Counterfeit Prescription Drugs a Growing Threat

In March, a Homeland Security official told Congress that counterfeit pharmaceuticals were “a major growing health and safety issue.” That same month an FDA official testified that the pharmaceutical supply chain from raw materials to consumer has become increasing complex, making “oversight significantly more difficult and leaves weaknesses through which counterfeit, adulterated and misbranded products might infiltrate the legitimate supply chain.”

It’s likely both these officials had been briefed about the case of Kevin Xu — a Chinese national who was caught trying to sell fake drugs to undercover Immigration and Customs Enforcement (ICE) and FDA agents in 2007.

Xu was brought to the attention of federal agents by investigators at large pharmaceutical companies. The big drug companies employ full units of ex-FBI and customs agents to seek out counterfeiters or those who are infringing on their intellectual property — their branded and copyright-protected medicine. Agents from the drug companies were walking through a huge chemical trade fair when they came across Xu.

Xu immediately stood out for the breadth of the products he claimed he could supply. We were told, off camera, by an investigator at a major drug company, that Xu was “either really, really good or full of shit.” Turns out he was really, really good.

After they had bought several of Xu’s fake drugs, the investigators at the pharmaceutical companies helped federal agents from the Intellectual Property Rights Coordination Center — a multi-agency partnership of more than seven federal agencies — design an elaborate, international sting operation to snare him.

The spectroscopic signature of a product, developed for PAT, may also be used in the field to determine whether a product is real or counterfeit.

We have the surveillance tapes that agents made at two meetings with Xu, first in Thailand and then in the United States. They show how a top-notch counterfeiter was hoping to get his fake medicine through customs control, how he could replicate authentic packaging and how he could supply as many as 200,000 boxes at a time. And these weren’t just so-called lifestyle drugs like Viagra — Xu was offering drugs for Alzheimer’s, heart conditions and cancer treatment. He even bragged to agents how he had been selling fakes in the legitimate supply chain in Europe for years and had never been caught.

What happened to Xu? You’ll have to watch our program.

Xu is emblematic of the increasing difficulty of securing the safety of the global drug supply. While customers in most developed countries can be pretty sure the medicines they buy at their local pharmacy are safe, patients in still developing nations do not have that luxury.

Months ago when we began investigating how and why counterfeit prescription medicines pose a rising threat in the United States, putting patients at risk, our reporting quickly led to widening the investigation into the implications around the world. This eventually took us to Nigeria.

WATCH:

I had been to the country before, briefly in the 1960s, 70s and 80s. Ever since it ceased being a British colony in 1960 it has been viewed as one of the African countries below the Sahara with the most potential. Rich in natural resources, especially oil. Comparatively well-educated English-speaking population. Proud, hard-working population.

But tribal conflicts, sporadic civil war and several failed attempts at changing military rule for representative government, plus deep-seated corruption (fueled in no small part by oil lust and its consequences) kept it too unstable, too unpredictable for it to reach anywhere near its potential.

So I returned, having not been there for about thirty years, with renewed interest and hope. Another effort at democratic civilian government started in 1999. The military has stayed in its barracks and the country has been making progress — economically, educationally and in many other ways.

We were invited to Lagos, the country’s biggest city, by Dr. Paul Orhii. Orhii is the director general of the small regulatory agency tasked with monitoring not only all the pharmaceuticals that come into the country but also all the cosmetics, raw chemicals, food and bottled water. A daunting job made even more difficult by the steady stream of fake drugs pouring across Nigeria’s borders.

Nigeria is the most populous country in Africa with 150 million people, and it still struggles with diseases all but forgotten elsewhere — malaria, cholera, infections. With all those people and all that illness, the demand for medicine is high. Enter the counterfeiters.

It is becoming increasingly obvious that there are organized operations making thousands and thousands of fake pills — Dr. Orhii calls them “Chinese Syndicates.” The final destination for most of these syndicates’ fakes? Africa, where the weak regulation makes it easy to mix the bad stuff in with the good. But Dr. Orhii is trying to change that. With some nifty new technology and old fashion PR campaigns, Orhii says he believes they have the percentage of fake drugs down to 10 percent, maybe less. Although this may be an optimistic estimate, there’s no doubt that Nigeria is a leader in this, has made significant gains and is continuing to move aggressively forward.

Orhii took us on whirlwind tour through Lagos, starting at the Apapa Port where 90 percent of the imports to Nigeria arrive, to the back alleys of one of the oldest markets in the city — Idumota Market on Lagos Island. We watched Orhii’s investigators do spot tests of medicines. What we found will surprise you, concern you and possibly even make you angry.

In our report on Tuesday night you will see exclusive undercover footage — pictures and sound — of a “sting” operation that caught on-camera a big-money Chinese criminal negotiating to get his fake medicines into the U.S. supply chain. We will take you inside big U.S. pharmaceutical companies and their efforts to beat back the threat of counterfeit drugs. They are concerned about their profits, certainly, but also are genuinely concerned about the suffering, and sometimes death, caused by fake medicines.

Even in countries widely though to be “safe,” such as the United States, Canada and many European Union countries, counterfeit medicines — especially prescription drugs — have entered the legitimate supply chain. These include Viagra, Cialis and other so-called “social medicines,” but also Lipitor, Plavix, Casodex, Norvasc, Zyprexa, Celebrex — all prescription drugs for serious health problems affecting people everywhere in the world.

In Nigeria, and in many other countries, the return of malaria is a major concern. Malaria is a treatable disease. But many thousands of people die from it in places like Nigeria. Many die after taking fake malaria drugs that fail to heal them.

We will take you into the marketplaces, drug stores, back alleys and makeshift warehouses of Nigeria, and onto the docks of its ports — we’ll put you there, you will be along on the hunt — as the trail of fake prescription drugs is followed.

Dan Rather Reports |September 19, 2010|Huffpost|