Counterfeit drugs that find their way to South Florida Rx supplies, and from there throughout the US, pose a deadly threat to patients according to Sun-Sentinel report

Vials of medicine prescribed for a 16-year-old boy recovering from a liver transplant arrived in the mail from a national pharmacy chain.The shots were painful and didn't seem to work. But Tim continued to take the medication, unaware it contained only 5 percent of the active ingredient.

"You think you're out of the woods and you get hit again," said the boy, whose family has asked that their last name not be used to protect their privacy. "It was horrible."

Tim, who lives on Long Island, is the face of an alarming national scandal. The U.S. pharmaceutical supply, long considered the safest in the world, has become tainted with fake, expired, stolen and diluted drugs. In stories last month, the South Florida Sun-Sentinel reported that more than $100 million in counterfeit and suspect prescription drugs passed through unscrupulous wholesalers in Broward, Palm Beach and Miami-Dade counties in the past two years, an unknown quantity reaching patients throughout the country. A statewide grand jury and law enforcement task force are investigating more than 50 people in South Florida, including convicted felons whom the state gave licenses to peddle medicines. Health officials nationwide fear patients have suffered and even died as a result of taking bad drugs. Quantifying the problem is difficult because doctors and pharmacists often attribute patients' failure to improve on their medical condition.

Tim's family never imagined medicine they bought from a division of a large pharmacy chain would not be authentic. Nor could they imagine how the drug companies would pass the buck, never explaining how the fake drug had slipped through. All told, more than 2,000 boxes of counterfeit Epogen, used to boost red blood cells in kidney, cancer and AIDS patients, may have been sold to unwitting patients like Tim.

The drugs traveled through a maze of wholesalers and distributors in at least five states, according to federal court and state health records. The Sun-Sentinel traced the counterfeit Epogen to several wholesalers in South Florida. No answers for the family. A year after Tim took the counterfeit drug, his family still doesn't know where it came from, and no one has been arrested.

"Everybody's pointing to the next guy," said his father, Kevin. "It's enraging."  Doctors told Tim he needed a new liver after cirrhosis destroyed his. The February 2002 surgery left him anemic, tired and weak. The Epogen was supposed to help him get stronger. But Tim noticed no improvement from the first shipment of the drug he received from CVS ProCare. Instead, several hours after each weekly shot, Tim said his "whole body went into, like, a charley horse."

"It breaks your heart," his father said, recalling how Tim would tell him, "I was praying you wouldn't give me another shot."
Doctors were baffled, Kevin said. After Tim had been taking Epogen for two months, the family got a frightening call from CVS. A second shipment that had just arrived might be counterfeit, the drugstore informed them.

The family discovered the lot numbers on Tim's vials matched those of the fake batch. They also discovered the Epogen Tim had been taking was not full strength. Kevin called CVS for answers and was told the company buys its drugs from AmerisourceBergen, one of the nation's three biggest distributors. AmerisourceBergen referred him to the manufacturer, Amgen in California, who sent him back to AmerisourceBergen. He discovered that big distributors do not always buy directly from manufacturers. They buy from smaller wholesalers as well. Authorities say that's where fake, diluted and expired drugs enter the supply. AmerisourceBergen has filed a federal lawsuit in Phoenix against Dialysist West, an Arizona wholesaler that sold the distributor 2,082 boxes of Epogen for $8.5 million. Anywhere from half to all of that Epogen contained only 5 percent of the active ingredient but had been relabeled to say it was full strength, according to the suit. Records filed in the case show how convoluted a drug's route from manufacturer to patient can be.Dialysist West bought the lower-strength Epogen from three wholesalers: AmeRx Inc., of Oakland Park; CSG Distributors, of Knoxville, Tenn.; and Optia Medical of North Salt Lake, Utah.
CSG bought the Epogen from Premier Medical Distributors, a defunct Fort Lauderdale wholesaler. Premier purchased the drugs from Infinity Medical, an unlicensed wholesaler in Miami, which bought the vials from McKesson Inc., another of the Big Three distributors, according to court records and lawyers involved in the case.

Wholesale denial

All of the wholesalers deny counterfeiting the drug.
"I know it was not my client," said Debra Hill, a Phoenix lawyer for CSG.
Susan Cavaliere, in charge of purchasing for AmeRx, said, "I logged it, I looked at it and I thought it was a good product."
Cavaliere wouldn't say where she bought the drugs, except that they passed through "three or four" licensed wholesalers before AmeRx.

Some Epogen with the same lot numbers as the diluted batch came from the Stone Group and Breckenridge, two Boca Raton wholesalers, state health records show. Florida health regulators have determined that much of the paperwork showing where they bought their drugs was faked. The true source of the counterfeit Epogen may never be known.

"What burns me is you're not talking about some mom and pop drugstore," Kevin said. "You're talking about AmerisourceBergen, a $40 billion-a-year company, Amgen and CVS. In the meantime, nobody knows anything."
In addition to the drug companies, Kevin contacted the U.S. Food and Drug Administration and offered to hand over his vials for testing. The FDA declined for months, until he persuaded Sen. Hillary Clinton, D-New York, to intervene. Two FDA agents then came to his home and later confirmed that both batches were 5 percent strength, he said. Tim, now 17, improved after he began getting full-strength Epogen last summer. He plans to study economics at Iona College in New Rochelle, N.Y., in the fall. His family now scrutinizes all prescriptions and wonders whether the drugs are authentic.

"It just adds so much stress," said Kevin. "On top of everything else, he's got to worry about this because he's going to be on medication the rest of his life."

 

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