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Science Friday > Archives > 2000 > May > May 5, 2000: 

Hour Two: Developing New Medicines / Clinical Trials

It takes about 15 years and 500 million dollars worth of research for a single new medicine to make it from its original discovery to FDA approval and finally to your local pharmacist.  In what's often called the "drug pipeline," ten thousand drugs fail for every one that makes it through the rigorous testing that's required to make sure that it's both safe and effective.

Before scientists test a new medicine on people, they first study how it acts on the molecular level, then on cells and tissue in a lab dish, then on healthy animals, then on animals that have a similar form of a human disease--and only then can it be tested on healthy humans.   The long testing process, and the multiple hoops that new medications must be put through, are often offered as an explanation for the high cost of prescription medications.

Nutritional supplements and herbal remedies fall under a different set of rules. Though they can affect your health, for either good or ill, they're regulated more like foods than like drugs. Manufacturers of supplements and herbal remedies, under the Dietary Supplement Health and Education Act of 1994, must only provide information that supports their conclusion that new ingredients may be reasonably expected to be safe. The FDA must show that a product on the market is unsafe before it can take steps to restrict use of the product. Still, supplements are big business - consumers spent over $6.5 billion on them in 1996, according to one study.

Coming up on Science Friday, we'll talk about the development process for new drugs and herbal remedies, and the different regulations that apply to each. We'll also take a look at the clinical trials process, and find out how and why some patients volunteer to test new medications.

 

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Guests:
Dr. Gillian R. Woollett
Associate Vice President for Biologics and Biotechnology
PhRMA, the Pharmaceutical Research and Manufacturers of America
Washington DC

Robert Finn
Author, "Cancer Clinical Trials" (O'Reilly & Associates)
Freelance Science and Medical Journalist
Half Moon Bay, California

Dr. Joseph Betz
Pharmacognosist
American Herbal Products Association
Silver Spring, Maryland

Books/Articles Discussed:

"Cancer Clinical Trials : Experimental Treatments & How They Can Help You (Patient-Centered Guides)" by Robert Finn. O'Reilly & Associates, 1999.

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Related Links:
Food and Drug Administration
PhRMA, the Pharmaceutical Research and Manufacturers of America
Federal Clinical Trials database (clinicaltrials.gov)
NIH Office of Dietary Supplements
Council for Responsible Nutrition
FDA Summary of the Dietary Supplement Health and Education Act of 1994
National Center for Complementary and Alternative Medicine (NIH)
American Herbal Products Association

Produced By: Nada Mangialetti
Web Producer: Charles Bergquist

 

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