The HIV sales force scandal just exploded in Pfizer's face.

Those of you following Question Authority know that I've spent a lot of time on Pfizer's maraviroc scandal and allegations about illegal premarketing and how the FDA suddenly delayed approval of this novel HIV drug for "unknown reasons . . . " in spite of recommendations by an advisory committee to approve the drug.

Ed Silverman over at Pharmalot just followed up with his own Pfizer HIV sales force whistleblower story, complete with e-mail and power point presentation, focusing on Viracept, which is the drug this HIV sales force is actually selling.

This well researched story is a must read and I'm simply reproducing Ed's outstanding work below. I can't wait for his next installment!

At Pfizer, Improper Marketing Is An Infectious Disease; Drugmaker Probes Another AIDS Med

June 26th, 2007 8:58 am By Ed Silverman

Over the past few weeks, Pfizer has had nothing but trouble with its new AIDS drug, maraviroc. The FDA unexpectedly delayed approval and the reasons aren’t clear. Meanwhile, the drugmaker quietly began investigating allegations that its sales team was instructed to promote maraviroc to physicians. This is a big no-no, because the drug still isn’t approved and this would violate a Corporate Integrity Agreement with the feds.

As it turns out, Pfizer is also investigating charges that the same HIV sales force was encouraged to improperly promote Viracept, an aging AIDS drug. Sales reps were given unapproved training and detailing materials (see below). The allegations, which also involve unapproved funding of CME programs, were made by a sales rep who now complains of retaliation. A Pfizer spokesman confirms the investigation is under way, adding that “we take any concerns about any appropriateness of activities involving the company very seriously.”

Why did this happen? A mix of panic and frustration. Pfizer got into the AIDS business in 2000 by acquiring Warner-Lambert, which itself had bought Agouron Pharma and its Viracept, or nelfinivir, a new AIDS med that generated about $420 million in sales in 1998. But Viracept was soon eclipsed by other drugs, such as Kaletra, Sustiva and Reyataz, and by last year, annual sales dwindled. Underscoring the point, Viracept is no longer listed separately in Pfizer financial reports. (Look here for the decline. On the far left, Viracept is the green line that begins at 20 percent and later plummets).

“We call it has-been-avir, not nelfinivir” says the sales rep. “They had to do something. And so we were given all sorts of materials to boost business. You know, a sales rep just doesn’t wake up one morning and say ‘I’ll use these unapproved studies or slides or whatever.’ It has to come from somewhere. And we were told that our performance was based on whether we were able to use that material in the field. But it violates Pfizer’s own policy. That’s why I reported these things.”

Here’s one example. This e-mail was written by a Pfizer professional science liasion, a position more commonly called medical science liasion at other big drugmakers. The note encourages HIV sales reps to show doctors a set of slides entitled ‘Treatment Considerations for HIV Today and Tomorrow.’ But the sales rep points out that the slides disclose a problem.

From: REDACTED

> > Sent: Thursday, November 09, 2006 11:09 AM
> > To: Wilson, Blythe Ashley; Weiss, Lawrence; Wynn, Jeffrey S;
> > Bilawsky, Leslie J; Miller, Vanessa Z; Raymond, James; Fazzina,
> > Douglas; DeRamus, Lisa A; Turner, Edward; Shimp, Christine Lynn
> > Cc: Zaleski, Carolyn
> > Subject: Slides - Today’s HIV Patient
> >
> > New York/New England Team,
> >
> > Attached are the slides that we discussed at the POA. This is an
> > excellent slide deck to present to your providers to provide value,
> > and sell Viracept. This is for your information, and to be shared
> > only with your providers. Please let me know if you have any
> > questions on utilizing these slides in your territory.
> >

POA is plan of action, a scheduled meeting for a sales force to discuss strategy. You can either flip through the slide set or go right to page 19, and there’s a chart that compares Viracept with other protease inhibitors and their affect on lipid levels. However, this is a prospective, observational study, not a head-to-head trial. In other words, it’s an inappropriate comparison.

This would appear to violate Pfizer’s own policy, which is described in The Field Guide, a manual given sales reps: “A comparative claim generally must be backed up by at least two adequate, well-controlled studies in which the drugs were compared head-to-head using comparable dosage regiments or a single, large, well-controlled study.” See pgs. 21 and 22.

The sales rep also alleges the slides and other materials were never approved by the Pfizer Review Committee, a mandatory step. This is the sort of activity that Pfizer is required to report to the HHS Office of Inspector General as part of its CIA, which Pfizer signed as a result of its settlement over improper marketing of Neurontin. “…Our obligations under these settlements include…disclosing activities by Pfizer colleagues that are non-compliant with the health care laws,” according to the drugmaker’s own rules on page 9 in The Field Guide.

