Theodore Fields was in a meeting discussing the latest medical journal articles one morning last month when someone came in with a printout announcing that Merck was voluntarily pulling its blockbuster drug Vioxx from the market. Concerns that had been plaguing the widely prescribed anti-inflammatory drug for about two years-that it increased the risk of heart attack and stroke-were soundly confirmed by a study being conducted on patients at risk for developing colon polyps. Merck stopped the study early for safety reasons.
After the meeting, Fields, director of the rheumatology faculty practice plan at the 138-bed Hospital for Special Surgery in New York, marched to his office and had his secretary call every patient whom he had prescribed the drug to in the last couple of years. He said he does not know how many that was, but it was a four- or five-day process to reach everyone. Some patients called him before he could call them.
"The immediate reactions were a broad spectrum, everything from `I have another two weeks, can I take it?' to `Oh my God, I just took one this morning. What should I do?' " Fields said.
Launched in the U.S. in 1999, Vioxx posted worldwide sales of $2.5 billion in 2003. Its sudden removal from the antipain medication arsenal was perhaps economically devastating only for Merck, which has promised to make good on unused pills, but it tested the healthcare system's ability to respond quickly to the largest prescription drug recall in U.S. history.
"It wasn't an easy proposition, but it didn't seem right to just count on the people who called us," Fields said.
With 41 rheumatologists on staff at the orthopedic specialty hospital, Vioxx was a prominent antipain remedy that was first introduced to many inpatients at HSS. Even before the recall, the hospital's Web site posted an article by Michael Lockshin, an attending rheumatologist, expressing his opinion that data from a 2001 study suggesting an increased cardiovascular risk from using Vioxx was inconclusive. Fields said he probably more frequently prescribed other drugs in the same class of COX-2 inhibitors as Vioxx, but it was because of patients' concerns about the cardiovascular risk, not his.
Now that those concerns are validated, "it's made a lot of patients anxious beyond the issue of Vioxx," he said. In the prior week, two different patients called because they said they had heard that two different drugs completely unrelated to Vioxx had been recalled, which was not true. "I think there has been an element of hysteria and false rumor," Fields said.
Last week in a conference call, Merck defended its handling of the recall, insisting that evidence of increased risk of heart attack and stroke had not been confirmed until after 18 months of treatment of Vioxx. The company will present data from the aborted study at a meeting of the American College of Rheumatology in San Antonio on Oct. 18. Merck officials did not respond to requests for an interview.
The recall tested the mettle of the 999-bed Cleveland (Ohio) Clinic's electronic medical record system. James Young, chairman of the division of medicine, said the information system is integrated into 12 regional healthcare centers. When the recall was announced, the system was queried as to which patients in the outpatient clinics were taking Vioxx on a chronic basis. The system spit out 11,000 names. The hospital sent letters to each of them, notifying them of Merck's recall, discussing the issues "in a non-inflammatory way," and recommending that they stop taking the drug and contact the doctor who had prescribed the medicine, Young said. The hospital also contacted the physicians of those 11,000 patients-many of whom were likely not the prescribing physicians-to let them know that their patients had been taking the recalled drug.
Young said he had little concern that the recall would raise the price of alternative drugs. A more important question is whether the problem with Vioxx is a problem just for Vioxx or for the entire class of COX-2 inhibitors, which are designed to minimize the gastrointestinal side effects of more traditional pain relievers and anti-inflammatories known as NSAIDS or nonsteroidal anti-inflammatory drugs. The two alternatives in the COX-2 class are Celebrex and Bextra, which are both made by Pfizer.
Many patients were first introduced to Vioxx in hospitals because of Merck's heavy promotion to hospitals and doctors' offices. Merck offered Vioxx to most group purchasing organizations at more than 90% off the wholesale price, said William Larkin, senior vice president of pharmacy at GNYHA Ventures, the for-profit subsidiary of the Greater New York Hospital Association. Such nominal pricing policies are employed by many drug companies as a way to get physicians in the habit of prescribing drugs, he said. Pfizer, however, does not discount the acute-care market, so hospitals will now be purchasing the alternatives at roughly greater than 10 times the price they paid for Vioxx, Larkin said. The impact on the 1,500 hospitals that purchase under Premier contracts will be approximately $4 million, according to Larkin.
But even with the nominal discounting program, Vioxx had less than a 50% share of COX-2 inhibitors sold under Novation's group purchasing contracts, said Michael Giboney, senior product manager for Novation. For the last 12 months, Novation hospitals spent $13 million on Vioxx, ranking it 140th on the top selling list of drugs sold; $16 million on Celebrex, 114th on the list; and $7.2 million on Bextra, ranking it at 231th. In total, Novation hospitals purchase approximately $9 billion in pharmacy products under Novation contracts.
"You have to remember also that while it will cause a steep price increase for hospitals that want to stay with the COX-2 class, hospitals don't generally spend a lot on these types of drugs because they are generally outpatient drugs," Larkin said. "Vioxx vs. Celebrex is not going to break the bank."
As of July, Celebrex outsold Vioxx in the U.S. with a 47.3% market share compared with 31.8% for Vioxx, according to IMS Health, a pharmaceutical information and consulting company. But Vioxx ranked fifth of all drugs promoted to professionals in 2003 with Merck spending $422 million to market it to doctors' offices and hospitals, also according to IMS Health.