The Fight Against Fake Drugs

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European Union ambassador to the United States to visit Hawaii

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Edible Bar Codes Aim to Swallow the Counterfeit Drug Market

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Business Week Magazine, Reinventing Business September 04, 2013 – By Caroline Winter. There’s something particularly alarming about counterfeit food and medicine. Knockoff pharmaceuticals have been found to contain chalk, brick dust, paint, pesticides, and even traces of human fetuses. The fakes, taken together with substandard meds, cause upwards of 100,000 deaths annually. Luckily, rubbing out […]

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Popular Science Radio

August 2013 –  Interview with TruTag CTO, Dr. Mike O’Neill. Click below to listen to the broadcast.

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Security Management Magazine

July 10, 2013 – By Ann Longmore-Ethridge.

Drug counterfeiting isn’t just costly in terms of corporate profits; it also has real-life consequences for those who don’t get the medicines they thought they were getting, but it is hard to get solid statistics on the true size and impact of the problem.

Groups like the World Health Organization (WHO) can make educated guesses about some aspects of it—for example, WHO estimates that counterfeit drugs may lead to the deaths of about 20 percent of malaria sufferers worldwide each year. In Russia, regulators think that drug counterfeiters take in from $750 million to $3 billion a year. In China, in 2012, more than 20,000 people were arrested for producing counterfeit medicine.

The impact on nations varies. “It can go from absolutely appalling in some locations to relatively trivial in others,” says Dr. Roger Bate, a resident scholar at the American Enterprise Institute in Washington, D.C., and author of Phake: The Deadly World of Falsified and Substandard Medicines. “From the sampling that we’ve done in the field, which includes [buying drugs in] 22 cities primarily in emerging markets, as well as over the Internet in the United States, we find that the poorest markets in the world have the biggest problems.”

Africa is one of the regions hardest hit by counterfeiting. Bate says that the most counterfeited drugs in Africa are anti-malarials. Malaria kills about one million people a year. “It used to kill about 1.5 million only a few years ago, and one of the reasons [the death toll] hasn’t plummeted even faster is because people have been taking fake antivirals,” he states.

international_magazineIn wealthier countries, the most counterfeited drugs are the most prescribed ones: Viagra, Plavix, Celebrex, and Lipitor, as well as diet pills. With these drugs, the counterfeiters want money and repeat business. “They don’t want to harm anybody, but they are entirely careless of what they put in there,” says Bate.

Because of the often poor hygienic conditions in which the pills are made, infections have resulted. In one case, the counterfeits contained a deadly concentration of heavy metals.

In the battle against counterfeiting, the pharmaceutical industry plays a major role, because they want to protect not only their profits but also their reputation. That means in some cases, they do the footwork when law enforcement doesn’t have the resources to pursue counterfeiters. “In the poorer countries, they almost act alone,” assembling dossiers on local counterfeiters, then giving them to the police, states Bate. “They say ‘please arrest these people because we can’t’.”

But that doesn’t mean the counterfeiter ends up in prison. According to Bate, many counterfeiters are released on bail and never brought to trial. The pharmaceutical industry also tries to combat the problem in other ways. For example, in partnership with technology providers, it has been creating ways to authenticate drugs through covert and overt means. Covert technologies include embedded images and digital watermarks that can only be viewed through a special filter, hidden printing marks, as well as laser coding that creates readable artifacts on packaging, markers printed in substrate levels such as UV fluorescing fibers, and even special odors mixed with printing inks or coatings.

Overt features include holograms on packaging and optical variable devices, which, like holograms, include images that alter under differing viewing angles or conditions. Another way has been through color shifting security inks and films that can be used as security seals or tamper-evident labels. Other packaging has been made more difficult to counterfeit by fine-line color printing, similar to what is used in bank notes, as well as sequential product numbering.

In addition to making the packaging hard to successfully duplicate, there are products that overtly mark individual doses. “These overt features represent an attempt to put authentication into the hands of the general public. However, to be effective, they demand public education and awareness, which is especially difficult in the challenged developing markets,” notes Geoff Power, director, packaging security, global quality assurance, at GlaxoSmithKline, in a WHO report, Anti-counterfeit Technologies for the Protection of Medicines.

In late 2011, the U.S. Food and Drug Administration (FDA) issued final guidance to the drug indus-try for the use of physical-chemical identifiers. This has spurred manufacturers to release new types of covert marking products that place the anti-counterfeiting measures directly on the solid oral doses. One of these is TruTag, by TruTag Technologies, Inc., of Honolulu, Hawaii.

Calling them “edible bar codes,” TruTag Technologies’ president, Kent Mansfield, explains that silica microtags are printed onto each pill. The silica is biologically inert, edible, and virtually invisible, and has been recognized by the FDA as safe for consumption. Each tag contains a code that is scanned using a portable spectrometer-based optical reader. Everyone working on the problems acknowledges that it can’t be easily solved. But those working at the problem day to day hope that the tactics being adopted can help drug wholesalers, hospitals, investigators, and law enforcement stop more of the counterfeit drugs that do get made from ever reaching patients.