Docs Not Immune to Sales Pitches: Med School to Teach How to Evaluate Drug Claims

By Tracy Wheeler, The Akron Beacon Journal, Ohio

Apr. 17–Neurontin was approved as an epilepsy drug in 1994.

But Warner-Lambert, the drug’s manufacturer, had bigger plans. So the company, according to the U.S. Justice Department, concocted a campaign to persuade doctors to prescribe the medication for a long list of unapproved and unproven uses — from attention deficit disorder to bipolar disorder, from migraines to restless leg syndrome.

The campaign worked.

By 2002, more than nine out of 10 patients on Neurontin were using it for something other than epilepsy. By 2004, the drug had attained blockbuster status, ringing up $2.7 billion in sales.

And none of this “success” would have been possible without doctors willing to write the prescriptions.

Now, the hope in medical circles is that doctors and pharmacists will begin to view drug company claims with a much more skeptical eye.

Attorneys general from states across the country last week announced the awarding of $9 million of grants “to educate health care professionals about pharmaceutical industry marketing practices and provide strategies for accessing unbiased sources of information about drugs.”

The $9 million is part of a $430 million fine paid by Pfizer — Warner-Lambert’s parent company — after Pfizer pleaded guilty in 2004 to illegally marketing Neurontin.

Local school gets grant

The Northeastern Ohio Universities College of Medicine is one of 24 institutions to win part of the grant and the only recipient in Ohio.

The medical school will use its $398,704 to improve curriculum for medical and pharmacy students, as well as train faculty who are practicing physicians and pharmacists. Clint Snyder, NEOUCOM’s associate dean for health profession education, said the training focus will be on how drugs are approved by the Food and Drug Administration and how to find evidence-based research on a drug.

Much of the new training will teach doctors and residents how to handle sales pitches from drug company representatives who visit hospitals and doctors’ offices to promote medications.

“One of the things we’re going to try to teach our students,” Snyder said, “is that what you see in academic, peer-reviewed journals is a more reliable source of information than the information from the person whose job it is to sell that drug.

“They need to understand that the makers of drug X will have information that makes drug X look good.”

The new curriculum will give medical students some tips on how to handle the sales pitches.

“Frequently, we don’t know how to say, ‘If you give me the information, I’ll read about it later,’ or the courage to say, ‘My understanding is this other treatment is more effective in this situation.’ “

Company’s stance

The Pharmaceutical Research and Manufacturers of America declined to comment on the Warner-Lambert settlement but said in a written statement from Senior Vice President Ken Johnson: “We have always believed that doctors should study different sources of information about medicines, including medical journals and other medical literature.

“At the same time, it would be a big mistake to discount or ignore information provided by sales representatives who work for the companies that spend 10 to 15 years developing each new drug. America’s pharmaceutical research companies have the most information about new treatments. Their researchers conduct extensive pre-clinical and clinical testing to comply with the strict standards of the Food and Drug Administration and generate thousands of pages of scientific data for each product.”

In the Warner-Lambert case, though, the company continued to promote Neurontin “when scientific studies had shown it was not effective,” the FDA said. In one case, the company promoted the drug as an effective treatment for bipolar disorder, even though a scientific study demonstrated that a placebo worked as well as or better than Neurontin.

In another case, Warner-Lambert pitched Neurontin as a stand-alone treatment for epileptic seizures, even though the FDA had already rejected that use.

Inaccurate claims

A 1995 study in the Journal of the American Medical Association looked at drug representations to doctors. Of 106 statements, 12 — or 11 percent — were inaccurate, always in favor of the drug. In each case, doctors failed to recognize the inaccuracies.

The drug industry spends about $22 billion each year promoting drugs directly to doctors.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said Warner-Lambert is just one example of a drug company pushing for profits over patients.

There are many examples of drug companies’ “overstating benefits and understating risks,” Wolfe said, “trying to convince doctors to do whatever is good for the company as opposed to what is best for the patients.”

And that’s what NEOUCOM and the other schools that got grants hope to warn doctors about.

“Ultimately, this is all aimed at how we improve patient outcomes,” Snyder said, “to get information accurately, timely and appropriately to patients.”

Tracy Wheeler can be reached at 330-996-3721 or tawheeler@thebeaconjournal.com.

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Copyright (c) 2006, The Akron Beacon Journal, Ohio

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