Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, November 16, 2008

Peter Rost's Blog's New Name: Peter Rost for FDA Commissioner

Today I noticed that Peter Rost -- former Pfizer Marketing VP, turned drug industry whistle blower, author, and blogger -- changed the name of his blog (again!) to PETER ROST FOR FDA COMMISSIONER.

It all started when I reported on Pharma marketing Blog that FDA Intern -- Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach! -- announced her endorsement of Peter Rost as president-elect Obama's nominee choice for the new FDA Commissioner (see "FDA Intern Supports Peter Rost for New FDA Commish!").

Peter himself had re-published on his blog a 2004 press release in which Rahm Emanuel -- Obama's new Chief of Staff -- expressed a glowing opinion of Rost (see "Emanuel Statement: Importation Press Conference with Pfizer Vice President Dr. Peter Rost").

Shortly afterward, I decided to start my "Who Should Obama Nominate for FDA Commissioner?" survey (see "Vote for New FDA Commissioner: Let Obama Know"). I picked names of 10 contenders from opinions expressed by various bloggers in the Pharma Blogosphere to include in the survey. Out of respect for FDA Intern, I included Peter Rost in that list. Respondents can also write-in their own choices.

I asked several bloggers to include notices about my survey on their blogs and a few, including Peter, did so.

What surprised me -- and I think Peter as well -- was that Peter became the leading contender very early on and still leads the pack with nearly 100 people voting to date (see "FDA Critics Lead the Pack of Contenders for New FDA Commissioner According to Poll!"). This despite the fact that I endorsed Susan Wood on Pharma Marketing Blog (see "Susan Wood: 'The One to Take the Lead' of the FDA").

At first, Rost did not take himself seriously as a contender for FDA Commissioner. But he also saw the results of mt survey and posted them to his site and the story was picked up by a German newspaper that obviously took all this seriously (see "Germany discusses possibility for Dr. Rost to become new FDA Commissioner").

I also pointed out to Rost that the Obama transition team had a Web site where people could submit their resumes for government jobs in the Obama administration. Peter thanked me for the heads-up and quickly applied.

I also notified the Obama transition team about my survey and suggested they keep up with the results and comments from respondents when I publish them in an upcoming issue of Pharma Marketing News.

Here are the top contenders to date for FDA Commissioner nominee, according to my survey respondents:

  1. Peter Rost - 24.5%
  2. Steven Nissen -- 14.9%
  3. Janet Woodcock -- 12.8%
  4. Susan Wood -- 10.6%
If we look at just respondents from the USA, the results are a bit different:
  1. Steven Nissen -- 17.3%
  2. Peter Rost -- 16.0 %
  3. Janet Woodcock -- 12.0%
  4. Susan Wood -- 12.0%
Of course, now that the ROST FOR FDA COMMISSIONER campaign is in full swing, we can expect even more votes for Rost!

What do you think? Is Rost your choice for FDA Commissioner? Vote now!

Wednesday, November 12, 2008

Who Do You Think Should be the New FDA Commissioner?

Click on the image to take the survey

Thursday, January 10, 2008

CMPI, aka DrugWonks, is a "breeding ground for industry moles"

According to Evelyn Pringle, investigative journalist writing for Counterpunch, the Center for Medicine in the Public Interest (CMPI), which brings us DrugWonks, is virtually run by ex-FDA staffers appointed by the Bush Administration. Here's what she has to say:

On its web site, the Center describes itself as "a non-partisan, non-profit educational charity," and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It's a breeding ground for industry moles preparing to enter "public service" and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA's Associate Commissioner from 2002 to 2004 as serving as the agency's "Chief Messaging Officer."

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: "I know Doug Arbesfeld and he is a guy devoted to advancing the public health."

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

"He is also a guy," Mr Pitts says, "who took a pretty significant pay cut to put in some time in public service."

Some would no doubt argue that it's difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts' sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg's bio also says he used to be Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the "Godfather of Preemption," sits on this "charity's" Advisory Board.

Troy,s bio points out that he "played a principal role in FDA,s generally successful assertion of preemption in selected product liability cases."

This "assertion of preemption" says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product's serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he's switched back to private practice, Mr Troy's CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with "particular focus" on what else - clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called "Patient-Centric and Prospective Medicine," CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, "former Medicare administrator and FDA commissioner, will chair the group."

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration's FDA can find it right in the middle of cyberspace on the CMPI web site.
Also see "Drug Wonks Are PR Wonks".

Friday, September 21, 2007

'Round the Sphere: PDUFA, DTC and Pet Turtles Too!

