Say the words ‘Continuing Medical Education’ these days and anyone who pays attention to the pharmaceutical industry knows trouble is coming. CME lies at the delicate intersection where drugmakers, doctors and money all meet, which explains why so many politicians, consumer advocates and academics complain about corruption. The issue haunts drugmakers even as they scramble for ways to educate docs about their meds.

Right now, Pfizer is battling such a ghost. As detailed on this site earlier this week, the drugmaker is conducting an internal investigation of its HIV marketing division, which allegedly encouraged sales reps to promote one drug, maraviroc, even though it’s not yet been approved by the FDA. Sales reps were also implored to peddle an aging AIDS pill, Viracept, using detailing and training materials that were never okayed by an internal review committee.

But there’s more. The same sales rep who told us about the internal firestorm surrounding promotional materials says that CME funds for Viracept speakers were sometimes distributed improperly. Like the other practices being investigated, this would run contrary to Pfizer’s policies and a Corporate Integrity Agreement with the HHS Office of Inspector General over improper marketing of another drug, Neurontin, several years ago.

“What happened with CME was troubling. Institutions - university medical centers, for example - were being deceived because they thought they were getting speakers who would speak neutrally about a topic. Instead, they would get a commercial talk designed to help sell one of our products. And internally, the paperwork and payments to the speaker weren’t handled according to Pfizer rules,” says the sales rep. “It was a symptom of a division willing to do anything to get business.”

At issue here is the difference between CME unrestricted educational grants, which don’t allow Pfizer to influence a speaker’s presentation, and what’s known as a peer-to-peer lecture, which is typically commercially oriented and can involve promoting Pfizer product. And so speaker payments are supposed to come from separate Pfizer pots of money in order to avoid running afoul of the Corporate Integrity Agreement.

Originally, Pfizer arranged for a doc to speak at Boston Medical Center through a CME educational grant, but the sales rep alleges that the classification was later changed, unbeknownst to BMC, to a peer-to-peer lecture by another Pfizer employee after the grant was unexpectedly denied. This meant Pfizer grant money was no longer officially available. But how was the doctor paid?

The sales rep alleges that the other employee was able to tap other funds, although the source of the funds isn’t clear. Nonetheless, this ensured a desired speaker would lecture at an important institution, but the reclassification and the use of alternate funds would appear to contradict Pfizer policy.

The company’s Field Guide, a compendium of compliance policies, contains a chapter on grants and has strict rules for arranging for speaking presentations. Please see page 29. You can also look at page M4 of the Health Compliance Manual; the intro was written by Pfizer ceo Jeff Kindler when he was still general counsel. And there’s also a Q&A following his letter that states “Pfizer’s financial support for an educational program (or enduring materials) must always be disclosed by the sponsor on its program materials and/or verbally at the program. Failure to disclose Pfizer’s financial support violates both Pfizer Policy and ACCME guidelines.”

Once the unrestricted educational grant was denied, the issue should have died, the sales rep alleges, adding that arranging for a new lecture with the same speaker at the same institution would have required entering into a new process from scratch. And that’s why this is being probed. In fact, the sales rep says Pfizer is auditing its HIV speaker program.

To illustrate this tale, we will show you a trail of e-mails between the following cast of characters: a sales rep; a professional medical liasion (known as a medical liasion at other drugmakers); a regional sales manager, and a medical education grants coordinator - all from Pfizer. Two employees from Boston Medical Center and one from Cardinal Health, which arranges peer-to-peer lectures, also appear briefly in the messages. The topic: lining up a speaker, obtaining the grant, and paying the speaker.

Why are we relying on e-mails, though? With help from the sales rep who has knowledge of these activies, these provide a road map of how CME funds, in this one instance, were handled. This first e-mail is from a Pfizer regional sales manager who urges the sales team to use a particular doctor, SM, as often as possible. This is not a suggestion; it is a directive. And so there was pressure to make sure SM was lined up as a speaker as often as possible, the sales rep says.

SM is a cardiologist in Connecticut who spoke often for Pfizer about the lipid affects of HIV drugs, including Viracept. We should note that SM hasn’t been accused of doing anything inappropriate and isn’t believed to be a subject of Pfizer’s probe. SM told Pharmalot that he doesn’t recall how payment was made for the lecture.

