Pfizer Pays $14.5M To Settle Detrol Off-Label Suit
11 CommentsBy Ed Silverman // October 20th, 2011 // 4:00 pm
Five years ago, a pair of former Pfizer sales reps accused Pfizer of illegally marketing its Detrol pill as a salve for enlarged prostates, even though the pill had only been approved to treat overactive bladders. Now, the drugmaker has agreed to pay $14.5 million to settle the charges in what is only the latest in a string of cases in which Pfizer engaged in off-label marketing.
The lawsuit, which the US Department of Justice declined to join, was brought by David Wetherholt and Marci Drimer, who also claim they suffered retaliation and wrongful termination for pursuing the whistleblower charges. However, their attorney, Tom Greene, declined to comment on whether claims concerning wrongful termination were settled.
Why did Pfizer covet the enlarged prostate crowd? Detrol was largely prescribed to women, but sales would grow if a way could be found to market the pill to men. And since the prevalence of enlarged prostates rises steadily as men grow older, “the sharply increasing prevalence of benign prostate hyperplasia after age 40 points to a veritable gold mine,” according to the lawsuit.
And so, Pfizer sought to boost Detrol by paying illegal kickbacks to doctors who prescribed large amounts of Detrol for off-label purposes; offering raises and bonuses to Pfizer employees who promoted off-label uses and denying salary increases and promotions to employees who refused, and actively trained employees on ways to avoid being caught by the FDA, according to the lawsuit
There’s more. Pfizer, the lawsuit charges, paid a medical writing firm to compose ghostwritten articles that appeared in such medical journals as the Journal of the American Medical Association; distributed studies to reps that lacked evidence Detrol could treat enlarged prostates; and funded and controlled content in continuing medical education programs.
As an example of the alleged shenanigans, Wetherhold claimed at a February 2004 plan of action, or POA, meeting, his district manager was conducting a training session that involved videotaping sales reps as they made their Detrol presentations. He declined to include the off-label information and she publicly chastised him. She also instructed reps to target military accounts, such as the Veterans Administration, because these are “filled with middle aged men with enlarged prostates.”
“Pfizer intentionally embarked on a course of unlawful conduct that it knew would lead to the submission by physicians and pharmacists of thousands of Medicaid claims for Detrol uses that were not covered by Medicaid and for which the drug was ineffective,” according to the lawsuit, which was joined by 22 states that charged their Medicaid programs were defrauded. Between 1998 and 2008, Medicaid reimbursements totaled about $1.4 billion, and the amounts rose steadily each year as a result of the alleged off-label promotion (here is the lawsuit).
And here is an interesting wrinkle. Remember Jeff Kindler? The former Pfizer ceo was general counsel at the time that Drimer blew the whistle on the off-label marketing and complained internally about retaliation. She wrote a letter to Kindler that mentioned illegal promotion of Detrol and the Bextrol painkiller, but the lawsuit alleges he did nothing, which contradicted the requirements of a Corporate Integrity Agreement that was already in place as a result of illegally marketing Neurontin (see this).
“The illegal promotion of Bextra for acute pain, and Detrol LA for the BPH patient, is documented in the enclosed business plan, which was emailed to the entire district on February 24, 2004,” she wrote in her May 2005 letter to Kindler and also to a senior vp of human resources. I understand from attending Pfizer’s ethics/compliance training that these reported practices violate federal law (you can read her letter here).
A Pfizer spokesman sent us this statement: “We are pleased to report that the company has settled these qui tam allegations on favorable terms. This settlement allows Pfizer to avoid the cost and distraction of litigation and put this matter behind us.” Pfizer, he adds, has a compliance program that includes a “dedicated chief compliance officer, corporate compliance committee, code of conduct, extensive compliance training, policies and procedures regarding the appropriate promotion of Pfizer’s products, auditing and monitoring, a compliance hotline and extensive procedures to investigate and remediate potential issues of non-compliance with company policy or applicable legal requirements.”
Presumably, this effort has improved since Kindler received her letter.
“Marketing fraud is profitable, even when you get caught,” says Greene, the attorney for the whistleblowers. “When the marketing teams of pharmaceutical companies like Pfizer are given an opening to increase sales off-label, they seem to take it ten times out of ten.” Meanwhile, the whistleblowers will receive 27 percent of the portion of the $14.5 settlement that goes to the federal government, or a total of $3.3 million, which they will have to divide. Their share of the proceeds to be received by the states has not yet been calculated, according to Greene.
pic thx to katerha on flickr
Dan Abshear
As many know, off label promotion and kickbacks are quite common, within big pharma in particular. CIAs are implemented, and settlements are paid by companies within big pharma, but that does not deter their behavior, illustrated by the fact that big pharma companies often pay numerous settlements. The same prosecutors who convict those within big pharma quite possibly may work for these corporations in time. There is a pathologically intimate relationship between the corporation, and the U.S. government- their collusion is expressed in the political revolving door.
