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Behind the scenes: How a drug becomes a drug

Scientific studies are just one element of the long process that gets a new drug ready for market. Everything factors into a drug's debut, from the medicine's name to an awareness of the disease it treats.

By Victoria Stagg Elliott, amednews staff. Jan. 6, 2003.

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Advertisements for "Talk IBS," a campaign to inform women about a specific type of irritable bowel syndrome, appeared last month in major newspapers. The advertisements featured a celebrity -- Lynda Carter, television's Wonder Woman -- whose mother had the condition. The ads listed the condition's symptoms, with the tagline: Talk to your doctor.

In the marketing biz, this type of effort is known as "an unbranded educational campaign." "Talk IBS" is funded by Novartis Pharmaceuticals, in the hope that raised awareness of the disease will trigger an increased demand for their new drug, Zelnorm (tegaserod maleate). The medication, approved by the Food and Drug Administration this past summer, is the only treatment for the particular IBS variant targeted. Marketing geared to physicians started in September 2002. But name-specific advertising directed to consumers still won't start for months.

"We're the first product in a new category, so the market has to be educated," said Kurt Graves, senior vice president and general manager for U.S. commercial operations at Novartis. "Your first priority has to be to get physicians comfortable with the product. The second phase is raise awareness and educate consumers about the condition and ask them to go in to see their doctor to get diagnosed. If they are diagnosed with it, the doctor will see if there are any treatments that can help them."

Such efforts are a common practice within the pharmaceutical industry. The plan is usually put into action years before the drug is even approved. And it comes with a price tag in the millions, on top of the investment necessary to research and develop the drug scientifically. But doing it right can make an enormous difference in how the pharmaceutical is received.