This first e-mail is from a Pfizer regional sales manager who urges the sales team and liasions to use a particular doctor, SM, as often as possible. This is not a suggestion; it is a directive.

______________________________________________
> > From: FEDACTED
> > Sent: Friday, October 14, 2005 4:45 PM
> > To: O’Keeffe, Dennis F; Stewart, Richard (Agouron); Deramus, Lisa;
> > Snyder, Elizabeth L; Fazzina, Douglas; Glazer, Bruce; Weiss, Lawrence;
> > Raymond, James; Turner, Edward
> > Subject: SM
> >
> > I met with REDACTED earlier this week and he has found out that Dr.
> > SM, a cardiologist from New Haven, is not available to provide presentations concerning CV risk of ARV therapy until after January 1st of 2006. He is completely booked until that time. Dr.
> > SM’s presentation provides a very positive supportive message on the use of Viracept as part of a viable and safe component of HAART
> > therapy. I would like to see this speaker utilized in each of the
> > territories during the current sales year. Please look at your
> > territory strategically and decide where this type of speaker could
> > best be put to use and provide me with two tentative dates and
> > locations where you would like to use Dr. SM in either a dinner
> > program or roundtable type venue. Send your information to REDACTED and CC me, so that we can work to get him lined up for you as soon as possible.
> >
> > Thanks
> >
> > REDACTED
> >

This next e-mail is from a sales rep to an administrative assistant at Boston Medical Center, which sought an unrestricted educational grant to pay for SM’s presentation. The Pfizer rep made a point of asking the BMC employee to note on the paperwork that Pfizer will not influence the speech.

—–Original Message—–
> From: REDACTED
> Sent: Thursday, November 17, 2005 10:38 AM
> To: Seekins, Heidi
> Subject: RE: grant for Jan 5
>
>
> Here is a copy of his cv his topic will be on
>cardio vascular risks and HIV in the Hart era. His honorarium is 2000.00
>he will be having a car service from CT so I would think 500. for travel
>expenses will do the job put the rest for cme related expenses fliers
>admin etc. I would try to be specific as possible this may not come out
>exact but all the money needs to be accounted for in the budget. The
>food will be done separately. Please make sure you say no Pfizer
>involvement with content and this program is open to any providers in
>and out of BMC. I hope this helps

This next e-mail from the BMC employee verifies that Pfizer will not influence SM’s lecture.

>
From: Seekins, Heidi [mailto:Heidi.Seekins@bmc.org]
>Sent: Friday, December 02, 2005 12:50 PM
>To: REDACTED
>Subject: RE: Jan 5 grant
>
>
>>This email is to confirm that Pfizer will not control the content of Dr. SM’s January 5 Clinical AIDS Lecture at Boston Medical Center.
>Please let me know if you need anything else.
>Best Wishes!
>Heidi Seekins
>—————————————————————
>Heidi E. Seekins
>Administrative Assistant
>Section of Infectious Diseases
>Center for HIV/AIDS Care and Research
>650 Albany St, EBRC 640
>Tel: (617) 414-3520
>Fax: (617) 414-5218
>heidi.seekins@bmc.org

This note is from a Pfizer employee who coordinates disbursement of educational grants. She writes the Pfizer sales rep that the BMC grant was denied.

From: Rice, Laurie
Sent: Wednesday, December 21, 2005 7:16 PM
To: REDACTED
Cc: REDACTED
Subject: Grant: Boston Medical Center Corp 1-5-06
I regret to inform you the grant you submitted has been denied by the Medical Education Grant Team (MEG). The reason given is that clarification documents were not received in ample enough time for the committee to review.
Please remember, HQ has given the Medical Education Grant Team (MEG) criteria. I am just the deliverer of the denial. We may have supported these types of educational components in the past, however, HQ has established their own guidelines, and we have no control over these decisions.
This denial does not limit the institution from submitting other future grants.
Thanks,
Laurie
Laurie Rice
BETSy Coordinator - Specialty Markets
Pfizer Inc
Irvine Sales Office
Phone: 949.794.1535
Fax: 949.794.1537

The next day, a Pfizer employee who works with the sales force writes the sales rep.>

From: REDACTED
>Sent: Thursday, December 22, 2005 6:57 AM
>To: REDACTED
>Subject: RE:
>
>
>I will take care of this…you understand…Thanks for letting me know.
>
>

The sales rep writes back saying thanks, but no thanks.

