Thursday, May 31, 2007
AstraZeneca will NOT fire Compliance & Ethics Leader
Andrea Paskman, AstraZeneca's Compliance & Ethics Leader, has been closely associated with the ZubeAffair, since she would normally have reviewed the offending newsletter that got regional sales director Mike Zubillaga fired, which was followed by the resignation of Zubillaga's boss, Scarlett Spring who will leave AstraZeneca today. Paskman also appears to have been involed in the subsequent investigation.Brandweek has been closely monitoring Paskman's role in this process and today revealed that Paskman will remain with AstraZeneca, although AstraZenca now refuses to answer even basic questions, sticking to their mantra, that they've already "taken the appropriate action."
Too bad that doesn't make the blog world stop writing about this story the way the regular press politely backs off when a company with a big advertising budget tells them there is no more story to tell.
PharmaGiles walks on water!
I got almost scared when I read this post. I mean, I thought I had written the whole thing, only that must've been in my dreams because I did not. I'm not PharmaGiles. I have no idea how he could write exactly what I was about to write but never did.Here's a few samples:
"So I don’t think that I have an “unfavourable bias towards the industry” at all. I love it. It’s just that there’s a difference between the way that I love the industry and the way some of its cheerleaders do. I love the pharmaceutical industry in a grown-up way. I want it do well and I want it to do good. I despair when its leaders run it off the rails and into the mud, in much the same way as a parent despairs when a much-loved son or daughter starts “hanging out with the wrong crowd”."
"Pharma cheerleaders and their “Astroturf” blogs (the artificial ones with corporate backing, rather than genuine “grass-roots”) seem to love the industry in a different way. They appear to love it in the same completely uncritical way that a four year old loves their Mommy. Mommy provides security and comfort. Everything Mommy does is therefore wonderful and anyone who criticises Mommy must therefore be bad. Or, as they prefer to say, a disgruntled loser."
Pfizer faces criminal charges and $2 billion fine . . . and what do you think happened to the whistleblower?
Nigeria has brought criminal charges against Pfizer for the company's alleged role in the deaths of children who received an unapproved drug called Trovan during a meningitis epidemic. Authorities filed eight charges, including "criminal conspiracy" and "voluntarily causing grievous harm."
They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer. More in Washington Post.
And what do you think happened to the internal Pfizer whistleblower who tried to stop the whole thing?
You got that one right: Pfizer fired his ass.
Read the original story from year 2000 in this article in the Washington Post:
"One Pfizer child disease specialist, Juan Walterspiel, complained that the experiment was too risky – oral Trovan had never been tested on a child, he later alleged in a lawsuit. The suit ultimately was dismissed at the request of the physician and Pfizer; neither side would comment on the litigation for this article."
So, Pfizer settled with Walterspiel.
They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer. More in Washington Post.
And what do you think happened to the internal Pfizer whistleblower who tried to stop the whole thing?
You got that one right: Pfizer fired his ass.
Read the original story from year 2000 in this article in the Washington Post:
"One Pfizer child disease specialist, Juan Walterspiel, complained that the experiment was too risky – oral Trovan had never been tested on a child, he later alleged in a lawsuit. The suit ultimately was dismissed at the request of the physician and Pfizer; neither side would comment on the litigation for this article."
So, Pfizer settled with Walterspiel.
Tomorrow: Interview with two angry Pfizer spy victims
Don't miss tomorrow's explosive interview with two of Pfizer's spy victims in India.What they say will surprise you.
More about Pfizer's finance scandal and how Pfizer hired detectives to spy on a former executive and others, 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.
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.
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.
Wednesday, May 30, 2007
PharmaFraud Blog is Under Construction
The new blog in its opening statement says:"PharmaFraud Blog is Under Construction
When this site goes live the Pharma Industry will long for the days when Peter Rost was their biggest worry."
Is "Question Authority with Dr. Peter Rost" spawning copies?
Sounds like it.
Pfizer Admits Finance Scandal Investigation in India
As for the content of this letter, personally I'm ROFL.
Only a lawyer could have written such a letter to Mr. Idnani, the poor whistleblower in India:
"We would like to inform you that our investigation has been concluded. Based upon the information provided, an investigation was opened, the appropriate parties were contacted, and the matter was reviewed and handled accordingly."
I consulted an expert in corporate legalese and this is his translation:
"WE'RE WETTING OUR PANTS BECAUSE WE'RE SO SCARED YOU FOUND OUT ABOUT OUR DIRTY LITTLE SECRETS IN INDIA. WHEN WE HAVE FINALIZED OUR INTERNAL COVER-UP WE'LL FIRE YOUR SORRY ASS TO ERADICATE ANY CORPORATE MEMORY OF THIS EVENT."
Six months after this memo was sent, in August 2006, the whistleblower, Pfizer Deputy Finance Manager Mr. Ashok Idnani, was fired. Pfizer refused to even pay him vaction pay owed until 2007, and also refused to give him his 25 year anniversary faithful service medal until Pfizer's treatment of Mr. Idnani was revealed on Question Authority.
Pfizer's public accounting firm - KPMG - reviews Pfizer India finance scandal
Pfizer's Board of Directors, upon the recommendation of its Audit Committee, ratified the selection of KPMG LLP as Pfizer's independent registered public accounting firm for 2007.
Why should this interest you?
Because no firm, except Pfizer, has been more interested in the following stories than KPMG:
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?
Based on KPMG's intense research of these stories, it appears likely that Pfizer will get some serious questions by its auditors.
After all, KPMG doesn't want to get caught missing a very public meltdown:
(Click on images to enlarge)
Why should this interest you?
Because no firm, except Pfizer, has been more interested in the following stories than KPMG:
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?
Based on KPMG's intense research of these stories, it appears likely that Pfizer will get some serious questions by its auditors.
After all, KPMG doesn't want to get caught missing a very public meltdown:
(Click on images to enlarge)
Tuesday, May 29, 2007
Don't miss these stories on Brandweek and Pharmalot!
Brandweek just posted some very interesting internal AstraZeneca documents. . . AZ Group of 7 Believe OIG Probe of Arimidex Marketing Is Stalled
And Pharmalot just published a must read post courtesy of the AstraZenca whistleblowers: The Nine Commandments Of Whistleblowing
You should definitely read both these posts!
Finally, Brandweek also published Hello, AZ Group of 7. Lawyers Would Like to Talk to You!
I have the response to that one from the AstraZeneca whistleblowers: Nope.
