— The government wants Novartis to turn over documents on 80,000 separate speaking events.
The US Department of Justice is seeking to greatly expand its investigation of Novartis “for engaging in a nationwide kickback scheme, spanning 10 years, to induce doctors to write prescriptions for certain of its cardiovascular (‘CV’) drugs.”
Last week the DOJ and Novartis battled over the case in separate court filings. In response to the government’s earlier demand that Novartis turn over documents for nearly 80,000 separate speaking and promotional events, Novartis last week complained that the government had unfairly expanded the size and scope of its original case. The government shot back with its own defense of its demands.
In 2013 the government joined a whistleblower case against Novartis. This followed the resolution of a similar case in 2010 in which Novartis settled with the government for $422.5 million. As part of the settlement Novartis agreed to follow a corporate integrity agreement for 5 years. In the new case the DOJ says that Novartis has violated that agreement and should now be subject to even stricter penalties.
Much of the case concentrates on sham speaking and other promotional programs for some of the company’s cardiovascular drugs, including Lotrel, the popular combination of amlodipine and benazepril, and Valturna, the combination of aliskiren and valsartan. In its original complaint the DOJ cited a few thousand speaking engagements. Now, Novartis asserts, the government has unfairly expanded the investigation to include nearly 80,000 events. The government responds that it had never suggested that the cases described in its original complaint composed its entire case.
Novartis also objected when the government “exploded” the size of the case by including roundtable events as well as speaker programs. But, the DOJ replied, “speaker programs and roundtables are substantially similar promotional events, at which a group of doctors is treated to a meal (often at a high-end restaurant) with the purported purpose of being educated about a particular Novartis drug. The two types of events concerned the same drugs, were organized by the same Novartis sales representatives, and were attended by the same groups of doctors.”
The original 2013 DOJ complaint contains a stunning number of details of apparent abuse and fraud. Many of the events “were often little or nothing more than social occasions for the doctors. The payments to the doctors, and the dinners, were kickbacks to the speakers and the attendees to induce them to write prescriptions for Novartis drugs.” At many events no educational activity took place. “Instead,” the government alleges, “Novartis simply wined and dined the doctors at high-end restaurants with astronomical costs, as well as in sports bars, on fishing trips, and at other venues not conducive to an educational program.”
The company’s “own internal analyses showed that speaker programs had a high return on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as ‘honoraria’ for speaking.”
Despite the supposed educational purpose of the programs, the government notes that “the vast majority of speakers for Novartis’s speaker programs were nominated by sales representatives, who picked doctors from among those they called on to promote Novartis drugs.” The company “approved all speaker nominations by sales representatives as long as the doctor had a valid license and had not been suspended or debarred from the practice of medicine.”
Despite Novartis policy that speaking events have at least three healthcare professionals in attendance, there were many programs with an audience fewer than three and “many programs took place with no one in attendance except members of the speaker’s own medical practice.”
In some cases, doctors “spoke repeatedly to the same attendees on exactly the same topics.” These same doctors “took turns in the roles of speaker and attendee, with doctors repeatedly attending programs regarding the very same topics they had spoken about.”