Celgene ‘downplayed’ Thalomid, Revlimid risks
pharmafile | February 7, 2014 | News story | Medical Communications, Sales and Marketing | Celgene, Revlimid, Thalidomide, thalomid
A former sales representative for US pharma firm Celgene is accusing her old company of promoting two of its key drugs off-label and downplaying its safety risks.
The federal suit which has just been unsealed by a US court today, alleges that Celgene marketed its cancer drugs Thalomid (thalidomide) and Revlimid (lenalidomide) to patients and their doctors for unapproved purposes.
The suit also alleges that Celgene paid ‘kickbacks’ to doctors for prescribing these medications, two of the biggest earners for the firm.
Furthermore, it is being accused of engaging in ‘unlawful marketing schemes’ of both Thalomid and Revlimid, potentially costing the US government and state healthcare payors hundreds of millions of dollars.
Thalomid is a form of thalidomide, a drug made notorious for causing severe birth defects in the 1960s after being given to mothers for morning sickness – it was later taken off the market.
It has now been re-developed by Celgene as a medicine for multiple myeloma, whilst Revlimid also has a similar licence for this type of cancer.
Filed in the US District Court for the Central District of California, the suit, U.S. ex rel. Beverly Brown v. Celgene Corp., was originally filed in 2007 – but was not available to the public until now.
‘Preying on patients’
The complainant Beverly Brown is a former sales rep at Celgene who is said by her law firm to have ‘worked heavily’ on marketing both Thalomid and Revlimid during her decade-long stint at the company (from 2001-11).
Brown alleges that Celgene “preyed on a vulnerable patient population” by aggressively marketing these two drugs for licences not approved by the FDA.
According to the suit, Celgene “knowingly concealed the risks of venous thromboembolism and deaths” associated with Thalomid use in cancer patients.
Brown also alleges that Celgene sales reps encouraged doctors to switch patients from Thalomid to Revlimid, regardless of whether the patients were stable.
Cases similar to the one against Celgene, including those brought against Abbott, Pfizer and GlaxoSmithKline, have resulted in the return of billions of dollars to government treasuries.
Reuben Guttman, director of the false claims litigation group at Grant & Eisenhofer, the law firm representing Brown, said: “Honest medical information about treatment options includes direction on appropriate drug regimens.
“Patients ravaged by cancer are among the most vulnerable and often desperate, and put extreme trust in their doctors that their regimens have been approved by the FDA for safety and efficacy. Unfortunately, we believe that this has not been the case in Celgene’s promotion of Thalomid and Revlimid.
“The company consistently bypassed government regulations through its misbranding and marketing these two drugs for off-label usage, putting countless patients at risk, and burdening a healthcare system.”
Thalidomide pay-out
Meanwhile, more than 100 Australian and New Zealand victims of thalidomide have been given $89 million in compensation today by a decision from the Victorian Supreme Court.
The money will be paid by the drug’s distributor, Diageo, with thalidomide’s original manufacturer Grünenthal not included in the agreement. The settlement ends a long compensation battle by the thalidomide victims, many of whom were born with missing or shortened limbs.
The drug was distributed in Australia and New Zealand around 1960 and 1961 by Distillers, which became part of Diageo in 1997.
Ben Adams
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