Jitters in drug industry over new Tylenol case may be short lived
Boston — It appears at this point that the tremors of concern about buying nonprescription drugs will remain just that -- tremors. Still, the tragic death of a Bronxville, N.Y., woman who took a cyanide-laced Tylenol capsule earlier this month has shaken the over-the-counter drug industry. For Johnson & Johnson, whose McNeil Consumer Products subsidiary makes the drug, the second episode of pharmaceutical ``terrorism'' will be expensive. (The first was in 1982, when seven people in the Chicago area were killed.)
Besides sales lost from the unfavorable publicity, the company will lose some sales as it discontinues production of all nonprescription capsules. That is a move that other drug manufacturers have, for now at least, refused to follow. Johnson & Johnson says its withdrawal from capsules could cost $150 million, after taxes.
For the consumer, the incident is rekindling concern over the safety of buying drugs straight from the shelf. The concern is centering not only on potential tampering but also on the drugs within the bottles.
On both scores, industry analysts and government regulators say, those concerns are, if not unfounded, at least temporary.
At this point, capsules appear to be a weak link in the tampering. They are more susceptible to chemical poisoning. Tablets or ``caplets,'' which are capsule-shaped tablets, would disintegrate if soaked in cyanide or other liquid poisons.
But ``not everyone can afford to abandon a $70 to $100 million product line,'' which is what capsules are worth to major competitors, says Oleh Denysyk, an drug analyst at the market research firm Charles Kline Company. A more likely option, he says, is using a design like Warner-Lambert Company's ``Kapseal,'' which has a gelatin band that goes around the center of the capsule and makes tampering readily evident.
Other drug manufacturers might license this or other technologies, like the one by Scherer Corporation that locks together the two pieces of the capsule using sound waves.
Other drugs like liquid medicines are an easier target than capsules, says John White, a pharmacist and senior editor of Drug Topics magazine.
But, he stresses, all over-the-counter drugs have safety seals. Moreover, he says, ``Tampering is not confined to the over-the-counter drug industry. It's a social issue or a psychopathic issue more than an over-the-counter drug issue.''
After the 1982 incidents, the industry spent between $500 million and $1 billion to buy new equipment and revamp its packaging processes.
Johnson & Johnson's triple seal -- on the box, a shrink seal around the neck of the bottle and foil over the mouth of the bottle -- is considered the most tamper resistant. Other companies have generally have used two seals.
``If they can figure out a slightly more tamperproof bottle, fine,'' says Sidney M. Wolfe, director of Public Citizen Health Research Group. ``But a more serious problem is what's in the bottle.''
He claims that the lack of warning labels on aspirin bottles has been blamed for 150 Reyes syndrome deaths of young children.
Dr. Wolfe seems to be in the minority in this assessment, however.
``I'm very comfortable with the safety of over-the-counter drugs,'' says Mr. White. ``The industry is well regulated'' by the Food and Drug Administration, he says, noting that after its recent review of nonprescription drugs, the FDA eliminated a number of drugs that were considered harmful or ineffective.
At this time, there are more than 100,000 nonprescription drugs on the shelf, according to the Proprietary Association, the industry trade group. That number has not increased significantly from year to year and has actually slowed since the last Tylenol incident to about 100 a year, says analyst Denysyk.
Moreover, the FDA is paring down the number of ingredients that can go into nonprescription drugs, says Edward Nida, a spokesman.
In 1972, there were about 700 ingredients, he says; now there are about a third less than that, ``and we may be in the high 300s by the time everything sifts out'' in the next few years.
``If anything,'' says Meir Statman, an associate professor at Santa Clara University, ``more drugs should be available over the counter. The penalties for something going wrong may be too high'' and the process for getting nonprescription drugs to the consumer too slow, he says.
It often takes 10 years or more for a drug to go from the laboratory stage to the market as a prescription drug. Then it can take another couple of years to reach the store shelves as a nonprescription drug. ``We're much slower than the rest of the world,'' says Denysyk.
``There's no danger [the switch from prescription to nonprescription drugs] is happening too fast,'' says Mr. Nida. ``There's a presumption of safety or they don't go over the counter.''