By Agnella Matic
What is the last medicine that you took? Do you remember its name? Chances are that you’re thinking of the medicine’s brand name, such as Tylenol® or Zithromax®. But these drugs have a generic name as well: acetaminophen and azithromycin, respectively. The generic drug name is the result of a formal negotiation process between the pharmaceutical company that is manufacturing the new drug and the United States Adopted Names (USAN) Council. Dr. Gail Karet, senior scientist at the American Medical Association (AMA), plays a crucial role in the naming process by acting as chief negotiator between pharmaceutical companies and the USAN Council.
As a new drug is developed, the pharmaceutical company will apply for an adopted name (more commonly known as a generic name). Dr. Karet (pronounced ca-RET) relies on her background in chemistry to understand the chemical structure and the supposed action of the drugs that are submitted for naming. The pharmaceutical company will submit several suggested names, working from a naming scheme that Dr. Karet and the USAN Council publish. The suggested drug names should all carry the same stem, which is based on the drug’s mode of action. For instance, azithromycin carries the “-mycin” stem, which indicates that it is an antibiotic against Streptomyces bacterial strains. The other part of the drug name, the prefix, carries no meaning, surprisingly. The prefix (“azi-“ in this example) is merely there to differentiate it from other drugs in the same class. One of Dr. Karet’s crucial responsibilities is to interpret the chemical and biological information on the application and determine if the company’s suggested names conform to the naming scheme.
Though the brand name of a drug is usually more recognizable to consumers, the adopted name is arguably the more important name for patient safety. “[The adopted name] can’t be too close to another [generic or brand] name that might get confused, either when written out, when spoken, or in electronic order entry,” Dr. Karet notes. There are other guidelines that relate to international use of the adopted name, such as letters or pronunciations that don’t exist in certain languages.
The naming process usually takes 1-2 rounds of negotiations between the USAN Council and the pharmaceutical company. Common reasons that the USAN Council asks a pharmaceutical company for alternative naming suggestions are a prefix that the Council deems too promotional, a newly created stem that is not supported by the accompanying data, or a name that suggests a part of the body that the drug acts on. After each round of deliberation by the USAN Council, Dr. Karet reports the results to the pharmaceutical company and facilitates any revisions that have been requested.
Once the USAN Council and the pharmaceutical company reach a consensus, the suggested name is brought to the World Health Organization (WHO) for approval by their international non-proprietary names group. When the WHO, the USAN Council, and the company agree on the same name, the drug receives its United States Adopted Name and a statement of adoption is issued, which includes information on the chemical structure, the molecular weight, and suggested pronunciation. Only after a drug receives an adopted name may the company market the drug to physicians and consumers.
In addition to over-the-counter and prescription drugs, Dr. Karet works on adopted name applications for new contact lens plastics, monoclonal antibodies, and veterinary drugs, to name a few. She estimates that the USAN Council adopts names for over 100 new substances each year, the majority of which are active pharmaceuticals. The USAN Council does not name items such as new formulations of existing substances, preventative vaccines (i.e. annual flu vaccine), or substances that have not yet been tested in clinical trials.
To arrive at her current position, Dr. Gail Karet has taken a path that even she could not have anticipated. After finishing her PhD dissertation at Northwestern University and a post-doctoral fellowship at Indiana University, Dr. Karet took on an editorial journalist role for several pharmaceutical industry magazines, winning regional and national journalism awards along the way. When the publisher’s headquarters moved to New Jersey, she transitioned to a position at the AMA and worked on educational products that are offered to physicians for continuing medical education. Dr. Karet credits her strong writing and editing skills, developed while an editorial journalist, for helping her succeed in the medical education position. Several years after joining the AMA, a scientist position opened up for the USAN program and, in her words, “I couldn’t not apply because it was a really good fit for my background.”
Dr. Karet appreciates the flexible work environment at the AMA and her husband’s involvement with raising their two children, both of which allow her to maintain a full-time position, spend time with her family, and go to her favorite morning yoga classes. She concedes that her life needs to be set up just the right way for everything to work. If something happens, a kid gets sick, then the balance of work, life, and family gets disrupted. Dr. Karet has been just as flexible with her own choices, noting that she and her husband, who is a researcher at Argonne National Laboratory, solved the “two-body problem” when she looked outside of academia for work so that she could remain in the Chicago area. Dr. Karet emphatically states, “I’m not sorry I left research. I agonized over it… but in retrospect I’m glad I did it.”