Talk:Epoetin alfa

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Epogen consent required.

I was very ill in 2014 with cancer and on 2 chemotherapies, both given in two administrations. When my blood values began to plummet even before the second nadir, I was given Neupogen (13 doses) and Epogen (1 dose). Although I was too sick to know what the form I signed said (I also had a fever, dehydration, and severe nausea and vomiting), I had to give signed consent for the Epogen, but not the Neupogen. I do not know if this is a universal practice, but you see at the top of this webpage from drugs.com, in emboldened, capitalized text, "WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE". So maybe signed consent is universal: https://www.drugs.com/pro/epogen.html Thank you, Wordreader (talk) 04:45, 4 January 2017 (UTC)[reply]

new section

This all needs to be reviewed and citations fixed. It contains unsourced content and editorializing that needs to go or be sourced.

Litigation and arbitration ==

The Ortho Pharmaceutical Corporation vs. Amgen, Inc. JAMS/ENDISPUTE Arbitration On September 30, 1985, Johnson & Johnson's wholly owned subsidiary, Ortho Pharmaceutical Corporation (whose name was later changed to Ortho Biotech Products, Inc, then Ortho Biotech Products, LP, and then to its present name of Janssen Biotech)(hereafter "Ortho") and Amgen, Inc., entered into a Product License Agreement which provided for the promotion, marketing and sale of Epoietin alfa, under the name of Procrit by Ortho and Epogen by Amgen. The Agreement provided for secret arbitrations to resolve differences and since early 1989,these arbitrations were conducted under the auspices of JAMS (Judicial Arbitration and Mediation Services)/ENDISPUTE, a private company. This Product License Agreement resulted in some of the most massive litigation in the history of the United States.

The relationship between Ortho and Amgen deteriorated substantially almost immediately. At the heart of the relationship was the contractual limitation of Amgen to sell to the dialysis market and Ortho to the rest of the Epoetin alfa market. Alleging breaches of the Product License Agreement, on August 31, 1995, Amgen sought termination of the contract in a private, secret arbitration because of Ortho's illegal breaches and also sought price erosion damages forced by Ortho's illegal competition. <8/31/95 Amgen's Demand For Termination of the Product License Agreement, Accounting of Ortho's Spillover Sales, and Damages filed in Ortho Pharmaceutical Corp. vs. Amgen, Inc., obtained in discovery by Paul E. Simmerly, Attorney for Mark Duxbury, in Duxbury vs. Ortho Biotech Products, King County Superior Court Cause No. 01-2-19764-9 SEA> Procrit was Johnson & Johnson's most profitable product. For several years, Epoetin alfa has accounted for the single greatest drug expenditure paid by the United States Medicare system; in 2010, it was $2 billion.

This secret JAMS/ENDISPUTE arbitration lasted for over seven years, with the final hearing in the case lasting five months. Mark Duxbury, a former Procrit salesperson for Ortho and a key witness for Amgen, was deposed three times and testified for two days at the final hearing. He estimated that ten to twenty million pages of documents had been produced and that over one hundred attorneys were in the room when he testified. He was informed that a similar number of attorneys were present during each day of the five month final hearing. <8/21/02 Declaration of Plaintiff Mark E. Duxbury in Opposition to Defendant's Motions For Protective Order and To Quash Depositions, Duxbury vs. Ortho Biotech, Inc., King County Superior Court Cause No. 01-2-19764-9 SEA.>

At the close of the final hearing in the secret arbitration, the attorneys for Ortho stated in a written closing argument as follows:

"III. Amgen's Conspiracy Theory is Contrary to the Sworn Testimony of Ortho Executives.

Amgen asks Your Honor to reject, virtually in whole, the testimony of Ortho executives as perjury. Executive after executive from Ortho testified about the reasons why the company implemented the programs it did, its analysis of its marketing opportunities and its efforts to limit dialysis sales. If this testimony is true, the Amgen's case utterly fails. In that event, the documented handful of FSDC sales reflects no more, and no less, than this reality: they were simply an incidental and unintended by-product of Ortho's efforts to obtain its legitimate market.

Thus, Amgen is forced to take an extraordinary litigation position. It must argue, as it has, that every senior member of Ortho's management has secretly conspired to breach the Product License Agreement and to lie about it when questioned under oath. This go-for-broke strategy collapses under the weight of its utter implausibility." <Closing argument of attorneys for Ortho Biotech in Ortho Pharmaceutical Corp. vs. Amgen, ENDISPUTE ARBITRATION>

On October 18, 2002, Arbitrator Frank J. McGarr, retired federal judge, decided the case in favor of Amgen and awarded $150 million in damages and later ordered another $150 million to Amgen for attorney fees.

In his Memorandum Opinion and Order dated October 18, 2002, Arbitrator McGarr made the following findings:

"Amgen has set forth the conduct of Ortho in breach of the Product License Agreement, not only by errant sales representatives, but also with the knowledge of and tacit approval of some Ortho Executives. The evidence demonstrates such conduct...And Ortho executives testify, some not convincingly, that they had no knowledge...Ortho knew or should have known what its sales reps were doing and all the evidence demonstrates the inadequacy of its controls...Amgen's evidence of sales rep's misconduct was compelling. And equally compelling is the evidence that Ortho management knew what was going on...Ortho's illegal conduct was aggressive and brazen, and Amgen's sensitivity to its competition was understandable...."

