Sunday, October 08, 2006

Trust? No--Verify

I'm awfully fond of TCS Daily, as some of you know, and find a good deal of intellectual fodder amongst the many and varied perspectives on technology, commerce and society which fill its electronic pages. Much of it is rather libertarian, with the occasional conservative twist, which suits me fine, and the authors are as diverse as the topics. I head there frequently. One of my favorite TCS authors is Dr. Henry I. Miller, and I have posted on his articles more than once. He writes about things that interest me; medical research, medical trends, biopharming, bioengineering and the like. Frequently, not surprising in a publication with a libertarian bent, I've seen him criticize government over-regulation in scientific matters. From the development of new drugs and treatments to gene-splicing, he usually comes down in favor of letting science come up with the best options possible, and scientists and scientific testing, rather than bureaucrats, judge their efficacy. From what I've read, I've gathered that he believes that over-regulation slows needed medical progress. I fully agree. (Note: I said over-regulation, not all regulation.) So, when I started reading an article in which Miller started calling for more regulations, I took note.

The problem he's addressing in an article titled "Are Bad Drugs Coming to a Pharmacy Near You?" is the growing number of counterfeit pharmaceuticals making their way into the medicine chests of the unsuspecting. According to Miller, it's a problem worldwide, and consumers in the U.S. are by no means exempt:

Although quantitative estimates are difficult, it appears that something on the order of ten percent of the world's drug supply is counterfeit, encompassing not only products that are completely fake, but also those that have been tampered with, contaminated, diluted, repackaged or mislabeled in a way that misrepresents the contents, dosage, origin or expiration date. The World Health Organization estimated in 2003 that as much as five to seven percent of all drugs sold in the United States may be fraudulent in some way.
Mafia and terrorist groups, drug cartels and other such nefarious do-badders make a huge profit producing knock-offs and slipping them through the vast and confusing pipelines that eventually bring them to that pharmacy near you. Actually, though, what's more likely, says Miller, is that they are coming to a pharmacy not near you, but that the chances you're going to get less than you "bargained" for go up when you try to save money by buying medicines from outside the country, especially online:
How do fraudulent medicines enter the drug supply? Primarily by counterfeiters taking advantage of an alternative to the mainstream pathway of pharmaceutical manufacturing and distribution through which drugs normally move linearly from manufacturer to distributor to pharmacy to patient.
He adds:
Increasingly, consumers are making the counterfeiters' job easier by buying drugs abroad. In a 2003 operation, spot-checks by the FDA and U.S. Customs Service found that 88 percent of drugs imported into the country by mail or courier violated federal safety standards in some way.
The risks here are obvious. Diluted, out of date, or outright fake medicines aren't going to perform as required. I'm sure you will agree that this could be a slight to serious problem. The slight problem may be self-correcting. For example, I have a medicine I take daily for chronic pain. If my pills weren't doing their job, I'd probably figure it out soon enough and see my doctor for an alternative. This could cause me discomfort, and inconvenience, but is unlikely to cause me any real harm. My mom, on the other hand, has a heart condition, and medication that she must take daily, without fail. What if the drug she takes was replaced with a replica, indistinguishable, but ineffective? She might not have any warning symptoms that the pill she was faithful to take wasn't doing its job until her heart wasn't doing its job either.

So, by Miller's account, what is the solution to this dilemma? I think it's worth quoting him directly again:

First, Congress must increase the penalties for drug counterfeiting, and the FDA must more aggressively enforce regulations that require documentation of the "pedigree," or history, of a drug as it moves through distribution channels.

Second, we need to apply new track-and-trace technologies to uniquely identify and track the distribution of drugs. (And similar to our confrontations with dealers of illicit drugs, in order to keep ahead of the bad guys we will have to innovate constantly.)

Third, new authentication technologies, such as holograms and ultra-violet and forensic tags, must be developed to make it more difficult for counterfeiters to imitate legitimate drugs. A promising new technology would attach mixtures of pH-sensitive fluorescent dyes to drug molecules and measure changes in fluorescence in the presence of solutions of different compositions.

Fourth, when making Internet purchases, consumers should patronize only pharmacies on the National Board of Pharmacy's recommended list (

Finally, consumers should be vigilant for anything amiss in any prescription drug obtained anywhere - unusual color, texture, markings or packaging and, when feasible, for any differences in effectiveness or side effects.

I'm surprised to find an area in life which I actually agree could need more regulation. That's not an easy sell with me, but Miller makes the case quite successfully that this is a matter of public safety. It's important that we know what we're getting, and that we can trust the source. In order to trust it, we need to know what that source is. Fortunately, as Miller explains, there are improving technologies which can help in the quest for reliable tracking and content verification methods. These, no doubt will add to the cost of popping prescription pills. So be it. I'm not a spendthrift kind of gal, and I do part with my money reluctantly, but this revelation that some of our pharmaceuticals may come from "mystery manufacturers" and be "fake pharma" has certainly made me more inclined to value safety over price.