Merck Statement on Zetia Mess Is a Masterpiece of Spin

You might be forgiven for thinking that Abbott Labs (ABT)’s Niaspan trounced Merck (MRK)’s Zetia in a trial known as “Arbiter 6 HALTS,” if you read the headlines today (FiercePharma has a guide here).

If you think the results of the trial — correctly guessed long ago by analysts, as BNET noted in July — show that Niaspan (niacin) is better at reducing carotid artery thickness than Zetia (and by extension Merck’s other cholesterol pill, Vytorin, which also uses Zetia), you’d be wrong — according to Merck.

Merck put out a fascinating press release Sunday to explain why everyone but Merck misunderstands the data. Arbiter 6 is small, biased, and subject to “misinterpretation,” and “limitations,” Merck says. Patients should ignore the man behind the curtain all the fuss and “continue taking their medication,” the company says. Here’s the release, coupled with some commentary:

Merck Expresses Confidence in the Efficacy and Safety Profiles of ZETIA® (ezetimibe) and VYTORIN® (ezetimibe/simvastatin) as Effective Medicines for Managing Elevated Cholesterol

You thought this study was negative for Zetia? Wrong! Zetia’s efficacy is effective, the headline clearly says.

[Merck] issued the following comment in response to misinterpretation of results from a small 200-patient imaging study called ARBITER 6.

“Nothing from this study, which a New England Journal of Medicine editorial says has ’several limitations,’ changes the well established understanding that lowering LDL cholesterol is the primary target of therapy according to the guidelines. ZETIA and VYTORIN, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol,” said [Peter S. Kim, Ph.D., president, Merck Research Laboratories.] “We encourage patients to continue taking their medication as prescribed by their physicians, and of course to speak to their physician if they have concerns.”

Got that? This is nothing to do with cholesterol! Stop thinking about artery thickness!

The results of ARBITER 6 were widely predicted because the study design favored niacin as the patient population selected had well-controlled LDL cholesterol and relatively low HDL cholesterol. Also, it is important to remember that ARBITER 6 is not an outcomes study, and does not have the rigor or size to provide meaningful insight into the effect of either niacin or ezetimibe on clinical outcomes.

You might think this is the most-anticipated Zetia study since the last one, but it’s not. It’s biased in favor of niacin so there’s no “meaningful insight” here — move along!

“Any suggestion that the results of ARBITER 6 can definitively answer the question of the impact of ezetimibe on cardiovascular outcomes or that its results have implications for clinical use should be met with skepticism,” said Dr. Kim. “Given the broadly accepted, scientifically validated importance of lowering LDL and the millions of people in the United States alone who are not at their recommended treatment goals, VYTORIN and ZETIA remain effective options for physicians to treat their appropriate patients.”

Skepticism! Don’t believe the hype! The rest of the release concentrates on lowering cholesterol, even though the study is about artery thickness:

“No other health care company is doing more to study cardiovascular disease than today’s Merck,” said Dr. Kim.

That’s probably true. With results like these, the FDA refusing to even look at Merck’s new cholesterol stuff, and two huge cholesterol pill franchises on the demise, it would have to be.

• Previously:
• Amateur Hour at Merck: FDA Refuses to Look at Zetia-Lipitor Combo Pill
• The New Merck, Day 1: a Catalog of Impending Doom
• Leerink Outlines Gloom Potential for Merck/Schering’s $2B Zetia Franchise
• Leerink Bets Abbott’s Niaspan Beat Merck/Schering’s Zetia in Mystery Trial
• Abbott Q2: Niaspan Sales Are a Bright Spot in a Lumpy Quarter
• UPDATED: Why Zetia Researchers’ Silence on Ending of Niaspan Trial Is Unfair to Merck