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Birth control for men: How well does new shot work?

May 05, 2009

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RATING:

In almost every way, this story overstates the benefits and essentially ignores the risks and limitations of testosterone injections for male contraceptive use.

Our Review Summary

In almost every way, this story overstates the benefits and essentially ignores the risks and limitations of testosterone injections for male contraceptive use. According to the reporter, the injections are safe and effective and reversible. While the researchers do use those words in their report, they also clearly state that long-term studies of testosterone injections are needed to investigate potentially serious side effects on the heart, prostate and behavior, to determine whether fertility returns after extended use, and whether the injections are as effective in men of non-Chinese background.

There is simply no support provided in this story for the reporter's claim that this method of contraception is likely to be available on the market within five years.

The story completely fails to put the results of this study in context with other evidence from the many decades of research into male contraception. It ignores side effects such as acne, weight gain, mood changes, and shrunken testes.

Oddly, this story appeared nearly two months after the research article was posted online, but just one day after a news release was issued. The timing and the absence of any independent sources or background raises questions about whether any original reporting was done.

The only cautionary note in the story is discussion of whether women could trust their men to reliably get monthly injections. It a good point that stands alone in a story that is virtually devoid of facts or balance.


 

Click on Criteria for definitions.

The reporter says male contraceptive shots should be on the market within five years, but she provides no attribution or other support for this claim. Indeed, the study authors note that further long-term safety studies are needed, indicating that years of further work remain.

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Discuss costs? - NOT SATISFACTORY

There is no mention of cost in this story. If the story portrayed this male contraceptive as merely an interesting experimental approach, the omission might be acceptable. However, the reporter claimed the product will be on the market soon; so the cost of this method should have been addressed. It is not hard to imagine that the out of pocket cost in the U.S. is likely to be substantially higher than other methods of contraception, given ongoing fees for monthly injections, plus laboratory tests, and possibly sperm banking fees (for men who want a back-up source in case their sperm count does not return to normal after injections are halted.)

Not applicable

not applicable in this case

This story improperly portrays a single two-year open label trial as conclusive proof of long-term safety and effectiveness. The study authors pointed out that long-term safety and effectiveness studies are still needed. The story failed to note any of the caveats and limitations in the research report.

The story errs by stating that one goal of this study was to see if the testosterone injections work "as well as everything else on the market." This study did not make any direct comparison between contraceptive methods. 

Importantly, the story does not mention that previous studies of similar male contraceptive injections have noted that Asian men respond more strongly than men of other ethnic backgrounds. A story broadcast to a U.S. audience should note that there is evidence that what works for Chinese men may not be as effective for American men of European, African or other descent.

 

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The anchor lead to the story says only that the drug has "relatively few side effects." Not only does Snyderman fail to mention what the side effects are, she concludes, "It looks pretty safe."

By contrast, the researchers write, "Despite the present encouraging results, the long-term safety of this hormonal male contraceptive regimen requires more extensive testing with a focus on cardiovascular, prostate and behavioural safety."

The story does not mention that nearly one-third of the men in this study (312 of 1045) withdrew or discontinued the injections.

The side effects reported in this study include, soreness at the injection site, acne, severe coughing, mood and behavior changes, facial swelling, and skin rash. Men in this study typically gained 1 to 3 pounds. More than one in four participants in this trial had smaller testis volume after the recovery period.

While the story claims that sperm counts return to normal after injection are halted, one man in this study did not begin producing sperm again and he had painful nodules that were not present before the trial. Another man had low sperm production 18 months after stopping the testosterone injections.

This study is an advance beyond previous work on male contraceptives, but the story portrays the results as bringing the treatment much closer to clinical use than the study justifies.

The story does not include any specific information about the results of the trial. Snyderman merely makes vague references to the testosterone injections comparing well with other forms of contraception, even though such direct comparisons were not part of this trial.

Snyderman says the injections "dropped the sperm rate such that men were temporarily infertile." She fails to report that the injections did not suppress sperm production in 5 percent of the men in this trial.

The story also says this method of contraception is reversible. While almost all the men in this trial did regain normal sperm counts after halting injections, the study did not track them to see if they were actually capable of fathering children again. The study authors report that sperm counts in two men did not return to normal. They also point out that this study lasted only two years, and that the reversibility of this method after longer use is unknown.

Because this story included so few specific facts and no quotes from the researchers, it is impossible to determine whether the reporter relied only on the press release. The story uses wording that is similar to the news release and fails to include any information from the actual trial report that was not also included in the news release.

The timing of this story is notable. While the journal article was posted online on March 17, 2009, this story did not run until May 5th, one day after a news release touting the article was issued by the journal's publisher.

3/17/09 online abstract: http://jcem.endojournals.org/cgi/content/abstract/jc.2008-1846v1

5/4/09 Eurekalert release: http://www.eurekalert.org/pub_releases/2009-05/tes-itm043009.php

The story does report the name of the journal publishing this research article. However, it does not include any information from independent sources. It does not mention the funding source: UNDP/UNFPA/WHO/World Bank Special
Programme of Research, Development and Research Training in Human Reproduction (HRP).

This story does list other contraceptive methods, however it improperly compares the trial results to effectiveness from clinical use. Results seen among participants in limited-term, closely monitored clinical trials are typically higher than what people experience during actual use, when the intervention may need to go on for many years and no one is monitoring compliance.

This story does highlight concern about compliance in the real world.

A barely acceptable "satisfactory" score on this criterion.  

Total Score: 2 of 8 Satisfactory

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