Men who order Viagra online because they are too shy to get a doctor's prescription run a high chance of buying snake oil – and putting their health at risk. Fortunately for them, researchers from the University of Montreal have come up with a new method to detect fake erectile-dysfunction drugs in 10 minutes flat.
The approach is five times faster than the older method used by Health Canada labs, and better able to identify potentially toxic compounds in low concentrations, according to a study published Wednesday in the Journal Chromatography A.
Erectile-dysfunction drugs are among the world's most counterfeited drugs, the World Health Organization has reported. Last year, the RCMP and Canada Border Services Agency seized 3,223 packages from 19 countries, containing a total of 238,820 fake and illicit medicines at a street value of more than $1-million.
The new approach combines technical advances in chromatography, a technique for separating compounds, as well as mass spectrometry, which sorts chemical substances based on their mass. Using newer equipment from manufacturers in both fields, the researchers identified substitute chemicals often used in counterfeit drugs based on their mass and chemical makeup, said co-author Dr. Karen Waldron, associate professor of chemistry at the University of Montreal.
"It's not a new technique," she said. "The innovation is simply that it's much faster."
In the study, Waldron and colleagues identified 80 substances commonly substituted for active ingredients in three erectile-dysfunction drugs: Viagra, Cialis and Levitra. They put the new method to the test by analyzing 30 pharmaceutical and natural products, some of which were seized at the Canadian border.
Counterfeit drug operations have cropped up in Canada but are concentrated in India and Asia. Their manufacturing techniques have gotten so sophisticated that without chemical testing, Waldron said, fakes are difficult to spot. "Many of them are made to look like the real McCoy," she said. "They even have the name of the manufacturer, such as Pfizer, right on the package."
Fake Viagra is a bargain at $1 a pill, versus about $15 for the real thing. But counterfeit pharmaceuticals carry severe health risks, especially when combined with prescription medications. In 2008, 150 patients in Singapore were hospitalized with severe hypoglycemia caused by a sudden drop in blood sugar. Four died and seven suffered brain damage after taking counterfeit erection-inducing drugs that contained glyburide, a drug to treat diabetes.
The main limitation of the new method is that scientists may have difficulty distinguishing between chemicals with the same mass and chemical makeup, which behave like mirror images – one biologically active, the other potentially toxic, Waldron said. But she added that manufacturers in chromatography are developing products that "specifically deal with these."
Dr. Amr Helmy, a professor of photonics at the University of Toronto, said the new method "looks promising," but he noted that fake pills in circulation may contain impurities that could skew results, whereas "this was a carefully prepared experiment."
Waldron said at least one Health Canada lab in Quebec began using the new analysis method starting in mid-2013. She added that the approach may have applications beyond detecting counterfeit drugs, including testing for chemical compounds in water-treatment plants.