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Vioxx, Celebrex Were Overused, Study Shows

3/4 of Users Had Little Need for Cox-2 Inhibitors

Jan 21, 2005 | WEBMD Celebrex and Vioxx were widely overused in the years before they were linked to heart attacks, researchers say.

Vioxx was pulled from the market last fall after a large clinical trial found that long-term use increased heart attack risk. Similar concerns have also been raised about two other pain relievers in the class known as Cox-2 inhibitors Celebrex and Bextra.

Cox-2 inhibitors are thought to carry a lower risk for potentially serious stomach problems, such as a bleeding ulcer. Because of this, they were widely considered to be a safer choice for arthritis sufferers and other people who take pain relievers regularly for chronic pain.

The use of Cox-2 inhibitors skyrocketed from the time Vioxx hit the market in 1999. But now researchers have found that this rise occurred largely in patients who had little risk of developing a bleeding stomach ulcer.

"We found a rapid nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history," says researcher G. Caleb Alexander, MD, MS, of the University of Chicago's MacLean Center for Clinical and Medical Ethics.

Striking Rise in Sales

Alexander and co-researcher Randall S. Stafford, MD, PhD, of Stanford University noted that the Cox-2 inhibitors have not been shown to be more effective for relieving pain than ibuprofen, naproxen, or any of the other older anti-inflammatory drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

But when Alexander and Stafford reviewed data from two large national surveys of physician practices, they found that almost three-quarters of the people prescribed Cox-2 inhibitors were at low risk for developing stomach problems. Only 2% of those prescribed Cox-2 inhibitors fell into the high-risk category, such as people with a previous stomach ulcer.

The drugs continued to gain popularity during the study period from 1999 to 2002.

In 1999, 35% of anti-inflammatory prescriptions were for a Cox-2 inhibitor. This rose to 61% by 2002. Among people at low risk of stomach problems, Cox-2 inhibitor use increased from 12% to 35%. The findings are reported in the Jan. 24 issue of Archives of Internal Medicine.

Vioxx Heavily Advertised

Just one year after the introduction of Vioxx and Celebrex, more patients were being prescribed Cox-2 drugs than standard NSAIDs, the researchers found.

In the case of Vioxx and the other Cox-2 inhibitors, Stafford says millions of people ended up paying 10 to 15 times as much for pain relief as they needed to and possibly exposed themselves to unnecessary risk.

In 2000, Vioxx was the most aggressively promoted drug on the market, with almost $161 million spent on direct-to-consumer advertising $15 million more than was spent to advertise Budweiser beer. During that year, sales of the drug rose from $326 million to $1.5 billion, according to government figures.

But the researchers believe aggressive marketing is just one of several explanations for the rapid rise of the Cox-2 inhibitors. Stafford tells WebMD that patients often want the newest drug and doctors also tend to believe that newer is better.

"Marketing reinforces this perception, but I think the perception has been there regardless of marketing," he says. "In light of the problems with the Cox-2s and with other drugs over the past few years, I do think there is a little more skepticism about newly introduced drugs than there has been."

Stafford has spent years studying prescription drug usage in the U.S. He says the tendency to abandon older drugs that work well in favor of newer drugs with very limited advantages has put patients at risk and cost the health care system billions.

In a report issued in 1999, a federal health group concluded that about 40% of the increases in prescription drug costs were due to the use of newer, more expensive drugs instead of older, cheaper ones.

Texas rheumatologist Scott Zashin, MD, who wrote the book Arthritis Without Pain, says one reason for the dramatic rise of the Cox-2 inhibitors is that doctors genuinely believed them to be safer than the older pain relievers.

"At first some physicians were saying that everyone should be taking these drugs," he says. "Especially older patients. It is not always easy to identify patients who are at risk for [stomach] complications, so the thinking was, 'Why take the risk?'"

Zashin says about half of his arthritis patients remain on Celebrex and the others have switched to a traditional NSAID.

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