"Centocor Psoriasis Drug May Pose Cancer Risk" | Arthritis Information

FYI. Psoriasis drugs end up being used to treat other conditions, you know:

http://www.pharmalot.com/2008/06/centocor-psoriasis-drug-may-pose-cancer-risk/
Here's more:
http://www.kansascity.com/438/story/662713.html

"The agency said the injectable drug showed positive results in two comprehensive studies conducted by the company. However, scientists said the drug may require labeling to warn doctors of possible carcinogenic risks.

While Horsham, Penn.-based Centocor did not assess those risks in its application, the FDA said studies in mice suggest the drug could encourage tumor growth. The agency said it would recommend that information be included in the drug's labeling if it is approved.

The FDA will seek input from its panelists next week, though it is not required to follow their advice.

Ustekinumab is part of a new class of drugs that fight psoriasis by targeting two proteins that regulate the body's immune system and are believed to contribute to the disease.

Johnson & Johnson already markets the drug Remicade in the U.S., which is approved to fight psoriasis, rheumatoid arthritis and the intestinal disorder Crohn's Disease. It competes against Abbott Laboratories' Humira and Amgen Inc. and Wyeth's Enbrel.

Earlier this month, the FDA announced it is investigating whether that class of drugs increase the risk of certain cancers in children."

I just don't understand how that can be - they do not assess those risks in the application, even though it was suggested in the studies????
Seems to me that the key word in this is MAY cause.....It's too early to jump to any conclusions. [QUOTE=Lynn49]Seems to me that the key word in this is MAY cause.....It's too early to jump to any conclusions. [/QUOTE]

Won't the prescribing info say "may" help psoriasis? Even it is proven to increase your risk of cancer, it would still say "may" because it won't happen in every patient, right?

And I'm not questioning that there is/isn't a risk. I would take a risk of a many, many different side effects, depending on what condition I was trying to treat, and that will vary among patients as to what they would risk. I'm questioning how something suggested in studies was left out of the application. That's unsettling to me and not a jump to any conclusion, it is in the newspaper article.
I don't believe everything that I read in the newspaper, on the internet or in medical studies...Findings are often reversed or found to be inconclusive. That's why I think it's to early to form any conclusions.

And, mice studies for cancer studies while very valuable, they are not always applicable to humans. A lot has been found out about cancer, and many drugs have been developed to treat cancer because of testing with mice. However, the results of mouse studies should be treated with caution.Lynn492008-06-15 07:55:28Okay, after rereading your response, I've come to the conclusion that we are discussing two different things. I should have read a little closer and while I may disagree with your point in general...It is well taken.Wll, what's interesting to me is that Centocor put out that fake documentary about the biologics - it wasn't a documentary, it was a 'sales tool'. But patients that didn't know the difference thought it was 'real'.

Pip