AstraZeneca's "Zubegate" is moving over to Abraxis BioScience's message board on CafePharma.
This appears to be a comment by an Abraxis BioScience sales rep. If so it supports what AstraZeneca's "Fantastic 7" have claimed:
"If I were a MSL or DSM, I will be very concerned because they are all complicit in off-label promotions. I have been told many times by my manager to use MSL to promote off-label and NEVER to put anything on email or in writing.
AZ counterpart received the same instruction. It is time we unite and do what the Gang of Seven at AZ has done. We should be policing our MSL, DSM, BF, CM, JH, RAMs, and make sure that we document and report all illegal activities. I still don't know the basis for my ridiculously high sales target!
Showing posts with label Abraxis BioScience. Show all posts
Showing posts with label Abraxis BioScience. Show all posts
Friday, April 20, 2007
Wednesday, April 18, 2007
Did Abraxis BioScience instruct AstraZeneca to use illegal marketing in their quest to increase sales?
In a February 2007 press release, Abraxis BioScience reported record revenue of $765 million in 2006 versus $521 million for 2005. They made that money selling a new version of an old cancer drug at $4,200 per dose.
That new drug is called Abraxane and it has pushed Abraxis BioScience stock from $5 in 2002 to $27 in 2007. The lofty stock price has made Abraxis CEO and Chairman, Dr. Patrick Soon-Shiong a billionaire; Dr. Soon-Shiong owns 84 percent of the stock, today worth about $3.8 billion.
Dr. Patrick Soon-Shiong is controversial; he has been criticized for hyping his research results and he has been accused of ripping off investors. Even his own brother, an early backer, sued him for fraud and fired him—twice—from the company they started. Their fight lasted two years and destroyed their relationship. But in the end, it is Dr. Soon-Shiong who has prevailed.
Today, Dr. Soon-Shiong is making money hand over fist. After all, his “new” drug costs 25 times more than an older, generic version (paclitaxel). There is, however, little difference between the new drug and older therapy; in fact, they both use the same active molecule. The only difference is that in Abraxane paclitaxel is bound to a protein, to make it easier to inject. And Abraxane doesn’t help patients live longer than the old, generic, version of the drug.
It is also noteworthy that an independent review article of Abraxane and similar drugs in “Annals of Oncology” concluded, “do these agents represent anything more than old wine in a new bottle? With currently available data, we have to say, ‘not really’.”
So how has Abraxis BioScience been able to sell so much of a drug that isn’t really much better than the old version and how has Dr. Patrick Soon-Shiong been able to get so rich?
Some AstraZeneca oncology sales reps think they have part of the answer. They claim that those rapidly escalating sales may have been built upon off-label marketing.
AstraZeneca co-promotes Abraxane with Abraxis BioScience, and those sales representatives claim that at a joint sales meeting between AstraZeneca and Abraxis, which took place in December 2006 in Pittsburg, things went awfully wrong.
The meeting was led by AstraZeneca Regional Sales Director Mike Zubillaga, who has since been terminated by AstraZeneca, together with an Abraxis Medical Science Liaison (MSL) and two District Sales Managers; one from Abraxis and one from AstraZeneca.
Eight AstraZeneca oncology sales reps and eight Abraxis reps participated in the training, and they received the assistance of a whopping seven oncologists, who made some extra cash, tutoring the sixteen sales reps.
According to some of those AstraZeneca sales reps, the Abraxis Medical Science Liaison made it known that the Abraxis MSLs were available for off-label discussions (such as lung cancer) with oncology doctors, and that the AstraZeneca reps should use them as a resource. Then the Abraxis District Sales Manager allegedly pointed out that coordination of these meetings should be done by cell phone only, and that email or voicemail should be avoided.
If these allegations are true, this all sounds very familiar.
In May 2004, Pfizer’s subsidiary Warner-Lambert paid a $430 million fine for off-label promotion of Neurontin. The Department of Justice stated that Warner-Lambert “utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.”
And the sales efforts for Abraxane are clearly paying off. Over 20,000 people have been treated with Abraxane, and sales are expected to reach $1 billion by 2010.
But that may not be how things play out.
Because those concerned AstraZeneca sales reps who participated in the meeting with Abraxis BioScience didn’t stay silent. They claim a “Code of Conduct report was submitted through the AstraZeneca hotline shortly thereafter.” They also told me that, “thus far we are not aware of any investigation or interviews by AZ. No official response from them as of today.”
So when AstraZeneca took no visible action, and did not respond, the AstraZeneca oncology sales reps decided to talk to me. And that’s the reason you’re reading this story today.
