Cephalon Reps Shown Trays of Cash to Promote Off Label Use
June 21st, 2013 // 12:14 pm @ jmpickett
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In 2010, an ex-manager at Cephalon filed a lawsuit and blew the whistle on the alleged illegal sales of 2 drugs – the painkiller Fentora and the treatment Treanda, which is for leukemia. This caused the US attorney’s office in New York to start an investigation of Cephalon, which has since been acquired by Teva Pharmaceutical.
Now, more details are coming out about how much execs at Cephalon were conspiring to use poor clinical studies and shady off labeling marketing techniques to increase sales of Treanda. These allegations were made by an ex-Cephalon worker.
According to his story, Cephalon tried to push Treanda for unapproved uses. In this situation, it was for treating on a first line basis, indolent, non Hodgkin’s lymphoma. The drug is approved soley for CLL and for a second or third line treatment for lymphoma.
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One of the off label attempts used a study by a consultant from Cephalon by the name of Mathias Rummel who is now the chief of hematology at University Hospital in Glessen Germany. His study said that Treanda could be used as a front line treatment for iNHL. But there were a number of problems with this study – it was not registered by FDA, so it could not be used to obtain FDA approval. The data collection methods in the study were poor and unreliable.
In Feb. 2011, a meeting was held by top management to figure out how to use the Rummel study and another study, known as BRIGHT. The whistle blower in the case was at this meeting. He reports in the lawsuit how the managers there were plotting how to hide the fact that the studies were very flawed and did not give the results required for an FDA approval.
A big problem they had was what slides to show the executive committee. There were obvious weaknesses in the studies that you could not print on slides. They did think though that the BRIGHT clinical study could be used to promote the off label use of the drug.
But another manager told them that the BRIGHT study did not have the required endpoint and was later amended to add more patients to fix a margin of non inferiority. The discussion in the meeting moved to decide how to give the bad news to the executive committee without indicating all that the managers really knew. One of the managers said that this sort of information lives forever.
Cephalon signed an agreement of corporate integrity 5 years ago to settle charges related to off label marketing of three other medicines. The drugmaker paid out over $400 million, and the agreement ran for 5 years. This means there would be serious sanctions if they broke the agreement.
The managers knew that both of the studies were really high risk, but they agreed to call them medium risk to duck the chance that the slide could be used later to show that the company had any doubt about either of the clinical studies.
There was another effort to promote off label use. At a meeting in Florida in 2008, about 100 sales reps were informed they could earn large bonuses and Treanda was thought to generate $500 million in sales that year. But the only way to do that would be to promote off label use for the drug.
To stress the chances of big bonuses, a VP had waiters come into the room with trays full of $50 bills. The reps were encouraged to grab the money, and the reps were also told that pushing Treanda for off label use would be akin to grabbing free money.
