The Whistleblower: Novartis Finally Replies
8 CommentsBy Ed Silverman // July 20th, 2007 // 5:51 pm
Well, it took the drugmaker 24 hours to respond to the whistleblower story, but someone at Novartis finally realized they had to say something. After all, a widely read story with explosive allegations can’t easily be explained by declining to comment, which is all Novartis did when asked about David Olagunju’s tale of manipulated trial data and retaliation.
So a short while ago, Novartis forwarded a statement:
“On May 22, 2007, Novartis was served with a complaint filed in Morristown Superior Court by a former employee whose employment was terminated earlier this year. The complaint alleges improprieties with presentation and statistical analysis of clinical data related to Tasigna. We do not comment on matters of pending litigation, however, we want to emphasize that we are confident in the integrity of our data.
Novartis has proactively shared all information with the FDA, the European Agency for the Evaluation of Medicinal Products and other health care authorities where Tasigna data is currently under review. The integrity of the safety and efficacy data for our medicines is paramount and Novartis has rigorous processes in place to ensure the accuracy of data generated in all of our clinical trials. We believe that Tasigna is an important and potentially life-saving new medicine for patients with chronic myeloid leukemia.
Regarding questions as to whether the recent delay has anything to do with the lawsuit, our response is: No. The FDA extended the goal date by three months to provide time for a full review of amendments to the NDA proactively made by Novartis. These amendments provide new analyses of the longer-term follow-up data of CML patients with nearly a year of Tasigna treatment.”
JS
wow how cool more BS I wonder who wrote that crap
Lisa Van Syckel
They must have taken this from the GSK,LILLY&PFIZER play book. The same was said about the safety and efficacy trials of antidepressants in children.
Ed,
You should ask NOVARTIS if they have have a “Prosecutors Manual” to defend their Psyche drugs.
We know Pfizer & GSK have a Prosecutor’s Manual to defend their Psyche drugs.
John Mack
Ed,
Peter Rost mentioned “his old friend”, David Schwab, “from the Star-Ledger who is now over at the PR department at Novartis” in connection with this response from Novartis.
Could this be the person who wrote this “crap” and responded to you and NOT to Peter?
Is there some conflict of interest story here involving Pharmalot, Newark Start Ledger, and Novartis?
Just thought I’d ask .
John
Ed Silverman
John,
No, let’s the clear the air immediately.
First, the comment came from Sheldon Jones, a former Ciba-Geigy pr person who now works in the Novartis corporate office in New York in communications.
David Schwab, with whom I worked at The Star-Ledger for many years, including several that involved sharing the pharma beat, left the paper last year to join Novartis as an internal communications person. He often fields reporter requests and then, if possible, redirects them to the appropriate pr person. I’ve never quoted him. As far as I know, he’s not assigned to ‘external communications.’
I reached out to him on Thursday afternoon to find the ‘right person’ at Novartis for a response. Late in the day, I received a call from a woman who does pr consulting for the company. I told her what I wanted and she called later to say there was no comment.
Now, about the belated Novartis statement. I knew nothing about it until I received an e-mail late yesterday from Jeff May, who works at The Star-Ledger as a business reporter covering pharma. He wanted to make sure that I was aware of the Novartis statement he received. He received it because he was following up my original Thursday post about the Olagunju lawsuit. I’d not seen it.
Why? Sheldon Jones unfortunately assumed that by sending it to May, I would also see it, that the bases were covered. They weren’t. I wrote Sheldon to complain about that and point out that pr people have to reach out to me/Pharmalot separately and, in this case, he was remiss not to have automatically sent me the statement. He wrote back with a ‘mea culpa’ reply.
Both Peter and I were free, of course, to follow up yesterday and again seek comment. I didn’t do so. I had received, less than 24 hours earlier, a no comment. I assumed that, if Novartis had something to say, they knew how to reach me.
But Novartis is a complicated beast - pr is run out of Basel, then there’s the New York corporate office and finally, there’s the pharma appartus in East Hanover, NJ. This makes it difficult for me to know where to turn, partly because Basel sometimes, I believe, viewed The Star-Ledger as local media. Pharmalot, however, is seen all over the place (and I noticed a great number of Basel readers over the past two days). So maybe now I’m on their radar.
In any event, I don’t know if Peter reached out to David or anyone else at Novartis yesterday to follow up. Did you ask him that? Did you call anyone at Novartis for their take on this? You have my rundown, and I stand by it.
And in the interest of further full disclosure, I’ve known David for many years, as I mentioned, and we sometimes socialized. Also, David, at my urging, wrote a profile of Peter a few years ago when Peter began making waves about reimportation and his story was the first - along with a similar profile the same morning in The Boston Globe. And I sometimes have met with Peter for coffee to discuss his Pfizer litigation, which I’ve sometimes written about; industry topics and, of all things, blogging. However, those have been what I would call working meetings; we don’t socialize. More full disclosure, I live two minutes away from both of them (along with a gazillion other pharma people).
So who will cast the next stone?
ed
John Mack
No stones were cast. More like a heads up. When a former Newark Star-Ledger employee, now Novartis PR person, and Pharmalot are mentioned in the same Peter Rost sentence about a statement from Novartis published on Pharmalot, there needs to be some clarification of roles before we go off speculating in public. I am glad, therefore, that you clarified.
Peter Rost
My comment about the fact that Novartis didn’t respond to me on the Novartis Whistleblower story appears to have started more questions about how the Novartis response to the Star Ledger unfolded, since they did get a response and I didn’t.
It is important to point out that while both Ed Silverman and I sought out David Schwab, formerly of the Star Ledger, since we know him, he is not the one who responds to journalists and no stones should be cast in his direction.
Clearly someone else at Novartis decides who deserves a response and who should be snubbed.
Perhaps also PR firm Ruder Finn has a finger in this decision; they’ve been going crazy reading this Novartis Whistleblower story.
As far as I’m concerned, in a way I take Novartis’ non-response as a compliment. The drug industry clearly is trying to pretend like I don’t exist. That won’t work too well, since Novartis’ non-response made me realize that the right thing to do will be to finally break my own, personal, Novartis Whistleblower story which involves when I met and interviewed with Novartis CEO Daniel Vasella.
It will be called “Does Novartis Hate Whistleblowers?”
Stay tuned for this story on Tuesday.
J Reno
Is someone really looking at the credibility of this whistleblower at Novartis. Common, wake up Novartis attorneys!!! May be you need to make public the reasons you fired this whistleblower.
Ed Silverman
Hi J Reno,
It’s not clear if you know more than you indicated. Beyond suggesting Novartis look at Olagunju’s credibility, which will undoubtedly occur during preparation for a trial, is there anything you know that you can share?
Thanks for stopping by,
ed