The FDA has formally issued new guidelines designed to speed the testing of experimental drugs on volunteers.
New rules will allow drugmakers to test "minute doses" of experimental drugs to determine if full-blown clinical tests are warranted.
This "micro-dosing" of small numbers of patients in a clinical environment is intended to replace some early experimentation currently done on animals, and is expected to be more accurate.
Experts claim the amount -- about 1 percent of the final dose -- would allow them to determine if the drug gets to the area of the body intended, and how a patient tolerates it.
However, critics have charged that the new guidelines would increase hazards for volunteers, and facilitate the approval of drugs before their risks were fully understood.
Essentially, this policy allows drugmakers to skip over some of the animal testing that is now required and use human guinea pigs earlier on. This is on par with the FDA's policy of fast-track drug approvals that have endangered your health for years by allowing dangerous, insufficiently tested drugs on the market.
The FDA claims "fast-tracking" and similar policies are designed to get new, life-saving drugs on the market quicker. In reality, though, only a very small proportion of drugs are breakthrough drugs -- perhaps only a few a year. Most "new" drugs are no better than the ones that exist, although they get treated as if they are.
The profit window for a drug is considered to be the lifespan of its patent. Once the patent runs out, the price can no longer be artificially inflated, as cheaper, generic versions of the drug can be made by other companies. So companies quickly bring other patented drugs on the market, claiming that they are newer, better, more effective, and safer than the older versions.
In fact, however, they usually aren't improvements. A drug they can sell for a higher price is much more important to them than a drug that is more effective. Meanwhile, the difference in price can be astonishing.
Folks, it's merely standard operating procedure for the drug-addicted paradigm that passes for conventional medicine with help from the FDA. That's why I remain so focused on my vision to transform the state of health care into a gentler, safer one focused on treating and preventing the underlying causes of disease.
Very shortly you will receive an e-mail about our video parody of the FDA, which we hope will spark a revolution and serve as a catalyst in the transformation of the health care system. Be on the lookout for it as you can play a major role in making this happen.