Pfizer, Sanofi, Sunovion and Novartis have failed to make publicly accessible the results of six large-scale clinical trials of psychiatric drugs.
In the wake of a series of high profile scandals and court cases, large pharmaceutical companies have tried to rebuild trust with doctors and patients by posting the results of clinical trials onto public trial registries as and when legally required to do so.
However, some companies' transparency commitments fail to extend to older clinical trials. Trials conducted a decade or two ago form the basis of much of today's clinical practice.
According to the Declaration of Helsinki, not making the results of clinical trials public is unethical:
"Researchers 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. (...) Negative and inconclusive as well as positive results must be published or otherwise made publicly available."
TranspariMED contacted Pfizer, Sanofi, Sunovion and Novartis to enquire about the results of six clinical trials of psychiatric drugs that the companies had completed between 2008 and 2011.
The six trials are among the largest-ever clinical trials whose results remain hidden, as identified in a study recently published in the Annals of Internal Medicine. The authors of that study kindly shared their data with TranspariMED for further analysis.
TranspariMED found that:
The results of five trials remain completely invisible to patients, doctors and medical researchers. The benefits and harms detected during these trials are known only to the companies that sponsored them.
The results of the sixth trial are hidden away on a company database. They have not been externally reviewed, and are de facto impossible to find. In consequence, the trial's results were not included in a recently published network meta-analysis of antidepressant drugs because, despite using a sophisticated search strategy, its authors had failed to locate them.
Most medicines taken by patients today were developed over a decade ago, so the results of 'older' clinical trials remain highly relevant to clinical practice.
Erick Turner, one of the authors of the meta-analysis, told TranspariMED that:
“These trials contain data on three widely used antidepressants, so their results should have been made available to meta-analysts, clinicians, and patients. It’s unfortunate that they have been kept secret.”
Mad in America first published elements of this blog under the title "Where Are the Results of These Five Clinical Trials of Antidepressant Drugs?". More information on the six clinical trials and full company responses received can be found in the original article.