And Pharmalot just published a must read post courtesy of the AstraZenca whistleblowers: The Nine Commandments Of Whistleblowing
You should definitely read both these posts!
Finally, Brandweek also published Hello, AZ Group of 7. Lawyers Would Like to Talk to You!
I have the response to that one from the AstraZeneca whistleblowers: Nope.
AstraZeneca's Scarlett S. waves goodbye.
As you may recall, after the AstraZeneca allegations revealed in April on Question Authority, Regional Oncology Sales Director Mike Zubillaga was terminated and his boss, National Sales Director Scarlett S. resigned. (Story here.)In a Memorial Day voice message this weekend Scarlett informs her people of her successor, Eric Vogel: Listen here.
PharmaGossip is on fire!
I don't know where I'd be today without PharmaGossip, the blog that is literally on fire . . . and also helps me when I sometimes miss a few details in my stories . . . thank you Jack for always being there!
The Pfizer Mirapex Whistleblower's amazing story . . .
A new Pfizer whistleblower claims Pfizer illegally marketed Mirapex for off-label indications, such as restless leg syndrome, before Mirapex got this approval. Mirapex was at the time only indicated for idiopathic Parkinson's disease.She had an amazing story to tell me, however, I couldn’t simply believe her off the bat, even though her tale was filled with details.
So I asked her to prove that she really worked as a sales rep for Pfizer.
And she sent the attached pay stub. Pretty good proof, I thought.
This is the Mirapex Whistleblower’s story:
I left Pfizer a few months ago and I am new to your website and only found it after being tipped off from one of my former Pfizer teammates.
It’s so interesting to see your recent Pfizer stories, as it reminds me of my time working as a Neurology Specialty Representative selling Mirapex.
Mirapex, I felt, was a low-grade Neurontin in that we were quietly pushed to sell it off-label for the treatment of Restless Leg Syndrome. Like Neurontin, most of the off-label use was being driven by the physicians themselves but we were encouraged to encourage them.
I did very well selling Mirapex and, at the time, I was one of the top reps in the country. I did so well, so consistently, that I was placed on the Mirapex Advisory Panel – you know, one of those BS rewards for top reps in a drug category.During a conference call a few years ago with the DMT I mentioned Restless Leg Syndrome and how, at least, 75% of my business came from RLS scripts as opposed to Parkinson's Disease (PD). The moderator of the call feigned shock and surprise at this which, I knew, was completely insincere. They sure as hell knew what was going on and where their business was coming from.
As in Watergate, the key was to “follow the money”. In this case – quotas. They had our quotas and growth targets so high that to meet them, practically every PD patient in the country would have to be put on Mirapex. Obviously, this was not ever going to happen. Not that Mirapex was a bad PD drug, it was quite effective. But no drug ever gets 100% of the business.
Obviously, they expected the growth to come from other areas. Areas outside the approved indication. There is no other way that we could have hit our quotas otherwise. And one didn’t need to be a forensic accountant to see that. It was blatantly obvious.
The push was especially strong a few years back when our main competitor, Requip, filed for a Restless Leg Syndrome indication that was expected to be approved.
So it was critical that we build up as much share and physician loyalty as possible before an “indication approved” competitor hit the market. Later, in 2005, Requip got their approval for Restless Legs Syndrome, and Mirapex was approved for RLS in 2006.
This was quite a story, so of course Question Authority had a few questions for the Mirapex Whistleblower. Like why did she leave Pfizer?
“I left Pfizer for two reasons: One, the job was becoming ridiculous. Despite all the rhetoric about ‘being entrepreneurs’ and ‘owning our own territories’ the reality was that Pfizer wanted and expected us to be drones. Ironically, they only wanted us to be entrepreneurial when they needed us to go off-label to increase sales. Which was more and more of the time by the time I left. Of course, they would deny everything and hang the rep out to dry if anyone got caught. But the direction came from the top.
Secondly, I wanted to make more money. And, unlike many in the pharma world, I was willing to accept the risks that entailed. I love my new job. There hasn't been one single day when I've regretted my decision. It hasn't been easy but at the end of the day I usually feel like I've accomplished something.
And finally, it's nice to be treated like an adult again.”
“Why did you decide to share you story at this time?”
“I guess it was just the memories brought about by seeing your stories about the marketing of maraviroc and recognizing some of the names. Nothing about the story surprised me. Not in the least. It seemed to me to be just Standard Pfizer Operating Procedure. I sold many different Pfizer drugs throughout my decade with the company and the ones that we WEREN'T pushed to sell off-label were in the minority.”
“As a rep I guess you talked to the other sales reps, which drugs did you hear your colleagues talk about promoting off-label?”
“Zithromax - Sinusitis, acne, dermatitis, those are the ones I can recall at the moment.”
“Neurontin - Christ! Pick a disease. Any disease! Although, much of this off-label use was physician-driven. I recall one of my Neurologists describing Neurontin as the ‘Swiss Army Knife’ of pharmaceuticals. Hot flashes associated with menopause was one of my personal favorites.”
“Lipitor - Not so much off-label as making claims supported by clinical data before it was officially in the label.”
“Viagra - Post-turp or radical prostatectomy surgery prophylactically. ‘100mg helps preserve function before it is lost forever.’ No real data to support that but, boy, it sure sounded good. Oddly enough, we were never really pushed to go for female use. At least I wasn't. But then, Pfizer never really knew how to sell that drug. Still don't, in my opinion.”
“Aricept - Vascular dementia, Severe Alzheimers (we didn't have the indication at the time).”
“Mirapex - Well, I covered that already, didn't I? And the list goes on . . .”
“Are you upset with Pfizer?”
“I really have no particular axe to grind against Pfizer. Off-label promotion of drugs is not a Pfizer invention. In fact, in the world of off-label and illegal promotion they aren't even one of the top-tier players (see Forest Pharmaceuticals). The only strong feelings I have towards them right now are related to the horrible way they treated the sales force during this recent round of layoffs. I saw good, talented people let go because of hired gun consultants. It was a shameful period in Pfizer history.”
“But you worked for them for many years, don’t you feel bad talking about all this?”
“Bottom line, the Pfizer that I once loved is dead and gone. I was once proud to bleed Pfizer blue, no longer.
"Why did you send your pay stub to me with your name redacted? You have left Pfizer, what are you so worried about?
Obviously, I do not wish to be identified by you or anyone else, so I've taken steps to ensure that nothing can be traced back to me. For starters, it would just be damned inconvenient. Then I have to be concerned with the effect this could have on my current and future career prospects. Frankly, the benefit does not exceed the cost.
