Pfizer Rep Describes Pushing Zyvox With Flawed Data

(MoneyWatch)  Pfizer's $2.3 billion settlement of the off-label Bextra case overshadows another case wrapped into the agreement, that of Ronald Rainero, a former district manager at Pfizer in New York City, regarding the antibiotic Zyvox.

• Download the complaint here.

In the case, Rainero alleged that Pfizer pushed Zyvox off-label for use against all infections of the superbug MRSA. The company did this even though Zyvox costs eight times as much as vancomycin and even though catheter patients treated with Zyvox had an eight percent greater chance of dying than with another antibiotic.

A Pfizer representative said:

Pfizer denies all federal, state and qui tam allegations, with two exceptions. We acknowledge certain improper actions related to the past promotion of Bextra and Zyvox. Beyond those two exceptions we deny all federal and state and qui tam claims.

Rainero alleged Pfizer's promotion of inappropriate antibiotic use contributed to the accelerated resistance of MRSA to treatment with conventional antibiotics. (Read more about how the over-prescription of antibiotics has created resistant superbugs here.)

The icing on the cake: Pfizer did all this using flawed data, and then gave its sales reps scripts to use in debates with doctors in which the reps argued that the flawed data was the same kind of data that the FDA uses to make new drug approvals.

Zyvox is FDA-approved for treating certain MRSA skin and pneumonia infections, not all MRSA infections. Thus, per the suit:

... there is virtually no reason for Pfizer's sales representatives to make sales call promoting Zyvox upon dialysis centers, chemotherapy/cancer infusion centers and/or hospitals offering primarily chemotherapy services.

Nonetheless, Pfizer held a sales meeting in March 2007 at the Kingsmill Resort & Conference Center in Williamsburg, Va., titled "Selling in Cancer Centers," Rainero alleged.

In 2003, a study favoring Zyvox was published in the journal CHEST. It was based on a nonrandom retrospective subgroup analysis -- and was thus cherry-picked data that ignored the finding in the entire dataset, Rainero claimed.

An article in a 2004 edition of CHEST attacked the study, so Pfizer reps were given sales materials to rebut the attack. Part of the script read:

Subgroup analyses are frequently used to inform medical decisions and are often used as the basis for FDA approval of new agents and indications.

It's too complicated to explain here, but if you know anything about stats you'll recognize that this statement is nonsense. The FDA may take into account a subgroup analysis, but it certainly doesn't approve drugs based solely on such data.

Zyvox currently sells more than $500 million a year in revenues for Pfizer.

• Previous BNET coverage of Bextra:
• Pfizer's West Side Story: How "the Sharks" Sold Bextra Off-Label
• 10 Amazing Facts About Pfizer's $2.3B Bextra Settlement
• Pfizer Exec Gets 6 Months' Home Confinement for Off-Label Bextra Sales
• Pfizer's Off-Label Bextra Team Was Called "The Highlanders"
• Pfizer Exec: Company Approved of Off-Label Bextra Promotion
• Document Shows Rogue Bextra Operation Inside Pfizer
• Pfizer District Sales Manager Guilty of Altering Off-Label Celebrex Documents
• Federal Prosecutor Warns Drug Companies on Off-Label Promotion: "This Must Stop"
• How Pfizer Hid a $2.3 Bill. Bextra Settlement in Plain Sight