THE FAUCI FILES, Vol 3( 83): Sesame Street NIH Science: Elmo, Max, Auggie, Bix ... and
Tony
August 28, 2000
Sesame
Street Medical Science:
Max the Zebra -- Auggie the Froggie -- Bix the Bullfrog
Medical Science Terminology for the New Millennium finally
gets down to what doctors really know best:
"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."
Dr Fauci, is Max really better than Auggie and Bix?
Ethics? Schmethics:
" At Pfizer and a growing number of other drug companies,
marketing executives, not scientists, are in charge."
"... 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 ...
Dr. Steele said that he disagreed with
the C.D.C. recommendations"
"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 issues arising from all drugs used for infectious disease are
certainly issues which directly fall upon the bureaucrat in
charge of the NIH National Institute of Allergy and
Infectious Disease, Dr. Anthony "Mussolini" Fauci. However,
these issues may have more to do with what Fauci has
failed to do in his critical position that has furthered the
the conversion of the FDA to paper tiger status during
the emergence of what has obviously become John
Wayne Gacy's clownish serial-killing dream of a
drug circus that best illustrates where doctors
actually DO get all their "science":
"...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."
Buyer beware ... of Elmo? ... or the FDA Paper Tiger:
"... 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.
But mommy, everybody's ELSE is doing it too:
"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."
And The Win-Win Wiz knows that university bribes and
bad science don't come cheap:
"... the Wizard trial, is looking at whether the antibiotic
could become part of the treatment for heart disease...
the study was an expensive, high-risk gamble.
"But if we win," he said, "we win big.""
Big Bucks for Armies of Big Schmucks
"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."
Once again, words to live by from the CDC's associate
diretor for global health, Dr. Scott Dowell:
"The industry is concerned about resistance, but
they need to sell their drugs."
Looks like the Centers for Disease Control has its priorities
in order, wouldn't you agree?
W. Fred Shaw, Editor
THE FAUCI FILES
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(excerpted)
New York Times, Sunday, August 27, 2000
What's Black and White and Sells Medicine?
By MELODY PETERSEN
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. In late 1998, Pfizer
donated a zebra to the San Francisco Zoo. The animal was
later named Max, just like the drug's mascot.
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.
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."
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."
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