Is This a Device That Spots Fake Viagra?

A handheld spectrometer for non-scientists is one of several new technologies aimed at detecting counterfeit drugs. 

 

The counterfeiting of commercial products has gone on as long as commercial products have existed.

Trade in counterfeit medications is not only harmful to the rightful owners of patents and the companies that legitimately make the drugs, but can be tremendously harmful to ordinary people. Though counterfeit drugs spread more easily in countries where regulations are less stringent, they’re everywhere, including in the United States and Canada. They may be smuggled by huge organized operations or by small-time operators. Some ways that drugs may be faked include:

• Not containing any active ingredients despite label claims
• Containing different active ingredients than what the label specifies
• Containing the correct strength of the active ingredients, but sourced from somewhere other than claimed on the label
• Containing specified active ingredients, but in different dosages than those declared

Official drug distribution channels do their best to keep counterfeits out, but phony products are still found next to the real ones in legitimate distribution channels, so it’s a constant battle.

Why Viagra Is Such a Popular Drug to Counterfeit

Viagra is believed to be the most commonly counterfeited drug ever. It’s fairly expensive, phenomenally popular, and it’s a drug that a lot of men are uncomfortable talking to their doctors about. Together, those conditions make the manufacture of bogus Viagra a multi-billion dollar per year industry.

And if you think you could easily spot a fake version of the drug, consider this: sometimes scientists at Pfizer (manufacturer of Viagra) can’t distinguish ersatz Viagra from the real thing without conducting laboratory tests.

It’s also popular among counterfeiters themselves, who are sometimes used as “guinea pigs” for the fakes. Reports from China’s Hunan province claim that producers may be forced to test the drugs themselves (but are allowed to put prostitute costs on expense reports).

New Technology Aimed at Combating Fake Viagra

A tech startup called Stratio in San Jose is working on a gadget that would connect to an ordinary smartphone and that would be able to distinguish fake Viagra from real Viagra. The technology shines light on an individual pill and, using science called spectrometry, can say whether it matches a reference scan of real Viagra.

The tiny spectrometer, called LinkSquare, measures the intensity of light wavelengths reflecting off the tablets. The idea is, once they have a standard reflective “signature” from actual Viagra, other pills that might or might not be Viagra can be compared by taking their reflective signature using the device.

LinkSquare is available, but is probably too pricey and not practical for the average person worried about whether they bought counterfeit Viagra. The basic unit is $549.

Mobile Labs Test for Counterfeits in India

Silicon Valley startups aren’t the only organizations developing technologies for detecting counterfeit drugs in a fast, cost-effective manner. India’s health ministry has started trials of mobile drug testing laboratories that can be pressed into service for surprise checks of medications. The effort involves not only the Drugs Controller General of India, but also the Indian Institute of Technology, the US Food and Drug Administration (FDA), and China’s version of the FDA.

Starting last summer, the mobile drug testing labs were rolled out in the state of Gujarat, and early reviews were positive. Now India’s central government plans to deploy mobile counterfeit testing labs throughout the country in phases. Use of mobile testing labs should enable drugs inspectors to embargo counterfeit medications at the factory or chemist, and only bring in samples of drugs suspected to be lacking in quality for further verification. Currently, massive regular sample collections overwhelm existing drug purity testing resources.

An Inexpensive Paper-Based Screening Tool in Kenya

A scientist in Eldoret, Kenya has come up with an inexpensive, paper-based screening tool to check the ingredients of medications prescribed by doctors at the Moi Teaching and Research Hospital. The test paper, known as a Paper Analytical Device (PAD) is basically a lab on a small card. A suspect tablet is applied to a specific area on the card, which is then dipped in water. Color reactions that show up on the card allow doctors to compare the results to calibrated standards for commonly counterfeited drugs to separate real from fake drugs.

The technology is based on twelve separate reaction strips on the paper, which create a sort of “colored barcode.” These can then be compared to standards to quickly make a determination of authenticity. A number of antibiotics, TB medications, and anti-malarial drugs have been tested using the technology, and non-standard results are reported to the Kenya Pharmacy and Poisons Board. The test papers can also detect problems such as drugs that don’t work properly due to mistakes in manufacturing, or poor storage or transportation conditions.

Screening Tools for Phony “Club Drugs”

Illicit drugs used recreationally at clubs and raves are also being tested by kits made by companies like DanceSafe, which are primarily concerned with identifying counterfeit MDMA, or “Ecstasy,” which is frequently bolstered with more dangerous substances like ParaMethoxyMethylAmphetamine (PMMA), which has been implicated in several deaths in the UK.

Companies like DanceSafe and their counterparts in Europe offer testing kits that can be used by individuals or by venues in “harm reduction booths” at events. The goal is to prevent recreational drug users from ingesting unknown or more dangerous versions of illicit substances, which is a particular problem with MDMA. In many cases, these companies offering on-site testing work with local public health departments and music events to encourage attendees to test substances before taking them in order to make more informed decisions.

 

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Test kits for recreational illicit drugs are touted as harm reduction tools.

How US CBP Agents Deal with Potentially Bogus Drugs

There are 196 countries in the world, and only a handful of them have specific services dedicated to dealing with counterfeit pharmaceuticals, according to Interpol. And some of those countries don’t have the budget or personnel to enforce laws that they have. Typically, when pharmaceuticals arrive at a country’s border, enforcement agents check the paper trail and spot-check packaging, chemistry, and appearance of the products. Of course, papers can be falsified, and around 30% of the countries in the world don’t have a functional equivalent of the US FDA.

Even in the US, where incoming drugs are tested more frequently, bogus products can get through, especially when they’re purchased online, because many internet “pharmacies” buy drugs from countries with lax to nonexistent regulatory systems. Overseas packages of pharmaceuticals sent by mail may be x-rayed and examined by drug-detection dogs, and if agents have been tipped off about recent drugs having falsified paper trails, or if they find problems with the paperwork, they may open packages and inspect what’s inside.

However, even if they do spot something suspicious, they may not seize the product, because seizures involve an intricate, multi-step process that is expensive and uses a lot of manpower. Seizures are more likely to occur with large shipments of product, and if Customs and Border Patrol agents suspect a small shipment of being counterfeit, they’ll set it aside and contact the intended recipient with their suspicions. Recipients have to assume all risks if they want the product anyway.

Someday There May be an App for That

Counterfeit drugs are an enormous problem, resulting in everything from disappointed customers who spent money on nothing to deaths from fake pharmaceuticals used to treat serious diseases. Viagra is a top target for counterfeiting because of its popularity, its relative expense, and its sensitive nature, and makers of phony Viagra have the ability to reproduce the look of the real tablets and packaging with remarkable accuracy.

A number of new technologies are emerging to help ordinary individuals, Customs agents, and legitimate drug manufacturers to test drugs for authenticity. If Stratio is successful with its proposed LinkSquare device, eventually ordinary people could have a small device and app for their smartphones that would let them check a number of commonly counterfeited drugs for authenticity.

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