Pfizer hires Ropes & Gray to investigate maraviroc scandal.

According to a source inside Pfizer, the company has hired Ropes & Gray to investigate the maraviroc allegations and maraviroc documents published on Question Authority (here).

Ropes & Gray are in a real rush to interrogate Pfizer's HIV Sales Representatives I'm told, and meetings are being scheduled as you read this.

Ropes & Gray only a few weeks ago wrote a very interesting alert to its pharma clients, click on image to view full size:



And the guy who conducts the investigation is Joshua S. Levy.

He is a litigation partner in the Boston Office of Ropes & Gray.

Levy recently defended a major pharmaceutical company in a wide-ranging criminal investigation into off-label promotion, fraudulent marketing, and pricing practices and he has also defended several other pharmaceutical manufacturers in a number of different criminal and civil proceedings.

He clearly is just what the doctor ordered for Pfizer to get out of the trouble caused by the recent allegations about illegal premarketing of maraviroc.

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'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.

Who reads Question Authority and how much?

I have reviewed the frequently returning visitors over the past week and here are the more well known names:


U.S. Department of Justice, U.S. Senate, U.S. Department of Commerce, FDA, National Institutes of Health, Institute for Defense Analysis, United Nations Office at Geneva, WHO/Uppsala Monitoring Center

New York Times, WSJ, BusinessWeek, Brandweek, Star-Ledger, Tribune Newspapers, Institutional Investor, Knight Ridder Newspapers, Medical Marketing & Media, Congressional Quarterly, Putnam Media

Pfizer, AstraZeneca, Novartis, Merck, BMS, Glaxo, Serono, Boehringer-Ingelheim, Amgen, Sanofi-Aventis, Eli Lilly, Wyeth, Eisai, Takeda, Johnson & Johnson, Biogen, Warner-Chilcott, IMS Health

Epstein Becker & Green, Covington & Burling, Arnold & Porter, Cantor Colburn, Gardner Carton & Dallas, Ropes & Gray, James Hoyer Newcome & Smiljanich, Pepper Hamilton & Sheetz, King & Spalding, Wilmer Cutler Pickering Hale, Hale & Dorr, Boies Schiller & Flexner

KPMG, PWC, Ernst & Young, McKinsey & Co, Morgan Stanley Group, Calvert Group, Taxpayers Against Fraud

Robinson Lerer & Montgomery, Ruder Finn, McCann-Ericsson/Torre Lazur, Ogilvy PR, Young & Rubicam, Grey Advertising, Ogilvy & Mather, WPP Group, D’Arcy Macius Benton & Bowles

All of these government agencies, newspapers, drug companies, law firms, accounting firms, investment firms, management consulting firms, and PR and advertising agencies read Question Authority during the course of their business, probably as part of their jobs, otherwise I wouldn't have captured those names.

So how often do people come here?

Below are the total numbers for the past 6 months, as well as the daily average, which also includes weekends when traffic is much lower. Total annualized page loads start to get close to a million, or more than 60,000 page loads on a monthly basis, equivalent to about 2,200 per day out of which 1,700 are registered as "unique visitors." Individual vistor numbers are inherently unreliable since many visitors from one company will register as one unique visitor from one IP address.

"Is Pfizer’s Pharmacia & Upjohn the Unnamed Growth Hormone Drug Pusher?"

CORPORATE CRIME REPORTER

Is Pfizer’s Pharmacia & Upjohn the Unnamed Growth Hormone Drug Pusher?
21 Corporate Crime Reporter 38, September 28, 2007

Earlier this week, the Justice Department entered into a deferred prosecution agreement with Specialty Distribution Services, Inc., a unit of Express Scripts.

In the agreement, the company admitted that it “knowingly distributed human growth hormone to certain well-known athletes and entertainers, including a well-known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement.”

The company agreed to pay a $10 million fine and cooperate with the government over three years.

But what was the drug?

And who was the supplier?

The government is mum on this.

The deferred prosecution agreement leads with this:

“Whereas, in October 2000, SDS, a wholly owned subsidiary of Express Scripts, Inc., was awarded a contract, by a pharmaceutical company, to distribute that pharmaceutical company's human growth hormone product.”

