Boston.com THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

Backed by study, Pfizer intensifies Lipitor pitch

WASHINGTON -- Pfizer Inc. , the world's largest drug company, is using the results of a study it sponsored to persuade doctors to switch patients to pricier doses of its blockbuster drug, Lipitor . And according to the latest sales figures, the marketing pitch is working.

Lipitor is the most valuable jewel in Pfizer's crown. More than 79 million prescriptions for the cholesterol-lowering statin were filled by Americans last year, accounting for $8.4 billion in US sales, according to IMS Health , a healthcare information company.

But it faces stiff competition from less expensive generics, especially the version of Zocor sold by Teva Pharmaceuticals Industries Ltd . Zocor, made by Merck & Co., was the nation's second-leading prescription drug last year, with $4.4 billion in sales.

Pfizer has a simple strategy for maintaining market share: The company has sent thousands of sales representatives to doctors' offices to convince them that higher doses of Lipitor are more effective than generic statins in protecting patients' hearts. In particular, the sales reps point to a Pfizer-sponsored study that said Lipitor in high doses reduces the chance that stroke survivors will be stricken again.

``It's been part of our strategy that we ought to be encouraging physicians to move their patients to the higher doses," Peter Brandt , Pfizer's newly promoted leader of US pharmaceuticals, told analysts in a recent call.

Pfizer also makes more money from higher doses of Lipitor. A 10 milligram Lipitor pill costs $2.44 . The 40 milligram and 80 milligram doses cost $3.33 apiece.

For the week ending Aug. 18 , prescriptions for higher doses of Lipitor jumped 12 percent , according to John Boris , a Bear Stearns analyst, promising a 2 percent revenue increase for Lipitor for the third quarter .

The Pfizer-sponsored study on Lipitor's impact on stroke was written by 11 authors who were either company employees or reported financial ties to it. The New England Journal of Medicine article linked daily , 80 milligram Lipitor doses with a 16 percent reduction in the risk of a repeat stroke.

An editorial, also published last month in the journal, could provide another driver for Lipitor revenue growth. The study adds to ``gathering momentum" that could convince insurers to count statin use as a measure of ``quality" after-stroke care, according to the editorial. Dr. David M. Kent , the editorial's author, reported receiving grant support from Pfizer .

Dr. Alice Jacobs , a Boston University professor of medicine and past president of the American Heart Association , said such changes to stroke guidelines do not happen quickly and are not guaranteed by publication of a single study.

But Kent, an assistant professor of medicine at Tufts New England Medical Center in Boston , said doctors already are moving some stroke patients to high-dose statins. Pfizer's marketing push for Lipitor ``very well might" accelerate the shift, he said, and physicians uncertain about which dose or statin to prescribe could look to the results of the Pfizer-sponsored trial ``for guidance."

Such industry-sponsored trials, however, are biased toward the sponsor's drug, said Dr. John Abramson , a clinical instructor at Harvard Medical School and author of ``Overdosed America." By using tactics like enrolling younger, healthier people than typical stroke patients, they can make a drug look safer than it is, he said.

Exercise , lowering high blood pressure, and stopping smoking more dramatically lower stroke risks than taking a higher dose of Lipitor, Abramson said.

``Because this is a drug company-sponsored study, what we're seeing is just a tunnel vision of the effect of high-dose Lipitor on stroke," he said.

Dr. Larry B. Goldstein , director of the Duke Center for Cerebrovascular Disease and a co-author of the study, said safeguards -- such as using independent scientists to supervise the study's design and analyze findings -- shielded the science from Pfizer's influence.

``One could make the same criticism or argument, or concern about any study that is sponsored by a pharmaceutical company," said Goldstein, who reported receiving consulting fees from nine medical device or drug companies, including Pfizer .

Even before the recent Pfizer study results were published, Lipitor already had a camp of medical heavyweights in its corner.

This summer, the American Heart Association and the American College of Cardiology recommended doctors reduce heart patients' levels of bad cholesterol to even lower levels. Pfizer quickly seized on the sales opportunity.

``You just can't get there" with a generic statin other than Lipitor, Hank McKinnell, Pfizer's chief executive at the time, told analysts. The new guidelines are ``going to change this market in quite a profound way," he said.

Meanwhile, in Massachusetts , the Group Insurance Commission -- which provides health insurance for nearly 130,000 state employees -- isn't quite buying the ``more Lipitor" campaign. It's promoting generic versions of cholesterol-lowering drugs as a way to cut healthcare costs.

High-dose Lipitor has ``proven to be very effective," said Bob Carey , a commission spokesman. ``But the vast majority of people don't need that megadose."

As an incentive to get state employees to choose generic Zocor, the commission has doubled the copayment for Lipitor, to $40 from $20.

At the end of last year -- when Lipitor cost $110 for a month's supply -- 67 percent of statin prescriptions filled through the state insurance plan were for Lipitor .

By the end of this July -- when the generic version of Zocor sold for roughly $80 for a 30-day supply -- Lipitor accounted for only 30 percent of prescriptions filled. Twenty-nine percent of state employees and retirees filling statin prescriptions picked generic Zocor and its lower copay.

Diedtra Henderson can be reached at dhenderson@globe.com.  

© Copyright 2006 The New York Times Company