Whistleblower action that led to $2.3 billion penalty against company is unsealed
By Lee Howard
Published on 9/18/2009
Pfizer Inc. paid the National Alliance for the Mentally Ill hundreds of thousands of dollars and its former president thousands more, turning the organization into a “Trojan horse” for an illegal marketing scheme that helped boost the schizophrenia drug Geodon's sales by millions of dollars a year, according to a lawsuit unsealed this week.
The lawsuit, part of a series of whistleblower actions that led to a $2.3 billion penalty imposed on Pfizer earlier this month for illegal marketing tactics, was filed in March by Mark R. Westlock of Fenton, Mo., a longtime sales representative for the company. The suit was initially sealed, meaning the allegations had never before been brought to light, but became public after federal criminal charges against Pfizer were finalized.
Pfizer denied the specific charges contained in Westlock's suit, only admitting to “certain improper actions related to the past promotion of (painkiller) Bextra and (bacterial-infection medication) Zyvox,” as it agreed to in settling the federal allegations.
Pfizer added in a statement: “We regret certain actions taken in the past, but are proud of the action we've taken to prevent improper practices in the future. ... These measures include mandatory compliance training for every one of our 80,000 employees; a code of conduct; proactive monitoring and surveillance; a dedicated U.S. healthcare compliance team that conducts numerous audits annually; and strengthened policies and procedures regarding the appropriate promotion of Pfizer products.”
Geodon, also known by its generic name ziprasidone hydrochloride, was discovered and developed at Pfizer's campuses in Groton and New London.
The U.S. Food and Drug Administration has approved Geodon for specific uses, but the suit alleges that Pfizer engaged in a strategy to boost sales by promoting so-called “off label” uses of the drug through various means, including influencing nonprofit organizations to help the cause. Doctors are allowed to prescribe drugs for conditions not specifically mentioned in FDA labeling requirements, but drug companies are banned from promoting such uses.
”Drug manufacturers have developed relationships with front organizations - industry-funded grass-roots, consumer advocacy, research and educational organizations whose primary goal is to promote marketing, influence regulations or advance other industry interests,” according to the suit.
The Arlington, Va.-based National Alliance for the Mentally Ill, which describes itself as “the nation's largest grass-roots mental health organization dedicated to improving the lives of persons living with serious mental illness,” has received at least $1.3 million from Pfizer over the years, according to the suit.
What's more, its former president, James McNulty, during his time as NAMI's leader, “received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers,” the suit said. “McNulty's relationship with Pfizer was particularly cozy,” the suit said, and the group's Web site “goes so far as to promote the off-label use of Geodon in children and the elderly, as well as for long-term use in the treatment of bipolar disease.”
The promotion of Geodon goes against the group's stated policy of not endorsing products, according to the suit. What's more, the suit said, such uses of the drug have not been approved by the FDA, and the prescription of Geodon for dementia has received a black-box warning from the agency.
Messages left for two officials at NAMI were not returned Thursday.
In addition to the claims against NAMI, the suit identified a group of medical doctors as serving Pfizer by promoting off-label uses of Geodon. The group's most prominent member, Dr. Neil Kaye of Wilmington, Del., became such a frequent speaker on behalf of Geodon promotion that he used his own helicopter to fly around the country at Pfizer's expense, receiving up to $4,000 a day, plus expenses, according to the suit.
”Doctors under the influence of pharmaceutical company propaganda and financial 'incentives' to prescribe these drugs are putting children's lives at risk by prescribing these highly toxic drugs,” according to the suit.
A snapshot of the $2.3 billion in penalties against Pfizer, seen at www.stopmedicarefraud.gov/pfizerfactsheet.html, shows that the $1 billion civil fine the company must pay includes about $300 million related to its illegal marketing of Geodon.
Westlock, the former sales rep who said he fought Pfizer's attempts to market Geodon off-label, claimed in the suit that he was forced to resign from the company two years ago after being placed on an unexplained administrative leave and then facing “intimidation, harassment and (an) intolerable work environment.”
Westlock received a portion of a $102 million whistleblower settlement against the company. Reached Thursday afternoon, Westlock said he was constrained from talking about the lawsuit, including how much he received.
But, according to the suit, the off-label marketing of Geodon was all about money. And it may have paid off: According to the suit, initial sales of Geodon eight years ago were a disappointing $150 million, leading the company to offer sales incentives to boost the drug to the $1 billion blockbuster category, which it reached last year for the first time - three years behind schedule.
”Pfizer has engaged in a deliberate pattern of false and misleading promotion,” the suit said. “Off-label promotion of Geodon ... became ingrained in the sales force and Pfizer management.”