Peter Rost, a former vice president at Pfizer’s Pharmacia & Upjohn, says he knows who the “pharmaceutical company” is.

It’s Pharmacia.

How does Rost know?

“I was the VP of the whole department at the time,” Rost says. “The person who managed this program worked for me.”

The question now is – why won’t the Justice Department name Pharmacia as the company involved?

Why the big secret?

Covington & Burling partner Ethan Posner, Pharmacia’s attorney, did not return calls seeking comment.

Neither did Ropes & Gray Partner Brien O’Connor, who represents Express Scripts.

Earlier this year, Pfizer’s Pharmacia & Upjohn Company Inc. unit pled guilty to offering a kickback in connection with the sale of its human growth hormone product.

A second Pfizer unit, Pharmacia & Upjohn Company LLC, entered into a deferred prosecution agreement for illegally promoting its human growth hormone drug Genotropin for such off-label uses as anti-aging, cosmetic use and athletic enhancement.

The companies will pay a total of $34.7 million in fines and penalties.

As a result of the plea agreement and the deferred prosecution agreement, Pfizer Inc. was granted a non-prosecution agreement.

In the past several years, human growth hormone has gained popularity with athletes and entertainers as a performance enhancement or “fountain of youth” drug.

Distribution by anyone, including a pharmacy such as SDS, or a physician, is illegal for these purposes under the federal law.

“This summer it seemed that not a week went by without a news report of some athlete receiving or using human growth hormone. It is important for the public to recognize that the use of human growth hormone for athletic or anti-aging purposes is not merely the dirty and increasingly poorly kept secret of the sports and entertainment industries,” said U.S. Attorney Michael Sullivan. “The distribution for these types of uses is illegal according to a specific federal statute. The public should also realize that human growth hormone has not been shown to be safe and effective for athletic, cosmetic or anti-aging uses, and it must not be promoted or distributed for such uses.”

Pfizer law firms getting caught polishing Wikipedia info.

Check out these two stories today:

Ropes & Gray, yet another Pfizer law firm caught changing Wikipedia.

Covington & Burling, a Pfizer law firm, caught cleaning up its reputation on Wikipedia.

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.

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.

Interview with two angry Pfizer spy victims.

I have spoken to two of the victims of Pfizer's spy operation in India, which I described in my article, Pfizer Finance Executive Blows the Whistle – Part Two. They are both very upset, but for completely different reasons.

I first contacted Shreeharsha Vasant Phene (picture left) to get his comments on the fact that Pfizer had sent their detectives to monitor him.

Mr. Phene, at the time Pfizer did this, was a corporate planning vice president of Trent Ltd, which owns supermarkets and retail stores, and belongs to the TATA group (more here).

He became very agitated during my phone call with him and berated me for writing about this story. He wanted to be left alone and had no interest in what Pfizer had done or if they had sent detectives to spy on him, he said.

This was, of course, a highly unusual reaction, since most people would probably be somewhat interested to hear that someone monitors them.

But not Mr. Phene.

He first claimed he knew nothing about me or the Pfizer's detectives, however, later in the call he changed his story and said this was a private matter between him and Pfizer and that he knew I was a "disgruntled employee." It appeared as if someone from Pfizer had already been in contact with him.

He also threatened me and said, "I will take action against you if you continued to write about this story."

I have, quite frankly, never been directly threatend like that before, so I asked, "what action are you planning to take?" After all, we have a free press and free speech in the U.S., just like India.

He responded, "Why should I tell you?"

I presume if I see some person lurching around the house with a sword I should start getting worried.

He was also very upset that I'd been able to find him and call him on his cell phone, and kept asking "Who gave you this number?"

It was very clear that Mr. Phene didn't want anything about him or his dealings with Pfizer India to become known publicly. Perhaps, he was simply very, very afraid about what Pfizer might do to him, just like a victim of the mob would be scared to death to talk

This, of course, made me even more interested in finding out what Mr. Phene was hiding and what he was so unwilling to reveal.