And, Pfizer is in the midst of defending itself against a myriad of lawsuits relating to the off-label use of Mirapex. In fact, the month before I left Pfizer one of my own physicians was served with a lawsuit from a patient he had put on Mirapex for RLS and months later, even though I was no longer with Pfizer and had not yet begun selling Mirapex when this physician prescribed the drug, I found myself on a multi-hour conference call with Pfizer attorneys.
"Are you telling me you don't live in California?"
"I could be from anywhere. My story is the same as hundreds of others."
"OK, finally, I must ask this, since I've never met you and many Question Authority readers have this idea that all drug reps are very attractive. Is that true?"
"I'm gorgeous and so were some of my colleagues. And life is good!”Investigator of Medicaid Fraud Calls Question Authority
This weekend I received a personal phone call from an investigator of state medicaid fraud. He works in the heartland. Said that the first thing he does every morning is read this blog.Unfortunately, he said, the government agency he works for blocks web images, so he has to use his computer back home to look at the pictures in the evening.
Interesting thing is, he works in a state where a real big pharma company is very entrenched. They pretty much own that state, he said. So his colleagues aren't always real happy when he does what he's hired to do; which includes scrutinizing that big pharma company.
By now most of you with pharma experience have probably both guessed that state and the powerful drug company that owns everyone, including the press in that state. You guessed it right, the state and the state capitol both start with an I . . . and the drug company with an L . . .The drug industry is powerful, but in some states it is more than powerful; it owns pretty much everyone. I feel bad for the people in those states.
Monday, May 28, 2007
Pfizer responds to allegations on Question Authority . . .
"Rost is on that website everyday, accusing people here of everything from wife beating to God knows what," says Bryant Haskins, a Pfizer spokesperson. "We're just not going to respond to every single allegation."This quote is taken from an article in the upcoming issue of Fortune:
BLOGGING ON DRUGS
"BOOTED OUT OF A LUCRATIVE CAREER, PETER ROST HAS BECOME THE DRUG INDUSTRY'S MOST ANNOYING - AND EFFECTIVE - ONLINE SCOURGE."
Fortune Magazine - Jun. 11, 2007
Stay tuned for full article . . .
Sunday, May 27, 2007
Links 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. Don't miss next week: The Pfizer Mirapex Whistlebl...
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. Don't miss next week: The Pfizer Mirapex Whistlebl...
Economic Times: "Pfizer CFO exit may've India angle"
Here is first "mainstream" coverage of the Pfizer India scandal. It is rather surprising that some individuals can deny allegations that are supported by written documents, which you can download right here on this site . . . see "Don't miss multiple evolving Pfizer scandals!"
Pfizer CFO exit may've India angle
GIREESH CHANDRA PRASAD & JAVED SAYED
TIMES NEWS NETWORK
MONDAY, MAY 28, 2007 02:44:12 AM
NEW DELHI: The recent exit of the world’s largest drug-maker Pfizer Inc’s CFO Alan Levin may have an India angle if the allegations of a US-based blog quoting a former Pfizer India employee are to be believed.
The blog, quoting Ashok S Idnani, an ex-deputy manager at Pfizer’s finance division in Mumbai alleges that Pfizer sold its Hyderabad manufacturing plant in 2004 at a price much lower than the market price, bribed government officials in violation of the MNC’s world-wide policies, and hired a detective agency to spy on unfriendly shareholders. It also accuses some unnamed Pfizer India officials of being involved in money laundering. Pfizer denies the allegations.
These allegations were made in a sensational three-part series carried by peterrost.blogspot.com in the week running up to the announcement of Mr Levin’s resignation on May 20. The blog claims that Mr Levin’s exit last Sunday may be a result of its campaign featuring the ‘revelations’ made by Mr Idnani.
However, it does not specify a direct link between Mr Levin and the allegations made by Mr Idnani. In a company statement Mr Levin said he was leaving the company to explore career opportunities outside Pfizer.
Pfizer India, on its part, completely denies the allegations. “Blog sites in general provide open and unfiltered forums for the exchange of all kinds of information that may or may not have any validity. To date, investigations completed in response to Mr Idnani’s claims have found them to be baseless.
Pfizer takes such claims seriously and has by Mr Idnani’s own admission dedicated significant amounts of time and resources to evaluate them thoroughly,” said a Pfizer India spokesperson in an e-mailed response to ET. Pfizer Inc did not respond to a questionnaire sent over the weekend.
A Pfizer India official told ET that the present top-level shifts in the parent company are very much part of its restructuring announced in January to cut costs and to invest in new business development. Pfizer had announced in January that it would cut 10,000 jobs and close down three research sites and two factories in the US, as well as a factory in Germany and research sites in Japan and France.
Sources in the domestic pharma industry however say some of the allegations are being taken seriously by Pfizer’s top brass in the US. Adds an industry veteran, who has visited the blog: “These charges don’t just appear serious. They are very serious.” But a Mumbai-based investment banker and ex-Pfizer employee, who has not seen these postings, dismisses the blog. “Peter Rost is a joker. I do not believe any of these allegations,” he says.
So far, the foreign media does not appear to have made any connection between Mr Levin’s departure and India. Overseas media reports have cited “Pfizer’s desire for a CFO with Wall Street experience” to be the reason for his departure.
Overseas reports quoting analysts said that Pfizer is reinventing itself to beat competition from generic rivals and to tackle the expiry of patents. One analyst said Pfizer may now want a CFO who is less of a traditional accountant and more of a deal-maker.
None of this appears to faze Peter Rost, a former Pfizer veep, who describes himself as a “recovering blogaholic”. “While it is impossible to know if the latest whistleblower revelations contributed to his exit, the timing should result in some serious questions about what precipitated the decision to get rid of the 45-year old CFO who had only held the job for two years,” writes Rost, in his blog.
According to the blog, Mr Idnani doesn’t have any proof that anyone took kick-backs to sell the Hyderabad plant at a discount. Still he informed the then Pfizer general counsel and the present CEO Jeff Kindler of his suspicion. The company responded by instituting an inquiry in early 2006.
Quoting Mr Idnani, the blog alleges that he was told that the outcome of the probe would not be disclosed to him and he was fired six months later on August 2006. Mr Idnani says that when Pfizer recently sold its Chandigarh plant, officials from the parent personally interviewed the bidders and local officials did not have full control over the matter.
