From ABCNews:
http://abcnews.go.com/Health/Story?id=5033303&page=1
"Physician and top smoking cessation researcher Dr John Spangler,
director of Tobacco Intervention Programs at the Wake Forest University
School of Medicine in Winston-Salem, N.C says U.S. regulators and
Pfizer brushed aside his concerns a year ago about possibly dangerous
side effects from longer-term use of the stop-smoking drug Chantix."
Found this story through Pharamgossip, BTW. If that concerns anyone, you've been warned and can skip it.
Wouldn't you love to be a director of Tobacco Intervention Programs in a city that inspired the names of two brands of cigarettes? Or did the cigarettes comes first?
From the article:
But last year's relatively small study is thus far the only one to look at safety in patients taking the drug for a year. And Spangler says his biggest concern is how this study is being used.
"I think it reveals that it is easy to put studies in low-level journals and say something just wrong, not true, that has no statistical basis whatsoever or scientific basis whatsoever," he notes. "The authors were making a false claim that was not justified by the data that had been published under the title of long-term safety."
And he says that the lack of response to his concerns by Pfizer and the FDA underscores what could be a hidden public health threat when it comes to drug safety.
"It turned out my only recourse was a letter to the editor in an obscure journal with no press coverage," Spangler says. "It's wrong, because I turned out to be right.
"There needs to be some way for the dissenting voices to be heard and for the FDA to respond much more proactively."
I don't know a lot about Chantix, but I was under the impression that it isn't intended for long term use. Can someone enlighten me?
Jan, I didn't even know there was a 12-step smokers program (I've never been a smoker, but my sister is). I think that's great and probably works for a lot of people, but maybe not everyone. A temporary drug to stop a long-term drug so in the end you're not on either may be the best/only option for some.www. Boneys brainstorm .co.Boney.orgI don't know a lot about Chantix, but I was under the impression that it isn't intended for long term use. Can someone enlighten me?
[QUOTE=Jan Lucinda] I wonder about taking a drug to stop a drug. [/QUOTE]"U.S. Sen. Charles Grassley asked U.S. regulators on Thursday to investigate whether drugmaker GlaxoSmithKline withheld data about a risk of suicide linked to its anxiety disorder drug Paxil.
Grassley, a Republican from Iowa, said in a letter that a British regulatory agency had found Glaxo knew Paxil was associated with a higher risk of suicidal behavior in adolescents as far back as 1998."