UPDATE: AstraZeneca has now responded to the sales reps. Five months after the first report was made, they finally left a message on the hotline for their internal whistleblowers, AFTER the story was leaked to the press.
That new drug is called Abraxane and it has pushed Abraxis BioScience stock from $5 in 2002 to $27 in 2007. The lofty stock price has made Abraxis CEO and Chairman, Dr. Patrick Soon-Shiong a billionaire; Dr. Soon-Shiong owns 84 percent of the stock, today worth about $3.8 billion.
Dr. Patrick Soon-Shiong is controversial; he has been criticized for hyping his research results and he has been accused of ripping off investors. Even his own brother, an early backer, sued him for fraud and fired him—twice—from the company they started. Their fight lasted two years and destroyed their relationship. But in the end, it is Dr. Soon-Shiong who has prevailed.
Today, Dr. Soon-Shiong is making money hand over fist. After all, his “new” drug costs 25 times more than an older, generic version (paclitaxel). There is, however, little difference between the new drug and older therapy; in fact, they both use the same active molecule. The only difference is that in Abraxane paclitaxel is bound to a protein, to make it easier to inject. And Abraxane doesn’t help patients live longer than the old, generic, version of the drug.
It is also noteworthy that an independent review article of Abraxane and similar drugs in “Annals of Oncology” concluded, “do these agents represent anything more than old wine in a new bottle? With currently available data, we have to say, ‘not really’.”
So how has Abraxis BioScience been able to sell so much of a drug that isn’t really much better than the old version and how has Dr. Patrick Soon-Shiong been able to get so rich?
Some AstraZeneca oncology sales reps think they have part of the answer. They claim that those rapidly escalating sales may have been built upon off-label marketing.
AstraZeneca co-promotes Abraxane with Abraxis BioScience, and those sales representatives claim that at a joint sales meeting between AstraZeneca and Abraxis, which took place in December 2006 in Pittsburg, things went awfully wrong.
The meeting was led by AstraZeneca Regional Sales Director Mike Zubillaga, who has since been terminated by AstraZeneca, together with an Abraxis Medical Science Liaison (MSL) and two District Sales Managers; one from Abraxis and one from AstraZeneca.
Eight AstraZeneca oncology sales reps and eight Abraxis reps participated in the training, and they received the assistance of a whopping seven oncologists, who made some extra cash, tutoring the sixteen sales reps.
According to some of those AstraZeneca sales reps, the Abraxis Medical Science Liaison made it known that the Abraxis MSLs were available for off-label discussions (such as lung cancer) with oncology doctors, and that the AstraZeneca reps should use them as a resource. Then the Abraxis District Sales Manager allegedly pointed out that coordination of these meetings should be done by cell phone only, and that email or voicemail should be avoided.
If these allegations are true, this all sounds very familiar.
In May 2004, Pfizer’s subsidiary Warner-Lambert paid a $430 million fine for off-label promotion of Neurontin. The Department of Justice stated that Warner-Lambert “utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.”
And the sales efforts for Abraxane are clearly paying off. Over 20,000 people have been treated with Abraxane, and sales are expected to reach $1 billion by 2010.
But that may not be how things play out.
Because those concerned AstraZeneca sales reps who participated in the meeting with Abraxis BioScience didn’t stay silent. They claim a “Code of Conduct report was submitted through the AstraZeneca hotline shortly thereafter.” They also told me that, “thus far we are not aware of any investigation or interviews by AZ. No official response from them as of today.”
So when AstraZeneca took no visible action, and did not respond, the AstraZeneca oncology sales reps decided to talk to me. And that’s the reason you’re reading this story today.
UPDATE: AstraZeneca has now responded to the sales reps. Five months after the first report was made, they finally left a message on the hotline for their internal whistleblowers, AFTER the story was leaked to the press.
Tuesday, April 17, 2007
AstraZeneca Oncology Scandal Spreading to Biotech Company?
Back in April 2006, AstraZeneca decided to do a deal with Abraxis BioScience to co-promote the cancer therapy ABRAXANE, see press release here.
But as you already know, problems were brewing in the AstraZeneca Oncology sales force.
And one of the persons, now known as the AstraZeneca "Fantastic Seven" whistleblowers decided to speak up. This person did that on CafePharma on March 15, 2007, and wrote to me this morning and said that the following posts on this message thread on CafePharma "are real."
We all know that CafePharma is an ongoing mud fight, notorious for all kinds of nasty language, gossip and unsubstantiated claims.