The Viracept investigation is occuring at the same time as the maravoric investigation, since the same marketing and sales teams were involved and many of the same sales reps are being questioned. The probe is being handled by the same outside lawyer, Ropes & Gray’s Josh Levy, who spoke with the sales rep who provided this information. The maravoric investigation was first disclosed in April by Peter Rost, who has subsequently posted numerous updates on the way Pfizer has handled the problem.

The slide set was just one of many materials and documents the sales rep tells us were part of a so-called road map designed to make it possible for the HIV sales force to ultimately convince doctors to write Viracept scrips. Internally, this effort was known as ‘promotional mapping,’ which the sales rep says contained various clinical arguments that also came in the form of obscure studies.

“This was a way to put all of these unapproved materials into one place and then train us. But it didn’t just appear – the sales rep didn’t get together one Sunday afternoon by themselves and decide to use these materials. We weren’t renegade reps. We went to a POA and it was represented to us as a way to do business.”

Two notes to Pharmalot viewers:

1 – There will be a few additional installments in coming days.
2 – The sales rep was granted anonymity due to this person’s role as a whistleblower.

Monogram Biosciences stock: Panic selling after news of delayed Pfizer HIV drug

Perhaps the initial panic selling of Monogram Biosciences stock this morning shouldn't be surprising. Monogram manufactures a diagnostic test used to identify HIV patients who would respond to Pfizer Inc's maraviroc drug, which didn't get the expected FDA approval on June 20.

Pfizer risked HIV drug approval "to make it a little harder" for plaintiff's lawyers.

According to the WSJ today, "Pfizer Inc.'s pipeline was dealt a surprise blow last night, when the FDA delayed the approval of one of its most interesting drug prospects, a new type of medicine for HIV."

I first wrote about the internal Pfizer whistleblower who alleged that Pfizer illegally premarketed the HIV drug maraviroc, before FDA approval, on April 30, 2007.

In response to these allegations, Mark Brown, Vice President, Sales, Pfizer Anti-Infective and HIV/AIDS Divisions on May 3, 2007, issued the following statement to Pfizer's sales force:

"The consequences of pre-approval promotion can be significant, and can go beyond disciplinary action for violation of a Company Policy. The FDA has not approved the Maraviroc label. Nor has the FDA finalized its views on an appropriate risk management plan for Maraviroc. Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan, could prompt the FDA to send Pfizer a Regulatory letter or could lead to other legal action."

Clearly Pfizer realized that the whistleblower's allegations were explosive and could impact the FDA approval of maraviroc.

These events constitute an indictment of Pfizer CEO Jeff Kindler's legal strategy:

Back in 2006 Kindler told the Wall Street Journal, "By virtue of being a large company we have a lot of resources. So we can go to war for a long period of time with plaintiffs lawyers if we need to. None of these cases are threatening the financial viability of this enterprise. We have the resources to take them on and we manage them, I think, very effectively. Plaintiffs lawyers are in business like anybody else. They think about how to most quickly and most easily get their rewards from their business. So we're hoping that when a plaintiffs lawyer is thinking about who to go after maybe they'll think Pfizer's going to make it a little harder for me than so-and-so, so maybe I'll go after so-and-so."

Pfizer had the opportunity to handle the maraviroc scandal internally, and to deal fairly with the whistleblower. Instead the company elected to fight and tried to shut down the maraviroc whistleblower, who then turned to the press.

Below is an e-mail from Pfizer HR, confirming Pfizer's initial investigation of the maraviroc affair. Please note that they write that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.”

The fact that they "may" have taken action certainly doesn't give anyone confidence that anything was done. And very clearly, the fact that they wrote "we have concluded our investigation" is something that indicates they didn't try very hard.

If they had tried harder, they wouldn't have been forced to start a new investigation when I started writing about the maraviroc scandal, and wouldn't have been forced to hire the law firm Ropes & Gray. So, it is easy to conclude that this letter is the smoking gun indicating a corporate cover-up:



In response to this letter, on April 10, 2007, the maraviroc whistleblower's attorney wrote a letter to Thomas “T.R.” Kelley, Office of the General Counsel of Pfizer, in which he stated:

"As a result of blowing the whistle on [redacted], [redacted] is now a pariah among upper level management at Pfizer . . . [redacted] also received a letter from Tina Hester of Pfizer Human Resources warning her that the details underlying his complaint must remain confidential. In addition, she wrote that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.” (Emphasis added). Without knowing what action Pfizer may have taken, what level of confidence can [redacted] have that Pfizer has addressed all of its ethical and legal obligations in this matter? Have federal regulators been informed? Has criminal conduct occurred triggering reporting obligations? I suggest that Pfizer’s so-called “Open Door” policy works both ways. However, not only has Pfizer refused to tell [redacted] what action has been taken in response to [redacted] complaint, [redacted] has been issued a threatening gag order. This hints at a concerted cover-up effort."

