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Judge Smales
New member
Saw this in the NY Times this morning. We are not the only people whe get scammed by fakes- it happens to legit drug stores too. Check it out:
June 5, 2001
3 Fake Drugs Are Found in Pharmacies
By MELODY PETERSEN
he Food and Drug
Administration is
investigating four cases of
counterfeit prescription drugs
making their way to pharmacy
shelves, and, in some cases, being
given to patients.
No one is known to have been
seriously injured, although some
patients have had adverse
reactions. But F.D.A. officials say
they are worried about the four
cases and have made the
investigation a high priority.
"This little spate of cases is highly
unusual," William K. Hubbard, a
senior associate commissioner at
the F.D.A., said. In the last
decade, he said, there have been
only a handful of similar instances.
The recent cases involve three
injectable drugs: Serostim, a
growth hormone sold by Serono
and used by AIDS patients;
Nutropin, a growth hormone sold by Genentech; and
Neupogen, a cancer drug sold by Amgen. All three drugs are
expensive, which could be why the counterfeiters selected them.
A 12-week course of Serostim, for instance, costs $21,000.
The counterfeiters may have been able to find an easy market
for their drugs since Serostim and Nutropin are sought by
people who believe the drugs will help them lose weight, build
muscle and smooth wrinkles. Some Web sites promote the drugs
for such uses, and, in some cases, offer to sell them without a
prescription.
F.D.A. officials and the drug companies have sent letters to
pharmacies, doctors and distributors all over the country to
warn them about the counterfeit drugs.
Serono first realized that someone was counterfeiting Serostim
late last year when patients began to call to complain that they
had suffered a slight swelling or a skin rash after being injected.
Counterfeit versions of Serostim have been found in at least
seven states.
Last month, F.D.A. officials reported three more cases of
counterfeit drugs, this time involving Neupogen, Nutropin and a
second fake batch of Serostim. Genentech, which makes
Nutropin, said pharmacies in Florida, California and Indiana
had found fake copies of the drug on their shelves.
F.D.A. officials say they cannot discuss many aspects of the
recent cases because of the ongoing investigation.
And it is not clear whether the counterfeit drugs were produced
in the United States or came from overseas. Counterfeiters are
drawn to prescription drugs, in part, because their small size
makes them easy to smuggle.
But either way, the drugs appear to be coming through networks
that operate largely beyond the reach of regulators.
At least some of the counterfeit Serostim ended up in
pharmacies after it was quickly bought and resold by a handful
of small drug distributors doing business in a gray market for
medicines that has repeatedly raised concerns among
government officials.
According to the distributors and government officials, a small
Florida distributor sold some counterfeit Serostim to Dutchess
Business Services Inc., a small distributor in Las Vegas, which
then sold it to Quality King Distributors Inc., a distributor in
Ronkonkoma, N.Y. Quality King officials said they then sold it
to other distributors.
Prescription drugs are often diverted into this gray market by
individuals or small businesses who say they are buying the
medicines for nursing homes or other institutions that are
offered steep price discounts by many pharmaceutical
companies. Instead, these buyers sell the discounted drugs into a
network of hundreds of small distributors who resell the drugs
any number of times, marking up the price in the process. The
origin of a drug can quickly become unclear as it passes from
warehouse to warehouse.
"Counterfeiting and diversion go hand in hand," said Stephen J.
Haynes, who retired last year from his job as a special agent in
charge of the investigative division of the office of criminal
investigation at the F.D.A.
Congress has also recently become concerned about whether
inspectors at the F.D.A. and the United States Customs Service
have enough resources to stop illicit medicines from coming
from overseas.
In a March letter to the F.D.A., Representative Billy Tauzin,
Republican of Louisiana and chairman of the House Energy and
Commerce Committee, said he was concerned that the
government's system of inspecting packages of prescription
drugs mailed into the United States from overseas "was
inadequate and incapable of protecting the public from
potentially adulterated and unsafe medicines."
