Therapeutic Dose: Avoiding "Cool Hand Luke" Syndrome: Part II

At a time when the amount of available data is increasing exponentially, why are we isolating ourselves from our brethren and the larger scientific community?

By Emil W. Ciurczak, Cadrai Technology Group

In my last commentary, I talked about the lack of communication among pharmaceutical science types. To be fair, not only pharma scientists, but all scientists are guilty of this flaw, I fear. But I have noticed that some people in pharma fail to see drug chemistry within the broader framework of chemistry. For those people, it’s "pharma versus everyone else."

For example, years ago, when I worked at a surfactant company, I remember that we had once had to run a simple two-layer titration method for sodium lauryl sulfate (SLS or sodium dodecyl sulphate). To summarize, the titration was with benzalkonium chloride and involved an ion pairing reaction. It was simple, straightforward and precise.

When I moved back to pharma, one of the first problems I encountered was an assay for benzalkonium chloride. Since the alkyl chain was not constant, an HPLC method (this was 1980) was difficult, so I suggested a titration with SLS in an ion pair reaction. The crowd went wild! Was this a proprietary assay? Not at all; it had been in the literature for decades.

Strother Martin from
In this scene from the 1967 classic "Cool Hand Luke," Strother Martin's character, known as Captain, is about to "communicate" with Luke in a manner not recommended for scientists. Photo courtesy of AmericanRhetoric.com.

So, what was the problem? Pharma scientists at the company wouldn’t "lower" themselves to read surfactant or, for that matter, any other journals except pharmaceutical journals. The prevailing idea appeared to be that drug chemistry is different from all the other chemistry on the planet. ("What we've got here is failure to communicate…")

And I thought that synthetic urea showed that there was no "life force" behind chemicals in the body… guess some of them didn’t read about that, either. It probably isn’t available on the Internet.

So, you may ask, why is this a salient point at this time? Well, for one thing, there has been little change in the attitude that pharmaceutical chemistry and all physical laws relating to the work done are different, directly owned, and not subject to outside influences. This is nowhere more apparent than in the science/art of near-infrared spectroscopy.

My friend Gary Ritchie, a scientific fellow with the U.S. Pharmacopeia (USP) sent me a 20-page transcript of a CNIRS (Council for Near-Infrared Spectroscopy) online forum discussion thread dating back to 2004, but still relevant today. In this series of messages, which spanned several weeks, the question of where the NIR begins and ends was debated (actually, beaten to death).

One expert discussed how the upper limit of NIR was somewhere between 2500 and 3000 nm. He then points out that the Photonics Dictionary defines the NIR as between 750-3000 nm. Another, from the U.K., pointed to a IUPAC definition, which had apparently appeared in Pure and Applied Chemistry in 1985, as 780-2500 nm. Yet another discussed how the ASTM task force on NIR (included in E131) defined the region as 780 to 2500 nm, too.

Now, Chapter 851 (on Spectrophotometry and Light-Scattering in the USP) speaks of the short-wavelength (Herschel) region as between 750-1100 nm and the “traditional” region as 1100-2500 nm. Then one other respected expert mentioned that CIE and ASTM define the “color” range as 360-830 nm, clearly overlapping the NIR region. The same two groups have a second definition of the full range as being 380-760 nm. Oy!

What bothered me was not the discussion, which, in itself, was a good exchange of ideas, but an underlying theme, a "pharma versus everybody else" tone that I found upsetting. Some of the scientific experts seemed to have the attitude that they were there first and the pharma industry should come to them and be enlightened. The truth is that the FDA and USP will set limits (recently, more and more, with the ASTM), regardless of the old-time experts out there pontificating.

This case was only another example of "everybody talking and nobody listening." It could simply be that we can’t know everything, although no one seems to be trying to tie all this stuff together. The Web is, at best, a kitchen "junk drawer" containing all these data.

I remember, as a newly-minted driver back in 1963, driving along and hearing an interesting factoid on the radio (AM, of course): Apparently, there was enough research published research DAILY to fill some number of Encyclopedia Britannicas! And that was 43 years ago. So, given the astounding amount of data (only some of it information) being generated, why are we simultaneously isolating ourselves from our brethren?

We put on more layers of professional blinders each year. We attend meetings less and less frequently. We trust ourselves to "know" all the correct keywords for a computer search and assume that all we need has been placed on the Web. But then some of us assume that anything outside of pharmaceutical chemistry isn’t important enough to search on.

Maybe, just maybe, we should start going back to places where we can talk with human beings once again. Oooops — gotta go — Yahoo.com says they’ve just discovered alien artifacts on Mars.

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