Pfizer sales rep: "PFE tried to find 'naïve doctors' for illegal premarketing of maraviroc!"

A Pfizer whistleblower a few weeks ago alleged that Pfizer used the HIV sales force to illegally market maraviroc to doctors before FDA approval.

The illegal conduct allegedly started already in November 2006, when Pfizer was trying to set up “expanded access sites” throughout the country for a maraviroc experience trial.

The whistleblower claimed the sales reps were used as liaisons to help medical affairs enroll new research sites and the sales reps were allegedly asked to promote the “trial,” in which doctors were paid $1200 per patient for one year, along with free drug.

For prior posts click here.

Yesterday, a Pfizer HIV sales rep contacted me with dozens of internal Pfizer e-mails that support the earlier allegations.

The Pfizer sales rep told me, "We were asked to solicit sites for Phase III trials prior to approval specifically for maraviroc. We were asked to solicit small community health centers because they had a lower threshold for following certain protocols that may be inside the larger academic centers . . . meaning Pfizer would be able to control the process and use reps as go betweens."

So in essence when this sales rep claims Pfizer was looking for doctors that "had a lower threshold for following certain protocols" he means Pfizer was looking for "stupid doctors" with little research experience.

Let's see if the documents he provided prove him right, but first some background on how this trial started:

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From: Rodriguez, Arthur (Agouron)
Sent: Friday, October 27, 2006 3:05 PM
To: Adcock, Bryan; Bestler, Michael; Cragar, John B; DeRamus, Lisa A; Evans, Jay; Fazzina, Douglas; Frank, Denise; Glazer, Bruce J; Grice, Karen; Jackson, Kyle A; Larralde, Mark; Lovelady, Johnny F; McCarty, Gene; McCauley, Nancy; Pieper, Shasta; Raymond, James; Root, Tamara; Shimp, Christine Lynn; Snody, Bonnie J; Snyder, Elizabeth L; Soler, Jennifer D; Staver, Kent; Stephenson, Kimberly T; Stinson, Kelly N; Tabraue, Alex; Taylor, Joan; Turner, Edward; Vollmers, Thomas L; Weiss, Lawrence; Williams, Brennetta C; Woll, Joyce M; Yost, John (La Jolla); Zaleski, Carolyn; Brake, Jeffrey; Ceperley, Mark A; Ebenroth, Joseph ; Ferguson, BJ; Hopkins, Melanie E; Jaconetta, James; Miller, Adam M; Rossbach, Mareen; Seaver, Scott
Cc: Brown, Mark (Sales); Meador, Tom; Lamoreaux, Kirk W.; Hornilla III, Lamberto Z; Lumpuy, Marcus; brenda.gleason@m2hcc.com
Subject: Immediate Action Required: siteFOCUS program
Importance: High

HIV Team,

The HIV Field Force has been selected by the NYO to participate in an innovative program called siteFOCUS. This program assists and trains research-naive, community-based physicians to conduct clinical research as part of a Phase III or Phase IV trail. Headquarters has identified a list of potential investigators and would now like to collect some additional information to determine which physicians may be appropriate targets. A Breeze presentation has been prepared to offer you an overview of this unique program and to also outline in more detail the role you will play. As you can imagine, there are some important legal and regulatory issues that you must be aware of before proceeding. Please pay special attention to these instructions.

/snip/

Kind regards,
Art Rodriguez

Art Rodriguez
National Director
Pfizer HIV/AIDS Division
National Sales Office
18500 Von Karman, Suite 600
Irvine, CA 92612
Office: (949) 794-1505
FAX: (949) 794-1509
Voice mail: 81945
Cell: (760) 473-1807

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The memo above was sent out only three days before Pfizer made the following announcement:

Broad Access Program for Patients with Limited Available Treatment Options

NEW YORK - Pfizer announced today that it plans to establish a multi-national Expanded Access Program (EAP) to make the investigational CCR5 antagonist maraviroc, currently in ongoing phase 3 clinical trials, available to HIV/AIDS patients with CCR5-tropic HIV-1 who have limited or no approved treatment options due to resistance or intolerance. Pending regulatory review and approvals of the EAP study protocol, the program will begin enrolling patients in the next few months, with a target to enroll patients from over 30 countries.

More here.

