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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Anthony Wong who wrote (8202)9/7/1999 1:17:00 AM
From: The Ox  Read Replies (2) | Respond to of 9523
 
Pfizer Takes On Federal Guidelines

.c The Associated Press

By DAVID HO

WASHINGTON (AP) - Pharmaceutical giant Pfizer Inc. is trying to convince doctors the best drug for children's ear infections is not the cheap, proven antibiotic the government recommends, but Pfizer's own pricey product.

The Centers for Disease Control and Prevention said in January that amoxicillin should be doctors' first choice for treating ear infections, which account for 25 million visits to doctors' offices each year.

The CDC ranked Pfizer's competing Zithromax among other antibiotics that ``lack good evidence' for effectiveness against ear infections.

But the consumer advocacy group Public Citizen uncovered a schedule for Pfizer teleconferences targeted at doctors nationwide ``to counter the CDC guidelines.

``We urge you to inform the nation's pediatricians ... of this campaign so they are not duped into draining the Medicaid program of needed resources and of wasting large amounts of money on treating other patients with this needlessly expensive and second-rate drug for ear infections,' the advocacy group said in a letter to Health and Human Services Secretary Donna Shalala.

A Pfizer spokeswoman defended the campaign, saying the Food and Drug Administration had approved Zithromax for treating ear infections.

Consequently, ``everything we're doing is under the umbrella of what we're allowed to do according to the FDA,' said spokeswoman Mariann Caprino.

The CDC is ``just basically weighing in with yet another opinion,' she added, noting the agency's amoxicillin recommendation is not an official treatment guideline.

As for the Pfizer teleconference schedule, Caprino said ``it's not a corporate document that came down from on high' and it probably came from ``someone in one of our sales forces.'

Pfizer has aggressively promoted Zithromax to doctors and parents, including giving away the drug's beanbag mascot ``Max the Zebra.' Max lives on an Internet site called KidsEars, which tells parents to ask their doctors about Pfizer's drug.

Zithromax, which had $1 billion in sales in 1998, has become popular largely because it is only given once a day for five days. In comparison, amoxicillin is taken twice a day for 10 days.

A standard treatment of amoxicillin for a 22-pound baby costs less than $10, while Zithromax costs about $30.

The FDA approves the sale of U.S. drugs, but it almost never ranks one drug as better than another, leaving the decision to doctors and medical societies. Because choosing the best antibiotic for each infection is crucial - especially now that bacteria evolve to resist treatments -the CDC issued its recommendations.

The CDC said using higher doses of amoxicillin can overcome some resistant ear infections, but the same tactic doesn't work with Pfizer's Zithromax.

``We stand behind what we recommend in the guidelines, and it's not surprising that not everybody's happy about the recommendations that we made or that a company whose product was not in the first line recommendations isn't happy,' said Dr. Scott Dowell, the leading author of the CDC paper.

But, he noted, the CDC was making ``suggestions' and ``didn't have any intent of endorsing any specific commercial product or company.'

The bigger issue is which drug would best benefit children.

On May 18, Dr. Russell Steele, vice-chairman of pediatrics at Louisiana State University, hosted a Pfizer teleconference in which he questioned the effectiveness of amoxicillin against resistant infections and proposed using the family of antibiotics that includes Zithromax as a first choice.

Steele, who was paid by Pfizer for his presentation, said the CDC's suggestion of increasing the dose of amoxicillin to overcome resistant infections would be too expensive.

But a 1998 study concluded the Pfizer drug ``had an unacceptably high failure rate,' said study author Dr. Candice Johnson of Children's Hospital in Denver.

In that study, Augmentin, which combines the antibiotics amoxicillin and clavulanate, wiped out children's ear infections 83 percent of the time, while Zithromax only worked in 49 percent.

``I've been involved in studies of this sort for about twenty years and this is the lowest rate I've ever seen for an antibiotic,' Johnson said.

Steele countered that when the study tested one of the most common types of bacteria that causes ear infections, the differences between the two drugs were too small to be significant.

Praising the CDC for providing guidance, Johnson said, ``It's been a very confusing thing for the average doctor and practice to know what drug to use.

(PROFILE (CO:Pfizer Inc; TS:PFE; IG:DRG;)

AP-NY-09-06-99 1431EDT

Copyright 1999 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without prior written authority of The Associated Press.