The AstraZeneca Scandal: Dear Feds
11 CommentsBy Ed Silverman // April 13th, 2007 // 12:41 pm
The controversy over the drugmaker’s newsletter - in which a regional sales manager likens a doc’s office to ‘a bucket of money’ - is threatening to morph into something larger. For the past few days, one or more alleged AstraZeneca employees - who use the nom de drug ‘Gang of Seven’ - have anonymously sent e-mails to several blogs, starting with whistleblower Peter Rost but also Pharmalot, containing hints and allegations of improper marketing.
The content of the e-mails have not been verified, but by virtue of appearing on a growing number of web sites, the e-mails are taking on a life of their own. At their heart, the e-mails speak to concerns over a growing problem in the pharmaceutical industry - the drive for profit pushing some individuals into illegal activities at a time of concern over safety and pricing.
To date, AstraZeneca has not responded directly to the e-mails, which allegedly refer to an effort by one or more managers to promote off-label use for Faslodex and a tactical strike against a rival drug, Novartis’ Femara, without the use of cell phones or any written record, and with the help of medical liasions. Here is the latest e-mail, a purported letter to HHS:
An Open Letter To:
Office of Inspector General (OIG)
Department of Health and Human Services
Attn: HOTLINE
330 Independence Ave., SW
Washington, DC 20201
1-800-447-8477
From: The AstraZeneca ‘Group of Seven’
Subject Company: AstraZeneca Pharmaceuticals & their Corporate Integrity Agreement
[Personal information redacted]
Summary and Chronology of Events:
Early November 2006 – At an oncology district meeting for the [Redacted] territories held in [Location and Name Redacted] instructed his pharmaceutical reps to:
1) Solicit requests from physicians for a visit from a Regional Scientific Manager (Medical Science Liaison) to discuss the off-label use of Faslodex/fulvestrant injection after an aromatase inhibitor (for which we are not indicated).
2) Solicit requests from physicians for a visit from a Regional Scientific Manager (Medical Science Liaison) to discuss the serious cardiovascular side effects of our competitor Femara/letrozole (for which we have no comparative data).
3) Repeatedly and emphatically instructed those present NOT to use email or voicemail when communicating these solicited off-label requests, but to use cell phones instead so as not to leave a permanent record of this activity.
Mid November 2006 - We called the AstraZeneca Code of Conduct hotline at 888-44-1769 and filed Report Number ASTR 06110001.
Mid December 2006 – Shortly after it became known that someone called the Code of Conduct hotline about the meeting, [Name Redacted] demoted the istrict manager and dissolved the district (despite some of the best sales in the country). We suspect retaliation.
April 10, 2007 – Despite persistent follow up with the Code of Conduct hotline every two weeks for five months, AstraZeneca provided NO RESPONSE AT ALL to our report. Unfortunatly, this led us to believe that [Name Redacted] actions were sanctioned by AstraZeneca and that we have no other alternative but to contact OIG directly and publicly.
Hat tip to Peter Rost.[tags]AstraZeneca, Mike Zubillaga[/tags]
Peter Pitts
Ed:
Why are you generating a feeding frenzy on what is still unsubstantiated gossip?
Laurie
Because without sites like Pharmalot and others, the public would only see the whitewashed version that AZ has put out there.
I, personally, want to hear what the employees are experiencing when trying to report problems.
It’s only when both sides are presented that the whole story comes out. Tthe employees have had to resort to the internet to get their experience out, because AZ has not responded to their concerns.
It absolutely warrants inviestigation.
JS
It may not be unsubstantiated for long and don’t you do have an obligation to report the report? I think everyone except me has been very careful to call it a single source report and we will have wait for the final result. I personally believe it. I think it has the ring of truth so I guess the ball is in AZ’s court now I say bring it on. Anyone who works for big pharma knows how this works just ask those who have been or are currently involved with reporting bad acts.
ed
Peter and Laurie, and anyone else, for that matter:
I grappled long and hard with this situation. And if anyone wants to take me to task, that’s f ine. I’d like to think that I understand both sides of this problem.
With that said, I certainly had choices.
I could have ignored everytihing - the other sites and the e-mails I’ve received.
I could have simply written something about the fact that other sites were posting those e-mails and included some dicussion, but no e-mails.
I could have posted the e-mails verbatim without any explanation or discussion.
I could have posted something about the other sites running the e-mails, with my own discussion, and then posted the e-mails as well.
In the end, I chose the latter, and tried to make clear the e-mails contain allegations.
Why this choice? The AZ affair has been a daily occurrence and I’ve attempted to track it. I wasn’t the first to post the e-mails this week, but now that these e-mails are circulating, they’ve become part of the story. With that said, I attempted to make clear that the e-mails remain allegations
In other words, this represents an opportunity for the reader to view them directly. Of course, I could simply save space and provide a link to another site, but for the sake of convenience, I’ve run two of the e-mails.
