COUNTERFEIT DRUGS FLOODING THE
COUNTRY: THE UNTOLD STORY
Yes, there IS a drug safety issue,
but not the one that consumed Congressional spin-meisters last
week. Sun-Sentinel's investigative reporter Bob LaMendola wrote
a block-buster expose on June 29th that's been totally ignored.
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
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
"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.
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
"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
All of the wholesalers deny counterfeiting the drug.
"I know it was not my client," said Debra Hill, a Phoenix lawyer
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
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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