Congress Probes FDA Smear Of Steve Nissen
4 CommentsBy Ed Silverman // June 7th, 2007 // 7:01 pm
Do you remember an e-mail sent by an FDA spokesman to several journalists? Entitled “What are St. Steven’s feed made of? Clay, perhaps?â€, Doug Arbesfeld forwarded a critical news story that included an anonymous blog accusing Nissen of playing favorites among drugmakers after his Avandia analysis caused a furor. Nissen accused the FDA of a smear campaign.
Arbesfeld, who previously worked at Johnson & Johnson, now works as a consultant at the agency, denied he was attempting to impugn Nissen’s reputation. For its part, the FDA played dumb: “The content of the e-mail from an FDA consultant was his own words and does not represent an FDA position.â€
Now, three senators and two congressmen are accusing Arbesfeld of “settling old scores,” and want FDA commish Andy von Eschenbach to explain agency policy on conflicts of interest regarding staff hired directly from drugmakers that are regulated by the FDA. Yesterday, Andy testified that Arbesfeld had been formally reprimanded with a letter in his employment file.
And what score might Arbesfeld have been settling?
On April 26, 2005, The New York Times reported quotes from Nissen that were critical of Natrecor, a J&J drug, and noted that Nissen cast the only vote against the med when an FDA advisory panel recommended it in 2001. And which J&J spokesman defended the drug in the article? Yes, Arbesfeld.
“After all the talk of reform by the FDA commissioner, it’s discouraging and alarming to see another situation where you can’t tell the difference between the actions of the FDA and those that might come from a drug maker it’s regulating,†says Sen. Chuck Grassley.
Peter Pitts
I know Doug Arbesfeld and he is a guy devoted to advancing the public health. He is also a guy who took a pretty significant pay cut to put in some time in public service. Are you saying that he is doing anything other than standing up for the FDA? I don’t think so — but it your comments could certainly be construed that way.
Peter Pitts
I know Doug Arbesfeld and he is a guy devoted to advancing the public health. He is also a guy who took a pretty significant pay cut to put in some time in public service. Are you saying that he is doing anything other than standing up for the FDA? I don’t think so — but your comments could certainly be construed that way.
Ed Silverman
Hi Peter,
Actually, I’m just reporting what’s out there. Doug, who I know from his J&J days, didn’t send me his famous e-mail, and I’ve not spoken with him about this situation. So I don’t know his motive for his e-mail, but I didn’t attribute one in my post. I just reported this tidbit that these five elected reps want von Eschenbach to look into this, and what they’re saying.
So I don’t know if Doug was ripping into Steve, or was standing up for the FDA, or simply being silly in an e-mail.
I’m not sure what I wrote that could be construed as any one thing. I didn’t add any commentary to this post. So….shrug. I don’t know how else to answer your question.
But thanks for stopping by. Good to hear from you.
ed
Peter Pitts
Fair enough! Hope you got a “W” at Little League.