Basel lair
Dan has a point that further proves democracy in USA, Canada and many other western democracies is completely broken. The corporations have the upper hand and they dictate to gov’t what they will or will not do. If ayone has any doubts what the Occupy Wall Street is all about, just look at what corporations get away with. At least in USA they pay some huge fines. This one is unusually small.But if we look at what they pay in Canada when exposed within what they call Rx&D (private club for bigpharma cos) one would laugh and laugh and…Yes the max they get fined is $10.000 regardless of fraud they did on their public care system. Neurontin was pushed for depression there too and no fine was paid by Pfizer for no one “complained” about it to Rx&D.Novartis paid that toke fine of $10K for defrauding their public health care by well over $100 Million using a fake post marketing sureillance trial.They pretended to do the the PMST while selling their drug Diovan to the trial subjects. Rx&D found it unethical and illegal but the gov’t authority was not alerted, thus they never were prosecuted criminally as they should have under Canadain criminal laws. If they had the False Claim Act type of the law things would have been different for Pfizer, Novartis and all Canadian bigpharma that do all kinds of illegal stuff with complete inpunity.
Bob Dylan
One more Pfizer contribution to trickle down economics.
Mark D. Walters
What an outrage that Pfizer would engage in a scheme like this to defraud US taxpayers. These whistleblower are heros and we need more like them.
Woody G.
Hopefully, no one died from this latest pharmascam, as they did when Pfizer did its clinical trials in Nigeria. Watch “The Constant Gardener” to see John LeCarre’s adaptation of this case.
Too bad Congress is bought and paid for and, by its complicity, permits 100,000 pharma deaths each year, plus all the fallout like diabetes from the effects of prescription drugs.
Steep price to pay for the bottom line.
Doc
Amen
Ryan
“Pfizer, he adds, has a compliance program that includes a ‘dedicated chief compliance officer, corporate compliance committee, code of conduct, extensive compliance training, policies and procedures regarding the appropriate promotion of Pfizer’s products…’”
Ha. In May 2005, Jeffrey Kindler WAS the Chief Compliance Officer.
Been There
SOP (Standard Operating Procedure) for Pfizer. It didn’t start with Kindler and it assuredly will not end with the likes of Read given his past. If the Justice Department is sincere with its investigations of overseas business practices, domestic fines will pale in comparison to Pfizer’s (and industry’s) violations of the Foreign Corrupt Practices Act.
Basel lair
Complience officer? Do you know hat complience officer does in a bigpharma company? No he is not there to watch and make sure they comply with all the rules and regulations. He is there to make sure they know how to get away with breaking of all the rules and regulations. Yes friends the complience officer’s job is to complement and complete the bigpharma’s business practice that includes use of illegal and unethical practices as part of their modus operandi. So there is no way he or she would stand in the way of, say product manager designing an off-label promotional program with accompanying literature etc. They work together to make sure nothing goes wrong and the Co gets away with the proverbial “murder”. We had a CO at Novartis once who used to open his presentation with “let me show you how we’ll do such and such without anyone ever discovering we did it illegaly”. Real Mafia? They have nothing on bigpharmafia.
john
I’m not a fan of off label marketing, but I think it is worth noting that a muscarinic blockade and the use of detrol in particular has been found effective in bph in multiple studies.
In fact, rather than being an example of pharmaceutical companies murdering for profit as implied by many posters above, I’d say that the use of detrol in this indication is an example of part of the price we pay for limiting the flow of information about potentially useful treatment modalities.
http://www.ncbi.nlm.nih.gov/m/pubmed/21344494/?i=3&from=detrol%20benign%20prostatic%20hypertrophy
http://www.ncbi.nlm.nih.gov/m/pubmed/21211380/?i=4&from=detrol%20benign%20prostatic%20hypertrophy
http://www.ncbi.nlm.nih.gov/m/pubmed/18639297/?i=18&from=detrol%20benign%20prostatic%20hypertrophy
Patrick
john,
I suppose you have a point — so long as those studies weren’t ghostwritten by Pfizer.
Wouldn’t be the first time. Detrusor muscle lets you empty bladder fully, a partial blockage like BPH makes it difficult to fully empty your bladder. Does it make sense, even, that if your urinary problem is not being able to fully empty because of a blockage, that making your detrusor muscle less active would cure urinary problems? Seems like there’d be more risk you couldn’t empty. The studies appear to be about “combo therapy” but what’s to say a combo therapy is more effective than just the medicine meant to alleviate the pressure of a large prostate.