The World Health Organization (WHO) is calling for an international campaign to combat the growing epidemic of counterfeit drugs. The agency intends to push for global input, political commitment, and creative solutions at a scheduled meeting in Rome beginning today.
The conference is being hosted by the Italian Pharmaceutical Agency (AIFA) and Italian Cooperation, and was organized with the support of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the German Government.
WHO has invited all interested parties to join the global task force which will focus on legislation and law enforcement, trade, risk communications, and innovative technology solutions regarding the detection of counterfeit drugs.
The counterfeiting of medicines occurs in every country on the globe, and is estimated to make up 10% of the global medicines trade.
In October 2005, two of the largest prescription drug companies in the world, Pfizer (No. 1) and Novartis (No. 7), made it clear that governments must cooperate to stop the global spread of counterfeit drugs, most of which come from India and China.
A worldwide explosion in online sales of bogus drugs has caused a major disruption in the marketplace and is significantly affecting sales of all types of drugs including antibiotics, Viagra, and even vitamin E.
“Most of the problem is in Asia, mainly India and China. But we are seeing more satellite countries,” including Myanmar, Cambodia, Indonesia and Thailand, Ray Velez, regional corporate asset protection & compliance officer for Eli Lilly Asia, told Reuters at a pharmaceuticals conference in Singapore.
“This is a very, very big business,” Velez said. “The competition today for us is not Viagra. It is counterfeit drugs.”
WHO estimates the trade in counterfeit drugs is now in the vicinity of $35 billion a year.
Although some governments are beginning to take the counterfeit drug trade more seriously, more must be done. China’s new regulations to curb Internet sales of counterfeit drugs are regarded as a step in the right direction.
The U.S. International Trade Commission is currently investigating complaints against several Internet-based companies offering all types of drugs via mail order. Cooperation between the U.S. and E.U. governments working with China and India to stop the spread of counterfeit drugs is essential if the problem is to be gotten under control.
As reported by Reuters, the “WHO considers a drug to be a fake if it has no active ingredients, the wrong substance, or the correct substance in the wrong quantity. Mislabeling and tampering with the expiration data of a medicine also makes it counterfeit.â€
In 2005, the Food and Drug Administration (FDA) and the United States Attorney for the Western District of Missouri, in Kansas City, announced the indictment of 11 individuals, a drug re-packer, and two wholesale distributors in cases related to the sale of counterfeit Lipitor, the most widely prescribed cholesterol reducing drug.
The indictment alleges numerous charges including conspiracy to sell counterfeit, illegally imported, and misbranded drugs as well as conspiracy to sell stolen drugs.
The conspiracy involved the manufacture of counterfeit Lipitor at a secret facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation of both products into the U.S.
“This case demonstrates that the FDA will take the necessary steps to protect the drug supply in America,” said then FDA Commissioner Dr. Lester Crawford. “I am pleased that the U.S. Attorney’s Office and FDA have been able to put together this case and stop these fraudulent schemes to sell pharmaceuticals of unknown safety and efficacy to the public.”
In 2003, Albers Medical Distributors, Kansas City, MO, (a drug wholesaler) distributed over $20 million in illegally imported and counterfeit Lipitor that was sold to H.D. Smith Wholesale Drug Company (Wood Dale, IL).
H.D. Smith distributed these Lipitor tablets throughout the U.S. The counterfeit Lipitor was repackaged by Med-Pro, Lexington, NE., a drug re-packer. All three participants in this scheme were named in the indictment. It is believed that these particular counterfeit Lipitor products are out of circulation.
In addition, it is alleged in the indictment that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals and counterfeited drugs.
The FDA’s Office of Criminal Investigation (OCI) was able to put together the case by tracing back the various steps in this scheme. OCI was able to document where the chemicals and products came from, where the counterfeit was being manufactured, and how it was distributed.
Working together with the U.S. Attorney’s Office in the Western District of Missouri, these findings led to today’s indictment of all parties involved.
