Seminar I: Chapter 5 Funding dilemma Mohd Nasir Ayob, Le Fu, Oscar Janson, Natasha Kamerlin, Arvind Parwal

Problem A company is funding a series of drug studies. Your research group has been given a large grant for such a study, in which you are comparing the company’s products with similar products from other manufacturers, under varying conditions and on different target groups. The company is taking care of publication, and after the first series of studies, they publish the most favourable results from their point of view first, the less positive ones much later, and the negative ones not at all. What action do you take?

Key points: Company does not decide how the study is conducted - no design bias, only selective publishing Research group agreed to let the company be in charge of publication The study is not finished

Ethical problems Protesting could mean losing the grant (which affects the entire research group) and hired researcher could lose their income and employment If only the favorable results are published, public will be misled, and harm could be anything from less efficacy to severe side effects. Ethically doubtful to cooperate with a company with bad ethical values. If we do not protest, the research fails to follow the communalism that all academic research shall follow.

Groups affected The research group: Career success and reputation, funding are at stake. The company: It is in their best interest to publish results that favors their corporate goals. Publishing bad results will negatively affect the commercialization of the product. The medical community: Depend heavily on pharmaceutical industries to provide direction for drug use. If the published results are biased, the treatment recommendations will be biased. It could results in detrimental effects, for instance, drug Tambour in 1980s which cost thousands of lives. The public: We need accurate view of the research. Biased results could lead to trust crisis. The academia: Academic researchers that read the published paper can get mislead and their research might get affected.    

Values and interest Responsibility Transparency Honesty Lose funding Trust (research group <>company) Trust (any publication must be acknowledge by both party) Money Prestige/ fame Misleading result might cause harm Openness Ethical issue Greater good

End of part 1

Part 2

What action do you take? Discontinue the study - lose funding Complete the study without protesting - keep funding, but results misleading Complete the study but withhold remaining results - negotiate publication Publish the negative results independently, acknowledge funding from the company

Qualitative effects of solutions 1. Risk to lose the project for research, which can be benefiting to society. However, the company wont feel the loss due to the availability of another research group. 2. This will be an unethical to the society by providing misleading results. Risk of flawed study. In a perfect world, money wouldn't matter — all scientific studies (regardless of funding source) would be completely objective. But of course, in the real world, funding heavily matters and may introduce biases. For example- A drug company funding for a study of a new drug/medication, for example, might influence the study's design or interpretation in ways that subtly favor the drug that they'd like to market and to produce much positive scientific results to publish and to be a strong competitor among others. 3. Despite the broad claims for worksite health promotion, the scientific data available to evaluate are limited, this situation might be an arise due to disagreement to alternative 3, if the company defer the scientific data to publish the negative results.

4. Scientific data (positive and negative) would be easily accessible to society by accessing open journals. In failure of alternatives 1-3, what should we make of all this? Should we ignore any research funded by companies or special interest groups? Certainly not. These groups provide invaluable funding for scientific research. Furthermore, science has many safeguards in place to catch instances of bias that affect research outcomes. Ultimately, misleading results will be corrected as science proceeds and accessible to other researchers; however, this process takes time. Meanwhile, it pays to scrutinize studies funded by industry or special interest groups with extra care.

Effects of the values and interests 1. Increased loyalty and accessibility: research would be more transparent and the knowledge can be shared with any stage researcher for betterment of the society. 2. Motivation to do good research and enhance the publications to be more open with honesty 3. Mutual relationship with the colleagues, the government, the study sponsors, and of course, the public could be improved and hence, these measures provide a healthy working environment for a good research. 4. Respect: The research needs to respect the safety and health of patients who might be inappropriately prescribed a new treatment based on studies that could be skewed by financial biases. 

What will you do to make sure that the use of the solution will be optimal with regards to ethical aspects? For instance, adapt the design of the product, use of research methods, cooperation with industry, information to stakeholders, etc? How exactly are you going to succeed with this? We think the reporting period should be clearly outlined in the funding agreement. If it is not a case of a patent application, the Swedish Research Council’s current 2010 rules does not allow a funding body to defer publication for more than two months. And if there is a patent involved, it is four months. It is important that researchers selected for such positions do not simply regard their appointment as a personal distinction, but also see themselves as representatives of the country’s research agencies and research community. More widely: Global system to register trials, make public all research results. 

Company should not be allowed to prevent publication of the results. Only completely separating public clinical research from pharmaceutical industry funding can eliminate sponsorship bias." Shared knowledge and research work should benefit our community and society as a whole. Fairness and openness is uppermost, goes before profit. Team results are uppermost, not individual goals. Open research and scientific data are our most valuable assets but must be shared. Publication would bring value to the shareholders should be an objective.

Distinctive success traits Characteristics Distinctive success traits   Collective spirit To make individual objectives compatible with the overall objectives of the research. Fairness and openness Honest and fair attitudes and conduct towards research, firm, clients, suppliers, employees, shareholders, authorities, others and even competitors. Criticism is accompanied with suggestions for improvement. Share and publish results with honest deed with the society. Social responsibility and environmental consciousness Conscious in complying with social standards and in making a contribution that benefits people, society as a whole and the environment. Relationships Form healthy, positive interpersonal relationships that are meaningful and reciprocal. Give and derive satisfaction from interactions with others.

Most leading medical journals now require an exact description of the funding sources and any potential financial interests that the authors of a research article may have. The disclosures are usually described in depth towards the end of the article, but some journals even indicate funding sources in the brief abstract of an article. This allows the readership of the published articles to consider the funding source and potential financial interests of the authors when evaluating the results and conclusions of a clinical trial. Many prominent medical journals require that a study be registered in a database of ongoing clinical studies for it to be considered for publication. Financial disclosure, reporting standards and trial registries. Registering all trials at the onset of the trial and ensuring safe and complete reporting Ref: Als-nielson, B., W. Chen, C. Gluud, and L.L. Kjaergard. 2003. Association of funding and conclusions in randomized drug trails: A reflection of treatment effect or adverse events? Journal of the American Medical Association 290:921-928.