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How could disclosure of interests work better in medicine, epidemiology and public health?
When Transparency International was founded in 1993, the focus for fighting corruption was mainly on bribes and corruption of civil servants in developing countries. While our definition of corruption was broad from the beginning, that is abuse of power or of a powerful position for personal advantage or benefit, the concept of preventing corruption had to be adjusted more recently. A first consideration of conflicts of interests appeared in our A–B–C of fighting corruption (2002) stating that
… conflicts between private and professionally consigned interests—be it in public office or in the private sector—create susceptibility to corruption. In addition to the general demand of keeping private and professional interests separate, specific codes of conduct should provide suitable examples of potential conflicts. A reliable code should contain the obligation to disclose and obtain a permit for acceptable cases or, vice versa, examples of unacceptable cases of conflicts of interests which should be explicitely prohibited, as well as tangible punishment or sanctions against infringements.1
Conflicts of interests are now considered as a major gateway for corruption in medicine and public health.2They predominantly affect the way that doctors evaluate and use the products of the pharmaceutical and medical device industry by a systematic and ubiquitous exposure during professional life, starting at medical school. Recent estimates of marketing expenditures of the pharmaceutical industry amount to US$57.5 billion (2004) in the USA alone, with 63.2 per cent or US$ 36.3 billion for samples and detailing directly addressing individual physicians, the majority of them working in private practice.3 The other 21.2 billion are spent on scientific meetings, e-promotion, promotional drug use trials, journal advertising, direct-to-consumer advertising and unmonitored promotion. Yearly marketing expenses for Europe in 2006 were estimated to be as high as US$60 billion.4 No wonder that in face of the enormous amount of money spent each year merely for drug marketing and for influencing the medical and scientific community, attempts of pushing back commercially driven interests by disclosure of conflicts of interests appear to be rather fruitless.5 Independent clinical research which can produce reliable results on new drugs or new medical technology has almost vanished and has been progressively replaced by industry-sponsored studies which are dominated by marketing interest of the manufacturers, including misleading selection or extensive falsification of data and results. Consequently, evidence-based guidelines or practice guidance often can no longer be assumed to be unbiased and free of conflicts of interests. Meta-analyses are at risk of being seriously distorted,6 even after adjusting for publication bias,7 due to inaccessible, unpublished data on clinical trials or inappropriate, for example non-reproducible, inclusion of such data as seen in a Cochrane Review by T E Towheed (2005) on the effects of glucosamine in osteoarthritis, in which—contrary to other glucosamine-containing drugs—an Italian product of ROTTA was rated effective based on unpublished clinical trials.8 Publication bias can most effectively be overcome by up-front study registration.9
Nowadays, medical expert committees are obliged to disclose conflicts of interests. Nevertheless, rarely is any action taken to control or to exclude advisers or experts with conflicts of interest since the extensive ties to industry of panel members have become the norm.10 It is therefore illusory to expect that disclosure alone without sanctions will be sufficient to increase transparency and decrease corruption in medicine and public health. Even if adequate sanctions follow, individual professional behaviour may not suffice for reversing the detrimental dependency of the medical and scientific community on industry. By the same token, corporate responsibility endeavours of drug and medical device companies should not remain voluntary efforts without tangible sanctions. This also applies to posted information on the internet, on corporate or institutional websites and in other media which aim at informing the public. We feel that we had to learn from our experiences with the strategies of the industry in governing medical science according to marketing needs that there will not be open and complete disclosure of financial or other links to the industry or their agents, if there is no legal and/or institutional pressure to do so. We consider incomplete listings of financial benefits to academic medical centres, medical associations, patient organisations and advocacy groups, and even individual consultants or experts, to be equally insufficient.
In the just published report of the working party on patients, physicians, the pharmaceutical industry and the NHS,11 the Royal College of Physicians considers the prohibition of individual gifts and the unlinking of financing from a single company to individuals or specific departments to be of paramount importance:
In rewriting the relationship between medicine and the pharmaceutical industry, and in the spirit of a more balanced and mutually respectful partnership, all gifts to doctors, including food and travel, become untenable and should end. (Section 3.41)
The ABPI (Association of British Pharmaceutical Industry) should change its Code of Practice to bring to an end the practice of industry representatives giving gifts to doctors and their support staff. Acting on this single recommendation alone would do much to rebalance the relationship between medicine and industry to one based on equality and mutual respect, with improved patient outcomes as the overriding objective of that relationship. (Section 5.25)
Transparency International, endorsing these principles, proposes several levels for immediate intervention concerning conflicts of interests in medicine and healthcare.
Professional codes of conduct for physicians and other health professionals, individual drug and medical device companies, health maintenance organisations, sickness funds, research organisations, etc. The common denominator of such codices consists of the ban of offering/accepting any personal gifts, including food and travel.
Organisational level within the medical system
Codes of conduct for academic medical centres, medical associations, patient and consumer organisations, organisations of healthcare professionals and producers of pharmaceuticals and medical devices. Each institution or organisation in healthcare as well as each professional in these institutions or organisations should be obliged to make any payments, honoraria or other benefits by pharmaceutical or medical device companies transparent.
Public registry of all clinical trials and other research activities involving patients, including post-marketing and pharmacovigilance studies. Publication of all relevant outcomes and results including null results, adverse effects and stopping rules, administrated and monitored by an independent institution such as the National Institutes of Health. Full disclosure of funding agencies, companies and responsible data centres.
Education of healthcare professionals including continuous medical education must be disentangled from commercial interests. The healthcare professional organisations should integrate graduate and continuing medical education in their codes of conduct. There is a great need for developing and updating high-quality, evidence-based efficient curricula for medical schools and postgraduate continuing medical education training, most preferably delivered by independent national institutions. Funding should ideally come from tax money, sickness funds, or both.
Drug and medical device approval legislation: necessary prerequisites for starting drug approval process should include a complete and consistent disclosure (including amount) of beneficiaries of involved institutions, experts and organisations. In addition, information on the marketing budget and a curb of marketing expenses to less than annual research expenditures of drug companies for all marketed drugs should become a mandatory legal requirement.
Implementing an expert anti-corruption agency for health at the national level authorised to take legal action. This includes activities in prosecuting conflicts of interest among health professionals and their institution, since such conflicts often result in rising healthcare expenditures without benefit for the public. In Germany, Transparency International has repeatedly criticised the current practice of voluntary anti-corruption activities within the bodies of the self-regulated healthcare system and insists on the implementation of an independent anti-corruption agency at the federal level, directly reporting to the parliament, entitled to pursue cases as well as to apply sanctions against professional misconduct such as non-disclosure of conflicts of interests or failure to comply with codes of conducts within the health system.
Monitoring of influence of commercial interests on public health and outcomes of medical interventions: annual reports to the public on health indicators and international comparisons including healthcare expenditures, estimated losses due to corruption and fraud in healthcare and recaptured resources by anti-fraud and anti-corruption measures.
We are convinced that the consequences of continuing uncontrolled conflict of interests in medicine and public health have a dramatic effect on the health and well-being of people worldwide and have to be addressed immediately.
Competing interests: None declared.
A comment by Anke Martiny, Peter Schoenhoefer and Angela Spelsberg for the Working Group on Health of Transparency International, German Chapter. All authors are members of Transparency International, German Chapter.
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