FDA Approves First Drug To Prevent Preterm Births
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Rating
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
Not Satisfactory
No discussion of costs, something we always look for and wish would be provided.
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.”
Satisfactory
Good discussion of concerns and ongoing monitoring of the drug’s safety.
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.”
Satisfactory
No disease-mongering of prematurity or its consequences.
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.)
Satisfactory
There was at least the historical perspective on “the last drug thought to prevent premature birth – a synthetic estrogen called diethylstilbesterol, or DES.”
Satisfactory
The focus of the story is FDA approval of the drug.
Satisfactory
Good historical context, explaining that “Interestingly, the drug is not new — it’s just taken a long and circuitous route to approval.”
Satisfactory
It’s clear the story didn’t rely solely on a news release.
Total Score: 9 of 10 Satisfactory
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