Off-label penis-straightening promotion by

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Last week the website reported that the FDA approved a drug for claw hand – a painful condition that causes bent fingers. That was the news of the day. But only briefly discussed claw hand before catapulting into a non-stop promotion of possible off-label use of the drug for Peyronie’s Disease – a condition in which the penis becomes painfully bent.

Look at how ABC framed this:

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The headline is hype. It’s not a penis-straightening drug in the eyes of the FDA. It hasn’t been submitted for approval for that use.

And is that really an appropriate stock photo to use for this story?

But this story repeatedly promotes off-label use – something the drug company would get in trouble for if they had done it. What was the company’s role in this story? The story says the drug company “says that – as a safety precaution – it will do everything it can to discourage off-label use.” Yet, the drug company PR guy is quoted citing specific data on alleged effectiveness of the drug for Peyronie’s Disease. And the story ends, “If all goes well, (the drug company) says they hope to have the drug approved for Peyronie’s within two years.”

Hmmm. That makes the Peyronie’s benefits of the drug sound pretty good and pretty certain.

And let’s count the ways the story promoted off-label use with these excerpts:

1. “may serve as double-duty as a penis-straightener”
2. “The release of the drug this spring may lead to off-label use for Peyronie’s Disease.”
3. “urologists and patients will find frustrating” any company attempt to discourage off-label use.
4. “…there is great demand for any drug that could be shown to work (for Peyronie’s). Xiaflex may be that drug.”
5. “Peyronie’s sufferers may be ‘very motivated’ to take risks, especially since few other treatments work.”
6. “I’m sure there will be pressure [on urologists] to use it off-label…they have a cohort of patients waiting.” (urologist’s quote)

Only deep in the story – 665 words deep in a 795 word story – after all of this off-label promotion took place – was there specific discussion of the safety concerns that could burst this balloon. Excerpt:

“It is an invasive procedure with potential bad side effects [such as] impotence [or] penile fracture. I don’t think too many urologists will do off-label use until FDA approval for use in Peyronie’s Disease,” (a UCSF urologist) says.

Bruising, pain, and swelling at the injection site has also been reported in clinical trials of Xiaflex.

And even this came after a bold heading, “Relief Will Have To Wait.

Why would ANYone report on a drug study that has yet to be completed, has not been subjected to peer review and is for an off label use?

Because ABC could put “penis-straightening” in the headline and draw more traffic?

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