Direct to consumer advertising….of clinical trials?

We’ve all gotten used to seeing television ads for drugs.  But  a television ad for an investigational new drug and a clinical trial?  That’s new.

The commercial has been showing up during Good Morning America this week in several markets.   Watch the ad here.

Celsion Corporation is running the ad to promote their  DIGNITY Breast Cancer Trial, a clinical trial for treatment of breast cancer that has recurred in the chest wall.   According to their press release they intend to also run the ad in NYC during National Breast Cancer Awareness Month.

Something tells me this isn’t about recruiting patients for the study.   The study is an early phase clinical trial, and is only looking to recruit 100 women.  I suspect this is a new pharma tactic – trying to build market interest in a new drug or product- before it even has FDA approval.

The study is looking at the safety and efficacy of a new targeted method for delivering doxorubicin, the chemotherapy nicknamed “the red devil”  because of it’s harsh side effects.  Celsion has developed “Thermodox,” as a way to deliver more doxorubicin to the tumor, but less to the rest of the body to avoid some of the harshest side effects.  The drug is packaged in a liposome, which will burst open and deliver the drug when exposed to heat.  During treatment the chest wall area will be heated – thus giving more targeted drug delivery.

This may turn out to be a great development in the treatment of breast cancer recurrent to the chest wall – but it’s important to separate the science from the marketing.  Are television advertisements on unapproved drugs or products a good idea?  Should the science  be evaluated and proven before it’s “marketed?”  Or, on the other hand, is it good to get information out to the public about research, and new possible treatments?

What do others think about this?

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Comments

  • Debbie Laxague  On September 17, 2009 at 10:09 am

    Interesting dilemma, Laura. We’ve long bemoaned how hard it can be to recruit for clinical trials, and how many don’t have the information that they need about trials that they are eligible for. And the then there’s the “guinea pig” stigma that prevents some people from even considering participation.

    In some ways, Celsion’s ad money could be improving both those circumstances. But as you say, clearly it’s a marketing strategy for them (although they must know there’s a possibility that the trial won’t support their product).

    Just last night I was listening to a podcast of Breast Cancer Update by Neil Love. I think he was interviewing Normal Wolmark at that point (or it could have been Mel Silverstein), and they discussed how little is known about best-practice treatments for chest wall recurrences. They discussed a study that was looking at chemo vs. no chemo. So Celsion is encouraging participation in a trail that’s looking at an area of treatment that lacks good information.

    That was a long ramble and it didn’t help me make up my mind. I guess that if I have to see commercials paid for by drug companies, I’d rather see one that encouraged clinical trial participation than one that encouraged me to ask for some drug without even telling me what it’s FOR. But better yet would be no direct-to-consumer marketing.

  • Musa Mayer  On September 17, 2009 at 10:59 am

    Laura, to me, this is marketing, and so may very well be illegal. I think this should be brought to the attention of FDA as an example of marketing of an unapproved drug masquerading as trial recruitment. I’m going to send a link to the video to my FDA contact, and I’ll let you know what they say. Thanks for finding this and drawing our attention to it.

    Musa

  • Marjorie Gallece  On September 17, 2009 at 12:07 pm

    I would like to see greater accrual to clinical trials and greater public understanding, but this really seems like an ad for both this product and the hospital. It’s certainly not a cheap one either, considering the graphics used and media buys for the ad placement.

    I have very mixed feelings about this since this ad should be directed to oncologists. In the current business model of medicine, who is actually going to send their patients to another facility for treatment? There’s no doubt about it, patient driven medicine drives up the profits.

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