I can believe that 79-year-old Pfizer pitchman Bob Dole uses the impotence treatment Viagra. I have a harder time believing that 37-year-old baseball star Rafael Palmeiro does -- he denied use prior to accepting a $500,000 endorsement deal from Pfizer.

In any event, such amusing celebrity endorsements have helped make Pfizer a marketing powerhouse in the pharmaceutical industry. But not all of Pfizer's marketing is so entertaining.

Take, for example, Pfizer's embattled schizophrenia drug Geodon (ziprasidone).

The Food and Drug Administration last month sent a notice of violation to Pfizer citing the company for "misleading promotion" of Geodon, saying promotional materials made the medication seem safer than it really is.

The drug's label warns doctors to be alert for changes in heart rhythm. Researchers have reported that Geodon can prolong the time between heartbeats to cause a condition called "torsade de pointes" -- a heart arrhythmia that causes sudden death even in healthy people.

This isn't a new concern with Geodon. The FDA initially denied approval of Geodon and required Pfizer to conduct clinical trials designed to measure this potential problem. Following approval, the FDA required Pfizer to expand labeling to include the number and types of drugs contraindicated for Geodon users.

It's certainly not unusual for medications to have adverse side effects. That's a fundamental reason for requiring physician prescription of many medications.

But Pfizer seems to be hiding Geodon's risks from physicians.

Pfizer operated a promotion booth at last May's meeting of the American Psychiatric Association called the "Geodon Challenge," featuring a 12-question "knowledge test" for the drug.

In reviewing conference participants' answers to the quiz, the FDA stated, "Pfizer representatives minimized important risk information regarding the greater capacity of Geodon to cause [heartbeat] prolongation and the potential to cause sudden death."

It seems one of the Geodon Challenge questions stated, "Geodon has a well-characterized electrocardiogram profile with no torsade de pointes in clinical trials … no confirmed cases of torsade de points in postmarketing experience …" A Pfizer representative stated, "We have not seen the QT risk that the label talks about."

The FDA characterized these claims as "false and misleading" since the pre-marketing and post-marketing data are too limited to rule out the risk.

Two Pfizer brochures claim the drug has caused no torsade de pointes, a rare incidence of heartbeat interval problems and has a good electrocardiogram (ECG) profile.

But the FDA said it received "several spontaneous reports" of heart beat abnormalities and reports of unexplained sudden deaths among Geodon users.

Pfizer was also cited by the FDA for representing that Geodon "has antidepressant effects" even though Geodon is not approved for the treatment of depression.

Pfizer's aggressive marketing isn't limited to the U.S. The Association of the British Pharmaceutical Industry ruled that Pfizer employees breached the industry's code of conduct by promoting Geodon in the U.K. before the drug was approved by the British government.

Why is Pfizer marketing Geodon so aggressively?

Geodon was approved by the FDA in 2001 and was expected to reach $1 billion in annual sales by 2004. But sales are lagging behind that pace. Geodon only rang up $150 million in sales during 2001 and had only reached $128 million at the end of the third quarter of this year.

That $1 billion goal is looking somewhat elusive.

Analysts say Geodon's risks have caused some doctors to stick with older drugs such as Eli Lilly's & Co.'s top-selling schizophrenia drug, Zyprexa -- sales of which rose 31 percent to $3.1 billion in 2001.

Pfizer is already under investigation by 47 state attorneys general for illegally marketing the epilepsy drug Neurontin.

Allegations include illegal payments to physicians to allow sales representatives into examining rooms to meet with patients and recommend what medicines to prescribe, and influencing doctors to prescribe drugs for uses not approved by the FDA.

Pfizer denies any wrongdoing and says, "It is firm and established Pfizer policy not to allow our sales representatives to make inappropriate claims or encourage off-label use of our medicines."

If this is Pfizer's actual policy, it seems the company sales force needs a refresher course.

Steven Milloy is the publisher of JunkScience.com , an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).

 

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