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okarol
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« on: June 17, 2011, 08:20:15 PM »

Amgen in Criminal Probe Over $1.5M Gift That Allegedly Supressed Witness Testimony

By Jim Edwards | June 17, 2011

Amgen (AMGN) has failed in an attempt to restrict an investigation by prosecutors holding criminal grand jury hearings into the contents of several employee whistleblower cases, including one which alleges Amgen paid $1.5 million to suppress testimony at a trial which established the company’s patent rights to Epogen, a kidney drug. The federal court ruling allows prosecutors to continue talking to past and current Amgen employees without management’s permission. Epogen, which treats anemia in kidney dialysis patients, made $2.5 billion for Amgen in 2010.

The ruling is a disaster for Amgen CEO Kevin Sharer, whose company has long sought to keep secret the complaints of its current and former employees.

Amgen uses binding arbitration contracts with its workers to prevent them from using the federal courts to sue if they believe the company has broken the law. In the last few years, a handful of those cases have landed in federal court anyway. Three cases allege that Amgen sales reps have rifled through confidential medical records looking for potential new patients for its products; and several allege that former sales reps and other executives believe Amgen is giving kickbacks to doctors to prescribe its drugs. Five former Amgen employees asserted their Fifth Amendment rights against self-incrimination in the latter case.

Who invented Epogen?

The allegation of the $1.5 million payment came in a dismissed whistleblower lawsuit filed by Darrell Dotson, an in-house patent litigation attorney at Amgen. He alleges that when Amgen went to trial against Roche in 2007 over the ownership of the patent rights to Epogen, Amgen’s lawyers agreed to give a $1.5 million endowment to the University of Washington, creating the Joseph W. Eschbach Endowed Chair in Kidney Research at the university’s Division of Nephrology. The endowment was in recognition of development work on Epogen done by Dr. Eugene Goldwasser, who originally isolated the proteins that led to the invention of Epogen. The endowment, Dotson alleges, satisfied two other academic witnesses in the case who felt that “Goldwasser had gotten screwed by Amgen.” Amgen maintained at trial that the sole owner of the Epogen patent was one of its own employees, Dr. Fu-Quen Lin.

Dotson claims he confronted Amgen’s lawyers during the trial to ask why they had donated such a large sum. One asked Dotson if it made any difference if “it was an endowed chair, not a payment to Goldwasser?”

With the endowment in place, Dotson alleges, witness testimony by Goldwasser’s colleagues helped convince a jury that Lin and Amgen indeed owned the Epogen patent. Goldwasser died in 2010. The Dotson case was voluntarily dismissed without prejudice, meaning he has the right to refile it in the future.

Probe ongoing since 2006

The new court ruling reveals that the Eastern District of New York’s U.S. Attorney’s office has been conducting a criminal probe of Amgen since 2006. Amgen initially cooperated with five subpoenas featuring 90 requests for information, gave the feds 3.5 million pages of documents and responded to numerous other informal requests for information, according to a preliminary ruling in the case.

But then prosecutors began contacting Amgen employees privately at their homes. Amgen, believing prosecutors had broken the “no contact” rule which bans lawyers from contacting directly clients who have their own lawyers, sought to prevent the interviews.

The judge ruled the visits were legitimate, and in so doing allowed prosecutors’ grand jury investigation to proceed. The feds have also shown interest in a case filed by former Amgen pharmacist Kassie Westmoreland and one from former Amgen senior project manager Shawn O’Brien.

The only good news for Amgen here is that the criminal case is probably years away from resolution. But if it turns up evidence that Dotson’s allegations are true, it could double Amgen’s normal liability: Roche, undoubtedly, would seek to return to court to appeal a verdict it could argue was tainted.



Read more: http://www.bnet.com/blog/drug-business/amgen-in-criminal-probe-over-15m-gift-that-allegedly-supressed-witness-testimony/8769#ixzz1Patd49Jd
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« Reply #1 on: June 18, 2011, 06:09:17 AM »

"This is the greatest honor of my career," said Dr. Eschbach in August 2007 upon learning of the endowed $1.5 million chair in his name (paid for by Amgen).  Dr. Eschbach died on Sept 7, 2007, days after that statement.  Dr. Eugene Goldwasser was still alive at that time, but he probably didn't testify at the Roche trial.

Wow, did Amgen lawyers actually said this endowment for Eschbach was a payoff to silence Goldwasser?  Well, that is what Dotson is claiming.

Amgen in Criminal Probe Over $1.5M Gift That Allegedly Supressed Witness Testimony

By Jim Edwards | June 17, 2011Who invented Epogen?

