DTC, Elections, and PhRMA

My post yesterday regarding PhRMA's response to my letter citing a violation of its DTC Guiding Principles by Sepracor (see "PhRMA's Response - PRwise, it Stinks!") generated a few comments.

Laurie Bredenfoerder -- a member of the PHARMA-MKTING Online Discussion Forum -- defended the enigmatic Emily M. Johnson who signed the letter:

"Cut this poor girl some slack! I smell the working of a summer intern who's
been given a pile of old mail to go through and clean up. The people
responsible for managing her had no say at all in her being brought on
board, but they are totally responsible if she screws up. So they are
working feverishly to think of "safe" (HAH!) tasks that suit Emily's lack of
both continuity and specific skills.

"On her end, I would bet that Emily has been given zero direction and only
the rudimentary technical support (since she's an intern). Her workspace,
carved out of the detritus of a busy office, is back in a dark and dusty
corner. No doubt she's given up because everyone around her is too busy to
give her advice. She's probably wishing she'd signed up for Summer term
like her friends did.

"Having been both a summer intern and a person charged with keeping a
patronage-job student busy and out of trouble, I feel for both of them.
Pharma may or may not be everything you say, but either way, Emily had
nothing to do with it."

[To test the theory that Emily is a hapless intern, I called PhRMA and left her a voicemail on her office phone as well as her cell phone (time: 9:06 AM). While we wait for Emily to return my calls, let's look a couple of other comments.]

Mark Senak over at EyeOnFDA had this to say:

"Interestingly, I had a posting on this at www.eyeonfda.com which talked about the response of the organization to DTC. In addition to having no writing paper, they also do not have much of a Web presence. I had trouble discerning on the site who the signatories are, and even more, what complaints have been filed and what action taken."

[Time: 9:45 AM; Emily hasn't called me back yet. I tried the PhRMA media office and left a voicemail for Erin Hubbard - hi Erin! She hasn't returned my call either. I asked the operator if there was anyone else in the office I could speak to. Apparently not. She suggested I give Erin and Emily a few more minutes and call back again to see if she could help me.]

Mark points out another reason why PhRMA needs to pay attention to its public relations regarding DTC -- the upcoming elections!

"DTC marketing is going to be the subject of greater debate in the upcoming election cycle," Senak says, "particularly as legislation is considered to reform the FDA. And while it is true that the PhRMA DTC Guidelines program was announced in August of last year, it only took effect in January 2006 and so far, there does not appear to be much substance that has come from it. Without that substance, repeating surveys about the impact of DTC is only half the message. The other half of the message needs to be that PhRMA has seriously stepped up to the plate to increase compliance and can begin offering the track record that proves that point."

"If PhRMA is going to wage a successful campaign around DTC, it needs to have more of its ducks in a row than a stack of speeches, press releases, guidelines and repeated use of statistics from aging surveys."

Senak, like me, wants PhRMA to be more transparent and accountable in its handling of complaints related to its DTC Guidelines. In particular, Senak would like to "compare the track record of [FDA] Warning Letters vis a vis the role of PhRMA in enforcing its guidelines." This would be an interesting accounting of how well self-regulation works. It obviously does not work any more speedily than gov't regulation by the FDA. I mean, what's faster, a "speeding bullet" (PhRMA) or "Superman" (FDA)?

"bc" -- a PR consultant -- had this to say:

"It's not a surprise to me that PhRMA responded the way they did, it's an obvious attempt to skirt the issue. I mean if Congress is already probing you, do you really want more public attention?

"I believe though that this shows the switch hitter nature of this group. They say transparent, they say unbiased, yet your letter wasn't sent through their proper channels. I find this a kin to their position on CME and the transparent nature of MECC's and required unbiased CME presentation(s) without influence from their client. I mean [come] on, we all know that if your client has asked for CME "they are darn well gonna get it". Will it be slanted to their product? The answer Chuck! Of course it will.

"It's all smoke and mirrors, that's why the public, congress and folks such as Michael Moore are hell bent on exposing what they preceive to be the truth...maybe their truth is our reality??? I don't think so..but if PhRMA is going to let one group break the rules...why not all in DTC or CME? Then what's the point of PhRMA at all? At least with a good PR team they could at least smoke a bit more and find some more mirrors to put up! ;-)"

In response to "bc" I must say that some people like to be "probed." My alter ego, professor John Mack at Harvard, has made a good living analyzing people who have been abducted and presumably probed by aliens (look up "John Mack" on Google for more on this).

As far as I know, Congress is not probing PhRMA itself and PhRMA's role is to meet bad publicity head-on in a pro-active manner, not to "cut and run" away from it and hide.

["bc," maybe you can help me get in touch with someone at PhRMA. It's 10:30 AM and still no return call! I'm getting worried. Is everyone OK over there? Perhaps they've been attacked by a Senator knocking on the door. Let him in for Pete's sake!]

Back to DTC, Elections, and PhRMA
Obviously, PhRMA's got more to worry about than just the Democrats. There's Senator Chuck Grassley (R., IA) probing away at the FDA (see, for example, "Spinning Bad News about FDA & Drug Safety" and "Could Chill Kill CME?") and Senate Majority Leader and 2008 presidential hopeful Bill Frist, (R., Tenn) pounding DTC and calling for a 2-year moratorium (see "Deconstructing Frist on DTC").

[It's 10:28 AM. Neither Erin nor Emily has gotten back to me yet, but Nina Delorenza from the Communications Office did return my call. I indicated that I had a few questions, such as:

1. Emily, what's your official job title? What's your role and position of authority with the Office of "Accountability?"
2. What's next regarding my complaint about Sepracor (see "Sepracor Sneaks In Lunesta Reminder Ad")? When did you forward my complaint to Sepracor anyway? Who did you send it to? Why the long delay?
3. BTW, how many complaints about violations of PhRMA's DTC Guidelines has the Office of "Accountability" received? Is there a list available with actions taken? If not, why not? Can I see it anyway?
4. Come on, is there really an "Office of Accountability?" When are you getting official stationery?
5. How about that Review Panel we've heard so much about? Can I speak to someone on that panel, like Dr. Brown? Do you have the names and contact information for panel members?
6. Most importantly, have you read my blog? Neat, huh? Oh, you haven't seen it :-(. OK, nevermind.

Nina, Emily, Erin. I hope one of them gets back to me soon (Nina promised!). If and when they do, I will let you know what they have to say.]