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FDA Approves First Drug To Prevent Preterm Births

Rating

5 Star

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FDA Approves First Drug To Prevent Preterm Births

Our Review Summary

Given that 50% of care is covered by Medicaid and 49% by private payors, the costs for this drug are invisible to the individual. It is administered in clinic or by home health nurses and does not typically have a co-pay structure although patients will sometimes tell providers they can’t afford it.

 

Why This Matters

News of new drug approvals can be washed over with giddy hype.  But not in this story, which offered perspective, context and restraint.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No discussion of costs, something we always look for and wish would be provided.

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

Satisfactory

As already noted, the story explained that the drug “isn’t a magic bullet. The study showed that 37 percent of women who got weekly injections of it delivered prematurely, compared to 55 percent of women who got injections of a placebo.”

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

Satisfactory

Good discussion of concerns and ongoing monitoring of the drug’s safety.

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

Satisfactory

The story explains the drug “isn’t a magic bullet. The study showed that 37 percent of women who got weekly injections of it delivered prematurely, compared to 55 percent of women who got injections of a placebo.”

Does the story commit disease-mongering?

Satisfactory

No disease-mongering of prematurity or its consequences.

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

Satisfactory

The medical director of The March of Dimes was quoted throughout. (Although they are seen as having a very pro-progesterone slant that is not held by consumer/advocacy/health policy/maternity care groups in UK, Australia, and Canada. in those countries surveys of providers uniformly get low utilization responses with the reason stated being need for more data. Similar surveys of US providers (specialty and generalists) show the vast majority use >70% (as opposed to low double digits in more evidence-driven countries) and that mission creep has started. Indications for which it is not tested see regular use in the US.)

Does the story compare the new approach with existing alternatives?

Satisfactory

There was at least the historical perspective on “the last drug thought to prevent premature birth – a synthetic estrogen called diethylstilbesterol, or DES.”

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

Satisfactory

The focus of the story is FDA approval of the drug.

Does the story establish the true novelty of the approach?

Satisfactory

Good historical context, explaining that “Interestingly, the drug is not new — it’s just taken a long and circuitous route to approval.”

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

Satisfactory

It’s clear the story didn’t rely solely on a news release.

Total Score: 9 of 10 Satisfactory

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