The recent judgement by the US Department of Justice (DoJ), rapping Pfizer with a $2.3-billion settlement is being referred to as the ?largest healthcare fraud settlement? in the department?s history. The lawsuit was slapped on Pfizer for promoting off-label use in Bextra and payments to physicians involving Zyvox, Geodon and Lyrica, as well as nine other Pfizer drugs. The DoJ?s investigation was triggered by whistleblower lawsuits and the DOJ says that ?six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery?. While Pfizer will pay the criminal fine, its subsidiary, Pharmacia & Upjohn, will plead guilty to a charge of felony misbranding (since Bextra came to Pfizer when it acquired Pharmacia in 2002).
Pfizer is by no means the only pharma company involved in over-zealous marketing practices. In January this year, Eli Lilly was hauled up by the DoJ on similar charges involving its Zyprexa and paid $1.4 billion. The settlement was a record among whistleblower cases at the time, but the Pfizer settlement clearly overshadows the January case.
The role of whistleblowers in both these cases cannot be overemphasised. In fact Judge Mark Rindner deliberating on the Eli Lilly case in Alaska in March 2008, went so far as to say that lawsuits play a vital role in drug safety and without them, claims of safety problems ?might well go unaddressed?. Evidence the State of Alaska presented in the course of the lawsuit shows that the FDA ?isn?t capable of policing this matter?, he said.
In fact, reactions to past articles in the press have opened up a can of worms, with medical students saying their professors are on the take and calling for a ban on ?pharma freebies? on campus.
Here in India, industry observers and patient activists NGOs have grimly observed the increasing ways in which pharma companies are wooing doctors. For instance, in a field like medicine which is advancing so rapidly, the concept of Continuing Medical Education (CME) programmes is sound, but unfortunately, this is grossly misused. The Pfizer settlement clearly shows the way forward.
?viveka.r@expressindia.com