FDA Deputy Commissioner Josh Sharfstein to resign, lied about and tried to ban e-cigarettes

[Bill Godshall]

Hopefully, the FDA will now end its prohibitionist campaign against e-cigarettes
FDA Deputy Commissioner Sharfstein to Resign - WSJ.com

 

[Vocalek]

The story makes him look like a hero. I wonder if the State of Maryland realizes that Dr. Sharfstein is perfectly willing to twist the truth to fit a political agenda, regardless of the harm that might befall members of the public.

How many smokers continued lighting up, thinking--because of the press conference orchestrated by Sharfstein--that e-cigarettes were more likely to cause cancer than inhaling real smoke? How many citiizens of foreign countries were not ever given the chance to switch to a safer alternative because their governments banned e-cigarettes, based on the FDA's "safety concerns"?

 

[Petrodus]

I'm a relative Noob in the E-cig political arena...so bear with me

Good News... However, (as Elaine mentioned) a tremendous amount of damage
has already been done... here and around the world. Many countries now
have laws on the books because of the "official" position of the the FDA.

Sharfstein was a "Major Player" in the war against E-cigarettes
but with him gone...How would that effect the FDA's "official" stand against E-cigarettes
or was the "Official" position of the FDA really nothing more than Sharfstein's position against E-cigs?

The FDA (because he's gone) will now....???

 

[Bill Godshall]

Josh Sharfstein's July 22, 2009 press conference misrepresenting the evidence about e-cigarettes is at:
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf

More FDA e-cigarette misinformation is at:
Electronic Cigarettes

 

[cigarbabe]

The story makes him look like a hero. I wonder if the State of Maryland realizes that Dr. Sharfstein is perfectly willing to twist the truth to fit a political agenda, regardless of the harm that might befall members of the public.

How many smokers continued lighting up, thinking--because of the press conference orchestrated by Sharfstein--that e-cigarettes were more likely to cause cancer than inhaling real smoke? How many citiizens of foreign countries were not ever given the chance to switch to a safer alternative because their governments banned e-cigarettes, based on the FDA's "safety concerns"?

Sharfstein really has no concerns for anyone it appears except those with whom he is aligning himself with at the moment.
As evidenced by his fast tracking this device for one; *article courtesy of WSJ and Vocalek*

"Among Dr. Sharfstein's first tasks at the FDA in 2009 was unraveling issues involving the controversial approval of a medical device for knee surgery that had been cleared in late 2008 over the repeated objections of a half-dozen FDA scientists and managers".

I wonder why ecigs are/were such a priority for Sharfstein when there are other
more harmful devices and drugs available to the public.
I'm also curious as to why he is going back to Baltimore now, pressure?
Perhaps it will be easier to ban ecigs in a state rather than a whole country?
I for one certainly hope this isn't the case.
We've had counties trying to implement bans based on the FDA's press release
and not on real facts, how idiotic is that?
C.B.

 

[D103]

This, shortly after the FDA announces its recent "transparency initiative" - interesting coincidence. This wouldn't be a 'strategic move(running away) on Dr. Sharfstein part would it? It will be interesting to see what transpires re: the FDA over the coming months. The FDA is on the list to be "investigated" by Rep. Darrell Issa (R-CA), that should be interesting as well. As far as the FDA's stance and approach towards e-cigs, I would expect nothing to change unless they are pressured/forced by a 'power greater than themselves' if one such exists.

 

[Bill Godshall]

Per D103's comment, the power that exists that is greater than the FDA are the US Courts, which have already ruled against the FDA's attempt to ban e-cigarettes by classifying them as unapproved drug devices.

Although the news media hasn't picked up on this yet, it was Sharfstein who organized the FDA's July 22, 2009 press conference (that was originally scheduled for May 5, but was postponed after I urged the FDA to do so) where he knowingly and intentionally misrepresented the health risks/benefits of e-cigarettes, misrepresented the FDA's own laboratory test to claim the products had toxic chemicals (i.e. diethylene glycol) and carcinogens (even though they were at similar levels to those in NRT), and invited other speakers to falsely claim that (flavored) e-cigarettes were target marketed to children.

I also strongly suspect that Sharfstein has been the leading proponent at FDA to continue appealing ad nauseum the e-cigarette litigation filed by SE/NJOY, which may have been a reason (and perhaps the key reason) for his departure from the agency.

