By Mary Pat Flaherty and Gilbert M. Gaul
Washington Post Staff Writers
Saturday, December 6, 2003
Federal prosecutors in Kansas City, Mo., charged a Miami man yesterday with selling the counterfeit Lipitor that spawned a nationwide recall this summer of nearly 1.8 million pills of the best-selling cholesterol-lowering drug.
The alleged scheme exposed serious weaknesses in the distribution network that moves medicines from drugmakers to patients. The Food and Drug Administration called it one of the largest domestic counterfeiting episodes yet uncovered.
The Rite-Aid and CVS drugstore chains were among those affected by the recall, and some pills were sold over the Internet. The counterfeiting involved tablets made for overseas sales that were illegally diverted into the U.S. market, and tablets made under unknown conditions that contained some active ingredient along with other material, according to court filings.
The Kansas City court records contend that Julio Cesar Cruz, 41, sold counterfeit Lipitor through small pharmaceutical wholesalers in Tennessee, Florida and Kansas City, and through a firm in Nebraska that repackages bulk shipments into smaller bottles for consumers. Cruz also faces state racketeering and fraud charges in Florida over alleged counterfeit drug sales.
Cruz has two prior convictions for cocaine trafficking, according to information filed in the Kansas City case. Cruz's attorney, Roy Kahn of Miami, said yesterday that the federal charge "is no surprise, given that Mr. Cruz already is defending himself on charges in Broward County [Fla.] tangentially related to this investigation."
A cooperating witness in the case has given investigators information that the counterfeiting was on an even larger scale, according to information obtained by The Washington Post. On Tuesday, the witness led agents to a Miami area warehouse where state and federal agents seized more than 1 million pills of the arthritis treatment Celebrex, and large quantities of another arthritis medication Bextra -- both made by Pfizer Inc. -- along with quantities of the allergy drug Allegra, according to three investigative sources familiar with the seizure.
Tests on the pills found Tuesday have not been done to determine what they contain. Some appear to have been intended originally for overseas sale but redirected into the U.S. market, where they could be sold for more, the sources said. The warehouse also contained packaging, bottling and labeling supplies, the sources said.
John M. Taylor, the FDA's associate commissioner for regulatory affairs, could not say for certain whether this summer's recalls intercepted all the suspicious Lipitor before it was used.
Another witness in the counterfeiting case has told investigators that the operation handled 4 million to 6 million Lipitor pills in a scheme that started last December and continued through spring, according to three sources familiar with the witness's statement.
Records uncovered in the scheme suggested the Lipitor originated in Puerto Rico, court filings in Kansas City show, but the Puerto Rican manufacturers deny involvement. Several federal and state investigators and some industry security officials briefed on the case previously told The Post that some counterfeit Lipitor came from shipments bound for overseas that were hijacked on loading docks in Miami, while other tablets appear to be fakes made in Costa Rica and illegally shipped to the United States.
Taylor declined to comment on the Miami area warehouse seizure but said that the FDA is "looking into whether, indeed, other pharmaceuticals may be involved."
A spokesman for Pfizer said the firm was unaware of additional seizures of its Celebrex and Bextra products. A spokesman for Aventis Pharmaceuticals Inc., maker of Allegra, could not be reached last night.
Records of the Lipitor sales were among items seized by Florida agents in their case. The recall also was prompted by complaints from patients who noticed that bottles containing their Lipitor were oversized, while other patients complained of a bitter taste to their pills. The FDA said there have been no reports of harm from the suspect Lipitor but that there was a chance patients received ineffective medicine or pills manufactured under less-than-ideal conditions.
A series of articles in October by The Post detailed lax oversight and monitoring in the nation's distribution system for drugs. Taylor said the Kansas City charge demonstrates "people are becoming more adept at these schemes," and "serves as a caution about the need for us to be vigilant."