Weekend Links: FDA Worries Theoretical Side Effect from Vedolizumab, Fecal Transplant Houston, Women Goes On Macrobiotic For Crohn's, Colon Test Detects 85% of Cases, NOTES Surgery for Gastrointestinal

FDA Worries About Theoretical Risk for Vedolizumab

So the great geniuses at the FDA have called into question the drug Entyvio (vedolizumab) for concerns that it could theoretically could happen. The FDA in their wisdom wrote a 177 report that can be found here. When I have some more time I will write a full blog post on this. What the FDA is worried about is that since vedolizumab operates similar to a drug named Tysabri (natalizumab). One potential side effect is PML which is a fatal brain infection that can be acquired from taking Tysabri. However, the risk of getting PML is estimated to be 1 in 1000. So even though 31 confirmed cases of PML have been reported you have to look at how many people overall are taking it. What is interesting is that now there is a test JC Virus Test to see if there is a presence of the virus to see if it can lead to PML. The JC Virus test is required in order before one takes Tysabri. Even having the JC Virus doesn't mean one will get PML it just means that one has an increased risk of getting it. With costs are benefits. Vedolizumab seems to be most beneficial for patients who have ulcerative colitis as in the clinical trial 47% of patients who took it after six weeks were in remission compared to the placebo of just 25.5% (result was statistically significant). 

The FDA said basically well since this drug vedolizumab is similar to Tysbari we should expect the same thing to happen. However, what is quite interesting is that even the FDA report states that "at this time no en cases [of PML] have be reported in patients taking vedolizumab. In the trial over 1400 patients received vedolizumab and not one patient actually contracted PML. The FDA is as usual over concerned about the potential side effect of a literal 1 in 1000 chance (the trial proves it is probably less considering no one actually got PML) when the condition of Crohn's or ulcerative colitis one could argue is much more dangerous.

Fecal Transplant Now Done In Houston

Here is a story out of Houston showing how a patient with c difficle got their life back after a fecal transplant. Dr. Herbert Dupont is leading the fecal transplant program in Houston. The procedure only takes 10 minutes and patients feel much better very soon. Dr. Dupont is currently doing a study to see if c difficle can help patients with Crohn's disease and ulcerative colitis. 

Women Goes On Macobiotic Diet for Crohn's: No Pain 

So I am always interested in seeing stories about diet and Crohn's disease. I think diet does play some role in Crohn's, however it is important to remember some patients can go decades without symptoms of Crohn's. So Ruth Twort has had Crohn's disease for 30 years (since 1983) she is now 49. She has changed her diet to just eat macrobiotic foods (she eats porridge, brown toast, and roast chicken). She substitutes agave syrup for sugar. She also eats Sushi 2-3 times per week. For Crohn's flare ups she will eat miso soup with soba noodles. She also never drinks whole milk. I think eating well in general is good for health. Being diagnosed with Crohn's has made me more health conscious in what I select as food. I really would like to see a study done of people before and after they try these diets (a colonoscopy at the beginning and one done 6 months to 1 year after the diet has been tried). 

Blood Test 85% Effective for Colon Cancer
So many people don't like having a scope inside of them (really a colonoscopy is a piece of cake the prep is the hardest part). About 50% of people avoid them because they don't want to deal with it which could mean many people have possible colon cancer or other gastro issues. A new blood test can now with 85% accuracy detect cases. I am sure as more people are studied (200 have been studied so far) the test will only become better and cheaper which can spare many people from having a colonoscopy which would free up gastro docs to see IBD patients and save insurance companies bundles of money.

NOTES (Natural Orifice Surgery) Being Used For Gastroenterologists: No Incision/Scar

I am always a fan of doing things better and more effective. NOTES (Natural Orifice Surgery) allows surgeons seems to offer advantages over conventional minimal surgery by avoiding incisions and as the name suggests goes through natural orifices in order to perform surgery. Some of the procedures that can be performed by NOTES are bariatric repairs, fistulas, and ulcers. Patients usually go home after 1-2 days with less pain and best of all no incision or scar. Currently, NOTES is relatively new and will take time before it becomes adopted by more surgeons.