BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Takeda Pharmaceutical Co. Ltd. (TKPYY) Consultant Loses Two Whistleblower Suits


11/20/2012 9:23:50 AM

Helen Ge is now 0-for-2. Earlier this month, a federal judge tossed two different whistleblower lawsuits that the former drug safety consultant had filed against Takeda Pharmaceuticals. She alleged the drugmaker misrepresented or altered descripions of adverse events for the Uloric gout treatment and failed to report instances of bladder cancer and congestive heart failure concerning the Actos diabetes pill to the FDA. A former associate medical director at Harvard Clinical Research Institute, Ge was hired as a medical reviewer in the Takeda pharmacovigilance division. As we reported previously, she repeatedly lodged complaints about alleged discrepancies and shortcomings in reporting assorted and sordid adverse events, but was shown the door for her trouble. The separate whisteblower lawsuits were subsequently filed earlier this year. In the lawsuit concerning Uloric, Ge charged that Takeda avoided reporting adverse events, such as bone marrow failure, or that occurred after patients took the pill and one of several other medications. Interactions caused some patients to experience fatal reactions, severe bleeding or renal failure. She also claims Takeda failed to properly amend the labeling to reflect the alleged harm that could be caused by interactions.

Read at Pharmalot

Pharmalot
 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES