U.S. drug manufacturers reacted quickly to the latest Tylenol poisoning scare by meeting yesterday with federal government officials to discuss the future of nonprescription drugs in capsule form.
However, the companies made it clear that they have no intention now of abandoning this popular drug form despite the decision of Tylenol's maker, Johnson & Johnson Co., to stop selling any over-the-counter drugs in capsules.
In announcing its decision on Monday, Johnson & Johnson said it no longer could "guarantee the safety of these capsules." The company's decision came just nine days after a New York woman died from taking a Tylenol capsule laced with cyanide and four days after another bottle of poisoned Tylenol was discovered in a nearby New York suburb. Johnson & Johnson said it would use "caplets" -- elongated, encoded tablets -- in place of capsules.
With the source of the poisoning still unknown, other drug firms said they were reluctant to take similar action. It is "premature to take any action until all the information is available," said Jerermy Heymself, director of corporate information for SmithKline/Beckman Corp., maker of the cold-capsule Contac, which is believed to be the second-largest selling over-the-counter capsule after Tylenol.
"We're very concerned with the situation, but we're not going to take any precipitous action," said a spokesman for A. H. Robins Co., which makes two over-the-counter capsule products, including Dimacol, a cold-and-cough product.
Echoing the comments of other drug companies and the Food and Drug Administration, Robins spokesman Roscoe E. Puckett Jr. added, "It's premature for the industry to follow Johnson & Johnson at this point."
Nonetheless, it was clear that the manufacturers were keeping close tabs on the situation: Packaging and manufacturing-control experts met with two FDA officials for five hours. The discussion's chief topic was the effectiveness of the current tamper-resistant packaging system that was developed three and a half years ago as a result of another Tylenol-poisoning scare that resulted in seven deaths in Illinois.
"Johnson & Johnson did what they had to -- it was their product that was under assault. . . . But the over-the-counter industry doesn't feel any need to stop making capsules," said John T. Walden, senior vice president of the Proprietary Association, which represents makers of over-the-counter drugs.
"The officials confirmed, and reaffirmed, their confidence in the integrity and the suitablity of the system they helped build in 1982. We were never trying for tamper-proof products -- you can't make bank vaults that are tamper-proof. But we were trying -- and will continue to try -- to make them tamper-evident, so they will leave some trace if tampered with," Walden added.
Interest in more tamper-resistant methods is already evident: One capsule manufacturer, Eli Lilly & Co., noted an increase in inquiries about a product it plans to introduce two months from now. The new product involves a gelatin band that is placed around the capsule to seal the two halves. Anyone attempting to tamper with the capsule by breaking the seal would end up tearing the capsule apart, said Ron Williams, general manager of Lilly's capsule operations.
Meanwhile, Warner-Lambert Co. is promoting a special capsule in which the top half slips down entirely over the bottom half and snaps into place. "It's extremely difficult to open without evidence of physical damage," a company official said.
Sterling Drug Co. already is using a sonic-sealing system that is being explored by other drug companies. The system, developed by capsule manufacturer R. P. Scherer Corp., uses sound waves to make a spot weld where the two halves of the capsule meet, making the capsule tear if anyone tries to separate the two halves.Sterling has been using the "sonic-seal" system on its Panadol, which, like Tylenol, is a pain-reliever made of acetaminophen.
Generally, most over-the-counter medications, including time-release pills, can be made in tablets as well as in capsules, noted Warner-Lambert spokesman Marshall Malloy. Contac, for example, is one of the few drugs that is not available in both forms. Other popular drugs in capsule form include pain killers such as Bufferin and Anacin-3 and cold medicines such as Comtrex and Dristan.
Drug companies are reluctant to give up capsules because research survey after survey has shown them to be a very popular form of medicine. For one thing, many consumers say they are easier to swallow than tablets and do not leave any bitter aftertaste. Additionally, studies have shown that consumers believe capsules are more effective than tablets, partly because the bulk of prescription drugs are in capsule form.
Despite the bad publicity and financial losses Johnson & Johnson is incurring from the latest poisoning scare, financial analysts predicted yesterday that the company -- which until the scare accounted for one-third of the over-the-counter pain reliever market -- will maintain its number one role. Even if the company were to lose all of the capsule business, it still would hold a 25 percent share of the annual $1.6 billion pain-reliever market.
The loss of sales, rebates for capsule medication and an advertising campaign needed to promote the "caplets" will cost the company $150 million, Johnson & Johnson Chairman James E. Burke said.
But in the long run, the company may win back its losses, financial analysts said. They noted it will be able to reduce its costs because tablets are far cheaper to make. One machine stamps out tablets, but several are needed to fill the capsules and join the halves together.
But even more significant, "Johnson & Johnson may preempt the rest of the industry," predicted Robert J. Hoehn, a financial analyst with Cyrus J. Lawrence Inc. "If we were to see poisoning in other capsule products, FDA will no doubt require a ban in capsules . In that case -- which I think is likely -- Johnson & Johnson will not lose market share but gain some."
Robert C. Hodgson, an analyst with Oppenheimer & Co., added, "If Johnson & Johnson is successful with the caplet -- if it can relaunch and regain market share -- other manufacturers will tend to phase out their capsules." The stock market apparently agreed yesterday: Johnson & Johnson stock closed up $1.37 a share at $49.12.
Consumers wishing to return any Tylenol capsule products should mail them to Tylenol Capsule Exchange, P.O. Box 2000, Maple Plain, Minn., 55348. In exchange, Johnson & Johnson will send back a coupon for the same-size bottle of Tylenol caplets.