What was Merck thinking -I bet it was money!
do they really care if the drugs harm us or kill us??




Pharmaceuticals
What Was Merck Thinking?
Matthew Herper, 04.13.07, 10:45 AM ET


Merck's earnings are surging, and it keeps winning battles related to Vioxx lawsuits. So why did the company bother with the quixotic effort to get its Vioxx sequel, Arcoxia, approved, especially at the risk of further tarnishing its image?

Merck kept insisting that its attempt to get approved its painkiller Arcoxia, designed years ago as a follow-up to the then-successful Vioxx, at least had a chance. But when a panel of outside experts convened by the Food and Drug Administration voted on whether Arcoxia deserved to be sold in the U.S., it delivered a resounding "No." The final tally: 20 to 1 against the pill.

In hindsight, Merck's decision to ask the FDA to even consider Arcoxia is baffling. The original FDA application for Arcoxia was pulled in 2002. Two years later, Merck decided to yank Vioxx from the market because it increased the risk of heart attacks and strokes. Arcoxia eases inflammation. Like Vioxx, it was designed to do so while causing fewer ulcers than older drugs, but those benefits are in question.

Merck decided to push forward with Arcoxia after the results of a big study comparing its cardiovascular risk with Voltaren, or diclofenac, from Novartis. But even as those results were released, it was pretty evident that study wouldn't satisfy Merck's critics. They were out in force poking holes in the results even before the study emerged.

The fact that Merck pushed forward despite criticism had some critics nervous. In an interview before the panel met, Steven Nissen of the Cleveland Clinic, one of the more prominent Vioxx critics, worried that there weren't enough cardiovascular experts on the FDA's 21-person panel.

Warren Wexelman, of Maimonides Medical Center in Brooklyn, banned Vioxx at his institution before it was withdrawn; he was unconvinced by Arcoxia. "Why should I think Arcoxia is any safer than Vioxx coming from the same group of people?" Wexelman asks.

By pressing the issue, Merck aroused all the drug safety concerns it had previously raised by withdrawing Vioxx, just as Congress is starting to talk about reforming the drug safety system at the FDA. The Arcoxia decision has probably made it more difficult for any new pain drug to be approved. There are 20 other arthritis pills already available, including ibuprofen, naproxen and diclofenac. Now the FDA and one of its panels have delivered the charge that new drugs must be better or safer than these old options.

That doesn't bode well for Novartis, which is hoping to launch its Prexige in the U.S. someday, or indeed for any new arthritis pain treatment. This is emblematic of the drug industry's larger problem: It is getting increasingly hard to invent new treatments for conditions like high blood pressure or arthritis pain, where the pills we have are pretty good.

"We've moved a long way from the era when the bias was to approve even when there were questions of safety," says Nissen. "It's getting harder and harder to find new drugs that are clean. The easy new drugs to develop have been developed."

The FDA's new message: just providing another option is no longer good enough. This way of thinking could even raise problems for Pfizer, which is currently running ads emphasizing that its Celebrex shares the same safety labeling as other, older arthritis medicines. Some experts argue the drugs are not alike; naproxen, for instance, seems to be safer for the heart than other options.

With Arcoxia, Merck is failing to get its own new drug approved while at the same time dredging up all the bad feelings that came from Vioxx. What is especially strange about this is that, in other ways, Merck is doing great.

Its sales keep beating Wall Street expectations. Last night, after the Arcoxia ruling came in, Merck raised its earnings outlook for the year by 10 cents, to between $2.75 to $2.85 per share, excluding items. The main reason seems to be cost restructuring and the success of diabetes drug Januvia and cervical cancer preventative Gardasil.

On the news, Goldman Sachs raised its rating on Merck from "sell" to "neutral." Analyst James Kelly noted that Merck has dealt with big patent expirations "in a superior manner to other industry participants."

And Merck keeps winning Vioxx cases. It has a winning record in court and has gotten thousands of cases dismissed. This morning, the company said that a New Jersey judge had dismissed a much-watched case filed by investors against the company. Merck still faces tens of thousands of suits, and it is far from out of the woods. But so far, so good.

So why did this company, which had better things to do, press forward with Arcoxia? Merck says it thinks the drug represents a good option for patients, and it will continue to sell it in the rest of the world.

Shares of Merck were up more than 7.6% to almost $50 in early trading this morning.