Hello, everyone! Welcome to the Restorative Health Solutions blog!
We were reading the Google news health feed a couple days ago and came across some excitement about a new drug for Multiple Sclerosis (MS). Any new autoimmune treatment is worth a look. After reading this, you will get a great look at the standard for autoimmune disease care with conventional medicine. This drug has hype around it, but when we pealed back the study, we were incredibly disappointed at its effectiveness. Let’s take a look.
What is the new drug and how is it different than other drugs?
Biogen has come out with its newest MS drug “Plegridy®” (interferon beta 1a). This drug is an immune cytokine stimulating drug. By altering the immune system, you can alter the course of an autoimmune disease like MS. This is the same active ingredient in its current MS drug, Avonex®. The new part of Plegridy® is they have hooked the active ingredient to polyethylene glycol (PEG). PEG is a synthetic polymer, which the body has difficulty detoxifying. This means the medicine stays in the system longer and thus this new drug only needs to be injected once every 2 weeks rather than 2-3 times a week like Avonex®. In short, this drug is easier to take, but works the same as the old drug.
How well did this do in trials?
The ADVANCE trial involved more than 1,500 patients with relapsing forms of MS (the most common kind). This drug reduced annualized relapse rate (ARR) at one year by 36% compared to placebo. That sounds good, right? Let me start by saying it is good, but it is not as good as you think. Let’s take a look at how they got that number.
Breakdown of the study:
Let us teach you the things we look for when breaking down a study. First, let’s talk about the basics. This study was published in the Lancet Neurology in July of 2014 by Calebresi entitled, “Pegylatted interferon B-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomized, phae 3, double-blind study.” The study started with 1516 patients and divided them into three groups. Groups either got a placebo, took the drug every 2 weeks or every 4 weeks. The results showed the adjusted annual relapse rate for placebo was 39.7% (range 32.8-48.1), 2 week group was 25.6% (range 20.6 to 31.8) and the 4 week group was 28.8% (range 23.4 to 35.5). Of the 1516 patients who started the study 1332 finished it.
1. Let’s start with the total number of patients and drop outs.
This is a super important number in studies. It is easy to make numbers appear better by having your unsuccessful patients drop out. Most people who drop out of a study drop out because the treatment is not working well for them (in fact it is usually not working well at all…). Drug companies also pre-screen the people in a trial like this because they aim to make a TON of money if this is successful and lose a ton of money if it is not. Of 1516 patients, only 1332 finished the study. That means there is 12% chance even some of these simple patients who were chosen for success will have a very bad reaction.
2. What does “This drug reduced annualized relapse rate (ARR) at one year by 36% compared to placebo” actually mean?
I’m going to simplify things to get my point across. If you look at the study let’s just assume with 1500 people there were 3 even groups of 500. The placebo group had a 39.7% chance of relapse, so that’s 200 of the 500 people. The people taking the drug every 2 weeks had a 25.6% relapse rate so that is 125 people. This means taking the drug took the relapse incidence from 200/500 to 125/500, or helped 75 total people.
3. Reported side effects:
“76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common.”
4. Cost of this drug and chance at success:
Plegridy® is expected to be priced around the same as Avonex®. The cost of Avonex® is $60,000 per year! This is what your money buys you. You have a 12% chance to react so poorly to this you’ll be forced to stop taking it. You have a 125/500(25%) chance you will still have problems just like people doing nothing. You have a 75/500 (15%) chance the drug will help you. You have a 300/500 chance you will do the same as someone taking a sugar pill 60%). This doesn’t take into account the other serious side effects we spoke of earlier. I was going over this with a fellow doctor and he said, “Wait, they are charging people $60,000 a year for something that has a 15% chance of helping with a 12% chance of serious side effects? I hope their marketing division is paid well!” I hope you can sense the sarcasm.
We could pull up treatments for other autoimmune diseases and they would be similar to the study we’ve just dissected. If you suffer from Hashimoto’s, Rheumatoid Arthritis, Lupus(SLE), Psoriasis, MS, or any other autoimmune disease, know that you must change your lifestyle. Just taking the drug is a dangerous game of chicken. We have articles elsewhere on how we go about helping our patients with autoimmune disease, but for this article, just know taking the medication and going about your life with no other changes is just not that likely to get you the health you need and want.
At Restorative Health Solutions, we provide a unique approach to your health. We take on a personalized/individualized approach to each patient’s case. We pride ourselves on figuring out the “why” and are determined to find the underlying cause of dysfunction in our patients’ health and, therefore, help them heal. If you are interested in what functional medicine can do for you, please give us a call at 952-479-7801 for a free 15-minute phone consultation!