The FDA's Insane New Drug Testing Rules

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http://www.mercola.com/2006/feb/2/the_fdas_insane_new_drug_testing_rules.htm

 

The FDA's Insane New Drug Testing Rules

 

 

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.

 

Los Angeles Times January 12, 2006

 

Dr. Mercola's Comment:

 

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.

 

Related Articles:

 

Can You Trust the FDA?

 

More Shady Dealings in the FDA

 

USA Today Exposes Conflicts of Interest in FDA Drug Approvals