I think there is plenty of blame to spread around for the Vioxx debacle. Physicians' enthuisiasm for Vioxx and other Cox-2 inhibitors clearly went beyond the evidence. And I think some physicians believed that Cox-2 inhibitors are actually more effective than regular non-steroidal anti-inflammatory drugs (NSAIDS), without evidence to support this belief.Payers are frustrated that MDs are prescribing drugs patients don’t need, driving up short term costs with no attendant benefit to patients. Meanwhile, these decisions may very well lead to additional costs, as patients suffering cardiovascular events who also took COX-2s for WC injuries seek compensation from their WC payer.
The net - payers see MD prescribing behavior as abdicating responsibility, and increasing payer costs. Frustration is rampant.
However, before 2004, it would have taken some digging to find evidence that suggested Cox-2 inhibitors were actually dangerous. The published VIGOR trial data did show heart attack risk was higher in the Vioxx group, but this could have been due to chance alone.[1] Although the most evidence-based discussions of Cox-2 inhibitors did raise questions about cardiac risk, they offered no definitive conlusions (see the Cochrane Review[2] and ACP Journal Club[3] from 2002.)
Furthermore, even the most evidence-based physician would have had a hard time discouraging a patient absolutely determined to get a Cox-2 inhibitor before 2004, especially in the context of the typical 15 minute visit during which Cox-2 may have been only one of many issues raised. Such patients were not rare, due to vigorous direct to consumer (DTC) advertisements.
Managed care, of course, has to accept some blame for deluging physicians with paper-work and bureaucracy, while cutting reimbursements for office visits, thus making it financially disadvantageous for physicians to spend enough time with patients to discuss benefits and harms of treatments. Managed care, of course, likes to talk about "evidence-based medicine," but has provided little real support for clinical trials, systematic reviews, or educating physicians about evidence-based medicine. And managed care did nothing to counter all those fancy pharamaceutical DTC advertising campaigns that down-played the adverse effects of drugs, including Cox-2 inhibitors.
If managed care organizations really want patients to get the best possible care based on the best possible evidence, they should provide support and incentives for physicians to take enough time with patients, and for physicians to understand, have access to, and be able to use the tools of evidence-based medicine.
References
[1] Bombardier C et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8.
[2] Garner S et al. Rofecoxib for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev 2002; CD003685.
[3] Meyerhoff J. Rofecoxib, 25 md/d, was more effective than rofecoxib, 12.5 md/d, or acetaminophen in osteoarthritis of the knee. ACP Journal Club 2002; 137: 26.
2 comments:
Knowledge of the harm of the Coxibs was hard to come by but knowledge of the lack of benefit was not. There was never good evidence that these wildly overpriced pain pills reduced GI bleeding in the sorts of patients ( if any) that they were written for. I believe the one study relied upon tested RA patients on steroids and even that one was discredited a couple of years back. When doctors prescribe pills that cost more than 10 fold the cost of Tylenol for no particular reason, there is a problem.
Not exactly. For example, the Cochrane review and the VIGOR trial cited above both showed an advantage in terms of decreased rates of significant upper GI adverse reactions for the Cox-2 inhibitor versus conventional NSAID. In the Cochrane review, such adverse drug reactions included perforations, ulcers, bleeds, or obstructions. Thus there was an argument for using Cox-2 inhibitors for patients at high risk of major upper GI events. Whether these drugs were fairly priced is another question. On the other hand, it is true that there was never good evidence that Cox-2 inhibitors were better at relieving pain and inflammation than were NSAIDs, and hence there never was a good argument for using them as first line analgesics or anti-inflammatory drugs for all comers.
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