The flip side of Wall Street Journal reporter Alicia Mundy’s well-documented and often demonstrated disdain for the FDA (and Janet Woodcock in particular) is her affinity for Sid Wolfe. She writes, “The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.” (“A Wolfe in Regulator's Clothing: Drug Industry Critic Joins the FDA,” Wall Street Journal, January 9, 2009.)
She is specifically referring to Dr. Wolfe’s appointment as a member of the FDA’s Drug Safety & Risk Management Advisory Committee. (His term officially began on August 8th of last year and runs through May 2012.)
The article continues, “Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker. Of the two, the doctor is sleeping more soundly.”
Well, I was interviewed for this article – and I sleep like a baby.
And while my interview wasn’t included in her story, she did mention drugwonks.com and quotes from one of my postings:
“Dr. Wolfe's critics say his judgments are just as one-sided as those he likes to blast. A pro-industry blog, Drugwonks.com, calls him the "general secretary of junk science," citing his group's call for a strong "black box" warning about blindness as a possible result of taking erectile-dysfunction drugs. Drugwonks says that is too rare a side effect for a black box.”
That posting, “The Vision Thing,” appeared on October 24, 2005 and reads as follows:
“Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible). To put this in perspective (something Public Citizen really prefers not to do), during that same period 89 million prescriptions were written just for the little blue pill. In July, FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes — and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode. A prudent move. But that’s not enough for Dr. Wolfe who says that, the FDA has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed. Suggesting that Sidney have his eyes examined would only be a partial diagnosis.”
During my more recent interview with Alicia, I told her my opinion was that Dr. Wolfe’s appointment was a good thing – that, when it comes to FDA advisory committees, all opinions deserve to be heard.
But I guess that, once again, it’s an “all the news that fits my thesis” situation.
She is specifically referring to Dr. Wolfe’s appointment as a member of the FDA’s Drug Safety & Risk Management Advisory Committee. (His term officially began on August 8th of last year and runs through May 2012.)
The article continues, “Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker. Of the two, the doctor is sleeping more soundly.”
Well, I was interviewed for this article – and I sleep like a baby.
And while my interview wasn’t included in her story, she did mention drugwonks.com and quotes from one of my postings:
“Dr. Wolfe's critics say his judgments are just as one-sided as those he likes to blast. A pro-industry blog, Drugwonks.com, calls him the "general secretary of junk science," citing his group's call for a strong "black box" warning about blindness as a possible result of taking erectile-dysfunction drugs. Drugwonks says that is too rare a side effect for a black box.”
That posting, “The Vision Thing,” appeared on October 24, 2005 and reads as follows:
“Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible). To put this in perspective (something Public Citizen really prefers not to do), during that same period 89 million prescriptions were written just for the little blue pill. In July, FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes — and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode. A prudent move. But that’s not enough for Dr. Wolfe who says that, the FDA has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed. Suggesting that Sidney have his eyes examined would only be a partial diagnosis.”
During my more recent interview with Alicia, I told her my opinion was that Dr. Wolfe’s appointment was a good thing – that, when it comes to FDA advisory committees, all opinions deserve to be heard.
But I guess that, once again, it’s an “all the news that fits my thesis” situation.
