The Dangers of Chloromycetin

There is no doubt that chloramphenicol, better known by Parke, Davis & Co.'s trade name of Chloromycetin, is a potent and valuable antibiotic. That has been clear since 1947, when it was found to kill a wider variety of bacteria than penicillin or other early antibiotics. Better yet, it was one of the first drugs to show activity against some odd ball microbes called rickettsiae. But Chloromycetin soon showed another side of its character: a few patients developed a severe anemia after taking it, and by 1952 it was clear that some of these patients had died as a result. The question arose: Under what conditions should doctors go on prescribing it?

Last week the Chloromycetin controversy boiled up again in hearings before the Senate Monopoly Subcommittee. Expert medical witnesses agreed that serious and fatal reactions to Chloromycetin are relatively rare. The University of Illinois' Dr. William R. Best suggested that only one patient out of 20,000 or even 100,000 might develop them. Dr. William Dameshek of Manhattan's Mount Sinai School of Medicine put the rate at about one in 10,000. Either way, it sounds few enough. But so many Americans took Chloromycetin that by 1964 the American Medical Association counted 298 U.S. cases of serious reaction, approximately half of them fatal. The California State Department of Public Health has adopted a compromise fatality rate of one in 60,000. Since 40 million Americans are believed to have taken the drug, that would work out at 666 deaths.

Typhoid & Typhus. Chloromycetin also saves lives, and in some cases when no other drug is likely to do so. How many? Most medical opinion holds that Chloromycetin is just about the best drug against psittacosis ("parrot fever"), of which there has been a recent median of 60 U.S. cases a year; against typhoid and paratyphoid fevers, a total of 484 cases; murine typhus, 33 cases; Rocky Mountain spotted fever, 263 cases; one form of meningitis caused by Hemophilus bacilli, exact number of cases not known, but probably less than 2,000.

Although the diseases against which Chloromycetin is clearly superior are far more common in tropical and underdeveloped countries than in the U.S., most of Parke, Davis' huge sales of the antibiotic (up to $86 million in 1960, $72 million in 1966) have been in domestic prescriptions. For what? Far too often, testified Dr. Best, for the common cold and similar viral infections (for which no drug is of any use), and against many bacterial infections for which safer drugs are just as effective. Dr. Dameshek added acne to the list of conditions for which Chloromycetin should not be prescribed.

Six-Figure Judgments. While Parke, Davis has aggressively promoted its product, it has had to yield to demands from the Food and Drug Administration to temper its advertising with warnings. In a current ad with one page of type, less than a quarter is devoted to recommending the drug, more than three-quarters to warnings about how not to use it. With every package goes a leaflet carrying the same warnings. They are reprinted in the manual that doctors keep on their desks. Last week Parke, Davis spokesmen added that their representatives urge doctors to report any adverse reactions in patients taking Chloromycetin. They point out that some such reactions are associated with any potent drug, and they believe that the choice of medication should be left to the physician.

Doctors' journals carry frequent accounts of severe anemia and deaths associated with Chloromycetin. A fatality rate of 58% has been reported among newborn infants treated for pneumonia or diarrhea. Also widely reported was a judgment of $180,000 against Parke, Davis in the case of a California woman who died seven years after receiving Chloromycetin.

Despite the conspicuousness of the warnings, said Dr. Dameshek, there is no evidence that prescribing physicians pay much heed. Yet Dr. Best was opposed to letting any Government agency decide what are the legitimate uses of Chloromycetin, arguing that this would infringe upon the doctor's right to treat his patient any way he thinks best. Dr. Dameshek reluctantly conceded that governmental restriction might be necessary. Whether the Government already has the right to impose restrictions is a matter of dispute within the Food and Drug Administration. So far, the faction which holds that FDA can only give information to doctors has prevailed. Now there is mounting pressure from the subcommittee chairman, Wisconsin Democrat Gaylord Nelson, for more stringent measures to control prescription of the drug.

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