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What's Black and White and Sells Medicine? (New York Times, 8/27/00)

 

> What's Black and White and Sells Medicine?

>

> August 27, 2000

> 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.

>

> "Direct-to-consumer advertising is a good thing," he said. "We

> get more complaints about our ads from politicians than

> consumers."

>

>

> 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.

>

>

>

> 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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