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Premature births may be reduced with hormone gel

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3 Star

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Premature births may be reduced with hormone gel

Our Review Summary

This story about a study on treatments to prevent preterm births could have taken some cues from a competing story by the Associated Press. It may end up confusing readers the way it introduced a drug that was not part of the study and explaining the cost information in a very disjointed way. AP also mentioned the other drug that’s been in the news lately – but explained the context much more clearly. We do applaud the LA Times blog piece, though, for making note of the small sample size of the study and for providing some of the raw numbers in the study.

 

Why This Matters

Preterm births can lead to serious complications for both the chlidren and the mothers and are a leading cause of neonatal death. So far, treatments to prevent preterm birth have had limited success. This study indicates that there is a superior intervention for women who meet certain criteria, and this story could have been more careful in making it clear to readers which intervention may be the best treatment.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story discusses costs but, because of the way it interjects the drug Makena, the story confuses the costs issue. It says in the lead, “A simple, safe, relatively inexpensive hormone treatment might help some high-risk pregnant women carry their babies longer, a new study suggests,” but then it says, “Even better, the newest one would appear unlikely to cost $690 a dose — unless drug makers are slow learners.” This raises the idea that the maker of the drug being studied has been considering selling the drug for $690 a dose. The story further confuses matters by saying, “One new drug, also progesterone-based, is marketed for women who have already had a spontaneous preterm birth. That drug, Makena, was the subject of considerable controversy recently after its manufacturer boosted the price from $20 per dose to $1,500 per dose before finally lowering it to $690. … If the progesterone gel is as effective as the study suggests, women would likely find the price tolerable. But probably not at $690 a dose.”

AP was much better on this, reporting: “Although the company didn’t address price, vaginal progesterone already is sold to treat different conditions, for roughly $20 for a day’s dose.”

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

Satisfactory

The story quantifies the benefits in a variety of ways. It excelled in providing numbers in absolute terms instead of merely in percentages.

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

Not Satisfactory

No discussion of harms. The study itself found that, “There were no differences in the incidence of treatment-related adverse events between the groups.” This is important context because pregnancy interventions can have consequences for both the mother and the child.

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

Satisfactory

Both stories were short on details about the study design, but this story did provide some basic information. Unlike the AP story, this story also provided this good context: “The data set isn’t very large: 21 of 235 women given progesterone delivered early compared with 36 of 223 women given a placebo.”

Does the story commit disease-mongering?

Satisfactory

The story makes it clear that the preferred treatment, as far as this study is concerned, would only work well with women in a specific category of pre-term labor risk. It was more specific than the AP story, saying, “The reduction applies only to women with a short cervix (between 1 centimeter and 2 centimeters), not for women at high risk for other reasons. But for these women, few medications have been found effective at keeping a baby in the womb longer.” We do wish that both stories had included some of the information provided by the National Institutes of Health, which said in its news release about the study, “Infants born preterm are at high risk of early death and long term health and developmental problems. In 2005, there were 12.9 million preterm births worldwide (http://www.ncbi.nlm.nih.gov/pubmed/20428351). In the United States, 12.8 percent of infants were born preterm in 2008 (http://www.childstats.gov/americaschildren/health.asp). Preterm infants are at increased risk for death in the first year of life, and breathing difficulties, cerebral palsy, learning disabilities, blindness…”

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

Not Satisfactory

The story quoted no independent experts and actually no experts ar all. The story also undercut the significance of the research by saying, “And, of course, the trial was funded by the maker of the progesterone gel, to be marketed as Prochieve.” That’s worth noting, but the AP story states, “The study was a collaboration between NIH and Prochieve maker Columbia Laboratories Inc. of Livingston, N.J., which plans to seek Food and Drug Administration approval for the drug for women with short cervix.”

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story did an adequate job explaining what the study examined but did not compare the progesterone treatments very effectively to existing methods of stalling birth.

In addition, as stated in “availability” above, this story might leave readers confused as to which drug could end up being a good therapy for certain women. The Times blog piece raises the issue of an expensive, injectable drug called Makena, which has made headlines recently because of its high price. The AP story said clearly, “This treatment is not related to an injection called Makena, a synthetic hormone that is controversial because of its high price tag. That drug is aimed at women who’ve already had one preemie and now are pregnant again.”

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

Not Satisfactory

First, the story was never clear about the availability of the hormone treatment – only a hint that it is “to be marketed as Prochieve.”  What does that mean about availability now?

Second, unlike the AP story, this story might leave readers confused as to which drug could end up being a good therapy for certain women. The Times blog piece raises the issue of an expensive, injectable drug called Makena, which has made headlines recently because of its high price. The AP story said clearly, “This treatment is not related to an injection called Makena, a synthetic hormone that is controversial because of its high price tag. That drug is aimed at women who’ve already had one preemie and now are pregnant again.”

Does the story establish the true novelty of the approach?

Satisfactory

Should this treatment method become standard for certain women, it would be a novel intervention. The AP story made that clear. This story, by introducing Makena, confuses the issue and leaves readers unclear which treatment method would be the superior intervention.

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

Satisfactory

This AP story went beyond the news releases from the journal and from the NIH, but the Times story provided little additional information beyond the releases.

Total Score: 5 of 10 Satisfactory

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