The allegation of the $1.5 million payment came in a dismissed whistleblower lawsuit filed by Darrell Dotson, an in-house patent litigation attorney at Amgen. He alleges that when Amgen went to trial against Roche in 2007 over the ownership of the patent rights to Epogen, Amgen’s lawyers agreed to give a $1.5 million endowment to the University of Washington, creating the Joseph W. Eschbach Endowed Chair in Kidney Research at the university’s Division of Nephrology. The endowment was in recognition of development work on Epogen done by Dr. Eugene Goldwasser, who originally isolated the proteins that led to the invention of Epogen. The endowment, Dotson alleges, satisfied two other academic witnesses in the case who felt that “Goldwasser had gotten screwed by Amgen.” Amgen maintained at trial that the sole owner of the Epogen patent was one of its own employees, Dr. Fu-Quen Lin.

Dotson claims he confronted Amgen’s lawyers during the trial to ask why they had donated such a large sum. One asked Dotson if it made any difference if “it was an endowed chair, not a payment to Goldwasser?”

With the endowment in place, Dotson alleges, witness testimony by Goldwasser’s colleagues helped convince a jury that Lin and Amgen indeed owned the Epogen patent. Goldwasser died in 2010. The Dotson case was voluntarily dismissed without prejudice, meaning he has the right to refile it in the future.
Read more: http://www.bnet.com/blog/drug-business/amgen-in-criminal-probe-over-15m-gift-that-allegedly-supressed-witness-testimony/8769#ixzz1Patd49Jd
« Last Edit: June 18, 2011, 06:11:25 AM by greg10 » Logged

Newbie caretaker, so I may not know what I am talking about :)
Caretaker for my elderly father who has his first and current graft in March, 2010.
Previously in-center hemodialysis in national chain, now doing NxStage home dialysis training.
End of September 2010: after twelve days of training, we were asked to start dialyzing on our own at home, reluctantly, we agreed.
If you are on HD, did you know that Rapid fluid removal (UF = ultrafiltration) during dialysis is associated with cardiovascular morbidity?  http://ihatedialysis.com/forum/index.php?topic=20596
We follow a modified version: UF limit = (weight in kg)  *  10 ml/kg/hr * (130 - age)/100

How do you know you are getting sufficient hemodialysis?  Know your HDP!  Scribner, B. H. and D. G. Oreopoulos (2002). "The Hemodialysis Product (HDP): A Better Index of Dialysis Adequacy than Kt/V." Dialysis & Transplantation 31(1).   http://www.therenalnetwork.org/qi/resources/HDP.pdf
Bill Peckham
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« Reply #2 on: June 18, 2011, 01:25:30 PM »


I was very involved in the creation of the Eschbach chair and I am kinda upset about this article (I'm glad Greg responded or would have missed it). One thing that is just factually wrong is that Amgen donated 1.5 million to establish the Eschbach chair. Kirin Amgen donated 1 million to upgrade a recently established Eschback professorship (Northwest Kidney Centers had donated the .5 million to establish the professorship), so this idea that Amgen donated 1.5 million is factually wrong.

I’m an unabashed fan of Dr. Eschbach, and for very good reason. In the early ’60s Scribner gave his Fellows different problems arising from longterm dialysis. For instance Sherrard got bone metabolism and Eschbach got anemia. This would have been the mid ’60s.

In 1969 Eschbach joins with Adamson (a hematologist) to do sheep studies. In the basement of the first outpatient kidney center in Seattle (and thus the first outpatient kidney center in the world), Eschbach and Adamson do experiments on sheep. As I understand it they exsanguinated one set of sheep thereby inducing amemia. They then collected the EPO rich plasma from the sheep with induced anemia and infused it into a sheep named Brunhilda in which they had induced anemia (by removing Brunhilda's kidneys they induced the same sort of anemia Scribner et al had noticed in dialyzors), they then sustained Brunhilda via dialysis.

This final step of taking the EPO rich plasma and injecting it reversed the anemia in Brunhilda.  I suspect that Echbach and Adamson's experiments with sheep, if nothing else, gave the green light to Goldwasser to use his precious sample of EPO. Goldwasser comes in to the story after Eschbach.

One thing to note is that Eschbach had a large practice during the day. He was the Medical Director of the home hemodialysis program at Northwest Kidney Centers (the first HHD program in the world). He followed many dialyzors through his practice at Minor and James a large Seattle medical practice. Imagine your doctor working nights to solve a problem that plagues you and everyone else on dialysis. And then succeeding. I feel like this article is slandering Joe who should be a hero to anyone whose anemia is treated with EPO.

Today the holder of the Eschbach chair serves as the director of the Kidney Research Institute, a partnership between Northwest Kidney Centers and University of Washington School of Medicine. Since its launch three years ago the KRI has generated over 20 million dollars in NIH funding, bring desperately needed resources to understanding CKD. I serve on the KRI council and was part of the group that founded the KRI and established the Eschbach chair. I know how it came about and Eugene Goldwasser claims on Amgen did not play role.

