3 Fake Drugs Are Found in Pharmacies

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My daughter was on Nutropin for two years, its one of the three drugs in this

article,~>Becky M.

3 Fake Drugs Are Found in Pharmacies

http://www.nytimes.com/2001/06/05/business/05DRUG.html

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June 5, 2001

3 Fake Drugs Are Found in Pharmacies

By MELODY PETERSEN

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An authentic vial of Neupogen by Amgen, left, and a counterfeit vial. Only small

differences in labeling and packaging distinguish the two vials.

[T] 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, " 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 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 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 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. "

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.

Kirkman, the company's president, was convicted of a misdemeanor

charge of selling misbranded drugs in 1999 and was given six months' probation.

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 L. Kantor, a lawyer in the New York office of & 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. "