Novartis CEO Vas Narasimhan on Wednesday defended his company’s decision to wait three months to tell authorities about falsified data submitted to the Food and Drug Administration, saying the company “tried to do the right things” in the process.
He also said Novartis was now “in the process of exiting” a small number of scientists at AveXis, Novartis’s gene therapy business, who were “involved in these data inaccuracies.”
About the Author Reprints
I am appalled at shallow, unfounded, and disrespectful comments. We are reading here about a drug treatment delivered mostly to 2 (two) most vulnerable groups of a global society: New born babies (children) and elder.
I believed scientist and technicians did not deliberately changed data. There is a great responsibility for a corporation to ensure it quality is controlled thus internally and third party auditioned frequently, at all levels of the drug research and development process.
This is not about a group or single scientist that can be incriminated when discrepancies, error and failure occur. There are system, processes, resources human and non- human interaction and before all above corporate strategy, policy, and decision making.
There should be granular traceability, where everything is properly accounted for and performed per FDA guidance best practices.
If that traceability finds a group at fault, then CEO, Narasimhan is in all his rights to act accordingly.
Best wishes for a better formulation or/and results.
This is utter, complete ,untruthful and offensive . information put out to we the people , specifically again .the portion or percentage of people whom are so much in love with hospitals ., doctors . and pain killers . Does any one of us need or require more evidence as to how Empires , act ,behave and conduct themselves . more to come .Trevor Merchant ,Thursday , August . 08, 2019 at 2.59 p.m . daylight savings time . .N. Y .C.
You will ever find black sheeps. Data and Integrity is our passion at Novartis. We deliver medicine because we belive in it and love our job.
Where do i begin . as this statement or defense is absolutely offensive , false . diengenious a fabrication and bare face to the core of indecent language . .As i wrote yesterday , Tuesday , August , 06, 2019 on this original report , issue or subject . One of the Giants Of The Pharmaceutical Empires Well Known and Established in Stone Namely Merck did the very same thing or crime with the then Wonder Drug ,Name Vioxx . that eventually killed Five Hundred Thousands Humans depending on which reports you read . Yes Merck Gave To or Presented To The F.D.A False Information .about Vioxx. What Was Even More Egregious Merck Took Research Studies On Vioxx .Which Showed And Resulted That Vioxx Would Be Killing Humans Rather Than Curing Them . Of Heart Attacks Or Strokes. See The Wall Street Journal?s Investigative Reports On Merck And Vioxx. We are really in trouble of the highest order of crimes . I thank you Trevor .Merchant . Wednesday . August , 07, 2019 at 4.31 p.m .daylight savings time . New York City .
As if a couple of lowly lab scientists decided to fudge the data? LOLOLOLOLOL…. At that company, how to generate phony stats is part of the on-boarding process, and are DEMANDED by the C-suite types! This CEO better get a good criminal lawyer, this time. It’s not the very-forgiving FDA reviewers who are coming for him.
What is your role and background in the pharmacutical business?