72 Pages Posted: 25 May 2010
Date Written: April 1, 2009
Four years ago at the age of 34, I heard the awful words "I'm sorry, but you have breast cancer" coming from my doctor. After the initial shock of the diagnosis wore off, I like many others who have faced life-threatening diseases began to work with a team of physicians to develop an appropriate treatment plan, which included contemplating enrollment in a clinical trial. Quite unexpectedly, my position as an intellectual property professor whose scholarship focuses primarily on information control, my role as a member of my university's Institutional Review Board that oversees studies involving human subjects, and my newly acquired status of "cancer patient" converged. While researching various investigative study options for confronting my own disease, I soon became aware of an unacceptable and unnecessary risk directly shouldered by study participants, but also indirectly borne by patients generally.
Each year approximately 10,000 clinical trials are conducted in the United States, with more than two million individuals enrolling in these studies on an annual basis. Individuals register to take part in such trials for a multiplicity of reasons. Often this includes the hope that they will potentially benefit from the offered treatment if they happen to be in the arm of the trial that receives the therapy under investigation. An additional rationale for most participants, is the belief that the information obtained from the study will contribute to the body of scientific knowledge, ultimately assisting future patients. Participating in a clinical trial is not, however, without risk. While it is impossible to completely eliminate all of the conceivable safety threats associated with enrollment in a clinical trial, patients are routinely exposed to a significant hazard of which they are not only unaware, but even more disturbing, one that is for the most part avoidable.
Historically, results from previous clinical studies have not been required to be made public and the pharmaceutical industry has generally been exceptionally resistant to such disclosure. Drug companies have taken the position that if they are funding the research, the data produced should consequently be deemed their property, protectable through trade secret, contract, and patent law. Additionally, the Food and Drug Administration ("FDA") has generally supported this view and the courts have by and large similarly agreed. Accordingly, only a small fraction of trial outcomes are
eventually made publicly available, usually through publication of articles concerning the study in medical journals.
Keywords: FDA, Food and Drug Administration Modernization Act, "FDAMA", disclosure, data, clinical, clinical trials, FDA, study results, Paxil, Vioxx, cancer, breast cancer, molecular, treatment, treatment plans, patient, disease, cancer patient, public access, information
Suggested Citation: Suggested Citation
Davik, Christine S, Dying to Know: A Demand for Genuine Public Access to Clinical Trial Results Data (April 1, 2009). Mississippi Law Journal, Vol. 78, No. 4, 2009. Available at SSRN: https://ssrn.com/abstract=1615611