In response to this letter, Pfizer sent the following reply:



What happened next is that Pfizer used the redacted e-mails in my maraviroc articles to triangulate and capture the whistleblower and then shut down this person's corporate e-mail account.

No retaliation, of course, simply what you do with a whistleblower who reports allegations about illegal marketing.

For Pfizer there is one final question: Was Pfizer CEO Jeff Kindler's legal strategy "to make it a little harder" for plaintiff's lawyers worth risking approval of a new drug?

After all, Pfizer already has admitted that "The consequences of pre-approval promotion can be significant . . . Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan."

So perhaps it would have been a good idea to cooperate with the whistleblower instead of trying to silence her.

Did Pfizer's maraviroc whistleblower delay FDA approval of HIV drug?

The WSJ today penned the headline Pfizer Is Dealt Setback On HIV-Drug Approval.

In the article the WSJ wrote about the new drug maraviroc: "Pfizer Inc.'s pipeline was dealt a surprise blow last night, when the FDA delayed the approval of one of its most interesting drug prospects, a new type of medicine for HIV."

The WSJ also said that "The FDA isn't asking for any more clinical trials."

The FDA apparently couldn't be reached for comment last night.

So did the allegations related to illegal premarketing of maraviroc result in this debacle?

Make up your own mind and read all the maraviroc allegations by Pfizer's internal whistleblower here.

Pfizer Receives Approvable Letter For Maraviroc. Investigation Continues.

Pfizer just announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, as a therapy for HIV patients. Labeling is not yet finalized.

Pfizer did not comment on the ongoing investigation related to unapproved marketing allegations by a sales rep.

You can read that story here.

Pfizer's letters to the maraviroc whistleblower!

Pfizer whistleblower Jane Roe contacted Question Authority in April which resulted in the story "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval".

After the additional articles, "Pfizer sales rep: "PFE tried to find 'naïve doctors' for illegal premarketing of maraviroc!" and "Pfizer's "Delete! Delete!" memo: "Do NOT forward or retain this e-mail . . ." were published, Pfizer hired the eminent Boston law firm Ropes & Gray to investigate the maraviroc scandal and the interrogation of numerous sales reps started.

I was just told that yet another sales rep who met with Josh Levy from Ropes & Gray in New York was "very disturbed to find out all they wanted to know was his involvement in the maraviroc issue and who was in contact with Rost."

Pfizer also used the redacted e-mails reproduced on Question Authority to identify Jane Roe* and haul her in for interrogation.

But before Jane came to Question Authority, she had tried for over a year to address the internal problems at Pfizer. And it didn't help that she'd worked almost a decade for Pfizer with outstanding performance appraisals; after she started to report her concerns her performance rating suddenly went into tailspin. It does appear, however, as if Pfizer took some action; the district manager Jane reported to "left Pfizer" and some senior managers within Pfizer allegedly has told the sales force that Jane "got her fired."

If true, I'm sure they did this just to make sure that Jane got real popular with her colleagues.

Below is an e-mail from Pfizer HR, confirming Pfizer's initial investigation of the maraviroc affair. Please note that they write that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.”

The fact that they "may" have taken action certainly doesn't give anyone confidence that anything was done. And very clearly, the fact that they wrote "we have concluded our investigation" is something that indicates they didn't try very hard.

If they had tried harder, they wouldn't have been forced to start a new investigation when I started writing, and wouldn't have been forced to hire Ropes & Gray. So, it is easy to conclude that this letter is the smoking gun indicating a corporate cover-up.



In response to this letter, on April 10, 2007, Jane Roe's attorney wrote a letter to Thomas “T.R.” Kelley, Office of the General Counsel of Pfizer, in which he stated that, Jane Roe's "continued employment at Pfizer is untenable. I have no doubt that Pfizer fired [name redacted] based upon Jane Roe's complaint about her conduct. This is common knowledge within the company even though Ms. Roe was given assurances of confidentiality."

