Health News Review

"An initial feasibility study in 30 men" is worthy of news coverage? With a company-sponsored investigator as the only source? Not in our view. 

Our Review Summary

Even in – or perhaps especially in – a business story, more critical analysis of such very early research is warranted.  More context and more background is necessary for investors or for patients to have in order to judge this extremely preliminary report that is framed by the company as "promising."


Why This Matters

We have seen how drugs for erectile dysfunction have been marketed – and how drug makers have tried to expand the market for these drugs.

Such an early story about a surgical approach should have emphasized just that – this is a surgical approach that may not be a good choice for many of the millions of men estimated to have some kind of erectile dysfunction.


Criteria

Not Satisfactory

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Sure, it’s early in development.

But just as surely, some estimate could have been made of what the stent, the surgery, and followup care would cost. 

If it’s not too early to report on "promising" results after ann initial feasibility study, then it’s not too early to start projecting costs – even in – or perhaps especially in – a business story.

Not Satisfactory

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

Not Satisfactory

As stated above in the "evidence" criterion, the potential benefit wasn’t made clear.  There was no critical evaluation or explanation of what it means to improve by 4 points on the 30-point index of erectile dysfunction scale. 

What difference does such an improvement mean in men’s lives?

Basically, to interpret the results, we would also need to know baseline function and then post-procedure function. More interpretable data would be responses to specific standard questions about erectile function, e.g., whether erections were firm enough for intercourse, how often did the man have an erection when he wanted one.

Not Satisfactory

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

Not Satisfactory

Yes, the story explained that there were no adverse events reported up to three months later but that risks may become evident much later. That’s an appropriate and important reminder.

But the story didn’t go far enough in providing available context.  The coronary stents are well known to have problems with clotting – generating a new generation of more expensive "coated" stents and the need for prolonged treatment with expensive oral medications to prevent clotting. The story could have addressed this – extrapolating that coronary artery complications could occur in penile arteries is not unreasonable. However, the trade-offs of stent risks – protecting the heart vs. protecting erectile dysfunction are quite different (and implicitly equating them smacks of another element of disease-mongering).

Not Satisfactory

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

Not Satisfactory

There was no critical evaluation of the evidence – and of how limited are the conclusions that can be drawn from an initial feasibility study in 30 men.

There was no critical evaluation or explanation of what it means to improve by 4 points on the 30-point index of erectile dysfunction scale. 

What difference does such an improvement mean in men’s lives?

Not Satisfactory

Does the story commit disease-mongering?

Not Satisfactory

We think there’s an element of disease-mongering at play here.

No source was cited for the estimates of 30 million US men and 300 million worldwide with erectile dysfunction. For example, it took us just seconds to find one citation:

  • The National Institutes of Health (NIH) estimates that erectile dysfunction affects as many as 30 million men in the United States. Incidence increases with age: About 4 percent of men in their 50s and nearly 17 percent of men in their 60s experience a total inability to achieve an erection. The incidence jumps to 47 percent for men older than 75. But erectile dysfunction is not an inevitable part of aging and is treatable at any age.

Second, the story could have noted that erectile dysfunction comes in many forms – some as the result of illness, some from treatment of another problem.  And many of these baseline problems – such as cardiovascular disease and diabetes – are preventable.  And the estimates take into account ALL degrees of erectile dysfunction – not all equate to a total inability to achieve an erection. 

Third, the vascular causes might not be safely amenable to stenting. We don’t know the inclusion/exclusion criteria for the study.

So, even in a business story, the "market" of "a real unmet clinical need" for a surgical procedure may have been inflated in this story.

Not Satisfactory

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

Not Satisfactory

No independent source was quoted -  the company-sponsored investigator was the only source quoted.

Not Satisfactory

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Some comparison was made with drug therapy for erectile dysfunction.  But there was no mention of a very safe and often effective alternative – the penile vacuum pump. Penile implants are also effective, though require surgical procedures. It would have required only an additional line to give this backgrounding context.  Even business story readers and investors would want this reminder.

Satisfactory

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

Satisfactory

The story was clear that "it could be several years before Medtronic undertakes a much larger late-stage trial" and that "this is still investigational."

Not Satisfactory

Does the story establish the true novelty of the approach?

Not Satisfactory

The story includes a quote that "this is the incepton of an entirely new way of treating ED that has never been seen before."

We don’t question the investigator’s comment.  We only question the editorial decision-making.  We easily found news stories from at least two years ago that talked about Medtronic’s development of this approach.  How many "inception" stories will we get before there is actually some meaningful, longterm experience to report in large numbers of men?

If it was "new" two years ago, is it still new today?  Is there still anything meaningful to report?

Not Applicable

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

Not Applicable

Not applicable.  We can’t be sure of the extent to which the story relied on a news release.  We do know that the company-sponsored investigator was the only source quoted.

Total Score: 1 of 9 Satisfactory


Comments

Gopi Nair posted on January 31, 2012 at 10:35 am

What about people who have several coronary stents (10) after bypass and on Plavix & aspirin, but still very active (1 hour walk) diabetic for 30 years. Can’t take viagra.

Reply

    Gary Schwitzer posted on January 31, 2012 at 12:44 pm

    If you’re asking for advice, we don’t give any – as clearly stated in our comments policy below. We only review news stories. We don’t give medical advice.

    Reply

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