He applied the “Page 99 Test” to his new book, The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics, and reported the following:
Page 99 is a loaded 1962 advertisement for Upjohn’s Panalba, a historically fascinating combination antibiotic that serves to orient us regarding how we’ve been able (or unable) to regulate antibiotics in this country over time. Despite the advent of the sulfa drugs in the late 1930s, penicillin by the mid-1940s, and such “broad-spectrum” antibiotics as tetracycline by the late 1940s and early 1950s, staph infections could still wreak havoc, as many were found resistant to such heavily used drugs. In an apparent arms race, the pharmaceutical industry developed and widely promoted “fixed-dose combination” antibiotics, whereby two or more antibiotics would be administered in the same pill. Yet when leading infectious disease researchers studied such heavily advertised and administered antibiotics by the late 1950s, they found them no better – and potentially worse or more toxic – than their component parts. They demanded that such remedies be justified by “well-controlled” investigations, rather than via “testimonials.” When their rhetoric spread to Senator Estes Kefauver’s congressional hearings on the pharmaceutical industry, it helped lead to the passage of the 1962 Kefauver-Harris drug amendments, whereby all new drugs would have to be proved efficacious through such rigorous studies, establishing the FDA’s regulatory framework that persists to this day. After the passage of the amendments, the FDA commissioned a review of existing drugs, with an eye to withdrawing those not meeting the more rigorous criteria. The FDA’s withdrawal of Panalba – a combination of tetracycline and novobiocin, and widely prescribed by physicians – would be contested by Upjohn all the way to the Supreme Court as an infringement on prescribing prerogatives, but the judiciary found in favor of the FDA, in a crucial empowering of the FDA to shape the pharmaceutical market.Learn more about The Antibiotic Era at the Johns Hopkins University Press website.
And yet, while seemingly inappropriate antibiotics were removed from the market, no one was empowered to regulate the inappropriate prescribing of appropriate antibiotics. And here is where the advertisement becomes doubly intriguing. The advertisement, labelled “Panalba promptly,” recommends the shoot-first use of the antibiotic as a “rational” approach to gaining “precious therapeutic hours … in bacterial tracheobronchitis.” Even at the time, infectious disease experts felt that most such infections were viral (and hence not treatable with antibiotics), and that even “bacterial” tracheobronchitis didn’t require antibiotics, or at the very least should be diagnosed by taking bacterial cultures. Instead, the widespread overuse of drugs like Panalba – and later broad-spectrum antibiotics – would help promote the development of the very antibiotic resistance that drugs like Panalba were supposedly designed to offset in the first place.