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Joseph Kugielsky for The New York Times
Pfizer created Max, a zebra mascot, to help sell Zithromax, an antibiotic.
Chang W. Lee/ The New York Times
Janice Saunders, left, of Pfizer, gave a presentation on the antibiotic
Zithromax to Dr. Naomi Jackman in Manhattan.
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Replicas of Max, a small plastic zebra, hang from the stethoscopes of so many
pediatricians at the Children's Hospital in Boston that at least one family
has asked whether he was the hospital's mascot. But no, Max is a creation of
Pfizer Inc., intended to sell an antibiotic called Zithromax. And with Max's
help, Zithromax has become a billion-dollar drug in just a few years.
Pediatricians open their mailboxes to find medical journals wrapped in paper
covered with Max's stripes. Zithromax sales representatives hand out stuffed
zebras to doctors to help console their young patients. And Pfizer has
donated a real zebra to the San Francisco Zoo and invited scores of children
to a celebration at which the zebra was named Max.
Last year, after federal health officials said that other antibiotics were
not only cheaper, but worked better for children's ear infections, Pfizer
sponsored a season of "Sesame Street," enlisting Elmo, the Muppet, to help in
the campaign.
The sales effort is classic Pfizer. It is also an example of what makes
Pfizer both the company that rivals try to emulate and a target of critics
who worry that the use of many prescription drugs now has more to do with
marketing than with the effectiveness or actual need for a drug.
Pfizer, based in New York, spends more than any other drug company to
advertise to consumers, and its marketing efforts have garnered warnings from
federal regulators and criticism from doctors. In recent months, the
complaints have grown, as state and federal officials have blamed aggressive
consumer advertising by drug companies in general for the skyrocketing cost
of drugs.
Pfizer, the largest drug maker in America, was probably the first in the
industry to transform itself so clearly from a research-driven company to one
that operates more like Procter & Gamble, the maker of Tide.
At Pfizer and a growing number of other drug companies, marketing executives,
not scientists, are in charge. William C. Steere Jr., the company's chairman
and chief executive, began his career there as a sales representative,
marketing the antibiotic Terramycin. Henry A. McKinnell, who will take over
when Mr. Steere retires next year, also came from Pfizer's business side.
In Pfizer's laboratories, marketers work side by side with scientists, even
during a drug's early development. Using financial forecasts, the sales
executives help to ensure that any drug the scientists are developing has a
ready market. Other drug companies use this system, too, but Pfizer says it
was one of the first to emphasize it.
Pfizer says its worldwide army of 20,000 sales representatives is the
industry's largest. And while the company has the biggest research budget in
the industry, it spends more than twice as much on marketing and
administrative expenses.
Last year, the company spent 39 percent of its $16 billion in revenue on
those expenses -- a rate that was about one-fifth higher than the industry
average.
Pfizer brushes aside the concern. In an interview, Mr. Steere said the
company's ads were helping to improve the public's health, not only by
supplying effective drugs to ailing patients, but also by prompting people
long reluctant to go to the doctor to set up appointments. And those
appointments, he said, may also lead to detection of other problems: some men
who have gone to the doctor to get a prescription for Viagra, Pfizer's
popular anti-impotence drug, have found out they had other medical problems,
like diabetes.
"Direct-to-consumer advertising is a good thing," he said. "We get more
complaints about our ads from politicians than consumers."
Peter DaSilva for The New York Times
In late 1998, Pfizer donated a zebra to the San Francisco Zoo. The animal
was later named Max, just like the drug's mascot.
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Pfizer's strategy has been so successful that the company expects to set an
industry milestone this year -- eight drugs that bring in sales of more than
$1 billion each. Six of those blockbuster drugs were discovered in Pfizer's
labs or in those of Warner-Lambert, a competitor that it acquired early this
year.
Pfizer is so respected as a marketer that more and more of its sales come
from drugs discovered by other companies that have hired Pfizer to help sell
their drugs. SG Cowen Securities estimates that Pfizer's revenue from
marketing just two drugs discovered by other companies -- Celebrex, a pain
reliever from Pharmacia, and Aricept, a treatment for Alzheimer's, from Eisai
-- will increase to $2.4 billion by 2004 from $680 million last year.
