Before you pop that pill – do you know it’s the genuine product? Sure, the packaging looks good and the pill inside seems like the real thing but how can you tell that the drug you are about to take is not a counterfeit? In written testimony before the Senate Health, Education, Labor and Pensions Committee, last month, Graham Satchwell, one of Europe's most respected voices on pharmaceutical fraud, said that "counterfeit medicines often appear so like the genuine product that no one, not the best specialist can tell the genuine packaging from the counterfeit. And no one, not the best specialist can tell the genuine product from the counterfeit unless the product is subjected to chemical analysis. The result is that everyone, poor, ignorant, rich and smart, all are at risk from counterfeit or sub-standard products - and they probably won't recognise them when they and if they see them."
What the doctor ordered – or is it?
The Food and Drug Administration (FDA) define counterfeit drugs as those sold under a product name without proper authorization. Counterfeiting applies to brand name and generic drugs, and while counterfeit drugs come in many guises, the common thread is that they are deliberately and fraudulently labeled to suggest that it is the authentic, approved product made by the genuine manufacturer. The World Health Organization (WHO) gives the following details concerning the types of counterfeit products.
A pharmaceutical product is considered counterfeit, if there is:
- fake packaging + correct quantity of correct ingredient;
- fake packaging + wrong ingredient;
- fake packaging + no active ingredient;
- fake packaging + incorrect quantity of correct ingredient;
- genuine packaging + wrong ingredient (deliberate);
- genuine packaging + no ingredient (deliberate); or
- genuine packaging + incorrect quantity of ingredient (deliberate).
Dysfunctional drugs
It’s extremely difficult to quantify the full extent of the drug counterfeiting problem as the counterfeiters make tremendous effects to make their products appear genuine. However, if you think that counterfeit drugs only pose a problem to poor countries then think again – drug counterfeiting is a serious problem that affects us all. In the United Kingdom, the Royal Pharmaceutical Society found that 50 percent of all drugs for erectile dysfunction sold on the Internet in 2004 were counterfeit. The FDA estimate that more than 10 percent of drugs worldwide are counterfeit and that in some countries over 50 percent of the drug supply may be composed of counterfeit drugs. The problem is also getting worse. According to the Pharmaceutical Security Institute, there were 32 incidents of counterfeit medicines in the United States in 2004, compared to 4 FDA counterfeit drug investigations in 1998. While the increase in the prevalence of counterfeiting activities is worrying enough, the FDA also report an increased sophistication in the methods used to introduce counterfeits drugs into the drug distribution system.
Close the borders!
The prevalence of counterfeit drugs and the ease in which they can become part of the otherwise legal drug distribution network is also becoming part of the discussion on drug importation in the United States. Many Americans regularly travel to Canada to fill their prescriptions where the government sets prices as much as 80 percent lower than in the United States. Some states are currently endorsing or running drug importation schemes and others are considering drug importation as a way to cut costs.
Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) has been quite vocal in his opposition to drug importation quoting safety and the threat of counterfeit drugs among his primary concerns.
In a comprehensive report entitled "Examination and Assessment of Prescription Drug Importation from Foreign Sources to the United States," commissioned by PhRMA, former New York City Mayor Rudy Giuliani, details security and safety concerns of allowing the importation of non-FDA approved prescription drugs from other countries. In the report released last week Giuliani states that the risks of importing drugs from outside the U.S. far outweigh any alleged benefits. "We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders".
Giuliani and Tauzin are not the only ones urging caution and warning of the threat of counterfeit drugs. Last month, Graham Satchwell, a former detective superintendent, urged the Senate Health, Education, Labor and Pensions Committee, to learn from the European Union's mixed experience in importing drugs and warned U.S. policymakers on how drug counterfeiters can exploit the opening of borders. He recommended Americans to consider the example of the United Kingdom which imports more prescription drugs than any other nation in the European community. A survey conducted in 2004 revealed that of 300 imported medicines examined, 25% should have failed on "safety reasons," 50% because of poor quality of product. In addition 80% failed on legal grounds such as intellectual property rights infringement.
Counterfeiting hotspot
The impact of counterfeits on drug profits has led some pharmaceutical companies to hire their own investigators to crack down on the problem. As John Theriault, vice president of global security at Pfizer puts it, ‘‘Federal authorities are focused on corporate wrongdoing like Enron, and local cops are doing murder and mayhem. Not a whole lot of people are focused on people stealing Pfizer's intellectual property."
In the United States, the FDA acknowledges it does not have enough resources to track down counterfeiters and is happy to work with pharmaceutical industry investigators. However, getting help from law enforcement officials in other countries is sometimes more difficult. China poses particular problems and has been described as a counterfeiting hotspot. Chemical analysis of counterfeit Viagra collected in 50 countries worldwide revealed that they were all manufactured at known factories in China. To help solve this enormous problem, Pfizer established a regional headquarters in Shanghai, and the company will provide anti-counterfeiting training and support for agents of the city's food and drug bureau agents. Pfizer also hired the former US customs attaché in Beijing to be their chief liaison for counterfeiting to the national government.
Drug tracking
The WHO is also playing an important role in combating drug counterfeiting which it describes as an “organized trans-national crime”. The organization is appealing to governments to cooperate in stopping the $35 billion a year global trade. In Manila last week, health and law enforcement experts from the WHO’s 37 Western Pacific member states met to discuss ways to curb drug counterfeiting. At the end of the three day event, the WHO unveiled the world's first web-based system for tracking the activities of the drug counterfeiters. The communication system known as Rapid Alert System (RAS) will transmit reports on the distribution of counterfeit medicine to the relevant authorities for them to take rapid and appropriate countermeasures. WHO stressed that, effective measures to protect people from counterfeit drugs will require collaboration and coordination among relevant stakeholders in each country, between member countries and relevant partner organizations. Each government's drug regulatory authorities will decide how they want to deal with the reports resulting from RAS.
Technology vs. anarchy
The solution to the mounting drug counterfeiting problem will not be found overnight. Technology such as holographic labeling, Radio Frequency Identification Tags (RFID) and RAS can be employed to make it more difficult to introduce counterfeit drugs into the drug distribution system but they are only part of the solution. Raising public awareness, promoting rapid information sharing and obtaining commitment from governments worldwide to tackle the counterfeiting crisis are all essential steps. A multi-pronged attack is needed to combat drug counterfeiting and it is needed now.
As Regional Director for the WHO's Western Pacific Office Shigeru Omi put it “We believe that unless firm and committed action is taken, anarchy will set in and the public's trust in pharmaceuticals will be dangerously eroded”.
Fiona Jones
P.I.L.S Compliance Columnist
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