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Results mixed on Merck’s new painkiller

Rating

3 Star

Results mixed on Merck’s new painkiller

Our Review Summary

The AP news story on the new painkiller Arcoxia raises an important question: Is it possible that the new drug poses more heart risks than the large clinical trials suggest? The story cites two critics to support this hypothesis. Like these critics, recent reviews of the literature suggest that some nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risks of heart attack, stroke and death more than other NSAIDs. These reviews suggest that the cardiovascular risks may be significantly greater with diclofenac (e.g. Voltaren) than the NSAID naproxen (Aleve). A new study in the journal Lancet shows that Arcoxia poses no more cardiovascular risks than diclofenac. Hence, critics say Arcoxia may not be benign. 

The news story nicely summarizes the key points in the new research. It points out that Arcoxia is a new drug, not yet approved by the FDA, and thus not yet available to patients and providers. 

The AP story succinctly captures the study’s main messages, and provides an accurate quantification of some of Arcoxia’s benefits and harms–but not all. It does not attempt to characterize the growing evidence suggesting that diclofenac (brand names Voltaren and Cataflam) may increase heart risks and that naproxen may not—key to evaluating the story’s main point. This problem “has not been well studied in large, long-term clinical trials,” according to the U.S. Agency for Healthcare Research and Quality. Hence, the article may misrepresent the evidence when it says that diclofenac is “known” to increase cardiovascular risks.  

The article accurately states the frequency and seriousness of cardiovascular risks and death in patients taking both Arcoxia and the comparison painkiller diclofenac. It quotes a credible source saying that most of the stomach problems are probably not clinically important. Although it mentions that the rates of serious gastrointestinal (GI) problems were similar in both groups, it misses an opportunity to shed light on this importance piece of information. The new Lancet study found that when it comes to the severe, sometimes catastrophic GI problems that some experts would say matter most, Arcoxia posed the same GI risks to patients as the traditional painkiller. Despite the advice offered by Dr. Fitzgerald in closing, there is no consensus in the medical community that Celebrex is an appropriate medication to recommend someone at high risk of an ulcer or stomach bleed.  

The AP story also fails to discuss cost, an important feature in the debate. If the FDA approves Arcoxia, the painkiller will likely be many times more expensive than traditional nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (e.g. Advil, Motrin) and naproxen (e.g. Aleve). Some observers question whether the COX-2 painkillers are worth the extra expense. 

The article does not mention other treatments for arthritis. For patients with osteoarthritis, there are multiple alternatives to painkillers, each with advantages and disadvantages. Patients with rheumatoid arthritis have fewer options, most involving powerful and toxic drugs. 

The article cites two of the Lancet study’s authors and two widely recognized experts. Three of the four have a conflict of interest. Although the story describes their conflicts, it remains overly reliant on their testimony. 

There is some irony in this tale. When Arcoxia’s competitor Celebrex underwent evaluation in the pivotal CLASS trial years ago, drug maker Pfizer compared Celebrex to two old standbys—ibuprofen (Advil, Motrin) and… diclofenac. In that study (as in the new study on Arcoxia), Celebrex and the comparison NSAIDs had virtually identical rates of cardiovascular complications. In that study (as in the new study on Arcoxia), Celebrex failed to reduce the occurrence of severe and life-threatening GI complications.  

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The AP story fails to discuss cost, an important feature in the debate over the use of COX-2 inhibitors such as Arcoxia (developed by Merck) and Celebrex (marketed by Pfizer). If the FDA approves Arcoxia, the painkiller will likely be many times more expensive than traditional nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (e.g. Advil, Motrin) and naproxen (e.g. Aleve). Some observers question whether the COX-2 painkillers are worth the extra expense.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The primary goal of the Lancet study was to look at harm—i.e. whether the cardiovascular risks of taking Arcoxia were no worse than the risks of taking diclofenac (a “noninferiority” study). The AP story quantifies the relatively fewer gastrointestinal problems among patients who take Arcoxia—which one could consider both a benefit as well as a harm. But the story does not put the GI “benefits” into context. Arcoxia provides no more protection against serious GI events than a traditional NSAID. (See “Harms of Treatment” above.) Arcoxia also provides no more analgesia. The improvement in symptoms among patients taking each drug was about two-thirds of 1 point (0.6 to 0.7) on a 5-point scale.  

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The article accurately states the frequency and seriousness of cardiovascular risks and death in patients taking both Arcoxia and the comparison painkiller diclofenac. This was the primary goal of the Lancet study. It also quotes a credible source saying that most of the stomach problems are probably not clinically important. Although it mentions that the rates of serious gastrointestinal (GI) problems were similar in both groups, it misses an opportunity to shed light on this important piece of information. The new Lancet study found that when it comes to the severe, sometimes catastrophic GI problems that some experts would say matter most, Arcoxia—designed specifically to protect the GI system–posed the same GI risks to patients as the traditional painkiller. And, despite the advice offered by Dr. Fitzgerald in closing, there is no consensus in the medical community that Celebrex is an appropriate medication to recommend someone at high risk of an ulcer or stomach bleed.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

This news article’s summary of the Lancet study is accurate, and succinctly captures the study’s main messages. However, the article does not mention that the study under discussion is an analysis of three randomized clinical trials or that no patients received a placebo or dummy pill. It also does not attempt to characterize the growing evidence suggesting that diclofenac (brand names Voltaren and Cataflam) may increase heart risks and that naproxen may not—key to evaluating the story’s main points.  As the U.S. Agency for Healthcare Research and Quality recently concluded, the current evidence points in that direction. However, the cardiovascular safety of these traditional painkillers “has not been well studied in large, long-term clinical trials.” Hence, the article may misrepresent the evidence when it says that diclofenac is “known” to increase cardiovascular risks.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The article cites two of the Lancet study’s authors and two widely recognized experts. Three of the four have a conflict of interest. The story describes their conflicts, but remains overly reliant on their testimony.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The article does not mention other treatments for arthritis. For patients with osteoarthritis, there are multiple alternatives to painkillers, each with advantages and disadvantages. Patients with rheumatoid arthritis have fewer options, and most of these involve toxic drugs.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The AP article makes it clear that the FDA has not yet approved Arcoxia (Merck’s brand name for the painkiller etoricoxib) and hence the drug is not yet available to patients and providers. The author did not note the availability of other members of this family of drugs, known as COX-2 inhibitors or COX-2 specific NSAIDS.

Does the story establish the true novelty of the approach?

Satisfactory

The article notes that Arcoxia is a relatively new drug that has not yet been approved by the FDA.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There was no obvious use of text from a press release.

Total Score: 6 of 10 Satisfactory

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