The Great Capsule Controversy

By Barbara Rudolph.

Four years ago, when seven people in the Chicago area died after taking cyanide-laced capsules of Tylenol pain reliever, the crime seemed so horrible --so peculiarly horrible--that it was hard to believe it would ever be repeated. And yet it has been, again and again. Last February tainted Tylenol capsules killed a Peekskill, N.Y., woman. A month later traces of rat poison were found in Contac cold capsules and Teldrin allergy medication in Houston and Orlando. Two weeks ago, medical investigators discovered that two residents of Auburn, Wash., had died as a result of swallowing toxic Excedrin capsules. Bristol-Myers quickly pulled Excedrin capsules off the market nationwide, but last week Auburn's cyanide scare spread to yet another brand of pain-killer. During a random check of a pharmacy in the Seattle suburb, Food and Drug Administration officials found poisoned capsules of Anacin-3, made by American Home Products. Within a day, the State of Washington imposed a 90-day ban on the sale of most nonprescription capsule drugs.

Manufacturing over-the-counter capsules has been a fast-growing, profitable business (1985 sales: $1.5 billion), but the market is suddenly shrinking. Within the past five months, both Bristol-Meyers and Johnson & Johnson, the maker of Tylenol, have stopped selling any of their nonprescription drugs in capsule form. While most other manufacturers insist that they have no current intention of walking away from this market, consumers and producers across the U.S. are pondering the uncertain fate of the still popular product.

Thousands of different kinds of nonprescription capsules continue to be sold today. In all, Americans bought about 10.5 billion doses of these gelatin-cased medications last year. Among the leading brands: Contac (made by SmithKline Beckman), and Sinutab and Benadryl (both made by Warner-Lambert). Nearly all over-the-counter drugs are two-piece capsules, although the single- piece model, used for some vitamins, is perhaps safer. If anyone were to try ; to pierce a single-piece shell, it would probably leak and be very difficult to seal again. In tampering with two-piece capsules, a criminal might be able to separate the two parts, contaminate the medication and later put the pieces back together. So far, though, single-piece capsules can hold only liquid drugs. Reason: the medication cannot pass through the special machinery used to make single-piece capsules unless it is in liquid form. Most over-the-counter medication comes in powder or solid-pellet form.

When the first deaths from capsule poisonings were reported, companies said they would be developing tamper-resistant products. In the beginning, manufacturers focused on making the outside of the packaging more secure. For example, they placed tightly sealed plastic around the tops of the bottles. Later came other ideas. R.P. Scherer, a capsule manufacturer, developed a "soniseal" machine that uses sonic waves to weld the two pieces of a capsule together. Eli Lilly last year made available to U.S. manufacturers a similar technique. A band of gelatin is placed around the waist of the capsule, where the two pieces overlap. That makes it tougher to open the casing without leaving a mark. But companies were slow to adopt the new technology, apparently because they thought that sealing the pill bottles was sufficient protection.

Now that more deaths have occurred, the gelatin-band method of sealing may soon become widespread. Last week Warner-Lambert, a drug company that is also the world's leading supplier of two-piece capsules, announced that it would use a method of fusing the capsules similar to Lilly's in manufacturing its product line. This summer SmithKline has begun using the gelatin band in its Contac and Teldrin capsules.

Producers candidly admit, though, that their new tamper-resistant packaging is far from tamperproof. Says Marshall Molloy, a spokesman for Warner-Lambert: "Given sufficient resources, skill and determination, the criminal can beat any safety measure known today."

Capsules remain popular with consumers despite the poison scares. While these pills are no more effective than tablets, many people find capsules better tasting and easier to swallow. Judy Newbold, a resident of Auburn, is resigned about the discovery of poisoned medication in her town. Says she: "It's just one of those things you have to take in stride. There are kooks everywhere."

No major consumer organization is currently pushing for a nationwide ban on % the sale of over-the-counter capsules. Dr. Sidney Wolfe, director of the Washington-based Health Research Group, argues that such a ban "would be a shortsighted solution to a terrorist threat." FDA Commissioner Dr. Frank Young concurs: "You are on a slippery slope when you allow a group of terrorists to start driving products off the market." The FDA, Young says, is not now considering any ban on capsules.

Still, manufacturers are facing tough decisions. It will cost Johnson & Johnson $150 million to pull out of the capsule market, and Bristol-Meyers will lose $38 million. These days executives are voicing varying degrees of commitment to the controversial capsule. Said a spokesman for American Home Products: "We have no intention at this point in time of discontinuing our over-the-counter capsule business." At another time, he implies, things could change. Echoed a spokesman for Sterling Drug, maker of Panadol and Midol pain relievers: "We are still marketing the capsules. But it's a fluid situation. Any instance, such as the recent tampering cases, causes us to review our products." A prudent middle course would be for all manufacturers to adopt one of the new technologies for safer capsules as quickly as possible. If that does not stop the poisonings, the companies may have to swallow hard and abandon capsules for good.

With reporting by Patricia Delaney/Washington and William J. Mitchell/Detroit