On Wednesday, August 2, FDA advisors voted 12-1 against approving the promising new RA drug, sirukumab. In a field dominated by TNF-targeted biologics, this was a new anti-IL-6 drug. Actemra and the recently announced Kevzara are the only other two IL-6 drugs on the market. While the trials proved that the drug’s effectiveness is “robust”, the primary concern, as reported by Medpage Today, is the drug’s safety, although earlier reports also mention potential flaws in the trial design that could impact the trial’s reported results.
I have mixed emotions about this announcement. On one hand, I hate to have major setbacks for what appears to be a great new option for RA patients, on the other hand, I want our drugs to be as safe as possible and applaud the caution in withholding approval.
There was another discordant note in this news story, however, that took me aback. This was the soundbite from the one person who voted FOR approval of the drug — he was the “1” in the 12-1 vote. His name is James Katz, MD and he is the director of the rheumatology fellowship and training branch of the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases in Bethesda, Md. According to MedPage, he said, “This drug doesn’t scare me any more than the other biologics. I’m scared of all the biologics.” And this is the guy who voted for approval???
Why does this bother me?
In a world of fake news and quotes taken out of context, I went in search of the full statement to see if he elaborated further. I was on a panel recently with another leading rheumatologist who stated, “RA is a serious disease and it takes serious treatments to combat it.” And let’s face it, serious drugs can be scary. I thought perhaps that Dr. Katz’s comment about biologics were along these lines.
But other than the mention in Medpage, I haven’t (yet) been able to find anything further on the comment. (I’m still looking so if you find it before I do, please let me know.)
My concern is the effect of these words can have on RA patients, particularly those who are contemplating a biologic for the first time. Yes, it’s true that biologics can have serious side effects. But it’s also true that thousands of thousands people use them on a daily basis without problem and are able to lead fuller, more productive lives by helping control the devastating effects of this disease. While treating RA is serious business, NOT treating RA is even more serious. Without treatment, RA can be debilitating and, once the damage is done, it cannot be reversed.
I personally am on a biologic and methotrexate and I am doing better than I have in a long while. But that’s not the right answer for everyone. I think treatment plans need to be personal, that they need to be decided upon by the patient and the doctor, and that the full mosaic of information needs to be considered when making that decision — not just a soundbite.
I hope the soundbites in your life today are happy news. Thanks for checking in.