It is unthinkable that a large drug company would conduct tests for FDA approval of a powerful drug, then secretly promote its use on children, not knowing whether it will do them harm.
It’s even worse when the motive is money – lots of it – and the fraud is committed by a leading drug company that hides behind shamelessly heart-warming rhetoric:
Every day and in many ways, the people of Bristol-Myers Squibb demonstrate their commitment to our mission of extending and enhancing human life. … We seek to make a real difference in the lives of people all over the world, by discovering, developing and providing innovative pharmaceuticals and other health care products (www.BMS.com).
My hands shake with fear and anger as I report this heinous fraud to you.
In 2002, Bristol-Myers Squibb received FDA approval for the sale of Abilify?, an anti-psychotic drug meant to treat adults with schizophrenia, and in 2004 the FDA extended its approval to acute bipolar mania. These two approvals, however, were based on strict limitations: The drug could not be used for any other conditions. In particular, it was imperative that it not be used for dementia-related psychosis. That is a completely different type of illness.
The FDA was so concerned about the potential for misuse that it required Bristol-Myers Squibb to place a “black box” warning on the package, stating that it must never be used to treat dementia-related psychosis.
In blatant disregard for this restriction, Bristol-Myers Squibb took their FDA approval and immediately began a promotion campaign of Abilify? as a new drug to treat dementia-related psychosis – in children.
Before they could be stopped, millions of dollars worth of this drug was prescribed to children with the very condition the FDA insisted should not be treated with Abilify? .
Ironically, Bristol-Myers Squibb claims to be a national leader in promoting the well-being of children. They are the makers of the popular baby formula Enfamil?. Yet they callously target children for prohibited, off-label use of powerful drugs.
In all fairness, Bristol-Myers Squibb did not single out children as guinea pigs for this unapproved drug. It also paid millions of dollars in illegal kickbacks to doctors to prescribe this same drug to the elderly population, despite the black box prohibition. For several years, the company secretly entered into phony consulting contracts with doctors, offering cash and luxurious vacations to those who prescribed their drugs for off-label uses.
Their greed is indiscriminate. They seemed willing to bilk the health care system in any way they can. It made no difference if their victims were unsuspecting elderly patients or suffering children.
The only silver lining is that a group of whistleblowers stood up to this giant. As a result, in 2007, Bristol-Myers Squibb was required to pay $325 million to the government and agreed to stop its illegal promotion of these off label uses for this one drug.
The Department of Justice gave the whistleblowers $50 million as their reward for stepping forward.
There are 4,000 other FDA-approved drugs, many of which are still being improperly promoted for off-label uses. The Department of Justice needs your help to put an end to it. A substantial reward might be available if you step forward and help stop these reprehensible practices by pharmaceutical companies.
In addition to a monetary reward, you may also be saving lives.