From: REDACTED
>Sent: Thursday, December 22, 2005 7:14 AM
>To: REDACTED
>Subject: RE:
>
>
>I think we had plenty of time but you can’t do a thing about it.
>
>Thanks again

The other employee, however, is very persistent and plans to call the person who coordinates peer-to-peer review speaking engagements in their region.

>From: REDACTED
>Sent: Thursday, December 22, 2005 9:22 AM
>To: REDACTED
>Subject: RE:
>
>
>I am in the airport this morning and I am going to call Kate Sullivan
>before I leave…just help me out on one thing…it’s the morning
>program that the grant was initially for correct?
>

The next day, the problem is suddenly solved.

From: REDACTED
>Sent: Friday, December 23, 2005 12:34 PM
>To: REDACTED
>Subject: FW: PRF received. Sent on Behalf of Kate Sullivan
>
>
>Just to let you know it is taken care of.
>

This e-mail is from Cardinal Health, which coordinates certain peer-to-peer programs. SM will speak at BMC, although BMC isn’t made aware that the lecture is no longer considered a CME unrestricted educational grant. That meant the speaker could openly discuss issues advantageous to Pfizer’s Viracept. And it’s not what BMC bargained for initially.

>—–Original Message—–
>From: Ryszewski, Kim [mailto:Kim.Ryszewski@pvt.cardinal.com]
>Sent: Friday, December 23, 2005 9:16 AM
>To: REDACTED
>Subject: PRF received. Sent on Behalf of Kate Sullivan
>
>
>I have received your program request for your . Your Meeting ID number is:
>20230759. Please use this number as a reference when you contact me with
>questions about your program. That will help me to be able to pull up your
>information quickly.
>
>Following are the details that you provided in your program request form
>(PRF):
>
>Program Date(s) Thursday, January 05, 2006
>Program Times 08:00 AM
>Speaker SM, MD
>Venue Boston Medical Center One Boston Medical Center Place Boston, MA
>
>
>If there are any changes to the information detailed above, please notify
>me
>at your earliest convenience. I look forward to working with you to make
>this program a success.
>
>If you have any questions or concerns, please contact me at (800) 800-4637
>x54550.
>
>Thank you,
>Kate Sullivan
>Kim Ryszewski | Program Coordinator | CardinalHealth
>Voice: (800) 800-4637, ext. 54526 | Fax: (313) 885-3834 |
>Kim.Ryszewski@cardinal.com

And finally, this last e-mail is an invitation from Boston University’s BMC to the Jan. 5, 2006. Note that the institution indicates the lecture is being funded by an unrestricted educational grant from Pfizer, indicating BMC is unaware that the funding source for the event was changed, and the lecture could take a different direction. Also, please note docs can receive CME credits for attending.

>From: Jon Fuller [mailto:jfuller@bu.edu]
>Sent: Tuesday, January 03, 2006 11:17 AM
>To: (A LONG LIST OF DOCS….REDACTED DUE TO LENGTH)

>Subject: CHACR AIDS Lectures for January 2006
>
>
>
>BMC Center for HIV/AIDS Care and Research Lecture Series for January, 2006
>
>Thursday, January 5
>
>Update on Cardiovascular Risks of HIV Infection
>
>SM, MD, FACC
> Associate Clinical Professor of Medicine, Yale University
>School
>of Medicine, Division of Cardiology
>
>Supported by an unrestricted educational grant from Pfizer
>
>Lunch provided by Pfizer
>
> The BMC Center for HIV/AIDS Care and Research Lecture Series is held from
>12:00 - 1:00 pm in the Evans
>Seminar Room, next to the Department of Medicine Office, first floor,
>Evans
>Building (next to the Evans B elevators).
>
>Boston University School of Medicine is accredited by the Accreditation
>Council for Continuing Medical Education to provide continuing medical
>education for physicians. Boston University School of Medicine
>designates this educational activity on an hour-for-hour basis in category
>1
>credit toward the AMA Physician’s Recognition Award. Each physician should
>claim only those hours of credit that he/she actually
>spent in the educational activity.
>
>For questions or to be added to the electronic mailing list for this
>conference series contact Jon Fuller (jfuller@bu.edu)