<10/18/02 ENDISPUTE ARBITRATION MEMORANDUM OPINION AND ORDER of Hon. Frank J. McGarr, Esq.>

Medicare Fraud and criminal guilty plea in the promotion, marketing and sale of Aranesp From 2004 through 2011, ten civil actions were commenced by whistleblowers under the provisions of the False Claims Act (or "Qui Tam" law), 11 U.S.C. Sec. 3729, against Amgen, Inc. alleging that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. The False Claims Act allows privates citizens to bring civil actions on behalf of the United States and share in the recovery. It is the primary way the United States recovers damages for fraud. Despite this important public purpose, and the fact that whistleblowers often make tremendous personal and professional sacrifices to bring their claims, the federal courts have come up with the derogatory term of "parasitic" to describe some categories of unsuccessful claimants.

If the Department of Justice ("DOJ") determines that the case is meritorious, the government is allowed to intervene in the case and take it over from the private litigants. The Department of Justice did so and, on December 19,2012, a settlement was reached between the Department of Justice and Amgen, Inc. whereby Amgen pled guilty to the crime of Illegally Introducing Drug into Market for Uses That the FDA Declined to Approve and agreed to pay $762 million to resolve its criminal liability and the False Claims Act allegations against it. The settlement represented the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history. All ten claimants shared in the reward. <12/19/12 Department of Justice Press Release, doj.gov>

The DOJ's criminal information alleged the following: Beginning at the launch of Aranesp in 2002 and extending until 2007, Amgen illegeally introduced Aranesp for uses and at doses levels that the FDA had specifically declined to approve due to insufficient clinical evidence to establish their safety and efficacy. In particular, Amgen illegally introduced Aranesp into the oncology and nephrology ESA markets, intending that it be used for patients suffering from anemia due to chronic kidney disease or chemotherapy at off-label, unapproved doses that were larger and less frequently administered than those approved by the FDA for these patient populations. Amgen also illegally introduced Aranesp into the oncology ESA market intending that it be used to treat anemia caused by cancer, irrespective of whether the patient had been prescribed chemotherapy - a use which the FDA had never approved and which the FDA subsequently determined caused an increase risk of death. In particular, in 2007, the FDA mandated that a "black box" label be added to Aranesp's label, warning that Aranesp "increased the risk of death...in patients with active malignant disease (cancer) receiving neither chemotherapy nor radiation." At approximately the time that the FDA issued the black box warning, Amgen ceased its promotion of Aranesp for the treatment of anemia caused by cancer rather than the cancer's treatment. Amgen's internal sales and marketing materials made plain that Amgen's misbranding of Aranesp was the company's core business strategy to gain market share from its only ESA competitor, Procrit, sold by Johnson & Johnson. At the time of Aranesp's 2002 launch, doctors typically prescribed Procrit to treat the anemic patient populations for which Aranesp was approved. To compete with Procrit, Amgen built the Aranesp commercial strategy around the unapproved, off-label approach of a less frequent dosing schedule, which Amgen sales representatives argued was more convenient for patients and more profitable for doctors. Amgen implemented this illegal commercial effort through its promotion of off-label doses from two to four times larger than those approved by the FDA, administered far less frequently than approved by the FDA. <12/19/12 Department of Justice Press Release, doj.gov>

The civil settlement contained similar allegations and further that Amgen used journal articles that were insufficient to support the safety and efficacy of the off-label uses at issue, and improperly obtained listings in medical compendia in an effort to establish that the off-label uses were medically accepted, and thereby eligible for coverage by federal health care programs. <12/19/12 Department of Justice Press Release, doj.gov>

United States of America ex rel. Floyd Landis vs. Tailwind Sports Corp. and Lance Armstrong, et al. Since the mid-1980's, Epoetin alfa "EPO", an anti-fatigue drug, has been used illegally by endurance athletes, including bicycle racers, to win competitions. This use is referred to as "doping". In many instances, the use of this drug has been fatal. The make of EPO, Amgen, has sponsored the Tour of California Bicycle Race. <Armstrong's fraud paralleled EPO-makers' feud, Cycling News,Kathleen Sharp> <10/11/12 A Drug to Quicken the Blood, NY Times Op-Ed Contributor Kathleen Sharp>

On April 19, 2018, a settlement was announced in the case of United State of America ex rel. Floyd Landis vs. Tailwind Sports Corp. and Lance Armstrong, et al., U.S. District Court No. 1:10-cv-00976 (CRC) (D.C.), a False Claims Act ("Qui Tam") case in which bicyclist Floyd Landis sued fellow bicyclist Lance Armstrong on behalf of the United States alleging that Armstrong had defrauded the federal government by using the banned performance enhancing drugs Epogen and Procrit to win a record seven Tour de France bicycle racing titles from 1999 to 2005. The settlement amount was $5 million, of which Landis will receive a reward of $1.1 million, and Armstrong will pay Landis' attorneys $1.65 million. The U.S. Postal Service had sponsored the U.S. racing team for $32.3 million and Armstrong had worn a Postal Service jersey during the first six of those victories, but Armstrong was stripped of all his victories in 2012 after an investigation determined that Armstrong and many of his teammates had been doping. The latest contract with the Postal Service contained an anti-doping provision. <4/19/18 Lance Armstrong Settles Federal Fraud Case for $5 Million, Juliet Macur, NY Times>

References

-- Jytdog (talk) 05:10, 20 April 2018 (UTC)[reply]

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