Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News |

The modern drug-regulation system traces back to a once-popular morning-sickness pill whose linkage to babies born with flipper-like limbs in the 1960s led the U.S. to tighten oversight for approving medications.


That makes it all the more amazing that Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid. Recently unsealed documents in a lawsuit by a company saleswoman-turned-whistleblower allege that its success is due to an aggressive campaign to encourage doctors to prescribe it and successor drugs to treat maladies beyond those the FDA authorized.


After some studies suggested thalidomide could treat blood cancer but long before it was authorized for it, Celgene created a thriving market by hiring doctors to tout uses beyond what the product was approved for and ghostwriters to promote the drug in medical journals, according to the suit (read "A Pharma Marketing 'Bait-and-Switch' Scheme: Sales Reps Disguised as Medical Science Liaisons”). Though doctors have broad latitude in prescribing drugs, even for uses that aren’t approved, drugmakers can’t push “off-label” uses.


Manufacturers including Pfizer Inc. and Johnson & Johnson have paid billions of dollars to settle such claims.


Even after the Food and Drug Administration approved Thalomid for multiple myeloma, a blood cancer, in the mid-2000s, Celgene continued to promote it for other forms of cancer, including cervix, thyroid and brain, whistleblower Beverly Brown alleges in the suit, filed in 2010.


Celgene vigorously disputes the allegations.


Although the U.S. Justice Department declined to join Brown’s suit, which claims Celgene defrauded government insurance programs by marketing its drugs for off-label uses, a California judge cleared her case for trial.


“These allegations, which date as far back as 15 years, are baseless,” Celgene spokesman Brian Gill said in a statement. “Celgene is committed to patient safety, and its products have improved and extended the lives of many thousands of cancer patients