Elidel, SAM, and Cancer

Imagine your child had eczema. It was not too bad, certainly not disfiguring. It got better with topical steroid cream, but the word steroid made you nervous. Your doctor told you kids with eczema were at increased risk of going on to develop asthma and that made you nervous as well.

When your doctor told you about a study to prevent your child from going on to get asthma you were enthusiastic, especially when you heard that it involved using a cream that would treat the eczema and that wasn't a steroid. In fact the nice adds on TV kept talking about how safe it was.

The study involved putting this new medicine or placebo, you weren't sure which, on your young child for long periods. Since everyone told you how safe the medicine was you figured it couldn't hurt.

But imagine it turned out the medicine might not be so safe. Imagine it turns out the medicine might cause cancer, and that the FDA is particularly concerned about long term use and use in young children. What would you expect the study investigators to do? Cancel the study or at least stop it until the safety of the medicine is clear? Inform the parents of patients enrolled in the study of the new warning, go over the risks and benefits of the study in light of the new information and reobtain consent? Or do nothing?

Incredibly, the answer to the question is do nothing. I have talked to 2 parents this week with children in the study WHO HAD NO IDEA ABOUT THE ELIDEL/CANCER LINK, and others who had only found about it on their own. So the investigators are sitting on this informationm, potentially increasing the risk of more than 1000 kids of getting cancer, and not even waring their parents.

I first blogged about the link at the end of February in one of my first posts, when the FDA issued it's warning to health care providers.

Six weeks later, parents of children in the study have not been informed of the new warnings! No one has called them, no one has sent them a letter, nothing.

Pretty outrageous, huh.

Even worse the study violates several of the specific warnings in the FDA alert:

From a Novartis press release:

a clinical trial called SAM (Study of the Atopic March), involving 1,100 infants aged 3-18 months who are currently being recruited at 20 centers in the US.

For the first 36 months of treatment in this study, investigators will assess the effect of long-term treatment with Elidel on the natural course of atopic eczema

From the FDA alert:

#Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.

#Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown.

Of course, unless you found it on your own, you'd have no way of knowing the risk you were exposing your child to.