1/17/24, 1:36 PM Drug name confusion: FDA regulations and pharma create bizarre new names.

EVERYDAY BLAH BLAH BLAH AND THE KITCHEN-TABLE ZZZZZZZZZZ

MEDICAL EXAMINER

With a Name Like Xalkori …

New drug names aren’t just bizarre—they’re dangerous.

BY DAVID SCHULTZ
AUG 22, 2013 • 2:46 PM

Who says palindromes that begin with X aren’t common?

Photo By BSIP/UIG Via Getty Images

What would Don Draper make of Xalkori? Pfizer’s lung cancer drug, released in 2011, has a
name that would make an old-school ad wizard scratch his Brylcreemed head.

It begins with one of the least commonly used letters of the alphabet. It’s impossible, at first
glance, to know how to pronounce it correctly. It looks like it could be the name of one of the
creatures from the Star Wars cantina.

In any other industry, calling your product Xalkori would be the business blunder of the
century. But this isn’t any other industry; this is pharma.

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“Xalkori is not just a crazy name,” says R. John Fidelino, who, as director of creative at the
firm InterbrandHealth, helped bring the word into existence.

Interbrand is an international marketing consultancy responsible for some of the most

strikingly odd words to enter the lexicon in recent years. In addition to Xalkori, Interbrand
created Zelboraf, Yondelis, and Horizant. It also helped invent Prozac and Viagra—words
that initially seemed bizarre but are now instantly recognizable.

Fidelino walked me through the thought process that leads him and colleagues to a name
like Xalkori. Their objectives are twofold: First, Fidelino needs to come up with a name that
can be trademarked. (It also helps if the name doesn’t have a negative connotation in any
foreign languages.)

His second goal, both more important and more difficult, is to come up with a name that can
win approval from the Food and Drug Administration and its counterpart the European
Medicines Agency.

The FDA has veto power over the monikers attached to all brand-name prescription drugs
sold in the United States. (Generic drug names, which are often even more bizarre than

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their brand-name counterparts, go through a different and much more complicated

approval process.)

When considering a brand name for approval, FDA reviewers run tests to see how likely it is
that a proposed name could be mistaken for an already existing drug with a similar-
sounding or similar-looking name. They do handwriting tests to catch names that might
look alike when scribbled out on a prescription pad. They also reject any names that could
be seen as a boast about the drug’s power or efficacy, which is why you won’t see any drugs
named Cholesterol Busters, or Angina-B-Gone. (Too bad. I’d love to see a commercial for
that one.)

The development of a brand name can take up to five years, Fidelino says, and the FDA
usually doesn’t issue its final ruling until 90 days before a drug is scheduled to go to market.
“So if you got it wrong, you better have a backup,” he says. “It can be a very expensive
process of throwing things at the wall if you don’t think strategically about it.”

When concocting the name for Xalkori, Fidelino and his team wanted something that
conveyed how the drug works. It’s one of the first treatments for a rare form of lung cancer
that affects nonsmokers, shrinking tumors by blocking a receptor on the ALK gene, which
can cause cancer if it malfunctions.

“With Xalkori, we went straight to the science,” Fidelino says.

His team took the gene’s letters—ALK—and added an X in front to signify that this drug
targets that gene. Because Xalkori is a specialty drug designed to treat a very rare, very
grave disease—not the kind of drug you’d see an advertisement for on TV—Fidelino says it
made sense to give it a science-focused name that probably only doctors and scientists
would understand.

“When you start to think of it this way,” he says, Xalkori “is actually a language that is
uniquely speaking to the physician community.”

“If a brand name is really good, it can do a lot of heavy lifting up front,” says William Leben,
an emeritus professor of linguistics at Stanford. “It can arouse our curiosity, or make a long-
awaited promise, or change our minds about things, or just make a spectacle of itself.”

Many of the names of drugs now on the market would seem, at first glance, to be aiming for
that last category: Zosyn, Ziac, Qnasl, Xeljanz, Isentress, et al., ad infinitum.

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Believe it or not, the recession might have something to do with the proliferation of these
head-scratching brand names. During tough financial times, Fidelino says, many drug
manufacturers skip human consultants and use computerized algorithmic name
generators because they just want something that will get quick approval from the FDA
and don’t care how ridiculous the name looks or sounds.

While this might make short-term sense, Leben says the companies using this strategy
miss out on crafting a brand name that can retain value for the life of the drug, even after its
patent expires. “Like one’s choice of words when introducing a friend, a brand name can
communicate so much,” Leben says.

However, spending five years developing a highly communicative, aesthetically pleasing

brand name is only going to become more challenging in the years to come. Because the
FDA requires all drug names to look and sound unique, any time a new drug comes on the
market it reduces the linguistic real estate available for the next drug. In this crowded field,
turning to quick and easy computer-generated names becomes more and more tempting.

What worries some doctors and pharmacists is that while drug names are becoming more
confusing and less intuitive, more drugs are falling through the FDA’s regulatory cracks.

Yes, that’s right: The FDA’s screening process is not perfect.

Even though the administration can strike fear in the hearts of pharmaceutical companies
(and their stockholders), it occasionally lets slip some look-alike and sound-alike names.
Think of Zantac and Xanax, Paxil and Plavix, Neulasta and Lunesta. Those three pairs are all
on a list of medications that doctors and pharmacists have reported as being confused for
one another. The list, compiled by the Institute for Safe Medication Practices, is eight pages
long.

Medication confusion is nothing to scoff at. If cancer patients think they’re taking Neulasta
to boost their immune system after chemotherapy, but they’re unwittingly taking the
sleeping pill Lunesta instead, that can have serious consequences. According to my analysis
of the FDA’s database of adverse drug events, there have been 174 incidents of drug name
confusion since the beginning of 2009. Of these, 16 resulted in death and at least nine more
caused life-threatening illnesses.

(The FDA wouldn’t grant me an interview for this story, but it did refer me to these white
papers on its name approval process.)

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Medication confusion is an especially acute hazard for physicians in certain drug-heavy

fields. One day last year, Marc Garnick, an oncologist at Beth Israel Deaconess Medical
Center in Boston who specializes in treating prostate cancer, was looking over the
treatment options for castration-resistant metastatic prostate cancer, a highly advanced
form of the disease. “It became just sort of uncanny to me that the trade names of so many
of these drugs were so similar,” he says.

These are the five drugs approved at that time for people suffering from this form of cancer:
Jevtana, Xgeva, Zytiga, Xtandi and Zometa.

“There’s this proclivity to begin drugs with either an X or a Z,” Garnick says, “and it’s
somewhat confusing.”

Garnick was becoming frustrated with this trend, so he wrote a letter voicing his concerns
to the New England Journal of Medicine, which published it earlier this year. The FDA
responded several months later with its own letter, stating that all of the new prostate
cancer drugs “underwent a thorough safety analysis” and that “a review of recently
approved and pending proprietary names did not find a disproportionate number of names
commencing with X or Z.”

Garnick was satisfied. After reading the FDA’s response, he was confident that the issue
was on its radar and that the administration would take steps to make drug names less
confusing.

Then, a few weeks later, Garnick saw that a new, sixth drug had been approved to treat
castration-resistant metastatic prostate cancer.

Its name: Xofigo.

“The oncology field is proliferating with very exciting new drugs that need to be named and
need to have distinguishing characteristics,” he says. “I don’t understand why five out of six
begin with X or Z.”

Garnick is no Don Draper, but he thinks big pharma and the FDA need to up their branding
game.

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