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And here's the next memo telling us about the "naïve doctors":

From: Fitzgerald, Kelly
Sent: Thursday, November 16, 2006 6:20 PM
To: DL-USPFF-SM-HIV-SALES-TSR
Cc: Rodriguez, Arthur (Agouron); Brake, Jeffrey; McCarty, Gene; Mumford, Robert E; Traylor, Rhoyge W; Vollmers, Thomas L; Yost, John (La Jolla); Zaleski, Carolyn
Subject: Site Focus

HIV Sales Team,

As a follow up to all of you who have identified sites/physicians that are interested in clinical trials. Please double check that the mailing and contact information in Orion is correct. Information is beginning to be sent out to some sites and to ensure the interested parties receive the information the correct contact information needs to be in Orion. After you have answered all 8 questions there is no follow up required or expected on your part.

If anyone has additional research naïve sites and/or physicians that are interested please pass that information onto to Pamela Clax directly.

Thanks to everyone for helping move this project forward.

Kelly

Kelly Fitzgerald
National ASD - Pfizer HIV/AIDS
18500 Von Karman, Suite 600
Irvine, CA 92612
VM 800-8331838 Ext 81886
Cell (410) 409-7736
Office (949) 794-1506
Fax (949)794-1509

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THESE TWO e-mails are pretty amazing. So here we have in black and white that Pfizer was looking for "research naïve doctors" WHICH MEANS DOCTORS WHO DIDN'T KNOW MUCH ABOUT RESEARCH!

Why, if Pfizer wanted GOOD research would they want such a thing?

BECAUSE, THEY WEREN'T LOOKING FOR GOOD RESEARCH, THEY JUST WANTED TO GET THE DOCS TO START USING THE DRUG AS PART OF WHAT THE PFIZER SALES REP CLAIMS IS ILLEGAL PREMARKETING!

The Pfizer rep who gave me this also added, "let me state the obvious . . . first they say don't follow up and then make us go out and recruit the docs - these people are nuts . . ."

And here are a whole lotta more e-mails proving just that:

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From: [Sales rep name redacted]
Sent: Wednesday, November 15, 2006 10:04 PM
To: [Doctor Name redacted]edu
Subject: Miraviroc

Hi DR [Redacted],

Our new medical director for miraviroc Dennis Pontani is in [redacted] on Monday [redacted] would you be available to meet briefly? I think his schedule is open right now.

Best Regards,
[Sales rep name redacted]

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From: [Doctor name redacted].edu
Sent: Thursday, November 16, 2006 5:03 PM
To: [Sales rep name redacted]
Subject: Re: maraviroc

[Sale rep name redacted]: we have clinic in the AM. If you want to come by with lunch
(enough for 20 people as we rotate with two other services), we'll be free by 12-12:30... that will get you the fellows and Karen and me! If not you can check with me Tues afternoon as I'm not sure what I'll be doing then.

[Doctor name redacted]

At 08:40 PM 11/15/2006, you wrote:

Hi DR [Name redacted],

Our new medical director for miraviroc Dennis Pontani is in town on Tuesday [redacted] would you be available to meet briefly? I think his schedule is open right now.

Best Regards,
[Sales rep name redacted]

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From: Pontani, Dennis
Sent: Tuesday, November 21, 2006 11:23 PM
To: [Doctor name redacted]
Cc: [Sales rep name redacted]
Subject: RE: Maraviroc EAP Clinical Study

Dr. [Name redacted],

I am the field-based medical director for Pfizer's HIV portfolio, which includes Viracept and soon to be new product, Maraviroc. I was hoping to discuss our EAP program with you on my next visit December 7th but just wanted to provide you with a quick overview.

This EAP is being run as a clinical trial, will enroll up to 6000 patients worldwide and will provide supplemental safety data to the FDA.

Investigators will be paid $1200 for each patient enrolled and also provided with financial support for the IRB process. All screened patients will need a tropism assay (only R5 tropic patients will be included) which will be paid by Pfizer.

If you would like more information and/or can meet on December [redacted] please let me know.

I look forward to working with you in the future,

Best regards,

Dennis Pontani, MS, PhD
Regional Medical Director, HIV Team
Pfizer Inc

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From: Pontani, Dennis
Sent: Tuesday, November 21, 2006 11:40 PM
To: [Doctor name redacted]
Cc: [Sales rep name redacted]
Subject: Visit

[Doctor name redacted],

I just wanted to thank you for the time to discuss Maraviroc and our EAP program. I hope that you will be able to have this trial set up in your institution. Please let me know if there is anything else I can provide.