Pfizer's need to market so aggressively is, in part, a product of its
success. Its strong performance over the last decade has raised investors'
expectations, and its acquisition of Warner-Lambert brought together
America's two fastest-growing drug companies, only adding to the Wall Street
pressure for sales growth. Mr. Steere said this year that Pfizer planned to
increase sales by 13 percent a year through 2002. That means more than $3.5
billion in new revenue this year, the equivalent of three new blockbuster
drugs.
"We've got to get everything out of a product in a short amount of time," Mr.
Steere said.
There is no doubt that Pfizer's drugs have helped millions of ailing
patients. The company is giving away millions of doses of Zithromax, for
example, to developing countries to help stop an eye infection that can lead
to blindness.
But criticism of the company's marketing tactics is growing. Last year, the
Food and Drug Administration requested a meeting with Mr. Steere, wanting to
discuss the repeated warning letters it had sent to Pfizer. The letters
contended that the company failed to follow federal drug-marketing
regulations by making claims about certain drugs that could not be supported.
Pfizer has received 11 warning letters since the end of 1996, including one
ordering it to stop using brochures that the agency says improperly implied
that Zithromax was more effective than Augmentin, an antibiotic made by
SmithKline Beecham. Other drug companies have received more warning letters
from the F.D.A., but an agency spokeswoman said it was "rare" for a chief
executive to be called in for a visit with Dr. Janet Woodcock, director of
the F.D.A.'s center that approves drugs.
Thomas McDonald for The New York Times
Two Pfizer scientists, Arthur E. Girard, left, and Gene Michael Bright, were
involved early on with Zithromax, used to treat children's ear infections.
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Two of Pfizer's most vocal critics, Dr. Joshua Sharfstein, a pediatrician at
Boston Medical Center, and Dr. Sidney Wolfe of Public Citizen, the consumer
group, have complained about Pfizer's Zithromax campaign to Donna E. Shalala,
the secretary of health and human services. The two doctors had obtained an
internal Pfizer document that listed a toll-free phone number for
pediatricians to call if they wondered whether to prescribe Zithromax to
children. When they called, they heard recorded advice from Dr. Russell
Steele, vice chairman of pediatrics at Louisiana State University's school of
medicine. He said, among other things, that most children's ear infections
would be cured with a drug like Zithromax.
The Pfizer internal document said the purpose of the recorded advice was to
"counter" recommendations of the Centers for Disease Control and Prevention
that were published in early 1999. Those guidelines said other antibiotics
were more effective than Zithromax at curing children's ear infections.
In their complaint, Dr. Sharfstein and Dr. Wolfe argued that part of the
advice from Dr. Steele, whose university had received a payment from an
advertising company hired by Pfizer, was not based on prevailing scientific
evidence.
"There is even more evidence now that Zithromax does not work for many kids,"
Dr. Sharfstein said. "It just prolongs pain and suffering for many kids and
is much more expensive than the other medications." He said, however, that he
believed Zithromax was effective in treating pneumonia.
Dr. Steele said that he disagreed with the C.D.C. recommendations, and that
he stood by what he said on the recording.
Pfizer says any problems that regulators found with its marketing were
isolated incidences that were corrected immediately. J. Patrick Kelly, the
vice president for worldwide marketing, said the company had investigated the
two doctors' complaint but did not find that it had done anything wrong. Mr.
Kelly said that Pfizer regularly gives grants to outside experts to talk
about its drugs as part of educational programs for doctors, but that the
experts give their own opinions. "We don't control the personal opinion of
doctors," he said.
Dr. Michael W. Dunne, director of clinical research for Pfizer's
anti-infective drugs, said the company had conducted studies comparing
Zithromax to all drugs recommended by the C.D.C. panel and found that
Zithromax was just as effective.
Aggressive marketing of any antibiotic, whether made by Pfizer or its
competitors, is increasingly controversial. C.D.C. officials say they fear
that overuse of antibiotics is threatening the public's health as more
bacteria become resistant to the drugs. But to drug companies, limiting the
sale of an antibiotic would be altruism that would not be good for the bottom
line.
