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FDA Approves Krystexxa to Treat Gout

Rating

2 Star

FDA Approves Krystexxa to Treat Gout

Our Review Summary

There are several ways to cover FDA approval of a new drug. 

You could take the FDA approval itself as gospel and/or take the word of the manufacturer as gospel.

Or you could do independent vetting of the claims and seek independent perspectives on "how big a story is this?"

This story chose the former approach. 

We prefer the latter.

 

Why This Matters

A story that doesn’t quantify benefits, doesn’t explain costs (of what is likely to be a costly approach), and doesn’t seek independent expert voices is not first-class health journalism.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of costs.  Why not?  And, since the drug must be administered every two weeks as an intravenous infusion, cost of delivery could be another substantial issue. (Our medical editor on this story says such biologic infusions tend to cost more than $1,000 per infusion.) How could this be excluded from such a story?

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

Not Satisfactory

Unsatisfactory.  All the story said was "that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue."

How many people saw a benefit? How much did the drug lower these levels?  Was that significant in peoples’ lives?  This, again, is where the story could have benefited from an independent perspective.

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

Satisfactory

The story did explain:

  • "A quarter of the patients who participated in the clinical trials experienced a severe allergic reaction to the new drug. The FDA recommends that health care providers provide patients a corticosteroid and an antihistamine to reduce the risk of an allergic reaction. Other reactions during the clinical trial included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain, and vomiting.  Doctors should exercise caution when administering Krystexxa to patients with congestive heart failure because that condition was not formally studied."

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

Not Satisfactory

There was no discussion of the quality of the evidence and, in fact, minimal discussion of how the research was done at all. 

Does the story commit disease-mongering?

Satisfactory

Story explains that "about 3% of the 3 million adults with gout are not helped by conventional therapy."  So no disease-mongering here.

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

Not Satisfactory

Inadequate. We weren’t told who funded the research.  And why do we have to hear claims of novelty only from a company president, lifted from a news release?  That’s inadequate sourcing.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The company president may say that "Krystexxa is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy" but a good news story would explain: 

  • is this the ONLY alternative approach that’s ever been tested? 
  • Presumably not – so how MUCH better was this than past alternative treatment attempts?
  • how much better this approach was than conventional treatment?

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

Satisfactory

The story is about new FDA approval of the drug.  It notes that the manufacturer expects it to be available by prescription later this year.

Does the story establish the true novelty of the approach?

Satisfactory

The story states: "Krystexxa is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," Paul Hamelin, RPh, president of Savient Pharmaceuticals, says in a news release." 

But why couldn’t we have heard that from an independent expert? 

We’ll give the story the benefit of the doubt, but barely.

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

Not Satisfactory

Unsatisfactory.  Both quotes – according to the story itself – came from a news release.  Why not do independent reporting on this? 

Total Score: 4 of 10 Satisfactory

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