DATE: Sunday, March 30, 1997                TAG: 9703280067

SECTION: DAILY BREAK             PAGE: E6   EDITION: FINAL 

COLUMN: IMPERFECT NAVIGATOR

SOURCE: ALEXANDRIA BERGER

                                            LENGTH:   77 lines

IS SUBSTANCE A DRUG OR A SUPPLEMENT?

THIS WEEK, the Associated Press ran a story which noted the Food and Drug Administration was investigating the ``dietary'' supplement, Cholestin, to determine whether it is actually a drug in disguise. A red yeast cholesterol-lowering product from China, Cholestin is sold mainly in health-food stores.

Key to this issue is labeling. Cholestin's label reads, ``Lower your cholesterol without drugs.'' Supplements may advertise ``general aid,'' but according to a 1994 congressional law, may not claim to fight a particular disease. If they do, they're reclassified a drug. Drugs or medicines come under the control of the government, requiring FDA approval after testing for safety and efficacy. Supplements made from natural substances as such do not.

Don't be fooled. This isn't some act of random FDA concern over proper labeling. Though, sadly, it should be.

Merck, Inc., America's largest pharmaceutical company, believes the inexpensive Cholestin may be guilty of patent infringement on their expensive competitor, Mevacor, a big profit maker. Both products are made from natural substances, which act as reductase inhibitors preventing cholesterol production. Both can cause liver damage. Cholestin is in its natural form, while Merck claims its medicine is a ``purified compound at the dosage suitable for treating disease.'' It seems to me, profit, not patent infringement has caught Merck's ire.

Fueling this is recent FDA approval of Lipitor, a newer cholesterol-lowering drug made by Parke Davis. Merck isn't alone. Other pharmaceutical companies make similar drugs, too. Goodbye, profits. Hello, lobbying.

So, now the FDA will examine when a dietary supplement crosses the line and becomes medicine. That shouldn't be the issue. The only difference between a natural substance (dietary supplement) and something manufactured in the lab from a natural substance (medicine) are patents and profits. Pure and simple. One can't patent a natural substance. The only issue is proper labeling, and it should be on everything we put into our bodies.

We should know the side effects, how much to take, what's in it, and what other substances interact with it. Period. Yet, the FDA and Congress can't seem to get this message, which over the years has arisen repeatedly. The problem has been reaction from lobbying factions, not action on behalf of the public good.

If you land in the hospital with kidney stones because you've overdosed on Vitamin C, or pass out from taking too much Vitamin B6 (a natural diuretic), does it matter if it was a medicine or a nutritional supplement? Before genetic manipulation and synthetics, almost all medicine came from the Earth's natural resources.

Taxol, the chemotherapeutic agent used to treat cancer, comes from tree bark. All antibiotics are made from spores and funguses, and added chemical modifications.

Digitalis was once made out of the foxglove flower, for centuries brewed as a tea to treat `dropsy' (now called heart failure).

Blood pressure medicines like Captopril were made from snake venom. Farmers in central Europe used to prevent infection by packing open wounds with fistfuls of cobwebs laced with fungus-grown penicillin. Zinc is being used, successfully, to shorten the length of the common cold. Is it a medicine or a supplement? Who cares?

If a natural substance works as well as a synthesized processed version to treat a condition effectively, the American public deserves to know the truth without lobbying interference from the big pharmaceutical houses who continually receive FDA backing to protect their profit margin. Since the chronically ill, disabled and elderly are always looking for increased wellness, they statistically ingest greater amounts of dietary supplements, than the general population. And they're more apt to try anything, which promises relief.

Often, physicians are unaware patients are taking supplements, or, if they are aware, are unfamiliar with toxic levels, drug interactions and side effects.

The FDA's continued battle with confusion is causing all of us to be improperly treated. It's time they stopped labeling the public ignorant, and gave confusion a rest. MEMO: Write to Alexandria Berger, c/o The Virginian-Pilot, 150 W.

Brambleton Ave., Norfolk, Va. 23510.

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