elelle
Here’s why I can be skeptical of it.
On the one hand (“Western medicine”) you have literally mountains of empirical data explaining in painstaking detail what a molecule is and what it does. There are peer-reviewed journal articles which describe in great detail what the present theory is, disseminated for all to see and (if possible) poke holes in.
On the other hand(“TCM”), there are…testimonials and fuzzy-headed hand-waving.
In case you haven’t been present at the birth of a new drug, allow me to explain the process. I’ll dispense with all the biochemistry and just focus on the nitty-gritty.
Once something looks promising in the test tube, it is time to put it into rats and mice and stuff. Not to see if it works, mind you; just to make sure that it doesn’t immediately kill said rat. At this point, “Good Laboratory Practice” (GLP) steps in.
A chemist makes a large amount of drug. They document everything they do in this process. It must be written in blue or black ink. Red is a no-no, as is the use of a pencil. Why? because these colors show up best in a Xerox and a pencil can be erased. Similarly, any solution they prepare in this process must be labelled with permanent ink listing what it is, what it’s concentration is, who made it, and when it will expire. If you make a typo, you must draw a single line throught the mistake, write the correct version, initial and date said remarks and indicate exactly why you made the change. Why? Simple answer: GLP.
Once they make the molecule, they must purify it and characterize it. That is, they must demonstrate that they made the molecule they intended to.
How does one do this? Through a variety of chemical and instrumental tests. In the case of instrumental analyses, of course, you need to verify that the instrument is working properly, and that you are operating it in a manner shown to produce accurate and precise (the two terms are not interchangable btw) results.
How do you prove this? Easy. You develop a procedure to test the instrument, codify it in a protocol which is then reviewed and archived. You then write another protocol describing how people will be trained to use the instrument, laying out specific targets to demonstrate profficiency and maintain strict records of everyone’s training.
Okay, fine. you have made you molecule and run it through the tests. Does it pass? Only if it has been demonstrated to be 99.98% pure. Current practices dictate that anything besides your desired material which is present in excess of 0.02% be characterized. That means that you have to determine what it is and how it got there (as a guideline, pretty much the only thing you’ll ever experience with that kind of purity is granulated sugar and aluminum foil).
Ok. Let’s say that the drug substance is sufficiently pure. The next step is to shove it into a rat. Of course, you don’t just stuff it down their throats. The amount administered is too small to be able to handle conveniently. Typically, you make a solution of the drug and inject it, or mix in with some inert material and feed it to the animal. This is called “formulation”
Next hurdle. How do you know that the drug doesn’t decompose when you formulate it? How do you know the pure compound is stable at all? Once again, you write up a plan of how you’re going to verify this, and what tests you will do. The formulation is made and tested. Did I mention that you must also prove proper storage conditions? That is, say you plan on sticking it in a refrigerator for a week. Fine. Just be prepared to prove that the refrigerator was working properly. How? Simple. Devise a plan to monitor the refrigerator’s temperature, write it up, have it verified and traceable to an appropriate standard, and do it.
I think that you catch my drift. Let’s just say that I have covered about 1-2% of the work involved in proving a drugs safety, efficacy, or dose setting.
I should also point out that the Food and Drug Administration has every right to march into any lab involved in the manufacture of drugs and demand to see and inspect absolutely everything. At any time they want.
And they do it, too. I once had a new asshole chewed out of me. My crime? I developed an analytical method, wrote it up, verified that it worked and analyzed a large batch of clinical samples. However, I did this before a relevant protocol was counter-signed by our QA department. My science was impeccable, the results were excellent, but because I had contravened GLP, I could not report the results, had to re-do the work (at a cost of app $30,000) and technically could have gone to jail.
Can proponents of traditional Chinese medicine offer anything remotely similar to this kind of rigor? Call me an old stick-in-the-mud, but something either works, or it doesn’t. The “western paradigm” provides a universal yardstick for determining this. I would think that if TCM works according to a “different paradigm,” it’s champions would be champing at the bit to demonstrate its superiority.