On 2 January 2011, the venerable CBS news magazine 60 Minutes aired a special report called “Bad Medicine” that featured an interview with Cheryl Eckard, a federal whistleblower and former GlaxoSmithKline quality assurance employee. She had reported to the US FDA certain quality problems at a GSK plant that included adulterated, mispackaged, and mislabeled drugs. After an FDA investigation and ensuing criminal and civil prosecutions, GSK settled the matter by pleading guilty to a criminal felony for distribution of adulterated drugs and paying a $750 million fine.

Yellow Pill, Pink Pill: Ms. Eckard told the story of an upset grandmother who, upon picking up an 8-year-old’s prescription medicine at a pharmacy, opened the induction-sealed bottle, looked at the tablets inside, and exclaimed, “I knew it! His medicine has always been yellow. But last month, it was pink. And he has been so sick.” In the interview, Ms. Eckard theorized that the grandmother’s incident may have involved 10-mg Paxil (yellow pills) being mixed up with 25-mg Paxil CR (pink pills), in which case the child could have been receiving 2.5 times his prescribed dosage. While she was at GSK, Eckard investigated and found that a number of drug products had been mixed in with one another, in some cases the antidepressant Paxil mixed in with the diabetes drug Avandia.

Quality Problems and Counterfeiting: The 60 Minutes report shows how quality issues, drug mix-ups and adulterated medicine can occur even at the top pharmaceutical companies. GSK says nobody was actually injured in this case, but even the threat of such problems can be troubling to consumers and resource draining for drug makers.

Counterfeiters pose an even larger challenge.Criminals are infiltrating the global drug supply chain to fake and adulterate legitimate medicines for their own profit. Well-known broadcast journalist Dan Rather has produced a report on this topic, “The Mysterious Case of Kevin Xu," episode 528 online at HDNet.

We've come across a few vendors working to offer solutions for these problems. One is TruTag Technologies, a spinout of Cellular Bioengineering, Inc. Selected as the 2010 North American Pharmaceutical and Biotechnology Innovation of the Year by Frost & Sullivan. TruTag microtags are secure, optically encoded micro-crystals made of pure, nanoporous silica, which is edible and deemed "Generally Regarded as Safe" (GRAS) by the FDA. The technology connects unique spectral codes to information at the dosage level, with tag readers that reveal lot number, expiration date, date and location of manufacture, distribution customer, and authorized country of sale, depending on a drug maker’s IT system capabilities.

For more information on these topics, check out the following articles in our archives:

• How to Justify Investment in Anticounterfeiting
  Ralph L. Dillon, Joseph F. Noferi
  BioProcess International, Vol. 6, No. 10, November 2008, pp. 24–29
  
• IP Strategies to Combat Distribution of Counterfeit Drugs
  Antoinette Konski
  BioProcess International, Vol. 6, No. 3, March 2008, pp. 2–5
  
• Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing
  Raymond W. Nims, Elizabeth Meyers
  BioProcess International, Vol. 8, No. 6, June 2010, pp. 16–20
  
• Biopharmaceutical Quality Assurance
  Paul Stockbridge
  BioProcess International, Vol. 6, No. S7, November 2008, pp. 34–42

You can also drop an email to Paula Page Public Relations or to Mike O’Neill, PhD, chief technology officer at TruTag Technologies.