In 2002 and 2003, I did extensive research at the MIT Auto-ID Center using the Electronic Product Code (EPC) and Radio Frequency Identification (RFID) for track and trace of pharmaceutical products. The purpose of doing the research was to detect counterfeit medicine in the supply chain.
A recent article, cited below, appears to recant the references that I used for the basic assumption of the research, namely that counterfeit medicine is a problem in the world economy even in developed countries.
If true, this is a major development and calls into question the validity of medical research, especially from Europe.
I co-authored a paper on the topic, published in 2003, which was presented in Zurich, Switzerland to a packed house as part of an Auto-ID Center meeting. This is the link:
The complexity of the United States health care system is increasing rapidly. Demographic changes, along with a host of new drugs, are causing greater volumes of raw materials and finished products to move through the pharmaceutical supply chain. Because drugs are expensive, there is always the possibility of counterfeit. Several recent cases of counterfeit medicines have raised American awareness of the problem. Auto-ID technology provides an effective information infrastructure to detect and control counterfeit drugs through track and trace and drug verification capabilities.
My book, Global RFID, published in 2007, contains an extensive chapter on the drug counterfeit issue. I included the following reference, among others, from the World Health Organization (WHO):
I have published many other articles on this topic, some as cover stories in industrial magazines.
All of this work referenced statistics appearing in journals and popular articles indicating that the counterfeit issue was a significant threat to the pharmaceutical industry. MIT focused it's effort on RFID systems to stop counterfeit, using the references from the WHO among others in support of the need.
Of concern to me, the recent article appearing in the WSJ calls into question the estimate by the WHO that counterfeit drugs equal 10% of all medicine. The quotes that I have identified below are extremely important to read (bold added):
Bialik, Carl, 2010. Counterfeit drug count is tough to swallow. The Wall Street Journal, Sept. 11.
"'I have a drug problem,' Paul Chang, IBM business strategist for emerging technologies, says in the ad. 'Ten percent of the world's medicine is counterfeit.' The ad touts IBM technology to tag drug packaging to screen for fakes, which can be merely impotent or downright toxic."
But the statistic itself might be fake. It long has been attributed to the World Health Organization or the U.S. Food and Drug Administration, but both agencies today disavow it. Fake pills likely make up 1% of sales or less in developed countries, where most drugs are sold, according to WHO."
Further from the WSJ article;
"The 10% figure appears to have surfaced initially in a 2002 editorial in the British Medical Journal, which reported that 'the World Health Organization estimates that 10% of global pharmaceutical commerce is in fakes.' The article attributed the WHO estimate to a study published in 1999 on counterfeit drugs in Myanmar and Vietnam. For the study, WHO researchers tested samples of 500 drugs, specifically selected because they were considered particularly susceptible to counterfeiting. A little over one in 10 didn't contain the labeled amount of active ingredient. But the paper made no claim about the overall counterfeiting rate in those countries, let alone world-wide."
'I am uncertain, after eight years, why there is the mismatch between the reference and the percentage,' Paul Newton, co-author of the BMJ editorial, wrote in an email. 'I do not trust any global poor-medicine-quality percentages,' says Dr. Newton, a senior scientist in tropical medicine at the University of Oxford in England. 'However, even 1% of essential medicines being poor-quality is a severe public-health problem.'"
I find the above statements unbelievable! The quality of this research is extremely poor given the significance of these estimates.
If the above article is the truth, then it means that my entire research program at the time was based in inaccurate or inconclusive estimates made by others and published in the medical literature as confirmed facts. Further, I know of companies, none involving me, which invested venture capital into developing track and trace systems for the pharmaceutical industry based on the assumption that counterfeit is a major, ongoing problem. I believe several of these companies have failed financially.
Overall, I consider this a significant recanting of published research. It is incredible!
No comments:
Post a Comment