Dr. Andy

Reflections on medicine and biology among other things

Wednesday, April 13, 2005

Elidel and Protopic manufacturers fund "yes groups"

which defend their products.

I decided to check the Elidel and Protopic web sites to see what their manufacturers response to the recent FDA advisory about a possible link to cancer was. Needless to say I'm a bit disappointed.

Neither site's main page directly mentions the link between the medicine and cancer. The Protpic site has a small box entitled "Recent FDA Advisory" with links to the American Academy of Dermatology (ADA) and the National Eczema Association for Science and Education (NEASE), whic have come out against the black box warning

The Elidel site has an inconspicuous link labelled "Recent FDA statement" which leads to statements downplaying the link from the AAD, NEASE and the Inflammatory Skin Disease Institute (ISDI). Here is the AAD statement:
"The American Academy of Dermatology is disappointed that the FDA has taken this action, despite the fact that there is no data that proves proper topical use of pimecrolimus and tacrolimus is dangerous in people. Because these medications are applied to the skin, virtually none of it gets inside the body. It's not the same as taking a pill. These are valuable medications...if used properly..."
I am familiar with the ADA, but have never heard of NEASE or ISDI, despite the fact I treat a fair amount of eczema.

The NEASE website allows you to download the annual report for the year ended 2003. Guess who the major contributors to NEASE are? If you guessed patients with eczema and their parents you would be wrong.

Fujisawa and Novartis each gave >$50,000 to NEASE in the 18 months ended 12/31/2003, with no other donors giving >$10,000 and only 2 giving more than $5000. So when NEASE downplays the risk of cancer with these medications, remeber they get a substantial proportion of their funding, perhaps the majority form their manufactueres.

How about the ISDI. I couldn't find the annual report or a donor list online, but this page on the ISDI site, conveniently displays the Elidel logo.

So when you here ISDI executive director LaDonna Williams testify:
"These medications have been the only treatments that have given my children anything resembling a normal quality of life,"
remember who pays her salary.

What about
The American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 14,000 physicians worldwide
Surely they are free of conflict. Nope.

Fujisawa is a "Diamond" level corporate donor, meaning they gave >$500,000 to the AAD in 2004. Novartis "only" made "Sapphire" level ($250,000-500,000). The AAD does have a wider range of pharma donors compared to the others.

So if you think these organizations press releases read like they could have been writting by Fujisawa and Novartis publicists, now you know why


At 12:57 AM, Anonymous Anonymous said...

As an eczema sufferer, this is a vital issue to me. So your professional opinion is that steroids are a better option over those topical tacrolimus? Steroids often cause me secondary infections. This black box warning is such a disappointment to me as I've been so dependent on the topical tacrolimus.... What to do...? My physicians have downplayed the warning, but of course I'm very concerned.

At 7:29 PM, Anonymous Anonymous said...

I have no connection with any manufacturer, I'm just someone with eczema who uses Elidel (pimecrolimus).

The AAD (NOT the ADA, a completely different organization) is not on the payroll of Novartis, and I suspect they treat a bit more dermatitis than you do. They expressed disappointment at the FDA action, and see nothing in the data to support it.

From what I can find in the literature available to those without online journal subscriptions, there were seven cancers reported in the clinical trials of pimecrolimus. Two of those cancers occurred in the pimecrolimus-treated patients, and five in the control group.

Sound to you like the drug caused the cancers? Not to me.

Reporting up to 3/2005 showed 17 patients with malignancies. After accounting for age, type of cancer and the spontaneous occurance rate in the general population, the incidence of cancers "was far below the expected number of cases in the general population". It would be nice to have more recent data, but without access to journals that isn't easy.

I'm currently using Elidel because steroids didn't work. After looking at the clinical trial results and at least a condensed report on the animal studies, I'm not even a little concerned about possible carcinogenicity. Frankly, it sounds like one of the more benign medications out there, and it's useful for a condition that can be absolutely awful. Besides, it isn't like steroids are all that wonderful.

Maybe there are problems with Elidel, but the data I've found so far doesn't support that conclusion. The fact that a drug manufacturer provides money to a patient support group might indicate a conflict of interest, but without a reasonable review of the data I think the assumption is unjustified.


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