TV News LIES

Monday, Dec 22nd

Last update06:35:19 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...


Hope for dementia patients: Study suggests lost memories can be restored

Memory loss might be restorableResearchers at UCLA say new science suggests lost memories are restorable, lending hope to the millions...

NY releases planned medical marijuana rules

NY medical marijuanaThe state took another step Thursday toward getting its medical marijuana program up and running, with...

Health study: Half of Dr. Oz's advice is bad

Dr. Oz information flawedThe British Medical Journal examined popular daytime medical talk shows "The Doctors" and "The Dr. Oz...

Ebola kills Sierra Leone's most senior doctor

Ebola kills senior doctorSierra Leone’s most senior doctor has died of Ebola just hours after an experimental drug to...
 
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!