Pfizer CFO exit may've India angle
GIREESH CHANDRA PRASAD & JAVED SAYED
TIMES NEWS NETWORK
MONDAY, MAY 28, 2007 02:44:12 AM
NEW DELHI: The recent exit of the world’s largest drug-maker Pfizer Inc’s CFO Alan Levin may have an India angle if the allegations of a US-based blog quoting a former Pfizer India employee are to be believed.
The blog, quoting Ashok S Idnani, an ex-deputy manager at Pfizer’s finance division in Mumbai alleges that Pfizer sold its Hyderabad manufacturing plant in 2004 at a price much lower than the market price, bribed government officials in violation of the MNC’s world-wide policies, and hired a detective agency to spy on unfriendly shareholders. It also accuses some unnamed Pfizer India officials of being involved in money laundering. Pfizer denies the allegations.
These allegations were made in a sensational three-part series carried by peterrost.blogspot.com in the week running up to the announcement of Mr Levin’s resignation on May 20. The blog claims that Mr Levin’s exit last Sunday may be a result of its campaign featuring the ‘revelations’ made by Mr Idnani.
However, it does not specify a direct link between Mr Levin and the allegations made by Mr Idnani. In a company statement Mr Levin said he was leaving the company to explore career opportunities outside Pfizer.
Pfizer India, on its part, completely denies the allegations. “Blog sites in general provide open and unfiltered forums for the exchange of all kinds of information that may or may not have any validity. To date, investigations completed in response to Mr Idnani’s claims have found them to be baseless.
Pfizer takes such claims seriously and has by Mr Idnani’s own admission dedicated significant amounts of time and resources to evaluate them thoroughly,” said a Pfizer India spokesperson in an e-mailed response to ET. Pfizer Inc did not respond to a questionnaire sent over the weekend.
A Pfizer India official told ET that the present top-level shifts in the parent company are very much part of its restructuring announced in January to cut costs and to invest in new business development. Pfizer had announced in January that it would cut 10,000 jobs and close down three research sites and two factories in the US, as well as a factory in Germany and research sites in Japan and France.
Sources in the domestic pharma industry however say some of the allegations are being taken seriously by Pfizer’s top brass in the US. Adds an industry veteran, who has visited the blog: “These charges don’t just appear serious. They are very serious.” But a Mumbai-based investment banker and ex-Pfizer employee, who has not seen these postings, dismisses the blog. “Peter Rost is a joker. I do not believe any of these allegations,” he says.
So far, the foreign media does not appear to have made any connection between Mr Levin’s departure and India. Overseas media reports have cited “Pfizer’s desire for a CFO with Wall Street experience” to be the reason for his departure.
Overseas reports quoting analysts said that Pfizer is reinventing itself to beat competition from generic rivals and to tackle the expiry of patents. One analyst said Pfizer may now want a CFO who is less of a traditional accountant and more of a deal-maker.
None of this appears to faze Peter Rost, a former Pfizer veep, who describes himself as a “recovering blogaholic”. “While it is impossible to know if the latest whistleblower revelations contributed to his exit, the timing should result in some serious questions about what precipitated the decision to get rid of the 45-year old CFO who had only held the job for two years,” writes Rost, in his blog.
According to the blog, Mr Idnani doesn’t have any proof that anyone took kick-backs to sell the Hyderabad plant at a discount. Still he informed the then Pfizer general counsel and the present CEO Jeff Kindler of his suspicion. The company responded by instituting an inquiry in early 2006.
Quoting Mr Idnani, the blog alleges that he was told that the outcome of the probe would not be disclosed to him and he was fired six months later on August 2006. Mr Idnani says that when Pfizer recently sold its Chandigarh plant, officials from the parent personally interviewed the bidders and local officials did not have full control over the matter.
Friday, May 25, 2007
Don't miss next week: The Pfizer Mirapex Whistleblower!
A new Pfizer whistleblower is coming forward next week; a sales representative who spent a decade working for Pfizer on the West-Coast.She just left the company, and will tell you all about her experience with off-label promotion and what she claims the company taught her to do . . .
And I will prove that she is for real.
As if that wasn't enough . . . next week I'll have more documents related to allegations of illegal premarketing of maraviroc.
All of this and much more, right here, on Question Authority, starting Tuesday next week.
I'm in the Kroll cross hairs . . .
The most famous international corporate spy agency is Kroll Inc.And I'm in their cross hairs.
They do lots of things; one of them is "anticipating trends, concerns or evolving events which have the potential to substantially impact a corporation, business or organization and its stakeholders."
Kroll proudly states, "The intervention is followed by developing strategies designed to best position the corporation, deflect the concern or mitigate the consequences of the identified issue.
The key to effective issue management is managing the issue rather than reacting to it.
Reputation-damaging issues can arise at any point in the crisis continuum.Early identification of an emerging issue which could mature into a crisis gives the organization more flexibility in its strategy to influence the direction the issue takes."
Finally, they give this advice: "issues which have matured into a problem for the organization can still be managed. This requires an intensive, clear-cut and multi-pronged strategy for intervention and satisfactory resolution of the issue with key stakeholder groups. It will involve the combined efforts of government relations, investor relations, marketing, brand, and product teams. (Rarely will a solution involve just media relations!)"
Of course, I'm used to detective agencies hired big pharma following me.
After all, anyone who's read my book "The Whistleblower" knows that Pharmacia did just that.And . . . funny . . . as we're talking about Kroll . . . here they are AGAIN!
If anything strange happens to me, call Kroll!!!
Thursday, May 24, 2007
Quote of the day: Why did Pfizer and other drug company CFO's leave?
Four drug company CFO's have recently resigned. WSJ asked "Is this a coincidence or is something bigger going on?"
Chris Langhoff, a CFO recruiter at Russell Reynolds Associates:
"The CFO is going to take a bullet if somebody does something deep down in the bowels of the organization that’s not right — anything that involves financing, anything that involves accounting and reporting."
Source: WSJ Health Blog.
Chris Langhoff, a CFO recruiter at Russell Reynolds Associates:
"The CFO is going to take a bullet if somebody does something deep down in the bowels of the organization that’s not right — anything that involves financing, anything that involves accounting and reporting."
Source: WSJ Health Blog.
Tomorrow: Mea Culpa by a Pfizer Lawyer!
Don't miss tomorrow's story: Mea Culpa by a Pfizer Lawyer!And if you haven't read the latest, here are convenient links:
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 prepares to get rid of maraviroc whistleblo...