Customs officials said their seizures of counterfeit and other
prescription drugs had risen sharply in recent years. The
service seized 9,725 parcels of prescription drugs in 1999,
compared with 2,145 the year before. Most of the seizures were
drugs purchased by Americans from Web sites operating in
foreign countries. But some of the seizures were commercial
shipments that were intended for resale, customs officials said.
The committee's Oversight and Investigations Subcommittee
plans to hold a hearing on imported prescription drugs on
Thursday.
Representative James C. Greenwood, Republican of
Pennsylvania, who is chairman of the subcommittee, said he had
recently visited an airport mail center where customs officials
showed him some parcels they had seized.
"There were unidentifiable pills coming in in plastic bags,"
Representative Greenwood said. "This is a big problem, and it
has a potential to kill people."
Paul K. Schwartz, director of trade enforcement at the Customs
Service, said he did not believe prescription drug counterfeiting
was on the rise.
"But," he added, "there is no way of knowing what we are not
catching."
All three companies with drugs that have been recently
counterfeited said they immediately told the F.D.A. when they
found the fake drugs.
In each case, the counterfeit drug looked nearly identical to the
real product. For Serostim, even the lot number, which is used
to trace drugs, was a real number. The expiration date,
however, had been changed from August 2001 to August 2002.
Some of the counterfeit vials were found to contain cheap,
generic versions of the drugs, while others had been filled with
clear liquid that contained no active drug ingredient. At least
one vial of Nutropin contained human insulin.
Two earlier cases provide a glimpse of how illegal drugs can
enter the system.
From 1991 to 1993, Moshe Milstein, operated a drug
wholesaling business out of his Brooklyn home and repackaged
drugs from overseas with labels made to look like those on the
brand-name drug, according to court records. Mr. Milstein then
sold the drugs to other wholesalers and to pharmacies and
doctors in the New York area. Prosecutors said laboratory tests
showed that some of the counterfeit drugs contained bacteria
and endotoxins, which are powerful poisons produced by
bacteria.
Mr. Milstein was convicted last year of five felonies, including
distribution of misbranded drugs, and is expected to be
sentenced on Thursday. The counterfeit drugs that he had sold
through his company, Gem Distributors, included Serono's
Pergonal and Metrodin, which are fertility drugs, and Eldepryl,
a drug for Parkinson's disease made by Somerset
Pharmaceuticals Inc.
Mr. Milstein's lawyer declined to comment.
In another case in 1997, Medical Sales Inc., a small company in
San Diego County, Calif., bought millions of doses of drugs
made by an Indian manufacturer and repackaged them under the
name "American Pharmaceutical," according to court
documents. The company planned to sell the drugs, which
included antibiotics, painkillers and diet drugs, to pharmacies
in Tijuana, Mexico, where they could be purchased by
American tourists.
Christopher Kirkman, the company's president, was convicted
of a misdemeanor charge of selling misbranded drugs in 1999
and was given six months' probation.
Robert S. Brewer Jr., Mr. Kirkman's lawyer, said his client
never sold any of the repackaged drugs because they were
seized by the F.D.A.
The drug distributors that bought and sold the counterfeit
Serostim late last year said they did not know the drug was
illegitimate until they heard about a warning Serono sent out.
Dutchess Business Services in Las Vegas said it immediately
contacted authorities when it discovered it had bought and sold
the counterfeit drug.
Quality King said it had voluntarily offered to repurchase
Serostim from any of the wholesalers it had sold it to.
The distributors say they play an important role in getting drugs
to consumers.
"You can't anticipate all the ways that people are going to
corrupt the system," said Patricia L. Kantor, a lawyer in the
New York office of Edwards & Angell who represents Quality
King.
A man answering the phone at Dutchess, who refused to give his
name, said Dutchess had lost $70,000 when Quality King
refused to pay for the counterfeit Serostim it bought. "We are
entrepreneurs," he said. "We're just trying to make a living."
