An interesting article is written by Trudo Lemmens and Candice Telfer titled “Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency,” which appeared in the 2011 issue of the American Journal of Law and Medicine (vol. 38, pages 63-112).
In the article the authors argue that information about clinical trials should be recognized as a fundamental component of the right to health.
The authors make a mention of two controversies in recent years. The first is of GlaxoSmithKline and its use of the antidepressant Paxil for treatment of depression in the pediatric population. In 2004, the Attorney General of New York prosecuted GSK for allegedly hiding negative data, selective publishing of positive data, and use of skewed publications to promote off-label prescriptions. The second case is the mention of Vioxx in which the company used ghost-writing and had lack of reporting of data.
The authors state
“We want to show that a system of transparency of data that allows the free flow of information among governmental regulators, public and private scientists, patient advocacy groups, global research-related public interest organizations such as the Cochrane Collaboration, and healthcare practitioners, is an essential tool for the promotion of evidence-informed medicine and the protection of public health.”
The authors later go on to state
“Various meta-analyses of clinical trials reporting in the medical literature provide strong evidence of bias; a host of studies indicate that industry-sponsored trials are much more likely than other trials to conclude that drugs produced by the sponsoring company are safe and effective.”
The authors state
“Various legal actions by federal and state legislators and plaintiffs lawyers in the United States against many of the largest pharmaceutical companies—resulting in some cases in settlements, penalties, or awards in the millions of dollars—provide an evidendary record of serious problems with clinical trials. Clinical trials are often designed, organized, conducted, analyzed, and reported more as a misleading marketing tool than as a valuable source of information on safety and effectiveness….”
“They reveal a widespread pattern of manipulative publication practices: hiding, or at least underreporting, negative data in scientific literature; spinning data (i.e., presenting neutral or negative studies as positive ones); using repetitive publications of single studies to boost public perception of effectiveness and safety; over-emphasizing small studies while ignoring in the reporting of these studies the totality of the evidence if it undermines the positive message; using established academics as “guest” authors on ghostwritten publications to increase the credibility and appearance of independence of company-organized clinical trials reports and so on.”
The authors later go on to say
“We believe that a comprehensive system of knowledge production is needed to protect patients, consumers, and overall healthcare systems from biased research. This requires a shift away from thinking about access to clinical trials data as an exception and towards seeing access to data as a crucial component of credible, accountable, and public safety-oriented research. The human rights argument for access to all data reflects a view of medical research on drug safety as necessitating an ongoing scientific dialogue between regulatory agencies, industry, patient advocacy groups, and independent research organizations, such as the Cochrane Collaboration.”
The authors end the article by stating
“…Considering the serious problems associated with the design, conduct, reporting of industry-controlled clinical research, and the limits of regulatory control, immediate steps have to be taken to safeguard the reliability of this crucial component of evidence-informed healthcare decision-making. Clinical trials registration and results reporting, we have argued, are crucial pillars of health information governance. A meaningful realization of the right to health is only possible if healthcare decisions, both at the individual and at the systems level, are built on well-governed and publicly accountable health information systems.”
This article is quite lengthy and full of information. I merely glossed over most of it and picked out some of the details and quotes that caught my eye. Clearly there are issues with the current approach to medical information and how it is regulated. The authors believe that regulatory bodies have largely failed and civil society needs to step in with independent organizations.