Tales from the Dark Side: Merck Takes on Global Counterfeiters

By Paul Thomas, Managing Editor

Advances in technology aren’t always a good thing. In the war against drug counterfeiting, new technologies are giving the “offense” an advantage over the “defense,” noted Bob Moore, Merck’s executive director of global security, at the recent BIO 2006 show in Chicago.

Increasingly, said Moore, counterfeiters of prescription drugs are well funded, with closer ties to organized crime and traffickers of illicit drugs. The Internet has been the “great enabler” of counterfeiting activity, Moore said, by facilitating the flow of ideas and information between criminals.

“There is a lot of money to be made, relatively light penalties and little interest socially” in confronting the problem, he added. Merck has worked with FDA and international authorities to combat specific cases of counterfeiting and diversion. Moore shared three such cases that illustrate the lengths to which counterfeiters will go, and to which Merck must go to track them down. (Summaries of these cases are provided below.)

Moore also touched upon data that has been compiled by the Pharmaceutical Security Institute, a group of 21 drug security experts from leading manufacturers (www.psi-inc.org/about.cfm). The data suggests that the scope and diversity of counterfeiting continue to rise. The numbers are particularly relevant in that they come not from FDA but from reports from the manufacturers and the media.

Among PSI’s tentative findings for 2005:

• The number of counterfeiting incidents rose 27% over 2004.



• The numbers of countries experiencing incidents increased 17%.



• The number of impacted products was up 25%.

Of the documented arrests made worldwide, 72% were for counterfeiting, 16% for diversion, 3% for theft, and 9% were unknown, Moore reported.

Tablets and capsules were the most commonly counterfeited type of medicine, Moore said. And, while drugs for erectile dysfunction remain a popular target, counterfeiters are looking at any drug with value that might provide a lucrative market for fakes.

In the spirit of sharing information on how best to combat the spread of counterfeit drugs, Moore detailed three cases in which Merck and authorities had foiled the bad guys:

1. U.S./Mexico Border:
A U.S. citizen traveled to the border region and purchased what he thought was Zocor, Merck’s cholesterol-lowering drug. When the patient’s subsequent blood tests showed cholesterol levels double what they should have been, he notified the company.

Merck sent undercover professionals to the pharmacy. The first, who spoke Spanish and portrayed himself as Mexican, was turned away. A second, an English-speaking “American,” was sold the product from a private stock behind the pharmacy. The tablets turned out to have no API in them.


2. Chiclayo, Peru:
Merck and police received reports of bogus Fosamax, a medication to enhance bone density, at a Peruvian pharmacy. A first raid on the pharmacy resulted in the seizure of one ton of counterfeit product. A second raid on the home of the pharmacist recovered 12,000 tablets, as well as fake labels and blister packs — the equivalent of one month’s sales of Fosamax in Peru, Moore noted.


3. Germany:
Counterfeit products (ostensibly from Merck and other large manufacturers) were being produced in China, shipped through the Balkans, and sold in the European market. Large amounts of fake Propecia and other counterfeits were seized in Germany.

Over 400 interrelated web sites had coordinated to market the counterfeit products, Moore said. The mastermind behind the scam was a former physician from New York.