Celgene Accused of Urging Unapproved Uses for Thalomid

Celgene Corp. was accused of promoting its cancer drug Thalomid and related compound Revlimid for uses not approved by U.S. regulators in a newly unsealed lawsuit filed by a former saleswoman.

Thalomid, which the U.S. Food and Drug Administration has approved to treat multiple myeloma, is a new generation of thalidomide, a morning-sickness drug linked to birth defects in the 1960s and revived decades later to fight cancer, according to the complaint. Celgene marketed the “highly toxic” Thalomid for a wide range of cancers while downplaying its risks for blood clots, according to the complaint.

“Celgene’s initial marketing efforts for Thalomid were tantamount to ongoing human experimentation,” ex-company saleswoman Beverly Brown said in the complaint unsealed yesterday in federal court in Los Angeles. “Because Celgene marketed the drug off-label, patients and their medical advisors were denied the appropriate warnings provided in a package insert when a product is used on-label.”

Brown said she worked as a Los Angeles-based pharmaceutical sales representative from 2001 to 2011. She previously filed her lawsuit under seal citing the False Claims Act, which allows private citizens to sue on behalf of the government and share in the recovery. Brown claims that Celgene’s conduct caused the government to pay millions in Medicare and Medicaid payments for prescriptions of the drugs when other treatments worked just as well or better.

‘Paying Doctors’

“Celgene profited by persuading -- and sometimes paying -- doctors to substitute its untried remedies for treatments proven to be safe and effective in desperately ill patients,” Brown said in the complaint.

The U.S. Justice Department chose not to intervene in the case, Reuben Guttman, Brown’s attorney, said in a phone interview.

Brian Gill, a spokesman for Summit, New Jersey-based Celgene, said the company learned today that the Justice Department declined to intervene in two other False Claims Act cases in Alabama and Texas. He said the plaintiff in Alabama dropped the case after the U.S. chose not to join it.

“We will vigorously defend our position in the two remaining actions,” he said in an e-mail.

Celgene tied compensation and bonuses for its sales employees to off-label sales of Thalomid and Revlimid, Brown said in the complaint. The company also gave sales representatives misleading titles such as “immunology specialist” to give the impression they were medical professionals, Brown said.

Sales Staff

The company coached its sales staff on off-label promotion at national sales meetings and presented patients taking Thalomid for diseases outside its label to “attest to the drug’s efficacy,” according to the complaint.

Thalomid was first approved by the FDA in 1998 to treat a skin disease associated with leprosy, according to Brown’s complaint. Instead of marketing the drug for that limited indication, Celgene allegedly instructed its sales force to market the medicine for blood cancers and solid tumors “on the basis of minimal evidence,” according to the complaint. Celgene announced as early as 1999 that more than 90 percent of Thalomid prescriptions were for oncology, a use not approved by the FDA until May 2006, Brown said.

Thalomid is approved only in combination with another drug, dexamethasone, for newly diagnosed multiple myeloma patients, according to the complaint. Multiple myeloma is a cancer that begins in plasma cells and over time spreads to bones.

19 Conditions

Celgene nevertheless marketed the drug for at least 19 other conditions including cancers of the blood, breast, brain, cervix and prostate. Prescriptions of the drug cost as much as $24,000 a year per patient, according to the complaint.

Celgene similarly marketed Revlimid, a derivative of Thalomid, for at least nine unapproved uses beyond its indication for the treatment of multiple myeloma in patients who have failed a prior therapy. The company promoted Revlimid, which was approved in June 2006 for multiple myeloma, for brain cancer and cancers including lymphoma and leukemia. Celgene also campaigned for patients to switch from Thalomid to Revlimid, which cost as much as $120,000-a-year per patient, according to the complaint.

Revlimid generated $4.3 billion in revenue last year. Sales of Thalomid decreased 19 percent to $245 million, the company announced Jan. 30.

Celgene fell $1.08 to $149.77 at 2:37 p.m. in New York. The shares have fallen 11 percent since the start of the year.

The case is U.S. ex rel. Beverly Brown v. Celgene Corp., 10-cv-03165, U.S. District Court, Central District of California (Los Angeles).

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