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AZ Backs Paskman in Bucket of Money Probe

Yesterday I noted that several unanswered questions remained over the role of AZ's Compliance & Ethics Leader in relation to the Bucket of Money newsletter scandal. (New readers start here. Summary: AZ was caught making dubious unjustified marketing comparisons between its cancer drug Arimidex and a rival brand, Femara.)

The main question was, What was the role of Andrea Paskman, the executive responsible for compliance on Arimidex in the production of all this non-compliant marketing and sales material?

AZ pr rep Emily Denney called me up and although she declined to answer the seven specific questions that were circling in my head yesterday, she did, in essence, clear Paskman's name of any association with the fiasco. This is what she said:

"As you know we have not been getting into a lot of detail" on why this whole thing occured because it's a "personnel matter" and therefore "confidential." But, Denney said, "This was an unapproved newsletter, it did not go through the approval system. That speaks for itself [in terms of] its evolution and how it came to be."

And then she reiterated that AZ had done its "full internal probe" and already "taken the appropriate action."

J&J's Dapoxetine ... Not Dead Yet!

Yesterday I published an item that indicated J&J had no luck with dapoxetine, the drug it was developing to cure premature ejaculation. I had been under the impression J&J was still working on it but  the FDA canned it in October 2005. There has been some buzz that such a drug could be the new Viagra (or anti-Viagra, if you like). I also heard from a source who indicated that J&J had closed up its dapoxetine  operations here in the  U.S.

But it turns out that J&J is still pouring money into dapoxetine. This blog says that was the case back in April 06 and a note today from analysts FBR indicates that Pharmaceutical Product Development Inc. is still working on the drug and is expecting milestone payments from J&J:

The company "noted that Johnson & Johnson expects to file dapoxetine for approval in Europe in 2007 and will host an R&D day on June 7, 2007, with new dapoxetine data. Eshelman also noted that Glaxo's Avandia is a different class of drug from Takeda's DPP4 inhibitor and reminded investors of Takeda's industry-leading diabetes franchise in support of the late-stage Phase III trials for the DPP4 inhibitor compound," per FBR.

Indeed, David Norton,J&J's chairman/worldwide commercial operations told the Citigroup Healthcare Conference on May 23 that  "Dapoxetine, we intend to file in Europe by the end of year."

So perhaps dapoxetine was a bit, er, longer lasting than I thought ...

Amid AZ Cancer Cupcake Ban, Questions Swirl Around One Executive

Peter Rost has just posted an extremely interesting internal email from AZ regarding its provision of promotional pink cupcakes to cancer patients (AZ markets the cancer drug Arimidex).

The email—which calls for AZ reps to stop giving cancer patients cupcakes—is interesting because it was written by Andrea Paskman, who Rost describes as "the full-time 'Compliance & Ethics Leader' in the Mid-Atlantic Regional Office where Mike Zubillaga worked." (Full email after the jump.)

Regular readers will remember that Mike Zubillaga was one of two AZ execs fired for encouraging AZ sales staff to improperly compare Arimidex to the rival brand Femara when there's no head-to-head data on such a comparison, and  when AZ had an agreement with the feds to not do exactly that. (New readers start here.)

The emergence of Paskman's name into the public sphere, however, raises some more unanswered questions about the Bucket of Money scandal. In a recent chat with a Group of 7 whistleblower, I learned that Paskman's role has never really been made clear.

I spoke to Paskman briefly just now, and she declined to comment.

These were the questions I had for her:

1. If Paskman is the compliance and ethics officer in Zubillaga's office, did she see the Bucket of Money newsletter that Zubillaga published encouraging wrongful Arimidex/Femara comparisons?

2. If she did see the newsletter, why did she let it be published?

3. If she did not see the newsletter, why not?

4. When AZ conducted its internal probe of Zubillaga's office—which resulted in the sudden departure of AZ’s national sales director/oncology, Scarlett Spring—did Paskman recuse herself from the probe?

5. If not, why not?

6. If Paskman did recuse herself, is that because she had a role in the publication of the newsletter and AZ's wrongful comparisons of these two drugs?

7. If so, what was her role?

I'd love to hear from you, Ms. Paskman. 646 654 5406.

Today's Press Release That Will Be Most Closely Scrutinized by the DOJ

You've kinda got to admire the bald-faced cheek of Pfizer in its press release today regarding its formulary positions with Express Scripts (see the full text after the jump). The company said it had secured spots on Express's lists for Celebrex.

Close readers of this blog will remember that Pfizer's relationship with Express re Celebrex is controversial because it has been under investigation by the Boston US Attorney's office. The allegation is that PFE gave Express a lucrative, over-priced contract to run part of its Gentropin franchese and in return Express kept Celebrex on the formulary.

So it's interesting that Pfizer still feels able to boast about its close relationship with Express.

From today's release: “We are pleased to have renewed our relationship with Pfizer consistent with Express Scripts’ business model of alignment with client and patient interests,” said George Paz, Express Scripts chairman and chief executive officer. “In reaching this agreement, Pfizer has demonstrated a strong commitment to working with payers in a way that benefits all, especially our clients and patients.”

Perhaps that "commitment to working with payers" has been historically a little bit too strong ...

Ooops! J&J's Dapoxetine Was Nixed by the FDA in 2005

Turns out I was wrong about J&J in the race for anti-Viagra. The company announced in 2005 that the FDA was not going to approve the drug. When you're a company of J&J's size, throwing $65 million down the toilet will hardly make a splash.

J&J Has Competition in the Race for the New Anti-Viagra

As Ed at Pharmalot noted recently, Vectura, a drug developer based in the UK, is boasting about a potential breakthrough for treating premature ejaculation, the frustrating sexual dysfunction which supposedly affects 30 per cent of men at some time in their life.

