Merck attacks Italian critic of cholesterol fighter Zetia, then backs off

In February and again in May, Merck ($MRK) sent a cease-and-desist order to Alberto Donzelli, head of education, appropriateness, and evidence-based medicine at Milan's public health authority. Donzelli had openly criticized Merck's cholesterol-lowering drug Ezetrol (ezetimibe), which is sold in the U.S. as Zetia. After analyzing data, he concluded the drug shouldn't be prescribed in combination with statins--advice he circulated to general practitioners in Italy and that he voiced on the web. Now the company is doing an about-face.

The company says it regrets threatening Donzelli and won't be pursuing any legal action against the Italian health authority. "Merck is committed to the open and transparent exchange of scientific information," a company spokesman told Forbes. "We believe this to be an isolated incident in Italy and regret how it was handled by our company."

Merck's mea culpa came just a few days after the British Medical Journal published an account of the six-month long tussle between the company and Donzelli. In Merck's second letter, the company threatened to go to court unless Donzelli stopped the "seriously damaging activity, [that was] tarnishing the company's and the drug's image and reputation," according to the BMJ. Donzelli removed some of his criticisms of the drug from his website in mid-June, saying he would bow to the company's demands "until the issue is further clarified within the scientific community."

Donzelli is far from the first critic to raise questions about Zetia, and in particular its usefulness and safety when combined with statins. When Merck was developing Vytorin--a combination of Zetia and its statin Zocor (simvastatin), the company came under fire for trying to change the primary endpoint of a failed Phase III study. Last year, Merck paid $688 million to settle two securities fraud lawsuits related to the study.

Shortly thereafter, Wall Street cheered when Merck got the go-ahead from an independent safety board to continue IMPROVE-IT, a high-profile study meant to show if Vytorin is better than Zocor alone at preventing heart attacks and related deaths. That study will end this September. And last May, Merck won FDA approval to market a combination of Zetia and Pfizer's ($PFE) now-generic blockbuster statin Lipitor (atorvastatin).

Merck certainly has good reason to continue to defend Zetia: The drug, both by itself and in combination, hauled in $5.6 billion in sales last year. But it's facing some fierce competition from statins, which continue to outsell other cholesterol drug types. In the five years ended in 2012, statin prescriptions grew 17% to 214 million a year, while scripts for other cholesterol remedies fell 28% to 50 million. Drugs like Zetia are further threatened by recently revised cholesterol guidelines from the American Heart Association, which strongly favor statins over other choices.

As for Italy's Donzelli, he's now free to openly voice his opinions about Zetia, Merck tells Forbes.

- here's the BMJ story
- read more at Forbes