Jane's lawyer also writes, "As a result of blowing the whistle on [redacted], Ms. Roe is now a pariah among upper level management at Pfizer . . . Ms. Roe also received a letter from Tina Hester of Pfizer Human Resources warning her that the details underlying his complaint must remain confidential. In addition, she wrote that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.” (Emphasis added). Without knowing what action Pfizer may have taken, what level of confidence can Ms. Roe have that Pfizer has addressed all of its ethical and legal obligations in this matter? Have federal regulators been informed? Has criminal conduct occurred triggering reporting obligations? I suggest that Pfizer’s so-called “Open Door” policy works both ways. However, not only has Pfizer refused to tell Ms. Roe what action has been taken in response to his complaint, she has been issued a threatening gag order. This hints at a concerted cover-up effort."

In response to this letter, Pfizer sent the following reply:


So about a week before Jane Roe contacted Question Authority, Pfizer claimed they took "appropriate remedial action," and they were looking into "additional acts of retaliation."

After doing this they apparently decided that the right course of action was to shut down Jane Roe's corporate e-mail account. No retaliation, of course, just what you do with a whistleblower who reports allegations about illegal marketing.

The question then remains, if they took "appropriate remedial action," why did they need to call in the lawyers again when the maraviroc story was published in Question Authority?

*Pseudonym.

Final farewell to Pfizer's maraviroc whistleblower . . .

Pfizer lawyer throws a fit over latest maraviroc whistleblower story

Pfizer's lawyer Joshua Levy from Ropes & Gray (who interrogated the maraviroc whistleblower last week), allegedly called the maraviroc whistleblower's lawyer and left a very caustic message this week.

Apparently Pfizer didn't appreciate my article PFIZER CATCHES MARAVIROC WHISTLEBLOWER.*

So to Joshua and the other Pfizer lawyers; and to the AstraZeneca PR people; and to anyone else featured on this blog, including Indian private detectives:

Please don't get upset. Write and tell me if you disagree with anything on this site and your letter will be published. Or just use the comment section to set the record straight. This is an open forum and we'd all love to hear from you!

This blog contains a mix of investigative reporting, spoofs, and satire.

That's one reason I have a broad TERMS OF USE AGREEMENT AND PRIVACY POLICY and this great and very Important Legal Disclaimer.

That disclaimer contains lots of words, among them this sentence describing Question Authority: "You can expect to encounter generalizations, simplifications, hypothecations, exaggerations, inflations, fabrications, but mostly a lot of truths no one ever had the guts to tell you before. (The last part I wrote, my lawyer made me put in those other words.)"

It also contains this sentence: "This blog is designed to be provocative, confrontational, irreverent, mocking, impertinent, flippant, impudent, bold, enlightening, naughty, mischievous, funny and tongue-in-cheek. If you have no humor or if you are a boring person you are not supposed to read this blog."

So seriously, Joshua, since I have been told that you are using this blog in the internal legal maraviroc investigation, even contradicting witnesses using this blog, perhaps you should show those important statements to the employees you interrogate . . . just a thought.

And to all the corporations out there, don't get upset and don't beat up the whistleblower:

Instead, write Question Authority and tell your version of the story!

We'd love to hear from you. And if you decide not to respond, you can't really complain.

At Question Authority we're always ready to set the record straight.


*Image is used for illustrative purposes only and does not depict anyone named or referred to in this article. It depicts a little boy. Duh.

U.S. Senate reviews Pfizer's maraviroc scandal.

You want proof?

Here it is:

PFIZER CATCHES MARAVIROC WHISTLEBLOWER

Several sources inside Pfizer have informed Question Authority that Pfizer has caught "Jane Roe," the maraviroc whistleblower.

"Once you posted the redacted e-mails it was easy," one source commented. (You can read those e-mails here.)

"Our security people searched millions of e-mails, looking for date and time and certain phrases. We had Jane Roe identified within hours of your article."

"We triangulated her name, and a few days later shut down her e-mail access," another source claims.

According to the second source, last week Jane and some of her colleagues were hauled in front of Pfizer's lawyer from Ropes & Gray, an associate or paralegal from Ropes & Gray, and an in-house Pfizer lawyer and and were interrogated for several hours.

"We left her knowing exactly what we know about her. Now she's is 'marinading.' That's the word we use to break someone. We leave them in limbo until the pressure makes them voluntarily resign, or they have a breakdown."

Apparently, Pfizer had reams and reams of documents and analysis to force Jane Roe to confess that she was the recipient or had written the e-mails that were posted on Question Authority.

Unfortunately for Pfizer, that doesn't prove that Jane is the one who actually forwarded them to me. And there was no other way for Pfizer to find out other than to ask Jane:

After showing all the proof they had, Joshua Levy from Ropes & Gray allegedly confronted Jane asking, "who's been sending material to Rost's site?"

