G.D. Searle Agrees to Change Labeling Under Pressure from Research Groups

International consumer groups recently won an important victory over pharmaceutical companies that continue to market dangerous drugs in the third world.

On September 28, representatives of the Chicago-based G.D. Searle company flew to London to meet with a small British consumer group, Social Audit; at the meeting, the company announced that it was changing its policy on the labelling of Lomotil, a drug marketed for the treatment of diarrhea.

Since 1973, the U.S. Food and Drug Administration has contraindicated Lomotil in the United States for children under the age of two. Adverse reactions to the drug, particularly among infant users, include: "dryness of the skin and mucous membranes, urinary retention, and flushing," according to the Physician's Desk Reference (PDR). Other adverse reactions include nausea, numbness of the extremities, anorexia, and comas, the PDR notes.

But "Lomotil was indicated for children down to three months" in age in many countries of Africa and Asia, says Richard McGraw, vice president for public relations at Searle.

No longer. "We agreed to revise labelling on Lomotil," says McGraw, "to indicate that it should not be used for children under the age of two." McGraw insists that "Lomotil is a symptomatic treatment, not a primary treatment of diarrhea," and as a result of the agreement reached with Social Audit, "we will emphasize even more strongly the adjunctive" application of the drug.

Why did the world's 32nd largest pharmaceutical company even bother to meet with a tiny consumer group, much less agree to change corporate policy?

Fear of negative publicity and consequently lower sales seem to be the reasons for this extraordinary "capitulation," as Charles Medawar, director of Social Audit, calls it.

"Social Audit may be a small organization," explains Seattle's McGraw, who was one of two Searle representatives at the meeting, "but there is a great movement afoot among international consumer groups and the World Health Organization" to tighten the regulations on marketing of drugs. "Social Audit is involved with the International Organization of Consumers' Unions and Health Action International, which was recently formed after the great deal" of publicity surrounding the infant formula issue, adds McGraw.

Social Audit and its affiliated groups "already were" disseminating negative publicity about Lomotil, passing out leaflets (see graphic), McGraw says, "replete with numerous errors, wrong citations, quotes out of context, and misquotes."

"If it was full of errors," responds Medawar, "they should never have agreed" to revise labelling. "We have no doubt that the way Lomotil is used, it is an extremely dangerous drug."

The Searle agreement is "a tremendously important break," says Medawar. "It sets a precedent that could apply to many drugs in the third world."

The accord may also contain an instructive lesson to those who are campaigning against giant and seemingly un moveable corporations.

"The message for consumer groups is to focus on a very small issue," says Medawar, so as not to "swamp your resources." In the case of the Lomotil campaign, "there were two of us working on this issue," he says, "and we kept Searle very busy indeed."