The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics by Scott H. Podolsky (review)

Without antibiotics, it has been estimated that nearly a third of us might not have existed because many of our progenitors would have succumbed to infections. Scott Podolsky’s new book on “the antibiotic era” is relevant today because from studying history, we can learn invaluable lessons, both good and bad.

Antibiotics revolutionized both medicine and civilization. Despite fantastic advances made in pharmaceuticals on all fronts, antibiotics are the only class of drugs that can cure diseases that are major killers. After antibiotics kill the bacteria, our infections are gone and we are cured. In contrast, other drugs are closer to palliatives. Anti-hypertensive drugs keep blood pressure in check, but hypertension will come back when one stops taking them. Insulin saves millions of lives, but diabetes does not disappear with insulin treatment. And blood thinners lower the chances of having a stroke, but they are not a cure.

Thanks to the importance of antibiotics, numerous volumes have been published on many different angles of the topic ever since the emergence of the “miracle” drug penicillin. Somewhat different from other books on antibiotics, Podolsky’s focuses on the role, positive or negative, played by different groups in the antibiotic era, including doctors, patients, the pharmaceutical industry, the FDA, medical academia, and the media, mainly from the American perspective.

The author traces the origins of antibiotic reforms from the proliferation of the drugs after World War II in chapter 1, and the controlled clinical trial in chapter 2. The role played by the FDA is showcased in chapter 3 by its interactions with regard to Pfizer’s Sigmamycin and Upjohn’s Panalba: both were fixed-dose combination antibiotics that entered the market without adequate controlled clinical trials. They epitomized many fixed-dose combinations that were merely a ploy to extend patent lives, a ploy still used today. The 1970s saw over-prescription, detailed in chapters 4 and 5. It took herculean efforts on many fronts to educate physicians and patients on the peril of abusing antibiotics.

Podolsky takes us on a journey through the antibiotic era via the roles the key stakeholders played; the most contentious was the relationship between the FDA and the pharmaceutical industry. Historically, drug companies invoked the “testimonial” of either a patient or a doctor to sell their products, but that became increasingly inadequate in the new antibiotic era. Through careful research grounded in a voluminous primary literature, Podolsky describes a series of events that ultimately led to the 1962 Kefauver-Harris Amendments, which mandated proof of a drug’s efficacy via “well-controlled studies” before the FDA could stamp its approval.

We learn how the FDA was influenced by physicians, drug companies, congressmen, and academicians in regulating antibiotics that were already on the market but had dubious results. On the one hand, patients demanded safe and efficacious antibiotics that required tougher FDA scrutiny with the aid of medical academicians. On the other hand, physicians and drug firms cried foul regarding “socializing medicine” with undue and excessive regulations, which were sure to squash pharmaceutical innovations. Reading these scenarios, it appears the situation for the antibiotics in the 1960s was not that far different from the FDA’s balancing acts in regulating today’s drugs. The antibiotics era was a dress rehearsal for what was to come for all future medicines, making Podolsky’s book relevant now.

This work is probably not for a layperson because it is not a page turner. However, people interested in the history of medicine in general and antibiotics in particular will find it deeply informative. In addition, it helps one begin to appreciate the contributions of some key people of that era, including Harry Dowling, Maxwell Finland, Calvin Kunin, Louis Lasagna, Félix Martí-Ibañez, and Henry Welch. Since Podolsky has liberally included their comments verbatim, the reader can appreciate many facets of the antibiotic era from the personalities who...