Lilly to Plead Guilty in Zyprexa case - Settlement $1.4 Billion

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

 

The US Attorney's office in Pennsylvania is close to settling criminal

and civil suit against Eli Lilly and its illegal marketing of Zyprexa, the

company's most profitable drug.

 

The New York Times reports that the settlement amount of $1.4 billion " is

a record sum for so-called corporate whistle-blower cases, which are

federal lawsuits prompted by tips from company employees or former

employees. In this case, the whistle-blowers have not been publicly

identified. "

 

However, the amount of $1.4 billion pales when compared with Zyprexa

sales: Zyprexa, one of a new class of antipsychotics, has generated more

than $39 billion since its approval in 1996, making it one of the

biggest-selling

drugs in the world--despite the fact that it was approved only for

schizophrenia and mania and agitation associated with bipolar disorder,

and despite its documented life-threatening severe adverse effects, coupled

with its failure to demonstrate improved efficacy.

 

Zyprexa sales of $4.8 billion in 2007. Lilly's profits from this drug

came mostly from its use for unapproved, off-label conditions paid for by

the government--i.e., taxpayers.

 

Although drug makers are prohibited from promoting drugs for uses not

approved by the FDA, the Times reports that: " The settlement may have

little impact on how doctors actually use Zyprexa, because physicians are

free to prescribe drugs as they see fit. "

 

The reason it won't have impact--just as the added Black Box warning

label failed to dissuade doctors (mostly psychiatrists) from prescribing

the drug--is deceptive marketing claims and corruption by drug manufacturers

who violate the prohibition against off-label marketing and equally corrupt

doctors whose promotion of drugs and prescribing practices are influenced

by fees from industry (kick-backs).

 

In large measure, the resolution of this case is due to the courageous

action by Dr. David Egilman, who broke the seal of silence and made the

Zyprexa documents available to The Times in 2006. Citing those internal

Eli Lilly documents, a series of articles by Alex Berenson demonstrated to

the world how the company engaged in corrupt practices to increase profits:

" The company urged geriatricians to use Zyprexa to sedate unruly nursing

home patients so as to reduce " nursing time and effort, " despite

knowledge that " Zyprexa increases the risks of sudden death, heart failure

and life-threatening infections like pneumonia in elderly patients with

dementia-related psychosis. "

 

And pressured doctors " to treat disruptive children with Zyprexa, even

though the medicine's tendency to cause severe weight gain and metabolic

disorders is particularly pronounced in children. "

 

Over the last decade, Zyprexa's use in children has soared. Pity the

children whose welfare is being sacrificed by psychiatrists who have

abandoned professional medical standards, prescribing drugs they know to

be " doing harm.

 

** AM LAW UPDATE below:

" Eli Lilly will in fact admit wrongdoing; the company has agreed to plead

guilty to a misdemeanor criminal charge of illegally promoting Zyprexa

and pay a $615 million fine. They will also pay $800 million in civil

penalties to end civil investigations of Medicaid and Medicare fraud

conducted by the federal government and 30 states, Bloomberg says. (The six

whistle-blowers, former Lilly employees, will get 18 percent of that $800

million). "

 

However, there is no compensation for the thousands of patients who

became human casualties of Zyprexa's toxic effects and Eli Lilly's greed.

See also: a just published report in The New England J of Medicine,

documenting the increased risk of sudden cardiac death for patients

regardless of age who are prescribed either the old or the newer

antipsychotics--Zyprexa, Risperdal, and Seroquel--compared to those who

did not use them.

 

Atypical Antipsychotic Drugs and the Risk of Sudden Cardiac Death

Wayne A. Ray, Ph.D., Cecilia P. Chung, M.D., M.P.H., Katherine T. Murray,

M.D., Kathi Hall, B.S., and C. Michael Stein, M.B., Ch.B.

NEJM, Volume 360:225-235 January 15, 2009

http://content.nejm.org/cgi/content/short/360/3/225