University of California, San Francisco.
Drug Industry Document Archives.
The Documents
The documents in DIDA were obtained from a number of court cases as well as investigations headed by US government committees and private interest groups. Click on a specific investigation below to learn more about the case and to access the documents from that case.
 
Investigations
Cochrane Review: neuraminidase inhibitors
In-depth review of clinical study reports (CSRs) for anti-influenza drugs

The documents in this collection are a sample of the documents provided by Roche to a Cochrane review group conducting a systematic review of neuraminidase inhibitors (anti-influenza drugs) including oseltamivir (Tamiflu). The documents were unconditionally released. This Cochrane review is based on full clinical study reports rather than journal articles. Clinical study reports (CSRs) are comprehensive, integrated summaries of trials, typically written according to the ICH E3 guidelines, and submitted by study sponsors to regulatory bodies in support of marketing applications. The detail in CSRs is evident in their length: approximately 100 times the page length of journal publications of trials.

See the New York Times article and the PloS Med article on the Cochrane Group and the importance of CSRs in the understanding of a drug's effects, safety and efficacy.

See all documents related to the Cochrane Review.

The Project on Government Oversight (POGO)
An investigation into ghostwriting in Academia

Using documents obtained from litigation* about Paxil (paroxetine), an antidepressant sold by GlaxoSmithKline (GSK), POGO discovered that the National Institutes of Health (NIH) funds researchers who used ghostwriters to write journal articles and other scientific communications. POGO used this information to ask Francis Collins, NIH Director, to "take a firm stance against ghostwriting both to protect public health and the integrity of NIH funding. We ask that you implement new policies that will require institutions to ban ghostwriting, and to make NIH funding contingent upon periodic certification from institutions that ghostwriting is strictly prohibited and that enforcement mechanisms such as disciplinary action and dismissal are in place." The POGO letter to Dr. Collins, and related documents, can be read here.

See all documents related to the Project on Government Oversight inquiry.

*The lawsuits:
Cunningham v. SmithKline Beecham Corp., U.S. District Court, Northern District of Indiana, Case No. 2:07-CV-174 (2006). Complaint;
Smith v. SmithKline Beecham Corp., Superior Court of California, Orange County, Case No. 04CC00590 (2004);
Bratt v. SmithKline Beecham Corp., United States District Court, Eastern District of California, Case No. 2:06-cv-1063 (2006);
Forst v. SmithKline Beecham Corp., United States District Court, Eastern District of Wisconsin, Case No. 07-CV-612 (2007);
Steinberg v. SmithKline Beecham Corp., Superior Court of California, County of Santa Clara, Case No. 1-04-CV-029096 (2004)

United States Senate Finance Committee - Charles Grassley
Investigation into payments made to physicians

Several studies over the years have shown that researchers who receive money from drug companies are more likely to report positive results from clinical trials. The Senate Finance Committee, spearheaded by Sen. Chuck Grassley (R-Iowa), has been conducting a far reaching investigation into the issues of transparency, conflict of interest and violations of federal research rules by some 30 academic researchers nationwide. In conjunction with this investigation, Grassley is promoting a bill called the Physician Payment Sunshine Act that would require pharmaceutical companies and medical device manufacturers to disclose all payments over $500 made to physicians. Dr. Charles Nemeroff, psychiatry department chair at Emory University, is one of a number of researchers being investigated by the committee. Nemeroff was found to have earned more than $2.8 million in consulting arrangements with various drugmakers between 2000 and 2007, but had failed to report at least one-third of this income to his university. See the New York Times article on the committee's investigation into Nemeroff and Emory University.

See all documents related to the Senate Finance Committee inquiry.



United States Congressional Committee on Government Reform - Henry A. Waxman
Investigation into the marketing of Vioxx to physicians

A select set of documents, obtained from the public records of the Minority Office of the Congressional Committee on Government Reform, which detail the marketing of Vioxx (rofecoxib) to physicians. In his report to the Committee, Representative Waxman concluded, "a review of over 20,000 pages of Merck documents suggests that the company used its sales force of thousands to counter growing evidence of concern over the safety of Vioxx. These efforts involved providing highly questionable information to physicians and pursuing aggressive marketing strategies."

See all documents related to the Government Reform Committee inquiry.

See related resources and articles.



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