News from the Drug Industry Documents Archive (DIDA)

Thursday, March 20, 2014

New Clinical Study Reports Posted

A new collection of documents, Cochrane Review: neuraminidase inhibitors, has been added to the Drug Industry Documents Archive (DIDA).  The documents in this collection are a sampling of  clinical study reports (CSRs) provided by the company Roche to a Cochrane review group conducting a systematic review of neuraminidase inhibitors (anti-influenza drugs) including oseltamivir (Tamiflu). These CSRs are comprehensive, integrated summaries of trials 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.

For more information see the full description under "Investigations" at Cochrane Review: neuraminidase inhibitors 

Thursday, October 3, 2013

Symposium on Institutional Corruption and Big Pharma


The Fall 2013 issue of The Journal of Law, Medicine & Ethics is devoted to a special topic: Institutional Corruption and the Pharmaceutical Industry. 

In this symposium issue, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. The authors show that Big Pharma's funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy and that certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations.


Special issue: SYMPOSIUM: Institutional corruption and the pharmaceutical industry.(2013). The Journal of Law, Medicine & Ethics, 41(3). 


Thursday, April 25, 2013

New "Hemophiliac Case" Collection


New collection added today:

Factor VIII or IX Concentrate Blood Products – 58 documents dealing with the marketing and distribution of contaminated AHF (anti-hemophiliac factor) blood products.

A little background: Bayer and its Cutter Laboratories manufactured AHF (anti-hemophiliac factor), a blood product used by hemophiliacs to treat uncontrolled bleeding. In the late 1960s the corporation began manufacturing AHF using pools of blood (plasma) from thousands of donors, often recruited from populations at high risk for hepatitis. In the early 1980s Cutter Laboratories realized that its AHF was contaminated with HIV but its financial investment in the product was considered too high to destroy the inventory. Cutter continued to sell the contaminated AHF to markets willing to accept it, including overseas markets in Asia and Latin America, without the recommended precaution of heat treating the product to eliminate the risk. Customers were not informed of the risk and as a consequence, hemophiliacs who infused the HIV-contaminated AHF tested positive for HIV and developed AIDS.

These documents are from class action litigation against Bayer from both US and Taiwanese plaintiffs. While "the hemo case" involved HIV-infected hemophiliacs in the United States and abroad, these documents focus on the marketing and distribution of contaminated blood products in Asia, the so-called "dumping" aspect of the larger body of cases litigated.
See all "hemo" documents

In addition to the new collection, we have also added documents to our Neurontin Marketing and Sales Practices Litigation collection, a collection of documents on the misrepresentation of Neurontin’s effectiveness.  These 3 new documents are industry conducted research reports of double blind placebo controlled studies to determine the efficacy and safety of Neurontin (gabapentin) for use in migraines.  Please note: These are very lengthy documents (4000+ pages) and may take a while to download.
See the Neurontin Research Reports


Thursday, July 26, 2012

Documents Related to the Recently Settled $3B GSK Suit

In July, 2012, GlaxoSmithKline pled guilty to off-label marketing of Paxil and Wellbutrin as well as failing to report on studies of the safety of the diabetes drug, Avandia.  They were fined a record $3 billion.
(http://www.npr.org/2012/07/02/156118688/drug-maker-glaxosmithkline-fined-record-3-billion)

Interested in learning more about this case?


The Project on Government Oversight (POGO) Collection on DIDA contains hundreds of internal documents related to the investigation of ghostwriting which involved GSK - http://dida.library.ucsf.edu/investigations.jsp

Within that collection, check out the documents related to Study "329" (the GSK study on Paxil and Adolescent Depression) which figures prominently in the Justice Department's complaint against GSK.

Monday, August 1, 2011

Fake drug studies as marketing tools

A number of sources last month have exposed the pharmaceutical industry marketing tactic known as “seeding trials”. The purpose of a seeding trial is not to advance research but to make doctors familiar with a new drug by inviting them to take part in a research study and paying them for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.

  • Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial: Narrative Account of a Gabapentin Seeding Trial
    Samuel Drumholz; David Egilman; Joseph Ross
    Archives of Internal Medicine 2011;171(12):1100-1107. doi:10.1001/archinternmed.2011.241

  • Useless Studies, Real Harm
    Carl Elliott, NY Times. July 29, 2011, page A27

Thursday, June 23, 2011

DIDA adds Paxil documents

We're pleased to announce the addition of 296 documents obtained by the Project on Government Oversight (POGO) from litigation about Paxil (paroxetine), an antidepressant manufactured by GlaxoSmithKline. POGO investigators found that NIH continues to fund academic researchers who use ghostwriters to write journal articles and other scientific communications.

POGO asked NIH to "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 documents can be found here. And more information about the POGO investigation can be found here.

Thursday, June 16, 2011

Medical Students Exposure to Drug Industry Marketing

PLoS Medicine article "Medical Students' Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review" delves into medical student exposure to the pharmaceutical industry during their schooling and how this affects their attitudes towards the drug industry's marketing practices. Finds "undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism about negative implications of these interactions."