Bad Medicine: The War on Counterfeit Drugs

Imagine opening a new tube of toothpaste and winding up with a mouthful of diethylene glycol, a poisonous chemical used in antifreeze. Sounds far-fetched, but that’s exactly what happened to consumers in New York, New Jersey, Pennsylvania and Maryland in 2007 when a batch of compromised Colgate toothpaste containing the potentially lethal ingredient turned up in various discount stores. The labels on the toxic tubes claimed they had been manufactured in South Africa (Colgate-Palmolive Co. does not manufacture there).¹

Best known as an industrial solvent, diethylene glycol is a potential killer. It is frequently used by counterfeiters hoping for a quick profit to replace the safe but pricier ingredient, glycerin. And, in the past few decades, this inexpensive syrup has compromised everything from cough and fever medication to teething formula for infants. In developing countries, at least eight mass poisonings have been linked to diethylene glycol, leading to thousands of deaths, many of them children. While identifying the origin of these counterfeit drugs is difficult, the warmest trails seem to lead to China, a country where safety regulations have yet to catch up with its expanding role as a global pharmaceutical supplier.²

The United States also has a history of diethylene glycolrelated deaths. In 1937, more than 100 people died after ingesting a product laced with it — an incident that became the impetus behind the 1938 Federal Food, Drug and Cosmetic Act. Now, 70 years later, drug counterfeiters are up to their same tricks, which begs the question: If counterfeit toothpaste has already arrived on our shores, could similarly compromised over-thecounter medicines be far behind?

In an interview with the Partnership for Safe Medicines, Anthony Barron, the European Federation of Pharmaceutical Industries and Associations’ coding and identification project coordinator, discussed the prospect of U.S. policymakers considering the importation of medicines as part of healthcare reform.

“U.S. policymakers should proceed cautiously in opening importation of medicines from other countries,” Barron stated. “So far, most warnings of counterfeit issues in the U.S. were related to drugs purchased on the Internet, as opposed to supply chain failures — a stark contrast to the cases of counterfeit drugs found in the U.K.’s legitimate supply chain.”⁴

The World Health Organization (WHO) estimates that up to 10 percent of globally traded drugs are counterfeit. According to an article published by the Center for Medicine in the Public Interest, worldwide counterfeit pharmaceutical sales are increasing at about 13 percent annually — nearly twice the pace of legitimate pharmaceuticals — and could become a $75 billion industry by the end of this year. That’s a 92 percent jump from 2005. Clearly, there is money to be made, and opportunistic criminals are cashing in.⁵

“We’ve made progress in terms of awareness, but there is still a lot that needs to be done, including federal legislation and more education for both healthcare professionals and consumers,” says Katherine Eban, investigative journalist and author of Dangerous Doses, an in-depth exposé of counterfeiting operations within the pharmaceutical supply chain. “Since my book was published in 2005, the Food and Drug Administration (FDA) has encouraged the industry to implement electronic pedigrees, but so far, we’re only seeing a response at the state level. Drug counterfeiting is a problem that is only going to get bigger as time goes on.”

Counterfeits Part of a Broader Problem

WHO defines counterfeit drugs as “those which are deliberately and fraudulently produced and/or mislabelled with respect to identity and/or source.” Counterfeits are actually just one part of the broader problem of substandard pharmaceuticals — those products in which the composition does not meet correct scientific specifications and are consequently ineffective and often dangerous to the patient. According to the WHO fact sheet, substandard medicines can result from many factors, including negligence, human error, insufficient resources or counterfeiting. And, both branded and generic medicines can be considered counterfeit or substandard.

A drug maybe considered counterfeit for many reasons, including:

• too much or not enough active ingredient
• no active ingredient • the wrong active ingredient
• dangerous excipients and dyes
• the wrong ingredients, but authentic packaging
• the correct ingredients, but fake packaging
• the wrong ingredients, as well as fake packaging In today’s global marketplace, no one is truly safe from the effects of counterfeit drugs.It’s a growing problem in the United States, Europe, Asia and Africa, with drug counterfeiters actively defrauding consumers and interfering with patient therapies that are necessary to alleviate suffering and save lives. Even if the ingredients are correct, counterfeit packaging may include mislabeling, false expiration dates and inaccurate information about dosage and origin. In any event, the consequences for patients can be deadly. WHO estimates that counterfeit drugs are associated with up to 20 percent of the one million malaria deaths worldwide.⁵
• While both industrialized and developing countries are impacted by drug counterfeiting, developing countries typically suffer the highest number of fatalities. For one thing, wealthier countries tend to see more counterfeit drugs pop up in the “lifestyle medication” category, rather than products used to treat life-threatening illnesses. In developing countries, it’s just the opposite, with the highest number of pirated drugs being used to treat serious diseases like malaria, tuberculosis and HIV/AIDS.⁶

Online Pharmacies: Poison in the Pipeline

Part of the reason counterfeit drugs are so deadly and difficult to detect is that counterfeiters go to great lengths to ensure the pirated product looks identical to the real thing. Last September, 29-year-old University of Maryland pharmacologist Carrie John died following an allergic reaction to a counterfeit version of a drug that was legal in the United States, but had been purchased online from the Philippines by a fellow postdoctoral research student. John was using the narcotic painkiller buprenorphine recreationally, and reports state that the drug she injected so closely resembled the legal version that two pharmacologists couldn’t tell the difference.⁷

