Eli Lilly Slapped for Off-Label Drug Use

Drug maker Eli Lilly and Co. has agreed to pay a $36-million settlement after pleading guilty to a federal misdemeanor charge that it promoted off-label use of its osteoporosis drug Evista.

A Department of Justice investigation found that, in 1998, Lilly sales representatives promoted Evista as a useful drug for preventing and reducing the risk of breast cancer and reducing the risk of heart disease. However, neither use has been approved by the Food and Drug Administration.

Though doctors may prescribe drugs for off-label uses, drug makers may not market them for unapproved uses.

A $6-Million Criminal Fine

A federal judge must approve the plea agreement, which includes a:

  • $6-million criminal fine
  • $6-million forfeiture to the government
  • Payment of $24 million to settle civil action

In addition, the settlement includes a permanent injunction and a consent decree in which Lilly promises not to use marketing and promotion practices that violate the Food, Drug, and Cosmetic Act.

Off-Label Use Promoted to "Expand Sales"

The Department of Justice reported that Lilly promoted Evista for the two off-label uses "to expand sales of the drug."

Lilly had forecasted sales of $401 million for Evista, however, first-year Evista sales amounted to only $120 million. 


Dr. Mercola's Comments:

Another shinning example of the amazing corruption that exists in the corporate drug world. You need to understand that any corporation's primary and essential responsibility is to their shareholders -- NOT to you.

Unfortunately, most don't realize that it is VERY short sighted to kill and permanently disable and cripple consumers for profits. Drug companies have accumulated so much wealth, power and government influence that they have been able to largely escape the consequences.

However, what they hadn't anticipated or planned for was the freedom and liberation that the Internet provides in exposing their corrupt plans.

I warned you about Eli Lilly's osteoporosis drug Evista being illegally promoted for treating heart disease back in 2002.

It's good to hear that the Justice Department is finally cracking down on Lilly for this deceptive marketing, but, in reality, the punishment is not likely to make a difference.

The $36 million that Lilly agreed to pay is merely "chump change" as well as "reasonable" and "affordable" for this multi-national corporation as one portfolio analyst said in the article.

The truth of the matter is this: The drug companies will stop at nothing to sell their products when billions of dollars are at stake.

They are out to make a profit so enticing doctors to prescribe their drugs for as many uses as possible, regardless of whether or not they have scientific evidence to back them up, will only allow them to sell more drugs and make more money.

Lilly is certainly not alone in this process. Off-label drug use is commonplace. In the UK, for instance, when a "suitable alternative" did not exist, off-label drugs were used in:

  • 90 percent of babies in neonatal intensive care units
  • 70 percent of children in pediatric intensive care units 
  • Two-thirds of children on general medical and surgical pediatric ward

The only way to surely avoid problems from taking drugs for unapproved uses (aren't there already enough problems taking them for approved uses?!) is to limit and avoid as much as possible your use of drugs.

Play it safe: Make sure all prescriptions you and your children take are absolutely necessary. One of the best ways to do this is to follow the Total Health Program.

+ Sources and References
  • San Francisco Chronicle December 21, 2005
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