Celgene off-label marketing lawsuit documents unsealed

Revlimid bottle

Celgene ($CELG) has successfully fought off several lawsuits suggesting the success of its blockbuster multiple myeloma meds Revlimid and Thalomid relied on aggressive off-label marketing. A California whistleblower case, however, has moved forward with the unsealing of thousands of pages of new documents that attorneys for a former sales rep think back up their client’s claims.

Among documents are emails by Celgene execs chastising employees for putting into writing information that tied Thalomid to blood clots and hadn’t been reported to the FDA, Bloomberg reports.

Celgene has repeatedly denied the allegations and said it will “vigorously defend,” its position. In an emailed statement to Bloomberg, a Celgene spokesman said: “These allegations, which date as far back as 15 years, are baseless. Celgene is committed to patient safety, and its products have improved and extended the lives of many thousands of cancer patients.”

The suit was filed in 2007 by saleswoman-turned-whistleblower Beverly Brown, who had joined the company in 2001. It claims Celgene put its sales team under heavy pressure to hype both of the drugs to oncologists for whatever cancers they were treating--including blood cancers as well as solid tumors--on the basis of minimal evidence.

The lawsuit was under seal for several years while the Justice Department also looked into the claims before deciding whether to join the suit, something it has done with many other whistleblower lawsuits alleging off-label marketing. The DOJ, however, decided not to join the California suit or similar suits that had been filed in Texas and Alabama. The Alabama lawsuit was voluntarily dismissed based on the DOJ's decision. Despite the DOJ’s decision not to participate, a federal judge that year decided there was enough merit for the case to proceed.

Brown’s suit claims that Celgene trained its salespeople to market Thalomid and Revlimid off-label at sales meetings and other events. The suit also points out that the initial label on Thalomid didn't include warnings related to its use in cancer, which she alleges made the off-label prescriptions "tantamount to ongoing human experimentation."

To bolster that position, Bloomberg reports, Brown’s suit points to an October 2000 email from Celgene drug safety official Todd Clark to an employee who sent messages talking about data linking Thalomid to blood clots that had not been disclosed to the FDA. Clark warned that “putting such statements in writing in an internal Celgene document is potentially a glaring red flag to the FDA.” Another email to Clark from Chief Medical Officer Jerry Zeldis pointed out that Clar’s memo was a “non-erasable message that can be audited by the FDA.”

Revlimid remains Celgene’s foundational product and the company has continued to study Revlimid for new cancer uses in hopes of boosting its sales beyond the $6.7 billion it is expected to reach this year. But a recent effort was a failure. Last month the drugmaker said it was giving up testing the drug as maintenance therapy for lymphoma patients after results in a trial did not hit an important endpoint. The drug delayed progression of diffuse large B-cell lymphoma in patients who’d responded to previous treatment with Rituxan and standard chemo, but it ultimately didn’t extend patients’ lives.

- read the Bloomberg story

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