Friday, June 14, 2019
5,600+ New Industry Documents Posted in Tobacco, Food and Drug Archives
Tobacco Industry Documents:
3189 new documents added
Drug Industry Documents:
A new set of documents from Paxil litigation demonstrate the ghostwriting of a medical article for a core journal. Includes communication between Sally Laden of the now-shuttered medical communications company, Scientific Therapeutics Information, Inc, (STI), SmithKline Beecham Pharmaceuticals, and Charles Nemeroff (as well as other academics/physicians) in the course of crafting an article for GSK's study 352 (A Double-Blind Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression) earmarked for publication in the American Journal of Psychiatry.
Food Industry Documents:
2634 documents were added to the USRTK Food Industry Collection. This set of documents concern the activities of the International Life Sciences Institute (ILSI), a global organization funded by large multinational food and beverage companies, including Coca-Cola. ILSI was founded in 1978 by Alex Malaspina, a vice president at Coca-Cola. The communications between ILSI and academic researchers at U.S. universities illustrate the network connecting for-profit food and beverage companies with scientific experts who produce research and recommendations affecting government policy and regulation.
New Papers and Publications:
The IDL Bibliography added 5 new papers written using Tobacco and Food Industry Documents.
Monday, July 23, 2018
Pinnacle Hip Replacement Litigation Documents Online
The UCSF Drug Industry Documents Archive (DIDA) is please to announce the Pinnacle Litigation Documents, a new collection of documents from the MDL lawsuit DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation.
From 2002 to 2012, DePuy Orthopaedics, a subsidiary of Johnson & Johnson (J&J), manufactured metal-on-metal (MoM) hip implants sold under the brand name Pinnacle. The lawsuit charged the hip implant was defectively designed and fraudulently marketed and that DePuy failed to warn patients and doctors about the risks of the devices. Prosecutors claimed that DePuy, in an effort to gain and keep a large share of the hip replacement market, rushed the Pinnacle metal-on-metal hip implant to market without ever testing it in humans. Instead, the company used a loophole known as the FDA's 510(k) regulatory pathway. The 510(k) allowed manufacturers to skip clinical trials and test the implants only on mechanical simulators if they could show the implants were 'substantially equivalent' to other devices already in use.
The plaintiffs in the Pinnacle lawsuits experienced high levels of cobalt and metal ion in their systems, a condition called metallosis, due to the wear from the surface of the implant’s femoral head. Ultimately, many of these hip implants failed and had to be replaced. In addition to defective design and health risks, the suit charged DePuy fraudulently marketed the Pinnacle hip replacement system by using a team of 'design surgeons' as a sales force. Called KOLs (key opinion leaders), these surgeons signed off on ghostwritten articles, hosted speaking engagements and large regional sales meetings, and taught other surgeons how to use the Pinnacle system. In return, documents show these design surgeons received millions of dollars in royalties from the sales of the Pinnacle hip replacement system.
Thursday, June 21, 2018
New Tobacco and Drug Industry Documents Posted345 new documents
were added to the Truth Tobacco Industry Documents library today.
New Collection of Cymbalta Litigation Documents
This set of documents comes from the MSJ: Hagan-Brown & Ali v. Eli Lilly and Company; Case No. 1:14-cv-01614-AJT-JFA
The case alleges Lilly omitted important information about the drug’s withdrawal risks in the company’s labeling and marketing materials and therefore consumers were unable to make an informed choice about whether to take Cymbalta.
Thursday, November 16, 2017
22,000+ Confidential Philip Morris Records Released and New Drug Industry Collections23,240 new documents
posted to the UCSF Industry Documents Library today!
2 New Drug Industry Documents collections:
Tuesday, October 03, 2017
Industry Documents Library Bibliography reaches 1000!
The UCSF Industry Documents Library Bibliography
reached its 1000th citation this September 2017. The IDL Bibliography is a running list of papers, publications and posts that utilize our Tobacco Industry, Drug Industry and Chemical Industry Documents as primary source materials. See what others have already written; consult the Bibliography first before delving into any new research project.
Thursday, September 21, 2017
New Celexa and Paxil Documents Posted179 new Drug Industry Documents
were posted today.
- 78 new Celexa documents
- 101 Paxil Litigation, Adult Suicide documents - This new collection of documents comes from Paxil litigation regarding adult suicide. Lawsuits alleged Glaxo SmithKline (GSK) was aware of the high rate of suicidal behavior in adults during clinical trials of Paxil. GSK argued that because the FDA did not mandate GSK warn about the suicidality risk, it could not have warned or disclosed these risks any sooner. GSK argued that Paxil’s FDA-approved label shielded the pharmaceutical company from liability for failing to warn doctors and patients of that elevated suicidal behavior risk, a legal defense called 'preemption.' Read more on our Paxil Litigation Adult Suicide collection page
Friday, September 30, 2016
New Documents Posted238 new documents
have been posted to the Industry Documents Library.