Why the Courts Should Know What Pharmaceutical Reps Tell Doctors

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Houston, TXThe story of the drug Vioxx speaks volumes about the way drug companies market their products to consumers and to the doctors that ultimately prescribe those drugs.

In 2005, a year after Merck withdrew its anti-inflammatory drug, Vioxx, from the market because of its four-fold link to heart attack and stroke, a government committee in Washington asked some pointed questions about what pharmaceutical representatives told physicians about Vioxx and its possible dangers to patients.

The answers offered a tiny but powerful peek into the world of pharmaceutical sales. The pages and pages of testimony revealed the aggressive and deceptive sales tactics Merck pharmaceutical representatives used to soft-pedal Vioxx and its risks to doctors and dodge questions about side effects listed on the Vioxx label.

“The pharmaceutical representative’s oral description of a drug in the physician’s office is often a highly selective version of the complete warning information that appears on the label,” offers Katherine Vukadin, a professor from the Thurgood Marshall School of Law at Texas Southern University in Houston.

In a comprehensive research paper on the role of pharmaceutical representatives and marketing tactics with respect to “failure to warn” pharmaceutical litigation, Vukadin has brought together an impressive collection of current research on drug marketing and offers an important point of view for consumer and lawyers litigating dangerous cases.

“These things do influence physicians,” Vukadin told LAS. “Not because physicians are trying to do anything improper. The physicians often don’t have time to read and they will get a summary of the package insert from the pharmaceutical representative. Plus the rep will give them a lot of reasons why they should disregard the package insert or the warnings in it.”

As many as 100,000 deaths a year in the US are due to side effects caused by drugs. Thousands more suffer some type of permanent injury. However, if the drug company lawyers can show that there was a warning on the packaging and that a consumer ought to have known there was risk, the case is quickly dismissed.

“The package insert is not the only warning information reaching physicians,” Vukadin writes. “So the package insert should not be the sole focus in a failure-to-warn case.

“Judges should consider a broader universe of warning information. Yes, bringing in more evidence about marketing,” says Vukadin.

Professor Vukadin argues that it’s time for judges to “face up to pharmaceutical marketing’s potent role in many prescribing decisions. Courts assessing a warning’s adequacy cannot stop at the package insert.”

The FDA spends a lot of time and effort carefully vetting the drug warnings, but the drug companies spend even more time and money on ways to manage that information.

Pharmaceutical representatives make 115 million visits every year to 340,000 doctors. Drug manufacturers spend $27 billion a year on marketing, according to recent statistics. That’s twice as much as they spend on research.

“We know that pharmaceutical companies study human behavior and psychology very carefully,” says Vukadin. “They study individual physicians to see what works and doesn’t work with individual physicians. So there is a very high level of sophistication (on the part of the drug companies) that people may not be aware of - it’s a huge part of their marketing.”

The FDA can reprimand drug companies for presenting “one-sided information” about medications. However, it has no power to do anything other than write them a letter. There’s literally nothing to stop drug companies from trying to use one-on-one influence to mitigate warnings.

And so for now, judges and juries have no way to know if or how the dangers were downplayed to doctors and patients.

Professor Vukadin’s paper will be published later this year.

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