Hundreds of recently unsealed documents may supply priceless evidence to bolster California whistleblower Beverly Brown’s claims alleging Celgene Corporation marketed thalidomide for off-label cancer treatments, Bloomberg announced Monday.
Yes, thalidomide, the once popular morning sickness pill used to treat pregnant women in the 50s and 60s. The same thalidomide that caused over 10,000 infants to be born with severe limb malformation, organ deformities and blindness. Only 50% of the children survived.
Morning Sickness Drug Thalidomide Banned For Causing Birth Defects
Officials promptly banned prescription of thalidomide as an anti-nausea medication for pregnant women, but in 1998, Celgene gained U.S. Food and Drug Administration (FDA) approval to use thalidomide, brand name Thalomid, to treat complications associated with leprosy. With around 200,000 cases of leprosy worldwide, Celgene wasn’t going to get rich off Thalomid sales, but more than 1.68 million Americans are diagnosed with cancer every year.
FDA Limits Celgene’s Thalidomide Use to Blood Cancer Treatment: Requires Warning Label
In 2006, the FDA approved Celgene’s application to use thalidomide for the treatment of the blood cancer, multiple myeloma. The FDA approval included an express requirement that the Thalomid label include a warning about increased risk of birth defects and blood clotting.
Whistleblower Beverly Brown Claims Celgene Pushed Off-Label Thalomid Marketing
In 2010, Celgene sales representative of nine years, Beverly Brown, filed a whistleblower lawsuit against the biopharmaceutical company in the US District Court for the Central District of California. Brown claims Celgene pressured sales representatives to market Thalomid to oncologists for FDA-unapproved treatments of brain, cervical and thyroid cancers, though the FDA had only approved Thalomid for treatment of multiple myeloma.
Brown’s suit claims that the Thalomid label did not contain warnings regarding its use, making the off-label use “tantamount to ongoing human experimentation.” The claim states that as early as 2003, Celgene was aware of the serious risk for increased blood clotting in patients taking Thalomid, but failed to inform providers or patients and “trained sales representatives to either conceal or downplay the risk."
Brown also alleges Celgene paid kickbacks to doctors for prescribing the drugs for FDA-unapproved uses. According to court documents, Seattle physician William Bensinger allegedly received $260,000 for his involvement in a “promotional speakers program.”
Executive Emails Reprimand Employees for Mentioning Blood Clotting Risks
After an employee had written down information regarding research data linking Thalomid to blood clot formation in October 2000, Celgene drug safety administrator Todd Clark allegedly sent an email reprimanding them, stating “putting such statements in writing in an internal Celgene document is potentially a glaring red flag to the FDA.” Chief Medical Officer Jerry Zeldis then chastised Todd Clark, saying that Clark’s email was a “non-erasable message that can be audited by the FDA.”
Whistleblower Beverly Brown Entitled to Collect Portion of Any Government Recovery
The U.S. Department of Justice decided not to intervene in Brown’s case, but Brown will still proceed with a private legal team.
Submitting claims to federal health care programs for prescriptions not approved by the FDA creates a huge safety risk and costs taxpayers millions of dollars in unapproved spending. Off-label marketing violates federal and state False Claims Acts, meaning private citizens with information on fraud against the government can file suit on behalf of the government and share in a 15% to 30% portion of any recovery.