Novartis Yanks Zelnorm and $85 million in Ads; Web Site Already Down

Novartis announced today that it was pulling Zelnorm from the market. The company noticed worrying incidents of heart attack and stroke, it says.

The anti-irritable bowel syndrome drug is best known for its ads featuring people's bare stomachs with pleas for help drawn on them. Novartis has wasted no time--even Zelnorm.com is currently showing "Error 404--Not Found." The company spent $85 million on consumer advertising for the brand last year, up from $62 million the year before.

The move punches a hole in Novartis's sales, Reuters reports: Revenues in 2006 were "$561 million, of which $488 million was in the United States, and [the brand] boasted growth rates of around 30 percent annually."

Novartis's press release on the subject is a masterpiece of diplomacy. It starts by noting that the FDA requested Zelnorm be yanked after reviewing the data. "A small (but not statistically significant) imbalance in cases of angina pectoris was recorded and included in the US label when Zelnorm was approved in 2002," Novartis says the FDA said.

"Not statistically insignificant"? In plain English: "Significant," am I right?* What does this mean?

Here are the actual numbers: "events occurred in 13 out of 11,614 patients treated with Zelnorm/Zelmac (0.11%), compared to one case in 7,031 placebo-treated patients (0.01%). All patients affected had pre-existing cardiovascular disease and/or CV risk factors."

OK, so that is a small number of people, but it is still an increase of incidents by a factor of 10. Multiply that across the entire patient base and that's a lot of lawsuits.

Note that "the affected patients had risk factors." Were they triple bypass patients or where they people who're merely carrying a couple of extra pounds? The release doesn't say.

"Give me something different," indeed!

*Typos by me, not Novartis. Apologies to Novartis for the error. But my point stands--a tenfold risk increase on a patient base in the hundreds of thousands or millions is either significant or it isn't.

Comments

[Joan Russo]

Dear Jim,

You are correct. I did the Fisher's Exact test, which calculates the probability of the 13 and the single folks given the sample size. The exact probability of that happening by chance is about .02. So about 2 in 100 times that would occur by chance alone and not the PHARMA.

So, it is STATISTICALLY SIGNIFICANT.

BTW - fisher's exact test.. is an exact p value.. not an estimate.

[Aaron]

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