The time may come when penicillin can be bought by anyone in the shops. Then there is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant. Here is a hypothetical illustration. Mr. X. has a sore throat. He buys some penicillin and gives himself, not enough to kill the streptococci but enough to educate them to resist penicillin. He then infects his wife. Mrs. X gets pneumonia and is treated with penicillin. As the streptococci are now resistant to penicillin the treatment fails. Mrs. X dies. Who is primarily responsible for Mrs. X’s death? Why Mr. X whose negligent use of penicillin changed the nature of the microbe. Moral: If you use penicillin, use enough.
-Alexander Fleming, Penicillin, Nobel Lecture, December 11, 1945
Dr. Fleming warned about the consequence of misusing antibiotics 70 years ago. Today, his caution is our reality. Misuse of antibiotics has led to a new era of antimicrobial resistance, causing panic among public health officials worldwide. The World Health Organization’s Antimicrobial Resistance Global Report on Surveillance warns that without drugs to treat virulent infections, we may be entering a post-antibiotic era where people die from something as simple as an infected scrape.
Last week, acting under authority provided by the Generating Antibiotic Incentives Now provisions of the FDA Safety and Innovation Act the Food and Drug Administration (FDA) designated special treatment for drugs developed specifically to treat a list of dangerous pathogens. Antibiotics are costly to develop and generally not a lucrative investment, so pharmaceutical companies have shifted resources to drugs generating greater profits. Intending to incentivize the research and development of new antibiotics, FDA declared these specific pathogens as eligible for fast-track product approval, and for an additional 5 years of exclusivity (the period during which antibiotics can be sold without generic competition).
FDA’s move is critical in providing incentives for development, and in acknowledging the severity of the problem. As a class of drugs, however, antibiotics are unique. Their efficacy will decrease in response to a changing host environment. Extraneous environmental factors and human behavior are largely responsible for the need for more powerful antibiotics in the first place. While public health officials are clamoring for an antidote, it is important to question what caused the emergence of antibiotic resistant microbes and to understand the necessity of changing consumption and use practices while simultaneously developing new therapies.
Change needs to happen at many levels and cannot be achieved without public awareness and patient/consumer participation. Here is a list of things we can all do to help prevent the spread of antimicrobial resistance:
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.