Bextra, Bextra!

This week, the Dept. of Justice announced that Pfizer will pay $2.3B in civil and criminal penalties for off-label marketing of four drugs.  The settlement, which alleges that off-label marketing tactics led to over-prescribing of Bextra, Lyrica, Geodon and Zyvox for unapproved indications, is the largest of its kind on record. The company plead guilty to misbranding Bextra, a pain medication pulled from the market in 2005, and along with returning funds to the Medicaid and Medicare programs, the settlement includes an corporate integrity agreement that, among other things, will require Pfizer to disclose payments made to doctors for honoraria and travel.

More at the Los Angeles Times, WSJ Health Blog, and ABC.

Such a corporate integrity agreement entered into as part of an earlier $1.4B settlement this year around the marketing of Zyprexa — has already yielded Eli Lilly’s “faculty registry” – a fancy name for a list of what doctors the company paid, for what, and how much. The St. Petersburg Times looked at what local docs took home from Lilly in the first quarter of 2009, and topping the list of Tampa-area docs was Dr. Maria-Carmen Wilson, a neurologist at the University of South Florida who gave an average of two talks a week at about 2000 per talk – by May she’d hit Lilly’s own $75,000/year per physician payment cap.

The Times reminded us of this striking industry calculus: “The drugmaker’s payoff for each dollar paid to physicians: more than $12 in additional prescription sales.”

The $36 million lunch

Documents released to Senate investigators reveal part of Forest Laboratories’ marketing strategy for the anti-depressive Lexapro was an aggressive physician payments plan much bigger than other companies its size, the New York Times reported. The company paid 2000 doctors a total of $34.7 million to give 15,000 talks to their peers – and that’s just in 2008.  Though it’s ranked 18th among U.S. pharmaceutical companies in revenue, Forest was number four among top spenders on physician payments in Vermont.

A Pew Prescription Project analysis of physician payments in Minnesota found that there, too, Forest spent a whole lot more on speaking and travel fees for doctors than other companies its size, reports the Minneapolis Star-Tribune. Both Minnesota and Vermont require companies to disclose payments made to practitioners.

“The analysis tells us that a lot of doctors in Minnesota have become extensions of Forest’s marketing campaign,” Project director Allan Coukell told the Star-Tribune.

And in other Minnesota news, University of Minnesota spine surgeon Dr. David Polly has resigned from the board of the American Academy of Orthopedic Surgeons in the wake of extensive investigations around payments he received from Medtronic medical device company.

FDA to increase overseas GMP inspections, albuterol sulfate goes missing

The FDA says it will double the number of foreign good manufacturing practices (GMP) inspections this year from 50 to 100 as a part of effort to “beef up” oversight, according to FDANews Drug Industry Daily. The announcement came at an annual GMP conference in Maryland.

And a subsidiary of Mylan, Dey, has reported that two lots of albuterol sulfate inhalation solution was stolen from a truck in McKinney, Texas.  The episode echoes the theft of batches of Levemir insulin in June; the FDA recently updated the Levemir advisory to say that only 2 percent of the 129,000 vials have been recovered and accounted for.

Mums-no-more at Harvard Medical School

And Harvard Medical School has lifted a new policy that would have restricted students from talking freely with the media, reports the New York Times. The school doesn’t deny that recent high-profile media stories in which students discussed the problem of faculty conflicts of interest contributed to the now-retracted policy.

“It is hard to imagine that this new policy is not somehow related to the past advocacy efforts of students,” two students that spoke out in March wrote the Times. “The reason we spoke out against conflicts of interest was to promote patient welfare as the primary concern of medicine, in the face of institutional practices that can harm patient care.”

The Other Big Ten

The University of Iowa has rounded out the ten medical schools that received an “A” on the AMSA Scorecard, which assesses conflict-of-interest policies at all U.S. med schools. The Hawkeye’s new policies went into effect July 1.