This news will be of interest to folks at J&J, who've been developing an anti-"I'm so sorry, I'm not normally like this" drug for some time. It's called dapoxetine.

The logic behind developing these drugs is obvious: Viagra was a huge success, it proved that men can be persuaded to ask their doctors for cures for even the most embarrasing problems. Thus we should repeat that success with a different but related condition.

Here's my prediction*: These drugs will be a flop. There's a big difference between not being able to perform at all, and being able to perform but not very well. Men will seek treatment for the former, not the latter. Also, ED is associated with age while PE is not. Without a clinical demographic to target, marketing this drug will be tough.

Regardless: Be on the lookout for clinical data inventing, er, or rather supporting, the notion that PE is some sort of clinical condition requiring treatment.

* I am willing to be wrong on this -- and will happily apologize if the evidence warrants it.

AZ Group of 7 Believe OIG Probe of Arimidex Marketing Is Stalled

I just finished having a nice chat with one of the Group of 7 whistleblowers at AZ. He had several updates, including:

1. That this is not the first time that AZ has indulged in an improper promotional campaign in which reps were encouraged to compare Arimidex to Femara even though there was no data supporting such a comparison. An earlier campaign took place in 2000 and 2001 (see download at the end of this post). Internal sales slides show: "During 2000 and 2001 we talked about Femara on 61% of our sales calls." In fact, according to the slides, the company regretted not spending more time talking about the opposition.

Why is this a big deal? AZ's agreement with the OIG not to engage in comparison selling was not enacted until 2003. The Group of 7 believe this is a big deal because even though such an agreement was absent, such comparisons—when there is no data backing them—are still generally frowned upon by the FDA.

"The FDA would say there's no way in hell you can do that," the whistleblower told me. "For 2 years they campaigned off-label and then they turned around and did it again."

2. The OIG has not contacted the group even though "I've offered to give them any information they want" regarding AZ's violations of the corporate intergrity agreement  that the company has signed with the OIG back in 2003.

3. He alleges that the salesforce trainer whose voice is on the roleplay tapes in which Armidex is compared to Femara (even though there is no data comparing the two) is the same AZ exec who hosted a phone conference with AZ sales reps earlier in May in which reps were given guidance on what they can and cannot do to promote Arimidex.

4. He gives "credit" to AZ management for not attempting to find the Group of 7 or retaliate against them. "There has not been a witchhunt...there seems to be an effort to clean this up."

5. He gave me another presentation slide which looks very much like a comparison of Arimedex vs. Letrozole (see second download at the end of this post.)

Bottom line: Now that AZ has fired two execs on this issue, the OIG's credibility is on the line. If it becomes known that the OIG doesn't bother to investigate violations of its own corporate integrity agreements, then there will be no incentive to follow them...and drug compoanies will stop bothering to fire execs who break them.

Download attachment_3_promotional_response.ppt

Download attachment_2_letrozole_arimidex_h2h1.doc

Hello, AZ Group of 7. Lawyers Would Like to Talk to You!

I've not updated the blog in about a week as I was taking a vacation in Spain. When I came back, I found this email in my inbox (full copy after the jump.) It seems that plaintiffs' lawyers would really like to begin building a case against AZ for its marketing of Arimidex (see backstory here).

The email is from a "consultant who "helps to forward leads from pharmaceutical reps specific to unethical/illegal promotional practices. I am able to provide a direct contact at a Washington DC law firm (Robins Kaplan & Miller) that specializes in healthcare fraud.  This firm filed against Lilly for Zyprexa promotions. The contact would provide free legal advice and suggestions."

The consultant is John Turner of jturner2007@charter.net.

What's interesting about this? Soliciting for clients this way could be a violation of the Delaware code of conduct for attorneys (see here).

Also while I was away:

Another AZ exec, Scarlett Spring, lost her job, according to Peter Rost. You first read about Ms. Spring on this blog, here. That brings to two the number of AZ execs who've been canned over this. Credit where it's due, AZ CEO Dave Brennan did say in The Independent that action would be taken if necessary.

Ambien vs. Generic Competition: Not as Bad as It Could Have Been

Wall St analysts Dresdner Kleinwort said "We expect Ambien's share to be decimated within a month,but Ambien CR (controlled-release) held 31% of the Ambien franchise TRX and 18% of the insomnia TRX, mitigating the effect on Sanofi."

Exclusive! David Beckham NOT in Deal With Botox

I'm a soccer fan (we call it football, actually, in the sense that it's a game you play with your feet, unlike "football.") So I was surprised to learn that David Beckham has signed on with Allergan to be the male "face" of Botox.

I was even more surprised to learn this from Lois Paul & Partners, a PR firm that does not represent Allergan. (see full email text after the jump). The email said: "Botox has come a long way since 2005, when the majority of users and potential users online thought of Botox as a danger. Now, Virginia Madsen and David Beckham are official spokespeople."

Uh, what? That would be huge -- and totally bizarre -- drug marketing news!!!

So I hit Google, and while there are plenty of stories suggesting that Bex's preternaturally boyish face comes from his being stabbed in the face with a Botox needle, nowhere does it say he's actually signed on as an endorser.

After that I decided to be a journalist, and call the company. The first rep I reached didn't pick up the phone. The second dissembled on the issue -- "I cannot say he is an official spokesperson" -- which to a journalist sounds like pharma double-speak for "I see you've got the story before we were ready to talk about it. Let me see if I can sew enough doubt in your mind to stop you publishing that." Then the third pr woman forthrightly declared "We don't have a relationship with him. Not at all," and burst out laughing.

So there it is. This is how tabloid rumors start, folks. You read it here first: Beckham does NOT have a deal with Botox!