Jane responded, "well it could be anyone, there are many disgruntled employees"

Levy allegedly then said "who? who?"

Jane responded, "maybe it is a composite of people."

Levy said "you still haven't answered me" and Jane responded, "I really can't say for sure. If you have any other questions send them to me."

Levy had one stack with postings from Question Authority, and how those posts corresponded to Jane's emails, a second stack of documents with various unapproved slide presentations, pdf-documents, and clinical studies on maraviroc and Viracept, and a meeting list with times and dates and names of physicians who had been approached.

My source claims they even brought testimony from other reps from around the country, and also from Dennis Pontani, Medical Affairs, Art Rodriquez, Sales Director, and Kelly Fitzgeralds, formerly Assistant Sales director and now District Manager for Boston.

The key objective in this situation (based on my personal experience with Pfizer), is for Pfizer lawyers to try to shoot as many holes as possible in the whistleblower story, and to build a defense against the allegations rather than dig for the truth.

Based on what I've been told, this meeting was no different.

The format was basically to ask questions that were aimed at disputing that any maraviroc pre-marketing meetings ever took place with physicians, or that if they were, that they didn't rise to the level of illegal promotion.

Unfortunately for Pfizer's lawyers, I hear they came back exasperated, since Jane Roe, without notes or anything, gave them the full story, the same way she's told it to me.

One person claimed, "If you hadn't made this public with all those documents, the company could have disavowed knowledge of the exsistence of any of these meetings."

Another HIV sales sales rep who was interrogated claims Joshua S. Levy from Ropes & Gray let it slip that others in sales management were disputing they had any knowledge of any of the allegations by Jane Roe.

Since there are only 43 reps in Pfizer's HIV sales force, it begs the question, if this assertion is true, shouldn't they have known this, and if they didn't know, why not? Have they had a sales force going crazy behind their backs? Or were they just not up to the job of supervising their employees? Or is this a truthful statement in the first place?

Levy was, as expected, not forthcoming with any information at all but it was clear Pfizer sees a problem and wants it fixed.

Among the most explosive allegations made at these meetings with Joshua Levy was that "in a conference call we were were told to delete all maraviroc info off our computers."

Levy allegedly disputed this saying "didn't they say to put it in a folder?"

The reps responded, "no they told us to do that with all the unapproved materials they have been asking us to use."

As expected, a number of Pfizer HIV sales reps are now corresponding with each other about the interrogations they've gone through and speculation is rampant what will happen to sales management in the HIV area.

As for Pfizer, they are sitting tight and have not yet fired Jane Roe.

"We expect FDA approval for maraviroc by June 20 and we'll be launching this baby in July. Until then, everyone has been ordered not to rock the boat."

So, perhaps, Jane Roe is safe in her job for another month.

As for Pfizer, clearly they have a very different approach to whistleblowers than AstraZeneca, who never started a witch hunt.

The whistleblowers at AstraZeneca stated, "We see that the company is making an effort to clean up their act and want to give them a chance to do so. To their credit, there has been no 'witch hunt' to discover our identities or retaliate against us."

Unfortunately, that is not a claim Pfizer can make.



[Identifying information in this article has been changed and certain quotes modified to maintain confidentiality of sources. For legal disclaimer go here. And read all about the maraviroc scandal here.]

Pfizer caught in maraviroc whistleblower's web.

Jane Roe, the maraviroc whistleblower just sent another slide set to me.

She says that, "These slides are or were being used by this physician as a paid speaker for Pfizer HIV. Remember we were not supposed to do any promotion of miraviroc prior to approval. Sales rep in NY were paying him to speak off label to promote an unapproved product... unapproved according to the Pfizer/FDA guidelines, wrong, wrong, wrong...."

Download presentation here.

Here's the tricky part:

Of course a doctor can discuss an unapproved drug with other doctors. Otherwise there wouldn't be any clinical trials. But a doctor paid by a drug company cannot promote or premarket an unapproved drug.

So was this promotion?

One test is if the speaking engagements were arranged by the medical department as part of clinical trial work. Then things would appear OK. But if the speaking engagements were arranged by the sales force, it looks like selling. After all, the job of the sales force is not to do clinical trials, but to sell.

Another indication that this is a paid-for, marketing presentation are the speakers notes, clearly written to guide the presenter(s) on what to say. And, of course, the third party which developed the presentation is one of those "medical eduction firms," check under "properties" in the slide presentation and you'll find out more.

So if what Jane says is true, and we certainly have seen many memos corroborating other parts of her story (here), then this presentation may be troublesome.

Monogram Bioscience investors had early warning.