9. Who REALLY REALLY cared about my Pfizer stories?
10. PFE CFO Alan Levin, 45, gets est. $8.6 million to ...
11. Pfizer India Whistleblower Finally Gets His "25 Year Service Award" Gold Coin
12. "Jeff Kindler is going to Pfizer India in June"
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 prepares to get rid of maraviroc whistleblower
I just obtained the communication below between Jane Roe, a Senior Therapeutic Sales Representative for Pfizer's HIV/AIDS Division, and Special Agent Lou Linder, U.S. Department of Health and Human Services, Office of Inspector General.
(Names have been changed to protect the investigation.)
The communication is amazing for several reasons:
1. In her first e-mail, Jane writes to the OIG: "We were recently asked to delete any mention of maraviroc . . ." If this is true, it may constitute obstruction of justice. I suggest Davis, Polk & Wardwell verify this information.
2. In her last e-mail Jane writes, "I am being forced out of my position which I estimate will take place by the end of May." If true, that means Pfizer is about to get rid of yet another whistleblower.
That may violate Pfizer's "Blue Book" business policy, NY State Law, and it may also violate Pfizer's 2004 Corporate Integrity Agreement, in which Pfizer promises the OIG that Pfizer has a "commitment to nonretaliation."
I suggest the Special Agent in charge of this investigation not only makes himself "available" but takes action to prevent a violation of Pfizer's corporate integrity agreement.
From: "Linder, Lou A (OIG/OI)"
To: "jane roe"
Subject: RE: power point slides
Date: Thu, 17 May 2007 12:02:10 -0400
Thank you for letting me know. When you want to speak with me about these matters, I will be available. You can reach me at the phone number below.
Take care,
Special Agent Lou Linder
U.S. Department of Health and Human Services
Office of Inspector General
50 Kennedy Plaza, Suite 750
Providence, RI 02903
Phone: (401) 528-41XX
Fax: (401) 528-41XX
-----Original Message-----
From: jane roe [mailto:janeroe@hotmail.com]
Sent: Wednesday, May 16, 2007 9:00 PM
To: Linder, Lou A (OIG/OI)
Subject: RE: power point slides
Dear Agent Linder,
I have decided not to meet at this time. I am being forced out of my position which I estimate will take place by the end of May. I am very concerned about how Pfizer has been able to act without regard for the law not just with the off label discussions of miraviroc but the marketing of Viracept with clinical science people who were not part of medical affairs but marketing.
They used methods that I am sure if held up to scrutiny would be illegal. I trust once you have all the information I have you would have the complete picture. The issue as I see it is I cannot afford a lawyer and Pfizer would never let you see correspondence now trapped in my computer.
I promise to contact you as soon as I have left Pfizer and hopefully be able to at the very least give you a picture of the situation as I have witnessed it.
Jane Roe
From: "Linder, Lou A (OIG/OI)"
To: "jane roe"
Subject: RE: power point slides
Date: Fri, 27 Apr 2007 11:24:13 -0400
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 Lou Linder
U.S. Department of Health and Human Services Office of Inspector
General 50 Kennedy Plaza, Suite 750 Providence, RI 02903
Phone: (401) 528-41XX
Fax: (401) 528-41XX
-----Original Message-----
From: jane roe[mailto:janeroe@hotmail.com]
Sent: Wednesday, April 25, 2007 10:16 PM
To: Linder, Lou A (OIG/OI)
Subject: power point slides
Agent Linder these are unapproved slides given to me. In November 06 we were asked to help solicit physicians buy in for miraviroc prior to the launch these slides were to help grease the wheels. They were sent from medical affairs at the direction of the sales director.
We were recently asked to delete any mention of miraviroc and I filed a complaint with Pfizer compliance with little expectation they would do much about the use of sales reps as medical liaisons.
Jane Roe
(Names have been changed to protect the investigation.)
The communication is amazing for several reasons:
1. In her first e-mail, Jane writes to the OIG: "We were recently asked to delete any mention of maraviroc . . ." If this is true, it may constitute obstruction of justice. I suggest Davis, Polk & Wardwell verify this information.
2. In her last e-mail Jane writes, "I am being forced out of my position which I estimate will take place by the end of May." If true, that means Pfizer is about to get rid of yet another whistleblower.
That may violate Pfizer's "Blue Book" business policy, NY State Law, and it may also violate Pfizer's 2004 Corporate Integrity Agreement, in which Pfizer promises the OIG that Pfizer has a "commitment to nonretaliation."
I suggest the Special Agent in charge of this investigation not only makes himself "available" but takes action to prevent a violation of Pfizer's corporate integrity agreement.
From: "Linder, Lou A (OIG/OI)"
To: "jane roe"
Subject: RE: power point slides
Date: Thu, 17 May 2007 12:02:10 -0400
Thank you for letting me know. When you want to speak with me about these matters, I will be available. You can reach me at the phone number below.
Take care,
Special Agent Lou Linder
U.S. Department of Health and Human Services
Office of Inspector General
50 Kennedy Plaza, Suite 750
Providence, RI 02903
Phone: (401) 528-41XX
Fax: (401) 528-41XX
-----Original Message-----
From: jane roe [mailto:janeroe@hotmail.com]
Sent: Wednesday, May 16, 2007 9:00 PM
To: Linder, Lou A (OIG/OI)
Subject: RE: power point slides
Dear Agent Linder,
I have decided not to meet at this time. I am being forced out of my position which I estimate will take place by the end of May. I am very concerned about how Pfizer has been able to act without regard for the law not just with the off label discussions of miraviroc but the marketing of Viracept with clinical science people who were not part of medical affairs but marketing.
They used methods that I am sure if held up to scrutiny would be illegal. I trust once you have all the information I have you would have the complete picture. The issue as I see it is I cannot afford a lawyer and Pfizer would never let you see correspondence now trapped in my computer.
I promise to contact you as soon as I have left Pfizer and hopefully be able to at the very least give you a picture of the situation as I have witnessed it.
Jane Roe
From: "Linder, Lou A (OIG/OI)"
To: "jane roe"
Subject: RE: power point slides
Date: Fri, 27 Apr 2007 11:24:13 -0400
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 Lou Linder
U.S. Department of Health and Human Services Office of Inspector
General 50 Kennedy Plaza, Suite 750 Providence, RI 02903
Phone: (401) 528-41XX
Fax: (401) 528-41XX
-----Original Message-----
From: jane roe[mailto:janeroe@hotmail.com]
Sent: Wednesday, April 25, 2007 10:16 PM
To: Linder, Lou A (OIG/OI)
Subject: power point slides
Agent Linder these are unapproved slides given to me. In November 06 we were asked to help solicit physicians buy in for miraviroc prior to the launch these slides were to help grease the wheels. They were sent from medical affairs at the direction of the sales director.
