Healthy Skepticism Library item: 19309

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Amgen Execs Take The 5th Over Alleged Kickbacks
Pharmalot 2011 Mar 3
http://www.pharmalot.com/2011/03/former-amgen-execs-take-the-fifth-before-trial/

Full text:

Five former Amgen execs have ‘taken the Fifth’ in depositions that were conducted as part of a False Claims Act lawsuit scheduled to go to trial in federal court in Boston later this year. And the former Amgen sales rep and product manager who brought the lawsuit is fighting to have the depositions filed in court and made public.

At issue are allegations that Amgen provided free ‘overfills’ of its Aranesp anemia medication and encouraged doctors to bill Medicare and Medicaid for the extra amounts. The lawsuit, which was filed by Kassie Westmoreland, also charges the biotech offered kickbacks to doctors in the form of fictitious consulting arrangements and weekend getaways in order to steal market share from Johnson & Johnson, which sells the rival Procrit treatment (read the lawsuit).

But the former Amgen execs are apparently worried their testimony may get them in hot water. “The former employees of Amgen – at every level of the corporation from sales representative to senior management – were unwilling to answer even basic questions about their tenure with Amgen for fear of exposing themselves to criminal prosecution,” according to a memo filed by Westmoreland’s attorney (read the memo). Also taking the Fifth Amendment was an office manager of a medical provider who purchased Aranesp from Amgen.

In her lawsuit, Westmoreland describes reports showing the additional profits Amgen – and doctors – could make if doctors billed Medicaid and Medicare for overfills. In fact, she cites internal documents concluding that Aranesp was less profitable for doctors unless Aranesp overfills were taken into account (see here), and that spreadsheets were used to convince doctors of the favorable ‘economics.’

Basically, the vials that Amgen would sell to doctors contained more Aranespt than was needed for a dose, which meant the overfill could be used for other patients, but Medicare would be billed for a regular dose and the overfill. This amounted to additional reimbursement to the doctors who followed Amgen suggestions. However, the lawsuit notes the practice can also lead to overmedicating patients, which can lead to strokes.

Aranesp is an important drug for Amgen. Between 2001 and 2008, the med generated more than $11 billion in revenue, with approximately $6 billion coming from federal and state health care programs such as Medicare and Medicaid. In 2005, spending for epoetin treatments – which include Aranesp, Procrit and Amgen’s Epogen – was the single largest Medicare drug expenditure, reaching $1.75 billion, and is the second-largest source of income for dialysis facilities, according to the lawsuit.

So far, 15 states have joined the lawsuit, although the federal government has so far not decided whether to take the same action.

EDITOR’S NOTE: This item was posted on Wednesday night, March 2, but we have placed it higher up on the page in the event that some readers would not have noticed it this morning.