June 5, 2001
3 Fake Drugs Are Found in Pharmacies
By MELODY PETERSEN
he Food and Drug
Administration is
investigating four cases of
counterfeit prescription drugs
making their way to pharmacy
shelves, and, in some cases, being
given to patients.
No one is known to have been
seriously injured, although some
patients have had adverse
reactions. But F.D.A. officials say
they are worried about the four
cases and have made the
investigation a high priority.
"This little spate of cases is highly
unusual," William K. Hubbard, a
senior associate commissioner at
the F.D.A., said. In the last
decade, he said, there have been
only a handful of similar instances.
The recent cases involve three
injectable drugs: Serostim, a
growth hormone sold by Serono
and used by AIDS patients;
Nutropin, a growth hormone sold by Genentech; and
Neupogen, a cancer drug sold by Amgen. All three drugs are
expensive, which could be why the counterfeiters selected them.
A 12-week course of Serostim, for instance, costs $21,000.
The counterfeiters may have been able to find an easy market
for their drugs since Serostim and Nutropin are sought by
people who believe the drugs will help them lose weight, build
muscle and smooth wrinkles. Some Web sites promote the drugs
for such uses, and, in some cases, offer to sell them without a
prescription.
F.D.A. officials and the drug companies have sent letters to
pharmacies, doctors and distributors all over the country to
warn them about the counterfeit drugs.
Serono first realized that someone was counterfeiting Serostim
late last year when patients began to call to complain that they
had suffered a slight swelling or a skin rash after being injected.
Counterfeit versions of Serostim have been found in at least
seven states.
Last month, F.D.A. officials reported three more cases of
counterfeit drugs, this time involving Neupogen, Nutropin and a
second fake batch of Serostim. Genentech, which makes
Nutropin, said pharmacies in Florida, California and Indiana
had found fake copies of the drug on their shelves.
F.D.A. officials say they cannot discuss many aspects of the
recent cases because of the ongoing investigation.
And it is not clear whether the counterfeit drugs were produced
in the United States or came from overseas. Counterfeiters are
drawn to prescription drugs, in part, because their small size
makes them easy to smuggle.
But either way, the drugs appear to be coming through networks
that operate largely beyond the reach of regulators.
At least some of the counterfeit Serostim ended up in
pharmacies after it was quickly bought and resold by a handful
of small drug distributors doing business in a gray market for
medicines that has repeatedly raised concerns among
government officials.
According to the distributors and government officials, a small
Florida distributor sold some counterfeit Serostim to Dutchess
Business Services Inc., a small distributor in Las Vegas, which
then sold it to Quality King Distributors Inc., a distributor in
Ronkonkoma, N.Y. Quality King officials said they then sold it
to other distributors.
Prescription drugs are often diverted into this gray market by
individuals or small businesses who say they are buying the
medicines for nursing homes or other institutions that are
offered steep price discounts by many pharmaceutical
companies. Instead, these buyers sell the discounted drugs into a
network of hundreds of small distributors who resell the drugs
any number of times, marking up the price in the process. The
origin of a drug can quickly become unclear as it passes from
warehouse to warehouse.
"Counterfeiting and diversion go hand in hand," said Stephen J.
Haynes, who retired last year from his job as a special agent in
charge of the investigative division of the office of criminal
investigation at the F.D.A.
Congress has also recently become concerned about whether
inspectors at the F.D.A. and the United States Customs Service
have enough resources to stop illicit medicines from coming
from overseas.
In a March letter to the F.D.A., Representative Billy Tauzin,
Republican of Louisiana and chairman of the House Energy and
Commerce Committee, said he was concerned that the
government's system of inspecting packages of prescription
drugs mailed into the United States from overseas "was
inadequate and incapable of protecting the public from
potentially adulterated and unsafe medicines."
