When Merck pulled Vioxx from the market on Sept. 30, it left 1.2 million Americans
without the medicine that relieved their arthritis pain, helped them recover
from orthopedic surgery and controlled their swelling after sports injuries.
It was a very popular prescription drug, No. 19 in the nation last year, according to NDCHealth, with $1.8 billion in sales. It still lagged well behind Pfizer’s Celebrex, which had $2.5 billion in U.S. sales, but doctors say it had several advantages.
Orthopedists favored it as a short-term pain reliever for post-op patients and injured athletes, especially in the extra-strength 50 mg dose. Unlike Celebrex and Bextra, also from Pfizer, Vioxx was safe for people sensitive to sulfonamides.
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And clinical trials suggested it might be gentler on the stomach than Celebrex – a plus given that the whole point of taking these drugs, known as Cox II inhibitors, is to get the anti-inflammatory benefits of older drugs like Advil or Aleve without the stomach irritation and potential for gastrointestinal bleeding that they can create.
Dr. John M. Conte, at Rheumatology Associates in Providence, said he’d prescribed Vioxx to about one-third of his patients on Cox II inhibitors, slightly fewer than he gave Celebrex. Others got Bextra or Mobic, a newer drug. For some patients, there was a clear choice, he said, but for others it was a tossup.
“The perception was that Celebrex in lower doses was not as strong a pain reliever as Vioxx was in the moderate to high doses,” Conte said.
But even before Merck withdrew Vioxx, he said, he’d become more cautious about dispensing it, because a study comparing Vioxx with naproxen (the ingredient in Aleve), had shown Vioxx patients had far-higher levels of cardiovascular problems.
Nationally, not only doctors but some insurers had started handling Vioxx with care. Kaiser Permanente, which had documented cardiovascular problems among its own subscribers taking Vioxx, had restricted access to the drug, as had Group Health, Premera Blue Cross in Washington, and the Veterans Administration.
Neither of Rhode Island’s two main health insurers, Blue Cross & Blue Shield of Rhode Island and UnitedHealthcare of New England, had such restrictions, though they also didn’t treat Vioxx as a preferred drug, favoring generics and older drugs.
In the second quarter of 2004, Blue Cross paid for 10,000 Vioxx prescriptions for 6,200 members, according to spokeswoman Megg Regner. In the third quarter, it dropped to 8,900 Vioxx prescriptions, she said, compared with 9,800 for Celebrex.
UnitedHealthcare didn’t have Rhode Island figures, but nationwide, it had paid for 155,000 subscribers’ Vioxx, spokeswoman Debora M. Spano said.
Both insurers quickly stopped filling the prescriptions when Vioxx was withdrawn, and Blue Cross’ mail-order prescription service, PharmaCare Direct, faxed all the doctors with active Vioxx prescriptions asking them to choose a substitute.
Most doctors themselves, however, didn’t have the capability to identify their Vioxx patients and quickly stop them from taking the drug.
“We don’t have a database to do that – I don’t think anybody has a database,” said Conte. “We would have to look up thousands of charts. So we have to rely on people hearing it on the news, or going to refill their prescriptions. We had a wave of calls for a week and then it died down, so most people figured it out.”
Dr. Stuart Schwartz, head of rheumatology at Rhode Island Hospital, said most of his patients heard about the Vioxx recall on the news, and some pharmacy benefits companies also sent him a list of patients who were on Vioxx. “If we hadn’t heard from them already, we contacted them.”
But what to prescribe instead? Within two weeks of Vioxx’s withdrawal, Pfizer disclosed that two-month-old clinical study results showed Bextra, which is newer than Vioxx or Celebrex, increased the risk of heart attack and stroke in patients undergoing coronary bypass surgery.
Dr. Gail Cawkwell, Pfizer’s medical team leader for Celebrex, told The New York Times that the Bextra study focused on such a “unique” situation that it wasn’t applicable to the broader population. And Pfizer has said data on Bextra use with arthritis and general surgery patients doesn’t show an increased risk of heart attack.
In general, Pfizer has stressed that each Cox II drug is chemically different, so one drug’s problems can’t be presumed to occur with other drugs in the family. And in a bold move, within days of the Bextra announcement, the company said it would conduct clinical tests to see if Celebrex actually helps prevent heart attacks.
On the other hand, Dr. Garret A. FitzGerald, chairman of pharmacology at the University of Pennsylvania’s Institute of Translational Medicine and Therapeutics, argued last month in the New England Journal of Medicine that all Cox II drugs carry a risk because they all suppress production of a fat that protects the heart.
And with Merck, which is already facing more than 300 lawsuits over Vioxx, being accused of deliberately trying to hide or minimize evidence of its drug’s problems, and the Food & Drug Administration only now releasing with key information (a memo released last week said an FDA/Kaiser study showed Vioxx might have contributed to 27,785 heart attacks and deaths from 1999 to 2003), many doctors are leery.
“There’s a lesson to be learned for us here,” said Dr. Fredric V. Christian, a cardiologist and president of the Rhode Island Medical Society. “Obviously Vioxx is off the table, but there’s some uncertainty as to whether the other Cox II inhibitors will be viable long term. There’s going to be some hesitancy among practitioners to use some of these drugs, and if they do use them, to only use them with the lowest-risk patients.”
