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Researcher touts test as an aid to preventing miscarriage — but neglects to disclose he holds a patent on it

Progesterone may be key to preventing recurrent miscarriage

Our Review Summary

This is a somewhat confusing news release that contained very few of the most important details from the study — effectiveness, safety and cost, for example — that anyone would want to know if they were interested in preventing miscarriage. The confusion arises around what is being tested: is it the progesterone, the nCyclinE molecular marker or the Endometrial Function Test (EFT) used in this experiment to identify a subset of women who would benefit from progesterone? Our reviewers were baffled and readers likely will be, too.

 

Why This Matters

Progesterone has been clinically used to prevent unexplained early miscarriage. Some early meta-analyses had suggested a reduction in miscarriages, but later trials showed no difference.

If you are going to make a claim that progesterone prevents miscarriage, you should have more than a 116-person study to back up that claim. Preventing miscarriages could be a major public health advance and have a very profound effect on the lives of parents and families. If a cheap, safe and effective treatment could be prescribed to prevent untimely deaths of fetuses that would be welcome news. Potential mothers who have experienced the pain of miscarriage, however, should not be inadvertently led astray from headlines that promise miscarriage prevention without adequate study of the safety and effectiveness of that treatment.

We’ve noted concerns with Yale’s PR communications previously, for example here and here.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not discuss costs.

Cost for generic progesterone range from about $20 to $30 for 30 – 100mg capsules, according to GoodRx’s drug prices tracker.

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

Not Satisfactory

The release claims that progesterone prevents miscarriages. How many miscarriages did it help prevent and how was this assessed? There aren’t any numbers.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

With any drug treatment related to pregnancy it is absolutely essential to discuss the effects of the drug on both mother and child. This news release doesn’t address safety risks to either.

The Mayo Clinic’s website for patients offers a long list of possible side effects from progesterone in adults. Much less information is available about progesterone’s risk to a developing fetus.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

There was no basic information provided about what kind of study this was, and few explanatory statements that would help readers to assess the quality of the evidence. At the end we receive this helpful quote — “The positive results show us that next we need to study progesterone as a treatment for recurrent pregnancy loss with a prospective randomized trial to validate the findings. — but it’s too late and insufficient to help readers evaluate the study.

Does the news release commit disease-mongering?

Satisfactory

There is no obvious disease mongering here. The release does provide some context about miscarriages, stating that it “affects 30,000 women each year in the United States. About 25% of all women who become pregnant have a first-trimester loss.”

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release doesn’t mention who funded the study, which is necessary to meet our standard. It does note that the “research team used the endometrial function test (EFT®), which was created by study co-author Harvey J. Kliman, M.D., director of the Reproductive and Placental Research Unit in the Department of Obstetrics, Gynecology and Reproductive Sciences at Yale School of Medicine.” However, the release doesn’t acknowledge an important conflict of interest that is addressed in the study manuscript itself: “H.J.K. is the inventor of a patent related to the monitoring of endometrial glandular development.”

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Are there alternative methods to determine the health of a fetus and other potential treatments to prevent miscarriage? The release doesn’t say.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Progesterone is widely available, but what about the EFT?  We don’t have any idea after reading this news release. We found no evidence relating to EFT in a review of clinical reproductive medicine guidelines.

Does the news release establish the true novelty of the approach?

Not Satisfactory

This release doesn’t establish the novelty of this approach. Other research studies have looked at the use of progesterone in preventing miscarriages.

According to the reference site “UpToDate” by medical publishers Wolter Kluwer, more than 50 research studies have examined the use of progesterone in preventing miscarriage or pre-term birth, with mixed results.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

There is no obvious use of unjustified language, but the last paragraph contains some somewhat intemperate language from one of the co-investigators who said: “We are very pleased to find that these results reinforce the evidence that progesterone could be a very beneficial, inexpensive, and safe treatment for many women with a history of recurrent pregnancy loss.”

Beneficial? Inexpensive? Safe?  None of these attributes were described adequately in this news release.

Total Score: 2 of 10 Satisfactory

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