Customs officials said their seizures of counterfeit and other
prescription drugs had risen sharply in recent years. The
service seized 9,725 parcels of prescription drugs in 1999,
compared with 2,145 the year before. Most of the seizures were
drugs purchased by Americans from Web sites operating in
foreign countries. But some of the seizures were commercial
shipments that were intended for resale, customs officials said.
The committee's Oversight and Investigations Subcommittee
plans to hold a hearing on imported prescription drugs on
Thursday.
Representative James C. Greenwood, Republican of
Pennsylvania, who is chairman of the subcommittee, said he had
recently visited an airport mail center where customs officials
showed him some parcels they had seized.
"There were unidentifiable pills coming in in plastic bags,"
Representative Greenwood said. "This is a big problem, and it
has a potential to kill people."
Paul K. Schwartz, director of trade enforcement at the Customs
Service, said he did not believe prescription drug counterfeiting
was on the rise.
"But," he added, "there is no way of knowing what we are not
catching."
All three companies with drugs that have been recently
counterfeited said they immediately told the F.D.A. when they
found the fake drugs.
In each case, the counterfeit drug looked nearly identical to the
real product. For Serostim, even the lot number, which is used
to trace drugs, was a real number. The expiration date,
however, had been changed from August 2001 to August 2002.
Some of the counterfeit vials were found to contain cheap,
generic versions of the drugs, while others had been filled with
clear liquid that contained no active drug ingredient. At least
one vial of Nutropin contained human insulin.
Two earlier cases provide a glimpse of how illegal drugs can
enter the system.
From 1991 to 1993, Moshe Milstein, operated a drug
wholesaling business out of his Brooklyn home and repackaged
drugs from overseas with labels made to look like those on the
brand-name drug, according to court records. Mr. Milstein then
sold the drugs to other wholesalers and to pharmacies and
doctors in the New York area. Prosecutors said laboratory tests
showed that some of the counterfeit drugs contained bacteria
and endotoxins, which are powerful poisons produced by
bacteria.
Mr. Milstein was convicted last year of five felonies, including
distribution of misbranded drugs, and is expected to be
sentenced on Thursday. The counterfeit drugs that he had sold
through his company, Gem Distributors, included Serono's
Pergonal and Metrodin, which are fertility drugs, and Eldepryl,
a drug for Parkinson's disease made by Somerset
Pharmaceuticals Inc.
Mr. Milstein's lawyer declined to comment.
In another case in 1997, Medical Sales Inc., a small company in
San Diego County, Calif., bought millions of doses of drugs
made by an Indian manufacturer and repackaged them under the
name "American Pharmaceutical," according to court
documents. The company planned to sell the drugs, which
included antibiotics, painkillers and diet drugs, to pharmacies
in Tijuana, Mexico, where they could be purchased by
American tourists.
Christopher Kirkman, the company's president, was convicted
of a misdemeanor charge of selling misbranded drugs in 1999
and was given six months' probation.
Robert S. Brewer Jr., Mr. Kirkman's lawyer, said his client
never sold any of the repackaged drugs because they were
seized by the F.D.A.
The drug distributors that bought and sold the counterfeit
Serostim late last year said they did not know the drug was
illegitimate until they heard about a warning Serono sent out.
Dutchess Business Services in Las Vegas said it immediately
contacted authorities when it discovered it had bought and sold
the counterfeit drug.
Quality King said it had voluntarily offered to repurchase
Serostim from any of the wholesalers it had sold it to.
The distributors say they play an important role in getting drugs
to consumers.
"You can't anticipate all the ways that people are going to
corrupt the system," said Patricia L. Kantor, a lawyer in the
New York office of Edwards & Angell who represents Quality
King.
A man answering the phone at Dutchess, who refused to give his
name, said Dutchess had lost $70,000 when Quality King
refused to pay for the counterfeit Serostim it bought. "We are
entrepreneurs," he said. "We're just trying to make a living."