Many Monogram Bioscience investor were mighty upset when I first revealed the maraviroc allegations on April 30.

That isn't surprising.

While maraviroc is too small to move Pfizer stock, Monogram Bioscience depends on the launch of maraviroc, so they can sell a blood test to determine if a patient falls into the category that should be treated with the Pfizer drug.

Almost a month has now passed with more revelations.

So what has happened with Monogram Bioscience stock?

Well, investors who sold after my first revelation have saved a bundle.

The stock has since experienced heavy selling pressure and dropped sharply on increasing volume.

Investors who didn't sell have so far lost about 20% of their money in less than a month.

Uh-oh.

The market has spoken.

And while a technical chart analysis would indicate that the stock is getting ready for an upside move, no one knows what will be revealed next week.

That's the downside with technical analysis.

Pfizer's "Delete! Delete!" memo: "Do NOT forward or retain this e-mail . . ."

Jane Roe, Pfizer's maraviroc whistleblower has provided a very unusual memo from Pfizer, see below. (For background click here.)

Jane says "The promoting of unapproved or off label material even to the sales reps is strictly forbidden. All training materials for training or distibution are to be regulatory approved. Arthur has sent out a directive for us to delete this information because it was unapproved even though he and the medical liaisons freely distributed it to us."

From: Rodriguez, Arthur (Agouron)
Sent: Thursday, January 04, 2007 2:46 PM
To: Binion, Russell A; Jones, Jackie E; Kerns, Jacqueline M; Krall, Jody; Lee, Jim; Mlambo, Debra; Pulliam, Wayne Anthony; Rascoe, Sharon Y; Smiley, Tracy; Traylor, Rhoyge W; Fitzgerald, Kelly; McCarty, Gene; Mumford, Robert E; Vollmers, Thomas L; Yost, John (La Jolla); Zaleski, Carolyn; Brake, Jeffrey; Ceperley, Mark A; Ebenroth, Joseph; Ferguson, Bettye J; Hopkins, Melanie E; Jaconetta, James; Miller, Adam M; Rossbach, Mareen; Seaver, David S; Snyder, Elizabeth L; 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; McCauley, Nancy; Pieper, Shasta; Raymond, James; Root, Tamara; Shimp, Christine Lynn; Snody, Bonnie J; Soler, Jennifer D; Staver, Kent; Stephenson, Kimberly A; Stinson, Kelly N; Tabraue, Alex; Taylor, Joan; Turner, Edward; Weiss, Lawrence; Williams, Brennetta C; Woll, Joyce M

Subject: Confidential: MARAVIROC Update - CCR5/Disease State Education
Program Launches

Team,

In an effort to keep the field informed of ongoing activities regarding MVC, please be aware of the following campaign which will initiate this month. This is for your information only. Please do not proactively discuss this with your physicians and customers. All educational materials and information will be the sole responsibility of the U.S. marketing team. Our response, if brought up by one of our customers, must be limited to acknowledgement of the program only.

Please Do NOT forward or retain this e-mail. FYI only. Do NOT Detail or discuss with Customers.

Thanks,

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






Clearly, Mr. Art "Delete! Delete!" Rodriguez doesn't realize that about the most stupid thing any corporate manager can do is to send an e-mail to over fifty co-workers and expect that if he writes "Please Do NOT forward or retain this e-mail" they will actually delete that e-mail and not forward it to all their friends, laughing.

He also doesn't seem to understand that to write such a memo is pretty close to corporate suicide, since only a person who THINKS he has something to hide goes on the record ordering document destruction of the e-mail he just wrote . . .

The revelation of this memo comes on the heels of another Pfizer HIV/AIDS division memo from Pfizer Vice President Mark Brown, in which he wrote "First, because Maraviroc has not been approved by the FDA, you must not engage in any form of pre-approval promotion . . . you must advise the questioner that you are not able to respond to the question in light of the pending regulatory application . . . The consequences of pre-approval promotion can be significant, and can go beyond disciplinary action for violation of a Company Policy . . . Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan, could prompt the FDA to send Pfizer a Regulatory letter or could lead to other legal action."

The only problem with THAT memo was that Mark "I told 'em not to do it!" Brown, sent his memo several days AFTER this blog had revealed allegations of illegal premarketing by Pfizer's HIV/AIDS sales force; allegations that were confirmed yesterday in numerous internal Pfizer e-mails republished in my article "Pfizer sales rep: 'PFE tried to find 'naïve doctors' for illegal premarketing of maraviroc!'"

For the entire maraviroc story, click here.

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:

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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.

