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Drug Eases Gout Flare-ups in Some Patients: Study

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Drug Eases Gout Flare-ups in Some Patients: Study

Our Review Summary

We will never sway from our position that it is unacceptable for major news media to publish stories making claims about medical interventions when those claims are based on news releases.  There was nothing so urgent about this story that it couldn’t have waited until one of the investigators involved in the work was available to explain it and answer questions about it.

 

Why This Matters

Gout can be a debilitating disease and the current treatments while very good are not ideal.  The FDA approved Arcalyst in November 2011 for the prevention of gout flares in people initiating treatment with drugs that lower uric acid levels such as allopurinol.  The drug was previously approved under an orphan drug designation for a rare inflammatory disease.  Painful flares are common during the first few months of treatment so a drug that can reduce the events would be welcomed.  However, Arcalyst was studied in 1,300 people in clinical trials prior to its approval for this very condition.  The rationale for writing a story – based on a news release – about its use in 83 people remains somewhat of a mystery.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

This issue was discussed only vaguely.

An independent expert said that rilonacept was “very expensive” and that “insurance will be an issue.”

It’s good that both issues were acknowledged.  But the story also explains that the drug is already used to treat another disease – so costs could have been nailed down precisely.  But they weren’t.  What does “very expensive” mean?

The NY Times reported the cost to be about $5,000 a week in a 2008 story.  That comes to a whopping $80,000 for a 16 week course.

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

Not Satisfactory

The story reports that “Rilonacept patients were less likely to have flare-ups, with 15 percent experiencing flare-ups three-months into the study compared with 45 percent among the non-rilonacept group.”

But not all flare-ups are equal.

How was a flare-up measured?  The story doesn’t explain.

Was it a measurement of uric acid levels?  Or was it patient self-reporting?

In other words, what difference did this make in subjects’ lives?  We can’t judge from the story the way it was reported.

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

Not Satisfactory

The standard line about “appears safe and well tolerated” is all we hear about harms.

Even the news release did better than that, stating: ” Common adverse events included infections reported in 15% of the rilonacept group compared with 26% with the placebo.”

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

Not Satisfactory

There was no critical analysis of the quality of research.

The story is based on a news release, with all investigator quotes lifted from a news release.

The only independent expert quoted really doesn’t critically evaluate – describing the findings only as “very promising.”

Does the story commit disease-mongering?

Satisfactory

There is no disease-mongering of gout in the story.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There are at least other 6 drugs under development for gout at the moment. The story didn’t mention anything about any of them.

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

Not Satisfactory

We are not told that the drug was approved by the FDA for use in gout in November 2011.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story doesn’t provide any context about whether this is the first look at rilonacept for gout.

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

Not Satisfactory

The story admits that it lifted its investigator quotes from this journal news release.

If the investigator wasn’t available immediately, this story was not of such urgent importance that it couldn’t have waited until someone involved in the research could be interviewed.

Total Score: 2 of 10 Satisfactory

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