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Zelnorm, a drug that was approve ...

Posted Oct 30 2008 3:21pm

Zelnorm TV ad image

Zelnorm, a drug that was approved in 2002 for short-term treatment of women with “irritable bowel syndrome” and in 2004 for chronic constipation for men and women under age 65, was withdrawn from the market in March 2007 after studies showed an increased risk of heart attacks and heart problems.

Zelnorm was also very aggressively advertised and promoted, particularly through infamous TV ads showing people with wavy lines and messages written on their stomachs. These ads, and the overall promotional campaign of which they were a part, didn’t just market Zelnorm — they also marketed “Irritable Bowel Syndrome” (IBS) as a condition, working to convince millions of viewers that they have “IBS,” rather than more conventional occasional and symptomatic digestive problems.

By the time Novartis voluntarily withdrew Zelnorm from the market in March 2007, millions of people had taken it, and certainly many who did not truly have IBS or chronic constipation. Novartis racked up $560 million in Zelnorm U.S. sales in 2006 - not technically a “blockbuster” (a term reserved for drugs with at least $1 billion in annual sales), but not too shabby either. As Ed Silverman at Pharmalot pointed out back in March:

The review showed that only 0.1 percent of 11,600 Zelnorm patients, or 13 people, experienced serious heart problems; one died. Of 7,000 placebo patients, 0.01 percent of the patients, or just one person, reported cardiovascular problems. In medical terms, the absolute risk of a serious problem was small, but the relative risk was high.

More than 2.6 million prescriptions were written for Zelnorm in 2006. If the 0.1 percent rate of patients holds true, that would mean that 2,600 of those 2.6 million had heart problems. It’s likely that, due to the aggressive advertising, a significant portion of those 2.6 million did not in fact have IBS. These patients were thus unnecessarily exposed to this heart attack risk - a risk that may be small, but even a small unnecessary risk is still unnecessary. This week, the FDA permitted Zelnorm to return to the market under a very restricted program. The FDA’s press release described it:

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.

In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.

In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.

For this population, the benefits of Zelnorm may outweigh the risks. But the aggressive ad campaign resulted in millions of people taking it for whom the benefits most certainly did not outweigh the risks.

And therein lies one of the main problems with Direct to Consumer Advertising of drugs: Drugs that may be important for a small subset of patients are instead marketed to all consumers, causing many people who don’t need the drug to ask their doctors for prescriptions for it, and for their doctors to prescribe them. By the time side effects that only surface after the drug has been on the market for several years have finally surfaced, millions of people who didn’t need the drug have taken it, and been exposed to that unnecessary risk (not to mention expense).

Vioxx is the most famous example of this. More than 20 million people took it, despite the fact that only 1-2% were actually at risk of the ulcers and gastric complications that Vioxx was designed to prevent. Vioxx was never any better at pain relief than pennies-a-pill over-the-counter ibuprofen. Its only advantage was a (somewhat) lower risk of gastrointestinal problems. But the majority of the 20 million people who took it did so not because they had ulcers, but because they saw the ads featuring Dorothy Hammill skating again after taking Vioxx.

One change that some have pushed to deal with this is to require a delay or moratorium on drug advertising for some period of time after a drug is approved. Provisions to require this were originally in the Congressional bills to reauthorize the Prescription Drug User Fee Act (PDUFA), but did not make it into the final House and Senate versions. PhRMA’s “Guiding Principles on Direct to Consumer Advertisements” call for companies to voluntarily wait an unspecified “appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign.”

Delays and moratoria might reduce the number of people who are exposed to such side effects, but they don’t address the core problems of DTCA in encouraging people who don’t need expensive and potentially hazardous brand-name prescription drugs to take them. Every other country by the U.S. and New Zealand has concluded that advertising prescription drugs directly to the public just doesn’t make sense, and thus don’t allow them. There’s no doubt that in the more than 50 other countries where Zelnorm is or was sold but without advertising, the number of people who took it, and who had heart problems as a result, was much lower.

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