We were recently asked to delete any mention of miraviroc and I filed a complaint with Pfizer compliance with little expectation they would do much about the use of sales reps as medical liaisons.
Jane Roe
"Jeff Kindler is going to Pfizer India in June"
Sources inside Pfizer claim that Jeff Kindler is likely to travel to Pfizer India beginning of June to review operations.Pfizer has not officially confirmed this information.
If true, timing appears to be impeccable.
Pfizer India Whistleblower Finally Gets His "25 Year Service Award" Gold Coin: 4 Years too Late!
Pfizer's finance department whistleblower has gone through some really hard times since he was fired from Pfizer, after 28 years of faithful service.
As you may remember he was terminated less than a year after he contacted Pfizer CEO Jeff Kindler with numerous allegations which I have covered on this blog. And after he was terminated Pfizer refused to pay him money they owed him for six months.
But they also did something else. For four years Pfizer refused to give Idnani the faithful service medal awarded to all Pfizer employees in India, after 25 years of service.
Idnani wrote numerous e-mails about this to Pfizer New York, but no one cared.
But now, finally, there is some good news for Ashok Idnani.
He just told me, "I received the 25-year service award gold coin on last Friday, May 18, after the first two articles and four years after I completed 25-years with Pfizer.
And, perhaps we should mention, almost one year after he was fired.
Shame on you Pfizer. SHAME ON YOU!
As you may remember he was terminated less than a year after he contacted Pfizer CEO Jeff Kindler with numerous allegations which I have covered on this blog. And after he was terminated Pfizer refused to pay him money they owed him for six months.
But they also did something else. For four years Pfizer refused to give Idnani the faithful service medal awarded to all Pfizer employees in India, after 25 years of service.Idnani wrote numerous e-mails about this to Pfizer New York, but no one cared.
But now, finally, there is some good news for Ashok Idnani.
He just told me, "I received the 25-year service award gold coin on last Friday, May 18, after the first two articles and four years after I completed 25-years with Pfizer.
And, perhaps we should mention, almost one year after he was fired.
Shame on you Pfizer. SHAME ON YOU!
Question Authority Legal Disclaimer
As always when I become the host of a number of new law firms searching my blog, I try to remind them to carefully read my TERMS OF USE AGREEMENT AND PRIVACY POLICY.
There are nasty surprises in that agreement, so I specifically request AstraZeneca's law firm Arnold & Porter and Pfizer's law firm Davis, Polk & Wardwell to familiarize themselves with the terms of the agreement. Violations can become very costly, and both firms should have no doubt that I will enforce those terms to the full extent permitted by applicable law.
Having said that, I now welcome our new legal readers who get paid $750 per hour to read my humble blog.
Perhaps this is also a good time to remind everyone that this blog is written with a smile, for your enjoyment. (At least I'm having fun.)
But during all that fun, don't forget that any company or person mentioned on this blog is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
Please also note that the Department of Justice has brought very few criminal cases against any individuals in the drug industry, and when they have done so they have often lost and ended up with lots of eggs on their faces.
Meanwhile, many of those drug companies have paid hundreds of millions in fines and settlements with the DOJ.
Defense lawyers explain this with the fact that if a company was found guilty, the government could do an "Arthur Andersen" on them. That means the government could stop doing business with them and they'd go belly up. So the defense attorneys claim the drug companies really don't have choice but to settle, since losing could make them go bankrupt.
Others claim the whole thing is just a shell game, meant to pacify the masses and make us believe there's justice, where the drug companies pay a pittance and are let off the hook more often than they are made to pay up.
Pick the flavor you prefer.
There are nasty surprises in that agreement, so I specifically request AstraZeneca's law firm Arnold & Porter and Pfizer's law firm Davis, Polk & Wardwell to familiarize themselves with the terms of the agreement. Violations can become very costly, and both firms should have no doubt that I will enforce those terms to the full extent permitted by applicable law.
Having said that, I now welcome our new legal readers who get paid $750 per hour to read my humble blog.
Perhaps this is also a good time to remind everyone that this blog is written with a smile, for your enjoyment. (At least I'm having fun.)
But during all that fun, don't forget that any company or person mentioned on this blog is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
Please also note that the Department of Justice has brought very few criminal cases against any individuals in the drug industry, and when they have done so they have often lost and ended up with lots of eggs on their faces.
Meanwhile, many of those drug companies have paid hundreds of millions in fines and settlements with the DOJ.
Defense lawyers explain this with the fact that if a company was found guilty, the government could do an "Arthur Andersen" on them. That means the government could stop doing business with them and they'd go belly up. So the defense attorneys claim the drug companies really don't have choice but to settle, since losing could make them go bankrupt.
Others claim the whole thing is just a shell game, meant to pacify the masses and make us believe there's justice, where the drug companies pay a pittance and are let off the hook more often than they are made to pay up.
Pick the flavor you prefer.
Wednesday, May 23, 2007
PFE CFO Alan Levin, 45, gets est. $8.6 million to leave Pfizer.
According to an SEC filing today, Pfizer CEO Alan Levin, who has "resigned," will receive a cash severance payments of $2.0 million, as well as the other estimated payments and benefits set forth in the table at the bottom of page 73 of the Company’s 2007 Definitive Proxy Statement filed on March 15, 2007.
The table at the bottom of page 73 of the proxy statement provides for an additional $6.6 million, for a total payment of $8.6 million.
The additional $6.6 million payment is provided "Upon Termination Due to Restructuring," according to the proxy statment.
So much for "voluntary resignation."
The table at the bottom of page 73 of the proxy statement provides for an additional $6.6 million, for a total payment of $8.6 million.
The additional $6.6 million payment is provided "Upon Termination Due to Restructuring," according to the proxy statment.
So much for "voluntary resignation."
Who REALLY REALLY cared about my Pfizer stories?
It's always fun to check who's coming by. After all, if no one did, it would feel pretty lonely. So the more the merrier.
And it shouldn't come as a surprise that the past week has been one of the busiest ever, based on number of visitors.
It probably also shouldn't be a surprise that the number one visitor was Pfizer. Close to 10,000 visits in a week. Wow. Seems like everyone must talk about the India affair and the maraviroc premarketing allegations over at Big Blue.
