Well helloooooo everyone. Been a while since I've been on here. Med school has been getting the best of me and my time. Between school, studying with high BGs, finals, working out and being a parent, there just hasn't been any extra time to be on here. Instead of blogging about everything here, I've just linked the previous sentence to a few of my recent blogs.
I go back later this month for my 2nd to last clinical trial visit. I'm having mixed feelings about it. Not because of the trial, but because of the mixed meal tolerance test (MMTT) and whether or not I should follow through with the protocol because this is going to be a negative study and the results may be pointless. I'm having health problems again. I have no idea if it's thyroid, celiac, endocrine or something else. Read the rest of it on the blog at:
I hate thinking it's a "negative study." We still have another year of visits. I recently asked a doctor why they have to say a trial failed when some of the study patients are obviously showing some benefit. Like, why does it have to be 100% when if you asked us (parents), we'd sign up for a drug that had a 50% chance of improving things? I'm talking about this drug & others like it. Anyway, I'd say we're sticking with Defend2 unless they kick Sam out for not checking her blood sugar enough! I hope you don't have another autoimmune disorder :( Maybe it's just stress?? I had the worst stomach problems when I was in college.
You hit the nail on the head with why it's a negative study. When you treat a general population with an targeted drug, only a small portion will gain benefit. In breast cancer 20-30% of women gain dramatic benefit from bevicizumab (Avastin), but at a cost of nearly $100,000 per year it's not logical to do that. The reason it's not being approved is we have no way of figuring out who will benefit, eg a marker. Other very effective drugs like trastuzumab (Herceptin) target only 20% of the breast cancer population (Her2 overexpression) and over 75% gain benefit. I think drugs like Otel and Dynamed will be similar. Eventually they will find a marker and see who benefits. Hopefully the genomic study at the 1 year mark of the trial will be beneficial.
