Clinical trials and advertising   (February 22, 2009)

DEFEND (Durable response therapy Evaluation For Early or New-onset type 1 Diabetes) is another of those ultra-cute acronyms for a research study. The study is evaluating a drug called otelixizumab to see if it helps folks with type 1 diabetes. Details of the study can be found both at the DEFEND website (defendagainstdiabetes.com [Editor's Note: Link no longer active as of February 2012]) and at ClinicalTrials.gov.

But that's not the main reason for me writing this essay. It's because someone has chosen to place identical comments at numerous diabetes websites encouraging people to learn more about the DEFEND study by visiting the DEFEND website.

Is it appropriate to post such requests? Well, maybe.

Many clinical trials use advertising, usually in newspapers or radio or television, to try to find subjects for their study. It's an accepted way of soliciting potential subjects, especially for trials with difficult inclusion and exclusion criteria. For instance, if a trial were trying to recruit in a narrow age range (18-35 in DEFEND), with "no more than 90 days between diagnosis and administration of study compounds," and a requirement that subjects have "8 outpatient visits on consecutive days, each lasting about 6 hours," it's going to be tough to find enough volunteers -- and DEFEND wants to enroll 240 subjects!

So advertising is appropriate to try to locate volunteers in this case.

But advertising by having someone place anonymous comments into various diabetes forums and blogs? A Google search found at least 30 times that this identically-worded solicitation has been placed on-line. The author of the solicitation is "allenxvr"; he leaves no information about who he is or who he works for -- and he's no amateur: each of the click-through links that he provides at different websites has a different subpage so the folks behind this campaign can track which sites are generating traffic to the DEFEND website:

At MyDiabetesCentral.com it goes to
http://www.defendagainstdiabetes.com/mdc
whereas at Yahoo! Health it goes to
http://www.defendagainstdiabetes.com/yh
and at Diabetes Health it goes to
http://www.defendagainstdiabetes.com/dh
and at Google Groups it goes to
http://www.defendagainstdiabetes.com/gg1
(and Google gives his e-mail address as allenxvr@gmail.com).

He's also hit Craigslist, where he gave a different e-mail address -- and one that gives away the game: the e-mail address there is at epharmasolutions.com, a commercial firm that helps pharmaceutical companies "improve their clinical trials."

I think my main concern about Allenxvr's postings is simple: I consider it unethical that he doesn't clarify who he is, nor who he works for. It's almost impossible for the average reader to decipher from the text of his message that DEFEND is legit, and that clicking through would be appropriate.

Well, DEFEND is legit, and advertising for it is legit, but Allenxvr is not. What he should do is sign his postings, letting the readers know that he works for a commercial firm to help increase enrollment. I challenge him to come clean, and let us all know who he is, what his role is, and then his postings will be somewhat more legit. But he really should be buying advertising space on these websites, not taking advantage of the ability to post comments to get free publicity for DEFEND.