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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:

--------------------------------------------------------------------------------------

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]

--------------------------------------------------------------------------------------

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]

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------

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]

--------------------------------------------------------------------------------------

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]

--------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------

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.

Pfizer's smoking gun . . .

On April 30 I wrote the post "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval."

It was followed by several additional posts over the next few days. See this.

Then on May 3 something interesting happened inside Pfizer which I haven't told you about yet. A memo was sent out to Pfizer's HIV sale force from a Sales VP.

Here it is; I have highlighted certain portions:

From: Mark Brown
Re: Maraviroc

I am certain that we are all encouraged by last week’s announcement that the FDA’s Antiviral Drugs Advisory Committee voted unanimously (12-0) to recommend the approval of Maraviroc for the treatment of antiretroviral experienced patients with CCR5 tropic HIV-1 infection. Of course, if approved by the FDA, Maraviroc would be the first member of a new class of oral HIV medicines in more than a decade.

We all recognize that the Advisory Committee action may generate a number of questions among practitioners who treat patients infected with HIV. For example, we appreciate that both the novel mechanism of action and the tropism assay will be unfamiliar to many of your healthcare professionals and may prompt inquiries.

Recognizing that you may receive a number of questions, we wanted to take this opportunity to remind you of two critically important points:

First, because Maraviroc has not been approved by the FDA, you must not engage in any form of pre-approval promotion. So, for example, Pfizer issued a press release to the media on April 24th following the Advisory Committee Hearing. You must not distribute or raise that press release or other media material with your customers.

Second, you may receive unsolicited questions about Maraviroc, tropism or the CCR5 class from your customers. In that event, you must advise the questioner that you are not able to respond to the question in light of the pending regulatory application.

Instead, you are to refer the customer to Global Medical Information at 1-800-438-1985. Global Medical Information is in the best position to respond to the inquiry.

The consequences of pre-approval promotion can be significant, and can go beyond disciplinary action for violation of a Company Policy. The FDA has not approved the Maraviroc label. Nor has the FDA finalized its views on an appropriate risk management plan for Maraviroc. Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan, could prompt the FDA to send Pfizer a Regulatory letter or could lead to other legal action.

If you have any questions, please contact either your management team or me at 212-733-8911.

Thank you for your attention to this very important matter.

Mark Brown
Vice President, Sales
Pfizer Anti-Infective and HIV/AIDS Divisions
212-733-8911

This letter, because of the time when it was sent, and the repeated warnings not to discuss maraviroc before FDA-approval, is what some people may call a "smoking gun."

I've seen a few of those in my career. When I joined Pharmacia to manage Genotropin I received a copy of a very unusal memo from my boss. This is what I wrote about that memo in my book, "The Whistleblower:"

The memo stated in bold letters that “Pharmacia does not, may not and will not promote or encourage the usage of our products outside of the approved labeling.”

Anyone who works in pharmaceutical marketing knows that it is illegal to promote a product beyond the FDA-approved labeling or before FDA approval. A company can’t say the drug works for a disease or use which has not been approved by the FDA. Companies that have been caught doing so have paid hundreds of millions of dollars in fines. The question in my mind at that time was simple: Since everyone knew this basic fact of pharmaceutical sales and marketing, why the memo?

Of course, now we know that Pfizer was forced to plead guilty on behalf of Pharmacia for illegal promotion of Genotropin and pay a $35 million fine.

And while Mr. Brown's memo is not an admission of having done anything wrong, the content and the timing indicates that he thinks he suddenly needs a memo which he can wave around, saying he told everyone "pre-approval promotion" is illegal.

I wonder, does Pfizer send such a memo to their sales force EVERY time they are about to launch a new drug?

Or just this time?

If so, why?

This reminds me of a story from my old home country. Parking meter maids collecting the coins in one city were caught putting a portion of the money in their own pockets. This hit the press and the following month parking meter income doubled in all Swedish cities. Doesn't prove anything but sure makes you wonder, doesn't it?

When crooks try to cover up their crimes, that's when they usually shoot themselves in the foot.

Please note that I don't consider Mr. Brown a crook, I just feel the timing of his memo is highly unusual. Finally, don't forget that any company or person is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

Did Pfizer hire Cohn & Wolf to "manage" maraviroc scandal?

Pfizer is having trouble with an internal whistleblower who claims that Pfizer illegally premarketed the HIV/AIDS maraviroc. See this. And now the OIG is getting involved.

In fact, the first link above leads to exactly the kind of data Cohn & Wolfe has been studying recently.

Cohn & Wolfe is a strategic marketing public relations firm dedicated to creating, building and protecting the world’s most prolific brands.