The H1N1 pandemic of 2009 created a unique opportunity for online criminals. The virus dramatically increased the demand for flu antidotes, and amid early widespread panic, many consumers went online looking for discounts on flufighting drugs like Tamiflu, playing right into the hands of waiting criminals. In Europe, Russian crime gangs are said to have raked in millions online by marketing counterfeit Tamiflu to anxious Britons.⁸

Last year in the U.S., the FDA, which continuously monitors the Internet, issued warnings to the producers and distributors of more than 135 products available online that were making false claims regarding the H1N1 virus. The FDA went so far as to buy some of these products to test their claims for accuracy. One product came from India and contained two nondescript white tablets that were sold as a Tamiflu equivalent. Instead of containing the antiviral oseltamivir, the tablets actually contained acetaminophen, the active ingredient in Tylenol. Four other products purchased by the FDA did contain oseltamivir, but in varying doses, which could have been ineffective or even caused dangerous side effects.⁹

Of course, antivirals were not the only flu drugs being peddled online last year. The seasonal flu vaccine, which was in short supply because production capacity was used to create the 2009 H1N1 vaccine, started showing up in various “gray markets” — often being peddled for as much as eight times the manufacturers’ original price. An article in the Cape Cod Times reported that the pharmacy head at one local hospital was contacted by a so-called secondary wholesaler offering to sell him up to 100 packs of Fluarix for $87 a dose. The vials normally sell for less than $10.¹⁰

Joining Forces and Fighting Back

Worldwide pharmaceutical counterfeiting may be on the rise, but so are the efforts to stop this insidious crime. Late last fall, Interpol officers in Europe, drug agents in the United States and task forces from Sweden to Singapore joined forces and conducted a series of highly organized raids targeting counterfeit drugs.The crackdown in the United States uncovered more than 700 alleged packages of fake or suspicious prescription drugs including Viagra, Vicodin and Claritin, and shut down 90 alleged rogue online pharmacies. The international operation took down 72 websites, seized nearly 1,000 packages and found more than 167,000 suspected illicit and counterfeit pills.¹¹

In other parts of the world, leaders from Benin, Burkina Faso, the Central African Republic, Congo-Republic, Niger and Senegal joined former French President Jacques Chirac in Cotonou, Benin, to campaign against the manufacturing and sale of fake pharmaceuticals.¹² And, in Taiwan, the High Prosecutors Office has formed a task force to crack down on criminal rings selling counterfeit and substandard drugs.¹³

Major pharmaceutical companies also have spearheaded campaigns to tackle the problem. Merck Serono, one of the world’s largest pharmaceutical companies, recently began funding the distribution of minilabs in developing countries to improve detection of fake ingredients in drugs used to combat malaria, HIV and tuberculosis.¹⁴ And, Pfizer has begun implementing safer packaging, using radio-frequency-identification tags on its popular Viagra blockbuster packs.¹⁵

In late 2009, a group of companies and associations from all facets of the pharmaceutical industry teamed up to form RX360, an international consortium aimed at securing the performance of the supply chain and making it easier for suppliers to share and receive information. To date, member companies include biopharmaceutical manufacturers like AstraZenica, Merck and Sanofi; suppliers such as West, Merck, KGaA and SAFC; and various trade organizations and independent auditing firms, including the European Generic Medicines Association. The consortium’s mission is to “create and monitor a global quality system by adopting standards and best practices for the supply chain, supporting technology developments for supply-chain security, monitoring the supply chain, and developing shared audit programs.”¹⁶

The Consumer Component: An Issue of Supply and Demand

Pharmaceutical counterfeits impact individuals and industry throughout society — not just patients at the end of the supply chain. Healthcare organizations, governments and even entire countries pay the price when counterfeiting is allowed to proliferate. Last year, the FDA launched the Secure Supply Chain pilot program, designed to protect pharmaceuticals and their ingredients that are produced outside of the U.S. Additionally, the FDA has opened offices in India and China in an attempt to better monitor the increasing numbers of pharmaceutical manufacturers in those countries.¹⁷ While these are clearly steps in the right direction, the problem of supply chain safety is not simply about supply; it’s also about demand.

The fact remains that consumers continue to make purchases outside of the secure supply chain, enticed by the availability of hard-to-find drugs and gray market pricing. From travelers restocking their medicine cabinets while on vacation to Internet shoppers hoping to score deep discounts on pricey lifestyle medications, purchasing abroad has a high level of consumer appeal. According to the Congressional Budget Office, brandname drugs on average cost from 35 percent to 55 percent less in other industrialized nations than they do in the U.S.¹⁸

That’s why education about the risks associated with these types of transactions needs to increase. And while some U.S. consumers may develop a false sense of security when purchasing from neighboring Canada, a 2005 FDA drug bust indicates that nothing could be further from the truth.The operation—in which the agency examined nearly 4,000 packages at airports in New York, Miami and Los Angeles — found that 85 percent of the drugs ordered from what customers believed were Canadian pharmacies actually came from 27 other countries. Not surprising number of the products also were found to be counterfeit.¹⁹

The road ahead in the war on counterfeit drug trafficking will not be an easy one; there are no simple solutions. Organized efforts by pharmaceutical companies, government agencies and consumer groups will need to pursue improved education and legislation to weed the poison out of the pipeline and create a safe, secure supply chain.