Fake Viagra and You

You have just jumped into bed with your sweetie half an hour after taking a dose of the Viagra you just bought at a respectable, trademarked pharmacy. To your utter embarrassment and your sweetie’s amusement, you now notice it doesn’t work.

It could be because it’s counterfeit, and you are likely to not be alone. Some US$75 billion in fake drugs were sold globally in 2010, vast amounts of them fake antipotency drugs, according to a background paper produced recently for the World Health Professions Alliance. That represents 15 percent of the entire legitimate pharmaceutical industry, according to the study.

Part of the problem is the enormous and inflated cost of conventional drugs, many of which are priced out of the reach of people without insurance. As Asia Sentinel reported, that led the Indian government a week ago to issue the first ever compulsory license to a generic drug manufacturer, effectively ending the German pharmaceutical company Bayer’s monopoly in India on the drug sorafenib tosylate, used to treat kidney and liver cancer – and cutting the cost for treatment from more than US$5,500 per month to about US$175, a reduction of nearly 97 percent.

“These alarming rates of growth are in part as a result of the growing size and sophistication of drug counterfeiting rings,” the World Health Professions Alliance paper said. “Poverty, weak economies and the rising cost of drugs have created a corresponding increase in incentives to produce counterfeit drugs because of profit margin.”

Much of the counterfeit drugs originate in Asia. Indeed, just two days ago, authorities in Spain and the United Kingdom arrested six people and seized 300,000 doses of fake medicines in sophisticated and genuine-appearing blister packs, including Viagra, Cialis, Levitra and weight-loss pills. Those arrested were thought to be part of a gang importing the fakes from Asia, mainly China and Singapore, according to news stories, and distributing them via the Internet to customers throughout Europe.

In 2002, according to World Health Organization statistics quoted by the medical journal Lancet, “as much as 35 percent of the fake and substandard drugs in the world are produced by India and 20 percent by China.” The fake drugs move in all directions throughout Asia, according to the World Health Professions Alliance.

That has made pharmaceuticals purchases in almost all Asian countries a major problem. The World Health Organization and Interpol in 2008 and 2009 in raids called Operation Storm and Operation Storm II, bringing together customs officials and police from Cambodia, China Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam, seized 36 million pills of various kinds, arrested 33 people and closed more than 100 pharmacies and illegal drug outlets.

While buying medicines off the Internet is obviously open to serious problems, respectable pharmacies are not immune, and there is the concern. While fake impotence, anti-baldness and weight reduction pills are largely harmless – although some do contain dangerous ingredients, like lead -- increasingly the counterfeiters have been getting into creating fake lifesaving drugs – ones for the treatment or prevention of asthma, malaria, cancer, HIV/AIDS, tuberculosis, blood pressure and heart conditions, diabetes, and severe diarrhea, according to a 2003 study titled Counterfeit Pharmaceuticals in Developing Nations by Kristina M. Lybecker of Drexel University in the United States.

The growing sophistication of the fake drug syndicates means that they are able to supply them to unsuspecting legitimate pharmacies.

The threat from the rising number of counterfeited or falsified medicines is aggravated by two factors, according to the background study. Traditionally the most common types of counterfeit drugs were those described as “lifestyle drugs” such as those used to treat erectile dysfunction or baldness. However, recently there has been an increase in the counterfeiting of “lifesaving” drugs meant to prevent or treat asthma, malaria, cancer, HIV/AIDS, tuberculosis, blood pressure and heart conditions, diabetes, and severe diarrhea.

Large professional factories have been established to produce tens of thousands of pills per day. In China and India, local drug manufacturers have been found to make legitimate products during the day and counterfeits by night, according to one study.

As with the raid in Spain and the UK earlier this week, the fake drug manufacturers now have the tools to copy high-tech foil packaging and blisters, imprinted markings and, according to the World Health Professions Organization report, they can even reproduce logos that are only visible under ultraviolet light.

In South Korea, for instance, the police in 2004 seized more than W150 million (US$132,800) in fake Cialis and Viagra from 123 pharmacies. In the first six months alone police seized US$77 million worth of smuggled impotence medicines, the preponderance of which were manufactured in China. In perhaps a statement about Korean male fears of inadequacy, 99 percent of counterfeit medicines are impotence cures either containing an illegal overdose of active ingredients such as sildenafil or dangerous ones like lead. In March 2011, more than a dozen pharmacies were indicted for distributing fake Viagra in South Korea.

Other countries that have been hit hard by counterfeit drugs include Thailand, where the fake drugs industry is estimated at US$30 million annually. The most common fakes are for treating AIDS, avian influenza, malaria, tuberculosis, anti-obesity and erectile dysfunction. The drugs are manufactured in China, India, Pakistan and Vietnam. In 2006, Thai authorities discovered counterfeits of Reductil in pharmacies in front of Siriraj Hospital, perhaps Thailand’s most prestigious medical institution, where King Bhumibol Adulyadej has been confined for months.

In the Philippines, according to the country risk assessment firm Pacific Strategies & Assessments, the Bureau of Customs announced that more than P400 million (US$9.3 million) worth of smuggled fakes had been smuggled into the Port of Manila from China from Hong Kong. According to an estimate by the Philippine Department of Health, one out of every 10 medicines in the country is fake.

Indonesia, like the Philippines, suffers from a porous coastline surrounding thousands of islands. It is estimated that fake drugs in the country cost consumers as much as US$500,000, according to a 2008 study. While border posts have been established in some areas, they are few and far between and there appears to be little risk of arrest – and even if there were, penalties are only a maximum fine of RP300,000 (US$40) and six months in jail.

Despite the fact that European authorities allege Singaporeans were involved in the smuggled shipments to Spain and the UK, the country does a good job of policing its own drug sales, according to the background report, which says illicit drug sales are confined to fringe areas and that there has been little penetration into the legitimate hospital sphere although in 2008 glyburide, a powerful drug used for the treatment of diabetes, was found to be a contaminant in counterfeit tadalafil and herbal preparations for treatment of erectile dysfunction. Of the 150 non-diabetic patients admitted to hospitals in Singapore in that episode, seven patients were comatose as a result of severe neuroglycopenia and four patients subsequently died.

Taiwan, ranked third in serious counterfeiting in the Asian region before 2003, has dramatically cleaned up its act, according to the report, with stiff new penalties enacted, coordination across law enforcement agencies, the establishment of a Good Supply System and infra-red spectrographic detection technology to detect 131 common counterfeit medicines.

“No drug is invulnerable and no country is immune,” the report concludes. “Even with reforms, Asia faces significant logistical and social challenges in cracking down on counterfeit production.“