NEWARK (CN) – Organon Pharmaceuticals juggled data to try to make bleeding problems from its Arixtra drug “almost disappear,” and harassed an executive as “insubordinate” for objecting, forcing him and another worker to resign, the company’s former associate director of medical services says.
Jeffrey D. Feldstein, and an expert in anti-thrombotic medication, sued Organon and its corporate parent, Akzo Nobel, in Essex County Court.
Feldstein says Organon hired him in 2000 to analyze information on a new drug, “Arixtra,” which was “designed to reduce the risk of orthopedic patients developing blood clots.”
Feldstein says he soon discovered Organon’s attempts to “cover up” potentially serious issues with “excessive bleeding in a number of patients” who took the drug. He says that Organon hired Ingenix, which acted as an “agent of record” under regulations, to “fairly disseminate information to the medical community” involving the developing drug.
The FDA requires drug makers to hire companies such as Ingenix “in order in ensure that a pharmaceutical company is not self-servingly presenting [medical] data in a misleading manner.”
Shorty after hiring Ingenix, Feldstein says, Organon tried to take “increasing control over the promotion and other direction of Arixtra.”
After Ingenix released safety data “illustrating excessive bleeding in a number of patients,” Feldstein says, he received an e-mail from a supervisor, stating that Organon had “decided that a two- or three-slide presentation should be developed” to “appropriately and succinctly address the data issue.”
Feldstein says that that violates several federal drug regulations.
The slides that were developed were also misleading, Feldstein says.
He says they “blended two studies,” one a for knee replacement and one for hip joint replacement, in order to make 11 cases of major bleeding caused by the drug “almost disappear.”
Feldstein says that Organon “had budgeted approximately $23 million for the calendar year 2001 for symposia and other promotional purposes to serve Arixtra.”
He says that later e-mails he received from supervisors said that “we have the flexibility to influence selection of speakers, topics and content to ensure the symposium complements our abstract presentations and our product messages.”
Feldstein says this violates Continuing Medical Education Regulations.
When Feldstein voiced his concerns about these violations, he says, he was “frequently harassed” by other doctors working on the drug, “chastised as being insubordinate,” and given a “disciplinary warning” about the complaints.
He says that a co-worker on Arixtra research “resigned his position for fear of endangering his professional licenses due to the pervasive culture within Organon.” Feldstein himself ended up resigning in June 2001.
Arixtra eventually was approved by the FDA, but with a “black box warning” indicating restricted use, which Feldstein claims “vindicated” his concerns about the drug.
He seeks damages for violation of the Conscientious Employee Protection Act and intentional infliction of emotional distress. He is represented by Steven Adler with Cole, Schotz, Meisel, Forman & Leonard of Hackensack, N.J.