus, it is rarely funded and there is no monetary incentive to publish the results.

Negative findings on a product habitually originate from independent sources without conflict of interest. The independence of government-related information gathering and research studies are depended upon by the public and by professionals. Faulty information systems within government and publication of promotional information by government removes the necessary balance for decision making and makes government an accessory for the promotion of commercial products. Suppression of information by governments and other agencies is difficult to see unless there is extensive investigation of the agencies. If the process takes place over several years, it implies that the aberrations are parts of policies and reflect deep problems within the organization.

Information Control Practices:

Faulty information can be inserted into publications. Such events are common but are easily recognizable or at least offer potential for discovery with minimal investigation. Suppression of important information is much more difficult to discern. It requires elaborate studies and correlation with existing information. In many instances and in the absence of insight provided by specialists and administrators directly involved in the event, suppression can pass unnoticed. Suppression policies applied systematically over many years produce aberrant literature and faulty information bases which can drastically affect public policies. Such situations in health care lead to health care disbursements for treatment of problems engendered by faulty policies.

More pernicious forms of information suppression can include abuses of process of law. Scientific publications and disclosures of importance to consumers can be hindered through coercion, fear and harassment of researchers and government officials in a litigational context. This form of suppression has reached a high level of sophistication. Termed ‘Strategic Litigation Against Public Participation’ (SLAPP), this activity now consumes resources which approach those spent on primary medical product research and development.

Some of the best examples of SLAPP activity include lawsuits to prevent publication of adverse reactions from Norplant, an implantable contraceptive system of highly controversial nature. The manufacturer, Leiras of Finland, sought an injunction to prevent the Finnish Ministry of Social Affairs and Health from releasing this information. Leiras contended that if the information was to be published the Ministry and its associated researchers would be "responsible for economic harm resulting to the company". The primary purpose of Leiras’ action was to make the researchers and the supporting Ministry abandon the publication of the findings. As a consequence, the product continued to be sold unimpeded for many years. As predicted by the researchers, adverse reactions continued leading ultimately to widespread morbidity and litigation on the safety of the product in the U.S. and abroad.

A less well known but more disturbing case is that of Bristol-Myers Squibb Canada Inc. (BMS), coincidentally a promoter of breast implants in the eighties, who sought to prevent release of unfavourable findings on its cholesterol-lowering drug. BMS targeted a quasi-governmental technology assessment agency, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), with a SLAPP suit in 1997. The aim was to prevent publication of an unfavourable appraisal of the product stating that the BMS drug, promoted primarily for control of cholesterol in the context of preventing cardiac disease, was simply one of several generic pharmaceuticals with a "class effect". Its alleged benefits were shared by all products of the class and were not specific to the BMS drug. The litigation consumed nearly $1 million dollars or 13% of the agency’s annual budget. The near totality of its human resources were diverted to defense of the suit. Predictably BMS lost the case. An appeal was filed and was also lost. The contentious report was published in part after a long delay but by then it was no longer timely. The case had a crippling effect on CCOHTA. It impaired the agency's research programs on other products and had a chilling worldwide effect on publication of scientific information on medical products safety.

Similar situations have arisen worldwide but have remained invisible because of confidentiality rulings by courts following settlements. The best known Canadian example concerns Deferiprone, an investigational drug promoted by a Canadian firm and currently under clinical study in Canada. It is intended to treat a rare blood disorder. In 1998, following a preliminary evaluation, Dr. Nancy Olivieri, one of the principal investigators at the University of Toronto and Hospital for Sick Children, alleged major safety problems with the drug. She became the object of harassment and litigation by the drug promoters following her attempt to publish the information. The case became public when the Hospital and the University sided with the drug promoters fearing loss of lucrative research grants. Portions of the results have since been published but the issue of the drug's safety and efficacy remain unresolved. Significant personal resources were consumed by Dr. Olivieri to defend her rights.

The Olivieri case exposed strong coercive forces within universities, hospitals and governments to silence adverse information in connection with health care products. In combination with the other known examples of information suppression, the case demonstrated that a professional is exposed to coercive action and has no ability to mount adequate defense against such activity. The release of information will have impact on profits from a product. Promotional information strongly stimulates sales and never has litigational aspects. Adverse information generally causes a decline in sales. Both aspects have economic consequences which are orders of magnitude beyond the lifetime income of professionals and are in the same range as program costs in the public sector. Yet, the discovery and eventual disclosure of adverse information about a health care product are natural business venture risks. When translated into SLAPP language, the impact of adverse information is termed 'lost economic advantage'. Established traditions in the context of SLAPPs are to produce elaborate calculations which purport to demonstrate enormous 'prospective losses'.

Researchers employed by the public sector are even more vulnerable. Specificities of the terms of employment, modest remuneration, public service regulations, confidentiality provisions and cross-currents created by industry-government relations and endemic lobbying produce even more powerful coercive forces. Individuals within the public service do not have access to effective mechanisms for redress within the framework of public service adjudication bodies.

Furthermore, there is a long standing history of information suppression by government agencies. Officials, in particular researchers, have a fundamental dilemma; as part of their employment contract they must perform work relevant to NHW’s programs on safety and efficacy of health care products. If unfavourable information is uncovered, it may affect commercial activity.

