The World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects was first adopted by the 18th WMA General Assembly in Helsinki, Finland, June 1964, and has thus been the global cornerstone of research ethics and guidelines. Article 30 states:
Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication.
Diametrically opposed to this noble ambition; however, is the reality of data reporting; a concept known as “spin.”
The Journal of the American Medical Association (JAMA) defines spin as the “specific reporting that could distort the interpretation of results and mislead readers.” Spin Doctors are, thus, the people falsifying data for reasons including financial ties to Big Pharma, to achieve higher professional status and to gain grant monies.
One of the most dramatic effects of spin is seen in a recent study published by JAMA. Researchers reported that over 40 percent of the best designed, peer-reviewed scientific papers published in the world’s top medical journals misrepresented the actual findings of the research. To confirm this and to identify the nature and frequency of distorted presentation or spin, Boutron et al. systematically evaluated 616 published reports of Random Control Trials (RCTs) and after appraising the 72 eligible studies concluded that, “In the representative sample of RCT’s published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results.” In other words, most of the published research has been intentionally falsified.
Spin has dramatically changed the course of healthcare and has deleteriously affected millions of people. One of the most shocking examples of this is when the National Institute of Health’s National Cholesterol Education Program dramatically lowered the ideal LDL level for cardiovascular disease prevention strategies in 2004; thereby, increasing the number of Americans for whom statins are recommended from 13 million to 36 million. Though, after a systematic review of the literature to confirm whether or not statins are even effective in managing heart disease, the highly acclaimed medical journal The Lancet published a paper concluding that, “In support of statin therapy for the primary prevention of this disease in women and people aged over 65 years, the guidelines cite seven and nine randomized trials, respectively. Yet not one of the studies provides such evidence.”
Thus, of the 23 million new people now with “high LDL levels;” however, there is no valid, scientifically proven reason to assume that they are at risk. Because of a spin on the data; however, they are labeled as being at elevated risk of developing coronary heart disease and are now being pressured by their medical doctors to take statins.
Sources for this article include:
• World Medical Association. WMA declaration of helsinki – ethical principles for medical research involving human subjects [Internet]; c2013 [cited 2013 March]. Available at: http://www.wma.net/en/30publications/10policies/b3/
• Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpreting of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010; 303(20): 2058-64.
• Hyman M. Dangerous spin doctors: seven steps to protect yourself from deception in medical research. Explore (NY) 2011; 7(2): 63-5.
• Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007; 369: 168-169.