The problems at Pfizer which led to the record $2.3 billion settlement were revealed by whistleblowers. Unfortunately, it was not just individual sales representatives who were pushing for sales based on off label uses. Sales managers, who have the responsibility of noticing and preventing these abuses, were the ones pushing for these sales to earn bigger bonuses.
One of the sales reps was Stefan Kruszewski, a psychiatrist. He did not merely disagree with the promotion of unapproved off-label usage of Geodon (an anti-psychotic drug), but actively went and researched it.
Kruszewski didn’t just say no. He went and checked the research and saw Geodon could have serious cardiac side effects not mentioned by the salesmen, who boasted of its relative safety, according to his lawyer, Brian Kenney. And he noticed that Pfizer was paying his peers to promote the drug to other psychiatrists.
He got a lawyer who specializes in these kinds of cases, and they presented their information to the government. Several years earlier, John Kopchinski (also a sales rep) did not fare as well. He joined with Kruszewski and also presented his information to the government.
So did John Kopchinski, who sold Pfizer’s arthritis drug Bextra but not as aggressively as the bosses wanted. They told the sales force to pitch it for post-surgical pain, acute pain, migraines and a host of other conditions for which the drug had been rejected by the U.S. Food and Drug Administration, says Kopchinski’s lawyer, Erika Kelton.
Nor would he advise doctors to boost the recommended dosage to two, four, even eight times the amount approved, though other salespeople did.
“The sales managers were having us do what was blatantly illegal,” Kopchinski told the BBC. Those who did were rewarded financially. He refused, was fired and spent the next six years depleting his retirement funds.
There are a total of 6 whistleblowers, and the awards they are getting range from $2.3 million to $51 million.
Pfizer may really be working hard behind the scenes to make sure all their divisions, subsidiaries, and related sales teams comply with the law, but this is not the first time something like this has happened.
To resolve claims it promoted off-label uses of Neurontin, an anti-seizure drug, Warner-Lambert, owned by Pfizer, paid $430 million in 2004, and Pfizer said it would institute a compliance program.
There’s a systemic problem going on, because the Pharmacia & Upjohn Co. division involved in this most recent case were involved in the same type of off-label promotion nonsense before.
Three years later, Pfizer’s Pharmacia & Upjohn Co. divisions agreed to pay almost $35 million to settle charges related to the human-growth hormone Genotropin. Among the allegations was that the drug was being promoted as an anti- aging treatment.
That same subsidiary has again pleaded guilty, this time as part of the overall settlement with Pfizer for its promotion of Bextra.
Part of Pfizer’s growth strategy involves acquiring other companies. These companies may bring with them an ingrained corrupt corporate culture which takes some time to purge. It is important to note the difference between a company promoting a safe off-label use for a drug, versus an off-label use specifically prohibited by the FDA because of the problems it causes.
We are still hesitant to label Pfizer as evil because killing customers is not a good corporate strategy, what with the big fines and bad publicity eating into profits. Big Tobacco is not a good counter example because none of their products are safe for use, on-label, off-label, or otherwise. They do a lot of good, and huge companies like it will run into the “left hand doesn’t know what the right hand is doing” problems at one point or another. However, although Pfizer can technically blame the Parmacia & Upjohn subsidiary here, it is imperative they have a thorough internal review and toughened compliance system put in place before they even consider any new acquisitions.