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Lilly team disrupts drug counterfeiters
January 19, 2004
Go shopping for the new male impotence
pill Cialis on the Internet and you'll likely
run into offers to sell you Cyalus, Apcalis
and Regalis.
Counterfeiters brazenly market bogus Cialis
under those names or others just two months
after the pill hit the U.S. market.
Mass counterfeiting from unregulated black-market
labs has become the norm for many popular prescription
drugs, and it's prompting drugmakers to fight
back.
Cialis co-developer Eli
Lilly and Co. helps lead the drug industry
counter- offensive to the bogus drug operators.
The Indianapolis drugmaker formed a separate
"product protection" team a year ago
to investigate counterfeiting of its drugs worldwide.
Working out of a building near the Lilly corporate
campus, the team of lawyers, scientists and
security personnel led by an ex-FBI special
agent aims to disrupt operations of increasingly
sophisticated drug counterfeiters.
"They are very aggressive. We are being
aggressive ourselves. You can disrupt them,
you can cost them a lot of money," said
Dillard W. "Buz" Howell II, director
of global product security for Lilly.
Howell, who worked 12 years for the FBI as
an agent and supervisor before joining Lilly
in 1982, heads the team that focuses solely
on counterfeiting and other product protection
issues.
Howell said his team, working with private
investigators, so far has gathered evidence
on 30 counterfeiting operations in seven countries.
Lilly turned its evidence over to authorities,
who have prosecuted all 30 cases, Howell said.
Counterfeiters tend to work in less- developed
nations where drug enforcement is lax. "It
was very evident to (Lilly) management that
just relying on law enforcement in these countries
wasn't sufficient. They don't have the resources,
quite frankly," Howell said.
So Lilly "essentially prepares a case
for them," he said, interviewing witnesses,
doing lab tests on the counterfeit products,
even describing distribution networks for the
illicit goods.
Howell pulls out photographs, taken by a Lilly
investigator, of a decrepit drug lab in Taiwan
that made counterfeit Cialis and other drugs.
They show a filthy production room with ramshackle
pill-making equipment. Using Lilly-gathered
evidence, police raided that lab and others
last August and arrested 35 people, he said.
Lilly knew Cialis would be popular with counterfeiters.
It's a high-priced drug that sells well over
the Internet, since men hesitate talking about
their sexual
problems with their doctors.
Cialis, which is co-marketed with Icos Corp.
of Bothell, Wash., became the first Lilly drug
sold in anti-counterfeiting packaging. The Lilly/Icos
logo on the package is printed with color-shifting
ink, similar to that used on new U.S. $20 bills,
said Mark A. Barbato, Cialis product team leader.
A second covert marking, which Lilly won't
reveal, also is put on the packaging, he said.
Lilly might use the anti-counterfeiting marks
on its other drugs as well, he said. Lilly/Icos
has notified wholesalers and pharmacies about
the color-shifting ink logo, so they can watch
out for counterfeit product.
Counterfeiters who operate over the Internet
pose another sort of problem. A host of e- pharmacy
sites sell what's billed as generic Cialis for
a third or less of what Cialis costs.
RX-Mex.com, for instance, which operates from
Monterrey, Mexico, recently was selling Regalis,
said to be a generic Cialis, for $30 for four
20 mg. pills, compared with $94 for four pills
of Cialis. The Mexican pharmacy's Web site says
the Regalis it sells is made by Gen Pharma,
a drug manufacturer in India, a nation that
does not honor U.S. drug patents.
Mistype the name Cialis as Cyalus and you get
the Web site Cyalus.com, which contains a doctored
Lilly/Icos news release about the U.S. approval
of "Cyalus," complete with quotes
from Lilly President Sidney Taurel referring
to "Cyalus." The site flips visitors
to RX-Mex, where "Cyalus aka Regalis"
can be bought by credit card.
"We're dealing with that as we speak.
Our legal group is," Howell said last week
of the Cyalus.com site. But the site was still
up and running days later.
The rising tide of counterfeiting prompted
the Food and Drug Administration to form a task
force last year to study the issue. Its recommendations,
expected to be out within several weeks, might
include requiring drugmakers to use anti-counterfeiting
packaging.
The FDA said its investigations of drug counterfeiting
have jumped from five a year in the late 1990s
to more than 20 a year in recent years.
"The technology (of counterfeiting) is
maturing very quickly," said Alan Goldhammer,
associate vice president of regulatory affairs
for Pharmaceutical Research and Manufacturers
of America, a trade group for drugmakers. "Anytime
you have a high value-added product, counterfeiters
will look for opportunities. Companies are doing
all kinds of things" to fight back, he
said.
Drug companies realize their efforts can save
not just sales, but lives, Howell said. Lilly
has tested counterfeits of its drugs and found
the counterfeit often contains little or no
active ingredient and sometimes include fillers
such as diet supplements, he said.
"You're getting a smorgasbord of product,"
he said.
Lilly sends the counterfeits it gets to the
FDA's forensic chemistry labs in Cincinnati.
"We cooperate fully with them," Howell
said. "Our main concern is they're aware"
of the counterfeiting.
In the past year, he said, Lilly spent more
money and man-hours for product protection than
it did in the 10 years leading up to the late
1990s, when cases of counterfeiting began to
jump.
source:-http://www.indystar.com
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