Amid speculation that the painkiller Bextra will join Vioxx as drugs recalled from the market, University athletes are still using the drug in their rehabilitation and training regimens.
The pharmaceutical corporation Merck & Co. pulled Vioxx off shelves in late September after studies showed the drug could triple the risk of heart attacks and strokes in some patients.
New data is showing Bextra, another commonly prescribed painkiller that blocks a protein linked to inflammation called COX-2, might cause some of the same problems as Vioxx.
But many University athletes who had used Vioxx have turned to Bextra, and University professor David Guay, among others, is raising warnings about using the drug.
Guay, a pharmacy professor, said he expects Bextra to follow the same path as Vioxx and it might also be pulled off the market soon.
“It has some of the same problems,” Guay said. “There is just a lot less data. I strongly believe (Pfizer) will pull it off the market.”
Merck is now under criminal investigations for allegedly ignoring data that suggested a connection with Vioxx and heart problems, which began to surface soon after the drug hit the market in 2000.
The company pulled the drug after a long-term clinical trial showed that some patients who took the drug for 18 months developed serious heart problems.
For every 1,000 users, researchers found 15 cases of heart attacks, strokes or blood clots in each year of the three-year trial. For every 1,000 placebo users, there were 7.5 cases of the same health problems.
Moira Novak, the University’s head athletics trainer, said physicians like Vioxx and the other inhibitors, Celebrex and Bextra, because they cause less damage to the stomach than traditional painkillers such as ibuprofen. She said University athletes have never had problems from using COX-2 drugs and added Bextra didn’t seem to have the same problems as Vioxx.
Novak said Vioxx, which is designed for arthritis patients and those with ulcer problems, had been a popular painkiller for student-athletes. After she heard news of the drug’s recall Sept. 30, she sent a memo to University trainers and physicians to stop prescribing Vioxx to athletes.
Guay pointed to data that is similar to early reports on Vioxx and a pending study on Bextra that is expected to show the same kind of problems that have been linked with the recalled painkiller.
Because Pfizer already has Celebrex, another COX-2 drug, on the market, Guay said the company probably wouldn’t risk leaving it on the market for much longer because of the number of lawsuits Merck is facing.
But with the unsettling data that has surfaced recently about the painkillers, many are questioning why the potential dangers weren’t discussed earlier.
“If you weren’t following the data carefully, it was hard to pinpoint,” Guay said. “But it was easy for myself and others who kept a scorecard, and we saw which way the data was pointing. We sounded the alarm more than two years ago – but no one listens.”
Switching to Bextra
With Vioxx off the market, Dr. William Roberts, a physician in the University’s department of family practice and the president of the American College of Sports Medicine, now prescribes Celebrex or Bextra.
But along with Guay, Roberts said he is concerned about COX-2 drugs in general.
“Right now, they’re treating it as an individual drug effect, but the big question is, ‘Are all drugs (in the COX-2 inhibitor class) going to cause the same problem?’ ” Roberts said. “When I switch people to Celebrex or Bextra, I usually mention that there could be a class effect.”
And, in light of the potential problems with Vioxx’s successors, one question is why the athletics department would continue to prescribe potentially dangerous drugs.
Former Gophers sprinter Mitch Potter said that he took Vioxx for 15 months, after recovering from foot surgery in 2001, sometimes without a prescription.
“I used to take a lot of it. I never got a prescription for it or anything. For 15 months, I couldn’t walk without taking it,” he said. “I don’t know how (the trainers) go about writing it down.”
Potter also said that when he “needed stuff here and there,” trainers would give him Bextra.
Gophers football player Jason Lamers said that he took Vioxx before August for four weeks but wasn’t taking it when team trainer Ed Lochrie told him the team had discontinued its use. Recently, Lamers said team physician Dr. J. Patrick Smith has prescribed him Bextra to deal with an ankle injury. But Lamers said Bextra wasn’t as effective and he preferred Vioxx.
“You have to take like four (Bextra) pills, when you only had to take one Vioxx,” he said. “I don’t really feel like it does much at all.”
Potter, who had nine surgeries – almost as many as his 12 All-American honors in his career with Minnesota’s men’s track and field team – said he also made the switch to Bextra. But he said it paled in comparison to Vioxx.
“That Vioxx, man, you take that and you feel like a million bucks,” he said. “I was taking the limit every day. At the time, they told me to take it. Obviously, it wasn’t smart, but it worked like magic. If I could still take Vioxx, I would.”
The Albertville, Minn., native finished 13th in the 400-meter dash at the summer Olympic trials. He said with both Celebrex and Bextra, he had a longer recovery time than with Vioxx.
Potter gave Bextra higher marks than Celebrex and said the latter isn’t effective; but neither did the job as well as Vioxx.
Volleyball player Paula Gentil said she started taking Bextra after her trainer told her to throw away her supply of Vioxx.
After the Vioxx announcement, the New England Journal of Medicine posted a report on its Web site questioning whether Celebrex and Bextra could cause similar problems. The report called for extensive testing of both drugs.
Pfizer has already acknowledged that Bextra poses problems to patients after heart surgery and some researchers are saying the effects might be broader.
Roberts said the problem with Vioxx, and possibly with Bextra, is that it blocks a system in the heart that helps keep the arteries free of blockage.
“One of those same pathways doesn’t allow the heart to heal,” he said. “The overall risk wasn’t that huge, but if you happen to be the guy who got the heart attack, it was a pretty big deal.”
Merck is producing a new drug called Arcoxia to replace Vioxx and has said short-term studies show the new drug won’t have the same effects as Vioxx. But Roberts said he is concerned the company hasn’t done enough research on the replacement drug to effectively market it.
Government involvement
Approximately 400 personal-injury lawsuits have already been filed against Merck, and more are expected in the aftermath of the congressional and Department of Justice investigations.
One Google search turns up thousands of Web sites telling former Vioxx users not to “miss out on your million dollars from the Vioxx lawsuit.”
The New York Times reported Nov. 14 that Merck executives allegedly turned a deaf ear to research done in 2000, which linked the drug to increased heart problems.
Food and Drug Administration officials have said that Merck acted responsibly with the drug by voluntarily pulling it off the market.
But the FDA is receiving criticism from government investigations for being too lax in dealing with Vioxx.
The Journal of the American Medical Association called for an “independent drug safety board” separate from the FDA on Nov. 22. The journal argued that the FDA shouldn’t be expected to prove itself wrong by showing drugs to be unsafe.
Why didn’t they know?
Approximately 1 1/2 years ago, Potter’s girlfriend’s father, who is a chiropractor, told him he should stop taking Vioxx because there were whispers it caused heart attacks.
“When he gave me a heads-up it was bad, I was pretty surprised,” Potter said. “I told the (Gophers) trainers about it eight months later, and they had no idea what I was talking about.”
Guay said that Vioxx was under huge financial pressure from Merck because of the decreasing number of drugs the company had on the market.
When Merck executives downplayed Vioxx’s possible risks in 2000, the company faced fierce competition from Pfizer’s painkiller Celebrex.
And when Vioxx was pulled off shelves, it was still one of Merck’s biggest products. IMS Health, a company that tracks drug sales, said Vioxx tallied $1.8 billion in sales last year.
“Just follow the money,” Guay said. “It was their blockbuster drug.”
And while University athletes continue to take Bextra, Guay and others said they won’t be surprised if the drug soon follows Vioxx off the market.