My only policy is this: everything will be considered on a case-by-case basis. By the way, I’m still waiting for AstraZeneca to respond. As you read, requests for interviews with Brennan and Zook were denied. And as Friday at 3:21 p.m., there’s still no comment concerning an internal investigation surrounding off-label marketing. If they ever reply, they’ll get their due.
Peter, thanks for writing with that question. I appreciate it. Each little twist and turn in this tale presents a new challenge. But I’m up for it.
ed
ed
Hi JS,
I missed your comment, because I started responding to the first two comments, then switched screens and didn’t realize you wrote something until just now.
So to respond: yes, I do have an obligation to report on what’s going on. And ultimately, that’s what drove me to make the choice I made (please see my comment above this one).
My experience with the ‘ring of truth’ has taught me to be cautious, but not invisible.
Thanks for your note.
ed
JS
Hi Ed,
I can appreciate your position as a reporter you duty is try to get the facts and produce a credible product. I guess what I see is the story behind the story but perhaps you as a journalist need proof the story is real first. My gut tells me it is real but even if I found it be a hoax it still uncovers at the very least what is wrong with these big pharma machines. That is the story that needs to be told what the heck is going on here.? Where is the accountability to employees, physicians, and patients. When big pharm committs bad acts what are the companies doing to report it and essentially what are they doing make it right. I have seen people reduced to shadows of their former self because of this process. It is not easy for us to wade through what the process is let alone what the outcome may be. The process itself is hidden from us and nothing will be discussed openly. The ethical people end up going to ground and the managers keep grinding the sales out at any cost. You might think it has gotten better with all the regulations but it hasn’t the unethical people just got more creative. This problem is industry wide although you can tell by the recent past what companies are more prone to bad acts. I enjoy your reporting, it has inspired me to try for some balance except I am on the receiving end of Pfizer’s corporate machine right now so I am less likely to be objective…Thanks again
JS
ed
Hi JS,
I understand what you’re saying and don’t doubt your perspecive. And quite frankly, yes, I’m always interested in evidence, but I also have a gut. And as I said earlier, being cautious isn’t the same thing as being invisible.
I chose to follow this and post what I did because I believe the issues being raised are important. For that reason, I deliberately chose not to remain on the sidelines.
One thing that may not be clear to Pharmalot readers is that I’ve worked for The Star-Ledger of New Jersey as a buiness writer for 12 years and covered the pharmaceutical industry during that entire period.
I suppose I’ve spoken with my share of people who saw things that disturbed them. And I’ve read internal reports and court documents in which all sorts of practices and behaviors took place.
We know the pharmaceutical industry makes money, but how does it make that money? Shining a light on improper activities is something I’ve attempted to do as part of my coverage all those years.
In other words, I understand where you’re coming from and why the process of publicizing the kind of activities as referred to in the AZ Group of 7 e-mails is important. And that’s why I’ve been sticking with the story and posted what I have.
Hope all this is clear. And as always, thanks for writing.
ed
mj
If the Group of Seven have the facts that they have, I hope they are getting good legal advice. They should check out whistleblowerlaws.com if they need help, it takes guts to do what they are doing.
mj
If the Group of Seven have the facts that they have, I hope they are getting good legal advice. They should check out whistleblowerlaws.com if they need help, it takes guts to do what they are doing.
Mark Cohen
I am amused to see how selective Peter Pitts is on the topic of spreading unsubstantiated gossip. He, of course, is the uncontrite master of the same when it comes to smearing honorable people like Vioxx whistleblower David Graham. I, for one, want to learn more about the Group of Seven’s allegations and second mj’s suggestion that they be sure to get good legal advice, whether from the website noted above or elsewhere, to ensure that justice be done.
Mark Cohen
Food and Drug Safety Director
Government Accountability Project
http://www.whistleblower.org
ed
Hi Mark,
Good to hear from you. And I’m not going to step into the middle of this, but I am happy to see everyone challenge one another.
Through the AZ scandal, I’ve tried to walk my own fine line between running the ‘unsubstantiated gossip’ and writing only what I could verify.
As I’ve explained in other comments, I’m following a story and, at times, this particular story has moved so quickly in sometimes surprising directions that to ignore it entirely may have been the wrong decision. So I’ve weighed each tidbit on its own merits and attempted to present what I kinow and what I don’t know first-hand in some meaniingful context. This is a bit of new frontier, and for me, a new role. So maybe I’ll make a mistake along the way. But its worth the risk.
Anyway, thanks for writing. And stop by again.
ed