Tuesday, June 7, 2005
By SUSAN IPAKTCHIAN
The Patriot Ledger
After years of working with cancer drugs with names like rituximab, alemtuzumab and cetuximab, Jeanette Wick had an epiphany.
"I had been handling all of these drugs that ended in 'mab' and I finally figured out that 'm-a-b' stood for 'monoclonal antibody'," says Wick, a senior clinical research pharmacist with the National Cancer Institute.
She confirmed her theory by poking around and discovering the pharmaceutical equivalent of the Rosetta Stone – a Web site listing the various word fragments used in developing the generic names for drugs.
That helped her decipher the origins of generic drug names, but Wick also wondered about the trade names for drugs – such as Zyrtec, Gleevec, Xanax and Pronestyl – that sound like they come from another planet. Trade names, she learned, are made-up words constructed to convey a sense of power or speed or tranquility without promising a cure. In short, trade names "shouldn't mean anything," Wick says. And yet a "meaningless" brand name that captures the public's attention (think Viagra) can be worth hundreds of millions of dollars in sales.
Wick had just waded into the often-perplexing world of drug names.
What adds to the complexity is that every drug has at least three names: a chemical name based on the compound's structure; a generic (or nonproprietary) name that is the drug's official name throughout its lifetime and a trade (or proprietary) name used by the pharmaceutical company for a 17-year period in which it has the exclusive rights to make and sell the drug.
Getting the generic name is the first big objective. When a drug company first seeks permission to test a new chemical compound in animals, it submits up to three possible generic names to the U.S. Adopted Names Council, the organization responsible for assigning generic drug names. Once the five-member USAN Council selects a generic drug name, it goes to the World Health Organization to ensure that it isn't too similar to generic names in other countries.
To guide the development of generic names, the council has a list of approved "stems" that allow therapeutically related drugs to have similar sounding names. For instance, atorvastatin (sold under the trade name Lipitor) contains the stem "-vastatin" for drugs that lower cholesterol and inhibit the buildup of plaque in veins and arteries.
Additional guidelines call for names to be simple to pronounce (with only one way to say it and no more than four syllables), reflect the drug's primary characteristics without implying a cure or applying to a specific part of the anatomy (since many drugs are later found to have other uses) and be distinct from existing generic drug names or trademarks.
The last requirement – that drug names be unique – is crucial. Studies estimate that anywhere from 7,000 to 20,000 people die or are injured each year in the United States because of drug name confusion.
By the time a drug has completed phase-I clinical testing in humans, the company is working to develop a trade or brand name. Authority over pharmaceutical trade names rests with the U.S. Food and Drug Administration as well as the U.S. Patent and Trademark Office.
"Coming up with a brand name used to be an afterthought," says Bill Trombetta, professor of pharmaceutical marketing at St. Joseph's University in Philadelphia. "But today, pharmaceutical companies realize that they need to brand drugs as early as they can and build equity in that brand."
Ideally, the trade name should be memorable without promising efficacy, which is why you'll probably never see an allergy drug called Sneez-B-Gone. Trombetta notes that the name Regain was an early suggestion for the hair-regrowth drug eventually sold as Rogaine; the original idea was nixed because it sounded like a guarantee for growing hair.
"The FDA won't approve a drug name that suggests what it does," Trombetta says, adding that he's surprised the agency approved the name Wellbutrin for an antidepressant because it sounds like a promise of wellness.
Experts note that Wellbutrin along with Celebrex (conveying celebration) and Claritin (implying clarity) are part of a growing trend in the use of experiential names for drugs. In other cases, the trade name is tied more closely to the drug's function. For instance, Lipitor combines a fragment of the word "lipid" with "-tor" from the generic name (atorvastatin).
To develop a trade name, drug-makers often work with branding agencies that use massive databases to help them generate unique names. The names often make use of linguistic tricks, such as plosive letters (P, T or D) to convey power, or fricative letters (X, F, S or Z) to imply speed. This, in part, helps explain the number of Xs that show up in drug names.
"The marketing industry has been in love with the letter X forever," says Steve Manning, managing director of the Igor branding agency in San Francisco. "It's a sexy letter and it gives it a sort of techie sound. Plus, there aren't a lot of words that have an X in them that you use all the time."
After the drug company chooses a trade name, it submits the name to the FDA, which checks for potential look-alike and sound-alike problems. The FDA's Office of Postmarketing Drug Risk Assessment puts proposed names through several screenings, including having health-care professionals interpret both written and verbal orders to simulate the real-world prescription ordering process. It flags problems that might arise because of variations in regional pronunciations. The office also uses software to check for possible name conflicts in the United States and other countries.
"The Holy Grail of drug marketing is the global brand – having one brand and one campaign for the entire world," Trombetta says. That almost never happens because trade names, as is the case with many words, often don't translate well into different languages and sometimes have offensive connotations in some cultures.
The average cost of developing a trade name is estimated at between $500,000 and $2.5 million on average, but Trombetta says it is a tiny fraction of the hundreds of millions involved in bringing a new drug to the market.
As a pharmacist, Wick says she prefers to use the generic names and believes that many drug-confusion errors could be eliminated if physicians writing prescriptions listed the generic name instead of the trade name and included the reason the medication was being prescribed. "I know that's a lot to write, but it makes the pharmacist part of the team" and reduces the likelihood of errors, she says.
Wick still has an appetite for knowledge about drug names, and has written articles and made presentations to other health-care professionals about what she's learned. Given her work in cancer research, she has an affinity for the "-mab" drugs. Her favorite drug name? "Infliximab," she says without hesitation. "Isn't that pretty?" At the bottom of her list is bevacizumab because "nobody can pronounce it."
And if she were ever given the opportunity to bestow a drug name, she's already got a candidate: Gorillicillin, which she says would be "a real chest-beater" of an antibiotic. Wick laughingly acknowledges that the name probably would never be approved, "but I love a drug name with a sense of humor."
To view the list of approved stems for generic drug names, visit the
USAN Council site at http://www.ama-assn.org/ama/pub/category/4782.html