What does it mean when a news release states that an approach “helps safeguard a man’s fertility?” The Limitations section of the study, which the news release describes, gives a very good look at what isn’t known and what perhaps can’t be said at this stage of research.
But the news release uses definitive, positive terms such as “could change the way men are treated for low testosterone.” Any time you see “could,” feel free to substitute “may not.” It could go either way as more evidence is gathered.
Many men must be confused about all of the advertising claims about treatments for low testosterone in recent years. Journal news releases can do a lot of good in helping to educate men in depth and with details. Or they can simply add to the cacophony.
It’s important to put a news release geared for the public into clear and honest context. This release didn’t do that. The study participants were young (average ages 45 to 49), obese men with low testosterone and secondary hypogonadism. This means that the testes were functional, but the men had problems with pituitary function. There are many causes for secondary hypogonadism, but the release and even the study failed to provide this detail. We also don’t know the indications for raising testosterone in these men. Were the volunteers having symptoms or medical problems related to hypogonadism? Again, this lack of clarity on several fronts precludes the extension of the research findings to the population at large.
The news release doesn’t give the cost of either of the drugs that are compared in the study.
The release simply states that “enclomiphene citrate restored blood testosterone levels to normal after 16 weeks.”
But in a news release for which the headline states testosterone “helps safeguard a man’s fertility,” we look for something more. And even the limitations discussion of the journal article in question discusses what isn’t revealed in the news release. Excerpts:
“Improvement in patient-reported outcomes (PROs) was not addressed in the present study”
“The true impact of a medication on male fertility is difficult to assess without actual pregnancy or live birth data,” admitting that semen analysis is “far from being a true proxy for fertility.”
“Finally, the duration of the study is relatively short-term compared with the length of therapy seen in clinical practice.”
The release doesn’t tell us about the fertility rates in subjects receiving the new drug, nor to what degree the “marked reductions” in sperm counts in the testosterone group affected fertility.
The news release did not include any mention of adverse events from the trial in question. We always look for an explicit discussion of potential harms. Excerpts from the journal manuscript:
“There were 53 (21%) men in the studies who had adverse events considered by the investigators to be possibly, probably, or definitely related to the study drug. None of these were severe and none were serious….
Other than a road traffic death, the only death was in the ZA-304 study. This was a 59-year-old Caucasian with secondary hypogonadism who was treated in a ‘blinded’ fashion with 12.5 mg enclomiphene citrate for 34 days before an ischaemic stroke….His high number of risk factors and limited exposure made it highly unlikely that the study medication was the cause of his death in the opinion of the investigator.”
Regarding the researchers’ statement that none of the adverse events were severe or serious, we always think that’s in the eye of the beholder — the patients, who, of course, are not heard from.
But what we’re reviewing is the news release, which is silent on potential harms.
Our reviewers noted that the FDA has issued a safety alert to add information to labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. If enclomiphene raises testosterone levels it’s hard to accept the investigator (with a possible financial conflict) dismissing the possibility that the drug caused the stroke.
Even though we’ve already given an unsatisfactory score in the “Benefits” criterion above for what the news release chose not to discuss, we think it deserves another unsatisfactory score in this criterion because it didn’t discuss any of the limitations of this work, thereby giving an incomplete look at the quality of the evidence.
How transferable are the findings from the small group of overweight men with hypogonadism who were studied to the broader population of men now treated for low testosterone? These are among the evidentiary questions that come to mind.
We must also raise the question whether there’s a clinical indication based on the evidence provided for younger men with secondary hypogonadism to raise their testosterone levels.
This is a tough call. It’s difficult to assign either a Satisfactory or Unsatisfactory grade to this criterion because the news release actually provides no meaningful discussion of the underlying condition that may lead a man to seek treatment. In such cases, we usually assign a Not Applicable score.
Two of the three researchers, co-authors of the journal manuscript, are consultants to Repros Therapeutics. This is disclosed in the journal manuscript but not mentioned in the news release. Enclomiphene is in their product pipeline.
The very basis of the news release — and the study upon which it is based — is a comparison of alternatives.
The news release did not explicitly describe the availability of Enclomiphene citrate.
The study indicated that clomiphene, closely related to the study drug, is used “off label” for hypogonadal men. It has not been approved by the FDA for use in men.
The news release doesn’t provide any information about other alternatives to testosterone replacement therapy.
Is there other research in this field? Are other drugs being investigated in a manner similar to these studies about Enclomiphene? We’d never know based on this news release.
Given the on-going disease mongering surrounding “low T” perpetrated by pharmaceutical companies, one obvious alternative is no treatment.
There was no overtly sensational language used in this news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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