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Anti-Inflammatory
Research Shows that FDA’s New Recommendations will Benefit COX-2 Inhibitors Though Physicians and Patients Remain Hesitant
By NOP World Health, Mar 24, 2005 - 9:47:38 AM

New FDA Advisory Committee Recommendations around COX-2s are likely to lead to prescribing gains for Bextra and Celebrex, though both physicians and patients will continue to shy away from Vioxx, even if it returns to market.New NOP World Health research shows that physicians, particularly general and family practitioners, anticipate increasing their Bextra prescribing, while internists, rheumatologists and orthopedic surgeons expect to boost their Celebrex prescribing.Patients taking Celebrex or Bextra are loyal to those products and plan to continue taking them.

Vioxx, however, will experience ongoing difficulties, even if Merck decides to reintroduce it. If Vioxx returns to market, most patients indicated they would be unwilling to take it—and most physicians would use it primarily as a second-line treatment, after Celebrex and Bextra.

Rheumatologists are most likely to return to Vioxx, if it once again becomes available.In contrast, a third of orthopedic surgeons say they will not prescribe Vioxx, if it is reintroduced.

“If Vioxx comes back to market, lingering concerns about cardiovascular risks may limit its potential,” according to Keith Loehlein, Senior Vice President of NOP World Health’s Market Assessment Practice.“To re-establish the product, Merck will have to ease fears about cardiovascular side effects.A good promotional starting point would be marketing first to rheumatologists—who are most receptive to a Vioxx return—before targeting primary care physicians or other specialists."

“Educational programs on the outcomes of the FDA’s recommendations also could be useful communications tools for influencing both physicians and patients.The FDA’s stance that all DTC advertising for COX-2s should be banned will make it difficult, however, for manufacturers to reach patients directly.”

Physicians and Patients Remain Uncertain about COX-2s
Both physicians and patients remain cautious about COX-2s. Overall, physicians are still undecided about whether the benefits of COX-2s outweigh their drawbacks.

Patients echo the concerns of many physicians. Former Vioxx users are particularly skeptical and unlikely to be swayed by the FDA’s recommendations.Patients taking pain medications other than COX-2s also are highly suspicious of the category—and findings indicate that manufacturers will have to make significant efforts to change those negative perceptions.

Unsure about COX-2s, many patients are turning to their doctors for answers. Rheumatologists report that 2 out of 3 patients have inquired about the Vioxx return.Questions tend to focus on comparisons between the COX-2s and the cardiovascular risks surrounding Vioxx.

New FDA Advisory Committee Recommendations Spur Research
NOP World Health conducted its research after an FDA Advisory Committee issued new recommendations on February 18, 2005, about the marketing of COX-2 Inhibitors.

The FDA decided that Celebrex and Bextra could remain on the market—and that Vioxx could potentially return.All three products, however, must now carry a black box warning about the increased risk of cardiovascular events. Overall, the committee agreed that, while the cardiovascular risk is a class effect, variations in that risk—based on specific drugs and dosages—necessitate a case-by-case consideration of COX-2 agents.

NOP World Health’s research provides an early read on physician and patient reactions to the panel’s recommendations.Both physician and patient studies were conducted via Internet.

The physician study was performed between February 24 and 28, 2005 among 200 doctors, including 50 internists…50 general and family practitioners…50 rheumatologists…and 50 orthopedic surgeons. The patient research was conducted between March 1 and 3, 2005 among 300 patients who have taken a prescription pain medication in the last nine months—116 of whom had taken a COX-2.

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