What’s next for pain?

Last Sept. 30, pharmaceutical giant Merck & Co. voluntarily pulled its popular pain medication Vioxx off the shelves when a study on its effects on cancer patients revealed the drug, used by an estimated 2 million Americans, increased the chance of heart attack and stroke.

Vioxx was approved in 1999 for the treatment of arthritis, menstrual pain and acute pain in adults. It was subsequently launched via the magic of direct-market television advertising of prescription drugs, in which the drug companies effectively make an end run around doctors directly to the patient-consumer. In 2003 Vioxx accounted for $2.5 billion in sales worldwide for Merck.

When Merck pulled Vioxx from the market, it left a lot of suffering people without the pain medication they were accustomed to, in Chico and elsewhere. And that was just the beginning.

On Dec. 10 the Federal Drug Administration increased the warning on labels of Bextra, a pain medication similar to Vioxx and marketed by Merck rival Pfizer, after clinical trials showed that heart bypass patients taking the drug had higher risks of stroke and heart attack.

One week later Pfizer reported that a clinical trial of its pain medicine Celebrex, another drug turned into a household word via TV, showed an increase in cardiovascular risks for its users.

While Pfizer has not pulled either of its popular pain medications off the shelf, the warnings are there, causing patients and their doctors to re-examine pain treatments.

The three drugs that showed so much promise are called COX-2 inhibitors and generally did not cause stomach problems, including bleeding, as do more conventional pain medications like aspirin.

Chico general practitioner Dr. Michael Ricci says the problem of recommending pain control substitutes for his patients who were on Vioxx is no easy task.

“That is a big, complex subject, and we could spend hours talking about it,” Ricci said last week. “It does leave a vacuum.”

He said a considerable part of his practice includes treating arthritis, and he prescribes arthritis medicine to a lot of patients.

“Celebrex and Bextra are a little bit different [than Vioxx], but there is a good chance they will be pulled,” Ricci predicted.

“Chemically they are a different structure, and I think it is premature to say that they are totally bad, that they shouldn’t be prescribed. I mean, I for one am on Celebrex myself, and I’ve gone from two to one pill per day.”

Ricci said each patient is different and that he relies on literature from drug companies, trade magazines and journals he subscribes to and discussions with fellow doctors to determine what medicines to prescribe.

“But of course if you ask 10 doctors, you’re going to get 10 different opinions,” he pointed out.

In addition, patients have been doing a lot of their own investigating in the years since the Federal Communications Commission first allowed prescription drug advertisements on television.

The ads for prescription drugs, Ricci said, have probably had a positive effect overall because they get patients talking to their doctors about what is available.

“These ads have only been around for five or six years,” he said. “It’s a whole new concept. You’ve got anti-depressants, Viagra and so forth. A lot of people don’t need Viagra, a lot don’t need Celebrex, but at least we can discuss it and get people talking.

“These ads cost a tremendous amount of money, and that adds to the tremendous cost of drugs. But that is a whole other issue.”

As for the alternatives, Ricci said there are always the tried-and-true drugs like aspirin and Aleve.

“Aspirin is an amazing drug,” he said, “but the problem is upset stomach, ulcers and bleeding. Vioxx, Celebrex and Bextra are a bit more tolerated by people. There is not as much of a problem on the stomach. They can cause some discomfort, but not as much. That’s why they were such a breakthrough.

“They are good for arthritis and don’t cause stomach problems. But it’s easy to toss the baby out with the bath water. These drugs could be OK with less dosage.”

The issue is complex and does not lend itself to an easy answer, Ricci advised.

“I would support more research [on the COX-2 inhibitors], and of course you must monitor your patients. Discontinue the medication if needed, or you can prescribe an H-2 inhibitor like Prilosec or Zantec for stomach protection.

“Now you’re prescribing two medications instead of one, and that is not something a purist would like to do. But the second drug protects against the side effects of the first one.”

Ricci said at the heart of the issue is the control of pain. There are some very strong medicines out there, including Vicodin and OxyContin.

“These are really addictive, but if there’s someone with really bad arthritis, somebody who really needs them, I don’t hesitate to prescribe.

“I don’t want to hurt anyone, but these drugs have helped a lot of people. Medicine is always a balancing act. I think much more work needs to be done. It’s sort of a knee-jerk reaction to pull them off the market. Doctors must practice judicious use."