TV News LIES

Sunday, Feb 07th

Last update05:20:13 AM GMT

You are here News Health Roche Overlooks 80,000 Adverse Reaction Complaints

Roche Overlooks 80,000 Adverse Reaction Complaints

E-mail Print PDF

Regulators visiting a Roche ($RHHBY) facility in the U.K. found a surprise lurking in the company’s computer system: 80,000 uninvestigated adverse reaction reports from the U.S.  The reports are on a hodgepodge of drugs made by the Swiss company and include more than 15,000 reports of deaths, with some of the notices dating back 5 years.

Given the reputation of the Germans for accuracy in record keeping, it is probably no surprise that the problem appears to lie with Genentech, its U.S. division.

The FDA tells The Wall Street Journal that it is working with the EMA to assess the impact.  In a mea culpa statement provided to Pharmalot, the company acknowledged the colossal oversight, said it understands how the news might worry consumers, and said it was working to address the mistake.  It said some of the reports can be traced to a Genentech “Patient Reimbursement Program in the U.S., which were not sent to the safety department for full evaluation, hence were not reported to the health authorities according to the applicable regulation.”

More...


Most Recent Related Stories...


Johnny Manziel's father: If son doesn't get help, QB 'won't live to see his 24th birthday'

Johnny ManzielJohnny Manziel's family is concerned for his well-being, but the NFL quarterback has twice declined to...

Former NFL quarterback Ken Stabler had brain disease CTE

CTEFormer Oakland Raiders quarterback Ken Stabler, the late NFL MVP and Super Bowl winner who is...

CTE in the NFL: The tragedy of Fred McNeill

CTE in the NFLThe night before Fred McNeill died in November, he was watching "Monday Night Football." The 63-year-old...

WHO declares Zika virus an global public health emergency

WHO declared emergency over Zika virusThe World Health Organization on Monday declared the mosquito-borne Zika virus to be an international public...
 
America's # 1 Enemy
Tee Shirt
& Help Support TvNewsLIES.org!
TVNL Tee Shirt
 
TVNL TOTE BAG
Conserve our Planet
& Help Support TvNewsLIES.org!
 
Get your 9/11 & Media
Deception Dollars
& Help Support TvNewsLIES.org!
 
The Loaded Deck
The First & the Best!
The Media & Bush Admin Exposed!