 

[D103]

The "...if one such exists" was of course sarcasm - obviously I recognize the U.S. courts are a higher authority than the FDA, however, the FDA has a nasty history of continuing to act 'contrary' to U.S. court rulings with an air of audacious impunity.

 

[Petrodus]

The "...if one such exists" was of course sarcasm - obviously I recognize the U.S. courts are a higher authority than the FDA, however, the FDA has a nasty history of continuing to act 'contrary' to U.S. court rulings with an air of audacious impunity.

D103 didn't make the news...He's just reporting it
KUDOS

 

[JonnyVapΣ]

"A physician and researcher, Dr. Sharfstein served as an aide to Rep. Henry Waxman (D., Calif.) and was public-health director for the city of Baltimore before joining the FDA."


And I'm Mickey Mouse.

Sorry Maryland....

 

[JohnKing]

This is why he had to go:

Another change that has alarmed the industry is the focus by the FDA on punishing individual executives and corporate lawyers, not just companies, over alleged wrongdoing

Can't be steppin on the white shoe boys..no no, no

Regulators work for the industries they regulate, they'll replace him with someone equally worthless. Not quite a win.

 

[DC2]

The FDA is on the list to be "investigated" by Rep. Darrell Issa (R-CA), that should be interesting as well.

Quoted for emphasis.

I've voted for Darrell Issa every chance I've gotten.
But then, I am a hardcore Republican.

Well, except when I decide that being an independant is the right choice for the future.

But this guy seems to have his heart and mind in the right place.
Or at least that is what I hope to believe.

 

[Petrodus]

The Daily Record (Baltimore, MD) just picked up the story
and posted a little more information

"I recruited Josh and hired Josh to be our health commissioner in Baltimore city, and I'm very delighted that he's willing to leave what is already a very important national position to come back to Maryland and to help us, especially at this time of transition into health care for all" .... O'Malley said

Article: Click Here

 

[wv2win]

Not that I needed any more evidence of this guy's biased and bankrupted position on personal vaporizers and that he could care less about people's health, when I read the following, I new the guy was useless:

A physician and researcher, Dr. Sharfstein served as an aide to Rep. Henry Waxman (D., Calif.) and was public-health director for the city of Baltimore before joining the FDA.

 

[maxx]

Just my opnion....it's a political hissy-fit. He wanted to be boss of the FDA, but ultimately, that plumb went to the Hamburgler. Also, with the Republicans in control of the House now, he probably thought it was best to git' while the gittin' was good. Republican House leaders plan to put the FDA under a microscope for what they call a "broken bureaucracy". I doubt anything he actually did was involved in the decision. It seems purely based on carreer and self-interest.

Anyway.....good riddens and my sympathy to all the Maryland members here.....

 

[Luisa]

I should imagine since his old friend Waxman will lose his chairmanship,Sharfstein will not have as much protection for his behavior concerning ecigs. I should imagine Waxman was also urging him on. These are just my thoughts for what they are worth.

 

[Vocalek]

The story was also in this morning's Washington Post.

I think you have to sign up as a member to read the story, but there is no charge to do so.

FDA's No. 2 leaving to helm Md. health department

 

[kristin]

Interesting that Dr. Siegel - an e-cig supporteer - sees Dr. Sharfstein's resignation as a loss: The Rest of the Story: Tobacco News Analysis and Commentary: In 1,2 Punch, Deputy Director of FDA and Leading Advocate on FDA's Tobacco Products Scientific Advisory Panel Resign

 

[yvilla]

Yeah, but he certainly doesn't characterize that as a loss in re: ecigs. And he couldn't!

For as Bill G. has often pointed out, Sharfstein was the engineer of the infamous summer 2009 FDA press conference that spread so many lies about ecigs to the entire world.

 

[maxx]

Keep in mind that although Michael Siegel is an e-cig supporter, he is foremost an anti-smoker. In that light, I suppose I could see why he feels losing this guy is bad for his primary cause of "public health"...even if bad for the secondary e-cig stance. He may fear that his replacement will not be as willing to take on tobacco companies. Don't get me wrong...I applaud that Siegel supports us, but it's his anti-smoking stance that really fuels his e-cig support, I think. I suppose Bill Godsall is in a similar position....e-cigs as a means to an end...eliminating smoke. But Bill seems to have a better grasp of what this Sharfstein character is all about.

Bill....if I am wrong in this characterization, feel free to correct me. Just making an observation...