09/30/04 — Vioxx recall surprises Wayne doctors

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Vioxx recall surprises Wayne doctors

By Staff and Wire
Published in News on September 30, 2004 2:03 PM

From staff and AP reports

Pharmaceutical giant Merck & Co. is pulling its blockbuster arthritis drug Vioxx from the market worldwide, because new data from a clinical trial found an increased risk of heart attack and stroke.

Some doctors in Wayne County who have prescribed the drug said they were caught off guard by the announcement.

Merck's stock price plunged more than 25 percent as the company said the recall would hurt its earnings.

Merck said today that data from the trial showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx.

The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. Such polyps can turn cancerous. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.

"It's a disaster for Merck, coming at the worst time," said independent health care analyst Hemant Shah of HKS & Co. in Warren, N.J.

Vioxx is one of Merck's most important drugs, with $2.5 billion in sales in 2003. But sales dipped 18 percent in the second quarter of this year to $653 million, partly due to increasing concerns about the drug's safety.

Dr. William DeAroujo of Goldsboro Orthopaedic Associates said he learned about it this morning watching CNN as he waited to perform surgery.

"The drug companies told us nothing," he said. "This has all hit us like a brick, so to speak."

DeAroujo said there has been more data over the last six months about side effects of Vioxx, but representatives from the drug companies had always been reassuring that as long as the patient did not have cardiac risk factors, it was safe to use.

"We were told that if a patient had cardiac risk factors, as long as they were taking an aspirin a day, it was safe," he said.

In today's market with the health plans, DeAroujo said that cox-2 inhibitors prescribed for arthritis, which include Vioxx, Celebrex and Bextra, are often cost-prohibitive and cannot be prescribed.

They are also not necessarily the first choice anyway, he said.

"They're never a primary drug that we use, but they have gained so much popularity for people."

DeAroujo said his initial recommendation is always the basics, Tylenol for pain or something like Alleve as an anti-inflammatory. After those, if the patient had no risk factors, he said he would go to the cox-2 inhibitors if the patient had no risk factors.

He said he expects his office will receive a lot of phone calls from patients regarding the recall.

"If they call in, we'll stop it and offer one of the other cox inhibitors," he said. "We'll probably have to look at their history and see what they can safely switch to."

The News-Argus also called Dr. Clark Gaither of Goldsboro Family Physicians and the medical director for the WATCH program, which caters to a large number of elderly patients for whom Vioxx has been prescribed.

Through his office staff, Gaither said he had not been contacted in advance of the recall and could not comment on the possible ramifications.

"We're taking this action because we believe it best serves the interest of patients," Ray V. Gilmartin, Merck's chairman, president and chief executive, said in a prepared statement.

"Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."

Merck, the world's third-biggest drug maker, announced the news before the stock market opened. In early trading on the New York Stock Exchange, Merck shares plunged $11.40, or more than 25 percent, to $33.67.

The analyst Shah said the withdrawal of Vioxx comes "at a time when they really need to get ready for expiration" of its patent for Zocor, a high cholesterol drug which is Merck's top-selling drug. Zocor loses patent protection early in 2006 and sales are expected to plunge when generic competition begins. In an effort to replace those revenues, Merck recently launched a drug with partner Schering-Plough Corp., Vytorin, that combines Zocor and Schering-Plough's Zetia to attack cholesterol levels in two complementary ways.

"This makes it almost inevitable for the company to find a merger partner for them to continue to grow," Shah said.

Merck's announcement stands to benefit rival Pfizer Inc., the world's biggest drug maker. The two companies have been battling for market share, with Pfizer's Celebrex dominating the market with about $5 billion in U.S. sales alone last year. Pfizer shares were up 68 cents, or more than 2 percent, to $30.86 in early trading on the NYSE.

"I think Celebrex sales are going to significantly increase," Shah said.

Vioxx, launched in the United States in 1999, and a successor drug called Arcoxia, approved in some other countries and awaiting Food and Drug Administration approval here, are part of a class of anti-inflammatory drugs heavily touted by the pharmaceutical industry as being more effective and having less side effects, particularly on the gastrointestinal system, than older drugs.

Pfizer's Celebrex and its successor drug, Bextra, which already is on the market in the United States, also are in that class, called cox-2 inhibitors.

"This has never been the massive innovation which was promoted to be," Shah said of the drug class. "In terms of pain relief, these drugs are no better than ibuprofen and they cost 10, 15 times more."

He said it is possible the news, along with some prior reports about heart risk and gastrointestinal bleeding linked to the drugs, could push some patients to go back to older, cheaper drugs.

Shah also said physicians prefer ibuprofen more than Celebrex and Vioxx combined.

The company said the Vioxx recall will slash about 50 cents to 60 cents a share from its earnings for the rest of this year. That includes foregone sales, writeoffs of inventory held by Merck, customer returns of product previously sold and other costs of the pullback. Merck expects foregone fourth quarter sales of Vioxx of $700 million to $750 million alone.

Merck, which is based in Whitehouse Station, N.J., had previously been expecting 2004 earnings per share of $3.11 to $3.17.