Pain, Pain Go Away Is Celebrex--the new arthritis drug--all it's cracked up to be?
By Andrea Rock

(MONEY Magazine) – As many of America's 23 million arthritis sufferers know all too well, the pills that provide welcome relief from joint pain and inflammation may, over time, also cause stomach trouble, ranging from occasional heartburn to fatal intestinal bleeding. These aspirinlike drugs, known as nonsteroidal anti-inflammatory drugs (NSAIDs), are sold over the counter under such brand names as Aleve and Motrin and in more than 40 prescription-only varieties. All told, about 33 million Americans swallow nearly $2 billion worth of prescription NSAIDs each year.

That's why there's been so much excitement about Celebrex, a new drug that's supposed to offer NSAIDs' benefits without their risks to the digestive tract. Along with Vioxx, a similar drug that's expected to hit the market this summer, Celebrex has been the talk of Wall Street drug analysts since 1996; investors bid up Monsanto (whose G.D. Searle unit developed Celebrex) and Merck (developers of Vioxx) on the assumption that the drugs would revolutionize arthritis treatment--and consequently sell like gangbusters.

The glowing advance publicity paid off. In its first three weeks on the market this past January, pharmacists filled 55,654 prescriptions for Celebrex, making it second only to Viagra as the most successful drug launch ever. So how does this new drug stack up against the alternatives?

The first issue: price

Before Celebrex made its debut, health plans warned about its expense, and some went so far as to charge a high co-payment to discourage overuse. It turns out they overstated the case. For consumers who pay for their own prescriptions, Celebrex costs around $67 a month--nearly 10 times as much as prescription-strength ibuprofen but in the same range as the popular prescription NSAIDs Relafen and Etodolac (the generic form of Lodine). All three more-established medications cause fewer severe stomach problems than many other arthritis drugs, according to a federally funded research program known as Arthritis Rheumatism and Aging Medical Information System (ARAMIS), which has monitored patients on various arthritis drugs since 1978 (see the information in the table). Data on Celebrex are not yet available from the ARAMIS program.

Many NSAID users don't take the drugs alone, however. If you need to take a stomach medication like Cytotec (about $100 a month) or Prilosec (about $160) along with NSAIDs, switching to Celebrex would actually save money, so long as you could discontinue the stomach drug. And Celebrex is less expensive than a few arthritis drugs, including Daypro, which costs about $81 a month, yet has a relatively high gastrointestinal complication rate, according to ARAMIS data.

The second issue: safety

Celebrex is no more effective than its competitors at fighting pain and inflammation--results for all of these drugs tend to vary among individuals. So the primary justification for switching to Celebrex--especially if you'll have to pay a premium--would be that it's a safer choice. But how much safer is it really?

The story behind the publicity is complex. Traditional NSAIDs block an enzyme called cyclo-oxygenase or COX, which scientists once identified as a cause of arthritis inflammation and pain. Then, in 1991, researchers discovered that there were two types of this enzyme: COX-2, which triggers inflammation, and COX-1, which seems to protect the stomach lining. In theory, a drug that blocked COX-2 without affecting COX-1 could alleviate aches and pains without damaging the digestive tract. Celebrex, Vioxx and similar drugs that are still in the pipeline are all designed to fit that profile. As a result, drugmakers are attempting to market them as a new class of drugs called COX-2 inhibitors.

Although the new COX-2 drugs offer great promise, the definitive answer on whether they cause fewer gastrointestinal complications is not in yet. The data that Searle's researchers submitted to the U.S. Food and Drug Administration came primarily from endoscope tests, in which patients' stomachs were examined visually for signs of ulcers after three months on the drug. The researchers found that between 7% and 7.5% of Celebrex users had visible ulcers, compared with 9.7% on Diclofenac, 23.3% on ibuprofen and 34.6% on Naproxen.

While these results are promising, the FDA said that to prove Celebrex's relative safety, Searle would have to do more studies. In the meantime, Celebrex's label must carry a warning about bleeding, ulcerations and perforation of the stomach or intestines, just as traditional NSAID labels do.

If you have been taking anti-inflammatories without problems, bear in mind that the longer you take them, the greater your risk of developing gastrointestinal complications, most of which occur without warning. Each year, 103,000 people are hospitalized and 16,500 die because of ulcers, internal bleeding and other NSAID side effects, says Gurkirpal Singh, director of the ARAMIS surveillance program. Even those who use NSAIDs short-term--say, after dental surgery--may experience serious side effects. Among the people most at risk are those who are 65 or older, have ever had an ulcer or gastrointestinal bleeding or take blood thinners or prednisone, a steroid, along with NSAIDs. Any of these risk factors could make you a Celebrex candidate, according to Steven Abramson, chairman of rheumatology at the Hospital for Joint Diseases in New York City.

Until more data are available, even Thomas Schnitzer, a Northwestern University professor who conducted clinical trials on the drugs for Searle and Merck, says Celebrex isn't necessary for all arthritics. Says Schnitzer: "If I had a 40-year-old patient taking generic ibuprofen, I'd see no reason to switch to Celebrex. But I would switch a 70-year-old patient simply because the risk of gastrointestinal bleeding is significantly higher."