Practices which impede this process are contrary to codes of ethics and may contravene basic aspects of law. Inevitably, and because of the public protection mandate of many government agencies, adverse information is bound to be discovered. It is cowardly, repulsive, unethical and counterproductive for a government agency to impose hardship or damage the reputation and career of vulnerable individuals it employs who may discover adverse information. Suppression of information leading to morbidity is a behaviour with criminal overtones independent of motivating factors, be they matters of protecting the image of the Minister or the profitability of business ventures deemed favourable to other government programs. More egregious breach of ethics that may take place incidental to influence peddling, attempted bribery and other dishonest practices are symptoms of deviant relations between public officials and stakeholders. They cannot be tolerated in any context.

Such abuses cast doubt on safety and efficacy claims for nearly every medical product released into commerce worldwide. The problem extends to other products including food. Illicit information control demonstrates that even government officials and scientists can be targeted and successfully silenced or suborned by commercial stakeholders. There are further complications with even more serious consequences. University researchers were at one time independent from commercial influence. This is no longer so. It is now well demonstrated that most, if not all, are either participating in studies involving specific commercial products or are under control of administrations which derive income from commercial development grants. University researchers who are not already funded directly by commercial agencies are under rising pressure from university administrations to remain silent about unfavourable discoveries for fear of jeopardizing lucrative program funding.

Publishing adverse reaction information of any kind, even for products and technologies in which the university has no stake, is strongly discouraged. A university where researchers have a history of disclosure of adverse reaction information on health care products is perceived as a "whistle blower" and is not habitually given priority for funding. This attitude even extends to government-granting agencies. More disturbing is the observation that government agencies such as NHW now depend overwhelmingly on university-based specialists for evaluation of pharmaceuticals, biologics and devices. Given the present university environment, the probability of finding an independent consultant-evaluator for product approval studies is nearly impossible. In many instances, the conflicts of interest are not only present but are deliberately hidden by the researchers and the university.

Situations of this kind arose in the context of the Olivieri case where the research program and the knowledge base for the drug under study was the result of a long term research contract with promotional overtones and where staff were expected to play a role in influencing the approval process. Another case involves researchers at Laval University. This group had a long history of studies on safety and efficacy of medical products. In the early-eighties, it produced several sobering publications on widely promoted medical products and technologies. Their findings were instrumental in terminating market activity for many products which have since proven to be defective, ineffective and harmful. The Laval work had direct impact on Canadian health care costs and resulted in significant savings. In spite of worldwide recognition, the researchers encountered funding difficulties and harassment from the outset. Relying mostly on government contracts, the work was often continued by researchers using their own funds or volunteering time. In the late-eighties, harassment by government agencies became part of the equation. Funding problems continued with increasing intensity amidst pressure from the university administration and lobbying by industry representatives until the closure of Laval's laboratories in the spring of 1999. Incidental SLAPP suits, internal university politics and external pressures from commercial and related sectors played a primary role in the dismantling of the laboratories. Another case example is that of expensive SLAPP actions against breast implants critics launched in 1993 by the Mentor Corporation, a surviving breast implant manufacturer claimg insufficient funds to compensate injured users of its products.

Faulty products lead to morbidity. This can be hidden for a time. When it becomes known that a product was transparently faulty several years have elapsed. Enquiries and audits show that adverse results were withheld, the work was biased or sloppy and was recognized as such by an inner circle of specialists. If the researchers had made their findings known, they would have become vulnerable to SLAPP suits by promoters claiming adverse economic consequences from the disclosure of such adverse information. Ironically, such researchers are simultaneously vulnerable to litigation from injured users claiming dereliction of duty and professional improprieties. Whereas the process as a whole is absurd and ultimately terminates with dismissal of the suits after several years, the process is debilitating and wasteful. It can inflict financial ruin and can severely damage health, reputation and career. At NHW, researchers were motivated to, and in some cases compelled to, remain silent with threats of demotion and loss of employment. Illicit processes were often used in order to achieve these ends.

Background Issues:

Allegations of conspiracy, fraud and information tampering have often been levied against manufacturers and distributors of health care products. Comparatively little is known about the details of such events other than that they involve suppression of information on the part of an industry which has prided itself for its service to the public. Seen as a whole, suppression of information from this part of the industry is out-of-step with their self-promoted image. Such activity is at best unethical and at worst of a criminal nature. It is undertaken to hide unfavourable information, maintain sales, silence professionals, manipulate government officials, intimidate witnesses and alter the outcome of trials. Most are forms of 'damage control' that demonstrate vulnerability of the public to information control and promotion of fraudulent or hazardous health care products and technologies.

The SLAPP cases against independent researchers further show a dark side on the part of commercial agencies which have historically been depended upon to engage in research for the benefit of society in exchange for a reasonable profit to its shareholders. Illicit coercive activities on the part of such agencies are in sharp contrast to such industries' self-promoted image of excellence in research, commitment to product safety and concerns for the public good. Even more conservative views still demand that such agencies at least abide by established ethical principles which include, but are not limited to, protecting the public from clear and present hazards associated with products they promote. It seems that even this modest expectation has been flouted giving a particularly repulsive image.