Best regards,
Dennis

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From: Rodriguez, Arthur (Agouron)
Sent: Wednesday, November 22, 2006 12:31 AM
To: Pontani, Dennis; [Sales rep name redacted]
Cc: Zaleski, Carolyn
Subject: RE:

[Sales rep name redacted]

Thanks for all of your help!

Art Rodriguez
National Director
Pfizer HIV/AIDS Division
National Sales Office
18500 Von Karman, Suite 600
Irvine, CA 92612
Office: (949) 794-1505
FAX: (949) 794-1509
Voice mail: 81945
Cell: (760) 473-1807

_____________________________________________
From: Pontani, Dennis
Sent: Tuesday, November 21, 2006 8:07 PM
To: [Sales rep name redacted]
Cc: Rodriguez, Arthur (Agouron); Zaleski, Carolyn
Subject: RE:

[Sales rep name redacted],

I just wanted to thank you for going above and beyond to set up a great set of introductory appointments with key HIV thought leaders in [redacted] on such short notice. I realize it was your great relationship with these KOLs that made this possible.

Thanks again for the productive appointments,

Dennis

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From: [Doctor name redacted]
Sent: Wednesday, November 29, 2006 12:13 PM
To: [Sales rep name redacted]
Cc: Addison, Geraldine N
Subject: RE: Miraviroc meeting

I will only be here early in the morning, I think I have a 10:30 flight, but would love to meet if we could!

[Doctor name redacted]

-----Original Message-----
From: [Sales rep name redacted]
Sent: Wednesday, November 29, 2006 12:06 PM
To: [Doctor name redacted]
Subject: Miraviroc meeting

Hi DR [Name redacted],

I am traveling with Dennis Pontani the medical director for Miraviroc on Dec [redacted] he would like to see if we could meet briefly about our recent advancements and the expanded access program that will be enrolling soon.

Best Regards,
[Sales rep name redacted]
Senior Therapeutic Sales Representative
Pfizer HIV/AIDS Division

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From: Pontani, Dennis
Sent: Friday, December 08, 2006 1:52 PM
To: [Doctor name redacted]
Cc: [Sales rep name redacted]
Subject: RE: Dinner

[Doctor name redacted],

It was a pleasure meeting you. Its always enjoyable to discuss work and hobbies over a good meal.

Here are the slides that we discussed. I look forward to seeing you in the near future,

Best regards,
Dennis

-----Original Message-----
From: [Doctor name redacted]
Sent: Thursday, December 07, 2006 9:23 PM
To: Pontani, Dennis
Subject: Dinner

HI:
Thanks for a lovely dinner and a fascinating discussion. I look forward to seeing your slides and animation; as well as hopefully sailing [redacted] when it gets warmer.

Thanks again for your time and assistance

Best
[Doctor name redacted]

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From: [Doctor name redacted]
Sent: Wednesday, December 06, 2006 3:57 PM
To: [Sales rep name redacted]
Subject: RE: Miraviroc meeting

I have to cover soemone's clinic Thurs AM an dget my kid that PM, so I only have time between 1:30 and 4 PM. Would that work? I would love to meet this person.

[Doctor name redacted]

________________________________

From: [Sales rep name redacted]
Sent: Wednesday, December 06, 2006 11:22 AM
To: [Doctor name redacted]
Subject: Miraviroc meeting

Hi [Doctor name redacted],

Do you have a few minutes in the afternoon tomorrow to meet with Dennis Pontani/Miraviroc Medical Director?

[Sales rep name redacted]

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In conclusion, there appears to be overwhelming written evidence that Pfizer systematically used the HIV sales force to premarket maraviroc, before FDA approval, to "research naïve doctors."

Meanwhile, I'm told by sources inside Pfizer that an internal legal investigation of this matter has just started and an external law firm is interrogating Pfizer sales representatives.

Not that Pfizer had much choice after all the information I've made public on this matter . . .

The Pfizer sales rep who gave me this concludes with the following comment: "I hope you see the amount of work I did on behalf of Maraviroc . . . all unsolicited."

And that is exactly the problem. Sales reps can't talk about unapproved indications or unapproved drugs unless the doctors ask them first . . . if they do, it is called OFF-LABEL MARKETING.

Stay tuned for more news on this story tomorrow.