"There is a conflict between the public health interest and the industry's
interest," said Dr. Scott Dowell, the C.D.C.'s acting associate director for
global health, speaking about all drug companies. "The industry is concerned
about resistance, but they need to sell their drugs."
The Associated Press
Pfizer and the producer of ``Sesame Street'' made a video featuring Elmo
going to a doctor with an ear infection.
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Mr. Kelly said Pfizer was monitoring which bacteria have become resistant to
Zithromax. So far, he said, Zithromax is holding up better than many other
drugs. It is now the nation's top-selling branded antibiotic.
In its marketing efforts, Pfizer has addressed the government's concerns
about antibiotic resistance, Mr. Kelly said. Company advertising, for
example, has urged parents not to demand a prescription for an antibiotic
from the doctor if a child's ear infection is caused by a virus -- a practice
that is contributing to antibiotic resistance.
Pfizer has acknowledged a downside to advertising. While Mr. Steere contends
that advertising has benefited consumers, he said it had also helped make the
industry a new corporate demon in some people's eyes.
"We used to be invisible," he said, "but now we're very visible."
Since its founding in 1849 by Charles Pfizer and his cousin, Charles Erhart,
in Brooklyn, Pfizer has had a knack for getting people to take more medicine.
They had their first breakthrough when they took a bitter treatment for
parasitic worms, blended it with almond-toffee flavoring and shaped it into a
candy cone.
Pfizer's presence in antibiotics dates to just before World War II, when the
company found how to produce penicillin in mass quantities. And in the late
1940's, Pfizer's scientists discovered Terramycin, which went on to become a
top seller. When the drug was approved by the F.D.A. in 1950, eight Pfizer
sales representatives were waiting for word at pay phones across the nation.
The company has been building its sales force ever since. Even during the
early 1990's, amid the uncertainty over managed care and President Clinton's
plan for a national health care system, Mr. Steere took a gamble by hiring
people when other drug companies were firing them.
With the Warner-Lambert merger, Pfizer now has 8,000 sales representatives in
the United States alone, the most in the industry.
Pfizer plans to spend about $4.7 billion this year on research -- an amount
that is more than the budget of the National Science Foundation in
Washington. The company's 12,000 scientists are focused both on finding drugs
and, with the help of sales experts, creating an ever greater market for
them.
At the main laboratory in Groton, Conn., the scientists call that teamwork
"Cram," for "Central Research Assists Marketing." About 25 percent of
Pfizer's research money finances clinical studies of drugs that Pfizer is
already selling. These studies, known as Phase 4, are common in the industry
and are conducted after the F.D.A. approves a drug.
Aimed at increasing the sales of existing drugs, Phase 4 studies try to show
that the company's drugs can be used by patients suffering from other
illnesses or that they work better than competitors' drugs. In effect, they
try to expand the claims that Pfizer's sales representatives can make about
the drugs.
"You can't promote a feature of a drug unless you've proven it," said Dr.
John F. Niblack, Pfizer's top scientist and vice chairman.
Outside the lab, Pfizer is also working hard to supplement its products. It
has aggressively wooed other companies that are developing new drugs, asking
to let Pfizer help sell them. In fact, of the four drugs in Pfizer's pipeline
that the company estimates could become billion-dollar-a-year sellers, two
were discovered by other companies. In a recent report, McKinsey & Company,
the consultants, called Pfizer "superior" at getting these contracts. Indeed,
the antibiotic that became Zithromax was discovered by Pliva, a company in
Zagreb, Croatia. Pfizer's scientists came across Pliva's patent in 1981 in a
search of records at the United States Patent Office. The companies soon
signed a licensing agreement.
The drug fascinated Pfizer's scientists because, in experiments, it stayed in
the body tissue of animals longer than other antibiotics.
Pfizer's marketers quickly realized that the science behind Zithromax would
make great ad copy. Gene Michael Bright and Arthur E. Girard, two Pfizer
scientists involved with early work on the drug, recalled how the marketing
executives decided to send them to international conferences to talk about it
years before it was approved.
At the suggestion of Pfizer's marketers, the scientists repeatedly used
snappy phrases like "the tissue is the issue," Dr. Bright said, to deliver
the message that Zithromax would be a powerful new drug.
