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Trial Help for Sex Problems

Rating

4 Star

Trial Help for Sex Problems

Our Review Summary

The one thing we didn’t like in the story was letting the independent urologist get away with his claim that the findings were "clinically significant."  We liked the way one observer put it in an online comment posted after the WSJ online story: 

  • "I had to chuckle when reading about the "clinically significant" 5.5-fold increase. Although the men rated their experience significantly higher on measures of control and satisfaction, was this 5.5 increase from about 56 seconds to 3 mins.18 seconds sufficient to make their experience as a couple more meaningful and rewarding? Did the partners rate their experiences as improved? I would characterize this finding as "less than perfect" just as the urologist quoted referred to the alternative treatments. Perhaps the study can be improved by combining spray plus sex therapy for one experimental group, spray treatment alone for another group, and sex therapy alone for the third group. I also think that giving the couples a stop watch injects an artificial component that is likely to have its own sent of negative ramifications."

 

Why This Matters

Sexual dysfunctions can be serious and life altering, and there is a steady parade of therapies being offered both through the standard scientific process and through outright hucksterism. It is important for reporters not to be blinded by the glare of sex therapy and to focus on the details the way they would with any other drug or treatment.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The company behind the product undoubtedly has done market research about how much of this product it might sell and at what price. At a minimum, that information should have been included here.

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

Satisfactory

It presents the benefits in both relative and absolute terms in the second paragraph of the story. It would be nice to have a NNT or number needed to treat in here. It also would be nice to see the range of performance after using the drug. Did some of the men on placebo have gains in ejaculation time that were unusually high? Did some on the drug have no gain or even a loss of time? It’s also not clear how the researchers knew what the "no drug" ejaculation time was, how they were chosen for the research or whether they fell into a particular age bracket. The story did a "satisfactory" job quantifying the benefits, not a perfect job. And in an imperfect world of health stories, this part of the story was actually above average.

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

Not Satisfactory

It talks about the potential side effects, but it limits that discussion to what the study found in a very small group of men. Are there long term effects from lidocaine exposure that have been found in other studies? Does the body build up resistance to lidocaine? This isn’t a short term problem that can be solved with a few weeks of therapy. It is usually a life long problem, and the story should be framed that way both in discussing the benefits and the harms.

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

Not Satisfactory

By using an outside expert to say in the third graph that the findings are "clinically significant," the story makes it sound as if the case for this drug has already been made. Perhaps Tom Lue gave some context around this comment, but that context is not included. Instead, we are told that patients will be "much happier." If you have this problem, you are looking up the company’s website to get on their mailing list. But both groups experienced a gain in ejaculation time. Why would that be? And, given that these sexual encounters were self timed, how confident can we be in the results? Another thing that the story never addresses is the idea of optimal time for sex. It also treats this particular sexual dysfunction as a purely single male problem instead of a larger issue of an unsatisfying sexual relationship between a man and his partner. The drug was tested with two people having sex, but the person who did not receive the spray is never taken into account. The men "rated their sexual experiences significantly higher" than those who got placebos. The only reference to the partners is literally the second to the last sentence, "Also, 0.6% of the men’s female partners reported at least some loss of sensation."

We don’t hear anything about the limitations of the study design. It appears to be a quasi-synthesis of 2 clinical trials.  There isn’t any caution about the limited or nonexistent peer-review which takes place for an "abstract" at a meeting.  Regarding study design, all we know is that researchers took 2 previous trials already made public (would have been helpful to include what the primary findings were) and "combined them with added new data." This study design is highly suspect. We do not know anything about whether the 2 trials were similar enough to combine, and in what manner they were combined.

Does the story commit disease-mongering?

Satisfactory

The section describing premature ejaculation does a better than average job attempting to define the scope of the problem while describing the limitations of the research that has been done in this area. One line could be a model for other journalists to learn from: "Surveys have suggested that as many as 20% to 30% of men may suffer from premature ejaculation, though these figures are often drawn from broadly worded survey questions and may overstate the number of men with significant problems." 

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

Satisfactory

The reporter clearly read a lot about the problem and the potential treatments and does a fairly good job synthesizing this information. The story makes it clear that the two outside sources were not involved in this research. It is unclear whether these doctors are involved in any competing research or research into a similar product.

Does the story compare the new approach with existing alternatives?

Satisfactory

There are three full graphs in a 12 graph story about the standard treatments and off-label treatments. I felt like I knew more about the state of premature ejaculation medicine after reading this story than I did about the actual success of these two trials.

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

Satisfactory

The story makes it clear, even in the headline, that these are the results of a trial and that there currently is no product even in the FDA pipeline. It also talks about a drug therapy from Johnson & Johnson and where it is being sold. It says at one point in the story that the "findings of both trials had previously been made public." It would have been nice to know where, how and why. Presumably at previous conferences, and, if so, why is this treatment not already in the FDA pipeline. Reporters should always be wary of scientists, especially corporate ones, who are using the trade show circuit to build momentum for their product instead of following a rigorous peer review process.

Does the story establish the true novelty of the approach?

Satisfactory

This story really is all about the novelty, and it does a good job of exploring some of the other treatments available.

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

Satisfactory

Clearly, there is no published study. The company involved in the drug did issue this press release (http://www.renalandurologynews.com/novel-treatment-for-premature-ejaculation-shows-promising-results/article/171435/)
There are some differences between the numbers used in the story and the numbers in the press release, but it’s not clear how much of this is because of different caveats. (The number of men who actually completed the study, for example, versus all of those who were involved.) The story goes well beyond the release and was finished before the press conference at the AUA meeting.

Total Score: 7 of 10 Satisfactory

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