Washington — Counterfeit medicines are a serious problem afflicting some 90 countries worldwide, and they kill an estimated 700,000 people annually. The key to fighting the “pandemic” of counterfeit drugs is building partnerships among drug companies, pharmaceutical trade groups, law enforcement and customs officials worldwide.
This was the message from the 2010 U.S.-Africa Private Sector Health Conference, organized by the Corporate Council on Africa, on October 6 in Washington.
Rubie Mages, the director of strategic planning for global security at the U.S. drug manufacturer Pfizer, told the conference that since 2004 her company alone has seized more than 62 million doses of counterfeit medicines worldwide, before those medications could be passed off to consumers by unscrupulous pharmacies and retailers.
INEFFECTIVE AND TOXIC COMPONENTS IN FAKE DRUGS
Counterfeit drugs, made to resemble real patented and trademarked drugs manufactured by a licensed pharmaceutical company, usually are composed of cornstarch and other, often toxic materials. These counterfeits are often harmful to consumers. At best, they have little or no medicinal value; at worst they are dangerous. In 2008, for example, adulterated heparin caused injury and some deaths in patients throughout the world.
Mages said the World Health Organization has estimated that between 8 percent and 10 percent of the world pharmaceutical market is made up of counterfeit drugs. In some cases in Asia, Africa and Latin America, counterfeit drugs amount to 10 percent to 30 percent of those markets. She cited estimates of the international counterfeit global drug market at $75 billion. Some estimate a 13 percent annual growth rate in fake drugs, outpacing the annual growth rate for legitimate pharmaceuticals by almost twofold.
Focusing on Africa, Mages said her company has seen counterfeit drugs in Nigeria, South Africa, Tanzania and Uganda. Mages singled out Nigeria for taking the lead in combating the onslaught of counterfeit drugs.
She said counterfeit drugs are often found to contain harmful levels of pesticide, rat poison, paint and ink (for coloring), and tablets are often given a sheen with common floor wax to resemble the legitimate product.
Mages told her audience that it can be “virtually impossible” to tell real drugs from counterfeit replicas by looking at the medicine or its packaging.
In fact, she cautioned, counterfeit medicines sometimes bear better defined marks and lettering than the real drugs “because the tools and dyes used to punch out millions and millions of [legitimate] tablets” by the drug companies become worn. The markings on a counterfeit tablet can have a “cleaner, crisper look” because the tools and dyes used by counterfeiters are often used in smaller batches and are therefore less worn.
TRANSSHIPMENT OF COUNTERFEIT DRUGS
Counterfeiting is a crime of “fraud and deceit,” Mages said, and counterfeiters — motivated by pure greed — see their enterprise as high-profit and low-risk. She said counterfeit drugs are often shipped to their final destinations via a complex route to try to throw off any law enforcement bodies that might be tracking the shipments. “There are instances where tablets going from Mauritius to Seychelles went by way of Paris, obviously not a direct route,” just to throw off authorities.
In another case, she said, counterfeit drugs manufactured in China were secretly shipped to Hong Kong, then to Dubai, then to the United Kingdom and on to the Bahamas — all in an attempt to bypass customs and law enforcement authorities. The shipment was then broken down and packed into small postal envelopes with patients’ names on them and clandestinely shipped back to the United Kingdom. The ultimate recipients in the United States got those counterfeit drugs through the mail from the U.K., thinking that they were legitimate drugs. In reality, the counterfeit drugs had been illicitly transshipped in a way to avoid customs and law enforcement authorities in all countries.
Mages said public-private partnerships are the key to enforcement against counterfeit drugs. The pharmaceutical companies must “monitor the supply chain” and alert authorities when counterfeit drugs are spotted, she said.
Paul Orhii, director-general of Nigeria’s National Agency for Food and Drug Administration and Control, told the conference that his agency recently seized one air shipment of counterfeit drugs worth $3 million alone. But he said his country has been able to reduce counterfeit drugs in Nigeria to less than 5 percent of the market by aggressively using new technology.
STOPPING COUNTERFEIT DRUGS THROUGH TECHNOLOGY
Ashifi Gogo, chief executive officer of Sproxil Corporation, described how new technology has helped stop counterfeiting.
Gogo said that, when purchasing pharmaceuticals, a consumer can send a free text message containing the serial number of the drug package to the manufacturer. The consumer will get an immediate text back saying either “good” or “fake” from the drug company, he said. The technology not only protects consumers, he said, but also alerts the company immediately if counterfeit supplies are entering the market so it can take prompt action.
Another way to use technology to combat counterfeiters was previewed by Julien Bradley, a director of product management and marketing for Thermo Fisher Scientific. His company is now manufacturing a handheld scanner that can instantly verify a drug shipment’s authenticity by analyzing a tablet’s complex chemical spectrum. Unless the entire spectrum checks out, he told his audience, the drug will show as counterfeit on the scanner, even if it contains some of the properties found in the authentic drug. He said some 700,000 people die worldwide annually from counterfeit drugs.
In an address to the Partnership for Safe Medicines Interchange October 8, U.S. Food and Drug Commissioner Margaret A. Hamburg warned, “Drug counterfeiting involves larceny and fraud on several levels. Certainly, it involves theft against the drug manufacturer, but perhaps even more importantly, it robs … people of the faith and confidence they deserve to have in drug products they believe are FDA-approved.”
Hamburg told her audience, “Fake medical products may contain too much, too little or the wrong active ingredient, and could contain toxic ingredients. They can also increase the likelihood of drug resistance, and they may prevent patients from getting the real medical products that they need to alleviate suffering and save lives.”
She warned that “counterfeits, diversions and cargo theft are all part of a growing criminal enterprise, which also includes the deliberate adulteration of drugs and consumer products to maximize profits and unknown threats that have yet to surface.”
The United States, Hamburg told her audience, is “working hard with its sister regulatory authorities around the world” on a bilateral and multilateral basis, with international and national organizations — such as the World Health Organization and the Permanent Forum on International Pharmaceutical Crime — and with industry to leverage international resources to combat counterfeits.
“We have seen that the threat from economically motivated adulteration, counterfeiting and cargo theft is real. And, unfortunately, we know that the results can be tragic,” she said.