The FDA and federal law enforcement authorities are also becoming increasingly concerned with the sale of counterfeit drugs over the Internet and at pharmacies in Mexican border towns.
Although the operators of several Internet (and mail-order) operations have been arrested recently and charged with illegal drug sales through online pharmacies, the authorities have been frustrated by the fact that new websites are up and running almost immediately.
The Mexican problem is also becoming quite serious since counterfeit versions of drugs like Lipitor, Viagra, and Evista, which can be quite dangerous, are readily available in border towns like Juarez, Los Algodones, Nogales, and Tijuana.
The FDA has been working with Mexican authorities to address this problem throughout Mexico and, as a result, 19 pharmacies have been suspended and over 105 tons of medicines have been confiscated. Significant amounts of counterfeiting are known to be taking place in China, India, and Russia.
In 2005, five heart patients in Hamilton, Ontario, Canada may have died after taking fake medication dispensed from the same pharmacy. The drug in question, Norvasc, is used to treat unstable angina and high blood pressure.
An investigation prompted by a local woman who was suspicious of an oddly colored pill in her supply of Norvasc. The pill turned out to be made of talcum powder.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which is the UK equivalent of the FDA, in conjunction with Pfizer, recently announced a recall of 20mg Lipitor tablets as a result of finding counterfeit versions of that particular dosage of the drug.
The fake tablets can be identified because they do not come in the sealed packages used to market the real 20mg pills.
Since 2004, the UK too has been encountering a growing problem with counterfeit medications. Previously, fake batches of Cialis and Reductil were discovered there.
The announcement from Pfizer and Novartis highlights the severity of the crisis as well as the need to have global cooperation in combating its spread. While the problem may never be eradicated, the hope is that it can be significantly reduced and brought under control.
Counterfeit medicines are extremely dangerous. They dupe sick people into believing they are taking something that will help them, when in reality, the fake drugs may have no effect, cause them to become even sicker, or even be deadly.
“People don’t die from carrying a fake handbag or wearing a fake t-shirt. They can die from taking a counterfeit medicine,†says Howard Zucker, Assistant Director General for Health Technology and Pharmaceuticals at WHO. “International police action against the factories and distribution networks should be as uncompromising as that applied to the pursuit of narcotic smuggling.â€
Substandard pharmaceuticals are a common problem in the international pharmaceutical trade, but counterfeit medication takes this phenomenon a step further. Counterfeits are labeled as legitimate, usually popular drugs, but have no therapeutic benefit. Those who take them can become resistant to drugs, and face the risk of death.
The counterfeit trade is particularly attractive to criminal networks because it is extremely lucrative. One report released in the United States estimates that counterfeit drug sales will reach $75 billion by 2010, a 92 % increase from 2005.
No country is immune from the problem, although some are far more prone to it than others. The counterfeiting networks are becoming more sophisticated, and detection is becoming increasingly difficult. This will require detection and enforcement procedures to be intensified. Simple measures like bar-coding, international surveillance, and education of patients, healthcare service providers, and pharmacists are no longer sufficient.
“These measures need to be intensified,†adds Dr Zucker. “Countries should think about ways to make the necessary technological, legislative and financial adjustments as quickly as possible to guarantee the availability of quality assured essential drugs.â€
WHO seeks further development of innovative high- and low-tech solutions for preventing the manufacture of fake drugs as well as for detection within the distribution chain.
WHO established the first web-based system for tracking the activities of fake drug makers in the Western Pacific Region in 2005. The Rapid Alert System (RAS) communications network sends reports on the distribution of counterfeit medicines to the relevant authorities.
Radio frequency identification (RFID) and more sophisticated technologies for product tracking are being developed. These more sophisticated tools must be made available to developing countries.
A worldwide information network needs to be established that would share data between various drug regulatory authorities, customs and police organizations, pharmaceutical companies, non-governmental organizations, and consumer groups.
Public awareness campaigns should also be developed and initiated, through the help of the media.
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