Purdue: Block Disclosure Of OxyContin Documents
1 CommentBy Ed Silverman // January 4th, 2012 // 8:32 am
A long-simmering court battle over a trove of OxyContin documents has finally won the attention of Purdue Pharma. The drugmaker is belatedly seeking to intervene in a 2008 lawsuit in a Massachusetts state court, where an attempt is being made to force the state attorney general to release documents that were used to prosecute Purdue and three current and former execs several years ago.
At issue are countless documents that were compiled by the US Department of Justice, which charged Purdue and the execs with misbranding - they facilitated improper use of the drug and misled patients, regulators and doctors about addictive risks. All totaled, $634 million in fines were paid, and the execs were barred from doing business with federal healthcare programs, such as Medicare and Medicaid (see here).
More background: The guilty plea took place in 2007. And at the same time, 26 states also brought consumer fraud charges against Purdue for encouraging doctors to overprescribe OxyContin and, collectively, received a $19.5 million, of which nearly $1 million went to Massachusetts. But in a motion filed late last month, Purdue argues the documents contain confidential and proprietary info, and maintains the state attorney general acknowledged these would be exempt from public disclosure and treated confidentially (read the motion here).
The lawsuit seeking disclosure was brought by David Egilman, a clinical associate professor in the Brown University Department of Family Medicine and a frequent expert witness for attorneys who file product-liability litigation against drugmakers. He played a key role in leaking sealed court documents concerning serious side effects of the Zyprexa antipsychotic to the media, which he undertook because the public was not aware of the extent of the problems, including diabetes and obesity. [Eli Lilly, which sells the pill, paid a $1.4 billion fine to settle civil and criminal charges, while Egilman reached a $100,000 settlement in lieu of civil and criminal penalties.]
As noted previously, Egilman believes the Purdue documents may indicate evidence of FDA and state regulatory incompetence, as well as malfeasance committed by the drugmaker. In a letter to the AG, one of his attorneys wrote that releasing the info “could only inform the general public and create an incentive for other pharmaceutical companies to obey consumer protection laws.”
However, the AG has refused to release the documents, arguing that an exemption permits the office to exercise its discretion, and cites state law that say releasing the documents would not be in the public interest because there is a possibility of prejudicing effective law enforcement (here is the lawsuit, a series of letters and other motions filed in the court and here is a list of documents sought).
Michael
For examples of regulatory incompetence (actually FDA incompetence in accepting flawed clinical trial protocols and result interpretations) regarding studies performed in pursuit of approval of the reformulated version of Purdue’s OxyContin, see the first comment in the comments section on the following web page:
http://www.getpharmacyadvice.com/oxycontin-op-vs-oc/
Or go directly to clinicaltrials.gov and enter “reformulated oxyconin” in the search box to see the actual studies without commentary.