The Food and Drug Administration Revitalization Act (S.1082) has been approved by Congress (see "Congress Expands FDA's Oversight On Drug Safety") and will soon be signed into law (you can read the entire bill here).

While Ed Silverman over at Pharmalot makes a big deal out the intense lobbying by advertising agencies and broadcasters to make sure the bill had no restrictions on DTC (see "Why Tougher DTC Restrictions Were Killed"), he overlooked the murky-water lobbyists who worked hard to ensure there were also no restrictions on the marketing and sales of pet turtles.

I refer, of course, to Title VII of the bill, which states that the FDA is prohibited from restricting the sale of turtles less than 10.2 centimeters in diameter.

The pet turtle industry feared a "turtle moratorium," however the Pet Turtle Advertising Council of America (PTACA) lobbied hard and long to have Title VII inserted into the bill. It would have been unseemly for turtle farmers, wholesalers, or other commercial retail sellers of pet turtles to do so directly.

For more on that, see "DTC Here to Stay; Pet Turtles Too!" over at Pharma Marketing Blog.

The WSJ Health Blog also covered this story (about the DTC advertisers' lobby, not the pet turtle lobby) -- see "Advertising Allies Turn Tide for Pharma."

PhRMA -- the US drug industry trade association -- was ecstatic about the bill's provision regarding the preview of broadcast TV ads, but was mysteriously silent about the turtles:

"...the legislation will enable FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit such advertisements to the agency before airing them, in accordance with PhRMA's Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs." (See "PhRMA Statement on Congressional Passage of PDUFA".)
NRx, of course, had more pressing news to report: ie, "Getting high on a can of Coke."

Hundreds of people every year are poisoned by pet turtles and we're talking about getting high from Coke?!!! Something's not right.

Finally, Mark Senak over at Eye On FDA, began his post ominously:
"As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all about and what is at stake."
Clearly, Mark is more worried about those poor FDA employees -- whom I calculate will be paid $231,481.48 per year to preview TV DTC ads (see my math here) -- than about those pet turtle owners who might have been denied licking the backs of their reptiles to get high!

Tuesday, July 31, 2007

Avandia Critic "Bitch Slapped" Says Wonker, But Who's the Bitch?

Have you ever been "bitch slapped" or has anyone chortled that "X sure bitch slapped Y", where "Y" was YOU? No?

Then, my blogger friend, you haven't lived and experienced the full wrath of the many Internet bozos out there -- especially the ones lurking over at CafePharma (I kid you guys!).

Enough about me... (HELP! It's summer and I can't focus on important work!)

The latest bozo to use the phrase "bitch slap" is Peter Pitts, chief wanker over at Drug Wonks.

"Okay," says Peter "the good news is a 22-1 Avandia vote, a bitch slap to David Graham, a view of the Steve Nissen spin machine in action, and a reminder that the FDA really does act in best interests of the public health."

That's interesting, because the bad news -- as I point out in my post over at Pharma Marketing Blog -- is that the open discord between FDA's Office of New Drugs (OND), which approved Avandia for sale in the US, and the Office of Surveillance and Epidemiology, which is responsible for monitoring drug safety, demonstrates that the FDA is somewhat dysfunctional and may not be able to act in the best interests of public health (see "FDA's Chang and Eng: Benefit vs. Risk").

But I digress ... back to bitch slapping.

I looked this term up in the Urban Dictionary, which is a social networking site where visitors can vote on definitions.

There seems to be 2 different camps when it comes to the definition of "bitch slap." One camp contends it describes the way a "bitch" would slap someone, as in:

A Bitch Slap is a sharp, openhanded, stinging, yet generally benign slap – similar to being slapped by a bitch. When you “bitch slap” someone, you are slapping him or her like a woman would! Scratching, hair pulling, cursing, and crying generally follow a well-placed bitch slap.

Usage: LaFawnda bitch slapped Rico for talkin bout her bunions.
Another camp contends that it says more about the slappee than the slapper; namely, the slappee deserves no respect:
To open handedley slap someone. Denote disrespect for the person being bitch slapped as they are not worthy of a man sized punch. Suggests the slap was met with little resistance and much whining

Usage: Kieth owed me that $20 for weeks and I had to bitch slap the M.F. to get it back.
I am sure Pitts was implying that Graham was treated like a bitch rather than his critics were acting like bitches.

In either case, is this the sort of derogatory language that a co-founder of Center for Medicine in the Public Interest and Senior Vice President for Health Affairs at Manning, Selvage & Lee should use?

Did I just "bitch slap" (a la variation #2) Pitts?