But what about the rest, who else cared about my Pfizer stories?
Some interesting stuff there. Lot's of biotech companies doing deals with Pfizer. I guess they may realize that Pfizer is spying on them too. Also some major Pfizer competitors, especially Merck. And many investment companies and hedge funds. Among the big ones, Merrill Lynch keeps coming back, over and over. And, of course, some of the companies Pfizer spied on in India are coming by.
Oh, and the International Trade Administration of the Department of Commerce seems to have taken a keen interest in the Pfizer India affair. They promote U.S. trade. Maybe they felt Pfizer's behavior in India was an embarrassment to the United States.
And, as always, the Department of Justice and the Department of Health and Human Services are visiting. Actually, lot's of visits by the Department of Health and Human Services, but I only show one of them below (click on images to see full size).
But no one stayed longer than two visitors - Institutional Investor and the law firm Davis, Polk & Wardwell . They stayed on my blog for over a day.
Davis, Polk & Wardwell is a law firm working for Pfizer, which has interviewed many Pfizer employees. Davis Polk ranked first among all U.S. law firms in a survey in which Fortune 250 law departments were asked to name the firms they rely on most in corporate transactions. They have a long history of representing institutions in complex criminal cases. Their white collar criminal practice includes the former U.S. Attorney for the Southern District of New York. They focus on advising clients in internal investigations, grand jury investigations and violations of the Foreign Corrupt Practices Act. Sounds like Pfizer came to the right place.
Most surprising of all, I think Pfizer CEO Jeff Kindler came by. Can't be 100% sure. It's been a long time since he was here. But I really think it was him . . . click on image.
I'm honored by the attention.
And the week is far from over.
Tomorrow we'll take a look at what Pfizer is doing with its most recent whistleblower and communication with the OIG.
Friday we'll check out the unusual Mea Culpa by a Pfizer lawyer.
It'll be an amazing week.
And it shouldn't come as a surprise that the past week has been one of the busiest ever, based on number of visitors.
It probably also shouldn't be a surprise that the number one visitor was Pfizer. Close to 10,000 visits in a week. Wow. Seems like everyone must talk about the India affair and the maraviroc premarketing allegations over at Big Blue.
But what about the rest, who else cared about my Pfizer stories?
Some interesting stuff there. Lot's of biotech companies doing deals with Pfizer. I guess they may realize that Pfizer is spying on them too. Also some major Pfizer competitors, especially Merck. And many investment companies and hedge funds. Among the big ones, Merrill Lynch keeps coming back, over and over. And, of course, some of the companies Pfizer spied on in India are coming by.
Oh, and the International Trade Administration of the Department of Commerce seems to have taken a keen interest in the Pfizer India affair. They promote U.S. trade. Maybe they felt Pfizer's behavior in India was an embarrassment to the United States.
And, as always, the Department of Justice and the Department of Health and Human Services are visiting. Actually, lot's of visits by the Department of Health and Human Services, but I only show one of them below (click on images to see full size).
But no one stayed longer than two visitors - Institutional Investor and the law firm Davis, Polk & Wardwell . They stayed on my blog for over a day.
Davis, Polk & Wardwell is a law firm working for Pfizer, which has interviewed many Pfizer employees. Davis Polk ranked first among all U.S. law firms in a survey in which Fortune 250 law departments were asked to name the firms they rely on most in corporate transactions. They have a long history of representing institutions in complex criminal cases. Their white collar criminal practice includes the former U.S. Attorney for the Southern District of New York. They focus on advising clients in internal investigations, grand jury investigations and violations of the Foreign Corrupt Practices Act. Sounds like Pfizer came to the right place.
Most surprising of all, I think Pfizer CEO Jeff Kindler came by. Can't be 100% sure. It's been a long time since he was here. But I really think it was him . . . click on image.
I'm honored by the attention.
And the week is far from over.
Tomorrow we'll take a look at what Pfizer is doing with its most recent whistleblower and communication with the OIG.
Friday we'll check out the unusual Mea Culpa by a Pfizer lawyer.
It'll be an amazing week.
Don't miss multiple evolving Pfizer scandals!
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...
Stay tuned for tomorrow's story:
Pfizer lawyer admits "several recent instances" that "violate Pfizer policy and put the company at risk."
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...
Stay tuned for tomorrow's story:
Pfizer lawyer admits "several recent instances" that "violate Pfizer policy and put the company at risk."
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.
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.
Tuesday, May 22, 2007
Congressional Quarterly: "Senior Manager Leaves AstraZeneca in Midst of Congressional Scrutiny"
Senior Manager Leaves AstraZeneca in Midst of Congressional Scrutiny
By Drew Armstrong, CQ Staff
As Congress continues to look closely at allegations of illegal marketing of a breast cancer drug by manufacturer AstraZeneca, a senior manager connected to the company’s off-label promotion of the drug, Arimidex, has resigned.
AstraZeneca Spokeswoman Emily Denney confirmed Monday that Scarlett Spring, the company’s national sales director of oncology, will resign from AstraZeneca, as of June 1. Spring was the supervisor of former AstraZeneca Regional Sales Manager Mike Zubillaga, who allegedly encouraged his regional sales team to promote Arimidex off-label and was fired by AstraZeneca in April as part of the company’s investigation into the allegations.
Off-label promotion of drugs by pharmaceutical sales personnel is illegal, according to the Food and Drug Administration.
Denney would not comment on Spring’s departure, other than to say that Spring was leaving the company for personal reasons.
"She announced internally that she decided to leave AstraZeneca for personal reasons to pursue other opportunities," Denney said.
Public scrutiny of the company’s marketing of its cancer medications began in April, when employees familiar with AstraZeneca’s cancer drug marketing operation leveled allegations that AstraZeneca ignored previous warnings the employees issued about being told to promote the drug off-label.
The employees say they first reported the alleged violations through an internal hotline in November 2006. The employees say they waited for five months without receiving a response, and that AstraZeneca only acted on their claims after the employees wrote a letter in March to the Department of Health and Human Services’ Office of Inspector General (OIG), and forwarded copies to a few industry news Web sites several weeks later. The letter detailed their allegations, including the purported lack of action by AstraZeneca.
Meanwhile, AstraZeneca has blamed a "systems error" that caused the results of AstraZeneca’s ongoing investigation into the matter not to be sent back to the employees.
The company faults an error within Global Compliance, an outside company that anonymously transmits employee complaints of ethical violations to AstraZeneca, which then sends a response back through Global Compliance to the employees.
