Impact on Healthcare
In any written or oral discussion of natural healing treatments, the mantra repeatedly echoed is, “But it’s not scientifically proven.” Yet, time after time individuals report their health condition improved or healed through use of one or another Natural Healing treatment. So the question is, What is the Scientific Method?
In my personal quest for wellness, my own mantra is, “I’m an experiment of one, and I’m the only one who matters.” It is of no consequence or importance to me and my body if a herb has been used by millions of people for 5,000 years and it causes me a rash. With a herb, at least I know it will not cause a heart attack, stroke, or other life-threatening reaction.
The Chinese Materia Medica documented the use of botanicals in curing illness in about 2500 B.C. In fact, the ancient texts are still studied and followed by practitioners today; much has been added but little removed over the centuries.1 The repeated usefulness of a pharmaceutical prescription medicine with limited disastrous effects is what moves a prescription drug to over-the-counter availability. This is the same testing procedure as Traditional Chinese Medicine, only we’re depending upon, maybe, 12 years of experimentation in the general population instead of five thousand years!
How Drugs are Tested in the U. S.
Let’s back up and look at how a drug gets the approval of the Food & Drug Administration. 2 The initial research and development in the pharmaceutical lab and pre-clinical (human) testing ranges from one to three years, 18 months being the average. This stage includes initial synthesis and animal testing. The next stage of clinical research and development, which consists of three phases of testing in humans, ranges two to 10 years, averaging five years.
In Phase 1, 20 to 100 healthy individuals take the drug for several months to test its safety. The size of dosage that can be safely taken without acute adverse effects and identification of those adverse effects are main objectives of this phase. How the body metabolizes the drug is measured–how much of the drug gets into the blood stream and various organs, how long it stays there, and how it is eliminated and side effects overcome.
If Phase 1 tests do not reveal major problems the next stage of testing is to administer the drug to patients with the condition intended to be treated. Phase 2 experiments may involve up to several hundred patients (numbers determined by the experimenters) for several months to two years. The primary objective is effectiveness of the drug but also short-term safety. About one-third of drugs tested successfully pass Phase 2. The last phase engages several hundred to several thousand patients for one to four years in Phase 3. Safety, dosage, and effectiveness of the product are being tested.
Following the clinical trials, data are submitted to the FDA for review, which can take two months to seven years, two years being the average. After the drug is released for sale, the FDA monitors the reception in the population at large by tracking reports (from consumers and physicians) of adverse reactions to the drug. Routine sampling tests of the drug and facility inspections are also part of post-marketing surveillance.
See also Flaws in the Scientific Method and Research and Regulation
1. Penelope Ody, Complete Guide to Medicinal Herbs, London: Dorling Kindersley, 2000
2. www.fda.gov/fdac/special/newdrugs/testing.html 6/21/02