Researcher takes on falsified medicine and supplements

Back in 2008, there was a big public health scam in China.

Manufacturers were selling infant formula with the compound melamine in it to mask the fact that they were watering down the formula to save money and maximize profit. Melamine increases the nitrogen content, making it appear as if the formula still contains the same concentration of protein even after it had been diluted. According to the World Health Organization, this resulted in kidney damage and kidney stones, with some infants dying due to kidney failure.

Assistant Professor of Electrical Engineering and Computer Science Soumyajit Mandal believes that a means of authenticating compounds in medicine can be commercialized and available to the public within the next few years.

“We want to put power back into the consumers’ hands,” said Mandal. “If you are a consumer or small pharmacy that is trying to figure out if the medication you have is fake or not, do you have the resources to examine what’s inside? It’s probably not feasible; it takes time and it’s expensive.”

According to Mandal, there is a large incentive for fraud with manufacturing medicine and vitamins. They don’t cost a lot to make and they can be sold for a lot. The Food and Drug Administration estimates that there are more than 29,000 nutritional supplements available for purchase today.

“The problem is that [drug] packaging has a label on it that you can scan and it will tell you what’s inside, but it can actually contain something else,” said Mandal. “Either that’s not the active ingredient, the wrong proportion, it contains contaminants or it can be labelled with the wrong expiry date.”

This is a significant public health problem, particularly in developing countries. Antimicrobials and anti-malarial medications are frequently falsified; according to Mandal, approximately 15 percent of this type of medication in Africa are substandard and do not contain what the packaging says.

An inexpensive way of detecting what these medications contain is needed, said Mandal. It must be widespread and cannot be complicated—the average person should be able to easily use it without needing access to a laboratory or knowing specialized training. The pill should be able to remain inside of its original container and remain unaltered.

Currently, mass spectrometry and liquid chromatography are the typical methods of analyzing compounds within medications. They are sensitive and do a good job, but they are not accessible to general consumers. Optical methods are a little more accessible, but they can only detect whether or not a substance is present, not its concentration. This is where Mandal’s research comes in. Using the science behind MRIs, he and his team created a method of using radio waves to detect the presence and concentration of compounds within a packaged entity.

Mandal, his colleagues in King’s College and Professor Swarup Bhunia, who previously worked at Case Western Reserve University and is now at the University of Florida, developed this method a few years ago.

“We came up with this technique, and then we were trying to find a way to use it,” said Mandal.

His colleagues in London were using the method to identify medicine; Bhunia is the reason that Mandal started looking at supplements as well. According to one of Mandal’s colleagues in the department of nutrition, they estimate that 20-30 percent of nutritional supplements have inaccurate labels.

“If a drug is already in a grey area—let’s say it’s illegal or not encouraged—then the potential for fraud is even higher because it isn’t regulated,” Mandal added.

Mandal is referring to diet pills and muscle enhancers, both of which are often sold on the Internet. He says that the rate of fraud from online pharmacies is significantly higher. This is why Mandal wants to eventually make a usable prototype that can even provide feedback if the package of medicine is inserted incorrectly into the detector.

Mandal has been looking for people to beta test the prototype they’ve created. The prototype examines medications and compares them to compounds stored in its database, alerting the user if there is an unknown compound. Mandal wants to expand its database and has been reaching out to CWRU’s Department of Nutrition to test their known compounds as well as the Centers for Disease Control to test anti-malarial drugs. The bigger the database, the more the scanner will be able to identify.

His prototype now is about four-by-four-by-four inches and attaches to a benchtop instrument that is about the size of a 10-inch laptop. They are working to miniaturize it so that someone can take it out into the field more easily. Eventually Mandal hopes to create a version that can hook into a mobile device, with an app that uses the database uploaded onto the Cloud.

What makes Mandal’s research unique is its flexibility; his device can look at multiple different compounds and doesn’t specialize in just one. It can test for a wide variety of materials because of its database. Mandal says that it can even detect explosives.

“At least now, you can be somewhat more assured that what you’re taking is actually what it says it is,” said Mandal. “It’s a wild world out there.”