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

===
(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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