A May 2 AstraZeneca memo sent to the sales team reads, "We subsequently became aware of a systems issue with our prior helpline vendor. Some employees who had reported suspected violations were prevented from receiving the information that AZ had provided as a follow-up to their reports. We address [sic] the systems issue as soon as we discovered it, and we do not expect it to recur. Responding promptly and appropriately to reported violations is a fundamental element of our compliance program," says the memo.
Under AstraZeneca’s compliance system, employees can call Global Compliance with concerns about a legal or ethical violation. Global Compliance then anonymously sends the claims to the company, which investigates them and returns a response that the employees can access with a unique code number.
AstraZeneca’s firing of Zubillaga — which occurred after the disclosure of other internal memos and training materials also provided to Congressional Quarterly by the employees — has been the most public result of its investigation.
The company has declined to state the exact timeline of its investigation. However, in an April 20 statement, AstraZeneca said that some of the claims were being examined before they were made public.
In the November 2006 call to the Global Compliance hotline, AstraZeneca employees say they reported that members of the cancer drug sales team had been instructed by managers to promote the off-label use of the drug Arimidex, also known as anastrozole.
On April 5, 2007, Web sites posted excerpts from a sales team newsletter in which a sales manager named Mike Zubillaga referred to cancer doctors’ offices as "a big bucket of money." According to the group of employees, Zubillaga also was the management figure encouraging the sales force to promote the off-label use of Arimidex. The employees released copies of the OIG letter a week later.
AstraZeneca fired Zubillaga April 6. Denney later confirmed that the company had hired an outside law firm to look into the allegations made in the OIG letter.
The OIG has confirmed that it is looking into the accusations, and House lawmakers are interested as well.
Henry A. Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, has asked AstraZeneca to provide documents on the marketing of the cancer drug. Rep. Pete Stark, D-Calif., also is looking into the claims.
By Drew Armstrong, CQ Staff
As Congress continues to look closely at allegations of illegal marketing of a breast cancer drug by manufacturer AstraZeneca, a senior manager connected to the company’s off-label promotion of the drug, Arimidex, has resigned.
AstraZeneca Spokeswoman Emily Denney confirmed Monday that Scarlett Spring, the company’s national sales director of oncology, will resign from AstraZeneca, as of June 1. Spring was the supervisor of former AstraZeneca Regional Sales Manager Mike Zubillaga, who allegedly encouraged his regional sales team to promote Arimidex off-label and was fired by AstraZeneca in April as part of the company’s investigation into the allegations.
Off-label promotion of drugs by pharmaceutical sales personnel is illegal, according to the Food and Drug Administration.
Denney would not comment on Spring’s departure, other than to say that Spring was leaving the company for personal reasons.
"She announced internally that she decided to leave AstraZeneca for personal reasons to pursue other opportunities," Denney said.
Public scrutiny of the company’s marketing of its cancer medications began in April, when employees familiar with AstraZeneca’s cancer drug marketing operation leveled allegations that AstraZeneca ignored previous warnings the employees issued about being told to promote the drug off-label.
The employees say they first reported the alleged violations through an internal hotline in November 2006. The employees say they waited for five months without receiving a response, and that AstraZeneca only acted on their claims after the employees wrote a letter in March to the Department of Health and Human Services’ Office of Inspector General (OIG), and forwarded copies to a few industry news Web sites several weeks later. The letter detailed their allegations, including the purported lack of action by AstraZeneca.
Meanwhile, AstraZeneca has blamed a "systems error" that caused the results of AstraZeneca’s ongoing investigation into the matter not to be sent back to the employees.
The company faults an error within Global Compliance, an outside company that anonymously transmits employee complaints of ethical violations to AstraZeneca, which then sends a response back through Global Compliance to the employees.
A May 2 AstraZeneca memo sent to the sales team reads, "We subsequently became aware of a systems issue with our prior helpline vendor. Some employees who had reported suspected violations were prevented from receiving the information that AZ had provided as a follow-up to their reports. We address [sic] the systems issue as soon as we discovered it, and we do not expect it to recur. Responding promptly and appropriately to reported violations is a fundamental element of our compliance program," says the memo.
Under AstraZeneca’s compliance system, employees can call Global Compliance with concerns about a legal or ethical violation. Global Compliance then anonymously sends the claims to the company, which investigates them and returns a response that the employees can access with a unique code number.
AstraZeneca’s firing of Zubillaga — which occurred after the disclosure of other internal memos and training materials also provided to Congressional Quarterly by the employees — has been the most public result of its investigation.
The company has declined to state the exact timeline of its investigation. However, in an April 20 statement, AstraZeneca said that some of the claims were being examined before they were made public.
In the November 2006 call to the Global Compliance hotline, AstraZeneca employees say they reported that members of the cancer drug sales team had been instructed by managers to promote the off-label use of the drug Arimidex, also known as anastrozole.
On April 5, 2007, Web sites posted excerpts from a sales team newsletter in which a sales manager named Mike Zubillaga referred to cancer doctors’ offices as "a big bucket of money." According to the group of employees, Zubillaga also was the management figure encouraging the sales force to promote the off-label use of Arimidex. The employees released copies of the OIG letter a week later.
AstraZeneca fired Zubillaga April 6. Denney later confirmed that the company had hired an outside law firm to look into the allegations made in the OIG letter.
The OIG has confirmed that it is looking into the accusations, and House lawmakers are interested as well.
Henry A. Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee, has asked AstraZeneca to provide documents on the marketing of the cancer drug. Rep. Pete Stark, D-Calif., also is looking into the claims.
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.
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]
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In conclusion, there appears to be overwhelming written evidence that Pfizer systematically used the HIV sales force to premarket maraviroc, before FDA approval, to "research naïve doctors."
Meanwhile, I'm told by sources inside Pfizer that an internal legal investigation of this matter has just started and an external law firm is interrogating Pfizer sales representatives.
Not that Pfizer had much choice after all the information I've made public on this matter . . .
The Pfizer sales rep who gave me this concludes with the following comment: "I hope you see the amount of work I did on behalf of Maraviroc . . . all unsolicited."
And that is exactly the problem. Sales reps can't talk about unapproved indications or unapproved drugs unless the doctors ask them first . . . if they do, it is called OFF-LABEL MARKETING.
Stay tuned for more news on this story tomorrow.
Scene from Michael Moores movie "Sicko"
This is the first ever scene available from the movie Sicko . . . it is not a trailer.
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