Whiskey-Tango-Foxtrot? - menwithcramps.com

This site may well be a joke, but I wanted to point out the strangeness of it. Something to consider when you see ads for clinical trials.
Update: Now that there is a companion site with videos, it's clear that this is a joke. The M&I site (separate) is currently still as described here, and the lesson about examining the legitimacy of ads for clinical trials stands.

Browsing through the Nashville Scene last night, I found an ad recruiting men into studies of "Cyclical Non-Uterine Dysmenorrhea," leading to the website menwithcramps.com [Note: At the time of the original post, this site led here, the "MacInnes and Porritt Institute" site, not to the current site with videos]. This struck me as odd, because in medical terminology, dysmenorrhea very specifically means painful menstruation. The second odd bit is that "cyclical non-uterine dysmenorrhea" does not seem to be a "real" term, and a Google search turned it up solely on the website of the MacInnes and Porritt Institute (the menwithcramps people). The site goes on to call the condition "male menstrual cramps," and the call for study volunteers states:

Do you experience monthly cramping and pain in the lower abdomen and upper groin?

Do these cramps interfere with work, sports, parenting, or fun?

Do you have monthly gas-like pain with no associated "release?"

You may have Male Cyclical Non-Uterine Dysmenorrhea, or "Male Menstrual Cramps." If so, you may be eligible to participate in a Phase I Clinical Research Study to evaluate new progressive treatments for this disorder. Qualified male volunteers will receive study-related care at no cost. Your identity and information will be held in the strictest confidence whenever possible.*

Other oddities from the site:

"We are very proud and excited to welcome Dr. Gerhardt Fardel as the MacInnes and Porritt "Alice MacInnes Visiting Fellow" for the period beginning August 2006. Fardel's field research seeking alternative methods to the Heimlich Maneuver is now complete and his work is singularly focused on finding a treatment and cure for Cyclical Non-Uterine Dysmenorrhea (CNUD), commonly called Male Menstrual Cramps. Dr. Fardel has conducted an enviable body of research over his distinguished career. He has posed over a thousand new hypotheses and theorems resulting in over 100 clinical studies..."
Well, a PubMed search for the author Fardel G turned up 10 results, primarily representing an infectious disease researcher working in France; it's not clear that this is the same Fardel.

"Over his own scientific career, Dr. Gerhardt Fardel has endeavored to avoid the great corrupting influences of fame, choosing to work only on under-reported projects, and managing to never attract financial success or professional notoriety of any kind. This has been his preference."
Um, okay. This is unusual because most scientists do their work with the intent of eventually having it peer-reviewed and published in order to share their findings. Given that a PubMed search for articles published in the last 1 year (which wouldn't even represent all of the health-related research published in a year) turned up 680,408 results, publishing a couple of papers on your research would hardly automatically make you susceptible to "corrupting influences of fame." The lack of published articles seems to contradict the website's claim that "Gerhardt Fardel is also a scientist of some note in certain scientific circles."

Where are they?
"We're Here to Stay
The MacInnes and Porritt Institute is housed in a beautiful landmark building just off the main commercial district located near the new downtown research park in a formerly unincorporated development zone. We welcome your visits."
That's incredibly vague. No other location information is available on the site. A WHOIS search turns up the following information for the domain registration; the PO Box address seems to belong to Network Solutions, providing no additional information about the Institute's location:
MacInnes and Porritt Institute
gv8ef6zd8bg@networksolutionsprivateregistration.com
ATTN: MENWITHCRAMPS.COM
c/o Network Solutions
P.O. Box 447
Herndon, VA 20172-0447
Phone: 570-708-8780

You can't actually volunteer for a study:
According to the site, "As of August 30, 2006, our study has been closed. Participants have been selected from the pool of volunteers." So why are they advertising in a late September issue of The Scene? The lack of solid information about where studies are conducted, who oversees them, and other details (such as contact information) is also troublesome. If any of you have additional information on this, I'd love to hear about it.

The terminology just bothers me - you can't have "Male Menstrual Cramps," because males don't menstruate. Males can have pelvic pain, but it's misleading to label it menstrual, and I have trouble with anyone who's starting a study from a false premise.

Questions to ask before consenting to be part of a clinical trial (provided by the FDA):
* What is the study trying to find out?
* What kinds of test and exams will I have to take while I'm in the study? How much time do these take? What is involved in each test?
* How often does the study require me to go to the doctor or clinic?
* Will I be hospitalized? If so, how often and for how long?
* What are the costs to me? Will my health insurance pay for it?
* What follow-up will there be?
* What will happen at the end of the study?
* What are my other treatment choices? How do they compare with the treatment being studied?
* What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
* How long will the study last?

Technorati Tags: clinical research; MacInnes and Porritt Institute
MeSH Tags: Clinical Trials; Dysmenorrhea; Ethics, Research; Pelvic Pain
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