But, let's play along and see what the whistleblower who brought down AZ Oncology Regional Sales Director Mike Zubillaga, claims "to be real":
#32 Just got back from an Abraxane meeting in Pittsburgh with our Abraxis counterparts. The Abraxis manager told all of us not to use email when dealing with Regional Scientific Managers but to stick to cells phones.AZ's Mid-Atlantic Abraxane DSM 'RD' was present & said nothing. This leads me to believe that what they are asking us to do is illegal. Is anyone else seeing this in other parts of the country?
#33 Lemme guess..help the RSM recruit for ad boards and sell Abraxane off-label. Keep it quiet. No email or voicemail. Cell phones only.
#35 Avoiding email is a way to hide evidence. I remember getting off the bus at a national oncology meeting years ago and being asked for my laptop so they could record the hard drive. This was during the Zoladex investigation. They pieced together every suspicious transaction. That included business plans, email, work day appraisals, evaluations and call notes. When reps were questioned they had everything laid out in chronological order. We were also told that at any time a federal investigator could knock on our with a subpeona. Comforting thoughts. So if you want to "be happy" that's fine. Just remember that if things go south the managers will step aside and let you take the blame because you signed off on the policy and can't produce a CYA document.
#36 This reminds me of the Neurontin case where MSL/RSMs were used to promote off-label:http://www.fda.gov/fdac/features/2004/404_wl.html"Warner-Lambert also used "medical liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin."
#38 The off-label promotion of Abraxane IV or Faslodex injection would be considered fraud under the False Claims Act
Clearly none of this is actual proof of anything. But considering what has been going on inside AstraZeneca over the past couple of weeks, and considering that this whistleblower has already been proven right once, he may be right about this too.
I guess AstraZeneca's legal department just got one more issue to investigate and send to the OIG per their Corporate Integrity Agreement.
As for Abraxis BioScience, they better make sure they start their own probe.
Wouldn't look good if AstraZeneca came clean and Abraxis got caught with their pants down. Not that we know if anyone has done anything wrong.
But once the accusations start flying like mud in the air, friendly co-promotion partners can rapidly tear each other apart.
But as you already know, problems were brewing in the AstraZeneca Oncology sales force.
And one of the persons, now known as the AstraZeneca "Fantastic Seven" whistleblowers decided to speak up. This person did that on CafePharma on March 15, 2007, and wrote to me this morning and said that the following posts on this message thread on CafePharma "are real."We all know that CafePharma is an ongoing mud fight, notorious for all kinds of nasty language, gossip and unsubstantiated claims.
But, let's play along and see what the whistleblower who brought down AZ Oncology Regional Sales Director Mike Zubillaga, claims "to be real":
#32 Just got back from an Abraxane meeting in Pittsburgh with our Abraxis counterparts. The Abraxis manager told all of us not to use email when dealing with Regional Scientific Managers but to stick to cells phones.AZ's Mid-Atlantic Abraxane DSM 'RD' was present & said nothing. This leads me to believe that what they are asking us to do is illegal. Is anyone else seeing this in other parts of the country?
#33 Lemme guess..help the RSM recruit for ad boards and sell Abraxane off-label. Keep it quiet. No email or voicemail. Cell phones only.
#35 Avoiding email is a way to hide evidence. I remember getting off the bus at a national oncology meeting years ago and being asked for my laptop so they could record the hard drive. This was during the Zoladex investigation. They pieced together every suspicious transaction. That included business plans, email, work day appraisals, evaluations and call notes. When reps were questioned they had everything laid out in chronological order. We were also told that at any time a federal investigator could knock on our with a subpeona. Comforting thoughts. So if you want to "be happy" that's fine. Just remember that if things go south the managers will step aside and let you take the blame because you signed off on the policy and can't produce a CYA document.
#36 This reminds me of the Neurontin case where MSL/RSMs were used to promote off-label:http://www.fda.gov/fdac/features/2004/404_wl.html"Warner-Lambert also used "medical liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin."
#38 The off-label promotion of Abraxane IV or Faslodex injection would be considered fraud under the False Claims Act
Clearly none of this is actual proof of anything. But considering what has been going on inside AstraZeneca over the past couple of weeks, and considering that this whistleblower has already been proven right once, he may be right about this too.
I guess AstraZeneca's legal department just got one more issue to investigate and send to the OIG per their Corporate Integrity Agreement.As for Abraxis BioScience, they better make sure they start their own probe.
Wouldn't look good if AstraZeneca came clean and Abraxis got caught with their pants down. Not that we know if anyone has done anything wrong.
But once the accusations start flying like mud in the air, friendly co-promotion partners can rapidly tear each other apart.
Subscribe to:
Posts (Atom)