In his self-published book, The First Question, Andrew Bodnar, MD, JD, reveals the story of how a drug launch negotiation went very wrong and almost landed him in jail.
What were they thinking?” We ask ourselves that question every time some pharmaceutical company gets caught doing something it shouldn’t, while also wondering how intelligent, well-intentioned professionals could find themselves going down the road to destruction. But that is exactly the story that Andrew G.
Bodnar—MD, JD, formerly senior vice president of Bristol- Myers Squibb—tells in the self-published The First Question (posted online at bit.ly/JeHEFG and available without charge).
Bodnar didn’t write the book because he wanted to, but because it was part of a federal plea agreement. The First Question is the story of corporate level bad-faith negotiations, and subsequent missteps that brought the high-achieving son of a Holocaust survivor before a federal judge in June 2009 to plead guilty to making misstatements to the Federal Trade Commission. At sentencing, the judge called Bodnar “an extraordinary person who has done extraordinary good,” fined him $5,000, imposed two years’ probation, and ordered him to recount his experiences in a book of at least 70,000 words.
The Harvard cardiologist-turned-pharma executive’s journey to the federal bench began in 2006, when BMS and Sanofi learned that Toronto-based Apotex was about to launch an early generic challenge to Plavix, their jointly marketed blockbuster. Hoping to avoid the uncertainties and costs of a patent fight, BMS/Sanofi opened negotiations with Apotex. Bodnar led the effort for BMS. His task was greatly complicated by anti-trust consent decrees (arising from earlier pay-to-delay deals) that limited outright payments to about $2 million and required that the U.S. Federal Trade Commission approve any generics accords. The negotiations slid into nightmare. Bodnar charges that Apotex submarined the talks from the beginning, maneuvering BMS into an agreement that the FTC would never approve, in order to provide Apotex with a casus belli to start shipping its massive clopidogrel inventory into the U.S. Bodnar further charges that Apotex also sabotaged the talks by feeding the FTC information that BMS, and Bodnar personally, was covering up a secret side agreement—an agreement that amounted to the sort of pay-to-delay agreement the consent decrees were intended to prevent.
Bodnar, for his part, maintained—and still maintains—that there were no secret agreements. He did tell Apotex’s CEO that he was personally opposed to BMS/Sanofi launching an authorized generic, but that he could not commit the company to following his wishes. When he pled guilty in 2009, it was for fail- ing to realize that this comment constituted a “representation” (as distinct from a promise) that should have been disclosed.
Apotex did launch generic clopidogrel in 2006. The company racked up $880 million in sales before BMS/Sanofi could get a restrain- ing order to stop them. In 2008, U.S. courts upheld the BMS/Sanofi patents and awarded them $444 million in damages (which Apotex, having exhausted its appeals, paid this past February). And, when the Plavix patent finally did expire (on May 17 this year), Dr. Reddy’s, Mylan, and Teva were the ones to bring generic clopidogrel to market.
Basically a court filing, The First Question is oddly constructed, consisting of third- person chapters of Bodnar’s family history alternating with first person accounts of the Plavix negotiations and subsequent prosecutions. The legal details—with long quotations from transcripts and briefs—are often mind numbing. And one must always remember that The First Question is Bodnar’s view of his own story.
But the book is a self-examination as well as a self-justification, and it shows precisely what people working in the pharma industry most need and almost never get: A detailed explanation of how a person with talent, intelligence, and a certain degree of idealism can fall afoul of the law–all while trying to do the right thing.