June 30, 2012 — Martin Keller, lead Author of the original published study, retires from Brown University. A Sept, 2012 post by the staff writers at Drug Watch notes:
"Study 329 has never been retracted, however, and its authors did not face sanctions. The universities they represented did not even issue a public acknowledgement of the danger their academics created when they published a fabricated study. Furthermore, the lead author of the study, Martin Keller, was allowed to quietly retire from his academic position at Brown University at the end of June and maintain the title of emeritus professor of psychiatry and human behavior."
July 20, 2012 — Dr. Jureidini requests the Editor of the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) to retract the original 329 study.
2012 — Throughout 2012, the 1boringold man blog of retired psychiatrist and statistician Mickey Nardo, records insights and observations about the growing debate over data integrity and access, describing the efforts of David Healy, Jon Jureidini, Peter Doshi, Tom Jefferon, Peter GØtzsche and others.
Oct 11, 2012 — GlaxoSmithKline announces plans to make data from clinical trials of drugs available to researchers beginning in 2013. Under the new policy, GSK will establish an independent panel of experts to review information requests submitted by researchers, which will be evaluated on scientific merit. The company then will make that data available to scientists on a secure website.
The policy will apply to global clinical trials dating back to 2007, as well as all clinical trials for drugs that have completed the approval process or have been abandoned starting in 2013. Following this announcement questions arise such as who will count as a qualified researcher? and exactly what data will be released?
As Micky Nardo notes Oct 9, 2013 (The Wisdom of the Dixie Chicks): "Having looked at GSK's proposed process for access myself, it gives GSK the choice of releasing the data based on the credentials of the applicant and GSK's opinion of the worthiness of their research proposal. I don't want access to their IPDs to do further research. I want it to check and see if they're cheating again like they've done countless times before."
Oct 26, 2012 — The U.S. Department of Justice brings an action in U.S. District Court to recover damages and civil penalties from GSK under the False Claims Act, and damages and other monetary relief under common law and equity for causing the submission of false of fraudulent claims to federal health care programs. The action was brought on behalf of the Department of Health and Human Services (the FDA is under this) and the Centres for Medicare and Medicaid Services (CMS). The claims relate to 3 drugs: Wellbutrin, Avandia, and Paxil.
Nov 19, 2012 — Dr David Healy posts a brief history and status review on the quest for transparency in drug clinical trials.
Dr Peter GØtzsche takes on the EMA over the issue of access to study reports the weight loss drugs rimonabant and sibutramine.
"The other driving force came from Peter Doshi and Tom Jefferson's efforts to conduct a Cochrane review on Roche's antiviral for influenza - Tamiflu. governments around the world stockpiled billions of dollars worth of this under the impression it saved lives by reducing transmission, kept people out of hospital and got them back to work faster Doshi and Jefferson asked Roche for access to the data - they agreed - but never delivered. The BMJ have picked the issue up as the most clear cut case on which to campaign for data access."
November, 2012 — GSK agrees to pay $US 3 billion to settle the U.S. Department of Justice lawsuit. This is the largest settlement ever.
The settlement includes $1 billion in criminal fines and $2 billion to resolve civil liabilities owed to the federal government and the states, the Justice Department said.
Dec 21, 2012 — Dr Andres Martin, Editor-in-Chief of JAACAP responds to Dr. Jureidini's request for retraction of the 329 study article, claiming that the Editorial Board did an extensive review. He states that there is no basis for retraction or other editorial action.