|
|
New Rules for Nature's Medicine Chest
| Article
# : |
18204 |
|
|
Section : |
NATURAL SCIENCE
|
| Issue
Date : |
11 / 1990 |
2,195 Words |
| Author
: |
Stephen L. DeFelice
|
Never has the medical promise of nutrition been so exciting, and never have the barriers to delivering on this promise been so great. It is puzzling to note that despite the intense media coverage of nutritional benefits to health, the barriers continue to go unnoticed.
Take a hypothetical case: Let's enter the dining room of "Christopher Meehan," who is the owner of Liquid Ambrosia, the famous soup company. One of his guests is the surgeon general of the United States, Dr. Tim Clydesdale. Dr. Clydesdale is discussing a devastating flu epidemic that is attacking both the very old and the very young. There is little benefit from the present therapeutic armamentarium. Meehan laughingly says, "Dr. Clydesdale, my mother used to give us ‘Jewish penicillin,' chicken soup, when we had a cold or the flu. I don't know what you docs think about this, but we all thought it was great. We felt better and got well more quickly."
There is a pause at the table, and Dr. Clydesdale is evidently in deep thought. Suddenly he challenges Meehan by saying, "Why don't you do a study on a thousand patients with the flu to see if chicken soup - your brand of course - can reduce the severity of symptoms and shorten the duration of the illness?" Meehan, being a true philanthropist, asks, "What would it cost?" Dr. Clydesdale replies, "About two million dollars."
"You've got a deal," says Meehan.
He then summons the experts from the National Institutes of Health and the academic community to plan the clinical study protocol. Six study centers are chosen in large cities where the flu epidemic is raging. The results of the study are quite startling: With regular doses of chicken soup, the symptoms and duration of illness are significantly reduced.
Thrilled with this discovery, Meehan's mind turns to the marketplace. He summons his staff and orders a mass mailing to announce that liquid Ambrosia Chicken Soup has a clinically beneficial effect in all patients with flu. But as the meeting ends, his chief legal counsel says, "Mr. Meehan, I hate to tell you, but you just can't do it."
"Why can't I?" asks the startled president.
"Because when you make a medical claim, your chicken soup goes from a food to a drug. And when it's a drug, the FDA must approve the medical claim that you are making. And this requires an official document known as a New Drug Application, or NDA."
"Well, let's get an NDA," replies Meehan.
"It's not as easy as all that. The FDA has never approved a soup for a medical indication, and also, if it were possible, it would cost millions of dollars more to fund and assemble all the testing required. And to really put the nail in the coffin, even if the FDA approved your Jewish penicillin as effective for flu, other companies could sell their chicken soups for the same purpose but at a cheaper price, since they didn't have to pay for the studies and NDA. You would be spending millions of dollars for the research, the NDA, and the marketing to create the market for other companies. Bluntly put, you would be the laughingstock of the
...
Read Full Article
|
|
