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BYU Widens Pfizer Fraud Complaint

BYU Widens Pfizer Fraud Complaint [The Day, New London, Conn.]

From Day, The (New London, CT) (July 8, 2010)


July 08--New allegations have emerged in a four-year-old lawsuit against Pfizer Inc., as Brigham Young University, which previously had accused the pharmaceutical firm of stealing a major drug discovery, now says the company has been engaged in a more wide-ranging fraud than it previously realized.

Among BYU’s allegations in its amended complaint: that Pfizer and its predecessor companies, most prominently Monsanto, filed fraudulent paperwork with the U.S. Food and Drug Administration and U.S. Patent and Trademark Office improperly claiming credit for a key discovery that led to the development of a class of anti-inflammatory drugs known as COX-2 inhibitors. BYU’s suit also said Pfizer published reports in academic journals that essentially rewrote the scientific history of COX-2 medications such as Celebrex and Bextra so that a university researcher who it says made the key discovery is barely mentioned at all.

BYU, in an amended suit filed last week in U.S. District Court in Utah, accused Pfizer and Monsanto of taking part in a scheme over nearly two decades to "usurp, protect and enhance profits from COX-2 related drugs" as it attempted to take credit away from BYU researcher Daniel L. Simmons. The companies were part of a group called the COX-2 Project Enterprise, the suit said, that concocted a scheme to withhold profits of at least $1 billion that BYU claims would have been due the university had the company abided by a research agreement that Monsanto signed in the early 1990s.

Pfizer said the amended complaint contained no new information.

"This is the latest attempt by BYU to distract attention away from the merits of this case," Pfizer spokesman Christopher Loder said in a statement. "We continue to maintain that the allegations raised by BYU and Simmons are baseless."

BYU said in its new filing that Pfizer has purposely withheld documents that would help prove allegations in its suit. The university claims in its suit that Monsanto initially entered into a research agreement with BYU, then backed out when it had accumulated enough confidential information to create the illusion that company researchers, rather than Simmons, had discovered COX-2.

Monsanto was acquired by Pfizer when it bought Pharmacia in 2003.

"Though the court has santioned Pfizer $852,315.80 for some of its discovery misconduct, Pfizer continues to withhold documents," the suit said. "Pfizer, in exchange for a one-time sanction of less than $1 million, will not put at risk the billions in profits that it has already improperly kept."

Large parts of the new filing have been redacted, but in sections that are left intact, BYU charges that Monsanto did not abide by FDA regulations in the keeping or re-creation of scientific notebooks. Some notebooks were destroyed, according to the suit, which also alleges that it "continues to find evidence that Pfizer was withholding documents."

Pfizer maintains the new allegations are not substantiated.

"We will continue to mount a vigorous defense," Loder, the Pfizer spokesman, said. "We are confident that the facts clearly show that Monsanto fully met all the obligations of its research agreement with BYU and Dr. Simmons."

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Posted: July 2010