When Zithromax was approved in 1992, Pfizer's marketing message changed to
focus on consumers. Because the drug stays in the body so long, patients need
fewer doses than they would of other antibiotics. Pfizer's marketers knew
that this would be a great selling point to parents struggling to get sick
children to take medicine. The marketing message became "just five doses and
you're done."
Although Zithromax is approved for use in adults with pneumonia and other
illnesses, Pfizer's marketers have focused much of their effort on millions
of children who get ear infections. Federal statistics show that almost
two-thirds of children under 5 get an acute ear infection every year.
When the pediatric formulation of Zithromax was approved in 1995, Dr. Candice
E. Johnson was a pediatrician at a clinic at Case Western Reserve University
in Cleveland. She said her clinic "was wallpapered with Zithromax zebras"
supplied by Pfizer sales representatives.
Dr. Johnson, now a pediatrics professor pediatrics at Children's Hospital in
Denver, recalled how Pfizer representatives had distributed rubber ink stamps
to doctors so that writing a prescription required only a quick stamp and
signature. She became upset, she said, when she found that emergency-room
doctors were prescribing Zithromax for illnesses like strep throat, which
could be treated with less powerful medicine.
A few years ago, she said, she asked to give a talk to the emergency-room
personnel on the proper use of antibiotics. But before she spoke, a Zithromax
sales representative was allowed to hand out pens and calendars, make a
five-minute presentation and pay for the breakfast buffet. "It really
disturbed me," she said.
Pfizer says its use of a zebra to promote Zithromax is typical of the
industry's approach to marketing pediatric drugs. SmithKline Beecham, for
example, uses "Auggie the Froggie" to market Augmentin, and Abbott
Laboratories uses a bulldog called Bix to sell Biaxin. Both drugs compete
with Zithromax.
Concerned early last year about the growing resistance of bacteria to drugs,
a C.D.C. panel of doctors recommended which antibiotics should be used to
treat children's ear infections. The panel recommended that a pediatrician's
first choice should be amoxicillin, which has been used for years. As a
second choice, the panel recommended several drugs made by Pfizer's
competitors.
Dr. Dowell, the C.D.C. official, said the panel did not recommend Zithromax
because most studies had shown that it was not as effective as the
recommended drugs against the bacteria that is the leading cause of
children's ear infections, if that bacteria had become resistant. A growing
number of ear infections are caused by resistant bacteria, he said.
"We still stand by the recommendations," he said. "The studies that have come
out since have supported them."
But Pfizer moved quickly to offset the recommendations. Soon after they were
published, Pfizer paid the Children's Television Workshop to sponsor a season
of "Sesame Street," running 15-second Pfizer announcements at the beginning
and end of each show.
Then, in an unusual partnership, Pfizer and the Children's Television
Workshop produced a video featuring Elmo going to a doctor with an ear
infection. Zithromax was not mentioned in the video, which was distributed to
doctors and child care centers, but the drug was advertised on a Pfizer Web
site, KidsEars.com, where the video was also given away in a drawing.
"We used something kids love," Mr. Kelly said, "to get them past something
they don't like."
Pfizer also paid for a children's health magazine that was produced by the
Children's Television Workshop and included Zithromax ads.
What happened next is open to interpretation. The latest sales statistics
suggest that the C.D.C.'s recommendations could be changing pediatricians'
minds. In the first half of this year, Zithromax sales fell 10 percent,
compared with the corresponding period last year. And prescription statistics
show that amoxicillin prescriptions began to climb in 1999 after declining
for years.
But Mr. Kelly of Pfizer said Zithromax prescriptions fell because the flu
season was shorter this year than last, and total sales of all antibiotics
declined. Zithromax continues to gain market share, he said.
To make sure it does, Pfizer is working on two new formulations for children,
including one that would require only one dose to treat an ear infection
instead of five.
The company is also working on a clinical study that could create a huge new
market for the drug. The study, nicknamed the Wizard trial, is looking at
whether the antibiotic could become part of the treatment for heart disease,
the leading cause of death among Americans.
Mr. Steere said the study was an expensive, high-risk gamble. "But if we
win," he said, "we win big."
