December 26, 2012 – California-based Amgen Inc has agreed to pay a $762 million fine for improper marketing practices involving its once top-selling Aranesp anemia drug reports Reuters. This amount includes $612 million to resolve False Claims Acts suits and $150 million in criminal penalties and forfeiture, according to a statement from the Justice Department.

Officials there also specified that this “represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.” In addition, Amgen is facing a dozen whistle-blower lawsuits.

At issue is how Amgen now admits it boosted Aranesp® (darbepoetin alfa) sales by illegally marketing it for uses and at dosage levels that the Food and Drug Administration (FDA) had specifically declined to approve due to insufficient clinical evidence linked to safety and efficacy.

“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease,” commented Marshall Miller, acting US attorney for the Eastern District of New York.

Cyclists should pay particular attention to this case for a few reasons. Firstly, Amgen has been the title sponsor of the UCI Tour of California (ToC) stage race since 2006. It is unclear how this large pay-out will affect Amgen’s ability to sponsor such a prestigious sporting event. Amgen reported net income of $3.7 billion in the last fiscal year from some $15.6 billion in global sales.

So far the 2013 ToC appears to be on track with twelve cities named official Host City partners. The race will begin Sunday, May 12 in Escondido, Calif. and finish in Santa Rosa, Calif. on Sunday May 19. <http://click.lv.enewsaxs.com/?qs=71922078217ef900e4bdfc7bddf48fe78c2644cdfa2408b8299e41b401cc80cd9a98c31220408098>The 2012 ToC was won by Robert Gesink of Rabobank while Canada’s Sebastian Salas (Optum-Kelly Benefit Strategies) from Vancouver, BC won the KOM jersey.

Amgen is described by Wikipedia as, “…an American-based multinational bio-pharmaceutical company head-quartered in Thousand Oaks, California,”. It produces prescription drugs: Epogen, Aranesp, Enbrel, Kineret, Neulasta, Neupogen, Sensipar/Mimpara, Nplate, Vectibix, Prolia and XGEVA. Both Aranesp and Epogen are both also known as erythropoietin (EPO).

We believe that Amgen is the world’s leading producer of EPO, one of the principal performance-enhancing drugs (PEDs) used by some cyclists and other endurance athletes. And of course, erythropoietin is a banned substance according to sporting authorities.

This apparent contradiction is addressed on Amgen’s website where it is explained that, “Amgen has been the title sponsor of the Amgen Tour of California, a professional cycling race, since 2006. Amgen’s sponsorship of this event provides a platform for the Company to speak out against abuse of the therapies it makes. Amgen strives to educate the public about proper use of Amgen’s medicines and the medical breakthroughs made possible through biotechnology.”

Reuters article HERE.
Read more HERE.
Amgen’s position on doping HERE.