GRRRRRRRRRRRR

EDITED to correct Dolly to Brunhilda

"This is the greatest honor of my career," said Dr. Eschbach in August 2007 upon learning of the endowed $1.5 million chair in his name (paid for by Amgen).  Dr. Eschbach died on Sept 7, 2007, days after that statement.  Dr. Eugene Goldwasser was still alive at that time, but he probably didn't testify at the Roche trial.

Wow, did Amgen lawyers actually said this endowment for Eschbach was a payoff to silence Goldwasser?  Well, that is what Dotson is claiming.

Amgen in Criminal Probe Over $1.5M Gift That Allegedly Supressed Witness Testimony

By Jim Edwards | June 17, 2011Who invented Epogen?

The allegation of the $1.5 million payment came in a dismissed whistleblower lawsuit filed by Darrell Dotson, an in-house patent litigation attorney at Amgen. He alleges that when Amgen went to trial against Roche in 2007 over the ownership of the patent rights to Epogen, Amgen’s lawyers agreed to give a $1.5 million endowment to the University of Washington, creating the Joseph W. Eschbach Endowed Chair in Kidney Research at the university’s Division of Nephrology. The endowment was in recognition of development work on Epogen done by Dr. Eugene Goldwasser, who originally isolated the proteins that led to the invention of Epogen. The endowment, Dotson alleges, satisfied two other academic witnesses in the case who felt that “Goldwasser had gotten screwed by Amgen.” Amgen maintained at trial that the sole owner of the Epogen patent was one of its own employees, Dr. Fu-Quen Lin.

Dotson claims he confronted Amgen’s lawyers during the trial to ask why they had donated such a large sum. One asked Dotson if it made any difference if “it was an endowed chair, not a payment to Goldwasser?”

With the endowment in place, Dotson alleges, witness testimony by Goldwasser’s colleagues helped convince a jury that Lin and Amgen indeed owned the Epogen patent. Goldwasser died in 2010. The Dotson case was voluntarily dismissed without prejudice, meaning he has the right to refile it in the future.
Read more: http://www.bnet.com/blog/drug-business/amgen-in-criminal-probe-over-15m-gift-that-allegedly-supressed-witness-testimony/8769#ixzz1Patd49Jd
« Last Edit: June 18, 2011, 01:49:53 PM by Bill Peckham » Logged

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« Reply #3 on: June 18, 2011, 05:58:54 PM »

"This is the greatest honor of my career," said Dr. Eschbach in August 2007 upon learning of the endowed $1.5 million chair in his name (paid for by Amgen).  Dr. Eschbach died on Sept 7, 2007, days after that statement.  Dr. Eugene Goldwasser was still alive at that time, but he probably didn't testify at the Roche trial.

Wow, did Amgen lawyers actually said this endowment for Eschbach was a payoff to silence Goldwasser?  Well, that is what Dotson is claiming.



The whistleblower isn't saying they bought Goldwasser's silence - if you read the suit (LINK) the whistleblower - Dotson - is saying that the Eschbach Chair influenced the testimony of a doctor named Browne.  Dotson is saying that the only way Browne would be willing to testify in the Amgen v Roche trial was if Goldwasser was given credit for EPO by Amgen. Browne testified that Lin, Amgen's scientist whose name is on the EPO patents, deserved the credit for the innovative spark behind the patents; Roche needed the court to believe that Goldwasser's research was the innovative spark and subsequent research by Lin was obvious. Roche lost.


Dotson is saying there must have been a payout because in his heart Dr. Browne (and another doc, Dr Egrie) knew that Goldwasser deserved the patent credit and since Browne testified that Lin deserved the credit patent-wise for EPO it must mean there was a payoff to Goldwasser.

Dotson's claims to have had conversations that let him put this together with the key piece of "evidence" that there is an Eschbach Chair and that it was established around the same time as the trial by a donation from Kirin Amgen.

I think Dotson has his head up his ass. The Eschbach Chair was established when it was because Eschbach was dying, it was a race to secure the chair before the cancer took him.  The whole theory of this case makes no sense.
« Last Edit: June 18, 2011, 06:05:35 PM by Bill Peckham » Logged

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Incenter Hemodialysis: 1990 - 2001
Home Hemodialysis: 2001 - Present
NxStage System One Cycler 2007 - Present
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« Reply #4 on: June 18, 2011, 06:40:18 PM »

Thanks for the link and detailed explanation, Bill.  Makes for interesting reading.  No doubt Dotson could just be making these claims to get to the whistle blower's reward.  It is interesting though, from reading Dotson's claim, that Dr. Browne was not a witness for Amgen until the endowment was officially announced.