But Cohn & Wolfe is so much more than that. They are also one of the PR firms on record for Pfizer.

HHS Special Agents Take Aim at Pfizer

The Office of the Inspector General (OIG) of the Department of Health and Human Services is clearly taking a sudden interest into Pfizer’s activities.

A week ago I told you about a Pfizer whistleblower who accused the company of using the sales force to illegally market maraviroc, a new AIDS-drug before FDA approval. The OIG soon got involved, see e-mail from an OIG special agent here.

Yesterday that agent spoke with Pfizer’s most recent whistleblower, Jane Roe, for about an hour about the drug maraviroc and the alleged illegal premarketing. Jane claims the agent informed her that OIG has started an investigation, but she also came away with the impression that they were looking into other suspicious areas (more about that below). She says she was told that OIG couldn’t formally interview her on the record, unless she had an attorney which she had to pay for or she’d have to allow a Pfizer attorney to represent her, because she’s still on the company payroll.

I'm not sure if that makes complete sense since they already talked, but that's what she told me.

Jane’s last words to me were “The OIG will not tell me what the nature of the investigation is . . . [all is] very hush-hush. I sense others have either come forward or been contacted by the OIG and if they are former employees [they] can sing like canaries...I smell a grand jury coming, just a guess.”

But maybe Jane isn’t too far off the mark. Clearly HHS agents also have an interest in learning more about how Pfizer has conducted itself in other areas:

In fact, yesterday, quite unannounced, two HHS agents came by. (And, yes, I could prove this if needed, otherwise I wouldn’t dare make these comments . . .)

The first agent only cared about the maraviroc premarketing allegations; the other one was oh, so interested in everything Pfizer and was in particular looking for information about Celebrex and Bextra. I think the fact that I had written the story “FBI investigating Pfizer's Celebrex and Bextra? “ set them off and the second agent was particularly interested in what I’d written about one particular special agent, Beth Ann Irvine. This agent also wanted to know what I knew about “Scanlan.”

I have no idea about anyone or anything called “Scanlan,” but I’ve done some research and there is a group of companies in the healthcare area using that name. This may mean nothing, or maybe more things are going on . . . who knows.

Please note that any target for an investigation is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

FDA and NY State Attorney General Review Pfizer HIV Allegations

My story "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval" has received the attention of both the FDA and the New York State Office of the Attorney General.

How do I know this?

They came by yesterday, reading all they could. Uh-oh.

Below are just a couple of samples.

NYS Office of the Attorney General came from--CafePharma (!)--and a post about my story:



Parklawn Computer Center is a US Government Computer Center for the Federal Food and Drug Administration. Verify here.

Monogram Bioscience stock drops 5%

Early selling in conjunction with the revelation on this site that the Office of Inspector General at the Department of Health and Human Services has contacted the Pfizer HIV whistleblower initially pushed the stock down 5%. Monogram is right now trading about 2% below yesterday's price, when it dropped about 4%, for a total loss in two days of 6%.

During yesterday and today, the stock has gone from a high of $1.97 to a low of $1.76 and is now trading at $1.83.

Also see my original story "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval"



Monogram Bioscience now trades about 6% below the price before the disclosures were made on this blog and 16% below the price 5 days ago.

OIG REQUESTS MEETING WITH PFIZER HIV WHISTLEBLOWER.

The Pfizer whistleblower in my story "Pfizer whistleblower accuses company of using sales force to illegally market new AIDS-drug before FDA approval" has contacted the Office of Inspector General at the Department of Health and Human Services with her concerns about what she alleges is Pfizer's illegal premarketing of the HIV/AIDS drug maraviroc. The Pfizer whistleblower just forwarded the response she received from an agent at the OIG:

I just wanted to send you a quick note to let you know that I have
received your emails. I am still in trial, but I do want to meet with
you in the next week or two. I will contact you (probably later next
week) to set up a time to meet up. If you have any additional
informaiton, feel free to send it along.

Thanks!

Special Agent NAME REDACTED
U.S. Department of Health and Human Services
Office of Inspector General
50 Kennedy Plaza, Suite 750
Providence, RI 02903
Phone: REDACTED
Fax: REDACTED

One reason the OIG is interested in this situation is that Pfizer has been forced to sign not just one, but two corporate integrity agreements (CIA) with this agency (download here), promising to conduct their business in an ethical manner.

Pfizer is obligated to notify the OIG of all "reportable events" within 30 days, such as suspicions of any illegal behavior. If Pfizer would not do this they would be in violation of the terms of the CIA and could receive fines, or, at worst, be excluded from federal health care programs.