Upon reviewing Pfizer's surveillance report of Phene, I learned that Phene's daughter "Sneha" is reported to be working for "Crawford Bayley." This is interesting, because she provides a direct link to Pfizer India:

Mr. R.A. Shah (left), Pfizer India's Chairman, "is a leading Solicitor and a Senior Partner of M/s. Crawford Bayley and Co., a firm of Advocates & Solicitors." He is not only the Chairman of Pfizer but also "the Chairman/Director of various public limited companies and Chairman/member of Audit Committees." All of this according to Pfizer India's website, here.

So suddenly there is a connection between Phene and Pfizer India, in a most surprising twist to this story. The Chairman of Pfizer India is directly linked to spying on the father of another employee of the esteemed law firm Crawford Bayley!!!

One can only imagine what Pfizer India's reason for doing this would be.

It is also noteworthy that according to another India source, a second Pfizer spy victim, investor Dinesh Vrajlal Lakhani, allegedly "hates R.A. Shah because during merger, R.A. Shah conducted the first legal meeting for the merger, where Lakhani objected and then approached court."

The Telegraph in India wrote an article with the headline:

One-man army turns fly in the ointment for drug majors

May 18, 2003:

"It has all the ingredients of a David versus Goliath story. Dinesh Vrajlal Lakhani (left), a small Mumbai investor, has single-handedly upset plans for a merger between Pfizer and Parke Davis in India.

He feels the swap ratio fixed the deal is loaded against Parke Davis shareholders. Sifting through a sheaf of painstakingly compiled papers he believes will win him a tortuous court battle, Lakhani has managed to throw a spanner in what would have been a routine, hassle-free corporate merger."

And here things get complicated. Pfizer spied on the investors during the time period April-May 2003 when the investors challenged the Pfizer/Warner-Lambert merger in court.

Pfizer hired detectives to monitor Lakhani in April and May 2003, and another investor who oppsed the merger, Janak Mathuradas, in May 2003.

But Pfizer's hired goons set out to spy on Phene first in December 2003 and they also spied on Mr. Pramod Lele, a former Warner-Lambert country manager, in December 2003. It appears as if Pfizer had separate motives for these two spy operations.

I also spoke to Mr. Pramod Lele (left), the former Warner-Lambert country manager of India who was an executive with Pfizer for a short while.

When I called him in his home in Mumbai, he told me he just arrived back from work as the CEO of Hinduja Hospital. He also said he had seen my recent postings about Pfizer India and the detectives Pfizer hired to follow him.

None of that surprised him, he said. He felt there was one word to describe Pfizer - corruption. His own experience was that he'd been promised the job as CEO for Pfizer India after the Warner-Lambert acquisition, however, Pfizer retracted that offer and asked him to resign.

I asked him how he felt when he discovered that Pfizer had hired detectives to follow him, after he'd left Pfizer.

"Disgusted about the whole thing," he replied, and added, "I'm amazed they could stoop down to such a low level."

He didn't know why Pfizer had followed him, but thought it might have something to do with the fight over the Pfizer/Warner-Lambert (Parke-Davis) merger. But the date of the spy operation against Lele, in December 2003, would appear to indicate a different motive.

Perhaps one day Pfizer's auditors, KPMG, will be able to tell us more about Pfizer India's shady dealings with S.V. Phene, Lele and the others.

And next week I will give you a clue to what may have set off Pfizer's spy operation against Mr. Lele.

Link to Pfizer whistleblower stories:

1. Pfizer Finance Executive Blows the Whistle - Part One
2. Pfizer Finance Executive Blows the Whistle – Part Two
3. Pfizer Finance Executive Blows the Whistle – Part Three
4. PFIZER CFO RESIGNS after PFE finance executive blows the whistle
5. Will Pfizer CEO Mr. Kindler also resign?
6. Pfizer sales rep: "PFE tried to find 'naïve doctor...
7. Pfizer's "Delete! Delete!" memo: "Do NOT forward o...
8. Pfizer India Whistleblower Finally Gets His "25 Ye...
9. "Jeff Kindler is going to Pfizer India in June"
10. Pfizer prepares to get rid of maraviroc whistleblo...
11. Mea Culpa by a Pfizer Lawyer
12. The Pfizer Mirapex Whistleblower's amazing story . . .
13. Pfizer hires Ropes & Gray to investigate maraviroc...
14. Pfizer caught in maraviroc whistleblower's web.

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.