The two url mentioned in the suit:
http://thedaily.washington.edu/2007/10/11/endowed-chair-in-kidney-research-honors-late/
http://web.archive.org/web/20080828035603/http://www.nwkidney.org/aboutUs/news/KRIpressrelease.html

Dotson's claim that he heard from another lawyer that Dr. Egrie and Dr. Browned demanded Amgen pay Dr. Goldwasser $1 million for his work:



"This is the greatest honor of my career," said Dr. Eschbach in August 2007 upon learning of the endowed $1.5 million chair in his name (paid for by Amgen).  Dr. Eschbach died on Sept 7, 2007, days after that statement.  Dr. Eugene Goldwasser was still alive at that time, but he probably didn't testify at the Roche trial.

Wow, did Amgen lawyers actually said this endowment for Eschbach was a payoff to silence Goldwasser?  Well, that is what Dotson is claiming.

..
http://i.bnet.com/blogs/amgen-dotson-comp.pdf?tag=content;drawer-container

I think Dotson has his head up his ass. The Eschbach Chair was established when it was because Eschbach was dying, it was a race to secure the chair before the cancer took him.  The whole theory of this case makes no sense.
« Last Edit: June 18, 2011, 06:42:19 PM by greg10 » Logged

Newbie caretaker, so I may not know what I am talking about :)
Caretaker for my elderly father who has his first and current graft in March, 2010.
Previously in-center hemodialysis in national chain, now doing NxStage home dialysis training.
End of September 2010: after twelve days of training, we were asked to start dialyzing on our own at home, reluctantly, we agreed.
If you are on HD, did you know that Rapid fluid removal (UF = ultrafiltration) during dialysis is associated with cardiovascular morbidity?  http://ihatedialysis.com/forum/index.php?topic=20596
We follow a modified version: UF limit = (weight in kg)  *  10 ml/kg/hr * (130 - age)/100

How do you know you are getting sufficient hemodialysis?  Know your HDP!  Scribner, B. H. and D. G. Oreopoulos (2002). "The Hemodialysis Product (HDP): A Better Index of Dialysis Adequacy than Kt/V." Dialysis & Transplantation 31(1).   http://www.therenalnetwork.org/qi/resources/HDP.pdf
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« Reply #5 on: June 18, 2011, 06:50:29 PM »

Just a thought from my paralegal classes....Evidence doesn't have to be real to be allowed into a trial.  It has to be reasonable, not proven.  If I submit a handwritten will and testify that I know it was written by the deceased because I worked with him for years and I know what his handwriting looks like - that's sufficient to make it admissible.  That doesn't mean it isn't a forgery.  It's up to the other side to call in the handwriting expert and the other people who knew the deceased's handwriting to rebut my testimony.  And after all of that - it's up to the jury to decide who they believe.

Dotson can claim anything, more or less, as long as he's got some way to make it reasonable for the judge to let it be entered into evidence.  He may be telling the truth; he might not be - but it's up to the jury in the long run.
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« Reply #6 on: June 18, 2011, 09:21:16 PM »

So even if you accept that what Dotson says he heard he did hear AND that it is true - that Browne wouldn't testify until Amgen pay Goldwasser one million dollars (you have to say that in a doctor evil voice), let's say all that is true. How does establishing an Eschbach Chair equate to paying Goldwasser? No where in the complaint does Dotson suggest a connection between the two doctors. Let alone a connection between Browne and Eschbach.

It doesn't make sense.

Edited to note:  There is one other link mentioned in the complaint http://en.wikipedia.org/wiki/Joseph_W._Eschbach
It's Eschbach's Wikipedia entry which I largely wrote
« Last Edit: June 18, 2011, 09:25:58 PM by Bill Peckham » Logged

http://www.billpeckham.com  "Dialysis from the sharp end of the needle" tracking  industry news and trends - in advocacy, reimbursement, politics and the provision of dialysis
Incenter Hemodialysis: 1990 - 2001
Home Hemodialysis: 2001 - Present
NxStage System One Cycler 2007 - Present
        * 4 to 6 days a week 30 Liters (using PureFlow) @ ~250 Qb ~ 8 hour per treatment FF~28
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« Reply #7 on: June 19, 2011, 11:01:16 AM »

I'd also be interested to hear the context behind that demand.  Was it a formal written letter?  A statement made before reliable witnesses in a formal setting, such as settlement talks?

Or was it an off-hand comment expressing disgust that they didn't follow through on or seriously mean in the first place?  Who hasn't said something like "I'm not going to do X unless Y happens," even when they are obviously going to do X anyhow?  Such as "I'm not going to pay my taxes until the state fixes the potholes on my road!"
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"Asbestos Gelos"  (As-bes-tos yay-lohs) Greek. Literally, "fireproof laughter".  A term used by Homer for invincible laughter in the face of death and mortality.

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